National Coverage Analysis (NCA) Tracking Sheet

External Counterpulsation (ECP) Therapy

CAG-00002N

Issue

External Counterpulsation (ECP) is a noninvasive therapy developed for the treatment of severe angina refractory to conventional therapies, acute myocardial infarction, and cardiogenic shock. Medicare coverage, effective July 1,1999, is limited to its use in patients with severe stable angina pectoris who fulfill certain criteria (Coverage Issues Manual 35-74).

Currently, the language of the initial instruction has led to confusion about coverage of this therapy in the provider, manufacturer, and beneficiary communities. Cardiomedics, Inc. requests that the current policy be reconsidered to include their device. The Medicare Contractor Medical Director New Technology Workgroup requests that Medicare rescind coverage for this procedure entirely. Because both requests ask us to reconsider our national policy referring to external counterpulsation, we are combining them to further evaluate this service.

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Cardiomedics, Inc, Irvine CA., Medicare Contractor Medical Director New Technology Workgroup, submitted by Paul G. Deutsch, MD, Crompond, NY. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/09/1999
Expected NCA Completion Date
01/03/2000
Public Comment Period
08/09/1999 - 09/08/1999
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
11/22/1999

Contacts

Lead Analysts
Perry Bridger, MHS
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

May 27, 1999

Meeting with Vasomedical, Inc.

June 30, 1999

Meeting with Cardiomedics, Inc.

July 7, 1999

Letter sent to Cardiomedics, Inc. requesting additional information.

July 9, 1999

Additional information received from Cardiomedics, Inc.

October 5, 1999

Letter received from Dr. Paul G. Deutsch on behalf of the Medicare Contractor Medical Director New Technology Workgroup requesting reconsideration of the original coverage decision.

This request includes a detailed analysis of how we allegedly materially misinterpreted the Multicenter Study of Enhanced External Counterpulsation (MUST-EECP), on which the original coverage determination was primarily based.

October 6, 1999

Letter sent to Paul G. Deutsch, MD, accepting request as formal.

October 6, 1999

Letter sent to Cardiomedics, Inc. informing them of the receipt of a request for reconsideration of the national coverage decision concerning this service and notifying them of the new timeframe for reviewing the combined requests.

November 22, 1999

Decision made. See Decision Memorandum dated 11/22 for details.