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Centers for Medicare & Medicaid Services

View Public Comments for Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decisions

Savickis, Mari
Assistant Director, Federal Affairs
American Medical Association

January 28, 2013

Marilyn B. Tavenner
Acting Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Draft Guidance – Coverage with Evidence Development

Dear Acting Administrator Tavenner:

On behalf of the physician and student members of the American Medical Association (AMA), I appreciate the opportunity to provide comments on the Draft Guidance for the Public, Industry, and Centers for Medicare & Medicaid Services (CMS) Staff Coverage with Evidence Development (CED) in the Context of Coverage Decisions (Draft Guidance). Overall, the AMA urges CMS to provide greater specificity for the application of the CED policy to new technologies (including more established diagnostic and treatment options). Rather than clarifying agency action in this area, the Draft Guidance raises a host of questions. We believe CMS and interested stakeholders would benefit from additional dialogue concerning the intended as well as possible unintended impact of the CED policy. We urge CMS to convene a meeting with interested stakeholders prior to finalizing the Draft Guidance.

As with all medical innovation, clear rules of the road are necessary in order to navigate the regulatory pathway to clinical application and uptake. As a related corollary, it is highly beneficial for physicians to understand the standards and criteria used by a payer such as Medicare in assessing the evidence base for purposes of coverage and payment. Clarity and transparency are essential to advancing the development and uptake of diagnostics and treatments that improve patient outcomes and value throughout the health care system. While the Draft Guidance has broad application, there is one area of medical innovation that is evolving rapidly where the Draft Guidance may have a disproportionate impact—the area of personalized medicine. Fully understanding what areas, and in what context, CMS intends to apply the Draft Guidance will allow stakeholders to provide more informed comments; thus, we urge CMS to outline anticipated areas of application before finalizing this policy.

In addition to the forgoing, there are a number of specific areas where the Draft Guidance should be modified in order to provide adequate notice of the agency’s intentions and expectations. The Draft Guidance does not provide sufficient standards or criteria for evidence review and the basis for accepting (or rejecting) the evidence offered for purposes of the CED policy. Furthermore, the Draft Guidance makes reference to the Agency for Healthcare Research and Quality (AHRQ) in the application of CED, but does not delineate the process or role of the AHRQ except in a broad manner. AHRQ is engaged in an array of activities, and it is difficult to determine what role or activities CMS intends for AHRQ. Furthermore, the process outlined by the agency to generate evidence may create significant entrance barriers to all but the most established health care stakeholders that may perversely prevent the entry and uptake of diagnostics and therapeutics that significantly improve patient outcomes as well as value. We strongly urge CMS to assess the possible long-term structural barriers that the agency is erecting and assess whether alternative methods and processes are available to support the application of the process outlined in the Draft Guidance. For example, there is significant concern that the CED policy may be applied in areas that constitute the practice of medicine, such as laboratory diagnostic tests (LDTs) which are performed and used by physicians and undertaken in laboratories that are already subject to rigorous oversight and review and subject to accreditation requirements. We would oppose issuance of evidentiary standards that negatively impact LDTs and subject them to the CED policy just because they are not FDA-approved, for example.

The AMA also believes it is essential that CMS apply the CED policy within the context of a National Coverage Determination (NCD). We are concerned that any other approach is misleading and inappropriately undermines adequate notice to impacted stakeholders. In addition, it could, in theory, lead to a duplication of effort if the CED policy is invoked in a number of regions for the same therapeutic or diagnostic (although this would be unlikely given that one region invoking the CED policy would likely result in de facto national application since it is probable that a subsequent determination made by the region would be adopted nationally). The NCD process is an established, well-known, transparent process that is open to the public. Support for the NCD process is also rooted in a growing concern that in certain areas of medical innovation, CMS should guard against delegation of national agency decision-making to entities or individuals that have not implemented transparent, stakeholder driven processes and are not adequately versed in the due process and notice requirements involved in the administration of federal health care program as CMS staff are.

Thank you for the opportunity to comment on the Draft Guidance. If you have questions, please contact Mari Savickis, Assistant Director of Federal Affairs at or (202) 789-7414.


James L. Madara, MD