WSR 05-17-160

PROPOSED RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)

[ Filed August 22, 2005, 4:25 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 05-08-088.

Title of Rule and Other Identifying Information: WAC 388-501-0165 Determination process for coverage of medical equipment and medical or dental services.

Hearing Location(s): Blake Office Park East (one block north of the intersection of Pacific Avenue S.E. and Alhadeff Lane, behind Goodyear Tire. A map or directions are available at http://www1.dshs.wa.gov/msa/rpau/docket.html or by calling (360) 664-6097), Rose Room, 4500 10th Avenue S.E., Lacey, WA 98503, on September 27, 2005, at 10:00 a.m.

Date of Intended Adoption: Not earlier than September 28, 2005.

Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504, delivery 4500 10th Avenue S.E., Lacey, WA 98503, e-mail fernaax@dshs.wa.gov, fax (360) 664-6185, by 5:00 p.m. September 27, 2005.

Assistance for Persons with Disabilities: Contact Stephanie Schiller, DSHS Rules Consultant, by September 23, 2005, TTY (360) 664-6178 or (360) 664-6097 or by e-mail at schilse@dshs.wa.gov.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The robust development and availability of new drugs, treatments, and therapies calls for greater diligence in assuring that medical assistance clients will not be harmed by inappropriate service utilization, along with the recognition that limitations on available health care resources require that Medicaid funds be expended in a cost-efficient and effective manner to improve the health of clients.

The legislature, in enacting RCW 41.05.013, chapter 276, Laws of 2003, ESHB 1299, directed the department, the Department of Labor and Industries, and the Washington Health Care Authority to collaborate in the adoption and implementation of health services policies and procedures necessary to ensure prudent, cost-effective purchasing. Specifically, the agencies are mandated to (1) maximize efficiencies in administration of state purchased health care programs, (2) improve the quality of care provided through state purchased health care programs, and (3) reduce administrative burdens on health care providers participating in state purchased health care programs. Further, the legislature has directed that the policies and procedures adopted by each agency should be based, to the extent possible, on the best available scientific and medical evidence.

Currently, the department approves requests for Medicaid payment for health care services determined to be "medically necessary." This process utilizes the department's longstanding definition of medical necessity found in WAC 388-500-0005. The medically necessary definition provides that, in order to be approved, there must be (1) a requested service determined to be (2) reasonably calculated to prevent, diagnose, correct, cure, alleviate, or prevent the worsening of (3) a medical condition that endangers life or causes suffering, pain, illness, infirmity, physical deformity, or malfunction (4) where there is no other equally effective, less costly alternative.

In accordance with legislative directive of RCW 41.05.013 and evolving standards in the practice of medicine, the department proposes these amendments to clarify and strengthen the process and standards used to determine medical necessity. Specifically, the department is making these enhancements to the prior approval process by revising the existing medical necessity determination procedures to apply an evidentiary hierarchy that assigns weight to objective indicators of the validity and reliability of medical evidence. The hierarchy is based on factors such as the source of the evidence, the empirical characteristics of studies or trials on which it is based, the consistency of the evidence with the outcome of comparable studies, and, as to evidence and information specific to a client, to results such as previously tried and failed treatments or treatments demonstrating substantial clinical improvement.

In implementing the evidence-based review and approval process in the proposed amendments, the department will continue to determine whether a requested health care service is reasonably calculated to reduce the incidence of mortality and morbidity in the client and whether there is an equally effective but less costly alternative, appropriate to the client's clinical condition that the department will approve instead.

Under the proposed amendment, the department will determine medical necessity individually and to base its review of requested service on the particular needs of each client by evaluating all relevant and available clinical information and medical evidence. The amendments will, however, strengthen the medical necessity determination process and increase confidence in the results reached by the department, by requiring that medical necessity decisions be made using a consistent, transparent, objective, and evidence-based framework, sensitive to both sound medical practice and effective utilization of funds.

In situations where early observational studies show positive results, the proposed amendments will not prevent the department's Medicaid clients from benefiting from ongoing advances in medical knowledge while multiple and exhaustive clinical studies are being fully completed. Nor will they prevent approval of requests for services or treatments due to circumstances, such as the infrequent occurrence of a particular condition or disease, making it unlikely that extensive clinical studies will be undertaken within the time period relevant to the client's health care needs. In addition, the proposed amendment will allow for FDA humanitarian device exceptions and treatment prescribed in conjunction with internal review organizations.

In those infrequent situations, however, in which careful evaluation of an emerging treatment or therapy is required due to potentially serious or life threatening adverse consequences, the department may limit approval to situations in which the potential benefits and potential detrimental results to the individual client can be carefully identified, analyzed, monitored, and subjected to peer review in an appropriate research setting. By doing so, the department, while not denying its clients access to emerging treatments or therapies, may provide a greater measure of protection from harm than might otherwise arise from inadequately designed, supervised, and nonpeer reviewed experimentation.

Reasons Supporting Proposal: See Purpose above.

Statutory Authority for Adoption: RCW 74.04.050, 74.08.090.

Statute Being Implemented: RCW 74.04.050, 74.08.090.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of Social and Health Services, governmental.

Name of Agency Personnel Responsible for Drafting: Kevin Sullivan, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1344; Implementation and Enforcement: Dr. Jeffery Thompson, P.O. Box 45506, Olympia, WA 98504-5506, (360) 725-1612.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule amendment and concludes that a small business economic impact statement is not required because the rule change will not impose new costs on small businesses.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Kevin Sullivan, P.O. Box 45533, Olympia, WA 98504-5533, phone (360) 725-1344, fax (360) 586-9727, e-mail sullikm@dshs.wa.gov.

August 18, 2005

Andy Fernando, Manager

Rules and Policies Assistance Unit

3591.2
AMENDATORY SECTION(Amending WSR 00-03-035, filed 1/12/00, effective 2/12/00)

WAC 388-501-0165   ((Determination process for coverage of medical equipment and medical or dental services)) Medical and dental coverage - fee-for-service (FFS) prior authorization -determination process for payment.   ((This section applies to fee for service (FFS) requests for medical equipment and medical or dental services that require prior authorization.

(1) MAA evaluates requests on an individual basis, and bases the decision to approve or deny on submitted and obtainable evidence.

(2) MAA denies a request when MAA determines the service or equipment is not:

(a) Medically/dentally necessary;

(b) Covered; or

(c) Generally considered as acceptable treatment by the medical/dental profession based on the medical/dental standard of practice, or is investigative or experimental in nature. However, MAA may approve such a request if the provider submits sufficient objective clinical evidence demonstrating that a client's particular circumstances make the request medically/dentally necessary.

(3) Requests for covered services and equipment are approved when MAA determines that the service or equipment is medically necessary as defined in WAC 388-500-0005 or dentally necessary as defined in WAC 388-535-1050.

(4) The examining physician/dentist responsible for the client's diagnosis and/or treatment must submit specific evidence sufficient to determine if the covered service or equipment is medically/dentally necessary. Such evidence may include, but is not limited to:

(a) A client-specific physiological description of the disease, injury, impairment, or other ailment;

(b) Pertinent laboratory findings;

(c) X-ray and/or imaging reports;

(d) Individual patient records pertinent to the case or request;

(e) Photographs and/or videos when requested by MAA;

(f) Dental X rays; and

(g) Objective medical/dental information, including but not limited to medically/dentally acceptable clinical findings and diagnoses resulting from physical or mental examinations.

(5) MAA gives substantial weight to objective medical/dental information and resulting conclusions from an examining physician/dentist responsible for the client's diagnosis and/or treatment.

(a) MAA accepts the examining physician's/dentist's uncontradicted and adequately substantiated conclusion with respect to medical/dental necessity, unless MAA presents specific detailed reasons for rejecting that conclusion. MAA's reasons will be consistent with sound medical/dental practice and supported by objective medical/dental information in the client's file.

(b) If two or more examining physicians/dentists provide conflicting medical/dental information or conclusions about medical/dental necessity for the request under review, MAA will use all information submitted to reach a decision. If MAA concludes the request is not medically/dentally necessary, MAA will enumerate specific reasons, supported by objective medical/dental information in the client's file, for that decision.

(6) Within fifteen calendar days of receiving a request:

(a) MAA approves or denies the request; or

(b) Requests additional justifying information from the prescribing physician, dentist, specialty therapist, and/or service vendor if the documentation submitted is insufficient to reasonably determine medical or dental necessity. Examples of information that MAA may request are shown in subsection (4) of this section. MAA sends a copy of the request to the client at the same time.

(i) If MAA does not receive the information within thirty days of the date requested, MAA denies the original request within the next five working days on the basis of insufficient justification of medical/dental necessity;

(ii) If MAA receives the information within thirty days, MAA makes a final determination on the request within five working days of the receipt of that additional information.

(7) When MAA denies all or part of a request for a covered service(s) or equipment, MAA sends the client and the provider written notice of the denial within five working days of the decision. The notice includes:

(a) The WAC reference(s) used as a basis for the decision;

(b) A summary statement of the specific facts MAA relied upon for the decision;

(c) An explanation of the reasons for the denial, including the reasons why the specific facts relied upon did not meet the requirements for approval;

(d) When required by subsection (5) of this section, a specific statement of the reasons and supporting facts for rejecting any medical/dental information or conclusions of an examining physician/dentist;

(e) Notice of the client's right to a fair hearing and filing deadlines;

(f) Instructions about how to request the hearing;

(g) A statement that the client may be represented at the hearing by legal counsel or other representative; and

(h) Upon the client's request, the name and address of the nearest legal services office.

(8) When MAA receives a request for a noncovered service(s) or equipment, MAA may:

(a) Approve the request as an exception to rule according to WAC 388-501-0160; or

(b) Deny the request as a noncovered service, and send the client and the provider written notice of the denial within five working days of the decision. The notice includes:

(i) The WAC reference(s) used as a basis for the decision;

(ii) The reason for the denial;

(iii) Notice of the client's right to a fair hearing and filing deadlines;

(iv) Instructions about how to request the hearing;

(v) A statement that the client may be represented at the hearing by legal counsel or other representative; and

(vi) Upon the client's request, the name and address of the nearest legal services office.

(9) If a fair hearing is requested, MAA or the client may request an independent medical/dental assessment. MAA will pay for the independent assessment if MAA agrees that it is necessary, or a fair hearing judge determines that the assessment is necessary)) (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; and

(b) Require prior authorization by the department.

(2) The following definitions and those found in WAC 388-500-0005 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 (e.g., 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 individuals are minimized and are not unreasonable;

(3) The risks to individuals 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 individual who is responsible for diagnosing, prescribing, and providing medical, dental, or mental health services to department clients.

(3) The department authorizes, on a case-by-case basis, requests described in subsection (1) when the department determines the service or equipment is medically necessary as defined in WAC 388-500-0005. The process the department uses to assess medical necessity is based on:

(a) The evaluation of submitted and obtainable medical, dental, or mental health evidence as described in subsections (4) and (5) of this section; and

(b) The application of the evidence-based rating process described in subsections (6) and (7) of this section.

(4) The department reviews available evidence relevant to a medical, dental, or mental 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 department considers and evaluates all available clinical information and credible evidence relevant to the client's condition. At the time of request, the provider responsible for the client's diagnosis and/or treatment must submit credible evidence specifically related to the client's condition, including but not limited to:

(a) A client-specific physiological description of the 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 and/or videos when requested by the department; and

(f) Objective medical/dental/mental health information such as medically/dentally acceptable clinical findings and diagnoses resulting from physical or mental examinations.

(6) The department uses the following processes to determine whether a requested service described in subsection (1) is medically necessary:

(a) Hierarchy of evidence. The department 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 non-randomized controlled, single group pre-post, cohort, time series, or matched case-controlled studies;

(iv) Type IV: Well-designed, non-experimental studies, such as comparative and correlation descriptive, and case studies (uncontrolled); and

(v) Type V: Credible evidence submitted by the provider.

(b) Evaluation of effectiveness and safety. Based on the quality of available evidence, the department 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, 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, 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 clinical guidelines or treatment pathways or guidelines that use the hierarchy of evidence in establishing the rationale for existing standards, as recognized by the department.

(iii) "C" level evidence: Shows only weak and inconclusive evidence regarding safety and/or efficacy such as:

(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.

(7) The department:

(a) Approves "A" and "B" rated requests if the service or equipment:

(i) Does not place the client at a greater risk of mortality or morbidity than an equally effective alternative treatment; and

(ii) Is not more costly than an equally effective alternative treatment.

(b) Approves a "C" rated request only if the provider can demonstrate that the evidence supporting the "C" rating fails to adequately address the client's specific condition or treatment needs, and the requested service:

(i) Does not place the client at a greater risk of mortality or morbidity than an equally effective alternative treatment; and

(ii) Is less costly to the department than an equally effective alternative treatment; and

(iii) Is the next reasonable step for the client in a well-documented tried-and-failed attempt at evidence-based care.

(c) Denies "D" rated requests unless:

(i) The requested service or equipment has a humanitarian device exemption from the Food and Drug Administration (FDA); or

(ii) There is a local Institutional Review Board (IRB) protocol addressing issues of efficacy and safety of the requested service that satisfies both the department and the requesting provider.

(8) Within fifteen days of receiving the request and supporting medical evidence from the client's provider, the department:

(a) Approves the request;

(b) Denies the request if the evidence submitted is sufficient to reasonably determine that the requested service is not medically necessary; or

(c) Requests additional justifying information from the prescribing physician, dentist, specialty therapist, and/or service vendor if the documentation submitted is insufficient to reasonably determine medical necessity. The department sends a copy of the request to the client at the same time.

(i) If the department does not receive the information within thirty days of the original request date, the department denies the original request within the next five business days on the basis of insufficient justification of medical necessity (see subsection (8) for further details); or

(ii) If the department receives the information within thirty days of the original request date, the department makes a final determination on the request within five business days of the receipt of that additional information.

(9) When the department denies all or part of a request for a covered service(s) or equipment, the department 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 department 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 department'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 department'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.

(10) If an administrative hearing is requested, the department 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 department will pay for the independent assessment if the department agrees that it is necessary, or an administrative law judge orders the assessment.

[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.]

Washington State Code Reviser's Office