I 
111TH CONGRESS 
1ST SESSION 
H. R. 684 
To amend title XVIII of the Social Security Act to deliver a meaningful 
benefit and lower prescription drug prices under the Medicare Program. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 26, 2009 
Mr. BERRY (for himself, Ms. SCHAKOWSKY, Mr. ABERCROMBIE, Mr. FRANK 
of Massachusetts, Ms. LEE of California, Mr. KENNEDY, Mr. TIERNEY, 
Mr. HINCHEY, Ms. MCCOLLUM, Mr. VAN HOLLEN, Mr. FILNER, Mr. 
BISHOP of New York, Mrs. MALONEY, and Ms. PINGREE of Maine) intro-
duced 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 deliver 
a meaningful benefit and lower prescription drug prices 
under the Medicare Program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Prescription 
Drug Savings and Choice Act of 2009’’. 
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SEC. 2. ESTABLISHMENT OF MEDICARE OPERATED PRE-
SCRIPTION DRUG PLAN OPTION. 
(a) IN GENERAL.—Subpart 2 of part D of the Social 
Security Act is amended by inserting after section 1860D– 
11 (42 U.S.C. 1395w–111) the following new section: 
‘‘MEDICARE OPERATED PRESCRIPTION DRUG PLAN 
OPTION 
‘‘SEC. 1860D–11A. (a) IN
GENERAL.—Notwith-
standing any other provision of this part, for each year 
(beginning with 2010), in addition to any plans offered 
under section 1860D–11, the Secretary shall offer one or 
more medicare operated prescription drug plans (as de-
fined in subsection (c)) with a service area that consists 
of the entire United States and shall enter into negotia-
tions in accordance with subsection (b) with pharma-
ceutical manufacturers to reduce the purchase cost of cov-
ered part D drugs for eligible part D individuals who en-
roll in such a plan. 
‘‘(b) 
NEGOTIATIONS.—Notwithstanding 
section 
1860D–11(i), for purposes of offering a medicare operated 
prescription drug plan under this section, the Secretary 
shall negotiate with pharmaceutical manufacturers with 
respect to the purchase price of covered part D drugs in 
a Medicare operated prescription drug plan and shall en-
courage the use of more affordable therapeutic equivalents 
to the extent such practices do not override medical neces-
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sity as determined by the prescribing physician. To the 
extent practicable and consistent with the previous sen-
tence, the Secretary shall implement strategies similar to 
those used by other Federal purchasers of prescription 
drugs, and other strategies, including the use of a for-
mulary and formulary incentives in subsection (e), to re-
duce the purchase cost of covered part D drugs. 
‘‘(c) MEDICARE OPERATED PRESCRIPTION DRUG 
PLAN DEFINED.—For purposes of this part, the term 
‘medicare operated prescription drug plan’ means a pre-
scription drug plan that offers qualified prescription drug 
coverage and access to negotiated prices described in sec-
tion 1860D–2(a)(1)(A). Such a plan may offer supple-
mental prescription drug coverage in the same manner as 
other qualified prescription drug coverage offered by other 
prescription drug plans. 
‘‘(d) MONTHLY BENEFICIARY PREMIUM.— 
‘‘(1) QUALIFIED
PRESCRIPTION
DRUG
COV-
ERAGE.—The monthly beneficiary premium for 
qualified prescription drug coverage and access to 
negotiated prices described in section 1860D– 
2(a)(1)(A) to be charged under a medicare operated 
prescription drug plan shall be uniform nationally. 
Such premium for months in 2010 and each suc-
ceeding year shall be based on the average monthly 
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Improvement, and Modernization Act 
of 2003; 
‘‘(II) other Federal entities, such 
as the Secretary of Veterans Affairs; 
and 
‘‘(III) other private and public 
entities, such as the Drug Effective-
ness Review Project and Medicaid 
programs; and 
‘‘(v) recommend to the Secretary— 
‘‘(I) those drugs in a class that 
provide a greater clinical benefit, in-
cluding fewer safety concerns or less 
risk of side-effects, than another drug 
in the same class that should be in-
cluded in the formulary; 
‘‘(II) those drugs in a class that 
provide less clinical benefit, including 
greater safety concerns or a greater 
risk of side-effects, than another drug 
in the same class that should be ex-
cluded from the formulary; and 
‘‘(III) drugs in a class with same 
or similar clinical benefit for which it 
would be appropriate for the Sec-
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option or for which a clear and significant ben-
efit has been demonstrated over other covered 
part D drugs. 
‘‘(4) ADDING
DRUGS
TO
THE
INITIAL
FOR-
MULARY.— 
‘‘(A) USE OF ADVISORY COMMITTEE.—The 
Secretary shall establish and appoint an advi-
sory committee (in this paragraph referred to 
as the ‘advisory committee’)— 
‘‘(i) to review petitions from drug 
manufacturers, health care provider orga-
nizations, patient groups, and other enti-
ties for inclusion of a drug in, or other 
changes to, such formulary; and 
‘‘(ii) to recommend any changes to the 
formulary established under this sub-
section. 
‘‘(B) COMPOSITION.—The advisory com-
mittee shall be composed of 9 members and 
shall include representatives of physicians, 
pharmacists, and consumers and others with ex-
pertise in evaluating prescription drugs. The 
Secretary shall select members based on their 
knowledge of pharmaceuticals and the Medicare 
population. Members shall be deemed to be spe-
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cial Government employees for purposes of ap-
plying the conflict of interest provisions under 
section 208 of title 18, United States Code, and 
no waiver of such provisions for such a member 
shall be permitted. 
‘‘(C) CONSULTATION.—The advisory com-
mittee shall consult, as necessary, with physi-
cians who are specialists in treating the disease 
for which a drug is being considered. 
‘‘(D) REQUEST FOR STUDIES.—The advi-
sory committee may request the Agency for 
Healthcare Research and Quality or an aca-
demic or research institution to study and make 
a report on a petition described in subpara-
graph (A)(ii) in order to assess— 
‘‘(i) clinical effectiveness; 
‘‘(ii) comparative effectiveness; 
‘‘(iii) safety; and 
‘‘(iv) enhanced compliance with a 
drug regimen. 
‘‘(E) RECOMMENDATIONS.—The advisory 
committee shall make recommendations to the 
Secretary regarding— 
‘‘(i) whether a covered part D drug is 
found to provide a greater clinical benefit, 
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including fewer safety concerns or less risk 
of side-effects, than another drug in the 
same class that is currently included in the 
formulary and should be included in the 
formulary; 
‘‘(ii) whether a covered part D drug is 
found to provide less clinical benefit, in-
cluding greater safety concerns or a great-
er risk of side-effects, than another drug in 
the same class that is currently included in 
the formulary and should not be included 
in the formulary; and 
‘‘(iii) whether a covered part D drug 
has the same or similar clinical benefit to 
a drug in the same class that is currently 
included in the formulary and whether the 
drug should be included in the formulary. 
‘‘(F) LIMITATIONS ON REVIEW OF MANU-
FACTURER
PETITIONS.—The advisory com-
mittee shall not review a petition of a drug 
manufacturer under subparagraph (A)(ii) with 
respect to a covered part D drug unless the pe-
tition is accompanied by the following: 
‘‘(i) Raw data from clinical trials on 
the safety and effectiveness of the drug. 
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‘‘(ii) Any data from clinical trials con-
ducted using active controls on the drug or 
drugs that are the current standard of 
care. 
‘‘(iii) Any available data on compara-
tive effectiveness of the drug. 
‘‘(iv) Any other information the Sec-
retary requires for the advisory committee 
to complete its review. 
‘‘(G) RESPONSE TO RECOMMENDATIONS.— 
The Secretary shall review the recommenda-
tions of the advisory committee and if the Sec-
retary accepts such recommendations the Sec-
retary shall modify the formulary established 
under this subsection accordingly. Nothing in 
this section shall preclude the Secretary from 
adding to the formulary a drug for which the 
Director of the Agency for Healthcare Research 
and Quality or the advisory committee has not 
made a recommendation. 
‘‘(H) NOTICE
OF
CHANGES.—The Sec-
retary shall provide timely notice to bene-
ficiaries and health professionals about changes 
to the formulary or formulary incentives. 
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‘‘(f) INFORMING
BENEFICIARIES.—The Secretary 
shall take steps to inform beneficiaries about the avail-
ability of a Medicare operated drug plan or plans including 
providing information in the annual handbook distributed 
to all beneficiaries and adding information to the official 
public Medicare website related to prescription drug cov-
erage available through this part. 
‘‘(g) APPLICATION OF ALL OTHER REQUIREMENTS 
FOR PRESCRIPTION DRUG PLANS.—Except as specifically 
provided in this section, any Medicare operated drug plan 
shall meet the same requirements as apply to any other 
prescription drug plan, including the requirements of sec-
tion 1860D–4(b)(1) relating to assuring pharmacy ac-
cess).’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 1860D–3(a) of the Social Security 
Act (42 U.S.C. 1395w–103(a)) is amended by add-
ing at the end the following new paragraph: 
‘‘(4) AVAILABILITY OF THE MEDICARE OPER-
ATED PRESCRIPTION DRUG PLAN.—A medicare oper-
ated prescription drug plan (as defined in section 
1860D–11A(c)) shall be offered nationally in accord-
ance with section 1860D–11A.’’. 
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(2)(A) Section 1860D–3 of the Social Security 
Act (42 U.S.C. 1395w–103) is amended by adding 
at the end the following new subsection: 
‘‘(c) PROVISIONS ONLY APPLICABLE IN 2006, 2007, 
2008, AND 2009.—The provisions of this section shall only 
apply with respect to 2006, 2007, 2008, and 2009.’’. 
(B) Section 1860D–11(g) of such Act (42 
U.S.C. 1395w–111(g)) is amended by adding at the 
end the following new paragraph: 
‘‘(8) NO
AUTHORITY
FOR
FALLBACK
PLANS 
AFTER 2009.—A fallback prescription drug plan shall 
not be available after December 31, 2009.’’. 
(3) Section 1860D–13(c)(3) of such Act (42 
U.S.C. 1395w–113(c)(3)) is amended— 
(A) in the heading, by inserting ‘‘AND 
MEDICARE
OPERATED
PRESCRIPTION
DRUG 
PLANS’’ after ‘‘FALLBACK PLANS’’; and 
(B) by inserting ‘‘or a medicare operated 
prescription drug plan’’ after ‘‘a fallback pre-
scription drug plan’’. 
(4) Section 1860D–16(b)(1) of such Act (42 
U.S.C.1395w–116(b)(1)) is amended— 
(A) in subparagraph (C), by striking 
‘‘and’’ after the semicolon at the end; 
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