SEC. 401. DRUG PRICE TRANSPARENCY. Part A of title XI of the Social Security Act is amended by adding at the end the following new sections:
“SEC. 1150D. REPORTING ON DRUG PRICES.
“(a) Definitions.—In this section:
“(1) MANUFACTURER.—The term ‘manufacturer’ means the person—
“(A) that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act; or
“(B) who is responsible for setting the wholesale acquisition cost for the drug.
“(2) QUALIFYING DRUG.—The term ‘qualifying drug’ means any drug that is approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under subsection (a) or (k) of section 351 of the Public Health Service Act—
“(A) that has a wholesale acquisition cost of $100 or more, adjusted for inflation occurring after the date of enactment of this section, for a month’s supply or a typical course of treatment that lasts less than a month, and is—
“(i) subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act; and
“(ii) not a preventative vaccine; and
“(B) for which, during the previous calendar year, at least 1 dollar of the total amount of sales were for individuals enrolled under the Medicare program under title XVIII or under a State Medicaid plan under title XIX or under a waiver of such plan.
“(3) WHOLESALE ACQUISITION COST.—The term ‘wholesale acquisition cost’ has the meaning given that term in section 1847A(c)(6)(B).
“(b) Report.—
“(1) REPORT REQUIRED.—The manufacturer of a qualifying drug shall submit a report to the Secretary if, with respect to the qualifying drug—
“(A) there is an increase in the price of the qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to—
“(i) 10 percent or more within a 12-month period beginning on or after January 1, 2021; or
“(ii) 25 percent or more within a 36-month period beginning on or after January 1, 2021;
“(B) the estimated price of the qualifying drug or spending per individual or per user of such drug (as estimated by the Secretary) for the applicable year (or per course of treatment in such applicable year as determined by the Secretary) is at least $26,000 beginning on or after January 1, 2023; or
“(C) there was an increase in the price of the qualifying drug that resulted in an increase in the wholesale acquisition cost of that drug that is equal to—
“(i) 10 percent or more within a 12-month period that begins and ends during the 5-year period preceding January 1, 2023; or
“(ii) 25 percent or more within a 36-month period that begins and ends during the 5-year period preceding January 1, 2023.
“(2) REPORT DEADLINE.—Each report described in paragraph (1) shall be submitted to the Secretary—
“(A) in the case of a report with respect to an increase in the price of a qualifying drug that occurs during the period beginning on January 1, 2021, and ending on the day that is 60 days after the date of the enactment of this section, not later than 90 days after such date of enactment;
“(B) in the case of a report with respect to an increase in the price of a qualifying drug that occurs after the period described in subparagraph (A), not later than 30 days prior to the planned effective date of such price increase for such qualifying drug;
“(C) in the case of a report with respect to a qualifying drug that meets the criteria under paragraph (1)(B), not later than 30 days after such drug meets such criteria; and
“(D) in the case of a report with respect to an increase in the price of a qualifying drug that occurs during a 12-month or 36-month period described in paragraph (1)(C), not later than April 1, 2023.
“(c) Contents.—A report under subsection (b), consistent with the standard for disclosures described in section 213.3(d) of title 12, Code of Federal Regulations (as in effect on the date of enactment of this section), shall, at a minimum, include—
“(1) with respect to the qualifying drug—
“(A) the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug within the 12-month period or 36-month period as described in subsection (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or (b)(1)(C)(ii), as applicable, and the effective date of such price increase or the cost associated with a qualifying drug if such drug meets the criteria under subsection (b)(1)(B) and the effective date at which such drug meets such criteria;