WSR 15-09-117 PROPOSED RULES HEALTH CARE AUTHORITY (Washington Apple Health) [Filed April 21, 2015, 9:37 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 15-04-096.
Title of Rule and Other Identifying Information: WAC 182-530-4100 Washington preferred drug list and 182-530-4125 Generics first for a client's first course of treatment.
Hearing Location(s): Health Care Authority (HCA), Cherry Street Plaza Building, Conference Room, 626 8th Avenue, Olympia, WA 98504 (metered public parking is available street side around building. A map is available at http://www.hca.wa.gov/documents/directions_to_csp.pdf or directions can be obtained by calling (360) 725-1000), on May 26, 2015, at 10:00 a.m.
Date of Intended Adoption: Not sooner than May 27, 2015.
Submit Written Comments to: HCA Rules Coordinator, P.O. Box 45504, Olympia, WA 98504-5504, delivery 626 8th Avenue, Olympia, WA 98504, e-mail arc@hca.wa.gov, fax (360) 586-9727, by 5:00 p.m. on May 26, 2015.
Assistance for Persons with Disabilities: Contact Kelly Richters by May 19, 2015, TTY (800) 848-5429 or (360) 725-1307 or e-mail kelly.richters@hca.wa.gov.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The agency is filing rules to clarify conditions for the dispensing and use of nonpreferred generic drugs.
Reasons Supporting Proposal: These revisions will improve clarity for the reader.
Statutory Authority for Adoption: RCW 41.05.021, 41.05.160.
Statute Being Implemented: RCW 41.05.021, 41.05.160.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: HCA, governmental.
Name of Agency Personnel Responsible for Drafting: Melinda Froud, P.O. Box 42716, Olympia, WA 98504-2716, (360) 725-1408; Implementation and Enforcement: Charles Agte, P.O. Box 45506, Olympia, WA 98504-5506, (360) 725-1301.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The agency has determined that the proposed filing does not impose a disproportionate cost impact on small businesses or nonprofits.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to HCA rules unless requested by the joint administrative rules review committee or applied voluntarily.
April 21, 2015
Jason R. P. Crabbe
Rules Coordinator
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-530-4100 Washington preferred drug list (PDL).
Under RCW 69.41.190 and 70.14.050, the ((department)) medicare agency and other state agencies cooperate in developing and maintaining the Washington preferred drug list (PDL).
(1) Washington state contracts with evidence-based practice center((())s(())) for systematic drug 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)) an 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)) 182-530-4150.
(6) Drugs in a drug class on the Washington PDL that have not been studied by ((the)) an 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)) agency 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)) agency-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)) an 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)) agency 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)) Food and Drug Administration's approved drug products with therapeutic equivalence evaluations (orange book).
(12) The dispensing of a brand name or nonpreferred generic 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))) 182-530-4125 and 182-530-4150(10).
AMENDATORY SECTION (Amending WSR 11-14-075, filed 6/30/11, effective 7/1/11)
WAC 182-530-4125 Generics first for a client's first course of treatment.
The ((department)) medicaid agency uses point-of-sale (POS) claim messaging to ((communicate to)) tell pharmacies to use a preferred generic drug for the client's first course of treatment in specific drug classes.
(1) The ((department)) agency may require preferred generic drug((())s(())) on the Washington preferred drug list (PDL) be used before any brand name or nonpreferred generic 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)) 182-530-4000 has reviewed the drug class and recommended to the ((department)) agency 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)) agency that 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)) 182-500-0070.
|