MTLF Report

By Tiran Dagan
January 29-30, 2003

Washington, DC

Overview

The purpose of this report is to summarize the January 29-30, 2003 Medical Technology Leadership Forum (MTLF) Capitol Forum in Washington, DC. I attended the session and held discussions with the attendees and panel members on the subject of Medicare Coverage and reimbursement.

During the forum, senior executives from CMS and OCSQ who are responsible for the approval of NCDs provided valuable feedback regarding current and future ECP coverage. Government and Regulatory Relations executives from J&J, 3M and Cook Scientific Research provided further information on plausible approaches to medical reimbursement issues which the manufacturers of ECP is facing.

Background

MTLF is a not-for-profit membership organization headquartered in Washington, DC. Founded in 1996, MTLF works to educate its own members, policy makers, the general public, and the media about the critical issues affecting or arising from the development and adoption of advanced medical technology.
MTLF members consist of 5 classes:

• Technology Innovator Members. Comprised of organizations that are involved with technological innovation in health care and who do not otherwise qualify as an Academic-Research Member, as a Consumer Health Organization Member, or as a Professional Society Member.
• Academic-Research Institute Members. Comprised of academic or non-profit research institutions that are involved with, or interested in, technological innovation in health care.
• Consumer Health Organization Members. Comprised of consumer health organizations or individuals affiliated with, or representing, consumer health organizations, that are involved with, or interested in, technological innovation in health care.
• Professional Society Members. Comprised of professional societies or individuals affiliated with, or representing, medical professional societies, that are involved with, or interested in, technological innovation in health care.
• At-Large Members. Comprised of interested members of the general public that are not admitted to any other class of membership, but are interested in technological innovation in health care and the mission of MTLF.
   

Participation in the Jan 29, 2003 Forum

The following key members attended the Medical Technology Leadership Forum in Washington, DC on January 29-30, 2003:

 
Medicare Priorities in 2003

Hon. Thomas A. Scully, Administrator, CMS provided an overview of pending Medicare reform as set forth in President Bush’s state of the Union Address on January 28, 2003.

Session Key Issues

The 2 key issues addressed by this summit were:

• “Medicare coverage policy: The balance between local and national decision making”: Trends, pathways, process in the approval of new technologies for reimbursement.
• Dual use products: Regulatory issues for new medical devices. This refers to products that fall under the classification of both “medical device” and “drug”, for instance: implantable devices with delay release mechanisms for drugs (such as drug coated stents). The basis for discussions on this subject was the MTLF Summit report titled “Defining a regulatory process for combination products:
The emergence of Tissue Engineering”.

Panel Discussion: “Medicare Coverage Policy Conversation”

A presentation by Dan Mendelson, the founder of Health Strategies Consultancy and a discussion ensued. The panel members were:

• Dr. Charlotte Yeh, Carrier Med Dir, Regional Administrator for New England CMS (Medicare, Medicaid) speaking from the med carrier perspective.
• Dr. Sean Tunis, Acting Deputy Director, OCSQ.
• Dr. Douglas Wood, MD – [Cardiologist] served on the regulatory reform commission for HHS.

<< This section available only in the full report >>

Local vs. National Coverage

As part of the approval for reimbursement by Medicare, companies first clear their technology/device with the Food & Drug Administration. The clearance by the FDA grants the company the authorization to market a product in the United States, and the efficacy of its clinical claims is evaluated in the clinical trial phase.

The clearance for marketing, however, does not constitute automatic approval for reimbursement by Medicare. The SSA 1995 rules specify that any device or medical service must fit within an included benefit category and must be determined to be “reasonable and necessary” in order to be covered under Medicare.

<< This rest of this section available only in the full report. The remainder of this part of the report addresses the difference between securing local coverage by way of LMRP's and national coverage by way of NCD's. >>

Personal Note

Over the years I, have become familiar with the specific clinical application of ECP from the provider side as well as a part of a distribution company. Further, I have gained experience in public policy and the Medicare Coverage Policy process on the local and the national level. As early back as 1994 I took part in national reimbursement hearings on the reimbursement of telemetry services with Medicare requesting additional coverage and reimbursement.

ECP is a proven technology cleared by FDA and by HCFA currently solely for the treatment of Angina. As reimbursement has increased over the past 3 years and the accumulation of evidence that ECP can alleviate the symptoms of CHF, ECP manufacturers should know which body of evidence, when submitted provide sufficient evidence of the efficacy of ECP for the purpose of reimbursement.

- Tiran Dagan, VP Strategic Alliances