Tenn. Comp. R. & Regs. 1200-13-16-.01 - DEFINITIONS

(1) ADEQUATE when applied to a medical item or service shall mean that the item or service, considered as part of a course of diagnosis or treatment, is sufficient, but not in excess of what is needed, for diagnosis or treatment of the particular medical condition. In order for a medical item or service to be determined adequate, such item or service must also satisfy the requirements at rule 1200-13-16-.05(5) regarding "safe and effective" and the requirements at rule 1200-13-16-.05(6) regarding "not experimental or investigational."

(2) BENEFITS shall mean the defined package of health care services, including long term care services, for which an enrollee is eligible under the TennCare Program including applicable limits on such services.

(3) BUREAU OF TENNCARE shall mean the single State Medicaid agency which is responsible for the administration of the TennCare program.

(4) CASE-CONTROL STUDY shall mean a study in which the study and control groups are selected on the basis of whether they have the disease (cases) rather than whether they have been exposed to a risk factor or clinical intervention. The design is therefore observational (as opposed to experimental) and retrospective (as opposed to prospective), with the clinical outcome already known at the outset. Principal disadvantages of this study design are that important confounding variables may be difficult to identify and adjust for, clinical outcome is already known and may influence the measurement and interpretation of data (observer bias), and participants may have difficulty in accurately recalling past medical history and previous exposures (recall bias).

(5) CASE REPORT shall mean an uncontrolled observational study (prospective or retrospective) involving an intervention and an outcome in a single patient.

(6) CASE SERIES shall mean an uncontrolled study (prospective or retrospective) of a succession of consecutive patients who receive a particular intervention and are followed to observe their outcomes.

(7) CLINICAL TRIAL shall mean a study that involves the administration of a test regimen to humans to evaluate its efficacy and safety.

(8) CONTROL GROUP shall mean a group of patients that serves as the basis of comparison when assessing the effects of the intervention of interest that is given to the patients in the treatment group. Depending upon the circumstances of the trial, a control group may receive no treatment, a "usual" or "standard" treatment, or a placebo. To make the comparison valid, the composition of the control group should resemble that of the treatment group as closely as possible.

(9) CONTROLLED CLINICAL TRIAL shall mean a clinical trial in which a control group (which receives a standard intervention, which may be no treatment) is compared to a study group (which receives the intervention under study) in order to test a research hypothesis. A controlled clinical trial may or may not be randomized.

(10) CONTROLLED COHORT STUDY shall mean an observational study in which outcomes in a group of patients that received an intervention are compared with outcomes in a similar group i.e., the cohort, either contemporary or historical, of patients that did not receive the intervention. Cohort studies are more subject to systematic bias than randomized trials because treatments, risk factors, and other covariables may be chosen by patients or physicians on the basis of important (and often unrecognized) factors that are related to outcome. Therefore, investigators in controlled cohort studies may identify and correct for confounding variables, which are related factors that may be more directly responsible for clinical outcome than the intervention/exposure in question. For example, in an adjusted- (or matched-) cohort study, investigators identify (or make statistical adjustments to provide) a cohort group that has characteristics (e.g., age, gender, disease severity) that are as similar as possible to the group that experienced the intervention.

(11) CONVENIENCE shall mean the degree to which an item or service is designed or recommended for the personal comfort or ease of an enrollee, caregiver, or provider. Alleviation of pain is not considered a matter of convenience.

(12) COST EFFECTIVE when applied to a medical item or service shall mean that the benefits associated with the item or service, considered as part of diagnosis or treatment, outweigh the costs associated with the item or service. When appropriate, such analysis may include assessment of aggregate, population-level data related to the costs or benefits of a medical item or service.

(13) COST-EFFECTIVE ALTERNATIVE SERVICE shall mean a service that is not a covered service but that is approved by TennCare and CMS and provided at an MCC's discretion. TennCare enrollees are not entitled to receive these services. Cost-effective alternative services may be provided because they are either (1) alternatives to covered Medicaid services that, in the MCC's judgment, are cost-effective or (2) preventative in nature and offered to avoid the development of conditions that, in the MCC's judgment, would require more costly treatment in the future. Cost-effective alternative services need not be determined medically necessary except to the extent that they are provided as an alternative to covered Medicaid services. Even if medically necessary, a cost effective alternative service is not a covered service and is provided only at an MCC's discretion.

(14) COVERED SERVICES shall mean medical items and services that are within an enrollee's scope of defined benefits, and not in excess of any applicable limits on such items or services. Covered services include long term care services for those enrollees eligible for long term care. With the exception of cost-effective alternative services and even in cases of emergency, only a covered service can be determined to be medically necessary for reimbursement purposes under the program.

(15) DIAGNOSIS shall mean the act or process of identifying or determining the nature and cause of a medical problem or condition through evaluation of patient history, examination, and review of laboratory data and other pertinent information. Diagnosis may include cost effective screening services provided in accordance with nationally accepted standards or guidelines developed or endorsed by respected medical organizations, such as the Centers for Disease Control and Prevention.

(16) EFFECTIVE describes the use of a medical item or service that produces the intended result and where the benefit of the medical item or service outweighs the adverse medical risks or consequences.

(17) ELIGIBLE describes a person who has been determined to meet the eligibility criteria for the TennCare program.

(18) ENROLLEE shall mean an individual who is eligible for and enrolled in the TennCare program.

(19) EVIDENCE-BASED shall mean the ordered and explicit use of the best medical evidence available when making health care decisions.

(20) EXPERIMENTAL STUDY shall mean a randomized controlled clinical trial.

(21) HIERARCHY OF EVIDENCE shall mean a ranking of the weight given to medical evidence depending on objective indicators of its validity and reliability including the nature and source of the medical evidence, the empirical characteristics of the studies or trials upon which the medical evidence is based, and the consistency of the outcome with comparable studies. The hierarchy in descending order, with Type I given the greatest weight is:

(a) Type I: Meta-analysis done with multiple, well-designed controlled clinical trials;

(b) Type II: One or more well-designed experimental studies;

(c) Type III: Well-designed, quasi-experimental studies;

(d) Type IV: Well-designed, non-experimental studies; and

(e) Type V: Other medical evidence defined as evidence-based

1. Clinical guidelines, standards or recommendations from respected medical organizations or governmental health agencies;

2. Analyses from independent health technology assessment organizations; or

3. Policies of other health plans.

(22) HOME HEALTH SERVICES shall mean those services as defined at 1200-13-13-.01 and 1200-13-14-.01.

(23) INSTITUTIONAL REVIEW BOARD shall mean a specifically constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

(24) LONG TERM CARE shall mean institutional services of a nursing facility, an intermediate care facility for the mentally retarded, or services provided through a Home and Community Based Services (HCBS) waiver program.

(25) MCC (MANAGED CARE CONTRACTOR) shall mean:

(a) A managed care organization, pharmacy benefits manager, and/or a dental benefits manager which has signed a TennCare Contract with the State and operates a provider network and provides covered health services to TennCare enrollees; or

(b) A pharmacy benefits manager, dental benefits manager, or behavioral health organization which subcontracts with a managed care organization to provide services; or

(c) A State government agency (i.e., Department of Children's Services and Division of Mental Retardation Services) that contracts with TennCare for the provision of services.

(26) MCO (MANAGED CARE ORGANIZATION) shall mean an appropriately licensed Health Maintenance Organization (HMO) contracted with the Bureau of TennCare to manage the delivery, provide for access, contain the cost, and ensure the quality of specified covered medical and behavioral benefits to TennCare enrollee-members through a network of qualified providers.

(27) MEDICAID shall mean the federal- and state-financed, state-run program of medical assistance pursuant to Title XIX of the Social Security Act.

(28) MEDICAL CONDITION shall mean a disorder or an abnormal condition of the body and/or mind.

(29) MEDICAL EVIDENCE shall mean Type I-IV analyses and studies and/or Type V evidence defined herein at "HIERARCHY OF EVIDENCE".

(30) MEDICAL ITEM OR SERVICE shall mean an item or service that is provided, ordered, or prescribed by a licensed health care provider and is primarily intended for a medical and/or behavioral purpose and designed to achieve that medical and/or behavioral purpose.

(31) MEDICAL NECESSITY shall mean the quality of being "medically necessary" as defined by Tennessee Code Annotated, Section 71-5-144, and applies to TennCare enrollees. Implementation of the term "medical necessity" is provided for in these rules, consistent with the statutory provisions, which control in case of ambiguity.

(32) MEDICAL NECESSITY DETERMINATION a decision made by the Chief Medical Officer of the Bureau of TennCare or his or her clinical designee or by the Medical Director of one of its Managed Care Contractors or his or her clinical designee regarding whether a requested medical item or service satisfies the definition of medical necessity contained in Tennessee Code Annotated, Section 71-5-144 and these rules as defined herein. Items or services that are not determined medically necessary shall not be paid for by TennCare.

(33) MEDICAL NECESSITY GUIDELINES shall mean evidence-based guidelines approved by the Chief Medical Officer of the Bureau of TennCare for the purpose of guiding medical necessity determinations for particular courses of diagnosis or treatment.

(34) MEDICALLY NECESSARY is defined by Tennessee Code Annotated, Section 71-5-144, and shall describe a medical item or service that meets the criteria set forth in that statute. The term "medically necessary," as defined by Tennessee Code Annotated, Section 71-5-144, applies to TennCare enrollees. Implementation of the term "medically necessary" is provided for in these rules, consistent with the statutory provisions, which control in case of ambiguity. No enrollee shall be entitled to receive and TennCare shall not be required to pay for any items or services that fail fully to satisfy all criteria of "medically necessary" items or services, as defined either in the statute or in these rules.

(35) MEDICAL RECORD shall mean all medical histories; records, reports and summaries; diagnoses; prognoses; records of treatment and medication ordered and given; x-ray and radiology interpretations; physical therapy charts and notes; lab reports; other individualized medical documentation in written or electronic format; and analyses of such information.

(36) META-ANALYSIS shall mean systematic methods that use statistical techniques for combining results from different studies to obtain a quantitative estimate of the overall effect of a particular intervention or variable on a defined outcome. This combination may produce a stronger conclusion than can be provided by any individual study.

(37) NON-CONTROLLED COHORT STUDY shall mean a longitudinal study in which a group of people who share a common characteristic or experience are tracked over time with observation of outcomes within the group.

(38) NON-COVERED SERVICE shall mean items and services that are not within the scope of defined benefits for which a beneficiary is eligible under TennCare, including cost-effective alternative services and medical items and services that are in excess of any applicable limits on such items or services that might otherwise be covered. With the exception of cost-effective alternative services, non-covered services under TennCare, 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.

(39) NON-EXPERIMENTAL STUDY shall mean a study that is not randomized or controlled. Examples of non-experimental studies include non-controlled cohort studies, case series or case reports.

(40) NON-RANDOMIZED CONTROLLED CLINICAL TRIAL shall mean a controlled clinical trial that assigns patients to intervention and control groups using a method that does not involve randomization, e.g., at the convenience of the investigators or some other technique such as alternate assignment. Controlled trials that are not randomized are subject to a variety of biases, including selection bias, in which persons who volunteer or are assigned by investigators to study groups may differ in characteristics other than the intervention itself.

(41) OFF-LABEL USE shall mean the use of a drug or biological product that has been approved for marketing by the United States Food and Drug Administration (FDA) but is proposed to be used for other than the FDA-approved purpose.

(42) PHYSICIAN shall mean a person licensed pursuant to Chapter 6 or 9 of Title 63 of the Tennessee Code Annotated.

(43) QUASI-EXPERIMENTAL STUDY shall mean a study in which the investigator lacks full control over randomization of subjects (lacks full control over the allocation and/or timing of intervention) but nonetheless conducts the study as if it were an experiment, allocating subjects to groups. Examples of quasi-experimental studies include non-randomized controlled clinical trials, controlled cohort studies, or case-control studies.

(44) RANDOMIZED CONTROLLED CLINICAL TRIAL shall mean a clinical trial in which participants are assigned in a randomized fashion to a study group (which receives the intervention) or a control group (which receives a standard treatment, which may be no intervention or a placebo). Randomization enhances the comparability of the groups and provides a more valid basis for measuring statistical uncertainty. In this manner, differences in outcomes can be attributed to the intervention rather than to differences between the groups. Randomized controlled trials may or may not be blinded. In a blinded trial, the investigators, the subjects, or both (double-blinded study) are not told to which group they have been assigned, so that this knowledge will not influence their assessment of outcome.

(45) SCREEN shall mean to test for or examine for the presence of a medical problem or condition in the absence of signs and symptoms of disease.

(46) STUDY shall mean a careful examination or analysis applying scientific methodology and published in a peer-reviewed scientific journal or periodical.

(47) TENNCARE shall mean the TennCare waiver demonstration program(s) and/or Tennessee's traditional Medicaid program.

(48) TREATING PHYSICIAN OR OTHER TREATING HEALTH CARE PROVIDER shall mean a licensed physician practicing within the scope of his or her license or other licensed health care provider practicing within the scope of his or her license who has personally examined a particular TennCare enrollee and who has provided diagnostic or treatment services for that particular enrollee (whether or not those services were covered by TennCare) for purposes of treating or supporting the treatment of a known or suspected medical condition of that particular enrollee. The term excludes all other providers, including those who have evaluated a particular enrollee's medical condition primarily or exclusively for the purposes of supporting or participating in a decision regarding TennCare coverage.

(49) TREATMENT shall mean the provision of medical items or services based on the recommendation of a treating physician or other treating health care provider practicing within the scope of his or her license.

Notes

Tenn. Comp. R. & Regs. 1200-13-16-.01

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 September 25, 2009; effective December 24, 2009.

Authority: T.C.A. §§ 4-5-202, 4-5-209, 71-5-105, 71-5-109, Executive Order No. 23.