Primary Care Coding Alert

Question: My provider billed an office call and then gave a patient an injection of the new migraine drug Ajovy, which we received as a sample by the manufacturer, Teva. As the Food and Drug Administration (FDA) only approved the drug in September, it currently has no HCPCS code. Can we bill for the drug and the injection, and if so, how do we go about documenting this?

Codify Subscriber

Answer: First, the Centers for Medicare and Medicaid (CMS) allows use of FDA-approved drugs whether or not they have been assigned HCPCS codes. Section 50.4.1 of Chapter 15 (Covered Medical and Other Health Services) in the Medicare Benefit Policy Manual makes it clear that “the program may pay for the use of an FDA approved drug or biological, if it was injected on or after the date of the FDA’s approval” and “it is reasonable and necessary for the individual patient” (Source: www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf).

So, CMS recognizes any drug used after the FDA date of approval providing it is medically necessary

However, section 60.1A of that same chapter makes two other points that apply in this situation. First, CMS stipulates that “supplies, including drugs and biologicals, must represent an expense to the physician.” As the drug company supplied the drug to your physician at no charge as a sample, it does not represent an expense to your physician, so it is not legal for your office to charge the patient for it. It is, however, legal for drug companies to supply samples, and legal for providers to use those samples to treat patients.

“However,” section 60.1A continues, “administration of the drug, regardless of the source, is a service that represents an expense to the physician. Therefore, administration of the drug is payable if the drug would have been covered if the physician purchased it.”

This means you can go ahead and bill for the administration of the drug using a code such as 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular), but you cannot bill for the drug that you have used.

Finally, in this scenario, you should also follow CMS guidelines for documenting the use of a drug that was brought in by the patient, or that was donated, by including the name of the drug on line 19 of the claim. (See, for example, the Billing and Coding Guideline for HONC-010 Chemotherapy Drugs and their Adjuncts at downloads.cms.gov/medicare-coverage-database/lcd_attachments/28576_69/l28576_honc010_cbg_120111.pdf.)