Humana Artificial Intervertebral Disc Replacement - Medicare Advantage Form

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 NCD and/or LCDs for artificial intervertebral disc replacement.

Description

Artificial Intervertebral Disc Replacement
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Artificial intervertebral disc replacement is an alternative to cervical and lumbar spinal fusion surgery for an individual suffering from back or neck pain due to degenerative disc disease (DDD). The artificial disc was designed to restore normal disc height, to preserve spinal flexibility and decrease degeneration of adjacent discs, which can occur as a result of DDD.

Examples of US Food & Drug Administration (FDA) devices approved for single-level cervical spine intervertebral disc replacement include, but may not be limited to:

• M6-C cervical disc
• MOBI-C cervical disc
• PCM cervical disc
• Prestige LP cervical disc system
• ProDisc C, ProDisc C Novo, ProDisc C SK, ProDisc C Vivo total disc replacement
• SECURE-C artificial cervical disc
• Simplify cervical artificial disc

Examples of FDA-approved devices for single- or two-level cervical spine intervertebral disc replacement include, but may not be limited to:

• MOBI-C cervical disc
• Prestige LP cervical disc system
• Simplify cervical artificial disc

Examples of FDA-approved devices for the lumbar spine include, but may not be limited to:

• activL artificial disc
• ProDisc L total disc replacement

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.

Artificial Intervertebral Disc Replacement

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.

Artificial Intervertebral Disc Replacement

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Coverage Limitations

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