text: 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).
target: Medicare Part D Drug Class Protection Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require that Medicare prescription drug plans using formularies cover all drugs included in six specified therapeutic categories.
  
  Sets forth special requirements for reconsideration of coverage determinations, and appeals for drugs included in such categories.
  
  Establishes reporting requirements for drugs in these categories.
feat_title: 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.