Source: http://lawfilesext.leg.wa.gov/law/wsr/2008/15/08-15-007.htm
Timestamp: 2020-04-08 06:41:27
Document Index: 667063568

Matched Legal Cases: ['§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388', '§ 388']

WSR 08-15-007
[ Filed July 3, 2008, 3:24 p.m. ]
Preproposal statement of inquiry was filed as WSR 08-10-109.
Title of Rule and Other Identifying Information: Chapter 388-530 WAC, Outpatient drug program.
5 p.m. on August 26, 2008.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule will improve provider community understanding about the outpatient drug program, setting the limitations to the expansion of the smoking cessation benefit. The proposed rule will also explain elements of the over-the-counter (OTC) coverage that answer small clarifying questions that the department receives from the pharmacy provider community. The following is a list of the proposed changes to chapter 388-530 WAC:
• Expand the smoking cessation benefit.
• Correct typographical and grammatical errors.
• Reinstate and clarify rules for vitamin and mineral coverage which were inadvertently omitted from the previous pharmacy WAC revision.
• Reinstate and clarify rules for OTC coverage, which were inadvertently omitted from the previous pharmacy WAC revision.
• Clarify (broaden) fluoride coverage, including age of children receiving fluoride.
• Remove reference to the prior authorization requirements for the number of brand name drugs filled in a calendar month because the therapeutic consultation service has been eliminated.
• Include combination drugs in the Washington PDL that have been studied by the evidence-based practice center and have been reviewed by the P&T committee.
• Clarify that some preferred drugs may require prior authorization or have specific limitations and still be subject to the therapeutic interchange program.
Reasons Supporting Proposal: The department continues to support transparent outpatient drug program rules.
Statute Being Implemented: RCW 74.09.700, chapter 245, Laws of 2008 (SB 6421).
Name of Agency Personnel Responsible for Drafting: Jonell O. Blatt, P.O. Box 45504, Olympia, WA 988504-5504 [98504-5504], (360) 725-1571; Implementation and Enforcement: Dr. Siri Childs, P.O. Box 45506, Olympia, WA 98504-5506, (360) 725-1564.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule and concluded that no new costs will be imposed on small business affected by the rule changes. Therefore, the preparation of a comprehensive small business economic impact statement is not required under RCW 19.85.030.
A cost-benefit analysis is not required under RCW 34.05.328. Under RCW 34.05.328 (5)(b), a cost-benefit analysis is not required for all proposed significant legislative rules when the rules have only housekeeping changes (typographical errors, address or name changes, or clarification of existing rule language), and when the rules have content dictated by statute.
WAC 388-530-1000 Outpatient drug program--General. (1) The purpose of the outpatient drug program is to ((pay)) reimburse providers for outpatient drugs, vitamins, minerals, devices, and drug-related supplies according to department rules and subject to the limitations and requirements in this chapter.
(2) The department reimburses for outpatient drugs, vitamins, minerals, devices, and pharmaceutical supplies that are:
(a) Covered. Refer to WAC 388-530-2000 for covered drugs, vitamins, minerals, devices, and drug-related supplies and to WAC 388-530-2100 for noncovered drugs and drug-related supplies;
(b) Prescribed by a provider with ((prescribing)) prescriptive authority (see exceptions for family planning and emergency contraception for ((woman [women])) women eighteen years of age and older in WAC 388-530-2000 (1)(b), and over-the-counter (OTC) drugs to promote smoking cessation in WAC 388-530-2000 (1)(a)(v);
(c) Within the scope of an eligible client's medical assistance program;
(d) Medically necessary as defined in WAC 388-500-0005 and determined according to the process found in WAC 388-501-0165; and
(e) Authorized, as required within this chapter;
(3) Coverage determinations are decided by the department:
(a) According to federal guidelines;
(b) In consultation with the drug use review (DUR board); or
(c) As recommended by the department's medical consultants and the department's pharmacists.
(4) The department may not ((pay)) reimburse for prescriptions written by healthcare practitioners whose application for a core provider agreement (CPA) has been denied, or whose CPA has been terminated.
(((4))) (5) The department may not ((pay)) reimburse for prescriptions written by non-CPA healthcare practitioners who do not have a current core provider agreement with the department when the department determines there is a potential danger to the client's health and/or safety.
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-1000, filed 9/26/07, effective 11/1/07; 06-24-036, § 388-530-1000, filed 11/30/06, effective 1/1/07. Statutory Authority: RCW 74.09.080, 74.04.050 and 42 C.F.R. Subpart K, subsection 162.1102. 02-17-023, § 388-530-1000, filed 8/9/02, effective 9/9/02. Statutory Authority: RCW 74.08.090, 74.04.050. 01-01-028, § 388-530-1000, filed 12/7/00, effective 1/7/01. Statutory Authority: RCW 74.08.090. 96-21-031, § 388-530-1000, filed 10/9/96, effective 11/9/96.]
WAC 388-530-1050 Definitions. In addition to the definitions and abbreviations found in WAC 388-500-0005, Medical definitions, the following definitions apply to this chapter.
"Active ingredient" - The chemical component of a drug responsible for a drug's prescribed/intended therapeutic effect. The department limits coverage of active ingredients to those with an eleven-digit national drug code (NDC) and those specifically authorized by the department.
"Actual acquisition cost (AAC)" - The net cost a provider paid for a drug, device, or drug-related supply marketed in the package size purchased. The ((ACC)) AAC includes discounts, rebates, charge backs and other adjustments to the price of the drug, device or drug-related supply, but excludes dispensing fees.
"Appointing authority" - For the evidence-based prescription drug program of the participating agencies in the state-operated health care programs, the following persons acting jointly: The administrator of the health care authority (HCA), the secretary of the department of social and health services (DSHS), and the director of the department of labor and industries (L&I).
"Automated authorization" - Adjudication of claims using submitted NCPDP data elements or claims history to verify that the department's authorization requirements have been satisfied without the need for the department to request additional clinical information.
"Automated maximum allowable cost (AMAC)" - The rate established by the department for a multiple-source drug that is not on the maximum allowable cost (MAC) list and that is designated by two or more products at least one of which must be under a federal drug rebate contract.
"Average wholesale price (AWP)" - The average price of a drug product that is calculated from wholesale list prices nationwide at a point in time and reported to the department by the department's drug file contractor.
"Dispensing fee" - The fee the department sets to pay pharmacy providers for dispensing department-covered prescriptions. The fee is the department's maximum reimbursement for expenses involved in the practice of pharmacy and is in addition to the department's reimbursement for the costs of covered ingredients.
"Drug file" - A list of drug products, pricing and other information provided to the department and maintained by a drug file contractor.
"Estimated acquisition cost (EAC)" - The department's estimate of the price providers generally and currently pay for a drug marketed or sold by a particular manufacturer or labeler.
"Evidence-based" and "evidenced-based medicine (EBM)" - The application of a set of principles and a method for the review of well-designed studies and objective clinical data to determine the level of evidence that proves to the greatest extent possible, that a healthcare service is safe, effective and beneficial when making population-based coverage policies or individual medical necessity decisions.
"Four brand name prescriptions per calendar month limit" - The maximum number of paid prescription claims for brand name drugs that the department allows for each client in a calendar month without a complete review of the client's drug profile.
"Maximum allowable cost (MAC)" - The maximum amount that the department reimburses for a drug, device, or drug-related supply.
"Point-of-sale (POS)" - A pharmacy claims processing system capable of receiving and adjudicating claims on-line.
"Terminated NDC" - [a] An eleven-digit national drug code (NDC) that is discontinued by the manufacturer for any reason. The NDC may be terminated immediately due to health or safety issues or it may be phased out based on the product's shelf life.
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-1050, filed 9/26/07, effective 11/1/07. Statutory Authority: RCW 74.08.090, 70.14.050, 69.41.150, 69.41.190, chapter 41.05 RCW. 05-02-044, § 388-530-1050, filed 12/30/04, effective 1/30/05. Statutory Authority: RCW 74.09.080, 74.04.050 and 42 C.F.R. Subpart K, subsection 162.1102. 02-17-023, § 388-530-1050, filed 8/9/02, effective 9/9/02. Statutory Authority: RCW 74.08.090, 74.04.050. 01-24-066, § 388-530-1050, filed 11/30/01, effective ½/02; 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.]
WAC 388-530-3000 When the department requires authorization. Pharmacies must obtain authorization for covered drugs, devices, or drug-related supplies in order to receive reimbursement as described in this section.
(a) Have determined that authorization for the drug, device, or drug-related supply is required, as described in WAC 388-530-3100; or
(2) The drug, device, or drug-related supply is in the therapeutic drug class on the Washington preferred drug list and the product is one of the following:
(ii) The drug is designated as exempt from the therapeutic interchange program per WAC 388-530-4100(6) or 388-530-4150 (2)(c);
(3) For the purpose of promoting safety, efficacy, and effectiveness of drug therapy, the department identifies clients or groups of clients who would benefit from further clinical review.
(4) The department designates the prescriber(s) as requiring authorization because the prescriber(s) is under department review or is sanctioned for substandard quality of care.
(f) ((Number of brand prescriptions filled per calendar month; and
(g))) Number of prescriptions filled per month in total or by therapeutic drug class.
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-3000, filed 9/26/07, effective 11/1/07.]
(f) The least costly therapeutically equivalent alternative ((between two or more products of equal effectiveness)).
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-3200, filed 9/26/07, effective 11/1/07.]
(10) Combination drugs ((are not on the Washington PDL and are considered for authorization according to WAC 388-530-3100)) that have been studied by the evidence-based practice center and have reviewed by the P&T committee may be included in the Washington PDL.
[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.]
(a) ((To drugs that require authorization;
(c))) When the pharmacy and therapeutics (P&T) committee determines that TIP does not apply to the therapeutic class on the PDL; or
(((d))) (b) To a drug prescribed by a nonendorsing practitioner.
[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.]
(iii) The drug is not excluded from coverage under WAC 388-530-2100; ((and))
(d) Drug-related devices and drug-related supplies as an outpatient pharmacy benefit when:
(f) Over-the-counter (OTC) drugs, without a prescription, to promote smoking cessation only for clients who are eighteen years of age or older and participating in a department-approved smoking cessation program. Limitation extensions as described in WAC 388-501-0169 are prohibited for the age and counseling requirements in this section.
(g) Prescription drugs to promote smoking cessation only for clients who are eighteen years of age or older and participating in a department-approved smoking cessation program. Limitation extensions as described in WAC 388-501-0169 are prohibited for the age and counseling requirements in this section.
(3) The department does not reimburse for any drug, device, or drug-related supply not meeting the coverage requirements under this section.
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-2000, filed 9/26/07, effective 11/1/07.]
(iii) For sexual or erectile dysfunction; or
(iv) For cosmetic purposes or hair growth((; or
(v) To promote tobacco cessation, except as described in WAC 388-533-0400(20) tobacco cessation for pregnant women)).
(i) Over-the-counter or prescription drugs to promote smoking cessation unless the client is eighteen years old or older and participating in a department-approved cessation program.
(2) A client can request an exception to rule (ETR) as described in WAC 388-501-0160.
[Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-2100, filed 9/26/07, effective 11/1/07.]