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CMS Releases Final Rule Concerning Direct Supervision

May 8, 2014

On May 7, 2014, the Centers for Medicare and Medicaid Services (CMS) released the Final Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction. This new rule finalized the previously proposed change of removing the term “direct" from the current requirement at § 482.53(b)(1).

We received several comments on our proposed change to § 482.53, primarily from professional organizations, hospitals and hospital systems, and individual nuclear medicine technologists. All commenters were supportive of the proposed change with no commenters opposed.

In accordance with the comments discussed above, we are finalizing the changes to § 482.53(b)(1) as proposed.”

The new final rule permits trained nuclear medicine technologists in hospitals to prepare radiopharmaceuticals for nuclear medicine without the supervising physician or pharmacist constantly being present, which will help speed services to patients, particularly during off hours. These changes will go into effect on July 12, 2014.

CMS had previously released the Proposed Rule on February 4, 2013.  Following SNMMI’s suggestions, CMS had proposed removing the word “direct.”

“We propose to revise the current requirement at § 482.53(b)(1) by removing the term “direct.” The revised requirement would then require that in-house preparation of radiopharmaceuticals be performed by, or under the supervision of, an appropriately trained registered pharmacist or doctor of medicine or osteopathy. The revision to “supervision” from “direct supervision” would allow for other appropriately trained hospital staff to prepare in-house radiopharmaceuticals under the oversight of a registered pharmacist or doctor of medicine or osteopathy, but it would not require that such oversight be exercised by the physical presence in the hospital at all times of one of these professionals, particularly during off-hours when such a professional would not be routinely present.”

Section § 482.53(b)(1) had required that the in-house preparation of radiopharmaceuticals be performed by, or under the direct supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. Direct supervision means that one of these professionals must be physically present in the hospital and immediately available during the preparation of all radiopharmaceuticals.

Hospitals had reported to CMS that the direct supervision requirement is extremely burdensome when the presence of a pharmacist or physician is required for the provision of off-hour nuclear medicine tests that require only minimal in-house preparation of radiopharmaceuticals.