Defense of Medicare and Real Medicare Prescription Drug Benefit Act - Directs the Secretary of Health and Human Services, in applying risk adjustment factors in a budget neutral manner to payment to Medicare+Choice organizations under part C (Medicare+Choice) of title XVIII (Medicare) of the Social Security Act (SSA), to assure that such factors, in the aggregate, take into account the actuarial characteristics of the entire Medicare population, and not merely the population of individuals enrolled under a Medicare+Choice plan.
Requires the Secretary to provide for adjustment of payment rates to such organizations so that they reflect only the payment rate relating to 100 percent fee-for-service payment.
Eliminates the Medicare Advantage (MA) Regional Plan Stabilization Fund established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Repeals cost containment provisions of such Act.
Amends SSA title XVIII (Medicare), as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to: (1) provide for phased-in elimination of the coverage gap; (2) eliminate discriminatory treatment of employer plans; (3) allow Medicaid wrap-around for dual-eligibles (persons eligible for Medicare and full Medicaid benefits, including drugs); (4) eliminate the assets test; and (5) eliminate Medicare Advantage Prescription Drug (MA-PD) plans from the meaning of qualifying prescription drug plans (PDPs) with respect to the choice of a minimum of two qualifying plans a SSA title XVIII part D (Voluntary Prescription Drug Benefit Program) eligible individual shall be allowed to choose between.
Prohibits any formulary from being established or applied under the new Medicare prescription drug program under SSA title XVIII part D (Voluntary Prescription Drug Benefit Program) unless the classes and categories used under it are specified by the Secretary.
Allows certain Medigap Rx policies that provide wrap-around prescription drug coverage to be sold, issued, and renewed.
Directs the Secretary to provide for appropriate adjustments in payments to PDP sponsors under SSA title XVIII part D, and to MA organizations offering MA-PD plans under SSA title XVIII part C, to assure that premiums of part D eligible individuals under PDPs and under MA-PD plans are not increased as a result of this Act.
Phases out the phased-down State contribution with respect to the Federal phase-in of the costs of premiums and cost-sharing subsidies for dual eligibles.
Amends the Federal Food, Drug, and Cosmetic Act, as amended by the Medicine Equity and Drug Safety Act of 2000, to: (1) direct the Secretary to promulgate regulations permitting pharmacists and wholesalers to import Health Canada-approved prescription drugs from Canada; and (2) exclude an infused or intravenously injected drug, or a drug that is inhaled during surgery.
Requires that a Canadian exporter: (1) register with the Secretary its name and place of business (including the place of business of each warehouse and establishment); (2) export only prescription drugs that have been approved by Health Canada and meet all requirements of Canadian law; (3) permit inspections by the Secretary (including inspections of all records, especially financial records) of each warehouse and establishment of the Canadian exporter; and (4) pay an inspection fee to the Secretary on a semiannual basis not to exceed five percent of the total price of prescription drugs exported by the Canadian exporter to the United States under the regulations (which fees the Secretary shall use solely to inspect the warehouses and establishments of Canadian exporters and to monitor imports of prescription drugs at ports of entry).
Requires that each prescription drug imported under the regulations be imported directly from a Canadian exporter through a limited number of ports of entry (at which the Secretary shall monitor such imports).
Prohibits discrimination in the sale of prescription drugs by manufacturers to pharmacists, wholesalers, or Canadian exporters, requiring: (1) terms as favorable as those provided to foreign purchasers; and (2) full access to drugs permitted to be imported.
Continues the requirement that exported donated prescription drugs may only be reimported by the manufacturer.
Permits the Secretary to waive the prohibition against importing a prescription drug or device on a case-by-case basis, particularly those from Canada that are FDA-approved and for personal use, not resale.
Amends SSA title XVIII, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to give the Secretary the authority similar to that of other Federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered Medicare part D drugs in order to ensure that beneficiaries enrolled under PDPs and MA-PD plans pay the lowest possible price.
Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to repeal the authorization and tax deduction under the Internal Revenue Code for Health Savings Accounts.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1992 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1992
To amend the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 to eliminate privatization of the medicare program, to
improve the medicare prescription drug benefit, to repeal health
savings accounts, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 9, 2003
Mr. Kennedy introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 to eliminate privatization of the medicare program, to
improve the medicare prescription drug benefit, to repeal health
savings accounts, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as ``Defense of Medicare
and Real Medicare Prescription Drug Benefit Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--DEFENSE OF MEDICARE
Sec. 101. Application of risk adjustment reflecting characteristics for
the entire medicare population.
Sec. 102. Phase-in to payment at 100 percent of fee-for-service rate.
Sec. 103. Elimination of MA Regional Plan Stabilization Fund (slush
fund).
Sec. 104. Repeal of premium support program.
Sec. 105. Repeal of medicare expenditures cap.
TITLE II--ESTABLISHMENT OF REAL MEDICARE PRESCRIPTION DRUG BENEFIT
Sec. 201. Elimination of coverage gap.
Sec. 202. Elimination of discriminatory treatment of employer plans.
Sec. 203. Allowing medicaid wrap.
Sec. 204. Elimination of assets test.
Sec. 205. Requiring two prescription drug plans to avoid federal
fallback.
Sec. 206. Secretary defining classes and categories under any
formulary.
Sec. 207. Provision of wrap-around prescription drug coverage through
medigap.
Sec. 208. No additional beneficiary premium.
Sec. 209. Elimination of State maintenance of effort.
TITLE III--REDUCTION IN PRESCRIPTION DRUG PRICES
Sec. 301. Importation of prescription drugs.
Sec. 302. Negotiating fair prices for medicare prescription drugs.
TITLE IV--REPEAL OF HEALTH SAVINGS ACCOUNTS
Sec. 401. Repeal of health savings accounts.
TITLE I--DEFENSE OF MEDICARE
SEC. 101. APPLICATION OF RISK ADJUSTMENT REFLECTING CHARACTERISTICS FOR
THE ENTIRE MEDICARE POPULATION.
Effective January 1, 2005, in applying risk adjustment factors to
payment to organizations under section 1853 of the Social Security Act
(42 U.S.C. 1395w-23) in a budget neutral manner, the Secretary of
Health and Human Services shall assure that such factors, in the
aggregate, take into account the actuarial characteristics of the
entire medicare population, and not merely the population of
individuals enrolled under a plan under part C of title XVIII of such
Act.
SEC. 102. PHASE-IN TO PAYMENT AT 100 PERCENT OF FEE-FOR-SERVICE RATE.
Notwithstanding any other provision of law, the Secretary of Health
and Human Services shall provide, in a phased-in manner over a 5-year
period beginning with 2005, for adjustment of payment rates to
organizations under section 1853 of the Social Security Act so that, at
the end of such phase-in period, such payment rates reflect only the
payment rate described in subsection (c)(1)(D) of such section
(relating to 100 percent fee-for-service payment).
SEC. 103. ELIMINATION OF MA REGIONAL PLAN STABILIZATION FUND (SLUSH
FUND).
Subsection (e) of section 1858 of the Social Security Act, as added
by section 221(c) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, is repealed.
SEC. 104. REPEAL OF PREMIUM SUPPORT PROGRAM.
Effective as if included in the enactment of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, subtitle
E of title I of such Act is repealed and any provisions of law amended
by such subtitle are restored as if such subtitle had not been enacted.
SEC. 105. REPEAL OF MEDICARE EXPENDITURE CAP.
Subtitle A of title VIII of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 is repealed and any
provisions of law amended by such subtitle are restored as if such
subtitle had not been enacted.
TITLE II--ESTABLISHMENT OF REAL MEDICARE PRESCRIPTION DRUG BENEFIT
SEC. 201. ELIMINATION OF COVERAGE GAP.
(a) In General.--Section 1860D-2(b) of the Social Security Act, as
added by section 101(a) of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003, is amended--
(1) in paragraph (3)(A), by striking ``paragraph (4)'' and
inserting ``paragraphs (4) and (5)'';
(2) by redesignating paragraph (5) as paragraph (7) and by
moving such paragraph to follow paragraph (6); and
(3) by inserting after paragraph (4) the following new
paragraph:
``(5) Phased-in elimination of coverage gap.--The coverage
provides continuation of benefits from the initial coverage
limit (under paragraph (3)) for expenditures incurred through
the total amount of expenditures at which benefits are
available under paragraph (4), subject to coinsurance of the
following:
``(A) 2006, 2007, and 2008.--During the years 2006
through 2008, 75 percent (or actuarially equivalent,
using processes and methods established under section
1860D-11(c)) to an average expected payment of 75
percent of such costs.
``(B) 2009, 2010, and 2011.--During the years 2009
through 2011, 50 percent (or actuarially equivalent,
using processes and methods established under section
1860D-11(c)) to an average expected payment of 50
percent of such costs.
``(C) 2012 and subsequent years.--During 2012 and
each subsequent year, 25 percent (or actuarially
equivalent, using processes and methods established
under section 1860D-11(c)) to an average expected
payment of 25 percent of such costs.
The provisions of paragraph (2)(B) shall apply under this
paragraph in the same manner as they apply with respect to
paragraph (2)(A).''.
(b) Conforming Amendment.--Section 1860D-14(a) of such Act, as so
added, is amended by striking subparagraph (C) of paragraphs (1) and
(2).
SEC. 202. ELIMINATION OF DISCRIMINATORY TREATMENT OF EMPLOYER PLANS.
(a) Elimination of True Out-of-Pocket Limitation.--Section 1860D-
2(b)(4)(C) of the Social Security Act, as added by section 101(a) of
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003, is amended to read as follows:
``(C) Application.--In applying subparagraph (A),
incurred costs shall only include costs incurred with
respect to covered part D drugs for the annual
deductible described in paragraph (1), for cost-sharing
described in paragraph (2), and for amounts for which
benefits are not provided because of the application of
the initial coverage limit described in paragraph (3),
but does not include any costs incurred for covered
part D drugs which are not included (or treated as
being included) in the plan's formulary.''.
(b) Equalization of Subsidies.--Notwithstanding any other provision
of law, the Secretary of Health and Human Services shall provide for
such increase in the special subsidy payment amounts under section
1860D-22(a)(3) of the Social Security Act, as added by section 101(a)
of the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, as may be appropriate to provide for payments in the aggregate
equivalent to the payments that would have been made under section
1860D-15 of such Act if the individuals were not enrolled in a
qualified retiree prescription drug plan. In making such computation,
the Secretary shall not take into account the application of the
amendments made by section 1202 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003.
SEC. 203. ALLOWING MEDICAID WRAP.
Section 1935(d) of the Social Security Act, as added by section
103(c) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, is repealed.
SEC. 204. ELIMINATION OF ASSETS TEST.
(a) In General.--Section 1860D-14 of the Social Security Act, as
added by section 101(a) of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003, is amended as follows:
(1) In subsection (a)(1), strike ``and who meets the
resource requirements of paragraph (3)(B)''.
(2) In subsection (a)(3)(A), add ``and'' at the end of
clause (i), strike ``; and'' at the end of clause (ii) and
inserting period, and strike clause (iii).
(3) In subsection (a)(3), strike subparagraphs (D) and (E).
(b) Conforming Amendment.--Section 107(e) of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 is
repealed.
SEC. 205. REQUIRING TWO PRESCRIPTION DRUG PLANS TO AVOID FEDERAL
FALLBACK.
Section 1860D-3(a) of the Social Security Act, as added by section
101(a) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, is amended--
(1) in paragraph (1), by striking ``qualifying plans (as
defined in paragraph (3)'' and inserting ``prescription drug
plans'';
(2) in paragraph (2), by striking ``qualifying plans'' and
inserting ``prescription drug plans'';
(3) by striking paragraph (3).
SEC. 206. SECRETARY DEFINING CLASSES AND CATEGORIES UNDER ANY
FORMULARY.
Notwithstanding any other provision of law, no formulary may be
established or applied under part D of title XVIII of the Social
Security Act, as added by section 101(a) of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, unless the classes
and categories used under such formulary are such classes and
categories as the Secretary of Health and Human Services shall specify.
SEC. 207. PROVISION OF WRAP-AROUND PRESCRIPTION DRUG COVERAGE THROUGH
MEDIGAP.
Section 1882(v) of the Social Security Act (42 U.S.C. 1395ss(v)),
as added by section 104(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, is amended as follows:
(1) In paragraph (1)(A), by inserting ``, other than such a
policy that provides wrap-around prescription drug coverage
included within a range of such coverage approved under
subparagraph (D)(ii),'' after ``paragraph (6)(A))''.
(2) Add at the end of paragraph (1) the following new
subparagraph:
``(D) Wrap-around prescription drug coverage.--
``(i) In general.--Notwithstanding any
other provision of this subsection, a medigap
Rx policy that provides wrap-around
prescription drug coverage included within a
range of such coverage approved by the
Secretary under clause (ii) may be offered to
part D enrollees.
``(ii) Development of standards.--The
Secretary shall approve a range of wrap-around
prescription drug coverage that may be offered
under this subparagraph to part D enrollees.''.
SEC. 208. NO ADDITIONAL BENEFICIARY PREMIUM.
Notwithstanding any other provision of law, the Secretary of Health
and Human Services shall provide for such adjustment in payments to PDP
sponsors under part D of title XVIII of the Social Security Act, and to
MA organizations offering MA-PD plans under part C of such title, as
may be appropriate to assure that premiums of part D eligible
individuals under prescription drug plans and under MA-PD plans are not
increased as a result of this Act (and the amendments made by this
Act).
SEC. 209. ELIMINATION OF STATE MAINTENANCE OF EFFORT.
Section 1935(c)(5) of the Social Security Act, as added by section
103(c) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, is amended--
(1) by striking ``or'' at the end of subparagraph (I); and
(2) by striking subparagraph (J) and inserting the
following new subparagraphs:
``(J) in each of 2014 and 2015 is 75 percent;
``(K) in 2016 is 67.5 percent;
``(L) in 2017 is 60 percent;
``(M) in 2018 is 52.5 percent;
``(N) in 2019 is 45 percent;
``(O) in 2020 is 37.5 percent;
``(P) in 2021 is 30 percent;
``(Q) in 2022 is 22.5 percent;
``(R) in 2023 is 15 percent;
``(S) in 2024 is 7.5 percent; or
``(T) after December 2024, is 0 percent.''.
TITLE III--REDUCTION IN PRESCRIPTION DRUG PRICES
SEC. 301. IMPORTATION OF PRESCRIPTION DRUGS.
(a) In General.--Chapter VIII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381 et seq.) is amended by striking section 804
and inserting the following:
``SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS.
``(a) Definitions.--In this section:
``(1) Canadian pharmacist.--The term `Canadian pharmacist'
means a person licensed in Canada to practice pharmacy,
including the dispensing and selling of prescription drugs.
``(2) Canadian wholesaler.--The term `Canadian wholesaler'
means a person licensed in Canada to distribute within Canada
prescription drugs that have been approved by Health Canada.
``(3) Canadian exporter.--The term `Canadian exporter'
means a Canadian pharmacist or Canadian wholesaler.
``(4) Importer.--The term `importer' means a pharmacist or
wholesaler.
``(5) Pharmacist.--The term `pharmacist' means a person
licensed by a State to practice pharmacy, including the
dispensing and selling of prescription drugs.
``(6) Prescription drug.--The term `prescription drug'
means a drug subject to section 503(b), other than--
``(A) a controlled substance (as defined in section
102 of the Controlled Substances Act (21 U.S.C. 802));
``(B) a biological product (as defined in section
351 of the Public Health Service Act (42 U.S.C. 262));
``(C) an infused drug (including a peritoneal
dialysis solution);
``(D) an intravenously injected drug; or
``(E) a drug that is inhaled during surgery.
``(7) Qualifying laboratory.--The term `qualifying
laboratory' means a laboratory in the United States that has
been approved by the Secretary for the purposes of this
section.
``(8) Wholesaler.--
``(A) In general.--The term `wholesaler' means a
person licensed as a wholesaler or distributor of
prescription drugs in the United States under section
503(e)(2)(A).
``(B) Exclusion.--The term `wholesaler' does not
include a person authorized to import drugs under
section 801(d)(1).
``(b) Regulations.--No later than 18 months after the date of
enactment of this section, the Secretary, after consultation with the
United States Trade Representative and the Commissioner of Customs,
shall promulgate regulations permitting pharmacists and wholesalers to
import prescription drugs from Canada into the United States.
``(c) Limitation.--The regulations under subsection (b) shall--
``(1) require that a Canadian exporter--
``(A) register with the Secretary the name and
place of business of the Canadian exporter (and
including the place of business of each warehouse and
establishment of the Canadian exporter);
``(B) export only prescription drugs that have been
approved by Health Canada and meet all requirements of
Canadian law;
``(C) permit inspections by the Secretary
(including inspections of all records, including
financial records) of each warehouse and establishment
of the Canadian exporter; and
``(D) pay an inspection fee to the Secretary on a
semiannual basis not to exceed 5 percent of the total
price of prescription drugs exported by the Canadian
exporter to the United States under the regulations
(which fees the Secretary shall use solely to inspect
the warehouses and establishments of Canadian exporters
and to monitor imports of prescription drugs at ports
of entry);
``(2) require that each prescription drug imported under
the regulations be imported directly from a Canadian exporter
through a limited number of ports of entry (at which the
Secretary shall monitor such imports);
``(3) require that safeguards be in place to ensure that
each prescription drug imported under the regulations complies
with section 505 (including with respect to being safe and
effective for the intended use of the prescription drug), with
sections 501 and 502, and with other applicable requirements of
this Act;
``(4) require that an importer of a prescription drug under
the regulations comply with subsections (d)(1) and (e); and
``(5) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the
public health or as a means to facilitate the importation of
prescription drugs.
``(d) Information and Records.--
``(1) In general.--The regulations under subsection (b)
shall require an importer of a prescription drug under
subsection (b) to submit to the Secretary the following
information and documentation:
``(A) The name and quantity of the active
ingredient of the prescription drug.
``(B) A description of the dosage form of the
prescription drug.
``(C) The date on which the prescription drug is
shipped.
``(D) The quantity of the prescription drug that is
shipped.
``(E) The point of origin and destination of the
prescription drug.
``(F) The price paid by the importer for the
prescription drug.
``(G) Documentation from the foreign seller
specifying--
``(i) the original source of the
prescription drug; and
``(ii) the quantity of each lot of the
prescription drug originally received by the
seller from that source.
``(H) The lot or control number assigned to the
prescription drug by the manufacturer of the
prescription drug.
``(I) The name, address, telephone number, and
professional license number (if any) of the importer.
``(J)(i) In the case of a prescription drug that is
shipped directly from the first foreign recipient of
the prescription drug from the manufacturer:
``(I) Documentation demonstrating that the
prescription drug was received by the recipient
from the manufacturer and subsequently shipped
by the first foreign recipient to the importer.
``(II) Documentation of the quantity of
each lot of the prescription drug received by
the first foreign recipient demonstrating that
the quantity being imported into the United
States is not more than the quantity that was
received by the first foreign recipient.
``(III)(aa) In the case of an initial
imported shipment, documentation demonstrating
that each batch of the prescription drug in the
shipment was statistically sampled and tested
for authenticity and degradation.
``(bb) In the case of any subsequent
shipment, documentation demonstrating that a
statistically valid sample of the shipment was
tested for authenticity and degradation.
``(ii) In the case of a prescription drug that is
not shipped directly from the first foreign recipient
of the prescription drug from the manufacturer,
documentation demonstrating that each batch in each
shipment offered for importation into the United States
was statistically sampled and tested for authenticity
and degradation.
``(K) Certification from the importer or
manufacturer of the prescription drug that the
prescription drug--
``(i) is approved for marketing in the
United States; and
``(ii) meets all labeling requirements
under this Act.
``(L) Laboratory records, including complete data
derived from all tests necessary to ensure that the
prescription drug is in compliance with established
specifications and standards.
``(M) Documentation demonstrating that the testing
required by subparagraphs (J) and (L) was conducted at
a qualifying laboratory.
``(N) Any other information that the Secretary
determines is necessary to ensure the protection of the
public health.
``(2) Maintenance by the secretary.--The Secretary shall
maintain information and documentation submitted under
paragraph (1) for such period of time as the Secretary
determines to be necessary.
``(e) Testing.--The regulations under subsection (b) shall
require--
``(1) that testing described in subparagraphs (J) and (L)
of subsection (d)(1) be conducted by the importer or by the
manufacturer of the prescription drug at a qualified
laboratory;
``(2) if the tests are conducted by the importer--
``(A) that information needed to--
``(i) authenticate the prescription drug
being tested; and
``(ii) confirm that the labeling of the
prescription drug complies with labeling
requirements under this Act;
be supplied by the manufacturer of the prescription
drug to the pharmacist or wholesaler; and
``(B) that the information supplied under
subparagraph (A) be kept in strict confidence and used
only for purposes of testing or otherwise complying
with this Act; and
``(3) may include such additional provisions as the
Secretary determines to be appropriate to provide for the
protection of trade secrets and commercial or financial
information that is privileged or confidential.
``(f) Suspension of Importation.--The Secretary shall require that
importations of a specific prescription drug or importations by a
specific importer or from a specific Canadian exporter under subsection
(b) be immediately suspended on discovery of a pattern of
importation of that specific prescription drug or by that specific
importer or Canadian exporter of drugs that are counterfeit or in
violation of any requirement under this section, until an investigation
is completed and the Secretary determines that the public is adequately
protected from counterfeit and violative prescription drugs being
imported under subsection (b).
``(g) Approved Labeling.--The manufacturer of a prescription drug
shall provide an importer written authorization for the importer to
use, at no cost, the approved labeling for the prescription drug.
``(h) Prohibition of Discrimination.--
``(1) In general.--It shall be unlawful for a manufacturer
of a prescription drug to discriminate against, or cause any
other person to discriminate against, a pharmacist, wholesaler,
or Canadian exporter that purchases or offers to purchase a
prescription drug from the manufacturer or from any person that
distributes a prescription drug manufactured by the drug
manufacturer.
``(2) Discrimination.--For the purposes of paragraph (1), a
manufacturer of a prescription drug shall be considered to
discriminate against a pharmacist, wholesaler, or Canadian
exporter if the manufacturer enters into a contract for sale of
a prescription drug, places a limit on supply, or employs any
other measure, that has the effect of--
``(A) providing pharmacists, wholesalers, or
Canadian exporters access to prescription drugs on
terms or conditions that are less favorable than the
terms or conditions provided to a foreign purchaser
(other than a charitable or humanitarian organization)
of the prescription drug; or
``(B) restricting the access of pharmacists,
wholesalers, or Canadian exporters to a prescription
drug that is permitted to be imported into the United
States under this section.
``(i) Charitable Contributions.--Notwithstanding any other
provision of this section, section 801(d)(1) continues to apply to a
prescription drug that is donated or otherwise supplied at no charge by
the manufacturer of the drug to a charitable or humanitarian
organization (including the United Nations and affiliates) or to a
government of a foreign country.
``(j) Waiver Authority for Importation by Individuals.--
``(1) Declarations.--Congress declares that in the
enforcement against individuals of the prohibition of
importation of prescription drugs and devices, the Secretary
should--
``(A) focus enforcement on cases in which the
importation by an individual poses a significant threat
to public health; and
``(B) exercise discretion to permit individuals to
make such importations in circumstances in which--
``(i) the importation is clearly for
personal use; and
``(ii) the prescription drug or device
imported does not appear to present an
unreasonable risk to the individual.
``(2) Waiver authority.--
``(A) In general.--The Secretary may grant to
individuals, by regulation or on a case-by-case basis,
a waiver of the prohibition of importation of a
prescription drug or device or class of prescription
drugs or devices, under such conditions as the
Secretary determines to be appropriate.
``(B) Guidance on case-by-case waivers.--The
Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in
which the Secretary will consistently grant waivers on
a case-by-case basis under subparagraph (A), so that
individuals may know with the greatest practicable
degree of certainty whether a particular importation
for personal use will be permitted.
``(3) Drugs imported from canada.--In particular, the
Secretary shall by regulation grant individuals a waiver to
permit individuals to import into the United States a
prescription drug that--
``(A) is imported from a licensed pharmacy for
personal use by an individual, not for resale, in
quantities that do not exceed a 90-day supply;
``(B) is accompanied by a copy of a valid
prescription;
``(C) is imported from Canada, from a Canadian
exporter registered with the Secretary;
``(D) is a prescription drug approved by the
Secretary under chapter V;
``(E) is in the form of a final finished dosage
that was manufactured in an establishment registered
under section 510; and
``(F) is imported under such other conditions as
the Secretary determines to be necessary to ensure
public safety.
``(k) Studies; Reports.--
``(1) By the institute of medicine of the national academy
of sciences.--
``(A) Study.--
``(i) In general.--The Secretary shall
request that the Institute of Medicine of the
National Academy of Sciences conduct a study
of--
``(I) importations of prescription
drugs made under the regulations under
subsection (b); and
``(II) information and
documentation submitted under
subsection (d).
``(ii) Requirements.--In conducting the
study, the Institute of Medicine shall--
``(I) evaluate the compliance of
importers with the regulations under
subsection (b);
``(II) compare the number of
shipments under the regulations under
subsection (b) during the study period
that are determined to be counterfeit,
misbranded, or adulterated, and compare
that number with the number of
shipments made during the study period
within the United States that are
determined to be counterfeit,
misbranded, or adulterated; and
``(III) consult with the Secretary,
the United States Trade Representative,
and the Commissioner of Patents and
Trademarks to evaluate the effect of
importations under the regulations
under subsection (b) on trade and
patent rights under Federal law.
``(B) Report.--Not later than 2 years after the
effective date of the regulations under subsection (b),
the Institute of Medicine shall submit to Congress a
report describing the findings of the study under
subparagraph (A).
``(2) By the comptroller general.--
``(A) Study.--The Comptroller General of the United
States shall conduct a study to determine the effect of
this section on the price of prescription drugs sold to
consumers at retail.
``(B) Report.--Not later than 18 months after the
effective date of the regulations under subsection (b),
the Comptroller General of the United States shall
submit to Congress a report describing the findings of
the study under subparagraph (A).
``(l) Construction.--Nothing in this section limits the authority
of the Secretary relating to the importation of prescription drugs,
other than with respect to section 801(d)(1) as provided in this
section.
``(m) Authorization of Appropriations.--There are authorized to be
appropriated such sums as are necessary to carry out this section.''.
(b) Conforming Amendments.--The Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 301(aa) (21 U.S.C. 331(aa)), by striking
``covered product in violation of section 804'' and inserting
``prescription drug in violation of section 804''; and
(2) in section 303(a)(6) (21 U.S.C. 333(a)(6), by striking
``covered product pursuant to section 804(a)'' and inserting
``prescription drug under section 804(b)''.
SEC. 302. NEGOTIATING FAIR PRICES FOR MEDICARE PRESCRIPTION DRUGS.
Section 1860D-11 of the Social Security Act, as added by section
101(a) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, is amended by striking subsection (i)
(relating to noninterference) and by inserting the following:
``(i) Authority to Negotiate Prices With Manufacturers.--In order
to ensure that beneficiaries enrolled under prescription drug plans and
MA-PD plans pay the lowest possible price, the Secretary shall have
authority similar to that of other Federal entities that purchase
prescription drugs in bulk to negotiate contracts with manufacturers of
covered part D drugs, consistent with the requirements and in
furtherance of the goals of providing quality care and containing costs
under this part.''.
TITLE IV--REPEAL OF HEALTH SAVINGS ACCOUNTS
SEC. 401. REPEAL OF HEALTH SAVINGS ACCOUNTS.
Section 1201 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 is repealed and any provisions of law amended
by such section are restored as if such section had not been enacted.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S16127-16128)
Received in the Senate and Read twice and referred to the Committee on Finance.
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