Medicare Part B Drug Average Sales Price
Manufacturer reporting of Average Sales Price (ASP) data
For submission of Average Sales Price (ASP) data for Part B drugs, CMS is only accepting data via the online ASP data collection system. Data submission via email or mail will no longer be accepted. If you have not already, please visit https://portal.cms.gov to register for the system.
A manufacturer's ASP must be calculated by the manufacturer every calendar quarter and submitted to CMS within 30 days of the close of the quarter. Each report also must be certified by one of the following: the manufacturer's Chief Executive Officer (CEO); the manufacturer's Chief Financial Officer (CFO); or an individual who has delegated authority to sign for, and who reports directly to, the manufacturer's CEO or CFO.
For all data submissions made on or after July 1, 2020 (that is, submissions of 1Q20 and subsequent data), manufacturers must use the online ASP data collection system. The ASP Data Collection System User Guide, as well as the data templates that must be used within the system, are located in the download section below. Also see "Tips for Successful ASP Data Submission" below.
If you have questions regarding the ASP data collection system, please contact firstname.lastname@example.org for assistance. For all other ASP related inquiries, please contact email@example.com. Thank you for you cooperation.
The MFN Model has been announced. More information is available on the MFN webpage (see related links section below).
HCPCS Codes for Which ASP Reporting Is Done in Units of Measure Other Than an NDC
A list of drugs that must be reported in units other than NDCs is posted in the Downloads section. More information is available in the 2012 physician fee schedule final rule (76 FR 73296-8, November 28, 2011).
Medicare Contractor Reporting Template for Medicare Part B Drugs - (Located in the "Downloads" section below)
As indicated in CR 4140, dated February 15, 2006, Medicare contractors shall use the Medicare Contractor Reporting Template for Part B drugs to report information on all Medicare Part B drugs not paid on a cost or prospective payment basis when payment limits are not listed in the quarterly drug pricing files, or in the OPPS Pricer. Contractors shall also use the template to report pricing information for the NOC drug billing codes. This information must be sent to CMS on a monthly basis to e-mail address: firstname.lastname@example.org.
Information Regarding Medicare Payment and Coding for Drugs and Biologics (See Downloads section below for additional information)
Section 303(c) of the Medicare Modernization Act of 2003 (MMA) revised the payment methodology for Part B covered drugs that are not paid on a cost or prospective payment basis. In particular, section 303(c) of the MMA amended Title XVIII of the Act by adding section 1847A, which established a new average sales price (ASP) drug payment system. Beginning January 1, 2005, drugs and biologicals not paid on a cost or prospective payment basis will be paid based on the ASP methodology, and payment to the providers will be 106 percent of the ASP. There are exceptions to this general rule which are listed in the Medicare Claims Processing Manual, Pub. 100-04, Chapter 17. The ASP methodology uses quarterly drug pricing data submitted to the CMS by drug manufacturers. CMS will supply contractors with the ASP drug pricing files for Medicare Part B drugs on a quarterly basis.
Newly Approved Drugs and Biologicals
The Affordable Care Act amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with a Food and Drug Administration (FDA)-licensed biological product. CMS will incorporate biosimilars that are approved under the abbreviated biological approval pathway into the Average Sales Price payment methodology, and issue additional guidance as necessary. Questions and answers can be found in MLN Matters® Special Edition Article SE1509 (PDF).
New ASP Data Collection System
The ASP Data Collection System began collecting Average Sales Price data for Part B drugs on April 1, 2019. Please visit https://portal.cms.gov to register for the system. The ASP Data Collection System User Guide can be found in the links below as well as the new data templates that must be used within the system.
If you have questions, please contact email@example.com. Thank you for you cooperation.