Original Notice.

Preproposal statement of inquiry was filed as WSR 01-13-070.

Title of Rule: Amending WAC 388-530-1050 Definitions and new section WAC 388-530-1260.

Purpose: To incorporate into rule, section 210(14), chapter 1, Laws of 2000 2nd sp.s. (EHB 2487), which provides funds to develop a therapeutic consultation program.

Statutory Authority for Adoption: RCW 74.08.090, 74.04.050.

Statute Being Implemented: RCW 74.08.090, 74.04.050.

Summary: The rules describe MAA's therapeutic consultation service (TCS) that provides a process to manage drug therapies for a medical assistance client whose utilization of brand name prescription drugs exceeds an established monthly limit, or whose drug claim is for a nonpreferred drug within therapeutic classes. The rules also clarify terms used in the TCS process by providing definitions.

Reasons Supporting Proposal: It will encourage less costly alternatives to expensive medications, while continuing to make client quality of care the highest priority.

Name of Agency Personnel Responsible for Drafting: Kathy Sayre, P.O. Box 45533, Olympia, WA 98504, (360) 725-1342; Implementation and Enforcement: Johnna Dodge, P.O. Box 45506, Olympia, WA 98504, (360) 725-1570.

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 new rules describe MAA's therapeutic consultation service (TCS), clarify and define terms used in the TCS process, and describe the requirements of the pharmacy provider, the prescriber, and the MAA designee in the TCS process. The purpose of the rules is to manage drug therapies for a client whose utilization of brand name prescription drugs exceeds an established monthly limit, or whose drug claim is for a nonpreferred drug within therapeutic drug classes. It is anticipated the TCS process will encourage less costly alternatives to expensive medications, while continuing to make client quality of care the highest priority.

Proposal Changes the Following Existing Rules: Adds several new definitions to WAC 388-530-1050 Definitions.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the new rules and concluded that no new costs will be imposed on businesses affected by them.

RCW 34.05.328 applies to this rule adoption. The department has analyzed the proposed rules and determined that they meet the definition of a "significant legislative rule." An analysis of the probable costs and 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 November 6, 2001, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Fred Swenson by November 1, 2001, phone (360) 664-6097, TTY (360) 664-6178, e-mail swensfh@dshs.wa.gov.

Submit Written Comments to: Identify WAC Numbers, Department of Social and Health Services, Rules Coordinator, Rules and Policies Assistance Unit, P.O. Box 45850, Olympia, WA 98504-5850, fax (360) 664-6185, by November 6, 2001.

Date of Intended Adoption: No sooner than November 7, 2001.

September 25, 2001

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

"Actual acquisition cost (AAC)" means the actual price a provider paid for a drug marketed in the package size of drug purchased, or sold by a particular manufacturer or labeler. Actual acquisition cost is calculated based on factors including, but not limited to:

(1) Invoice price, including other invoice-based considerations;

(2) Order quantity and periodic purchase volume discount policies of suppliers (wholesalers and/or manufacturers);

(3) Membership/participation in purchasing cooperatives;

(4) Advertising and other promotion/display allowances, free merchandise deals; and

(5) Transportation or freight allowances.

"Administer" means the direct application of a prescription drug by injection, inhalation, ingestion, or any other means, to the body of a patient by a practitioner, or at the direction of the practitioner.

"Automated maximum allowable cost (AMAC)" means the rate established for all multiple-source drugs designated by three or more products at least one of which must be under a federal drug rebate contract and which are not on the maximum allowable cost (MAC) list.

"Average wholesale price (AWP)" means the average price of a drug product from wholesalers nationwide at a point in time.

"Compendia of drug information" includes the following:

(1) The American Hospital Formulary Service Drug Information;

(2) The United States Pharmacopeia Drug Information; and

(3) DRUGDEX Information System.

"Compounding" means the act of combining two or more active ingredients or adjusting therapeutic strengths in the preparation of a prescription.

"Contract drugs" means drugs manufactured or distributed by manufacturers/labelers who signed a drug rebate agreement with the federal Department of Health and Human Services (DHHS).

"Deliver or delivery" means the transfer of a drug or device from one person to another.

"Department" means the department of social and health services (DSHS).

"Dispense as written (DAW)" means an instruction to the pharmacist forbidding substitution of a generic drug or a therapeutically equivalent product for the specific drug product prescribed.

"Dispensing fee" means the fee MAA sets to reimburse pharmacy providers in addition to ingredient costs, for expenses that include but are not limited to, information provided to the client as required by state laws and federal regulations, compounding time, and overhead expenses incurred in filling medical assistance prescriptions.

"Drug file" means a list of drugs provided to the medical assistance administration's (MAA's) drug data base and maintained by a drug file contractor.

"Drug file contractor" also referred to as "drug pricing file contractor," means the entity which has contracted to provide MAA, at specified intervals, the latest information and/or data base on drugs and related supplies produced, prepared, processed, packaged, labeled, distributed, marketed, or sold in the marketplace. Contractor-provided information includes, but is not limited to, identifying characteristics of the drug (national drug code, drug name, manufacturer/labeler, dosage form, and strength) for the purpose of identifying and facilitating payment for drugs billed to MAA.

"Drug rebates" means payments provided by pharmaceutical manufacturers to state Medicaid programs under the terms of the manufacturers' agreements with the Department of Health and Human Services.

"Drug-related supplies" means nonpharmaceutical items necessary for administration or delivery of a drug.

"Drug utilization review (DUR)" means a quality review for covered outpatient drugs that assures prescriptions are appropriate, medically necessary, and not likely to result in adverse medical outcomes.

"Emergency kit" means a set of limited pharmaceuticals furnished to a nursing facility by the pharmacy that provides prescription dispensing services to that facility. Each kit is specifically set up to meet the emergency needs of an individual nursing facility.

"Estimated acquisition cost (EAC)" means MAA's estimate of the price providers generally and currently pay for a drug marketed or sold by a particular manufacturer or labeler.

"Expedited prior authorization" means the process for authorizing selected drugs in which providers use a set of numeric codes to indicate to MAA the acceptable indications/conditions/diagnoses/criteria that are applicable to a particular request for drug authorization.

"Experimental drugs" means drugs the FDA has not approved, or approved drugs when used for medical indications other than those listed by the FDA.

"Federal upper limit (FUL)" means the maximum allowable payment set by the Health Care Financing Administration (HCFA) for a multiple source drug.

"Four brand name prescriptions per calendar month limit" means the maximum number of paid prescription claims for brand name drugs that MAA allows for each client in a calendar month without a complete review of the client's drug profile.

"Generic drug" means a nonproprietary drug that is required to meet the same bioequivalency tests as the original brand name drug.

"Ingredient cost" means the portion of a prescription's cost attributable to the drug ingredients, chemical components, and/or substances.

"Less than effective drug" or "DESI" means a drug for which:

(1) Effective approval of the drug application has been withdrawn by the Food and Drug Administration (FDA) for safety or efficacy reasons as a result of the drug efficacy study implementation (DESI) review; or

(2) The secretary of the department of health and human services (DHHS) has issued a notice of an opportunity for a hearing under section 505(e) of the federal Food, Drug, and Cosmetic Act on a proposed order of the secretary to withdraw approval of an application for such drug under such section because the secretary has determined the drug is less than effective for some or all conditions of use prescribed, recommended, or suggested in its labeling.

"Long-term therapy" means treatment a client receives or will receive continuously through and beyond ninety days.

"Maximum allowable cost (MAC)" means the maximum amount that MAA will pay for a specific dosage form and strength of a multiple source drug product.

"Medically accepted indication" means any indicated use for a covered outpatient drug:

(1) Approved under the federal Food, Drug, and Cosmetic Act;

(2) Which appears in peer-reviewed medical literature; or

(3) Which is accepted by one or more of the references listed in the compendia of drug information.

"Modified unit dose delivery system" (also known as blister packs or "bingo/punch cards") means a method in which each patient's medication is delivered to a nursing facility:

(1) In individually sealed, single dose packages or "blisters"; and

(2) In quantities for one month's supply, unless the prescriber specifies short-term therapy.

"Multiple-source drug" means a drug marketed or sold by:

(1) Two or more manufacturers or labelers; or

(2) The same manufacturer or labeler:

(a) Under two or more different proprietary names; or

(b) Under a proprietary name and a generic name.

"National drug code (NDC)" means the eleven-digit number the manufacturer or labeler assigns to a pharmaceutical product and attaches to the product container at the time of packaging that identifies the product's manufacturer, dose form and strength, and package size.

"Noncontract drugs" are drugs manufactured or distributed by manufacturers/labelers who have not signed a drug rebate agreement with the federal Department of Health and Human Services.

"Nonprescription drugs" means drugs that may be lawfully sold without a prescription.

"Obsolete NDC" means a national drug code replaced or discontinued by the manufacturer or labeler.

"Over-the-counter (OTC) drugs" means drugs that do not require a prescription before they can be dispensed.

"Pharmacist" means a person licensed in the practice of pharmacy by the state in which the prescription is filled.

"Pharmacy research specialist" means a licensed pharmacist employed by MAA.

"Pharmacy" means every location licensed by the State Board of Pharmacy in the state where the practice of pharmacy is conducted.

"Point-of-sale (POS)" means a pharmacy claims processing system capable of receiving and adjudicating claims on-line.

"Practice of pharmacy" means the practice of and responsibility for:

(1) Accurately interpreting prescription orders;

(2) Compounding, dispensing, labeling, administering, and distributing of drugs and devices;

(3) Providing drug information to the client that includes, but is not limited to, the advising of therapeutic values, hazards, and the uses of drugs and devices;

(4) Monitoring of drug therapy and use;

(5) Proper and safe storage of drugs and devices;

(6) Documenting and maintaining records;

(7) Initiating or modifying drug therapy in accordance with written guidelines or protocols previously established and approved for a pharmacist's practice by a practitioner authorized to prescribe drugs; and

(8) Participating in drug utilization reviews.

"Practitioner" means an individual who has met the professional and legal requirements necessary to provide a health care service, such as a physician, nurse, dentist, physical therapist, pharmacist or other person authorized by state law as a practitioner.

"Preferred drug" means MAA's drug(s) of choice within a selected therapeutic class.

"Prescriber" means a physician, osteopathic physician/surgeon, dentist, nurse, physician assistant, optometrist, pharmacist, or other person authorized by law or rule to prescribe drugs. See WAC 246-863-100 for pharmacists' prescriptive authority.

"Prescription" means an order for drugs or devices issued by a practitioner authorized by state law or rule to prescribe drugs or devices in the course of the practitioner's professional practice for a legitimate medical purpose.

"Prescription drugs" means drugs required by any applicable federal or state law or regulation to be dispensed by prescription only or that are restricted to use by practitioners only.

"Prior authorization program" means a medical assistance administration (MAA) program, subject to the requirements of 42 U.S.C. 1396r-8 (d)(5), that may require, as condition of payment, that a drug on MAA's drug file be prior authorized. See WAC 388-530-1200.

"Prospective drug utilization review (Pro-DUR)" means a process in which a request for a drug product for a particular patient is screened, before the product is dispensed, for potential drug therapy problems.

"Reconstitution" means the process of returning a single active ingredient, previously altered for preservation and storage, to its approximate original state.

"Retrospective drug utilization review (Retro-DUR)" means the process in which patient drug utilization is reviewed on a periodic basis to identify patterns of fraud, abuse, gross overuse, or inappropriate or unnecessary care.

"Risk/benefit ratio" means the result of assessing the side effects compared to the positive therapeutic outcome of therapy.

"Single source drug" means a drug produced or distributed under an original new drug application approved by the FDA.

"Substitute" means to replace, with the prescriber's authorization:

(1) An equivalent generic drug product of the identical base or salt as the specific drug product prescribed; or

(2) A therapeutically equivalent drug other than the identical base or salt.

"TCS" See "therapeutic consultation service."

"Terminated drug product" means a product for which the shelf life expiration date has been met, per manufacturer notification.

"Therapeutic alternative" means a drug product that contains a different therapeutic agent than the drug in question, but is the same pharmacological or therapeutic class and can be expected to have a similar therapeutic effect when administered to patients in a therapeutically equivalent dosage.

"Therapeutic class" means a group of drugs used for the treatment, remediation, or cure of a specific disorder or disease.

"Therapeutic consultation service (TCS)" means the prescriber and an MAA-designated clinical pharmacist jointly review prescribing activity when drug claims for a medical assistance client exceed program limitations.

"Therapeutically equivalent" means chemically dissimilar prescription drugs with the same efficacy and safety when administered to an individual, as determined by:

(1) Information from the FDA;

(2) Published and peer-reviewed scientific data;

(3) Randomized controlled clinical trials; and

(4) Other scientific evidence.

"Tiered dispensing fee system" means a system of paying pharmacies different dispensing fee rates, based on the individual pharmacy's total annual prescription volume and/or drug delivery system used.

"True unit dose delivery" means a method in which each patient's medication is delivered to the nursing facility in quantities sufficient only for the day's required dosage.

"Unit dose drug delivery" means true unit dose or modified unit dose delivery systems.

"Usual and customary charge" means the fee that the provider typically charges the general public for the product or service.

[Statutory Authority: RCW 74.08.090, 74.04.050. 01-01-028, 388-530-1050, filed 12/7/00, effective 1/7/01. Statutory Authority: RCW 74.08.090. 96-21-031, 388-530-1050, filed 10/9/96, effective 11/9/96.]

(2) A TCS occurs when a drug claim:

(a) Exceeds the four brand name prescriptions per calendar month limit; or

(b) Is for a nonpreferred drug within selected therapeutic classes.

(3) Through TCS, MAA:

(a) Provides a complete drug profile review for each client whose claims exceed four brand name prescriptions in a calendar month. MAA excludes the following from the four brand name prescriptions per calendar month limit:

(i) Generic drugs; and

(ii) The following drugs:

(A) Antidepressants;

(B) Antipsychotics;

(C) Chemotherapy;

(D) Contraceptives;

(E) HIV;

(F) Immunosuppressants; and

(G) Hypoglycemia rescue agents.

(b) Publishes a list of preferred drugs within selected therapeutic classes. MAA chooses a drug or drugs from a selected therapeutic class for placement on the preferred list when:

(i) The drugs in the class are essentially equal in terms of safety and efficacy; and

(ii) The selected drug or drugs may be the least costly in the therapeutic class.

(4) When a pharmacy provider submits a claim that exceeds TCS limitations for a client, MAA notifies the pharmacy provider that a TCS is required.

(5) The TCS process includes all of the following:

(a) Pharmacy provider requirements:

(i) The pharmacy provider notifies the prescriber that the prescriber or prescriber designee must call the TCS toll-free telephone number to begin a TCS; and

(ii) If the TCS cannot take place due to the prescriber's or prescriber designee's unavailability, the pharmacy provider has the option to dispense an emergency supply of the requested drug only when:

(A) Given in an emergency;

(B) MAA receives ((adequate)) justification within seventy-two hours of the fill date, excluding weekends and Washington state holidays; and

(C) MAA agrees with the justification and approves the request.

(b) Prescriber requirements:

(i) When the pharmacy provider contacts the client's prescriber as described in subsection (5)(a)(i) of this section, the prescriber or prescriber designee contacts the MAA designee to begin a TCS;

(ii) After the prescriber or prescriber designee and the MAA-designated clinical pharmacist review the client's drug profile and discuss clinically sound options and cost effective alternative drug(s), the prescriber does one of the following:

(A) Changes the prescription to an alternate drug or preferred drug and contacts the client's pharmacy with the new prescription;

(B) Provides the MAA designee with adequate medical justification for the requested drug and the MAA designee authorizes the drug under the provisions of medical necessity as defined in WAC 388-500-0005; or

(C) Does not agree to prescribe an alternate drug or preferred drug and does not provide adequate medical justification for the requested drug, then:

(I) The MAA designee authorizes only a one-month supply of the requested drug with no refills and sends the initiating prescriber a copy of the client's drug profile and a therapy authorization turnaround form;

(II) The prescriber signs the therapy authorization turnaround form and returns it to the MAA designee; and

(III) Upon receipt of the therapy authorization turnaround form, the MAA designee authorizes six additional months of the requested drug.

(c) MAA designee responsibilities:

(i) Notifies the following, in writing, of the results of the TCS:

(A) Prescriber;

(B) Pharmacy provider; and

(C) MAA for notification to the client.

(ii) Notifies MAA clinical program staff when concerns for client safety are identified during the TCS. See WAC 388-530-1100(2) for how MAA determines restrictions on drug coverage based on, but not limited to, client safety.

(iii) Contacts other prescribers identified during the TCS when opportunities to further improve the client's healthcare outcome are discovered.

(6) A client who does not agree with a TCS decision has a right to a fair hearing under chapter 388-02 WAC. After receiving a request for a fair hearing, MAA may request additional information from the client, the prescriber, or the pharmacy provider. After MAA reviews the available information, the result may be:

(a) A reversal of the initial department decision;

(b) Resolution of the client's issue(s); or

(c) A fair hearing conducted per chapter 388-02 WAC.

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Reviser's note: The unnecessary strike-through in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.

Washington State Code Reviser's Office