Sources: 42 C.F.R. § 411.355(h)

12. Preventive Screening Tests, Immunizations and Vaccines

Preventive screening tests, immunizations, and vaccines that meet the following conditions:
 

  1. They are subject to CMS-mandated frequency limits;

  2. The arrangement does not violate the anti-kickback statute or any laws or regulations governing billing or claims submission;

  3. All billing and claims submission for the preventive screening tests, immunizations, and vaccines does not violate any Federal or State law or regulation governing billing or claims submission; and

  4. The preventive screening tests, immunizations, and vaccines must be covered by Medicare and must be listed as eligible for this exception on the List of CPT/HCPCS Codes.

Stark General Exception