Sec. 3307. IMPROVING FORMULARY REQUIREMENTS FOR PRESCRIPTION DRUG PLANS AND MA–PD PLANS WITH RESPECT TO CERTAIN CATEGORIES OR CLASSES OF DRUGS

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## SEC. 3307 IMPROVING FORMULARY REQUIREMENTS FOR PRESCRIPTION DRUG PLANS AND MA–PD PLANS WITH RESPECT TO CERTAIN CATEGORIES OR CLASSES OF DRUGS ###

(a)Improving Formulary Requirements Section 1860D–4(b)(3)(G) of the Social Security Act is amended to read as follows: > > ##### “(G) Required inclusion of drugs in certain categories and classes > > > ###### “(i) Formulary requirements > > > ###### “(I) In general > > Subject to subclause (II), a PDP sponsor offering a prescription drug plan shall be required to include all covered part D drugs in the categories and classes identified by the Secretary under clause (ii)(I). > > > ###### “(II) Exceptions > > The Secretary may establish exceptions that permit a PDP sponsor offering a prescription drug plan to exclude from its formulary a particular covered part D drug in a category or class that is otherwise required to be included in the formulary under subclause

(I)(or to otherwise limit access to such a drug, including through prior authorization or utilization management). > > > ###### “(ii) Identification of drugs in certain categories and classes > > > ###### “(I) In general > > Subject to clause (iv), the Secretary shall identify, as appropriate, categories and classes of drugs for which the Secretary determines are of clinical concern. > > > ###### “(II) Criteria > > The Secretary shall use criteria established by the Secretary in making any determination under subclause (I). > > > ###### “(iii) Implementation > > The Secretary shall establish the criteria under clause (ii)(II) and any exceptions under clause (i)(II) through the promulgation of a regulation which includes a public notice and comment period. > > > ###### “(iv) Requirement for certain categories and classes until criteria established > > Until such time as the Secretary establishes the criteria under clause (ii)(II) the following categories and classes of drugs shall be identified under clause (ii)(I): > > > ###### “(I) > > Anticonvulsants. > > > ###### “(II) > > Antidepressants. > > > ###### “(III) > > Antineoplastics. > > > ###### “(IV) > > Antipsychotics. > > > ###### “(V) > > Antiretrovirals. > > > ###### “(VI) > > Immunosuppressants for the treatment of transplant rejection.” > . ###

(b)Effective Date **[**[42 U.S.C. 1395w–104 note](/us/usc/t42/s1395w–104)**]** The amendments made by this section shall apply to plan year 2011 and subsequent plan years.

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42 USC 1395w–104

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Sec. 3307

IMPROVING FORMULARY REQUIREMENTS FOR PRESCRIPTION DRUG PLANS AND MA–PD PLANS WITH RESPECT TO CERTAIN CATEGORIES OR CLASSES OF DRUGS

Cite42 USC 1395w–104

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