[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5102 Introduced in House (IH)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Drug Formulary Protection 
Act''.

SEC. 2. REMOVAL OF COVERED PART D DRUGS FROM THE PRESCRIPTION DRUG PLAN 
              FORMULARY.

    (a) Limitation on Removal or Change of Covered 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 formulary or imposing a 
                restriction or limitation on coverage.--
                            ``(i) Limitation on removal, limitation, or 
                        restriction.--
                                    ``(I) In general.--Subject to 
                                subclause (II) and clause (ii), 
                                beginning with 2006, the PDP sponsor of 
                                a prescription drug 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 
                                restriction, step therapy, prior 
                                authorization, or quantity limitation) 
                                other than at the beginning of each 
                                plan year except as the Secretary may 
                                permit to take into account new 
                                therapeutic 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 enactment of the Medicare 
                                Drug Formulary Protection Act, the PDP 
                                sponsor 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 
                                restriction, step therapy, prior 
                                authorization, or quantity limitation) 
                                during the period beginning on the date 
                                of such enrollment and ending on 
                                December 31 of the immediately 
                                succeeding plan year except as the 
                                Secretary may permit to take into 
                                account new therapeutic 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 approved 
                                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 subclause (I) or (II) of clause 
                                (i) if such generic drug is included in 
                                the formulary without any restriction 
                                or limitation 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 application of this subclause;
                                    ``(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 
                                appropriate pharmacy and therapeutic 
                                committee determines, based on evidence 
                                from peer-reviewed research, to be 
                                unsafe or ineffective during such 
                                period; or
                                    ``(VI) is any other drug that 
                                satisfies any other requirement 
                                determined appropriate by the 
                                Secretary.
                            ``(iii) Notice of removal under application 
                        of exception to limitation.--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 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 adding at the end the following new 
        paragraph:
            ``(5) Annual notice of changes in formulary and other 
        restrictions or limitations on coverage.--Each PDP sponsor 
        offering a prescription 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 enactment of this Act.
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