PROPOSED RULES
SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)
Original Notice.
Preproposal statement of inquiry was filed as WSR 07-04-017.
Title of Rule and Other Identifying Information: Part 4 of 4: WAC 388-530-7200 Reimbursement -- Out-of-state prescriptions, 388-530-7250 Reimbursement -- Miscellaneous, 388-530-7300 Reimbursement -- Requesting a change, 388-530-7350 Reimbursement -- Unit does drug delivery, 388-530-7400 Reimbursement -- Compliance packaging services, 388-530-7500 Reimbursement -- Drug rebate requirement, 388-530-7600 Reimbursement -- Clients enrolled in managed care, 388-530-7700 Reimbursement -- Dual eligible clients/medicare, 388-530-7800 Reimbursement -- Clients with third party liability, 388-530-7900 Drugs purchased under the Public Health Service (PHS) Act, 388-530-8000 Reimbursement method -- Estimated acquisition cost (EAC), 388-530-8050 Reimbursement -- Federal upper limit (FUL), 388-530-8100 Reimbursement -- Maximum allowable cost (MAC), and 388-530-8150 Reimbursement -- Automated maximum allowable cost (AMAC).
Hearing Location(s): Blake Office Park East, Rose Room, 4500 10th Avenue S.E., Lacey, WA 98503 (one block north of the intersection of Pacific Avenue S.E. and Alhadeff Lane. A map or directions are available at http://www1.dshs.wa.gov/msa/rpau/docket.html or by calling (360) 664-6097), on June 26, 2007, at 10:00 a.m.
Date of Intended Adoption: Not earlier than June 27, 2007.
Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504, delivery 4500 10th Avenue S.E., Lacey, WA 98503, e-mail schilse@dshs.wa.gov, fax (360) 664-6185, by 5:00 p.m. on June 26, 2007.
Assistance for Persons with Disabilities: Contact Stephanie Schiller by June 19, 2007, TTY (360) 664-6178 or (360) 664-6097 or by e-mail at schilse@dshs.wa.gov.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The health and recovery services administration (HRSA) is amending chapter 388-530 WAC, Pharmacy services. A complete reorganization of the pharmacy chapter was necessary prior to the implementation of the new ProviderOne point-of-sale system and also to be in compliance with the reimbursement changes mandated by the Centers for Medicare/Medicaid Services (CMS) regarding the new FUL, AMP, and ASP pricing. Changes include:
| • | Organizing the sections in a logical order; |
| • | Removing redundant or outdated sections; |
| • | Clarifying the existing language; |
| • | Adding information on Medicare Part D, managed care, and dual eligible clients; |
| • | Eliminating circular references; |
| • | Updating WAC references. |
Reasons Supporting Proposal: See above.
Statutory Authority for Adoption: RCW 74.08.090.
Statute Being Implemented: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of social and health services, health and recovery services administration, governmental.
Name of Agency Personnel Responsible for Drafting: Wendy Boedigheimer, P.O. Box 45504, Olympia, WA 98504-5504, (360) 725-1306; Implementation and Enforcement: 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 businesses affected by them. The preparation of a comprehensive SBEIS is not required.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Siri Childs, P.O. Box 45506, Health and Recovery Service Administration, Olympia, WA 98504-5506, phone (360) 725-1564, fax (360) 586-9727.
May 16, 2007
Stephanie E. Schiller
Rules Coordinator
3875.1(a) Contracts with the department to be an enrolled provider; and
(b) Meets the same criteria the department requires for in-state pharmacy providers.
(2) The department considers pharmacies located in bordering areas listed in WAC 388-501-0175 the same as in-state pharmacies.
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(1) The department reimburses for drugs administered or prepared and delivered for individual use by an authorized prescriber during an office visit according to specific program rules found in:
(a) Chapter 388-531 WAC, Physician-related services;
(b) Chapter 388-532 WAC, Reproductive Health/Family Planning Only/TAKE CHARGE; and
(c) Chapter 388-540 WAC, Kidney services.
(2) Providers who are purchasers of Public Health Services (PHS) discounted drugs must comply with PHS 340b program requirements. (See WAC 388-530-7900).
(3) The department may request providers to submit a current invoice for the actual cost of the drug, device, or pharmaceutical supply billed. If an invoice is requested, the invoice must show the:
(a) Name of the drug, device, or pharmaceutical supply;
(b) Drug or product manufacturer;
(c) NDC of the product(s);
(d) Drug strength;
(e) Product description;
(f) Quantity; and
(g) Cost, including any free goods associated with the invoice.
(4) The department does not reimburse providers for the cost of vaccines obtained through the state department of health (DOH). The department does pay physicians, advanced registered nurse practitioners (ARNP), and pharmacists a fee for administering the vaccine.
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(1) The availability of lower cost equivalents in the marketplace is severely curtailed and the price disparity between AAC for the drug and the MAC reimbursement affects clients' access; and
(2) An invoice documenting actual acquisition cost relevant to the date the drug was dispensed is provided to the department.
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(2) Unit dose delivery systems may be either true or modified unit dose.
(3) The department pays pharmacies that provide unit dose delivery services the department's highest allowable dispensing fee for each unit dose prescription dispensed to clients in nursing facilities. The department reimburses ingredient costs for drugs under unit dose systems as described in WAC 388-530-7000.
(4) The department pays a pharmacy that dispenses drugs in bulk containers or multidose forms to clients in nursing facilities the regular dispensing fee applicable to the pharmacy's total annual prescription volume tier. Drugs the department considers not deliverable in unit dose form include, but are not limited to, liquids, creams, ointments, ophthalmic and otic solutions. The department reimburses ingredient costs as described in WAC 388-530-7000.
(5) The department pays a pharmacy that dispenses drugs prepackaged by the manufacturer in unit dose form to clients in nursing facilities the regular dispensing fee applicable under WAC 388-530-7050. The department reimburses ingredient costs for drugs prepackaged by the manufacturer in unit dose form as described in WAC 388-530-7000.
(6) The department limits its coverage and payment for manufacturer-designated unit dose packaging to the following conditions:
(a) The drug is a single source drug and a multidose package for the drug is not available;
(b) The drug is a multiple source drug but there is no other multidose package available among the drug's generic equivalents; or
(c) The manufacturer-designated unit dose package is the most cost-effective package available or it is the least costly alternative form of the drug.
(7) The department reimburses a pharmacy provider for manufacturer-designated unit dose drugs dispensed to clients not residing in nursing facilities only when such drugs:
(a) Are available in the marketplace only in manufacturer-designated unit dose packaging; and
(b) Would otherwise be covered as an outpatient drug. The unit dose dispensing fee does not apply in such cases. The department pays the pharmacy the dispensing fee applicable to the pharmacy's total annual prescription volume tier.
(8) The department may pay for unit dose delivery systems for clients of the division of developmental disabilities (DDD) residing in approved community living arrangements.
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(a) Have one or more of the following representative disease conditions:
(i) Alzheimer's disease;
(ii) Blood clotting disorders;
(iii) Cardiac arrhythmia;
(iv) Congestive heart failure;
(v) Depression;
(vi) Diabetes;
(vii) Epilepsy;
(viii) HIV/AIDS;
(ix) Hypertension;
(x) Schizophrenia; or
(xi) Tuberculosis.
(b) Concurrently consume two or more prescribed medications for chronic medical conditions, that are dosed at three or more intervals per day; or
(c) Have demonstrated a pattern of noncompliance that is potentially harmful to the client's health. The client's pattern of noncompliance with the prescribed drug regimen must be fully documented in the provider's file.
(2) Compliance packaging services include:
(a) Reusable hard plastic containers of any type (e.g., medisets); and
(b) Nonreusable compliance packaging devices (e.g., blister packs).
(3) The department pays a filling fee and reimburses pharmacies for the compliance packaging device and/or container. The frequency of fills and number of payable compliance packaging devices per client is subject to limits specified by the department. The department does not pay filling or preparation fees for blister packs.
(4) Pharmacies must use the CMS-1500 claim form to bill the department for compliance packaging services.
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(2) The fill date must be within the manufacturer's beginning and ending eligibility dates to be reimbursed by the department.
(3) The department may extend this rebate requirement to any outpatient drug reimbursements as allowed or required by federal law.
(4) The department may exempt drugs from the rebate requirement, on a case-by-case basis, when:
(a) It determines that the availability of a single source drug or innovator multiple source drug is essential to the health of beneficiaries; and
(b) All other rebate exemption requirements of SSA Sec 1927 (42 U.S.C. 1396r-8) (3) are also satisfied.
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(1) Medicare Part B, the department pays providers for:
(a) An amount up to the department's maximum allowable fee for drugs medicare does not cover, but the department covers; or
(b) Deductible and/or coinsurance amounts up to medicare's or the department's maximum allowable fee, whichever is less, for drugs medicare and the department cover; or
(c) Deductible and/or coinsurance amounts for clients under the qualified medicare beneficiary (QMB) program for drugs medicare covers but the department does not cover.
(2) Medicare Part D:
(a) For payment of medicare Part D drugs:
(i) Medicare is the primary payer for covered Part D drugs;
(ii) The department pays only the copayment up to a maximum amount set by the centers for medicare and medicaid services (CMS); and
(iii) The client is responsible for copayments above the maximum amount.
(b) For drugs excluded from the basic medicare Part D benefits:
(i) The department offers the same drug benefit as a non-dual eligible client has within those same classes;
(ii) If the client has another third party insurer, that insurer is the primary payer; and
(iii) The department is the payer of last resort.
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(2) The following definitions apply to this section:
(a) "Closed pharmacy network" means an arrangement made by an insurer which restricts prescription coverage to an exclusive list of pharmacies. This arrangement prohibits the coverage and/or payment of prescriptions provided by a pharmacy that is not included on the exclusive list.
(b) "Private point-of-sale (POS) authorization system" means an insurer's system, other than the department's POS system, which requires that coverage be verified by or submitted to the insurer for authorization at the time of service and at the time the prescription is filled.
(3) This subsection applies to clients who have a third-party resource that is a managed care entity other than a department-contracted plan, or have other insurance that requires the use of "closed pharmacy networks" or "private point-of-sale authorization system." The department will not pay pharmacies for prescription drug claims until the pharmacy provider submits an explanation of benefits from the private insurance demonstrating that the pharmacy provider has complied with the terms of the third-party's coverage.
(a) If the private insurer pays a fee based on the incident of care, the pharmacy provider must file a claim with the department consistent with the department's billing requirements.
(b) If the private insurer pays the pharmacy provider a monthly capitation fee for all prescription costs related to the client, the pharmacy provider must submit a claim to the department for the amount of the client copayment, coinsurance, and/or deductible. The department pays the provider the lesser of:
(i) The billed amount; or
(ii) The department's maximum allowable fee for the prescription.
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(2) Providers dispensing drugs under this section are required to submit their valid medical assistance provider number(s) to the PHS health resources and services administration, office of pharmacy affairs. This requirement is to ensure that claims for drugs dispensed under this section and paid by the department are excluded from the drug rebate claims that are submitted to the manufacturers of the drugs. See WAC 388-530-7500 for information on the drug rebate program.
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REIMBURSEMENT METHODOLOGY(a) Acquisition cost data made available to the department; or
(b) Information provided by any of the following:
(i) Audit agencies, federal or state;
(ii) Other state health care purchasing agencies;
(iii) Pharmacy benefit managers;
(iv) Individual pharmacy providers participating in the department's programs;
(v) Centers for medicare and medicaid services (CMS);
(vi) Other third party payers;
(vii) Drug file databases; and/or
(viii) Actuaries or other consultants.
(2) The department implements EAC by applying a percentage adjustment to available reference pricing from national sources such as wholesale acquisition cost (WAC), average wholesale price (AWP), average sale price (ASP), and average manufacturer price (AMP).
(3) The department may set EAC for specified drugs or drug categories at a percentage other than that determined in subsection (1)(a) of this section when the department considers it necessary. The factors the department considers in setting a rate for a class of drugs under this subsection include, but are not limited to:
(a) Product acquisition cost;
(b) The department's documented clinical concerns; and
(c) The department's budget limits.
(4) The department bases EAC drug reimbursement on the actual package size dispensed.
(5) The department uses the EAC as the department's reimbursement for a drug when the EAC is the lowest of the rates calculated under the methods listed in WAC 388-530-7000, or when the conditions of WAC 388-530-7300 are met.
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(2) The department's maximum payment for multiple-source drugs for which CMS has set FULs will not exceed, in the aggregate, the prescribed upper limits plus the dispensing fees set by the department.
(3) Except as provided in WAC 388-530-7300, the department uses the FUL as the department's reimbursement rate for the drug when the FUL price is the lowest of the rates calculated under the methods listed in WAC 388-530-7000.
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(2) The department determines the MAC for a multiple-source drug:
(a) When drug acquisition cost data is available, the department:
(i) Identifies what products are available from wholesalers for each drug being considered for MAC pricing;
(ii) Determines pharmacy providers' approximate acquisition costs for these products; and
(iii) Establishes the MAC at a level which gives pharmacists access to at least one product from a manufacturer with a qualified rebate agreement (see WAC 388-530-7500(4)).
(b) When drug acquisition cost data is not available, the department may estimate acquisition cost.
(3) The MAC established for a multiple-source drug does not apply if the written prescription identifies that a specific brand is medically necessary for a particular client. In such cases, the estimated acquisition cost (EAC) for the particular brand applies, provided authorization is obtained from the department as specified under WAC 388-530-3000.
(4) Except as provided in subsection (3) of this section, the department reimburses providers for a multiple-source drug at the lowest of the rates calculated under the methods listed in WAC 388-530-7000.
(5) The MAC established for a multiple-source drug may vary by package size, including those identified as unit dose national drug codes (NDCs) by the manufacturer(s) of the drug.
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(a) Not on the published maximum allowable cost (MAC); and
(b) Produced by two or more manufacturers/labelers, at least one of which must have a current, signed federal drug rebate agreement.
(2) The department establishes AMAC as a specified percentage of the published average wholesale price (AWP). The department may use different percentage discounts from AWP for the estimated acquisition cost (EAC) and AMAC.
(3) The department sets the percentage discount from AWP for AMAC reimbursement using any of the information sources identified in WAC 388-530-8000.
(4) The department may set AMAC reimbursement at different percentage discounts from AWP for different multiple source drugs. The department considers the same factors as those in WAC 388-530-8000.
(5) AMAC reimbursement for all products with the same ingredient, form and strength is at the AMAC determined for the second lowest priced product, or the AMAC of the lowest priced drug from a manufacturer with a current, signed federal rebate agreement.
(6) The department recalculates AMAC each time the drug file contractor provides a pricing update.
(7) Except as provided in WAC 388-530-7300, the department reimburses at the lowest of the rates calculated under the methods listed in WAC 388-530-7000.
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The following sections of the Washington Administrative Code are repealed:
| WAC 388-530-1100 | Covered drugs, devices, and pharmaceutical supplies. |
| WAC 388-530-1125 | Drug rebate program. |
| WAC 388-530-1150 | Noncovered drugs and pharmaceutical supplies and reimbursement limitations. |
| WAC 388-530-1200 | Prior authorization program. |
| WAC 388-530-1250 | Prior authorization process. |
| WAC 388-530-1260 | Therapeutic consultation service. |
| WAC 388-530-1270 | Mail-order services. |
| WAC 388-530-1280 | Preferred drug list(s). |
| WAC 388-530-1290 | Therapeutic interchange program (TIP). |
| WAC 388-530-1300 | General reimbursement methodology. |
| WAC 388-530-1350 | Estimated acquisition cost (EAC) methodology. |
| WAC 388-530-1360 | Certified average wholesale price (CAWP). |
| WAC 388-530-1400 | Maximum allowable cost (MAC) methodology. |
| WAC 388-530-1405 | Automated maximum allowable cost (AMAC). |
| WAC 388-530-1410 | Federal upper limit (FUL) methodology. |
| WAC 388-530-1425 | Payment methodology for drugs purchased under the Public Health Service (PHS) Act. |
| WAC 388-530-1450 | Dispensing fee determination. |
| WAC 388-530-1500 | Reimbursement for compounded prescriptions. |
| WAC 388-530-1550 | Unit dose drug delivery systems. |
| WAC 388-530-1600 | Unit dose pharmacy billing requirements. |
| WAC 388-530-1625 | Compliance packaging services. |
| WAC 388-530-1650 | Reimbursement for pharmaceutical supplies. |
| WAC 388-530-1700 | Drugs and drug-related supplies from nonpharmacy providers. |
| WAC 388-530-1750 | Drugs and pharmaceutical supplies for clients with any third-party coverage. |
| WAC 388-530-1800 | Requirements for pharmacy claim payment. |
| WAC 388-530-1850 | Drug use review (DUR) board. |
| WAC 388-530-1900 | Drug use and claims review. |
| WAC 388-530-1950 | Point-of-sale (POS) system/prospective drug use review (Pro-DUR). |
| WAC 388-530-2050 | Reimbursement for out-of-state prescriptions. |