2000
[DOCID: f:h1512ih.txt]
107th CONGRESS
1st Session
H. R. 1512
To amend title XVIII of the Social Security Act to provide a
prescription benefit program for all Medicare beneficiaries.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 4, 2001
Mr. Sanders (for himself, Mr. Kucinich, Mr. Bonior, Mr. Conyers, Mr.
Hilliard, Ms. Lee, Mr. DeFazio, Mr. Abercrombie, Mr. Nadler, Ms.
Kaptur, Mr. Hinchey, Mr. Olver, Mr. Serrano, Mr. Thompson of
Mississippi, Mr. Clay, Ms. Carson of Indiana, Ms. Woolsey, Mr. Payne,
Ms. McKinney, Mr. Pastor, Ms. Norton, Mr. Owens, Mr. McGovern, and Mr.
Filner) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to provide a
prescription benefit program for all Medicare beneficiaries.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medicare Extension
of Drugs to Seniors (MEDS) Act of 2001''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Prescription medicine benefit program.
``Part D--Prescription Medicine Benefit for the Aged and Disabled
``Sec. 1860. Establishment of prescription medicine benefit
program for the aged and disabled.
``Sec. 1860A. Scope of benefits.
``Sec. 1860B. Payment of benefits; benefit limits.
``Sec. 1860C. Eligibility and enrollment.
``Sec. 1860D. Premiums.
``Sec. 1860E. Special eligibility, enrollment, and copayment
rules for low-income individuals.
``Sec. 1860F. Prescription Medicine Insurance Account.
``Sec. 1860G. Administration of benefits.
``Sec. 1860H. Employer incentive program for employment-based
retiree medicine coverage.
``Sec. 1860I. Promotion of pharmaceutical research on break-
through medicines while providing program
cost containment.
``Sec. 1860J. Appropriations to cover Government contributions.
``Sec. 1860K. Prescription medicine defined.
Sec. 4. Substantial reductions in the price of prescription drugs for
medicare beneficiaries.
Sec. 5. Amendments to program for importation of certain prescription
drugs by pharmacists and wholesalers.
Sec. 6. Reasonable price agreement for federally funded research.
Sec. 7. GAO ongoing studies and reports on program; miscellaneous
reports.
Sec. 8. Medigap transition provisions.
Sec. 9. Offset for catastrophic prescription medicine benefit.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) Prescription medicine coverage was not a standard part
of health insurance when the medicare program under title XVIII
of the Social Security Act was enacted in 1965. Since 1965,
however, medicine coverage has become a key component of most
private and public health insurance coverage, except for the
medicare program.
(2) At least \2/3\ of medicare beneficiaries have
unreliable, inadequate, or no medicine coverage at all.
(3) Seniors who do not have medicine coverage typically
pay, at a minimum, 15 percent more than people with coverage.
(4) Medicare beneficiaries at all income levels lack
prescription medicine coverage, with more than \1/2\ of such
beneficiaries having incomes greater than 150 percent of the
poverty line.
(5) The number of private firms offering retiree health
coverage is declining.
(6) Medigap premiums for medicines are too expensive for
most beneficiaries and are highest for older senior citizens,
who need prescription medicine coverage the most and typically
have the lowest incomes.
(7) All medicare beneficiaries should have access to a
voluntary, reliable, affordable, and defined outpatient
medicine benefit as part of the medicare program that assists
with the high cost of prescription medicines and protects them
against excessive out-of-pocket costs.
SEC. 3. PRESCRIPTION MEDICINE BENEFIT PROGRAM.
(a) In General.--Title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.) is amended--
(1) by redesignating part D as part E; and
(2) by inserting after part C the following new part:
``Part D--Prescription Medicine Benefit for the Aged and Disabled
``establishment of prescription medicine benefit program for the aged
and disabled
``Sec. 1860. There is established a voluntary insurance program to
provide prescription medicine benefits, including pharmacy services, in
accordance with the provisions of this part for individuals who are
aged or disabled or have end-stage renal disease and who elect to
enroll under such program, to be financed from premium payments by
enrollees together with contributions from funds appropriated by the
Federal Government.
``scope of benefits
``Sec. 1860A. (a) In General.--The benefits provided to an
individual enrolled in the insurance program under this part shall
consist of--
``(1) payments made, in accordance with the provisions of
this part, for covered prescription medicines (as specified in
subsection (b)) dispensed by any pharmacy participating in the
program under this part (and, in circumstances designated by
the Secretary, by a nonparticipating pharmacy), including any
specifically named medicine prescribed for the individual by a
qualified health care professional regardless of whether the
medicine is included in any formulary established under this
part if such medicine is certified as medically necessary by
such health care professional (except that the Secretary shall
encourage to the maximum extent possible the substitution and
use of lower-cost generics), up to the benefit limits specified
in section 1860B; and
``(2) charging by pharmacies of the negotiated price--
``(A) for all covered prescription medicines,
without regard to such benefit limit; and
``(B) established with respect to any drugs or
classes of drugs described in subparagraphs (A), (B),
(D), (E), or (F) of section 1927(d)(2) that are
available to individuals receiving benefits under this
title.
``(b) Covered Prescription Medicines.--
``(1) In general.--Covered prescription medicines, for
purposes of this part, include all prescription medicines (as
defined in section 1860K(1)), including smoking cessation
agents, except as otherwise provided in this subsection.
``(2) Exclusions from coverage.--Covered prescription
medicines shall not include drugs or classes of drugs described
in subparagraphs (A) through (D) and (F) through (H) of section
1927(d)(2) unless--
``(A) specifically provided otherwise by the
Secretary with respect to a drug in any of such
classe
2000
s; or
``(B) a drug in any of such classes is certified to
be medically necessary by a health care professional.
``(3) Exclusion of prescription medicines to the extent
covered under part a or b.--A medicine prescribed for an
individual that would otherwise be a covered prescription
medicine under this part shall not be so considered to the
extent that payment for such medicine is available under part A
or B, including all injectable drugs and biologicals for which
payment was made or should have been made by a carrier under
section 1861(s)(2) (A) or (B) as of the date of enactment of
the Medicare Extension of Drugs to Seniors (MEDS) Act of 2001.
Medicines otherwise covered under part A or B shall be covered
under this part to the extent that benefits under part A or B
are exhausted.
``(4) Study on inclusion of home infusion therapy
services.--Not later than one year after the date of the
enactment of the Medicare Extension of Drugs to Seniors (MEDS)
Act of 2001, the Secretary shall submit to Congress a
legislative proposal for the delivery of home infusion therapy
services under this title and for a system of payment for such
a benefit that coordinates items and services furnished under
part B and under this part.
``payment of benefits; benefit limits
``Sec. 1860B. (a) Payment of Benefits.--
``(1) In general.--There shall be paid from the
Prescription Medicine Insurance Account within the
Supplementary Medical Insurance Trust Fund, in the case of each
individual who is enrolled in the insurance program under this
part and who purchases covered prescription medicines in a
calendar year--
``(A) with respect to costs incurred for covered
prescription medicine furnished during a year, before
the individual has incurred out-of-pocket expenses
under this subsection equal to the catastrophic out-of-
pocket limit specified in subsection (b), an amount
equal to the applicable percentage (specified in
paragraph (2)) of the negotiated price for each such
covered prescription medicine or such higher percentage
as is proposed under section 1860G(b)(7); and
``(B) with respect to costs incurred for covered
prescription medicine furnished during a year, after
the individual has incurred out-of-pocket expenses
under this subsection equal to the catastrophic out-of-
pocket limit specified in subsection (b), an amount
equal to 100 percent of the negotiated price for each
such covered prescription medicine.
``(2) Applicable percentage.--The applicable percentage
specified in this paragraph is 80 percent or such higher
percentage as is proposed under section 1860G(b)(7), if the
Secretary finds that such higher percentage will not increase
aggregate costs to the Prescription Medicine Insurance Account.
``(b) Catastrophic Limit on Out-of-Pocket Expenses.--
``(1) In general.--The catastrophic limit on out-of-pocket
expenses specified in this subsection for--
``(A) for each of calendar years 2003 and 2004,
$2,000; and
``(B) subject to paragraph (2), for calendar year
2005 and each subsequent calendar year is equal the
limit for the preceding year under this paragraph
adjusted by the sustainable growth rate percentage
(determined under section 1861I(b)) for the year
involved.
``(2) Rounding.--Any amount determined under paragraph
(1)(E) that is not a multiple of $10 shall be rounded to the
nearest multiple of $10.
``eligibility and enrollment
``Sec. 1860C. (a) Eligibility.--Every individual who, in or after
2003, is entitled to hospital insurance benefits under part A or
enrolled in the medical insurance program under part B is eligible to
enroll, in accordance with the provisions of this section, in the
insurance program under this part, during an enrollment period
prescribed in or under this section, in such manner and form as may be
prescribed by regulations.
``(b) Enrollment.--
``(1) In general.--Each individual who satisfies subsection
(a) shall be enrolled (or eligible to enroll) in the program
under this part in accordance with the provisions of section
1837, as if that section applied to this part, except as
otherwise explicitly provided in this part.
``(2) Single enrollment period.--Except as provided in
section 1837(i) (as such section applies to this part), 1860E,
or 1860H(e), or as otherwise explicitly provided, no individual
shall be entitled to enroll in the program under this part at
any time after the initial enrollment period without penalty,
and in the case of all other late enrollments, the Secretary shall
develop a late enrollment penalty for the individual that fully
recovers the additional actuarial risk involved providing coverage for
the individual.
``(3) Special enrollment period for 2003.--
``(A) In general.--An individual who first
satisfies subsection (a) in 2003 may, at any time on or
before December 31, 2003--
``(i) enroll in the program under this
part; and
``(ii) enroll or reenroll in such program
after having previously declined or terminated
enrollment in such program.
``(B) Effective date of coverage.--An individual
who enrolls under the program under this part pursuant
to subparagraph (A) shall be entitled to benefits under
this part beginning on the first day of the month
following the month in which such enrollment occurs.
``(c) Period of Coverage.--
``(1) In general.--Except as otherwise provided in this
part, an individual's coverage under the program under this
part shall be effective for the period provided in section
1838, as if that section applied to the program under this
part.
``(2) Part d coverage terminated by termination of coverage
under parts a and b.--In addition to the causes of termination
specified in section 1838, an individual's coverage under this
part shall be terminated when the individual retains coverage
under neither the program under part A nor the program under
part B, effective on the effective date of termination of
coverage under part A or (if later) under part B.
``premiums
``Sec. 1860D. (a) Annual Establishment of Monthly Premium Rates.--
``(1) In general.--The Secretary shall, during September of
2002 and of each succeeding year, determine and promulgate a
monthly premium rate for the succeeding year in accordance with
the provisions of this subsection.
``(2) Initial premiums.--For months in 2003, the monthly
premium rate under this subsection shall be--
``(A) $24, in the case of premiums paid by an
individual enrolled in the program under this part; and
``(B) $32, in the case of premiums paid for such an
individual by a former employer (as defined in section
1860H(f)(2)).
``(3) Subsequent years.--
``(A) In general.--For months in a year
2000
after 2003,
the monthly premium under this subsection shall be
(subject to subparagraph (B)) the monthly premium
(computed under this subsection without regard to
subparagraph (B)) for the previous year increased by
the annual percentage increase in average per capita
aggregate expenditures for covered outpatient medicines
in the United States for medicare beneficiaries, as
estimated and published by the Secretary in September
before the year and for the year involved.
``(B) Rounding.--The monthly premium determined
under subparagraph (A) shall be rounded to the nearest
multiple of 10 cents if it is not a multiple of 10
cents.
``(C) Publication of assumptions.--The Secretary
shall publish, together with the promulgation of the
monthly premium rates under this paragraph, a statement
setting forth the actuarial assumptions and bases
employed in arriving at the monthly premium under
subparagraph (A).
``(b) Payment of Premiums.--
``(1) Payments by deduction from social security, railroad
retirement benefits, or benefits administered by opm.--
``(A) Deduction from benefits.--In the case of an
individual who is entitled to or receiving benefits as
described in subsection (a), (b), or (d) of section
1840, premiums payable under this part shall be
collected by deduction from such benefits at the same
time and in the same manner as premiums payable under
part B are collected pursuant to section 1840.
``(B) Transfers to prescription medicine insurance
account.--The Secretary of the Treasury shall, from
time to time, but not less often than quarterly,
transfer premiums collected pursuant to subparagraph
(A) to the Prescription Medicine Insurance Account from
the appropriate funds and accounts described in
subsections (a)(2), (b)(2), and (d)(2) of section 1840,
on the basis of the certifications described in such
subsections. The amounts of such transfers shall be
appropriately adjusted to the extent that prior
transfers were too great or too small.
``(2) Direct payments to secretary.--
``(A) Additional payment by enrollee.--An
individual to whom paragraph (1) applies (other than an
individual receiving benefits as described in section
1840(d)) and who estimates that the amount that will be
available for deduction under such paragraph for any
premium payment period will be less than the amount of
the monthly premiums for such period may (under
regulations) pay to the Secretary the estimated
balance, or such greater portion of the monthly premium
as the individual chooses.
``(B) Payments by other enrollees.--An individual
enrolled in the insurance program under this part with
respect to whom none of the preceding provisions of
this subsection applies (or to whom section 1840(c)
applies) shall pay premiums to the Secretary at such
times and in such manner as the Secretary shall by
regulations prescribe.
``(C) Deposit of premiums.--Amounts paid to the
Secretary under this paragraph shall be deposited in
the Treasury to the credit of the Prescription Medicine Insurance
Account in the Supplementary Medical Insurance Trust Fund.
``(c) Certain Low-Income Individuals.--For rules concerning
premiums for certain low-income individuals, see section 1860E.
``special eligibility, enrollment, and copayment rules for low-income
individuals
``Sec. 1860E. (a) State Agreements for Coverage.--
``(1) In general.--The Secretary shall, at the request of a
State, enter into an agreement with the State under which all
individuals described in paragraph (2) are enrolled in the
program under this part, without regard to whether any such
individual has previously declined the opportunity to enroll in
such program.
``(2) Eligibility groups.--The individuals described in
this paragraph, for purposes of paragraph (1), are individuals
who satisfy section 1860C(a) and who are--
``(A)(i) eligible individuals within the meaning of
section 1843; and
``(ii) in a coverage group or groups permitted
under section 1843 (as selected by the State and
specified in the agreement); or
``(B) qualified medicare medicine beneficiaries (as
defined in subsection (e)(1)).
``(3) Coverage period.--The period of coverage under this
part of an individual enrolled under an agreement under this
subsection shall be as follows:
``(A) Individuals eligible (at state option) for
part b buy-in.--In the case of an individual described
in subsection (a)(2)(A), the coverage period shall be
the same period that applies (or would apply) pursuant
to section 1843(d).
``(B) Qualified medicare medicine beneficiaries.--
In the case of an individual described in subsection
(a)(2)(B)--
``(i) the coverage period shall begin on
the latest of--
``(I) January 1, 2003;
``(II) the first day of the third
month following the month in which the
State agreement is entered into; or
``(III) the first day of the first
month following the month in which the
individual satisfies section 1860C(a);
and
``(ii) the coverage period shall end on the
last day of the month in which the individual
is determined by the State to have become
ineligible for medicare medicine cost-sharing.
``(4) Alternative enrollment methods.--In the process of
enrolling low-income individuals under this part, the Secretary
shall use the system provided under section 154 of the Social
Security Act Amendments of 1994 for newly eligible medicare
beneficiaries and shall apply a similar system for other
medicare beneficiaries. Such system shall use existing Federal
government databases to identify eligibility. Such system shall
not require that beneficiaries apply for, or enroll through,
State medicaid systems in order to obtain low-income assistance
described in this section.
``(b) Special Part D Enrollment Opportunity for Individuals Losing
Medicaid Eligibility.--In the case of an individual who--
``(1) satisfies section 1860C(a); and
``(2) loses eligibility for benefits under the State plan
under title XIX after having been enrolled under such plan or
having been determined eligible for such benefits;
the Secretary shall provide an opportunity for enrollment under the
program under this part during the period that begins on the date that
such individual loses such eligibility and ends on the d
2000
ate specified
by the Secretary.
``(c) State Option To Buy-In Dually Eligible Individuals.--
``(1) Coverage of premiums as medical assistance.--For
purposes of applying the second sentence of section 1905(a),
any reference to premiums under part B shall be considered to
include a reference to premiums under this part.
``(2) State commitment to continue participation in part d
after benefit limit reached.--As a condition of additional
funding to a State under subsection (d), the State, in its
State plan under title XIX, shall provide that in the case of
any individual whose eligibility for medical assistance under
title XIX is not limited to medicare cost-sharing and for whom
the State elects to pay premiums under this part pursuant to
this section, the State will purchase all prescription
medicines for such individual in accordance with the provisions
of this part without regard to whether the benefit limit for such
individual under section 1860B(b) has been reached.
``(3) Medicare cost-sharing required for qualified medicare
beneficiaries.--In applying title XIX, the term `medicare cost-
sharing' (as defined in section 1905(p)(3)) is deemed to
include--
``(A) premiums under section 1860D; and
``(B) the difference between the amount that is
paid under section 1860B and the amount that would be
paid under such section if any reference to `80
percent' in subsection (a)(2) of such section were
deemed a reference to `100 percent' (or, if the
Secretary approves a higher percentage under such
section, if such percentage were deemed to be 100
percent).
``(d) Payment to States for Coverage of Certain Medicare Cost-
Sharing.--
``(1) In general.--The Secretary shall provide for payment
under this subsection to each State that provides for--
``(A) medicare cost-sharing described in section
1905(p)(3)(A)(ii) for individuals who would be
qualified medicare beneficiaries described in section
1905(p)(1) but for the fact that their income exceeds
the income level established by the State under section
1905(p)(2) and is at least 120 percent, but less than
135 percent, of the official poverty line (referred to
in such section) for a family of the size involved and
who are not otherwise eligible for medical assistance
under the State plan; and
``(B) medicare medicine cost-sharing (as defined in
subsection (e)(2)) for qualified medicare medicine
beneficiaries described in subsection (e)(1).
``(2) Amount of payment.--The amount of payment under
paragraph (1) shall equal 100 percent of the cost-sharing
described in such paragraph, except that, in the case of an
individual whose eligibility for medical assistance under title
XIX is not limited to medicare cost-sharing or medicare
medicine cost-sharing, the amount of payment under paragraph
(1)(B) shall be equal to the Federal medical assistance
percentage described in section 1905(b)) of amounts as expended
for such cost-sharing.
``(3) Method of payment; relation to other payments.--
Amounts shall be paid to States under this subsection in a
manner similar to that provided under section 1903(d). Payments
under this subsection shall be made in lieu of any payments
that otherwise may be made for medical assistance provided
under section 1902(a)(10)(E)(iv).
``(4) Treatment of territories.--
``(A) In general.--Subject to subparagraph (B),
this subsection shall not apply to States other than
the 50 States and the District of Columbia.
``(B) Payments.--In the case of a State (other than
the 50 States and the District of Columbia) that
develops and implements a plan of assistance for
pharmaceuticals provided to low-income medicare
beneficiaries, the Secretary shall provide for payment
to the State in an amount that is reasonable in
relation to the payment levels provided to other States
under paragraph (2).
``(e) Definitions; Special Rules.--For purposes of this section:
``(1) Qualified medicare medicine beneficiary.--The term
`qualified medicare medicine beneficiary' means an individual--
``(A) who is entitled to hospital insurance
benefits under part A (including an individual entitled
to such benefits pursuant to an enrollment under
section 1818, but not including an individual entitled
to such benefits only pursuant to an enrollment under
section 1818A);
``(B) whose income (as determined under section
1612 for purposes of the supplemental security income
program, except as provided in section 1905(p)(2)(D))
is above 100 percent but below 150 percent of the
official poverty line (as defined by the Office of
Management and Budget, and revised annually in
accordance with section 673(2) of the Omnibus Budget
Reconciliation Act of 1981) applicable to a family of
the size involved; and
``(C) whose resources (as determined under section
1613 for purposes of the supplemental security income
program) do not exceed twice the maximum amount of
resources that an individual may have and obtain
benefits under that program.
``(2) Medicare medicine cost-sharing.--The term `medicare
medicine cost-sharing' means the following costs incurred with
respect to a qualified medicare medicine beneficiary, without
regard to whether the costs incurred were for items and
services for which medical assistance is otherwise available
under a State plan under title XIX:
``(A) In the case of a qualified medicare medicine
beneficiary whose income (as determined under paragraph
(1)) is less than 135 percent of the official poverty
line--
``(i) premiums under section 1860D; and
``(ii) the difference between the amount
that is paid under section 1860B and the amount
that would be paid under such section if any
reference to `50 percent' therein were deemed a
reference to `100 percent' (or, if the
Secretary approves a higher percentage under
such section, if such percentage were deemed to
be 100 percent).
``(B) In the case of a qualified medicare medicine
beneficiary whose income (as determined under paragraph
(1)) is at least 135 percent but less than 150 percent
of the official poverty line, a percentage of premiums
under section 1860D, determined on a linear
sliding scale ranging from 100 percent for individuals with incomes at
135 percent of such line to 0 percent for individuals with incomes at
150 percent of such line.
``(3) State.--The term `State' has the meaning given such
term under section 1101(a) for purposes of title XIX.
``(4) Treatment of drugs purchased.--The provisions of
section
2000
1927 shall not apply to prescription drugs purchased
under this part pursuant to an agreement with the Secretary
under this section (including any drugs so purchased after the
limit under section 1860B(b) has been exceeded).
``prescription medicine insurance account
``Sec. 1860F. (a) Establishment.--There is created within the
Federal Supplemental Medical Insurance Trust Fund established by
section 1841 an account to be known as the `Prescription Medicine
Insurance Account' (in this section referred to as the `Account').
``(b) Amounts in Account.--
``(1) In general.--The Account shall consist of--
``(A) such amounts as may be deposited in, or
appropriated to, such fund as provided in this part;
and
``(B) such gifts and bequests as may be made as
provided in section 201(i)(1).
``(2) Separation of funds.--Funds provided under this part
to the Account shall be kept separate from all other funds
within the Federal Supplemental Medical Insurance Trust Fund.
``(c) Payments From Account.--The Managing Trustee shall pay from
time to time from the Account such amounts as the Secretary certifies
are necessary to make the payments provided for by this part, and the
payments with respect to administrative expenses in accordance with
section 201(g).
``administration of benefits
``Sec. 1860G. (a) Through HCFA.--The Secretary shall provide for
administration of the benefits under this part through the Health Care
Financing Administration in accordance with the provisions of this
section. The Administrator of such Administration may enter into
contracts with carriers to administer this part in the same manner as
the Administrator enters into such contracts to administer part B. Any
such contract shall be separate from any contract under section 1842.
``(b) Administration Functions.--In carrying out this part, the
Administrator (or a carrier under a contract with the Administrator)
shall (or in the case of the function described in paragraph (9), may)
perform the following functions:
``(1) Participation agreements, prices, and fees.--
``(A) Negotiated prices.--Establish, through
negotiations with medicine manufacturers and
wholesalers and pharmacies, a schedule of prices for
covered prescription medicines.
``(B) Agreements with pharmacies.--Enter into
participation agreements under subsection (c) with
pharmacies, that include terms that--
``(i) secure the participation of
sufficient numbers of pharmacies to ensure
convenient access (including adequate emergency
access);
``(ii) permit the participation of any
pharmacy in the service area that meets the
participation requirements described in
subsection (c); and
``(iii) allow for reasonable dispensing and
consultation fees for pharmacies.
``(C) Lists of prices and participating
pharmacies.--Ensure that the negotiated prices
established under subparagraph (A) and the list of
pharmacies with agreements under subsection (c) are
regularly updated and readily available to health care
professionals authorized to prescribe medicines,
participating pharmacies, and enrolled individuals.
``(2) Tracking of covered enrolled individuals.--Maintain
accurate, updated records of all enrolled individuals (other
than individuals enrolled in a plan under part C).
``(3) Payment and coordination of benefits.--
``(A) Payment.--
``(i) Administer claims for payment of
benefits under this part and encourage, to the
maximum extent possible, use of electronic
means for the submissions of claims.
``(ii) Determine amounts of benefit
payments to be made.
``(iii) Receive, disburse, and account for
funds used in making such payments, including
through the activities specified in the
provisions of this paragraph.
``(B) Coordination.--Coordinate with other private
benefit providers, pharmacies, and other relevant
entities as necessary to ensure appropriate
coordination of benefits with respect to enrolled
individuals, including coordination of access to and
payment for covered prescription medicines according to
an individual's in-service area plan provisions, when
such individual is traveling outside the home service
area, and under such other circumstances as the
Secretary may specify.
``(C) Explanation of benefits.--Furnish to enrolled
individuals an explanation of benefits in accordance
with section 1806(a), and a notice of the balance of
benefits remaining for the current year, whenever
prescription medicine benefits are provided under this
part (except that such notice need not be provided more
often than monthly).
``(4) Rules relating to provision of benefits.--
``(A) In general.--In providing benefits under this
part, the Secretary (directly or through contracts)
shall employ mechanisms to provide benefits
economically, including the use of--
``(i) formularies (consistent with
subparagraph (B));
``(ii) automatic generic medicine
substitution (unless the physician specifies
otherwise, in which case a 30-day prescription
may be dispensed pending a consultation with
the physician on whether a generic substitute
can be dispensed in the future);
``(iii) tiered copayments (which may
include copayments at a rate lower than 20
percent) to encourage the use of the lowest
cost, on-formulary product in cases where there
is no restrictive prescription (described in
subparagraph (D)(i)); and
``(iv) therapeutic interchange.
``(B) Requirements with respect to formularies.--If
a formulary is used to contain costs under this part--
``(i) use an advisory committee (or a
therapeutics committee) comprised of licensed
practicing physicians, pharmacists, and other
health care practitioners to develop and manage
the formulary;
``(ii) include in the formulary at least 1
medicine from each therapeutic class and, if
available, a generic equivalent thereof; and
``(iii) disclose to current and prospective
enrollees and to participating providers and
pharmacies, the nature of the formulary
restrictions, including information regarding
the medicines included in the formulary and any
2000
difference in cost-sharing amounts.
``(C) Construction.--Nothing in this subsection
shall be construed to prevent the Secretary (directly
or through contracts) from using incentives (including
a lower beneficiary coinsurance) to encourage enrollees
to select generic or other cost-effective medicines, so
long as--
``(i) such incentives are designed not to
result in any increase in the aggregate
expenditures under the Federal Medicare
Prescription Medicine Trust Fund;
``(ii) the average coinsurance charged to
all beneficiaries by the Secretary (directly or
through contractors) shall seek to approximate
(but in no case exceed) 20 percent for on-
formulary medicines;
``(iii) a beneficiary's coinsurance shall
be no greater than 20 percent if the
prescription is a restrictive prescription; and
``(iv) the reimbursement for a prescribed
nonformulary medicine without a restrictive
prescription in no case shall be more than the
lowest reimbursement for a formulary medicine
in the therapeutic class of the prescribed
medicine.
``(D) Restrictive prescription.--For purposes of
this section:
``(i) Written prescriptions.--In the case
of a written prescription for a medicine, it is
a restrictive prescription only if the
prescription indicates, in the writing of the
physician or other qualified person prescribing
the medicine and with an appropriate phrase
(such as `brand medically necessary')
recognized by the Secretary, that a particular
medicine product must be dispensed based upon a
belief by the physician or person prescribing
the medicine that the particular medicine will
provide even marginally superior therapeutic
benefits to the individual for whom the
medicine is prescribed or would have marginally
fewer adverse reactions with respect to such
individual.
``(ii) Telephone prescriptions.--In the
case of a prescription issued by telephone for
a medicine, it is a restrictive prescription
only if the prescription cannot be longer than
30 days and the physician or other qualified
person prescribing the medicine (through use of
such an appropriate phrase) states that a
particular medicine product must be dispensed,
and the physician or other qualified person
submits to the pharmacy involved, within 30
days after the date of the telephone
prescription, a written confirmation from the
physician or other qualified person prescribing
the medicine and which indicates with such
appropriate phrase that the particular medicine
product was required to have been dispensed
based upon a belief by the physician or person
prescribing the medicine that the particular
medicine will provide even marginally superior
therapeutic benefits to the individual for whom
the medicine is prescribed or would have
marginally fewer adverse reactions with respect
to such individual. Such written confirmation
is required to refill the prescription.
``(iii) Review of restrictive
prescriptions.--The advisory committee
(established under subparagraph (B)(i)) may
decide to review a restrictive prescription
and, if so, it may approve or disapprove such
restrictive prescription. It may not disapprove
such restrictive prescription unless it finds
that there is no literature approved by the
Food and Drug Administration that supports a
determination that the particular medicine
provides even marginally superior therapeutic
benefits to the individual for whom the
medicine is prescribed or would have marginally
fewer adverse reactions with respect to such
individual. If it disapproves, upon request of
the prescribing physician or the enrollee, the
committee must provide for a review by an
independent contractor of such decision within
48 hours of the time of submission of the
prescription, to determine whether the prescription is an eligible
benefit under this part. The Secretary shall ensure that independent
contractors so used are completely independent of the contractor or its
advisory committee.
``(5) Cost and utilization management; quality assurance.--
Have in place effective cost and utilization management, drug
utilization review, quality assurance measures, and systems to
reduce medical errors, including at least the following,
together with such additional measures as the Administrator may
specify:
``(A) Drug utilization review.--A drug utilization
review program conforming to the standards provided in
section 1927(g)(2) (with such modifications as the
Administrator finds appropriate).
``(B) Fraud and abuse control.--Activities to
control fraud, abuse, and waste, including prevention
of diversion of pharmaceuticals to the illegal market.
``(C) Medication therapy management.--
``(i) In general.--A program of medicine
therapy management and medication
administration that is designed to assure that
covered outpatient medicines are appropriately
used to achieve therapeutic goals and reduce
the risk of adverse events, including adverse
drug interactions.
``(ii) Elements.--Such program may
include--
``(I) enhanced beneficiary
understanding of such appropriate use
through beneficiary education,
counseling, and other appropriate
means; and
``(II) increased beneficiary
adherence with prescription medication
regimens through medication refill
reminders, special packaging, and other
appropriate means.
``(iii) Development of program in
2000
cooperation with licensed pharmacists.--The
program shall be developed in cooperation with
licensed pharmacists and physicians.
``(iv) Considerations in pharmacy fees.--
There shall be taken into account, in
establishing fees for pharmacists and others
providing services under the medication therapy
management program, the resources and time used
in implementing the program.
``(6) Education and information activities.--Have in place
mechanisms for disseminating educational and informational
materials to enrolled individuals and health care providers
designed to encourage effective and cost-effective use of
prescription medicine benefits and to ensure that enrolled
individuals understand their rights and obligations under the
program.
``(7) Beneficiary protections.--
``(A) Confidentiality of health information.--Have
in effect systems to safeguard the confidentiality of
health care information on enrolled individuals, which
comply with section 1106 and with section 552a of title
5, United States Code, and meet such additional
standards as the Administrator may prescribe.
``(B) Grievance and appeal procedures.--Have in
place such procedures as the Administrator may specify
for hearing and resolving grievances and appeals,
including expedited appeals, brought by enrolled
individuals against the Administrator or a pharmacy
concerning benefits under this part, which shall
include procedures equivalent to those specified in
subsections (f) and (g) of section 1852.
``(8) Records, reports, and audits.--
``(A) Records and audits.--Maintain adequate
records, and afford the Administrator access to such
records (including for audit purposes).
``(B) Reports.--Make such reports and submissions
of financial and utilization data as the Administrator
may require taking into account standard commercial
practices.
``(9) Proposal for alternative coinsurance amount.--
``(A) Submission.--The Administrator may provide
for increased Government cost-sharing for generic
prescription medicines, prescription medicines on a
formulary, or prescription medicines obtained through
mail order pharmacies.
``(B) Contents.--The proposal submitted under
subparagraph (A) shall contain evidence that such
increased cost-sharing would not result in an increase
in aggregate costs to the Account, including an
analysis of differences in projected drug utilization
patterns by beneficiaries whose cost-sharing would be
reduced under the proposal and those making the cost-
sharing payments that would otherwise apply.
``(10) Other requirements.--Meet such other requirements as
the Secretary may specify.
The Administrator shall negotiate a schedule of prices under paragraph
(1)(A), except that nothing in this sentence shall prevent a carrier
under a contract with the Administrator from negotiating a lower
schedule of prices for covered prescription medicines.
``(c) Pharmacy Participation Agreements.--
``(1) In general.--A pharmacy that meets the requirements
of this subsection shall be eligible to enter an agreement with
the Administrator to furnish covered prescription medicines and
pharmacists' services to enrolled individuals.
``(2) Terms of agreement.--An agreement under this
subsection shall include the following terms and requirements:
``(A) Licensing.--The pharmacy and pharmacists
shall meet (and throughout the contract period will
continue to meet) all applicable State and local
licensing requirements.
``(B) Limitation on charges.--Pharmacies
participating under this part shall not charge an
enrolled individual more than the negotiated price for
an individual medicine as established under subsection
(b)(1), regardless of whether such individual has
attained the benefit limit under section 1860B(b), and
shall not charge an enrolled individual more than the
individual's share of the negotiated price as
determined under the provisions of this part.
``(C) Performance standards.--The pharmacy and the
pharmacist shall comply with performance standards
relating to--
``(i) measures for quality assurance,
reduction of medical errors, and participation
in the drug utilization review program
described in subsection (b)(3)(A);
``(ii) systems to ensure compliance with
the confidentiality standards applicable under
subsection (b)(5)(A); and
``(iii) other requirements as the Secretary
may impose to ensure integrity, efficiency, and
the quality of the program.
``(D) Disclosure of price of generic medicine.--A
pharmacy participating under this part shall inform an
enrollee of the difference in price between generic and
non-generic equivalents.
``(d) Special Attention to Rural and Hard-To-Serve Areas.--
``(1) In general.--The Secretary shall ensure that all
beneficiaries have access to the full range of pharmaceuticals
under this part, and shall give special attention to access,
pharmacist counseling, and delivery in rural and hard-to-serve
areas (as the Secretary may define by regulation).
``(2) Special attention defined.--For purposes of paragraph
(1), the term `special attention' may include bonus payments to
retail pharmacists in rural areas and any other actions the
Secretary determines are necessary to ensure full access to
rural and hard-to-serve beneficiaries.
``(3) GAO report.--Not later than 2 years after the
implementation of this part the Comptroller General of the
United States shall submit to Congress a report on the access
of medicare beneficiaries to pharmaceuticals and pharmacists'
services in rural and hard-to-serve areas under this part
together with any recommendations of the Comptroller General
regarding any additional steps the Secretary may need to take
to ensure the access of medicare beneficiaries to
pharmaceuticals and pharmacists' services in such areas under
this part.
``(e) Incentives for Cost and Utilization Management and Quality
Improvement.--The Secretary is authorized to include in a contract
awarded under subsection (b) with a carrier such incentives for cost
and utilization management and quality improvement as the Secretary may
deem appropriate, including--
``(1) bonus and penalty incentives to encourage
administrative efficiency;
``(2) incentives under which carriers share in any benefit
savings achieved;
``(3) risk-sharing arrangements related to initiatives to
encourage savings in benefit payments;
``(4) f
2000
inancial incentives under which savings derived from
the substitution of generic medicines in lieu of non-generic
medicines are made available to carriers, pharmacies, and the
Prescription Medicine Insurance Account; and
``(5) any other incentive that the Secretary deems
appropriate and likely to be effective in managing costs or
utilization.
``employer incentive program for employment-based retiree medicine
coverage
``Sec. 1860H. (a) Program Authority.--The Secretary shall develop
and implement a program under this section called the `Employer
Incentive Program' that encourages employers and other sponsors of
employment-based health care coverage to provide adequate prescription
medicine benefits to retired individuals and to maintain such existing
benefit programs, by subsidizing, in part, the sponsor's cost of
providing coverage under qualifying plans.
``(b) Sponsor Requirements.--In order to be eligible to receive an
incentive payment under this section with respect to coverage of an
individual under a qualified retiree prescription medicine plan (as
defined in subsection (f)(3)), a sponsor shall meet the following
requirements:
``(1) Assurances.--The sponsor shall--
``(A) annually attest, and provide such assurances
as the Secretary may require, that the coverage offered
by the sponsor is a qualified retiree prescription
medicine plan, and will remain such a plan for the duration of the
sponsor's participation in the program under this section; and
``(B) guarantee that it will give notice to the
Secretary and covered retirees--
``(i) at least 120 days before terminating
its plan; and
``(ii) immediately upon determining that
the actuarial value of the prescription
medicine benefit under the plan falls below the
actuarial value of the insurance benefit under
this part.
``(2) Other requirements.--The sponsor shall provide such
information, and comply with such requirements, including
information requirements to ensure the integrity of the
program, as the Secretary may find necessary to administer the
program under this section.
``(c) Incentive Payment.--
``(1) In general.--A sponsor that meets the requirements of
subsection (b) with respect to a quarter in a calendar year
shall have payment made by the Secretary on a quarterly basis
(to the sponsor or, at the sponsor's direction, to the
appropriate employment-based health plan) of an incentive
payment, in the amount determined as described in paragraph
(2), for each retired individual (or spouse) who--
``(A) was covered under the sponsor's qualified
retiree prescription medicine plan during such quarter;
and
``(B) was eligible for but was not enrolled in the
insurance program under this part.
``(2) Amount of incentive.--The payment under this section
with respect to each individual described in paragraph (1) for
a month shall be equal to \2/3\ of the monthly premium amount
payable from the Prescription Medicine Insurance Account for an
enrolled individual, as set for the calendar year pursuant to
section 1860D(a)(2).
``(3) Payment date.--The incentive under this section with
respect to a calendar quarter shall be payable as of the end of
the next succeeding calendar quarter.
``(d) Civil Money Penalties.--A sponsor, health plan, or other
entity that the Secretary determines has, directly or through its
agent, provided information in connection with a request for an
incentive payment under this section that the entity knew or should
have known to be false shall be subject to a civil monetary penalty in
an amount equal to $2,000 for each false representation plus an amount
not to exceed 3 times the total incentive amounts under subsection (c)
that were paid (or would have been payable) on the basis of such
information.
``(e) Part D Enrollment for Certain Individuals Covered by
Employment-Based Retiree Health Coverage Plans.--
``(1) Eligible individuals.--An individual shall be given
the opportunity to enroll in the program under this part during
the period specified in paragraph (2) if--
``(A) the individual declined enrollment in the
program under this part at the time the individual
first satisfied section 1860C(a);
``(B) at that time, the individual was covered
under a qualified retiree prescription medicine plan
for which an incentive payment was paid under this
section; and
``(C)(i) the sponsor subsequently ceased to offer
such plan; or
``(ii) the value of prescription medicine coverage
under such plan is reduced below the value of the
coverage provided at the time the individual first
became eligible to participate in the program under
this part.
``(2) Special enrollment period.--An individual described
in paragraph (1) shall be eligible to enroll in the program
under this part during the 6-month period beginning on the
first day of the month in which--
``(A) the individual receives a notice that
coverage under such plan has terminated (in the
circumstance described in paragraph (1)(C)(i)) or
notice that a claim has been denied because of such a
termination; or
``(B) the individual received notice of the change
in benefits (in the circumstance described in paragraph
(1)(C)(ii)).
``(f) Definitions.--In this section:
``(1) Employment-based retiree health coverage.--The term
`employment-based retiree health coverage' means health
insurance or other coverage of health care costs for retired
individuals (or for such individuals and their spouses and
dependents) based on their status as former employees or labor
union members.
``(2) Employer.--The term `employer' has the meaning given
to such term by section 3(5) of the Employee Retirement Income
Security Act of 1974 (except that such term shall include only
employers of 2 or more employees).
``(3) Qualified retiree prescription medicine plan.--The
term `qualified retiree prescription medicine plan' means
health insurance coverage included in employment-based retiree
health coverage that--
``(A) provides coverage of the cost of prescription
medicines whose actuarial value to each retired
beneficiary equals or exceeds the actuarial value of
the benefits provided to an individual enrolled in the
program under this part; and
``(B) does not deny, limit, or condition the
coverage or provision of prescription medicine benefits
for retired individuals based on age or any health
status-related factor described in section 2702(a)(1)
of the Public Health Service Act.
``(4) Sponsor.--The term `sponsor' has the meaning given
the term `plan sponsor' by section 3(16)(B) of the Employee
Retirement Income Security Act of 1974.
``promotion of pharmaceutical research on break-through medicines while
providing program cost containment
``Sec. 1
2000
860I. (a) Monitoring Expenditures.--The Secretary shall
monitor expenditures under this part. On October 1, 2003, Secretary
shall estimate total expenditures under this part for 2003.
``(b) Establishment of Sustainable Growth Rate.--
``(1) In general.--The Secretary shall establish a
sustainable growth rate prescription medicine target system for
expenditures under this part for each year after 2003.
``(2) Initial computation.--Such target shall equal the
amount of total expenditures estimated for 2003 adjusted by the
Secretary's estimate of a sustainable growth rate (in this
section referred to as an `SGR') percentage between 2003 and
2004. Such SGR shall be estimated based on the following:
``(A) Reasonable changes in the cost of production
or price of covered pharmaceuticals, but in no event
more than the rate of increase in the consumer price
index for all urban consumers for the period involved.
``(B) Population enrolled in this part, both in
numbers and in average age and severity of chronic and
acute illnesses.
``(C) Appropriate changes in utilization of
pharmaceuticals, as determined by the Drug Review Board
(established under subsection (c)(3)) and based on best
estimates of utilization change if there were no
direct-to-consumer advertising or promotions to
providers.
``(D) Productivity index of manufacturers and
distributors.
``(E) Percentage of products with patent and market
exclusivity protection versus products without patent
protection and changes in the availability of generic
substitutes.
``(F) Such other factors as the Secretary may
determine are appropriate.
In no event may the sustainable growth rate exceed 120 percent
of the estimated per capita growth in total spending under this
title.
``(3) Computation for subsequent years.--In October of 2004
and each year thereafter, for purposes of setting the SGRs for
the succeeding year, the Secretary shall adjust each current
year's estimated expenditures by the estimated SGR for the
succeeding year, further adjusted for corrections in earlier
estimates and the receipt of additional data on previous years
spending as follows:
``(A) Error estimates.--An adjustment (up or down)
for errors in the estimate of total expenditures under
this part for the previous year.
``(B) Costs.--An adjustment (up or down) for
corrections in the cost of production of prescriptions
covered under this part between the current calendar
year and the previous year.
``(C) Target.--An adjustment for any amount (over
or under) that expenditures in the current year under
this part are estimated to differ from the target
amount set for the year. If expenditures in the current
year are estimated to be--
``(i) less than the target amount, future
target amounts will be adjusted downward; or
``(ii) more than the target amount, the
Secretary shall notify all pharmaceutical
manufacturers with sales of pharmaceutical
prescription medicine products to medicare
beneficiaries under this part, of a rebate
requirement (except as provided in this
subparagraph) to be deposited in the Federal
Medicare Prescription Medicine Trust Fund.
``(D) Rebate determination.--The amount of the
rebate described in subparagraph (C)(ii) may vary among
manufacturers and shall be based on the manufacturer's
estimated contribution to the expenditure above the
target amount, taking into consideration such factors
as--
``(i) above average increases in the cost
of the manufacturer's product;
``(ii) increases in utilization due to
promotion activities of the manufacturer,
wholesaler, or retailer;
``(iii) launch prices of new drugs at the
same or higher prices as similar drugs already
in the marketplace (so-called `me too' or
`copy-cat' drugs);
``(iv) the role of the manufacturer in
delaying the entry of generic products into the
market; and
``(v) such other actions by the
manufacturer that the Secretary may determine
has contributed to the failure to meet the SGR
target.
The rebates shall be established under such
subparagraph so that the total amount of the rebates is
estimated to ensure that the amount the target for the
current year is estimated to be exceeded is recovered
in lower spending in the subsequent year; except that,
no rebate shall be made in any manufacturer's product
which the Food and Drug Administration has determined
is a breakthrough medicine (as determined under
subsection (c)) or an orphan medicine.
``(c) Breakthrough Medicines.--
``(1) Determination.--For purposes of this section, a
medicine is a `breakthrough medicine' if the Drug Review Board
(established under paragraph (3)) determines--
``(A) it is a new product that will make a
significant and major improvement by reducing physical
or mental illness, reducing mortality, or reducing
disability; and
``(B) that no other product is available to
beneficiaries that achieves similar results for the
same condition at a lower cost.
``(2) Condition.--An exemption from rebates under
subsection (b)(3) for a breakthrough medicine shall continue as
long as the medicine is certified as a breakthrough medicine
but shall be limited to 7 calendar years from 2003 or 7
calendar years from the date of the initial determination under
paragraph (1), whichever is later.
``(3) Drug review board.--The Drug Review Board under this
paragraph shall consist of the Commissioner of Food and Drugs,
the Directors of the National Institutes of Health, the
Director of the National Science Foundation, and 10 experts in
pharmaceuticals, medical research, and clinical care, selected
by the Commissioner of Food and Drugs from the faculty of
academic medical centers, except that no person who has (or who
has an immediate family member that has) any conflict of
interest with any pharmaceutical manufacturer shall serve on
the Board.
``(d) No Review.--The Secretary's determination of the rebate
amounts under this section, and the Drug Review Board's determination
of what is a breakthrough drug, are not subject to administrative or
judicial review.
``appropriations to cover government contributions
``Sec. 1860J. (a) In General.--There are authorized to be
appropriated from time to time, out of any moneys in the Treasury n
2000
ot
otherwise appropriated, to the Prescription Medicine Insurance Account,
a Government contribution equal to--
``(1) the aggregate premiums payable for a month pursuant
to section 1860D(a)(2) by individuals enrolled in the program
under this part; plus
``(2) one-half the aggregate premiums payable for a month
pursuant to such section for such individuals by former
employers; plus
``(3) the benefits payable by reason of the application of
paragraph (2) of section 1860B(a) (relating to catastrophic
benefits).
``(b) Appropriations To Cover Incentives for Employment-Based
Retiree Medicine Coverage.--There are authorized to be appropriated to
the Prescription Medicine Insurance Account from time to time, out of
any moneys in the Treasury not otherwise appropriated such sums as may
be necessary for payment of incentive payments under section 1860H(c).
``prescription medicine defined
``Sec. 1860K. As used in this part, the term `prescription
medicine' means--
``(1) a drug that may be dispensed only upon a
prescription, and that is described in subparagraph (A)(i),
(A)(ii), or (B) of section 1927(k)(2); and
``(2) insulin certified under section 506 of the Federal
Food, Drug, and Cosmetic Act, and needles, syringes, and
disposable pumps for the administration of such insulin.''.
(b) Conforming Amendments.--
(1) Amendments to federal supplementary health insurance
trust fund.--Section 1841 of the Social Security Act (42 U.S.C.
1395t) is amended--
(A) in the last sentence of subsection (a)--
(i) by striking ``and'' after ``section
201(i)(1)''; and
(ii) by inserting before the period the
following: ``, and such amounts as may be
deposited in, or appropriated to, the
Prescription Medicine Insurance Account
established by section 1860F'';
(B) in subsection (g), by inserting after ``by this
part,'' the following: ``the payments provided for
under part D (in which case the payments shall come
from the Prescription Medicine Insurance Account in the
Supplementary Medical Insurance Trust Fund),'';
(C) in the first sentence of subsection (h), by
inserting before the period the following: ``and
section 1860D(b)(4) (in which case the payments shall
come from the Prescription Medicine Insurance Account
in the Supplementary Medical Insurance Trust Fund)'';
and
(D) in the first sentence of subsection (i)--
(i) by striking ``and'' after ``section
1840(b)(1)''; and
(ii) by inserting before the period the
following: ``, section 1860D(b)(2) (in which
case the payments shall come from the
Prescription Medicine Insurance Account in the
Supplementary Medical Insurance Trust Fund)''.
(2) Prescription medicine option under medicare+choice
plans.--
(A) Eligibility, election, and enrollment.--Section
1851 of the Social Security Act (42 U.S.C. 1395w-21) is
amended--
(i) in subsection (a)(1)(A), by striking
``parts A and B'' inserting ``parts A, B, and
D''; and
(ii) in subsection (i)(1), by striking
``parts A and B'' and inserting ``parts A, B,
and D''.
(B) Voluntary beneficiary enrollment for medicine
coverage.--Section 1852(a)(1)(A) of such Act (42 U.S.C.
1395w-22(a)(1)(A)) is amended by inserting ``(and under
part D to individuals also enrolled under that part)''
after ``parts A and B''.
(C) Access to services.--Section 1852(d)(1) of such
Act (42 U.S.C. 1395w-22(d)(1)) is amended--
(i) in subparagraph (D), by striking
``and'' at the end;
(ii) in subparagraph (E), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(F) the plan for prescription medicine benefits
under part D guarantees coverage of any specifically
named covered prescription medicine for an enrollee,
when prescribed by a physician in accordance with the provisions of
such part, regardless of whether such medicine would otherwise be
covered under an applicable formulary or discount arrangement.''.
(D) Payments to organizations.--Section
1853(a)(1)(A) of such Act (42 U.S.C. 1395w-23(a)(1)(A))
is amended--
(i) by inserting ``determined separately
for benefits under parts A and B and under part
D (for individuals enrolled under that part)''
after ``as calculated under subsection (c)'';
(ii) by striking ``that area, adjusted for
such risk factors'' and inserting ``that area.
In the case of payment for benefits under parts
A and B, such payment shall be adjusted for
such risk factors as''; and
(iii) by inserting before the last sentence
the following: ``In the case of the payments
for benefits under part D, such payment shall
initially be adjusted for the risk factors of
each enrollee as the Secretary determines to be
feasible and appropriate. By 2006, the
adjustments would be for the same risk factors
applicable for benefits under parts A and B.''.
(E) Calculation of annual medicare +choice
capitation rates.--Section 1853(c) of such Act (42
U.S.C. 1395w-23(c)) is amended--
(i) in paragraph (1), in the matter
preceding subparagraph (A), by inserting ``for
benefits under parts A and B'' after
``capitation rate'';
(ii) in paragraph (6)(A), by striking
``rate of growth in expenditures under this
title'' and inserting ``rate of growth in
expenditures for benefits available under parts
A and B''; and
(iii) by adding at the end the following
new paragraph:
``(8) Payment for prescription medicines.--The Secretary
shall determine a capitation rate for prescription medicines--
``(A) dispensed in 2003, which is based on the
projected national per capita costs for prescription
medicine benefits under part D and associated claims
processing costs for beneficiaries under the original
medicare fee-for-service program; and
``(B) dispensed in each subsequent year, which
shall be equal to the rate for the previous year
updated by the Secretary's estimate of the projected
per capita rate of growth in expenditur
2000
es under this
title for an individual enrolled under part D.''.
(F) Limitation on enrollee liability.--Section
1854(e) of such Act (42 U.S.C. 1395w-24(e)) is amended
by adding at the end the following new paragraph:
``(5) Special rule for provision of part d benefits.--In no
event may a Medicare+Choice organization include as part of a
plan for prescription medicine benefits under part D a
requirement that an enrollee pay a deductible, or a coinsurance
percentage that exceeds 20 percent.''.
(G) Requirement for additional benefits.--Section
1854(f)(1) of such Act (42 U.S.C. 1395w-24(f)(1)) is
amended by adding at the end the following new
sentence: ``Such determination shall be made separately
for benefits under parts A and B and for prescription
medicine benefits under part D.''.
(3) Exclusions from coverage.--
(A) Application to part d.--Section 1862(a) of the
Social Security Act (42 U.S.C. 1395y(a)) is amended in
the matter preceding paragraph (1) by striking ``part A
or part B'' and inserting ``part A, B, or D''.
(B) Prescription medicines not excluded from
coverage if appropriately prescribed.--Section
1862(a)(1) of such Act (42 U.S.C. 1395y(a)(1)) is
amended--
(i) in subparagraph (H), by striking
``and'' at the end;
(ii) in subparagraph (I), by striking the
semicolon at the end and inserting ``, and'';
and
(iii) by adding at the end the following
new subparagraph:
``(J) in the case of prescription medicines covered
under part D, which are not prescribed in accordance
with such part;''.
SEC. 4. SUBSTANTIAL REDUCTIONS IN THE PRICE OF PRESCRIPTION DRUGS FOR
MEDICARE BENEFICIARIES.
(a) Participating Manufacturers.--
(1) In General.--Each participating manufacturer of a
covered outpatient drug shall make available for purchase by
each pharmacy such covered outpatient drug in the amount
described in paragraph (2) at the price described in paragraph
(3).
(2) Description of amount of drugs.--The amount of a
covered outpatient drug that a participating manufacturer shall
make available for purchase by a pharmacy is an amount equal to
the aggregate amount of the covered outpatient drug sold or
distributed by the pharmacy to Medicare beneficiaries.
(3) Description of price.--The price at which a
participating manufacturer shall make a covered outpatient drug
available for purchase by a pharmacy is the price equal to the
lowest of the following:
(A) The lowest price paid for the covered
outpatient drug by any agency or department of the
United States.
(B) The manufacturer's best price for the covered
outpatient drug, as defined in section 1927(c)(1)(C) of
the Social Security Act (42 U.S.C. 1396r-8(c)(1)(C)).
(C) The lowest price at which the drug is available
(as determined by the Secretary) through importation
consistent with the provisions of section 804 of the
Federal Food, Drug, and Cosmetic Act.
(b) Special Provision With Respect to Hospice Programs.--For
purposes of determining the amount of a covered outpatient drug that a
participating manufacturer shall make available for purchase by a
pharmacy under subsection (a), there shall be included in the
calculation of such amount the amount of the covered outpatient drug
sold or distributed by a pharmacy to a hospice program. In calculating
such amount, only amounts of the covered outpatient drug furnished to a
Medicare beneficiary enrolled in the hospice program shall be included.
(c) Administration.--The Secretary shall issue such regulations as
may be necessary to implement this section.
(d) Reports to Congress Regarding Effectiveness of Section.--
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, and annually thereafter, the
Secretary shall report to the Congress regarding the
effectiveness of this section in--
(A) protecting Medicare beneficiaries from
discriminatory pricing by drug manufacturers; and
(B) making prescription drugs available to Medicare
beneficiaries at substantially reduced prices.
(2) Consultation.--In preparing such reports, the Secretary
shall consult with public health experts, affected industries,
organizations representing consumers and older Americans, and
other interested persons.
(3) Recommendations.--The Secretary shall include in such
reports any recommendations they consider appropriate for
changes in this section to further reduce the cost of covered
outpatient drugs to Medicare beneficiaries.
(f) Definitions.--For purposes of this section:
(1) Participating manufacturer.--The term ``participating
manufacturer'' means any manufacturer of drugs or biologicals
that, on or after the date of the enactment of this Act, enters
into a contract or agreement with the United States for the
sale or distribution of covered outpatient drugs to the United
States.
(2) Covered outpatient drug.--The term ``covered outpatient
drug'' has the meaning given that term in section 1927(k)(2) of
the Social Security Act (42 U.S.C. 1396r-8(k)(2)).
(3) Medicare beneficiary.--The term ``Medicare
beneficiary'' means an individual entitled to benefits under
part A of title XVIII of the Social Security Act or enrolled
under part B of such title, or both.
(4) Hospice program.--The term ``hospice program'' has the
meaning given that term under section 1861(dd)(2) of the Social
Security Act (42 U.S.C. 1395x(dd)(2)).
(5) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(f) Effective Date.--The Secretary shall implement this section as
expeditiously as practicable and in a manner consistent with the
obligations of the United States.
SEC. 5. AMENDMENTS TO PROGRAM FOR IMPORTATION OF CERTAIN PRESCRIPTION
DRUGS BY PHARMACISTS AND WHOLESALERS.
Section 804 of the Federal Food, Drug, and Cosmetic Act (as added
by section 745(c)(2) of Public Law 106-387) is amended--
(1) by striking subsections (e) and (f) and inserting the
following subsections:
``(e) Testing; Approved Labeling.--
``(1) Testing.--Regulations under subsection (a)--
``(A) shall require that testing referred to in
paragraphs (6) through (8) of subsection (d) be
conducted by the importer of the covered product
pursuant to subsection (a), or the manufacturer of the
product;
``(B) shall require that, if such tests are
conducted by the importer, information needed to
authenticate the product being tested be supplied by
the manufacturer of such product to the importer; and
``(C) shall provide for the protection of any
information supplied by the manufacturer under
subparagraph (B) that is a trade secret or commercial
or financial information that is privileged or
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confidential.
``(2) Approved labeling.--For purposes of importing a
covered product pursuant to subsection (a), the importer
involved may use the labeling approved for the product under
section 505, notwithstanding any other provision of law.
``(f) Discretion of Secretary Regarding Testing.--The Secretary may
waive or modify testing requirements described in subsection (d) if,
with respect to specific countries or specific distribution chains, the
Secretary has entered into agreements or otherwise approved
arrangements that the Secretary determines ensure that the covered
products involved are not adulterated or in violation of section
505.'';
(2) by striking subsections (h) and (i) and inserting the
following subsections:
``(h) Prohibited Agreements; Nondiscrimination.--
``(1) Prohibited agreements.--No manufacturer of a covered
product may enter into a contract or agreement that includes a
provision to prevent the sale or distribution of covered
products imported pursuant to subsection (a).
``(2) Nondiscrimination.--No manufacturer of a covered
product may take actions that discriminate against, or cause
other persons to discriminate against, United States
pharmacists, wholesalers, or consumers regarding the sale or
distribution of covered products.
``(i) Study and Report.--
``(1) Study.--The Comptroller General of the United States
shall conduct a study on the imports permitted under this
section, taking into consideration the information received
under subsection (a). In conducting such study, the Comptroller
General shall--
``(A) evaluate importers' compliance with
regulations, determine the number of shipments, if any,
permitted under this section that have been determined
to be counterfeit, misbranded, or adulterated; and
``(B) consult with the United States Trade
Representative and United States Patent and Trademark
Office to evaluate the effect of importations permitted
under this section on trade and patent rights under
Federal law.
``(2) Report.--Not later than 5 years after the effective
date of final regulations issued pursuant to this section, the
Comptroller General of the United States shall prepare and
submit to Congress a report containing the study described in
paragraph (1).'';
(3) in subsection (k)(2)--
(A) by redesignating subparagraphs (A) through (E)
as subparagraphs (B) through (F), respectively; and
(B) by inserting before subparagraph (B) (as so
redesignated) the following subparagraph:
``(A) The term `discrimination' includes a contract
provision, a limitation on supply, or other measure
which has the effect of providing United States
pharmacists, wholesalers, or consumers access to
covered products on terms or conditions that are less
favorable than the terms or conditions provided to any
foreign purchaser of such products.'';
(4) by striking subsection (m); and
(5) by inserting after subsection (l) the following
subsection:
``(m) Funding.--For the purpose of carrying out this section, there
are authorized to be appropriated such sums as may be necessary for
fiscal year 2002 and each subsequent fiscal year.''.
SEC. 6. REASONABLE PRICE AGREEMENT FOR FEDERALLY FUNDED RESEARCH.
(a) In General.--If any Federal agency or any non-profit entity
undertakes federally funded health care research and development and is
to convey or provide a patent or other exclusive right to use such
research and development for a drug or other health care technology,
such agency or entity shall not make such conveyance or provide such
patent or other right until the person who will receive such conveyance
or patent or other right first agrees to a reasonable pricing agreement
with the Secretary of Health and Human Services or the Secretary makes
a determination that the public interest is served by a waiver of the
reasonable pricing agreement provided in accordance with subsection
(c).
(b) Consideration of Competitive Bidding.--In cases where the
Federal Government conveys or licenses exclusive rights to federally
funded research under subsection (a), consideration shall be given to
mechanisms for determining reasonable prices which are based upon a
competitive bidding process. When appropriate, the mechanisms should be
considered where--
(1) qualified bidders compete on the basis of the lowest
prices that will be charged to consumers;
(2) qualified bidders compete on the basis of the least
sales revenues before prices are adjusted in accordance with a
cost based reasonable pricing formula;
(3) qualified bidders compete on the basis of the least
period of time before prices are adjusted in accordance with a
cost based reasonable pricing formula;
(4) qualified bidders compete on the basis of the shortest
period of exclusivity; or
(5) qualified bidders compete under other competitive
bidding systems.
Such competitive bidding process may incorporate requirements for
minimum levels of expenditures on research, marketing, maximum price,
or other factors.
(c) Waiver.--No waiver shall take effect under subsection (a)
before the public is given notice of the proposed waiver and provided a
reasonable opportunity to comment on the proposed waiver. A decision to
grant a waiver shall set out the Secretary's finding that such a waiver
is in the public interest.
SEC. 7. GAO ONGOING STUDIES AND REPORTS ON PROGRAM; MISCELLANEOUS
REPORTS.
(a) Ongoing Study.--The Comptroller General of the United States
shall conduct an ongoing study and analysis of the prescription
medicine benefit program under part D of the Medicare program under
title XVIII of the Social Security Act (as added by section 3 of this
Act), including an analysis of each of the following:
(1) The extent to which the administering entities have
achieved volume-based discounts similar to the favored price
paid by other large purchasers.
(2) Whether access to the benefits under such program are
in fact available to all beneficiaries, with special attention
given to access for beneficiaries living in rural and hard-to-
serve areas.
(3) The success of such program in reducing medication
error and adverse medicine reactions and improving quality of
care, and whether it is probable that the program has resulted
in savings through reduced hospitalizations and morbidity due
to medication errors and adverse medicine reactions.
(4) Whether patient medical record confidentiality is being
maintained and safe-guarded.
(5) Such other issues as the Comptroller General may
consider.
(b) Reports.--The Comptroller General shall issue such reports on
the results of the ongoing study described in (a) as the Comptroller
General shall deem appropriate and shall notify Congress on a timely
basis of significant problems in the operation of the part D
prescription medicine program and the need for legislative adjustments
and improvements.
(c) Miscellaneous Studies and Reports.--
(1) Study on methods to encourage additional research on
breakthrough pharmaceuticals.--
(A) In general.--The Secretary of Health and Human
Services shall seek the advice of the Secretary of the
Treasury on possible tax and trade law changes to
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encourage increased original research on new
pharmaceutical breakthrough products designed to
address disease and illness.
(B) Report.--Not later than January 1, 2003, the
Secretary shall submit to Congress a report on such
study. The report shall include recommended methods to
encourage the pharmaceutical industry to devote more
resources to research and development of new covered
products than it devotes to overhead expenses.
(2) Study on pharmaceutical sales practices and impact on
costs and quality of care.--
(A) In general.--The Secretary of Health and Human
Services shall conduct a study on the methods used by
the pharmaceutical industry to advertise and sell to
consumers and educate and sell to providers.
(B) Report.--Not later than January 1, 2003, the
Secretary shall submit to Congress a report on such
study. The report shall include the estimated direct
and indirect costs of the sales methods used, the
quality of the information conveyed, and whether such
sales efforts leads (or could lead) to inappropriate
prescribing. Such report may include legislative and
regulatory recommendations to encourage more
appropriate education and prescribing practices.
(3) Study on cost of pharmaceutical research.--
(A) In general.--The Secretary of Health and Human
Services shall conduct a study on the costs of, and
needs for, the pharmaceutical research and the role
that the taxpayer provides in encouraging such
research.
(B) Report.--Not later than January 1, 2003, the
Secretary shall submit to Congress a report on such
study. The report shall include a description of the
full-range of taxpayer-assisted programs impacting
pharmaceutical research, including tax, trade,
government research, and regulatory assistance. The
report may also include legislative and regulatory
recommendations that are designed to ensure that the
taxpayer's investment in pharmaceutical research
results in the availability of pharmaceuticals at
reasonable prices.
(4) Report on pharmaceutical prices in major foreign
nations.--Not later than January 1, 2003, the Secretary of
Health and Human Services shall submit to Congress a report on
the retail price of major pharmaceutical products in various
developed nations, compared to prices for the same or similar
products in the United States. The report shall include a
description of the principal reasons for any price differences
that may exist.
SEC. 8. MEDIGAP TRANSITION PROVISIONS.
(a) In General.--Notwithstanding any other provision of law, no new
medicare supplemental policy that provides coverage of expenses for
prescription drugs may be issued under section 1882 of the Social
Security Act on or after January 1, 2003, to an individual unless it
replaces a medicare supplemental policy that was issued to that
individual and that provided some coverage of expenses for prescription
drugs.
(b) Issuance of Substitute Policies if Obtain Prescription Drug
Coverage Through Medicare.--
(1) In general.--The issuer of a medicare supplemental
policy--
(A) may not deny or condition the issuance or
effectiveness of a medicare supplemental policy that
has a benefit package classified as ``A'', ``B'',
``C'', ``D'', ``E'', ``F'', or ``G'' (under the
standards established under subsection (p)(2) of
section 1882 of the Social Security Act, 42 U.S.C.
1395ss) and that is offered and is available for
issuance to new enrollees by such issuer;
(B) may not discriminate in the pricing of such
policy, because of health status, claims experience,
receipt of health care, or medical condition; and
(C) may not impose an exclusion of benefits based
on a pre-existing condition under such policy,
in the case of an individual described in paragraph (2) who
seeks to enroll under the policy not later than 63 days after
the date of the termination of enrollment described in such
paragraph and who submits evidence of the date of termination
or disenrollment along with the application for such medicare
supplemental policy.
(2) Individual covered.--An individual described in this
paragraph is an individual who--
(A) enrolls in a prescription drug plan under part
D of title XVIII of the Social Security Act; and
(B) at the time of such enrollment was enrolled and
terminates enrollment in a medicare supplemental policy
which has a benefit package classified as ``H'', ``I'',
or ``J'' under the standards referred to in paragraph
(1)(A) or terminates enrollment in a policy to which
such standards do not apply but which provides benefits
for prescription drugs.
(3) Enforcement.--The provisions of paragraph (1) shall be
enforced as though they were included in section 1882(s) of the
Social Security Act (42 U.S.C. 1395ss(s)).
(4) Definitions.--For purposes of this subsection, the term
``medicare supplemental policy'' has the meaning given such
term in section 1882(g) of the Social Security Act (42 U.S.C.
1395ss(g)).
SEC. 9. OFFSET FOR CATASTROPHIC PRESCRIPTION MEDICINE BENEFIT.
If the mid-summer 2000 budget estimate prepared by the Director of
the Congressional Budget Office results in a higher level of projected
on-budget surplus over the ten-fiscal-year period beginning with fiscal
year 2001 than projected on-budget surplus in the estimate prepared by
the Director in March, 2000, there shall be transferred out of any
moneys in the Treasury not otherwise appropriated in a fiscal year
(beginning with fiscal year 2003) to the Prescription Medicine
Insurance Account (created in the Federal Supplemental Medical
Insurance Trust Fund established by section 1841 of the Social Security
Act (42 U.S.C. 1395t)) such sums as are necessary to offset the costs
attributable to the operation of section 1860B(a)(1)(B) of the Social
Security Act (as added by section 3) (relating to catastrophic benefit
payment amounts) in that fiscal year.
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