To ensure that health care reform reduces health care costs for American families, small businesses, and taxpayers.

TEXT OF AMENDMENTS

SA 3586. Mr. LeMIEUX submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. MEMBERS OF CONGRESS REQUIRED TO HAVE COVERAGE
UNDER MEDICAID INSTEAD OF THROUGH FEHBP.

(a) In General.--Notwithstanding chapter 89 of title 5,
United States Code, title XIX of the Social Security Act, or
any provision of this Act, effective on the date of enactment
of this Act--
(1) each Member of Congress shall be eligible for medical
assistance under the Medicaid plan of the State in which the
Member resides; and
(2) any employer contribution under chapter 89 of title 5
of such Code on behalf of the Member may be paid only to the
State agency responsible for administering the Medicaid plan
in which the Member enrolls and not to the offeror of a plan
offered through the Federal employees health benefit program
under such chapter.
(b) Payments by Federal Government.--The Secretary of
Health and Human Services, in consultation with the Director
of the Office of Personnel Management, shall establish
procedures under which the employer contributions that would
otherwise be made on behalf of a Member of Congress if the

[[Page S2029]]

Member were enrolled in a plan offered through the Federal
employees health benefit program may be made directly to the
State agencies described in subsection (a).
(c) Ineligible for FEHBP.--Effective on the date of
enactment of this Act, no Member of Congress shall be
eligible to obtain health insurance coverage under the
program chapter 89 of title 5, United States Code.
(d) Definition.--In this section, the term ``Member of
Congress'' means any member of the House of Representatives
or the Senate.
______

SA 3587. Mr. BROWNBACK (for himself and Mr. Vitter) submitted an
amendment intended to be proposed by him to the bill H.R. 4872, to
provide for reconciliation pursuant to Title II of the concurrent
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); which
was ordered to lie on the table; as follows:

Strike section 1107.
______

SA 3588. Mr. INHOFE submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 99, between lines 9 and 10, insert the following:
(e) Exclusion of Medical Devices for Pediatric Use and
Persons With Disabilities.--
(1) In general.--For purposes of section 4191(b)(1) of the
Internal Revenue Code of 1986, as added by subsection (a),
the term ``taxable medical device'' shall not include any
device which is primarily designed--
(A) to be used by or for pediatric patients, or
(B) to assist persons with disabilities with tasks of daily
life.
(2) Expansion of affordability exception to individual
mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code
of 1986, as added by section 1501(b) of the Patient
Protection and Affordable Care Act and amended by section
10106 of such Act, is amended by striking ``8 percent'' and
inserting ``5 percent''.
(3) Application of provision.--The amendment made by
paragraph (2) shall apply as if included in the Patient
Protection and Affordable Care Act.
______

SA 3589. Ms. SNOWE submitted an amendment intended to be proposed by
her to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 64, between lines 4 and 5, insert the following:

SEC. 1201A. TRANSITIONAL STATE SHARE FOR COVERAGE OF PARENTS
BY EXPANSION STATES.

Section 1905(z) of the Social Security Act (42 U.S.C.
1396d(z)), as amended by section 1201, is amended by adding
at the end the following:
``(4) In the case of an expansion State described in
paragraph (3), the State percentage with respect to amounts
expended for medical assistance for individuals who are
parents described in subclause (VIII) of section
1902(a)(10)(A)(i) whose income (as determined under section
1902(e)(14)) exceeds 67 percent, but does not exceed 133
percent, of the poverty line (as defined in section
2110(c)(5)) applicable to a family of the size involved, and
who are not newly eligible (as defined in subsection (y)(2)),
shall be reduced as follows:
``(A) In the case of such expenditures for 2014, by 50
percent.
``(B) In the case of such expenditures for 2015, by 60
percent.
``(C) In the case of such expenditures for 2016, by 70
percent.
``(D) In the case of such expenditures for 2017, by 80
percent.
``(E) In the case of such expenditures for 2018, by 90
percent.''.
______

SA 3590. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle A of title I, add the following:

SEC. 1110. SPECIAL RULES TO ENSURE CITIZENS AND NATIONALS OF
THE UNITED STATES HAVE THE SAME HEALTH CARE
CHOICES AS LEGAL IMMIGRANTS.

Section 36B(c)(1) of the Internal Revenue Code of 1986, as
added by section 1401 of the Patient Protection and
Affordable Care Act and amended by section 10105 of such Act,
is amended by adding at the end the following:
``(E) Special rules to ensure citizens and nationals of the
united states have the same health care choices as legal
immigrants.--
``(i) In general.--Notwithstanding any other provision of
this Code, the Patient Protection and Affordable Care Act, or
any amendment made by that Act, any taxpayer who--

``(I) is a citizen or national of the United States; and
``(II) has a household income which is not greater than 133
percent of an amount equal to the poverty line for a family
of the size involved,

may elect to enroll in a qualified health plan through the
Exchange established by the State under section 1311 of the
Patient Protection and Affordable Care Act instead of
enrolling in the State Medicaid plan under title XIX of the
Social Security, or under a waiver of such plan.
``(ii) Special rules.--

``(I) An individual making an election under clause (i)
shall waive being provided with medical assistance under the
State Medicaid plan under title XIX of the Social Security,
or under a waiver of such plan while enrolled in a qualified
health plan.
``(II) In the case of an individual who is a child, the
child's parent or legal guardian may make such an election on
behalf of the child.
``(III) Any individual making such an election, or on whose
behalf such an election is made, shall--

``(aa) for purposes of the credit under this section, be
treated as an applicable taxpayer and the applicable
percentage with respect to such taxpayer shall be the
percentage determined under subsection (b)(3)(A)(i); and
``(bb) for purposes of reduced cost-sharing under section
1402 of the Patient Protection and Affordable Care Act, be
treated as an eligible individual whose household income is
in the category described in subsection (c)(2)(A) of such
section.''.
______

SA 3591. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title II, add the following:

SEC. 23__. TREATMENT OF HIGH DEDUCTIBLE HEALTH PLANS AS
QUALIFIED HEALTH PLANS.

Subparagraph (B) of section 1301(a)(1) of the Patient
Protection and Affordable Care Act is amended by inserting
``or meets the requirements for a high deductible health plan
under section 223(c)(2) of the Internal Revenue Code of
1986'' after ``section 1302(a)''.
______

SA 3592. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1__. PROTECTION OF ACCESS TO QUALITY HEALTH CARE THROUGH
THE DEPARTMENT OF VETERANS AFFAIRS AND THE
DEPARTMENT OF DEFENSE.

(a) Health Care Through Department of Veterans Affairs.--
Nothing in this Act or the Patient Protection and Affordable
Care Act (or any amendment made by either such Act) shall be
construed to prohibit, limit, or otherwise penalize veterans
and dependents eligible for health care through the
Department of Veterans Affairs under the laws administered by
the Secretary of Veterans Affairs from receiving timely
access to quality health care in any facility of the
Department or from any non-Department health care provider
through which the Secretary provides health care.
(b) Health Care Through Department of Defense.--
(1) In general.--Nothing in this Act or the Patient
Protection and Affordable Care Act (or any amendment made by
either such Act) shall be construed to prohibit, limit, or
otherwise penalize eligible beneficiaries from receiving
timely access to quality health care in any military medical
treatment facility or under the TRICARE program.
(2) Definitions.--In this subsection:
(A) The term ``eligible beneficiaries'' means covered
beneficiaries (as defined in section 1072(5) of title 10,
United States Code) for purposes of eligibility for mental
and dental care under chapter 55 of title 10, United States
Code.
(B) The term ``TRICARE program'' has the meaning given that
term in section 1072(7) of title 10, United States Code.
______

SA 3593. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title II, insert the following:

SEC. 2__. HEALTH CARE SAFETY NET ENHANCEMENT.

(a) Limitation on Liability.--Notwithstanding any other
provision of law, a health care professional shall not be
liable in any medical malpractice lawsuit for a cause of

[[Page S2030]]

action arising out of the provision of, or the failure to
provide, any medical service to a medically underserved or
indigent individual while engaging in the provision of pro
bono medical services.
(b) Requirements.--Subsection (a) shall not apply--
(1) to any act or omission by a health care professional
that is outside the scope of the services for which such
professional is deemed to be licensed or certified to
provide, unless such act or omission can reasonably be
determined to be necessary to prevent serious bodily harm or
preserve the life of the individual being treated;
(2) if the services on which the medical malpractice claim
is based did not arise out of the rendering of pro bono care
for a medically underserved or indigent individual; or
(3) to an act or omission by a health care professional
that constitutes willful or criminal misconduct, gross
negligence, reckless misconduct, or a conscious, flagrant
indifference to the rights or safety of the individual harmed
by such professional.
(c) Definition.--In this section--
(1) the term ``medically underserved individual'' means an
individual who does not have health care coverage under a
group health plan, health insurance coverage, or any other
health care coverage program; and
(2) the term ``indigent individual'' means and individual
who is unable to pay for the health care services that are
provided to the individual.
______

SA 3594. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 15__. EQUIVALENT BANKRUPTCY PROTECTIONS FOR HEALTH
SAVINGS ACCOUNTS AS RETIREMENT FUNDS.

(a) In General.--Section 522 of title 11, United States
Code, is amended by adding at the end the following new
subsection:
``(r) Treatment of Health Savings Accounts.--For purposes
of this section, any health savings account (as described in
section 223 of the Internal Revenue Code of 1986) shall be
treated in the same manner as an individual retirement
account described in section 408 of such Code.''.
(b) Effective Date.--The amendment made by this section
shall apply to cases commencing under title 11, United States
Code, after the date of the enactment of this Act.
______

SA 3595. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title II, insert the following:

SEC. 2304. APPLICATION OF WELLNESS PROGRAMS PROVISIONS TO
CARRIERS PROVIDING FEDERAL EMPLOYEE HEALTH
BENEFITS PLANS.

(a) In General.--Notwithstanding section 8906 of title 5,
United States Code (including subsections (b)(1) and (b)(2)
of such section), section 2705(j) of the Public Health
Service Act (relating to wellness programs) shall apply to
carriers entering into contracts under section 8902 of title
5, United States Code.
(b) Proposals.--Carriers may submit separate proposals
relating to voluntary wellness program offerings as part of
the annual call for benefit and rate proposals to the Office
of Personnel Management.
(c) Effective Date.--This section shall take effect on the
date of enactment of this Act and shall apply to contracts
entered into under section 8902 of title 5, United States
Code, that take effect with respect to calendar years that
begin more than 1 year after that date.
______

SA 3596. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. STATE OPTION TO OPT-OUT OF MEDICAID COVERAGE
EXPANSION TO AVOID ASSUMING UNFUNDED FEDERAL
MANDATE.

Notwithstanding any provision of the Patient Protection and
Affordable Care Act (or any amendment made by such Act), the
Governor of a State shall have the authority to opt out of
any provision under such Act or any amendment made by such
Act that requires the State to expand coverage under the
Medicaid program if the State agency responsible for
administering the State plan under title XIX certifies that
such expansion would result in an increase of at least 1
percent in the total amount of expenditures by the State for
providing medical assistance to all individuals enrolled
under the State plan, when compared to the total amount of
such expenditures for the most recently ended State fiscal
year.
______

SA 3597. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title II, add the following:

SEC. 23__. SOCIAL SECURITY NUMBER REQUIREMENT FOR
PARTICIPATION IN EXCHANGES.

Section 1411(b)(2) of the Patient Protection and Affordable
Care Act is amended by adding at the end the following new
flush sentence:

``For purposes of this section, the term `social security
number' means a social    security number issued to an
individual by the Social Security    Administration. Such
term shall not include a taxpayer identification number or
TIN issued by    the Internal Revenue Service.''.
______

SA 3598. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. ENSURING MEDICARE SAVINGS ARE KEPT IN THE MEDICARE
PROGRAM.

No reduction in outlays under the Medicare program under
title XVIII of the Social Security Act under the provisions
of, and amendments made by, this Act or the Patient
Protection and Affordable Care Act may be utilized to offset
any outlays under any other program or activity of the
Federal government.
______

SA 3599. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET
PROGRAMS UNRELATED TO MEDICARE.

Title III of the Congressional Budget Act of 1974 (2 U.S.C.
621 et seq.) is amended by adding at the end the following:

``SEC. 316. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET
PROGRAMS UNRELATED TO MEDICARE.

``For purposes of this title and title IV, a reduction in
outlays under title XVIII of the Social Security Act may not
be counted as an offset to any outlays under any other
program or activity of the Federal Government.''.
______

SA 3600. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET
PROGRAMS UNRELATED TO MEDICARE.

Title III of the Congressional Budget Act of 1974 (2 U.S.C.
621 et seq.) is amended by adding at the end the following:

``SEC. 316. PROHIBITION ON USING MEDICARE SAVINGS TO OFFSET
PROGRAMS UNRELATED TO MEDICARE.

``(a) In General.--For purposes of this title and title IV,
a reduction in outlays under title XVIII of the Social
Security Act or an increase in revenues resulting from an
increase in taxes assessed for purposes of such title may not
be counted as an offset to any outlays under any other
program or activity of the Federal Government.
``(b) Point of Order.--
``(1) In general.--It shall not be in order to consider any
bill, resolution, amendment, conference report, or motion
that violates subsection (a).
``(2) Waiver and appeal.--
``(A) Waiver.--This subsection may be waived or suspended
in the Senate only by the affirmative vote of three-fifths of
the Members, duly chosen and sworn.
``(B) Appeals.--Appeals in the Senate from the decisions of
the Chair relating to any provision of this subsection shall
be limited to 1 hour, to be equally divided between, and
controlled by, the appellant and the manager of the bill or
joint resolution, as the case may be. An affirmative vote of
three-fifths of the Members of the Senate, duly chosen and
sworn, shall be required to sustain an appeal of the ruling
of the Chair on a point of order raised under this
subsection.''.
______

SA 3601. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for

[[Page S2031]]

reconciliation pursuant to Title II of the concurrent resolution on the
budget for fiscal year 2010 (S. Con. Res. 13); which was ordered to lie
on the table; as follows:

At the end of section 1002, add the following:
(c) Limitation on Liens and Levies.--Section 5000A(g)(2) of
the Internal Revenue Code of 1986, as added by the Patient
Protection and Affordable Care Act, is amended by striking
subparagraphs (A) and (B) and inserting the following:
``(A) Waiver of criminal and civil penalties and
interest.--In the case of any failure by a taxpayer to timely
pay any penalty imposed by this section--
``(i) such taxpayer shall not be subject to any criminal
prosecution or penalty with respect to such failure, and
``(ii) no penalty, addition to tax, or interest shall be
imposed with respect to such failure or such penalty.
``(B) Limited collection actions permitted.--In the case of
the assessment of any penalty imposed by this section, the
Secretary shall not take any action with respect to the
collection of such penalty other than--
``(i) giving notice and demand for such penalty under
section 6303,
``(ii) crediting under section 6402(a) the amount of any
overpayment of the taxpayer against such penalty, and
``(iii) offsetting any payment owed by any Federal agency
to the taxpayer against such penalty under the Treasury
offset program.''.
______

SA 3602. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM
HSAS AND MSAS.

(a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue
Code of 1986, as amended by section 9004 of the Patient
Protection and Affordable Care Act, is amended by striking
``20 percent'' and inserting ``10 percent''.
(b) Archer MSAs.--Section 220(f)(4)(A) of the Internal
Revenue Code of 1986, as amended by section 9004 of the
Patient Protection and Affordable Care Act, is amended by
striking ``20 percent'' and inserting ``15 percent''.
(c) Effective Date.--The amendments made by this section
shall apply to distributions made after December 31, 2010.
______

SA 3603. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1403 and insert the following:

SEC. 1403. ELIMINATION OF LIMITATION ON HEALTH FLEXIBLE
SPENDING ARRANGEMENTS UNDER CAFETERIA PLANS.

(a) In General.--Section 125 of the Internal Revenue Code
of 1986, as amended by sections 9005 and 10902 of the Patient
Protection and Affordable Care Act, is amended by striking
subsection (i).
(b) Effective Date.--The amendment made by this section
shall apply to taxable years beginning after December 31,
2010.
______

SA 3604. Mr. BENNETT submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SEC. 1412. SUNSET FOR EXPANSIONS OF ENTITLEMENT SPENDING.

(a) In General.--Notwithstanding any other provision of
this Act or the Patient Protection and Affordable Care Act
(or any amendments made by such Acts), any establishment or
expansion of entitlement authority (as defined in subsection
(b)) that is provided for under this Act or the Patient
Protection and Affordable Care Act (or any amendments made by
such Acts) that would draw from the general funds of the
Treasury, the Federal Hospital Insurance Trust Fund (as
established under section 1817 of the Social Security Act (42
U.S.C. 1395i)), the Federal Supplementary Medical Insurance
Trust Fund (as established under section 1841 of such Act (42
U.S.C. 1395t)), or any other such trust fund, shall terminate
at the end of fiscal year 2020.
(b) Entitlement Authority.--In this section, the term
``entitlement authority'' means the authority to make
payments (including loans and grants), the budget authority
for which is not provided for in advance by appropriation
Acts, to any person or government if, under the provisions of
the law containing that authority, the United States is
obligated to make such payments to persons or government who
meet the requirements established by that law.
______

SA 3605. Mr. BENNETT submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. STATE EXEMPTION FROM MEDICAID EXPANSION TO PREVENT
REDUCTION IN MEDICAL SERVICES.

Notwithstanding any other provision of law, no State shall
be required to expand coverage under the Medicaid program on
or after the date of enactment of the Patient Protection and
Affordable Care Act if the State agency responsible for
administering the State Medicaid plan under title XIX of the
Social Security Act certifies that such expansion would
require the State to reduce or eliminate care or services
provided to individuals who are eligible for medical
assistance under such State plan on the date of enactment of
the Patient Protection and Affordable Care Act.
______

SA 3606. Mr. BENNETT submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 61, between lines 3 and 4, insert the following:

SEC. 1110. APPLICATION OF UNUSED STIMULUS FUNDS FOR UPDATING
OF THE MEDICARE PHYSICIAN FEE SCHEDULE.

(a) Rescission in ARRA.--Effective as the date of enactment
of this Act, any unobligated balances available on such date
of funds made available by division A of the American
Recovery and Reinvestment Act of 2009 (Public Law 111-5) are
rescinded.
(b) Update of Medicare Physician Fee Schedule.--The
Secretary of Health and Human Services shall increase the
update to the conversion factor under section 1848 of the
Social Security Act (42 U.S.C. 1395w-4) for physicians'
services so that the estimated total amount of payments for
such services furnished during fiscal years 2010 through 2019
is equal to the estimated total amount of payments for such
services that would have been made in such fiscal years if
this section did not apply plus an amount equal to the total
funds rescinded under subsection (a).
______

SA 3607. Mr. BENNETT submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 113, after line 21, insert the following:

SEC. 1502. STATE OPTION TO OPT-OUT OF NEW FEDERAL PROGRAM AND
REQUIREMENTS.

(a) In General.--In accordance with this section, a State
may elect for the provisions of the Patient Protection and
Affordable Care Act to not apply within such State to the
extent that such provisions violate the protections described
in subsection (b).
(b) Effect of Opt-Out.--In the case of a State that makes
an election under subsection (a)--
(1) the residents of such State shall not be subject to any
requirement under such Act, including tax provisions or
penalties, that would otherwise require such residents to
purchase health insurance;
(2) the employers located in such State shall not be
subject to any requirement under such Act, including tax
provisions or penalties, that would otherwise require such
employers to provide health insurance to their employees or
make contributions relating to health insurance;
(3) the residents of such State shall not be prohibited
under such Act from receiving health care services from any
provider of health care services under terms and conditions
subject to the laws of such State and mutually acceptable to
the patient and the provider;
(4) the residents of such State shall not be prohibited
under such Act from entering into a contract subject to the
laws of such State with any group health plan, health
insurance issuer, or other business, for the provision of, or
payment to other parties for, health care services;
(5) the eligibility of residents of such State for any
program operated by or funded wholly or partly by the Federal
Government shall not be adversely affected as a result of
having received services in a manner consistent with
paragraphs (3) and (4);
(6) the health care providers within such State shall not
be denied participation in or payment from a Federal program
for which they would otherwise be eligible as a result of
having provided services in a manner consistent with
paragraphs (3) and (4); and
(7) such State shall not be subject to the taxes and fees
enumerated in the amendments made by title IX of such Act.

[[Page S2032]]

(c) Process.--A State shall be treated as making an
election under subsection (a) if--
(1) the Governor of such State provides timely and
appropriate notice, at least 180 days before the election is
to become effective, to the Secretary of Health and Human
Services notifying the Secretary that the State is making
such election; or
(2) the legislature of such State enacts a law to provide
for such election.
______

SA 3608. Mrs. HUTCHISON (for herself, Mr. Enzi, Mr. Coburn, Mr. Burr,
Mr. Brown of Massachusetts, and Mr. Crapo) proposed an amendment to the
bill H.R. 4872, to provide for reconciliation pursuant to Title II of
the concurrent resolution on the budget for fiscal year 2010 (S. Con.
Res. 13); as follows:

At the end of section 1002, insert the following:
(c) Right of States to Opt Out of Federal Health Care
Takeover.--Section 1321(d) of the Patient Protection and
Affordable Care Act is amended--
(1) by striking ``Nothing'' and inserting:
``(1) In general.--Except as provided in paragraph (2),
nothing''; and
(2) by adding at the end the following:
``(2) Exception for opt out of health care reform.--The
provisions of, and the amendments made by, this Act shall not
preempt any State law enacted after the date of enactment of
this Act that exempts the State from such provisions or
amendments, including, but not limited to, provisions and
amendments relating to the individual mandate, the employer
mandate, taxes on prescription drugs, taxes on medical
devices, taxes on high value health plans, Medicare cuts, and
the unfunded expansion of Medicaid.''.
______

SA 3609. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. ___. DISCLOSURE OF AGREEMENTS WITH COMPANIES, UNIONS,
AND ASSOCIATIONS.

Not later than 30 days after the date of enactment of this
Act, the President shall disclose any agreement made between
the White House or any of its designees and a company, union,
or association on the Patient Protection and Affordable Care
Act or this Act.
______

SA 3610. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. ONGOING RECORD OF JOBS LOST.

The Secretary of Labor shall keep an ongoing record of jobs
lost due to the termination of the Robert T. Stafford Federal
Student Loan Program.
______

SA 3611. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. DELAYED IMPLEMENTATION.

Notwithstanding any other provision of this Act or the
Patient Protection and Affordable Care Act, or the amendments
made by this Act or the Patient Protection and Affordable
Care Act, such provisions and amendments shall not take
effect before the date that the Board of Trustees of the
Federal Hospital Insurance Trust Fund under section 1817 of
the Social Security Act (42 U.S.C. 1395i) submits an annual
report to Congress under subsection (b)(2) of such section
that includes a statement that such Trust Fund is projected
to be solvent through 2037.
______

SA 3612. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. ___. STATE OPT OUT.

A State may opt out of the application of the Patient
Protection and Affordable Care Act and this Act effective
upon notice by the Governor of that State to the President.
______

SA 3613. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. ___. PROHIBITING IRS HIRING.

The Internal Revenue Service shall not hire any additional
staff for the purpose of enforcing, implementing, or
administering the Patient Protection and Affordable Care Act
and this Act.
______

SA 3614. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. ___. JOB LOSS RECORDS DUE TO HEALTH CARE BILL.

The Director of the Office of Management and Budget, in
coordination with the Secretary of Labor, shall submit a
semiannual public report to Congress detailing the record of
jobs lost due to additional taxes, fees, and mandates
contained in the Patient Protection and Affordable Care Act
and this Act.
______

SA 3615. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. NONAPPLICATION OF ANY MEDICAID ELIGIBILITY
EXPANSION UNTIL REDUCTION IN MEDICAID FRAUD
RATE.

Notwithstanding any other provision of law, with respect to
a State, any provision of law that imposes on or after the
date of enactment of this Act a federally-mandated expansion
of eligibility for Medicaid shall not apply to the State
before the date on which the State Medicaid Director
certifies to the Secretary of Health and Human Services that
the Medicaid payment error rate measurement (commonly
referred to as ``PERM'') for the State does not exceed 5
percent.
______

SA 3616. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. EXEMPTING CRITICAL ACCESS HOSPITALS FROM
RECOMMENDATIONS OF THE INDEPENDENT PAYMENT
ADVISORY BOARD.

Section 1899A(c)(2)(A) of the Social Security Act, as added
by section 3403 of the Patient Protection and Affordable Care
Act and amended by section 10320 of such Act, is amended by
adding at the end the following new clause:
``(vii) The proposal shall not include any recommendation
that would reduce payment rates for items and services
furnished by a critical access hospital (as defined in
section 1861(mm)(1)).''.
______

SA 3617. Mr. JOHANNS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. PROHIBITION REGARDING SPENDING FOR ADDITIONAL
EDUCATION EMPLOYEES AND FOR IMPLEMENTING THE
GOVERNMENT TAKEOVER OF THE STUDENT LOAN
INDUSTRY.

Notwithstanding any other provision of this subtitle, none
of the funds made available under this subtitle or the
amendments made by this subtitle shall be available to hire
additional employees at the Department of Education who are
responsible for implementing, or to implement, the provisions
of this subtitle or the amendments made by this subtitle
related to the termination of the Robert T. Stafford Federal
Student Loan Program.
______

SA 3618. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1403 and insert the following:

[[Page S2033]]

SECTION 1403. REPEAL OF LIMITATION ON FLEXIBLE SPENDING
ARRANGEMENTS UNDER CAFETERIA PLANS.

Sections 9005 and 10902 of the Patient Protection and
Affordable Care Act are hereby repealed effective as of the
date of the enactment of such Act and any provisions of law
amended by such sections are amended to read as such
provisions would read if such sections had never been
enacted.
______

SA 3619.  Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1105 and insert the following:

SEC. 1105. REPEAL OF THE PRODUCTIVITY AND OTHER MARKET BASKET
ADJUSTMENTS.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, sections 3401 and 10319
of such Act (and the amendments made by such sections) are
repealed.
______

SA 3620. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of section 1003, add the following:
(e) Increase in Size of Applicable Large Employer.--Section
4980H(d)(2) of the Internal Revenue Code of 1986, as added by
the Patient Protection and Affordable Care Act, is amended by
striking ``50'' each place it appears and inserting ``499''.
______

SA 3621. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SECTION 14__. REPEAL OF LIMITATION ON DEDUCTIONS FOR OVER-
THE-COUNTER MEDICINE.

Section 9003 of the Patient Protection and Affordable Care
Act is hereby repealed effective as of the date of the
enactment of such Act and any provisions of law amended by
such section is amended to read as such provision would read
if such section had never been enacted.
______

SA 3622. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM
HSAS AND MSAS.

(a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue
Code of 1986, as amended by section 9004 of the Patient
Protection and Affordable Care Act, is amended by striking
``20 percent'' and inserting ``10 percent''.
(b) Archer MSAs.--Section 220(f)(4)(A) of the Internal
Revenue Code of 1986, as amended by section 9004 of the
Patient Protection and Affordable Care Act, is amended by
striking ``20 percent'' and inserting ``15 percent''.
(c) Effective Date.--The amendments made by this section
shall apply to distributions made after December 31, 2010.
______

SA 3623. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1402 and insert the following:

SECTION 1402. REPEAL OF ADDITIONAL HOSPITAL INSURANCE TAX AND
UNEARNED INCOME MEDICARE CONTRIBUTION.

Sections 9015 and 10906 of the Patient Protection and
Affordable Care Act are hereby repealed effective as of the
date of the enactment of such Act and any provisions of law
amended by such sections are amended to read as such
provisions would read if such sections had never been
enacted.
______

SA 3624. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SECTION 14__. REPEAL OF MODIFICATION OF ITEMIZED DEDUCTION
FOR MEDICAL EXPENSES.

Section 9013 of the Patient Protection and Affordable Care
Act is hereby repealed effective as of the date of the
enactment of such Act and any provisions of law amended by
such section is amended to read as such provision would read
if such section had never been enacted.
______

SA 3625. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1401 and insert the following:

SECTION 1401. REPEAL OF EXCISE TAX ON HIGH COST EMPLOYER-
SPONSORED HEALTH COVERAGE.

Sections 9001 and 10901 of the Patient Protection and
Affordable Care Act are hereby repealed effective as of the
date of the enactment of such Act and any provisions of law
amended by such sections are amended to read as such
provisions would read if such sections had never been
enacted.
______

SA 3626. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following::

SEC. 15__. NON-APPLICATION OF PROVISIONS TO CERTAIN
INDIVIDUALS.

(a) In General.--Notwithstanding any provision of, or
amendment made by, this Act or the Patient Protection and
Affordable Care Act, no such provision or amendment which,
directly or indirectly, results in an increase in Federal tax
liability with respect to any taxpayer for any taxable year
described in subsection (b) shall be administered in such a
manner as to impose such an increase on such taxpayer.
(b) Federal Tax Increase.--An increase in Federal tax
liability with respect to any taxpayer for any taxable year
is described in this subsection if the amount of Federal
taxes owed for such taxable year is in excess of the amount
of Federal taxes which would be owed by such taxpayer for
such taxable year under the Internal Revenue Code of 1986 as
in effect for taxable years beginning in 1999.
______

SA 3627. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SEC. 14__. NO FEDERAL TAX INCREASE IMPOSED ON MIDDLE INCOME
INDIVIDUALS AND FAMILIES.

(a) In General.--Notwithstanding any provision of, or
amendment made by, this Act or the Patient Protection and
Affordable Care Act, no such provision or amendment which,
directly or indirectly, results in a Federal tax increase
shall be administered in such manner as to impose such an
increase on any middle income taxpayer.
(b) Middle Income Taxpayer.--For purposes of this section,
the term ``middle income taxpayer'' means, for any taxable
year, any taxpayer with adjusted gross income (as defined in
section 62 of the Internal Revenue Code of 1986) of less than
$200,000 ($250,000 in the case of a joint return of tax).
______

SA 3628. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. REPEAL OF THE CENTER FOR MEDICARE AND MEDICAID
INNOVATION.

(a) In General.--Effective as if included in the enactment
of the Patient Protection and Affordable Care Act, sections
3021 and 10306 of such Act (and the amendments made by such
sections) are repealed.
(b) Conforming Amendments.--
(1) Section 2705 of the Patient Protection and Affordable
Care Act is amended--
(A) in subsection (a), by striking ``shall, in
coordination'' and that follows through ``establish'' and
inserting ``shall establish''; and
(B) in subsection (d)(2), by striking ``section 1115A(b)(3)
of the Social Security Act (as so added)'' and inserting
``the Social Security Act''.
(2) Section 1899(b)(4) of the Social Security Act, as added
by section 3022 of the Patient Protection and Affordable Care
Act, is amended by striking ``any of the following''

[[Page S2034]]

and all that follows through the period at the end of
subparagraph (B) and inserting ``the independence at home
medical practice pilot program under section 1866E.''.
(3) Section 933 of the Public Health Service Act, as added
by section 3501 of the Patient Protection and Affordable Care
Act, is amended by striking subsection (f).
(4) Section 10328(b) of the Patient Protection and
Affordable Care Act is amended by striking ``or to study''
and all that follows through ``3021''.
(5) Effective date.--The amendments made by this subsection
shall take effect as if included in the enactment of the
Patient Protection and Affordable Care Act.
______

SA 3629. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. REPEAL OF THE INDEPENDENT PAYMENT ADVISORY BOARD.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, sections 3403 and 10320
of such Act (and the amendments made by such sections) are
repealed.
______

SA 3630. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Beginning on page 30, strike line 17 and all that follows
through page 50, line 11.
______

SA 3631. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. __. REPEALING PAYMENT ADJUSTMENTS FOR HOME HEALTH CARE.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, sections 3131 and 3401(e)
of such Act (and the amendments made by such sections) are
repealed.
______

SA 3632. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. __. REPEALING PAYMENT ADJUSTMENTS FOR HOSPICE CARE.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, sections 3004(c), 3132,
and 3401(g) of such Act (and the amendments made by such
sections) are repealed.
______

SA 3633. Mr. CRAPO submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1104 and insert the following:

SEC. 1104. REPEALING CUTS TO MEDICARE DISPROPORTIONATE SHARE
HOSPITAL PAYMENTS.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, sections 3133 and 10316
of such Act (and the amendments made by such sections) are
repealed.
______

SA 3634. Mrs. HUTCHISON submitted an amendment intended to be
proposed by her to the bill H.R. 4872, to provide for reconciliation
pursuant to Title II of the concurrent resolution on the budget for
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the
table; as follows:

At the end of subtitle A of title I, insert the following:

SEC. 1006. REPEAL OF TAXABLE YEAR LIMITATION ON SMALL
BUSINESS TAX CREDIT.

(a) In General.--Section 45R of the Internal Revenue Code
of 1986, as added by section 1421 of the Patient Protection
and Affordable Care Act and amended by section 10105(e) of
such Act, is amended--
(1) by striking ``in the credit period'' in subsection (a),
(2) in subsection (e), by striking paragraph (2) and
redesignating paragraphs (3), (4), and (5) as paragraphs (2),
(3), and (4), respectively,
(3) in subsection (g), by striking paragraph (1) and
redesignating paragraphs (2) and (3) as paragraphs (1) and
(2), respectively, and
(4) by striking ``to prevent the avoidance of the 2-year
limit on the credit period through the use of successor
entities and'' in subsection (i).
(b) Effective Date.--The amendments made by this section
shall take effect as if included in the provisions of the
Patient Protection and Affordable Care Act to which the
amendments relate.
______

SA 3635. Mrs. HUTCHISON submitted an amendment intended to be
proposed by her to the bill H.R. 4872, to provide for reconciliation
pursuant to Title II of the concurrent resolution on the budget for
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the
table; as follows:

At the end of subtitle F of title I, add the following:

SEC. 15__. PERMANENT TAX RELIEF PROVISIONS.

(a) Repeal of Sunset on Marriage Penalty Relief.--Title IX
of the Economic Growth and Tax Relief Reconciliation Act of
2001 (relating to sunset of provisions of such Act) shall not
apply to sections 301, 302, and 303(a) of such Act (relating
to marriage penalty relief).
(b) Permanent Extension of Election to Deduct State and
Local Sales Taxes.--Subparagraph (I) of section 164(b)(5) of
the Internal Revenue Code of 1986 is amended by striking ``,
and before January 1, 2010''.
(c) Rescission of Stimulus Funds.--Any amounts appropriated
or made available and remaining unobligated under division A
of the American Recovery and Reinvestment Act of 2009 (Public
Law 111-5; 123 Stat. 115) (other than under title X of such
division A), are hereby rescinded.
______

SA 3636. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 113, after line 21, add the following:

SEC. 1502. CIVIL ACTIONS.

For purposes of any civil action in which a State
challenges any provision of this Act, or an amendment made by
this Act, the State shall be--
(1) deemed to be a party for purposes of section 2412(d) of
title 28, United States Code; and
(2) entitled to an award of attorney's fees under section
2412(d)(1)(A) of title 28, United States Code, if the State
is a prevailing party, without regard to whether the position
of the United States was substantially justified or whether
there are special circumstances.
______

SA 3637. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 113, after line 21, add the following:

SEC. 1502. OPEN FUEL STANDARD.

(a) Short Title.--This section may be cited as the ``Open
Fuel Standard Act of 2009'' or the ``OFS Act''.
(b) Findings.--Congress makes the following findings:
(1) The status of oil as a strategic commodity, which
derives from its domination of the transportation sector,
presents a clear and present danger to the United States;
(2) in a prior era, when salt was a strategic commodity,
salt mines conferred national power and wars were fought over
the control of such mines;
(3) technology, in the form of electricity and
refrigeration, decisively ended salt's monopoly of meat
preservation and greatly reduced its strategic importance;
(4) fuel competition and consumer choice would similarly
serve to end oil's monopoly in the transportation sector and
strip oil of its strategic status;
(5) the current closed fuel market has allowed a cartel of
petroleum exporting countries to inflate fuel prices,
effectively imposing a harmful tax on the economy of the
United States;
(6) much of the inflated petroleum revenues the oil cartel
earns at the expense of the people of the United States are
used for purposes antithetical to the interests of the United
States and its allies;
(7) alcohol fuels, including ethanol and methanol, could
potentially provide significant supplies of additional fuels
that could be produced in the United States and in many other
countries in the Western Hemisphere that are friendly to the
United States;
(8) alcohol fuels can only play a major role in securing
the energy independence of the United States if a substantial
portion of vehicles in the United States are capable of
operating on such fuels;
(9) it is not in the best interest of United States
consumers or the United States Government to be constrained
to depend solely upon petroleum resources for vehicle fuels
if alcohol fuels are potentially available;

[[Page S2035]]

(10) existing technology, in the form of flexible fuel
vehicles, allows internal combustion engine cars and trucks
to be produced at little or no additional cost, which are
capable of operating on conventional gasoline, alcohol fuels,
or any combination of such fuels, as availability or cost
advantage dictates, providing a platform on which fuels can
compete;
(11) the necessary distribution system for such alcohol
fuels will not be developed in the United States until a
substantial fraction of the vehicles in the United States are
capable of operating on such fuels;
(12) the establishment of such a vehicle fleet and
distribution system would provide a large market that would
mobilize private resources to substantially advance the
technology and expand the production of alcohol fuels in the
United States and abroad;
(13) the United States has an urgent national security
interest to develop alcohol fuels technology, production, and
distribution systems as rapidly as possible;
(14) new cars sold in the United States that are equipped
with an internal combustion engine should allow for fuel
competition by being flexible fuel vehicles, and new diesel
cars should be capable of operating on biodiesel; and
(15) such an open fuel standard would help to protect the
United States economy from high and volatile oil prices and
from the threats caused by global instability, terrorism, and
natural disaster.
(c) Open Fuel Standard for Transportation.--
(1) In general.--Chapter 329 of title 49, United States
Code, is amended by adding at the end the following:

``Sec. 32920. Open fuel standard for transportation

``(a) Definitions.--In this section:
``(1) E85.--The term `E85' means a fuel mixture containing
85 percent ethanol and 15 percent gasoline by volume.
``(2) Flexible fuel automobile.--The term `flexible fuel
automobile' means an automobile that has been warranted by
its manufacturer to operate on gasoline, E85, and M85.
``(3) Fuel choice-enabling automobile.--The term `fuel
choice-enabling automobile' means--
``(A) a flexible fuel automobile; or
``(B) an automobile that has been warranted by its
manufacturer to operate on biodiesel.
``(4) Light-duty automobile.--The term `light-duty
automobile' means--
``(A) a passenger automobile; or
``(B) a non-passenger automobile.
``(5) Light-duty automobile manufacturer's annual covered
inventory.--The term `light-duty automobile manufacturer's
annual covered inventory' means the number of light-duty
automobiles powered by an internal combustion engine that a
manufacturer, during a given calendar year, manufactures in
the United States or imports from outside of the United
States for sale in the United States.
``(6) M85.--The term `M85' means a fuel mixture containing
85 percent methanol and 15 percent gasoline by volume.
``(b) Open Fuel Standard for Transportation.--
``(1) In general.--Except as provided in paragraph (2),
each light-duty automobile manufacturer's annual covered
inventory shall be comprised of--
``(A) not less than 50 percent fuel choice-enabling
automobiles in 2012, 2013, and 2014; and
``(B) not less than 80 percent fuel choice-enabling
automobiles in 2015, and in each subsequent year.
``(2) Temporary exemption from requirements.--
``(A) Application.--A manufacturer may request an exemption
from the requirement described in paragraph (1) by submitting
an application to the Secretary, at such time, in such
manner, and containing such information as the Secretary may
require by regulation. Each such application shall specify
the models, lines, and types of automobiles affected.
``(B) Evaluation.--After evaluating an application received
from a manufacturer, the Secretary may at any time, under
such terms and conditions, and to such extent as the
Secretary considers appropriate, temporarily exempt, or renew
the exemption of, a light-duty automobile from the
requirement described in paragraph (1) if the Secretary
determines that unavoidable events that are not under the
control of the manufacturer prevent the manufacturer of such
automobile from meeting its required production volume of
fuel choice-enabling automobiles, including--
``(i) a disruption in the supply of any component required
for compliance with the regulations;
``(ii) a disruption in the use and installation by the
manufacturer of such component; or
``(iii) the failure for plug-in hybrid electric automobiles
to meet State air quality requirements as a result of the
requirement described in paragraph (1).
``(C) Consolidation.--The Secretary may consolidate
applications received from multiple manufactures under
subparagraph (A) if they are of a similar nature.
``(D) Conditions.--Any exemption granted under subparagraph
(B) shall be conditioned upon the manufacturer's commitment
to recall the exempted automobiles for installation of the
omitted components within a reasonable time proposed by the
manufacturer and approved by the Secretary after such
components become available in sufficient quantities to
satisfy both anticipated production and recall volume
requirements.
``(E) Notice.--The Secretary shall publish in the Federal
Register--
``(i) notice of each application received from a
manufacturer;
``(ii) notice of each decision to grant or deny a temporary
exemption; and
``(iii) the reasons for granting or denying such
exemptions.
``(c) Limited Liability Protection for Renewable Fuel and
Ethanol Manufacture, Use, or Distribution.--
``(1) In general.--Notwithstanding any other provision of
Federal or State law, any fuel containing ethanol or a
renewable fuel (as defined in section 211(o)(1) of the Clean
Air Act) that is used or intended to be used to operate an
internal combustion engine shall not be deemed to be a
defective product or subject to a failure to warn due to such
ethanol or renewable fuel content unless such fuel violates a
control or prohibition imposed by the Administrator under
section 211 of the Clean Air Act (42 U.S.C. 7545).
``(2) Savings provision.--Nothing in this subsection may be
construed to affect the liability of any person other than
liability based upon a claim of defective product and failure
to warn described in paragraph (1).
``(d) Rulemaking.--Not later than 1 year after the date of
the enactment of this section, the Secretary of
Transportation shall promulgate regulations to carry out this
section.''.
(2) Clerical amendment.--The table of sections for chapter
329 of title 49, United States Code, is amended by adding at
the end the following:

``32920. Open fuel standard for transportation.''.
______

SA 3638. Ms. COLLINS proposed an amendment to the bill H.R. 4872, to
provide for reconciliation pursuant to Title II of the concurrent
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as
follows:

At the end of section 1003, add the following:
(e) Unemployed Individual Not Taken Into Account.--
Paragraph (5) of section 4980H(d) of the Internal Revenue
Code of 1986, as added by the Patient Protection and
Affordable Care Act, is amended by adding at the end the
following new subparagraph:
``(C) Exception for previously unemployed individuals.--
``(i) In general.--The term `full-time employee' shall not
include any individual who certifies by signed affidavit,
under penalties of perjury, that such individual has not been
employed from more than 40 hours during the 60-day period
ending on the date such individual begins such employment.
``(ii) Exception for replacement workers.--Clause (i) shall
not apply to an individual who is employed by the employer to
replace another employee of such employer unless such other
employee separated from employment voluntarily or for
cause.''.
______

SA 3639. Mr. THUNE proposed an amendment to the bill H.R. 4872, to
provide for reconciliation pursuant to Title II of the concurrent
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as
follows:

Beginning on page 123, strike line 10 and all that follows
through page 124, line 10, and insert the following:

SEC. 2201. TERMINATION OF FEDERAL FAMILY EDUCATION LOAN
APPROPRIATIONS.

Section 421 (20 U.S.C. 1071) is amended--
(1) in subsection (b), in the first sentence of the matter
following paragraph (6), by inserting ``, except that no sums
may be expended after June 30, 2010, with respect to loans
under this part for which the first disbursement is after
such date if the Secretary certifies that no State will
experience a net job loss as a result of the enactment of the
SAFRA Act'' after ``expended''; and
(2) by adding at the end the following new subsection:
``(d) Termination of Authority to Make or Insure New
Loans.--Notwithstanding paragraphs (1) through (6) of
subsection (b) or any other provision of law--
``(1) no new loans (including consolidation loans) may be
made or insured under this part after June 30, 2010 if the
Secretary certifies that no State will experience a net job
loss as a result of the enactment of the SAFRA Act; and
``(2) no funds are authorized to be appropriated, or may be
expended, under this Act or any other Act to make or insure
loans under this part (including consolidation loans) for
which the first disbursement is after June 30, 2010 if the
Secretary certifies that no State will experience a net job
loss as a result of the enactment of the SAFRA Act,

except as expressly authorized by an Act of Congress enacted
after the date of enactment of the SAFRA Act.''.
______

SA 3640. Mr. THUNE (for himself, Mr. Coburn, and Mr. Crapo) proposed
an amendment to the bill H.R. 4872, to provide for reconciliation
pursuant to Title II of the concurrent resolution on the budget for
fiscal year 2010 (S. Con. Res. 13); as follows:

At the end of subtitle B of title II, add the following:

[[Page S2036]]

SEC. 2304. REPEAL OF THE CLASS ACT.

Title VIII of the Patient Protection and Affordable Care
Act and the amendments made by that title are repealed.
______

SA 3641. Mr. DeMINT submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. SECRET BALLOT PROTECTION.

(a) Short Title.--This section may be cited as the ``Secret
Ballot Protection Act of 2010''.
(b) Findings.--Congress makes the following findings:
(1) The right of employees under the National Labor
Relations Act (29 U.S.C. 151 et seq.) to choose whether to be
represented by a labor organization by way of secret ballot
election conducted by the National Labor Relations Board is
among the most important protections afforded under Federal
labor law.
(2) The right of employees to choose by secret ballot is
the only method that ensures a choice free of coercion,
intimidation, irregularity, or illegality.
(3) The recognition of a labor organization by using a
private agreement, rather than a secret ballot election
overseen by the National Labor Relations Board, threatens the
freedom of employees to choose whether to be represented by a
labor organization, and severely limits the ability of the
National Labor Relations Board to ensure the protection of
workers.
(c) National Labor Relations Act.--
(1) Recognition of representative.--
(A) In general.--Section 8(a)(2) of the National Labor
Relations Act (29 U.S.C. 158(a)(2)) is amended by inserting
before the colon the following: ``or to recognize or bargain
collectively with a labor organization that has not been
selected by a majority of such employees in a secret ballot
election conducted by the Board in accordance with section
9''.
(B) Application.--The amendment made by subparagraph (A)
shall not apply to collective bargaining relationships in
which a labor organization with majority support was lawfully
recognized prior to the date of enactment of this Act.
(2) Election required.--
(A) In general.--Section 8(b) of the National Labor
Relations Act (29 U.S.C. 158(b)) is amended--
(i) in paragraph (6), by striking ``and'' at the end;
(ii) in paragraph (7), by striking the period at the end
and inserting ``; and''; and
(iii) by adding at the end the following:
``(8) to cause or attempt to cause an employer to recognize
or bargain collectively with a representative of a labor
organization that has not been selected by a majority of such
employees in a secret ballot election conducted by the Board
in accordance with section 9.''.
(B) Application.--The amendment made by subparagraph (A)
shall not apply to collective bargaining relationships that
were recognized prior to the date of enactment of this Act.
(3) Secret ballot election.--Section 9(a) of the National
Labor Relations Act (29 U.S.C. 159(a)) is amended--
(A) by striking ``Representatives'' and inserting ``(1)
Representatives'';
(B) by inserting after ``designated or selected'' the
following: ``by a secret ballot election conducted by the
Board in accordance with this section''; and
(C) by adding at the end the following:
``(2) The secret ballot election requirement under
paragraph (1) shall not apply to collective bargaining
relationships that were recognized before the date of the
enactment of the Health Care and Education Reconciliation Act
of 2010.''.
(d) Regulations and Authority.--
(1) Regulations.--Not later than 6 months after the date of
enactment of this Act, the National Labor Relations Board
shall review and revise all regulations promulgated prior to
such date of enactment to implement the amendments made by
this section.
(2) Authority.--Nothing in this section (or the amendments
made by this section) shall be construed to limit or
otherwise diminish the remedial authority of the National
Labor Relations Board.
______

SA 3642. Mr. DeMINT submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. ALLOWING INDIVIDUALS TO CHOOSE TO OPT OUT OF THE
MEDICARE PART A BENEFIT.

Notwithstanding any other provision of law, in the case of
an individual who elects to opt-out of benefits under part A
of title XVIII of the Social Security Act, such individual
shall not be required to--
(1) opt-out of benefits under title II of such Act as a
condition for making such election; and
(2) repay any amount paid under such part A for items and
services furnished prior to making such election.
______

SA 3643. Ms. MURKOWSKI submitted an amendment intended to be proposed
by her to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. __. ALLOWING INDIVIDUALS TO CHOOSE TO OPT OUT OF THE
MEDICARE PART A BENEFIT.

Notwithstanding any other provision of law, in the case of
an individual who elects to opt-out of benefits under part A
of title XVIII of the Social Security Act, such individual
shall not be required to--
(1) opt-out of benefits under title II of such Act as a
condition for making such election; and
(2) repay any amount paid under such part A for items and
services furnished prior to making such election.
______

SA 3644. Mr. HATCH (for himself, Mr. Coburn, and Mr. Crapo) proposed
an amendment to the bill H.R. 4872, to provide for reconciliation
pursuant to Title II of the concurrent resolution on the budget for
fiscal year 2010 (S. Con. Res. 13); as follows:

On page 99, between lines 9 and 10, insert the following:
(e) Exclusion of Medical Devices Sold Under the TRICARE for
Life Program or Veteran's Health Care Programs.--
(1) In general.--For purposes of section 4191(b)(1) of the
Internal Revenue Code of 1986, as added by subsection (a),
the term ``taxable medical device'' shall not include any
device which is sold to individuals covered under the TRICARE
for Life program or the veteran's health care program under
chapter 17 of title 38, United States Code, any portion of
the cost of which is paid or reimbursed under either such
program.
(2) Expansion of affordability exception to individual
mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code
of 1986, as added by section 1501(b) of the Patient
Protection and Affordable Care Act and amended by section
10106 of such Act, is amended by striking ``8 percent'' and
inserting ``5 percent''.
(3) Application of provision.--The amendment made by
paragraph (2) shall apply as if included in the Patient
Protection and Affordable Care Act.
______

SA 3645. Mr. RISCH (for himself and Mr. Crapo) submitted an amendment
intended to be proposed by him to the bill H.R. 4872, to provide for
reconciliation pursuant to Title II of the concurrent resolution on the
budget for fiscal year 2010 (S. Con. Res. 13); as follows:

At the end of subtitle E of title I, insert the following:

SECTION--.REPEAL OF LIMITATION ON ITEMIZED DEDUCTIONS FOR
MEDICAL EXPENSES.

(a) In General.--Section 9013 of the Patient Protection and
Affordable Care Act is hereby repealed effective as of the
date of the enactment of such Act and any provisions of law
amended by such section are amended to read as such
provisions would read if such section had never been enacted.
(b) Expansion of Affordability Exception to Individual
Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code
of 1986, as added by section 1501(b) of the Patient
Protection and Affordable Care Act and amended by section
10106 of such Act, is amended by striking ``8 percent'' and
inserting ``5 percent''.
(c) Application of Provision.--The amendment made by
subsection (b) shall apply as if included in the Patient
Protection and Affordable Care Act.
______

SA 3646. Mr. RISCH submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. REQUIREMENT FOR ALL MEDICAID AND CHIP APPLICANTS
TO PRESENT AN IDENTIFICATION DOCUMENT.

(a) In General.--Section 1902 of the Social Security Act
(42 U.S.C. 1396a), as amended by section 211(a)(1)(A)(i) of
Public Law 111-3, section 2303(a)(2) of the Patient
Protection and Affordable Care Act, and section 1202 of this
Act, is amended--
(1) in subsection (a)(46), --
(A) in subparagraph (A), by striking ``and'' after the
semicolon;
(B) in subparagraph (B), by adding ``and'' after the
semicolon; and
(C) by adding at the end the following:
``(C) provide that each applicant for medical assistance
(or the parent or guardian of an applicant who has not
attained age 18), regardless of whether the applicant is
described in paragraph (2) of section 1903(x), shall present
an identification document described in subsection (kk) when
applying for

[[Page S2037]]

medical assistance (and shall be provided with at least the
reasonable opportunity to present such identification as is
provided under clauses (i) and (ii) of section 1137(d)(4)(A)
to an individual for the submittal to the State of evidence
indicating a satisfactory immigration status;''; and
(2) by adding at the end the following:
``(kk) For purposes of subsection (a)(46)(C), a document
described in this subsection is--
``(1) in the case of an individual who is a national of the
United States--
``(A) a United States passport, or passport card issued
pursuant to the Secretary of State's authority under the
first section of the Act of July 3, 1926 (44 Stat. 887,
Chapter 772; 22 U.S.C. 211a); or
``(B) a driver's license or identity card issued by a
State, the Commonwealth of the Northern Mariana Islands, or
an outlying possession of the United States that--
``(i) contains a photograph of the individual and other
identifying information, including the individual's name,
date of birth, gender, and address; and
``(ii) contains security features to make the license or
card resistant to tampering, counterfeiting, and fraudulent
use;
``(2) in the case of an alien lawfully admitted for
permanent residence in the United States, a permanent
resident card, as specified by the Secretary of Homeland
Security that meets the requirements of clauses (i) and (ii)
of paragraph (1)(B);
``(3) in the case of an alien who is authorized to be
employed in the United States, an employment authorization
card, as specified by the Secretary of Homeland Security that
meets the requirements of clauses (i) and (ii) of paragraph
(1)(B); or
``(4) in the case of an individual who is unable to obtain
a document described in paragraph (1), (2), or (3), a
document designated by the Secretary of Homeland Security
that meets the requirements of clauses (i) and (ii) of
paragraph (1)(B).''.
(b) Application to CHIP.--Section 2105(c)(9)(A) (42 U.S.C.
1397ee(c)(9)(A)) is amended by striking ``section
1902(a)(46)(B)'' and inserting ``subparagraphs (B) and (C) of
subsection (a)(46) and subsection (kk) of section 1902''.
______

SA 3647. Mr. COLLINS submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of section 1001, insert the following:
(c) Bereavement Exception in Determining Family Size.--
(1) In general.--Section 36B(d)(1) of the Internal Revenue
Code of 1986, as added by section 1401 of the Patient
Protection and Affordable Care Act and amended by section
10105 of such Act is amended by adding at the end the
following new sentence: ``If an individual taken into account
under the preceding sentence for any taxable year dies during
such taxable year, such individual shall be taken into
account in determining family size for the following taxable
year unless the family size for the taxable year of death was
only one.''
(2) Effective date.--The amendment made by this section
shall take effect as if included in the provision of the
Patient Protection and Affordable Care Act to which the
amendment relates.
______

SA 3648. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. DIRECT LOAN ORIGINATION FEE REDETERMINATION.

Notwithstanding section 455(c) of the Higher Education Act
of 1965 (20 U.S.C. 1087e(c)), the Secretary of Education
shall determine under such section an increase to the
origination fee charged to a borrower of a loan made under
part D of title IV of such Act (20 U.S.C. 1087a et seq.) for
the subsequent award year to take into account any increase
in actual program costs for the Federal Direct Loan Program
under such part D, as determined by the Office of Management
and Budget in the program re-estimate contained in the
President's current fiscal year budget.
______

SA 3649. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. QUALIFICATION REQUIREMENT FOR DEPARTMENT OF
EDUCATION STAFF.

Not later than 6 years after the date of enactment of this
Act, each employee of the Department of Education Office of
Federal Student Aid shall become highly qualified in fiscal
management by earning a bachelor's degree in finance or
business management/administration.
______

SA 3650. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. REDUCTION OF FEDERAL PELL GRANT ADD ON.

Notwithstanding any other provision of law, the additional
funds amount provided under section 401(b)(8) of the Higher
Education Act of 1965 (20 U.S.C. 1070a(b)(8)) for Federal
Pell Grants for a fiscal year shall be reduced for such
fiscal year by the amount that reflects any increase in
actual program costs for the Federal Direct Loan Program
under part D of title IV of the Higher Education Act of 1965
(20 U.S.C. 1087a et seq.), as determined by the Office of
Management and Budget in the program re-estimate contained in
the President's current fiscal year budget.
______

SA 3651. Mr. GREGG proposed an amendment to the bill H.R. 4872, to
provide for reconciliation pursuant to Title II of the concurrent
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); as
follows:

On page 61, between lines 3 and 4, insert the following:

SEC. __. INCREASE IN THE MEDICARE PHYSICIAN PAYMENT UPDATE
FOR THE LAST 9 MONTHS OF 2010 AND ALL OF 2011
THROUGH 2013.

Paragraph (1) of section 1848(d) of the Social Security
Act, as added by section 1011(a) of the Department of Defense
Appropriations Act, 2010 (Public Law 111-118) and as amended
by section 5 of the Temporary Extension Act of 2010 (Public
Law 111-144), is amended to read as follows:
``(10) Update for 2010 through 2013.--
``(A) In general.--Subject to paragraphs (7)(B), (8)(B),
and (9)(B), in lieu of the update to the single conversion
factor established in paragraph (1)(C) that would otherwise
apply for each of 2010, 2011, 2012, and 2013, the update to
the single conversion factor shall be 0 percent for such
years.
``(B) No effect on computation of conversion factor for
2014 and subsequent years.--The conversion factor under this
subsection shall be computed under paragraph (1)(A) for 2014
and subsequent years as if subparagraph (A) had never
applied.''.
______

SA 3652. Mr. BURR (for himself, Mr. Graham, Mr. Crapo, Mr. Barrasso,
Mr. McCain and Mr. Brown of Massachusetts) proposed an amendment to the
bill H.R. 4872, to provide for reconciliation pursuant to Title II of
the concurrent resolution on the budget for fiscal year 2010 (S. Con.
Res. 13); as follows:

At the end of subtitle F of title I, insert the following:

SEC. 1__. TREATMENT OF DEPARTMENT OF VETERANS AFFAIRS AND
DEPARTMENT OF DEFENSE HEALTH PROGRAMS.

Subtitle G of title I of the Patient Protection and
Affordable Care Act is amended by adding at the end the
following new section:

``SEC. 1564. DEPARTMENT OF VETERANS AFFAIRS AND DEPARTMENT OF
DEFENSE HEALTH PROGRAMS.

``(a) Clarifications With Respect to Certain Programs and
Authorities.--Nothing in this Act or in the amendments made
by this Act shall be construed as affecting any of the
following:
``(1) Any authority under title 38, United States Code.
``(2) Any authority under chapter 55 of title 10, United
States Code.
``(3) Any health care or health care benefit provided under
the TRICARE program under chapter 55 of title 10, United
States Code, or by the Secretary of Veterans Affairs under
the laws administered by such Secretary.
``(b) Clarification With Respect to Minimum Essential
Coverage.--For purposes of this Act and the amendments made
by this Act, the term `minimum essential coverage' includes
the following:
``(1) Coverage provided under chapter 55 of title 10,
United States Code.
``(2) Eligibility for health care provided by the Secretary
of Veterans Affairs under title 38, United States Code.''.
______

SA 3653. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of subtitle F of title I, add the following:

SEC. 15__. RENEWABLE FUEL.

(a) Definition of Renewable Fuel.--Section 211(o)(1)(J) of
the Clean Air Act (42 U.S.C. 7545(o)(1)(J)) is amended by
striking ``fuel that is produced'' and inserting ``a blend of
fuel at least 85 percent of the content of which is
derived''.
(b) Liability Protection for Renewable Fuel or Ethanol
Manufacture, Use, or Distribution.--
(1) In general.--Section 211(o) of the Clean Air Act (42
U.S.C. 7545(o)) is amended by adding at the end the
following:
``(13) Liability protection for renewable fuel or ethanol
manufacture, use, or distribution.--

[[Page S2038]]

``(A) In general.--Notwithstanding any other provision of
Federal or State law, no renewable fuel or ethanol used or
intended to be used as a motor vehicle fuel, nor any motor
vehicle fuel containing renewable fuel or ethanol, shall be
considered a defective product or subject to a failure to
warn by virtue of the fact that the renewable fuel or ethanol
is, or contains, the renewable fuel or ethanol, if the
renewable fuel or ethanol does not violate a control or
prohibition imposed by the Administrator under this section.
``(B) Effect on liability.--Nothing in this paragraph
affects the liability of any person other than liability
based on a claim of a defective product and failure to warn
of the defect.''.
(2) Effective date; application.--The amendment made by
paragraph (1) shall--
(A) be effective on the earlier of--
(i) the date of enactment of this Act; or
(ii) the date on which the Administrator of the
Environmental Protection Agency approves for use fuel blends
with greater than 10 percent ethanol by volume; and
(B) apply with respect to all claims filed on or after the
earlier date described in subparagraph (A).
______

SA 3654. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of subtitle A of title I, add the following:

SEC. 1006. SUNSET IF PREMIUMS INCREASE TOO RAPIDLY.

(a) In General.--The following requirements of the Patient
Protection and Affordable Care Act shall not apply to health
insurance coverage and group health plans offered in the
individual or group market within a State during plan years
beginning after the sunset date with respect to that market:
(1) Any requirement under section 1301 of such Act, section
2707 of the Public Health Service Act, or any other provision
of, or amendment made by, such Act that a health plan provide
an essential health benefits package described in section
1302(a) of such Act, including any requirement that the plan
provide--
(A) for essential health benefits described in section
1302(b) of such Act;
(B) in the case of a plan offered in the group market, an
annual limitation on the plan's deductible described in
section 1302(c)(2) of such Act; and
(C) a level of coverage described in section 1302(d) of
such Act.
(2) The requirements of section 2701 of the Public Health
Service Act (relating to limits on premiums).
(b) Coordination With Qualified Health Plans and Premium
Tax Credits and Cost-Sharing Reductions.--In the case of a
State to which subsection (a) applies, the Secretary of
health and Human Services shall establish procedures for
establishing which health plans shall be treated as qualified
health plans for purposes of the Exchanges established within
such State. Such procedures shall ensure that the aggregate
amount of premium tax credits under section 36B of the
Internal Revenue Code of 1986 and cost-sharing reductions
under section 1402 of the Patient Protection and Affordable
Care Act with respect to qualified health plans in the
individual market within such State does not exceed the
aggregate amount of such credits and reductions that would
have been allowed if subsection (a) did not apply to such
State.
(c) Sunset Date.--For purposes of this section--
(1) In general.--The term ``sunset date'' means, with
respect to the individual or group market within a State, the
first date on which the applicable State authority determines
under paragraph (2) that the percentage increase in average
annual premiums within such market for a calendar year over
the preceding calendar year exceeds the percentage increase
for such period in the Consumer Price Index for all urban
consumers published by the Department of Labor.
(2) Determination.--The applicable State authority shall
for each calendar year after 2013 make the determination
described in paragraph (1).
(3) Applicable state authority.--The term ``applicable
State authority'' has the meaning given such term by section
2791(d)(1) of the Public Health Service Act.
______

SA 3655. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

In subtitle A of title I, add at the end the following:

SEC. 1__. EXEMPTION FROM MANDATE.

Section 5000A of the Internal Revenue Code of 1986, as
added by section 1501(b) of the Patient Protection and
Affordable Care Act, is amended--
(1) by redesignating subsection (g) as subsection (h); and
(2) by inserting after subsection (f), the following:
``(g) Limitation.--This section shall not apply to an
individual for a taxable year if such individual--
``(1) in under 30 years of age when such year begins; or
``(2) has a modified gross income that does not exceed
$30,000 for such year.''.
______

SA 3656. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of section 1002, insert the following:
(c) High Deductible Health Plans Treated as Minimum
Essential Coverage.--Section 5000A(f) of the Internal Revenue
Code of 1986, as so added and amended, is amended by
redesignating paragraph (5) as paragraph (6) and by inserting
after paragraph (4) the following:
``(5) High deductible health plan.--
``(A) In general.--If an applicable individual--
``(i) is an employee of an employer who ceases to offer the
employee the opportunity to enroll in an eligible employer-
sponsored plan, or
``(ii) ceases employment with an employer and is not
otherwise eligible to enroll in an eligible employer-
sponsored plan,
the applicable individual may enroll in a high deductible
health plan described in subparagraph (C) and such plan shall
be treated as minimum essential coverage.
``(B) Continued enrollment.--If an individual described in
subparagraph (A) enrolls in a high deductible health plan
described in subparagraph (C), such plan shall continue to be
treated as minimum essential coverage with respect to that
individual during any continuous period of enrollment even if
the individual is otherwise eligible to enroll in an eligible
employer-sponsored plan.
``(C) Plan described.--A health plan is described in this
subparagraph if it is a high deductible health plan (as
defined in section 223(c)(2)) that meets all requirements
under such section to be offered in connection with a health
savings account. No requirement imposed by any provision of,
or any amendment made by, the Patient Protection and
Affordable Care Act shall apply with respect to the plan or
issuer thereof.''.
______

SA 3657. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of section 1002, insert the following:
(c) Individual Mandate Penalties Credited to Individual
Accounts and Used for Premiums.--Section 5000A of the
Internal Revenue Code of 1986, as so added and amended, is
amended by adding at the end the following:
``(h) Penalties Credited to Individual Accounts and Used
for Premiums.--
``(1) In general.--The Secretary shall not later than
January 1, 2014, establish and implement a program under
which--
``(A) if a penalty has been imposed under this section with
respect to an applicable individual for months during any
calendar year, the Secretary--
``(i) establishes an account on behalf of the applicable
individual, and
``(ii) credits such account with an amount equal to the
amount of the penalty, and
``(B) if the applicable individual subsequently becomes
covered under minimum essential coverage for 1 or more
months, the Secretary pays to or on behalf of the applicable
individual an amount equal to the premiums paid by the
individual for such coverage (or, if lesser, the balance in
the account established under subparagraph (A)).
``(2) Amounts available only for 3 years.--
``(A) In general.--If an account is credited under
paragraph (1)(A) with an amount for any calendar year, such
amount shall be available for payment under paragraph (1)(B)
only for premiums for minimum essential coverage for months
occurring during the 3 calendar years immediately following
such calendar year.
``(B) Special rules.--For purposes of this subsection--
``(i) the Secretary need only establish 1 account for an
individual, and
``(ii) amounts shall be treated as paid out of an account
on a first-in, first-out basis.''.
______

SA 3658. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 61, between lines 3 and 4, insert the following:

SEC. __. USE OF PRIVATE CONTRACTS BY MEDICARE BENEFICIARIES
FOR PROFESSIONAL SERVICES.

(a) In General.--Section 1802(b) of the Social Security Act
(42 U.S.C. 1395a) is amended to read as follows:
``(b) Clarification of Use of Private Contracts by Medicare
Beneficiaries for Professional Services.--
``(1) In general.--Nothing in this title shall prohibit a
medicare beneficiary from

[[Page S2039]]

entering into a private contract with a physician or health
care practitioner for the provision of medicare covered
professional services (as defined in paragraph (5)(C)) if--
``(A) the services are covered under a private contract
that is between the beneficiary and the physician or
practitioner and meets the requirements of paragraph (2);
``(B) under the private contract no claim for payment for
services covered under the contract is to be submitted (and
no payment made) under part A or B, under a contract under
section 1876, or under an MA plan (other than an MSA plan);
and
``(C)(i) the Secretary has been provided with the minimum
information necessary to avoid any payment under part A or B
for services covered under the contract, or
``(ii) in the case of an individual enrolled under a
contract under section 1876 or an MA plan (other than an MSA
plan) under part C, the eligible organization under the
contract or the MA organization offering the plan has been
provided the minimum information necessary to avoid any
payment under such contract or plan for services covered
under the contract.
``(2) Requirements for private contracts.--The requirements
in this paragraph for a private contract between a medicare
beneficiary and a physician or health care practitioner are
as follows:
``(A) General form of contract.--The contract is in writing
and is signed by the medicare beneficiary.
``(B) No claims to be submitted for covered services.--The
contract provides that no party to the contract (and no
entity on behalf of any party to the contract) shall submit
any claim for (or request) payment for services covered under
the contract under part A or B, under a contract under
section 1876, or under an MA plan (other than an MSA plan).
``(C) Scope of services.--The contract identifies the
medicare covered professional services and the period (if
any) to be covered under the contract, but does not cover any
services furnished--
``(i) before the contract is entered into; or
``(ii) for the treatment of an emergency medical condition
(as defined in section 1867(e)(1)(A)), unless the contract
was entered into before the onset of the emergency medical
condition.
``(D) Clear disclosure of terms.--The contract clearly
indicates that by signing the contract the medicare
beneficiary--
``(i) agrees not to submit a claim (or to request that
anyone submit a claim) under part A or B (or under section
1876 or under an MA plan, other than an MSA plan) for
services covered under the contract;
``(ii) agrees to be responsible, whether through insurance
or otherwise, for payment for such services and understands
that no reimbursement will be provided under such part,
contract, or plan for such services;
``(iii) acknowledges that no limits under this title
(including limits under paragraphs (1) and (3) of section
1848(g)) will apply to amounts that may be charged for such
services;
``(iv) acknowledges that medicare supplemental policies
under section 1882 do not, and other supplemental health
plans and policies may elect not to, make payments for such
services because payment is not made under this title; and
``(v) acknowledges that the beneficiary has the right to
have such services provided by (or under the supervision of)
other physicians or health care practitioners for whom
payment would be made under such part, contract, or plan.

Such contract shall also clearly indicate whether the
physician or practitioner involved is excluded from
participation under this title.
``(3) Modifications.--The parties to a private contract may
mutually agree at any time to modify or terminate the
contract on a prospective basis, consistent with the
provisions of paragraphs (1) and (2).
``(4) No requirements for services furnished to msa plan
enrollees.--The requirements of paragraphs (1) and (2) do not
apply to any contract or arrangement for the provision of
services to a medicare beneficiary enrolled in an MSA plan
under part C.
``(5) Definitions.--In this subsection:
``(A) Health care practitioner.--The term `health care
practitioner' means a practitioner described in section
1842(b)(18)(C).
``(B) Medicare beneficiary.--The term `medicare
beneficiary' means an individual who is enrolled under part
B.
``(C) Medicare covered professional services.--The term
`medicare covered professional services' means--
``(i) physicians' services (as defined in section 1861(q),
and including services described in section 1861(s)(2)(A)),
and
``(ii) professional services of health care practitioners,
including services described in section 1842(b)(18)(D),

for which payment may be made under part A or B, under a
contract under section 1876, or under a Medicare Advantage
plan but for the provisions of a private contract that meets
the requirements of paragraph (2).
``(D) MA plan; msa plan.--The terms `MA plan' and `MSA
plan' have the meanings given such terms in section 1859.
``(E) Physician.--The term `physician' has the meaning
given such term in section 1861(r).''.
(b) Conforming Amendments Clarifying Exemption From
Limiting Charge and From Requirement for Submission of
Claims.--Section 1848(g) of the Social Security Act (42
U.S.C. 1395w-4(g)) is amended--
(1) in paragraph (1)(A), by striking ``In'' and inserting
``Subject to paragraph (8), in'';
(2) in paragraph (3)(A), by striking ``Payment'' and
inserting ``Subject to paragraph (8), payment'';
(3) in paragraph (4)(A), by striking ``For'' and inserting
``Subject to paragraph (8), for''; and
(4) by adding at the end the following new paragraph:
``(8) Exemption from requirements for services furnished
under private contracts.--
``(A) In general.--Pursuant to section 1802(b)(1),
paragraphs (1), (3), and (4) do not apply with respect to
physicians' services (and services described in section
1861(s)(2)(A)) furnished to an individual by (or under the
supervision of) a physician if the conditions described in
section 1802(b)(1) are met with respect to the services.
``(B) No restrictions for enrollees in msa plans.--Such
paragraphs do not apply with respect to services furnished to
individuals enrolled with MSA plans under part C, without
regard to whether the conditions described in subparagraphs
(A) through (C) of section 1802(b)(1) are met.
``(C) Application to enrollees in other plans.--Subject to
subparagraph (B) and section 1852(k)(2), the provisions of
subparagraph (A) shall apply in the case of an individual
enrolled under a contract under section 1876 or under an MA
plan (other than an MSA plan) under part C, in the same
manner as they apply to individuals not enrolled under such a
contract or plan.''.
(c) Conforming Amendments.--(1) Section 1842(b)(18) of the
Social Security Act (42 U.S.C. 1395u(b)(18)) is amended by
adding at the end the following:
``(E) The provisions of section 1848(g)(8) shall apply with
respect to exemption from limitations on charges and from
billing requirements for services of health care
practitioners described in this paragraph in the same manner
as such provisions apply to exemption from the requirements
referred to in section 1848(g)(8)(A) for physicians'
services.''.
(2) Section 1866(a)(1)(O) of such Act (42 U.S.C.
1395cc(a)(1)(O)) is amended by striking ``enrolled with a
Medicare Advantage organization under part C'' and inserting
``enrolled with an MA organization under part C (other than
under an MSA plan)''.
(d) Effective Date.--The amendments made by this section
shall take effect on the date that is 6 months after the date
of the enactment of this Act and apply to contracts entered
into on or after that date.
______

SA 3659. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, insert the following:

SEC. 1__. CONTINUED ABILITY TO PAY FOR HEALTH CARE.

Title I of the Patient Protection and Affordable Care Act
is amended by adding at the end the following:

``SEC. 1564. CONTINUED ABILITY TO PAY FOR HEALTH CARE.

``Nothing in this title (or an amendment made by this
title) shall be construed to prohibit an individual from
purchasing or otherwise paying for health care items or
services on an out-of-pocket basis.''.
______

SA 3660. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, insert the following:

SEC. 1__. PROTECTING THE TAXPAYERS.

Title I of the Patient Protection and Affordable Care Act
is amended by adding at the end the following:

``SEC. 1564. PROTECTING THE TAXPAYERS.

``The provisions of this title (and the amendments made by
this title) shall not apply with respect to a fiscal year if
the Director of the Office of Management and Budget fails to
certify to Congress that the application of such provisions
(and amendments) in such fiscal year will not increase the
Federal budget deficit.''.
______

SA 3661. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

In subtitle A of title I, add at the end the following:

SEC. 1__. EXEMPTION FROM MANDATE.

Section 5000A of the Internal Revenue Code of 1986, as
added by section 1501(b) of the Patient Protection and
Affordable Care Act, is amended--
(1) by redesignating subsection (g) as subsection (h); and

[[Page S2040]]

(2) by inserting after subsection (f), the following:
``(g) Limitation.--This section shall not apply to an
individual for a taxable year if such individual--
``(1) in under 30 years of age when such year begins; or
``(2) has a modified gross income that does not exceed
$30,000 for such year.''.
______

SA 3662. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, add the following:

SEC. 14__. REPEAL OF ADDITIONAL TAX FROM DISTRIBUTIONS FROM
HSAS AND MSAS.

(a) HSAs.--Section 223(f)(4)(A) of the Internal Revenue
Code of 1986, as amended by section 9004 of the Patient
Protection and Affordable Care Act, is amended by striking
``20 percent'' and inserting ``10 percent''.
(b) Archer MSAs.--Section 220(f)(4)(A) of the Internal
Revenue Code of 1986, as amended by section 9004 of the
Patient Protection and Affordable Care Act, is amended by
striking ``20 percent'' and inserting ``15 percent''.
(c) Effective Date.--The amendments made by this section
shall apply to distributions made after December 31, 2010.
______

SA 3663. Mr. BARRASSO submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 56, between lines 20 and 21, insert the following:
(f) Budget-Neutral Exemption of Certain Providers.--
Notwithstanding the provisions of, and amendments made by,
the preceding subsections of this section and sections 3401
and 10319 of the Patient Protection and Affordable Care Act--
(1) such provisions and amendments shall not apply to a
health care provider that--
(A) is described in section 340B(a)(4) of the Public Health
Service Act or 1927(c)(1)(D)(i)(IV) of the Social Security
Act (42 U.S.C. 1396r-8(c)(1)(D)(i)(IV)); and
(B) is located in an area that is not a metropolitan
statistical area (as determined by the Bureau of the Census);
and
(2) the Secretary of Health and Human Services shall make
appropriate adjustments in the application of such provisions
and amendments to ensure that the amount of expenditures
under title XVIII of the Social Security Act is equal to the
amount of expenditures that would have been made under such
title if this subsection had not been enacted, as estimated
by the Secretary.
______

SA 3664. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1502. VERIFICATION OF IDENTITY.

No individual may receive assistance of any kind provided
by the Federal Government to obtain health insurance coverage
unless the individual provides to the appropriate agency or
department of the Federal Government an appropriate
identification that was issued by a governmental entity and
that includes a photograph and the name, date of birth, and
social security number of the individual.
______

SA 3665. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, insert the following:

SEC. ___. SUSPENSION OF THE ACT.

If at the beginning of any fiscal year OMB determines that
the deficit targets set forth in the CBO report of March 20,
2010 will not be met, the provisions of this Act and the
Patient Protection and Affordable Care Act shall be suspended
for that year.
______

SA 3666. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1502. ELIMINATION OF AUTOMATIC PAY ADJUSTMENTS FOR
MEMBERS OF CONGRESS.

(a) In General.--Paragraph (2) of section 601(a) of the
Legislative Reorganization Act of 1946 (2 U.S.C. 31) is
repealed.
(b) Technical and Conforming Amendments.--Section 601(a)(1)
of such Act is amended--
(1) by striking ``(a)(1)'' and inserting ``(a)'';
(2) by redesignating subparagraphs (A), (B), and (C) as
paragraphs (1), (2), and (3), respectively; and
(3) by striking ``as adjusted by paragraph (2) of this
subsection'' and inserting ``adjusted as provided by law''.
(c) Effective Date.--This section shall take effect on
December 31, 2011.
______

SA 3667. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1502. ELIMINATION OF SPECIAL HEALTH CARE PRIVILEGES FOR
MEMBERS OF CONGRESS.

Section 1312(d)(3) of the Patient Protection and Affordable
Care Act is amended by striking subparagraph (D) and
inserting the following:
``(D) Requirement of members of congress to enroll in an
exchange.--
``(i) Requirement.--Notwithstanding any other provision of
law, all Members of Congress shall be enrolled in an Exchange
when established under section 1321.
``(ii) Ineligible for fehbp.--Effective on the date on
which an Exchange is established under section 1321, no
Member of Congress shall be eligible to participate in a
health benefits plan under chapter 89 of title 5, United
States Code.
``(iii) Employer contribution.--

``(I) In general.--The Secretary of the Senate or the Chief
Administrative Officer of the House of Representatives shall
pay the amount determined under subclause (II) to the
appropriate Exchange.
``(II) Amount of employer contribution.--The Director of
the Office Of Personnel Management shall determine the amount
of the employer contribution for each Member of Congress
enrolled in an Exchange. The amount shall be equal to the
employer contribution for the health benefits plan under
chapter 89 of title 5, United States Code, with the greatest
number of enrollees, except that the contribution shall be
actuarially adjusted for age.

``(iv) Military medical treatment facilities and the office
of the attending physician.--

``(I) In general.--Notwithstanding any other provision of
law, a Member of Congress may not receive health care or
medical treatment at any military medical treatment facility
or at the Office of the Attending Physician.
``(II) Exception.--Subclause (I) shall not apply to any
case of a medical emergency in which the life of a Member of
Congress is in immediate danger.

``(v) Definitions.--In this subparagraph:

``(I) Exchange.--The term `Exchange' means an Exchange
established under section 1321.
``(II) Member of congress.--The term `Member of Congress'
means any member of the House of Representatives or the
Senate.''.

______

SA 3668. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 15__. REFUNDS OF FEDERAL MOTOR FUEL EXCISE TAXES FOR
FUEL USED IN MOBILE MAMMOGRAPHY VEHICLES.

(a) Refunds.--Section 6427 of the Internal Revenue Code of
1986 (relating to fuels not used for taxable purposes) is
amended by inserting after subsection (f) the following new
subsection:
``(g) Fuels Used in Mobile Mammography Vehicles.--Except as
provided in subsection (k), if any fuel on which tax was
imposed by section 4041 or 4081 is used in any highway
vehicle designed exclusively to provide mobile mammography
services to patients within such vehicle, the Secretary shall
pay (without interest) to the ultimate purchaser of such fuel
an amount equal to the aggregate amount of the tax imposed on
such fuel.''.
(b) Exemption From Retail Tax.--Section 4041 of such Code
is amended by adding at the end the following new subsection:
``(n) Fuels Used in Mobile Mammography Vehicles.--No tax
shall be imposed under this section on any liquid sold for
use in, or used in, any highway vehicle designed exclusively
to provide mobile mammography services to patients within
such vehicle.''.
(c) Effective Date.--The amendments made by this section
shall take effect on the date of the enactment of this Act.
______

SA 3669. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13);

[[Page S2041]]

which was ordered to lie on the table; as follows:

At the end, add the following:

TITLE III--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 3001. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Market
Access Act of 2010''.

SEC. 3002. FINDINGS.

Congress finds as follows:
(1) Americans unjustly pay up to 1,000 percent more to fill
their prescriptions than consumers in other countries.
(2) The United States is the world's largest market for
pharmaceuticals yet consumers still pay the world's highest
prices.
(3) An unaffordable drug is neither safe nor effective.
Allowing and structuring the importation of prescription
drugs ensures access to affordable drugs, thus providing a
level of safety to American consumers they do not currently
enjoy.
(4) Prescription drugs are a leading cost of the growth in
health care spending in the United States, which is projected
to reach $2,600,000,000,000 in 2009, according to the
Congressional Budget Office.
(5) According to the Congressional Budget Office, American
seniors alone will spend $1,800,000,000,000 on
pharmaceuticals over the next 10 years.
(6) Allowing open pharmaceutical markets could save
American consumers at least $635,000,000,000 of their own
money.

SEC. 3003. PURPOSES.

The purposes of this title are to--
(1) give all Americans immediate relief from the
outrageously high cost of pharmaceuticals;
(2) reverse the perverse economics of the American
pharmaceutical market;
(3) allow the importation of prescription drugs only if the
drugs and facilities where such drugs are manufactured are
approved by the Food and Drug Administration, and to exclude
pharmaceutical narcotics; and
(4) ensure continued integrity to the prescription drug
supply of the United States by--
(A) requiring that imported prescription drugs be packaged
and shipped using counterfeit-resistant technologies;
(B) requiring Internet pharmacies to register with the
United States Government for Americans to verify authenticity
before purchases over the Internet;
(C) requiring all foreign sellers to register with United
States Government and submit to facility inspections by the
Government without prior notice; and
(D) limiting the eligible countries from which prescription
drugs may be imported to Canada, member countries of the
European Union, and other highly industrialized nations with
safe pharmaceutical infrastructures.

SEC. 3004. AMENDMENTS TO SECTION 804 OF THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT.

(a) Definitions.--Section 804(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(a)) is amended to read as
follows:
``(a) Definitions.--In this section:
``(1) Importer.--The term `importer' means a pharmacy,
group of pharmacies, pharmacist, or wholesaler.
``(2) Permitted country.--The term `permitted country'
means Australia, Canada, Israel, Japan, New Zealand,
Switzerland, South Africa, Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxemburg,
Netherlands, Portugal, Spain, Sweden, the United Kingdom,
Iceland, Liechtenstein, and Norway, except that the
Secretary--
``(A) may add a country, union, or economic area as a
permitted country for purposes of this section if the
Secretary determines that the country, union, or economic
area has a pharmaceutical infrastructure that is
substantially equivalent or superior to the pharmaceutical
infrastructure of the United States, taking into
consideration pharmacist qualifications, pharmacy storage
procedures, the drug distribution system, the drug dispensing
system, and market regulation; and
``(B) may remove a country, union, or economic area as a
permitted country for purposes of this section if the
Secretary determines that the country, union, or economic
area does not have such a pharmaceutical infrastructure.
``(3) Pharmacist.--The term `pharmacist' means a person
licensed by the relevant governmental authority to practice
pharmacy, including the dispensing and selling of
prescription drugs.
``(4) Pharmacy.--The term `pharmacy' means a person that is
licensed by the relevant governmental authority to engage in
the business of selling prescription drugs that employs 1 or
more pharmacists.
``(5) Prescription drug.--The term `prescription drug'
means a drug subject to section 503(b), other than--
``(A) a controlled substance (as defined in section 102 of
the Controlled Substances Act (21 U.S.C. 802));
``(B) a biological product (as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262));
``(C) an infused drug (including a peritoneal dialysis
solution);
``(D) an intravenously injected drug;
``(E) a drug that is inhaled during surgery; or
``(F) a drug which is a parenteral drug, the importation of
which pursuant to subsection (b) is determined by the
Secretary to pose a threat to the public health, in which
case section 801(d)(1) shall continue to apply.
``(6) Qualifying drug.--The term `qualifying drug' means a
prescription drug that--
``(A) is approved pursuant to an application submitted
under section 505(b)(1); and
``(B) is not--
``(i) a drug manufactured through 1 or more biotechnology
processes;
``(ii) a drug that is required to be refrigerated; or
``(iii) a photoreactive drug.
``(7) Qualifying internet pharmacy.--The term `qualifying
Internet pharmacy' means a registered exporter that dispenses
qualifying drugs to individuals over an Internet Web site.
``(8) Qualifying laboratory.--The term `qualifying
laboratory' means a laboratory in the United States that has
been approved by the Secretary for the purposes of this
section.
``(9) Registered exporter.--The term `registered exporter'
means a person that is in the business of exporting a drug to
persons in the United States (or that seeks to be in such
business), for which a registration under this section has
been approved and is in effect.
``(10) Wholesaler.--
``(A) In general.--The term `wholesaler' means a person
licensed as a wholesaler or distributor of prescription drugs
in the United States under section 503(e)(2)(A).
``(B) Exclusion.--The term `wholesaler' does not include a
person authorized to import drugs under section 801(d)(1).''.
(b) Regulations.--Section 804(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(b)) is amended to read as
follows:
``(b) Regulations.--Not later than 180 days after the date
of enactment of the Pharmaceutical Market Access Act of 2010,
the Secretary, after consultation with the United States
Trade Representative and the Commissioner of the U.S. Customs
and Border Protection, shall promulgate regulations
permitting pharmacists, pharmacies, and wholesalers to import
qualifying drugs from permitted countries into the United
States.''.
(c) Limitation.--Section 804(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(c)) is amended by striking
``prescription drug'' each place it appears and inserting
``qualifying drug''.
(d) Information and Records.--Section 804(d)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(d)(1)) is
amended--
(1) by striking subparagraph (G) and redesignating
subparagraphs (H) through (N) as subparagraphs (G) through
(M), respectively;
(2) in subparagraph (H) (as so redesignated), by striking
``telephone number, and professional license number (if
any)'' and inserting ``and telephone number''; and
(3) in subparagraph (L) (as so redesignated), by striking
``(J) and (L)'' and inserting ``(I) and (K)''.
(e) Testing.--Section 804(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(e)) is amended to read as
follows:
``(e) Testing.--The regulations under subsection (b) shall
require that the testing described under subparagraphs (I)
and (K) of subsection (d)(1) be conducted by the importer of
the qualifying drug, unless the qualifying drug is subject to
the requirements under section 505E for counterfeit-resistant
technologies.''.
(f) Registration of Exporters; Inspections.--Section 804(f)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384(f)) is amended to read as follows:
``(f) Registration of Exporters; Inspections.--
``(1) In general.--Any person that seeks to be a registered
exporter (referred to in this subsection as the `registrant')
shall submit to the Secretary a registration that includes
the following:
``(A) The name of the registrant and identification of all
places of business of the registrant that relate to
qualifying drugs, including each warehouse or other facility
owned or controlled by, or operated for, the registrant.
``(B) An agreement by the registrant to--
``(i) make its places of business that relate to qualifying
drugs (including warehouses and other facilities owned or
controlled by, or operated for, the exporter) and records
available to the Secretary for on-site inspections, without
prior notice, for the purpose of determining whether the
registrant is in compliance with this Act's requirements;
``(ii) export only qualifying drugs;
``(iii) export only to persons authorized to import the
drugs;
``(iv) notify the Secretary of a recall or withdrawal of a
qualifying drug distributed in a permitted country to or from
which the registrant has exported or imported, or intends to
export or import, to the United States;
``(v) monitor compliance with registration conditions and
report any noncompliance promptly;
``(vi) submit a compliance plan showing how the registrant
will correct violations, if any; and
``(vii) promptly notify the Secretary of changes in the
registration information of the registrant.
``(2) Notice of approval or disapproval.--
``(A) In general.--Not later than 90 days after receiving a
completed registration from a registrant, the Secretary
shall--
``(i) notify such registrant of receipt of the
registration;
``(ii) assign such registrant a registration number; and

[[Page S2042]]

``(iii) approve or disapprove the application.
``(B) Disapproval of application.--
``(i) In general.--The Secretary shall disapprove a
registration, and notify the registrant of such disapproval,
if the Secretary has reason to believe that such registrant
is not in compliance with a registration condition.
``(ii) Subsequent approval.--The Secretary may subsequently
approve a registration that was denied under clause (i) if
the Secretary finds that the registrant is in compliance with
all registration conditions.
``(3) List.--The Secretary shall--
``(A) maintain an up-to-date list of registered exporters
(including qualifying Internet pharmacies that sell
qualifying drugs to individuals);
``(B) make such list available to the public on the
Internet Web site of the Food and Drug Administration and via
a toll-free telephone number; and
``(C) update such list promptly after the approval of a
registration under this subsection.
``(4) Education of consumers.--The Secretary shall carry
out activities, by use of the Internet Web site and toll-free
telephone number under paragraph (3), that educate consumers
with regard to the availability of qualifying drugs for
import for personal use under this section, including
information on how to verify whether an exporter is
registered.
``(5) Inspection of importers and registered exporters.--
The Secretary shall inspect the warehouses, other facilities,
and records of importers and registered exporters as often as
the Secretary determines necessary to ensure that such
importers and registered exporters are in compliance with
this section.''.
(g) Suspension of Importation.--Section 804(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(g)) is
amended by--
(1) striking ``and the Secretary determines that the public
is adequately protected from counterfeit and violative
prescription drugs being imported under subsection (b)''; and
(2) by adding after the period at the end the following:
``The Secretary shall reinstate the importation by a specific
importer upon a determination by the Secretary that the
violation has been corrected and that the importer has
demonstrated that further violations will not occur. This
subsection shall not apply to a prescription drug imported by
an individual, or to a prescription drug shipped to an
individual by a qualifying Internet pharmacy.''.
(h) Waiver Authority for Individuals.--Section 804(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j))
is amended to read as follows:
``(j) Importation by Individuals.--
``(1) In general.--Not later than 180 days after the
enactment of the Pharmaceutical Market Access Act of 2010,
the Secretary shall by regulation permit an individual to
import a drug from a permitted country to the United States
if the drug is--
``(A) a qualifying drug;
``(B) imported from a licensed pharmacy or qualifying
Internet pharmacy;
``(C) for personal use by an individual, or family member
of the individual, not for resale;
``(D) in a quantity that does not exceed a 90-day supply
during any 90-day period; and
``(E) accompanied by a copy of a prescription for the drug,
which--
``(i) is valid under applicable Federal and State laws; and
``(ii) was issued by a practitioner who is authorized to
administer prescription drugs.
``(2) Drugs dispensed outside the united states.--An
individual may import a drug from a country that is not a
permitted country if--
``(A) the drug was dispensed to the individual while the
individual was in such country, and the drug was dispensed in
accordance with the laws and regulations of such country;
``(B) the individual is entering the United States and the
drug accompanies the individual at the time of entry;
``(C) the drug is approved for commercial distribution in
the country in which the drug was obtained;
``(D) the drug does not appear to be adulterated; and
``(E) the quantity of the drug does not exceed a 14-day
supply.''.
(i) Repeal of Certain Provisions.--Section 804 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is
amended by striking subsections (l) and (m).

SEC. 3005. REGISTRATION FEES.

Subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at
the end the following:

``PART 6--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION

``SEC. 743. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.

``(a) Registration Fee.--The Secretary shall establish a
registration fee program under which a registered exporter
under section 804 shall be required to pay an annual fee to
the Secretary in accordance with this subsection.
``(b) Collection.--
``(1) Collection on initial registration.--A fee under this
section shall be payable for the fiscal year in which the
registered exporter first submits a registration under
section 804 (or reregisters under that section if that person
has withdrawn its registration and subsequently reregisters)
in a amount of $10,000, due on the date the exporter first
submits a registration to the Secretary under section 804.
``(2) Collection in subsequent years.--After the fee is
paid for the first fiscal year, the fee described under this
subsection shall be payable on or before October 1 of each
year.
``(3) One fee per facility.--The fee shall be paid only
once for each registered exporter for a fiscal year in which
the fee is payable.
``(c) Fee Amount.--
``(1) In general.--Subject to subsection (b)(1), the amount
of the fee shall be determined each year by the Secretary and
shall be based on the anticipated costs to the Secretary of
enforcing the amendments made by the Pharmaceutical Market
Access Act of 2010 in the subsequent fiscal year.
``(2) Limitation.--
``(A) In general.--The aggregate total of fees collected
under this section shall not exceed 1 percent of the total
price of drugs exported annually to the United States by
registered exporters under this section.
``(B) Reasonable estimate.--Subject to the limitation
described in subparagraph (A), a fee under this subsection
for an exporter shall be an amount that is a reasonable
estimate by the Secretary of the annual share of the exporter
of the volume of drugs exported by exporters under this
section.
``(d) Use of Fees.--The fees collected under this section
shall be used for the sole purpose of administering this
section with respect to registered exporters, including the
costs associated with--
``(1) inspecting the facilities of registered exporters,
and of other entities in the chain of custody of a qualifying
drug;
``(2) developing, implementing, and maintaining a system to
determine registered exporters' compliance with the
registration conditions under the Pharmaceutical Market
Access Act of 2010, including when shipments of qualifying
drugs are offered for import into the United States; and
``(3) inspecting such shipments, as necessary, when offered
for import into the United States to determine if any such
shipment should be refused admission.
``(e) Annual Fee Setting.--The Secretary shall establish,
60 days before the beginning of each fiscal year beginning
after September 30, 2009, for that fiscal year, registration
fees.
``(f) Effect of Failure To Pay Fees.--
``(1) Due date.--A fee payable under this section shall be
paid by the date that is 30 days after the date on which the
fee is due.
``(2) Failure to pay.--If a registered exporter subject to
a fee under this section fails to pay the fee, the Secretary
shall not permit the registered exporter to engage in
exportation to the United States or offering for exportation
prescription drugs under this Act until all such fees owed by
that person are paid.
``(g) Reports.--
``(1) Fee establishment.--Not later than 60 days before the
beginning of each fiscal year, the Secretary shall--
``(A) publish registration fees under this section for that
fiscal year;
``(B) hold a meeting at which the public may comment on the
recommendations; and
``(C) provide for a period of 30 days for the public to
provide written comments on the recommendations.
``(2) Performance and fiscal report.--Beginning with fiscal
year 2009, not later than 60 days after the end of each
fiscal year during which fees are collected under this
section, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that describes--
``(A) implementation of the registration fee authority
during the fiscal year; and
``(B) the use by the Secretary of the fees collected during
the fiscal year for which the report is made.''.

SEC. 3006. COUNTERFEIT-RESISTANT TECHNOLOGY.

(a) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to
be misbranded) is amended by adding at the end the following:
``(aa) If it is a drug subject to section 503(b), unless
the packaging of such drug complies with the requirements of
section 505E for counterfeit-resistant technologies.''.
(b) Requirements.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 505D the following:

``SEC. 505E. COUNTERFEIT-RESISTANT TECHNOLOGIES.

``(a) Incorporation of Counterfeit-Resistant Technologies
Into Prescription Drug Packaging.--The Secretary shall
require that the packaging of any drug subject to section
503(b) incorporate--
``(1) overt optically variable counterfeit-resistant
technologies that are described in subsection (b) and comply
with the standards of subsection (c); or
``(2) technologies that have an equivalent function of
security, as determined by the Secretary.
``(b) Eligible Technologies.--Technologies described in
this subsection--
``(1) shall be visible to the naked eye, providing for
visual identification of product authenticity without the
need for readers, microscopes, lighting devices, or scanners;
``(2) shall be similar to that used by the Bureau of
Engraving and Printing to secure United States currency;

[[Page S2043]]

``(3) shall be manufactured and distributed in a highly
secure, tightly controlled environment; and
``(4) should incorporate additional layers of non-visible
covert security features up to and including forensic
capability.
``(c) Standards for Packaging.--
``(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of drugs subject to
section 503(b), manufacturers of the drugs shall incorporate
the technologies described in subsection (b) into multiple
elements of the physical packaging of the drugs, including
blister packs, shrink wrap, package labels, package seals,
bottles, and boxes.
``(2) Labeling of shipping container.--Shipments of drugs
described in subsection (a) shall include a label on the
shipping container that incorporates the technologies
described in subsection (b), so that officials inspecting the
packages will be able to determine the authenticity of the
shipment. Chain of custody procedures shall apply to such
labels and shall include procedures applicable to contractual
agreements for the use and distribution of the labels,
methods to audit the use of the labels, and database access
for the relevant governmental agencies for audit or
verification of the use and distribution of the labels.
``(d) Effective Date.--This section shall take effect 180
days after the date of enactment of the Pharmaceutical Market
Access Act of 2010.''.

SEC. 3007. PROHIBITED ACTS.

Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331) is amended by inserting after subsection (k) the
following:
``(l) The failure to register in accordance with section
804(f) or to import or offer to import a prescription drug in
violation of a suspension order under section 804(g).''.

SEC. 3008. PATENTS.

Section 271 of title 35, United States Code, is amended--
(1) by redesignating subsections (h) and (i) as subsections
(i) and (j), respectively; and
(2) by inserting after subsection (g) the following:
``(h) It shall not be an act of infringement to use, offer
to sell, or sell within the United States or to import into
the United States any patented invention under section 804 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) that
was first sold abroad by or under authority of the owner or
licensee of such patent.''.

SEC. 3009. OTHER ENFORCEMENT ACTIONS.

(a) In General.--Section 804 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 3004, is amended by
adding at the end the following:
``(l) Unfair or Discriminatory Acts and Practices.--
``(1) In general.--It is unlawful for a manufacturer,
directly or indirectly (including by being a party to a
licensing or other agreement) to--
``(A) discriminate by charging a higher price for a
prescription drug sold to a person in a permitted country
that exports a prescription drug to the United States under
this section than the price that is charged to another person
that is in the same country and that does not export a
prescription drug into the United States under this section;
``(B) discriminate by charging a higher price for a
prescription drug sold to a person that distributes, sells,
or uses a prescription drug imported into the United States
under this section than the price that is charged to another
person in the United States that does not import a
prescription drug under this section, or that does not
distribute, sell, or use such a drug;
``(C) discriminate by denying supplies of a prescription
drug to a person in a permitted country that exports a
prescription drug to the United States under this section or
distributes, sells, or uses a prescription drug imported into
the United States under this section;
``(D) discriminate by publicly, privately, or otherwise
refusing to do business with a person in a permitted country
that exports a prescription drug to the United States under
this section or distributes, sells, or uses a prescription
drug imported into the United States under this section;
``(E) discriminate by specifically restricting or delaying
the supply of a prescription drug to a person in a permitted
country that exports a prescription drug to the United States
under this section or distributes, sells, or uses a
prescription drug imported into the United States under this
section;
``(F) cause there to be a difference (including a
difference in active ingredient, route of administration,
dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and the drug for
distribution in a permitted country for the purpose of
restricting importation of the drug into the United States
under this section;
``(G) refuse to allow an inspection authorized under this
section of an establishment that manufactures a prescription
drug that may be imported or offered for import under this
section;
``(H) fail to conform to the methods used in, or the
facilities used for, the manufacturing, processing, packing,
or holding of a prescription drug that may be imported or
offered for import under this section to good manufacturing
practice under this Act;
``(I) become a party to a licensing or other agreement
related to a prescription drug that fails to provide for
compliance with all requirements of this section with respect
to such prescription drug or that has the effect of
prohibiting importation of the drug under this section; or
``(J) engage in any other action that the Federal Trade
Commission determines to discriminate against a person that
engages in, or to impede, delay, or block the process for,
the importation of a prescription drug under this section.
``(2) Affirmative defense.--It shall be an affirmative
defense to a charge that a person has discriminated under
subparagraph (A), (B), (C), (D), or (E) of paragraph (1) that
the higher price charged for a prescription drug sold to a
person, the denial of supplies of a prescription drug to a
person, the refusal to do business with a person, or the
specific restriction or delay of supplies to a person is not
based, in whole or in part, on--
``(A) the person exporting or importing a prescription drug
into the United States under this section; or
``(B) the person distributing, selling, or using a
prescription drug imported into the United States under this
section.
``(3) Presumption and affirmative defense.--
``(A) Presumption.--A difference (including a difference in
active ingredient, route of administration, dosage form,
strength, formulation, manufacturing establishment,
manufacturing process, or person that manufactures the drug)
created after January 1, 2009, between a prescription drug
for distribution in the United States and the drug for
distribution in a permitted country shall be presumed under
paragraph (1)(F) to be for the purpose of restricting
importation of the drug into the United States under this
section.
``(B) Affirmative defense.--It shall be an affirmative
defense to the presumption under subparagraph (A) that--
``(i) the difference was required by the country in which
the drug is distributed; or
``(ii) the Secretary has determined that the difference was
necessary to improve the safety or effectiveness of the drug.
``(4) Effect of subsection.--
``(A) Sales in other countries.--This subsection applies
only to the sale or distribution of a prescription drug in a
country if the manufacturer of the drug chooses to sell or
distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a
drug to distribute or sell the drug in a country.
``(B) Discounts to insurers, health plans, pharmacy benefit
managers, and covered entities.--Nothing in this subsection
shall be construed to--
``(i) prevent or restrict a manufacturer of a prescription
drug from providing discounts to an insurer, health plan,
pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B of the
Public Health Service Act (42 U.S.C. 256b) in return for
inclusion of the drug on a formulary;
``(ii) require that such discounts be made available to
other purchasers of the prescription drug; or
``(iii) prevent or restrict any other measures taken by an
insurer, health plan, or pharmacy benefit manager to
encourage consumption of such prescription drug.
``(C) Charitable contributions.--Nothing in this subsection
shall be construed to--
``(i) prevent a manufacturer from donating a prescription
drug, or supplying a prescription drug at nominal cost, to a
charitable or humanitarian organization, including the United
Nations and affiliates, or to a government of a foreign
country; or
``(ii) apply to such donations or supplying of a
prescription drug.
``(5) Enforcement.--
``(A) Unfair or deceptive act or practice.--A violation of
this subsection shall be treated as a violation of a rule
defining an unfair or deceptive act or practice prescribed
under section 18(a)(1)(B) of the Federal Trade Commission
Act.
``(B) Actions by the commission.--The Federal Trade
Commission--
``(i) shall enforce this subsection in the same manner, by
the same means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of the
Federal Trade Commission Act were incorporated into and made
a part of this section; and
``(ii) may seek monetary relief threefold the damages
sustained.
``(6) Actions by states.--
``(A) In general.--
``(i) Civil actions.--The attorney general of a State may
bring a civil action on behalf of the residents of the State,
and persons doing business in the State, in a district court
of the United States of appropriate jurisdiction for a
violation of paragraph (1) to--

``(I) enjoin that practice;
``(II) enforce compliance with this subsection;
``(III) obtain damages, restitution, or other compensation
on behalf of residents of the State and persons doing
business in the State, including threefold the damages; or
``(IV) obtain such other relief as the court may consider
to be appropriate.

``(ii) Notice.--

``(I) In general.--Before filing an action under clause
(i), the attorney general of the State involved shall provide
to the Federal Trade Commission--

``(aa) written notice of that action; and
``(bb) a copy of the complaint for that action.

[[Page S2044]]

``(II) Exemption.--Subclause (I) shall not apply with
respect to the filing of an action by an attorney general of
a State under this paragraph, if the attorney general
determines that it is not feasible to provide the notice
described in that subclause before filing of the action. In
such case, the attorney general of a State shall provide
notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the
action.

``(B) Intervention.--
``(i) In general.--On receiving notice under subparagraph
(A)(ii), the Commission shall have the right to intervene in
the action that is the subject of the notice.
``(ii) Effect of intervention.--If the Commission
intervenes in an action under subparagraph (A), it shall have
the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(C) Construction.--For purposes of bringing any civil
action under subparagraph (A), nothing in this subsection
shall be construed to prevent an attorney general of a State
from exercising the powers conferred on the attorney general
by the laws of that State to--
``(i) conduct investigations;
``(ii) administer oaths or affirmations; or
``(iii) compel the attendance of witnesses or the
production of documentary and other evidence.
``(D) Actions by the commission.--
``(i) In general.--In any case in which an action is
instituted by or on behalf of the Commission for a violation
of paragraph (1), a State may not, during the pendency of
that action, institute an action under subparagraph (A) for
the same violation against any defendant named in the
complaint in that action.
``(ii) Intervention.--An attorney general of a State may
intervene, on behalf of the residents of that State, in an
action instituted by the Commission.
``(iii) Effect of intervention.--If an attorney general of
a State intervenes in an action instituted by the Commission,
such attorney general shall have the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(E) Venue.--Any action brought under subparagraph (A) may
be brought in the district court of the United States that
meets applicable requirements relating to venue under section
1391 of title 28, United States Code.
``(F) Service of process.--In an action brought under
subparagraph (A), process may be served in any district in
which the defendant--
``(i) is an inhabitant; or
``(ii) may be found.
``(G) Limitation of actions.--Any action under this
paragraph to enforce a cause of action under this subsection
by the Federal Trade Commission or the attorney general of a
State shall be forever barred unless commenced within 5 years
after the Federal Trade Commission, or the attorney general,
as the case may be, knew or should have known that the cause
of action accrued. No cause of action barred under existing
law on the effective date of the Pharmaceutical Market Access
Act of 2010 shall be revived by such Act.
``(H) Measurement of damages.--In any action under this
paragraph to enforce a cause of action under this subsection
in which there has been a determination that a defendant has
violated a provision of this subsection, damages may be
proved and assessed in the aggregate by statistical or
sampling methods, by the computation of illegal overcharges
or by such other reasonable system of estimating aggregate
damages as the court in its discretion may permit without the
necessity of separately proving the individual claim of, or
amount of damage to, persons on whose behalf the suit was
brought.
``(I) Exclusion on duplicative relief.--The district court
shall exclude from the amount of monetary relief awarded in
an action under this paragraph brought by the attorney
general of a State any amount of monetary relief which
duplicates amounts which have been awarded for the same
injury.
``(7) Effect on antitrust laws.--Nothing in this subsection
shall be construed to modify, impair, or supersede the
operation of the antitrust laws. For the purpose of this
subsection, the term `antitrust laws' has the meaning given
it in the first section of the Clayton Act, except that it
includes section 5 of the Federal Trade Commission Act to the
extent that such section 5 applies to unfair methods of
competition.
``(8) Manufacturer.--In this subsection, the term
`manufacturer' means any entity, including any affiliate or
licensee of that entity, that is engaged in--
``(A) the production, preparation, propagation,
compounding, conversion, or processing of a prescription
drug, either directly or indirectly by extraction from
substances of natural origin, or independently by means of
chemical synthesis, or by a combination of extraction and
chemical synthesis; or
``(B) the packaging, repackaging, labeling, relabeling, or
distribution of a prescription drug.''.
(b) Regulations.--The Federal Trade Commission shall
promulgate regulations to carry out the enforcement program
under section 804(l) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)).
(c) Suspension and Termination of Exporters.--Section
804(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384(g)), as amended by section 3004(g), is amended by--
(1) striking ``Suspension of Importation.--The Secretary''
and inserting ``Suspension of Importation.--
``(1) In general.--The Secretary''; and
(2) adding at the end the following:
``(2) Suspension and termination of exporters.--
``(A) Suspension.--With respect to the effectiveness of a
registration submitted under subsection (f) by a registered
exporter:
``(i) Subject to clause (ii), if the Secretary determines,
after notice and opportunity for a hearing, that the
registered exporter has failed to maintain substantial
compliance with all registration conditions, the Secretary
may suspend the registration.
``(ii) If the Secretary determines that, under color of the
registration, the registered exporter has exported a drug
that is not a qualifying drug, or a drug that does not meet
the criteria under this section, or has exported a qualifying
drug to an individual in violation of this section, the
Secretary shall immediately suspend the registration. A
suspension under the preceding sentence is not subject to the
provision by the Secretary of prior notice, and the Secretary
shall provide to the registered exporter involved an
opportunity for a hearing not later than 10 days after the
date on which the registration is suspended.
``(iii) The Secretary may reinstate the registration,
whether suspended under clause (i) or (ii), if the Secretary
determines that the registered exporter has demonstrated that
further violations of registration conditions will not occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the registration
under subsection (f) of a registered exporter if the
Secretary determines that the registered exporter has engaged
in a pattern or practice of violating 1 or more registration
conditions, or if on 1 or more occasions the Secretary has
under subparagraph (A)(ii) suspended the registration of the
registered exporter. The Secretary may make the termination
permanent, or for a fixed period of not less than 1 year.
During the period in which the registration of a registered
exporter is terminated, any registration submitted under
subsection (f) by such exporter or a person who is a partner
in the export enterprise or a principal officer in such
enterprise, and any registration prepared with the assistance
of such exporter or such a person, has no legal effect under
this section.''.

SEC. 3010. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated such sums as may be
necessary to carry out this title (and the amendments made by
this title).
______

SA 3670. Mr. ENZI submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 143, between lines 17 and 18, insert the following:

SEC. 2213. DIRECT LENDING ADMINISTRATIVE EXPENSES.

Section 458(a) (20 U.S.C. 1087h(a)) (as amended by section
2212(b)(1)) is amended--
(1) by striking paragraph (3) and inserting the following:
``(2) Mandatory funds for administrative costs in fiscal
years 2010 through 2019.--For each of the fiscal years 2010
through 2019, there shall be available to the Secretary, from
funds not otherwise appropriated, such sums as may be
necessary for the administrative costs under this part and
part B, including the costs of the direct student loan
programs under this part, in each such fiscal year.'';
(2) in paragraph (4), by striking ``through 2014'' and
inserting ``through 2019''.
______

SA 3671. Mr. ENZI (for himself and Mr. Coburn) submitted an amendment
intended to be proposed by him to the bill H.R. 4872, to provide for
reconciliation pursuant to Title II of the concurrent resolution on the
budget for fiscal year 2010 (S. Con. Res. 13); which was ordered to lie
on the table; as follows:

On page 114, between lines 12 and 13, insert the following:

SEC. 2002. ELIMINATION OF SPENDING IN ORDER TO REDUCE THE
PUBLIC DEBT.

Notwithstanding any other provision of this title, sections
2101, 2102, 2103, and 2213, and the amendments made by such
sections, shall have no force and effect, and the resulting
savings shall be used to reduce the public debt.
______

SA 3672. Mr. ENZI submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Beginning on page 114, strike line 13 and all that follows
through line 8 on page 123 and insert the following:

[[Page S2045]]

PART I--EXTENSION OF ECASLA

SEC. 2101. EXTENSION OF STUDENT LOAN PURCHASE AUTHORITY.

Section 459A (20 U.S.C. 1087i-1) is amended--
(1) in subsections (a)(1), (a)(3)(A), and (f), by striking
``July 1, 2010'' and inserting ``July 1, 2011''; and
(2) in subsection (e)--
(A) in the matter preceding clause (i) of paragraph (1)(A)
and the matter preceding subparagraph (A) of paragraph (2),
by striking ``September 30, 2010'' and inserting ``September
30, 2011'';
(B) in paragraph (2), by striking ``February 15, 2011'' and
inserting ``February 15, 2012''; and
(C) in paragraph (3), by striking ``2010, and 2011'' and
inserting ``2010, 2011, and 2012''.

SEC. 2102. EXTENSION OF AUTHORITY TO DESIGNATE LENDERS FOR
LENDER-OF-LAST-RESORT PROGRAM.

Section 428(j) (20 U.S.C. 1078(j)) is amended--
(1) in paragraph (6), by striking ``June 30, 2010'' and
inserting ``June 30, 2011'';
(2) in paragraph (7), by striking ``June 30, 2010'' and
inserting ``June 30, 2011''; and
(3) in paragraph (9)(A)--
(A) in the matter preceding subclause (I) of clause (ii),
by striking ``June 30, 2011'' and inserting ``June 30,
2012'';
(B) in subclause (III) of clause (ii), by striking ``June
30, 2010'' and inserting ``June 30, 2011''; and
(C) in the matter preceding subclause (I) of clause (iii),
by striking ``July 1, 2011'' and inserting ``July 1, 2012''.

SEC. 2103. ONE-YEAR DELAY OF FFEL TERMINATION.

(a) One-Year Delay.--Title IV (as amended by part II) (20
U.S.C. 1070 et seq.) is further amended--
(1) in section 427A(l)(4), by inserting the following:
``(D) For a loan for which the first disbursement is made
on or after July 1, 2010, and before July 1, 2011, 4.5
percent on the unpaid principal balance of the loan.'';
(2) in section 438(c)(2)(B)--
(A) in clause (iii), by striking ``; and'' and inserting a
semicolon;
(B) in clause (iv), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(v) by substituting `0.0 percent' for `3.0 percent' with
respect to loans for which the first disbursement of
principal is made on or after July 1, 2010 and before July 1,
2011.'';
(3) in section 456(a)(4)(A)(iii), by striking ``2014'' and
inserting ``2015''; and
(4) in section 458(a)(2), by striking ``2010 through 2019''
and inserting ``2011 through 2019'';
(5) in sections 458(a)(7)(B) and 459B(a)(3), by striking
``2011'' and inserting ``2012'';
(6) in the headings of sections 427A(l), 438(b)(2)(I), and
438(b)(2)(I)(vi), by striking ``2010'' and inserting
``2011'';
(7) in sections 421(b), 428B(a)(1), 458(a)(6)(B), and
459B(a)(3), subsections (f) and (j)(1) of section 428,
subsections (c)(2)(B)(6) and (d)(2)(B) of section 438, and
subsections (a)(1) and (g) of section 455, by striking
``2010'' and inserting ``2011'';
(8) in sections 421(d), 424(a), 427A(l), 428B(a)(1), 428C,
428H, 438(b)(2)(I), and 458(a)(7), and subsections (a) and
(b)(1) of section 428, by striking ``2010'' each place the
term appears and inserting ``2011''; and
(9) in sections 424(a) and 456(c)(1)(B), by striking
``2009'' each place the term appears and inserting ``2010''.
(b) Delayed Implementation.--Notwithstanding section
2209(b)(2), 2210(b), or 2211(b) or any other provision of
this title--
(1) subsection (a) and part II, and the amendments made by
such subsection and part, shall not be effective until the
day that is one year after the date of enactment of this Act;
and
(2) sections 2210(b) and 2211(b) shall be applied,
beginning on the date described in paragraph (1), by striking
``July 1, 2010'' and inserting ``July 1, 2011''.

SEC. 2104. ELIMINATION OF INCOME-BASED REPAYMENT CHANGES.

Notwithstanding any other provision of this title, section
2213 and the amendments made by such section shall have no
force and effect.
______

SA 3673. Mr. ENZI submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of part II of subtitle A of title II, add the
following:

SEC. 2214. GRANT PROHIBITION.

For fiscal year 2012 and succeeding fiscal years, and
notwithstanding any other provision of law, the Secretary of
Education, the Secretary of Health and Human Services, and
the Secretary of Labor shall not award a grant to an
institution of higher education that increases the tuition
and fees charged for attendance at the institution at a rate
that is greater than the annual increase in the Consumer
Price Index prepared by the Department of Labor.
______

SA 3674. Mr. HATCH submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title II, insert the following:

SEC. 2__. EXEMPTION RELATING TO EXCHANGE REQUIREMENTS.

Section 1311 of the Patient Protection and Affordable Care
Act is amended by adding at the end the following:
``(l) Exemption.--The provisions of this section shall not
apply to any State that has a State exchange in operation on
the date of enactment of this Act. Such exchange shall be
deemed to meet all requirements applicable to Exchanges under
this section.''.
______

SA 3675. Mr. HATCH submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle A of title I, insert the following:

SEC. 1__. REPEAL OF INDIVIDUAL MANDATE.

Section 5000A of the Internal Revenue Code of 1986, as
added by section 1501(b) of the Patient Protection and
Affordable Care Act, is repealed.
______

SA 3676. Ms. COLLINS submitted an amendment intended to be proposed
by her to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle E of title I, insert the following:

SECTION __. HEALTH CARE COST INCREASE TAX CREDIT.

(a) In General.--Subpart A of part IV of subchapter A of
chapter 1 of the Internal Revenue Code of 1986 is amended by
inserting after section 25D the following new section:

``SEC. 25E. HEALTH CARE COST INCREASE TAX CREDIT.

``(a) In General.--In the case of an eligible taxpayer,
there shall be allowed a credit against the tax imposed by
this chapter for the taxable year in an amount equal to the
lesser of--
``(1) the health care cost increase amount for such taxable
year, or
``(2) the eligible taxpayer's premium increase amount for
such taxable year.
``(b) Eligible Taxpayer.--For purposes of this section, the
term `eligible taxpayer' means an individual who purchases
self-only or family health insurance coverage which is a
qualified health plan within the meaning of section
36B(c)(3)(A) for all months in the taxable year.
``(c) Health Care Cost Increase Amount.--
``(1) In general.--For purposes of this section, with
respect to taxable years beginning in any calendar year after
2009, the health care cost increase amount is the amount, as
determined by the Secretary of Health and Human Services, by
which the average national premium cost for a plan in the
silver level of coverage (within the meaning of section
1302(d)(1)(B) of the Patient Protection and Affordable Care
Act) for such calendar year exceeds the average national
premium cost for such a plan as of March 23, 2010.
``(2) Publication of determination.--The Secretary of
Health and Human Services shall publish the health care cost
increase amount determined under paragraph (1) for each
calendar year not later than December 31 of such calendar
year.
``(d) Premium Increase Amount.--
``(1) In general.--For purposes of this section, with
respect to an eligible taxpayer, the premium increase amount
is the amount by which the total premiums paid by such
taxpayer for months during the taxable year for coverage
described in subsection (b) exceed the total premiums paid by
such taxpayer for such coverage for the last plan year ending
before March 23, 2010, except that such amount--
``(A) shall be adjusted to reflect any changes in coverage
under the taxpayer's plan or in the family size of the
taxpayer, and
``(B) shall be reduced by the amount of any credit under
section 36B and any Federal cost sharing subsidy with respect
to such coverage.
``(2) Regulatory authority.--The Secretary of Health and
Human Services shall prescribe regulations for determining
the adjustments required under paragraph (1)(A).
``(e) Credit Allowed Against Alternative Minimum Tax.--In
the case of a taxable year to which section 26(a)(2) does not
apply, the credit allowed under subsection (a) for any
taxable year shall not exceed the excess of--
``(1) the sum of the regular tax liability (as defined in
section 26(b)) plus the tax imposed by section 55, over
``(2) the sum of the credits allowable under this subpart
(other than this section and sections 23, 25D, and 30D) and
section 27 for the taxable year.''.
(b) Clerical Amendment.--The table of sections for subpart
A of part IV of subchapter A of chapter 1 of the Internal
Revenue Code of 1986 is amended by inserting after the item
relating to section 25D the following new item:

[[Page S2046]]

``Sec. 25E. Health care cost increase credit.''.
(c) Conforming Amendments.--
(1) Section 24(b)(3)(B) of the Internal Revenue Code of
1986 is amended by inserting ``25E,'' after ``25D,''.
(2) Section 25(e)(1)(C)(ii) of such Code is amended by
inserting ``25E,'' after ``25D,''.
(3) Section 26(a)(1) of such Code is amended by inserting
``25E,'' after ``25D,''.
(4) Section 25B(g)(2) of such Code is amended by inserting
``25E,'' after ``25D,''.
(5) Section 904(i) of such Code is amended by inserting
``25E,'' after ``25B,''.
(6) Section 1400C(d)(2) of such Code is amended by
inserting ``25E,'' after ``25D,''.
(d) Application of EGGTRA Sunset.--The amendment made by
subsection (c)(1) shall be subject to title IX of the
Economic Growth and Tax Relief Reconciliation Act of 2001 in
the same manner as the provision of such Act to which such
amendment relates.
(e) Effective Date.--The amendments made by subsections
(a), (b), and (c) shall apply to taxable years ending after
March 23, 2010.
______

SA 3677. Mr. LeMIEUX submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle D of title I, add the following:

SEC. 1305. HEALTH CARE FRAUD PREVENTION SYSTEM.

(a) Health Care Fraud Prevention System.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
establish a fraud prevention system which shall be designed
as follows:
(A) In general.--The fraud prevention system shall--
(i) be holistic;
(ii) be able to view all provider and patient activities
across all Federal health program payers;
(iii) be able to integrate into the existing health care
claims flow with minimal effort, time, and cost;
(iv) be modeled after systems used in the Financial
Services industry; and
(v) utilize integrated real-time transaction risk scoring
and referral strategy capabilities to identify claims that
are statistically unusual.
(B) Modularized architecture.--The fraud prevention system
shall be designed from an end-to-end modularized perspective
to allow for ease of integration into multiple points along a
health care claim flow (pre- or post-adjudication), which
shall--
(i) utilize a single entity to host, support, manage, and
maintain software-based services, predictive models, and
solutions from a central location for the customers who
access the fraud prevention system;
(ii) allow access through a secure private data connection
rather than the installation of software in multiple
information technology infrastructures (and data facilities);
(iii) provide access to the best and latest software
without the need for upgrades, data security, and costly
installations;
(iv) permit modifications to the software and system edits
in a rapid and timely manner;
(v) ensure that all technology and decision components
reside within the module; and
(vi) ensure that the third party host of the modular
solution is not a party, payer, or stakeholder that reports
claims data, accesses the results of the fraud prevention
systems analysis, or is otherwise required under this section
to verify, research, or investigate the risk of claims.
(C) Processing, scoring, and storage.--The platform of the
fraud prevention system shall be a high volume, rapid, real-
time information technology solution, which includes data
pooling, data storage, and scoring capabilities to quickly
and accurately capture and evaluate data from millions of
claims per day. Such platform shall be secure and have (at a
minimum) data centers that comply with Federal and State
privacy laws.
(D) Data consortium.--The fraud prevention system shall
provide for the establishment of a centralized data file
(referred to as a ``consortium'') that accumulates data from
all government health insurance claims data sources.
Notwithstanding any other provision of law, Federal health
care payers shall provide to the consortium existing claims
data, such as Medicare's ``Common Working File'' and Medicaid
claims data, for the purpose of fraud and abuse prevention.
Such accumulated data shall be transmitted and stored in an
industry standard secure data environment that complies with
applicable Federal privacy laws for use in building medical
waste, fraud, and abuse prevention predictive models that
have a comprehensive view of provider activity across all
payers (and markets).
(E) Market view.--The fraud prevention system shall ensure
that claims data from Federal health programs and all markets
flows through a central source so the waste, fraud, and abuse
system can look across all markets and geographies in health
care to identify fraud and abuse in Medicare, Medicaid, the
State Children's Health Program, TRICARE, and the Department
of Veterans Affairs, holistically. Such cross-market
visibility shall identify unusual provider and patient
behavior patterns and fraud and abuse schemes that may not be
identified by looking independently at one Federal payer's
transactions.
(F) Behavior engine.--The fraud prevention system shall
ensure that the technology used provides real-time ability to
identify high-risk behavior patterns across markets,
geographies, and specialty group providers to detect waste,
fraud, and abuse, and to identify providers that exhibit
unusual behavior patterns. Behavior pattern technology that
provides the capability to compare a provider's current
behavior to their own past behavior and to compare a
provider's current behavior to that of other providers in the
same specialty group and geographic location shall be used in
order to provide a comprehensive waste, fraud, and abuse
prevention solution.
(G) Predictive model.--The fraud prevention system shall
involve the implementation of a statistically sound,
empirically derived predictive modeling technology that is
designed to prevent (versus post-payment detect) waste,
fraud, and abuse. Such prevention system shall utilize
historical transaction data, from across all Federal health
programs and markets, to build and re-develop scoring models,
have the capability to incorporate external data and external
models from other sources into the health care predictive
waste, fraud, and abuse model, and provide for a feedback
loop to provide outcome information on verified claims so
future system enhancements can be developed based on previous
claims experience.
(H) Change control.--The fraud prevention system platform
shall have the infrastructure to implement new models and
attributes in a test environment prior to moving into a
production environment. Capabilities shall be developed to
quickly make changes to models, attributes, or strategies to
react to changing patterns in waste, fraud, and abuse.
(I) Scoring engine.--The fraud prevention system shall
identify high-risk claims by scoring all such claims on a
real-time capacity prior to payment. Such scores shall then
be communicated to the fraud management system provided for
under subparagraph (J).
(J) Fraud management system.--The fraud prevention system
shall utilize a fraud management system, that contains
workflow management and workstation tools to provide the
ability to systematically present scores, reason codes, and
treatment actions for high-risk scored transactions. The
fraud prevention system shall ensure that analysts who review
claims have the capability to access, review, and research
claims efficiently, as well as decline or approve claims
(payments) in an automated manner. Workflow management under
this subparagraph shall be combined with the ability to
utilize principles of experimental design to compare and
measure prevention and detection rates between test and
control strategies. Such strategy testing shall allow for
continuous improvement and maximum effectiveness in keeping
up with ever changing fraud and abuse patterns. Such system
shall provide the capability to test different treatments or
actions randomly (typically through use of random digit
assignments).
(K) Decision technology.--The fraud prevention system shall
have the capability to monitor consumer transactions in real-
time and monitor provider behavior at different stages within
the transaction flow based upon provider, transaction and
consumer trends. The fraud prevention system shall provide
for the identification of provider and claims excessive usage
patterns and trends that differ from similar peer groups,
have the capability to trigger on multiple criteria, such as
predictive model scores or custom attributes, and be able to
segment transaction waste, fraud, and abuse into multiple
types for health care categories and business types.
(L) Feedback loop.--The fraud prevention system shall have
a feedback loop where all Federal health payers provide pre-
payment and post-payment information about the eventual
status of a claim designated as ``Normal'', ``Waste'',
``Fraud'', ``Abuse'', or ``Education Required''. Such
feedback loop shall enable Federal health agencies to measure
the actual amount of waste, fraud, and abuse as well as the
savings in the system and provide the ability to retrain
future, enhanced models. Such feedback loop shall be an
industry file that contains information on previous fraud and
abuse claims as well as abuse perpetrated by consumers,
providers, and fraud rings, to be used to alert other payers,
as well as for subsequent fraud and abuse solution
development.
(M) Tracking and reporting.--The fraud prevention system
shall ensure that the infrastructure exists to ascertain
system, strategy, and predictive model return on investment.
Dynamic model validation and strategy validation analysis and
reporting shall be made available to ensure a strategy or
predictive model has not degraded over time or is no longer
effective. Queue reporting shall be established and made
available for population estimates of what claims were
flagged, what claims received treatment, and ultimately what
results occurred. The capability shall exist to complete
tracking and reporting for prevention strategies and actions
residing farther upstream in the health care payment flow.
The fraud prevention system shall establish a reliable metric
to measure the dollars that are never paid due to
identification of fraud and abuse, as well

[[Page S2047]]

as a capability to effectively test and estimate the impact
from different actions and treatments utilized to detect and
prevent fraud and abuse for legitimate claims. Measuring
results shall include waste and abuse.
(N) Operating tenet.--The fraud prevention system shall not
be designed to deny health care services or to negatively
impact prompt-pay laws because assessments are late. The
database shall be designed to speed up the payment process.
The fraud prevention system shall require the implementation
of constant and consistent test and control strategies by
stakeholders, with results shared with Federal health program
leadership on a quarterly basis to validate improving
progress in identifying and preventing waste, fraud, and
abuse. Under such implementation, Federal health care payers
shall use standard industry waste, fraud, and abuse measures
of success.
(2) Coordination.--The Secretary shall coordinate the
operation of the fraud prevention system with the Department
of Justice and other related Federal fraud prevention
systems.
(3) Operation.--The Secretary shall phase-in the
implementation of the system under this subsection beginning
not later than 18 months after the date of enactment of this
Act, through the analysis of a limited number of Federal
health program claims. Not later than 5 years after such date
of enactment, the Secretary shall ensure that such system is
fully phased-in and applicable to all Federal health program
claims.
(4) Non-payment of claims.--The Secretary shall promulgate
regulations to prohibit the payment of any health care claim
that has been identified as potentially ``fraudulent'',
``wasteful'', or ``abusive'' until such time as the claim has
been verified as valid.
(5) Application.--The system under this section shall only
apply to Federal health programs (all such programs),
including programs established after the date of enactment of
this Act.
(6) Regulations.--The Secretary shall promulgate
regulations providing the maximum appropriate protection of
personal privacy.
(b) Protecting Participation in Health Care Antifraud
Programs.--
(1) In general.--Notwithstanding any other provision of
law, no person providing information to the Secretary under
this section shall be held, by reason of having provided such
information, to have violated any criminal law, or to be
civilly liable under any law of the United States or of any
State (or political subdivision thereof) unless such
information is false and the person providing it knew, or had
reason to believe, that such information was false.
(2) Confidentiality.--The Secretary shall, through the
promulgation of regulations, establish standards for--
(A) the protection of confidential information submitted or
obtained with regard to suspected or actual health care
fraud;
(B) the protection of the ability of representatives the
Department of Health and Human Services to testify in private
civil actions concerning any such information; and
(C) the sharing by the Department of Health and Human
Services of any such information related to the medical
antifraud programs established under this section.
(c) Use of Savings.--Notwithstanding any other provision of
law, amounts remaining at the end of a fiscal year in the
account for any Federal health program to which this section
applies that the Secretary of Health and Human Services
determines are remaining as a result of the fraud prevention
activities applied under this section shall remain in such
account and be used for such program for the next fiscal
year.
(d) Definition.--In this section, the term ``Federal health
program'' means any program that provides Federal payments or
reimbursements to providers of health-related items or
services, or suppliers of such items, for the provision of
such items or services to an individual patient.
(e) Recission of Certain Stimulus Funds.--Notwithstanding
section 5 of the American Recovery and Reinvestment Act of
2009 (Public Law 111-5; 123 Stat. 116), from the amounts
appropriated or made available under division A of such Act
(other than under title X of such division A), there is
rescinded, of the remaining unobligated amounts as of the
date of the enactment of this Act, funds in the amount as may
be necessary to carry out this section. The Director of the
Office of Management and Budget shall report to each
congressional committee the amounts so rescinded within the
jurisdiction of such committee.
______

SA 3678. Mr. LeMIEUX submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1__. PRODUCTIVITY AWARD PROGRAM.

Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall
establish a Productivity Award Program to recognize
employees, work units, and contractors of the Centers for
Medicare & Medicaid whose work significantly and measurably
increases productivity and promotes innovation to improve the
delivery of services and achieving savings for taxpayers. The
amount of any such award shall be equal to 10 percent of the
amount of the estimated saving to the Federal Government as a
result of the action resulting in the award (as determined by
the Secretary), but not to exceed $50,000.
______

SA 3679. Mr. LeMIEUX submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1__. CONSUMER RIGHT-TO-KNOW.

(a) Development of Information System.--Not later than 1
year after the date of enactment of this Act, the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary'') shall develop a system for the collection
of quality and pricing information related to the provision
of health care services. Through the use of such information,
the Secretary shall, to the extent practicable--
(1) determine the lowest, median, average, and highest
charged amount and reimbursed amount for each outpatient and
inpatient health care procedure conducted at each facility in
the United States;
(2) provide comparisons of such prices with respect to
procedures in similar facilities in the same county, city,
State and on a national basis; and
(3) develop quality of care data, including data on
consumer satisfaction, coordination and continuity of care,
infrastructure, the results of accreditation, Medicare-
related information, and other survey information, and
combine such data with price information to enable consumers
to make informed choices.
(b) Use of Existing Sources.--To the extent that the
information required under subsection (a) is being collected
by the Centers for Medicare & Medicaid Services, States,
State medical societies, or private sector entities, the
Secretary, to the extent practicable, utilize such
information to carry out such subsection.
(c) Availability of Information.--The Secretary, either
directly or through contract, shall make the information and
data collected and developed under this section available on
an Internet website. Such information and data shall be
displayed by payer (such as Medicare, Medicaid, health
insurance plans, employer-based health plans, and other types
of health care coverage).
______

SA 3680. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

TITLE _MEDICAL CARE ACCESS PROTECTION

SEC. _1. SHORT TITLE.

This title may be cited as the ``Medical Care Access
Protection Act of 2009'' or the ``MCAP Act''.

SEC. _2. DEFINITIONS.

In this title:
(1) Alternative dispute resolution system; adr.--The term
``alternative dispute resolution system'' or ``ADR'' means a
system that provides for the resolution of health care
lawsuits in a manner other than through a civil action
brought in a State or Federal court.
(2) Claimant.--The term ``claimant'' means any person who
brings a health care lawsuit, including a person who asserts
or claims a right to legal or equitable contribution,
indemnity or subrogation, arising out of a health care
liability claim or action, and any person on whose behalf
such a claim is asserted or such an action is brought,
whether deceased, incompetent, or a minor.
(3) Collateral source benefits.--The term ``collateral
source benefits'' means any amount paid or reasonably likely
to be paid in the future to or on behalf of the claimant, or
any service, product or other benefit provided or reasonably
likely to be provided in the future to or on behalf of the
claimant, as a result of the injury or wrongful death,
pursuant to--
(A) any State or Federal health, sickness, income-
disability, accident, or workers' compensation law;
(B) any health, sickness, income-disability, or accident
insurance that provides health benefits or income-disability
coverage;
(C) any contract or agreement of any group, organization,
partnership, or corporation to provide, pay for, or reimburse
the cost of medical, hospital, dental, or income disability
benefits; and
(D) any other publicly or privately funded program.
(4) Compensatory damages.--The term ``compensatory
damages'' means objectively verifiable monetary losses
incurred as a result of the provision of, use of, or payment
for (or failure to provide, use, or pay for) health care
services or medical products, such as past and future medical
expenses, loss of past and future earnings, cost of obtaining
domestic services, loss of employment, and loss of business
or employment

[[Page S2048]]

opportunities, damages for physical and emotional pain,
suffering, inconvenience, physical impairment, mental
anguish, disfigurement, loss of enjoyment of life, loss of
society and companionship, loss of consortium (other than
loss of domestic service), hedonic damages, injury to
reputation, and all other nonpecuniary losses of any kind or
nature. Such term includes economic damages and noneconomic
damages, as such terms are defined in this section.
(5) Contingent fee.--The term ``contingent fee'' includes
all compensation to any person or persons which is payable
only if a recovery is effected on behalf of one or more
claimants.
(6) Economic damages.--The term ``economic damages'' means
objectively verifiable monetary losses incurred as a result
of the provision of, use of, or payment for (or failure to
provide, use, or pay for) health care services or medical
products, such as past and future medical expenses, loss of
past and future earnings, cost of obtaining domestic
services, loss of employment, and loss of business or
employment opportunities.
(7) Health care goods or services.--The term ``health care
goods or services'' means any goods or services provided by a
health care institution, provider, or by any individual
working under the supervision of a health care provider, that
relates to the diagnosis, prevention, care, or treatment of
any human disease or impairment, or the assessment of the
health of human beings.
(8) Health care institution.--The term ``health care
institution'' means any entity licensed under Federal or
State law to provide health care services (including but not
limited to ambulatory surgical centers, assisted living
facilities, emergency medical services providers, hospices,
hospitals and hospital systems, nursing homes, or other
entities licensed to provide such services).
(9) Health care lawsuit.--The term ``health care lawsuit''
means any health care liability claim concerning the
provision of health care goods or services affecting
interstate commerce, or any health care liability action
concerning the provision of (or the failure to provide)
health care goods or services affecting interstate commerce,
brought in a State or Federal court or pursuant to an
alternative dispute resolution system, against a health care
provider or a health care institution regardless of the
theory of liability on which the claim is based, or the
number of claimants, plaintiffs, defendants, or other
parties, or the number of claims or causes of action, in
which the claimant alleges a health care liability claim.
(10) Health care liability action.--The term ``health care
liability action'' means a civil action brought in a State or
Federal Court or pursuant to an alternative dispute
resolution system, against a health care provider or a health
care institution regardless of the theory of liability on
which the claim is based, or the number of plaintiffs,
defendants, or other parties, or the number of causes of
action, in which the claimant alleges a health care liability
claim.
(11) Health care liability claim.--The term ``health care
liability claim'' means a demand by any person, whether or
not pursuant to ADR, against a health care provider or health
care institution, including third-party claims, cross-claims,
counter-claims, or contribution claims, which are based upon
the provision of, use of, or payment for (or the failure to
provide, use, or pay for) health care services, regardless of
the theory of liability on which the claim is based, or the
number of plaintiffs, defendants, or other parties, or the
number of causes of action.
(12) Health care provider.--
(A) In general.--The term ``health care provider'' means
any person (including but not limited to a physician (as
defined by section 1861(r) of the Social Security Act (42
U.S.C. 1395x(r)), registered nurse, dentist, podiatrist,
pharmacist, chiropractor, or optometrist) required by State
or Federal law to be licensed, registered, or certified to
provide health care services, and being either so licensed,
registered, or certified, or exempted from such requirement
by other statute or regulation.
(B) Treatment of certain professional associations.--For
purposes of this title, a professional association that is
organized under State law by an individual physician or group
of physicians, a partnership or limited liability partnership
formed by a group of physicians, a nonprofit health
corporation certified under State law, or a company formed by
a group of physicians under State law shall be treated as a
health care provider under subparagraph (A).
(13) Malicious intent to injure.--The term ``malicious
intent to injure'' means intentionally causing or attempting
to cause physical injury other than providing health care
goods or services.
(14) Noneconomic damages.--The term ``noneconomic damages''
means damages for physical and emotional pain, suffering,
inconvenience, physical impairment, mental anguish,
disfigurement, loss of enjoyment of life, loss of society and
companionship, loss of consortium (other than loss of
domestic service), hedonic damages, injury to reputation, and
all other nonpecuniary losses of any kind or nature.
(15) Punitive damages.--The term ``punitive damages'' means
damages awarded, for the purpose of punishment or deterrence,
and not solely for compensatory purposes, against a health
care provider or health care institution. Punitive damages
are neither economic nor noneconomic damages.
(16) Recovery.--The term ``recovery'' means the net sum
recovered after deducting any disbursements or costs incurred
in connection with prosecution or settlement of the claim,
including all costs paid or advanced by any person. Costs of
health care incurred by the plaintiff and the attorneys'
office overhead costs or charges for legal services are not
deductible disbursements or costs for such purpose.
(17) State.--The term ``State'' means each of the several
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern
Mariana Islands, the Trust Territory of the Pacific Islands,
and any other territory or possession of the United States,
or any political subdivision thereof.

SEC. _3. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS.

(a) In General.--Except as otherwise provided for in this
section, the time for the commencement of a health care
lawsuit shall be 3 years after the date of manifestation of
injury or 1 year after the claimant discovers, or through the
use of reasonable diligence should have discovered, the
injury, whichever occurs first.
(b) General Exception.--The time for the commencement of a
health care lawsuit shall not exceed 3 years after the date
of manifestation of injury unless the tolling of time was
delayed as a result of--
(1) fraud;
(2) intentional concealment; or
(3) the presence of a foreign body, which has no
therapeutic or diagnostic purpose or effect, in the person of
the injured person.
(c) Minors.--An action by a minor shall be commenced within
3 years from the date of the alleged manifestation of injury
except that if such minor is under the full age of 6 years,
such action shall be commenced within 3 years of the
manifestation of injury, or prior to the eighth birthday of
the minor, whichever provides a longer period. Such time
limitation shall be tolled for minors for any period during
which a parent or guardian and a health care provider or
health care institution have committed fraud or collusion in
the failure to bring an action on behalf of the injured
minor.
(d) Rule 11 Sanctions.--Whenever a Federal or State court
determines (whether by motion of the parties or whether on
the motion of the court) that there has been a violation of
Rule 11 of the Federal Rules of Civil Procedure (or a similar
violation of applicable State court rules) in a health care
liability action to which this title applies, the court shall
impose upon the attorneys, law firms, or pro se litigants
that have violated Rule 11 or are responsible for the
violation, an appropriate sanction, which shall include an
order to pay the other party or parties for the reasonable
expenses incurred as a direct result of the filing of the
pleading, motion, or other paper that is the subject of the
violation, including a reasonable attorneys' fee. Such
sanction shall be sufficient to deter repetition of such
conduct or comparable conduct by others similarly situated,
and to compensate the party or parties injured by such
conduct.

SEC. _4. COMPENSATING PATIENT INJURY.

(a) Unlimited Amount of Damages for Actual Economic Losses
in Health Care Lawsuits.--In any health care lawsuit, nothing
in this title shall limit the recovery by a claimant of the
full amount of the available economic damages,
notwithstanding the limitation contained in subsection (b).
(b) Additional Noneconomic Damages.--
(1) Health care providers.--In any health care lawsuit
where final judgment is rendered against a health care
provider, the amount of noneconomic damages recovered from
the provider, if otherwise available under applicable Federal
or State law, may be as much as $250,000, regardless of the
number of parties other than a health care institution
against whom the action is brought or the number of separate
claims or actions brought with respect to the same
occurrence.
(2) Health care institutions.--
(A) Single institution.--In any health care lawsuit where
final judgment is rendered against a single health care
institution, the amount of noneconomic damages recovered from
the institution, if otherwise available under applicable
Federal or State law, may be as much as $250,000, regardless
of the number of parties against whom the action is brought
or the number of separate claims or actions brought with
respect to the same occurrence.
(B) Multiple institutions.--In any health care lawsuit
where final judgment is rendered against more than one health
care institution, the amount of noneconomic damages recovered
from each institution, if otherwise available under
applicable Federal or State law, may be as much as $250,000,
regardless of the number of parties against whom the action
is brought or the number of separate claims or actions
brought with respect to the same occurrence, except that the
total amount recovered from all such institutions in such
lawsuit shall not exceed $500,000.
(c) No Discount of Award for Noneconomic Damages.--In any
health care lawsuit--
(1) an award for future noneconomic damages shall not be
discounted to present value;
(2) the jury shall not be informed about the maximum award
for noneconomic damages under subsection (b);
(3) an award for noneconomic damages in excess of the
limitations provided for in subsection (b) shall be reduced
either before the

[[Page S2049]]

entry of judgment, or by amendment of the judgment after
entry of judgment, and such reduction shall be made before
accounting for any other reduction in damages required by
law; and
(4) if separate awards are rendered for past and future
noneconomic damages and the combined awards exceed the
limitations described in subsection (b), the future
noneconomic damages shall be reduced first.
(d) Fair Share Rule.--In any health care lawsuit, each
party shall be liable for that party's several share of any
damages only and not for the share of any other person. Each
party shall be liable only for the amount of damages
allocated to such party in direct proportion to such party's
percentage of responsibility. A separate judgment shall be
rendered against each such party for the amount allocated to
such party. For purposes of this section, the trier of fact
shall determine the proportion of responsibility of each
party for the claimant's harm.

SEC. _5. MAXIMIZING PATIENT RECOVERY.

(a) Court Supervision of Share of Damages Actually Paid to
Claimants.--
(1) In general.--In any health care lawsuit, the court
shall supervise the arrangements for payment of damages to
protect against conflicts of interest that may have the
effect of reducing the amount of damages awarded that are
actually paid to claimants.
(2) Contingency fees.--
(A) In general.--In any health care lawsuit in which the
attorney for a party claims a financial stake in the outcome
by virtue of a contingent fee, the court shall have the power
to restrict the payment of a claimant's damage recovery to
such attorney, and to redirect such damages to the claimant
based upon the interests of justice and principles of equity.
(B) Limitation.--The total of all contingent fees for
representing all claimants in a health care lawsuit shall not
exceed the following limits:
(i) 40 percent of the first $50,000 recovered by the
claimant(s).
(ii) 33\1/3\ percent of the next $50,000 recovered by the
claimant(s).
(iii) 25 percent of the next $500,000 recovered by the
claimant(s).
(iv) 15 percent of any amount by which the recovery by the
claimant(s) is in excess of $600,000.
(b) Applicability.--
(1) In general.--The limitations in subsection (a) shall
apply whether the recovery is by judgment, settlement,
mediation, arbitration, or any other form of alternative
dispute resolution.
(2) Minors.--In a health care lawsuit involving a minor or
incompetent person, a court retains the authority to
authorize or approve a fee that is less than the maximum
permitted under this section.
(c) Expert Witnesses.--
(1) Requirement.--No individual shall be qualified to
testify as an expert witness concerning issues of negligence
in any health care lawsuit against a defendant unless such
individual--
(A) except as required under paragraph (2), is a health
care professional who--
(i) is appropriately credentialed or licensed in 1 or more
States to deliver health care services; and
(ii) typically treats the diagnosis or condition or
provides the type of treatment under review; and
(B) can demonstrate by competent evidence that, as a result
of training, education, knowledge, and experience in the
evaluation, diagnosis, and treatment of the disease or injury
which is the subject matter of the lawsuit against the
defendant, the individual was substantially familiar with
applicable standards of care and practice as they relate to
the act or omission which is the subject of the lawsuit on
the date of the incident.
(2) Physician review.--In a health care lawsuit, if the
claim of the plaintiff involved treatment that is recommended
or provided by a physician (allopathic or osteopathic), an
individual shall not be qualified to be an expert witness
under this subsection with respect to issues of negligence
concerning such treatment unless such individual is a
physician.
(3) Specialties and subspecialties.--With respect to a
lawsuit described in paragraph (1), a court shall not permit
an expert in one medical specialty or subspecialty to testify
against a defendant in another medical specialty or
subspecialty unless, in addition to a showing of substantial
familiarity in accordance with paragraph (1)(B), there is a
showing that the standards of care and practice in the two
specialty or subspecialty fields are similar.
(4) Limitation.--The limitations in this subsection shall
not apply to expert witnesses testifying as to the degree or
permanency of medical or physical impairment.

SEC. _6. ADDITIONAL HEALTH BENEFITS.

(a) In General.--The amount of any damages received by a
claimant in any health care lawsuit shall be reduced by the
court by the amount of any collateral source benefits to
which the claimant is entitled, less any insurance premiums
or other payments made by the claimant (or by the spouse,
parent, child, or legal guardian of the claimant) to obtain
or secure such benefits.
(b) Preservation of Current Law.--Where a payor of
collateral source benefits has a right of recovery by
reimbursement or subrogation and such right is permitted
under Federal or State law, subsection (a) shall not apply.
(c) Application of Provision.--This section shall apply to
any health care lawsuit that is settled or resolved by a fact
finder.

SEC. _7. PUNITIVE DAMAGES.

(a) Punitive Damages Permitted.--
(1) In general.--Punitive damages may, if otherwise
available under applicable State or Federal law, be awarded
against any person in a health care lawsuit only if it is
proven by clear and convincing evidence that such person
acted with malicious intent to injure the claimant, or that
such person deliberately failed to avoid unnecessary injury
that such person knew the claimant was substantially certain
to suffer.
(2) Filing of lawsuit.--No demand for punitive damages
shall be included in a health care lawsuit as initially
filed. A court may allow a claimant to file an amended
pleading for punitive damages only upon a motion by the
claimant and after a finding by the court, upon review of
supporting and opposing affidavits or after a hearing, after
weighing the evidence, that the claimant has established by a
substantial probability that the claimant will prevail on the
claim for punitive damages.
(3) Separate proceeding.--At the request of any party in a
health care lawsuit, the trier of fact shall consider in a
separate proceeding--
(A) whether punitive damages are to be awarded and the
amount of such award; and
(B) the amount of punitive damages following a
determination of punitive liability.
If a separate proceeding is requested, evidence relevant only
to the claim for punitive damages, as determined by
applicable State law, shall be inadmissible in any proceeding
to determine whether compensatory damages are to be awarded.
(4) Limitation where no compensatory damages are awarded.--
In any health care lawsuit where no judgment for compensatory
damages is rendered against a person, no punitive damages may
be awarded with respect to the claim in such lawsuit against
such person.
(b) Determining Amount of Punitive Damages.--
(1) Factors considered.--In determining the amount of
punitive damages under this section, the trier of fact shall
consider only the following:
(A) the severity of the harm caused by the conduct of such
party;
(B) the duration of the conduct or any concealment of it by
such party;
(C) the profitability of the conduct to such party;
(D) the number of products sold or medical procedures
rendered for compensation, as the case may be, by such party,
of the kind causing the harm complained of by the claimant;
(E) any criminal penalties imposed on such party, as a
result of the conduct complained of by the claimant; and
(F) the amount of any civil fines assessed against such
party as a result of the conduct complained of by the
claimant.
(2) Maximum award.--The amount of punitive damages awarded
in a health care lawsuit may not exceed an amount equal to
two times the amount of economic damages awarded in the
lawsuit or $250,000, whichever is greater. The jury shall not
be informed of the limitation under the preceding sentence.
(c) Liability of Health Care Providers.--
(1) In general.--A health care provider who prescribes, or
who dispenses pursuant to a prescription, a drug, biological
product, or medical device approved by the Food and Drug
Administration, for an approved indication of the drug,
biological product, or medical device, shall not be named as
a party to a product liability lawsuit invoking such drug,
biological product, or medical device and shall not be liable
to a claimant in a class action lawsuit against the
manufacturer, distributor, or product seller of such drug,
biological product, or medical device.
(2) Medical product.--The term ``medical product'' means a
drug or device intended for humans. The terms ``drug'' and
``device'' have the meanings given such terms in sections
201(g)(1) and 201(h) of the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 321), respectively, including any component or
raw material used therein, but excluding health care
services.

SEC. _8. AUTHORIZATION OF PAYMENT OF FUTURE DAMAGES TO
CLAIMANTS IN HEALTH CARE LAWSUITS.

(a) In General.--In any health care lawsuit, if an award of
future damages, without reduction to present value, equaling
or exceeding $50,000 is made against a party with sufficient
insurance or other assets to fund a periodic payment of such
a judgment, the court shall, at the request of any party,
enter a judgment ordering that the future damages be paid by
periodic payments in accordance with the Uniform Periodic
Payment of Judgments Act promulgated by the National
Conference of Commissioners on Uniform State Laws.
(b) Applicability.--This section applies to all actions
which have not been first set for trial or retrial before the
effective date of this title.

SEC. _9. EFFECT ON OTHER LAWS.

(a) General Vaccine Injury.--
(1) In general.--To the extent that title XXI of the Public
Health Service Act establishes a Federal rule of law
applicable to a civil action brought for a vaccine-related
injury or death--
(A) this title shall not affect the application of the rule
of law to such an action; and
(B) any rule of law prescribed by this title in conflict
with a rule of law of such title XXI shall not apply to such
action.

[[Page S2050]]

(2) Exception.--If there is an aspect of a civil action
brought for a vaccine-related injury or death to which a
Federal rule of law under title XXI of the Public Health
Service Act does not apply, then this title or otherwise
applicable law (as determined under this title) will apply to
such aspect of such action.
(b) Smallpox Vaccine Injury.--
(1) In general.--To the extent that part C of title II of
the Public Health Service Act establishes a Federal rule of
law applicable to a civil action brought for a smallpox
vaccine-related injury or death--
(A) this title shall not affect the application of the rule
of law to such an action; and
(B) any rule of law prescribed by this title in conflict
with a rule of law of such part C shall not apply to such
action.
(2) Exception.--If there is an aspect of a civil action
brought for a smallpox vaccine-related injury or death to
which a Federal rule of law under part C of title II of the
Public Health Service Act does not apply, then this title or
otherwise applicable law (as determined under this title)
will apply to such aspect of such action.
(c) Other Federal Law.--Except as provided in this section,
nothing in this title shall be deemed to affect any defense
available, or any limitation on liability that applies to, a
defendant in a health care lawsuit or action under any other
provision of Federal law.

SEC. _10. STATE FLEXIBILITY AND PROTECTION OF STATES' RIGHTS.

(a) Health Care Lawsuits.--The provisions governing health
care lawsuits set forth in this title shall preempt, subject
to subsections (b) and (c), State law to the extent that
State law prevents the application of any provisions of law
established by or under this title. The provisions governing
health care lawsuits set forth in this title supersede
chapter 171 of title 28, United States Code, to the extent
that such chapter--
(1) provides for a greater amount of damages or contingent
fees, a longer period in which a health care lawsuit may be
commenced, or a reduced applicability or scope of periodic
payment of future damages, than provided in this title; or
(2) prohibits the introduction of evidence regarding
collateral source benefits.
(b) Preemption of Certain State Laws.--No provision of this
title shall be construed to preempt any State law (whether
effective before, on, or after the date of the enactment of
this title) that specifies a particular monetary amount of
compensatory or punitive damages (or the total amount of
damages) that may be awarded in a health care lawsuit,
regardless of whether such monetary amount is greater or
lesser than is provided for under this title, notwithstanding
section __4(a).
(c) Protection of State's Rights and Other Laws.--
(1) In general.--Any issue that is not governed by a
provision of law established by or under this title
(including the State standards of negligence) shall be
governed by otherwise applicable Federal or State law.
(2) Rule of construction.--Nothing in this title shall be
construed to--
(A) preempt or supersede any Federal or State law that
imposes greater procedural or substantive protections (such
as a shorter statute of limitations) for a health care
provider or health care institution from liability, loss, or
damages than those provided by this title;
(B) preempt or supercede any State law that permits and
provides for the enforcement of any arbitration agreement
related to a health care liability claim whether enacted
prior to or after the date of enactment of this title;
(C) create a cause of action that is not otherwise
available under Federal or State law; or
(D) affect the scope of preemption of any other Federal
law.

SEC. _11. APPLICABILITY; EFFECTIVE DATE.

This title shall apply to any health care lawsuit brought
in a Federal or State court, or subject to an alternative
dispute resolution system, that is initiated on or after the
date of the enactment of this title, except that any health
care lawsuit arising from an injury occurring prior to the
date of enactment of this title shall be governed by the
applicable statute of limitations provisions in effect at the
time the injury occurred.
______

SA 3681. Mr. BUNNING submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle B of title I, add the following:

SEC. __. ALLOWING INDIVIDUALS TO ELECT TO OPT OUT OF THE
MEDICARE PART A BENEFIT.

Notwithstanding any other provision of law, in the case of
an individual who elects to opt out of benefits under part A
of title XVIII of the Social Security Act, such individual
shall not be required to--
(1) opt out of benefits under title II of such Act as a
condition for making such election; and
(2) repay any amount paid under such part A for items and
services furnished prior to making such election.
______

SA 3682. Mr. McCAIN (for himself and Mr. Kyl) submitted an amendment
intended to be proposed by him to the bill H.R. 4872, to provide for
reconciliation pursuant to Title II of the concurrent resolution on the
budget for fiscal year 2010 (S. Con. Res. 13); which was ordered to lie
on the table; as follows:

On page 113, after line 21, insert the following:

SEC. 1502. COMPENSATION TO STATES FOR APPLYING DAVIS-BACON
WAGE REQUIREMENTS TO CERTAIN WATER TREATMENT
PROJECTS.

(a) In General.--The Administrator of the Environmental
Protection Agency shall compensate States for any increased
administrative and project labor costs incurred by the States
as the result of the provisions of title II of the Department
of the Interior, Environment, and Related Agencies
Appropriations Act, 2010 (Public Law 111-88), that apply the
provisions of subchapter IV of chapter 31 of part A of
subtitle II of title 40, United States Code (commonly
referred to as the ``Davis-Bacon Act''), to any projects
carried out, in whole or in part, with assistance made
available from the State drinking water treatment revolving
loan funds established under section 1452 of the Safe
Drinking Water Act (42 U.S.C. 300j-12) or State water
pollution control revolving funds established under title VI
of the Federal Water Pollution Control Act (33 U.S.C. 1381 et
seq.).
(b) Offset.--Any amounts otherwise made available to pay
the salaries and expenses of the Office of the Administrator
of the Environmental Protection Agency shall be reduced by
the amount necessary to carry out subsection (a).
______

SA 3683. Mr. THUNE submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 113, after line 21, insert the following:

SEC. __. FAIL-SAFE MECHANISM TO PREVENT INCREASE IN FEDERAL
BUDGET DEFICIT.

(a) Estimate and Certification of Effect of Patient
Protection and Affordable Care Act and This Act on Budget
Deficit.--
(1) In general.--The President shall include in the
submission under section 1105 of title 31, United States
Code, of the budget of the United States Government for
fiscal year 2013 and each fiscal year thereafter an estimate
of the budgetary effects for the fiscal year of the
provisions of (and the amendments made by) the Patient
Protection and Affordable Care Act and this Act, based on the
information available as of the date of such submission.
(2) Certification.--The President shall include with the
estimate under paragraph (1) for any fiscal year a
certification as to whether the sum of the decreases in
revenues and increases in outlays for the fiscal year by
reason of the provisions of (and the amendments made by) the
Patient Protection and Affordable Care Act and this Act
exceed (or do not exceed) the sum of the increases in
revenues and decreases in outlays for the fiscal year by
reason of the provisions and amendments.
(b) Effect of Deficit.--If the President certifies an
excess under subsection (a)(2) for any fiscal year--
(1) the President shall include with the certification the
percentage by which the credits allowable under section 36B
of the Internal Revenue Code of 1986 and the cost-sharing
subsidies under section 1402 of the Patient Protection and
Affordable Care Act must be reduced for plan years beginning
during such fiscal year such that there is an aggregate
decrease in the amount of such credits and subsidies equal to
the amount of such excess; and
(2) the President shall instruct the Secretary of Health
and Human Services and the Secretary of the Treasury to
reduce such credits and subsidies for such plan years by such
percentage.
(c) Expansion of Affordability Exception to Individual
Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code
of 1986, as added by section 1501(b) of the Patient
Protection and Affordable Care Act, is amended by striking
``8 percent'' and inserting ``5 percent''.
______

SA 3684. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1202 and insert the following:

SEC. 1202. PAYMENTS TO PRIMARY CARE PROVIDERS.

(a) Grants to States To Increase Payments.--From the
amounts appropriated under subsection (b), the Secretary of
Health and Human Services shall award grants to States with
an approved State plan amendment under the Medicaid program
under title XIX of the Social Security Act to permanently
increase payment rates to primary

[[Page S2051]]

care providers under the State Medicaid program above the
rates applicable under the State Medicaid program on the date
of enactment of this Act. Funds paid to a State from such a
grant shall only be used for expenditures attributable to the
additional amounts paid to such providers as a result of the
increase in such rates.
(b) Appropriation.--Out of any funds in the Treasury not
otherwise appropriated, there is appropriated to the
Secretary of Health and Human Services, $8,000,000,000, to
remain available until expended.
(c) Effective Date.--This section shall take effect on
January 1, 2013.
______

SA 3685. Mr. BROWNBACK (for himself and Mr. Roberts) submitted an
amendment intended to be proposed by him to the bill H.R. 4872, to
provide for reconciliation pursuant to Title II of the concurrent
resolution on the budget for fiscal year 2010 (S. Con. Res. 13); which
was ordered to lie on the table; as follows:

On page 61, after line 3, insert the following:

SEC. ___. RESTORING STATE AUTHORITY TO WAIVE THE 35-MILE RULE
FOR MEDICARE CRITICAL ACCESS HOSPITAL
DESIGNATIONS.

(a) In General.--Section 1820(c)(2)(B)(i)(II) of the Social
Security Act (42 U.S.C. 1395i-4(c)(2)(B)(i)(II)) is amended
by inserting ``or on or after the date of enactment of the
Health Care and Education Reconciliation Act of 2010'' after
``January 1, 2006,''.
(b) Expansion of Affordability Exception to Individual
Mandate.--Section 5000A(e)(1)(A) of the Internal Revenue Code
of 1986, as added by section 1501(b) of the Patient
Protection and Affordable Care Act, is amended by striking
``8 percent'' and inserting ``5 percent''.
______

SA 3686. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle C of title I, add the following:

SEC. 1207. INCREASING THE TRANSPARENCY OF INFORMATION ON
HOSPITAL CHARGES AND MAKING AVAILABLE
INFORMATION ON ESTIMATED OUT-OF-POCKET COSTS
FOR HEALTH CARE SERVICES.

(a) In General.--Section 1902(a) of the Social Security Act
(42 U.S.C. 1396a(a)), as amended by section 3021(b) of the
Patient Protection and Affordable Care Act, is amended--
(1) by striking ``and'' at the end of paragraph (82);
(2) by striking the period at the end of paragraph (83) and
inserting ``; and'';
(3) by inserting after paragraph (83) the following new
paragraph:
``(84) provide that the State will establish and maintain
laws, in accordance with the requirements of section 1921A,
to require disclosure of information on hospital charges, to
make such information available to the public, and to provide
individuals with information about estimated out-of-pocket
costs for health care services.''; and
(4) by inserting after section 1921 the following new
section:

``increasing the transparency of information on hospital charges and
providing consumers with estimates of out-of-pocket costs for health
care services

``Sec. 1921A.  (a) In General.--The requirements referred
to in section 1902(a)(84) are that the laws of a State must--
``(1) in accordance with subsection (b)--
``(A) require the disclosure of information on hospital
charges; and
``(B) provide for access to such information; and
``(2) in accordance with subsection (c), require the
provision of a statement of the estimated out-of-pocket costs
of an individual for anticipated future health care services.
``(b) Information on Hospital Charges.--The laws of a State
must--
``(1) require disclosure, by each hospital located in the
State, of information on the charges for certain inpatient
and outpatient hospital services (as determined by the State)
provided at the hospital; and
``(2) provide for timely access to such information by
individuals seeking or requiring such services.
``(c) Estimated Out-of-Pocket Costs.--The laws of a State
must require that, upon the request of any individual with
health insurance coverage sponsored by a health insurance
issuer, the issuer must provide a statement of the estimated
out-of-pocket costs that are likely to be incurred by the
individual if the individual receives particular health care
items and services within a specified period of time.
``(d) Rules of Construction.--Nothing in this section shall
be construed as--
``(1) authorizing or requiring the Secretary to establish
uniform standards for the State laws required by subsections
(b) and (c);
``(2) requiring any State with a law enacted on or before
the date of the enactment of this section that--
``(A) meets the requirements of subsection (b) or
subsection (c) to modify or amend such law; or
``(B) meets some but not all of the requirements of
subsection (b) or subsection (c) to modify or amend such law
except to the extent necessary to address the unmet
requirements;
``(3) precluding any State in which a program of voluntary
disclosure of information on hospital charges is in effect
from adopting a law codifying such program (other than its
voluntary nature) to satisfy the requirement of subsection
(b)(1); or
``(4) guaranteeing that the out-of-pocket costs of an
individual will not exceed the estimate of such costs
provided pursuant to subsection (c).
``(e) Definitions.--For purposes of this section:
``(1) The term `health insurance coverage' has the meaning
given such term in section 2791(b)(1) of the Public Health
Service Act.
``(2) The term `health insurance issuer' has the meaning
given such term in section 2791(b)(2) of the Public Health
Service Act, except that such term also includes--
``(A) a Medicaid managed care organization (as defined in
section 1903(m)); and
``(B) a Medicare Advantage organization (as defined in
1859(a)(1), taking into account the operation of section
201(b) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003).

Section 1856(b)(3) shall not preclude the application to a
Medicare Advantage organization or a Medicare Advantage plan
offered by such an organization of any State law adopted to
carry out the requirements of subsection (b) or (c).
``(3) The term `hospital' means an institution that meets
the requirements of paragraphs (1) and (7) of section 1861(e)
and includes those to which section 1820(c) applies.''.
(b) Effective Date.--
(1) In general.--Except as provided in paragraph (2), the
amendments made by subsection (a) shall take effect on
October 1, 2010.
(2) Exception.--In the case of a State plan for medical
assistance under title XIX of the Social Security Act which
the Secretary of Health and Human Services determines
requires State legislation (other than legislation
appropriating funds) in order for the plan to meet the
additional requirements imposed by the amendment made by
subsection (a), the State plan shall not be regarded as
failing to comply with the requirements of such title solely
on the basis of its failure to meet these additional
requirements before the first day of the first calendar
quarter beginning after the close of the first regular
session of the State legislature that begins after the date
of the enactment of this Act. For purposes of the previous
sentence, in the case of a State that has a 2-year
legislative session, each year of such session shall be
deemed to be a separate regular session of the State
legislature.
______

SA 3687. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. ____. CONDITIONS FOR TREATMENT OF CERTAIN PERSONS AS
ADJUDICATED MENTALLY INCOMPETENT FOR CERTAIN
PURPOSES.

(a) In General.--Chapter 55 of title 38, United States
Code, is amended by adding at the end the following new
section:

``Sec. 5511. Conditions for treatment of certain persons as
adjudicated mentally incompetent for certain purposes

``In any case arising out of the administration by the
Secretary of laws and benefits under this title, a person who
is mentally incapacitated, deemed mentally incompetent, or
experiencing an extended loss of consciousness shall not be
considered adjudicated as a mental defective under subsection
(d)(4) or (g)(4) of section 922 of title 18 without the order
or finding of a judge, magistrate, or other judicial
authority of competent jurisdiction that such person is a
danger to himself or herself or others.''.
(b) Clerical Amendment.--The table of sections at the
beginning of chapter 55 of such title is amended by adding at
the end the following new item:

``5511. Conditions for treatment of certain persons as
adjudicated mentally incompetent for certain
purposes.''.
______

SA 3688. Ms. SNOWE (for herself, Mr. McCain, Mr. Vitter, Mr. Thune,
Mr. Grassley, and Ms. Collins) submitted an amendment intended to be
proposed by her to the bill H.R. 4872, to provide for reconciliation
pursuant to Title II of the concurrent resolution on the budget for
fiscal year 2010 (S. Con. Res. 13); which was ordered to lie on the
table; as follows:

At the end, add the following:

[[Page S2052]]

TITLE III--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 3001. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Market
Access and Drug Safety Act of 2010''.

SEC. 3002. FINDINGS.

Congress finds that--
(1) Americans unjustly pay up to 5 times more to fill their
prescriptions than consumers in other countries;
(2) the United States is the largest market for
pharmaceuticals in the world, yet American consumers pay the
highest prices for brand pharmaceuticals in the world;
(3) a prescription drug is neither safe nor effective to an
individual who cannot afford it;
(4) allowing and structuring the importation of
prescription drugs to ensure access to safe and affordable
drugs approved by the Food and Drug Administration will
provide a level of safety to American consumers that they do
not currently enjoy;
(5) American spend more than $200,000,000,000 on
prescription drugs every year;
(6) the Congressional Budget Office has found that the cost
of prescription drugs are between 35 to 55 percent less in
other highly-developed countries than in the United States;
and
(7) promoting competitive market pricing would both
contribute to health care savings and allow greater access to
therapy, improving health and saving lives.

SEC. 3003. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF
PRESCRIPTION DRUGS.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381 et seq.) is amended by striking section 804.

SEC. 3004. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF
CERTAIN IMPORT RESTRICTIONS.

(a) In General.--Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by
section 3003, is further amended by inserting after section
803 the following:

``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF
PRESCRIPTION DRUGS.

``(a) Importation of Prescription Drugs.--
``(1) In general.--In the case of qualifying drugs imported
or offered for import into the United States from registered
exporters or by registered importers--
``(A) the limitation on importation that is established in
section 801(d)(1) is waived; and
``(B) the standards referred to in section 801(a) regarding
admission of the drugs are subject to subsection (g) of this
section (including with respect to qualifying drugs to which
section 801(d)(1) does not apply).
``(2) Importers.--A qualifying drug may not be imported
under paragraph (1) unless--
``(A) the drug is imported by a pharmacy, group of
pharmacies, or a wholesaler that is a registered importer; or
``(B) the drug is imported by an individual for personal
use or for the use of a family member of the individual (not
for resale) from a registered exporter.
``(3) Rule of construction.--This section shall apply only
with respect to a drug that is imported or offered for import
into the United States--
``(A) by a registered importer; or
``(B) from a registered exporter to an individual.
``(4) Definitions.--
``(A) Registered exporter; registered importer.--For
purposes of this section:
``(i) The term `registered exporter' means an exporter for
which a registration under subsection (b) has been approved
and is in effect.
``(ii) The term `registered importer' means a pharmacy,
group of pharmacies, or a wholesaler for which a registration
under subsection (b) has been approved and is in effect.
``(iii) The term `registration condition' means a condition
that must exist for a registration under subsection (b) to be
approved.
``(B) Qualifying drug.--For purposes of this section, the
term `qualifying drug' means a drug for which there is a
corresponding U.S. label drug.
``(C) U.S. label drug.--For purposes of this section, the
term `U.S. label drug' means a prescription drug that--
``(i) with respect to a qualifying drug, has the same
active ingredient or ingredients, route of administration,
dosage form, and strength as the qualifying drug;
``(ii) with respect to the qualifying drug, is manufactured
by or for the person that manufactures the qualifying drug;
``(iii) is approved under section 505(c); and
``(iv) is not--

``(I) a controlled substance, as defined in section 102 of
the Controlled Substances Act (21 U.S.C. 802);
``(II) a biological product, as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262), including--

``(aa) a therapeutic DNA plasmid product;
``(bb) a therapeutic synthetic peptide product;
``(cc) a monoclonal antibody product for in vivo use; and
``(dd) a therapeutic recombinant DNA-derived product;

``(III) an infused drug, including a peritoneal dialysis
solution;
``(IV) an injected drug;
``(V) a drug that is inhaled during surgery;
``(VI) a drug that is the listed drug referred to in 2 or
more abbreviated new drug applications under which the drug
is commercially marketed; or
``(VII) a sterile opthlamic drug intended for topical use
on or in the eye.

``(D) Other definitions.--For purposes of this section:
``(i)(I) The term `exporter' means a person that is in the
business of exporting a drug to individuals in the United
States from Canada or from a permitted country designated by
the Secretary under subclause (II), or that, pursuant to
submitting a registration under subsection (b), seeks to be
in such business.
``(II) The Secretary shall designate a permitted country
under subparagraph (E) (other than Canada) as a country from
which an exporter may export a drug to individuals in the
United States if the Secretary determines that--

``(aa) the country has statutory or regulatory standards
that are equivalent to the standards in the United States and
Canada with respect to--

``(AA) the training of pharmacists;
``(BB) the practice of pharmacy; and
``(CC) the protection of the privacy of personal medical
information; and

``(bb) the importation of drugs to individuals in the
United States from the country will not adversely affect
public health.

``(ii) The term `importer' means a pharmacy, a group of
pharmacies, or a wholesaler that is in the business of
importing a drug into the United States or that, pursuant to
submitting a registration under subsection (b), seeks to be
in such business.
``(iii) The term `pharmacist' means a person licensed by a
State to practice pharmacy, including the dispensing and
selling of prescription drugs.
``(iv) The term `pharmacy' means a person that--

``(I) is licensed by a State to engage in the business of
selling prescription drugs at retail; and
``(II) employs 1 or more pharmacists.

``(v) The term `prescription drug' means a drug that is
described in section 503(b)(1).
``(vi) The term `wholesaler'--

``(I) means a person licensed as a wholesaler or
distributor of prescription drugs in the United States under
section 503(e)(2)(A); and
``(II) does not include a person authorized to import drugs
under section 801(d)(1).

``(E) Permitted country.--The term `permitted country'
means--
``(i) Australia;
``(ii) Canada;
``(iii) a member country of the European Union, but does
not include a member country with respect to which--

``(I) the country's Annex to the Treaty of Accession to the
European Union 2003 includes a transitional measure for the
regulation of human pharmaceutical products that has not
expired; or
``(II) the Secretary determines that the requirements
described in subclauses (I) and (II) of clause (vii) will not
be met by the date on which such transitional measure for the
regulation of human pharmaceutical products expires;

``(iv) Japan;
``(v) New Zealand;
``(vi) Switzerland; and
``(vii) a country in which the Secretary determines the
following requirements are met:

``(I) The country has statutory or regulatory
requirements--

``(aa) that require the review of drugs for safety and
effectiveness by an entity of the government of the country;
``(bb) that authorize the approval of only those drugs that
have been determined to be safe and effective by experts
employed by or acting on behalf of such entity and qualified
by scientific training and experience to evaluate the safety
and effectiveness of drugs on the basis of adequate and well-
controlled investigations, including clinical investigations,
conducted by experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs;
``(cc) that require the methods used in, and the facilities
and controls used for the manufacture, processing, and
packing of drugs in the country to be adequate to preserve
their identity, quality, purity, and strength;
``(dd) for the reporting of adverse reactions to drugs and
procedures to withdraw approval and remove drugs found not to
be safe or effective; and
``(ee) that require the labeling and promotion of drugs to
be in accordance with the approval of the drug.

``(II) The valid marketing authorization system in the
country is equivalent to the systems in the countries
described in clauses (i) through (vi).
``(III) The importation of drugs to the United States from
the country will not adversely affect public health.

``(b) Registration of Importers and Exporters.--
``(1) Registration of importers and exporters.--A
registration condition is that the importer or exporter
involved (referred to in this subsection as a `registrant')
submits to the Secretary a registration containing the
following:
``(A)(i) In the case of an exporter, the name of the
exporter and an identification of all places of business of
the exporter that relate to qualifying drugs, including each
warehouse or other facility owned or controlled by, or
operated for, the exporter.

[[Page S2053]]

``(ii) In the case of an importer, the name of the importer
and an identification of the places of business of the
importer at which the importer initially receives a
qualifying drug after importation (which shall not exceed 3
places of business except by permission of the Secretary).
``(B) Such information as the Secretary determines to be
necessary to demonstrate that the registrant is in compliance
with registration conditions under--
``(i) in the case of an importer, subsections (c), (d),
(e), (g), and (j) (relating to the sources of imported
qualifying drugs; the inspection of facilities of the
importer; the payment of fees; compliance with the standards
referred to in section 801(a); and maintenance of records and
samples); or
``(ii) in the case of an exporter, subsections (c), (d),
(f), (g), (h), (i), and (j) (relating to the sources of
exported qualifying drugs; the inspection of facilities of
the exporter and the marking of compliant shipments; the
payment of fees; and compliance with the standards referred
to in section 801(a); being licensed as a pharmacist;
conditions for individual importation; and maintenance of
records and samples).
``(C) An agreement by the registrant that the registrant
will not under subsection (a) import or export any drug that
is not a qualifying drug.
``(D) An agreement by the registrant to--
``(i) notify the Secretary of a recall or withdrawal of a
qualifying drug distributed in a permitted country that the
registrant has exported or imported, or intends to export or
import, to the United States under subsection (a);
``(ii) provide for the return to the registrant of such
drug; and
``(iii) cease, or not begin, the exportation or importation
of such drug unless the Secretary has notified the registrant
that exportation or importation of such drug may proceed.
``(E) An agreement by the registrant to ensure and monitor
compliance with each registration condition, to promptly
correct any noncompliance with such a condition, and to
promptly report to the Secretary any such noncompliance.
``(F) A plan describing the manner in which the registrant
will comply with the agreement under subparagraph (E).
``(G) An agreement by the registrant to enforce a contract
under subsection (c)(3)(B) against a party in the chain of
custody of a qualifying drug with respect to the authority of
the Secretary under clauses (ii) and (iii) of that
subsection.
``(H) An agreement by the registrant to notify the
Secretary not more than 30 days before the registrant intends
to make the change, of--
``(i) any change that the registrant intends to make
regarding information provided under subparagraph (A) or (B);
and
``(ii) any change that the registrant intends to make in
the compliance plan under subparagraph (F).
``(I) In the case of an exporter:
``(i) An agreement by the exporter that a qualifying drug
will not under subsection (a) be exported to any individual
not authorized pursuant to subsection (a)(2)(B) to be an
importer of such drug.
``(ii) An agreement to post a bond, payable to the Treasury
of the United States that is equal in value to the lesser
of--

``(I) the value of drugs exported by the exporter to the
United States in a typical 4-week period over the course of a
year under this section; or
``(II) $1,000,000.

``(iii) An agreement by the exporter to comply with
applicable provisions of Canadian law, or the law of the
permitted country designated under subsection
(a)(4)(D)(i)(II) in which the exporter is located, that
protect the privacy of personal information with respect to
each individual importing a prescription drug from the
exporter under subsection (a)(2)(B).
``(iv) An agreement by the exporter to report to the
Secretary--

``(I) not later than August 1 of each fiscal year, the
total price and the total volume of drugs exported to the
United States by the exporter during the 6-month period from
January 1 through June 30 of that year; and
``(II) not later than January 1 of each fiscal year, the
total price and the total volume of drugs exported to the
United States by the exporter during the previous fiscal
year.

``(J) In the case of an importer, an agreement by the
importer to report to the Secretary--
``(i) not later than August 1 of each fiscal year, the
total price and the total volume of drugs imported to the
United States by the importer during the 6-month period from
January 1 through June 30 of that fiscal year; and
``(ii) not later than January 1 of each fiscal year, the
total price and the total volume of drugs imported to the
United States by the importer during the previous fiscal
year.
``(K) Such other provisions as the Secretary may require by
regulation to protect the public health while permitting--
``(i) the importation by pharmacies, groups of pharmacies,
and wholesalers as registered importers of qualifying drugs
under subsection (a); and
``(ii) importation by individuals of qualifying drugs under
subsection (a).
``(2) Approval or disapproval of registration.--
``(A) In general.--Not later than 90 days after the date on
which a registrant submits to the Secretary a registration
under paragraph (1), the Secretary shall notify the
registrant whether the registration is approved or is
disapproved. The Secretary shall disapprove a registration if
there is reason to believe that the registrant is not in
compliance with one or more registration conditions, and
shall notify the registrant of such reason. In the case of a
disapproved registration, the Secretary shall subsequently
notify the registrant that the registration is approved if
the Secretary determines that the registrant is in compliance
with such conditions.
``(B) Changes in registration information.--Not later than
30 days after receiving a notice under paragraph (1)(H) from
a registrant, the Secretary shall determine whether the
change involved affects the approval of the registration of
the registrant under paragraph (1), and shall inform the
registrant of the determination.
``(3) Publication of contact information for registered
exporters.--Through the Internet website of the Food and Drug
Administration and a toll-free telephone number, the
Secretary shall make readily available to the public a list
of registered exporters, including contact information for
the exporters. Promptly after the approval of a registration
submitted under paragraph (1), the Secretary shall update the
Internet website and the information provided through the
toll-free telephone number accordingly.
``(4) Suspension and termination.--
``(A) Suspension.--With respect to the effectiveness of a
registration submitted under paragraph (1):
``(i) Subject to clause (ii), the Secretary may suspend the
registration if the Secretary determines, after notice and
opportunity for a hearing, that the registrant has failed to
maintain substantial compliance with a registration
condition.
``(ii) If the Secretary determines that, under color of the
registration, the exporter has exported a drug or the
importer has imported a drug that is not a qualifying drug,
or a drug that does not comply with subsection (g)(2)(A) or
(g)(4), or has exported a qualifying drug to an individual in
violation of subsection (i), the Secretary shall immediately
suspend the registration. A suspension under the preceding
sentence is not subject to the provision by the Secretary of
prior notice, and the Secretary shall provide to the
registrant an opportunity for a hearing not later than 10
days after the date on which the registration is suspended.
``(iii) The Secretary may reinstate the registration,
whether suspended under clause (i) or (ii), if the Secretary
determines that the registrant has demonstrated that further
violations of registration conditions will not occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the registration
under paragraph (1) of a registrant if the Secretary
determines that the registrant has engaged in a pattern or
practice of violating 1 or more registration conditions, or
if on 1 or more occasions the Secretary has under
subparagraph (A)(ii) suspended the registration of the
registrant. The Secretary may make the termination permanent,
or for a fixed period of not less than 1 year. During the
period in which the registration is terminated, any
registration submitted under paragraph (1) by the registrant,
or a person that is a partner in the export or import
enterprise, or a principal officer in such enterprise, and
any registration prepared with the assistance of the
registrant or such a person, has no legal effect under this
section.
``(5) Default of bond.--A bond required to be posted by an
exporter under paragraph (1)(I)(ii) shall be defaulted and
paid to the Treasury of the United States if, after
opportunity for an informal hearing, the Secretary determines
that the exporter has--
``(A) exported a drug to the United States that is not a
qualifying drug or that is not in compliance with subsection
(g)(2)(A), (g)(4), or (i); or
``(B) failed to permit the Secretary to conduct an
inspection described under subsection (d).
``(c) Sources of Qualifying Drugs.--A registration
condition is that the exporter or importer involved agrees
that a qualifying drug will under subsection (a) be exported
or imported into the United States only if there is
compliance with the following:
``(1) The drug was manufactured in an establishment--
``(A) required to register under subsection (h) or (i) of
section 510; and
``(B)(i) inspected by the Secretary; or
``(ii) for which the Secretary has elected to rely on a
satisfactory report of a good manufacturing practice
inspection of the establishment from a permitted country
whose regulatory system the Secretary recognizes as
equivalent under a mutual recognition agreement, as provided
for under section 510(i)(3), section 803, or part 26 of title
21, Code of Federal Regulations (or any corresponding
successor rule or regulation).
``(2) The establishment is located in any country, and the
establishment manufactured the drug for distribution in the
United States or for distribution in 1 or more of the
permitted countries (without regard to whether in addition
the drug is manufactured for distribution in a foreign
country that is not a permitted country).
``(3) The exporter or importer obtained the drug--
``(A) directly from the establishment; or
``(B) directly from an entity that, by contract with the
exporter or importer--

[[Page S2054]]

``(i) provides to the exporter or importer a statement (in
such form and containing such information as the Secretary
may require) that, for the chain of custody from the
establishment, identifies each prior sale, purchase, or trade
of the drug (including the date of the transaction and the
names and addresses of all parties to the transaction);
``(ii) agrees to permit the Secretary to inspect such
statements and related records to determine their accuracy;
``(iii) agrees, with respect to the qualifying drugs
involved, to permit the Secretary to inspect warehouses and
other facilities, including records, of the entity for
purposes of determining whether the facilities are in
compliance with any standards under this Act that are
applicable to facilities of that type in the United States;
and
``(iv) has ensured, through such contractual relationships
as may be necessary, that the Secretary has the same
authority regarding other parties in the chain of custody
from the establishment that the Secretary has under clauses
(ii) and (iii) regarding such entity.
``(4)(A) The foreign country from which the importer will
import the drug is a permitted country; or
``(B) The foreign country from which the exporter will
export the drug is the permitted country in which the
exporter is located.
``(5) During any period in which the drug was not in the
control of the manufacturer of the drug, the drug did not
enter any country that is not a permitted country.
``(6) The exporter or importer retains a sample of each lot
of the drug for testing by the Secretary.
``(d) Inspection of Facilities; Marking of Shipments.--
``(1) Inspection of facilities.--A registration condition
is that, for the purpose of assisting the Secretary in
determining whether the exporter involved is in compliance
with all other registration conditions--
``(A) the exporter agrees to permit the Secretary--
``(i) to conduct onsite inspections, including monitoring
on a day-to-day basis, of places of business of the exporter
that relate to qualifying drugs, including each warehouse or
other facility owned or controlled by, or operated for, the
exporter;
``(ii) to have access, including on a day-to-day basis,
to--

``(I) records of the exporter that relate to the export of
such drugs, including financial records; and
``(II) samples of such drugs;

``(iii) to carry out the duties described in paragraph (3);
and
``(iv) to carry out any other functions determined by the
Secretary to be necessary regarding the compliance of the
exporter; and
``(B) the Secretary has assigned 1 or more employees of the
Secretary to carry out the functions described in this
subsection for the Secretary randomly, but not less than 12
times annually, on the premises of places of businesses
referred to in subparagraph (A)(i), and such an assignment
remains in effect on a continuous basis.
``(2) Marking of compliant shipments.--A registration
condition is that the exporter involved agrees to affix to
each shipping container of qualifying drugs exported under
subsection (a) such markings as the Secretary determines to
be necessary to identify the shipment as being in compliance
with all registration conditions. Markings under the
preceding sentence shall--
``(A) be designed to prevent affixation of the markings to
any shipping container that is not authorized to bear the
markings; and
``(B) include anticounterfeiting or track-and-trace
technologies, taking into account the economic and technical
feasibility of those technologies.
``(3) Certain duties relating to exporters.--Duties of the
Secretary with respect to an exporter include the following:
``(A) Inspecting, randomly, but not less than 12 times
annually, the places of business of the exporter at which
qualifying drugs are stored and from which qualifying drugs
are shipped.
``(B) During the inspections under subparagraph (A),
verifying the chain of custody of a statistically significant
sample of qualifying drugs from the establishment in which
the drug was manufactured to the exporter, which shall be
accomplished or supplemented by the use of anticounterfeiting
or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies,
except that a drug that lacks such technologies from the
point of manufacture shall not for that reason be excluded
from importation by an exporter.
``(C) Randomly reviewing records of exports to individuals
for the purpose of determining whether the drugs are being
imported by the individuals in accordance with the conditions
under subsection (i). Such reviews shall be conducted in a
manner that will result in a statistically significant
determination of compliance with all such conditions.
``(D) Monitoring the affixing of markings under paragraph
(2).
``(E) Inspecting as the Secretary determines is necessary
the warehouses and other facilities, including records, of
other parties in the chain of custody of qualifying drugs.
``(F) Determining whether the exporter is in compliance
with all other registration conditions.
``(4) Prior notice of shipments.--A registration condition
is that, not less than 8 hours and not more than 5 days in
advance of the time of the importation of a shipment of
qualifying drugs, the importer involved agrees to submit to
the Secretary a notice with respect to the shipment of drugs
to be imported or offered for import into the United States
under subsection (a). A notice under the preceding sentence
shall include--
``(A) the name and complete contact information of the
person submitting the notice;
``(B) the name and complete contact information of the
importer involved;
``(C) the identity of the drug, including the established
name of the drug, the quantity of the drug, and the lot
number assigned by the manufacturer;
``(D) the identity of the manufacturer of the drug,
including the identity of the establishment at which the drug
was manufactured;
``(E) the country from which the drug is shipped;
``(F) the name and complete contact information for the
shipper of the drug;
``(G) anticipated arrival information, including the port
of arrival and crossing location within that port, and the
date and time;
``(H) a summary of the chain of custody of the drug from
the establishment in which the drug was manufactured to the
importer;
``(I) a declaration as to whether the Secretary has ordered
that importation of the drug from the permitted country cease
under subsection (g)(2)(C) or (D); and
``(J) such other information as the Secretary may require
by regulation.
``(5) Marking of compliant shipments.--A registration
condition is that the importer involved agrees, before
wholesale distribution (as defined in section 503(e)) of a
qualifying drug that has been imported under subsection (a),
to affix to each container of such drug such markings or
other technology as the Secretary determines necessary to
identify the shipment as being in compliance with all
registration conditions, except that the markings or other
technology shall not be required on a drug that bears
comparable, compatible markings or technology from the
manufacturer of the drug. Markings or other technology under
the preceding sentence shall--
``(A) be designed to prevent affixation of the markings or
other technology to any container that is not authorized to
bear the markings; and
``(B) shall include anticounterfeiting or track-and-trace
technologies, taking into account the economic and technical
feasibility of such technologies.
``(6) Certain duties relating to importers.--Duties of the
Secretary with respect to an importer include the following:
``(A) Inspecting, randomly, but not less than 12 times
annually, the places of business of the importer at which a
qualifying drug is initially received after importation.
``(B) During the inspections under subparagraph (A),
verifying the chain of custody of a statistically significant
sample of qualifying drugs from the establishment in which
the drug was manufactured to the importer, which shall be
accomplished or supplemented by the use of anticounterfeiting
or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies,
except that a drug that lacks such technologies from the
point of manufacture shall not for that reason be excluded
from importation by an importer.
``(C) Reviewing notices under paragraph (4).
``(D) Inspecting as the Secretary determines is necessary
the warehouses and other facilities, including records of
other parties in the chain of custody of qualifying drugs.
``(E) Determining whether the importer is in compliance
with all other registration conditions.
``(e) Importer Fees.--
``(1) Registration fee.--A registration condition is that
the importer involved pays to the Secretary a fee of $10,000
due on the date on which the importer first submits the
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
importer involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30 days
before the start of each fiscal year, the Secretary, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for importers for
that fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
importers, including the costs associated with--
``(i) inspecting the facilities of registered importers,
and of other entities in the chain of custody of a qualifying
drug as necessary, under subsection (d)(6);
``(ii) developing, implementing, and operating under such
subsection an electronic system for submission and review of
the notices required under subsection (d)(4) with respect to
shipments of qualifying drugs under subsection (a) to assess
compliance with all registration conditions when such
shipments are offered for import into the United States; and
``(iii) inspecting such shipments as necessary, when
offered for import into the

[[Page S2055]]

United States to determine if such a shipment should be
refused admission under subsection (g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2) for a
fiscal year shall not exceed 2.5 percent of the total price
of qualifying drugs imported during that fiscal year into the
United States by registered importers under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of complying with the
limitation described in subparagraph (B) when establishing
under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the
Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered importers
during that fiscal year by adding the total price of
qualifying drugs imported by each registered importer during
the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each
registered importer under subsection (b)(1)(J).
``(ii) Calculation.--Not later than March 1 of the fiscal
year that follows the fiscal year for which the estimate
under clause (i) is made, the Secretary shall calculate the
total price of qualifying drugs imported into the United
States by registered importers during that fiscal year by
adding the total price of qualifying drugs imported by each
registered importer during that fiscal year, as reported to
the Secretary by each registered importer under subsection
(b)(1)(J).
``(iii) Adjustment.--If the total price of qualifying drugs
imported into the United States by registered importers
during a fiscal year as calculated under clause (ii) is less
than the aggregate total of fees collected under paragraph
(2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered
importer on April 1 of the subsequent fiscal year so that the
limitation described in subparagraph (B) is observed.
``(D) Individual importer fee.--Subject to the limitation
described in subparagraph (B), the fee under paragraph (2) to
be paid on October 1 and April 1 by an importer shall be an
amount that is proportional to a reasonable estimate by the
Secretary of the semiannual share of the importer of the
volume of qualifying drugs imported by importers under
subsection (a).
``(4) Use of fees.--
``(A) In general.--Fees collected by the Secretary under
paragraphs (1) and (2) shall be credited to the appropriation
account for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year
limitation), and the Secretary may, in consultation with the
Secretary of Homeland Security and the Secretary of the
Treasury, transfer some proportion of such fees to the
appropriation account for salaries and expenses of the Bureau
of Customs and Border Protection until expended (without
fiscal year limitation).
``(B) Availability.--Fees collected by the Secretary under
paragraphs (1) and (2) shall be made available to the Food
and Drug Administration.
``(C) Sole purpose.--Fees collected by the Secretary under
paragraphs (1) and (2) are only available to the Secretary
and, if transferred, to the Secretary of Homeland Security,
and are for the sole purpose of paying the costs referred to
in paragraph (3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph
(1) or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(f) Exporter Fees.--
``(1) Registration fee.--A registration condition is that
the exporter involved pays to the Secretary a fee of $10,000
due on the date on which the exporter first submits that
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
exporter involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30 days
before the start of each fiscal year, the Secretary, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for exporters for
that fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
exporters, including the costs associated with--
``(i) inspecting the facilities of registered exporters,
and of other entities in the chain of custody of a qualifying
drug as necessary, under subsection (d)(3);
``(ii) developing, implementing, and operating under such
subsection a system to screen marks on shipments of
qualifying drugs under subsection (a) that indicate
compliance with all registration conditions, when such
shipments are offered for import into the United States; and
``(iii) screening such markings, and inspecting such
shipments as necessary, when offered for import into the
United States to determine if such a shipment should be
refused admission under subsection (g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2) for a
fiscal year shall not exceed 2.5 percent of the total price
of qualifying drugs imported during that fiscal year into the
United States by registered exporters under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of complying with the
limitation described in subparagraph (B) when establishing
under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the
Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered exporters
during that fiscal year by adding the total price of
qualifying drugs exported by each registered exporter during
the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each
registered exporter under subsection (b)(1)(I)(iv).
``(ii) Calculation.--Not later than March 1 of the fiscal
year that follows the fiscal year for which the estimate
under clause (i) is made, the Secretary shall calculate the
total price of qualifying drugs imported into the United
States by registered exporters during that fiscal year by
adding the total price of qualifying drugs exported by each
registered exporter during that fiscal year, as reported to
the Secretary by each registered exporter under subsection
(b)(1)(I)(iv).
``(iii) Adjustment.--If the total price of qualifying drugs
imported into the United States by registered exporters
during a fiscal year as calculated under clause (ii) is less
than the aggregate total of fees collected under paragraph
(2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered
exporter on April 1 of the subsequent fiscal year so that the
limitation described in subparagraph (B) is observed.
``(D) Individual exporter fee.--Subject to the limitation
described in subparagraph (B), the fee under paragraph (2) to
be paid on October 1 and April 1 by an exporter shall be an
amount that is proportional to a reasonable estimate by the
Secretary of the semiannual share of the exporter of the
volume of qualifying drugs exported by exporters under
subsection (a).
``(4) Use of fees.--
``(A) In general.--Fees collected by the Secretary under
paragraphs (1) and (2) shall be credited to the appropriation
account for salaries and expenses of the Food and Drug
Administration until expended (without fiscal year
limitation), and the Secretary may, in consultation with the
Secretary of Homeland Security and the Secretary of the
Treasury, transfer some proportion of such fees to the
appropriation account for salaries and expenses of the Bureau
of Customs and Border Protection until expended (without
fiscal year limitation).
``(B) Availability.--Fees collected by the Secretary under
paragraphs (1) and (2) shall be made available to the Food
and Drug Administration.
``(C) Sole purpose.--Fees collected by the Secretary under
paragraphs (1) and (2) are only available to the Secretary
and, if transferred, to the Secretary of Homeland Security,
and are for the sole purpose of paying the costs referred to
in paragraph (3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph
(1) or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(g) Compliance With Section 801(a).--
``(1) In general.--A registration condition is that each
qualifying drug exported under subsection (a) by the
registered exporter involved or imported under subsection (a)
by the registered importer involved is in compliance with the
standards referred to in section 801(a) regarding admission
of the drug into the United States, subject to paragraphs
(2), (3), and (4).
``(2) Section 505; approval status.--
``(A) In general.--A qualifying drug that is imported or
offered for import under subsection (a) shall comply with the
conditions established in the approved application under
section 505(b) for the U.S. label drug as described under
this subsection.
``(B) Notice by manufacturer; general provisions.--
``(i) In general.--The person that manufactures a
qualifying drug that is, or will be, introduced for
commercial distribution in a permitted country shall in
accordance with this paragraph submit to the Secretary a
notice that--

``(I) includes each difference in the qualifying drug from
a condition established in the approved application for the
U.S. label drug beyond--

``(aa) the variations provided for in the application; and
``(bb) any difference in labeling (except ingredient
labeling); or

``(II) states that there is no difference in the qualifying
drug from a condition established in the approved application
for the U.S. label drug beyond--

``(aa) the variations provided for in the application; and
``(bb) any difference in labeling (except ingredient
labeling).
``(ii) Information in notice.--A notice under clause (i)(I)
shall include the information that the Secretary may require
under section 506A, any additional information the Secretary
may require (which may include data on bioequivalence if such
data are not

[[Page S2056]]

required under section 506A), and, with respect to the
permitted country that approved the qualifying drug for
commercial distribution, or with respect to which such
approval is sought, include the following:

``(I) The date on which the qualifying drug with such
difference was, or will be, introduced for commercial
distribution in the permitted country.
``(II) Information demonstrating that the person submitting
the notice has also notified the government of the permitted
country in writing that the person is submitting to the
Secretary a notice under clause (i)(I), which notice
describes the difference in the qualifying drug from a
condition established in the approved application for the
U.S. label drug.
``(III) The information that the person submitted or will
submit to the government of the permitted country for
purposes of obtaining approval for commercial distribution of
the drug in the country which, if in a language other than
English, shall be accompanied by an English translation
verified to be complete and accurate, with the name, address,
and a brief statement of the qualifications of the person
that made the translation.

``(iii) Certifications.--The chief executive officer and
the chief medical officer of the manufacturer involved shall
each certify in the notice under clause (i) that--

``(I) the information provided in the notice is complete
and true; and
``(II) a copy of the notice has been provided to the
Federal Trade Commission and to the State attorneys general.

``(iv) Fee.--

``(I) In general.--If a notice submitted under clause (i)
includes a difference that would, under section 506A, require
the submission of a supplemental application if made as a
change to the U.S. label drug, the person that submits the
notice shall pay to the Secretary a fee in the same amount as
would apply if the person were paying a fee pursuant to
section 736(a)(1)(A)(ii). Fees collected by the Secretary
under the preceding sentence are available only to the
Secretary and are for the sole purpose of paying the costs of
reviewing notices submitted under clause (i).
``(II) Fee amount for certain years.--If no fee amount is
in effect under section 736(a)(1)(A)(ii) for a fiscal year,
then the amount paid by a person under subclause (I) shall--

``(aa) for the first fiscal year in which no fee amount
under such section in effect, be equal to the fee amount
under section 736(a)(1)(A)(ii) for the most recent fiscal
year for which such section was in effect, adjusted in
accordance with section 736(c); and
``(bb) for each subsequent fiscal year in which no fee
amount under such section is effect, be equal to the
applicable fee amount for the previous fiscal year, adjusted
in accordance with section 736(c).
``(v) Timing of submission of notices.--

``(I) Prior approval notices.--A notice under clause (i) to
which subparagraph (C) applies shall be submitted to the
Secretary not later than 120 days before the qualifying drug
with the difference is introduced for commercial distribution
in a permitted country, unless the country requires that
distribution of the qualifying drug with the difference begin
less than 120 days after the country requires the difference.
``(II) Other approval notices.--A notice under clause (i)
to which subparagraph (D) applies shall be submitted to the
Secretary not later than the day on which the qualifying drug
with the difference is introduced for commercial distribution
in a permitted country.
``(III) Other notices.--A notice under clause (i) to which
subparagraph (E) applies shall be submitted to the Secretary
on the date that the qualifying drug is first introduced for
commercial distribution in a permitted country and annually
thereafter.

``(vi) Review by secretary.--

``(I) In general.--In this paragraph, the difference in a
qualifying drug that is submitted in a notice under clause
(i) from the U.S. label drug shall be treated by the
Secretary as if it were a manufacturing change to the U.S.
label drug under section 506A.
``(II) Standard of review.--Except as provided in subclause
(III), the Secretary shall review and approve or disapprove
the difference in a notice submitted under clause (i), if
required under section 506A, using the safe and effective
standard for approving or disapproving a manufacturing change
under section 506A.
``(III) Bioequivalence.--If the Secretary would approve the
difference in a notice submitted under clause (i) using the
safe and effective standard under section 506A and if the
Secretary determines that the qualifying drug is not
bioequivalent to the U.S. label drug, the Secretary shall--

``(aa) include in the labeling provided under paragraph (3)
a prominent advisory that the qualifying drug is safe and
effective but is not bioequivalent to the U.S. label drug if
the Secretary determines that such an advisory is necessary
for health care practitioners and patients to use the
qualifying drug safely and effectively; or
``(bb) decline to approve the difference if the Secretary
determines that the availability of both the qualifying drug
and the U.S. label drug would pose a threat to the public
health.

``(IV) Review by the secretary.--The Secretary shall review
and approve or disapprove the difference in a notice
submitted under clause (i), if required under section 506A,
not later than 120 days after the date on which the notice is
submitted.
``(V) Establishment inspection.--If review of such
difference would require an inspection of the establishment
in which the qualifying drug is manufactured--

``(aa) such inspection by the Secretary shall be
authorized; and
``(bb) the Secretary may rely on a satisfactory report of a
good manufacturing practice inspection of the establishment
from a permitted country whose regulatory system the
Secretary recognizes as equivalent under a mutual recognition
agreement, as provided under section 510(i)(3), section 803,
or part 26 of title 21, Code of Federal Regulations (or any
corresponding successor rule or regulation).
``(vii) Publication of information on notices.--

``(I) In general.--Through the Internet website of the Food
and Drug Administration and a toll-free telephone number, the
Secretary shall readily make available to the public a list
of notices submitted under clause (i).
``(II) Contents.--The list under subclause (I) shall
include the date on which a notice is submitted and whether--

``(aa) a notice is under review;
``(bb) the Secretary has ordered that importation of the
qualifying drug from a permitted country cease; or
``(cc) the importation of the drug is permitted under
subsection (a).

``(III) Update.--The Secretary shall promptly update the
Internet website with any changes to the list.

``(C) Notice; drug difference requiring prior approval.--In
the case of a notice under subparagraph (B)(i) that includes
a difference that would, under subsection (c) or (d)(3)(B)(i)
of section 506A, require the approval of a supplemental
application before the difference could be made to the U.S.
label drug the following shall occur:
``(i) Promptly after the notice is submitted, the Secretary
shall notify registered exporters, registered importers, the
Federal Trade Commission, and the State attorneys general
that the notice has been submitted with respect to the
qualifying drug involved.
``(ii) If the Secretary has not made a determination
whether such a supplemental application regarding the U.S.
label drug would be approved or disapproved by the date on
which the qualifying drug involved is to be introduced for
commercial distribution in a permitted country, the Secretary
shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country not begin until the
Secretary completes review of the notice; and
``(II) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the order.

``(iii) If the Secretary determines that such a
supplemental application regarding the U.S. label drug would
not be approved, the Secretary shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country cease, or provide that an
order under clause (ii), if any, remains in effect;
``(II) notify the permitted country that approved the
qualifying drug for commercial distribution of the
determination; and
``(III) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(iv) If the Secretary determines that such a supplemental
application regarding the U.S. label drug would be approved,
the Secretary shall--

``(I) vacate the order under clause (ii), if any;
``(II) consider the difference to be a variation provided
for in the approved application for the U.S. label drug;
``(III) permit importation of the qualifying drug under
subsection (a); and
``(IV) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(D) Notice; drug difference not requiring prior
approval.--In the case of a notice under subparagraph (B)(i)
that includes a difference that would, under section
506A(d)(3)(B)(ii), not require the approval of a supplemental
application before the difference could be made to the U.S.
label drug the following shall occur:
``(i) During the period in which the notice is being
reviewed by the Secretary, the authority under this
subsection to import the qualifying drug involved continues
in effect.
``(ii) If the Secretary determines that such a supplemental
application regarding the U.S. label drug would not be
approved, the Secretary shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country cease;
``(II) notify the permitted country that approved the
qualifying drug for commercial distribution of the
determination; and
``(III) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(iii) If the Secretary determines that such a
supplemental application regarding the U.S. label drug would
be approved, the difference shall be considered to be a
variation provided for in the approved application for the
U.S. label drug.
``(E) Notice; drug difference not requiring approval; no
difference.--In the case of

[[Page S2057]]

a notice under subparagraph (B)(i) that includes a difference
for which, under section 506A(d)(1)(A), a supplemental
application would not be required for the difference to be
made to the U.S. label drug, or that states that there is no
difference, the Secretary--
``(i) shall consider such difference to be a variation
provided for in the approved application for the U.S. label
drug;
``(ii) may not order that the importation of the qualifying
drug involved cease; and
``(iii) shall promptly notify registered exporters and
registered importers.
``(F) Differences in active ingredient, route of
administration, dosage form, or strength.--
``(i) In general.--A person who manufactures a drug
approved under section 505(b) shall submit an application
under section 505(b) for approval of another drug that is
manufactured for distribution in a permitted country by or
for the person that manufactures the drug approved under
section 505(b) if--

``(I) there is no qualifying drug in commercial
distribution in permitted countries whose combined population
represents at least 50 percent of the total population of all
permitted countries with the same active ingredient or
ingredients, route of administration, dosage form, and
strength as the drug approved under section 505(b); and
``(II) each active ingredient of the other drug is related
to an active ingredient of the drug approved under section
505(b), as defined in clause (v).

``(ii) Application under section 505(b).--The application
under section 505(b) required under clause (i) shall--

``(I) request approval of the other drug for the indication
or indications for which the drug approved under section
505(b) is labeled;
``(II) include the information that the person submitted to
the government of the permitted country for purposes of
obtaining approval for commercial distribution of the other
drug in that country, which if in a language other than
English, shall be accompanied by an English translation
verified to be complete and accurate, with the name, address,
and a brief statement of the qualifications of the person
that made the translation;
``(III) include a right of reference to the application for
the drug approved under section 505(b); and
``(IV) include such additional information as the Secretary
may require.

``(iii) Timing of submission of application.--An
application under section 505(b) required under clause (i)
shall be submitted to the Secretary not later than the day on
which the information referred to in clause (ii)(II) is
submitted to the government of the permitted country.
``(iv) Notice of decision on application.--The Secretary
shall promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of a determination to approve or to
disapprove an application under section 505(b) required under
clause (i).
``(v) Related active ingredients.--For purposes of clause
(i)(II), 2 active ingredients are related if they are--

``(I) the same; or
``(II) different salts, esters, or complexes of the same
moiety.

``(3) Section 502; labeling.--
``(A) Importation by registered importer.--
``(i) In general.--In the case of a qualifying drug that is
imported or offered for import by a registered importer, such
drug shall be considered to be in compliance with section 502
and the labeling requirements under the approved application
for the U.S. label drug if the qualifying drug bears--

``(I) a copy of the labeling approved for the U.S. label
drug under section 505, without regard to whether the copy
bears any trademark involved;
``(II) the name of the manufacturer and location of the
manufacturer;
``(III) the lot number assigned by the manufacturer;
``(IV) the name, location, and registration number of the
importer; and
``(V) the National Drug Code number assigned to the
qualifying drug by the Secretary.

``(ii) Request for copy of the labeling.--The Secretary
shall provide such copy to the registered importer involved,
upon request of the importer.
``(iii) Requested labeling.--The labeling provided by the
Secretary under clause (ii) shall--

``(I) include the established name, as defined in section
502(e)(3), for each active ingredient in the qualifying drug;
``(II) not include the proprietary name of the U.S. label
drug or any active ingredient thereof;
``(III) if required under paragraph (2)(B)(vi)(III), a
prominent advisory that the qualifying drug is safe and
effective but not bioequivalent to the U.S. label drug; and
``(IV) if the inactive ingredients of the qualifying drug
are different from the inactive ingredients for the U.S.
label drug, include--

``(aa) a prominent notice that the ingredients of the
qualifying drug differ from the ingredients of the U.S. label
drug and that the qualifying drug must be dispensed with an
advisory to people with allergies about this difference and a
list of ingredients; and
``(bb) a list of the ingredients of the qualifying drug as
would be required under section 502(e).
``(B) Importation by individual.--
``(i) In general.--In the case of a qualifying drug that is
imported or offered for import by a registered exporter to an
individual, such drug shall be considered to be in compliance
with section 502 and the labeling requirements under the
approved application for the U.S. label drug if the packaging
and labeling of the qualifying drug complies with all
applicable regulations promulgated under sections 3 and 4 of
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471
et seq.) and the labeling of the qualifying drug includes--

``(I) directions for use by the consumer;
``(II) the lot number assigned by the manufacturer;
``(III) the name and registration number of the exporter;
``(IV) if required under paragraph (2)(B)(vi)(III), a
prominent advisory that the drug is safe and effective but
not bioequivalent to the U.S. label drug;
``(V) if the inactive ingredients of the drug are different
from the inactive ingredients for the U.S. label drug--

``(aa) a prominent advisory that persons with an allergy
should check the ingredient list of the drug because the
ingredients of the drug differ from the ingredients of the
U.S. label drug; and
``(bb) a list of the ingredients of the drug as would be
required under section 502(e); and

``(VI) a copy of any special labeling that would be
required by the Secretary had the U.S. label drug been
dispensed by a pharmacist in the United States, without
regard to whether the special labeling bears any trademark
involved.

``(ii) Packaging.--A qualifying drug offered for import to
an individual by an exporter under this section that is
packaged in a unit-of-use container (as those items are
defined in the United States Pharmacopeia and National
Formulary) shall not be repackaged, provided that--

``(I) the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
``(II) the consumer consents to waive the requirements of
such Act, after being informed that the packaging does not
comply with such Act and that the exporter will provide the
drug in packaging that is compliant at no additional cost.

``(iii) Request for copy of special labeling and ingredient
list.--The Secretary shall provide to the registered exporter
involved a copy of the special labeling, the advisory, and
the ingredient list described under clause (i), upon request
of the exporter.
``(iv) Requested labeling and ingredient list.--The
labeling and ingredient list provided by the Secretary under
clause (iii) shall--

``(I) include the established name, as defined in section
502(e)(3), for each active ingredient in the drug; and
``(II) not include the proprietary name of the U.S. label
drug or any active ingredient thereof.

``(4) Section 501; adulteration.--A qualifying drug that is
imported or offered for import under subsection (a) shall be
considered to be in compliance with section 501 if the drug
is in compliance with subsection (c).
``(5) Standards for refusing admission.--A drug exported
under subsection (a) from a registered exporter or imported
by a registered importer may be refused admission into the
United States if 1 or more of the following applies:
``(A) The drug is not a qualifying drug.
``(B) A notice for the drug required under paragraph (2)(B)
has not been submitted to the Secretary.
``(C) The Secretary has ordered that importation of the
drug from the permitted country cease under subparagraph (C)
or (D) of paragraph (2).
``(D) The drug does not comply with paragraph (3) or (4).
``(E) The shipping container appears damaged in a way that
may affect the strength, quality, or purity of the drug.
``(F) The Secretary becomes aware that--
``(i) the drug may be counterfeit;
``(ii) the drug may have been prepared, packed, or held
under insanitary conditions; or
``(iii) the methods used in, or the facilities or controls
used for, the manufacturing, processing, packing, or holding
of the drug do not conform to good manufacturing practice.
``(G) The Secretary has obtained an injunction under
section 302 that prohibits the distribution of the drug in
interstate commerce.
``(H) The Secretary has under section 505(e) withdrawn
approval of the drug.
``(I) The manufacturer of the drug has instituted a recall
of the drug.
``(J) If the drug is imported or offered for import by a
registered importer without submission of a notice in
accordance with subsection (d)(4).
``(K) If the drug is imported or offered for import from a
registered exporter to an individual and 1 or more of the
following applies:
``(i) The shipping container for such drug does not bear
the markings required under subsection (d)(2).
``(ii) The markings on the shipping container appear to be
counterfeit.
``(iii) The shipping container or markings appear to have
been tampered with.
``(h) Exporter Licensure in Permitted Country.--A
registration condition is that

[[Page S2058]]

the exporter involved agrees that a qualifying drug will be
exported to an individual only if the Secretary has verified
that--
``(1) the exporter is authorized under the law of the
permitted country in which the exporter is located to
dispense prescription drugs; and
``(2) the exporter employs persons that are licensed under
the law of the permitted country in which the exporter is
located to dispense prescription drugs in sufficient number
to dispense safely the drugs exported by the exporter to
individuals, and the exporter assigns to those persons
responsibility for dispensing such drugs to individuals.
``(i) Individuals; Conditions for Importation.--
``(1) In general.--For purposes of subsection (a)(2)(B),
the importation of a qualifying drug by an individual is in
accordance with this subsection if the following conditions
are met:
``(A) The drug is accompanied by a copy of a prescription
for the drug, which prescription--
``(i) is valid under applicable Federal and State laws; and
``(ii) was issued by a practitioner who, under the law of a
State of which the individual is a resident, or in which the
individual receives care from the practitioner who issues the
prescription, is authorized to administer prescription drugs.
``(B) The drug is accompanied by a copy of the
documentation that was required under the law or regulations
of the permitted country in which the exporter is located, as
a condition of dispensing the drug to the individual.
``(C) The copies referred to in subparagraphs (A)(i) and
(B) are marked in a manner sufficient--
``(i) to indicate that the prescription, and the equivalent
document in the permitted country in which the exporter is
located, have been filled; and
``(ii) to prevent a duplicative filling by another
pharmacist.
``(D) The individual has provided to the registered
exporter a complete list of all drugs used by the individual
for review by the individuals who dispense the drug.
``(E) The quantity of the drug does not exceed a 90-day
supply.
``(F) The drug is not an ineligible subpart H drug. For
purposes of this section, a prescription drug is an
`ineligible subpart H drug' if the drug was approved by the
Secretary under subpart H of part 314 of title 21, Code of
Federal Regulations (relating to accelerated approval), with
restrictions under section 520 of such part to assure safe
use, and the Secretary has published in the Federal Register
a notice that the Secretary has determined that good cause
exists to prohibit the drug from being imported pursuant to
this subsection.
``(2) Notice regarding drug refused admission.--If a
registered exporter ships a drug to an individual pursuant to
subsection (a)(2)(B) and the drug is refused admission to the
United States, a written notice shall be sent to the
individual and to the exporter that informs the individual
and the exporter of such refusal and the reason for the
refusal.
``(j) Maintenance of Records and Samples.--
``(1) In general.--A registration condition is that the
importer or exporter involved shall--
``(A) maintain records required under this section for not
less than 2 years; and
``(B) maintain samples of each lot of a qualifying drug
required under this section for not more than 2 years.
``(2) Place of record maintenance.--The records described
under paragraph (1) shall be maintained--
``(A) in the case of an importer, at the place of business
of the importer at which the importer initially receives the
qualifying drug after importation; or
``(B) in the case of an exporter, at the facility from
which the exporter ships the qualifying drug to the United
States.
``(k) Drug Recalls.--
``(1) Manufacturers.--A person that manufactures a
qualifying drug imported from a permitted country under this
section shall promptly inform the Secretary--
``(A) if the drug is recalled or withdrawn from the market
in a permitted country;
``(B) how the drug may be identified, including lot number;
and
``(C) the reason for the recall or withdrawal.
``(2) Secretary.--With respect to each permitted country,
the Secretary shall--
``(A) enter into an agreement with the government of the
country to receive information about recalls and withdrawals
of qualifying drugs in the country; or
``(B) monitor recalls and withdrawals of qualifying drugs
in the country using any information that is available to the
public in any media.
``(3) Notice.--The Secretary may notify, as appropriate,
registered exporters, registered importers, wholesalers,
pharmacies, or the public of a recall or withdrawal of a
qualifying drug in a permitted country.
``(l) Drug Labeling and Packaging.--
``(1) In general.--When a qualifying drug that is imported
into the United States by an importer under subsection (a) is
dispensed by a pharmacist to an individual, the pharmacist
shall provide that the packaging and labeling of the drug
complies with all applicable regulations promulgated under
sections 3 and 4 of the Poison Prevention Packaging Act of
1970 (15 U.S.C. 1471 et seq.) and shall include with any
other labeling provided to the individual the following:
``(A) The lot number assigned by the manufacturer.
``(B) The name and registration number of the importer.
``(C) If required under paragraph (2)(B)(vi)(III) of
subsection (g), a prominent advisory that the drug is safe
and effective but not bioequivalent to the U.S. label drug.
``(D) If the inactive ingredients of the drug are different
from the inactive ingredients for the U.S. label drug--
``(i) a prominent advisory that persons with allergies
should check the ingredient list of the drug because the
ingredients of the drug differ from the ingredients of the
U.S. label drug; and
``(ii) a list of the ingredients of the drug as would be
required under section 502(e).
``(2) Packaging.--A qualifying drug that is packaged in a
unit-of-use container (as those terms are defined in the
United States Pharmacopeia and National Formulary) shall not
be repackaged, provided that--
``(A) the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
``(B) the consumer consents to waive the requirements of
such Act, after being informed that the packaging does not
comply with such Act and that the pharmacist will provide the
drug in packaging that is compliant at no additional cost.
``(m) Charitable Contributions.--Notwithstanding any other
provision of this section, this section does not authorize
the importation into the United States of a qualifying drug
donated or otherwise supplied for free or at nominal cost by
the manufacturer of the drug to a charitable or humanitarian
organization, including the United Nations and affiliates, or
to a government of a foreign country.
``(n) Unfair and Discriminatory Acts and Practices.--
``(1) In general.--It is unlawful for a manufacturer,
directly or indirectly (including by being a party to a
licensing agreement or other agreement), to--
``(A) discriminate by charging a higher price for a
prescription drug sold to a registered exporter or other
person in a permitted country that exports a qualifying drug
to the United States under this section than the price that
is charged, inclusive of rebates or other incentives to the
permitted country or other person, to another person that is
in the same country and that does not export a qualifying
drug into the United States under this section;
``(B) discriminate by charging a higher price for a
prescription drug sold to a registered importer or other
person that distributes, sells, or uses a qualifying drug
imported into the United States under this section than the
price that is charged to another person in the United States
that does not import a qualifying drug under this section, or
that does not distribute, sell, or use such a drug;
``(C) discriminate by denying, restricting, or delaying
supplies of a prescription drug to a registered exporter or
other person in a permitted country that exports a qualifying
drug to the United States under this section or to a
registered importer or other person that distributes, sells,
or uses a qualifying drug imported into the United States
under this section;
``(D) discriminate by publicly, privately, or otherwise
refusing to do business with a registered exporter or other
person in a permitted country that exports a qualifying drug
to the United States under this section or with a registered
importer or other person that distributes, sells, or uses a
qualifying drug imported into the United States under this
section;
``(E) knowingly fail to submit a notice under subsection
(g)(2)(B)(i), knowingly fail to submit such a notice on or
before the date specified in subsection (g)(2)(B)(v) or as
otherwise required under paragraphs (3), (4), and (5) of
section 3004(e) of the Pharmaceutical Market Access and Drug
Safety Act of 2010, knowingly submit such a notice that makes
a materially false, fictitious, or fraudulent statement, or
knowingly fail to provide promptly any information requested
by the Secretary to review such a notice;
``(F) knowingly fail to submit an application required
under subsection (g)(2)(F), knowingly fail to submit such an
application on or before the date specified in subsection
(g)(2)(F)(iii), knowingly submit such an application that
makes a materially false, fictitious, or fraudulent
statement, or knowingly fail to provide promptly any
information requested by the Secretary to review such an
application;
``(G) cause there to be a difference (including a
difference in active ingredient, route of administration,
dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and the drug for
distribution in a permitted country;
``(H) refuse to allow an inspection authorized under this
section of an establishment that manufactures a qualifying
drug that is, or will be, introduced for commercial
distribution in a permitted country;
``(I) fail to conform to the methods used in, or the
facilities used for, the manufacturing, processing, packing,
or holding of a qualifying drug that is, or will be,
introduced for commercial distribution in a permitted country
to good manufacturing practice under this Act;

[[Page S2059]]

``(J) become a party to a licensing agreement or other
agreement related to a qualifying drug that fails to provide
for compliance with all requirements of this section with
respect to such drug;
``(K) enter into a contract that restricts, prohibits, or
delays the importation of a qualifying drug under this
section;
``(L) engage in any other action to restrict, prohibit, or
delay the importation of a qualifying drug under this
section; or
``(M) engage in any other action that the Federal Trade
Commission determines to discriminate against a person that
engages or attempts to engage in the importation of a
qualifying drug under this section.
``(2) Referral of potential violations.--The Secretary
shall promptly refer to the Federal Trade Commission each
potential violation of subparagraph (E), (F), (G), (H), or
(I) of paragraph (1) that becomes known to the Secretary.
``(3) Affirmative defense.--
``(A) Discrimination.--It shall be an affirmative defense
to a charge that a manufacturer has discriminated under
subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that
the higher price charged for a prescription drug sold to a
person, the denial, restriction, or delay of supplies of a
prescription drug to a person, the refusal to do business
with a person, or other discriminatory activity against a
person, is not based, in whole or in part, on--
``(i) the person exporting or importing a qualifying drug
into the United States under this section; or
``(ii) the person distributing, selling, or using a
qualifying drug imported into the United States under this
section.
``(B) Drug differences.--It shall be an affirmative defense
to a charge that a manufacturer has caused there to be a
difference described in subparagraph (G) of paragraph (1)
that--
``(i) the difference was required by the country in which
the drug is distributed;
``(ii) the Secretary has determined that the difference was
necessary to improve the safety or effectiveness of the drug;
``(iii) the person manufacturing the drug for distribution
in the United States has given notice to the Secretary under
subsection (g)(2)(B)(i) that the drug for distribution in the
United States is not different from a drug for distribution
in permitted countries whose combined population represents
at least 50 percent of the total population of all permitted
countries; or
``(iv) the difference was not caused, in whole or in part,
for the purpose of restricting importation of the drug into
the United States under this section.
``(4) Effect of subsection.--
``(A) Sales in other countries.--This subsection applies
only to the sale or distribution of a prescription drug in a
country if the manufacturer of the drug chooses to sell or
distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a
drug to distribute or sell the drug in a country.
``(B) Discounts to insurers, health plans, pharmacy benefit
managers, and covered entities.--Nothing in this subsection
shall be construed to--
``(i) prevent or restrict a manufacturer of a prescription
drug from providing discounts to an insurer, health plan,
pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B of the
Public Health Service Act (42 U.S.C. 256b) in return for
inclusion of the drug on a formulary;
``(ii) require that such discounts be made available to
other purchasers of the prescription drug; or
``(iii) prevent or restrict any other measures taken by an
insurer, health plan, or pharmacy benefit manager to
encourage consumption of such prescription drug.
``(C) Charitable contributions.--Nothing in this subsection
shall be construed to--
``(i) prevent a manufacturer from donating a prescription
drug, or supplying a prescription drug at nominal cost, to a
charitable or humanitarian organization, including the United
Nations and affiliates, or to a government of a foreign
country; or
``(ii) apply to such donations or supplying of a
prescription drug.
``(5) Enforcement.--
``(A) Unfair or deceptive act or practice.--A violation of
this subsection shall be treated as a violation of a rule
defining an unfair or deceptive act or practice prescribed
under section 18(a)(1)(B) of the Federal Trade Commission Act
(15 U.S.C. 57a(a)(1)(B)).
``(B) Actions by the commission.--The Federal Trade
Commission--
``(i) shall enforce this subsection in the same manner, by
the same means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of the
Federal Trade Commission Act (15 U.S.C. 41 et seq.) were
incorporated into and made a part of this section; and
``(ii) may seek monetary relief threefold the damages
sustained, in addition to any other remedy available to the
Federal Trade Commission under the Federal Trade Commission
Act (15 U.S.C. 41 et seq.).
``(6) Actions by states.--
``(A) In general.--
``(i) Civil actions.--In any case in which the attorney
general of a State has reason to believe that an interest of
the residents of that State have been adversely affected by
any manufacturer that violates paragraph (1), the attorney
general of a State may bring a civil action on behalf of the
residents of the State, and persons doing business in the
State, in a district court of the United States of
appropriate jurisdiction to--

``(I) enjoin that practice;
``(II) enforce compliance with this subsection;
``(III) obtain damages, restitution, or other compensation
on behalf of residents of the State and persons doing
business in the State, including threefold the damages; or
``(IV) obtain such other relief as the court may consider
to be appropriate.

``(ii) Notice.--

``(I) In general.--Before filing an action under clause
(i), the attorney general of the State involved shall provide
to the Federal Trade Commission--

``(aa) written notice of that action; and
``(bb) a copy of the complaint for that action.

``(II) Exemption.--Subclause (I) shall not apply with
respect to the filing of an action by an attorney general of
a State under this paragraph, if the attorney general
determines that it is not feasible to provide the notice
described in that subclause before filing of the action. In
such case, the attorney general of a State shall provide
notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the
action.

``(B) Intervention.--
``(i) In general.--On receiving notice under subparagraph
(A)(ii), the Federal Trade Commission shall have the right to
intervene in the action that is the subject of the notice.
``(ii) Effect of intervention.--If the Federal Trade
Commission intervenes in an action under subparagraph (A), it
shall have the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(C) Construction.--For purposes of bringing any civil
action under subparagraph (A), nothing in this subsection
shall be construed to prevent an attorney general of a State
from exercising the powers conferred on the attorney general
by the laws of that State to--
``(i) conduct investigations;
``(ii) administer oaths or affirmations; or
``(iii) compel the attendance of witnesses or the
production of documentary and other evidence.
``(D) Actions by the commission.--In any case in which an
action is instituted by or on behalf of the Federal Trade
Commission for a violation of paragraph (1), a State may not,
during the pendency of that action, institute an action under
subparagraph (A) for the same violation against any defendant
named in the complaint in that action.
``(E) Venue.--Any action brought under subparagraph (A) may
be brought in the district court of the United States that
meets applicable requirements relating to venue under section
1391 of title 28, United States Code.
``(F) Service of process.--In an action brought under
subparagraph (A), process may be served in any district in
which the defendant--
``(i) is an inhabitant; or
``(ii) may be found.
``(G) Measurement of damages.--In any action under this
paragraph to enforce a cause of action under this subsection
in which there has been a determination that a defendant has
violated a provision of this subsection, damages may be
proved and assessed in the aggregate by statistical or
sampling methods, by the computation of illegal overcharges
or by such other reasonable system of estimating aggregate
damages as the court in its discretion may permit without the
necessity of separately proving the individual claim of, or
amount of damage to, persons on whose behalf the suit was
brought.
``(H) Exclusion on duplicative relief.--The district court
shall exclude from the amount of monetary relief awarded in
an action under this paragraph brought by the attorney
general of a State any amount of monetary relief which
duplicates amounts which have been awarded for the same
injury.
``(7) Effect on antitrust laws.--Nothing in this subsection
shall be construed to modify, impair, or supersede the
operation of the antitrust laws. For the purpose of this
subsection, the term `antitrust laws' has the meaning given
it in the first section of the Clayton Act, except that it
includes section 5 of the Federal Trade Commission Act to the
extent that such section 5 applies to unfair methods of
competition.
``(8) Manufacturer.--In this subsection, the term
`manufacturer' means any entity, including any affiliate or
licensee of that entity, that is engaged in--
``(A) the production, preparation, propagation,
compounding, conversion, or processing of a prescription
drug, either directly or indirectly by extraction from
substances of natural origin, or independently by means of
chemical synthesis, or by a combination of extraction and
chemical synthesis; or
``(B) the packaging, repackaging, labeling, relabeling, or
distribution of a prescription drug.''.
(b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 301 (21 U.S.C. 331), by striking paragraph
(aa) and inserting the following:
``(aa)(1) The sale or trade by a pharmacist, or by a
business organization of which the pharmacist is a part, of a
qualifying drug that under section 804(a)(2)(A) was imported
by the pharmacist, other than--

[[Page S2060]]

``(A) a sale at retail made pursuant to dispensing the drug
to a customer of the pharmacist or organization; or
``(B) a sale or trade of the drug to a pharmacy or a
wholesaler registered to import drugs under section 804.
``(2) The sale or trade by an individual of a qualifying
drug that under section 804(a)(2)(B) was imported by the
individual.
``(3) The making of a materially false, fictitious, or
fraudulent statement or representation, or a material
omission, in a notice under clause (i) of section
804(g)(2)(B) or in an application required under section
804(g)(2)(F), or the failure to submit such a notice or
application.
``(4) The importation of a drug in violation of a
registration condition or other requirement under section
804, the falsification of any record required to be
maintained, or provided to the Secretary, under such section,
or the violation of any registration condition or other
requirement under such section.''; and
(2) in section 303(a) (21 U.S.C. 333(a)), by striking
paragraph (6) and inserting the following:
``(6) Notwithstanding subsection (a), any person that
knowingly violates section 301(i) (2) or (3) or section
301(aa)(4) shall be imprisoned not more than 10 years, or
fined in accordance with title 18, United States Code, or
both.''.
(c) Amendment of Certain Provisions.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by striking
subsection (g) and inserting the following:
``(g) With respect to a prescription drug that is imported
or offered for import into the United States by an individual
who is not in the business of such importation, that is not
shipped by a registered exporter under section 804, and that
is refused admission under subsection (a), the Secretary
shall notify the individual that--
``(1) the drug has been refused admission because the drug
was not a lawful import under section 804;
``(2) the drug is not otherwise subject to a waiver of the
requirements of subsection (a);
``(3) the individual may under section 804 lawfully import
certain prescription drugs from exporters registered with the
Secretary under section 804; and
``(4) the individual can find information about such
importation, including a list of registered exporters, on the
Internet website of the Food and Drug Administration or
through a toll-free telephone number required under section
804.''.
(2) Establishment registration.--Section 510(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is
amended in paragraph (1) by inserting after ``import into the
United States'' the following: ``, including a drug that is,
or may be, imported or offered for import into the United
States under section 804,''.
(3) Effective date.--The amendments made by this subsection
shall take effect on the date that is 90 days after the date
of enactment of this Act.
(d) Exhaustion.--
(1) In general.--Section 271 of title 35, United States
Code, is amended--
(A) by redesignating subsections (h) and (i) as (i) and
(j), respectively; and
(B) by inserting after subsection (g) the following:
``(h) It shall not be an act of infringement to use, offer
to sell, or sell within the United States or to import into
the United States any patented invention under section 804 of
the Federal Food, Drug, and Cosmetic Act that was first sold
abroad by or under authority of the owner or licensee of such
patent.''.
(2) Rule of construction.--Nothing in the amendment made by
paragraph (1) shall be construed to affect the ability of a
patent owner or licensee to enforce their patent, subject to
such amendment.
(e) Effect of Section 804.--
(1) In general.--Section 804 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall permit the
importation of qualifying drugs (as defined in such section
804) into the United States without regard to the status of
the issuance of implementing regulations--
(A) from exporters registered under such section 804 on the
date that is 90 days after the date of enactment of this Act;
and
(B) from permitted countries, as defined in such section
804, by importers registered under such section 804 on the
date that is 1 year after the date of enactment of this Act.
(2) Review of registration by certain exporters.--
(A) Review priority.--In the review of registrations
submitted under subsection (b) of such section 804,
registrations submitted by entities in Canada that are
significant exporters of prescription drugs to individuals in
the United States as of the date of enactment of this Act
will have priority during the 90 day period that begins on
such date of enactment.
(B) Period for review.--During such 90-day period, the
reference in subsection (b)(2)(A) of such section 804 to 90
days (relating to approval or disapproval of registrations)
is, as applied to such entities, deemed to be 30 days.
(C) Limitation.--That an exporter in Canada exports, or has
exported, prescription drugs to individuals in the United
States on or before the date that is 90 days after the date
of enactment of this Act shall not serve as a basis, in whole
or in part, for disapproving a registration under such
section 804 from the exporter.
(D) First year limit on number of exporters.--During the 1-
year period beginning on the date of enactment of this Act,
the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') may limit the number of
registered exporters under such section 804 to not less than
50, so long as the Secretary gives priority to those
exporters with demonstrated ability to process a high volume
of shipments of drugs to individuals in the United States.
(E) Second year limit on number of exporters.--During the
1-year period beginning on the date that is 1 year after the
date of enactment of this Act, the Secretary may limit the
number of registered exporters under such section 804 to not
less than 100, so long as the Secretary gives priority to
those exporters with demonstrated ability to process a high
volume of shipments of drugs to individuals in the United
States.
(F) Further limit on number of exporters.--During any 1-
year period beginning on a date that is 2 or more years after
the date of enactment of this Act, the Secretary may limit
the number of registered exporters under such section 804 to
not less than 25 more than the number of such exporters
during the previous 1-year period, so long as the Secretary
gives priority to those exporters with demonstrated ability
to process a high volume of shipments of drugs to individuals
in the United States.
(3) Limits on number of importers.--
(A) First year limit on number of importers.--During the 1-
year period beginning on the date that is 1 year after the
date of enactment of this Act, the Secretary may limit the
number of registered importers under such section 804 to not
less than 100 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with demonstrated
ability to process a high volume of shipments of drugs
imported into the United States.
(B) Second year limit on number of importers.--During the
1-year period beginning on the date that is 2 years after the
date of enactment of this Act, the Secretary may limit the
number of registered importers under such section 804 to not
less than 200 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with demonstrated
ability to process a high volume of shipments of drugs into
the United States.
(C) Further limit on number of importers.--During any 1-
year period beginning on a date that is 3 or more years after
the date of enactment of this Act, the Secretary may limit
the number of registered importers under such section 804 to
not less than 50 more (of which at least a significant number
shall be groups of pharmacies, to the extent feasible given
the applications submitted by such groups) than the number of
such importers during the previous 1-year period, so long as
the Secretary gives priority to those importers with
demonstrated ability to process a high volume of shipments of
drugs to the United States.
(4) Notices for drugs for import from canada.--The notice
with respect to a qualifying drug introduced for commercial
distribution in Canada as of the date of enactment of this
Act that is required under subsection (g)(2)(B)(i) of such
section 804 shall be submitted to the Secretary not later
than 30 days after the date of enactment of this Act if--
(A) the U.S. label drug (as defined in such section 804)
for the qualifying drug is 1 of the 100 prescription drugs
with the highest dollar volume of sales in the United States
based on the 12 calendar month period most recently completed
before the date of enactment of this Act; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(5) Notice for drugs for import from other countries.--The
notice with respect to a qualifying drug introduced for
commercial distribution in a permitted country other than
Canada as of the date of enactment of this Act that is
required under subsection (g)(2)(B)(i) of such section 804
shall be submitted to the Secretary not later than 180 days
after the date of enactment of this Act if--
(A) the U.S. label drug for the qualifying drug is 1 of the
100 prescription drugs with the highest dollar volume of
sales in the United States based on the 12 calendar month
period that is first completed on the date that is 120 days
after the date of enactment of this Act; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(6) Notice for other drugs for import.--
(A) Guidance on submission dates.--The Secretary shall by
guidance establish a series of submission dates for the
notices under subsection (g)(2)(B)(i) of such section 804
with respect to qualifying drugs introduced for commercial
distribution as of the date of enactment of this Act and that
are not required to be submitted under paragraph (4) or (5).
(B) Consistent and efficient use of resources.--The
Secretary shall establish the dates described under
subparagraph (A) so that such notices described under
subparagraph (A) are submitted and reviewed at a rate that
allows consistent and efficient use of the resources and
staff available to the

[[Page S2061]]

Secretary for such reviews. The Secretary may condition the
requirement to submit such a notice, and the review of such a
notice, on the submission by a registered exporter or a
registered importer to the Secretary of a notice that such
exporter or importer intends to import such qualifying drug
to the United States under such section 804.
(C) Priority for drugs with higher sales.--The Secretary
shall establish the dates described under subparagraph (A) so
that the Secretary reviews the notices described under such
subparagraph with respect to qualifying drugs with higher
dollar volume of sales in the United States before the
notices with respect to drugs with lower sales in the United
States.
(7) Notices for drugs approved after effective date.--The
notice required under subsection (g)(2)(B)(i) of such section
804 for a qualifying drug first introduced for commercial
distribution in a permitted country (as defined in such
section 804) after the date of enactment of this Act shall be
submitted to and reviewed by the Secretary as provided under
subsection (g)(2)(B) of such section 804, without regard to
paragraph (4), (5), or (6).
(8) Report.--Beginning with the first full fiscal year
after the date of enactment of this Act, not later than 90
days after the end of each fiscal year during which the
Secretary reviews a notice referred to in paragraph (4), (5),
or (6), the Secretary shall submit a report to Congress
concerning the progress of the Food and Drug Administration
in reviewing the notices referred to in paragraphs (4), (5),
and (6).
(9) User fees.--
(A) Exporters.--When establishing an aggregate total of
fees to be collected from exporters under subsection (f)(2)
of such section 804, the Secretary shall, under subsection
(f)(3)(C)(i) of such section 804, estimate the total price of
drugs imported under subsection (a) of such section 804 into
the United States by registered exporters during the first
fiscal year in which this title takes effect to be an amount
equal to the amount which bears the same ratio to
$1,000,000,000 as the number of days in such fiscal year
during which this title is effective bears to 365.
(B) Importers.--When establishing an aggregate total of
fees to be collected from importers under subsection (e)(2)
of such section 804, the Secretary shall, under subsection
(e)(3)(C)(i) of such section 804, estimate the total price of
drugs imported under subsection (a) of such section 804 into
the United States by registered importers during--
(i) the first fiscal year in which this title takes effect
to be an amount equal to the amount which bears the same
ratio to $1,000,000,000 as the number of days in such fiscal
year during which this title is effective bears to 365; and
(ii) the second fiscal year in which this title is in
effect to be $3,000,000,000.
(C) Second year adjustment.--
(i) Reports.--Not later than February 20 of the second
fiscal year in which this title is in effect, registered
importers shall report to the Secretary the total price and
the total volume of drugs imported to the United States by
the importer during the 4-month period from October 1 through
January 31 of such fiscal year.
(ii) Reestimate.--Notwithstanding subsection (e)(3)(C)(ii)
of such section 804 or subparagraph (B), the Secretary shall
reestimate the total price of qualifying drugs imported under
subsection (a) of such section 804 into the United States by
registered importers during the second fiscal year in which
this title is in effect. Such reestimate shall be equal to--

(I) the total price of qualifying drugs imported by each
importer as reported under clause (i); multiplied by
(II) 3.

(iii) Adjustment.--The Secretary shall adjust the fee due
on April 1 of the second fiscal year in which this title is
in effect, from each importer so that the aggregate total of
fees collected under subsection (e)(2) for such fiscal year
does not exceed the total price of qualifying drugs imported
under subsection (a) of such section 804 into the United
States by registered importers during such fiscal year as
reestimated under clause (ii).
(D) Failure to pay fees.--Notwithstanding any other
provision of this section, the Secretary may prohibit a
registered importer or exporter that is required to pay user
fees under subsection (e) or (f) of such section 804 and that
fails to pay such fees within 30 days after the date on which
it is due, from importing or offering for importation a
qualifying drug under such section 804 until such fee is
paid.
(E) Annual report.--
(i) Food and drug administration.--Not later than 180 days
after the end of each fiscal year during which fees are
collected under subsection (e), (f), or (g)(2)(B)(iv) of such
section 804, the Secretary shall prepare and submit to the
House of Representatives and the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for the fiscal year for which the
report is made and credited to the Food and Drug
Administration.
(ii) Customs and border protection.--Not later than 180
days after the end of each fiscal year during which fees are
collected under subsection (e) or (f) of such section 804,
the Secretary of Homeland Security, in consultation with the
Secretary of the Treasury, shall prepare and submit to the
House of Representatives and the Senate a report on the use,
by the Bureau of Customs and Border Protection, of the fees,
if any, transferred by the Secretary to the Bureau of Customs
and Border Protection for the fiscal year for which the
report is made.
(10) Special rule regarding importation by individuals.--
(A) In general.--Notwithstanding any provision of this
title (or an amendment made by this title), the Secretary
shall expedite the designation of any additional permitted
countries from which an individual may import a qualifying
drug into the United States under such section 804 if any
action implemented by the Government of Canada has the effect
of limiting or prohibiting the importation of qualifying
drugs into the United States from Canada.
(B) Timing and criteria.--The Secretary shall designate
such additional permitted countries under subparagraph (A)--
(i) not later than 6 months after the date of the action by
the Government of Canada described under such subparagraph;
and
(ii) using the criteria described under subsection
(a)(4)(D)(i)(II) of such section 804.
(f) Implementation of Section 804.--
(1) Interim rule.--The Secretary may promulgate an interim
rule for implementing section 804 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a) of this section.
(2) No notice of proposed rulemaking.--The interim rule
described under paragraph (1) may be developed and
promulgated by the Secretary without providing general notice
of proposed rulemaking.
(3) Final rule.--Not later than 1 year after the date on
which the Secretary promulgates an interim rule under
paragraph (1), the Secretary shall, in accordance with
procedures under section 553 of title 5, United States Code,
promulgate a final rule for implementing such section 804,
which may incorporate by reference provisions of the interim
rule provided for under paragraph (1), to the extent that
such provisions are not modified.
(g) Consumer Education.--The Secretary shall carry out
activities that educate consumers--
(1) with regard to the availability of qualifying drugs for
import for personal use from an exporter registered with and
approved by the Food and Drug Administration under section
804 of the Federal Food, Drug, and Cosmetic Act, as added by
this section, including information on how to verify whether
an exporter is registered and approved by use of the Internet
website of the Food and Drug Administration and the toll-free
telephone number required by this title;
(2) that drugs that consumers attempt to import from an
exporter that is not registered with and approved by the Food
and Drug Administration can be seized by the United States
Customs Service and destroyed, and that such drugs may be
counterfeit, unapproved, unsafe, or ineffective;
(3) with regard to the suspension and termination of any
registration of a registered importer or exporter under such
section 804; and
(4) with regard to the availability at domestic retail
pharmacies of qualifying drugs imported under such section
804 by domestic wholesalers and pharmacies registered with
and approved by the Food and Drug Administration.
(h) Effect on Administration Practices.--Notwithstanding
any provision of this title (and the amendments made by this
title), the practices and policies of the Food and Drug
Administration and Bureau of Customs and Border Protection,
in effect on January 1, 2004, with respect to the importation
of prescription drugs into the United States by an
individual, on the person of such individual, for personal
use, shall remain in effect.
(i) Report to Congress.--The Federal Trade Commission
shall, on an annual basis, submit to Congress a report that
describes any action taken during the period for which the
report is being prepared to enforce the provisions of section
804(n) of the Federal Food, Drug, and Cosmetic Act (as added
by this title), including any pending investigations or civil
actions under such section.

SEC. 3005. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO
UNITED STATES.

(a) In General.--Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by
section 3004, is further amended by adding at the end the
following section:

``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

``(a) In General.--The Secretary of Homeland Security shall
deliver to the Secretary a shipment of drugs that is imported
or offered for import into the United States if--
``(1) the shipment has a declared value of less than
$10,000; and
``(2)(A) the shipping container for such drugs does not
bear the markings required under section 804(d)(2); or
``(B) the Secretary has requested delivery of such shipment
of drugs.
``(b) No Bond or Export.--Section 801(b) does not authorize
the delivery to the owner or consignee of drugs delivered to
the Secretary under subsection (a) pursuant to the execution
of a bond, and such drugs may not be exported.
``(c) Destruction of Violative Shipment.--The Secretary
shall destroy a shipment of drugs delivered by the Secretary
of Homeland Security to the Secretary under subsection (a)
if--

[[Page S2062]]

``(1) in the case of drugs that are imported or offered for
import from a registered exporter under section 804, the
drugs are in violation of any standard described in section
804(g)(5); or
``(2) in the case of drugs that are not imported or offered
for import from a registered exporter under section 804, the
drugs are in violation of a standard referred to in section
801(a) or 801(d)(1).
``(d) Certain Procedures.--
``(1) In general.--The delivery and destruction of drugs
under this section may be carried out without notice to the
importer, owner, or consignee of the drugs except as required
by section 801(g) or section 804(i)(2). The issuance of
receipts for the drugs, and recordkeeping activities
regarding the drugs, may be carried out on a summary basis.
``(2) Objective of procedures.--Procedures promulgated
under paragraph (1) shall be designed toward the objective of
ensuring that, with respect to efficiently utilizing Federal
resources available for carrying out this section, a
substantial majority of shipments of drugs subject to
described in subsection (c) are identified and destroyed.
``(e) Evidence Exception.--Drugs may not be destroyed under
subsection (c) to the extent that the Attorney General of the
United States determines that the drugs should be preserved
as evidence or potential evidence with respect to an offense
against the United States.
``(f) Rule of Construction.--This section may not be
construed as having any legal effect on applicable law with
respect to a shipment of drugs that is imported or offered
for import into the United States and has a declared value
equal to or greater than $10,000.''.
(b) Procedures.--Procedures for carrying out section 805 of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), shall be established not later than 90 days
after the date of the enactment of this Act.
(c) Effective Date.--The amendments made by this section
shall take effect on the date that is 90 days after the date
of enactment of this Act.

SEC. 3006. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS
REGARDING PRIOR SALE, PURCHASE, OR TRADE.

(a) Striking of Exemptions; Applicability to Registered
Exporters.--Section 503(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(e)) is amended--
(1) in paragraph (1)--
(A) by striking ``and who is not the manufacturer or an
authorized distributor of record of such drug'';
(B) by striking ``to an authorized distributor of record
or''; and
(C) by striking subparagraph (B) and inserting the
following:
``(B) The fact that a drug subject to subsection (b) is
exported from the United States does not with respect to such
drug exempt any person that is engaged in the business of the
wholesale distribution of the drug from providing the
statement described in subparagraph (A) to the person that
receives the drug pursuant to the export of the drug.
``(C)(i) The Secretary shall by regulation establish
requirements that supersede subparagraph (A) (referred to in
this subparagraph as `alternative requirements') to identify
the chain of custody of a drug subject to subsection (b) from
the manufacturer of the drug throughout the wholesale
distribution of the drug to a pharmacist who intends to sell
the drug at retail if the Secretary determines that the
alternative requirements, which may include standardized
anti-counterfeiting or track-and-trace technologies, will
identify such chain of custody or the identity of the
discrete package of the drug from which the drug is dispensed
with equal or greater certainty to the requirements of
subparagraph (A), and that the alternative requirements are
economically and technically feasible.
``(ii) When the Secretary promulgates a final rule to
establish such alternative requirements, the final rule in
addition shall, with respect to the registration condition
established in clause (i) of section 804(c)(3)(B), establish
a condition equivalent to the alternative requirements, and
such equivalent condition may be met in lieu of the
registration condition established in such clause (i).'';
(2) in paragraph (2)(A), by adding at the end the
following: ``The preceding sentence may not be construed as
having any applicability with respect to a registered
exporter under section 804.''; and
(3) in paragraph (3), by striking ``and subsection (d)--''
in the matter preceding subparagraph (A) and all that follows
through ``the term `wholesale distribution' means'' in
subparagraph (B) and inserting the following: ``and
subsection (d), the term `wholesale distribution' means''.
(b) Conforming Amendment.--Section 503(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by
adding at the end the following:
``(4) Each manufacturer of a drug subject to subsection (b)
shall maintain at its corporate offices a current list of the
authorized distributors of record of such drug.
``(5) For purposes of this subsection, the term `authorized
distributors of record' means those distributors with whom a
manufacturer has established an ongoing relationship to
distribute such manufacturer's products.''.
(c) Effective Date.--
(1) In general.--The amendments made by paragraphs (1) and
(3) of subsection (a) and by subsection (b) shall take effect
on January 1, 2012.
(2) Drugs imported by registered importers under section
804.--Notwithstanding paragraph (1), the amendments made by
paragraphs (1) and (3) of subsection (a) and by subsection
(b) shall take effect on the date that is 90 days after the
date of enactment of this Act with respect to qualifying
drugs imported under section 804 of the Federal Food, Drug,
and Cosmetic Act, as added by section 3004.
(3) Effect with respect to registered exporters.--The
amendment made by subsection (a)(2) shall take effect on the
date that is 90 days after the date of enactment of this Act.
(4) Alternative requirements.--The Secretary shall issue
regulations to establish the alternative requirements,
referred to in the amendment made by subsection (a)(1), that
take effect not later than January 1, 2012.
(5) Intermediate requirements.--The Secretary shall by
regulation require the use of standardized anti-
counterfeiting or track-and-trace technologies on
prescription drugs at the case and pallet level effective not
later than 1 year after the date of enactment of this Act.
(6) Additional requirements.--
(A) In general.--Notwithstanding any other provision of
this section, the Secretary shall, not later than 18 months
after the date of enactment of this Act, require that the
packaging of any prescription drug incorporates--
(i) a standardized numerical identifier unique to each
package of such drug, applied at the point of manufacturing
and repackaging (in which case the numerical identifier shall
be linked to the numerical identifier applied at the point of
manufacturing); and
(ii)(I) overt optically variable counterfeit-resistant
technologies that--

(aa) are visible to the naked eye, providing for visual
identification of product authenticity without the need for
readers, microscopes, lighting devices, or scanners;
(bb) are similar to that used by the Bureau of Engraving
and Printing to secure United States currency;
(cc) are manufactured and distributed in a highly secure,
tightly controlled environment; and
(dd) incorporate additional layers of nonvisible convert
security features up to and including forensic capability, as
described in subparagraph (B); or

(II) technologies that have a function of security
comparable to that described in subclause (I), as determined
by the Secretary.
(B) Standards for packaging.--For the purpose of making it
more difficult to counterfeit the packaging of drugs subject
to this paragraph, the manufacturers of such drugs shall
incorporate the technologies described in subparagraph (A)
into at least 1 additional element of the physical packaging
of the drugs, including blister packs, shrink wrap, package
labels, package seals, bottles, and boxes.

SEC. 3007. INTERNET SALES OF PRESCRIPTION DRUGS.

(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 503B the following:

``SEC. 503C. INTERNET SALES OF PRESCRIPTION DRUGS.

``(a) Requirements Regarding Information on Internet
Site.--
``(1) In general.--A person may not dispense a prescription
drug pursuant to a sale of the drug by such person if--
``(A) the purchaser of the drug submitted the purchase
order for the drug, or conducted any other part of the sales
transaction for the drug, through an Internet site;
``(B) the person dispenses the drug to the purchaser by
mailing or shipping the drug to the purchaser; and
``(C) such site, or any other Internet site used by such
person for purposes of sales of a prescription drug, fails to
meet each of the requirements specified in paragraph (2),
other than a site or pages on a site that--
``(i) are not intended to be accessed by purchasers or
prospective purchasers; or
``(ii) provide an Internet information location tool within
the meaning of section 231(e)(5) of the Communications Act of
1934 (47 U.S.C. 231(e)(5)).
``(2) Requirements.--With respect to an Internet site, the
requirements referred to in subparagraph (C) of paragraph (1)
for a person to whom such paragraph applies are as follows:
``(A) Each page of the site shall include either the
following information or a link to a page that provides the
following information:
``(i) The name of such person.
``(ii) Each State in which the person is authorized by law
to dispense prescription drugs.
``(iii) The address and telephone number of each place of
business of the person with respect to sales of prescription
drugs through the Internet, other than a place of business
that does not mail or ship prescription drugs to purchasers.
``(iv) The name of each individual who serves as a
pharmacist for prescription drugs that are mailed or shipped
pursuant to the site, and each State in which the individual
is authorized by law to dispense prescription drugs.
``(v) If the person provides for medical consultations
through the site for purposes of providing prescriptions, the
name of each individual who provides such consultations;

[[Page S2063]]

each State in which the individual is licensed or otherwise
authorized by law to provide such consultations or practice
medicine; and the type or types of health professions for
which the individual holds such licenses or other
authorizations.
``(B) A link to which paragraph (1) applies shall be
displayed in a clear and prominent place and manner, and
shall include in the caption for the link the words
`licensing and contact information'.
``(b) Internet Sales Without Appropriate Medical
Relationships.--
``(1) In general.--Except as provided in paragraph (2), a
person may not dispense a prescription drug, or sell such a
drug, if--
``(A) for purposes of such dispensing or sale, the
purchaser communicated with the person through the Internet;
``(B) the patient for whom the drug was dispensed or
purchased did not, when such communications began, have a
prescription for the drug that is valid in the United States;
``(C) pursuant to such communications, the person provided
for the involvement of a practitioner, or an individual
represented by the person as a practitioner, and the
practitioner or such individual issued a prescription for the
drug that was purchased;
``(D) the person knew, or had reason to know, that the
practitioner or the individual referred to in subparagraph
(C) did not, when issuing the prescription, have a qualifying
medical relationship with the patient; and
``(E) the person received payment for the dispensing or
sale of the drug.
For purposes of subparagraph (E), payment is received if
money or other valuable consideration is received.
``(2) Exceptions.--Paragraph (1) does not apply to--
``(A) the dispensing or selling of a prescription drug
pursuant to telemedicine practices sponsored by--
``(i) a hospital that has in effect a provider agreement
under title XVIII of the Social Security Act (relating to the
Medicare program); or
``(ii) a group practice that has not fewer than 100
physicians who have in effect provider agreements under such
title; or
``(B) the dispensing or selling of a prescription drug
pursuant to practices that promote the public health, as
determined by the Secretary by regulation.
``(3) Qualifying medical relationship.--
``(A) In general.--With respect to issuing a prescription
for a drug for a patient, a practitioner has a qualifying
medical relationship with the patient for purposes of this
section if--
``(i) at least one in-person medical evaluation of the
patient has been conducted by the practitioner; or
``(ii) the practitioner conducts a medical evaluation of
the patient as a covering practitioner.
``(B) In-person medical evaluation.--A medical evaluation
by a practitioner is an in-person medical evaluation for
purposes of this section if the practitioner is in the
physical presence of the patient as part of conducting the
evaluation, without regard to whether portions of the
evaluation are conducted by other health professionals.
``(C) Covering practitioner.--With respect to a patient, a
practitioner is a covering practitioner for purposes of this
section if the practitioner conducts a medical evaluation of
the patient at the request of a practitioner who has
conducted at least one in-person medical evaluation of the
patient and is temporarily unavailable to conduct the
evaluation of the patient. A practitioner is a covering
practitioner without regard to whether the practitioner has
conducted any in-person medical evaluation of the patient
involved.
``(4) Rules of construction.--
``(A) Individuals represented as practitioners.--A person
who is not a practitioner (as defined in subsection (e)(1))
lacks legal capacity under this section to have a qualifying
medical relationship with any patient.
``(B) Standard practice of pharmacy.--Paragraph (1) may not
be construed as prohibiting any conduct that is a standard
practice in the practice of pharmacy.
``(C) Applicability of requirements.--Paragraph (3) may not
be construed as having any applicability beyond this section,
and does not affect any State law, or interpretation of State
law, concerning the practice of medicine.
``(c) Actions by States.--
``(1) In general.--Whenever an attorney general of any
State has reason to believe that the interests of the
residents of that State have been or are being threatened or
adversely affected because any person has engaged or is
engaging in a pattern or practice that violates section
301(l), the State may bring a civil action on behalf of its
residents in an appropriate district court of the United
States to enjoin such practice, to enforce compliance with
such section (including a nationwide injunction), to obtain
damages, restitution, or other compensation on behalf of
residents of such State, to obtain reasonable attorneys fees
and costs if the State prevails in the civil action, or to
obtain such further and other relief as the court may deem
appropriate.
``(2) Notice.--The State shall serve prior written notice
of any civil action under paragraph (1) or (5)(B) upon the
Secretary and provide the Secretary with a copy of its
complaint, except that if it is not feasible for the State to
provide such prior notice, the State shall serve such notice
immediately upon instituting such action. Upon receiving a
notice respecting a civil action, the Secretary shall have
the right--
``(A) to intervene in such action;
``(B) upon so intervening, to be heard on all matters
arising therein; and
``(C) to file petitions for appeal.
``(3) Construction.--For purposes of bringing any civil
action under paragraph (1), nothing in this chapter shall
prevent an attorney general of a State from exercising the
powers conferred on the attorney general by the laws of such
State to conduct investigations or to administer oaths or
affirmations or to compel the attendance of witnesses or the
production of documentary and other evidence.
``(4) Venue; service of process.--Any civil action brought
under paragraph (1) in a district court of the United States
may be brought in the district in which the defendant is
found, is an inhabitant, or transacts business or wherever
venue is proper under section 1391 of title 28, United States
Code. Process in such an action may be served in any district
in which the defendant is an inhabitant or in which the
defendant may be found.
``(5) Actions by other state officials.--
``(A) Nothing contained in this section shall prohibit an
authorized State official from proceeding in State court on
the basis of an alleged violation of any civil or criminal
statute of such State.
``(B) In addition to actions brought by an attorney general
of a State under paragraph (1), such an action may be brought
by officers of such State who are authorized by the State to
bring actions in such State on behalf of its residents.
``(d) Effect of Section.--This section shall not apply to a
person that is a registered exporter under section 804.
``(e) General Definitions.--For purposes of this section:
``(1) The term `practitioner' means a practitioner referred
to in section 503(b)(1) with respect to issuing a written or
oral prescription.
``(2) The term `prescription drug' means a drug that is
described in section 503(b)(1).
``(3) The term `qualifying medical relationship', with
respect to a practitioner and a patient, has the meaning
indicated for such term in subsection (b).
``(f) Internet-Related Definitions.--
``(1) In general.--For purposes of this section:
``(A) The term `Internet' means collectively the myriad of
computer and telecommunications facilities, including
equipment and operating software, which comprise the
interconnected world-wide network of networks that employ the
transmission control protocol/internet protocol, or any
predecessor or successor protocols to such protocol, to
communicate information of all kinds by wire or radio.
``(B) The term `link', with respect to the Internet, means
one or more letters, words, numbers, symbols, or graphic
items that appear on a page of an Internet site for the
purpose of serving, when activated, as a method for executing
an electronic command--
``(i) to move from viewing one portion of a page on such
site to another portion of the page;
``(ii) to move from viewing one page on such site to
another page on such site; or
``(iii) to move from viewing a page on one Internet site to
a page on another Internet site.
``(C) The term `page', with respect to the Internet, means
a document or other file accessed at an Internet site.
``(D)(i) The terms `site' and `address', with respect to
the Internet, mean a specific location on the Internet that
is determined by Internet Protocol numbers. Such term
includes the domain name, if any.
``(ii) The term `domain name' means a method of
representing an Internet address without direct reference to
the Internet Protocol numbers for the address, including
methods that use designations such as `.com', `.edu', `.gov',
`.net', or `.org'.
``(iii) The term `Internet Protocol numbers' includes any
successor protocol for determining a specific location on the
Internet.
``(2) Authority of secretary.--The Secretary may by
regulation modify any definition under paragraph (1) to take
into account changes in technology.
``(g) Interactive Computer Service; Advertising.--No
provider of an interactive computer service, as defined in
section 230(f)(2) of the Communications Act of 1934 (47
U.S.C. 230(f)(2)), or of advertising services shall be liable
under this section for dispensing or selling prescription
drugs in violation of this section on account of another
person's selling or dispensing such drugs, provided that the
provider of the interactive computer service or of
advertising services does not own or exercise corporate
control over such person.
``(h) No Effect on Other Requirements; Coordination.--The
requirements of this section are in addition to, and do not
supersede, any requirements under the Controlled Substances
Act or the Controlled Substances Import and Export Act (or
any regulation promulgated under either such Act) regarding
Internet pharmacies and controlled substances. In
promulgating regulations to carry out this section, the
Secretary shall coordinate with the Attorney General to
ensure that such regulations do not duplicate or conflict
with the requirements described in the previous sentence, and
that such regulations and requirements coordinate to the
extent practicable.''.

[[Page S2064]]

(b) Inclusion as Prohibited Act.--Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is
amended by inserting after paragraph (k) the following:
``(l) The dispensing or selling of a prescription drug in
violation of section 503C.''.
(c) Internet Sales of Prescription Drugs; Consideration by
Secretary of Practices and Procedures for Certification of
Legitimate Businesses.--In carrying out section 503C of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a) of this section), the Secretary of Health and Human
Services shall take into consideration the practices and
procedures of public or private entities that certify that
businesses selling prescription drugs through Internet sites
are legitimate businesses, including practices and procedures
regarding disclosure formats and verification programs.
(d) Reports Regarding Internet-Related Violations of
Federal and State Laws on Dispensing of Drugs.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall,
pursuant to the submission of an application meeting the
criteria of the Secretary, make an award of a grant or
contract to the National Clearinghouse on Internet
Prescribing (operated by the Federation of State Medical
Boards) for the purpose of--
(A) identifying Internet sites that appear to be in
violation of Federal or State laws concerning the dispensing
of drugs;
(B) reporting such sites to State medical licensing boards
and State pharmacy licensing boards, and to the Attorney
General and the Secretary, for further investigation; and
(C) submitting, for each fiscal year for which the award
under this subsection is made, a report to the Secretary
describing investigations undertaken with respect to
violations described in subparagraph (A).
(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there is authorized to be
appropriated $100,000 for each of the first 3 fiscal years in
which this section is in effect.
(e) Effective Date.--The amendments made by subsections (a)
and (b) take effect 90 days after the date of enactment of
this Act, without regard to whether a final rule to implement
such amendments has been promulgated by the Secretary of
Health and Human Services under section 701(a) of the Federal
Food, Drug, and Cosmetic Act. The preceding sentence may not
be construed as affecting the authority of such Secretary to
promulgate such a final rule.

SEC. 3008. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN
PHARMACIES.

(a) In General.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end
the following:
``(h) Restricted Transactions.--
``(1) In general.--The introduction of restricted
transactions into a payment system or the completion of
restricted transactions using a payment system is prohibited.
``(2) Payment system.--
``(A) In general.--The term `payment system' means a system
used by a person described in subparagraph (B) to effect a
credit transaction, electronic fund transfer, or money
transmitting service that may be used in connection with, or
to facilitate, a restricted transaction, and includes--
``(i) a credit card system;
``(ii) an international, national, regional, or local
network used to effect a credit transaction, an electronic
fund transfer, or a money transmitting service; and
``(iii) any other system that is centrally managed and is
primarily engaged in the transmission and settlement of
credit transactions, electronic fund transfers, or money
transmitting services.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic
fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national,
regional, or local network used to effect a credit
transaction, electronic fund transfer, or money transmitting
service.
``(3) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of
an individual who places an unlawful drug importation request
to any person engaged in the operation of an unregistered
foreign pharmacy, of--
``(A) credit, or the proceeds of credit, extended to or on
behalf of the individual for the purpose of the unlawful drug
importation request (including credit extended through the
use of a credit card);
``(B) an electronic fund transfer or funds transmitted by
or through a money transmitting business, or the proceeds of
an electronic fund transfer or money transmitting service,
from or on behalf of the individual for the purpose of the
unlawful drug importation request;
``(C) a check, draft, or similar instrument which is drawn
by or on behalf of the individual for the purpose of the
unlawful drug importation request and is drawn on or payable
at or through any financial institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Board by regulation) that
involves a financial institution as a payor or financial
intermediary on behalf of or for the benefit of the
individual for the purpose of the unlawful drug importation
request.
``(4) Unlawful drug importation request.--The term
`unlawful drug importation request' means the request, or
transmittal of a request, made to an unregistered foreign
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, phone, or electronic mail, or by a means
that involves the use, in whole or in part, of the Internet.
``(5) Unregistered foreign pharmacy.--The term
`unregistered foreign pharmacy' means a person in a country
other than the United States that is not a registered
exporter under section 804.
``(6) Other definitions.--
``(A) Credit; creditor; credit card.--The terms `credit',
`creditor', and `credit card' have the meanings given the
terms in section 103 of the Truth in Lending Act (15 U.S.C.
1602).
``(B) Access device; electronic fund transfer.--The terms
`access device' and `electronic fund transfer'--
``(i) have the meaning given the term in section 903 of the
Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) the term `electronic fund transfer' also includes
any fund transfer covered under Article 4A of the Uniform
Commercial Code, as in effect in any State.
``(C) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in section 903 of the
Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(D) Money transmitting business; money transmitting
service.--The terms `money transmitting business' and `money
transmitting service' have the meaning given the terms in
section 5330(d) of title 31, United States Code.
``(E) Board.--The term `Board' means the Board of Governors
of the Federal Reserve System.
``(7) Policies and procedures required to prevent
restricted transactions.--
``(A) Regulations.--The Board shall promulgate regulations
requiring--
``(i) an operator of a credit card system;
``(ii) an operator of an international, national, regional,
or local network used to effect a credit transaction, an
electronic fund transfer, or a money transmitting service;
``(iii) an operator of any other payment system that is
centrally managed and is primarily engaged in the
transmission and settlement of credit transactions,
electronic transfers or money transmitting services where at
least one party to the transaction or transfer is an
individual; and
``(iv) any other person described in paragraph (2)(B) and
specified by the Board in such regulations,
to establish policies and procedures that are reasonably
designed to prevent the introduction of a restricted
transaction into a payment system or the completion of a
restricted transaction using a payment system
``(B) Requirements for policies and procedures.--In
promulgating regulations under subparagraph (A), the Board
shall--
``(i) identify types of policies and procedures, including
nonexclusive examples, that shall be considered to be
reasonably designed to prevent the introduction of restricted
transactions into a payment system or the completion of
restricted transactions using a payment system; and
``(ii) to the extent practicable, permit any payment
system, or person described in paragraph (2)(B), as
applicable, to choose among alternative means of preventing
the introduction or completion of restricted transactions.
``(C) No liability for blocking or refusing to honor
restricted transaction.--
``(i) In general.--A payment system, or a person described
in paragraph (2)(B) that is subject to a regulation issued
under this subsection, and any participant in such payment
system that prevents or otherwise refuses to honor
transactions in an effort to implement the policies and
procedures required under this subsection or to otherwise
comply with this subsection shall not be liable to any party
for such action.
``(ii) Compliance.--A person described in paragraph (2)(B)
meets the requirements of this subsection if the person
relies on and complies with the policies and procedures of a
payment system of which the person is a member or in which
the person is a participant, and such policies and procedures
of the payment system comply with the requirements of the
regulations promulgated under subparagraph (A).
``(D) Enforcement.--
``(i) In general.--This subsection, and the regulations
promulgated under this subsection, shall be enforced
exclusively by the Federal functional regulators and the
Federal Trade Commission under applicable law in the manner
provided in section 505(a) of the Gramm-Leach-Bliley Act (15
U.S.C. 6805(a)).
``(ii) Factors to be considered.--In considering any
enforcement action under this subsection against a payment
system or person described in paragraph (2)(B), the Federal
functional regulators and the Federal Trade Commission shall
consider the following factors:

``(I) The extent to which the payment system or person
knowingly permits restricted transactions.

[[Page S2065]]

``(II) The history of the payment system or person in
connection with permitting restricted transactions.
``(III) The extent to which the payment system or person
has established and is maintaining policies and procedures in
compliance with regulations prescribed under this subsection.

``(8) Transactions permitted.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, is authorized to
engage in transactions with foreign pharmacies in connection
with investigating violations or potential violations of any
rule or requirement adopted by the payment system or person
in connection with complying with paragraph (7). A payment
system, or such a person, and its agents and employees shall
not be found to be in violation of, or liable under, any
Federal, State or other law by virtue of engaging in any such
transaction.
``(9) Relation to state laws.--No requirement, prohibition,
or liability may be imposed on a payment system, or a person
described in paragraph (2)(B) that is subject to a regulation
issued under this subsection, under the laws of any state
with respect to any payment transaction by an individual
because the payment transaction involves a payment to a
foreign pharmacy.
``(10) Timing of requirements.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, must adopt policies
and procedures reasonably designed to comply with any
regulations required under paragraph (7) within 60 days after
such regulations are issued in final form.
``(11) Compliance.--A payment system, and any person
described in paragraph (2)(B), shall not be deemed to be in
violation of paragraph (1)--
``(A)(i) if an alleged violation of paragraph (1) occurs
prior to the mandatory compliance date of the regulations
issued under paragraph (7); and
``(ii) such entity has adopted or relied on policies and
procedures that are reasonably designed to prevent the
introduction of restricted transactions into a payment system
or the completion of restricted transactions using a payment
system; or
``(B)(i) if an alleged violation of paragraph (1) occurs
after the mandatory compliance date of such regulations; and
``(ii) such entity is in compliance with such
regulations.''.
(b) Effective Date.--The amendment made by this section
shall take effect on the day that is 90 days after the date
of enactment of this Act.
(c) Implementation.--The Board of Governors of the Federal
Reserve System shall promulgate regulations as required by
subsection (h)(7) of section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333), as added by subsection (a),
not later than 90 days after the date of enactment of this
Act.

SEC. 3009. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES
IMPORT AND EXPORT ACT.

Section 1006(a)(2) of the Controlled Substances Import and
Export Act (21 U.S.C. 956(a)(2)) is amended by striking ``not
import the controlled substance into the United States in an
amount that exceeds 50 dosage units of the controlled
substance.'' and inserting ``import into the United States
not more than 10 dosage units combined of all such controlled
substances.''.

SEC. 3010. SEVERABILITY.

If any provision of this title, an amendment by this title,
or the application of such provision or amendment to any
person or circumstance is held to be unconstitutional, the
remainder of this title, the amendments made by this title,
and the application of the provisions of such to any person
or circumstance shall not affected thereby.
______

SA 3689. Mr. COBURN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1502. NO PAY RAISE FOR MEMBERS OF CONGRESS UNTIL THEY
BALANCE THE BUDGET.

(a) Restriction on COLA Adjustments.--Notwithstanding any
other provision of law, no adjustment shall be made under
section 601(a) of the Legislative Reorganization Act of 1946
(2 U.S.C. 31) (relating to cost of living adjustments for
Members of Congress) during fiscal year 2011 or any
succeeding fiscal year, until the fiscal year following the
first fiscal year that the annual Federal budget deficit is
$0 as determined in the report submitted under subsection
(b).
(b) Determinations and Reports.--
(1) In general.--Not later than 30 days after the end of
each fiscal year, the Secretary of the Treasury shall--
(A) make a determination of whether or not the annual
Federal budget deficit was $0 for that fiscal year; and
(B) if the determination is that the annual Federal budget
deficit was $0 for that fiscal year, submit a report to
Congress of that determination.
(2) Restriction of cola adjustments.--Not later than the
end of each calendar year, the Secretary of the Treasury
shall submit a report to the Secretary of the Senate and the
Chief Administrative Officer of the House of Representatives
on--
(A) any determination made under paragraph (1); and
(B) whether or not the restriction under subsection (a)
shall apply to the succeeding fiscal year.
______

SA 3690. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 113, after line 21, add the following:

SEC. 1502. RELOCATION OF THE UNITED STATES EMBASSY TO
JERUSALEM.

(a) Removal of Waiver Authority.--The Jerusalem Embassy Act
of 1995 (Public Law 104-45; 109 Stat. 398) is amended--
(1) by striking section 7; and
(2) by redesignating section 8 as section 7.
(b) Timetable.--Not more than 50 percent of the funds
appropriated to the Department of State for fiscal year 2012
for ``Acquisition and Maintenance of Buildings Abroad'' may
be obligated until the Secretary of State determines and
reports to Congress that the United States Embassy in
Jerusalem has officially opened.
(c) Fiscal Years 2010 and 2011 Funding.--
(1) Fiscal year 2010.--Of the funds authorized to be
appropriated for ``Acquisition and Maintenance of Buildings
Abroad'' for the Department of State for fiscal year 2010,
such sums as may be necessary shall be made available until
expended only for construction and other costs associated
with the establishment of the United States Embassy in Israel
in the capital of Jerusalem.
(2) Fiscal year 2011.--Of the funds authorized to be
appropriated for ``Acquisition and Maintenance of Buildings
Abroad'' for the Department of State for fiscal year 2011,
such sums as may be necessary shall be made available until
expended only for construction and other costs associated
with the establishment of the United States Embassy in Israel
in the capital of Jerusalem.
(d) Definition.--In this section, the term ``United States
Embassy'' means the offices of the United States diplomatic
mission and the residence of the United States chief of
mission.
______

SA 3691. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, add the following:

SEC. 1502. PAYMENT FOR ILLEGAL UNAPPROVED DRUGS.

(a) Listing of Drugs and Devices.--Section 510 of the Food,
Drug and Cosmetic Act (21 U.S.C. 360) is amended--
(1) in subsection (j)(1)(B)--
(A) in clause (i), by inserting ``in the case of a drug,
the authority under this Act that does not require such drug
to be subject to section 505 and section 512,'' after
``labeling for such drug or device,''; and
(B) in clause (ii), by inserting ``, in the case of a drug,
the authority under this Act that does not require such drug
to be subject to section 505 and section 512,'' after ``for
such drug or device''; and
(2) in subsection (f)--
(A) by striking ``(f) The Secretary'' and inserting the
following:
``(f) Inspection by Public of Registration.--
``(1) In general.--The Secretary''; and
(B) by adding at the end the following:
``(2) List of drugs that are not approved under section 505
or 512.--Not later than January 1, 2011, the Secretary shall
make available to the public on the Internet website of the
Food and Drug Administration a list that includes, for each
drug described in subsection (j)(1)(B)--
``(A) the drug;
``(B) the person who listed such drug; and
``(C) the authority under this Act that does not require
such drug to be subject to section 505 and section 512, as
provided by such person in such list.''.
(b) Payment for Covered Outpatient Drugs.--Section 1927 of
the Social Security Act (42 U.S.C. 1396r-8) is amended by
inserting at the end the following:
``(l) Condition.--Beginning January 1, 2011, no State shall
make any payment under this section for any covered
outpatient drug unless such State first verifies with the
Food and Drug Administration that such covered outpatient
drug has been approved by the Food and Drug Administration
under a new drug application under section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) or an
abbreviated new drug application under section 505(j) of such
Act, or that such drug is not subject to such section 505 or
section 512 due to the application of section 201(p) of such
Act (21 U.S.C. 321(p)). The Secretary shall have the
authority to proscribe regulations to create an information
sharing protocol to allow States to verify that a covered
outpatient drug has been approved by the Food and Drug
Administration.''.
______

SA 3692. Mr. GRASSLEY submitted an amendment intended to be proposed

[[Page S2066]]

by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

On page 82, after line 9, insert the following:

SEC. ___. EXTENSION AND EXPANSION OF OVERSIGHT FOR CLAIMS OF
DME SUPPLIERS.

Section 1866(j) of the Social Security Act, as amended by
section 1304, is further amended--
(1) in paragraph (4)--
(A) in the heading, by striking ``90-day'' and inserting
``180-day''; and
(B) by striking ``90-day'' and inserting ``180-day'';
(2) by redesignating paragraphs (5) through (8) as
paragraphs (6) through (9), respectively; and
(3) by inserting after paragraph (4) the following new
paragraph:
``(5) 180-day period of enhanced oversight and additional
review for other claims of dme suppliers.--For periods
beginning after January 1, 2011, if the Secretary determines
that there is a significant risk of fraudulent activity among
suppliers of durable medical equipment, in the case of a
supplier of durable medical equipment not described in
paragraph (4) who is within a category or geographic area
under title XVIII identified pursuant to such determination,
the Secretary shall, notwithstanding sections 1816(c),
1842(c), and 1869(a)(2)--
``(A) withhold payment under such title with respect to
durable medical equipment furnished by such supplier during
the 180-day period beginning on the date of such
determination; and
``(B) conduct a review of claims for payment under such
title with respect to durable medical equipment furnished by
such supplier submitted during the 12-month period prior to
the date of such determination.''.
______

SA 3693. Ms. MURKOWSKI submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

In section 1402, strike subsection (a).
______

SA 3694. Mr. GRAHAM submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

On page 144, between lines 2 and 3, insert the following:

SEC. 2214. SAVINGS TO FUND FEDERAL PELL GRANTS.

Notwithstanding any other provision of this Act, the
savings resulting from this subtitle that are spent on
healthcare under subtitle B shall instead be used to provide
additional funding for the Federal Pell Grant program under
section 401 of the Higher Education Act of 1965 (20 U.S.C.
1070a), in order to address budgetary shortfalls for such
program for fiscal years 2010 through 2019.
______

SA 3695. Mr. ALEXANDER submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

On page 143, strike lines 1 through 13 and insert the
following:
``(7) Interest rate disclosure.--
``(A) Provision of assistance.--The Secretary shall provide
annual disclosures to student and parent borrowers of student
loans under this part on the annual and cumulative difference
of the interest rate and amounts owed in interest paid by the
student, as compared to the interest rate paid by the
Department of Education to the Department of the Treasury.
``(B) Funds.--There are authorized to be appropriated, and
there are appropriated, to carry out this paragraph (in
addition to any other amounts appropriated to carry out this
paragraph and out of any money in the Treasury not otherwise
appropriated), $5,000,000 for each of the fiscal years 2010
through 2019.''.
______

SA 3696. Mr. ENSIGN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

Strike section 1002 and insert the following:

SEC. 1002. REPEAL OF INDIVIDUAL MANDATE.

Sections 1501 and 1502 and subsections (a), (b), (c), and
(d) of section 10106 of the Patient Protection and Affordable
Care Act (and the amendments made by such sections and
subsections) are repealed and the Internal Revenue Code of
1986 shall be applied and administered as if such provisions
and amendments had never been enacted.
______

SA 3697. Mr. BROWNBACK submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of section 1402(a), insert the following:
(5) Inflation adjustment.--Section 1411 of the Internal
Revenue Code of 1986, as added by paragraph (1), is amended
by adding at the end the following new subsection:
``(f) Adjustment for Inflation.--In the case of any taxable
year beginning after December 31, 2013, each of the dollar
amounts under paragraphs (1) and (3) of subsection (b),
subparagraphs (A) and (C) of section 3101(b)(2), and clauses
(i) and (iii) of section 1401(b)(2)(A) shall be increased by
an amount equal to--
``(1) such amount, multiplied by
``(2) the cost-of-living adjustment determined under
section 1(f)(3) for the calendar year in which such taxable
year begins by substituting `calendar year 2012' for
`calendar year 1992' in subparagraph (B) thereof.
If any increase determined under this subsection is not a
multiple of $1,000, such increase shall be rounded to the
next lowest multiple of $1,000.''.
______

SA 3698. Mr. CORNYN submitted an amendment intended to be proposed by
him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); which was ordered to lie on the table; as
follows:

At the end of subtitle F of title I, insert the following:

SEC. 1__. LIMITATION ON APPLICATION OF ACTS.

Notwithstanding any other provision of law, the Secretary
of Health and Human Services shall not implement the Patient
Protection and Affordable Care Act and the Health Care and
Education Reconciliation Act of 2011 until the Office of the
Actuary at the Centers for Medicare & Medicaid Services
certifies to Congress that such Acts will reduce National
health expenditures relative to the level of such
expenditures under current law.
______

SA 3699. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill H.R. 4872, to provide for reconciliation pursuant to
Title II of the concurrent resolution on the budget for fiscal year
2010 (S. Con. Res. 13); as follows:

At the end of the bill, insert:

TITLE III--TEMPORARY EXTENSION OF CERTAIN PROGRAMS

SEC. 300. SHORT TITLE.

This title may be cited as the ``Continuing Extension Act
of 2010''.

SEC. 301. EXTENSION OF UNEMPLOYMENT INSURANCE PROVISIONS.

(a) In General.--(1) Section 4007 of the Supplemental
Appropriations Act, 2008 (Public Law 110-252; 26 U.S.C. 3304
note) is amended--
(A) by striking ``April 5, 2010'' each place it appears and
inserting ``May 5, 2010'';
(B) in the heading for subsection (b)(2), by striking
``april 5, 2010'' and inserting ``may 5, 2010''; and
(C) in subsection (b)(3), by striking ``September 4, 2010''
and inserting ``October 2, 2010''.
(2) Section 2002(e) of the Assistance for Unemployed
Workers and Struggling Families Act, as contained in Public
Law 111-5 (26 U.S.C. 3304 note; 123 Stat. 438), is amended--
(A) in paragraph (1)(B), by striking ``April 5, 2010'' and
inserting ``May 5, 2010'';
(B) in the heading for paragraph (2), by striking ``april
5, 2010'' and inserting ``may 5, 2010''; and
(C) in paragraph (3), by striking ``October 5, 2010'' and
inserting ``November 5, 2010''.
(3) Section 2005 of the Assistance for Unemployed Workers
and Struggling Families Act, as contained in Public Law 111-5
(26 U.S.C. 3304 note; 123 Stat. 444), is amended--
(A) by striking ``April 5, 2010'' each place it appears and
inserting ``May 5, 2010''; and
(B) in subsection (c), by striking ``September 4, 2010''
and inserting ``October 2, 2010''.
(4) Section 5 of the Unemployment Compensation Extension
Act of 2008 (Public Law 110-449; 26 U.S.C. 3304 note) is
amended by striking ``September 4, 2010'' and inserting
``October 2, 2010''.
(b) Funding.--Section 4004(e)(1) of the Supplemental
Appropriations Act, 2008 (Public Law 110-252; 26 U.S.C. 3304
note) is amended--
(1) in subparagraph (C), by striking ``and'' at the end;
(2) by inserting after subparagraph (D) the following new
subparagraph:
``(E) the amendments made by section 2(a)(1) of the
Continuing Extension Act of 2010; and''.
(c) Effective Date.--The amendments made by this section
shall take effect as if included in the amendments made by
section 2 of the Temporary Extension Act of 2010 (Public Law
111-144).

[[Page S2067]]

SEC. 302. EXTENSION AND IMPROVEMENT OF PREMIUM ASSISTANCE FOR
COBRA BENEFITS.

Subsection (a)(3)(A) of section 3001 of division B of the
American Recovery and Reinvestment Act of 2009 (Public Law
111-5), as amended by section 3(a) of the Temporary Extension
Act of 2010 (Public Law 111-144), is amended by striking
``March 31, 2010'' and inserting ``April 30, 2010''.

SEC. 303. INCREASE IN THE MEDICARE PHYSICIAN PAYMENT UPDATE.

Paragraph (10) of section 1848(d) of the Social Security
Act, as added by section 1011(a) of the Department of Defense
Appropriations Act, 2010 (Public Law 111-118) and as amended
by section 5 of the Temporary Extension Act of 2010 (Public
Law 111-144), is amended--
(1) in subparagraph (A), by striking ``March 31, 2010'' and
inserting ``April 30, 2010''; and
(2) in subparagraph (B), by striking ``April 1, 2010'' and
inserting ``May 1, 2010''.

SEC. 304. EHR CLARIFICATION.

(a) Qualification for Clinic-Based Physicians.--
(1) Medicare.--Section 1848(o)(1)(C)(ii) of the Social
Security Act (42 U.S.C. 1395w-4(o)(1)(C)(ii)) is amended by
striking ``setting (whether inpatient or outpatient)'' and
inserting ``inpatient or emergency room setting''.
(2) Medicaid.--Section 1903(t)(3)(D) of the Social Security
Act (42 U.S.C. 1396b(t)(3)(D)) is amended by striking
``setting (whether inpatient or outpatient)'' and inserting
``inpatient or emergency room setting''.
(b) Effective Date.--The amendments made by subsection (a)
shall be effective as if included in the enactment of the
HITECH Act (included in the American Recovery and
Reinvestment Act of 2009 (Public Law 111-5)).
(c) Implementation.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendments made by this section by program instruction or
otherwise.

SEC. 305. ELIMINATION OF A SWEETHEART DEAL THAT INCREASES
MEDICARE REIMBURSEMENT JUST FOR FRONTIER
STATES.

Effective as if included in the enactment of the Patient
Protection and Affordable Care Act, section 10324 of such Act
(and the amendments made by such section) is repealed.

SEC. 306. EXTENSION OF USE OF 2009 POVERTY GUIDELINES.

Section 1012 of the Department of Defense Appropriations
Act, 2010 (Public Law 111-118), as amended by section 7 of
the Temporary Extension Act of 2010 (Public Law 111-144), is
amended by striking ``March 31, 2010'' and inserting ``April
30, 2010''.

SEC. 307. EXTENSION OF NATIONAL FLOOD INSURANCE PROGRAM.

(a) Extension.--Section 129 of the Continuing
Appropriations Resolution, 2010 (Public Law 111-68), as
amended by section 8 of Public Law 111-144, is amended by
striking ``by substituting'' and all that follows through the
period at the end and inserting ``by substituting April 30,
2010, for the date specified in each such section.''.
(b) Effective Date.--The amendments made by subsection (a)
shall be considered to have taken effect on February 28,
2010.

SEC. 308. SATELLITE TELEVISION EXTENSION.

(a) Amendments to Section 119 of Title 17, United States
Code.--
(1) In general.--Section 119 of title 17, United States
Code, is amended--
(A) in subsection (c)(1)(E), by striking ``March 28, 2010''
and inserting ``April 30, 2010''; and
(B) in subsection (e), by striking ``March 28, 2010'' and
inserting ``April 30, 2010''.
(2) Termination of license.--Section 1003(a)(2)(A) of
Public Law 111-118 is amended by striking ``March 28, 2010'',
and inserting ``April 30, 2010''.
(b) Amendments to Communications Act of 1934.--Section
325(b) of the Communications Act of 1934 (47 U.S.C. 325(b))
is amended--
(1) in paragraph (2)(C), by striking ``March 28, 2010'' and
inserting ``April 30, 2010''; and
(2) in paragraph (3)(C), by striking ``March 29, 2010''
each place it appears in clauses (ii) and (iii) and inserting
``May 1, 2010''.

SEC. 309. COMPENSATION AND RATIFICATION OF AUTHORITY RELATED
TO LAPSE IN HIGHWAY PROGRAMS.

(a) Compensation for Federal Employees.--Any Federal
employees furloughed as a result of the lapse in expenditure
authority from the Highway Trust Fund after 11:59 p.m. on
February 28, 2010, through March 2, 2010, shall be
compensated for the period of that lapse at their standard
rates of compensation, as determined under policies
established by the Secretary of Transportation.
(b) Ratification of Essential Actions.--All actions taken
by Federal employees, contractors, and grantees for the
purposes of maintaining the essential level of Government
operations, services, and activities to protect life and
property and to bring about orderly termination of Government
functions during the lapse in expenditure authority from the
Highway Trust Fund after 11:59 p.m. on February 28, 2010,
through March 2, 2010, are hereby ratified and approved if
otherwise in accord with the provisions of the Continuing
Appropriations Resolution, 2010 (division B of Public Law
111-68).
(c) Funding.--Funds used by the Secretary to compensate
employees described in subsection (a) shall be derived from
funds previously authorized out of the Highway Trust Fund and
made available or limited to the Department of Transportation
by the Consolidated Appropriations Act, 2010 (Public Law 111-
117) and shall be subject to the obligation limitations
established in such Act.
(d) Expenditures From Highway Trust Fund.--To permit
expenditures from the Highway Trust Fund to effectuate the
purposes of this section, this section shall be deemed to be
a section of the Continuing Appropriations Resolution, 2010
(division B of Public Law 111-68), as in effect on the date
of the enactment of the last amendment to such Resolution.

SEC. 310. USE OF STIMULUS FUNDS TO OFFSET SPENDING.

The unobligated balance of each amount appropriated or made
available under the American Recovery and Reinvestment Act of
2009 (Public Law 111-5) (other than under title X of division
A of such Act) is rescinded pro rata such that the aggregate
amount of such rescissions equals $9,200,000,000 in order to
offset the net increase in spending resulting from the
provisions of, and amendments made by, sections 2 through 10.
The Director of the Office of Management and Budget shall
report to each congressional committee the amounts so
rescinded within the jurisdiction of such committee.

SEC. 311. ELIMINATION OF ADVANCE REFUNDABILITY OF EARNED
INCOME CREDIT.

(a) In General.--Section 3507, subsection (g) of section
32, and paragraph (7) of section 6051(a) are repealed.
(b) Conforming Amendments.--
(1) Section 6012(a) is amended by striking paragraph (8)
and by redesignating paragraph (9) as paragraph (8).
(2) Section 6302 is amended by striking subsection (i).
(c) Effective Date.--The repeals and amendments made by
this section shall apply to taxable years beginning after
December 31, 2010.

____________________