CMS re-charters committee to advise on evaluating medical technologies

The Centers for Medicare & Medicaid Services (CMS) today announced that the Medicare Coverage Advisory Committee has been re-chartered through 2008, and as part of this re-charter, the agency has updated the Committee?s role in the Medicare national coverage process.

Today?s re-chartering extends the life of the Committee through autumn 2008, and signals three important changes.

First, the new charter re-designates the Committee from the Medicare Coverage Advisory Committee (MCAC) to the Medicare Evidence Development & Coverage Advisory Committee (MedCAC).

The Committee?s new name follows in response to the second change made in this year?s charter?MedCAC now has an explicit responsibility to advise CMS as part of its coverage with evidence development (CED) activities. The CED initiative involves the issuance of national coverage determinations that include, as a condition of payment, requirements for developing additional clinical data on a particular medical technology.

?We see enormous potential in working with the MedCAC to expand the coverage process to include additional data collection that will ensure appropriate provision of care, while also developing data of direct clinical relevance to Medicare beneficiaries and the doctors who treat them,? said Acting CMS Administrator Leslie V. Norwalk, Esq. ?And by renaming the Committee the MedCAC, we are acknowledging its new role in our evidence development initiatives.?

Thirdly, the new charter formalizes the role of patient advocates on the Committee. Since 2005, each Committee meeting has included a patient advocate as a voting member on each expert panel. By establishing the patient advocate as a permanent MedCAC role, CMS is ensuring that the beneficiary community is represented on the panels?these advocates will identify issues most important to patients, communicate the patient perspective, and vote on the Committee?s recommendations with patients? general interests in mind.

?Adding the patient advocate is another excellent example of CMS? efforts to establish formal networks with the numerous constituencies that the Medicare program works to serve,? said Barry M. Straube, M.D., Chief Medical Officer of CMS and Director of the Office of Clinical Standards and Quality. ?As part of the MedCAC, the patient advocate will help steer the development of evidence that is most important to our beneficiary population.?

CMS has relied on the expertise of this Committee since 1998 to develop recommendations about specific issues of Medicare coverage and to review and comment upon proposed or existing Medicare coverage policies. The Committee consists of up to 100 appointed members, who are selected for their expertise in clinical and administrative medicine, biologic and physical sciences, public health administration, patient advocacy, health care data and information management and analysis, health care economics, medical ethics, and other related disciplines. Up to 88 members are at-large standing voting members, with 12 nonvoting members (6 representing consumer interests, and 6 representing industry interests).

The Committee reviews and evaluates medical literature and technology assessments, and examines other available data and information on the effectiveness and appropriateness of medical items and services that are under evaluation at CMS. The Committee conducts several public meetings per year to review the submitted evidence, listen to testimony, deliberate, and, after arriving at a considered judgment, provide CMS with recommendations as to the strength of the evidence reviewed. Recent topics under the Committee?s consideration include treatments for the prevention of sudden cardiac death, techniques for managing types I and II diabetes, and pharmaceutical options for stopping the progression of degenerative eye diseases that lead to blindness.

?Members will welcome the expanded responsibilities of the Committee. With their new role in implementation of the CED initiative, they will draw upon their expertise to help improve the information that guides coverage and clinical decisions,? said Alan M. Garber, M.D., Ph.D., MedCAC chair. ?Ultimately, this will lead to better care for Medicare beneficiaries.?

To accompany the changes in the MedCAC charter, CMS has issued a guidance document entitled, ?Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee.? This document is consistent with Section 731 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, and is in line with CMS? goal of continuing to develop a more open, transparent, and understandable national coverage process.

Today?s guidance document follows a 60-day public comment period in spring 2005, in which CMS received several comments from the stakeholder community, many of which were incorporated into today?s final document.

CMS has also issued guidance documents on the factors the Agency considers in opening national coverage determinations, commissioning external health technology assessments, and collecting data as part of the CED initiative. While these documents outline major components of the NCD process, they continue to be non-binding documents that serve to communicate CMS? current thinking on a given topic.

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