National Coverage Analysis (NCA) Tracking Sheet

Percutaneous Transluminal Angioplasty (PTA) and Stenting of the Renal Arteries

CAG-00085R4

Issue

The Centers for Medicare and Medicaid Services (CMS) has internally generated a national coverage analysis (NCA) in order to examine the best treatment for patients with atherosclerotic renal artery stenosis (ARAS) and develop a national coverage determination (NCD) for PTA and stenting of the renal arteries.

Currently, Medicare covers percutaneous transluminal angioplasty (PTA) of the renal arteries “for patients in whom there is an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. The PTA for this group of patients is an alternative to surgery, not simply an addition to medical management” (Medicare NCD Manual, 20.7 B1).  Medicare coverage of renal artery stenting is at the discretion of local Medicare contractors.

In 2006, the Agency for Healthcare Research and Quality (AHRQ) issued a report summarizing the evidence evaluating the effect and safety of angioplasty with stent placements and medical therapies in the treatment of atherosclerotic renal artery stenosis(ARAS). The National Institutes of Health (NIH) has sponsored the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial to examine which patients with ARAS would benefit from angioplasty with stent placement versus aggressive medical therapy. Due to the recent increase in concern regarding renal artery PTA and stenting and external questions regarding Medicare’s impact on current research and utilization of these procedures, we are initiating this reconsideration. 

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
Internally generated by CMS. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/26/2007
Expected NCA Completion Date
02/18/2008
Public Comment Period
02/26/2007 - 03/28/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
11/20/2007
Proposed Decision Memo Public Comment Period
11/20/2007 - 12/20/2007
Decision Memo Released
02/14/2008
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Sarah Fulton, MHS
Lead Medical Officers
Lawrence Schott, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

February 26, 2007

CMS initiates this reconsideration to examine what patient population and under what circumstances Medicare coverage of renal artery stenting is reasonable and necessary.

The initial 30-day public comment period begins. Of particular interest to CMS are comments supported by specific references to scientific studies. CMS is most interested in the quality of comments received rather than the quantity submitted.

Please submit public comments by using the "comment" button located at the top of the tracking sheet. This will provide you with a new window in which you may type your comment or cut and past a previously prepared comment. Additional instructions for submitting public comments are available at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

May 3, 2007

CMS announces that a public meeting of the Medicare Evidence Development Coverage Advisory Committee (MedCAC), formerly the Medicare Coverage Advisory Committee, to consider PTA and stenting of renal arteries will be held in Baltimore on July 18, 2007. Details of the meeting will be published in a Federal Register notice and questions for the Committee's consideration will be posted here in the next month.

May 21, 2007

CMS announces that this national coverage analysis, as well as the July 18, 2007 MedCAC, will be also evaluating evidence regarding surgical treatments for patients with atherosclerotic renal artery stenosis.

August 23, 2007

Posted comments [PDF, 522KB] received.

View comments  received through the website.

November 20, 2007

CMS posts a proposed decision memorandum to make no change to section 20.7 of the Medicare NCD Manual. The 30-day public comment period begins.

CMS is requesting public comments on the proposed decision memorandum. CMS is particularly interested in the quality of data and evidence cited in public comments rather than the quantity of comments received.

Please submit public comments by using the "comment" button located at the top of the tracking sheet. This will provide you with a new window in which you may type your comment or cut and past a previously prepared comment. Additional instructions for submitting public comments are available at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

January 15, 2008

Posted comments [PDF, 429KB] received.

View comments received through the website.

February 14, 2008