Regulatory Issues

Conditions of Participation

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).

Coverage with Evidence Development

On September 27, 2013 CMS released their final decision memo for beta-amyloid positron emission tomography (PET) in dementia and neurodegenerative disease (CAG-00431N).  SNMMI was disappointed that the final decision requires coverage with evidence development (CED). Under the decision, CMS will cover one PET scan to exclude Alzheimer's disease, but only for patients participating in specific clinical studies under a CED program, which grants conditional reimbursement upon collection of specific data.

Medicare Reimbursement Rates

The Hospital Outpatient Prospective payment System (HOPPS) and the Medicare Physician Fee Schedule (MPFS) set the reimbursement rates for hospitals and physicians.  Each year, CMS releases the proposed rule for the following calendar year in July and the final rule in November.

21 CFR 212 — Current Good Manufacturing Practice (CGMP) for PET Radiopharmaceuticals

On December 10, 2009, the FDA published the final rule for 21 CFR 212, Current Good Manufacturing Practice (CGMP) for PET Radiopharmaceuticals.

10 CFR Part 35 — Medical Use of Byproduct Material

On August 8, 2013, the NRC released the Proposed Rule: Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments (RIN 3150-AI63). 10 CFR Part 35 contains the requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. 

Other Regulatory Issues

SNMMI works with other federal agencies on a variety of issues.