Calculate ASP each calendar quarter and submit it within 30 days of the close of the quarter:

Use the ASP Data Collection System to report ASP data. View educational resources and templates for reporting ASP data.

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.

For more help using the ASP Data Collection System, view the ASP Education & Outreach page. If you still need help, email the ASP Helpdesk.

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

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.

MACs use the Medicare Contractor Reporting Template for Medicare Part B Drugs (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.

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.

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.