Comparison Chart of Anti-Kickback Safe Harbors and Stark Exceptions -- Preventive Screening Tests, Immunizations, and Vaccines

Preventive Screening Tests, Immunizations, and Vaccines – Current as of March 2021

Stark
Stark exception to the referral prohibition related to both ownership/investment and compensation for preventive screening tests, immunizations, and vaccines

Anti-Kickback
[No comparable safe harbor

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.

 

The preventive screening tests, immunizations, and vaccines are subject to CMS-mandated frequency limits.

 

The arrangement for the provision of the preventive screening tests, immunizations, and vaccines does not violate the anti-kickback statute.

 

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.

 
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