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Hierarchy of Medicare Regulations

Have you wondered how Medicare determines what is covered? Below you will find the hierarchy of how Medicare regulations are created.

Social Security Act

Title XVIII of the Social Security Act is administered by the CMS. The following sections are from Title XVIII-Health Insurance for the Aged and Disabled. 

Code of Federal Regulations

The CFR is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.

CMS’ Rulings

CMS' Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters.

Coverage provisions in Interpretive Manuals or Internet-Only Manuals, including Medical Review Guidance in Medicare Program Integrity Manual

CMS IOMs are a replica of the Agency's official record copy. They are CMS' program issuances, day-to-day operating instructions, policies, and procedures that are based on statutes, regulations, guidelines, models, and directives. The CMS program components, providers, contractors, Medicare Advantage organizations and state survey agencies use the IOMs to administer CMS programs. They are also a good source of Medicare and Medicaid information for the general public.

National Coverage Determination

Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury (and within the scope of a Medicare benefit category). NCDs are made through an evidence-based process, with opportunities for public participation. In some cases, CMS' own research is supplemented by an outside technology assessment and/or consultation with the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). In the absence of a national coverage policy, an item or service may be covered at the discretion of the Medicare contractors based on a local coverage determination (LCD).

Technical Direction Letters

TDLs that contain Medicare Regulation guidance may provide an exception to this hierarchy.

A TDL (also sometimes called “Technical Instructions”) provides agency guidance to a contractor after award about a task in a contract's performance work statement.

MAC’s Local Coverage Determination

LCDs are defined in Section 1869(f)(2)(B) of the Social Security Act (the Act). This section states: “For purposes of this section, the term ‘local coverage determination' means a determination by a fiscal intermediary or a carrier under part A or part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis under such parts, in accordance with section 1862(a)(1)(A).”

MAC’s Local Coverage Articles

Local Coverage Articles are a type of educational document published by the MAC. Articles often contain coding or other guidelines that are related to a LCD.

Federal law takes precedence over state laws and private contracts. Even if an entity believes that it is the secondary payer to Medicare due to state law or the contents of its insurance policy, the MSP provisions would apply when billing for services.

Medicare Secondary Payer | CMS

Note: There are many operating rules and sub regulatory guidelines that come into play during the Medicare determination process.

Posted 3/22/2023