Original Notice.

     Preproposal statement of inquiry was filed as WSR 02-24-010.

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

     Purpose: The department is updating the definition of "medical necessity" and supporting terms in order to incorporate the use of medical information that is supported by scientific evidence in its determination of services. In order to ensure consistency with the updated definitions and support the use of evidence-based health care service determinations, the department is amending WAC 388-501-0165 to include definitions specific to the determination process, clarify provider responsibilities to support the determination of a service or equipment as being medically necessary, and clarify the department's basis for determining medical necessity.

     Statutory Authority for Adoption: RCW 74.08.090, ESHB 1299 (chapter 276, Laws of 2003).

     Statute Being Implemented: RCW 74.08.090, ESHB 1299 (chapter 276, Laws of 2003).

     Summary: See Purpose above.

     Reasons Supporting Proposal: See Purpose above.

     Name of Agency Personnel Responsible for Drafting: Ann Myers, P.O. Box 45533, Olympia, WA 98504, (360) 725-1345; Implementation and Enforcement: Bill Hagens, P.O. Box 45500, Olympia, WA 98504, (360) 725-1337.

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

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

     Explanation of Rule, its Purpose, and Anticipated Effects: The rule is being amended to include the use of scientific evidence in the department's coverage and service determinations; to help ensure the department's clients will not be harmed or injured by inappropriate service utilization in view of the robust development and availability of new drugs, treatments, and therapies; to help ensure that available resources be spent in the most effective manner to improve the health of clients; and to help expedite service determinations.

     The anticipated effects are as stated above.

     Proposal Changes the Following Existing Rules: The rule described in Title of Rule and Purpose above is being amended to include definitions related to the new definition of "medical necessity" and ensure the process and provisions described in the rule are consistent with the new definition.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule and concludes that it will not have a more than minor impact on the small businesses affected by it.

     RCW 34.05.328 applies to this rule adoption. The department has analyzed the proposed rule and concludes that it meets the definition of a "significant legislative rule" as defined by the legislature. An analysis of the probable costs and probable benefits is available from the person listed above.

     Hearing Location: Blake Office Park (behind Goodyear Courtesy Tire), 4500 10th Avenue S.E., Rose Room, Lacey, WA 98503, on December 9, 2003, at 10:00 a.m.

     Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by December 5, 2003, phone (360) 664-6097, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.

     Submit Written Comments to: Identify WAC Numbers, DSHS Rules Coordinator, Rules and Policies Assistance Unit, mail to P.O. Box 45850, Olympia, WA 98504-5850, deliver to 4500 10th Avenue S.E., Lacey, WA, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., December 9, 2003.

     Date of Intended Adoption: Not sooner than December 10, 2003.

October 30, 2003

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

     (1) ((MAA evaluates requests on an individual basis, and bases the decision to approve or deny on submitted and obtainable evidence)) The following definitions apply to the terms used this section:

     (a) "Efficacy" means that the service or supply has been studied in peer-reviewed literature or under acceptable scientific standards which demonstrate results under ideal conditions.

     (b) "Evidence" means information demonstrating that services are effective in improving health outcomes. For new health care services, effectiveness is determined by scientific evidence. For existing health care services, effectiveness is determined first by scientific evidence, then by professional standards, then by expert opinion.

     (c) "Purpose" means a health care service that is intended to treat a medical condition.

     (d) "Scope" means the most appropriate supply or level of service, considering potential benefits and harms to the client.

     (2) MAA evaluates requests for services or equipment on an individual basis. MAA approves a request for an eligible client when the service or equipment is:

     (a) Medically necessary; and

     (b) Covered under the scope of coverage of the client's medical assistance program.

     (3) MAA evaluates requests for services or equipment on an individual basis. 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))) under the scope of coverage of the client's medical assistance program;

     (c) Covered because the client is not eligible at the time the service or equipment is received, regardless of any prior authorization; or

     (d) Considered by MAA to be safe because the effectiveness in the provider community differs greatly from the efficacy reported in the peer reviewed literature.

     (4) The examining health care provider responsible for the client's diagnosis and/or treatment must submit ((specific evidence)) information to document that the purpose, scope, and evidence is 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; and

     (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) When determining medical necessity, 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)) the purpose, scope, and evidence submitted by the health care provider in a request for service or equipment.

     (6) Within fifteen calendar days of receiving a request for services or equipment:

     (a) MAA approves or denies the request (in the case of a request for emergency service(s), MAA approves or denies a request within seventy-two hours of receipt); 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)) MAA classifies the request as pending when additional information to document the purpose, scope, and evidence is requested.

     (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)) If applicable under 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)) health care provider;

     (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)) A statement that the client may 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))) (a) The WAC reference(s) used as a basis for the decision;

     (((ii))) (b) The reason for the denial;

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

     (((iv))) (d) Instructions about how to request the hearing;

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

     (((vi) Upon the client's))

     (f) A statement that the client may request((,)) the name and address of the nearest legal services office.

     (9) When MAA denies a request for a noncovered service(s) or equipment, a client whose request is denied may request MAA to approve the request as an exception to rule according to WAC 388-501-0160.

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

[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.]

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.

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