Outpatient FAQ May 2019

on Tuesday, 28 May 2019. All News Items | FAQ

Billing for New FDA-Approved Drugs not yet Assigned a HCPCS Code


Our facility plans to start giving the new drug, Evenity (romosozumab-aqqg), but we are unable to find a HCPCS code for this newly FDA-approved drug. How should we bill Medicare for it and what can we expect to be paid?


For Medicare, it would be appropriate to report HCPCS code C9399 (unclassified drug or biological). Medicare says this code can be reported for new drugs & biologicals that are approved by the FDA for which there is no HCPCS code that describes the drug.

From the FDA announcement on April 9, 2019, “The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.”

Instructions for billing and payment of newly approved drugs that have not yet been assigned a HCPCS code can be found in Chapter 17 of the Medicare Claims Processing Manual, Section 90.3. Beginning January 1, 2004, hospitals can bill for new drugs and biologicals that are approved by the FDA for which a product-specific HCPCS code has not been assigned with HCPCS code C9399 (Unclassified drug or biological).

In addition to reporting C9399, the hospital should enter the National Drug Code (NDC), the quantity of the drug administered, and the date furnished in the Remarks section of the claim. The Medicare Administrative Contractor (MAC) will manually price the drug or biological at 95 percent of Average Wholesale Price (AWP). Medicare pays 80% of this amount and the Medicare beneficiary is liable for the remaining 20%, after their deductible is met.

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc.  Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system.  In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers.  You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information.  MMP, Inc. is not offering legal advice.  Every reasonable effort has been taken to ensure the information is accurate and useful.






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