mp-153 - Medical Policies - Alabama
Policy Number: MP-153
Latest Review Date: April 2022
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 below).
Contraindications for total hip resurfacing:
- 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 1cm)
- 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 of the fetus of metal ion release
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 hip resurfacing are considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
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 (THR) 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. Available prostheses are metal-on-metal devices.
THR has been investigated in patients with osteoarthritis, rheumatoid arthritis, and advanced avascular necrosis as an alternative to THA, 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 THA. Proposed advantages of THR compared with THA include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a THR, 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 with THA.
THR has undergone various evolutions, with modifications in prosthetic design and composition and implantation techniques. For example, similar to total hip prostheses, the acetabular components of THR have been composed of polyethylene. However, over time it became 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.
The most recent literature update was performed through February 23, 2022.
Summary of Evidence
For individuals who have an indication for hip replacement who would outlive a traditional prosthesis and have no contraindication for hip resurfacing who receive a metal-on-metal total hip resurfacing device, the evidence includes RCTs, numerous large observational studies, large registry studies, and systematic reviews. Relevant outcomes are symptoms, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related morbidity. The efficacy of total hip resurfacing performed with current techniques is similar to that for THA over the short-to-medium term, and total hip resurfacing may permit easier conversion to a THA for younger patients expected to outlive their prosthesis. Based on potential ease of revision of total hip resurfacing compared with THA, current evidence supports conclusions that hip resurfacing presents a reasonable alternative for active patients who are considered too young for THA when performed by surgeons experienced in the technique. The literature on adverse events (e.g., metallosis, pseudotumor formation, implant failure) is evolving as longer follow-up data become available. Due to the uncertain risk with metal-on-metal implants, the risk-benefit ratio needs to be considered carefully on an individual basis. In addition, emerging evidence has suggested an increased risk of failure in women, possibly due to smaller implant size. Therefore, these factors should also be considered in the overall patient evaluation for total hip resurfacing, and patients should make an informed choice with their treating physicians. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have an indication for hip replacement who would outlive a traditional prosthesis and have no contraindication for hip resurfacing who receive a partial hip resurfacing device, the evidence includes a comparative study. Relevant outcomes are symptoms, change in disease status, functional outcomes, health status measures, QOL, and treatment-related morbidity. Although evidence has shown better outcomes with THR than with partial hip resurfacing, partial hip resurfacing would be appropriate in younger patients with osteonecrosis who have contraindications for a metal-on-metal prosthesis. These factors should be considered in the overall patient evaluation for THR, and patients should make an informed choice with their treating physicians. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
The Hip Society (2012) published an algorithmic approach to the diagnosis and management of metal-on-metal (MoM) arthroplasty (total hip arthroplasty [THA], total hip resurfacing [THR]. The review indicated that adverse local tissue reactions to metal debris are escalating and that all arthroplasty patients returning for follow-up should be queried for pain, discomfort, or compromise of function. Symptomatic patients should be evaluated for all intra-articular and extra-articular causes of pain, including aseptic loosening, sepsis, component malposition, or fluid collections and/or masses about the hip. The Hip Society stated that there is still a role for MoM resurfacing arthroplasty in select patients groups. The ideal candidate is a man younger than age 55 with osteoarthritis and a femoral head size larger than 50 mm. Another relative indication is the need or desire to return to a very high activity level at work or in recreation. Contraindications to MoM resurfacing include known or suspected metal sensitivity; moderate or worse renal function; women who may become pregnant; osteoporosis; large cysts; and avascular necrosis more than 50%.
American Academy of Orthopaedic Surgeons
In 2010, the American Academy of Orthopaedic Surgeons published a technology overview on MoM hip resurfacing. To compare revision rates between MoM hip resurfacing and THA, the Academy analyzed three joint registries, which indicated that patients who received THR were at greater risk for revision than patients who received THA. One registry suggested that younger men may have a lower revision rate after THR than THA, although the available data were not found to clearly establish an advantage for this subgroup. There was no conclusive evidence on predictors of successful or unsuccessful outcomes.
National Institute for Health and Care Excellence
The NICE (2014) updated its guidance on THA and THR for end-stage arthritis of the hip. The NICE concluded that both THA and THR were options for treating end-stage arthritis of the hip, although clinicians may be more likely to offer resurfacing arthroplasty to men than to women because of higher revision rates observed in women. The NICE concluded that THA was more effective and less costly than THR in all analyses, that the revision rate was the most important key driver of costs and quality-adjusted life years, and that because the predicted revision rate of THA was less than 5% at ten years in the population for whom both THA and THR were suitable, the revision rate standard for THR should be the same as that for THA. The NICE recommended specific prostheses for THA and THR only if the prostheses have revision rates of 5% or less at ten years.
U.S. Preventive Services Task Force Recommendations
Total hip resurfacing, partial hip resurfacing, total hip arthroplasty, Buechel-Pappas Integrated Total Hip Replacement, Conserve Plus, Cormet 2000, Birmingham hip resurfacing device, BHR
APPROVED BY GOVERNING BODIES:
In 2006, FDA approved the Birmingham Hip Resurfacing (BHR; Smith & Nephew Orthopaedics, Cordova, TN) system, a MoM resurfacing system, through the premarket approval (PMA) process for use in patients requiring primary hip resurfacing arthroplasty for non-inflammatory or inflammatory arthritis. This decision was primarily based on a series of 2385 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.
Two additional MoM hip resurfacing systems have been approved: in 2007, the Cormet™ Hip Resurfacing System (Corin, Tampa, FL) and, in 2009, the Conserve® Plus Total Hip Resurfacing System (MicroPort Orthopedics, Arlington, TN). Both implants were approved for skeletally mature patients with either non-inflammatory degenerative arthritis (e.g., osteoarthritis and avascular necrosis) or inflammatory arthritis (e.g., rheumatoid arthritis). (Note: patients with the latter arthritis might be individuals who, due to younger age or increased activity level, may not be suitable for traditional THA because it would increase the possibility of requiring ipsilateral hip joint revision.)
Various devices have been cleared for marketing by FDA through the 510(k) process for partial hip (femoral) resurfacing. Some surgeons may be using a femoral resurfacing component together with an acetabular cup (total arthroplasty component) as an "off-label" application.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA and will be reviewed for medical necessity.
There is no specific CPT code for total hip resurfacing. The American Academy of Orthopaedic Surgeon’s coding committee has written several articles stating that this procedure should be reported with the regular total hip CPT code 27130.
Unlisted procedure, pelvis or hip joint
Arthroplasty, acetabular and proximal femoral prosthetic replacement [total hip replacement], with or without autograft or allograft
Metal-on-metal total hip resurfacing, including acetabular and femoral components
- Amstutz HC, Le Duff MJ, Campbell PA et al. Clinical and radiographic results of metal-on-metal hip resurfacing with a minimum ten-year follow-up. J Bone Joint Surg Am 2010; 92(16):2663-2671.
- Australian Orthopedic Association. National Joint Replacement Registry Annual Report. 2006.
- Azam MQ, McMahon S, Hawdon G, et al. Survivorship and clinical outcome of Birmingham hip resurfacing: a minimum ten years' follow-up. Int Orthop. Jan 2016; 40(1):1-7.
- Ball ST, LeDuff MJ and Amstutz HC. Early results of conversion of a failed femoral component in hip resurfacing arthroplasty. J Bone Joint Surg Am, April 2007; 89(4): 735-741.
- Beaule PE, Amstutz HC, Le Duff M et al. Surface arthroplasty for osteonecrosis of the hip: hemiresurfacing versus metal-on-metal hybrid resurfacing. J Arthroplasty 2004; 19(8 Suppl 3):54-58.
- Daniel J, Pradhan C, Ziaee H, et al. Results of Birmingham hip resurfacing at 12 to 15 years: a single-surgeon series. Bone Joint J. Oct 2014; 96- B(10):1298-1306.
- de Steiger RN, Miller LN, Prosser GH et al. Poor outcome of revised resurfacing hip arthroplasty. Acta Orthop 2010; 81(1):72-76.
- Food and Drug Administration. P040033: Birmingham Hip Resurfacing (BHR) System. 2006; http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040033a.pdf.
- Garbuz DS, Tanzer M, Greidanus NV et al. The John Charnley award: metal-on-metal hip resurfacing versus large-diameter head metal-on-metal total hip arthroplasty: a randomized clinical trial. Clin Orthop Relat Res Feb 2010; 468(2):318-325.
- Grecula MJ. Resurfacing arthroplasty in osteonecrosis of the hip. Orthop Clin North Am 2005; 36(2):231-242, x.
- Gross TP, Liu F, Webb LA. Clinical outcome of the metal-on-metal hybrid Corin Cormet 2000 hip resurfacing system: an up to 11-year follow-up study. J Arthroplasty 2012; 27(4):533-538 e531.
- Haddad FS, Konan S, Tahmassebi J. A prospective comparative study of cementless total hip arthroplasty and hip resurfacing in patients under the age of 55 years: a ten-year follow-up. Bone Joint J. May 2015;97-B(5):617-622.
- Jiang Y, Zhang K, Die J et al. A systematic review of modern metal-on-metal total hip resurfacing vs standard total hip arthroplasty in active young patients. J Arthroplasty 2011; 26(3):419-426.
- Kim PR, Beaule PE, Lafamme Gy et al. Causes of early failure in a multicenter clinical trial of hip resurfacing. J Arthroplasty 2008; 23(6 Suppl 1):44-49.
- Kwon YM, Ostlere SJ, McLardy-Smith P et al. Asymptomatic pseudotumors after metal-on-metal hip resurfacing arthroplasty: prevalence and metal ion study. J Arthroplasty 2011; 26(4):511-518.
- Lavigne M, Therrien M, Nantel J et al. The John Charnley award: the functional outcome of hip resurfacing and large-head THA is the same: a randomized, double-blind study. Clin Orthop Relat Res. Feb 2010; 468(2): 326-336.
- Lombardi AV, Jr., Barrack RL, Berend KR, et al. The Hip Society: algorithmic approach to diagnosis and management of metal-on-metal arthroplasty. J Bone Joint Surg Br. Nov 2012; 94(11 Suppl A):14-18.
- Marker DR, Strimbu K, McGrath MS et al. Resurfacing versus conventional total hip arthroplasty-review of comparative clinical and basic science studies. Bull NYU Hosp Jt Dis 2009; 67(2):120-127.
- Matharu GS, McBryde CW, Pynsent WB, et al. The outcome of the Birmingham Hip Resurfacing in patients aged < 50 years up to 14 years post-operatively. Bone Joint J. Sep 2013; 95-B(9):1172-1177.
- McGrath MS, Marker DR, Seyler TM et al. Surface replacement is comparable to primary total hip arthroplasty. Clin Orthop Related Res. Jan 2009; 467(1):94-100.
- McGrory B, Barrack R, Lachiewicz PF, et al. Modern metal-on-metal hip resurfacing. J Am Acad Orthop Surg. May 2010;18(5):306-314.
- Mont MA, Seyler TM, Ragland PS, Starr R, et al. Gait analysis of patients with resurfacing hip arthroplasty compared with hip osteoarthritis and standard total hip arthroplasty. J Arthroplasty, January 2007; 22(1): 100-108.
- Mont MA, Seyler TM, Ulrich SD, et al. Effect of changing indications and techniques on total hip resurfacing. Clin Orthop Relat Res, December 2007; 465; 63-70.
- Murray DW, Grammatopoulos G, Pandit H, et al. The ten-year survival of the Birmingham hip resurfacing: an independent series. J Bone Joint Surg Br. Sep 2012; 94(9):1180-1186.
- National Institute for Health and Care Excellence (NICE). Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip [TA304]. 2014; www.nice.org.uk/guidance/ta304.
- Nunley RM, De la Valle CJ, Barrack RL. Is patient selection important for hip resurfacing? Clin Orthop Relat Res 2009; 467(1):56-65.
- Nunley RM, Zhu J, Brooks PJ et al. The learning curve for adopting hip resurfacing among hip specialists. Clin Orthop Relat Res Feb 2010; 468(2):382-391.
- Ollivere B, Darrah C, Barker T et al. Early clinical failure of the Birmingham metal-on-metal hip resurfacing is associated with metallosis and soft-tissue necrosis. J Bone Joint Surg Br 2009; 91(8):1025-1030.
- Pailhe R, Matharu GS, Sharma A, et al. Survival and functional outcome of the Birmingham Hip Resurfacing system in patients aged 65 and older at up to ten years of follow-up. Int Orthop. Jun 2014; 38(6):1139-1145.
- Quesada MJ, Marker DR, Mont MA. Metal-on-metal hip resurfacing: advantages and disadvantages. J Arthroplasty 2008; 23(7 Suppl); 69-73.
- Reito A, Puolakka T, Elo P, et al. Outcome of Birmingham hip resurfacing at ten years: role of routine whole blood metal ion measurements in screening for pseudotumours. Int Orthop. Nov 2014; 38(11):2251-2257.
- Steffen RT, Pandit HP, Palan J et al. The five-year results of the Birmingham Hip Resurfacing arthroplasty: an independent series. J Bone Joint Surg Br 2008; 90(4):436-441.
- Stoney J, Graves SE, de Steiger RN, et al. Is the Survivorship of Birmingham Hip Resurfacing Better Than Selected Conventional Hip Arthroplasties in Men Younger Than 65 Years of Age? A Study from the Australian Orthopaedic Association National Joint Replacement Registry. Clin Orthop Relat Res. Nov 2020; 478(11): 2625-2636.
- Stulberg BN, Fitts SM, Zadzilka JD et al. Resurfacing arthroplasty for patients with osteonecrosis. Bull NYU Hosp Jt Dis 2009; 67(2):138-141.
- Su EP, Ho H, Bhal V, et al. Results of the First U.S. FDA-Approved Hip Resurfacing Device at 10-Year Follow-up. J Bone Joint Surg Am. Jul 21 2021; 103(14): 1303-1311.
- Vendittoli PA, Lavigne M, Roy AG, et al. A prospective randomized clinical trial comparing metal-on-metal total hip arthroplasty and metal-on-metal total hip resurfacing in patients less than 65 years old. Hip Int. 2006; 16 Suppl 4:73-81.
- Williams DH, Greidanus NV, Masri BA et al. Prevalence of pseudotumor in asymptomatic patients after metal-on-metal hip arthroplasty. J Bone Joint Surg Am 2011; 93(23):2164-2171.
Medical Policy Group, March 2004
Medical Policy Administration Committee, April 2004
Available for comment May 17-June 30, 2004
Medical Policy Group, March 2006 (1)
Medical Policy Group, January 2007 (2)
Medical Policy Administration Committee, January 2007
Available for comment January 19-March 5, 2007
Medical Policy Group, January 2009 (1)
Medical Policy Group, December 2009 (3)
Medical Policy Group, January 2010 (2)
Medical Policy Administration Committee, February 2010
Available for comment February 6-March 22, 2010
Medical Policy Group, October 2012 (2): 2012 Updates to Key Points and References
Medical Policy Panel, September 2013
Medical Policy Group, November 2013 (2): Description, References, Current Coding, and References updated with results of literature review through August 2013. No change in policy statement.
Medical Policy Panel, September 2014
Medical Policy Group, September 2014 (3): 2014 Updates to Key Points & References; no change in policy statement.
Medical Policy Panel, September 2015
Medical Policy Group, October 2015 (2): 2015 Updates to Description, Key Points, and References; no change in policy statement.
Medical Policy Panel, August 2017
Medical Policy Group, September 2017 (7): 2017 Updates to Description, Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2018
Medical Policy Group, May 2018 (7): Updates to Key Points and References. No change in Policy Statement.
Medical Policy Panel, April 2019
Medical Policy Group, May 2019 (7): Updates to Description, Key Points and Approved by Governing Bodies. No change in Policy Statement.
Medical Policy Panel, April 2020
Medical Policy Group, May 2020 (7): 2020 Minor updates to Key Points. No new literature to add. No change in Policy Statement
Medical Policy Panel, April 2021
Medical Policy Group, April 2021 (7): Updates to Description, Key Points and References. Policy statement updated to remove "not medically necessary". No change to policy intent.
Medical Policy Panel, April 2022
Medical Policy Group, April 2022 (7): Update to Key Points and References. No change in Policy Statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.