National Coverage Analysis (NCA) Tracking Sheet

Ultrasound Stimulation for Nonunion Fracture Healing

CAG-00022R

Issue

Ultrasonic osteogenic stimulators are applied to the skin surface at a fracture site via a coupling gel. They emit low intensity, pulsed ultrasound and are used to stimulate fracture healing. CMS has covered ultrasonic osteogenic stimulators as medically reasonable and necessary for the treatment of nonunion fractures excluding the skull, vertebrae and tumor-related nonunions. Fracture nonunion has been based on two sets of radiographs separated by a minimum of 90 days that demonstrate no clinical evidence of fracture healing. Coverage has been further limited by requiring that patients must have failed at least one surgical intervention for treatment of the nonunion. Fresh fractures and delayed unions are national noncovered. We have received a request to reconsider this NCD and remove the failed surgery limitation.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Smith & Nephew, 252 Links View Drive, Maineville, OH 45039, www.smith-nephew.com View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/27/2004
Expected NCA Completion Date
04/22/2005
Public Comment Period
07/27/2004 - 08/27/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
01/27/2005
Proposed Decision Memo Public Comment Period
01/27/2005 - 02/25/2005
Decision Memo Released
04/27/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Niccole Corbin, DPM
Lead Medical Officers
Shamiram Feinglass, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

July 27, 2004

Opened formal NCD reconsideration and posted tracking sheet and request.

September 20, 2004

All public comments [PDF, 44KB] received have been posted on the Internet.

January 27, 2005

CMS is posting a proposed Decision Memorandum  for a 30-day public comment period. CMS is interested in comments on the proposed decision, the interpretation of evidence, and the proposal to cover beneficiaries enrolled in comparative prospective clinical trials.

Instructions for submitting public comments are available at http://www.cms.hhs.gov/coverage/8h.asp .

April 27, 2005