Medical Policy: 07.01.80
Original Effective Date: December 2018
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.
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.
In 2016, a synthetic polyvinyl alcohol hydrogel disc (Cartiva) received marketing approval by the U.S. Food and Drug Administration for the treatment of degenerative or posttraumatic arthritis in the first metatarsophalangeal (MTP) 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.
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.
Synthetic cartilage implants (e.g. Cartiva) are considered investigational for the treatment of articular cartilage damage, including but not limited to the toe.
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 synthetic cartilage implant has 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.
To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
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.