Section 3307

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- The amendments made by this section shall apply to plan year 2011 and subsequent plan years.