Medicare Part B Drug Average Sales Price
Manufacturer reporting of Average Sales Price (ASP) data during the Public Health Emergency involving COVID-19
As of April 10, 2020, manufacturers should not submit quarterly ASP data using the US Postal Service or other means of physical delivery such as delivery services because the physical delivery of the ASP submissions may be significantly delayed. As discussed in the New ASP Data Collection System section at the bottom of this webpage, all manufacturers should submit their data using the automated ASP Data Collection System and a second method, such as email. CMS is continuing the transition to the exclusive use of the automated ASP Data Collection System.
The 60-Day Federal Register (FR) Notice for the Average Sales Price (ASP) Data Collection Instrument CMS-10110 has been published to the Federal Register (85 FR 32397). This notice is available for review and comment at https://www.federalregister.gov/documents/2020/05/29/2020-11387/agency-information-collection-activities-proposed-collection-comment-request. The public comment period will end on July 28, 2020.
Manufacturer reporting of Average Sales Price (ASP) data
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 January 1, 2012 (that is, submissions of 4Q2011 and subsequent data), manufacturers must use the 2012 revision of the Microsoft Excel template entitled “ASP Data Form (Addendum A).” Revisions to the Addendum A template include a validation macro, changes in the layout of the data fields, and new data fields. Additional information about the use of the revised Addendum A template is available in the Average Sale Price (ASP) Data Collection CM Validation Macro User Guide. Both the revised Addendum A template and the User Guide are available in the Downloads section below.
Manufacturers must complete the ASP Certification Form (Addendum B) to certify that their data submissions are accurate, true, and current. Addendum B is available in the Downloads section below; no changes have been made to Addendum B for 2012.
Prior to April 10, 2020, completed ASP data forms (Addendum A) and certification forms (Addendum B) were sent to CMS via first class mail, federal express mail, or overnight delivery.
Please send any questions to: firstname.lastname@example.org.
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: email@example.com.
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.
Please use the system to submit 3Q2019 data. Please also submit these data via your traditional method, either mail or email. However, as of April 10, 2020, manufacturers should not submit quarterly ASP data using the US Mail or other means of physical delivery.
If you have questions, please contact firstname.lastname@example.org. Thank you for you cooperation.