[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2196 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 2196
To improve the quality, availability, diversity, personal privacy, and
innovation of health care in the United States.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 21, 2003
Mr. Rohrabacher introduced the following bill; which was referred to
the Committee on Ways and Means, and in addition to the Committees on
Government Reform, and Energy and Commerce, for a period to be
subsequently determined by the Speaker, in each case for consideration
of such provisions as fall within the jurisdiction of the committee
concerned
_______________________________________________________________________
A BILL
To improve the quality, availability, diversity, personal privacy, and
innovation of health care in the United States.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medical
Independence, Privacy, and Innovation Act of 2003''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--TAX-RELATED PROVISIONS
Sec. 101. Findings.
Sec. 102. Deduction of medical expenses for individuals.
Sec. 103. Medical checking accounts.
Sec. 104. Decrease in minimum annual deductibles under a high
deductible health plan for purposes of
Archer MSAs.
TITLE II--MEDICAL PRIVACY
Sec. 201. Findings.
Sec. 202. Modification of regulations on privacy of individually
identifiable health information.
Sec. 203. Restrictions on the use of the social security account
number.
Sec. 204. Prohibition of governmentwide uniform identifying numbers.
Sec. 205. Prohibition of government-established identifiers.
TITLE III--MODIFICATIONS REGARDING REGULATION OF DRUGS UNDER FEDERAL
FOOD, DRUG, AND COSMETIC ACT
Sec. 301. Definition of drug.
Sec. 302. Striking of effectiveness requirement; modifications
regarding patent listings, patent
certifications, and thirty-month rule.
Sec. 303. Importation of certain drugs.
TITLE I--TAX-RELATED PROVISIONS
SEC. 101. FINDINGS.
The Congress finds the following:
(1) Current law confers tax benefits for health insurance
provided as an employee fringe benefit, but no similar tax
benefit for health insurance purchased by individuals thus
creating an unfair bias toward employer provided medical
insurance plans and an unfair discrimination against
individuals who seek marketplace alternatives to health
insurance.
(2) Current law confers a tax benefits for third party
payment of medical expenses but no similar tax benefits for
direct individual payment of medical expenses. This has
promoted employer-provided third party payment systems and
discouraged direct doctor-patient relationships.
(3) The current tax treatment of medical expenses has
resulted in a greatly distorted marketplace in medical
insurance where decreased opportunities for private personal
health insurance has reduced competition both for medical
insurance and health care services. This has resulted in an
increased cost of both health insurance and health care
services and fostered overuse of low high premium health
insurance plans.
(4) The current tax treatment of medical expenses has
restricted the freedom of individuals to exercise direct
control over their health care dollars. The exclusion from
gross income for employer-provided health care with no
corresponding tax benefit for health insurance and health care
costs borne by individuals represents a strong incentive toward
employers group plans.
(5) The tax codes preferment of employer-provided group
plans has triggered a marketplace response reflected in the
significant increases in large health care delivery, and the
creation of a relative few health care conglomerates in lieu of
thousands of competitive providers of medical insurance and
services. This has increasingly placed medical decisions in the
hands of health care bureaucracies and has eroded doctor-
patient relationships.
(6) The role of the marketplace in both medical insurance
and medical services should be strengthened. The discriminatory
tax policies in the area of health insurance and health care
should be ended. Private individuals should be able to contract
for their health insurance and health care delivery in an
atmosphere free of discriminatory tax pressures. High
deductible low premium as well as catastrophic alternatives in
health insurance should be viable options for all Americans.
(7) Consumers should have the freedom to purchase the
health insurance types of their own choice, to choose their own
doctors and to make their own decisions about their health
care. Elimination of the discriminatory tax codes regarding
health choices will encourage greater choice and competition,
thereby reducing the cost of necessary insurance for
all Americans. This will enable millions more Americans to obtain
needed health coverage.
SEC. 102. DEDUCTION OF MEDICAL EXPENSES FOR INDIVIDUALS.
(a) In General.--Subsection (a) of section 213 of the Internal
Revenue Code of 1986 (relating to treatment of medical, dental, etc.,
expenses) is amended to read as follows:
``(a) Allowance of Deduction.--There shall be allowed as a
deduction the expenses paid during the taxable year, not compensated
for by insurance or otherwise, for medical care of the taxpayer, his
spouse, or a dependent (as defined by section 152).''.
(b) Deduction Allowed in Computing Adjusted Gross Income.--
Subsection (a) of section 62 of such Code is amended by inserting after
paragraph (18) the following new paragraph:
``(19) Medical Care.--The deduction allowed by section
213.''.
(c) Conforming Amendments.--
(1) Section 56(b)(1) of such Code is amended by striking
subparagraph (B).
(2) Section 67(b) is amended by striking paragraph (5).
(3) Section 72(t)(B) of such Code is amended by striking
``to the extent such distributions do not exceed the amount''
and inserting ``which are''.
(4) Sections 104(a) and 105(b) of such Code are both
amended by striking ``(and not in excess of)''.
(d) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2003.
SEC. 103. MEDICAL CHECKING ACCOUNTS.
(a) In General.--Subchapter F of chapter 1 of the Internal Revenue
Code of 1986 (relating to exempt organizations) is amended by adding at
the end the following:
``PART IX--MEDICAL CHECKING ACCOUNTS
``Sec. 530A. Medical checking accounts.
``SEC. 530A. MEDICAL CHECKING ACCOUNTS.
``(a) General Rule.--A medical checking account shall be exempt
from taxation under this subtitle. Notwithstanding the preceding
sentence, any medical checking account shall be subject to the taxes
imposed by section 511 (relating to imposition of tax on unrelated
business income of charitable, etc., organizations). Rules similar to
the rules of paragraphs (2) and (4) of section 408(e) shall apply to
medical checking accounts, and any amount treated as distributed under
such rules shall be treated as not used to pay qualified medical
expenses.
``(b) Deduction for Contributions.--
``(1) In general.--In the case of an individual, there
shall be allowed as a deduction an amount equal to the
aggregate amount paid in cash during the taxable year to a
medical checking account of the taxpayer.
``(2) Limitations.--
``(A) Maximum annual contribution.--The deduction
under paragraph (1) for a taxable year shall not exceed
$1,000 ($2,000 in the case of a joint return).
``(B) Maximum allowable deduction based on balance
in account.--No deduction shall be allowed for a
taxable year for any amount contributed to a medical
checking account if the sum of such amount plus the
balance in the account determined as the end of the
taxable year would exceed $2,000 ($4,000 in the case of
married individuals filing a joint return, a surviving
spouse, and a head of household).
``(c) Credit for Contributions.--
``(1) In general.--In the case of an individual, there
shall be allowed as a credit against the tax imposed by this
chapter for the taxable year an amount equal to the credit
amount with respect to contributions made during the taxable
year to the medical checking account of the taxpayer.
``(2) Credit amount.--For purposes of paragraph (1), the
credit amount is the lesser of--
``(A) the total amount of contributions to the
medical checking account for the taxable year reduced
by the amount of contributions allowed as a deduction
under subsection (b), and
``(B) $1,000.
``(d) Definitions and Special Rules.--For purposes of this
section--
``(1) Medical checking account.--The term `medical checking
account' means a trust created or organized in the United
States for the exclusive benefit of a qualified individual or
his beneficiaries, but only if the written governing instrument
creating the trust meets the following requirements:
``(A) Except in the case of a rollover contribution
described in paragraph (4)(C), no contribution will be
accepted unless it is in cash, or it exceeds $1,000
($2,000 in the case of married individuals filing a
joint return, a surviving spouse, and a head of
household).
``(B) The trustee is a bank (as defined in section
408(n)), an insurance company (as defined in section
816), or another person who demonstrates to the
satisfaction of the Secretary that the manner in which
such person will administer the trust will be
consistent with the requirements of this section.
``(C) No part of the trust assets will be invested
in life insurance contracts.
``(D) The assets of the trust will not be
commingled with other property except in a common trust
fund or common investment fund.
``(E) The interest of an individual in the balance
in his account is nonforfeitable.
``(2) Qualified medical expenses.--The term `qualified
medical expenses' means, with respect to an account holder,
amounts paid by such holder for medical care (as defined in
section 213(d)) for such individual, the spouse of such
individual, and any dependent (as defined in section 152) of
such individual, but only to the extent such amounts are not
compensated for by insurance or otherwise (including
distributions from an Archer MSA which are not includible in gross
income by reason of section 220(f)(1)).
``(3) Change in filing status.--In the case of a taxpayer
whose filing status changes during the taxable year, the
limitation under subparagraph (B) shall be apportioned among
the filing statuses of the taxpayer in accordance with
regulations prescribed by the Secretary.
``(4) Certain rules to apply.--Rules similar to the
following rules shall apply for purposes of this section:
``(A) Section 219(d)(2) (relating to no deduction
for rollovers).
``(B) Section 219(f)(3) (relating to time when
contributions deemed made).
``(C) Section 219(f)(5) (relating to employer
payments).
``(D) Section 220(f)(5) (relating to rollover
contributions).
``(E) Section 220(f)(7) (relating to transfer of
account incident to divorce).
``(F) Section 220(f)(8) (relating to treatment
after death of account holder).
``(G) Section 408(g) (relating to community
property laws).
``(H) Section 408(h) (relating to custodial
accounts).
``(e) Tax Treatment of Distributions.--
``(1) Amounts used for qualified medical expenses.--Any
amount paid or distributed out of a medical checking account
which is used exclusively to pay qualified medical expenses of
any account holder shall not be includible in gross income.
``(2) Inclusion of amounts not used for qualified medical
expenses.--Any amount paid or distributed out of a medical
checking account which is not used exclusively to pay the
qualified medical expenses of the account holder shall be
included in the gross income of such holder.
``(3) Additional tax on distributions not used for
qualified medical expenses.--For purposes of this section,
rules similar to the rules of section 220(f)(4) shall apply.
``(4) Coordination with medical expense deduction.--For
purposes of determining the amount of the deduction under
section 213, any payment or distribution out of a medical
checking account for qualified medical expenses shall not be
treated as an expense paid for medical care.
``(f) Reports.--The Secretary may require the trustee of a medical
checking account to make such reports regarding such account to the
Secretary and to the account holder with respect to contributions,
distributions, and such other matters as the Secretary determines
appropriate. The reports required by this subsection shall be filed at
such time and in such manner and furnished to such individuals at such
time and in such manner as may be required by the Secretary.''.
(b) Tax on Excess Contributions.--Section 4973 of such Code
(relating to tax on excess contributions to individual retirement
accounts, certain section 403(b) contracts, and certain individual
retirement annuities) is amended--
(1) in subsection (a) by striking ``or'' at the end of
paragraph (3), by inserting ``or'' at the end of paragraph (4),
and by inserting after paragraph (4) the following:
``(5) a medical checking account (within the meaning of
section 530A(d)),'', and
(2) by adding at the end the following new subsection:
``(g) Excess Contributions to Medical Checking Accounts.--For
purposes of this section, in the case of medical checking accounts
(within the meaning of section 530A(d)), the term `excess
contributions' means the sum of--
``(1) the aggregate amount contributed for the taxable year
to the accounts (other than rollover contributions referred to
in section 530A(d)(4)(C)) which is neither excludable from
gross income under section 106(b) nor allowable as a deduction
or credit under section 530A for such year, and
``(2) the amount determined under this subsection for the
preceding taxable year, reduced by the sum of--
``(A) the distributions out of the accounts which
were included in gross income under section 530A(e)(2),
and
``(B) the excess (if any) of--
``(i) the sum of the maximum amount
allowable as a deduction or credit under
section 530A (determined without regard to
section 106(b)) for the taxable year, over
``(ii) the amount contributed to the
accounts for the taxable year.
For purposes of this subsection, any contribution which is distributed
out of the medical savings account in a distribution to which section
530A(d)(4)(B) applies shall be treated as an amount not contributed.''.
(c) Tax on Prohibited Transactions.--
(1) Section 4975 of such Code (relating to tax on
prohibited transactions) is amended by adding at the end of
subsection (c) the following new paragraph:
``(6) Special rule for medical checking accounts.--An
individual for whose benefit a medical checking account (within
the meaning of section 530A(d)) is established shall be exempt
from the tax imposed by this section with respect to any
transaction concerning such account (which would otherwise be
taxable under this section) if, with respect to such
transaction, the account ceases to be a medical checking
account by reason of the application of section 530A(e)(2) to
such account.''.
(2) Paragraph (1) of section 4975(e) of such Code is
amended by striking ``or'' at the end of subparagraph (E), by
redesignating subparagraph (F) as subparagraph (G), and by
inserting after subparagraph (E) the following new
subparagraph:
``(F) a medical checking account described in
section 530A(d), or''.
(d) Failure To Provide Reports on Medical Checking Accounts.--
Paragraph (2) of section 6693(a) (relating to general rule on reports)
is amended by striking ``and'' at the end of subparagraph (C), by
striking the period at the end of subparagraph (D) and inserting
``, and'', and by inserting after subparagraph (D) the following new
subparagraph:
``(E) section 530A(g) (relating to medical savings
accounts).''.
(e) Clerical Amendment.--The table of parts for subchapter F of
chapter 1 of such Code is amended by adding at the end the following
new item:
``Part IX. Medical Checking Accounts.''.
(f) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2003.
SEC. 104. DECREASE IN MINIMUM ANNUAL DEDUCTIBLES UNDER A HIGH
DEDUCTIBLE HEALTH PLAN FOR PURPOSES OF ARCHER MSAS.
(a) In General.--Subparagraph (A) of section 220(c)(2) of the
Internal Revenue Code of 1986 (defining high deductible health plan) is
amended--
(1) in clause (i) by striking ``$1,500'' and inserting
``$1,000'', and
(2) in clause (ii) by striking ``$3,000'' and inserting
``$2,000''.
(b) Minimum Not Increased by Inflation.--Section 220(g) of such
Code is amended by inserting ``(other than the $1,000 amount in
subparagraph (A)(i) and the $2,000 amount in subparagraph (A)(ii)
thereof)'' after ``subsection (c)(2)''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2003.
TITLE II--MEDICAL PRIVACY
SEC. 201. FINDINGS.
The Congress finds the following:
(1) Medical privacy is an issue that concerns a growing
number of people in the United States. The culture of the
United States has always strongly favored a close physician-
patient relationship. One of the key elements of this
relationship is the trust that a patient has that their
personal information will be treated as confidential by medical
personnel and will not be made public or accessible to other
persons without their permission.
(2) In our increasingly complex times, two trends are
combining to exert pressure on maintaining the confidentiality
of health care information. First, public policy favors an
increased ability to provide protection against harmful
prescription interactions and for the reporting of medications'
serious side effects. Second, health care insurers desire to
take advantage of economies of scale in controlling health care
costs. These trends have greatly reduced expectations for the
privacy of health care information.
(3) For the first time in our Nation's history, serious
loopholes have been written into privacy protections that were
created to protect the right of individuals. Positive changes
in privacy law have been made in recent years to guarantee that
patients are notified regarding the use of their health
information, have access to their own medical records, and are
able to request corrections of such records. These protections
must be maintained and strengthened.
(4) One of the greatest needs in the area of health privacy
is to protect individuals against the use of their confidential
health information for profit-generating consumer marketing.
Patients justifiably have objections to this use of their
information without their consent.
(5) There recently have been implemented a series of
alarming modifications to the standards previously finalized to
protect the privacy of individually identifiable health
information. These include changes in important definitions,
additions to the category of health care operations for which
patient consent for the use of their information is not
required, and changes in permitted use of patient information
without consent for public health purposes.
(6) Recent rollbacks in health privacy need to be reversed,
and the individuals' confidence that their private
conversations with medical personnel will remain private needs
to be strengthened.
(7) There is also a need to protect the integrity and
confidentiality of social security account numbers and to
prohibit Federal agencies from imposing national standards for
identification of individuals.
SEC. 202. MODIFICATION OF REGULATIONS ON PRIVACY OF INDIVIDUALLY
IDENTIFIABLE HEALTH INFORMATION.
(a) Marketing.--
(1) In general.--The modifications made by the August 2002
medical privacy rule to the definition of the term
``marketing'' in section 164.501 of title 45, Code of Federal
Regulations, shall have no force or effect.
(2) Authorizations for marketing.--Section 164.508 of title
45, Code of Federal Regulations, shall be construed and applied
so as to require that, if an authorization is required for a
use or disclosure of protected health information for
marketing, the authorization shall be considered invalid unless
it--
(A) uses the term ``marketing'';
(B) states that the purpose of the use or
disclosure involved is marketing; and
(C) describes the specific marketing uses and
disclosures authorized.
(b) Consent for Uses or Disclosures To Carry Out Treatment,
Payment, or Health Care Operations.--
(1) In general.--The modifications made to section 164.506
of title 45, Code of Federal Regulations, by the August 2002
medical privacy rule shall have no force or effect.
(2) Use or disclosure without consent.--
(A) In general.--Section 164.506 of title 45, Code
of Federal Regulations, insofar as it permits any use
or disclosure of protected health information without
consent, shall have no force or effect.
(B) Circumstances where consent not required.--A
health care provider may use or disclose an
individual's protected health information without
obtaining the prior consent of the individual only in
the following circumstances:
(i) To fill or dispense a prescription, and
to search for drug interactions related to that
prescription, if the health care provider
obtains written consent from the individual as
soon as practicable.
(ii) To carry out treatment of that
individual if--
(I) the individual has not executed
a Universal Health Privacy Declaration
promulgated under subparagraph (C);
(II) the individual and the health
care provider have not had in-person
communication regarding such treatment;
and
(III) obtaining consent would be
impracticable.
(C) Universal health privacy declaration.--
(i) In general.--The Secretary of Health
and Human Services shall promulgate a document
which shall be known as the ``Universal Health
Privacy Declaration''.
(ii) Eligibility.--A Universal Health
Privacy Declaration may be executed by any
individual who is a citizen of the United
States or an alien lawfully admitted to the
United States for permanent residence.
(iii) Purpose.--A Universal Health Privacy
Declaration, once executed by an individual
described in clause (ii) and not revoked, shall
be considered to prohibit, as provided under
subparagraph (B), a health care provider from
using or disclosing the individual's protected
health information for treatment without
obtaining the prior consent of the individual.
(iv) Enforcement.--There is established in
the Department of Health and Human Services an
Office of the Health Privacy Ombudsman, which
shall be headed by an individual known as the
``Health Privacy Ombudsman''. The Health
Privacy Ombudsman shall be charged with
investigating complaints submitted by
individuals described in clause (ii) regarding
a use or disclosure of protected health
information in violation of their Universal
Health Privacy Declaration.
(c) Disclosures for Law Enforcement Purposes.--Subparagraph (C) of
section 164.506(f)(1)(ii) of title 45, Code of Federal Regulations
shall have no force or effect.
(d) Definitions.--
(1) In general.--For purposes of this section:
(A) December 2000 medical privacy rule.--The term
``December 2000 medical privacy rule'' means the final
rule on standards for privacy of individually
identifiable health information published on December
28, 2000, in the Federal Register (65 Fed. Reg. 82462),
including the provisions of title 45, Code of Federal
Regulations, revised or added by such rule.
(B) August 2002 medical privacy rule.--The term
``August 2002 medical privacy rule'' means the final
rule, published on August 14, 2002, in the Federal
Register (67 Fed. Reg. 53182), that modified the
December 2000 medical privacy rule.
(2) Other terms defined.--For purposes of this section:
(A) Health care provider.--The term ``health care
provider'' shall have the meaning given such term in
section 160.103 of title 45, Code of Federal
Regulations, as contained in the December 2000 medical
privacy rule.
(B) Disclosure; individual; protected health
information; treatment; use.--The terms ``disclosure'',
``individual'', ``protected health information'',
``treatment'', and ``use'' shall have the meaning given
such terms in section 164.501 of title 45, Code of
Federal Regulations, as contained in the December 2000
medical privacy rule.
SEC. 203. RESTRICTIONS ON THE USE OF THE SOCIAL SECURITY ACCOUNT
NUMBER.
(a) Repeal of Provisions Authorizing Certain Usages of the Social
Security Account Number.--Section 205(c)(2) of the Social Security Act
(42 U.S.C. 405(c)(2)) is amended--
(1) in subparagraph (C), by striking ``(C)(i) It is the
policy'' and all that follows through clause (vi);
(2) by striking clause (ix) of subparagraph (C) and
redesignating clauses (vii) and (viii) of subparagraph (C) as
clauses (iv) and (v), respectively;
(3) by striking subparagraphs (E) and (H);
(4) by redesignating subparagraphs (F) and (G) as
subparagraphs (E) and (F), respectively; and
(5) in subparagraph (E) (as redesignated by paragraph (4)),
by inserting ``(i)'' after ``(E)'', and by adding at the end
the following new clause:
``(ii) No individual shall be treated under any provision of law,
rule, or regulation as required for any purpose to apply for assignment
of a social security account number for himself or herself or on behalf
of any other individual, except as a condition for receipt of benefits
under this title as provided in clause (i).''.
(b) New Rules Applicable to Social Security Account Numbers.--
Section 205(c)(2) of such Act is amended further--
(1) by inserting after subparagraph (B) the following:
``(C)(i) All social security account numbers issued
under this subsection shall be randomly generated.
``(ii) Except as otherwise provided in this
paragraph--
``(I) the social security account number
issued under this subsection to any individual
shall be the exclusive property of such
individual, and
``(II) the Social Security Administration
shall not divulge the social security account
number issued to any individual under this
subsection to any agency or instrumentality of
the Federal Government, to any State, political
subdivision of a State, or agency or
instrumentality of a State or political
subdivision thereof, or to any other
individual.
``(iii) Clause (ii) shall not apply with respect to
the use of the social security account number as an
identifying number to the extent provided in section
6109(d) of the Internal Revenue Code of 1986 (relating
to use of the social security account number for social
security and related purposes).''.
(c) Effective Dates and Related Rules.--
(1) Effective dates.--Not later than 60 days after the date
of the enactment of this Act, the Commissioner of Social
Security shall publish in the Federal Register the date
determined by the Commissioner, in consultation with the
Secretary of the Treasury, to be the earliest date thereafter
by which implementation of the amendments made by this section
is practicable. The amendments made by subsection (a) shall
take effect on the earlier of such date or the date which
occurs 5 years after the date of the enactment of this Act. The
amendments made by subsection (b) shall apply with respect to
social security account numbers issued on or after such earlier
date. The amendments made by subsection (c) shall apply with
respect to calendar quarters and taxable years beginning on or
after such earlier date.
(2) Reissuance of numbers.--The Commissioner of Social
Security shall ensure that, not later than 5 years after the
date of the enactment of this Act, all individuals who have
been issued social security account numbers under section
205(c) of the Social Security Act as of the date prior to the
earlier date specified in paragraph (1) can request new social
security account numbers in accordance with such section as
amended by this section. Upon issuance of such new social
security account numbers, any social security account numbers
issued to such individuals prior to such earlier date specified
in paragraph (1) shall be null and void and subject to the
requirements of section 205(c)(2)(C)(ii)(II) of such Act, as
amended by this section. Any individual to whom, or on behalf
of whom, such a new social security account number has been
issued pursuant to a request made under this paragraph shall be
exempt from any requirement under the laws of the United States
or of any State or political subdivision thereof, or under the
rules and regulations of any agency or instrumentality of the
United States or any State or political subdivision thereof, to
divulge, use, or acknowledge any social security account number
previously issued to such individual. All persons who obtain
new social security account numbers under this Act are granted
lawful immunity from any Federal, State, or local government
agency requirement to divulge, use, or acknowledge previously
issued social security account numbers. Nothing in this section
or the amendments made thereby shall be construed to preclude
the Social Security Administration and the Secretary of the
Treasury from cross-referencing such social security account
numbers newly issued to individuals pursuant to this paragraph
to the former social security account numbers of such
individuals for purposes of administering title II or title XVI
of such Act or administering the Internal Revenue Code of 1986
in connection with section 86, chapter 2, and subtitle C
thereof.
SEC. 204. PROHIBITION OF GOVERNMENTWIDE UNIFORM IDENTIFYING NUMBERS.
(a) In General.--Except as authorized under section 205(c)(2) of
the Social Security Act, any two agencies or instrumentalities of the
Federal Government may not implement the same identifying number with
respect to any individual.
(b) Identifying Numbers.--For purposes of this section--
(1) the term ``identifying number'', with respect to an
individual means any combination of alpha-numeric symbols which
serves to identify such individual; and
(2) any identifying number and any one or more derivatives
of such number shall be treated as the same identifying number.
(c) Effective Date.--The provisions of this section shall take
effect January 1, 2005.
SEC. 205. PROHIBITION OF GOVERNMENT-ESTABLISHED IDENTIFIERS.
(a) In General.--Subject to subsection (b), a Federal agency may
not--
(1) establish or mandate a uniform standard for
identification of an individual that is required to be used by
any other Federal agency, a State agency, or a private person
for any purpose other than the purpose of conducting the
authorized activities of the Federal agency establishing or
mandating the standard; or
(2) condition receipt of any Federal grant or contract or
other Federal funding on the adoption, by a State, a State
agency, or a political subdivision of a State, of a uniform
standard for identification of an individual.
(b) Transactions Between Private Persons.--Notwithstanding
subsection (a), a Federal agency may not establish, mandate, or
encourage the use of a uniform standard for identification of an
individual that is required to be used within the agency, or by any
other Federal agency, a State agency, or a private person, for the
purpose of--
(1) investigating, monitoring, overseeing, or otherwise
regulating a transaction to which the Federal Government is not
a party; or
(2) administrative simplification.
(c) Amendment of Privacy Act of 1974.--(1) Section 7 of the Privacy
Act of 1974 (5 U.S.C. 552a note) is amended--
(A) in subsection (a)(2), by striking ``respect to--'' and
all that follows through the end of subparagraph (B) and
inserting ``respect to any disclosure which is required by
Federal statute.''; and
(B) in subsection (b), by inserting ``Federal'' before
``statutory''.
(2) Section 205(c)(2)(C)(ii) of the Social Security Act (42 U.S.C.
405(c)(2)(C)(ii)) is amended by striking ``, unless section 7(a)'' and
all that follows through the end of the section and inserting a period.
(d) Enforcement.--
(1) Amendments relating to privacy act of 1974.--Subsection
(g) of section 552a of title 5, United States Code, is
amended--
(A) in subparagraph (D), by inserting after ``this
section,'' the following: ``subsection (a) or (b) of
section 207 of the Medical Independence, Privacy, and
Innovation Act of 2003, or section 7 of the Privacy Act
of 1974,''; and
(B) by adding at the end the following new
paragraph:
``(6) For purposes of any suit brought under the provisions of
subsection (g)(1)(D) for failure to comply with any provision of
section 7 of the Privacy Act of 1974, the term `agency' shall include
an agency of a State or local government.''.
(2) Criminal penalties for misuse of social security
account numbers.--Section 208(a) of the Social Security Act (42
U.S.C. 408(a)) is amended--
(A) by adding ``or'' at the end of paragraph (8);
and
(B) by inserting after paragraph (8) the following
new paragraph:
``(9) is a medical service provider or health insurance
issuer and--
``(A) uses a social security account number as a
medical patient tracking number, patient record number,
or prescription tracking number; or
``(B) denies any person medical care or health
insurance coverage based upon such person's refusal to
disclose his or her social security account number;''.
TITLE III--MODIFICATIONS REGARDING REGULATION OF DRUGS UNDER FEDERAL
FOOD, DRUG, AND COSMETIC ACT
SEC. 301. DEFINITION OF DRUG.
Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(g)(1)) is amended in the first sentence by striking ``and
(B) articles intended'' and all that follows and inserting the
following: ``and (B) articles intended for use in the diagnosis, cure,
or treatment (but not mitigation or prevention) of disease in man or
other animals.''.
SEC. 302. STRIKING OF EFFECTIVENESS REQUIREMENT; MODIFICATIONS
REGARDING PATENT LISTINGS, PATENT CERTIFICATIONS, AND
THIRTY-MONTH RULE.
(a) Striking of Effectiveness Requirement; Prohibition Against
Listing of Certain Patents.--
(1) In general.--Section 505(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(b)) is amended by striking
``(b)(1)'' and all that follows through ``clinical trials
required by clause (A).'' and inserting the following:
``(b) Application.--
``(1) Contents.--
``(A) In general.--Any person may file with the
Secretary an application with respect to any drug
subject to the provisions of subsection (a). Such
persons shall submit to the Secretary as a part of the
application--
``(i) full reports of investigations which
have been made to show whether or not such drug
is safe for use;
``(ii) a full list of the articles used as
components of such drug;
``(iii) a full statement of the composition
of such drug;
``(iv) a full description of the methods
used in, and the facilities and controls used
for, the manufacture, processing, and packing
of such drug;
``(v) such samples of such drug and of the
articles used as components thereof as the
Secretary may require; and
``(vi) specimens of the labeling proposed
to be used for such drug.
``(B) Patent information.--
``(i) Requirement.--The applicant shall
file with the application the patent number and
the expiration date of any patent which claims
the drug for which the applicant submitted the
application or which claims a method of using
such drug and with respect to which a claim of
patent infringement could reasonably be
asserted if a person not licensed by the owner
engaged in the manufacture use, or sale of the
drug.
``(ii) Types of patents.--
``(I) Patents subject to
requirement.--The patents for which
information under clause (i)
is required to be filed with the Secretary are drug substance
(ingredient) patents, drug product (formulation and composition)
patents, product by process patents, and method of use patents.
``(II) Prohibition regarding
certain patents.--Process patents,
patents claiming packaging, patents
claiming metabolites, and patents
claiming intermediates are not patents
described in subclause (I), and
information on such patents may not be
filed with the Secretary.
``(III) Patent regarding drug
substance.--For patents that claim the
drug substance, the applicant shall
submit information only on patents that
claim the drug substance that is the
subject of the pending or approved
application or that claim a drug
substance that is the same as the
active ingredient that is the subject
of an approved or pending application
within the meaning of subsection
(j)(2)(A)(ii).
``(IV) Patent regarding drug
product.--For patents that claim a drug
product, the applicant shall submit
information only on those patents that
claim a drug product that is the
subject of a pending or approved
application.
``(V) Patent regarding method of
use.--For patents that claim a method
of use, the applicant shall submit
information only on those patents that
claim indications or other conditions
of use that are the subject of a
pending or approved application. For
approved applications, the applicant
shall identify the indication or other
condition of use in the approved
labeling that corresponds to the listed
patent and claim identified.
``(iii) Filing of patent after submission
of application.--If a application is filed
under this subsection for a drug and a patent
which claims such drug or a method of using
such drug is issued after the filing date but
before approval of the application, the
applicant shall amend the application to
include the information required by clauses (i)
and (ii).
``(iv) Publication of patent information.--
Upon approval of the application, the Secretary
shall publish information submitted under
clauses (i) through (iii).
``(C) Guidance regarding inclusion of women and
minorities in clinical trials.--The Secretary shall, in
consultation with the Director of the National
Institutes of Health and with representatives of the
drug manufacturing industry, review and develop
guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by subparagraph
(A)(i).''.
(2) Conforming amendments.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(A) in section 201(p)--
(i) by striking ``safety and effectiveness
of'' and inserting ``safety of''; and
(ii) by striking ``safe and effective for
use'' and inserting ``safe for use''; and
(B) in section 505--
(i) by striking ``safety and
effectiveness'' each place such term appears
and inserting ``safety'';
(ii) by striking ``safety or
effectiveness'' each place such term appears
and inserting ``safety''; and
(iii) in subsection (i)(1)(D), by striking
``pediatric safety and efficacy'' and inserting
``pediatric safety''.
(b) Abbreviated Applications; Single Certification Regarding Patent
Invalidity or Noninfringement; Single Thirty-Month Delay in Approval.--
Section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(A)) is amended in the matter after and below clause
(viii) by adding at the end the following sentence: ``With respect to a
certification under clause (vii)(IV), an abbreviated application
(whether or not amended) may not contain more than one such
certification, without regard to patents filed after the date of the
certification.''.
SEC. 303. IMPORTATION OF CERTAIN DRUGS.
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381 et seq.) is amended by striking section 804 and inserting the
following:
``importation of certain drugs
``Sec. 804. (a) Regulations.--The Secretary, after consultation
with the United States Trade Representative and the Commissioner of
Customs, shall promulgate regulations permitting pharmacists and
wholesalers to import prescription drugs from foreign nations.
``(b) Limitation.--The regulations under subsection (a) shall
require that safeguards be in place to ensure that each prescription
drug imported under the regulations complies with section 505
(including being safe for the intended use of the prescription drug)
with sections 501 and 502 and with other applicable requirements of
this Act.''.
<all>