00-21084. Medicare Program; Open Town Hall Meeting to Discuss Criteria for Making Coverage Decisions-August 31, 2000

AGENCY:

Health Care Financing Administration (HCFA), HHS.

ACTION:

Notice of meeting.

SUMMARY:

This document announces a town hall meeting for all interested parties to discuss criteria we would use to make certain national coverage decisions. This meeting presents one aspect of the evolving process for making the Medicare coverage process more open and responsive to the public.

DATES:

August 31, 2000, from 9 a.m. until 12 noon, E.D.T.

ADDRESSES:

The meeting will be held at the HCFA headquarters auditorium, 7500 Security Boulevard, Baltimore, Maryland 21244.

FOR FURTHER INFORMATION CONTACT:

Patricia Brocato-Simons at 410-786-0261.

SUPPLEMENTARY INFORMATION:

I. Background

On April 27, 1999, we published a notice in the Federal Register (64 FR 22619) that announced the process we use to make national coverage decisions under the Medicare program. We also announced that we would not be adopting, as final, a 1989 proposed rule that set forth the criteria we would have used to make coverage decisions under Medicare. On May 16, 2000, we published a notice of intent (NOI) in the Federal Register (65 FR 31124) that announced our intention to issue a proposed rule and solicited advance public comments on the criteria we would use to make national coverage decisions under the “reasonable and necessary” provisions of section 1862(a)(1) of the Social Security Act (the Act). We extended the closing date of the comment period from June 15, 2000 to July 17, 2000. We received 118 public comments from major organizations and individuals with an interest in our coverage process. Commenters expressed their views on the following issues:

• Cost as a coverage criterion.
• Increased evidence burden.
• Limited choice or interference with the practice of medicine.
• Withdrawal of coverage.
• Burden of proof.

In the NOI, we explained that these coverage decisions are prospective, population-based policies that apply to a clinical subset or class of Medicare beneficiaries. We described the clinical circumstances and setting under which an item or service is available (or not available). We included information and approaches we are considering at this time for making coverage decisions. We also clarified that the NOI was not intended to address individual medical necessity determinations and claims adjudications by our contractors and other adjudicators, nor was it intended to address changes in current Medicare payment policies.

II. Format of Meeting

We will begin the meeting with a brief overview of the May NOI that solicited advance public comments on proposed criteria we would use in making future, national coverage decisions. Following this introduction will be a more detailed explanation of HCFA's NOI criteria for sake of clarity. This discussion will then be followed by a specified amount of time for public presentations by participants who submit a prior request to speak.

III. Registration

Individuals may register by contacting Ms. Patricia Brocato-Simons either by telephone at 410-786-0261, by mail, at 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, Maryland 21244-1850, fax, at 410-786-9286, or electronically at [e-mail]. Please provide, as applicable, your name, title, firm name, address, telephone number, fax number, and electronic mailing address. Participants who wish to display an exhibit or make a presentation at the meeting are asked to contact Ms. Brocato-Simons at 410-786-0261 or via E-mail at [e-mail] as soon as possible. Please identify the topic(s) for your presentation and an estimate of the amount of time required to make the presentation. Because of time constraints, we may need to limit the number of individuals who make presentations. We will notify participants who have been selected to make a presentation. We will assign presentation times before the meeting. While the meeting is open to the public, attendance is limited to the space available.

We will accept written questions, comments, or other materials, before and during the meeting, or up to 14 days after the meeting. Address comments to: DHHS, HCFA, ATTN: Patricia Brocato-Simons, Office of Clinical Standards and Quality/CAG, Room S3-02-01, 7500 Security Boulevard, Baltimore, Maryland 21244-1850, Telephone Number: [phone], Fax Number: [phone], E-mail: [e-mail]. Although there is no special format for the materials, we request that commenters be clear about the issue or aspect of the proposed process on which they have a question, comment, or suggestion.

Authority: Sections 1102 and 1871 of the Act (42 U.S.C. 1302 and 1395hh).

(Catalog of Federal Domestic Assistance Program No. 98.773, Medicare-Hospital Insurance; and Program No. 93.774, Medicare-Supplementary Medicare insurance Program.)

Dated: August 14, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing Administration.