(a) Enrollees under the TennCare program are eligible to receive, and TennCare shall provide payment for, only those medical items and services that are:

(1) Within the scope of defined benefits for which the enrollee is eligible under the TennCare program; and

(2) Determined by the TennCare program to be medically necessary.

(b) To be determined to be medically necessary, a medical item or service must be recommended by a physician who is treating the enrollee or other licensed healthcare provider practicing within the scope of the physician's license who is treating the enrollee and must satisfy each of the following criteria:

(1) It must be required in order to diagnose or treat an enrollee's medical condition. The convenience of an enrollee, the enrollee's family, or a provider, shall not be a factor or justification in determining that a medical item or service is medically necessary;

(2) It must be safe and effective. To qualify as safe and effective, the type and level of medical item or service must be consistent with the symptoms or diagnosis and treatment of the particular medical condition, and the reasonably anticipated medical benefits of the item or service must outweigh the reasonably anticipated medical risks based on the enrollee's condition and scientifically supported evidence;

(3) It must be the least costly alternative course of diagnosis or treatment that is adequate for the medical condition of the enrollee. When applied to medical items or services delivered in an inpatient setting, it further means that the medical item or service cannot be safely provided for the same or lesser cost to the person in an outpatient setting. Where there are less costly alternative courses of diagnosis or treatment, including less costly alternative settings, that are adequate for the medical condition of the enrollee, more costly alternative courses of diagnosis or treatment are not medically necessary. An alternative course of diagnosis or treatment may include observation, lifestyle or behavioral changes or, where appropriate, no treatment at all; and

(4)

(A) It must not be experimental or investigational. A medical item or service is experimental or investigational if there is inadequate empirically-based objective clinical scientific evidence of its safety and effectiveness for the particular use in question. This standard is not satisfied by a provider's subjective clinical judgment on the safety and effectiveness of a medical item or service or by a reasonable medical or clinical hypothesis based on an extrapolation from use in another setting or from use in diagnosing or treating another condition;

(B) Use of a drug or biological product that has not been approved under a new drug application for marketing by the United States Food and Drug Administration (FDA) is deemed experimental;

(C) Use of a drug or biological product that has been approved for marketing by the FDA but is proposed to be used for other than the FDA-approved purpose will not be deemed medically necessary unless the use can be shown to be widespread, to be generally accepted by the professional medical community as an effective and proven treatment in the setting and for the condition for which it is used, and to satisfy the requirements of subdivisions (b)(1)-(3).

(c) It is the responsibility of the bureau of TennCare ultimately to determine what medical items and services are medically necessary for the TennCare program. The fact that a provider has prescribed, recommended or approved a medical item or service does not, in itself, make such item or service medically necessary.

(d) The medical necessity standard set forth in this section shall govern the delivery of all services and items to all enrollees or classes of beneficiaries in the TennCare program. The bureau of TennCare is authorized to make limited special provisions for particular items or services, such as long-term care, or such as may be required for compliance with federal law.

(e) Medical protocols developed using evidence-based medicine that are authorized by the bureau of TennCare pursuant to § 71-5-107 shall satisfy the standard of medical necessity. Such protocols shall be appropriately published to all TennCare providers and managed care organizations.

(f) The bureau of TennCare is authorized to promulgate such rules and regulations as may be necessary to implement this section.