Proposed MEDCAC Charter

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I am an Independent Patient Advocate. I am "truly" Independent. Indeed, we are in a day and age when the scrutiny of raw "Conflicts of Interest" as well as mere hints and allegations of "Conflicts of Interest" must be examined, ventilated, and vetted as never before.

I am eager to be on this Committee.

Evidence based outcomes should always be the highest priority.

Peer-reviewed outcomes analysis are of paramount importance to the administration of CMS activities.

If there are to be exceptions to the above, then those exceptions should only be considered by objective panels of experts.

Public Communiques by CMS are essential to addressing Public concerns, ideas, cost-benefit scenarios, etc.

Due Process and Due Diligence should be our mainstay of behavior for and on behalf of the people of the United States of America.

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The proposed change to the charter was supposed to incorporate: "The most substantial change we are proposing to the current Charter is the ability for CMS to broaden the use of the Representative role on MEDCAC." and " Under the proposed Charter, at-large members to MEDCAC (those not in special roles like the Chairs, industry representatives and patient advocates) will be able to elect to serve as either an Special Government Employee (SGE) or a Representative. The Representative is allowed to be informed by his/her supporting constituency prior to the meeting, in comparison to the SGE who represents only himself or herself."

The previous 11/2012 charter on page 3 paragraph 3 sentence 1 "...100 member that will be appointed as Special Government Employees or Representatives." The current proposed charter 11/2014 says the same thing. No where in the current charter is there any mention of the language that printed at the top of the "Public Comment page". If there is a change to expanding the role then where is it defined?? Is there another document or a page of definitions? Because it is NOT in the proposed Charter.

But what is in the proposed charter is deleting the term "non-voting" when referencing industry representatives and guests. It is assumed that with this change then industry representatives and guests can now vote and contribute to a majority opinion coming out of subcommittees and the Committee work. The industry and guest being able to influence the process will assure that the concensus process will be watered down and the concensus will make recommendations that may not be supported by the medical data or even be medical best practices. I would recommend against industry and guests being given the power to vote and contribute to the concensus process. This is very self serving.

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• Members of Industry request that the change in the new charter be clearer and that it include what the anticipated balance is between Special Government Employees (SGEs) and representatives for a given meeting.
• CMS should denote who is serving in what role when they post the roster in advance of the meeting so that the representatives, if permitted, can be engaged accordingly.
• CMS should ensure the roster and the panels selected for each meeting has adequate representation of experts of the technology or procedure under discussion. Despite the majority of MEDCAC meetings being on diagnostics, preventive services, devices, and surgical procedures, there are still few representatives of these industries on the roster and panels

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Dear Administrator Tavenner,

The Alzheimer’s Association appreciates the opportunity to comment on the proposed changes to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Charter.

The Alzheimer’s Association is the world’s leading voluntary health organization in Alzheimer’s care, support, and research. Today, there are more than 5 million Americans living with Alzheimer’s disease. Alzheimer’s is the sixth leading cause of death in the United States, and the only cause of death among the top 10 without a way to prevent, cure, or even slow its progression. The vast majority of these individuals depend on the Medicare program for access to health coverage and services.

In January 2013, the Alzheimer’s Association, along with other experts in the dementia care and research fields, had the opportunity to testify before MEDCAC on beta amyloid positron emission tomography (PET) imaging and its role in early and accurate diagnoses of Alzheimer’s disease. The question at hand amyloid PET scanning was highly technical; unfortunately, MEDCAC members lacked a fundamental understanding of and sensitivity to dementia and the population affected by it. Panelists were forced to spend their limited time before MEDCAC providing a very basic education on the disease, leaving little opportunity to discuss the risks, benefits, and significance of the test. MEDCAC members lacked a rudimentary understanding of a disease prevalent and growing among Medicare beneficiaries.

The Alzheimer’s Association believes that one particular proposed change to the MEDCAC Charter can better educate MEDCAC members in the future. Allowing supporting constituencies to inform Representatives will bring broader and deeper knowledge to the complex issues MEDCAC faces. We support CMS’s proposed change to the Charter and encourage the agency to explore additional actions to ensure that those charged with crucial decisions such as coverage determinations are as knowledgeable as possible.

Thank you for the opportunity to comment. The Alzheimer’s Association would welcome a chance to serve as a resource to MEDCAC and how its work relates to individuals living with Alzheimer’s and related dementias. Please contact Laura Thornhill, Manager of Regulatory Affairs, at 202-638-7042 or lthornhill@alz.org if you have questions or if we can be of additional assistance.

Sincerely,

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August 29, 2014

BY ELECTRONIC DELIVERY

Sylvia M. Burwell
Secretary
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201

RE: Proposed Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) Charter

Dear Secretary Burwell:

The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the proposed changes to the Medicare Evidence Development and Coverage Advisory Committee’s (MEDCAC’s) charter, which were released on August 1, 2014.¹ BIO represents more than 1,000 biotechnology companies, state biotechnology centers, academic institutions, and related organizations both in the United States and abroad. BIO members are critical contributors to the research and development of innovative health care, agricultural, industrial, and environmental biotechnology products.

The novel therapeutics, vaccines, and diagnostics our members bring to market can improve health outcomes and reduce healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions—but only if patients have access to them. Consequently, BIO has a vested interest in MEDCAC’s role as an advisor to the Centers for Medicare and Medicaid Services (CMS) on issues of coverage, which can impact whether beneficiaries have timely access to the medical technologies that are most appropriate for them. BIO believes that the diverse composition of MEDCAC has the potential to lend tailored expertise to the issues that come before the Committee, but in the past not all members were able to participate to the same extent.

BIO supports the proposed changes to the MEDCAC charter because we believe they address this issue effectively. Specifically, many of the changes serve to remove the “nonvoting” status previously assigned to all six required representatives of the industry. If finalized, these changes will allow members representing industry to participate to the same extent as all other MEDCAC at-large members. This is important to be able to more effectively leverage the clinical, scientific, and policy expertise these members possess to better inform the Committee’s recommendations to CMS. These industry representatives also can provide needed perspective on the practicalities of medical technology research and development and use. Thus, we urge that these proposals be finalized and the updated charter approved.

BIO would also like to take this opportunity to remind CMS that one of MEDCAC’s primary strengths is the ability to populate MEDCAC panels for a specific meeting with committee members who have the most relevant expertise on the issues to be discussed. In part, the number of members is kept relatively high—up to 100 Special Government Employees and Representatives—in order to maintain access to a diversity of experts willing to participate on the Committee. However, it is our observation that this expertise has not always been deployed as judiciously as needed, such that the expertise of participants on individual MEDCAC panels has not always been the most appropriate for the issues being discussed. BIO is concerned that, in these instances, the Committee’s recommendations may not be on the soundest scientific, clinical, or policy footing. Therefore, simultaneous to approving the proposed changes to the charter, we urge MEDCAC to review its internal policies for assigning members to particular meeting panels to better ensure that those making coverage recommendations have the specific expertise and experience to do so well.

BIO reiterates our appreciation for the opportunity to comment on the proposed changes to the MEDCAC charter and looks forward to continuing to engage with the Committee on important issues impacting Medicare beneficiaries’ access to needed care. Please do not hesitate to contact me with any questions.

Respectfully submitted,

1 Centers for Medicare and Medicaid Services. 2014 (August 1). Proposed MEDCAC Charter. Baltimore, MD: CMS, Available at: http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=25.

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