CMS Pub. 100-02, ch. 15, § 50.3

B3-2049.3

In order to meet all the general requirements for coverage under the incident-to provision, an FDA approved

drug or biological must:

• Be of a form that is not usually self-administered;

• Must be furnished by a physician; and

• Must be administered by the physician, or by auxiliary personnel employed by the physician and

under the physician’s personal supervision.

The charge, if any, for the drug or biological must be included in the physician’s bill, and the cost of the

drug or biological must represent an expense to the physician. Drugs and biologicals furnished by other

health professionals may also meet these requirements. (See §§170, 180, 190 and 200 for specific

instructions.)

Whole blood is a biological, which cannot be self-administered and is covered when furnished incident to a

physician’s services. Payment may also be made for blood fractions if all coverage requirements are

satisfied and the blood deductible has been met.