I 
110TH CONGRESS 
1ST SESSION H. R. 3061 
To amend title XVIII of the Social Security Act to require that Medicare 
prescription drug plans using formularies cover all drugs included in 
6 specified therapeutic categories, to establish protective requirements 
for coverage determinations, reconsiderations, and appeals related to such 
drugs, and to require annual reports on such determinations, reconsider-
ations, and appeals. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 17, 2007 
Mr. DOGGETT (for himself, Mr. ABERCROMBIE, Mr. ALLEN, Mr. DAVIS of Illi-
nois, Mr. EMANUEL, Mr. ENGEL, Mr. AL GREEN of Texas, Mr. HIN-
CHEY, Ms. KAPTUR, Mr. LARSON of Connecticut, Ms. MCCOLLUM of 
Minnesota, Mr. MCDERMOTT, and Mr. STARK) 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 sub-
sequently 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 require 
that Medicare prescription drug plans using formularies 
cover all drugs included in 6 specified therapeutic cat-
egories, to establish protective requirements for coverage 
determinations, reconsiderations, and appeals related to 
such drugs, and to require annual reports on such deter-
minations, reconsiderations, and appeals. 
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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 Part D Drug 
Class Protection Act of 2007’’. 
SEC. 2. SPECIAL TREATMENT UNDER MEDICARE PART D 
FOR DRUGS IN 6 SPECIFIED THERAPEUTIC 
CATEGORIES. 
(a) MEDICARE PART D FORMULARIES REQUIRED TO 
COVER ALL DRUGS IN 6 SPECIFIED THERAPEUTIC CAT-
EGORIES.— 
(1) IN
GENERAL.—Section 1860D–4(b)(3) of 
the Social Security Act (42 U.S.C. 1395w– 
104(b)(3)) is amended— 
(A) in subparagraph (C)(i), by inserting ‘‘, 
except as provided in subparagraph (G),’’ after 
‘‘although’’; and 
(B) by inserting after subparagraph (F) 
the following new subparagraph: 
‘‘(G) REQUIRED INCLUSION OF DRUGS IN 
CERTAIN
THERAPEUTIC
CATEGORIES
AND 
CLASSES.— 
‘‘(i) REQUIREMENT.—The formulary 
must include, subject to clause (iii), all or 
substantially all drugs in each of the fol-
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lowing therapeutic categories of covered 
part D drugs: 
‘‘(I) Immunosuppresessants. 
‘‘(II) Antidepressants. 
‘‘(III) Antipsychotics. 
‘‘(IV) Anticonvulsants. 
‘‘(V) Antiretrovials. 
‘‘(VI) Antineoplastics. 
‘‘(ii) COVERAGE OF ALL UNIQUE DOS-
AGE
FORMS.—To meet the requirement 
under clause (i), the formulary must in-
clude all covered part D drugs and unique 
dosages and forms of such drugs in the 
categories specified in such clause, except 
for— 
‘‘(I) multi-source brands of the 
identical molecular structure; 
‘‘(II) extended release products 
in the case that the immediate release 
product involved is included on the 
formulary; 
‘‘(III) products that have the 
same active ingredient; and 
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‘‘(IV) dosage forms that do not 
provide a unique route of administra-
tion, such as tablets and capsules. 
‘‘(iii) APPLICATION TO NEW FDA-AP-
PROVED DRUGS.—In the case of a drug 
that becomes a covered part D drug and 
that is included in a category specified in 
clause (i), clause (i) shall apply to such 
drug 30 days after the drug has been 
placed on the market. Nothing in the pre-
vious sentence shall be construed as pre-
venting a pharmacy and therapeutic com-
mittee from advising a PDP sponsor of a 
prescription drug plan on the clinical ap-
propriateness of formulary management 
practices and policies related to new drugs 
in such categories. 
‘‘(iv) 
UTILIZATION
MANAGEMENT 
TOOLS NOT PERMITTED.—A PDP sponsor 
of a prescription drug plan may not apply 
a utilization management tool, such as 
prior authorization or step therapy, to a 
drug required under clause (i) to be in-
cluded on the formulary. 
‘‘(v) RULES OF CONSTRUCTION.— 
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‘‘(I) ISSUANCE OF GUIDANCE OR 
REGULATIONS
TO
ESTABLISH
FOR-
MULARY
OR
UTILIZATION
MANAGE-
MENT REQUIREMENTS PERMITTED.— 
Nothing in this subparagraph shall be 
construed as prohibiting the Secretary 
from issuing guidance or regulations 
to establish formulary or utilization 
management requirements under this 
section for any category or class of 
covered part D drugs if such guidance 
or regulations are consistent with the 
requirements of this subparagraph. 
‘‘(II) ADDITIONAL THERAPEUTIC 
CATEGORIES PERMITTED.—Nothing in 
this subparagraph shall be construed 
as prohibiting the Secretary from in-
cluding any additional therapeutic cat-
egory or class of covered part D drugs 
under clause (i) for purposes of this 
subparagraph.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to plan years beginning 
on or after January 1, 2008. 
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(b) SPECIAL REQUIREMENTS FOR COVERAGE DE-
TERMINATIONS, RECONSIDERATIONS, AND APPEALS FOR 
DRUGS INCLUDED
IN SPECIFIED THERAPEUTIC CAT-
EGORIES.— 
(1) IN GENERAL.—Section 1860D–4(g) of the 
Social Security Act (42 U.S.C. 1395w–104(g)) is 
amended by adding at the end the following new 
paragraph: 
‘‘(3) RECONSIDERATION
OF
DETERMINATIONS 
RELATED
TO
DRUGS
INCLUDED
IN
SPECIFIED 
THERAPEUTIC
CATEGORIES
CONDUCTED
BY
INDE-
PENDENT REVIEW ENTITY.—With respect to a part 
D eligible individual enrolled in a prescription drug 
plan, in the case of a determination under this sub-
section that denies such individual coverage (in 
whole or in part) of a drug in a category specified 
in subsection (b)(3)(G)(i), the individual may re-
quest that the reconsideration of such determination 
authorized under section 1852(g)(2) (as applied by 
paragraph (1)) be conducted by the independent, 
outside entity described in paragraph (4) of section 
1852(g) in accordance with the procedures for an 
expedited reconsideration under paragraph (3) of 
such section. 
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