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. CONYERS, 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. MARSHALL, 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 provisions 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 individual has enrolled in the plan. 


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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Drug For5 mulary Protection Act’’. 

6 SEC. 2. REMOVAL OF COVERED PART D DRUGS FROM THE 

7 PRESCRIPTION DRUG PLAN FORMULARY. 

8 (a) LIMITATION ON REMOVAL OR CHANGE OF COV9 ERED PART D DRUGS FROM THE PRESCRIPTION DRUG

10 PLAN FORMULARY.—Section 1860D–4(b)(3)(E) of the 

11 Social Security Act (42 U.S.C. 1395w–104(b)(3)(E)) is 

12 amended to read as follows: 

13 ‘‘(E) REMOVING A DRUG FROM FOR14 MULARY OR IMPOSING A RESTRICTION OR LIMI15 TATION ON COVERAGE.— 

16 ‘‘(i) LIMITATION ON REMOVAL, LIMI17 TATION, OR RESTRICTION.— 

18 ‘‘(I) IN GENERAL.—Subject to 

19 subclause (II) and clause (ii), begin20 ning with 2006, the PDP sponsor of 

21 a prescription drug plan may not re22 move a covered part D drug from the 

23 plan formulary or impose a restriction 

24 or limitation on the coverage of such 

25 a drug (such as through the applicaVerDate Aug 31 2005 23:48 Apr 07, 2006 Jkt 049196 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5102.IH H5102

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1 tion of a preferred status, usage re2 striction, step therapy, prior author3 ization, or quantity limitation) other 

4 than at the beginning of each plan 

5 year except as the Secretary may per6 mit to take into account new thera7 peutic uses and newly covered part D 

8 drugs. 

9 ‘‘(II) SPECIAL RULE FOR NEWLY

10 ENROLLED INDIVIDUALS.—Subject to 

11 clause (ii), in the case of an individual 

12 who enrolls in a prescription drug 

13 plan on or after the date of the enact14 ment of the Medicare Drug For15 mulary Protection Act, the PDP spon16 sor of such plan may not remove a 

17 covered part D drug from the plan 

18 formulary or impose a restriction or 

19 limitation on the coverage of such a 

20 drug (such as through the application 

21 of a preferred status, usage restric22 tion, step therapy, prior authorization, 

23 or quantity limitation) during the pe24 riod beginning on the date of such en25 rollment and ending on December 31 


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1 of the immediately succeeding plan 

2 year except as the Secretary may per3 mit to take into account new thera4 peutic uses and newly covered part D 

5 drugs. 

6 ‘‘(ii) EXCEPTIONS TO LIMITATION ON

7 REMOVAL.—Clause (i) shall not apply with 

8 respect to a covered part D drug that— 

9 ‘‘(I) is a brand name drug for 

10 which there is a generic drug ap11 proved under section 505(j) of the 

12 Food and Drug Cosmetic Act (21 

13 U.S.C. 355(j)) that is placed on the 

14 market during the period in which 

15 there are limitations on removal or 

16 change in the formulary under sub17 clause (I) or (II) of clause (i) if such 

18 generic drug is included in the for19 mulary without any restriction or limi20 tation placed on the coverage of such 

21 generic drug other than a restriction 

22 or limitation that would be placed on 

23 the coverage of the brand name drug 

24 during such period without the appli25 cation of this subclause; 


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1 ‘‘(II) is a brand name drug that 

2 goes off-patent during such period; 

3 ‘‘(III) is a drug for which the 

4 Commissioner of Food and Drugs 

5 issues a clinical warning that imposes 

6 a restriction or limitation on the drug 

7 during such period; 

8 ‘‘(IV) has been determined to be 

9 ineffective during such period; 

10 ‘‘(V) is a drug that the appro11 priate pharmacy and therapeutic com12 mittee determines, based on evidence 

13 from peer-reviewed research, to be un14 safe or ineffective during such period; 

15 or 

16 ‘‘(VI) is any other drug that sat17 isfies any other requirement deter18 mined appropriate by the Secretary. 

19 ‘‘(iii) NOTICE OF REMOVAL UNDER

20 APPLICATION OF EXCEPTION TO LIMITA21 TION.—The PDP sponsor of a prescription 

22 drug plan shall provide appropriate notice 

23 (such as under subsection (a)(3)) of any 

24 removal or change under clause (ii) to the 


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1 Secretary, affected enrollees, physicians, 

2 pharmacies, and pharmacists.’’. 

3 (b) NOTICE FOR CHANGE IN FORMULARY AND

4 OTHER RESTRICTIONS OR LIMITATIONS ON COVERAGE.— 

5 (1) IN GENERAL.—Section 1860D–4(a) of such 

6 Act (42 U.S.C. 1395w–104(a)) is amended by add7 ing at the end the following new paragraph: 

8 ‘‘(5) ANNUAL NOTICE OF CHANGES IN FOR9 MULARY AND OTHER RESTRICTIONS OR LIMITATIONS

10 ON COVERAGE.—Each PDP sponsor offering a pre11 scription drug plan shall furnish to each enrollee at 

12 the time of each annual coordinated election period 

13 (referred to in section 1860D–1(b)(1)(B)(iii)) for a 

14 plan year a notice of any changes in the formulary 

15 or other restrictions or limitations on coverage of a 

16 covered part D drug under the plan that will take 

17 effect for the plan year.’’. 

18 (2) EFFECTIVE DATE.—The amendment made 

19 by paragraph (1) shall apply to annual coordinated 

20 election periods beginning after the date of the en21 actment of this Act. 

Æ 


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