WSR 10-06-011

PERMANENT RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)

[ Filed February 19, 2010, 11:02 a.m. , effective March 22, 2010 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: These amendments are required to implement ESSB 5892 which authorizes state purchasing health care programs to maximize appropriate prescription drug use in a cost-effective manner.

Citation of Existing Rules Affected by this Order: Amending WAC 388-530-4100 and 388-530-4150.

Statutory Authority for Adoption: RCW 74.04.050, 74.09.700, and 74.08.090; chapter 575, Laws of 2009 (ESSB 5892).

Adopted under notice filed as WSR 09-23-074 on November 16, 2009.

Changes Other than Editing from Proposed to Adopted Version: WAC 388-530-4100(11), added a new last sentence as follows:

(11) When a brand name drug has been reviewed by the P&T committee, the department may immediately designate an available, less expensive, equally effective, generic equivalent as a preferred drug. For the purpose of this chapter, generic equivalent drugs are those identified in the FDA's approved drug products with therapeutic equivalence evaluations (orange book).

WAC 388-530-4100(12), fixed one place where the incorrect word was used and fixed cross-reference:

"... as a client's first choice course of treatment within that therapeutic class may be subject to restrictions under WAC 388-530-4125 and WAC 388-530-4150 (8) (10)."

WAC 388-530-4125, fixed two places where the incorrect word was used:

Intro and under (1)(b): "... client's first choice" of treatment should have been "client's first course" of treatment.

WAC 388-530-4125(3), added "and nonpreferred generics":

"Endorsing practitioners' prescriptions written "Dispense as written (DAW)" for preferred nonpreferred brand name drugs and nonpreferred generics in the specific drug classes on the ...."

WAC 388-530-4150(5) Therapeutic interchange program (TIP), cross-reference correction:

(5) With the exception of subsection (7) and (8) (10) of this section, when an endorsing practitioner determines that a nonpreferred drug is medically necessary, all of the following apply:

Renumbered the proposed subsections (7)(c) to (9).

New subsection (8) as follows:

(8) While the endorsing practitioner is engaged in the activities described in subsection (7)(b)(ii) or (7)(b)(iii) of this section, his or her endorsing practitioner status is maintained.

Renumbered proposed subsection (8) to (10) with the following revision:

(8) (10) Except as otherwise provided in subsection (11) of this section, for a client's first course of treatment within a therapeutic class of drugs, the endorsing practitioner's option to write DAW does not apply when:

(a) There is a less expensive, equally effective therapeutic alternative generic product available to treat the condition; and

(b) The drug use review (DUR) board established under WAC 388-530-4000 has reviewed the drug class and recommended to the department that the drug class is appropriate to require generic drugs as a client's first course of treatment.

Renumbered proposed subsection (9) to (11) as a result of previous changes and inserted a missing cross reference:

(9) (11) In accordance with WAC 388-530-4125(3) and WAC 388-501-0165, the department will request and review the endorsing practitioner's medical justification for preferred and nonpreferred brand name drugs and nonpreferred generic drugs for the client's first course of treatment.

A final cost-benefit analysis is available by contacting Siri A. Childs, PharmD, P.O. Box 45506, Olympia, WA 98504-5506, phone (360) 725-1564, fax (360) 586-9727, e-mail childsa@dshs.wa.gov.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 1, Amended 2, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 2, Repealed 0.

Date Adopted: February 18, 2010.

Susan N. Dreyfus

Secretary

4148.8
AMENDATORY SECTION(Amending WSR 08-21-107, filed 10/16/08, effective 11/16/08)

WAC 388-530-4100   Washington preferred drug list (PDL).   Under RCW 69.41.190 and 70.14.050, the department((,)) and other state agencies cooperate in developing and maintaining the Washington preferred drug list.

(1) Washington state contracts with evidence-based practice center(s) for systematic reviews of drug(s).

(2) The pharmacy and therapeutics (P&T) committee reviews and evaluates the safety, efficacy, and outcomes of prescribed drugs, using evidence-based information provided by the evidence-based practice center(s).

(3) The P&T committee makes recommendations to state agencies as to which drug(s) to include on the Washington PDL((,)) under chapter 182-50 WAC.

(4) The appointing authority makes the final selection of drugs included on the Washington PDL.

(5) Drugs in a drug class on the Washington PDL((,)) that have been studied by the evidence-based practice center(s) and reviewed by the P&T committee((,)) and which have not been selected as preferred are considered nonpreferred drugs and are subject to the therapeutic interchange program (TIP) and dispense as written (DAW) rules under WAC 388-530-4150.

(6) Drugs in a drug class on the Washington PDL that have not been studied by the evidence-based practice center(s) and have not been reviewed by the P&T committee will be treated as nonpreferred drugs not subject to the dispense as written (DAW) or the therapeutic interchange program (TIP).

(7) A nonpreferred drug((,)) which the department determines as covered((,)) is considered for authorization after the client has:

(a) Tried and failed or is intolerant to at least one preferred drug; and

(b) Met department established criteria for the nonpreferred drug.

(8) Drugs in a drug class on the Washington PDL may be designated as preferred drugs for special populations or specific indications.

(9) Drugs in a drug class on the Washington PDL may require authorization for safety.

(10) Combination drugs that have been studied by the evidence-based practice center and have been reviewed by the P&T committee may be included in the Washington PDL.

(11) When a brand name drug has been reviewed by the P&T committee, the department may immediately designate an available, less expensive, equally effective, generic equivalent as a preferred drug. For the purpose of this chapter, generic equivalent drugs are those identified in the FDA's approved drug products with therapeutic equivalence evaluations (orange book).

(12) The dispensing of a brand name drug in a drug class on the Washington PDL as a client's first course of treatment within that therapeutic class may be subject to restrictions under WAC 388-530-4125 and WAC 388-530-4150(10).

[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.700, 2008 c 245. 08-21-107, 388-530-4100, filed 10/16/08, effective 11/16/08. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, 388-530-4100, filed 9/26/07, effective 11/1/07.]


NEW SECTION
WAC 388-530-4125   Generics first for a client's first course of treatment.   The department uses point-of-sale (POS) claim messaging to communicate to pharmacies to use a preferred generic drug for the client's first course of treatment in specific drug classes.

(1) The department may require preferred generic drug(s) on the Washington preferred drug list (PDL) be used before any brand name drugs for a client's first course of treatment within that therapeutic class of drugs, when:

(a) There is a less expensive, equally effective therapeutic alternative generic product available to treat the condition; and

(b) The drug use review (DUR) board established under WAC 388-530-4000 has reviewed the drug class and recommended to the department that the drug class is appropriate to require generic drugs as a client's first course of treatment.

(2) For drug classes selected by the department which meet the criteria of subsection (1) of this section, only preferred generic drugs are covered for a client's first course of treatment, except as identified in subsection (3) of this section.

(3) Endorsing practitioners' prescriptions written "Dispense as written (DAW)" for preferred and nonpreferred brand name drugs and nonpreferred generics in the specific drug classes on the Washington PDL reviewed by the DUR board will be subject to authorization to establish medical necessity as defined in WAC 388-500-0005.

[]


AMENDATORY SECTION(Amending WSR 08-21-107, filed 10/16/08, effective 11/16/08)

WAC 388-530-4150   Therapeutic interchange program (TIP).   This section contains the department's rules for the endorsing practitioner therapeutic interchange program (TIP). TIP is established under RCW 69.41.190 and 70.14.050. The statutes require state-operated prescription drug programs to allow physicians and other prescribers to endorse a Washington preferred drug list (PDL) and, in most cases, requires pharmacists to automatically substitute a preferred, equivalent drug from the list.

(1) The therapeutic interchange program (TIP) applies only to drugs:

(a) Within therapeutic classes on the Washington PDL;

(b) Studied by the evidence-based practice center(s);

(c) Reviewed by the pharmacy and therapeutics (P&T) committee; and

(d) Prescribed by an endorsing practitioner.

(2) TIP does not apply:

(a) When the ((pharmacy and therapeutics ())P&T(())) committee determines that TIP does not apply to the therapeutic class on the PDL; or

(b) To a drug prescribed by a nonendorsing practitioner.

(3) A practitioner who wishes to become an endorsing practitioner must specifically enroll with the health care authority (HCA) as an endorsing practitioner((,)) under the provisions of chapter 182-50 WAC and RCW 69.41.190(2).

(4) When an endorsing practitioner writes a prescription for a client for a nonpreferred drug, or for a preferred drug for a special population or indication other than the client's population or indication, and indicates that substitution is permitted, the pharmacist must:

(a) Dispense a preferred drug in that therapeutic class in place of the nonpreferred drug; and

(b) Notify the endorsing practitioner of the specific drug and dose dispensed.

(5) With the exception of subsection (7) and (10) of this section, when an endorsing practitioner determines that a nonpreferred drug is medically necessary, all of the following apply:

(a) The practitioner must indicate that the prescription is to be dispensed as written (DAW);

(b) The pharmacist dispenses the nonpreferred drug as prescribed; and

(c) The department does not require prior authorization to dispense the nonpreferred drug in place of a preferred drug except when the drug requires authorization for safety.

(6) In the event the following therapeutic drug classes are on the Washington PDL, pharmacists will not substitute a preferred drug for a nonpreferred drug in these therapeutic drug classes when the endorsing practitioner prescribes a refill (including the renewal of a previous prescription or adjustments in dosage((, and samples))):

(a) Antipsychotic;

(b) Antidepressant;

(c) Antiepileptic;

(d) Chemotherapy;

(((d))) (e) Antiretroviral;

(((e))) (f) Immunosuppressive; or

(((f))) (g) Immunomodulator/antiviral treatment for hepatitis C for which an established, fixed duration of therapy is prescribed for at least twenty-four weeks but no more than forty-eight weeks.

(7) The department may impose nonendorsing status on an endorsing practitioner only under the following circumstances:

(a) The department runs three quarterly reports demonstrating that, within any therapeutic class of drugs on the Washington PDL, the endorsing practitioner's frequency of prescribing DAW varies from the prescribing patterns of the endorsing practitioner's department-designated peer grouping with a ninety-five percent confidence interval; and

(b) The medical director has:

(i) Delivered by mail to the endorsing practitioner the quarterly reports described in subsection (7)(a) of this section which demonstrate the endorsing practitioner's variance in prescribing patterns; and

(ii) Provided the endorsing practitioner an opportunity to explain the variation in prescribing patterns as medically necessary as defined under WAC 388-500-0005; or

(iii) Provided the endorsing practitioner two calendar quarters to change his or her prescribing patterns to align with those of the department-designated peer groupings.

(8) While the endorsing practitioner is engaged in the activities described in subsection (7)(b)(ii) or (7)(b)(iii) of this section, his or her endorsing practitioner status is maintained.

(9) The nonendorsing status restrictions imposed under this section will remain in effect until the quarterly reports demonstrate that the endorsing practitioner's prescribing patterns no longer vary in comparison to his or her department designated peer-grouping over a period of four calendar quarters, with a ninety-five percent confidence interval.

(10) Except as otherwise provided in subsection (11) of this section, for a client's first course of treatment within a therapeutic class of drugs, the endorsing practitioner's option to write DAW does not apply when:

(a) There is a less expensive, equally effective therapeutic alternative generic product available to treat the condition; and

(b) The drug use review (DUR) board established under WAC 388-530-4000 has reviewed the drug class and recommended to the department that the drug class is appropriate to require generic drugs as a client's first course of treatment.

(11) In accordance with WAC 388-530-4125(3) and WAC 388-501-0165, the department will request and review the endorsing practitioner's medical justification for preferred and nonpreferred brand name drugs and nonpreferred generic drugs for the client's first course of treatment.

[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.700, 2008 c 245. 08-21-107, 388-530-4150, filed 10/16/08, effective 11/16/08. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, 388-530-4150, filed 9/26/07, effective 11/1/07.]

Washington State Code Reviser's Office