; or (II) that was listed on such drug and biological shortage list within the preceding 5 years and for which the manufacturing capacity of manufacturers with an approved application for such drug or biological, or the number of manufacturers with an approved application for such drug or biological, 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, the 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 length of the shortage with respect to such drug. . (b) Additional payment under IPPS Section 1886(d)(5) of the Social Security Act ( 42 U.S.C. 1395ww(d)(5) ) is amended by adding at the end the following new subparagraph: (N) The Secretary shall establish a modifier or other mechanism for purposes of tracking utilization of drugs on the shortage list pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act, and update the modifier to reflect the drugs on such list each calendar year. . (c) GAO study on drug shortages Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall— (1) conduct a study on— (A) drugs and biologicals for which payment is made under the inpatient prospective payment system (IPPS) under section 1886 of the Social Security Act ( 42 U.S.C. 1395ww ) and the hospital outpatient prospective payment system (OPPS) under section 1833(t) of the Social Security Act ( 42 U.S.C. 1395l(t) ) that have been on the shortage list under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e(c)(2) ) in the last 5 years