In a final rule likely to have huge impact upon providers of mobile diagnostic testing services and the physicians who have long or short term contracts with such providers, the Center for Medicare and Medicaid Services has determined that entities furnishing mobile diagnostic services will be required, as of January 1, 2009, to enroll in Medicare the program as an Independent Diagnostic Testing Facility (IDTF) regardless of where the services are furnished and bill directly for the diagnostic services they furnish.

CMS just released the final rule for Mobile Entity Billing requirements last month, after reviewing commentary to the proposed rule. In the final rule, CMS stated, "We believe that entities furnishing mobile diagnostic services to Medicare beneficiaries must be enrolled in the Medicare program, comply with the IDTF performance standards, and directly bill Medicare for the services they furnish."

CMS is instituting different requirements for mobile entities who have arrangements with hospitals. CMS reports in the Final Rule that several commenters requested that the requirement for mobile testing entities would not apply when services are furnished "under arrangement to hospital inpatients and outpatients," and that the mobile diagnostic testing facilities that furnish services to hospitals be excluded from the proposed IDTF performance standards. CMS states that although all mobile entities that furnish diagnostic testing programs are required to enroll in the Medicare program, CMS is not requiring the mobile entities to bill directly to Medicare when the mobile diagnostic service is part of a hospital service and furnished under arrangement with that hospital as described in sections 1861(w)(1) and 1862(a)(14) of the Social Security Act and 42 CFR Section 482.12(e).
To ensure that IDTFs are actually furnishing services under arrangement with a hospital, CMS says it will require that mobile IDTFs provide documentation of the arrangement with their initial or revalidation enrollment application, or change in enrollment application.

While CMS acknowledged that several commenters requested that mobile units not be required to enroll in Medicare or to be required to bill for all services they furnish, CMS stated it disagreed. The agency held that to maintain program integrity and enable CMS to monitor services provided by the mobile units, "we maintain that a mobile entity providing diagnostic testing services must enroll for diagnostic imaging services that it furnishes to a Medicare beneficiary, regardless of whether the service is furnished in a mobile or fixed base location. We are requiring these mobile IDTFs to bill for the services that they furnish unless they are billing under arrangement with hospitals."

"By enrolling in the Medicare program, CMS or our contractor can determine if the mobile IDTF meets all of the performance standards found in (42 CFR) Section 410.33(g) and that its owners are not otherwise excluded or barred from participation in the Medicare program," CMS stated in concluding the final rule. CMS also stated that an owner of a mobile IDTF is responsible for ensuring that the mobile IDTF meets all applicable regulatory requirements to maintain their enrollment in the Medicare program.

The Federal Register with the Final Rule may be found at: http://frwebgate6.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=499652235673+0+2+0&WAISaction=retrieve

The CMS IDTF Performance Standards can be found at: http://www.cms.hhs.gov/medicareprovidersupenroll/downloads/independentdiagnostictestingfacility.pdf

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