WSR 21-11-088
PERMANENT RULES
DEPARTMENT OF HEALTH
[Filed May 18, 2021, 12:43 p.m., effective June 18, 2021]
Effective Date of Rule: Thirty-one days after filing.
Purpose: WAC 246-470-030, 246-470-052, and 246-470-053, the department of health is adopting rules that will bring the rules into alignment with the statutory changes resulting from SSB 5380 (chapter 314, Laws of 2019), including amendments to timelines for submission of information by dispensers, and eliminating requirements for facilities or entities to be trading partners with the state's health information exchange.
Citation of Rules Affected by this Order: Amending WAC 246-470-030, 246-470-052, and 246-470-053.
Statutory Authority for Adoption: RCW 70.225.025.
Other Authority: RCW 70.25.040 [70.225.040] and 70.225.020 as amended by SSB 5380.
Adopted under notice filed as WSR 21-01-123 on December 15, 2020.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 3, Repealed 0.
Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 3, Repealed 0.
Date Adopted: May 16, 2021.
Jessica Todorovich
Chief of Staff
for Umair A. Shah, MD, MPH
Secretary
OTS-2599.1
AMENDATORY SECTION(Amending WSR 16-15-014, filed 7/8/16, effective 8/8/16)
WAC 246-470-030Data submission requirements for dispensers.
(1) A dispenser shall provide to the department the dispensing information required by RCW 70.225.020 and this section for all scheduled II, III, IV, and V controlled substances and for drugs identified by the pharmacy quality assurance commission under WAC 246-470-020. Only drugs dispensed for more than one day use must be reported.
(2) Dispenser identification number. A dispenser shall acquire and maintain an identification number issued to dispensing pharmacies by the National Council for Prescription Drug Programs or a prescriber identifier issued to authorized prescribers of controlled substances by the Drug Enforcement Administration, United States Department of Justice.
(3) Submitting data. A dispenser shall submit data to the department electronically, ((not))as soon as readily available, but no later than one business day from the date of dispensing, and in the format required by the department. When the dispenser has not dispensed any drugs during a business day which require reporting, then within seven days the dispenser shall report that no drugs requiring reporting were dispensed. The notification shall be in a format established by the department.
(a) A dispenser shall submit for each dispensing the following information and any additional information required by the department:
(i) Patient identifier. A patient identifier is the unique identifier assigned to a particular patient by the dispenser;
(ii) Name of the patient for whom the prescription is ordered including first name, middle initial, last name, and generational suffixes, if any;
(iii) Patient date of birth;
(iv) Patient address;
(v) Patient gender and species code;
(vi) Drug dispensed;
(vii) Date of dispensing;
(viii) Quantity and days supply dispensed;
(ix) Refill and partial fill information;
(x) Prescriber identifiers including the National Provider Identifier and the Drug Enforcement Administration number including any suffix used;
(xi) Prescription issued date;
(xii) Dispenser identifiers including the Drug Enforcement Administration number and the National Provider Identifier;
(xiii) Prescription fill date and number;
(xiv) Source of payment indicated by one of the following:
(A) Private pay (cash, change, credit card, check);
(B) Medicaid;
(C) Medicare;
(D) Commercial insurance;
(E) Military installations and veterans affairs;
(F) Workers compensation;
(G) Indian nations;
(H) Other;
(xv) When practicable, the name of the person picking up or dropping off the prescription as verified by valid photographic identification; and
(xvi) The prescriber's and dispenser's business phone numbers.
(b) A nonresident, licensed pharmacy that delivers controlled substances, as defined in RCW 18.64.360, is required to submit only the transactions for patients with a Washington state zip code.
(c) Data submission requirements do not apply to:
(i) The department of corrections or pharmacies operated by a county for the purpose of providing medications to offenders in state or county correctional institutions who are receiving pharmaceutical services from a state or county correctional institution's pharmacy. A state or county correctional institution's pharmacy must submit data to the program related to each offender's current prescriptions for controlled substances upon the offender's release from a state or county correctional institution.
(ii) Medications provided to patients receiving inpatient services provided at hospitals licensed under chapter 70.41 RCW or patients of such hospitals receiving services at the clinics, day surgery areas, or other settings within the hospital's license where the medications are administered in single doses; or medications provided to patients receiving outpatient services provided at ambulatory surgical facilities licensed under chapter 70.230 RCW.
AMENDATORY SECTION(Amending WSR 18-17-048, filed 8/8/18, effective 9/8/18)
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 or for quality improvement purposes ((only under the following conditions:
(i))), provided that 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, or for quality improvement purposes, ((only under the following conditions:
(i)))provided that 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 identified in subsection (1)(a) of this section or a provider group of five or more prescribers 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 facility, entity, or provider group before allowing access to any prescription monitoring information.
(4) Procedure for accessing prescription information. A 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))a method approved by the department.
(5) If the connection between the facility, entity, or provider group and the ((health information exchange))program is compromised, the facility, entity, or provider group 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.
AMENDATORY SECTION(Amending WSR 18-17-048, filed 8/8/18, effective 9/8/18)
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))a method approved by the department. 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))program 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.