According to the 2010 Proposed Physician Fee Schedule (PPFS), as of January 1, 2012, the Center for Medicare and Medicaid Services (CMS) proposes that Medicare payment be made only for the technical component (TC) of advanced diagnostic imaging services to suppliers who have met the accreditation requirements set forth by the Secretary. According to CMs, the new rule will set forth the criteria for designating organizations to accredit suppliers furnishing the technical component. Additionally, the new rule would ensure that the criteria used by an accreditation organization meet minimum standards for each imaging modality. “Advanced diagnostic imaging services” is defined in the PPFS as “diagnostic magnetic resonance imaging, computed tomography, nuclear medicine, and positron emission tomography.”
The proposed regulation requires medical directors and supervising physicians to have a number of qualifications including having proper training in advanced imaging services through a residency program; having the expertise to be a medical director or supervising physician; having completed continuing medical education courses pertaining to advanced imaging services; and any other requirements the Secretary deems appropriate. Additionally, suppliers have a number of requirements, including implementing a quality control program ensuring “the technical quality of diagnostic images produced by the supplier;” ensuring the equipment meets performance specifications; and ensuring the safety of personnel.
To become an accredited supplier, the independent accreditation organization must submit an application to CMS including, but not limited to, the following information:
– A detailed description of how the organization’s accreditation criteria satisfy the statutory standards;
– An agreement conforming the accreditation requirements with any statutory Medicare changes;
– A description of the organization’s knowledge and experience in the advanced diagnostic imaging field; and – Any other requirements designated by CMS.
Once an application has been sent, CMS will send a notification stating whether or not the organization’s application has been accepted or denied. For denied applications, applicants have an opportunity to ask for reconsideration, resubmit the application, or withdraw the application.
For those organizations that have been accredited, CMS will conduct validation audits to ensure that those organizations maintain the criteria and follow the procedures necessary for an entity supplying advanced diagnostic imaging. The audits will be conducted on a representative sample of accredited suppliers. If an organization is determined to fail the audit, its accreditation will be revoked.
Following audits, CMS will be alerted to entities that display the following:
– A 10% rate of disparity between findings by the accreditation organization and findings by CMS or its contractor on standards that did not constitute immediate jeopardy to patient health and safety if not met;
– Any disparity between findings by the accreditation organization and findings by CMS or its contractor on standards that constitute immediate jeopardy to patient health and safety if not met; or – Widespread or systematic problems in the organization’s accreditation process such that the accreditation no longer provided assurance that suppliers met or exceeded the Medicare requirements, irrespective of the rate disparity.
After further review of the organizations displaying any of these signs, those organizations will be evaluated and will be subject to having their approval withdrawn if they display any of the following:
– The organization no longer provides sufficient assurance that the suppliers meet the requirements of the Act;
– Anything that constitutes a significant hazard to public health; or – The organization failed to meet is application or reapplication procedures.
For organizations that fail the audit, CMS will send a notice of intent to withdraw approval. Those organizations may ask for reconsideration.
For more information, please call Adrienne Dresevic, Esq., or Carey F. Kalmowitz, Esq. at (248) 996-8510 or visit The HLP website.
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