Pyrocarbon Metacarpophalangeal and Proximal Interphalangeal Joint Implants

POLICY NUMBER

L.7.01.411

DESCRIPTION

Pyrocarbon two-component metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joint implants are intended for use as a surgical treatment option for patients with symptomatic joint disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization. The devices are an alternative to one-component, silicone-elastomer total joint replacement implants.

Rheumatoid arthritis (RA) and osteoarthritis (OA) often affect the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints in the human hand and can cause severe and painful disability. The MCP joint, considered by many to be the cornerstone in the architecture of the hand, is a three-dimensional joint with 3 degrees of constrained motion to provide both stability and mobility. A properly functioning MCP joint is key to integrated hand function. Over 2 million Americans are afflicted with RA, while over 20 million have OA. There is no known cure for RA or OA; the mainstay treatment strategy is usually a sequence of disease-modifying drugs, together with various types of occupational therapy and physical therapy to delay disease progression, often in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve symptoms. In cases where pain and disability are due to ulnar deviation, described as a 3-dimentional dislocation of the MCP joint, arthroplasty of the MCP joint may be considered. While a variety of implant designs have been brought to market over the years, including silicone spacers, plastic-on-plastic, metal-on-plastic, and metal-on-metal devices, poor outcomes have hampered extended use of these devices. Consequently, while large joint arthroplasty has advanced rapidly over the past 20 years, it is only recently that new implants for finger arthroplasty have been brought to market, including the Ascension® MCP and PIP prostheses (Ascension Orthopedics, Inc., Austin, TX), which are made of pyrocarbon.

The Ascension® MCP and PIP prostheses (Ascension Orthopedics, Inc., Austin, TX) are two-component, semiconstrained, uncemented, finger joint prostheses designed to replace the articulating surfaces of the MCP and PIP joints. The prostheses are fabricated from a thick pyrocarbon layer encasing a graphite substrate material that is impregnated with a small amount (1 atomic percent) of tungsten that renders it radiopaque. The bicondylar design, proximal "ball-shaped" articulating surface and stem and distal "cup-shaped" articular surface and stem, is designed to allow joint flexion-extension motion while restricting abduction-adduction motion. The proximal component replaces the articular surface at the head of the metacarpal bone, while the distal component replaces the articular surface at the base of the proximal phalanx. Component stems have an anatomic shape and are designed to be press-fit, without the use of bone cement into the shaft of the finger bone or intramedullary canal. The devices are implanted during open surgery (FDA, 2001a; FDA, 2002).

Ascension MCP® and PIP components are available in five sizes and four sizes, respectively. To ensure proper fitting of the PIP to the patient, the proximal and distal component sizes are interchangeable, allowing each component to be matched with a component of the same size, one size smaller, or one size larger. However, the size of the MCP proximal and distal components should not be mismatched. The wear behavior of mismatched MCP proximal and distal component size combinations has not been evaluated (FDA, 2001a; FDA, 2002).

POLICY

Use of pyrocarbon MCP/PIP joint implants in patients with symptomatic joint disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization is considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

3/2003: Approved by Medical Policy Advisory Committee (MPAC)

1/6/2004: Code Reference section completed, CPT code 26531, 26536 added, ICD-9 diagnosis code 736.09 deleted, ICD-9 diagnosis code range 714.0-714.9, 715.00-715.98 listed separately

8/8/2005: Code Reference section updated, HCPCS L8630, L8631, L8658 added

12/31/2008: Policy reviewed, no changes.

08/28/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure code 81.71. Added HCPCS code L8659.

06/01/2016: Policy number L.7.01.411 added. Investigative definition updated in Policy Guidelines section.

01/18/2023: Policy reviewed; no changes.

02/15/2024: Policy reviewed; no changes.

03/13/2025: Policy reviewed; no changes.

10/01/2025: Code Reference section updated to add new HCPCS codes L6035 and L6036.

SOURCE(S)

Hayes Medical Technology Directory

CODE REFERENCE

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

Investigational Codes

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