Tenn. Comp. R. & Regs. 1200-13-16-.05

Current through April 28, 2024

Section 1200-13-16-.05 - MEDICAL NECESSITY CRITERIA

(1) To be medically necessary, a medical item or service must satisfy each of the following criteria:

(a) It must be recommended by a licensed physician who is treating the enrollee or other licensed healthcare provider practicing within the scope of his or her license who is treating the enrollee;

(b) It must be required in order to diagnose or treat an enrollee's medical condition;

(c) It must be safe and effective;

(d) It must not be experimental or investigational; and

(e) It must be the least costly alternative course of diagnosis or treatment that is adequate for the enrollee's medical condition.

(2) The convenience of an enrollee, the enrollee's family, the enrollee's caregiver, or a provider, shall not be a factor or justification in determining that a medical item or service is medically necessary.

(3) Services required to diagnose an enrollee's medical condition.

(a) Provided that all the other medical necessity criteria are satisfied, services required to diagnose an enrollee's medical condition may include screening services, as appropriate.

(b) Screening services are "appropriate" if they meet one of the following three categories:

1. Services required to achieve compliance with federal statutory or regulatory mandates under the EPSDT program;

2. Newborn testing for metabolic/genetic defects as set forth in Tennessee Code Annotated, Section 68-5-401; or

3. Pap smears, mammograms, prostate cancer screenings, colorectal cancer screenings, and screening for tuberculosis and sexually transmitted diseases, including HIV, in accordance with nationally accepted clinical guidelines adopted by the Bureau of TennCare.

(c) Unless specifically provided for herein, other screening services are "appropriate" only if they satisfy each of the following criteria:

1. The Bureau of TennCare, a managed care contractor, or a state agency performing the functions of a managed care contractor determines that the screening services are cost effective;

2. The screening must have a significant probability of detecting the disease;

3. The disease for which the screening is conducted must have a significant detrimental effect on the health status of the affected person;

4. Tests must be available at a reasonable cost;

5. Evidence-based methods of treatment must be available for treating the disease at the disease stage which the screening is designed to detect; and

6. Treatment in the asymptomatic phase must yield a therapeutic result.

(d) Services required to diagnose an enrollee's medical condition include diagnostic services mandated by EPSDT requirements.

(4) Services required to treat an enrollee's medical condition. Provided that all other elements of medical necessity are satisfied, treatment of an enrollee's medical condition may only include:

(a) Medical care that is essential in order to treat a diagnosed medical condition, the symptoms of a diagnosed medical condition, or the effects of a diagnosed medical condition and which, if not provided, would have a significant and demonstrable adverse impact on quality or length of life.

(b) Medical care that is essential in order to treat the significant side effects of another medically necessary treatment (e.g., nausea medications for side effects of chemotherapy).

(c) Medical care that is essential, based on an individualized determination of a particular patient's medical condition, to avoid the onset of significant health problems or significant complications that, with reasonable medical probability, will arise from that medical condition in the absence of such care.

(d) Home health services.

1. Home health aide services are necessary to treat an enrollee's medical condition only if such services;

(i) Are of a type that the enrollee cannot perform for himself or herself;

(ii) Are of a type for which there is no caregiver able to provide the services; and

(iii) Consist of hands-on care of the enrollee.

2. All other home health services are necessary to treat an enrollee's medical condition only if they are ordered by the treating physician, are pursuant to a plan of care, and meet the requirements described at subparagraph (a), (b), or (c) immediately above or (f) immediately below. Services that do not meet these requirements, such as general child care services, cleaning services or preparation of meals, are not required to treat an enrollee's medical condition and will not be provided. Because children typically have non-medical care needs which must be met, to the extent that home health services or private duty nursing services are provided to a person under 18 years of age, a responsible adult (other than the health care provider) must be present at all times in the home during provision of home health or private duty nursing services unless all of the following criteria are met:

(i) The child is non-ambulatory; and

(ii) The child has no or extremely limited ability to interact with caregivers; and

(iii) The child shall not reasonably be expected to have needs that fall outside the scope of medically necessary TennCare covered benefits (e.g. the child has no need for general supervision or meal preparation) during the time the home health provider or private duty nurse is in the home without the presence of another responsible adult; and

(iv) No other children shall be present in the home during the time the home health provider or private duty nurse is present in the home without the presence of another responsible adult.

3. Private Duty Nursing services are separate services from home health services. When private duty nurses are authorized by the MCC to provide home health aide services pursuant to rule 1200-13-13-.04(7)(f) or 1200-13-14-.04(8)(f), these services must meet the requirements described at part 1. immediately above.

4. Home health services may not be denied on any of the following grounds:

(i) Because such services are medically necessary on a long term basis or are required for the treatment of a chronic condition;

(ii) Because such services are deemed to be custodial care;

(iii) Because the enrollee is not homebound;

(iv) Because private insurance utilization guidelines, including but not limited to those published by Milliman & Robertson or developed in-house by TennCare managed care contractors, do not authorize such health care as referenced above;

(v) Because the enrollee does not meet coverage criteria for Medicare or some other health insurance program, other than TennCare;

(vi) Because the home health care that is needed does not require or involve a skilled nursing service;

(vii) Because the care that is required involves assistance with activities of daily living;

(viii) Because the home health service that is needed involves home health aide services; or

(ix) Because the enrollee meets the criteria for receiving Medicaid nursing facility services.

(e) Personal Care Services.

1. Personal care services are necessary to treat an enrollee's medical condition only if such services are ordered by the treating physician pursuant to a plan of care to address a medical condition identified as a result of an EPSDT screening. Personal care services must be supervised by a registered nurse and delivered by a home health aide. In addition the services must:

(i) Be of a type that the enrollee cannot perform for himself or herself;

(ii) Be of a type for which there is no caregiver able to provide the services; and

(iii) Consist of hands-on care of the enrollee.

2. Services that do not meet these requirements, such as general child care services, cleaning services or preparation of meals, are not required to treat an enrollee's medical condition and will not be provided. For this reason, to the extent that personal care services are provided to a person under 18 years of age, a responsible adult (other than the home health aide) must be present at all times during provision of personal care services.

(f) The following preventive services:

1. Prenatal and maternity care delivered in accordance with standards endorsed by the American College of Obstetrics and Gynecology;

2. Family planning services;

3. Age-appropriate childhood immunizations delivered according to guidelines developed by the Advisory Committee on Immunization Practices;

4. Health education services for TennCare-eligible children under age 21 in accordance with 42 U.S.C. Section 1396d;

5. Other preventive services that are required to achieve compliance with federal statutory or regulatory mandates under the EPSDT program; or

6. Other preventive services that have been endorsed by the Bureau of TennCare or a particular managed care contractor as representing a cost effective approach to meeting the medically necessary health care needs of an individual enrollee or group of enrollees.

(5) Safe and effective.

(a) To qualify as being safe and effective, the type, scope, frequency, intensity, and duration of a medical item or service must be consistent with the symptoms or confirmed diagnosis and treatment of the particular medical condition. The type, scope, frequency, intensity, and duration of a medical item or service must not be in excess of the enrollee's needs.

(b) The reasonably anticipated medical benefits of the item or service must outweigh the reasonably anticipated medical risks based on:

1. The enrollee's condition; and

2. The weight of medical evidence as ranked in the hierarchy of evidence in rule 1200-13-16-.01(21) and as applied in rule 1200-13-16-.06(6) and (7).

(6) Not experimental or investigational.

(a) A medical item or service is not experimental or investigational if the weight of medical evidence supports the safety and efficacy of the medical item or service in question as ranked in the hierarchy of evidence in rule 1200-13-16-.01(21) and as applied in rule 1200-13-16-.06(6) and (7). 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 diagnosing or treating another condition. However, 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.

(b) Subject to the provisions set forth in subparagraph (c) immediately below, use of adrug or biological product that has not been approved for marketing under a new drug application or abbreviated new drug application 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 (i.e., off-label use) is experimental and not medically necessary unless the off-label use is shown to be widespread and all other medical necessity criteria as set forth in rule 1200-13-16-.05(1)(a), (b), (c) and (e) are satisfied.

(d) Items or services provided or performed for research purposes are experimental and not medically necessary. Evidence of such research purposes may include written protocols in which evaluation of the safety and efficacy of the service is a stated objective or when the ability to perform the service is contingent upon approval from an Institutional Review Board, or a similar body.

(e) Unless a proposed diagnosis or treatment independently satisfies the criteria for "not experimental or investigational", and satisfies all other medical necessity criteria, the fact that an experimental/investigational treatment is the only available treatment for a particular medical condition or that the patient has tried other more conventional therapies without success does not qualify the service for coverage.

(7) The least costly alternative course of diagnosis or treatment that is adequate for the medical condition of the enrollee.

(a) Where there are less costly alternative courses of diagnosis or treatment that are adequate for the medical condition of the enrollee, more costly alternative courses of diagnosis or treatment are not medically necessary, even if the less costly alternative is a non-covered service under TennCare.

(b) Where there are less costly alternative settings in which a course of diagnosis or treatment can be provided that is adequate for the medical condition of the enrollee, the provision of services in a setting more costly to TennCare is not medically necessary.

(c) If a medical item or service can be safely provided to a person in an outpatient setting for the same or lesser cost than providing the same item or service in an inpatient setting, the provision of such medical item or service in an inpatient setting is not medically necessary and TennCare shall not provide payment for that inpatient service.

(d) An alternative course of diagnosis or treatment may include observation, lifestyle, or behavioral changes or, where appropriate, no treatment at all when such alternative is adequate for the medical condition of the enrollee.

(e) The following is a non-exhaustive illustrative set of circumstances that could fit within the provisions of rule 1200-13-16-.05(7)(d). These examples may or may not be appropriate, depending on an individualized medical assessment of a patient's unique circumstances:

1. Rest, fluids and over-the-counter medication for symptomatic relief might be recommended for a viral respiratory infection, as opposed to a prescription for an antibiotic;

2. Rest, ice packs and/or heat for acute, uncomplicated, mechanical low back pain along with over-the-counter pain medicine, as opposed to x-rays and a prescription for analgesics;

3. Clear liquids and advance diet as tolerated for uncomplicated, acute gastroenteritis, as opposed to prescription antidiarrheals.

(8) The Bureau of TennCare may make limited special exceptions to the medical necessity requirements described at rule 1200-13-16-.05(1) for particular items or services, such as long term care, or such as may be required for compliance with federal law.

(9) Transportation services that meet the requirements described at rule 1200-13-13-.04 and 1200-13-14-.04 shall be deemed to be medically necessary if provided in connection with medically necessary items or services.

Tenn. Comp. R. & Regs. 1200-13-16-.05

Public necessity rule filed December 1, 2006; expires May 15, 2007. Original rule filed March 1, 2007; effective May 15, 2007. Amendment filed October 11, 2007; effective December 25, 2007. Public necessity rule filed September 8, 2008; effective through February 20, 2009. Amendment filed December 5, 2008; effective February 18, 2009. Amendments 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.