Medicare Coverage Policy ~ MCAC

Executive Committee

Minutes of March 1, 2000 Meeting
(For more information, contact the Executive Secretary.)

OPEN SESSION

In accordance with the provisions of Public Law 92-463 this meeting was open to the
public; no part of this meeting was closed to public participation

Health Care Financing Administration
Main Auditorium
7500 Security Boulevard
Baltimore, MD 21244

The Executive Committee (EC) of the Medicare Coverage Advisory Committee (MCAC) met to hear a report from its Subcommittee and to discuss and consider the levels of evidence and types and presentation of information that it believes should be considered by the medical specialty panels at future MCAC meetings. The meeting began with the introduction of the Committee, a reading of the conflict of interest statement, and the call to order.

Opening Remarks. The Office of Clinical Standards and Quality (OCSQ) made opening remarks, stressing that HCFA continues to see its mission as beneficiary-focused and stated its goal to assure access to health care for the Medicare population. The representative stressed that science should have a role in coverage decisions, keeping in mind the Congressional mandate that Medicare will pay only for those items or services that are reasonable and necessary for the diagnosis or treatment of an illness or injury. He concluded that critical examination of the scientific literature is complex and that HCFA is grateful for the Committee’s work in this area.

Subcommittee Report. The Chairperson introduced the members of the Subcommittee and presented their report entitled "Recommendations for Evaluating Effectiveness." He stated the document’s two purposes: 1) to provide general guidance to the panels on how to evaluate evidence, and 2) to suggest specific procedures the panels should follow when drawing conclusions about the adequacy of the evidence and the magnitude of its effect. The goals of the document are to make the evaluation process more predictable and consistent, so that panel decisions are more understandable, accountable, and transparent. He then went through the report on an item-by-item basis. He concluded by proposing a timeline for a typical MCAC evaluation and solicited comments from the Subcommittee. The Industry Representative raised three concerns about the report: 1) its overall tone and assumption that new technology must first be proven, 2) the availability and rigor of evidence over time for a technology was not taken into account, and 3) its implementation process was unclear. The Consumer Representative emphasized the amount of effort and discussion that occurred during Subcommittee deliberations, including editing tone and verbiage before reaching the present draft.

Open Public Comments and Scheduled Commentaries. During the morning session, panelists heard from nine speakers and testimony from the ACP-ASIM was recited by the Executive Secretary.

Dr. Guido Tricot, Director, Myeloma Transplant Center, University of Arkansas, expressed a number of issues. Firstly, in considering autologous stem cell transplants for multiple myeloma patients, exclusion criteria should be used to assess co-morbid conditions, not biological age. Secondly, he felt that mechanisms are needed to assure that the explanation of the panel’s conclusion reflects the view of the panel and not just that of the Chairperson. Thirdly, he stated that the conclusions of a medical specialty panel should be publicly available to afford review and comment prior to the EC meeting. Dr. Tricot then addressed the difficulties of performing randomized clinical trials. He cited barriers in obtaining data using new treatment regimens, such as the affects of patient referral patterns on randomization. Finally, he suggested that time lapses between the process initiation and implementation of coverage determinations could be shortened using a temporary approval mechanism.

Dr. Richard Justman, National Medical Director of United Health Group, spoke on behalf of the American Association of Health Plans (AAHP). He stated that AAHP endorses a rigorous, evidence-based approach to coverage determinations. He applauded the establishment of MCAC, and asserted that the Subcommittee’s report will promote systematic and consistent evaluation of the clinical evidence. Dr. Justman stated that the variation, use, and quality of heath care services and the proliferation of unproven treatments, illuminate the importance of promoting a delivery of care that is based on robust, scientific evidence. He then gave some illustrative examples.

Morgan Downey, Executive Director of the American Obesity Association, gave statistics on the increase in obesity in the U.S. He proposed that when the EC evaluates evidence for new services or items, it consider whether a representative sample, by weight, of the current Medicare population was included. He also proposed that the EC begin a process to clarify Medicare coverage of obesity and cited examples of discrepancies in the Coverage Issues Manual.

Dr. Donald S. Baim, Chief of Interventional Cardiology, Beth Israel Deaconess Hospital, spoke on behalf of the Health Industry Manufacturers Association (HIMA). His three main points were: 1) a variety of evidentiary sources, such as randomized clinical trials, registries, equivalence trials and objective performance criteria (OPCs), are needed; 2) evidence trials used to support FDA approval should be considered; and, 3) delays in coverage decisions restrict application of new therapies and add to hospital’s and industry’s financial burden. Dr. Baim then gave a history of the use of patient registries in the area of interventional cardiology that led to the development of OPCs.

Wayne I. Roe, Chairman of Covance Health Economics & Outcome Services, spoke at HIMA’s request. He stated the importance of the EC encouraging better science, but questioned whether the report’s tone would have that effect. He said the EC should be realistic about levels of evidence, rather than requiring randomized controlled trials (RTCs) and that such a requirement would prevent decision-making and stall medical progress. He suggested the EC use data gathered in support of FDA approvals. He asked the EC to question old technologies as well as new innovations. Lastly, he advocated implementing a provisional coverage process so as not to discourage innovation and research.

Vicki Gottlich, an attorney for the Center for Medicare Advocacy, Healthcare Rights Project, stated that her organization represents low-income Medicare beneficiaries. She expressed concern that the current process available to beneficiaries (national coverage, claims and appeals processes) does not protect beneficiary rights and is too slow. She applauded the EC for its efforts in clarifying coverage issues, but pointed out that a lengthy process deprives beneficiaries of prescribed services because of delays incurred while evidence is reviewed. She advocated an efficient coverage determination process, and an effective and expeditious appeals process.

Dr. Larry Weisenthal, a medical oncologist in private practice, expressed his concerns that the Subcommittee’s report lacked adequate consideration of laboratory issues. He stated his frustration after a recent experience at an MCAC meeting on human tumor assay systems (HTAS). He felt that key parts of the proponent’s presentations were not given adequate opportunity for the panel’s review or consideration. He emphasized that his purpose was to help develop a better process for future reviews, not to complain about the past. He encouraged the EC to appreciate important advances in medicine that are occurring outside the traditional NIH and university research arenas and that HCFA must ensure these proponents hold a central role in the evaluation of new technology. He proposed a modification to the overall process by which panel members receive, review, and transmit information to the proponents prior to a meeting. Dr. Weisenthal then submitted written remarks for consideration.

Sandy Sherman presented a statement from Dr. E. Ratcliffe Anderson, Executive Vice President and CEO of the American Medical Association (AMA). Dr. Anderson stated that he was impressed and gratified by the commitment of the EC and HCFA to ensure that MCAC recommendations would be grounded in scientific evidence. The AMA commended the EC for recommending that panelists play an active role in the process. Dr. Anderson stated that the report has allayed fears that those with vested interests, rather than medical evidence, might drive coverage decisions. He concluded by encouraging adoption of the Subcommittee report.

Thomas Meskan, President of Medical Alley, provided a number of suggestions and modifications for improving the report. He requested that a panel’s written explanation be specific about which health outcome (e.g., mortality, morbidity, quality of life, etc.) factored into its decision. Additionally, Mr. Meskan suggested amending some of the report’s wording and volunteered to assist the EC.

The Executive Secretary read into the record a letter received from Dr. Whitney W. Addington, President of the American College of Physicians-American Society of Internal Medicine (ACP-ASIM). The letter offered a number of suggestions on the Subcommittee report and was generally supportive of the report’s recommendations and objectives.

HCFA Presentation. Dr. Jeffrey L. Kang discussed his experience in evaluating new technologies. He asked the EC to consider, during its deliberation how the patient’s condition, availability of alternatives, and risks associated with the service should affect viewing the evidence. Dr. Hugh F. Hill noted HCFA’s intent to balance timeliness with a national coverage process that is accountable. He stated HCFA’s goal to reach well-reasoned, scientifically sound decisions as rapidly as can be consistent with the level of quality. He raised a couple of concerns about the report. He stated that written panel explanations should not delay a decision; and, indicated HCFA’s commitment to present high-quality and well-organized information within stated timeframes –using outside expert review of evidence reports only if required. Dr. Hill reiterated HCFA understood its responsibility for making final coverage decisions, but that MCAC input is integral to the review process.

Open Committee Deliberation. One panelist raised a process issue. He proposed adopting the current Subcommittee report for the next round of medical specialty panel meetings while soliciting written comments to be considered at the next EC meeting. Panelists agreed the present document was an interim version, but preferred to go through the document section by section in order to make comments or suggestions on its language. They expressed their intent to revisit the document at future meetings, as needed and as new information became available. The Chairperson asked the EC to focus on the technical content of the document rather than on its tone, recognizing that written public comments will be forthcoming. The committee agreed with the Chairperson’s request, adding that revisions to the report’s tone could be made if time permitted. The report was then computer-projected as an overhead and the Chairperson solicited remarks from the EC on a paragraph by paragraph basis. Panelists had a number of suggestions and comments. A few panelists were assigned tasks to revise specific passages. These panelists then submitted their remarks for the entire EC’s consideration. The EC openly discussed each suggestion or comment, and if agreed upon, the report was amended to reflect the change. The Committee deliberated extensively on the report’s requirement that a panel must explain its conclusions in writing, commenting on the form and process that should be used, and whether or not the Chair should be responsible for the written explanation.

Motion, Discussion and Vote. The EC voted on the following motion related to the Subcommittee’s document. A quorum of 11 voting members was present, no member was recused due to an appearance of a conflict of interest:

A motion was made and seconded that the operational documents of a panel meeting should consist of the transcripts and meeting summary (prepared by HCFA, using the transcripts and certified by the Chairperson) including the content/reason for the vote. At the panel meeting, the agenda will include an opportunity for each panel member to give their rationale for his/her vote, and an opportunity for the Chairperson to provide his/her opinion. Each member also has the option of providing his/her written opinion, including any dissenting or minority views. The motion carried with 8 for, 2 against, and 1 abstention.

Those opposed were uncertain about when these documents would be prepared or available. Others felt that the Chairperson should be responsible for drafting the explanation of the panel’s conclusions, which should then be circulated to panel members for their comments and/or approval. Another panelist felt the Federal Advisory Committee Act (FACA) reporting requirements were sufficient.

Open Committee Deliberation. The EC continued its discussion on the Subcommittee report and made recommendations regarding the structure of the evidence to be provided to the medical specialty panels. One member suggested the medical specialty panels gain experience creating evidence reports before the EC make recommendations. Another panelist stated her preference to receive the literature, not just a summary report of the evidence. The Industry Representative raised concerns about timeframes, panel involvement, and assembly of the evidence report. The EC also discussed having the evidence report reviewed by experts.

Open Public Comments. During the afternoon session, panelists heard testimony from 4 speakers:

Steven Northrup, Executive Director of the Medical Device Manufacturers Association (MDMA), asked the Committee to keep in mind the incremental nature of medical advances and that they don’t necessarily require de novo review. He asked that the evidence hurdle not be set so high that manufacturers would have difficulty in meeting their requirements. He also stressed that the MCAC process should be timely as to prevent unnecessarily slowing down innovation.

Kenneth Cook, a facilitator for a cancer support group at the University of Maryland Medical Center, commented on issues of external validity and Medicare patient enrollment in clinical trials. He noted that since Medicare does not pay for experimental protocols, and most Medicare beneficiaries don’t carry separate insurance, they are often left out of the clinical studies if they have no other independent means. Secondly, he pointed out the number of patients enrolled in rare disease studies will be small compared to more prevalent disorders. He asked the EC to not require the same degree of proof for all studies.

Thomas Meskan of Medical Alley asked the EC if it would accept public comments concerning tone of the document. The Chairperson stated that the report would be available for comment and those comments will be considered on a periodic basis.

Dr. Steve Lascher, of ACP-ASIM, commented on an overhead that was presented. He noted that statistical power was mentioned on the issue of generalizability. He stated that since statistical power relates to a Type II error, perhaps sample size would be a more appropriate term than generalizability.

Motion, Discussion and Vote. The EC voted on the following motion as it related to the Subcommittee’s document. A quorum of 10 voting members was present, 1 member voted in absentia:

A motion was made and seconded that the EC approve the Subcommittee’s report and recommendations as amended, as an interim report, and that the EC would revisit the report and revise it as needed, in response to comments from MCAC members and the public. The EC would consider revisions to the document at its next meeting. The motion was carried on a unanimous vote, 10 in favor, and 1 one absentee vote in favor.

Adjournment, Wednesday, March 1, 2000, 3:40 p.m. The meeting adjourned at 3:40 p.m.

	I certify that I attended the meeting of the Executive Committee on March 1, 2000, and that these minutes accurately reflect what transpired. _________________________________ Sharon K. Lappalainen, Executive Secretary, HCFA
I approve the minutes of this meeting as recorded in this summary. ______________________________ Harold C. Sox, M.D. Chairperson