National Coverage Analysis (NCA) Tracking Sheet

Intensive Cardiac Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease



CMS has internally generated a national coverage analysis (NCA) to establish a national coverage determination (NCD) for the Dr. Ornish's Program for Reversing Heart Disease. This NCA will review evidence to determine whether or not the Ornish program demonstrates the statutorily mandated accomplishments and outcomes improvements identified in section 144(a) of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008: Payment and Coverage Improvements for Patients with Chronic Obstructive Pulmonary Disease and Other Conditions - Coverage of Pulmonary and Cardiac Rehabilitation. Section 144(a) requires that these accomplishments be demonstrated in peer-reviewed published research.

To implement this provision of the MIPPA, CMS added, §410.49, Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage, to the Public Health Code of Federal Regulations (42 C.F.R.). This section was added through rule making in the CY 2010 Physician Fee Schedule Final Rule with Comment Period which was finalized and put on display Friday October 30, 2009 (available at The Final Rule will be published in the Federal Register on November 25, 2009.

In 42 C.F.R. 410.49, CMS covers ICR items and services in approved settings when such services are provided via an approved ICR program. ICR programs must be approved through the NCD process to ensure that they demonstrate the accomplishments and outcomes improvements set forth in the MIPPA and implemented in §410.49.

An ICR program must demonstrate through peer-reviewed, published research that it has accomplished one or more of the following for its patients:

  1. Positively affected the progression of coronary heart disease.
  2. Reduced the need for coronary bypass surgery.
  3. Reduced the need for percutaneous coronary interventions.

An ICR program must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services:

  1. Low density lipoprotein.
  2. Triglycerides.
  3. Body mass index.
  4. Systolic blood pressure.
  5. Diastolic blood pressure.
  6. The need for cholesterol, blood pressure, and diabetes medications.

Benefit Category

Intensive Cardiac Rehabilitation Program

Requestor Information

Requestor Name Requestor Letter
Internally generated N/A

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
11/17/2009 - 12/17/2009
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
05/14/2010 - 06/13/2010
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Sarah Fulton, MHS
Lead Medical Officers
Joseph Chin, MD
Irwin Lotwin, MD

Medicare Benefit Category Determination Date

Actions Taken

November 17, 2009

Internally generated NCA.

During the initial 30-day public comment period, CMS is requesting public comments on whether peer-reviewed, published research supports approval of the Ornish program as an ICR program.

May 14, 2010

Proposed decision memorandum posted. 30-day public comment period begins.

August 12, 2010

Final decision memorandum posted. NCD becomes effective.