42 CFR 414.902 – Definitions
As used in this subpart, unless the context indicates otherwise—
Applicable five-year period means:
(1) For a qualifying biosimilar biological product for which payment has been made under section 1847A(b)(8) of the Act as of September 30, 2022, the 5-year period beginning on October 1, 2022; and
(2) For a qualifying biosimilar biological product for which payment is first made under section 1847A(b)(8) of the Act during a calendar quarter during the period beginning October 1, 2022 and ending December 31, 2027, the 5-year period beginning on the first day of such calendar quarter during which such payment is first made.
Approved CAP vendor means an entity that has been awarded a contract by CMS to participate in the competitive acquisition program under 1847B of the Act.
Bid means an offer to furnish a CAP drug within a category of CAP drugs in a competitive acquisition area for a particular price and time period.
Biosimilar biological product means a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 351 of the Public Health Service Act (PHSA) as defined at section 1847A(c)(6)(H) of the Act.
CAP drug means a physician-administered drug or biological furnished on or after January 1, 2006 described in section 1842(o)(1)(C) of the Act and supplied by an approved CAP vendor under the CAP as provided in this subpart.
Competitive acquisition area means a geographic area established by the Secretary for purposes of implementing the CAP required by section 1847B of the Act.
Competitive acquisition program (CAP) means a program as defined under section 1847B of the Act.
Designated carrier means an entity assigned by CMS to process and pay claims for drugs and biologicals under the CAP.
Drug means both drugs and biologicals.
Emergency delivery means delivery of a CAP drug within one business day in appropriate shipping and packaging, in all areas of the United States and its territories, with the exception of the Pacific Territories. In the Pacific Territories, emergency delivery means delivery of a CAP drug within 5 business days in appropriate shipping and packaging. In each case, this timeframe shall be reduced if product stability requires it, meaning that the manufacturer’s labeling instructions, drug compendia, or specialized drug stability references indicate that a shorter delivery timeframe is necessary to avoid adversely affecting the product’s integrity, safety, or efficacy.
Emergency situation means, for the purposes of the CAP, an unforeseen occurrence or situation determined by the participating CAP physician, in his or her clinical judgment, to require prompt action or attention for purposes of permitting the participating CAP physician to use a drug from his or her own stock, if the other requirements of § 414.906(e) are met.
Local carrier means an entity assigned by CMS to process and pay claims for administration of drugs and biologicals under the CAP.
Low volume dose means, with respect to determination of whether an increased applicable percentage is warranted, an FDA-labeled dose of a drug for which the volume removed from the vial or container containing the labeled dose does not exceed 0.4 mL.
Manufacturer’s average sales price means the price calculated and reported by a manufacturer under part 414, subpart J of this chapter.
Multiple source drug means a drug described by section 1847A(c)(6)(C) of the Act.
New refund quarter means a calendar quarter that is included in a report described in § 414.940(a) that is sent in the first year following the year in which the calendar quarter occurs.
Pacific Territories means, for purposes of the CAP, American Samoa, Guam, or the Northern Mariana Islands.
Participating CAP physician means a physician electing to participate in the CAP, as described in this subpart. The participating CAP physician must complete and sign the participating CAP physician election agreement. Physicians who do not participate in Medicare but who elect to participate in the CAP must agree to accept assignment for CAP drug administration claims.
Participating CAP physician election agreement means the agreement that the physician signs to notify CMS of the physician’s election to participate in the CAP and to agree to the terms and conditions of CAP participation as set forth in this subpart.
Prescription order means a written order submitted by the participating CAP physician to the approved CAP vendor that meets the requirements of this subpart.
Qualifying biosimilar biological product means a biosimilar biological product (as described in section 1847A(b)(1)(C) of the Act) with an average sales price (as described in section 1847A(b)(8)(A)(i) of the Act) less than the average sales price of the reference biological for a calendar quarter during the applicable 5-year period.
Reference biological product means the biological product licensed under such section 351 of the PHSA that is referred to in the application of the biosimilar biological product as defined at section 1847A(c)(6)(I) of the Act.
Refundable single-dose container or single-use package drug means a single source drug or biological or a biosimilar biological product for which payment is made under this part and that is furnished from a single-dose container or single-use package based on FDA-approved labeling or product information. The term “refundable single-dose container or single-use package drug” excludes—
(1) A drug that is a therapeutic radiopharmaceutical, a diagnostic radiopharmaceutical, or an imaging agent as identified in the drug’s FDA-approved labeling.
(2) A drug for which the FDA-approved labeling for any National Drug Code assigned to a billing and payment code of such drug requires filtration during the drug preparation process, prior to dilution and administration and that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process.
(3) A drug approved or licensed by the FDA on or after November 15, 2021, until the last day of the sixth full quarter for which the drug has been marketed (as reported to CMS) for the first National Drug Code assigned to the billing and payment code of such drug.
Routine delivery means delivery of a drug within 2 business days in appropriate shipping and packaging in all areas of the United States and its territories, with the exception of the Pacific Territories. In the Pacific Territories, routine delivery of drug means delivery of a CAP drug within 7 business days in appropriate shipping and packaging. In each case, this timeframe will be reduced if product stability requires it, meaning that the manufacturer’s labeling instructions, drug compendia, or specialized drug stability references indicate that a shorter delivery timeframe is necessary to avoid adversely affecting the product’s integrity, safety, or efficacy.
Single source drug means a drug described by section 1847A(c)(6)(D) of the Act.
Timely delivery means delivery of a CAP drug within the defined routine and emergency delivery timeframes. Compliance with timely delivery standards is also a factor for evaluation of potential and approved CAP vendors.
Unit is defined as in part 414, subpart J of this chapter.
Updated refund quarter means a calendar quarter that is included in a report described in § 414.940(a) that is sent in the second year following the year in which the calendar quarter occurs.
Wholesale acquisition cost (WAC) means the price described by section 1847A(c)(6)(B) of the Act.