WSR 06-08-093

PROPOSED RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)

(Medical Assistance Administration)

[ Filed April 4, 2006, 4:22 p.m. ]

     Original Notice.

     Preproposal statement of inquiry was filed as WSR 05-06-079.

     Title of Rule and Other Identifying Information: WAC 388-501-0135 Patient review and restriction.

     Hearing Location(s): Blake Office Park East, Rose Room, 4500 10th Avenue S.E., Lacey, WA 98503 (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), on May 9, 2006, at 10:00 a.m.

     Date of Intended Adoption: Not earlier than May 10, 2006.

     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., May 9, 2006.

     Assistance for Persons with Disabilities: Contact Stephanie Schiller, DSHS Rules Consultant, by May 5, 2006, 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: This proposal updates and clarifies policy; adds language that allows the department or department-contracted managed care organization (MCO) to restrict a fee-for-service client or MCO enrollee to one narcotic prescriber.

     Reasons Supporting Proposal: This proposal supports improved, safer health outcomes for DSHS clients.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.520, 74.04.055, 42 C.F.R. 431.54.

     Statute Being Implemented: RCW 74.08.090, 74.09.520, 74.04.055, 42 C.F.R. 431.54.

     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: Kathy Sayre, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1342; Implementation and Enforcement: Bernice Lawson, P.O. Box 45532, Olympia, WA 98504-5532, (360) 725-1392.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule and concluded that no new costs will be imposed on businesses affected by the rule change. The preparation of a comprehensive small business economic impact statement is not required.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Bernice Lawson, P.O. Box 45532, Olympia, WA 98504-5532, phone (360) 725-1392, fax (360) 753-0286, e-mail lawsoba@dshs.wa.gov.

March 30, 2006

Andy Fernando, Manager

Rules and Policies Assistance Unit

3651.2
AMENDATORY SECTION(Amending WSR 04-01-099, filed 12/16/03, effective 1/16/04)

WAC 388-501-0135   Patient review and restriction (PRR).   (1) Patient review and restriction (PRR) is a ((medical assistance administration (MAA))) health and safety program for medical assistance fee-for-service clients and managed care organization (MCO) enrollees needing help ((in the appropriate use of)) with using medical services appropriately. PRR is authorized under federal Medicaid law by 42 USC 1396n (a)(2) and 42 CFR 431.54. ((A client is assigned to the PRR program based upon a determination by MAA of overuse or inappropriate use of medical services.

     (1))) (2) Definitions(( -- )). The following definitions apply to this section only:

     "Abusive practices" means services and/or treatment that are one or both of the following:

     • Not medically necessary and may result in unnecessary costs to a medical assistance program; or

     • Improper or excessive.

     "Appropriate use" means use of health care services that are adapted to or appropriate for a client's or enrollee's medical needs.

     "Assigned provider"(( - ))((A)) means a department-enrolled or MCO contracted medical provider who agrees to be assigned ((by MAA staff in the PRR program to be the)) as a primary provider and coordinator of services for a medical assistance client or MCO enrollee in the PRR program. ((A PRR client may have an assigned medical provider; an assigned pharmacy and an assigned hospital and may be restricted to these provider(s))) Assigned providers can include a primary care provider (PCP), a pharmacy, a narcotic prescriber, and, for non-emergency medical services, a hospital.

     "At-risk" means a medical history that ((includes evidence)) may include one or more of the following:

     • Indicators of forging or altering prescriptions;

     • Overuse of health care services that were or are beyond the fee-for-service client's or MCO enrollee's medically necessary care;

     • Indicators of ((life-threatening or)) potentially life-threatening events or life-threatening conditions ((which)) that required or may require medical intervention;

     • A client's or enrollee's medical assistance identification card reportedly used by an unauthorized person(s) or for an unauthorized purpose(s); or

     • Other behaviors or abusive practices that could jeopardize a client's or enrollee's medical treatment or health.

     "Conflicting" means drugs and or health care services that are incompatible and/or unsuitable for use together because of undesirable chemical or physiological effects.

     "Contraindicated" means to indicate or show that a medical treatment or procedure is inadvisable or not recommended or warranted.

     "Duplicative" applies to the use of the same or similar drugs and health care services without due justification. Example: A client (or MCO enrollee) receives health care services from two or more providers for the same or similar condition(s) in an overlapping time frame, or the client receives two or more similarly acting drugs in an overlapping time frame, which could result in a harmful drug interaction or an adverse reaction.

     (("Inappropriate use" - means use of medical services which are not adapted to or appropriate for a patient's medical needs.

     "Medically unnecessary" - means services that are nonessential, redundant, and/or not necessary for a patient's medical care.

     "Overuse" - means the excessive use of medical services well beyond the patient's medically necessary care.))

     "Managed care organization" or "MCO" means an organization having a certificate of authority or certificate of registration from the office of insurance commissioner, that contracts with the department under a comprehensive risk contract to provide prepaid health care services to eligible medical assistance clients under the department's managed care programs.

     "MCO enrollee" means a medical assistance client enrolled in, and receiving medical services from, a department-contracted managed care organization (MCO).

     "Narcotic prescriber" means any of the following health care professionals who, within their scope of professional practice, are licensed to prescribe and administer controlled substances (see chapter 69.50 RCW, Uniform Controlled Substance Act) for a legitimate medical purpose:

     • A physician under chapter 18.71 RCW;

     • A physician assistant under chapter 18.71A RCW;

     • An osteopathic physician under chapter 18.57 RCW;

     • An osteopathic physician assistant under chapter 18.57A RCW; and

     • An advanced registered nurse practitioner under chapter 18.79 RCW.

     "Primary care provider" or "PCP" means a person licensed or certified under title 18 RCW including, but not limited to, a physician, an advanced registered nurse practitioner (ARNP), or a physician assistant who supervises, coordinates, and provides health care services to a client or an MCO enrollee, initiates referrals for specialty and ancillary care, and maintains the client's or enrollee's continuity of care.

     (3) Restrictions under the PRR program:

     (a) Do not apply to a client eligible for a family planning only program; and

     (b) Do apply to a fee-for-service client or an MCO enrollee currently assigned to the PRR program.

     (4) The prior authorization process described in WAC 388-530-1250 may be required for a fee-for-service client:

     (a) Prior to or during a PRR review; or

     (b) Currently placed in the PRR program.

     (((2))) (5) Clients selected for PRR review(( -- )).((Clients are selected)) The department or MCO selects a fee-for-service client or MCO enrollee for PRR review ((by)) when either or both of the following occur:

     (a) ((An "exception report" produced by the Medicaid Management Information System)) A utilization review report indicates the client or enrollee has utilized health care services as described in subsection (6) of this section; or

     (b) ((Direct referral from)) Medical providers, social service agencies, or other concerned parties have provided direct referrals.

     (((3) Initial review criteria -- Any client of the department's medical programs may be considered for assignment to PRR if conditions in either (a) or (b) of this subsection apply:))

     (6) PRR review for placement in the PRR program. When the department or MCO selects a client or enrollee for PRR review, the department or MCO staff, with clinical oversight, reviews a client's or enrollee's medical and/or billing history to determine if the client or enrollee has utilized medical services at a frequency or amount that is not medically necessary (42 CFR 431.54(e)). The utilization guidelines in subsection (7) of this section establish that a client or enrollee has utilized medical services at a frequency or amount that is not medically necessary when:

     (a) There is a history of medical services that are duplicative, excessive, or contraindicated;

     (b) There is a history of conflicting health care services, drugs, or supplies that are not within acceptable medical practice; or

     (c) The medical history shows indicators of "at-risk" utilization patterns.

     (7) Utilization guidelines for PRR placement. Department and MCO staff use the following utilization guidelines to determine PRR placement and may place a client or enrollee in the PRR program when medical and/or billing histories document any of the following:

     (a) Any two or more of the following conditions ((have been met)) occurred in a period of ninety calendar days ((in the previous twelve months)). The client or enrollee:

     (i) Received services from four or more different providers, including physicians, advanced registered nurse practitioners (ARNPs), and physician assistants (PAs);

     (ii) Had prescriptions filled by four or more different pharmacies;

     (iii) Received ten or more prescriptions;

     (iv) Had prescriptions written by four or more different prescribers; ((or))

     (v) Received similar services from two or more providers in the same day; or

     (vi) Had ten or more office visits.

     (b) Any one of the following ((conditions applies:)) occurred within a period of ninety calendar days. The client or enrollee has:

     (i) Made two or more emergency department visits ((in a ninety-day period));

     (ii) A medical history ((indicating)) that indicates "at-risk" utilization patterns; ((or))

     (iii) Made repeated and documented efforts to seek ((medically unnecessary)) health care services that are not medically necessary; or

     (iv) ((and)) Been counseled at least once by a health care provider ((or managed care representative)), a managed care plan clinical or program staff member, or a department clinical or PRR program staff member about the appropriate use of health care services.

     (((4) Request for clinical review -- If either subsection (2)(a) or (b) of this section applies, PRR program staff may review the client's medical and billing history for overuse or inappropriate use of medical services and on a case-by-case basis decide to)) (c) The client or enrollee received prescriptions for controlled substances from two or more different prescribers in any month.

     (8) PRR review outcomes. As a result of the PRR review, department or MCO staff may:

     (a) Determine no action is needed and close the client's or enrollee's file;

     (b) Send the client or enrollee and, if applicable, the client's or enrollee's authorized representative, a letter of concern with information on specific findings and notice of potential placement in the PRR program; or

     (c) ((Request a clinical review of the records.

     (5) Clinical review -- A nurse consultant, physician, or other qualified clinical staff at MAA may review the client's medical records to determine if there is a history of overuse or inappropriate or medically unnecessary use of services. The reviewer relies on established medical guidelines and may on a case-by-case basis decide to:

     (a) Take no action and close the PRR file; or

     (b) Proceed with any or all of the following:

     (i) Continue to monitor the client's utilization pattern for thirty to sixty days;

     (ii) Refer the client for education on appropriate use of services;

     (iii) Refer the client to other support services or agencies; or

     (iv) Assign the client to the PRR program.

     (6) Client restriction -- When the clinical review determines that the client has obtained inappropriate or medically unnecessary services, by established medical guidelines, the client will be restricted:

     (a) The department will send a written notice to the client or the client's authorized representative that:

     (i) Asks the client to select a primary care provider (PCP) and/or a pharmacy and/or a hospital. (See WAC 388-546-5000 through 388-546-5400 for limitations on nonemergency transportation services.)

     (ii) Directs the client to respond to the department within twenty calendar days after receiving the written notice:

     (A) To provide information on the selected provider(s);

     (B) To submit additional medical information, justifying the client's use of medical services; or

     (C) To request assistance from PRR program staff.

     (iii) Informs the client of fair hearing rights (see subsection (8) of this section); and

     (iv) Informs the client that, if a response is not received within twenty calendar days, the client will be restricted to provider(s) assigned by the PRR program.

     (b) After twenty calendar days, the PRR program may restrict the client to the specific provider(s) either chosen by the client or assigned by the program.

     (7) Assigned providers -- Assigned providers will be:

     (a) Located in the client's local geographic area; and/or

     (b) Reasonably accessible to the client.

     (8) Fair hearing rights

     (a) A client has ninety calendar days following the date of the department's notice in which to request a fair hearing.

     (b) A client who requests a fair hearing within twenty calendar days from the date the client receives notice under subsection (6)(a) of this section, will not be assigned to the PRR program until a fair hearing decision is made or if the client appeals, until a final order is issued.

     (c) A client who requests a fair hearing after twenty calendar days from the date the client receives notice under subsection (6)(a) of this section, and who has already been assigned a provider or providers, will remain in PRR until a fair hearing decision is made and a final administrative order is issued. (The client will remain in PRR if the fair hearing decision is adverse to the client.)

     (9) Provider selection and role -- For fee for service clients the providers must be contracted with MAA.

     (a) The selected primary care provider (PCP) must be either:

     (i) A physician who meets the criteria under WAC 388-502-0020 and 388-502-0030;

     (ii) An advanced registered nurse practitioner (ARNP) who meets criteria under WAC 388-502-0020 and 388-502-0030; or

     (iii) A licensed physician assistant, practicing with a sponsoring supervising physician.

     (b) The PCP supervises and coordinates medical care for the client on restriction. The PCP provides continuity of care and refers to specialists when necessary.

     (c) A single pharmacy fills all prescriptions for the client.

     (d) A single hospital provides all nonemergent and outpatient hospital care for the client.

     (10) Provider changes -- A client in PRR cannot change the assigned providers for twelve months after the assignments are made, unless:

     (a) The client moves to a residence outside the provider's geographic area;

     (b) The provider moves out of the client's geographical area;

     (c) The provider refuses to continue to serve the client; or

     (d) The client did not select the provider. The client may change a department-assigned provider once within sixty calendar days of the initial assignment.

     (11) Managed care clients on PRR -- A client in PRR enrolled in an MAA managed care plan must select a primary care provider (PCP) and/or a pharmacy and/or a hospital from those identified as available within the plan. In addition to the reasons given in subsection (9) of this section, the client may change a provider if the chosen or assigned PCP or pharmacy no longer participates with the plan. In such a situation, the client may:

     (a) Select a new PCP from the list of available PCPs provided by the plan; or

     (b) Transfer enrollment of all family members to the new department-contracted plan that the established PCP has joined.

     (12) Lifting or continuing restrictions -- After twenty-four months of assignment to the PRR program, a PRR client's use of services is reviewed.

     (a) A client is removed from PRR after the twenty-four-month review if:

     (i) Clinical and billing documentation show the client's care was reasonable and appropriate; and/or

     (ii) The PCP reports the services requested and received were reasonable and appropriate.

     (b) If the client is not removed from PRR after the twenty-four-month review, the client remains in PRR for an additional twelve months. After that twelve-month period, the client is reviewed again pursuant to this subsection.

     (13) Client financial responsibility -- So long as the requirements of WAC 388-502-0160 are followed, a client who is restricted under the PRR program may be billed for services and held financially responsible for:

     (a) Services that MAA and/or the client's health plan determine are not medically necessary; and:

     (b) Nonemergent services obtained from providers or facilities other than those assigned under the PRR program)) Determine that the utilization guidelines for PRR placement establish that the client or enrollee has utilized medical services at an amount or frequency that is not medically necessary and take one or more of the following actions. The department or MCO staff:

     (i) Refers the client or enrollee for education on appropriate use of health care services;

     (ii) Refers the client or enrollee to other support services or agencies; or

     (iii) Places the client or enrollee into the PRR program for an initial restriction period of twenty-four months.

     (9) PRR program placement. When a fee-for-service client or MCO enrollee is initially placed in the PRR program, the department or the MCO sends the client or enrollee and, if applicable, the client's or enrollee's authorized representative, a written notice of the PRR placement that:

     (a) Restricts the client or enrollee for twenty-four months to one or more of the following types of providers when obtaining health care services:

     (i) Primary care physician (PCP) (as defined in subsection (2) of this section.);

     (ii) Pharmacy;

     (iii) Narcotic prescriber;

     (iv) Hospital (for nonemergency medical services); or

     (v) Another qualified provider-type, as determined by department or MCO program staff on a case-by-case basis.

     (b) Directs the client or enrollee to respond to the department or the MCO within ten days of the date of the written notice:

     (i) To select providers, subject to department or MCO approval;

     (ii) To submit additional medical information, justifying the client's or enrollee's use of medical services; or

     (iii) To request assistance, if needed, from the department or MCO program staff.

     (c) Informs the client or enrollee of hearing rights (see subsection (14) of this section).

     (d) Informs the client or enrollee that if a response is not received within ten days of the date of the notice, the client or enrollee will be assigned providers.

     (10) Selection and role of assigned provider. A fee-for-service client and an MCO enrollee may be afforded a limited choice of providers for the types of services that are to be restricted (see subsection (9)(a) of this section for a list of provider-types that the department may assign).

     (a) For a fee-for-service client placed in the PRR program, the assigned:

     (i) Provider(s) must be located in the client's local geographic area and/or reasonably accessible to the client.

     (ii) Department-enrolled primary care provider (PCP) supervises and coordinates health care services for the client, including providing continuity of care and referrals to specialists when necessary. The PCP must be one of the following:

     (A) A physician who meets the criteria under WAC 388-502-0020 and 388-502-0030;

     (B) An advanced registered nurse practitioner (ARNP) who meets the criteria under WAC 388-502-0020 and 388-502-0030; or

     (C) A licensed physician assistant (PA), practicing with a sponsored supervising physician.

     (iii) Narcotic prescriber prescribes all controlled substances for the client.

     (iv) Pharmacy fills all prescriptions for the client.

     (v) Hospital provides all nonemergency and outpatient hospital care for the client.

     (b) For an MCO enrollee placed in the PRR program, the assigned PCP, narcotic prescriber, pharmacy, and hospital must be:

     (i) Available within the enrollee's selected MCO; and

     (ii) Located in the enrollee's local geographic area and/or reasonably accessible to the enrollee.

     (c) A client or enrollee placed in the PRR program cannot change assigned providers for twelve months after the assignments are made, unless:

     (i) The client or enrollee moves to a residence outside the provider's geographic area;

     (ii) The provider moves out of the client's or enrollee's local geographic area and is no longer reasonably accessible to the client or enrollee;

     (iii) The provider refuses to continue to serve the client or enrollee;

     (iv) The client or enrollee did not select the provider. The client or enrollee may request to change an assigned provider once within thirty calendar days of the initial assignment;

     (v) The enrollee's assigned provider no longer participates with the MCO. In this case, the enrollee may select a new provider from the list of available providers in the MCO or transfer enrollment of all family members to the new department-contracted MCO that the established provider has joined;

     (vi) The provider has been suspended or disqualified from participating as a department-enrolled or MCO-contracted provider; or

     (vii) The provider's business license has been suspended or revoked by the licensing authority;

     (d) When an assigned prescribing provider no longer contracts with the department:

     (i) All prescriptions from the provider are invalid thirty days following the date the contract ends;

     (ii) All prescriptions from the provider are subject to applicable pharmacy rules in chapter 388-530 WAC or appropriate MCO rules; and

     (iii) The client or enrollee must choose or be assigned another provider according to the requirements in this section.

     (11) PRR restriction periods. The length of time for a fee-for-service client's or MCO enrollee's:

     (a) Initial restriction period of PRR placement is:

     (i) A minimum of twenty-four consecutive months; or

     (ii) If the client or enrollee is not eligible for a medical assistance program for any month(s) during the span of the twenty-four consecutive months of PRR placement, the restriction period is for the duration of the client's or enrollee's medical assistance program eligibility plus any subsequent period of eligibility up to but not exceeding twenty-four months;

     (b) Second restriction period of PRR placement is:

     (i) An additional thirty-six consecutive months; or

     (ii) If the client or enrollee is not eligible for a medical assistance program for any month(s) during the span of the thirty-six consecutive months, the restriction period is for the duration of the client's or enrollee's eligibility for a medical assistance program plus any subsequent period of eligibility up to but not exceeding thirty-six months; and

     (c) Third restriction period and each subsequent period of PRR placement is:

     (i) An additional seventy-two consecutive months; or

     (ii) If the client or enrollee is not eligible for a medical assistance program for any month(s) during the span of the seventy-two consecutive months, the restriction period is for the duration of the client's or enrollee's eligibility for a medical assistance program plus any subsequent period of eligibility up to but not exceeding each seventy-two month placement.

     (12) Department review of a PRR restriction period assignment. The department reviews a fee-for-service client's or MCO enrollee's use of health care services prior to the end of each assigned PRR restriction period described in subsection (11) of this section using the utilization guidelines in subsection (7) of this section.

     (a) The department assigns the next PRR restriction period if the utilization guidelines for PRR placement in subsection (7) apply to the client or enrollee.

     (b) When the department assigns a subsequent PRR restriction period, the department sends the client or enrollee and, if applicable, the client's or enrollee's authorized representative, a written notice that informs the client or enrollee:

     (i) That the current providers assigned to the client or enrollee continue to be assigned to the client during the subsequent PRR restriction period;

     (ii) That all PRR program rules continue to apply; and

     (iii) Of hearing rights (see subsection (14) of this section).

     (c) The department may lift any assigned PRR restriction period if the client or enrollee:

     (i) Successfully completes a treatment program that is provided by a chemical dependency service provider certified by the department under chapter 388-805 WAC;

     (ii) Submits documentation of completion of the approved treatment program to the department; and

     (iii) Maintains appropriate use of health care services within the utilization guidelines described in subsection (7) for six months after the date the treatment ends.

     (d) A client or enrollee who is placed in the PRR program after being removed from any PRR restriction period will be placed at the next PRR restriction period described in subsections (11)(b) and (c) of this section.

     (e) A client or enrollee will remain placed in the PRR program regardless of change in eligibility program type or change in address.

     (13) Client financial responsibility. This subsection takes precedence over WAC 388-502-0160. A fee-for-service client or MCO enrollee placed in the PRR program may be billed by a provider and held financially responsible for health care services when the client or enrollee:

     (a) Obtains nonemergency services and the provider who renders the services is not assigned or referred under the PRR program.

     (b) Obtains services that are not medically necessary.

     (14) Right to hearing. A fee-for-service client or MCO enrollee who believes the department or MCO has taken action erroneously may request a hearing.

     (a) A client or enrollee must request the hearing within ninety days after the client or enrollee receives the written notice of restriction. Chapter 388-538 WAC does not apply to the department's or MCO's decision to place an enrollee in the PRR program.

     (b) The department conducts a hearing according to chapter 388-02 WAC. Definitions for the terms "hearing", "initial order", and "final order" used in this subsection are found in WAC 388-02-0010.

     (c) A client or enrollee who requests a hearing within ten calendar days from the date of the written notice of an initial restriction period of PRR placement under subsection (11)(a) of this section will not be placed in the PRR program until the date an initial order is issued that supports the client's or enrollee's placement in the PRR program.

     (d) A client or enrollee who requests a hearing after ten days from the date of the written notice under subsection (11)(a) of this section will remain placed in the PRR program unless a final administrative order is entered that orders their removal from restriction.

     (e) A client or enrollee who requests a hearing within ninety days from the date of receiving the written notice under subsection (11)(b) or (c) or this section and who has already been assigned providers will remain placed in the PRR program unless a final administrative order is entered that orders the client's or enrollee's removal from restriction.

     (f) An administrative law judge (ALJ) may rule that the client or enrollee be placed in the PRR program prior to the date the record is closed and prior to the date the initial order is issued based on a showing of just cause (a showing of just cause means it has been demonstrated that there is a legitimate cause to justify the action taken) to protect the health and safety of the client or enrollee.

[Statutory Authority: RCW 74.08.090, 74.04.055, and 42 C.F.R. Subpart B 431.51, 431.54 (e) and (3), and 456.1. 04-01-099, § 388-501-0135, filed 12/16/03, effective 1/16/04. Statutory Authority: RCW 74.08.090. 01-02-076, § 388-501-0135, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 74.04.050, 74.04.055, 74.04.057 and 74.08.090. 98-16-044, § 388-501-0135, filed 7/31/98, effective 9/1/98. Statutory Authority: RCW 74.08.090 and 74.09.522. 97-03-038, § 388-501-0135, filed 1/9/97, effective 2/9/97. Statutory Authority: RCW 74.08.090. 94-10-065 (Order 3732), § 388-501-0135, filed 5/3/94, effective 6/3/94. Formerly WAC 388-81-100.]

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