Medicare Improvements for Patients and Providers Act of 2008/Title I/Subtitle E/Part II

PART II — OTHER PROVISIONS

Sec. 175. Inclusion of Barbiturates and Benzodiazepines as Covered PART D Drugs.

(a) In General.—

Section 1860D–2(e)(2)(A) of the Social Security Act (42 U.S.C. 1395w–102(e)(2)(A)) is amended by inserting after ``agents),´´ the following ``other than subparagraph (I) of such section (relating to barbiturates) if the barbiturate is used in the treatment of epilepsy, cancer, or a chronic mental health disorder, and other than subparagraph (J) of such section (relating to benzodiazepines),´´.

(b) Effective Date.—

The amendments made by subsection (a) shall apply to prescriptions dispensed on or after January 1, 2013.

Sec. 176. Formulary Requirements with Respect to Certain Categories or Classes of Drugs.

Section 1860D–4(b)(3) of the Social Security Act (42 U.S.C. 1395w–104(b)(3)) is amended—

(1) in subparagraph (C)(i), by striking ``The formulary´´ and inserting ``Subject to subparagraph (G), the formulary´´; and

(2) by inserting after subparagraph (F) the following new subparagraph:

``(G) Required inclusion of drugs in certain categories and classes.—

``(i) Identification of drugs in certain categories and classes.—Beginning with plan year 2010, the Secretary shall identify, as appropriate, categories and classes of drugs for which both of the following criteria are met:

``(I) Restricted access to drugs in the category or class would have major or life threatening clinical consequences for individuals who have a disease or disorder treated by the drugs in such category or class.

``(II) There is significant clinical need for such individuals to have access to multiple drugs within a category or class due to unique chemical actions and pharmacological effects of the drugs within the category or class, such as drugs used in the treatment of cancer.

``(ii) Formulary requirements.—Subject to clause (iii), PDP sponsors offering prescription drug plans shall be required to include all covered part D drugs in the categories and classes identified by the Secretary under clause (i).

``(iii) Exceptions.—The Secretary may establish exceptions that permits a PDP sponsor of 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 clause (ii) (or to otherwise limit access to such a drug, including through prior authorization or utilization management). Any exceptions established under the preceding sentence shall be provided under a process that—

``(I) ensures that any exception to such requirement is based upon scientific evidence and medical standards of practice (and, in the case of antiretroviral medications, is consistent with the Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents); and

``(II) includes a public notice and comment period.´´.