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View Public Comments for Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decisions

Ravitz, J.D., Karen S
Senior Policy Advisory
The Coalition of Wound Care Manufacturers (the Coalition)

January 28, 2013

Dr. Louis Jacques
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244–1850

Submitted Electronically

Re: Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the Context of Coverage Decisions

Dear Dr. Jacques:

The Coalition of Wound Care Manufacturers (the Coalition) is submitting the following comments in response to the “Draft Guidance for Coverage with Evidence Development in the Context of Coverage Decisions”. The Coalition represents leading manufacturers of Negative Pressure Wound Therapy (NPWT) as well as surgical dressings and other medical devices and supplies used by Medicare beneficiaries for the treatment of wounds. There has been and continues to be innovative products that are being manufactured within the wound care space. Some of our products would benefit from Coverage with Evidence Development (CED). Since our members have a vested interest in CED this newly released guidance document is of interest and concern to us. The Coalition appreciates the opportunity to offer our comments.

The Coalition welcomes the work that CMS has done with respect to this topic and agrees with the concept of coverage with evidence development. The recent coverage with evidence development for autologous platelet-rich plasma wound therapy was very well received in our industry. Many of the concepts that were outlined in the CED for this subject were in line with the wound research principles that the Alliance of Wound Care Stakeholders had created. This paper, “Consensus Principles for Wound Care Research” was published in the May/June 2012 edition of Wound Repair and Regeneration. The Coalition supported the Principles contained in this document and we recommend that CMS continue to utilize the information contained in the Alliance paper in the context of first line coverage and when applying CED for wound care items and services. With the wide variation in design, conduct, and reporting of wound care research studies, it is hoped that these consensus principles will improve the standard and practice of care in our field.

That being said, we have concerns that the Agency might use CED as a first-line coverage mechanism for emerging or existing technologies; we urge CMS to continue its long-standing practice of allowing coverage at the local contractor level, and then considering alternative policies (including CED) when there is a reason to question the reasonableness and necessity of coverage under Social Security Act § 1862(a)(1)(A). As such, the Coalition requests further clarification about CED at the local contractor level. It is unclear how CED at the local level would work. With the potential for different study design and different types of studies in various jurisdictions – which could be contradictory – the Coalition believes that it would be too confusing and costly to manufacturers to have CED at the local level. Therefore, the Coalition recommends that CED be limited to national coverage decisions rather than at the local level in order to remove the potential for duplicative and inconsistent evidence requirements across the various jurisdictions.

CMS also noted that “there is a potential period of non-coverage between the end of the study and the agency’s review of the scientific results”. The Coalition requests that CMS continue to cover the item or service while the evidence is being reviewed and only if CMS determines the evidence to be insufficient or not satisfactory, to issue a non-coverage for the item or service. This will allow for more continuity of care – which benefits the patient. Therefore, the Coalition recommends that CMS continue to cover the item or service until CMS has reviewed the evidence and a decision has been issued.

Finally – the 2006 guidance contained 8 principles for CED that were not included in this newly revised draft guidance document. These 8 principles provided a useful benchmark for all stakeholders and helped ensure that CED would be applied consistently and would not unnecessarily limit access to items and services for patients. The 8 principles include:

  1. NCDs requiring CED will occur within the NCD process, which is transparent and open to public comment.
  2. CED will not be used when other forms of coverage are justified by the available evidence.
  3. CED will in general expand access to technologies and treatments for Medicare beneficiaries.
  4. CMS expects to use CED infrequently.
  5. CED will lead to the production of evidence complimentary to existing medical evidence.
  6. CED will not duplicate or replace FDA’s authority in assuring the safety, efficacy and security of drugs, biological products and devices.
  7. CED will not assume NIH’s role in fostering, managing or prioritizing clinical trials.
  8. Any application of CED will be consistent with Federal laws, regulations and patient protections.

In the draft guidance, CMS provides a different list of standards of scientific integrity and relevance to the Medicare population and deletes these 8 principles governing the application of CED from the 2006 Guidance, saying that "some" of the 2006 principles are now moot. The Coalition strongly disagrees. We believe that all the principles and guidelines of the 2006 Guidance continue to be relevant. As such, the Coalition urges CMS to ensure that the 8 principles are included in the final 2013 CED guidance.

We appreciate the opportunity to comment on this guidance document. If you need more information or have any questions, please do not hesitate to contact me.


Karen S Ravitz, J.D.
Senior Policy Advisory