I 
109TH CONGRESS 
2D SESSION 
H. R. 5102 
To amend title XVIII of the Social Security Act to prohibit removal of 
covered part D drugs from a prescription drug plan formulary during 
the plan year once an individual has enrolled in the plan. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 5, 2006 
Mr. BECERRA (for himself, Mr. DEFAZIO, Mr. SALAZAR, Mr. HONDA, Mr. 
JEFFERSON, Mr. KENNEDY
of Rhode Island, Mr. BOUCHER, Mr. 
WEXLER, Mr. CARDOZA, Mr. MCGOVERN, Mr. MOLLOHAN, Mr. GENE 
GREEN of Texas, Mr. GRIJALVA, Mr. RANGEL, Mr. STARK, Mr. CON-
YERS, Mr. MCDERMOTT, Ms. HERSETH, Mr. HINCHEY, Mr. BROWN of 
Ohio, Mr. REYES, Mr. RUPPERSBERGER, Mr. LARSON of Connecticut, 
Mr. MCNULTY, Ms. MATSUI, Mr. COSTELLO, Mrs. MALONEY, Mr. MAR-
SHALL, Mr. LEVIN, Ms. NORTON, Mr. INSLEE, Mr. LYNCH, Mr. 
DELAHUNT, Mr. OWENS, Mr. ORTIZ, Ms. SCHAKOWSKY, Mrs. 
NAPOLITANO, Mr. RYAN of Ohio, Mr. DOYLE, Mr. POMEROY, Mr. SCOTT 
of Virginia, Mr. BACA, Mr. SANDERS, Mr. CUMMINGS, Mr. OBERSTAR, 
Mr. PAYNE, Mr. GONZALEZ, Mr. EMANUEL, Mr. LANTOS, Mr. DOGGETT, 
Ms. WASSERMAN SCHULTZ, Mr. BRADY of Pennsylvania, Mrs. CAPPS, 
and Ms. MCCOLLUM of Minnesota) 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 provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to prohibit 
removal of covered part D drugs from a prescription 
drug plan formulary during the plan year once an indi-
vidual has enrolled in the plan. 
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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 Drug For-
mulary Protection Act’’. 
SEC. 2. REMOVAL OF COVERED PART D DRUGS FROM THE 
PRESCRIPTION DRUG PLAN FORMULARY. 
(a) LIMITATION ON REMOVAL OR CHANGE OF COV-
ERED PART D DRUGS FROM THE PRESCRIPTION DRUG 
PLAN FORMULARY.—Section 1860D–4(b)(3)(E) of the 
Social Security Act (42 U.S.C. 1395w–104(b)(3)(E)) is 
amended to read as follows: 
‘‘(E) REMOVING
A
DRUG
FROM
FOR-
MULARY OR IMPOSING A RESTRICTION OR LIMI-
TATION ON COVERAGE.— 
‘‘(i) LIMITATION ON REMOVAL, LIMI-
TATION, OR RESTRICTION.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II) and clause (ii), begin-
ning with 2006, the PDP sponsor of 
a prescription drug plan may not re-
move a covered part D drug from the 
plan formulary or impose a restriction 
or limitation on the coverage of such 
a drug (such as through the applica-
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tion of a preferred status, usage re-
striction, step therapy, prior author-
ization, or quantity limitation) other 
than at the beginning of each plan 
year except as the Secretary may per-
mit to take into account new thera-
peutic uses and newly covered part D 
drugs. 
‘‘(II) SPECIAL RULE FOR NEWLY 
ENROLLED INDIVIDUALS.—Subject to 
clause (ii), in the case of an individual 
who enrolls in a prescription drug 
plan on or after the date of the enact-
ment of the Medicare Drug For-
mulary Protection Act, the PDP spon-
sor of such plan may not remove a 
covered part D drug from the plan 
formulary or impose a restriction or 
limitation on the coverage of such a 
drug (such as through the application 
of a preferred status, usage restric-
tion, step therapy, prior authorization, 
or quantity limitation) during the pe-
riod beginning on the date of such en-
rollment and ending on December 31 
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of the immediately succeeding plan 
year except as the Secretary may per-
mit to take into account new thera-
peutic uses and newly covered part D 
drugs. 
‘‘(ii) EXCEPTIONS TO LIMITATION ON 
REMOVAL.—Clause (i) shall not apply with 
respect to a covered part D drug that— 
‘‘(I) is a brand name drug for 
which there is a generic drug ap-
proved under section 505(j) of the 
Food and Drug Cosmetic Act (21 
U.S.C. 355(j)) that is placed on the 
market during the period in which 
there are limitations on removal or 
change in the formulary under sub-
clause (I) or (II) of clause (i) if such 
generic drug is included in the for-
mulary without any restriction or limi-
tation placed on the coverage of such 
generic drug other than a restriction 
or limitation that would be placed on 
the coverage of the brand name drug 
during such period without the appli-
cation of this subclause; 
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‘‘(II) is a brand name drug that 
goes off-patent during such period; 
‘‘(III) is a drug for which the 
Commissioner of Food and Drugs 
issues a clinical warning that imposes 
a restriction or limitation on the drug 
during such period; 
‘‘(IV) has been determined to be 
ineffective during such period; 
‘‘(V) is a drug that the appro-
priate pharmacy and therapeutic com-
mittee determines, based on evidence 
from peer-reviewed research, to be un-
safe or ineffective during such period; 
or 
‘‘(VI) is any other drug that sat-
isfies any other requirement deter-
mined appropriate by the Secretary. 
‘‘(iii) NOTICE
OF
REMOVAL
UNDER 
APPLICATION
OF
EXCEPTION
TO
LIMITA-
TION.—The PDP sponsor of a prescription 
drug plan shall provide appropriate notice 
(such as under subsection (a)(3)) of any 
removal or change under clause (ii) to the 
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Secretary, affected enrollees, physicians, 
pharmacies, and pharmacists.’’. 
(b) NOTICE
FOR CHANGE
IN FORMULARY
AND 
OTHER RESTRICTIONS OR LIMITATIONS ON COVERAGE.— 
(1) IN GENERAL.—Section 1860D–4(a) of such 
Act (42 U.S.C. 1395w–104(a)) is amended by add-
ing at the end the following new paragraph: 
‘‘(5) ANNUAL
NOTICE
OF
CHANGES
IN
FOR-
MULARY AND OTHER RESTRICTIONS OR LIMITATIONS 
ON COVERAGE.—Each PDP sponsor offering a pre-
scription drug plan shall furnish to each enrollee at 
the time of each annual coordinated election period 
(referred to in section 1860D–1(b)(1)(B)(iii)) for a 
plan year a notice of any changes in the formulary 
or other restrictions or limitations on coverage of a 
covered part D drug under the plan that will take 
effect for the plan year.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1) shall apply to annual coordinated 
election periods beginning after the date of the en-
actment of this Act. 
Æ 
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