Medicare does not cover items and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member. Section 1862(a)(1) of the Social Security Act is the basis for denying payment for types of care, or specific items, services or procedures that are not excluded by any other statutory clause and meet all technical requirements for coverage but are determined to be any of the following:
- Not generally accepted in the medical community as safe and effective in the setting and for the condition for which it is used.
- Not proven to be safe and effective based on peer review or scientific literature.
- Not medically necessary in the particular case.
- Furnished at a level, duration or frequency that is not medically appropriate.
- Not furnished in accordance with accepted standards of medical practice.
- Not furnished in a setting (such as inpatient care at a hospital or Skilled Nursing Facility (SNF), outpatient care through a hospital or physician’s office, or home care) appropriate to the patient’s medical needs and condition.
To be considered medically necessary, items and services must have been established as safe and effective. That is, the items and services must be:
- Consistent with the symptoms or diagnosis of the illness or injury under treatment.
- Necessary and consistent with generally accepted professional medical standards (e.g., not experimental or investigational).
- Not furnished primarily for the convenience of the patient, the attending physician, or other physician or supplier.
- Furnished at the most appropriate level that can be provided safely and effectively to the patient.
Medical devices that are not approved for marketing by the Food and Drug Administration (FDA) are considered investigational by Medicare and are not considered reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve functioning of a malformed body member. Program payment, therefore, may not be made for medical procedures and services performed using devices that have not been approved for marketing by the FDA or for those not included in an FDA-approved Investigational Device Exemption trial.
If a test, treatment or procedure is neither specifically covered nor excluded in Medicare law or guidelines, contractors must make a coverage determination that is based upon the general acceptance of the test, treatment or procedure by the professional medical community as an effective and proven treatment for the condition for which it is being used. Medicare will make payment only when a service is accepted as effective and proven. The tests or procedures may be paid only if the physician who performs them satisfactorily justifies the medical need for the procedure(s).
It is important to note that the fact that a new service or procedure has been issued a Current Procedural Terminology code or is FDA-approved does not, in itself, make the procedure medically reasonable and necessary. Your Medicare Intermediary evaluates new services, procedures, drugs or technology and considers national and local policies before these new services may be considered Medicare covered services.
As published in the Center for Medicare and Medicaid Services (CMS) Internet Only Manual (IOM) 100-08, Ch.13, Section 13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed Local Coverage Determination (LCD) for the service is considered reasonable and necessary under Section 1862(a) (1) (A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective
- Not experimental or investigational
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member
- Furnished in a setting appropriate to the patient’s medical needs and condition
- Ordered and furnished by qualified personnel
- One that meets, but does not exceed, the patient’s medical need
- At least as beneficial as an existing and available medically appropriate alternative
- A service can be considered a non-covered service for many different reasons.
Services that are not considered to be medically reasonable to the patient’s condition and reported diagnosis will not be covered.
- Excluded items and services
- Items and Services Furnished Outside the U.S.
- Items and Services Required as a Result of War
- Personal Comfort Items and Services
- Routine Services and Appliances
- Custodial Care
- Cosmetic Surgery
- Items and services furnished by the patient’s immediate relatives and members of the patient’s household
- Dental services – (Exclusions Routine dental care (fillings, extractions, cleaning, periodontal, etc.) any services related to a non- covered dental service (x-rays, anesthesia for extractions.)
- Non-Physician services furnished to hospital and skilled nursing facility inpatients that are not provided directly or under arrangement
- Certain podiatry and supportive devices for the feet
- Investigational devices
- Services Related to and required as a result of services that are not covered
- Services and supplies that have been denied as bundled or included in the basic allowance of another service.
- Fragmented services included in the basic allowance of the initial service;
- Prolonged care (indirect)
- Physician standby services
- Case management services (e.g., telephone calls to and from the beneficiary)
- Supplies included in the basic allowance of a procedure
- Items and services reimbursable by other organizations or furnished without charge.
- Services reimbursable under automobile, no-fault, or liability insurance or workers’ Compensation (Medicare Secondary Payer Program)
- Items and services authorized or paid for by a government entity
- Items and services for which the patient, another individual, or an organization has no legal obligation to pay for or furnish
- Defective equipment or medical devices covered under warranty
If the service does not have an LCD or National Coverage Determination, the provider can submit medical documentation to support medical necessity of the service.
Due to mandatory claim submission, providers must file claims on behalf of Medicare beneficiaries for non-covered services. This allows the claim to process and provide the beneficiary the necessary information to submit to other insurers.