medically accepted indication
Defined in 2 places of the United States Code.
For purposes of paragraph (1), the term “medically accepted indication” has the meaning given that term—
(i) in the case of a covered part D drug used in an anticancer chemotherapeutic regimen, in section 1395x(t)(2)(B) of this title, except that in applying such section—
(I) “prescription drug plan or MA–PD plan” shall be substituted for “carrier” each place it appears; and
(II) subject to subparagraph (B), the compendia described in section 1396r–8(g)(1)(B)(i)(III) of this title shall be included in the list of compendia described in clause (ii)(I) section 1395x(t)(2)(B) of this title; and
(ii) in the case of any other covered part D drug, in section 1396r–8(k)(6) of this title.
Source
- 2008–present42 U.S.C. § 1395WThe Public Health and Welfare · Prescription drug benefits · in this section
The term “medically accepted indication” means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i).
Source
- 2016–present42 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter
The term “medically accepted indication” means any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the use of which is supported by one or more citations included or approved for inclusion in any of the compendia described in subsection (g)(1)(B)(i) of this section.
Source
- 1994–201642 U.S.C. § 1396RThe Public Health and Welfare · Payment for covered outpatient drugs · under this subchapter