National Coverage Analysis (NCA) Tracking Sheet

Intensive Cardiac Rehabilitation (ICR) Program - Benson-Henry Institute Cardiac Wellness Program

CAG-00434N

Issue

CMS has a formal request for a national coverage analysis (NCA) to establish a national coverage determination (NCD) for the Benson-Henry Institute Cardiac Wellness Program. This NCA will review evidence to determine whether the Benson-Henry Institute Cardiac Wellness Program demonstrates the statutorily mandated accomplishments and outcome improvements as established in 42 C.F.R. 410.49.

Through the statute Medicare Improvements for Patients and Providers Act of 2008 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 statute; and 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.

CMS is opening this national coverage analysis (NCA) to complete a thorough review of the evidence to determine if the ICR provided through the Benson-Henry Institute Cardiac Wellness Program demonstrates the statutorily mandated accomplishments and outcomes improvements to Medicare beneficiaries.

Benefit Category

Intensive Cardiac Rehabilitation Program

Requestor Information

Requestor Name Requestor Letter
Gregory Fricchione, MD View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
09/03/2013
Expected NCA Completion Date
05/28/2014
Public Comment Period
09/03/2013 - 10/03/2013
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/27/2014
Proposed Decision Memo Public Comment Period
02/27/2014 - 03/29/2014
Decision Memo Released
05/06/2014
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Michelle Issa
Lead Medical Officers
Joseph Chin, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

September 3, 2013

CMS initiates this NCA of the Benson-Henry Institute Cardiac Wellness Program. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS is requesting public comment on the clinical evidence of health benefit outcomes, specifically those listed above, provided by this program in the Medicare population.

CMS considers all public comments, and is particularly interested in comments that include published clinical studies and other scientific information that provides evidence for improvement in short and long term outcomes related to this program.

Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word "comment" in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

February 27, 2014

May 6, 2014