Section 1200-13-16-.06 - DETERMINATION OF MEDICAL NECESSITY(1) The Bureau of TennCare is ultimately responsible for determining whether specific medical items and/or services under TennCare (a) are covered services and (b) are medically necessary. In the vast majority of cases, medical necessity determinations will be made as part of a prior authorization or concurrent review process. However, less frequently such determinations may be made retrospectively in the course of the investigation of unusual billing or practice patterns. The Bureau of TennCare may delegate covered services and/or medical necessity decisions to managed care contractors. All medical necessity decisions must be made by licensed medical staff with appropriate clinical expertise. The Bureau may review such decisions as a part of routine monitoring or as a result of an enrollee appeal or provider complaint and may overturn such decisions if not made in accordance with these rules.(2) Non-covered services, including medical items and services in excess of benefit limits, are never to be paid for by TennCare, even if they otherwise would qualify as "medically necessary," regardless of the medical circumstances involved, unless an MCC, in its discretion, provides a cost effective alternative service.(3) If, after an enrollee is provided the opportunity by the State or managed care contractor to consult with a physician, a medical item or service has not been recommended, ordered or prescribed by a treating physician or other treating health care provider practicing within the scope of his or her license, it is not medically necessary and is not covered under TennCare.(4) In making a medical necessity determination, TennCare or its designee will consider a recommendation, order, or prescription for a covered medical item or service from a treating physician or other treating health care provider.(a) A recommendation, order or prescription from a treating physician or other treating health care professional shall be based on a thorough, up-to-date assessment of the enrollee's medical condition, with careful consideration of all required medical necessity criteria as defined by statute and by these rules.(b) The managed care contractor will evaluate the information provided by the treating provider in support of a recommendation, order or prescription for a covered service. If the information or opinion of the treating provider deviates significantly from that of the MCC, the MCC will request further explanation from the treating provider. Upon request from the enrollee's MCC or the Bureau of TennCare for purposes of making an individualized medical necessity determination, the treating physician or other treating health care provider shall provide information and/or documentation supporting the need for the recommended medical item or service in order to diagnose or treat the enrollee's medical condition.(c) In addition, when requested, the treating physician or other treating health care provider will provide a written explanation as to why a less costly alternative proposed by the MCC is not believed to be adequate to address the enrollee's medical condition.(d) Information/documentation requested by the managed care contractor or the Bureau of TennCare for purposes of making a medical necessity determination will be provided free of charge.(e) Providers who fail to provide information/documentation requested by the managed care contractor or the Bureau of TennCare for purposes of making a medical necessity determination shall not be entitled to payment for provision of the applicable medical item or service. In such instances, providers may not seek payment from patients or third parties for items or services denied payment.(5) The treating physician's conclusory statements, without more, are not binding on the State.(6) In evaluating the request/recommendation of the treating physician or other treating health care provider, a managed care contractor and/or the Bureau of TennCare shall use the hierarchy of evidence to determine if the requested item or service is safe and effective, as referenced at rule1200-13-16-.05(5) and (6)(a), for the enrollee by classifying the item or service as having an A, B, C or D level of supporting evidence, as indicated below. In classifying the item or service as having A, B, C or D level of supporting evidence, extrapolation from one population group to another (e.g. from adults to children) may be appropriate. For example, extrapolation may be appropriate when the item or service has been proven effective, but not yet tested in the population group in question. (a) "A" level evidence: Shows the requested medical item or service is a proven benefit to the enrollee's condition as demonstrated by strong scientific literature and well-designed clinical trials such as Type I evidence or multiple Type II evidence or combinations of Type II, III, or IV evidence with consistent results. An "A" rating cannot be based on Type III, Type IV, or Type V evidence alone.(b) "B" level evidence: Shows the requested medical item or service has some proven benefit to the enrollee's condition as demonstrated by:1. Multiple Type II or III evidence or combinations of Type II, III, or IV evidence with generally consistent findings of effectiveness and safety. A "B" rating cannot be based on Type IV or V evidence alone; or2. Singular Type II, III, IV, or V evidence when consistent with Bureau of TennCare endorsed or established evidence-based clinical guidelines.(c) "C" level evidence: Shows only weak and inconclusive evidence regarding safety and/or efficacy for the enrollee's condition such as: 1. Type II, III, or IV evidence with inconsistent findings; or2. Only Type V evidence is available.(d) "D" level evidence: Is not supported by any evidence regarding safety and efficacy for the enrollee's condition.(7) Application of the Hierarchy of Evidence. After classifying the available evidence, the Bureau of TennCare or a managed care contractor will approve items or services in the following manner:(a) Medical items or services with supporting "A" and "B" rated evidence will be considered safe and effective if the item or service does not place the enrollee at a greater risk of morbidity and mortality than an equally effective alternative treatment.(b) Medical items or services with "C" rated evidence or a physician's clinical judgment that is not supported by objective evidence, will be considered safe and effective only if the provider shows that the requested service is the optimal intervention for meeting the enrollee's specific condition or treatment needs, and:1. Does not place the enrollee at greater risk of morbidity or mortality than an equally effective alternative treatment; and2. Is the next reasonable step for the enrollee in light of the enrollee's past medical treatment.(c) Medical items or services with "D" rated evidence will not be considered safe and effective and, therefore, will not be determined medically necessary.(8) The Bureau of TennCare or the managed care contractor's classification of available medical evidence as defined at rule 1200-13-16-.01(21) and any resulting approval of items or services as described at rule 1200-13-16-.06(6) and (7) shall be binding on TennCare enrollees and providers.(9) The managed care contractor or the Bureau of TennCare will rely upon all relevant information in making a medical necessity determination. Such determinations must be individualized and made in the context of medical/behavioral history information included in the enrollee's medical record.(10) The fact that a particular medical item or service has been covered in one instance does not make such item or service medically necessary in any other case, even if such case is similar in certain respects to the situation in which the item or service was determined to be medically necessary.(11) Items or services that are not determined medically necessary, as defined by the statute or by these rules, shall not be paid for by TennCare.Tenn. Comp. R. & Regs. 1200-13-16-.06
Public necessity rule filed December 1, 2006; expires May 15, 2007. Original rule filed March 1, 2007; effective May 15, 2007. Amendment filed June 17, 2011; effective November 28, 2011.Authority: T.C.A. §§ 4-5-202, 4-5-209, 71-5-105, 71-5-109, 71-5-144 and Executive Order No. 23.