National Coverage Analysis (NCA) Tracking Sheet

Lumbar Artificial Disc Replacement

CAG-00292N

Issue

CMS received an external formal request for a national coverage determination on lumbar artificial intervertebral disc. The artificial disc, made from metal and plastic with two endplates and a sliding core, is used to treat pain associated with degenerative disc disease. 

Charite™, approved in October of 2004, is currently the only FDA approved artificial disc.  The disc is surgically implanted between vertebrae to replace a diseased or damaged intervertebral disc in the lumbar region.  Surgical implantation of the device may reduce pain, increase movement at the site of surgery, and restore intervertebral disc height.  The approved indication is for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1.  Two notable contraindications to the surgery are osteoporosis and osteopenia, which may be more prevalent in the Medicare population.

We are currently reviewing literature and evidence for all artificial discs to include those currently being reviewed by FDA.

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Richard A. Deyo MD, MPH, University of Washington, School of Medicine View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/16/2005
Expected NCA Completion Date
05/16/2006
Public Comment Period
08/16/2005 - 09/16/2005
Proposed Decision Memo Due Date
Proposed Decision Memo Released
02/15/2006
Proposed Decision Memo Public Comment Period
02/15/2006 - 03/17/2006
Decision Memo Released
05/16/2006
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Deirdre O'Connor
Lead Medical Officers
Jyme Schafer MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

August 16, 2005

CMS opens this national coverage determination (NCD) request to review the coverage of the lumbar artificial intervertebral disc. CMS is requesting public comment on whether there is adequate evidence for evaluating health outcomes of the lumbar artificial intervertebral disc surgery in the Medicare population? After considering the public comments and reviewing relevant evidence, we will release a proposed decision memorandum. Instructions for submitting public comments can be found at https://www.cms.hhs.gov/coverage/8h.asp

September 12, 2005

Meeting with DePuy Spine.

September 16, 2005

The initial 30 day public comment period ended.

February 15, 2006

CMS is requesting public comments on this proposed decision memorandum 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 is also requesting public comment on whether there is interest in performing further clinical trials for lumbar artificial disc replacement with the Charite lumbar artificial disc.

CMS encourages public comment on this proposed decision 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.

May 16, 2006

The final decision is now posted.