January 20, 2012
Louis Jacques, M.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: Public Comments regarding CED Public Solicitation
Dear Dr. Jacques,
On behalf of the Neurostimulation Device Alliance (NDA), we appreciate the opportunity to provide comments in response to the Center for Medicare & Medicaid's (CMS) public solicitation of November 7, 2011 on ways to improve the Coverage with Evidence Development (CED) process.
The NDA represents the leading United States manufacturers and providers of high-quality products used for rehabilitation, pain management, and physical therapy. Among other products, NDA members manufacture and distribute home electrotherapy products, which include Transcutaneous Electrical Nerve Stimulation (TENS) devices for pain management and such related supplies as cutaneous electrodes. Our members and affiliates manufacture and provide the vast majority of TENS devices and supplies on the United States market today. We are the market leaders in this medical device sector and have substantial and longstanding clinical, technical, and regulatory expertise.
The opportunity to comment is especially important to NDA members because of the recent decision by CMS to initiate a review of existing TENS coverage with the possibility of using CED as a coverage option (See CAG-00429N, 09/13/2011). The possibility that CED would apply to an existing technology which is already covered raises an important question about the scope of the revised CED guidance document which we discuss in greater detail below. We also ask CMS to consider our suggestions on other matters regarding CED also discussed below.
CMS should limit the scope of CED to promising, new technologies rather than those already covered
Historically, CED has been used as a coverage pathway for promising, new technology and treatments. However, the recent decision by CMS to consider application of CED for TENS, a therapy that is covered under a national coverage determination (NCD), effective in 1995, and subsequent local coverage determinations (LCDs) detailing indications and limitations of coverage, raises questions and concerns about the proposed scope of the prospective CED guidelines.
The history of the CED initiative shows that it has been used to influence coverage decisions applicable to newly emerging technologies, or new indications for use, that appear promising but lack a sufficient evidence base to support full coverage. According to CMS's April 2005 draft CED guidance, the CED was deemed necessary because of the "growing recognition that the rapid adoption of promising new technologies that improve outcomes could be promoted by linking technology diffusion to timely demonstrations of the value of new technologies in actual practice involving Medicare beneficiaries."1
The rationale on which the CED initiative rests is that some promising but unproven service might meet the "reasonable and necessary" mandate of the Medicare statute if more evidence is developed through registries or more rigorous clinical trials. According to Dr. Sean Tunis, former Chief Medical Officer and Director of CMS's Office of Clinical Standards and Quality, which oversees the Coverage and Analysis Group, the CED initiative was intended to link "Medicare coverage of specific promising technologies to a requirement that the patients participate in a registry or clinical trial.”2 The Final Report of the Center for Medical Technology Policy submitted to the Medicare Payment Advisory Commission ("MEDPAC") in May 2010 describes CED as one limited to coverage for "potentially important new technologies" and a "special provision or program that provides policyholders with temporary coverage for a medical technology deemed 'experimental' or 'investigational' and excluded from normal coverage."3 The report further notes that CED was originally established to "provide rapid access to potentially important new technologies, frequently at a point when those technologies have not been fully evaluated."4
The NDA supports the historic goal of using CED as a pathway to gain evidentiary support for promising new technologies. Such an approach is in keeping with implementing CED to “accelerate Medicare beneficiaries’ access to innovative items and services” as mentioned in the recent solicitation. Yet, in recent public meetings as well as in the notice to review TENS coverage, CMS has indicated it may use CED to review technologies already determined reasonable and necessary under 1862(a)(1)(A) of the Social Security Act. Using the CED process described in the 2006 guideline in this manner raises serious concerns. It would create barriers rather than enhance patient access which was the original intent of CED and creates uncertainty for stakeholders who have already gone through the CMS approval and FDA process. An item or service that is commonplace in clinical use would now be restricted to the chosen few beneficiaries and providers who are participants in the trial or registry.
In short, the original purpose of the CED initiative would be defeated if CMS adopted a revised CED process that limited patient access to existing technologies that have long shown to be reasonable and necessary.
CMS should consider alternatives for implementing Coverage with Appropriateness Determination (CAD)
According to its July 12, 2006 CED guidance document, CMS could require CAD to ensure that new technology is provided appropriately to patients meeting specific characteristics as described in the national coverage determination (NCD). Under the 2006 guideline (now removed with the most recent request for comments), CAD would require providers to submit extra data to databases or registries specifically designed for collecting data and “only items or services for patients who are included in the data collection are covered.” CMS should take this opportunity to review existing CAD requirements. For instance, CMS should consider expansion of coverage beyond the existing, restrictive situations where evidence is collected. CMS should also consider other forms of data collection to gather relevant evidence besides automatically requiring use of costly and time consuming registries. Other possibilities include development of beneficiary surveys or other claims-based reporting already mentioned by others who have commented.
The CED guidelines should not apply to NCDs until the guidelines are finalized
In its solicitation, CMS asked for comments about “implementation of CED through the national coverage determination (NCD)” process. First, the NDA recommends that CMS refrain from initiating any new NCDs envisioning the application of CEDs until all public input has been considered and the CED review process is finalized. Second, in cases where CMS has already initiated a review of existing NCDs envisioning use of the CED, the Agency should withdraw the NCD until stakeholders have had a chance to provide input about the impact of the CED changes on the NCD. Otherwise, an untenable and unfair situation could arise similar to that of coverage review of TENS. In September 2011, CMS initiated review of existing TENS coverage and specifically sought comment on how the 2006 CED paradigm could apply to TENS. The NDA responded to this request based on its understanding of the 2006 CED guideline before the NCD comment period closed in October 2011. In November 2011, the 2006 CED guideline was formally withdrawn even though CMS still plans to issue its proposed decision memo regarding TENS in March 2011, presumably before a new CED is published. By imposing an uncertain CED process on a proposed NCD, CMS is preventing stakeholders such as the NDA from fully understanding and submitting views on the impact of the CED on their technology.
The principle CMS adopted as part of its 2006 guidelines require CED occurring within the NCD processes to be “transparent and open to public comment” should apply here. This principle was also incorporated into the 2003 Medicare Prescription Drug, Improvement, and Modernization Act which imposed long sought procedural and transparency changes to Medicare's national and local coverage determination process in order to better inform the public, the Congress, and the Medicare stakeholder community about CMS coverage decisions and their underlying assumptions.5 The NDA urges CMS to refrain from initiating or withdraw from review NCDs that include application of CED. Only after the CED process is complete should the NCD process be reinstated, thus allowing stakeholders an opportunity to comment on the impact new CED criteria may have on the NCD.
CMS should develop a process to enhance stakeholder involvement
In its recent notice, CMS says it “believes that public input should inform” the CED development process. We agree and suggest that stakeholder input should go beyond a one-time provision of comments to include a subsequent process of involvement. This process would allow CMS and other stakeholders to engage in a deeper dialogue about the issues raised here and by others who have commented. Such an approach would ensure that Medicare beneficiaries have access to treatments while developing research strategies aimed at developing more evidence.
The NDA appreciates this opportunity to provide these comments. We look forward to being involved in any subsequent discussions regarding the use of CED as part of coverage development.
/ Thomas P. Hughes/
Thomas P. Hughes, JD
Neurostimulation Device Alliance
12400 Whitewater Drive, Suite 2010
Minnetonka, Minnesota 55343
1 CMS Draft Guidance for the Public, Industry, and CMS Staff, Factors CMS Considers in Making a Determination of Coverage with Evidence Development, April 7, 2005, p. 4.
2 Medicare's Coverage With Evidence Development: A Policy-Making Tool, 3 Journal of Oncology Practice 296-301, 297-98 (2007).
3 The Comparative Effectiveness Research Landscape in the United States and Its Relevance to the Medicare Program, Final Report prepared for The Medicare Payment Advisory Commission by the Center for Medical Technology Policy, May 31, 2010, p. 26
5 Pub. L. No. 108-173, § 731 (2003).