CMS Releases Proposed Rule Concerning Direct Supervision

February 5, 2013

On Sunday, February 4, 2013, the Centers for Medicare and Medicaid Services (CMS) released the Proposed Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.  This long awaited proposed rule is important to nuclear medicine and addresses the issue of direct supervision in the preparation of radiopharmaceuticals.

The current requirement at § 482.53(b)(1) requires 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.

Following SNMMI’s suggestions, CMS has 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.

In the past, hospitals have 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.

Please find the proposed rule below.

2013 Conditions of Participation Proposed Rule