For questions regarding specific National Coverage Determinations, please call the Coverage and Analysis Group’s main number, at (410) 786-2281.

For questions regarding the National Coverage Determination Process, please contact Kimberly Long at (410) 786-5702.

I.    Purpose of this Guidance Document

This guidance document relates the factors CMS considers in referring issues to the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). It details the function, structure, process and role of MEDCAC in the National Coverage Determination (NCD) process. More information about MEDCAC is available on the Medicare Coverage Center website.¹

II.    Background

On December 14, 1998, we published a notice in the Federal Register (63 FR 68780) that announced the establishment of the Medicare Coverage Advisory Committee (MCAC), described the qualifications of the members, and solicited nominations for membership.² The MCAC was established to provide independent guidance and expert advice to CMS on specific clinical topics. The Committee operates under a 2-year charter. The current charter, which changed the name to MEDCAC, is available on our website.³ The MEDCAC can be an integral part of the NCD process. The statutorily mandated timeframe for releasing a proposed decision is six (6) months after the formal request date. If CMS requests recommendations from the MEDCAC, the timeframe is extended to nine (9) months.

Topics for deliberation are referred to the MEDCAC when CMS would like independent expert advice in making decisions based upon the reasoned application of scientific evidence. In addition to relying on the MEDCAC for certain NCDs, CMS may convene the MEDCAC to address broad, significant issues relevant to coverage policy development. For example, the MEDCAC has provided expertise and input to help CMS consider the appropriateness of a framework for the evaluation of diagnostic tests; in assessing the strength of the evidence for multi-factorial, non-invasive, “lifestyle” modifying interventions to treat cardiac disease; or in clarifying what constitutes the standard of care in wound therapy. CMS may also make use of the MEDCAC for horizon scanning to help identify developing technologies that may be appropriate for Medicare coverage.

III.    Function

The MEDCAC is advisory in nature, with the final decision on all issues resting with CMS. Accordingly, the advice rendered by the MEDCAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion, in an open forum, with careful framing of recommendations and clear identification of the basis of those recommendations. The MEDCAC is used to supplement CMS's internal expertise and to ensure an unbiased and contemporary consideration of "state of the art" technology and science. MEDCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical, and other related fields.

We base coverage determinations on our evaluation of the strength of the evidence and the potential health outcomes of coverage. The MEDCAC 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 MEDCAC meets in an open forum approximately six (6) times a year to review the submitted evidence, listen to testimony, and deliberate about the quality of the evidence. The MEDCAC judges the strength of the available evidence and makes recommendations to CMS based on that evidence.

IV.    Structure

The MEDCAC consists of a maximum of 100 appointed members. Members are selected by the Secretary from among authorities 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 professions. The Secretary has designated the Director of the Office of Clinical Standards and Quality (OCSQ) as the appointing authority. Members are invited to serve a 2-year term with the option of a 2-year extension. A maximum of 88 members are at-large standing members, 6 represent consumer interests, and 6 represent industry interests. Six of the 88 at-large member positions are reserved for patient advocates. A Chair and Vice-Chair are appointed from among the pool of at-large members. The Chair and Vice-Chair serve 1-year terms and may not serve more than 2 consecutive years in their respective capacities.

Solicitation for new membership is published in the Federal Register (FR), which provides the information required to be considered for nomination. Persons interested in nominating a qualified individual or submitting a nomination for themselves must submit current curriculum vitae that demonstrate expertise in one of the above mentioned authorities. Potential candidates are required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts so that CMS knows the candidates’ potential conflicts of interest. If a candidate is chosen, the potential conflicts of interest will be considered when selecting a candidate for participation in a specific MEDCAC. Interested stakeholders may submit suggestions for member nominations using the comment function on our coverage website.⁴

At-large members have voting rights and must have competence commensurate with the purpose of the MEDCAC. Voting members include clinical and methodologic experts and patient advocates. The members bring clinical, methodologic, ethical or other expertise to the deliberations. Patient advocates identify the issues important to patients and communicate their perspective on topics that come before the MEDCAC. Consumer and industry representatives are non-voting members, but bring the perspectives of beneficiaries and product developers to the MEDCAC discussions. The MEDCAC Chair presides at and conducts the meeting and ensures a balanced discussion of the issues.

All MEDCAC meetings are public. The MEDCAC conducts four to six meetings per year. Thirteen to fifteen members serve at any one meeting including the MEDCAC chairperson and vice chairperson. As of this writing, we select one consumer representative, one industry representative, and one patient advocate to participate at every meeting. We select members to participate in a given meeting for their clinical and scientific expertise related to the topic or topics being reviewed for a specific MEDCAC. CMS may recruit non-MEDCAC members who are subject matter or methodological experts to serve as non-voting panelists to provide additional input to panel members. We may also invite experts to make formal presentations to the MEDCAC for a particular meeting.

V.    Criteria for Referral to the MEDCAC

CMS may refer a topic to the MEDCAC under any of the following circumstances:

• There is significant controversy among experts. The opinions of clinical and scientific experts about the medical benefit of the item or service, the level of competence of providers, the requirements of facilities, or some other significant consideration that would affect whether the item or service is "reasonable and necessary" under the Social Security Act;
  
• The existing published studies contain potentially significant methodological flaws such as flawed design, inappropriate data analysis or small sample size and do not meet our reasonable and necessary standards;
  
• The available research has not addressed policy relevant questions;
  
• The available research has not addressed diseases and conditions or the special needs of the elderly in the Medicare population;
  
• The existing published studies show conflicting results;
  
• CMS would like additional expert review of the methods used in external technology assessments (TAs), particularly when there were questions about a TA, complex clinical issues, or specialized methods such as decision modeling (see guidance document entitled “Factors CMS Considers in Commissioning External Technology Assessments”).⁵
  
• CMS would like greater public input by receiving and considering comments on the effectiveness of an item or service that could be subject to varying interpretations. Obtaining the perspective of affected patients and caregivers (e.g., the degree of perceived benefit, subjective assessment of risk, or burden of side effects) through public comments and voting representatives on the panel may be relevant;
  
• Use of the technology is the subject of controversy among the general public;
  
• When presentation, public discussion, and clarification of the appropriate scope for the technical review, a preferred methodological approach, or a clinical management issue would benefit future NCDs;
  
• Dissemination of a technology may a major impact on the Medicare program, the Medicare population, or the clinical care for specific beneficiary groups;
  
• CMS determines that the NCD process would be better informed by deliberation that incorporates the viewpoint of patient advocates as well as a broad societal perspective of factors not directly related to the scientific review of the evidence but nevertheless relevant to the decision.
  

VI.    Process

Once a coverage issue is referred to the MEDCAC, we schedule a public meeting to discuss the coverage issue under consideration. We develop a structured series of voting questions to be addressed at the MEDCAC. The questions are developed by CMS staff and are reviewed by the MEDCAC Chair and Vice-Chair so that they can offer input and suggest changes. These questions form the basis for the MEDCAC’s deliberations. At the end of a meeting, each voting MEDCAC member scores the questions. The final score is average of each member’s votes.

We publish a notice in the Federal Register on approximately the last Friday of the month, about two months before the meeting. For example, the notice announcing the August 30, 2006 MEDCAC meeting was published on June 23, 2006. The notice describes the topic to be discussed, the time and place of the meeting and how to gain access to the CMS headquarters if needed, how to register for the meeting, and a link to the voting questions on the Coverage website. The Federal Register notice includes instructions for public participation and, if a participant would like to make a presentation, the notice gives instructions for submission of the presentation to CMS, contacts, and the dead line for submission. Notification of the meeting and the voting questions are posted on the coverage website in tandem with the Federal Register announcement. Submissions should include (1) a brief statement of the general nature of the evidence or arguments you wish to present; (2) the names and addresses of proposed participants; and (3) a written copy of your presentation. The presentation should consider the voting questions we have posed to the Committee and focus on the issues specific to the topic.

We require all requests for presentations, any written testimony, and consideration of evidence for the MEDCAC be submitted to us in writing at least 20 days before the meeting. Once a meeting is announced in the Federal Register, we encourage feedback about the voting questions that are to be addressed at that meeting. The public may submit recommendations at any time using our coverage website.⁶ There is no formal process for stakeholders to provide feedback on the questions but CMS always welcome suggestions. During the meeting, time is also devoted to public testimony. The amount of time assigned to each presenter depends on the number of requests.

The meetings usually follow the same agenda structure. The CMS Medical Officer or Lead Analyst assigned to the topic under discussion briefly summarizes the current coverage, coverage request (if any), and presents the voting questions being addressed. Next, if there is a technology assessment relevant to the topic, this is presented, followed by public presentations. There is also time on the agenda for unscheduled open public comments so that the attendees may briefly address the MEDCAC directly relevant issues. Those interested in speaking during the public comment period should sign up during the morning session.

During the last half of the meeting the MEDCAC members deliberate openly on the issue for the remainder of the meeting. Although the public may observe the deliberations, the MEDCAC will not hear further comments except at the request of the chairperson. MEDCAC members may question the presenters for further clarification. Based on their considered judgment, the MEDCAC members make recommendations to CMS on the strength (quality) of the evidence reviewed at the end of the meeting. Then the questions are put before the MEDCAC for voting.

We post the official transcript and executive summary of the meeting on our website. We attempt to post these documents within 30 days of the meeting.

VII.    Review Material

The MEDCAC receives background material in preparation for the meeting. This pre-meeting material is usually distributed to the members in two mailings. The first mailing may include external health technology assessment(s) (TAs) conducted by the Agency for Healthcare Research and Quality (AHRQ) or an Evidence-based Practice Center (EPC) under contract with that agency; any other relevant TAs; an evidence summary prepared by CMS staff; copies of relevant articles reviewed by CMS; FDA documents pertinent to the issue; voting questions; and any other relevant material specific to the topic under review. The second mailing contains the written testimony, public testimony and slide presentations that were submitted by interested parties by the deadline designated in the Federal Register notice. This material is usually distributed to the MEDCAC at least 20 days prior to the meeting. This process is intended to allow sufficient time for the MEDCAC members to review the background materials and prepare for the meeting. In most cases, all materials distributed to the MEDCAC are made available to the public on our website once they are distributed to the MEDCAC members.

VIII.    How to Access CMS’s Home Page

Users can access our home page by entering http://www.cms.hhs.gov. To access information about the MEDCAC, select “Medicare Coverage Center,” then select “Medicare Coverage Advisory Committee” listed under Coverage Process or go to http://www.cms.hhs.gov/FACA/02_MEDCAC.asp#TopOfPage.

¹ See http://www.cms.hhs.gov/FACA/02_MEDCAC.asp#TopOfPage

² http://www.cms.hhs.gov/FACA/Downloads/establish.pdf

³ http://www.cms.hhs.gov/FACA/Downloads/MEDCACcharter.pdf

⁴ http://www.cms.hhs.gov/InfoExchange/06_contactus.asp#TopOfPage

⁵ http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=7

⁶ http://www.cms.hhs.gov/InfoExchange/06_contactus.asp#TopOfPage