Medicare Program Integrity Manual (Pub. 100-08), Ch. 6 § 6.4.2
Emergency Medical Services (EMS) Protocols
6.4.2 – Emergency Medical Services (EMS) Protocols
(Rev. 308, Issued: 10-30-09, Effective: 11-30-09, Implementation: 11-30-09)
Per Section 415 of the Medicare Modernization act of 2003, the reasonable and necessary
requirement for rural air transport may be “deemed” to be met when the service is
provided pursuant to an established State or regional emergency medical services (EMS)
agency protocol. CMS defines “established” to mean those protocols, which have been
reviewed and approved by State EMS agencies or have been developed according to
State EMS umbrella guidelines. Additionally, the protocol must be recognized or
approved by the Secretary.
The information on the FI, carrier, or MAC Web site must inform rural air ambulance
providers that if they anticipate transport based upon the contents of such a protocol
(either State or regional) they must submit that protocol in advance to the fiscal
intermediaries, carriers, or MACs for review and approval. Include instructions on the
Web site for submitting the protocol. The contractor will review the protocol to ensure
that the contents are consistent with statutory requirements at 1862(a)(1)(A), which direct
that all services paid for by Medicare must be reasonable and necessary for the diagnosis
or treatment of an illness or injury. The contractor shall make a determination regarding
the protocol and/or subsequent revisions and notify the rural air ambulance provider of
their determination within 30 days of receipt of the protocol.
Approval of a protocol does not exempt the provider from requirements in the Act at
1861(s)(7) and regulatory requirements at 42 CFR 424.106 which outlines the criteria for
determining whether the hospital was the most accessible. Regardless of protocol
instructions regarding transport locations Medicare payment can be made only to the
closet facility capable of providing the care needed by the beneficiary.