[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3061 Introduced in House (IH)]







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, reconsiderations, and appeals.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 17, 2007

  Mr. Doggett (for himself, Mr. Abercrombie, Mr. Allen, Mr. Davis of 
 Illinois, Mr. Emanuel, Mr. Engel, Mr. Al Green of Texas, Mr. Hinchey, 
 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 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 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, reconsiderations, and appeals.

    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 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 Categories.--
            (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 
                        following therapeutic categories of covered 
                        part D drugs:
                                    ``(I) Immunosuppresessants.
                                    ``(II) Antidepressants.
                                    ``(III) Antipsychotics.
                                    ``(IV) Anticonvulsants.
                                    ``(V) Antiretrovials.
                                    ``(VI) Antineoplastics.
                            ``(ii) Coverage of all unique dosage 
                        forms.--To meet the requirement under clause 
                        (i), the formulary must include 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
                                    ``(IV) dosage forms that do not 
                                provide a unique route of 
                                administration, such as tablets and 
                                capsules.
                            ``(iii) Application to new fda-approved 
                        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 
                        previous sentence shall be construed as 
                        preventing a pharmacy and therapeutic committee 
                        from advising a PDP sponsor of a prescription 
                        drug plan on the clinical appropriateness 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 included on the formulary.
                            ``(v) Rules of construction.--
                                    ``(I) Issuance of guidance or 
                                regulations to establish formulary or 
                                utilization management 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 
                                including any additional therapeutic 
                                category 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.
    (b) Special Requirements for Coverage Determinations, 
Reconsiderations, and Appeals for Drugs Included in Specified 
Therapeutic Categories.--
            (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 
        independent review entity.--With respect to a part D eligible 
        individual enrolled in a prescription drug plan, in the case of 
        a determination under this subsection 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 request 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.
            ``(4) Required coverage of drugs included in specified 
        therapeutic categories during determinations, reconsiderations, 
        and appeals.--If a part D eligible individual enrolled in a 
        prescription drug plan offered by a PDP sponsor requests a 
        redetermination or reconsideration under this subsection (or an 
        appeal under subsection (h)) with respect to an utilization 
        management requirement or denial of coverage (in whole or in 
        part) of a drug in a category specified in subsection 
        (b)(3)(G)(i), such sponsor shall provide such individual with 
        coverage of such drug as prescribed during the pendency of such 
        redetermination, reconsideration, or appeal until 60 days after 
        the date of receipt of a written notification of--
                    ``(A) in the case that the individual does not 
                request a reconsideration or appeal, the determination 
                on such redetermination;
                    ``(B) in the case that the individual requests a 
                reconsideration but not an appeal, the determination on 
                such reconsideration; or
                    ``(C) in the case that the individual requests an 
                appeal, the determination on such appeal or the 
                dismissal of the appeal;
        except that in no case shall such coverage end before the end 
        of the period in which an individual may file an appeal with 
        respect to the determination involved.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall apply to requests for redeterminations, reconsiderations, 
        and appeal hearings made on or after the effective date 
        described in subsection (a)(2).
    (c) Reporting Requirements for Drugs Included in Specified 
Therapeutic Categories.--
            (1) In general.--Section 1860D-4(b) of the Social Security 
        Act (42 U.S.C. 1395w-104(b)) is amended by adding at the end 
        the following new paragraph:
            ``(4) Reporting requirements for drugs included in 
        specified therapeutic categories.--
                    ``(A) Reports by pdp sponsors.--A PDP sponsor 
                offering a prescription drug plan shall submit to the 
                Secretary (in a form and manner specified by the 
                Secretary), with respect to drugs in a category of 
                covered part D drugs specified in subsection 
                (b)(3)(G)(i), information on the number of favorable 
                and unfavorable decisions under the plan relating to 
                coverage determinations, redeterminations, 
                reconsiderations, appeals, and enrollee requests for 
                exceptions to formulary policies for such drugs.
                    ``(B) Report to congress.--The Secretary shall 
                submit an annual report to Congress summarizing the 
                information submitted under subparagraph (A) and shall 
                publish each report in the Federal Register.''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall apply to prescription drug plans and MA plans for plan 
        years beginning on or after the effective date described in 
        subsection (a)(2).
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