WSR 08-03-110

PROPOSED RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)

[ Filed January 22, 2008, 12:31 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-22-083.

Title of Rule and Other Identifying Information: The department is creating WAC 388-530-1075 Requirements -- Use of tamper resistant prescription pads. The department is adding this rule to comply with federal law that mandates the use of tamper-resistant prescriptions for all medicaid, nonelectronic prescriptions.

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) 664-6094), on February 26, 2008, at 10:00 a.m.

Date of Intended Adoption: Not sooner than February 27, 2008.

Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504-5850, delivery 4500 10th Avenue S.E., Lacey, WA 98503, e-mail DSHSRPAURulesCoordinator@dshs.wa.gov, fax (360) 664-6185, by

5 p.m. on February 26, 2008.

Assistance for Persons with Disabilities: Contact Jennisha Johnson, DSHS Rules Consultant, by February 19, 2008, TTY (360) 664-6178 or (360) 664-6094 or by e-mail at johnsjl4@dshs.wa.gov.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: This rule adopts without material change federal regulations mandated by the adoption of Section 7002(b) of the federal U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (Pub.L.110-28), which amends section 1903(i) of the Social Security Act (42 U.S.C. section 1936b (i)(23)).

Reasons Supporting Proposal: Mandated by federal regulation as outlined above.

Statutory Authority for Adoption: RCW 74.04.050, 74.04.057, 74.08.090, and 74.09.500.

Statute Being Implemented: Section 7002(b), U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (Pub.L.110-28).

Rule is necessary because of federal law, Section 7002(b), U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (Pub.L.110-28).

Name of Proponent: Department of social and health services, governmental.

Name of Agency Personnel Responsible for Drafting: Jonell O. Blatt, 626 8th Avenue, Olympia, WA, (360) 725-1571; Implementation and Enforcement: Phyllis Coolen, 626 8th Avenue, Olympia, WA, (360) 725-1395.

No small business economic impact statement has been prepared under chapter 19.85 RCW. A small business economic impact statement (SBEIS) is not required when adopting rules that simply conform to and/or comply with a federal statute or regulation. Instead, under RCW 19.85.061, a statement is prepared that:

Cites the specific federal statute or regulation under which the rule is conforming; and

Describes the consequences to our state if the rule is not adopted.

RCW 19.85.061 - Prepared statement to explain why no SBEIS is required: The department is merely adopting a federal statute without changing content or incorporating additional state requirements concerning the use of federally implemented tamper-resistant prescriptions. The specific federal statute, which amends section 1903(i) of the Social Security Act (42 U.S.C. section 1936b (i)(23)), states that payment shall not be made for "...amounts expended for medical assistance for covered outpatient drugs (as defined in section 1927 (k)(2)) for which the prescription was executed in written (and nonelectronic) form unless the prescription was executed on a tamper-resistant pad."

A cost-benefit analysis is not required under RCW 34.05.328. This rule is exempt per RCW 34.05.328 (5)(b)(iii). This rule adopts and incorporates, by reference without material change, the adoption of Section 7002(b) of the federal U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007, which amends section 1903(i) of the Social Security Act (42 U.S.C. section 1936b (i)(23)).

January 16, 2008

Stephanie E. Schiller

Rules Coordinator

3944.1
NEW SECTION
WAC 388-530-1075   Requirements-Use of tamper-resistant prescription pads.   (1) The department requires providers to use tamper-resistant prescription pads or paper for written outpatient prescriptions, including over-the-counter drugs, for medical assistance clients.

(2) This requirement applies to all outpatient prescription drugs including:

(a) Prescriptions when Medicaid is primary or secondary payer (including Medicare Part D prescriptions).

(b) Signed hardcopy prescriptions given to a client, whether handwritten or computer-generated.

(3) This requirement does not apply to:

(a) Prescriptions paid for by Washington's healthy options (HO) program or other department contracted managed care organizations.

(b) Prescription drugs that are part of the per diem or bundled rate and not reimbursed separately in designated institutional or clinical settings, such as a nursing facility, ICF/MR, dental office, hospice, or radiology. For example, a morphine prescription used to control a hospice client's cancer pain is covered under the hospice per diem rate and therefore the tamper-resistant prescription requirement is not required.

(c) Telephone, fax or electronic prescriptions.

(d) Refill prescriptions, if the original written prescriptions were presented at a pharmacy before April 1, 2008.

(e) Prescriber or clinic drug samples given directly to the client.

(f) An institutional setting, as defined in WAC 388-500-0005, where the prescriber writes the order into the medical records and the orders go directly to the pharmacy.

(4) Effective April 1, 2008, the tamper-resistant prescription pads and paper must meet at least one of the following industry recognized characteristics:

(a) One or more features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) One or more features designed to prevent the erasure or modification of information written on the prescription by the prescriber; or

(c) One or more features designed to prevent the use of counterfeit prescription forms.

(5) Effective October 1, 2008, the tamper-resistant prescription pads and paper must contain all of the three characteristics in subsection (4) of this section.

(6) If the written prescription is not on tamper-resistant paper, the pharmacy may provide the prescription on an emergency basis. The pharmacy must verify the prescription with the prescriber by telephone, fax, or electronic communication, or by physical receipt of a tamper-resistant written prescription within seventy-two hours of filling the prescription.

(7) Federal controlled substance laws on controlled substances apply when prescribing or dispensing schedule II drugs.

(8) Record retention requirements (WAC 388-502-0020) remain in effect. Additional documentation is required as follows:

(a) Documentation by the pharmacy of verbal confirmation of a noncompliant written prescription.

(b) Documentation by the pharmacy of verbal confirmation about the authenticity of the tamper-resistant prescription.

(9) To submit a claim for a Medicaid client retroactively certified for Medicaid, the following applies:

(a) The prescription must meet the tamper-resistant compliance requirement.

(b) Refills that occur after the date on which the client is determined to be eligible require a new, tamper-resistant prescription in compliance with this WAC.

(c) If the original order is not compliant with subsection (4) of this section, the pharmacy must obtain a verbal, faxed, or email confirmation of the prescription from the prescriber.

(d) The pharmacy must reimburse the client in accordance with WAC 388-502-0160.

(10) The pharmacy accepting a prescription transfer from another pharmacy must confirm the authenticity of the prescription by telephone or facsimile from the transferring pharmacy.

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Washington State Code Reviser's Office