Date of Adoption: December 7, 2000.

Purpose: To update and clarify MAA's prescription drug program policy to reflect current department practice. The amended sections reflect clearly written and updated policy that is consistent with federal regulations and agency goals.

Citation of Existing Rules Affected by this Order: Amending WAC 388-530-1000, 388-530-1050, 388-530-1100, 388-530-1150, 388-530-1200, 388-530-1250, 388-530-1850, 388-530-1900, 388-530-1950, and 388-530-2050.

Statutory Authority for Adoption: RCW 74.08.090, 74.04.050.

Adopted under notice filed as WSR 00-17-080 on August 14, 2000.

Changes Other than Editing from Proposed to Adopted Version: (Text additions are indicated by underlining and deletions are indicated by strikeouts.)

WAC 388-530-1050:

DESI" or "Less than effective drug" or "DESI" means a drug for which:... (changed order of terms being defined and moved to correct alphabetical order)

"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 pricing file contractor," also referred to as "drug pricing file contractor, means the entity which....

"Drug formulary" means a list of MAA-covered outpatient drugs not requiring prior authorization.

"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.

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

"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.

"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.

WAC 388-550-1100:

(1) …Covered drugs and supplies include:

(b) Over-the-counter (OTC) drugs when the drug is:

(i) Is a less costly therapeutic alternative; and

(ii) Formulary Does not require prior authorization.

(c) Nonformulary drugs Drugs requiring prior authorization when: …

(ii) They meet MAA's published expedited prior authorization criteria and follow the process described defined in WAC 388-530-1250(4) 1050.

(2) MAA determines if certain drugs are medically necessary and covered with or without…

WAC 388-530-1150:

(1)(c) The medical assistance administration (MAA) does not cover: … (c) OTC drugs/supplies, unless approved for formulary use, described under WAC 388-530-1100 (1)(b), or for family planning as described under chapter 388-532 WAC.

(1)(e) A drug prescribed for an indication that is not medically accepted evidence based as determined by:

(1)(h)(ii) Prescribed for non-FDA approved indications or dosing unless prior authorized; or

WAC 388-530-1200:

Drug formulary. Prior authorization program.

(1) The medical assistance administration (MAA) pharmacy research specialist, medical consultants, and an advisory board evaluate drugs for formulary inclusion, MAA's drug utilization review team evaluate drugs to determine prior authorization status on the drug file, and may consult with the Drug Utilization and Education (DUE) Council, and/or participating MAA providers.

(2) To request consideration to include a drug product in MAA's drug formulary, a drug manufacturer must send the To facilitate the evaluation process for a drug product, a drug manufacturer may send the pharmacy research specialist a written request and the following supporting documentation:

(3) The criteria used to determine whether to include or exclude a drug from MAA's formulary include, but are not limited to, an evaluation of whether: Evaluation of a drug includes, but is not limited to, the following criteria:

(a) There is a federal drug rebate contract agreement signed by the manufacturer;

(b) There are like drugs already on the formulary The drug is a less-than-effective drug;

(c) The drug has a favorable risk/benefit ratio;

(d) The drug is a less-than-effective drug The drug file status of:

(i) Like drugs; and

(ii) Less costly therapeutic alternative drugs;

(a) The drug falls into one of the categories authorized by federal law to be excluded from coverage; and

(f) There are less costly therapeutic alternative drugs already on the formulary; and The drug has a potential for abuse.

(g) The drug has a potential for abuse.

(4) MAA does not require prior approval for drug preparations listed in the MAA drug formulary. MAA updates and reviews the formulary list drug file list as necessary, and publishes the list periodically publishes a list of drugs not requiring prior authorization.

(5) Manufacturers may seek review of formulary decisions the drug file status by writing to the MAA medical director.

WAC 388-530-1250:

Prior authorization process.

(1)(a) MAA requires pharmacies to obtain prior authorization for: (a) Nonformulary drugs; Drugs with a prior authorization indicator on the drug file;

(6) MAA provides a response to a request pays for drugs requiring prior authorization by telephone or other telecommunication device within twenty-four hours if the request is received during normal state business hours. If a provider needs prior authorization to dispense a drug during a weekend or Washington state holiday, the provider may dispense the drug that are dispensed without prior authorization only when:

(a) Given in an emergency;

(b) MAA receives 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.

WAC 388-530-1850:

Drug Utilization and Education (DUE) Council.

MAA establishes a Drug Utilization and Education (DUE) Council (DUEC) and determines membership rotations.

(1) The DUEC DUE Council must:

(2) The DUEC DUE Council meets periodically to:

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 10, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 10, 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 0, Amended 10, Repealed 0. Effective Date of Rule: Thirty-one days after filing.

December 7, 2000

Marie Myerchin-Redifer, Manager

Rules and Policies Assistance Unit

Reviser's note: The material contained in this filing exceeded the page-count limitations of WAC 1-21-040 for appearance in this issue of the Register. It will appear in the 01-02 issue of the Register.

Washington State Code Reviser's Office