II 

109TH CONGRESS 

2D SESSION S. 2255 

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 SENATE OF THE UNITED STATES 

FEBRUARY 8, 2006 

Mrs. FEINSTEIN (for herself, Ms. COLLINS, Mr. DORGAN, Ms. SNOWE, Mr. 

BINGAMAN, Mr. CHAFEE, Mrs. CLINTON, Mr. SCHUMER, Mrs. MURRAY, 

and Mrs. BOXER) introduced the following bill; which was read twice and 

referred to the Committee on Finance 

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. 

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’’. 
2 

•S 2255 IS

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

2 PRESCRIPTION DRUG PLAN FORMULARY. 

3 (a) LIMITATION ON REMOVAL OR CHANGE OF COV4 ERED PART D DRUGS FROM THE PRESCRIPTION DRUG

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

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

7 amended to read as follows: 

8 ‘‘(E) REMOVING A DRUG FROM FOR9 MULARY OR IMPOSING A RESTRICTION OR LIMI10 TATION ON COVERAGE.— 

11 ‘‘(i) LIMITATION ON REMOVAL, LIMI12 TATION, OR RESTRICTION.— 

13 ‘‘(I) IN GENERAL.—Subject to 

14 subclause (II) and clause (ii), begin15 ning with 2006, the PDP sponsor of 

16 a prescription drug plan may not re17 move a covered part D drug from the 

18 plan formulary or impose a restriction 

19 or limitation on the coverage of such 

20 a drug (such as through the applica21 tion of a preferred status, usage re22 striction, step therapy, prior author23 ization, or quantity limitation) other 

24 than at the beginning of each plan 

25 year except as the Secretary may per26 mit to take into account new thera-
3 

•S 2255 IS

1 peutic uses and newly covered part D 

2 drugs. 

3 ‘‘(II) SPECIAL RULE FOR NEWLY

4 ENROLLED INDIVIDUALS.—Subject to 

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

6 who enrolls in a prescription drug 

7 plan on or after the date of enactment 

8 of this subparagraph, the PDP spon9 sor of such plan may not remove a 

10 covered part D drug from the plan 

11 formulary or impose a restriction or 

12 limitation on the coverage of such a 

13 drug (such as through the application 

14 of a preferred status, usage restric15 tion, step therapy, prior authorization, 

16 or quantity limitation) during the pe17 riod beginning on the date of such en18 rollment and ending on December 31 

19 of the immediately succeeding plan 

20 year except as the Secretary may per21 mit to take into account new thera22 peutic uses and newly covered part D 

23 drugs. 
4 

•S 2255 IS

1 ‘‘(ii) EXCEPTIONS TO LIMITATION ON

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

3 respect to a covered part D drug that— 

4 ‘‘(I) is a brand name drug for 

5 which there is a generic drug ap6 proved under section 505(j) of the 

7 Food and Drug Cosmetic Act (21 

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

9 market during the period in which 

10 there are limitations on removal or 

11 change in the formulary under sub12 clause (I) or (II) of clause (i); 

13 ‘‘(II) is a brand name drug that 

14 goes off-patent during such period; 

15 ‘‘(III) is a drug for which the 

16 Commissioner of Food and Drugs 

17 issues a clinical warning that imposes 

18 a restriction or limitation on the drug 

19 during such period; or 

20 ‘‘(IV) has been determined to be 

21 ineffective during such period. 

22 ‘‘(iii) NOTICE OF REMOVAL UNDER

23 APPLICATION OF EXCEPTION TO LIMITA24 TION.—The PDP sponsor of a prescription 

25 drug plan shall provide appropriate notice 
5 

•S 2255 IS

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

2 removal or change under clause (ii) to the 

3 Secretary, affected enrollees, physicians, 

4 pharmacies, and pharmacists.’’. 

5 (b) NOTICE FOR CHANGE IN FORMULARY AND

6 OTHER RESTRICTIONS OR LIMITATIONS ON COVERAGE.— 

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

8 Act (42 U.S.C. 1395w–104(a)) is amended by add9 ing at the end the following new paragraph: 

10 ‘‘(5) ANNUAL NOTICE OF CHANGES IN FOR11 MULARY AND OTHER RESTRICTIONS OR LIMITATIONS

12 ON COVERAGE.—Each PDP sponsor offering a pre13 scription drug plan shall furnish to each enrollee at 

14 the time of each annual coordinated election period 

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

16 plan year a notice of any changes in the formulary 

17 or other restrictions or limitations on coverage of a 

18 covered part D drug under the plan that will take 

19 effect for the plan year.’’. 

20 (2) EFFECTIVE DATE.—The amendment made 

21 by paragraph (1) shall apply to annual coordinated 

22 election periods beginning after the date of the en23 actment of this Act. 

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