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Preventative screening tests, immunizations and vaccines exception

Preventive screening tests, immunizations and vaccines

There is a general exception at 42 CFR 411.355(h) for ownership/investment interest and compensation arrangements and physician referrals for certain preventive screening tests, immunizations and vaccines covered by Medicare.

These screening tests, immunizations and vaccines must meet additional requirements:
  • They must be subject to CMS-mandated frequency limits;
  • The arrangement for their provision does not violate the anti-kickback statute;
  • All billing and claims submissions for the preventive screening tests, immunization and vaccines do not violate federal or state laws or regulations governing billing or claim submission; and
  • The preventive screening tests, immunizations and vaccines must be covered by Medicare and be listed as eligible for this exception on the list of CPT/HCPCS codes.
Only those preventive screening tests, immunizations and vaccines covered by Medicare and listed on the CMS Web site are subject to this particular exception. The exception covers such tests when they are furnished for screening purposes; they will not be covered if furnished outside of the Medicare-mandated frequency limits. As a practical matter, this exception is limited to a very small class of immunizations, vaccines and screening tests.

As with other provisions of the final rule, the inclusion of services in list of CPT codes that are covered by this exception does not change the underlying character of the item or service. A test that is otherwise covered by the exception will, nonetheless, continue to be defined as a designated health service.

The exception allows for the referral for such tests and items when a physician has a financial relationship with an entity that furnishes the services, when the services are furnished as part of a screening test, or if the item is subject to frequency limits. The services and items are still, however, designated health services and as such, are subject to the Stark law’s prohibitions if furnished outside of the narrow confines of this exception. Moreover, when such services are furnished in reliance on the Stark law’s exception for in-office ancillary services, the items/services must be treated appropriately within the group practice for other purposes (i.e., compensation plans).
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