National Coverage Analysis (NCA) Tracking Sheet

Cavernous Nerves Electrical Stimulation with Penile Plethysmography

CAG-00311N

Issue

The assessment of the function of the cavernous nerves by direct application of electrical stimulation with penile plethysmography is a diagnostic test, also referred to as cavernosal nerve mapping, which may be performed prior to, during, or after a nerve-sparing radical prostatectomy to assess the integrity of the cavernous nerves. Through an open or laparoscopic procedure, most typically performed after a radical prostatectomy, the surgeon may want to assess the function of the cavernous nerves by stimulating the most distal end of the nerve that can be located by using an electrical nerve stimulator. A functioning and stimulated nerve will trigger blood flow either into or out of the penis. A penile plethysmography sensor will have been fitted around the penis and been connected to a nerve stimulator control unit. The sensor detects slight changes in penile girth, which occur when the nerves stimulate a response to cavernous blood flow. If the nerves are intact, there is blood flow. The presence of a response, and the degree of the response may be used to provide the surgeon with a more realistic assessment of the chance of the patient regaining potency and assist in choosing appropriate therapy. It is this use of the procedure during both open and post-radical prostatectomy that the requestor has asked us to review and not its use prior to a prostatectomy. At present, there is no NCD or national Medicare coverage policy that has been issued by CMS on this procedure. In the absence of a NCD or national coverage policy on a subject, however, local Medicare contractors have the discretion to cover the test whenever it is determined to be medically necessary for the individual patient.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Blue Torch Medical Technologies, Inc. View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
12/09/2005
Expected NCA Completion Date
09/07/2006
Public Comment Period
12/09/2005 - 01/09/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
06/09/2006
Proposed Decision Memo Public Comment Period
06/09/2006 - 07/09/2006
Decision Memo Released
08/24/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
William Larson
Lead Medical Officers
Lawrence Schott, MD

Medicare Benefit Category Determination Date

Actions Taken

December 9, 2005

CMS is opening an NCD to evaluate the use of cavernosal nerve mapping both during both open and post-radical prostatectomy in the Medicare population. CMS begins a national coverage determination review in response to an external request. We are interested in all public comments on use of the mapping procedure. A 30-day public comment period opens. Instructions on submitting comment can be found at:  http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

View Requestor Letter [PDF, 26KB]. 

February 17, 2006

The name of this NCA was changed to ensure that the topic appeared in the appropriate portion of our index.

June 9, 2006

CMS posts a proposed decision memorandum indicating our intent to issue a national noncoverage determination for electrical stimulation of the cavernous and associated parasympathetic nerves with penile plethysmography.

A 30 day public comment period opens.

CMS is requesting public comments on this proposed determination pursuant to section 731 of the Medicare Modernization Act, with particular interest in comments on any additional evidence we did not review or that assess how we evaluated the evidence included.

CMS encourages public comment on this proposed determination through our website: http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage.

After considering public comments, we will release a final decision memorandum.

August 24, 2006

The final decision is now posted