; or (ii) that— (I) is described in section 506C(a) of such Act; (II) was listed on the drug shortage list maintained by the Food and Drug Administration pursuant to section 506E of such Act within the preceding 5 years; and (III) for which the total manufacturing capacity of all manufacturers with an approved application for such drug or biological that is currently marketed or total number of manufacturers with an approved application for such drug or biological that is currently marketed declines during a 6-month period, as determined by the Secretary. (C) Provision of additional information For each quarter in which the amount of payment for a drug or biological described in subparagraph (B) pursuant to subparagraph (A) exceeds the amount of payment for the drug or biological otherwise applicable under this section, each manufacturer of such drug or biological shall provide to the Secretary information related to the potential cause or causes of the shortage and the expected duration of the shortage with respect to such drug. . (b) Tracking shortage drugs through claims The Secretary of Health and Human Services (referred to in this section as the Secretary ) shall establish a mechanism (such as a modifier) for purposes of tracking utilization under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.) of drugs and biologicals listed on the drug shortage list maintained by the Food and Drug Administration pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ). (c) HHS report and recommendations (1) In general Not later than July 1, 2021, the Secretary shall submit to Congress a report on shortages of drugs within the Medicare program under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq.). The report shall include— (A) an analysis of— (i) the effect of drug shortages on Medicare beneficiary access, quality, safety, and out-of-pocket costs