Purpose of the Medicare Advantage Medical Policy Manual

Important Note: This policy manual applies to services rendered to Medicare Advantage members only.

The purpose of the Medicare Advantage Medical Policy Manual is to provide the guidelines used for determining coverage criteria for specific medical and behavioral health services, including procedures, durable medical equipment, devices, and inpatient services for Medicare Advantage members. The same process is used to determine coverage criteria for medical and behavioral health services.

Application of Benefits

Benefit determinations are based on any applicable Centers for Medicare & Medicaid Services (CMS) policy, when available, and Evidence of Coverage (EOC) language. In order to be eligible for coverage, services must be a covered benefit and must not be a direct exclusion according to CMS guidelines and the member’s EOC language. In addition, the services must be considered reasonable and necessary as defined by Title XVIII of the Social Security Act, Section 1862(a)(1)(A) (see below).

To the extent there may be any conflict, the applicable EOC language or CMS policy will take precedence over Medicare Advantage Medical Policy. The Medicare Advantage Medical Policy is not intended to override the health insurance contract which defines the insured’s benefits, nor is it intended to dictate to providers how to practice medicine. Physicians and other health care providers are expected to exercise their medical judgment in providing the most appropriate care; however, not all services, procedures, devices, or equipment may be considered eligible for coverage under Medicare Advantage.

Definition of Medical Necessity

Medical necessity is defined by Title XVIII of the Social Security Act, Section 1862(a)(1)(A),^[1] which details coverage and payment provisions:

“No payment may be made under part A or part B for any expenses incurred for items or services… which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

Note that U.S. Food and Drug Administration (FDA)-approval for a specific indication or the issuance of a CPT code is not sufficient for a procedure to be considered medically reasonable and necessary. Similarly, the presence of a procedure/device code or payment amount for the service in the Medicare fee schedule does not necessarily indicate coverage.^[2] If a service is deemed not reasonable and necessary to treat illness or injury for any reason (including lack of safety and efficacy because it is an experimental procedure, etc.), the procedure is considered non-covered.

Requests for health care services, treatments, procedures, or devices that are not addressed by a Medicare reference may be reviewed to determine if sufficient evidence exists regarding safety and efficacy, ensuring the services are medically reasonable and necessary for Medicare Advantage members. This includes services or items reported with an unspecified (i.e., unlisted) CPT or HCPCS code.

Medicare Advantage Medical Policy Development

Medicare Advantage Medical Policies identify the clinical criteria for determining when services are considered ‘medically reasonable and necessary’. Medicare Advantage plans are required by CMS to provide the same medical benefits to Medicare Advantage members as Original Medicare. As such, whenever possible, Medicare Advantage Medical Policies are based on Medicare coverage manuals, National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and/or articles published by CMS or a Medicare Administrative Contractor (MAC). If there is no applicable Medicare guidance for the service under review, then other evidence-based criteria may be applied. In addition, each member’s unique, clinical situation is considered in conjunction with current CMS guidelines.

Policy Hierarchy

The following hierarchy is used to determine Medicare Advantage Medical Policy (some topics may refer to more than one tier of the hierarchy):

1. CMS Coverage Manuals or Other CMS-based Resource
   
   Medicare Advantage organizations (MAOs) are expected to stay apprised of new and/or changing Medicare Part A and Part B coverage policies, which include various CMS sources.^[3] Examples include general coverage guidelines included in Medicare manuals, such as Chapter 8 of the Medicare Benefit Policy Manual, which provides clinical criteria for skilled nursing facility (SNF) coverage.
   
   Other CMS-based resources include, but are not limited to, documentation such as Change Requests (CR),^[4] Transmittals (TRs),^[4] Medicare Learning Network (MLN) and Federal Register (FR) publications.
   
   
2. National Coverage Determinations (NCD)
   
   For some services, procedures, and technologies, CMS has published an NCD, which is to be applied on a national basis for all Medicare beneficiaries. NCDs are binding for all Medicare Advantage plans.^[4-5]
   
   
3. Local Coverage Determinations (LCD), Articles , and Other Contractor-based Bulletins
   
   When there is no NCD or other coverage provision outlining medical necessity criteria within a Medicare manual, or when there is a need to further define an NCD, then the MAC for a service area may develop a local coverage determination (LCD) or article.^[5]
   
   Noridian Healthcare Solutions (Noridian) is the designated MAC for all four (4) states within the health plan’s service area (Idaho, Oregon, Utah, and Washington).
   
   Noridian may provide coverage or non-coverage guidance in a Part B News Article published on the noridianmedicare.com website. These articles may be used in Medicare Advantage medical policy development.
   
   For some topics, an LCD or article from a MAC other than Noridian may be used, either due to unusual or extenuating circumstances, or when required to remain compliant with CMS guidelines. For example, when a single contractor has exclusive jurisdiction over a Medicare covered item or service (e.g., when there is only one provider of a particular pathology or lab test), CMS requires the coverage requirements of the contractor for the provider’s geographical area be applied.^[6] In general, the health plan uses LCDs and articles for diagnostic laboratory tests when they exist by the MAC holding jurisdiction, and this includes molecular and genetic testing. However, if there is no LCD or article available for a specific test by the laboratory’s service area MAC, then other MAC guidelines may be used if they are available.
   
   Finally, Noridian has implemented the guidelines published by Palmetto GBA under the Molecular Diagnostic (MolDX) Program for their Jurisdiction F (J-F) service area, which address genetic and molecular diagnostic testing.^[7] Several other Medicare contractors have also adopted the MolDX Program guidelines.^[8] Therefore, requests for genetic and molecular diagnostic testing may apply MolDX guidelines when applicable. This includes the denial of panel tests when specific excluded gene components are a part of the panel, as indicated by the MolDX contractor.
   
   
4. Commercial Medical Policies
   
   In the absence of a national or local Medicare coverage guidance regarding a procedure or device, then CMS guidelines allow for a Medicare Advantage organization (MAO) to make its own coverage determination. However, it must use an objective, evidence-based process based on authoritative evidence.^[9] In these situations, the MAO may apply the health plan’s Medical Policy criteria to the services under review. The health plan’s medical policies are developed following an objective, evidence-based process based on scientific evidence, generally accepted and current standards of medical practice, and authoritative clinical practice guidelines.
   
   The MAO may consider some services to be investigational. When a procedure or device is deemed “investigational” by the MAO, the term “investigational” is not meant to imply the procedure or device has not received approval by the Food and Drug Administration (FDA). Rather, the use of this term simply means the procedure or device does not meet the health plan’s objective, evidence-based technology assessment based on authoritative evidence. See the MAO’s Medical Policy Development Process for further details regarding their evidence-based policy development process.
   
   In addition, most services related to or required as a result of non-covered services are also non-covered under Medicare.^[10] Thus, services directly associated with the investigational procedure or technology may also be denied as not medically necessary. As previously stated, the issuance of a procedure code (CPT or HCPCS) or FDA approval does not, in itself, make the procedure medically reasonable and necessary. While the FDA reviews data from studies and clinical trials to determine safety and effectiveness prior to approval, it does not establish medical necessity of that device or drug. Medicare may adopt FDA determinations regarding safety and effectiveness, but Original Medicare, Medicare contractors, and MAOs evaluate whether or not the drug or device is reasonable and necessary for the Medicare population under §1862(a)(1)(A).
   
   
5. MCG™ (formerly Milliman Care Guidelines)
   
   If no policy criteria are available within an NCD, LCD, coverage manual, article, or existing medical policy for the services in question, MCG guidelines may be applied when available.

Selection of Topics for Policy Development

Issues are selected for Medicare Advantage Medical Policy development through referrals from staff, the physician and provider community, and members. Priority may be given to the following:

• New policies developed by CMS
• New diagnostic tests, therapeutic procedures or medical devices
• Technologies that are considered life-saving
• Medical technologies that are controversial with respect to their clinical utility
• Medical technologies that have generated a high level of interest for members and/or providers
• New information published in the peer-reviewed scientific literature that may change the status of a technology from investigational to medically necessary

Approval Process

All policy drafts are presented to the Medical and Behavioral Health Policy Governance for final approval.  The Governance body consists of professional medical policy staff, a diverse group of physician medical directors from Idaho, Oregon, Utah and Washington, and other key stakeholders from teams involved in the review and application of medical policies.

Medical Policy Updates

Medicare Advantage Medical Policies are re-evaluated and updated annually or more often as new information is published by CMS or Noridian, or as new evidence that alters the clinical criteria becomes available.

Medicare Advantage Medical Policy Dissemination

Medicare Advantage Medical Policies are published on-line and available to members, providers, and the general public at http://blue.regence.com/medicare/index.html.  Significant policy changes are communicated through provider newsletters and are noted on-line at: http://blue.regence.com/medicare/update/index.html.

References:

1. Title XVIII of the Social Security Act, §1862(a)(1)(A)
2. Medicare Claims Processing Manual, Pub. #100-04, Chapter 23 - Fee Schedule Administration and Coding Requirements, §30 - Services Paid Under the Medicare Physician’s Fee Schedule, A. Physician’s Services
3. Medicare Managed Care Manual, Pub. #100-16, Chapter 4 - Benefits and Beneficiary Protections, §90.1 – Overview
4. Medicare Managed Care Manual, Pub. #100-16, Chapter 4 - Benefits and Beneficiary Protections, §90.6 – Sources for Obtaining Information
5. Medicare Managed Care Manual, Pub. #100-16, Chapter 4 - Benefits and Beneficiary Protections, §90.3 – General Rules for NCDs
6. Medicare Managed Care Manual, Pub. #100-16, Chapter 4 - Benefits and Beneficiary Protections, §90.4.1 – MACS with Exclusive Jurisdiction over a Medicare Item or Service
7. Noridian MolDX Website https://med.noridianmedicare.com/web/jfb/policies/moldx
8. Molecular Diagnostics (MolDX) Program General Webpage
9. Medicare Managed Care Manual, Pub. #100-16, Chapter 4 - Benefits and Beneficiary Protections, §90.5 - Creating New Guidance
10. Medicare Benefit Policy Manual, Pub. #100-02, Chapter 16 - General Exclusions From Coverage, §180 - Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare