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Centers for Medicare & Medicaid Services

View Public Comments for CED Public Solicitation

Daubert, R. N., J.D., Gail L.
Reimbursement Counsel for CORAR
Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR)

Marilyn Tavenner
Acting Administrator
Centers for Medicare & Medicaid Services
Mailstop: C1-09-06
7500 Security Blvd.
Baltimore, MD  21244

RE: Coverage with Evidence Development (CED) Public Solicitation

Dear Ms. Tavenner:

The Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) thanks CMS for this opportunity to share its observations and recommendations regarding possible revisions to the guidance document on Coverage with Evidence Development (CED).[1] CORAR has met with the Coverage and Analysis Group (CAG) on several occasions to discuss issues with the National Coverage Determination (NCD) process and CED, specifically as it relates to new PET radiopharmaceuticals and new indications for existing PET agents.  We look forward to continuing this dialogue and working with CMS. 

As we have explained in the past, we believe that the CED / NCD process could and should be streamlined to facilitate patient access to new products and procedures.  We therefore offer the following recommendations to make the CED / NCD process more flexible and make the pathway to national coverage more predictable:

  • Coverage for all new radiopharmaceuticals approved by the Food and Drug Administration (FDA) should be assumed unless there are specific safety concerns, consistent with CMS’s traditional approach to drug coverage.

  • CMS should remove the current NCD exclusionary language on new PET imaging agents, which requires a lengthy, full NCD review, and provide coverage for new FDA-approved PET imaging agents at the local or national level.

  • Manufacturers should be encouraged to engage CMS directly to discuss CED outside of the NCD review process, and stakeholders should develop agreements on CED prior to CMS opening or issuing a proposed NCD.

  • CED for radiopharmaceuticals should remain at the national level and not be imposed at the local level. 

  • CMS should clarify and streamline Coverage with Appropriateness Determination (CAD).  For instance, for new indications of already approved radiopharmaceuticals we believe that CAD should be modified to include claims-based reporting of additional data, and/or CMS should revise registry requirements so that manufacturer-collected data would be considered by CMS.

  • CMS should require the collection of the minimum necessary data for both CAD and CED, and the endpoints and outcomes should be reasonable and relevant to the diagnostic question being asked.  In no case should CED require outcomes and endpoints for diagnostic radiopharmaceuticals that are more applicable to therapeutic drugs (e.g., requiring improved patient outcomes).

  • If CED is going to be a part of the NCD process, we strongly believe that the timeline for the NCD process can and should be shortened dramatically.  For example, we recommend a 30 day comment period once the draft NCD with the agreed on CED recommendations is posted, and the interim NCD should be posted within 90 days, with CED effective immediately.  The “final” NCD would be posted as soon as possible after the evidence and results were analyzed.

  • CMS/FDA should allow requestors to implement CED in a manner consistent with possible post-approval data collection required by the FDA to reduce duplication of efforts, when requested by the manufacturer of new radiopharmaceuticals.

Generally, we believe that streamlining and making the NCD / CED process more efficient and expeditious would more quickly bring promising new technologies to patients who need them.  To that end, there are several other extant issues with the NCD / CED process that would be helpful for CMS to consider during the public solicitation period. 

First, CMS could create a more effective approach to CED studies and registries.  For example, CMS may improve Medicare patient access to new technologies, including new nuclear medicine imaging tests, by implementing a more streamlined approach to CED that looks at meaningful data sources that industry and CMS mutually agree will be beneficial.  Establishing high-level quality controls in data collection would help ensure this goal.  

Second, CMS should clarify who can fund and conduct CED studies. Such studies are expensive, and it is currently unclear whether a for-profit entity can conduct a CED study directly. 

Third, CMS should improve CED study implementation by:  (1) simplifying the submission of data to CMS; (2) standardizing CED claims processing by local Medicare administrative contractors; and (3) coordinating CED between FDA-required post-marketing data collection and CED registries, which could prevent duplicative data approvals, collection, and reporting. 

Finally, if CMS expedites the initiation of CED and broadens its coverage, a larger number of Medicare beneficiaries could more readily have access to promising new technologies.  Under the current framework, before CED can be implemented, a new technology must undergo a long National Coverage Analysis (NCA) process, which takes approximately nine to twelve months to complete.  It is only after this drawn-out process that a CED study can begin.  CMS could expedite the initiation of CED by removing the need for an NCA and simply deciding the data collection requirements with the requestor of the CED technology

In summary, we feely strongly that the recommendations discussed above could greatly improve and expand acceptance of the CED and coverage process, while at the same time protecting manufacturers’ interest and facilitating patient access to promising medical technologies.

We applaud CMS’s request for public input on CED and expect that this outreach to stakeholders reflects CMS’s commitment to continuing to refine the evidentiary standards applied to nuclear medicine imaging products and procedures, as well as the NCD and CED process.  We look forward to playing a central role in the ongoing dialogue.

Please feel free to contact me at 202.414.9241 or if you have questions or if you need additional information.


Gail L. Daubert, R. N., J.D.
Reimbursement Counsel for CORAR cc: Louis Jacques, MD., Director, Coverage and Analysis Group, CMS
CORAR Members via email                           
[1] Centers for Medicare & Medicaid Services CED Public Solicitation, November 7, 2011;