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Centers for Medicare & Medicaid Services

View Public Comments for Positron Emission Tomography (CAG-00065R2)

Rodriguez, Gail
Executive Director


Re: National Coverage Analysis Reconsideration Request for Positron Emission Tomography (CAG-00065R2)

Dear Dr. Roche and Mr. Caplan:

The Medical Imaging & Technology Alliance (MITA) appreciates this opportunity to respond to the Centers for Medicare and Medicaid Services’ (CMS’s) request for comments on the reconsideration request of the National Coverage Determination (NCD) for the use of positron emission tomography (PET) at Section 220.6 of the Medicare Coverage Manual. As the leading trade association representing medical imaging, radiotherapy technology, and radiopharmaceutical manufacturers, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provide. MITA is pleased to work with CMS to ensure Medicare beneficiaries have proper access to these life-saving technologies. We appreciate CMS’s steps forward in considering MITA’s reconsideration request and are pleased to respond to the areas of interest CMS expressed in its request for comments.

Breadth of the request
MITA’s reconsideration request appropriately addresses new FDA-approved PET radiopharmaceuticals. We stand firm in our belief that approving this request would not reverse the existing National Coverage Determination which encompasses 18F-FDG, 18F-NaF, 13-N ammonia, or 82-Rb rubidium. For PET tracers emerging onto the marketplace now and in the future, this request allows for or enables an updated application of the policy, acknowledging the higher regulatory approval standards for the new tracers. CMS’s approval of the request would also allow Medicare beneficiaries access to these innovative technologies upon FDA-approval, leading to potentially more expedient treatment decisions and individualized patient management. We also note that by approving this request, CMS will treat newly-approved PET radiopharmaceuticals in the same manner as any other diagnostic radiopharmaceutical drug that earns approval through the FDA process. In doing so, CMS will level the playing field and afford all diagnostic radiopharmaceuticals the same opportunity for coverage.

MITA would like to express its appreciation to all of the organizations that joined us as cosigners on the reconsideration request: American College of Radiology (ACR); Council on Radionuclides and Radiopharmaceuticals (CORAR); Society of Nuclear Medicine and Molecular Imaging (SNMMI); and the World Molecular Imaging Society (WMIS). We also are pleased that CORAR has agreed to join us in signing this comment. Collectively, we appreciate CMS’s willingness to open this request and receive input from various stakeholders and interested parties. In some responses to CMS’s request for comments, MITA member companies may provide examples of the types of evidence being gathered to demonstrate coverage for the product.

Assuring success by approving the request
We would like to reiterate that any approval for coverage would involve consideration of the evidence for coverage; MITA’s position is that this evidence is inherent to the newly approved tracers, as opposed to the evidence that was needed for 18F-FDG, 18F-NaF, and 13-N ammonia, which are now covered under Section 220.6 of the CMS National Coverage Determinations Manual.

We acknowledge the concerns expressed by some commenters on the reconsideration request that FDA approval alone should not equate to coverage because there may be circumstances in which FDA approval does not show patient outcomes. However, we reiterate our statement that a newly approved tracer that overcomes the rigorously well-controlled clinical trials that demonstrate safety and efficacy for the FDA approval process also provides a level of evidence which is sufficient to merit coverage. Thus, PET radiopharmaceuticals should receive the same level of consideration.

We also acknowledge CMS’s, including local contractors’, ability to impose boundaries for coverage on any new item entering the marketplace. We appreciate that by approving this reconsideration request, CMS will allow for coverage rather than specifically disallowing coverage for new products. This request is simply a process change allowing for coverage of newly approved PET radiopharmaceuticals upon or shortly after FDA approval. It would eliminate the significant delay incurred while awaiting a decision through the current National Coverage Analysis process.

MITA also understands that CMS needs to ensure that coverage of new products utilized by Medicare beneficiaries may not deserve interminable coverage. It would be unfortunate to withdraw coverage from a particular item or service, but in cases where evidence emerges that Medicare patients do not benefit from a new product, and that evidence outweighs the benefits of coverage, we acknowledge that CMS has recourse in such provision of coverage.

As always, MITA appreciates the open and cooperative nature that CMS has exhibited throughout this process. If you have additional questions, please contact Brian Abraham, Sr. Policy Director, at or 703-841-3258.


Gail M. Rodriguez, Ph.D.
Executive Director, MITA
Vice President, National Association
of Electrical Manufacturers (NEMA)

Michael Guastella
Executive Director, Council on
Radionuclides and Radiopharmaceuticals