ASP Regulations & Policy

ASP Regulations & Policy

Payment Policy for Drugs and Biologicals under Medicare Part B

Section 303(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended Title XVIII of the Social Security Act (the Act) by adding new section 1847A. This section established the use of the average sales price (ASP) methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. For calendar quarters beginning on or after January 1, 2004, section 1927(b)(3)(A)(iii)(I) of the Act requires manufacturers to report manufacturer's ASP data to CMS for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (D), (E), or (G) or 1881(b)(14)(B) of the Act with a Medicaid drug rebate agreement.  

Section 401 of Division CC, Title IV of the Consolidated Appropriations Act, 2021 (CAA) (Pub. L. 116-260) amended section 1847A of the Act to add new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreement to report ASP information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological.

Policy References

Statutes 

List of statutory references relating to Medicare Part B Drug payment methodology and ASP reporting. This is not an all-inclusive list. 

SSA Reference

Description

Section 1842(o)

Reimbursement for drugs and biologicals 

Section 1847A

Use of average sales price payment methodology

Section 1847A(h): Refund for certain discarded single-dose container or single-use package drugs

Section 1847A(i): Rebate by manufacturers for single source drugs and biologicals with prices increasing faster than inflation

Section 1847B

Competitive acquisition of outpatient drugs and biologicals. 

Note: this has been on hold since 2009.  See https://www.cms.gov/medicare/payment/fee-for-service-providers/competitive-acquisition.

Section 1927(b)(3)(A)(iii) 

Requirement for manufacturers with a Medicaid drug rebate agreement to report average sales price (ASP) information to CMS.

Regulations 

CFR Reference

Description

42 CFR 410.57

Preventive vaccines

42 CFR 410.63

Hepatitis B vaccine and blood clotting factors

42 CFR 414 Subpart I

(§ 414.700 – 414.707)

Payment for Drugs and Biologicals

42 CFR 414 Subpart J

(§ 414.800 – 414.806)

Submission of Manufacturer’s Average Sales Price Data 

§ 414.800

Purpose

§ 414.802

Definitions

§ 414.804

Basis of payment

§ 414.806

Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data

42 CFR 414 Subpart K 

(§ 414.900 – 414.940) 

Payment for Drugs and Biologicals under Part B

§ 414.900

Basis and Scope

§ 414.902

Definitions

§ 414.904

Average sales price as the basis for payment

§ 414.940

Refund for certain discarded single-dose container or single-use package drugs

42 CFR 414 Subpart L

(§ 414.1000 – 414.1001)

Supplying and Dispensing Fees

Rules

Below is a list of some recent rules issued by CMS regarding payment for Part B drugs.  This list is not an all-inclusive list. 

Rule  

Topics Related to Medicare Part B Drugs

CY 24 PFS FR

• Payment for drugs under Medicare Part B during an initial period

• Temporary increase in Medicare Part B payment for certain biosimilar biological products

• Inflation-adjusted beneficiary coinsurance and Medicare payment for Medicare Part B rebatable drugs

• Limitations on monthly coinsurance and adjustments to supplier payment under Medicare Part B for insulin furnished through durable medical equipment

• Request for information: Drugs and biologicals which are not usually self-administered by the patient

• Requiring manufacturers of certain single-dose container or single-use package drugs to provide refunds with respect to discarded amounts

• In-home additional payment for administration of COVID-19 vaccines

CY 23 PFS FR

• Requiring manufacturers of certain single-dose container or single-use package drugs to provide refunds with respect to discarded amounts

• Medicare Part B payment for preventive vaccine administration services

CY 22 PFS FR

• Requiring certain manufacturers to report drug pricing information for Part B (section 401 of the CAA, 2021)

• Determination of ASP for certain self-administered drug products (section 405 of the CAA, 2021)

• Comment solicitation for Medicare Part B payment for drugs approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act

CY 21 PFS FR

• Medicare Part B payment for drugs approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, & Cosmetic Act

CY 19 PFS FR

• Application of an add-on percentage for certain wholesale acquisition cost (WAC)-based payments

CY 18 PFS FR

• Payment for biosimilar biological products under section 1847A of the Act

• Part B drug payment: Infusion drugs furnished through an item of durable medical equipment 

CY 16 PFS FR

• Payment for biosimilar biological products under section 1847A of the Act

Additional Guidance

 This list is not an all-inclusive list.

Frequently Asked Question Resources

This list is not an all-inclusive list.

Manuals

This list is not an all-inclusive list.

Archive Documents

 

Page Last Modified:
02/12/2024 01:35 PM