Related Medicare Advantage Medical/Pharmacy Coverage Policies

None

Related Documents

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

There are no NCDs and/or LCDs for bunion and bunionette surgery.

Description

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A bunion or hallux valgus deformity consists of a lateral deviation from a straight line of the great toe toward the other toes of the foot with medial deviation of the 1st metatarsophalangeal (MTP) joint. The tissues surrounding the joint may become inflamed and painful. However, not all bunion deformities may cause symptoms. A bunion has many etiologies including, but not limited to, arthritic conditions, heredity or trauma while aggravation to the deformity may occur due to faulty foot mechanics or tight fitting shoe wear. This progressive deformity is not a single disorder but a complex deformity of the 1st ray or the column of bones that form the medial border of the forefoot.

Surgery may be recommended to correct the deformity and reconstruct the bones and joints, restoring normal pain-free function to individuals having difficulty walking and/or experiencing pain despite accepted conservative treatments.

Surgical repair of hallux valgus may include an osteotomy (cutting portions of bone on each side of the toe joint followed by realignment), shortening or lengthening tendons or ligaments, shaving tissue from the bunion, or arthrodesis (removing damaged portions of the joint and using screws, wires or a plate to hold the joint together). Several operative procedures and osteotomies have been devised and modified over time. The precise intervention employed depends on careful clinical and radiological evaluation and planning, as all hallux valgus deformities are unique and no single osteotomy procedure can treat them all.

Bunionette or tailor's bunion is a bony prominence on the lateral side of the 5th metatarsal head (toe). A painful callus or a localized keratosis may form beneath the 5th metatarsal head along with the bursa on the lateral side of the toe. Surgical repair may be necessary when severe pain limits an individual's ability to walk.

Hallux limitus refers to a great toe that lacks normal motion but does not demonstrate degenerative arthritic changes at the MTP joint. This condition may originate from inflammation, thickening of the joint capsule or from an unknown cause. Uncontrolled studies suggest that surgery provides long term relief of pain and improved function.

Hallux rigidus is a progressive disorder characterized by limitation of movement along with a dorsal bunion at the MTP joint of the great toe most often caused in an adult by degenerative arthritis. An individual with hallux rigidus may have a history of pain and stiffness in the 1st MTP joint that increases with activity and is aggravated by shoes. Many surgical procedures for hallux rigidus have been recommended including, but not limited to, arthrodesis (fusion) or resection arthroplasty.

A 1st MTP joint replacement, also known as total prosthetic arthroplasty, is an alternative to an arthrodesis surgical procedure for those individuals with disabling pain and lack of motion in the 1st MTP joint not improved with conservative and/or surgical treatment due to degenerative or post traumatic arthritis (hallux rigidus). The US Food & Drug Administration (FDA) have approved both partial and full replacement implants made of acrylic, biocompatible hydrogel, metal, metal alloys and silastic.

Ceramic (eg, Moje implant) and modular (eg, Metis implant) 1st MTP joint total replacement implants are currently not approved by the FDA.

A molded cylindrical 1st MTP joint implant, created from a biocompatible hydrogel made of polyvinyl alcohol and saline, purportedly has elastic and compressive mechanical properties similar to articular

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cartilage and maintains range of motion in the joint. An example of an FDA-approved molded cylindrical implant includes, but may not be limited to, Cartiva Synthetic Cartilage Implant (SCI).

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:

Bunion and Bunionette Surgical Treatments

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage