The Centers for Medicare and Medicaid Services has released its Final 2009 Changes to Payment Policies and Rates under Medicare Physician Fee Schedule with a surprise to regulatory observers--the Agency is not moving ahead with provisions to prevent unnecessary use of imaging services and physician self-referral of imaging services.

The final rule establishes payment rates and policy changes that will go into effect for services furnished by physicians and non-physician practitioners (NPPs) to people with Medicare on or after January 1, 2009. Expectations have been high that the final rules would include the self-referral proposals, which included a requirement for physicians and non-physician practitioners (NPPs) who performed imaging to register as independent diagnostic testing facilities (IDTFs) for each practice location furnishing such services. The Agency originally indicated that the enrollment requirement would be necessary to ensure that beneficiaries are receiving "the quality of care that can only be administered by appropriately licensed or credentialed non-physician personnel." Under the proposal, if the physician or NPP organizations did not enroll as an IDTF they would be subject to claims denial for diagnostic testing services or a revocation of their billing privileges.

Within the application for its Final Rule, CMS stated that in light of the Medicare Improvements for Patients and Providers Acts of 2008 legislation, and after reviewing public comments, it would defer the implementation of the proposals while continuing to review the public comments received on this provision: "[W]e are not adopting our proposal to require physicians and NPPs to meet certain quality and performance standards when providing diagnostic testing services, except mammography services, within their medical practice setting and have removed the paperwork burden and regulatory impact analysis associated with this provision in this final rule with comment period." CMS leaves open the possibility of finalizing the provision in future rulemaking. Section 135 of the MIPPA requires an accreditation process for entities furnishing advanced diagnostic testing procedures (MRI, CT, and nuclear medicine including PET) by January 1, 2012.

In addition, the CMS had a proposed anti-markup provision intended to take the profit out of reassignment of benefits for diagnostic tests billed by one entity but provided by another. CMS had originally proposed restrictions that would make it difficult for a practice to nominate one of their own physicians as the supervising physician in such tests. However, upon CMS review of the comments to the proposed rule, it decided to relax its requirements on both how it defines physicians who are part of a practice, and the parameters for site of service where the procedures are performed.

The American College of Radiologists expressed disappointment that the CMS proposal requiring enrollment as IDTFs was not enacted, stating it believed "all providers in every practice setting should be required to meet all quality and performance standards that are required of IDTFs and accredited sites."

Finally, CMS also refrained from its proposed exception to the federal rules against self-referrals allowing certain types of incentive payments and or shared savings programs with physicians. CMS stated that it needs additional information in order to finalize an exception that will allow the benefits of such programs for industry but without posing a risk of patient or program abuse.

Advanced Medical Technology Association (AdvaMed) has released a statement supporting CMS' decision delaying the implementation of the incentive payment/shared savings programs exception. (See https://www.dotmed.com/news/story/7316).

The application for CMS' Final Rule may be found here: http://www.cms.hhs.gov/physicianfeesched/downloads/CMS-1403-FC.pdf?agree=yes&next=Accept

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