To strengthen protections for consumers against misleading direct-to-consumer drug advertising.

TEXT OF AMENDMENTS

SA 975. Mr. ROCKEFELLER (for himself, Ms. Mikulski, and Mrs. Clinton)
proposed an amendment to the bill S. 1, to amend title XVIII of the
Social Security Act to make improvements in the medicare program, to
provide prescription drug coverage under the medicare program, and for
other purposes; as follows:
On page 10, lines 12 and 13, strike ``(other than a dual
eligible individual, as defined in section 1860D-
19(a)(4)(E))''.
On page 21, strike lines 22 through 25, and insert ``title
XIX through a waiver under 1115 where covered outpatient
drugs are the sole medical assistance benefit.''
On page 107, line 3, strike ``30 percent'' and insert
``27.5 percent''.
On page 116, line 10, insert ``and'' after the semi-colon.
On page 116, line 12, strike ``; and'' and insert a period.
On page 116, strike lines 13 through 17.
On page 116, line 24, insert ``and'' after the semi-colon.
On page 117, line 2, strike ``; and'' and insert a period.
On page 117, strike lines 3 through 7.
On page 117, line 13, insert ``and'' after the semicolon.
On page 117, line 17, strike ``; and'' and insert a period.
On page 117, strike lines 18 through 23.
On page 118, line 6, insert ``and'' after the semicolon.
On page 118, in line 13, insert ``or'' after the semi-
colon.
On page 118, line 14, strike ``; or'' and insert a period.
On page 118, strike line 15.
Beginning on page 118, strike line 16 and all that follows
through page 119, line 9.
On page 119, line 10, strike ``(F)'' and insert ``(E)''.
On page 119, line 15, strike ``(G)'' and insert ``(F)''.
On page 119, line 19, strike ``(C), (D), or (E)'' and
insert ``(C), or (D)''.
On page 120, line 3, strike ``(H)'' and insert ``(G)''.
On page 120, lines 5 and 6, strike ``who is a dual eligible
individual or an individual''.
Beginning on page 121, line 24, strike ``dual eligible''
and all that follows through ``and'' on page 122, line 1.
On page 146, line 6, insert before the period ``and to the
design, development, acquisition or installation of improved
data systems necessary to track prescription drug spending
for purposes of implementing section 1935(c)''.
Beginning on page 146, strike line 23 and all that follows
through page 149, line 21, and insert the following:
``(c) Federal Assumption of Medicaid Prescription Drug
Costs for Dually Eligible Beneficiaries.--
``(1) In general.--For purpose of section 1903(a)(1) for a
State for a calendar quarter in a year (beginning with 2006)
the amount computed under this subsection is equal to the
product of the following:
``(A) Standard prescription drug coverage under medicare.--
With respect to individuals who are residents of the State,
who are entitled to, or enrolled for, benefits under part A
of title XVIII, or are enrolled under part B of title XVIII
and are receiving medical assistance under subparagraph
(A)(i), (A)(ii), or (C) of section 1902(a)(10) (or as the
result of the application of section 1902(f)) that includes
covered outpatient drugs (as defined for purposes of section
1927) under the State plan under this title (including such a
plan operated under a waiver under section 1115)--
``(i) the total amounts attributable to such individuals in
the quarter under section 1860D-19 (relating to premium and
cost-sharing subsidies for low-income medicare
beneficiaries); and
``(ii) the actuarial value of standard prescription drug
coverage (as determined under section 1860D-6(f)) provided to
such individuals in the quarter.
``(B) State matching rate.--A proportion computed by
subtracting from 100 percent the Federal medical assistance
percentage (as defined in section 1905(b)) applicable to the
State and the quarter.
``(C) Phase-out proportion.--Subject to subparagraph (D),
the phase-out proportion for a quarter in--
``(i) 2006 is 95 percent;
``(ii) 2007 is 90 percent;
``(iii) 2008 is 85 percent;
``(iv) 2009 is 80 percent;
``(v) 2010 is 75 percent; or
``(vi) 2011, 2012 and 2013 is 70 percent.
``(d) Medicaid as Secondary Payor.--In the case of an
individual who is entitled to a Medicare Prescription Drug
plan under part D or drug coverage under a MedicareAdvantage
plan, and medical assistance including covered outpatient
drugs under this title, medical assistance shall continue to
be provided under this title for covered outpatient drugs to
the extent payment is not made under the Medicare
Prescription Drug plan or a MedicareAdvantage plan.
Beginning on page 152, strike line 3 and all that follows
through page 153, line 15, and insert the following:
``(f) Definition.--For purposes of this section, the term
`subsidy-eligible individual' has the meaning given that term
in subparagraph (D) of section 1860D-19(a)(4).''.

[[Page S8368]]

(C) Conforming amendments.--
(1) Section 1903(a)(1) (42 U.S.C. 1396a(a)(1)) is amended
by inserting before the semicolon the following: ``, reduced
by the amount computed under section 1935(c)(1) for the State
and the quarter''.
(2) Section 1108(f) (42 U.S.C. 1308(f)) is amended by
inserting ``and section 1935(e)(1)(B)'' after ``Subject to
subsection (g)''.
Beginning on page 157, strike line 21 and all that follows
through page 158, line 4.
On page 173, beginning on line 15, strike ``that is not''
and all that follows through ``includes'' on line 18 on that
page, and insert ``that includes but is limited solely to''.
On page 190, in line 18, strike ``and''.
On page 190, between lines 18 and 19, insert the following:
``(B) is not a dual eligible beneficiary as defined under
section 1807(i)(1)(B); and''.
On page 190, line 19, strike ``(B)'' and insert ``(C)''.
______

SA 976. Mr. ROCKEFELLER (for himself, Mr. Carper, Mr. Graham of
Florida, Ms. Mikulski, Mrs. Clinton, and Mr. Dodd) proposed an
amendment to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; as follows:

On page 51, strike lines 15 through 25 and insert the
following:
``(ii) such costs shall be treated as incurred without
regard to whether the individual or another person, including
a State program or other third-party coverage, has paid for
such costs.
______

SA 977. Mr. DAYTON submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; as
follows:

On page 134, strike line 9 and insert the following:
under paragraph (1).
``(d) Implementation of Part D.--Notwithstanding section
1860D-1(a)(4) or any other provision of this part or part C,
the Secretary shall implement, and make benefits available
under, this part on January 1, 2004. The Secretary shall
carry out this part until the Administrator is appointed and
able to carry out this part. The Secretary shall not
implement sections 1807 and 1807A.
______

SA 978. Mr. JEFFORDS (for himself, Mr. Kerry, Mr. Reid, Mr. Durbin,
and Mr. Lautenberg) submitted an amendment intended to be proposed by
him to the bill S. 14, to enhance the energy security of the United
States, and for other purposes; which was ordered to lie on the table;
as follows:

On page 467, after line 16, add the following:

Subtitle I--Renewable Portfolio Standard

SEC. 192. RENEWABLE PORTFOLIO STANDARD.

Title VI of the Public Utility Regulatory Policies Act of
1978 (16 U.S.C. 2601 et seq.) is amended by adding at the end
the following:

``SEC. 606. FEDERAL RENEWABLE PORTFOLIO STANDARD.

``(a) Renewable Energy Requirements.--
``(1) In general.--For each calendar year beginning in
Calendar year 2006, each retail electric supplier shall
submit to the Secretary, not later than April 30 of each
year, renewable energy credits in an amount equal to the
required annual percentage of the retail electric supplier's
total amount of kilowatt-hours of non-hydropower (excluding
incremental hydropower) electricity sold to retail consumers
during the previous calendar year.
``(2) Carryover.--A renewable energy credit for any year
that is not used to satisfy the minimum requirement for that
year may be carried over for use within the next two years.
``(b) Required Annual Percentage.--Of the total amount of
non-hydropower (excluding incremental hydropower) electricity
sold by each retail electric supplier during a calendar year,
the amount generated by renewable energy sources shall be not
less than the percentage specified below:

Percentage of
Renewable energy
Calendar years:
each year:
2006-2009.............................................................5
2010-2014............................................................10
2015-2019............................................................15
2020 and subsequent years............................................20

``(c) Submission of Renewable Energy Credits.--
``(1) In general.--To meet the requirements under
subsection (a), a retail electric supplier shall submit to
the Secretary either--
``(A) renewable energy credits issued to the retail
electric supplier under subsection (e);
``(B) renewable energy credits obtained by purchase or
exchange under subsection (f);
``(C) renewable energy credits purchased from the United
States under subsection (g); or
``(D) any combination of credits under subsections (e), (f)
or (g).
``(2) Prohibition on double counting.--A credit may be
counted toward compliance with subsection (a) only once.
``(d) Renewable Energy Credit Program.--The Secretary shall
establish, not later than 1 year after the date of enactment
of this Act, a program to issue, monitor the sale or exchange
of, and track, renewable energy credits.
``(e) Issuance of Renewable Energy Credits.--
``(1) In general.--Under the program established in
subsection (d), an entity that generates electric energy
through the use of a renewable energy resource may apply to
the Secretary for the issuance of renewable energy credits.
``(2) Application.--An application for the issuance of
renewable energy credits shall indicate--
``(A) the type of renewable energy resource used to produce
the electric energy;
``(B) the State in which the electric energy was produced;
and
``(C) any other information the Secretary determines
appropriate.
``(3) Credit value.--Except as provided in subparagraph
(4), the Secretary shall issue to an entity applying under
this subsection one renewable energy credit for each
kilowatt-hour of renewable energy generated in any State from
the date of enactment of this Act and in each subsequent
calendar year.
``(4) Credit value for distributed generation.--The
Secretary shall issue three renewable energy credits for each
kilowatt-hour of distributed generation.
``(5) Vesting.--A renewable energy credit will vest with
the owner of the system or facility that generates the
renewable energy unless such owner explicitly transfers the
credit.
``(6) Credit eligibility.--To be eligible for a renewable
energy credit, the unit of electricity generated through the
use of a renewable energy resource shall be sold for retail
consumption or used by the generator. If both a renewable
energy resource and a non-renewable energy resource are used
to generate the electric energy, the Secretary shall issue
renewable energy credits based on the proportion of the
renewable energy resource used.
``(7) Identifying credits.--The Secretary shall identify
renewable energy credits by the type and date of generation.
``(8) Sale under purpa contract.--When a generator sells
electric energy generated through the use of a renewable
energy resource to a retail electric supplier under a
contract subject to section 210 of the Public Utilities
Regulatory Policies Act of 1978 (16 U.S.C. 824a-3), the
retail electric supplier is treated as the generator of the
electric energy for the purposes of this Act for the duration
of the contract.
``(f) Sale or Exchange of Renewable Energy Credits.--A
renewable energy credit may be sold or exchanged by the
entity issued the renewable energy credit or by any other
entity that acquires the renewable energy credit. Credits
may be sold or exchanged in any manner not in conflict
with existing law, including on the spot market or by
contractual arrangements of any duration.
``(g) Purchase From the United States.--The Secretary shall
offer renewable energy credits for sale at the lesser of
three cents per kilowatt-hour or 110 percent of the average
market value of credits for the applicable compliance period.
On January 1 of each year following calendar year 2006, the
Secretary shall adjust for inflation the price charged per
credit for such calendar year.
``(h) State Programs.--Nothing in this section shall
preclude any State from requiring additional renewable energy
generation in the State under any renewable energy program
conducted by the State.
``(i) Consumer Allocation.--The rates charged to classes of
consumers by a retail electric supplier shall reflect a
proportional percentage of the cost of generating or
acquiring the required annual percentage of renewable energy
under subsection (a). A retail electric supplier shall not
represent to any customer or prospective customer that any
product contains more than the percentage of eligible
resources if the additional amount of eligible resources is
being used to satisfy the renewable generation requirement
under subsection (a).
``(j) Enforcement.--A retail electric supplier that does
not submit renewable energy credits as required under
subsection (a) shall be liable for the payment of a civil
penalty. That penalty shall be calculated on the basis of the
number of renewable energy credits not submitted, multiplied
by the lesser of 4.5 cents or 300 percent of the average
market value of credits for the compliance period.
``(k) Information Collection.--The Secretary may collect
the information necessary to verify and audit--
``(1) the annual electric energy generation and renewable
energy generation of any entity applying for renewable energy
credits under this section;
``(2) the validity of renewable energy credits submitted by
a retail electric supplier to the Secretary; and
``(3) the quantity of electricity sales of all retail
electric suppliers.
``(l) Voluntary Participation.--The Secretary may issue a
renewable energy credit pursuant to subsection (e) to any
entity not subject to the requirements of this Act only if
the entity applying for such credit meets the terms and
conditions of this Act to the same extent as entities subject
to this Act.
``(m) State Renewable Energy Grant Program.

[[Page S8369]]

``(1) Distribution to states.--The Secretary shall
distribute amounts received from sales under subsection (g)
and from amounts received under subsection (j) to States to
be used for the purposes of this section.
``(2) Regional equity program.--
``(A) Establishment of program.--Within one year from the
date of enactment of this Act, the Secretary shall establish
a program to promote renewable energy production and use
consistent with the purposes of this section.
``(B) Eligibility.--The Secretary shall make funds
available under this section to State energy agencies for
grant programs for--
``(i) renewable energy research and development;
``(ii) loan guarantees to encourage construction of
renewable energy facilities;
``(iii) consumer rebate or other programs to offset costs
of small residential or small commercial renewable energy
systems including solar hot water; or
``(iv) promoting distributed generation.
``(3) Allocation preferences.--In allocating funds under
the program, the Secretary shall give preference to
``(A) States in regions which have a disproportionately
small share of economically sustainable renewable energy
generation capacity; and
``(B) State grant programs most likely to stimulate or
enhance innovative renewable energy technologies.
``(n) Definitions.--In this section:
``(1) Biomass.--
``(A) In general.--The term ``biomass'' means--
``(i) organic material from a plant that is planted for the
purpose of being used to produce energy;
``(ii) nonhazardous, cellulosic or agricultural waste
material that is segregated from other waste materials and is
derived from-- ``(I) a forest-related resource, including--
``(aa) mill and harvesting residue;
``(bb) precommercial thinnings;
``(cc) slash; and
``(dd) brush;
``(II) agricultural resources, including--
``(aa) orchard tree crops;
``(bb) vineyards;
``(cc) grains;
``(dd) legumes;
``(ee) sugar; and
``(ff) other crop by-products or residues; or
``(III) miscellaneous waste such as--
``(aa) waste pallet;
``(bb) crate; and
``(cc) landscape or right-of-way tree trimmings;
``(iii) animal waste that is converted to a fuel rather
than directly combusted, the residue of which is converted to
a biological fertilizer, oil, or activated carbon.
``(B) Exclusions.--The term `biomass' shall not include--
``(i) municipal solid waste that is incinerated;
``(ii) recyclable post-consumer waste paper;
``(iii) painted, treated, or pressurized wood;
``(iv) wood contaminated with plastics or metals; or
``(v) tires.
``(2) Distributed generation.--The term `distributed
generation' means reduced electricity consumption from the
electric grid due to use by a customer of renewable energy
generated at a customer site.
``(3) Incremental hydropower.--The term `incremental
hydropower' means additional generation achieved from
increased efficiency after January 1, 2003, at a
hydroelectric dam that was placed in service before January
1, 2003.
``(4) Landfill gas.--The term `landfill gas' means gas
generated from the decomposition of household solid waste,
commercial solid waste, and industrial solid waste disposed
of in a municipal solid waste landfill unit (as those terms
are defined in regulations promulgated under subtitle D of
the Solid Waste Disposal Act (42 U.S.C. 6941 et seq.)).
``(5) Renewable energy.--The term `renewable energy' means
electricity generated from
``(A) a renewable energy source; or
``(B) hydrogen that is produced from a renewable energy
source.
``(5) Renewable energy source.--The term `renewable energy
source' means--
``(A) wind;
``(B) ocean waves;
``(C) biomass;
``(D) solar;
``(E) landfill gas;
``(F) incremental hydropower; or
``(G) geothermal.
``(6) Retail electric supplier.--The term `retail electric
supplier' means a person or entity that sells retail
electricity to consumers, and which sold not less than
500,000 megawatt-hours of electric energy to consumers for
purposes other than resale during the preceding calendar
year.
``(7) Secretary.--The term `Secretary' means the Secretary
of Energy.
______

SA 979. Mr. AKAKA (for himself, Mr. Sarbanes, and Ms. Mikulski)
proposed an amendment to the bill S. 1, to amend title XVIII of the
Social Security Act to make improvements in the medicare program, to
provide prescription drug coverage under the medicare program, and for
other purposes; as follows:

At the appropriate place, insert the following:

SEC.  . NEGOTIATIONS BY THE OFFICE OF PERSONNEL MANAGEMENT.

The Office of Personnel Management may not negotiate a
prescription drug benefit for any health benefits plan under
chapter 89 of title 5, United States Code, that would provide
a prescription drug benefit to a medicare eligible enrollee
in that plan that is of lesser actuarial value, based on 2003
constant dollars, than the prescription drug benefit
available to a medicare eligible enrollee of such plan on the
date of enactment of this Act.
______

SA 980. Mr. AKAKA proposed an amendment to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

On page 636, line 16, insert ``and citizens of the Freely
Associated States, which include the Federated States of
Micronesia, the Republic of the Marshall Islands, and the
Republic of Palau, lawfully residing in the United States''
after ``Act''.
______

SA 981. Mr. PRYOR proposed an amendment to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

At the appropriate place, add the following:

SEC. __. EQUAL ACCESS TO COMPETITIVE GLOBAL PRESCRIPTION
MEDICINE PRICES FOR AMERICAN PURCHASERS.

(a) Definition of Covered Product.--In this section, the
term ``covered product'' has the meaning given the term in
section 804 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 384).
(b) Prohibition.--It shall be unlawful for the manufacturer
of a covered product or any other person that sells a covered
product to refuse to sell to any wholesaler or retailer (or
other purchaser representing a group of wholesalers or
retailers) of covered products in the United States on terms
(including such terms as prompt payment, cash payment, volume
purchase, single-site delivery, the use of formularies by
purchasers, and any other term that effectively reduces the
cost to the manufacturer of supplying the drug) that are not
substantially the same as the most favorable (to the
purchaser) terms on which the person has sold or has agreed
to sell the covered product to any purchaser in Canada.
(c) Enforcement.--The Secretary of Health and Human
Services, or any wholesaler or retailer in the United States
aggrieved by a violation of subsection (b), may bring a civil
action in United States district court against a person that
violates subsection (b) for an order--
(1) enjoining the violation; and
(2) awarding damages in the amount that is equal to 3 times
the amount of the value of the difference between--
(A) the terms on which the person sold a covered product to
the wholesaler or retailer; and
(B) the terms on which the person sold the covered product
to a person in Canada.
(d) Effectiveness of Section.--This section takes effect on
the date that is 2 years after the date of enactment of this
Act, except that this section shall not be in effect during
any period after that date in which there is in effect a
final regulation promulgated by the Secretary of Health and
Human Services permitting the importation or reimportation of
prescription drugs under section 804 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 384).
______

SA 982. Mr. LAUTENBERG submitted an amendment intended to be proposed
by him to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

At the end of title I, insert the following:

SEC. __. IMPLEMENTATION OF TITLE.

Notwithstanding any other provision of this Act, the
amendments made by this title shall be implemented and
administered so that prescription drug coverage is first
provided under part D of title XVIII beginning on July 1,
2004.
______

SA 983. Mr. SPECTER submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

On page 676, after line 22, insert the following:

SEC. __. PROVISION OF INFORMATION ON ADVANCE DIRECTIVES.

Section 1804(c) of the Social Security Act (42 U.S.C.
1395b-2(c)) is amended--
(1) by redesignating paragraphs (1) through (4) as
subparagraphs (A) through (D), respectively;

[[Page S8370]]

(2) in the matter preceding subparagraph (A), as so
redesignated, by striking ``The notice'' and inserting ``(1)
The notice''; and
(3) by adding at the end the following:
``(2)(A) The Secretary shall annually provide each medicare
beneficiary with information concerning advance directives.
Such information shall be provided by the Secretary as part
of the Medicare and You handbook that is provided to each
such beneficiary. Such handbook shall include a separate
section on advanced directives and specific details on living
wills and the durable power of attorney for health care. The
Secretary shall ensure that the introductory letter that
accompanies such handbook contain a statement concerning the
inclusion of such information.
``(B) In this section:
``(i) The term `advance directive' has the meaning given
such term in section 1866(f)(3).
``(ii) The term `medicare beneficiary' means an individual
who is entitled to, or enrolled for, benefits under part A or
enrolled under part B, of this title.''.
______

SA 984. Mr. BINGAMAN proposed an amendment to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

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

SEC. __. CARVING OUT DSH PAYMENTS FROM PAYMENTS TO
MEDICARE+CHOICE AND MEDICAREADVANTAGE
ORGANIZATIONS AND PAYING THE AMOUNTS DIRECTLY
TO DSH HOSPITALS ENROLLING MEDICARE+CHOICE AND
MEDICAREADVANTAGE ENROLLEES.

(a) Removal of DSH Payments From Calculation of Adjusted
Average Per Capita Cost.--
(1) Under medicare+choice.--Section 1853(c)(3) (42 U.S.C.
1395w-23(c)(3) and as amended by section 203) is amended--
(A) in subparagraph (A), by striking ``subparagraph (B)''
and inserting ``subparagraphs (B) and (E)'',
(B) by adding at the end the following new subparagraph:
``(E) Removal of payments attributable to disproportionate
share payments from calculation of adjusted average per
capita cost.--For each year (beginning with 2004), the area-
specific Medicare+Choice capitation rate under subparagraph
(A)(ii) shall be adjusted to exclude from such rate the
portion of such rate that the Secretary estimates is
attributable to additional payment amounts described in
section 1886(d)(5)(F) (treating hospitals reimbursed under
section 1814(b)(3) as if such hospitals were reimbursed under
section 1886).''.
(2) Under medicareadvantage.--Section 1853(a)(5) (as
amended by section 203) is amended by adding at the end the
following new subparagraph:
``(C) Removal of payments attributable to disproportionate
share payments from calculation of adjusted average per
capita cost.--For each year (beginning with 2004), the area-
specific Medicare+Choice capitation rate under subparagraph
(A)(ii) shall be adjusted to exclude from such rate the
portion of such rate that the Secretary estimates is
attributable to additional payment amounts described in
section 1886(d)(5)(F) (treating hospitals reimbursed under
section 1814(b)(3) as if such hospitals were reimbursed under
section 1886).''.
(3) Effective dates.--The amendments made--
(A) by paragraph (1) shall apply to plan years beginning on
and after January 1, 2004 and shall continue to apply to plan
years beginning on and after January 1, 2006; and
(B) by paragraph (2) shall apply to plan years beginning on
and after January 1, 2006.
(b) Additional DSH Payments for Managed Care Enrollees.--
Section 1886(d)(5)(F) ((42 U.S.C. 1395ww(d)(5)(F)) is
amended--
(1) in clause (ii), by striking ``clause (ix)'' and
inserting ``clauses (ix) and (xvi)''; and
(2) by adding at the end the following new clause:
``(xvi)(I) For portions of cost reporting periods occurring
on or after January 1, 2004, the Secretary shall provide for
an additional payment amount for each applicable discharge of
any subsection (d) hospital that is a disproportionate share
hospital (as described in clause (i)).
``(II) For purposes of this clause the term `applicable
discharge' means the discharge of any individual who is
enrolled under a risk-sharing contract with a eligible
organization under section 1876 and who is entitled to
benefits under part A and any individual who is enrolled with
a Medicare+Choice organization or a MedicareAdvantage
organization under part C.
``(III) The amount of the payment under this clause with
respect to any applicable discharge shall be equal to the
estimated average per discharge amount that would otherwise
have been paid under this subparagraph if the individuals had
not been enrolled as described in subclause (II).
``(IV) The Secretary shall establish rules for paying an
additional amount for any hospital reimbursed under a
reimbursement system authorized under 1814(b)(3) if such
hospital would qualify as a disproportionate share hospital
under clause (i) were it not so reimbursed. Such payment
shall be determined in the same manner as the amount of
payment is determined under this clause for disproportionate
share hospitals.''.
______

SA 985. Mr. BAUCUS (for Mr. Edwards (for himself and Mr. Harkin))
proposed an amendment to the bill S. 1, to amend title XVIII of the
Social Security Act to make improvements in the medicare program, to
provide prescription drug coverage under the medicare program, and for
other purposes; as follows:

At the end, add the following:

TITLE __--DIRECT-TO-CONSUMER PRESCRIPTION DRUG ADVERTISING

SEC. __01. HEAD-TO-HEAD TESTING AND DIRECT-TO-CONSUMER
ADVERTISING.

(a) New Drug Application.--Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subparagraph (A) of the second sentence of
subsection (b)(1), by inserting before the semicolon at the
end the following ``(including whether the drug is safe and
effective for use in comparison with other drugs available
for substantially the same indications for use prescribed,
recommended, or suggested in the labeling proposed for the
drug)''; and
(2) in subsection (d)(5)--
(A) by inserting ``(A)'' after ``will''; and
(B) by inserting after ``thereof'' the following: ``or (B)
offer a benefit with respect to safety, effectiveness, or
cost (including effectiveness with respect to a sub
population or condition) that is greater than the benefit
offered by other drugs available for substantially the same
indications for use prescribed, recommended, or suggested in
the labeling proposed for the drug''.
(b) Misbranding.--Section 502(n)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 352(n)(3)) is amended by
inserting after ``effectiveness'' the following: ``(including
effectiveness in comparison to other drugs for substantially
the same condition or conditions)''.
(c) Regulations.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate amended regulations governing
prescription drug advertisements.
(2) Contents.--In addition to any other requirements, the
regulations under paragraph (1) shall require that--
(A) any advertisement present a fair balance, comparable in
depth and detail, between--
(B) any advertisement present a fair balance, comparable in
depth, between--
(i)aural and visual presentations relating to effectiveness
of the drug; and
(ii) aural and visual presentations relating to side
effects and contraindications, provided that, nothing in this
section shall require explicit images or sounds depicting
side effects and contraindication;
(i) information relating to effectiveness of the drug
(including effectiveness in comparison to similar drugs for
substantially the same condition or conditions); and
(ii) information relating to side effects and
contraindications;
(C) prohibit false or misleading advertising that would
encourage a consumer to take the prescription drug for a use
other than a use for which the prescription drug is approved
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355); and
(D) require that any prescription drug that is the subject
of a direct-to-consumer advertisement include in the package
in which the prescription drug is sold to consumers a
medication guide explaining the benefits and risks of use of
the prescription drug in terms designed to be understandable
to the general public.

SEC. __02. CIVIL PENALTY.

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) Direct-to-Consumer Prescription Drug Advertising.--
``(1) In general.--A person that commits a violation of
section 301 involving the misbranding of a prescription drug
(within the meaning of section 502(n)) in a direct-to-
consumer advertisement shall be assessed a civil penalty if--
``(A) the Secretary provides the person written notice of
the violation; and
``(B) the person fails to correct or cease the
advertisement so as to eliminate the violation not later than
180 days after the date of the notice.
``(2) Amount.--The amount of a civil penalty under
paragraph (1)--
``(A) shall not exceed $500,000 in the case of an
individual and $5,000,000 in the case of any other person;
and
``(B) shall not exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
``(3) Procedure.--Paragraphs (3) through (5) of subsection
(g) apply with respect to a civil penalty under paragraph (1)
of this subsection to the same extent and in the same manner
as those paragraphs apply with respect to a civil penalty
under paragraph (1) or (2) of subsection (g).''.

SEC. __03. REPORTS.

The Secretary of Health and Human Services shall annually
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, for
the most recent 1-year period for which data are available--
(1) provides the total number of direct-to-consumer
prescription drug advertisements made by television, radio,
the Internet, written publication, or other media;

[[Page S8371]]

(2) identifies, for each such advertisement--
(A) the dates on which, the times at which, and the markets
in which the advertisement was made; and
(B) the type of advertisement (reminder, help-seeking, or
product-claim); and
(3)(A) identifies the advertisements that violated or
appeared to violate section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)); and
(B) describes the actions taken by the Secretary in
response to the violations.

SEC. __04. REVIEW OF DIRECT-TO-CONSUMER DRUG ADVERTISEMENTS.

(a) In General.--The Secretary of Health and Human Services
shall expedite, to the maximum extent practicable, reviews of
the legality of direct-to-consumer drug advertisements.
(b) Policy.--The Secretary of Health and Human Services
shall not adopt or follow any policy that would have the
purpose or effect of delaying reviews of the legality of
direct-to-consumer drug advertisements except--
(1) as a result of notice-and-comment rulemaking; or
(2) as the Secretary determines to be necessary to protect
public health and safety.
______

SA 986. Mr. BAUCUS (for Mr. Lautenberg (for himself, Mr. Reed, Mrs.
Clinton, and Mr. Corzine)) proposed an amendment to the bill S. 1, to
amend title XVIII of the Social Security Act to make improvements in
the medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

At the end of title I, insert the following:

SEC. __. IMPLEMENTATION OF TITLE.

Notwithstanding any other provision of this Act, the
amendments made by this title shall be implemented and
administered so that prescription drug coverage is first
provided under part D of title XVIII beginning on July 1,
2004.
______

SA 987. Mrs. HUTCHISON (for herself, Mr. Kennedy, Mr. Durbin, Mr.
Kerry, Mr. Talent, Mr. Reed, Mrs. Murray, Mr. Specter, Mrs. Feinstein,
Mr. Corzine, Mr. Biden, Mr. Bond, and Mr. Schumer) submitted an
amendment intended to be proposed by her to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; which was ordered to lie on
the table; as follows:

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

SEC. __. FREEZING INDIRECT MEDICAL EDUCATION (IME) ADJUSTMENT
PERCENTAGE AT 6.5 PERCENT.

(a) In General.--Section 1886(d)(5)(B)(ii) (42 U.S.C.
1395ww(d)(5)(B)(ii)) is amended--
(1) in subclause (VI), by striking ``and'' at the end; and
(2) by striking subclause (VII) and inserting the following
new subclauses:
``(VII) during fiscal year 2003, ``c'' is equal to 1.35;
and
``(VIII) on or after October 1, 2003, `c' is equal to
1.6.''.
(b) Conforming Amendment Relating to Determination of
Standardized Amount.--Section 1886(d)(2)(C)(i) (42 U.S.C.
1395ww(d)(2)(C)(i)) is amended--
(1) by striking ``1999 or'' and inserting ``1999,''; and
(2) by inserting ``, or the Prescription Drug and Medicare
Improvement Act of 2003'' after ``2000''.jennifer
______

SA 988. Mr. THOMAS (for himself and Mrs. Lincoln) submitted an
amendment intended to be proposed by him to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; which was ordered to lie on
the table; as follows:

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

SEC. __. COVERAGE OF MARRIAGE AND FAMILY THERAPIST SERVICES
AND MENTAL HEALTH COUNSELOR SERVICES UNDER PART
B OF THE MEDICARE PROGRAM.

(a) Coverage of Services.--
(1) In general.--Section 1861(s)(2) (42 U.S.C. 1395x(s)(2))
is amended--
(A) in subparagraph (U), by striking ``and'' after the
semicolon at the end;
(B) in subparagraph (V)(iii), by inserting ``and'' after
the semicolon at the end; and
(C) by adding at the end the following new subparagraph:
``(W) marriage and family therapist services (as defined in
subsection (ww)(1)) and mental health counselor services (as
defined in subsection (ww)(3));''.
(2) Definitions.--Section 1861 (42 U.S.C. 1395x) is amended
by adding at the end the following new subsection:

``Marriage and Family Therapist Services; Marriage and Family
Therapist; Mental Health Counselor Services; Mental Health Counselor

``(ww)(1) The term `marriage and family therapist services'
means services performed by a marriage and family therapist
(as defined in paragraph (2)) for the diagnosis and treatment
of mental illnesses, which the marriage and family therapist
is legally authorized to perform under State law (or the
State regulatory mechanism provided by State law) of the
State in which such services are performed, as would
otherwise be covered if furnished by a physician or as an
incident to a physician's professional service, but only if
no facility or other provider charges or is paid any amounts
with respect to the furnishing of such services.
``(2) The term `marriage and family therapist' means an
individual who--
``(A) possesses a master's or doctoral degree which
qualifies for licensure or certification as a marriage and
family therapist pursuant to State law;
``(B) after obtaining such degree has performed at least 2
years of clinical supervised experience in marriage and
family therapy; and
``(C) in the case of an individual performing services in a
State that provides for licensure or certification of
marriage and family therapists, is licensed or certified as a
marriage and family therapist in such State.
``(3) The term `mental health counselor services' means
services performed by a mental health counselor (as defined
in paragraph (4)) for the diagnosis and treatment of mental
illnesses which the mental health counselor is legally
authorized to perform under State law (or the State
regulatory mechanism provided by the State law) of the State
in which such services are performed, as would otherwise be
covered if furnished by a physician or as incident to a
physician's professional service, but only if no facility or
other provider charges or is paid any amounts with respect to
the furnishing of such services.
``(4) The term `mental health counselor' means an
individual who--
``(A) possesses a master's or doctor's degree in mental
health counseling or a related field;
``(B) after obtaining such a degree has performed at least
2 years of supervised mental health counselor practice; and
``(C) in the case of an individual performing services in a
State that provides for licensure or certification of mental
health counselors or professional counselors, is licensed or
certified as a mental health counselor or professional
counselor in such State.''.
(3) Provision for payment under part b.--Section
1832(a)(2)(B) (42 U.S.C. 1395k(a)(2)(B)) is amended by adding
at the end the following new clause:
``(v) marriage and family therapist services and mental
health counselor services;''.
(4) Amount of payment.--Section 1833(a)(1) (42 U.S.C.
1395l(a)(1)) is amended--
(A) by striking ``and (U)'' and inserting ``(U)''; and
(B) by inserting before the semicolon at the end the
following: ``, and (V) with respect to marriage and family
therapist services and mental health counselor services under
section 1861(s)(2)(W), the amounts paid shall be 80 percent
of the lesser of the actual charge for the services or 75
percent of the amount determined for payment of a
psychologist under subparagraph (L)''.
(5) Exclusion of marriage and family therapist services and
mental health counselor services from skilled nursing
facility prospective payment system.--Section
1888(e)(2)(A)(ii) (42 U.S.C. 1395yy(e)(2)(A)(ii)), as amended
in section 301(a), is amended by inserting ``marriage and
family therapist services (as defined in subsection (ww)(1)),
mental health counselor services (as defined in section
1861(ww)(3)),'' after ``qualified psychologist services,''.
(6) Inclusion of marriage and family therapists and mental
health counselors as practitioners for assignment of
claims.--Section 1842(b)(18)(C) (42 U.S.C. 1395u(b)(18)(C))
is amended by adding at the end the following new clauses:
``(vii) A marriage and family therapist (as defined in
section 1861(ww)(2)).
``(viii) A mental health counselor (as defined in section
1861(ww)(4)).''.
(b) Coverage of Certain Mental Health Services Provided in
Certain Settings.--
(1) Rural health clinics and federally qualified health
centers.--Section 1861(aa)(1)(B) (42 U.S.C. 1395x(aa)(1)(B))
is amended by striking ``or by a clinical social worker (as
defined in subsection (hh)(1)),'' and inserting ``, by a
clinical social worker (as defined in subsection (hh)(1)), by
a marriage and family therapist (as defined in subsection
(ww)(2)), or by a mental health counselor (as defined in
subsection (ww)(4)),''.
(2) Hospice programs.--Section 1861(dd)(2)(B)(i)(III) (42
U.S.C. 1395x(dd)(2)(B)(i)(III)) is amended by inserting ``or
a marriage and family therapist (as defined in subsection
(ww)(2))'' after ``social worker''.
(c) Authorization of Marriage and Family Therapists To
Develop Discharge Plans for Post-Hospital Services.--Section
1861(ee)(2)(G) (42 U.S.C. 1395x(ee)(2)(G)) is amended by
inserting ``marriage and family therapist (as defined in
subsection (ww)(2)),'' after ``social worker,''.
(d) Effective Date.--The amendments made by this section
shall apply with respect to services furnished on or after
January 1, 2004.
______

SA 989. Ms. COLLINS submitted an amendment intended to be proposed by
her to the bill S. 1, to amend title

[[Page S8372]]

XVIII of the Social Security Act to make improvements in the medicare
program, to provide prescription drug coverage under the medicare
program, and for other purposes; which was ordered to lie on the table;
as follows:

At the appropriate place in subtitle C of title IV, insert
the following:

SEC. __. INCREASE IN MEDICARE PAYMENT FOR CERTAIN HOME HEALTH
SERVICES.

(a) In General.--Section 1895 of the Social Security Act
(42 U.S.C. 1395fff) is amended by adding at the end the
following:
``(f) Increase in Payment for Services Furnished in a Rural
Area.--
``(1) In general.--In the case of home health services
furnished in a rural area (as defined in section
1886(d)(2)(D)) on or after October 1, 2003 and before October
1, 2006, the Secretary shall increase the payment amount
otherwise made under this section for such services by 10
percent.
``(2) Waiver of budget neutrality.--The Secretary shall not
reduce the standard prospective payment amount (or amounts)
under this section applicable to home health services
furnished during any period to offset the increase in
payments resulting from the application of paragraph (1).''.
(b) Payment Adjustment.--Section 1895(b)(5) of the Social
Security Act (42 U.S. C. 1395fff(b)(5)) is amended by adding
at the end the following:``Notwithstanding this paragraph,
the total amount of the additional payments or payment
adjustments made under this paragraph may not exceed, with
respect to fiscal year 2004, 3 percent, and, with respect to
fiscal years 2005 and 2006, 4 percent, of the total payments
projected or estimated to be made based on the prospective
payment system under this subsection in the year involved.''.
(c) Effective Date.--The amendments made by this section
shall apply to services furnished on or after October 1,
2003.
______

SA 990. Mrs. MURRAY proposed an amendment to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

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

SEC. __. IMPROVEMENTS IN MEDICAREADVANTAGE BENCHMARK
DETERMINATIONS.

(a) Revision of National Average Used in Calculation of
Blend.--Section 1853(c)(4)(B)(i)(II) (42 U.S.C. 1395w-
23(c)(4)(B)(i)(II)), as amended by section 203, is amended by
inserting ``who are enrolled in a MedicareAdvantage plan''
after ``the average number of medicare beneficiaries''.
(b) Change in Budget Neutrality.--Section 1853(c) (42
U.S.C. 1395w-23(c)), as amended by section 203, is amended--
(1) in paragraph (1)(A)--
(A) in clause (ii), by striking the comma at the end and
inserting a period; and
(B) by striking the flush matter following clause (ii); and
(2) by striking paragraph (5).
(c) Inclusion of Costs of DOD and VA Military Facility
Services to Medicare-eligible Beneficiaries in Calculation of
MedicareAdvantage Payment Rates.--
(1) For purposes of calculating medicare+choice payment
rates.--Section 1853(c)(3) (42 U.S.C. 1395w-23(c)(3)), as
amended by section 203, is amended--
(A) in subparagraph (A), by striking ``subparagraph (B)''
and inserting ``subparagraphs (B) and (E)''; and
(B) by adding at the end the following new subparagraph:
``(E) Inclusion of costs of dod and va military facility
services to medicare-eligible beneficiaries.--In determining
the area-specific Medicare+Choice capitation rate under
subparagraph (A) for a year (beginning with 2006), the annual
per capita rate of payment for 1997 determined under section
1876(a)(1)(C) shall be adjusted to include in the rate the
Secretary's estimate, on a per capita basis, of the amount of
additional payments that would have been made in the area
involved under this title if individuals entitled to benefits
under this title had not received services from facilities of
the Department of Defense or the Department of Veterans
Affairs.''.
(2) For purposes of calculating local fee-for-service
rates.--Section 1853(d)(5) (42 U.S.C. 1395w-23(d)(5)), as
amended by section 203, is amended--
(A) in subparagraph (A), by striking ``subparagraph (B)''
and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following new subparagraph:
``(C) Inclusion of costs of dod and va military facility
services to medicare-eligible beneficiaries.--In determining
the local fee-for-service rate under subparagraph (A) for a
year (beginning with 2006), the annual per capita rate of
payment for 1997 determined under section 1876(a)(1)(C) shall
be adjusted to include in the rate the Secretary's estimate,
on a per capita basis, of the amount of additional payments
that would have been made in the area involved under this
title if individuals entitled to benefits under this title
had not received services from facilities of the Department
of Defense or the Department of Veterans Affairs.''.
(d) Effective Date.--The amendments made by this section
shall apply with respect to plan years beginning on and after
January 1, 2006.
______

SA 991. Mr. HARKIN proposed an amendment to the bill S. 1, to amend
title XVIII of the Social Security Act to make improvements in the
medicare program, to provide prescription drug coverage under the
medicare program, and for other purposes; as follows:

At the appropriate place, insert the following:

TITLE __--MEDICAID DEMONSTRATION PROJECTS

SEC. __01. SHORT TITLE.

This title may be cited as the ``Money Follows the Person
Act of 2003''.

SEC. __02. FINDINGS.

Congress makes the following findings:
(1) In his budget for fiscal year 2004, President George W.
Bush proposes a ``Money Follows the Person'' rebalancing
initiative under the medicaid program to help States
rebalance their long-term services support systems more
evenly between institutional and community-based services.
(2) The President, by proposing this initiative, and
Congress, recognize that States have not fully developed the
systems needed to create a more equitable balance between
institutional and community-based services spending under the
medicaid program.
(3) While a few States have been successful at achieving
this balance, nationally, approximately 70 percent of the
medicaid funding spent for long-term services is devoted to
nursing facilities and intermediate care facilities for the
mentally retarded. Only 30 percent of such funding is spent
for community-based services.
(4) As a result, there are often long waiting lists for
community-based services and supports.
(5) In the Americans with Disabilities Act of 1990,
Congress found that individuals with disabilities continue to
encounter various forms of discrimination, including
segregation, and that discrimination persists in such
critical areas as institutionalization.
(6) In 1999, the Supreme Court held in Olmstead v. LC (527
U.S. 581 (1999)) that needless institutionalization is
discrimination under the Americans with Disabilities Act of
1990, noting that institutional placement of people who can
be served in the community ``perpetuates unwarranted
assumptions that persons so isolated are unworthy of
participating in community life.'' (Id. at 600). The Court
further found that ``confinement in an institution severely
diminishes the everyday life activities of individuals,
including family relations, social contacts, work options,
economic independence, educational advancement, and cultural
enrichment.'' (Id. at 601).
(7) Additional resources would be helpful for assisting
States in rebalancing their long-term services support system
and complying with the Olmstead decision.

SEC. __03. AUTHORITY TO CONDUCT MEDICAID DEMONSTRATION
PROJECTS.

(a) Definitions.--In this section:
(1) Community-based services and supports.--The term
``community-based services and supports'' means, with respect
to a State, any items or services that are an allowable
expenditure for medical assistance under the State medicaid
program, or under a waiver of such program and that the State
determines would allow an individual to live in the
community.
(2) Individual's representative; representative.--The terms
``individual's representative'' and ``representative'' mean a
parent, family member, guardian, advocate, or authorized
representative of an individual.
(3) Medicaid long-term care facility.--The term ``medicaid
long-term care facility'' means a hospital, nursing facility,
or intermediate care facility for the mentally retarded, as
such terms are defined for purposes of the medicaid program.
(4) Medicaid program.--The term ``medicaid program'' means
the State medical assistance program established under title
XIX of the Social Security Act (42 U.S.C. 1396 et seq.).
(5) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(6) State.--The term ``State'' has the meaning given such
term for purposes of the medicaid program.
(b) State Application.--A State may apply to the Secretary
for approval to conduct a demonstration project under which
the State shall provide community-based services and supports
to individuals--
(1) who are eligible for medical assistance under the
medicaid program;
(2) who are residing in a medicaid long-term care facility
and who have resided in such facility for at least 90 days;
and
(3) with respect to whom there has been a determination
that but for the provision of community-based services and
supports, the individuals would continue to require the level
of care provided in a medicaid long-term care facility.
(c) Requirements.--A State is not eligible to conduct a
demonstration project under this section unless the State
certifies the following:
(1) With respect to any individual provided community-based
services and supports under the demonstration project, the
State shall continue to provide community-based services and
supports to the individual under the medicaid program (and at
the State's Federal medical assistance percentage (as

[[Page S8373]]

defined in section 1905(b) of the Social Security Act)
reimbursement rate), for as long as the individual remains
eligible for medical assistance under the State medicaid
program and continues to require such services and supports,
beginning with the month that begins after the 12-month
period in which the individual is provided such services and
supports under the demonstration project.
(2) The State shall allow an individual participating in
the demonstration project (or, as appropriate, the
individual's representative) to choose the setting in which
the individual desires to receives the community-based
services and supports provided under the project.
(3) The State shall identify and educate individuals
residing in a medicaid long-term care facility who are
eligible to participate in the demonstration project (and, as
appropriate the individual's representative) about the
opportunity for the individual to receive community-based
services and supports under the demonstration project.
(4) The State shall ensure that each individual identified
in accordance with paragraph (3) (and, as appropriate, the
individual's representative), has the opportunity,
information, and tools to make an informed choice regarding
whether to transition to the community through participation
in the demonstration project or to remain in the medicaid
long-term care facility.
(5) The State shall maintain an adequate quality
improvement system so that individuals participating in the
demonstration project receive adequate services and supports.
(6) The State shall conduct a process for public
participation in the design and development of the
demonstration project and such process shall include the
participation of individuals with disabilities, elderly
individuals, or individuals with chronic conditions who are
part of the target populations to be served by the
demonstration project, and the representatives of such
individuals.
(7) The Federal funds paid to a State pursuant to this
section shall only supplement, and shall not supplant, the
level of State funds expended for providing community-based
services and supports for individuals under the State
medicaid program as of the date the State application to
conduct a demonstration project under this section is
approved.
(d) Approval of Demonstration Projects.--
(1) In general.--Subject to paragraph (2), the Secretary
shall conduct a competitive application process with respect
to applications submitted under subsection (b) (taking into
consideration the preferences provided under paragraph (2))
that meet the requirements of subsection (c). In determining
whether to approve such an application, the Secretary may
waive the requirement of--
(A) section 1902(a)(1) of the Social Security Act (42
U.S.C. 1396a(a)(1)) to allow for sub-State demonstrations;
(B) section 1902(a)(10)(B) of such Act (42 U.S.C.
1396a(a)(10)(B)) with respect to comparability; and
(C) section 1902(a)(10)(C)(i)(III) of such Act (42 U.S.C.
1396a(a)(10)(C)(i)(III)) with respect to income and resource
limitations.
(2) Preference for certain applications.--In approving
applications to conduct demonstration projects under this
section, the Secretary shall give preference to approving
applications that indicate that the State shall do the
following:
(A) Design and implement enduring improvements in
community-based long-term services support systems within the
State to enable individuals with disabilities to live and
participate in community life, particularly with respect to
those practices that will ensure the successful transition of
such individuals from medicaid long-term care facilities into
the community.
(B) Design and implement a long-term services support
system in the State that prevents individuals from entering
medicaid long-term care facilities in order to gain access to
community-based services and supports.
(C) Engage in systemic reform activities within the State
to rebalance expenditures for long-term services under the
State medicaid program through administrative actions that
reduce reliance on institutional forms of service and build
up more community capacity.
(D) Address the needs of populations that have been
underserved with respect to the availability of community
services or involve individuals or entities that have not
previously participated in the efforts of the State to
increase access to community-based services.
(E) Actively engage in collaboration between public housing
agencies, the State medicaid agency, independent living
centers, and other agencies and entities in order to
coordinate strategies for obtaining community integrated
housing and supportive services for an individual who
participates in the demonstration project, both with respect
to the period during which such individual participates in
the project and after the individual's participation in the
project concludes, in order to enable the individual to
continue to reside in the community.
(F) Develop and implement policies and procedures that
allow the State medicaid agency to administratively transfer
or integrate funds from the State budget accounts that are
obligated for expenditures for medicaid long-term care
facilities to other accounts for obligation for the provision
of community-based services and supports (including accounts
related to the provision of such services under a waiver
approved under section 1915 of the Social Security Act (42
U.S.C. 1396n)) when an individual transitions from residing
in such a facility to residing in the community.
(e) Payments to States.--
(1) In general.--The Secretary shall pay to each State with
a demonstration project approved under this section an amount
for each quarter occurring during the period described in
paragraph (2) equal to 100 percent of the State's
expenditures in the quarter for providing community-based
services and supports to individuals participating in the
demonstration project.
(2) Period described.--The period described in this
paragraph is the 12-month period that begins on the date on
which an individual first receives community-based services
and supports under the demonstration project in a setting
that is not a medicaid long-term care facility and is
selected by the individual.
(f) Reports.--
(1) In general.--Each State conducting a demonstration
project under this section shall submit a report to the
Secretary that, in addition to such other requirements as the
Secretary may require, includes information regarding--
(A) the types of community-based services and supports
provided under the demonstration project;
(B) the number of individuals served under the project;
(C) the expenditures for, and savings resulting from,
conducting the project; and
(D) to the extent applicable, the changes in State's long-
term services system developed in accordance with the
provisions of subsection (d)(2).
(2) Uniform data format.--In requiring information under
this subsection, the Secretary shall develop a uniform data
format to be used by States in the collection and submission
of data in the State report required under paragraph (1).
(g) Evaluations.--The Secretary shall use an amount, not to
exceed one-half of 1 percent of the amount appropriated under
subsection (h) for each fiscal year, to provide, directly or
through contract--
(1) for the evaluation of the demonstration projects
conducted under this section;
(2) technical assistance to States concerning the
development or implementation of such projects; and
(3) for the collection of the data described in subsection
(f)(1).
(h) Funding.--There is appropriated to carry out this
section, $350,000,000 for each of fiscal years 2004 through
2008. Funds appropriated under the preceding sentence for a
fiscal year shall remain available until expended, but not
later than September 30, 2008.

SEC. __04. MEDICARE SECONDARY PAYOR (MSP) PROVISIONS.

(a) Technical Amendment Concerning Secretary's Authority To
Make Conditional Payment When Certain Primary Plans Do Not
Pay Promptly.--
(1) In general.--Section 1862(b)(2) (42 U.S.C. 1395y(b)(2))
is amended--
(A) in subparagraph (A)(ii), by striking ``promptly (as
determined in accordance with regulations)'';
(B) in subparagraph (B)--
(i) by redesignating clauses (i) through (iii) as clauses
(ii) through (iv), respectively; and
(ii) by inserting before clause (ii), as so redesignated,
the following new clause:
``(i) Authority to make conditional payment.--The Secretary
may make payment under this title with respect to an item or
service if a primary plan described in subparagraph (A)(ii)
has not made or cannot reasonably be expected to make payment
with respect to such item or service promptly (as determined
in accordance with regulations). Any such payment by the
Secretary shall be conditioned on reimbursement to the
appropriate Trust Fund in accordance with the succeeding
provisions of this subsection.''.
(2) Effective date.--The amendments made by paragraph (1)
shall be effective as if included in the enactment of title
III of the Medicare and Medicaid Budget Reconciliation
Amendments of 1984 (Public Law 98-369).
(b) Clarifying Amendments to Conditional Payment
Provisions.--Section 1862(b)(2) (42 U.S.C. 1395y(b)(2)) is
further amended--
(1) in subparagraph (A), in the matter following clause
(ii), by inserting the following sentence at the end: ``An
entity that engages in a business, trade, or profession shall
be deemed to have a self-insured plan if it carries its own
risk (whether by a failure to obtain insurance, or otherwise)
in whole or in part.'';
(2) in subparagraph (B)(ii), as redesignated by subsection
(a)(2)(B)--
(A) by striking the first sentence and inserting the
following: ``A primary plan, and an entity that receives
payment from a primary plan, shall reimburse the appropriate
Trust Fund for any payment made by the Secretary under this
title with respect to an item or service if it is
demonstrated that such primary plan has or had a
responsibility to make payment with respect to such item or
service. A primary plan's responsibility for such payment may
be demonstrated by a judgment, a payment conditioned upon the
recipient's compromise, waiver, or release (whether or not
there is a determination or admission of liability) of
payment for items or services included in a

[[Page S8374]]

claim against the primary plan or the primary plan's insured,
or by other means.''; and
(B) in the final sentence, by striking ``on the date such
notice or other information is received'' and inserting ``on
the date notice of, or information related to, a primary
plan's responsibility for such payment or other information
is received''; and
(3) in subparagraph (B)(iii), as redesignated by subsection
(a)(2)(B), by striking the first sentence and inserting the
following: ``In order to recover payment made under this
title for an item or service, the United States may bring an
action against any or all entities that are or were required
or responsible (directly, as an insurer or self-insurer, as a
third-party administrator, as an employer that sponsors or
contributes to a group health plan, or large group health
plan, or otherwise) to make payment with respect to the same
item or service (or any portion thereof) under a primary
plan. The United States may, in accordance with paragraph
(3)(A) collect double damages against any such entity. In
addition, the United States may recover under this clause
from any entity that has received payment from a primary plan
or from the proceeds of a primary plan's payment to any
entity.''.
(c) Clerical Amendments.--Section 1862(b) (42 U.S.C.
1395y(b)) is amended--
(1) in paragraph (1)(A), by moving the indentation of
clauses (ii) through (v) 2 ems to the left; and
(2) in paragraph (3)(A), by striking ``such'' before
``paragraphs''.
______

SA 992. Mr. BAUCUS (for Ms. Stabenow (for herself and Ms. Snowe))
proposed an amendment to the bill S. 1, to amend title XVIII of the
Social Security Act to make improvements in the medicare program, to
provide prescription drug coverage under the medicare program, and for
other purposes; as follows:

On page 158, between lines 4 and 5, insert the following:
(f) Clarification of State Authority Relating to Medicaid
Drug Rebate Agreements.--Section 1927 (42 U.S.C. 1396r-8) is
amended by adding at the end the following:
``(l) Rule of Construction.--Nothing in this section shall
be construed as prohibiting a State from--
``(1) directly entering into rebate agreements (on the
State's own initiative or under a section 1115 waiver
approved by the Secretary before, on, or after the date of
enactment of this subsection) that are similar to a rebate
agreement described in subsection (b) with a manufacturer for
purposes of ensuring the affordability of outpatient
prescription drugs in order to provide access to such drugs
by residents of a State who are not otherwise eligible for
medical assistance under this title; or
``(2) making prior authorization (that satisfies the
requirements of subsection (d) and that does not violate any
requirements of this title that are designed to ensure access
to medically necessary prescribed drugs for individuals
enrolled in the State program under this title) a condition
of not participating in such a similar rebate agreement.''.
______

SA 993. Mr. BAUCUS (for Mr. Dorgan) proposed an amendment to the bill
S. 1, to amend title XVIII of the Social Security Act to make
improvements in the medicare program, to provide prescription drug
coverage under the medicare program, and for other purposes; as
follows:

At the appropriate place in title IV, insert the following:

SEC. __. COVERAGE OF CARDIOVASCULAR SCREENING TESTS.

(a) Coverage.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (U), by striking ``and'' at the end;
(2) in subparagraph (V)(iii), by inserting ``and'' at the
end; and
(3) by adding at the end the following new subparagraph:
``(W) cardiovascular screening tests (as defined in
subsection (ww)(1));''.
(b) Services Described.--Section 1861 of the Social
Security Act (42 U.S.C. 1395x) is amended by adding at the
end the following new subsection:

``Cardiovascular Screening Tests

``(ww)(1) The term `cardiovascular screening tests' means
the following diagnostic tests for the early detection of
cardiovascular disease:
``(A) Tests for the determination of cholesterol levels.
``(B) Tests for the determination of lipid levels of the
blood.
``(C) Such other tests for cardiovascular disease as the
Secretary may approve.
``(2)(A) Subject to subparagraph (B), the Secretary shall
establish standards, in consultation with appropriate
organizations, regarding the frequency and type of
cardiovascular screening tests.
``(B) With respect to the frequency of cardiovascular
screening tests approved by the Secretary under subparagraph
(A), in no case may the frequency of such tests be more often
than once every 2 years.''.
(c) Frequency.--Section 1862(a)(1) of the Social Security
Act (42 U.S.C. 1395y(a)(1)) is amended--
(1) by striking ``and'' at the end of subparagraph (H);
(2) by striking the semicolon at the end of subparagraph
(I) and inserting ``, and''; and
(3) by adding at the end the following new subparagraph:
``(J) in the case of a cardiovascular screening test (as
defined in section 1861(ww)(1)), which is performed more
frequently than is covered under section 1861(ww)(2).''.
(d) Effective Date.--The amendments made by this section
shall apply to tests furnished on or after January 1, 2004.
______

SA 994. Mr. DURBIN (for himself, Mr. Corzine, Mr. Harkin, Mrs. Boxer,
Ms. Stabenow, Mr. Dayton, and Mr. Byrd) proposed an amendment to the
bill S. 1, to amend title XVIII of the Social Security Act to make
improvements in the medicare program, to provide prescription drug
coverage under the medicare program, and for other purposes; as
follows:

Beginning on page 48, strike line 13 through page 50, line
2 and insert the following:
``(1) No deductible.--
``(A) In general.--The coverage provides for benefits
without the application of a deductible.
``(B) Application.--Notwithstanding the succeeding
provisions of this part, the Administrator shall not apply
section 1860D-19(a)(3)(A)(ii).
``(2) Limits on cost-sharing.--
``(A) In general.--The coverage has cost-sharing (for costs
up to the annual out-of-pocket limit under paragraph (4))
that is equal to 30 percent or that is actuarially consistent
(using processes established under subsection (f)) with an
average expected payment of 30 percent of such costs.
``(B) Application.--Notwithstanding the succeeding
provisions of this part, the Administrator shall not apply
subsection (d)(1)(C) and paragraphs (1)(D), (2)(D), and
(3)(A)(iv) of section 1860D-19(a).
On page 50, line 15, strike ``$3,700'' and insert
``$1,500''.
On page 51, strike lines 15 through 25 and insert the
following:
``(ii) such costs shall be treated as incurred without
regard to whether the individual or another person, including
a State program or other third-party coverage, has paid for
such costs.
Beginning on page 77, strike line 10 and all that follows
through page 84, line 7, and insert the following:
``(e) Medicare Operated Plan Option.--
``(1) Access.--The Administrator shall establish and
operate a national plan to provide any eligible beneficiary
enrolled under this part (and not, except for an MSA plan or
a private fee-for-service plan that does not provide
qualified prescription drug coverage, enrolled in a
MedicareAdvantage plan) electing such plan with standard
prescription drug coverage. Under such plan, the
Administrator shall negotiate with pharmaceutical
manufacturers with respect to the purchase price of covered
drugs and shall encourage the use of more affordable
therapeutic equivalents to the extent such practices do not
override medical necessity as determined by the prescribing
physician. To the extent practicable and consistent with the
previous sentence, the Administrator shall implement
strategies similar to those used by other Federal purchasers
of prescription drugs, and other strategies, to reduce the
purchase cost of covered drugs. Eligible beneficiaries
enrolled under this part shall have the option of enrolling
in such plan or in a Medicare Prescription Drug plan or a
MedicareAdvantage plan available in the area in which the
beneficiary resides.
``(2) Monthly beneficiary obligation for enrollment.--
``(A) In general.--In the case of an eligible beneficiary
enrolled in the plan operated by the Administrator under
paragraph (1), the monthly beneficiary obligation of such
beneficiary for such enrollment shall be--
``(i) for months in the first year of implementation, $35;
and
``(ii) for months in a subsequent year, the lesser of--

``(I) the amount determined under this paragraph for months
in the previous year, increased by the annual percentage
increase described in section 1860D-6(c)(5) for the year
involved; or
``(II) in the case of months in years prior to 2014, the
specified amount.

``(B) Specified amount.--For purposes of this paragraph,
the term `specified amount' means--
``(i) for months in the second year of implementation, $37;
``(ii) for months in the third year of implementation, $40;
``(iii) for months in the fourth year of implementation,
$43;
``(iv) for months in the fifth year of implementation, $46;
``(v) for months in the sixth year of implementation, $51;
``(vi) for months in the seventh year of implementation,
$54; and
``(vii) for months in the eighth year of implementation,
$59.
``(3) No affect on access requirements.--The plan operated
by the Administrator under paragraph (1) shall be in addition
to the plans required under subsection (d)(1).
``(4) Requirement to prevent increased costs.--If the
Administrator determines that Federal payments made with
respect to

[[Page S8375]]

eligible beneficiaries enrolled in the plan operated by the
Administrator under paragraph (1) exceed on average the
Federal payments made with respect to eligible beneficiaries
enrolled in a Medicare Prescription Drug plan or a
MedicareAdvantage plan (with respect to qualified
prescription drug coverage), the Administrator shall adjust
the requirements or payments under such a contract to
eliminate such excess.
``(f) Two-Year Contracts.--A contract approved under this
section for a Medicare Prescription Drug plan shall be for a
2-year period.
``(g) Implementation of Part D.--Notwithstanding any other
provision of this part or part C, the Secretary shall
implement, and make benefits available under, this part as
soon as practicable after the date of enactment of the
Prescription Drug and Medicare Improvement Act of 2003, but
in no case later than January 1, 2006. The Secretary shall
carry out this part until the Administrator is appointed and
able to carry out this part.
On page 134, strike line 9 and insert the following:
under paragraph (1).
``(d) Special Rules for State Pharmaceutical Assistance
Programs.--
``(1) In general.--Notwithstanding any other provision of
this part, in the case of the sponsor of a State
pharmaceutical assistance program that seeks to offer a
Medicare Prescription Drug plan under this part, the
following special rules apply:
``(A) Waiver of licensure.--Section 1860D-7(a)(1) shall not
apply.
``(B) Permitting limitation on enrollment.--The sponsor may
restrict eligibility to enroll in the plan to those low-
income individuals who qualify (or meet the standards for
qualification) for the State pharmaceutical assistance
program.
``(C) Other requirements.--The Administrator may waive such
other requirements of this part as the Administrator finds
appropriate to promote the role of State pharmaceutical
assistance programs under this part.
``(2) Definition.--For purposes of this part, the term
`State pharmaceutical assistance program' means a program, in
operation as of the date of enactment of this title, that is
sponsored or underwritten by a State, that was established
pursuant to a waiver under section 1115 or otherwise, and
that provides financial assistance with out-of-pocket
expenses with respect to covered outpatient drugs for
individuals in the State who meet income-related
qualifications specified under such program.
``(3) Construction.--Nothing in this subsection shall
affect the provisions of subsection (b).''.
At the end of title VI, add the following:

SEC. __. NEED FOR RENEWAL.

(a) In General.--Notwithstanding any other provision of
law, the provisions of, and amendments made by, this Act
shall remain in effect but shall be superseded by the
Director of the Office of Management and Budget on the date
that the total of the increased Federal expenditures by
reason of such amendments and provisions has reached
$400,000,000,000.
(b) Application.--Any provision of law amended or effected
by this Act shall be applied and administered after the date
described in subsection (a) as if the provisions of, and
amendments made by, this Act had never been enacted.
(c) Notification.--The Director of the Office of Management
and Budget shall notify Congress 6 months prior to the date
that the provisions of, and amendments made by, this Act will
be superseded pursuant to subsection (a).
______

SA 995. Mr. REED submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

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

SEC. __. ELIMINATION OF LIMITATION ON WORK GEOGRAPHIC
ADJUSTMENT UNDER THE PHYSICIAN FEE SCHEDULE.

Section 1848(e)(1)(A)(iii) (42 U.S.C. 1395w-
4(e)(1)(A)(iii)) is amended by inserting ``(or, for purposes
of payment for services furnished on or after January 1,
2005, and before January 1, 2008, 100 percent)'' after ``\1/
4\''.
______

SA 996. Mr. REED submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

In section 445(a) of the bill, strike paragraph (6) and
insert the following:
``(6) an evaluation of the appropriateness of extending
such adjustment or making such adjustment permanent;
``(7) an evaluation of the adjustment of the work
geographic practice cost index required under section
1848(e)(1)(A)(iii) of the Social Security Act (42 U.S.C.
1395w-4(e)(1)(A)(iii)) to reflect \1/4\ of the area cost
difference in physician work;
``(8) an evaluation of the effect of the adjustment
described in paragraph (7) on physician location and
retention in higher than average cost-of-living areas, taking
into account difference in recruitment costs and retention
rates for physicians, including specialists; and
``(9) an evaluation of the appropriateness of the \1/4\
adjustment for the work geographic practice cost index.''.
______

SA 997. Mr. REED submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

On page 401, between lines 4 and 5, insert the following:
``(C) Education and outreach campaign.--
``(i) Program requirements.--

``(I) In general.--The Office of Beneficiary Assistance, in
collaboration with the Administrator of the Center for
Medicare & Medicaid Services, shall conduct education and
outreach programs that are designed to inform hard to reach
populations, minority populations, and rural and frontier
populations, about the medicare program, and particularly
about the medicare fee-for-service program under parts A and
B, and the prescription drug benefit established under part D
and the plan options under that part, including the low-
income subsidies provided under section 1860D-19.
``(II) Dissemination.--Programs conducted under clause (i)
shall produce and disseminate information in major languages,
and shall conduct other outreach activities, including
mailings and low-income subsidy enrollment assistance, in
coordination with other appropriate Federal and State
agencies.
``(III) Sites.--Outreach and enrollment assistance
activities shall be conducted under such programs at sites
that provide, determine eligibility for, or enroll, low-
income individuals under other Federal, State, or local
assistance programs, including such sites operated under
Federal, State, or local low-income housing, energy,
nutrition, health, and social services programs.
``(IV) Costs.--The Administrator of the Center for Medicare
Choices shall reimburse other Federal, State, and local
agencies for the expenses such agencies incur that are
attributable to providing coordination with the education and
outreach programs conducted under this subparagraph. The
Secretary shall determine the appropriate administrative
expenses that are to be allocated between the Center for
Medicare Choices and the Centers for Medicare & Medicaid
Services as a result of the collaboration required under this
clause.

``(ii) Model form.--

``(I) In general.--The Office of Beneficiary Assistance, in
coordination and cooperation with the Administrator of the
Center for Medicare & Medicaid Services, shall devise a model
application form for the premium and cost-sharing subsidies
established under section 1860D-19 and shall make such form
available for use by the States.
``(II) Requirements.--The model form devised under
subclause (I) shall be as simple as possible, shall be
designed so that the form is capable of being completed
without a face-to-face interview and of being filed
electronically, and shall apply for multiyear periods, with
beneficiaries required to report any disqualifying increases
in income or assets to the Administrator of the Center for
Medicare Choices.

______

SA 998. Mr. DODD submitted an amendment intended to be proposed by
him to the bill S. 1, to amend title XVIII of the Social Security Act
to make improvements in the medicare program, to provide prescription
drug coverage under the medicare program, and for other purposes; which
was ordered to lie on the table; as follows:

On page 129, strike lines 3 through 20, and insert the
following:
``(2) Amount of payment.--The amount of the payment under
paragraph (1) shall be an amount equal to the monthly
national average premium for the year (determined under
section 1860D-15), as adjusted using the risk adjusters that
apply to the standard prescription drug coverage published
under section 1860D-11.
______

SA 999. Mrs. CLINTON submitted an amendment intended to be proposed
by her to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

On page 389, between lines 6 and 7, insert the following:

SEC. __. PRIORITY AREA QUALITY INDICATORS.

(a) In General.--The Director of the Agency for Healthcare
Research and Quality, in consultation with the Quality
Interagency Coordination Task Force, the Institute of
Medicine, the Joint Commission on Accreditation of Healthcare
Organizations, the National Committee for Quality Assurance,
the American Health Quality Association, the

[[Page S8376]]

National Quality Forum, and other individuals and
organizations determined appropriate by the Secretary of
Health and Human Services, shall assemble, evaluate, and,
where necessary, develop or update quality indicators for
each of the 20 priority areas for improvement in health care
quality as identified by the Institute of Medicine in their
report entitled ``Priority Areas for National Action'' in
2003, in order to assist medicare beneficiaries in making
informed choices about health plans. The selection of
appropriate quality indicators under this subsection shall
include the evaluation criteria formulated by clinical
professionals, consumers, data collection experts.
(b) Risk Adjustment.--In developing the quality indicators
under subsection (a), the Director of the Agency for
Healthcare Research and Quality shall ensure that adequate
risk adjustment is provided for.
(c) Best Practices.--In carrying out this section, the
Director of the Agency for Healthcare Research and Quality
shall--
(1) assess data concerning appropriate clinical treatments
based on the best scientific evidence available;
(2) determine areas in which there is insufficient evidence
to determine best practices; and
(3) compare existing quality indicators to best clinical
practices, validate appropriate indicators, and report on
areas where additional research is needed before indicators
can be developed.
(d) Report.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter, the Director
of the Agency for Healthcare Research and Quality shall--
(1) submit to the Director of the National Institutes of
Health a report concerning areas of clinical care requiring
farther research necessary to establish effective clinical
treatments that will serve as a basis for quality indicators;
and
(2) submit to Congress a report on the state of quality
measurement for priority areas that links data to the report
submitted under paragraph (1) for the year involved.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $12,000,000 for
fiscal year 2004, and $8,000,000 for each of fiscal years
2005 through 2009.

SEC. __. STANDARDIZED QUALITY INDICATORS FOR FEDERAL
AGENCIES.

(a) In General.--In addition to other activities to be
carried out by the Quality Interagency Coordination Taskforce
(as established by executive order on March 13, 1998), such
Taskforce shall standardize indicators of health care quality
that are used in all Federal agencies, as appropriate.
(b) Consultation.--In carrying out subsection (a), the
Quality Interagency Coordination Taskforce shall consult with
a public-private consensus organization (such as the National
Quality Forum) to enhance the likelihood of the simultaneous
application of the standardized indicators under subsection
(a) in the private sector.
(c) Report.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter, the Secretary
of Health and Human Services shall submit to Congress a
report on the progress made by the Quality Interagency
Coordination Taskforce to standardizing quality indicators
throughout the Federal Government.

SEC. __. DEMONSTRATION PROGRAM FOR COMMUNITY HEALTH CARE
QUALITY DATA REPORTING.

(a) In General.--The Secretary of Health and Human
Services, acting through the Director of the Centers for
Disease Control and Prevention and the Director of the Agency
for Healthcare Quality and Research, shall award not to
exceed 20 grants to eligible communities for the
establishment of demonstration programs for the reporting of
health care quality information at the community level.
(b) Quality Indicators.--
(1) In general.--For purposes of reporting information
under the demonstration programs under this section,
indicators of health care quality may include the indicators
developed for the 20 priority areas as identified by the
Institute of Medicine in the report entitled ``Priority Areas
for National Action'', 2003, or other indicators determined
appropriate by the Secretary of Health and Human Services.
(2) Type of data.--All quality indicators with respect to
which reporting will be carried out under the demonstration
program shall be reported by race, ethnicity, gender, and
age.
(c) Eligibility.--The Secretary of Health and Human
Services shall award grants to communities under this section
based on competitive proposals and criteria to be determined
jointly by the Director of the Centers for Disease Control
and Prevention and the Director of the Agency for Healthcare
Research and Quality. Such criteria may include a
demonstrated ability of the community to collect data on
quality indicators and a demonstrated ability to effectively
transmit community-level health status results to relevant
stakeholders.
(d) Technical Advisory Committee.--The Secretary of Health
and Human Services shall establish a technical advisory
committee to assist grantees in data collection, data
analysis, and report dissemination.
(e) Report.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter, the Director
of the Centers for Disease Control and Prevention and the
Director of the Agency for Healthcare Research and Quality
shall--
(1) submit to the Congress a report on the results of the
demonstration programs under this section; and
(2) make such reports publicly available, including by
posting the reports on the Internet.
(f) Evaluation.--The Secretary of Health and Human Services
shall, upon awarding grants under subsection (a), enter into
a contract for the evaluation of demonstration programs under
this section. Such evaluation shall compare the effectiveness
of such demonstration programs in collecting and reporting
required data, and on the effectiveness of distributing
information to key stakeholders in a timely fashion. Such
evaluations shall provide for a report on best practices.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $25,000,000 for
fiscal year 2004, and such sums as may be necessary for each
fiscal year thereafter.
______

SA 1000. Mrs. CLINTON submitted an amendment intended to be proposed
by her to the bill S. 1, to amend title XVIII of the Social Security
Act to make improvements in the medicare program, to provide
prescription drug coverage under the medicare program, and for other
purposes; which was ordered to lie on the table; as follows:

At the end of title VI, add the following:

SEC. __. STUDY ON EFFECTIVENESS OF CERTAIN PRESCRIPTION
DRUGS.

(a) In General.--
(1) Research by nih.--The Director of the National
Institutes of Health, in coordination with the Director of
the Agency for Healthcare Research and Quality and the
Commissioner of Food and Drugs, shall conduct research, which
may include clinical research, to develop valid scientific
evidence regarding the comparative effectiveness and, where
appropriate, comparative safety of covered prescription drugs
relative to other drugs and treatments for the same disease
or condition.
(2) Analysis by ahrq.--
(A) In general.--The Director of the Agency for Healthcare
Research and Quality, taking into consideration the research
and data from the National Institutes of Health and the Food
and Drug Administration, shall use evidence-based practice
centers to synthesize available data or conduct other
analyses of the comparative effectiveness and, where
appropriate, comparative safety of covered prescription drugs
relative to other drugs and treatments for the same disease
or condition.
(B) Safety.--In any analysis of comparative effectiveness
under this subparagraph, the Director of the Agency for
Healthcare Research and Quality shall include a discussion of
available information on relative safety.
(3) Standards.--The Director of the Agency for Healthcare
Research and Quality, in consultation with the Commissioner
of Food and Drugs, the Director of the National Institutes of
Health, and with input from stakeholders, shall develop
standards for the design and conduct of studies under this
subsection.
(b) Covered Prescription Drugs.--For purposes of this
section, the term ``covered prescription drugs'' means
prescription drugs that, as determined by the Director of the
Agency for Healthcare Research and Quality in consultation
with the Administrator of the Centers for Medicare & Medicaid
Services, account for high levels of expenditures, high
levels of use, or high levels of risk to individuals in
federally funded health programs, including Medicare and
Medicaid.
(c) Dissemination.--
(1) Annual report.--Each year the Secretary shall prepare a
report on the results of the research, studies, and analyses
conducted by the National Institutes of Health and the Agency
for Healthcare Research and Quality, and the Food and Drug
Administration under this section and submit the report to
the following:
(A) Congress.
(B) The Secretary of Defense.
(C) The Secretary of Veterans Affairs.
(D) The Administrator of the Centers for Medicare &
Medicaid Services.
(E) The Director of the Indian Health Service.
(F) The Director of the National Institutes of Health.
(G) The Director of the Office of Personnel Management.
(H) The Commissioner of Food and Drugs.
(2) Reports for practitioners.--As soon as possible, but
not later than a year after the completion of any study
pursuant to subsection (a)(2), the Director of the Agency for
Healthcare Research and Quality shall--
(A) prepare a report on the results of such study for the
purpose of informing health care practitioners; and
(B) transmit the report to the Director of the National
Institutes of Health.
(3) FDA drug information.--The Commissioner of Food and
Drugs shall--
(A) review all data and information from studies and
analyses conducted or prepared under this section; and
(B) develop appropriate summaries of such information for
inclusion in adequate directions for use under section
502(f)(1) of the Federal Food, Drug, and Cosmetic Act and in
summaries relating to side effects, contraindications, and
effectiveness under section 502(n) of that Act.

[[Page S8377]]

(4) NIH internet site.--The Director of the National
Institutes of Health shall publish on the Institutes'
Internet site and through other means that will facilitate
access by practitioners, each report prepared under this
subsection by the Director of the Agency for Healthcare
Research and Quality.
(d) Evidence.--In carrying out this section, the Director
of the National Institutes of Health and the Agency for
Healthcare Research and Quality shall consider only
methodologically sound studies, giving preference to studies
for which the Directors have access to sufficient underlying
data and analysis to address any significant concerns about
methodology or the reliability of data.
(e) Authorizations of Appropriations.--There are authorized
to be appropriated to carry out this section, $75,000,000 for
fiscal year 2004, and such sums as may be necessary for each
fiscal year thereafter.

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