DEPARTMENT OF HEALTH

[Filed August 8, 2018, 1:52 p.m., effective September 8, 2018]

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

Purpose: Chapter 246-470 WAC, Prescription monitoring program (PMP), the adopted rule amendments and new sections implement section 9 of ESHB 1427 (chapter 297, Laws of 2017). These rules are needed to establish a framework, structure, and guidance for the exchange of PMP data that will assure the integrity of protected patient information while providing meaningful dispenser and provider data.

Citation of Rules Affected by this Order: New WAC 246-470-053, 246-470-054 and 246-470-082; and amending WAC 246-470-010, 246-470-050, and 246-470-052.

Statutory Authority for Adoption: RCW 70.225.020, 70.225.025, 70.225.040.

Other Authority: ESHB 1427 (chapter 297, Laws of 2017).

Adopted under notice filed as WSR 18-08-021 on March 23, 2018.

Changes Other than Editing from Proposed to Adopted Version: A single, nonsubstantive change was made, striking "licensed" from WAC 246-470-052(2). The word remained after a previous edit intended to remove the entire phrase "licensed by the department" did not remove the single word "licensed." The remaining word caused the sentence to be awkward and unclear.

A final cost-benefit analysis is available by contacting Gary Garrety, P.O. Box 47852-7852, Olympia, WA 98504-7852, phone 360-236-4802, fax 360-236-2901, TTY 360-833-6388 or 711, email gary.garrety@doh.wa.gov, web site www.doh.wa.gov/pmp.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 3, Amended 3, Repealed 0.

Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 3, Amended 3, Repealed 0.

Date Adopted: August 7, 2018.

John Wiesman, DrPH, MPH

AMENDATORY SECTION(Amending WSR 17-18-103, filed 9/6/17, effective 10/7/17)

WAC 246-470-010Definitions.

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) "Indirect patient identifiers" means data that may include: Hospital or provider identifiers; a five-digit zip code, county, state, and country of residence; dates that include month and year; age in years; and race and ethnicity; but does not include the patient's first name; middle name; last name; Social Security number; control or medical record number; zip code plus four digits; dates that include day, month, and year; or admission and discharge date in combination.

(6) "Local health officer" means the legally qualified physician who has been appointed as the health officer for a county or district health department, consistent with RCW 70.05.010(2).

(7) "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)))(8) "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.

(((7)))(9) "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

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

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

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

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

(((12)))(14) "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 17-18-103, filed 9/6/17, effective 10/7/17)

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

(1) Access.

(a) The local health officer or a licensed health care practitioner authorized by the local health officer may obtain prescription monitoring information for the purposes of patient follow-up and care coordination following a controlled substance overdose event.

(b) 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.

(((b)))(c) 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 local health officer, pharmacist, prescriber, or licensed health care practitioner authorized by a local health officer, prescriber or pharmacist shall register by using the registration process established by the department in order to receive an authentication to access the electronic system.

(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 local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, 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.

(4) Procedure for accessing prescription information.

(a) A local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, 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.

(b) A local health officer, pharmacist, prescriber, or licensed health care practitioner authorized by a local health officer, 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 local health officer, pharmacist, prescriber, licensed health care practitioner authorized by a local health officer, 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.

AMENDATORY SECTION(Amending WSR 17-18-103, filed 9/6/17, effective 10/7/17)

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

(1) Access.

(a) A health care facility or entity may have access to prescription monitoring information for the purpose of providing medical or pharmaceutical care to the patients of the facility or entity ((if))or for quality improvement purposes only under the following conditions:

(i) The facility or entity is licensed by the department, operated by the federal government, or a federally recognized Indian tribe; and

(ii) 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 prescription monitoring information for the purpose of providing medical or pharmaceutical care to the patients ((if)), or for quality improvement purposes, only under the following conditions:

(i) All prescribers in the provider group are licensed by the department, the provider group is operated by the federal government or a federally recognized Indian tribe; and

(ii) 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,))identified in subsection (1)(a) of this section or a provider group of five or more prescribers ((all licensed by the department))identified in subsection (1)(b) of this section 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 identified in subsection (1) of this section 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))exchange is compromised, the facility, entity, or provider group shall notify the department's designee by telephone and in writing as soon as reasonably possible.

WAC 246-470-053The coordinated care electronic tracking program access to information from the program.

(1) Access. The coordinated care electronic tracking program may have access to data for the purposes of:

(a) Providing program data to emergency department personnel when the patient registers in the emergency department; and

(b) Providing notice to the patient's providers, appropriate care coordination staff, and prescribers listed in the patient's prescription monitoring program record when the patient has experienced a controlled substance overdose event.

(2) Registration for access. The coordinated care electronic tracking program 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 coordinated care electronic tracking program before allowing access to any prescription monitoring information.

(4) Procedure for accessing prescription data. The coordinated care electronic tracking program must access data from the program electronically through the state health information exchange. The data shall only be retained long enough by the tracking program to create the report needed by emergency department personnel when the patient registered or to provide notice of an overdose event.

(5) If the secure connection between the coordinated care electronic tracking program and the state health information exchange is compromised, the coordinated care electronic tracking program 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 mandate as outlined in RCW 70.225.040 and this chapter.

WAC 246-470-054Facility, entity, and provider group access to prescriber information.

(1) Access. Facilities, entities, and provider groups which have elected to receive information as identified in WAC 246-470-052 shall receive quarterly reports from the department with facility or entity and individual prescriber information for quality improvement purposes of the facility, entity, or provider group.

(2) Requesting a report. The facility, entity, or provider group shall submit a request for each quarterly report using a format established by the department and containing the names and credentials of the providers they employ.

(3) Verification. The department will establish a process for verifying the point of contact at each facility, entity or provider group who will receive the report.

(4) Providing a report. The department will establish a secure method for delivering the report to the facility, entity or provider group.

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

WAC 246-470-082Access by the Washington state hospital association to information from the program.

(1) The department may provide dispenser and prescriber data that includes indirect patient identifiers to the Washington state hospital association's coordinated quality improvement program (CQIP).

(2) Before providing data to the association's CQIP the department will enter into a data use agreement that outlines the following:

(a) The data fields that will be provided;

(b) The security methods used to protect and transmit the data;

(c) Any allowed redisclosure of the data provided to the CQIP must be consistent with the purpose of the data use agreement; and

(d) How indirect patient identifiers will be protected from any attempts to reidentify the patient or their family.

(3) All requests for, uses of, and disclosures of prescription monitoring information by the requesting entity must be consistent with the mandate as outlined in RCW 70.225.040 and this chapter.