All Part B drug manufacturers report Average Sales Price (ASP) data for Part B-covered drugs and biologicals and related items, services, supplies, and products that are paid as drugs or biologicals. Report this information to CMS for calendar quarters starting January 1, 2022. Learn more.
- When Do I Report ASP?
Calculate ASP each calendar quarter and submit it within 30 days of the close of the quarter:
2024 Quarter Close of Quarter Close of the Submission Window First March 31, 2024 Tuesday, April 30, 2024 Second June 30, 2024 Tuesday, July 30, 2024 Third September 30, 2024 Wednesday, October 30, 2024 Fourth December 31, 2024 Thursday, January 30, 2025
- How Do I Report ASP?
Tips for Using the Data Collection System
Tips to help you successfully submit and certify your data:
- Use the product and financial templates for the automated system when you upload data.
- Register the manufacturer name only once.
- Use the same spelling format for the manufacturer name when adding product data.
- Input 11-Digit National Drug Codes (NDCs) in the NDC1, NDC2, and NDC3 fields. If an NDC isn’t available, use an alternative ID, like a Stock Keeping Number (SKN), catalog number, or other alternate ID. Be sure the identifier is consistent with the 1 published on the manufacturer’s public website.
- Report these drugs in units other than NDCs. See the 2012 Physician Fee Schedule Final Rule.
- Don’t submit duplicate NDCs in the ASP report.
- Input the expiration date of the last lot sold for discontinued NDCs or those from another manufacturer. The NDC will continue to appear on the compliance summary until the end of the reporting period when the expiration date occurs.
- Use the Assumptions tab to upload a completed Addendum A and B with an explanation for the late submission and a summary of changes for restatements prior to 3Q18. Label the documents with the quarter.
- Enter the drug name in the drug name field.
- Enter complete product data in required fields. Entering N/A isn’t acceptable.
- Report products consistent with product information on publicly available sources, like FDA-approved labels and manufacturers' websites.
- Notify the registered certifier to certify the reported data.
- Which Drugs & Biologicals Do I Need to Report?
CMS uses ASP to pay for these Part B-covered drugs and biologicals that it doesn’t pay on a cost or prospective payment basis:
- Drugs furnished incident to a physician's service
- Drugs administered via a covered item of durable medical equipment (DME)
- Other drugs covered under Part B, including:
- Immunosuppressive drugs (drugs used after Medicare-covered organ transplants)
- Certain oral anticancer drugs
- Certain oral antiemetic drugs
- Certain vaccines
- Hemophilia blood clotting factors
- Intravenous immune globulin (IVIG) for primary immunodeficiency administered in the home
- Items, services, supplies, and products that are payable under Part B as a drug or biological
Biosimilar or Interchangeable Products
Biological products determined to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product have an abbreviated licensure pathway.
Medicare Part B payment for newly approved drugs and biologicals is available once the FDA approves a product. CMS incorporates approved biosimilars into the ASP methodology. Once ASP information is available for a biosimilar product, Medicare payment will equal the ASP for the biosimilar product plus 6% of the ASP for the reference product.
- How Does CMS Pay for External Infusion Pumps?
Medicare pays for drugs and biologicals which are not usually self-administered by the patient and furnished “incident to” physicians’ services rendered to patients while in the physician’s office or the hospital outpatient department. In some situations, a hospital outpatient department or physician office may:
- Purchase a drug for a medically reasonable and necessary prolonged drug infusion
- Begin the drug infusion in the care setting using an external pump
- Send the patient home for a portion of the infusion
- Have the patient return at the end of the infusion period
In this case, bill the drug or biological, the administration, and the external infusion pump to your MAC. However, because prolonged drug and biological infusions started incident to a physician's service using an external pump should be treated as an incident to service, you can’t bill it on suppliers’ claims to DME MACs.
- How Do MACs Report Part B Drugs that They Manually Price?
MACs use the Medicare Contractor Reporting Template for Medicare Part B Drugs (ZIP) (ZIP) to report information on all Part B drugs Medicare doesn’t pay on a cost or prospective payment basis when payment limits aren’t listed in the quarterly ASP Drug Pricing Files or the Outpatient PPS (OPPS) Pricer. Use this template to report pricing information for the Not Otherwise Classified (NOC) drug billing codes. Email this to CMS each month.
- How Does CMS Calculate ASP for Certain Self-Administered Drugs?
The Department of Health and Human Services (HHS) Office of the Inspector General (OIG) conducts periodic studies on certain self-administered drugs or biologicals paid under the statutory payment limit and allows CMS to apply a “lesser of” methodology to the ASP calculation, if appropriate. The payment amount for the drug or biological billing code would be the lesser of 1 of these:
- The payment limit CMS determines using the current ASP+6% methodology
- The ASP+6% amount obtained by excluding the self-administered products identified in an OIG study
CMS calculates the ASP-based payment for billing codes that include certain self-administered products identified in a July 2020 OIG report using the lesser of methodology, as of July 1, 2021. This report identified certain versions of Orencia® and Cimzia®.
Starting with the July 2021 ASP Drug Pricing File, CMS applies the lesser of methodology to the payment limit calculations for billing and payment codes representing certolizumab pegol (J0717) and abatacept (J0129). CMS includes a notation of the lesser of methodology in the ASP Drug Pricing Files.
- What’s the Temporary Increase in Payment for Biosimilar Biologicals?
Medicare pays the ASP plus 8% (rather than 6%) of the reference biological for a 5-year period for certain biosimilar biological products. A qualifying biosimilar biological product is a biosimilar with an ASP that isn’t more than the ASP of the reference biological:
- For existing qualifying biosimilar biological products which CMS paid using ASP as of September 30, 2022, the applicable 5-year period began on October 1, 2022
- For new qualifying biosimilar biological products for which CMS paid using ASP between October 1, 2022 – December 31, 2027, the applicable 5-year period began the first day of the calendar quarter
Starting with the October 2022 ASP Drug Pricing File, CMS shows the temporary increased amount for qualifying biosimilar biological products for a period of 5 years.
- Reporting Resources
- ASP Certification Form (Addendum B) – Revised 2018 (PDF)
- Medicare ASP Financial data template for New System (ZIP): View an example layout of the financial data needed for upload into the ASP reporting system. You may use this template for uploading data, instead of entering manually one NDC at a time.
- Medicare ASP Product data template for New System (ZIP)
- ASP Report in Units other Than NDC - Updated October 2022
- Medicare Demonstration Projects & Evaluation Reports
- Details for RTC-Sales of Drugs and Biologicals to Large Volume Purchasers
- Get More Information
View the Manufacturers Reporting Requirements Under the CAA 2021 (PDF) (PDF) letter CMS sent to manufacturers