Print Hip Resurfacing

Hip Resurfacing

 

DESCRIPTION

Hip resurfacing is an alternative to total hip arthroplasty (THA, also known as hip replacement) for patients with advanced arthritis of the hip. Total hip resurfacing describes the placement of a shell that covers the femoral head together with implantation of an acetabular cup in patients with painful hip joints. Partial hip resurfacing is considered a treatment option for avascular necrosis with collapse of the femoral head. Hip resurfacing may be considered an alternative to hip arthroplasty, particularly in young active patients who would potentially outlive a total hip prosthesis. Therefore, hip resurfacing could be viewed as a time-buying procedure to delay the need for a total hip arthroplasty. Proposed advantages of total hip resurfacing compared to total hip arthroplasty include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a total hip replacement, if required. In addition, the resurfaced head is more similar in size to the normal femoral head, thus increasing the stability and decreasing the risk of dislocation compared to total hip arthroplasty.

Total hip resurfacing has undergone various evolutions over the past several decades, with modifications in prosthetic design and composition and implantation techniques. For example, similar to total hip prostheses, the acetabular components of total hip resurfacing have been composed of polyethylene. However, over the years it has become apparent that device failure was frequently related to the inflammatory osteolytic reaction to polyethylene debris wear particles. Metal acetabular components have since been designed to improve implant longevity. Sensitivity to wear particles from metal-on-metal chromium and cobalt implant components are of increasing concern.

In May 2006, FDA granted premarket application (PMA) approval to the Birmingham Hip Resurfacing (BHR) system for use in patients requiring primary hip resurfacing arthroplasty for non-inflammatory or inflammatory arthritis. This decision was primarily based on a series of 2,385 patients who received this device by a single surgeon in England. A number of post-approval requirements were agreed to, including the following items:

  • Study longer term safety and effectiveness through 10-year follow-up of the initial 350 patients in the patient cohort that was part of the PMA.
  • Study the “learning curve” and the longer term safety and effectiveness of the BHR in the United States by studying 350 patients at up to 8 sites where clinical and radiographic data will be assessed annually through 5 years and at 10 years. Also, determine cobalt and chromium serum concentration and renal function in these patients at 1, 4, and 10 years.
  • Implement a training program to provide clinical updates to investigators.

The Cormet Hip Resurfacing System (Corin) and the Conserve®Plus (Wright Medical Technology) are metal-on-metal total hip resurfacing systems that were FDA approved in 2007 and 2009, respectively. The approval order for the Cormet system states that the device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision. 

Total Hip Resurfacing Devices

Device Name

Composition

FDA Status

Cormet 2000

Metal femoral and acetabular component

FDA approved

Conserve® Plus

Metal femoral and acetabular component

FDA approved

Birmingham hip resurfacing device

Metal femoral and acetabular component

FDA approved

 

A variety of devices have been cleared by the FDA for partial hip (femoral) resurfacing under the FDA’s 510(k) mechanism. Some surgeons may be using a femoral resurfacing component together with an acetabular cup (total arthroplasty component) as an "off-label" application.

In January 2013, FDA issued a safety communication on metal-on-metal hip implants (including both hip resurfacing and hip replacement). FDA states that metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.

  • With metal-on-metal implants, some tiny metal particles wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.
  • Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body (systemic reactions).

Presently, FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.

Also, see the Surgical Treatment of Femoroacetabular Impingement medical policy. 

 

POLICY

Metal-on-metal total hip resurfacing with an FDA approved device system may be considered medically necessary as an alternative to total hip replacement when the patient:
  • Is a candidate for total hip replacement; AND
  • Is likely to outlive a traditional prosthesis; AND 
  • Does not have a contraindication for total hip resurfacing (See Policy Guidelines).

Partial hip resurfacing with an FDA-approved device may be considered medically necessary in patients with osteonecrosis of the femoral head who have one or more contraindications for metal-on-metal implants and meet the following criteria:

  • The patient is a candidate for total hip replacement; AND 
  • Is likely to outlive a traditional prosthesis; AND 
  • The patient has known or suspected metal sensitivity or concern about potential effects of metal ions; AND 
  • There is no more than 50% involvement of the femoral head; AND 
  • There is minimal change in acetabular cartilage or articular cartilage space identified on radiography.

All other types and applications of total hip resurfacing are considered investigational.

 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity

   

POLICY GUIDELINES

The U.S. Food and Drug Administration (FDA) lists several contraindications for total hip resurfacing. These contraindications include (not a complete listing) the following:

-Bone stock inadequate to support the device due to:

  • severe osteopenia or a family history of severe osteoporosis or severe osteopenia
  • osteonecrosis or avascular necrosis with more than 50% involvement of the femoral head.
  • multiple cysts of the femoral head (more than 1 cm)

-Skeletal immaturity

-Vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery

-Known moderate to severe renal insufficiency

-Severely overweight

-Known or suspected metal sensitivity

-Immunosuppressed or receiving high doses of corticosteroids

-Females of child bearing age due to unknown effects on the fetus of metal ion release

A 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems. The FDA advises that a metal-on-metal hip implant should be selected only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system. Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level. Patients should be informed about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Patient expectations and the potential complications of surgery with a metal-on-metal hip implant should be discussed.

Total hip resurfacing should be performed by surgeons who are adequately trained and experienced in the specific techniques and devices used.

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

 

POLICY HISTORY

11/2001: Approved Medical Policy Advisory Committee (MPAC)

2/7/2002: Investigational definition added

5/8/2002: Type of Service and Place of Service deleted

11/3/2004: Code Reference section completed

2/18/2005: Policy reviewed, no changes

3/13/2006: Policy reviewed, devices were updated, investigational policy statement unchanged

9/18/2006:  Coding updated.  ICD9 2006 revisions added to policy

4/30/2007: Policy updated to allow for metal-on-metal total hip resurfacing. CPT 27299, ICD-9 procedures 00.85 and 81.40 moved to covered. Added ICD-9 diagnosis 714.0, 715.0-715.9, 733.42

5/16/2007: Policy reviewed, description updated. Added "who do not have contraindications for total hip resurfacing," and removed "who are likely to out live a traditional prosthesis," under the Policy section

7/19/2007: Reviewed and approved by MPAC

6/24/2008: Policy reviewed, no changes

8/26/2008: Quarterly HCPCS code updates applied

08/18/2010:  Policy description updated regarding FDA approval of devices and treatment approaches. The total resurfacing policy statement was revised to add “is likely to outlive a traditional prosthesis” to the criteria. Added policy statements for partial resurfacing, which is considered medically necessary in specific conditions. Supporting explanations added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Added ICD-9 procedure codes 00.75, 00.86, and 00.87.

07/29/2011: Deleted "Total" from the policy title to align with the scope of the policy statement. Policy statement unchanged.

07/12/2012: Policy reviewed; no changes.

10/17/2013: Policy reviewed; no changes to policy statement. Policy guidelines updated regarding patient selection criteria.

11/25/2014: Policy reviewed; description updated regarding devices and metal-on-metal implants. Policy statements unchanged.

 

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.80

 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

Code Number

Description

CPT-4

27299Unlisted procedure, pelvis or hip joint

ICD-9 Procedure

00.75Hip bearing surface, metal-on-metal
00.85Resurfacing hip, total, acetabulum and femoral head
00.86 Resurfacing hip, partial, femoral head
00.87Resurfacing hip, partial, acetabulum
81.40Repair of hip, not elsewhere classified
  

ICD-9 Diagnosis

714.0Rheumatoid arthritis
715.0, 715.1, 715.2, 715.3, 715.8, 715.9Osteoarthrosis
733.42Aseptic necrosis of head and neck of femur

HCPCS

S2118Metal-on-metal total hip resurfacing, including acetabular and femoral components

 

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