SPECIAL RULE FOR DETERMINATION OF ASP IN CASES OF CERTAIN NONCOVERED SELF-ADMINISTERED DRUG PRODUCTS.

SEC. 405. SPECIAL RULE FOR DETERMINATION OF ASP IN CASES OF CERTAIN NONCOVERED SELF-ADMINISTERED DRUG PRODUCTS. Section 1847A of the Social Security Act (42 U.S.C. 1395w-3a) is amended by redesignating subsection (g) as subsection (h) and by inserting after subsection (f) the following: “(g) Payment Adjustment for Certain Drugs for Which There Is a Self-administered NDC.— “(1) OIG studies.—The Inspector General of the Department of Health and Human Services shall conduct periodic studies to identify National Drug Codes for drug or biological products that are self-administered for which payment may not be made under this part because such products are not covered pursuant to section 1861(s)(2) and which the Inspector General determines (based on the same or similar methodologies to the methodologies used in the final recommendation followup report of the Inspector General described in paragraph (3) or in the November 2017 final report of the Inspector General entitled ‘Excluding Noncovered Versions When Setting Payment for Two Part B Drugs Would Have Resulted in Lower Drug Costs for Medicare and its Beneficiaries’) should be excluded from the determination of the payment amount under this section. “(2) Payment adjustment.—If the Inspector General identifies a National Drug Code for a drug or biological product under paragraph (1), the Inspector General shall inform the Secretary (at such times as the Secretary may specify to carry out this paragraph) and the Secretary shall, to the extent the Secretary deems appropriate, apply as the amount of payment under this section for the applicable billing and payment code the lesser of— “(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such product so identified under paragraph (1) were excluded from such determination; or “(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection. “(3) Application to certain identified products.—In the case of a National Drug Code for a drug or biological product that is self-administered for which payment is not made under this part because such product is not covered pursuant to section 1861(s)(2) that was identified by the Inspector General of the Department of Health and Human Services in the final recommendation followup report of the Inspector General published July 2020, entitled Loophole in Drug Payment Rule Continues To Cost Medicare and Beneficiaries Hundreds of Millions of Dollars, beginning July 1, 2021, the amount of payment under this section for the applicable billing and payment code shall be the lesser of— “(A) the amount of payment that would be determined under this section for such billing and payment code if such National Drug Code for such drug or biological products so identified were excluded from such determination; or “(B) the amount of payment otherwise determined under this section for such billing and payment code without application of this subsection.” .