May 20, 1999

Jeffrey L. Kang, MD, MPH
Director, Office of Clinical Standards and Quality
Department of Health and Human Services
Health Care Financing Administration
Room C5 - 16 - 03
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: [HCFA - 3432 - GN]
RIN 0938-AJ31

Dear Dr. Kang:

This letter represents the comments of the National Electrical Manufacturers Association (NEMA) to the announcement in the Federal Register, 64 FR 22619, April 27, 1999, pertaining to: Procedures for Making National Coverage Decisions for the Medicare Program. NEMA appreciates the opportunity to provide its comments on the procedures which HCFA will follow in making these decisions.

NEMA, the National Electrical Manufacturers Association, is the leading U.S. organization representing and serving America's electroindustry. NEMA's Diagnostic Imaging and Therapy Systems Division represents more than 95% of U.S. manufacturers of x-ray imaging, computed tomography, diagnostic ultrasound, radiation therapy, magnetic resonance, nuclear medicine imaging and medical informatics equipment.

For many years, the processes HCFA has employed for making national coverage decisions have been closed with little participation from the public. NEMA commends HCFA for seeking to implement changes to its national coverage decision-making procedures to make the process more open, streamlined and understandable, and to allow for greater public input.

We are pleased that HCFA appreciates the need for timely decision-making, for establishing a mechanism to revisit HCFA decisions and for providing an agency explanation for those decisions. NEMA agrees that the posting of notices on the internet via the HCFA home page will serve as a useful tool in helping to ensure broad public awareness of HCFA decisions.

While we believe these changes to be important and positive steps forward, we wish to raise a number of serious concerns about the Medicare national decision-making process, as described in this notice, which, if not addressed, will impair and obstruct, rather than facilitate, the implementation of a fair and effective system.

First, the process as described in the notice does not provide for a commitment by HCFA to convene early collaborative meetings between the agency and the requestor of Medicare coverage. NEMA strongly believes that holding early collaborative meetings between requestors and HCFA is absolutely essential in ensuring that both the agency and requestors have a clear and complete understanding of the requirements which must be satified to achieve a favorable coverage decision. A fair and efficient system demands that requestors know from the outset what evidence is needed to demonstrate coverage eligibility for a service.

Both HCFA and requestors stand to gain very significant benefits from these collaborative meetings. The agency, as well as the requestor, will be able to avoid considerable expenses in manpower and resources by precluding the lengthy and time-consuming review of unnecessary or extraneous data. This will result in the savings of months, or even years, of time spent in conducting clinical trials of little value and in reviewing and analyzing their findings. Instead, all interested parties will be able to focus efficiently and exclusively on analysis of relevant data. NEMA strongly urges that HCFA establish a clear procedure whereby both the agency and requestor will have the opportunity to meet and formulate mutually agreed upon "ground rules" for proceeding with an application for coverage.

HCFA has stated in the notice that it welcomes comments from the public on its national coverage decision-making process. NEMA appreciates the recognition by the agency of the importance of an open process for Medicare coverage decisions.

We are concerned, however, that in this notice HCFA makes no commitment to the issuance of official responses to those comments. Without an agency reply to comments, there is no way an applicant requesting coverage for a service, or any other interested party, may know whether the information which it had submitted was considered. A lack of response will fail to reveal the method of analysis and rationale HCFA uses in making its decisions. Thus, an applicant will lose any opportunity to inform HCFA of possible misinterpretations of the data by the agency. This will result in the discouragement, rather than encouragement, of public participation and thereby undermine public faith in the national decision-making process. The only means for ensuring meaningful public participation is through creation of a formal process providing for an honest, open dialogue between HCFA and interested parties, so that valid concerns of all may be addressed. We strongly urge HCFA to make a commitment to establish as agency policy and procedure the issuance of an official response to comments made by interested parties as an integral part of the national decision-making process.

On December 14, 1998, in 63 FR 6870, the Medicare Coverage Advisory Committee ( MCAC) was established. The reason for its creation was to enable HCFA to obtain advice of clinical, public and industry representatives on complex issues to facilitate the agency's national decision-making process.

NEMA commends HCFA for establishing the MCAC. Convening a panel of "experts" from the clinical community, consumers and industry will be invaluable to HCFA in addressing the many complex, technical and clinical issues which underly Medicare coverage decisions.

HCFA has provided in the April 27, 1999 notice that if the agency decides to refer an issue to the MCAC, a notice will be published in the Federal Register generally 30 days before a meeting of MCAC is convened. The April notice further states that all evidentiary presentations must be submitted to HCFA in writing at least 20 days before the meeting. This means that any interested individual who wishes to submit an evidentiary presentation will have only 10 days to develop and make an evidentiary submission to HCFA.

A 10 day time frame is simply insufficient to enable a party to develop a well-researched and articulated presentation. Given the complexity and far reaching implications of the issues pertinent to medical technology and its use in clinical practice, the 10 day requirement will severely reduce any benefits which could be derived from the use of MCAC. By adhering to this 10 day requirement, HCFA will be depriving itself of potentially essential information. It is strongly urged that HCFA provide for an adequate time period to permit stakeholders to submit well prepared evidentiary presentations so that their value to the Medicare decision-making process can be fully realized.

The notice states that HCFA's intent is to work with various sectors of the medical community to develop and publish guidance documents specific to their interests and needs. However, a detailed process as to how guidance development will work is not identified. Since these documents will provide a vehicle for HCFA to explain how general criteria apply to special circumstances unique to a particular sector, it is imperative that all the essential parties to the process be completely apprised of how the process will operate. We request that HCFA provide further specific information on the procedures for guidance document development.

NEMA is encouraged that HCFA recognizes the need for instituting an established, structured appeal process from national coverage decisions. Nevertheless, the April 27 notice does not set forth the specific details of the operation of the appeals process. An orderly process with time frames for each step should be established. Due process demands that requestors be fully apprised of their rights and responsibilities under the system. We would urge HCFA to set forth in detail how such an appeals process would work.

NEMA appreciates HCFA's acknowledgement of the need for finite time frames for making national coverage decisions. We are very concerned however about the overall length of time which might occur in the decision-making process.

For example, in one scenario, HCFA might decide to seek a technology assessment subsequent to a review of the completed submission. In addition, in the same scenario, the agency also could refer the matter to MCAC for a recommendation. Added together, obtaining a completed technology assessment and a recommendation from MCAC could approach 2 years. Following the review of the recommendation of MCAC, a number of months could quite likely be incurred to produce and publish the final decision. Finally, a period of up to 9 months could be required before a payment change would be effective. In this scenario then, a total time period from submission to payment change could thus amount to over 3 years.

NEMA is concerned that these very lengthy time frames will ultimately serve to deprive patients of needed coverage for services. A wait of this duration for a coverage determination will cause severe hardship given the substantial costs of medical care. We believe all interested parties should work together on development of meaningful timeframes which will allow for coverage decisions to be made in the most efficient manner possible, and will at the same time take into account the workload demands placed on HCFA.

Again, we wish to thank HCFA for the positive steps it has taken in recognizing the deficiencies in the Medicare coverage process and in beginning to seek ways to address them. NEMA is committed to opening a dialogue with HCFA to work together for further process improvements to achieve our mutual goals of enhancing the delivery of quality health care to Medicare patients.

If you have any questions, or need further information, please do not hesitate to contact me at (703) 841 - 3241.

Sincerely,

Robert G. Britain,
Vice President Medical Products