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National Coverage Analysis (NCA) Tracking Sheet

External Counterpulsation (ECP) Therapy

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Issue

External counterpulsation (ECP) is a noninvasive treatment for coronary artery disease refractory to medical and/or surgical therapy. The Food and Drug Administration (FDA) has cleared ECP devices for use in unstable and stable angina pectoris, acute myocardial infarction, congestive heart failure and cardiogenic shock.

External counterpulsation involves the sequential compression (inflation/deflation) of cuffs wrapped around the patient’s calves, thighs, and buttocks. By timing the inflation/deflation sequence to the patient’s cardiac cycle, the intention of ECP is to increase diastolic aortic pressure, thereby increasing coronary perfusion pressure possibly by enhancing the development of coronary collateral circulation and reducing the workload of the heart. Treatment usually consists of one-hour sessions, five days a week, for seven weeks.

Although the Food and Drug Administration has approved ECP devices for the uses mentioned above, most of the medical literature surrounding this treatment has focused on its use for the treatment of severe angina refractory to other medical and surgical treatment.

The CMS policy on ECP can be found in Section 20.20 of the NCD Manual.  Currently coverage is provided for the use of ECP for patients who have been diagnosed with disabling angina  (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) who in the opinion of a cardiologist or cardiothoracic surgeon are not readily amenable to surgical intervention because their condition is inoperable, and/or their coronary anatomy is not readily amenable to such procedures, and/or they have comorbid conditions which can create excessive risk.

CMS has received a formal request from Vasomedical Inc. to expand coverage to patients with Class II angina and to patients with New York Heart Association (NYHA) Class II/III stable heart failure symptoms with an ejection fraction ≤ 35%.

National Coverage Determinations

Benefit Category

Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Vasomedical Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/20/2005
Expected NCA Completion Date
03/20/2006
Public Comment Period
06/20/2005 - 07/29/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/20/2005
Proposed Decision Memo Public Comment Period
12/20/2005 - 01/20/2006
Decision Memo Released
03/20/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Deirdre O'Connor
Lead Medical Officers
Jyme Schafer, M.D., M.P.H.

Medicare Benefit Category Determination Date

Actions Taken

June 20, 2005

CMS opens this reconsideration for review of the coverage of ECP for use in the treatment of patients with Class II angina and for use in patients with NYHA Class II/III stable heart failure symptoms with an ejection fraction ≤ 35%. CMS is requesting public comment on the following issues, as well as any others of concern to the public:

  • Is the evidence adequate for evaluating health outcomes of ECP for Class II angina listed in the request?
  • Is the evidence adequate for evaluating health outcomes of the ECP for patients with NYHA Class II/III stable heart failure listed in the request?

After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum.

Instructions for submitting public comments can be found at https://www.cms.hhs.gov/coverage/8h.asp

June 29, 2005

CMS has received an additional request to expand coverage for ECP to include the treatment of

(1) Acute heart failure,

(2) Acute Myocardial Infarction (AMI),

(3) Cardiogenic Shock, and

(4) Stable heart failure including persons with an ejection fraction of less than or equal to 40%.

CMS is extending the public comment period to receive public comments on whether the evidence is adequate for evaluating health outcomes of ECP for these new indications. In addition, we are requesting public comment on the following 2 questions:

  • For each listed condition, is the evidence sufficient to evaluate the effectiveness of ECP for treatment of patients as an adjunct or alternative to a surgical intervention?
  • Is the evidence sufficient to determine the effectiveness of ECP graduated low pressure regimen as compared to the standard ECP pressure regimen in the treatment of patients with congestive heart failure?

The public comment period will close 30 days from the posting of these new questions.

July 29, 2005

Initial Public Comment period closed.

August 29, 2005

Meeting with Vasomedical

September 15, 2005

Cardiomedics amended their request to include NYHA class heart failure.

December 14, 2005

Meeting with Cardiomedics. Cardiomedics requests to amend their submission to withdraw request for coverage for acute heart failure and to amend request for coverage for acute myocardial infarction where PTCA or CABG is not available.

December 20, 2005

CMS posts a proposed decision memorandum to keep the existing coverage for external counter pulsation therapy, with no changes for expansion for the additional cardiac conditions requested.

A 30 day public comment period opens.

CMS is requesting public comment on this proposed decision. After considering public comment, we will release a final decision memorandum.

Instructions for submitting public comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

January 17, 2006

Meeting with Vasomedical. PEECH trial sub-group data provided for consideration.

January 20, 2006

Public comment period for proposed decision closes.

March 6, 2006

March 20, 2006

The final decision is now posted.
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