SOCIAL AND HEALTH SERVICES
(Health and Recovery Services Administration)
Effective Date of Rule: Thirty-one days after filing.
Purpose: New WAC 388-530-1075 Use of tamper-resistant prescriptions, is being adopted to comply with federal law which mandates as of April 1, 2008, the use of nonelectronic tamper-resistant prescription pads for medicaid clients. This rule adopts without material change federal regulations mandated by the adoption of Section 7002(b) of the federal United States 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)).
Statutory Authority for Adoption: RCW 74.08.090, 74.04.050, 74.04.057, and 74.09.500.
Other Authority: Section 1903(i) of the Social Security Act (42 U.S.C. Section 1936b (i)(23)); Section 7002(b), U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act, 2007 (Pub.L. 110-28).
Adopted under notice filed as WSR 08-03-110 on January 22, 2008.
Number of Sections Adopted in Order to Comply with Federal Statute: New 1, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 0, Repealed 0.
Date Adopted: March 11, 2008.
Stephanie E. Schiller
(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.