December 20, 1999

Via Facsimile 202-401-1405 and First-Class U.S. Mail

Sheree R. Kanner
Chief Counsel
Health Care Financing Administration
Office of the General Counsel
Room 5309, Cohen Building
330 Independence Avenue, SW
Washington, D.C. 20201

Re: MCAC Subcommittee Meetings

Dear Ms. Kanner:

On behalf of the Health Industry Manufacturers Association ("HIMA"), we must express our concern regarding both the past and contemplated practices of the Medicare Coverage Advisory Committee, its Executive Committee (the "EC") and the individual panels (individually or collectively, the "MCAC").

Based on a motion made at the December 8, 1999, EC meeting, HIMA understands that the EC intends to task a subcommittee with formulating the formal structure and process for the panels to follow in evaluating new services and items for coverage. This structure and process as described and contemplated by the EC translates into essentially the "reasonable and necessary" criteria and evidentiary standards the individual panels will use in making their Medicare coverage recommendations ("Criteria"). Further, HIMA understands that this subcommittee hopes to meet in private, and plans to report back to the EC. However, apparently in parallel, an April 27, 1999, Notice published by the Health Care Financing Administration ("HCFA") announced a future rulemaking to formulate these same Criteria. See 64 Fed. Reg. 22619, 22620-21.

HIMA is troubled by the EC's plan to circumvent the rulemaking process, and requests that you advise the EC on the procedural requirements that prohibit the EC's proposed course of action. To help clarify the issues, HIMA offers the following comments on the MCAC's charted course to develop the Criteria.

  1. The MCAC And Its Subcommittees Cannot Meet in Private

    HCFA established the MCAC pursuant to the Federal Advisory Committee Act ("FACA"). See MCAC Charter, at 1; see also 5 USC App. II ' 3(2). FACA is Congress' method to "control the advisory committee process and to open to public scrutiny the manner in which government agencies obtain advice from private individuals and groups." Washington Legal Found. v. ABA, 648 F. Supp. 1353, 1358 (D.D.C. 1986).

    As a means to those important ends, FACA provides strict procedural requirements, including a mandate that "[e]ach advisory committee meeting shall be open to the public." 5 USC App. II ' 10(a)(1). "To do otherwise would allow the powerful executive branch of government to conduct its business behind closed doors in a manner that would prevent" public awareness and involvement. Food Chemical News, Inc. v. Davis, 378 F. Supp. 1048, 1052 (D.D.C. 1974).

    Meetings to discuss and formulate the structure and process of the panel reviews are precisely the kind of action on which the Congress took aim when passing FACA. Absent a valid and detailed explanation by HCFA to the contrary, the drafting meetings, if they occur at all, must be open to the public and must meet all other FACA requirements. Nader v. Dunlop, 370 F. Supp. 177, 179 (D.D.C. 1973).

    HCFA should be mindful that the Congress included "any subcommittee or other subgroup thereof" in the "advisory committee" definition. See 5 USC § 3(2). Further, the General Services Administration ("GSA"), the keeper of advisory committees, announced:

      GSA believes all requirements of advisory committees in the [FACA] Act also apply to subcommittees. Furthermore, the Act itself contains no provisions for subcommittees which differ from those applicable to a full or parent committee. Absent more specific language in the Act, additional guidance by GSA which might serve to differentiate any requirements of subcommittees from those of advisory committees would be inconsistent with the Act.

    52 Fed. Reg. 45926, 45927 (Dec. 2, 1987)1. Fragmenting an advisory committee does not change Congress' concerns underlying the passage of FACA and cannot circumvent FACA's procedural requirements to protect the public. Moreover, the mere fact that a subcommittee reports back to the full committee does not make the subcommittee activities any less subject to the act. Were that the case, the individual MCAC panels could operate outside the public eye-an approach that HCFA itself has clearly already rejected.

    HCFA has expressly indicated it will look to the U.S. Food & Drug Administration's ("FDA") advisory committee experience for guidance on managing the MCAC. FDA has had numerous occasions to consider the proper management of advisory committees and has developed procedures which reflect many of the concerns HIMA raises in this letter. We offer the following excerpts from the FDA Policy & Guidance Handbook for FDA Advisory Committees (Jan. 1, 1994) ("Handbook") for HCFA's consideration:

      An advisory committee includes any of its subgroups when the subgroups are working on behalf of the committee; such a subgroup, working on behalf of the committee to advise the Agency, is therefore considered to be an advisory committee.

    Handbook; see also id. § 14.1(b)(3). FDA also properly warns against private gatherings such as the planned drafting meetings:

      FACA requires that committee deliberations generally occur in the public meeting. Although preliminary discussions among committee members do not violate the FACA, they must be limited in scope. … Members should avoid situations where the conversation moves beyond preliminary information-gathering steps and into deliberations that will ultimately detract from the public discussion, particularly by giving the impression that decisions have already been made. … It is important to distinguish here between deliberate discussion aimed at reaching a decision and other types of discourse. Examples of entirely permissible discussions include general training sessions for committee members, administrative procedural briefings (where no substantive deliberation occurs), questions regarding clarification of background materials, and social gatherings. Social lunches and dinners are permissible, but must not be used as closed advisory committee meetings, or as a private extension of the meeting. Therefore, discussions of items on the agenda of an upcoming or ongoing advisory committee meeting should be deferred until the meeting is convened formally and publicly.

    Handbook2. In light of FACA and GSA's implementing regulations, FDA has carefully circumscribed advisory committee activities. The drafting meeting planned here is designed to recommend to the EC and to HCFA the "proper" Criteria. HCFA should follow FDA's lead and must be careful not to hide the subcommittee deliberations from the public oversight FACA was designed to accommodate. HIMA representatives plan on attending any such drafting meetings.

  2. MCAC Criteria Formulation Improperly Undermines the Notice and Comment Rulemaking

    The Criteria will be the standards against which new medical technology and procedures are judged and will determine which treatments are made available to Medicare beneficiaries. Further, this standard will shape the development of new products, because HCFA's evidentiary requirements will directly affect the cost, length and likely success of the innovation process. Simply put, the Criteria will establish the underpinnings of the entire Medicare coverage program.

    Using any part of the MCAC as drafter of these critically important Criteria circumvents both the letter and spirit of HCFA's April 27, 1999, Notice announcing the rulemaking. HCFA is free to use the MCAC as a forum to raise various Criteria options, and to use the EC to retrospectively evaluate and coordinate the decisions of the individual panels. HCFA crosses the line, however, when it coopts the MCAC's advisory role for substantive rulemaking. HCFA must be diligent not to displace or otherwise taint rulemaking's public input function.

    In addition, HCFA, in its presentations to the committee, must be careful not to issue any directives regarding the agency's views of the "proper" substantive criteria to be used, without first allowing for public input pursuant to the rulemaking requirements. HCFA must be diligent to avoid tainting the public process, or using the podium to announce what are in effect substantive rules. We are concerned that Dr. Burke did just that in his December 8, 1999, presentation to the EC.

  3. The MCAC Is Not Empowered to Formulate Policy

    FACA further constrains the MCAC to the terms of its Charter (although in no event can a charter be used to abrogate FACA's protections). 5 USC App. II ' 9(c). By the Charter's own terms, the MCAC panels are tasked with "develop[ing] technical advice to be reviewed and ratified by the MCAC." MCAC Charter, at 1. An example of this technical role is the upcoming meeting of the Medical & Surgical Procedures Panel, which will discuss pelvic muscle rehabilitation for the management of non-neurogenic urinary incontinence in adults. See 64 Fed. Reg. 69538 (Dec. 13, 1999).

    The EC is similarly limited in function, empowered only to facilitate and coordinate for the various panels and submit their reports to HCFA. See MCAC Charter, at 2. The MCAC advises HCFA on whether it believes a specific medical technology or procedure should be covered. It is up to HCFA to develop the Criteria by which the MCAC will judge these technologies and procedures. Allowed to run its proper course, HCFA's rulemaking will do just that.

    The Charter and the rules governing technical vs. policy advisory committees have real substance behind them. They guided the process of recruiting and selecting the members of the committee. The MCAC is a technically oriented committee comprised largely of academic researchers and clinicians. These people were carefully chosen for their technical prowess3. Policy-making, however, is a rather unique obligation assigned only to the Congress or, by delegation, to agencies. Policy committees generally are comprised of people who represent the stakeholders at issue, rather than people selected for their knowledge of technical subjects.

    HIMA stresses that it is not suggesting the MCAC cannot raise these broad policy matters for public discussion. It is clear, however, that the MCAC C an inherently technical committee4 — should not and cannot formulate HCFA's interpretation of "reasonable and necessary."

  4. Deliberations by the MCAC on Criteria are Premature

    The EC itself expressed frustration at not having rules for evaluating evidence in the Medicare coverage process. That is a problem, to be sure. Indeed, we think HCFA ought to proceed with its rulemaking expeditiously to avoid leaving the MCAC in the lurch. However, the answer is not for the MCAC to proceed to fill the void left by the agency.

    Further, it is hard to understand how the MCAC could proceed without answers to some fundamental policy/legal questions regarding, for example, (1) the meaning of FDA clearance/approval, (2) the role of cost effectiveness and (3) whether subsequent items and services must be superior to those that have gone before. As a technical committee, they need guidance on those underlying legal and policy issues before they can proceed to fill in the technical details. This is one reason why we suspect that the subcommittee would want agency representatives to participate in the drafting meetings. Such participation, though, adds to the injury in that the recommendations of the subcommittee would be effectively delivered directly to the agency outside the public view.

      Conclusion

      HIMA is enthusiastic about participating in the rulemaking's public process and looks forward to open and effective deliberations on what will, in effect, shape the Medicare program of tomorrow. We respectfully ask that HCFA address our concerns. If you should have any questions, please do not hesitate to contact me.

      Very truly yours,

      Bradley Merrill Thompson

      cc: Sharon Lappalainen
      Hugh Hill, M.D., J.D

      1 While the GSA did allow subcommittees to avoid the chartering formalities, all other FACA requirements, including public access, apply with equal force to subcommittees. See 41 CFR § 101-6.1007(a)(3).

      2 As the above passage indicates, FDA does provide a narrow exception for activities "of a preliminary fact gathering nature" which "do not include advice directly to the Agency." Handbook. Because the drafting subcommittee's assignment goes far beyond mere fact-finding and is expressly designed to develop policy positions, it could not fit within this FACA exception.

      3 FDA has spoken to the proper qualifications of advisory committee member. Policy advisory committee members "[s]hall have diverse interests, education, training, and experience; specific technical expertise is not a requirement[,]" while technical advisory committee members "[s]hall have expertise in the subject matter with which the committee is concerned and have diverse professional education, training, and experience so that the committee will reflect a balanced composition of sufficient scientific expertise to handle problems that come before it[.]" Handbook § 14.80.

      4 Again, the FDA's Handbook is instructive: "An advisory committee may be a policy advisory committee or a technical advisory committee. A policy advisory committee advises on broad and general matters. A technical advisory committee advises on specific technical or scientific issues, which may relate to regulatory decisions before FDA." Handbook § 14.1(b)(2); see also Id.