Artificial Cervical Disc Replacement

Maggie Callan

07/07/2010 03:54 pm

CLINICAL CRITERIA FOR UM DECISIONS

Download the pdf of the policy for Artificial Cervical Disc Replacement (pdf 40.74 kB) .

 

Artificial Cervical Disc Replacement

1. Symptomatic cervical disc disease (SCDD) in only one vertebral level between C3-C7 defined as: Neck or arm (radicular) pain; and/or a functional/neurological deficit

AND

At least one of the following conditions confirmed by imaging (CT, MRI, or X-rays)

  • Herniated nucleus pulposus
  • Spondylosis (defined by the presence of osteophytes)
  • Loss of disc height

2. Age between 18 and 60 years.

3. Unresponsive to non-operative treatment for at least six weeks, including treatment at the Center for Orthopedic & Sports Physical Therapy, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment.

4. Artificial disc to be used has been given Food and Drug Administration approval.

 

Artificial Disc Replacement is not covered if any of the following are present:

1. More than one vertebral level requiring treatment.

2. Marked cervical instability on resting lateral or flexion/extension radiographs:

  • Translation greater than 3 mm and/or
  • Greater than 11 degrees of rotational difference to that of either adjacent level.

3. Has a fusion at the level to be treated.

4. Radiographic confirmation of severe facet joint disease or degeneration.

5. Known allergy to cobalt, chromium, molybdenum, titanium or polyethylene.

6. Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma, e.g., by the radiographic appearance of fracture callus, malunion or nonunion.

7. Prior surgery at the level to be treated.

8. Severe spondylosis at the level to be treated as characterized by any of the following:

  • Bridging osteophytes;
  • A loss of disc height greater than 50%; or
  • Absence of motion (<2 degrees).

9. Neck or arm pain of unknown etiology.

10. Osteoporosis: defined as a DEXA bone density measured T score less than or equal to -2.5 (the World Health Organization definition of osteoporosis).

11. Paget’s disease, osteomalacia or any metabolic bone disease (excluding osteoporosis which is addressed above).

12. Severe uncontrolled diabetes mellitus.

13. Pregnant.

14. Active infection – systemic or local.

15. Taking chronic medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).

16. Rheumatoid arthritis or other autoimmune disease.

17. Systemic disease including AIDS, HIV, hepatitis.

18. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.

 

Medical Necessity Approvals to be made by:
Y Medical Director
Chief of Eye Care
Medical Services Coordinator
Nurse Reviewer
Authorized CCD staff when UM criteria are met

 

These criteria apply to the following products when determined to be included in the member’s benefit package:
Y Commercial

 

CPT Coding Information:
COVERED: 22856 for total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical
NON-COVERED: Category III code 0092T for total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), each additional interspace, cervical (list separately in addition to code for primary procedure)

 

Source Documents:

  • MCMC Reviews 10/07 and 1/08
  • Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, and Zdeblick TA: Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 6:198-209, 2007.
  • Sasso RC, Smucker JD, Hacker RJ, and Heller JG: Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine. 2007 Dec 15;32(26);2933-40; discussion 2941-2.
  • FDA New Device Approval for PRESTIGE® Cervical Disc System (July 16, 2007)
  • FDA New Device Approval for ProDisc™-C Total Disc Replacement (December 17, 2007)
  • FDA Summary of Safety and Effectiveness Data for ProDisc™-C Total Disc Replacement, December 17, 2007.

 

 

Approved QIMT 6/19/08, 6/11/09

 

Capital Health Plan reserves the right to make changes to these criteria at any time to accommodate changes in medical necessity and industry standards.