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(1) In general
Except as provided in this subsection, for purposes of this part, the term “covered part D drug” means—
(A) a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r–8(k)(2) of this title ;
(B) a biological product described in clauses (i) through (iii) of subparagraph (B) of such section or insulin described in subparagraph (C) of such section and medical supplies associated with the injection of insulin (as defined in regulations of the Secretary); or
(C) for the period beginning on December 29, 2022 , and ending on December 31, 2026 , an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 360bbb–3 of title 21 , on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed. Reg. 18250 et seq.),
and such term includes a vaccine licensed under section 262 of this title (and, for vaccines administered on or after January 1, 2008 , its administration) and any use of a covered part D drug for a medically accepted indication (as defined in paragraph (4)).
a drug that may be dispensed only upon a prescription and that is described in subparagraph (A)(i), (A)(ii), or (A)(iii) of section 1396r–8(k)(2) of this title ;
a biological product described in clauses (i) through (iii) of subparagraph (B) of such section or insulin described in subparagraph (C) of such section and medical supplies associated with the injection of insulin (as defined in regulations of the Secretary); or
for the period beginning on December 29, 2022 , and ending on December 31, 2026 , an oral antiviral drug that may be dispensed only upon a prescription and is authorized under section 360bbb–3 of title 21 , on the basis of the declaration published in the Federal Register by the Secretary of Health and Human Services on April 1, 2020 (85 Fed. Reg. 18250 et seq.),
(A) In general Such term does not include drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section 1396r–8(d)(2) of this title , other than subparagraph (E) of such section (relating to smoking cessation agents), 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), or under section 1396r–8(d)(3) of this title , as such sections were in effect on December 8, 2003 . Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.
(B) Medicare covered drugs A drug prescribed for a part D eligible individual that would otherwise be a covered part D drug under this part shall not be so considered if payment for such drug as so prescribed and dispensed or administered with respect to that individual is available (or would be available but for the application of a deductible) under part A or B for that individual.
Such term does not include drugs or classes of drugs, or their medical uses, which may be excluded from coverage or otherwise restricted under section 1396r–8(d)(2) of this title , other than subparagraph (E) of such section (relating to smoking cessation agents), 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), or under section 1396r–8(d)(3) of this title , as such sections were in effect on December 8, 2003 . Such term also does not include a drug when used for the treatment of sexual or erectile dysfunction, unless such drug were used to treat a condition, other than sexual or erectile dysfunction, for which the drug has been approved by the Food and Drug Administration.
A drug prescribed for a part D eligible individual that would otherwise be a covered part D drug under this part shall not be so considered if payment for such drug as so prescribed and dispensed or administered with respect to that individual is available (or would be available but for the application of a deductible) under part A or B for that individual.
A prescription drug plan or an MA–PD plan may exclude from qualified prescription drug coverage any covered part D drug—
(A) for which payment would not be made if section 1395y(a) of this title applied to this part; or
(B) which is not prescribed in accordance with the plan or this part.
Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of section 1395w–104 of this title .
for which payment would not be made if section 1395y(a) of this title applied to this part; or
which is not prescribed in accordance with the plan or this part.
(A) In general 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 .
(B) Conflict of interest On and after January 1, 2010 , subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1396r–8(g)(1)(B)(i)(III) of this title meets 3 3 So in original. Probably should be “meet”. the requirement in the third sentence of section 1395x(t)(2)(B) of this title .
(C) Update For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section 1396r–8(g)(1)(B)(i) of this title as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section 1395x(t)(2)(B) of this title .
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 .
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
“prescription drug plan or MA–PD plan” shall be substituted for “carrier” each place it appears; and
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
in the case of any other covered part D drug, in section 1396r–8(k)(6) of this title .
On and after January 1, 2010 , subparagraph (A)(i)(II) shall not apply unless the compendia described in section 1396r–8(g)(1)(B)(i)(III) of this title meets 3 3 So in original. Probably should be “meet”. the requirement in the third sentence of section 1395x(t)(2)(B) of this title .
For purposes of applying subparagraph (A)(ii), the Secretary shall revise the list of compendia described in section 1396r–8(g)(1)(B)(i) of this title as is appropriate for identifying medically accepted indications for drugs. Any such revision shall be done in a manner consistent with the process for revising compendia under section 1395x(t)(2)(B) of this title .