As used in this part, the following definitions apply:

Annual manufacturer price (AnMP) means the amount determined under § 428.202(b).

Applicable period means a 12-month period beginning with October 1 of a year (beginning with October 1, 2022).

Applicable period Consumer Price Index for All Urban Consumers (CPI-U) means, with respect to an applicable period, the CPI-U for the first month of such applicable period (that is, October).

Applicable threshold means the amount determined under § 428.101(b)(2).

Average manufacturer price (AMP) means the average price paid to the manufacturer for the drug by wholesalers for drugs distributed to retail community pharmacies and retail community pharmacies that purchase drugs directly from the manufacturer, determined under § 447.504 of this chapter.

Benchmark period CPI-U means the CPI-U identified as set forth in § 428.202(e).

Benchmark period manufacturer price means the amount determined under § 428.202(d).

Covered Part D Drug has the meaning set forth in section 1860D-2(e) of the Act and § 423.100 of this chapter.

CPI-U means the monthly Consumer Price Index for All Urban Consumers (United States city average) index level for all items from the Bureau of Labor Statistics.

First marketed date means the date that a manufacturer is required to report for a Part D rebatable drug as its “market date” under section 1927(b)(3)(A)(v) of the Act.

Inflation-adjusted payment amount means the amount determined under § 428.202(f).

Manufacturer has the meaning set forth in section 1927(k)(5) of the Act.

National Drug Code (NDC) means the unique identifying prescription drug product number that is listed with FDA identifying the product.

Part D rebatable drug means, subject to the exclusion set forth in § 428.101(b), a drug or biological that is a covered Part D drug that, as of the first day of the applicable period, is:

1. (1) A drug approved under a New Drug Application (NDA) under section 505(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act;

2. (2) A generic drug approved under an Abbreviated New Drug Application (ANDA) under section 505(j) of the FD&C Act (“section 505(j) ANDA”), in the case where:

   1. (i) The reference listed drug approved under an NDA under section 505(c) of the FD&C Act, including any authorized generic drug as defined in section 505(t)(3) of the FD&C Act, is not being marketed, as identified in the Food and Drug Administration's (FDA) NDC Directory;
   2. (ii) There is no other drug approved under section 505(j) of the FD&C Act that is rated as therapeutically equivalent in FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book), and that is being marketed, as identified in FDA's NDC Directory;
   3. (iii) The manufacturer is not a “first applicant” during the “180-day exclusivity period,” as those terms are defined in section 505(j)(5)(B)(iv) of the FD&C Act; and
   4. (iv) The manufacturer is not a “first approved applicant” for a competitive generic therapy, as that term is defined in section 505(j)(5)(B)(v) of the FD&C Act; or
3. (3) A biological licensed under section 351 of the Public Health Service (PHS) Act, including a biosimilar.

Payment amount benchmark period means the period identified as set forth in § 428.202(c).

Subsequently approved drug means a Part D rebatable drug first approved or licensed by the FDA after October 1, 2021.

Unit means, with respect to a Part D rebatable drug, the lowest dispensable amount (such as a capsule or tablet, milligram of molecules, or grams) of the Part D rebatable drug, as reported under section 1927 of the Act.