Current through Register Vol. 24-18, September 15, 2024
(1) This section applies to fee-for-service
(FFS) requests for medical or dental services and medical equipment that:
(a) Are identified as covered services or
early and periodic screening, diagnosis, and treatment services; and
(b) Require prior authorization by the
medicaid agency.
(2) The
following definitions and those found in chapter 182-500 WAC apply to this
section:
"Controlled studies" - Studies in which defined
groups are compared with each other to reduce bias.
"Credible evidence" - Type I-IV evidence or
evidence-based information from any of the following sources:
* Clinical guidelines
* Government sources
* Independent medical evaluation (IME)
* Independent review organization (IRO)
* Independent technology assessment organizations
* Medical and hospital associations
* Policies of other health plans
* Regulating agencies (for example, the Federal Drug
Administration or Department of Health)
* Treating provider
* Treatment pathways
"Evidence-based" - The ordered and explicit use
of the best evidence available (see "hierarchy of evidence" in subsection
(6)(a) of this section) when making health care decisions.
"Health outcome" - Changes in health status
(mortality and morbidity) which result from the provision of health care
services.
"Institutional review board (IRB)" - A board or
committee responsible for reviewing research protocols and determining
whether:
(1) The rights and welfare of
human subjects are adequately protected;
(2) The risks to people are minimized and are
not unreasonable;
(3) The risks to
people are outweighed by the potential benefit to them or by the knowledge to
be gained; and
(4) The proposed
study design and methods are adequate and appropriate in the light of stated
study objectives.
"Independent review organization (IRO)" - A
panel of medical and benefit experts intended to provide unbiased, independent,
clinical, evidence-based reviews of adverse decisions.
"Independent medical evaluation (IME)" - An
objective medical examination of the client to establish the medical
facts.
"Provider" - The person who is responsible for
diagnosing, prescribing, and providing medical, dental, or behavioral health
services to agency clients.
(3) The agency authorizes, on a case-by-case
basis, requests described in subsection (1) of this section when the agency
determines the service or equipment is medically necessary as defined in WAC
182-500-070. The process the agency uses to assess medical necessity is based
on:
(a) The evaluation of submitted and
obtainable medical, dental, or behavioral health evidence as described in
subsections (4) and (5) of this section; and
(b) The application of the evidence-based
rating process described in subsection (6) of this section.
(4) The agency reviews available
evidence relevant to a medical, dental, or behavioral health service or
equipment to:
(a) Determine its efficacy,
effectiveness, and safety;
(b)
Determine its impact on health outcomes;
(c) Identify indications for use;
(d) Evaluate pertinent client
information;
(e) Compare to
alternative technologies; and
(f)
Identify sources of credible evidence that use and report evidence-based
information.
(5) The
agency considers and evaluates all available clinical information and credible
evidence relevant to the client's condition. The provider responsible for the
client's diagnosis, or treatment, or both, must submit with the request
credible evidence specifically related to the client's condition including, but
not limited to:
(a) A physiological
description of the client's disease, injury, impairment, or other
ailment;
(b) Pertinent laboratory
findings;
(c) Pertinent X-ray
and/or imaging reports;
(d)
Individual patient records pertinent to the case or request;
(e) Photographs, or videos, or both, if
requested; and
(f) Objective
medical/dental/ behavioral health information such as medically/dentally
acceptable clinical findings and diagnoses resulting from physical or
behavioral health examinations.
(6) The agency uses the following processes
to determine whether a requested service described in subsection (1) is
medically necessary:
(a)
Hierarchy of
evidence - How defined. The agency uses a hierarchy of evidence to
determine the weight given to available data. The weight of medical evidence
depends on objective indicators of its validity and reliability including the
nature and source of the evidence, the empirical characteristics of the studies
or trials upon which the 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:
(i) Type I:
Meta-analysis done with multiple, well-designed controlled studies;
(ii) Type II: One or more well-designed
experimental studies;
(iii) Type
III: Well-designed, quasi-experimental studies such as nonrandomized
controlled, single group pre-post, cohort, time series, or matched
case-controlled studies;
(iv) Type
IV: Well-designed, nonexperimental studies, such as comparative and correlation
descriptive, and case studies (uncontrolled); and
(v) Type V: Credible evidence submitted by
the provider.
(b)
Hierarchy of evidence - How classified. Based on the quality of
available evidence, the agency determines if the requested service is effective
and safe for the client by classifying it as an
"A," "B," "C," or
"D" level of evidence:
(i)
"A" level evidence: Shows the requested service or equipment is a
proven benefit to the client's condition 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 or Type IV evidence
alone).
(ii)
"B" level
evidence: Shows the requested service or equipment has some proven
benefit supported by:
(A) 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 evidence alone); or
(B) Singular Type II, III, or IV evidence in
combination with agency-recognized:
(I)
Clinical guidelines;
(II) Treatment
pathways; or
(III) Other guidelines
that use the hierarchy of evidence in establishing the rationale for existing
standards.
(iii)
"C" level evidence: Shows
only weak and inconclusive evidence regarding safety, or efficacy, or both. For
example:
(A) Type II, III, or IV evidence
with inconsistent findings; or
(B)
Only Type V evidence is available.
(iv)
"D" level evidence: Is not
supported by any evidence regarding its safety and efficacy, for example that
which is considered investigational or experimental.
(c)
Hierarchy of evidence - How
applied. After classifying the available evidence, the agency:
(i) Approves
"A"
and
"B" rated requests if the service or equipment:
(A) Does not place the client at a greater
risk of mortality or morbidity than an equally effective alternative treatment;
and
(B) Is not more costly than an
equally effective alternative treatment.
(ii) Approves a
"C" rated request
only if the provider shows the requested service is the optimal intervention
for meeting the client's specific condition or treatment needs, and:
(A) Does not place the client at a greater
risk of mortality or morbidity than an equally effective alternative
treatment;
(B) Is less costly to
the agency than an equally effective alternative treatment; and
(C) Is the next reasonable step for the
client in a well-documented tried-and-failed attempt at evidence-based
care.
(iii)
Denies
"D" rated requests unless:
(A) The requested service or equipment has a
humanitarian device exemption from the Food and Drug Administration (FDA);
or
(B) There is a local
institutional review board (IRB) protocol addressing issues of efficacy and
safety of the requested service that satisfies both the agency and the
requesting provider.
(7) Within fifteen days of receiving the
request from the client's provider, the agency reviews all evidence submitted
and:
(a) Approves the request;
(b) Denies the request if the requested
service is not medically necessary; or
(c) Requests the provider submit additional
justifying information. The agency sends a copy of the request to the client at
the same time.
(i) The provider must submit
the additional information within thirty days of the agency's
request.
(ii) The agency approves
or denies the request within five business days of the receipt of the
additional information.
(iii) If
the provider fails to provide the additional information, the agency will deny
the requested service.
(8) When the agency denies all or part of a
request for a covered service or equipment, the agency sends the client and the
provider written notice, within ten business days of the date the information
is received, that:
(a) Includes a statement
of the action the agency intends to take;
(b) Includes the specific factual basis for
the intended action;
(c) Includes
reference to the specific WAC provision upon which the denial is
based;
(d) Is in sufficient detail
to enable the recipient to:
(i) Learn why the
agency's action was taken; and
(ii)
Prepare an appropriate response.
(e) Is in sufficient detail to determine what
additional or different information might be provided to challenge the agency's
determination;
(f) Includes the
client's administrative hearing rights;
(g) Includes an explanation of the
circumstances under which the denied service is continued or reinstated if a
hearing is requested; and
(h)
Includes examples(s) of "lesser cost alternatives" that permit the affected
party to prepare an appropriate response.
(9) If an administrative hearing is
requested, the agency or the client may request an independent review
organization (IRO) or independent medical examination (IME) to provide an
opinion regarding whether the requested service or equipment is medically
necessary. The agency pays for the independent assessment if the agency agrees
that it is necessary, or an administrative law judge orders the
assessment.
11-14-075, recodified as §182-501-0165, filed 6/30/11,
effective 7/1/11. Statutory Authority:
RCW
74.04.050,
74.08.090. 05-23-031, §
388-501-0165, filed 11/8/05, effective 12/9/05. Statutory Authority:
RCW
74.08.090,
74.04.050,
74.09.035. 00-03-035, §
388-501-0165, filed 1/12/00, effective 2/12/00. Statutory Authority:
RCW
74.08.090. 94-10-065 (Order 3732), §
388-501-0165, filed 5/3/94, effective 6/3/94. Formerly WAC
388-81-038.
