Medical Policy: 07.01.80 

Original Effective Date: December 2018 

Reviewed: December 2020 

Revised: December 2020 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Articular cartilage damage, either from a focal lesion or diffuse osteoarthritis, can result in disabling pain. Cartilage is a hydrogel, comprised mostly of water with collagen and glycosaminoglycans that does not typically heal on its own. The most common site of arthritis in the foot is at the base of the big toe. This joint is called the metatarsophalangeal, or MTP joint. It's important because it has to bend every time you take a step. If the joint starts to stiffen, walking can become painful and difficult. In the MTP joint, as in any joint, the ends of the bones are covered by a smooth articular cartilage. If wear-and-tear or injury damage the articular cartilage, the raw bone ends can rub together. A bone spur, or overgrowth, may develop on the top of the bone. This overgrowth can prevent the toe from bending as much as it needs to when you walk. The result is a stiff big toe, or hallux rigidus. Hallux rigidus usually develops in adults between the ages of 30 and 60 years. No one knows why it appears in some people and not others. It may result from an injury to the toe that damages the articular cartilage or from differences in foot anatomy that increase stress on the joint.

 

Implants have the potential to reduce pain and maintain mobility in the first MTP joint but have in the past been compromised by fragmentation, dislocation, particle wear, osteolysis, and loosening. For individuals who have early-stage first MTP osteoarthritis who receive a synthetic cartilage implant, the evidence is lacking. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment related morbidity. The pivotal study was performed in patients with Coughlin stage 2, 3, or 4 hallux rigidus. No evidence was identified in patients with stage 0 to early-stage 2 hallux rigidus. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Early-stage OA of the first MTP is typically treated with conservative management, including pain medication and change in footwear. Failure of conservative management in patients with advanced OA of the MTP joint may be treated surgically. Cheliectomy (removal of bone osteophytes) and interpositional spacers with autograft or allograft have been used as temporary measures to relieve pain. MTP arthrodesis is considered the most reliable and primary surgical option. Arthrodesis can lead to a pain-free foot, but the loss of mobility in the MTP joint alters gait, may restrict participation in running and other sports, and limits footwear options, leading to patient dissatisfaction. Transfer of stress and arthritis in an adjacent joint may also develop over time.

 

Cartiva Implant

The Cartiva implant is an 8- to 10-mm PVA disc that is implanted with a slight (1- to 1.5-mm) protrusion to act as a spacer for the first MTP joint. It comes with dedicated reusable instrumentation, which includes a drill bit, introducer, and placer. The Cartiva PVA implant was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of arthritis of the MTP joint.

 

In July 2016, Cartiva® Synthetic Cartilage Implant (Cartiva, Alpharetta, GA) was approved by the FDA through the premarket approval process for painful degenerative or posttraumatic arthritis in the first MTP joint along with hallux valgus or hallux limitus and hallux rigidus. Lesions greater than 10 mm in size and insufficient quality or quantity of bone are contraindications. Continued approval depends on a study evaluating long-term safety and effectiveness. The post-approval study will follow the subjects treated with Cartiva® Synthetic Cartilage Implant for 5 years.

 

The pivotal trial compared the implant with arthrodesis and showed patient-reported pain scores to be slightly worse than arthrodesis with similar outcomes between the 2 groups on scores for activities of daily living and sports. Five-year follow-up was reported in 2017 for about 20% of the original cohort, which showed no evidence of implant degradation or reduction in pain and function. Continued Food and Drug Administration approval depends on a 5-year follow-up of the complete cohort and will provide needed information on implant durability. There is a high possibility of bias in favor of the novel device. Corroboration of long-term results in an independent study would provide greater confidence in the findings of the pivotal trial. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

The HemiCAP Implant

The HemiCAP® Toe Contoured Articular Prosthetic implant consists of a metallic articular resurfacing component mounted on a taper post. The system is intended to be implanted with bone cement to treat stiffness, instability, or pain associated with arthritis in the first metatarsophalangeal (MTP) joint (hallux rigidus) or to treat bunions (hallux valgus). Metatarsal head resurfacing (hemi-arthroplasty) is intended as an alternative to joint fusion (arthrodesis), total joint replacement (TJR), or bone spur removal.

 

Limited evidence from two small comparative studies and small case series at high risk of bias suggests that HemiCAP reduced pain in patients with hallux rigidus. Although two of these studies were comparative, they reported on too few patients and are at too high a risk of bias to determine whether HemiCAP works as well as arthrodesis or TJR. Randomized controlled trials (RCTs) are needed to assess HemiCAP's impact on pain, patient functional status, quality of life, and adverse events compared with that of other treatments, but none are ongoing.

 

Toefit-Plus

The prosthesis is composed of a tapered, threaded, conical titanium core, which avoids any need for cement. On the metatarsal side, a cobalt chrome metatarsal head is tapped into the titanium core and to accommodate the proximal phalanx, a polyethylene phalangeal plate is clipped to the core.

 

There is a high rate of complications with the Toefit-Plus™ implant resulting in revision surgery.

 

The Moje Implant

The Moje ceramic toe implant is made of zirconium oxide and was developed in 1994 by Dieter Werner (an orthopedic surgeon) and Hans Jurgen Moje (a ceramic engineer). The original implant was screw-fit but complications of osteolysis and metallosis led to the replacement of the design with the press-fit one. The press-fit implant is a 2-component ceramic prosthesis coated with apatite and fosterite crystals (Bioverit). It relies mainly on interference fit coupled with osseo-integration encouraged by the Bioverit coating.

 

There is an unacceptably high incidence of failure of the press-fit Moje implant

 

OsteoMed ReFlexion 1st MTP Implant System

This three-piece implant system designed for the reconstruction of the 1st MTP, resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis or revision of previous arthroplasty. The cone in cone implant secures bone to implant seating.

 

The METIS prosthesis

The METIS® prosthesis consists of three components: metatarsal (cobalt-chromium alloy), phalangel (titanium), and a third-generation interposition component composed of polyethylene. Metatarsal and phalangeal components are coated with hydroxyapatite. The design seeks to preserve the normal anatomy of the MTP joint, preserving the sesamoid bones and their tendinous insertions, with an expected range of motion of about 85°.

 

Bioabsorbable poly-L-D-lactic acid RegJoint inter-positional implant

The bioabsorbable poly-L-D-lactic acid RegJoint inter-positional implant provides temporary support to the joint, and the implant is subsequently replaced by the patient's own tissue.

 

Regulatory Status

Numerous prostheses fabricated from various components including metal (e.g., Titanium), acrylic, silastic, and metal alloys, have received FDA approval as Class II devices through the 510(k) process.

 

The Moje ceramic implant (Orthosonics, Ltd., Devon UK) is a two-component first MTP endoprosthesis made of zirconium oxide coated with the machinable, bioreactive glass ceramic Bioverit. The Moje implant has not received FDA approval.

 

In 2016 the Cartiva Synthetic Cartilage (Cartiva, Inc., Alpharetta, GA) Implant received premarket approval application (PMA) approval from the FDA and is indicated for use in the treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus. Nine supplemental approvals have been issued for this device since the original PMA but the indications for use have not changed with the reasons for the supplemental approvals included manufacturing process changes, approval for a postapproval study protocol, modification of the Surgical Implantation Technique Guide, and the addition of a new manufacturing site.

 

Prior Approval:

Not applicable

 

Policy:

The following great toe/metatarsal implants are considered investigational due to minimal long-term results and high rates of complications:

  1. Ceramic prosthesis: including but not limited to Moje implant OR
  2. Modular implants: including but not limited to:
    • Metis Prosthesis
    • The OsteoMed ReFlexion 1st MTP Implant System
    • ToeMotion with/without HemiCap Implant
    • The ToeFit-Plus prosthesis OR
  3. Molded cylindrical implants: including but not limited to Cartiva Implant OR
  4. Bioabsorbable implants: including but not limited to bioabsorbable poly-L-D-lactic acid RegJoint inter-positional implant

 

A multitude of great toe implants have been studied over the years in an attempt to maintain toe motion. These often fail as a result of loosening, dislocation, implant fragmentation and bone loss. After implant failure, salvage therapy with arthrodesis (fusion) often results in a poorer functional outcome than primary fusion. Because of this, primary first MTP arthrodesis has been considered the most reliable surgical option for advanced osteoarthritis of the great toe. The implants have been proposed as an alternative to fusion for hallux limitus or hallux rigidus in the first MTP joint to reduce pain, improve function and maintain joint motion, but allow for the option of fusion if needed. The long term outcomes cannot be proven at this time. The current results of first MTP joint replacement with these implants are inferior to arthrodesis. Surgery has failed to preserve the function and increase the range of movement in most cases for the long duration.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 28291 Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; with implant
  • L8641 Metatarsal joint implant
  • L8642 Hallux implant
  • L8658 Interphalangeal joint spacer, silicone or equal, each
  • L8699 Prosthetic Implant, not otherwise specified

 

Selected References:

  • U.S. Food and Drug Administration. Cartiva: Post approval studies. 2016;
  • Goldberg A, Singh D, Glazebrook M, et al. Association between patient factors and outcome of synthetic cartilage implant hemiarthroplasty vs first metatarsophalangeal joint arthrodesis in advanced hallux rigidus. Foot Ankle Int. Aug 01 2017:1071100717723334. PMID 28820949
  • Baker MI, Walsh SP, Schwartz Z, et al. A review of polyvinyl alcohol and its uses in cartilage and orthopedic applications. J Biomed Mater Res B Appl Biomater. Jul 2012;100(5):1451-1457. PMID 22514196
  • Baumhauer JF, Singh D, Glazebrook M, et al. Prospective, randomized, multi-centered clinical trial assessing safety and efficacy of a synthetic cartilage implant versus first metatarsophalangeal arthrodesis in advanced hallux rigidus. Foot Ankle Int. May 2016;37(5):457-469. PMID 26922669
  • Daniels TR, Younger AS, Penner MJ, et al. Midterm outcomes of polyvinyl alcohol hydrogel hemiarthroplasty of the first metatarsophalangeal joint in advanced hallux rigidus. Foot Ankle Int. Mar 2017;38(3):243-247. PMID 27909032
  • Uptodate (November 2018) Evaluation and diagnosis of common causes of forefoot pain in adults. Hallus rigidus:
  • Coughlin, M. Shurnas, P. (2003) Hallux Rigidus: Demographics, Etiology, and Radiographic Assessment.
  • Glazebrook M, Blundell CM, O'Dowd D, et al. Midterm outcomes of a synthetic cartilage implant for the first metatarsophalangeal joint in advanced hallux rigidus. Foot Ankle Int. 2019;40(4):374-383.
  • Cassinelli SJ, Chen S, Charlton TP et al. Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States. Foot Ankle Int, 2019 Jun 15;1071100719855049:1071100719855049. PMID 31195830
  • Circi, E, Tuzuner, T, Sukur, E, Baris, A, and Kanay, E. Metatarsal head resurfacing arthroplasty in the treatment of hallux rigidus: is it reliable treatment option? Musculoskelet Surg. 2016;100(2):139-144.
  • Hilario, H, Garrett, A, Motley, T, Suzuki, S, and Carpenter, B. Ten-year follow-up of metatarsal head resurfacing implants for treatment of hallux rigidus. J Foot Ankle Surg. 2017;56(5):1052-1057.
  • ECRI Institute, HemiCAP MTP Resurfacing Hemi-arthroplasty Implant (Arthrosurface Inc.) for Treating Arthritis of the First Metatarsophalangeal Joint. Custom Product Brief 9/9/2019
  • Gupta,S., Masus, S. Long term results of the Toefit-Plus replacement for first metatarsophalangeal joint arthritis, Foot (Edinb). 2017 Jun;31:67-71. doi: 10.1016/j.foot.2017.04.006. Epub 2017 May 8.
  • Partio N, Ponkilainen VT, Rinkinen V, et al. Interpositional arthroplasty of the first metatarsophalangeal joint with bioresorbable Pldla implant in the treatment of hallux rigidus and arthritic hallux valgus: A 9-year case series follow-up. Scand J Surg. 2019 Dec 29
  • ECRI Institute. Cartiva (Wright Medical Group N.V.) for Treating Arthritis of the First Metatarsophalangeal Joint. Plymouth Meeting (PA): ECRI Institute; 2020 Jan 15. (Custom Product Brief).
  • An TW, Cassinelli S, Charlton TP, et al.(2020) Radiographic and Magnetic Resonance Imaging of the Symptomatic Synthetic Cartilage Implant. Foot Ankle Int. Jan 2020; 41(1): 25-30. PMID 31538827
  • Thordarson DB, Cassinelli SJ, Charlton TP, et al. Response to Letter Regarding: Early Outcomes and Complications of Synthetic Cartilage Implant for Treatment of Hallux Rigidus in the United States. Foot Ankle Int. Oct 2019; 40(10): 1152-1153. PMID 31600477

     

 

Policy History:

  • December 2020 - Annual Review, Policy Revised
  • December 2019 - Annual Review, Policy Revised
  • December 2018 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.