National Coverage Analysis (NCA) Tracking Sheet for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

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Issue

CMS received an NCA request to establish a national coverage determination (NCD) for coverage of supervised exercise therapy (SET) for the treatment of peripheral artery disease (PAD).

PAD is a cardiovascular disease that occurs when plaque buildup narrows the arteries outside the heart. PAD most commonly affects the lower extremities and can cause claudication (pain/discomfort) in the legs during exercise, but can also occur while at rest if the disease worsens. Individuals suffering from claudication due to PAD will often limit their walking to avoid/relieve symptoms which could dramatically impact their quality of life (i.e., loss of functional independence, abandoning hobbies, increased isolation, etc.). SET is a low risk and non-invasive treatment option and is indicated for patients with documented PAD and claudication.

Endovascular procedures and medical therapy are beyond the scope of this NCA.

CMS is soliciting public comment relevant to this NCA. We are particularly interested in comments that include scientific evidence.

Benefit Category

Incident to a physician's professional Service
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services

Requestor Information

Requestor Name(s): American Heart Association (AHA)

Requestor Letter(s): View Letter

Important Dates

Formal Request Accepted and Review Initiated: 09/15/2016

Expected NCA Completion Date: 05/31/2017

Public Comment Period: 09/15/2016 - 10/15/2016

Proposed Decision Memo Released: 03/02/2017

Proposed Decision Memo Public Comment Period: 03/02/2017 - 04/01/2017

Decision Memo Released: 05/25/2017

Comments for this NCA: View Public Comments

Contacts

Lead Analyst(s):

David Dolan, MBA, MA
david.dolan@cms.hhs.gov
410-786-3365

Lead Medical Officer(s):

Jyme Schafer, MD, MPH

Actions Taken

September 15, 2016

CMS initiates this national coverage analysis for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD). The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

March 2, 2017

Posted proposed decision memo

May 25, 2017

Posted final decision memo.

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