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
regarding "safe and effective" and the
requirements at rule 1200-13-16-.05(6)
regarding "not experimental or
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
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
(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
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
(20) EXPERIMENTAL STUDY
shall mean a randomized controlled clinical trial.
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
(b) Type II: One or more
well-designed experimental studies;
(c) Type III: Well-designed,
Type IV: Well-designed, non-experimental studies; and
Type V: Other medical evidence defined as
1. Clinical guidelines,
standards or recommendations from respected medical organizations or
governmental health agencies;
Analyses from independent health technology assessment organizations;
3. Policies of other health
(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
(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.
MCC (MANAGED CARE CONTRACTOR) shall
(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.
MEDICAL CONDITION shall mean a disorder or an abnormal condition of the body
(29) MEDICAL EVIDENCE
shall mean Type I-IV analyses and studies and/or Type V evidence defined herein
at "HIERARCHY OF EVIDENCE".
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
(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.
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
(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
STUDY shall mean a study that is not randomized or controlled. Examples of
non-experimental studies include non-controlled cohort studies, case series or
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.
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
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.
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
(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
(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.