Sec. 201. Inclusion of value of coupons in determination of average sales price for drugs and biologicals under Medicare part B
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Section 1847A(c) of the Social Security Act (42 U.S.C. 1395w–3a(c)) is amended— in paragraph (3)— by striking and inserting discounts .—In calculating discounts to purchasers and coupons provided to privately insured individuals .— In calculating ; and by adding at the end the following new subparagraph: For calendar quarters beginning on or after July 1, 2024, in calculating the manufacturer's average sales price under this subsection, such price shall include the value (as defined in paragraph (6)(J)) of any coupons provided under a drug coupon program of a manufacturer (as those terms are defined in subparagraphs
(K)and (L), respectively, of paragraph (6)). ; and in paragraph (6), by adding at the end the following new subparagraphs: The term value means, with respect to a coupon (as defined in subparagraph (K)), the difference, if any, between— the amount of any reduction or elimination of cost-sharing or other out-of-pocket costs described in such subparagraph to a patient as a result of the use of such coupon; and any charge to the patient for the use of such coupon. The term coupon means any financial support that is provided to a patient, either directly to the patient or indirectly to the patient through a physician, prescriber, pharmacy, or other provider, under a drug coupon program of a manufacturer (as defined in subparagraph (L)) that is used to reduce or eliminate cost-sharing or other out-of-pocket costs of the patient, including costs related to a deductible, coinsurance, or copayment, with respect to a drug or biological, including a biosimilar biological product, of the manufacturer. Subject to clause (ii), the term drug coupon program means, with respect to a manufacturer, a program through which the manufacturer provides coupons to patients as described in subparagraph (K). Such term does not include— a patient assistance program operated by a manufacturer that provides free or discounted drugs or biologicals, including biosimilar biological products, (through in-kind donations) to patients of low income; or a contribution by a manufacturer to a nonprofit or Foundation that provides free or discounted drugs or biologicals, including biosimilar biological products, (through in-kind donations) to patients of low income. .
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- 42 USC 1395w–3a(c)
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Sec. 201
Inclusion of value of coupons in determination of average sales price for drugs and biologicals under Medicare part B
Cite42 USC 1395w–3a(c)
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