WSR 17-18-103

PERMANENT RULES

DEPARTMENT OF HEALTH

[Filed September 6, 2017, 10:45 a.m., effective October 7, 2017]

Effective Date of Rule: Thirty-one days after filing.

Purpose: Chapter 246-470 WAC, Prescription monitoring program (PMP), the adopted rules align with legislatively mandated amendments to chapter 70.225 RCW by adding language that provides medical test sites authority to access PMP data. The adopted rules also add language and a new section that provides prescribers of legend drugs, health care facilities and provider groups of five or more authority to access PMP data on the PMP database.

Citation of Rules Affected by this Order: New WAC 246-470-052; and amending WAC 246-470-010 and 246-470-050.

Statutory Authority for Adoption: Chapter 70.225 RCW.

Other Authority: SHB 2730 (chapter 104, Laws of 2016); SSB 5027 (chapter 259, Laws of 2015).

Adopted under notice filed as WSR 17-11-033 on May 11, 2017.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 1, Amended 2, Repealed 0.

Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 1, Amended 2, Repealed 0.

Date Adopted: September 1, 2017.

John Wiesman, DrPH, MPH

Secretary

AMENDATORY SECTION (Amending WSR 14-07-099, filed 3/18/14, effective 4/18/14)

WAC 246-470-010 Definitions.

The definitions in this section apply throughout this chapter unless the context clearly indicates otherwise:

(1) "Authentication" means information, electronic device, or certificate provided by the department or their designee to a data requestor to electronically access prescription monitoring information. The authentication may include, but is not limited to, a user name, password, or an identification electronic device or certificate.

(2) "Controlled substance" has the same meaning provided in RCW 69.50.101.

(3) "Department" means the department of health.

(4) "Dispenser" means a practitioner or pharmacy that delivers to the ultimate user a schedule II, III, IV, or V controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020, but does not include:

(a) A practitioner or other authorized person who only administers, as defined in RCW 69.41.010, a controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020;

(b) A licensed wholesale distributor or manufacturer, as defined in chapter 18.64 RCW, of a controlled substance or other drugs identified by the pharmacy quality assurance commission in WAC 246-470-020; or

(c) A veterinarian licensed under chapter 18.92 RCW. Data submission requirements for veterinarians are included in WAC 246-470-035.

(5) "Qualifying medical test site" means a medical test site licensed by the department under chapter 70.42 RCW, and certified as a drug testing laboratory by the United States department of health and human services, substance abuse and mental health services administration.

(6) "Patient" means the person or animal who is the ultimate user of a drug for whom a prescription is issued or for whom a drug is dispensed.

(((6))) (7) "Patient address" means the current geographic location of the patient's residence. If the patient address is in care of another person or entity, the address of that person or entity is the "patient address" of record. When alternate addresses are possible, they must be recorded in the following order of preference:

(a) The geographical location of the residence, as would be identified when a telephone is used to place a 9-1-1 call; or

(b) An address as listed by the United States Postal Service; or

(((7))) (8) "Pharmacist" means a person licensed to engage in the practice of pharmacy.

(((8))) (9) "Prescriber" means a licensed health care professional with authority to prescribe controlled substances or legend drugs.

(((9))) (10) "Prescription monitoring information" means information submitted to and maintained by the prescription monitoring program.

(((10))) (11) "Program" means the prescription monitoring program established under chapter 70.225 RCW.

(((11))) (12) "Valid photographic identification" means:

(a) A driver's license or instruction permit issued by any United States state or province of Canada. If the patient's driver's license has expired, the patient must also show a valid temporary driver's license with the expired card.

(b) A state identification card issued by any United States state or province of Canada.

(d) A United States armed forces identification card issued to active duty, reserve, and retired personnel and the personnel's dependents.

(e) A merchant marine identification card issued by the United States Coast Guard.

(f) A state liquor control identification card. An official age identification card issued by the liquor control authority of any United States state or Canadian province.

(g) An enrollment card issued by the governing authority of a federally recognized Indian tribe located in Washington, if the enrollment card incorporates security features comparable to those implemented by the department of licensing for Washington drivers' licenses and are recognized by the liquor control board.

AMENDATORY SECTION (Amending WSR 16-15-014, filed 7/8/16, effective 8/8/16)

WAC 246-470-050 Pharmacist, prescriber or other health care practitioner and medical test site access to information from the program.

(1) Access.

(a) A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber or pharmacist may obtain prescription monitoring information relating to their patients, for the purpose of providing medical or pharmaceutical care.

(((1))) (b) A qualifying medical test site may have access to prescription monitoring information for the purpose of providing assistance to a prescriber or dispenser for determining medications an identified patient, in the care of the prescriber or dispenser, is taking.

(2) Registration for access.

(a) A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber or pharmacist shall register ((with)) by using the registration process established by the department in order to receive an authentication to access the electronic system. ((The registration process shall be established by the department)).

(((2))) (b) Staff of a qualifying medical test site, meeting requirements of (a) of this subsection may register for access by using the registration process established by the department.

(3) Verification by the department. The department shall verify the authentication and identity of the pharmacist, prescriber, ((or)) licensed health care practitioner authorized by a prescriber or pharmacist, or staff of a qualifying medical test site before allowing access to any prescription monitoring information. The qualifying medical testing laboratory's registered substance abuse and mental health services administration responsible person must designate and report to the program those staff who may access the prescription monitoring information.

(((3))) (4) Procedure for accessing prescription information.

(a) A pharmacist, prescriber, ((or)) licensed health care practitioner authorized by a prescriber or pharmacist, or staff of a qualifying medical test site center may access information from the program electronically, using the authentication issued by the department or the department's designee.

(((4))) (b) A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber or pharmacist may alternately submit a written request via mail or facsimile transmission in a manner and format established by the department.

(5) Reporting lost or stolen authentication. If the authentication issued by the department is lost, missing, or the security of the authentication is compromised, the pharmacist, prescriber, ((or)) licensed health care practitioner authorized by a prescriber or pharmacist, or staff of a qualifying medical test site shall notify the department's designee by telephone and in writing as soon as reasonably possible.

(6) All requests for, uses of, and disclosures of prescription monitoring information by authorized persons must be consistent with the program's mandate as outlined in RCW 70.225.040 and this chapter.

NEW SECTION

WAC 246-470-052 Facility and provider group access to information from the program.

(1) Access.

(a) A health care facility or entity may have access to information for the purpose of providing medical or pharmaceutical care to the patients of the facility or entity if the facility or entity is licensed by the department and the facility or entity is a trading partner with the state's health information exchange.

(b) A health care provider group of five or more prescribers may have access to information for the purpose of providing medical or pharmaceutical care to the patients if all prescribers in the provider group are licensed by the department and the provider group is a trading partner with the state's health information exchange.

(2) Registration for access. A facility or entity licensed by the department, or a provider group of five or more prescribers all licensed by the department may register for access by using the registration process established by the department.

(3) Verification by the department. The department or its designee shall verify the authentication and identity of the licensed facility, entity, or provider group before allowing access to any prescription monitoring information.

(4) Procedure for accessing prescription information. A licensed facility, entity, or provider group must access information from the program electronically through the state health information exchange.

(5) If the connection between the facility, entity, or provider group and the health information exchanged is compromised, the facility, entity, or provider group shall notify the department's designee by telephone and in writing as soon as reasonably possible.