CMS has put on display a final rule that reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. Two provisions address imaging services offered in ambulatory surgical centers (ASCs) and hospitals.

Supervision of Radiology Services in ASCs

CMS is reducing the requirements that ASCs must meet in order to provide radiological services to patients. Under the new rule radiology services performed as an integral part of surgical procedures in an ASCs are no longer required to be supervised by a radiologist. Instead, the ASC’s governing body must appoint an individual qualified in accordance with state law and the ASC’s policies who is responsible for assuring that all radiologic services are provided in accordance with the ASC Conditions of Coverage.

Under current rules, an ASC must have procedures for obtaining radiological services from a Medicare-approved facility to meet the needs of the ASC’s patients, and that radiologic services must meet the hospital Conditions of Participation (CoPs) for radiologic services. 42 C.F.R. 416.49(b). The hospital CoPs for radiologic services state, in part, that a qualified full-time, part-time, or consulting radiologist “must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist’s specialized knowledge.” 42 C.F.R. 482.26(c)(1). Interpretive guidance in Appendix L of the State Operation Manual provides further insight into this requirement. Namely, CMS has interpreted Section 482.26(c)(1) such that “[s]upervision of the radiology services may only be performed by a radiologist who is a member of the medical staff.” CMS directs surveyors to “[v]erify that supervision of the radiology services is restricted to a radiologist who is a member of the medical staff.”

CMS states in the final rule that it has learned that some of the hospital CoP requirements are unduly burdensome for ASCs to meet. In particular, the rule states that “the hospital CoP requirement to have a radiologist supervise the provision of radiologic services is unduly burdensome and overly aggressive, as many ASCs are having great difficulty locating a radiologist to supervise the minimal ASC radiologic services provided.”

In 2013 CMS initially proposed relaxing the supervision requirement by allowing any doctor of medicine (MD) or osteopathy (DO) qualified by education and experience in accordance with state law and ASC policy to supervise radiology services. Now, in this final rule, CMS provides additional flexibility by allowing any individual qualified by education and experience in accordance with state law and ASC policy (likely not a radiologist) to supervise radiology services. Depending on applicable state law, the individual charged with supervision need not be an MD or DO. However, they must be appropriately qualified to supervise the ASC’s use of safety precautions against radiation hazards, regular equipment inspection and hazard correction, regular review of radiation workers for the amount of radiation exposure, use of radiologic equipment only by qualified personnel, and maintenance of imaging results or records.

Preparation of Radiopharmaceuticals in Hospitals

CMS is modifying hospital requirements for in-house preparation of radiopharmaceuticals. Current hospital nuclear medicine services CoPs require that such services be performed by, or under the direct supervision of, an appropriately-trained registered pharmacist, MD, or DO. Direct supervision means that one of these professionals must be physically present in the hospital and immediately available during the preparation of all radiopharmaceuticals. CMS is revising the COP to remove the modifier “direct” from the in-house preparation supervision requirement. The presence of a pharmacist, MD, or DO will no longer be required during the delivery of off-hour nuclear medicine tests. According to CMS, these changes are based on the Society of Nuclear Medicine and Molecular Imaging recommendations on this issue.

The rule is scheduled to be published on May 12, 2014.