National Coverage Analysis (NCA) Tracking Sheet

Ultrasound Stimulation for Nonunion Fracture Healing

CAG-00022N

Issue

Ultrasonic bone growth stimulators are portable, non-invasive devices which employ low-level micromechanical force via ultrasonic acoustic pressure waves at the fracture site to aid bone healing.

Exogen, Inc. recently received approval from the Food and Drug Administration (FDA) to market the Sonic Accelerated Fracture Healing System (SAFHS7) for the non-invasive treatment of established nonunions excluding the skull and vertebra. Previously, SAFHS was only approved for the treatment of fresh fractures under certain conditions.

Currently, section 35-48 (B) of the Coverage Issues Manual states that there is insufficient evidence to support the medical necessity of using an ultrasonic osteogenic stimulator. Therefore, the device is not covered by Medicare. Requestor asks that we review the clinical-based evidence and the associated publications and consider this device for coverage of nonunion fractures.

National Coverage Determinations

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Exogen, Inc., Piscataway, NJ. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
05/08/2000
Expected NCA Completion Date
08/07/2000
Public Comment Period
06/07/2000 - 07/07/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
07/31/2000

Contacts

Lead Analysts
Perry Bridger, MHS
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

May 12, 2000

Letter sent to Exogen, Inc. accepting request as formal.

May 12, 2000

Issue referred to the Center for Health Plans and Providers (CHPP) for final benefit category determination.

July 31, 2000

Decision made. Please see final Decision Memorandum.