Medicare Coverage Indications, Limitations, and/or Medical Necessity

It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

Inclusion of a service or procedure in this non-coverage LCD indicates that the service is considered to be not reasonable and necessary and claims reporting the service will be denied as such.

The Centers for Medicare and Medicaid Services (CMS) Internet-Only Manual (IOM) Publication 100-08, Chapter 13, Section 13.5.1 defines that in order to be covered under Medicare, a service shall be considered reasonable and necessary, and further, that when appropriate, a contractor shall describe the circumstances under which the service is reasonable and necessary as part of its Local Coverage Determination (LCD) process.

Section 1862(a)(1)(A) of the Social Security Act is the basis for the above manual citation, and is the fundamental determinant of the coverage of a specific service for a Medicare Beneficiary. Services considered not reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the function of a malformed body member are excluded from this coverage.

A service that appears to meet the technical requirements for coverage may also be excluded if that service:

• is not generally accepted as safe and effective by the medical community
• is not supported in peer-reviewed medical literature
• is experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary)
• is not medically necessary in a specific case, or for a specific medical diagnosis
• is furnished at a level, duration, dosage or frequency not appropriate for a specific patient or clinical condition
• is not furnished in a manner consistent with community standards of care
• is not furnished in a setting (place of service) consistent with the patient's medical needs and condition
• is furnished in a manner primarily for patient convenience or provider convenience
• is a device not approved for marketing by the FDA and is not included in an FDA approved IDE trial
• is a test or service now considered obsolete by the medical community, and replaced by more efficacious services

Please note that a new service is not immediately considered covered or medically reasonable and necessary with the issuance of either FDA approval or the issuance of a CPT code. The contractor reserves the right to review the safety and efficacy of the treatment in comparison to existing treatment, both in peer-reviewed literature and in clinical application before making a determination of local coverage. For very new or infrequently done services, there may be little available literature. If providers believe that any of the Category III codes have been proven safe and effective, those providers may request removal of the code from this list through the Novitas LCD Reconsideration Process. If a code is removed from the non-coverage listing, documentation to support its use in a particular situation should be submitted with the claim so that it may be evaluated on an individual consideration basis.