Proposed Decision Memo for Positron Emission Tomography (CAG-00065R2)

full-text:
Proposed Decision Memo for Positron Emission Tomography (CAG-00065R2)

 

The Centers for Medicare & Medicaid Services (CMS) proposes that local Medicare Administrative Contractors (MACs) may determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their labeled indications for oncologic imaging that are approved by the U.S. Food and Drug Administration (FDA).

The effect of this decision, if finalized without change, would be to remove the national noncoverage for any of these identified uses of these radiopharmaceuticals that have not been more specifically determined nationally. Thus this change would not apply to any use of PET using radiopharmaceuticals FDG (2-deoxy-2-[F-18] fluoro-D-Glucose (fluorodeoxyglucose)), NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or rubidium Rb-82. This would not prevent CMS from determining national coverage for any of these uses in the future, and if such determinations are made, a future determination would supersede local contractor determinations under §1862(a)(1)(A) of the Social Security Act (the Act).

We are requesting public comments on this proposed decision pursuant to §1862(l) of the Act. After consideration of these public comments and any additional evidence, we will issue a final determination responding to the public comments consistent with §1862(l)(3) of the Act.