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dmprograms.com • Medication Therapy Management Program • Other Statutory Provisions

Medication Therapy Management Program

Multiple Source Drugs Defined

This provision is referenced in Section 1860D-4(c)(1)(A).

Social Security Act
Sec. 1927 (k) DEFINITIONS —In the section—

(7) MULTIPLE SOURCE DRUG; INNOVATOR MULTIPLE SOURCE DRUG; NONINNOVATOR MULTIPLE SOURCE DRUG; SINGLE SOURCE DRUG. —

(A) Defined.—

(i) MULTIPLE SOURCE DRUG. —The term “multiple source drug” means, with respect to a rebate period, a covered outpatient drug (not including any drug described in paragraph (5)) for which there are 2 or more drug products which—

(I) are rated as therapeutically equivalent (under the Food and Drug Administration’s most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”),

(II) except as provided in subparagraph (B), are pharmaceutically equivalent and bioequivalent, as defined in subparagraph (C) and as determined by the Food and Drug Administration, and

(III) are sold or marketed in the State during the period.

Provisions of Disclosure

This provision is referenced in Section 1860D-4(c)(2)(E).

Social Security Act
Sec. 1927 (b) TERMS OF REBATE AGREEMENT —

(3) Manufacturer provision of price information. —

(D) CONFIDENTIALITY OF INFORMATION. — Notwithstanding any other provision of law, information disclosed by manufacturers or wholesalers under this paragraph or under an agreement with the Secretary of Veterans Affairs described in subsection (a)(6)(A)(ii) is confidential and shall not be disclosed by the Secretary or the Secretary of Veterans Affairs or a State agency (or contractor therewith) in a form which discloses the identity of a specific manufacturer or wholesaler, prices charged for drugs by such manufacturer or wholesaler, except—

(i) as the Secretary determines to be necessary to carry out this section,

(ii) to permit the Comptroller General to review the information provided, and

(iii) to permit the Director of the Congressional Budget Office to review the information provided.

Coordination With Care Management Plans

Section 1807, which is referenced in 1860D-4(c)(2)(D), is reproduced at MMA Statutory Language: Section 721.