Preproposal statement of inquiry was filed as WSR 07-10-069.
Title of Rule and Other Identifying Information: WAC 182-50-005 Definitions and 182-50-200 Endorsing practitioner therapeutic interchange program; effect of practitioner's endorsing status; dispense as written instructions.
Hearing Location(s): Health Care Authority, The Sue Crystal Center, 676 Woodland Square Loop S.E., Olympia, WA 98504, on September 11, 2007, at 9:00 a.m.
Date of Intended Adoption: September 12, 2007.
Submit Written Comments to: Duane Thurman, Health Care Authority, Mailstop TB-51, 1511 Third Avenue, Suite 202, Seattle, WA 98101, e-mail email@example.com, fax (206) 521-2001, by 5:00 p.m., September 11, 2007.
Assistance for Persons with Disabilities: Contact Nikki Johnson by August 28, 2007, TTY (888) 923-5622 or (360) 923-2805.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this proposal is to revise WAC 182-50-005(9) and 182-50-200 (1)(b) to include "the refill of a 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" as a basis for exemption from preferred drug substitution as required by RCW 69.41.180.
Reasons Supporting Proposal: To incorporate amendments to RCW 69.41.180 created by SSB 5838 (chapter 233, Laws of 2006).
Statutory Authority for Adoption: RCW 41.05.160.
Statute Being Implemented: RCW 69.41.180.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Duane Thurman, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Duane Thurman, Mailstop TB-51, 1511 Third Avenue, Suite 201, Seattle, WA 98101, (206) 521-2036.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The joint administrative rules review committee has not requested the filing of a small business economic impact statement, and there will be no costs to small businesses.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to the health care authority rules unless requested by the joint administrative rules [review] committee or applied voluntarily.
June 26, 2007
AMENDATORY SECTION(Amending Order 03-02, filed 2/23/04, effective 3/25/04)
WAC 182-50-005 Definitions. When used in this chapter:
(1) "Appointing authority" shall mean the following persons acting jointly: The administrator of the health care authority, the secretary of the department of social and health services, and the director of the department of labor and industries.
(2) "Committee" means the independent Washington state pharmacy and therapeutics committee created by RCW 41.05.021 (1)(a)(iii) and 70.14.050. At the election of the department of social and health services, the committee may serve as the drug use review board provided for in WAC 388-530-1850.
(3) "Drug" means the term as it is defined in RCW 69.41.010 (9) and (12).
(4) "Endorsing practitioner" means a practitioner who has reviewed the preferred drug list and has notified the health care authority that he or she has agreed to allow therapeutic interchange of a preferred drug for any nonpreferred drug in a given therapeutic class.
(5) "Practitioner" means a health care provider, except a veterinarian, as defined at RCW 18.64.011(9).
(6) "Preferred drug" means a drug selected by the appointing authority for inclusion in the preferred drug list used by applicable state agencies for state purchased health care programs.
(7) "Preferred drug list" or "PDL" means the list of drugs selected by the appointing authority to be used by applicable state agencies as the basis for the purchase of drugs in state purchased health care programs.
(8) "Prescription" has the meaning set forth in RCW 18.64.011(8).
(9) "Refill" means the continuation of therapy with the same drug (including the renewal of a previous prescription or adjustments in dosage) when a prescription is for an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug, or for the refill of a 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.
(10) "State purchased health care" has the meaning set forth in RCW 41.05.011(2).
(11) "Therapeutic alternatives" are drug products of different chemical structure within the same pharmacologic or therapeutic class and that are expected to have similar therapeutic effects and safety profiles when administered in therapeutically equivalent doses.
(12) "Therapeutic interchange" means to dispense, with the endorsing practitioner's authorization, a therapeutic alternative to the prescribed drug.
[Statutory Authority: RCW 41.05.160; 2004 1st sp.s. c 29 § 10. 04-06-021 (Order 03-02), § 182-50-005, filed 2/23/04, effective 3/25/04.]
(a) If the endorsing practitioner determines the nonpreferred drug is medically necessary by indicating "dispense as written" on the prescription; or
(b) If the prescription is a refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug, or for the refill of a 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.
(2) When a therapeutic interchange is made, the pharmacist shall notify the endorsing practitioner of the specific drug and dose dispensed.
(3) When a nonendorsing practitioner issues a prescription for a drug not included in the preferred drug list, the pharmacist shall dispense the prescribed drug in accordance with the requirements of RCW 69.41.100 through 69.41.180.
[Statutory Authority: RCW 41.05.160; 2004 1st sp.s. c 29 § 10. 04-06-021 (Order 03-02), § 182-50-200, filed 2/23/04, effective 3/25/04.]