Rule-Making Activity

Rescission of Policy Statement P004, Regulatory Standards Applicable to Remote Dispensing Sites. Filed February 8, 2024.

The pharmacy quality assurance commission (commission) is rescinding the policy statement Regulatory Standards Applicable to Remote Dispensing Sites, which was filed on July 2, 2020, and published as WSR 20-15-011.

The department of health is rescinding this policy statement because rulemaking was completed allowing a pharmacy to extend its pharmacy license to a remote dispensing site where technology is used to dispense medications used for the treatment of opioid use disorder or its symptoms. The CR-103P was filed under WSR 24-01-098 and went into effect on January 18, 2024.

Individuals requiring information on this rule should contact Joshua Munroe, rules and legislative consultant, phone 360-502-5058, email PharmacyRules@doh.wa.gov. 

The Department of Health withdrew the CR-101 published as WSR 23-04-061 and the CR-102 published as WSR 23-23-186 for WAC 246-282-990, Shellfish fees, because the 2024 Legislature passed a budget proviso that gives the department funding to contract with an independent third-party consultant to study the commercial shellfish regulatory program and make recommendations on fees. The budget proviso prohibits the department from increasing commercial shellfish fees during fiscal year 2025. Filed as WSR 24-08-079 and WSR 24-08-079A.

The Department of Health rescinded the CR103E filed as WSR 24-07-062 amending behavioral health agency licensing and certification requirements because it was incomplete. The emergency rule was refiled correctly under WSR 24-07-100. Filed March 20, 2024.

The Department of Health is rescinded the CR-103E for the Sixth Emergency rule for proprietary treatment products and the use of substitution products under WAC 246-272A-0110, published as WSR 24-04-071 because a permanent rule WSR 24-06-046 filed on March 1, 2024 makes the emergency rule redundant.

Withdrawal of WSR 23-12-089, for chapter 246-562 WAC Physician Visa Waivers. The department is expanding the scope of the rule making project under a new CR-101.

This memo serves as notice that the Department of Health is withdrawing CR-101, filed January 8, 2021, published under WSR 21-03-011, and CR-102 filed on May 24, 2023, published under WSR 23-11-166. The department is withdrawing this CR-101 and CR-102 because the comments received from interested parties during the public comment process indicated substantial opposition to the rule as proposed.

As a result, the department will continue to use its existing authority and rules to determine the need for new trauma centers and the optimal distribution of trauma services to ensure equitable access to trauma care. Individuals requiring information on this rule should contact Anthony Partridge, Program Manager, at anthony.partridge@doh.wa.gov.

Rescission of interpretive statement NCIS2.00 for WAC 246-840-4659 because a permanent rule has been adopted in its place. The rule clarifies the application of the advanced practice pain management rules in nursing homes and long-term acute care hospitals and incorporated the interpretive statement into permanent rule. Filed on January 31, 2024.

The board engaged in rulemaking to clarify the application of the advanced practice pain management rules in nursing homes and long-term acute care hospitals and incorporated the interpretive statement into permanent rule. The proposed rule was adopted by the board in a rule hearing on May 12, 2023. The permanent rule was filed on June 29, 2023 as WSR 23-14-082.

The Emergency rule amending specific training requirements for Nursing Assistant Certified (NAC) and Nursing Assistant Registered (NAR) has been rescinded with an effective date of November 4, 2023, because it has been replaced by permanent rules in chapter 246-841A WAC.

The board is rescinding this emergency rule which amended specific training requirements for Nursing Assistant Certified (NAC) and Nursing Assistant Registered (NAR) effective November 4, 2023, because it is no longer necessary.

Rescission of Interpretive Statement BON 21-01, Continuing Education Pharmacology Documentation. Filed February 8, 2024.

The board is rescinding this interpretive statement because the board has adopted amendments to WAC 246-836-080 Continuing competency program, that clarify what forms of documentation are acceptable to verify meeting the pharmacology continuing education requirements. Thus, the interpretive statement is no longer necessary.

Individuals requiring information on this rule should contact Rachel Phipps, program manager, phone 564-233-1277, email naturopathy@doh.wa.gov.

This policy statement provided guidance to donor milk banks and insurance carriers consistent with RCW 43.70.645 until the department adopted permanent rules. The policy statement served as the milk bank safety standards established by the department for inpatient use for the purpose of RCW 43.70.645 and 48.43.815, clarified and added a definition addressing donor human milk obtained from a milk bank for the purposes of ensuring inclusion of donor milk provided by renumerated donors and ensuring inclusive language use.

The department is rescinding this policy statement because it is superseded by permanent rules that were adopted August 22, 2023, filed as WSR 23-17-149 with an effective date of September 22, 2023, making the policy statement obsolete.

Individuals requiring information on this should contact Me'kyel Bailey, lead policy advisor, email mekyel.bailey@doh.wa.gov, or phone 360-754-9161. Filed February 5, 2024.

The Department of Health (department) is considering amending chapter 246-790 WAC to increase flexibility in allowed vendor types and update program requirements for vendors. The department is also considering amendments to the Participant Compliance rules to reflect virtual service options.

Jocelyn W. Jones
360-236-3020

Stuart Glasoe
360-236-4111

The Pharmacy Quality Assurance Commission is considering creating a new section(s) in chapter 246-945 WAC related to the regulation of the practices of “white bagging” and “brown bagging” or any other transfer of a prescription or drug for the purpose of re-dispensing or subsequent administration to a patient. Concerns have been raised over ensuring the integrity and quality of these medications is maintained if such practices are used by prescribers, hospitals, or patients because these practices can create an unknown chain of custody.

The Washington State Board of Health (Board) is considering adding Guanidinoacetate methyltransferase deficiency (GAMT) and Arginase 1 deficiency (ARG1-D) to the list of mandatory conditions for newborn screening conducted by the Department of Health (Department).

The Board has the authority under RCW 70.83.050 to define and adopt rules for screening Washington-born infants for hereditary conditions. WAC 246-650-010 defines the conditions, and WAC 246-650-020 lists the conditions for which all Washington-born newborns are to be screened. GAMT deficiency and ARG1-D are rare inherited metabolic conditions that can result in severe disability and in some cases death if not detected and treated early. Early diagnosis of GAMT deficiency and ARG1-D through newborn screening is essential to save lives and to improve the quality of life for impacted infants and their families.

To be added to the listserv for notifications regarding this rulemaking, email Molly.Dinardo@sboh.wa.gov with the subject line "Newborn Screening – GAMT & ARG1-D."

Amending WAC 246-840-010, 246-840-340, 246-840-342, and other related sections in chapter 246-840 WAC. The Washington State Board of Nursing is considering amendments to education requirements for ARNP licensure in response to the Joint Administrative Rules Review Committee’s (JARRC) recommendation.

The Department of Health is considering a chapter review to reorganize sections and amend rules regarding J-1 Physician Visa waivers. The department is exploring updates to help meet the greatest needs across Washington State. The department will also look for increased clarity in the organizational structure, application criteria, and requirements for letters of support.

Clarifying terms and information about prescription history for the PMP. The Department of Health (department) is considering clarifying that prescribers can request the history of prescriptions they have written. The department is considering changes to WAC 246-470- 010, 246-470-030, and 246-470-050 and potentially other related sections in chapter 246-470 WAC to help clarify rules including terms and definitions relating to the Prescription Monitoring Program.

The Department of Health is considering amendments to WAC 246-835-010 and WAC 246-835-025 to clarify the definition of “culturally congruent care” and to ensure education and training requirements related to “culturally congruent care” are clear.

The Board of Osteopathic Medicine and Surgery is considering amending WAC 246-853-661 Exclusions, WAC 246-853-730 Periodic review, and WAC 246-853-755 Tapering requirements, to modernize the language, add clarity, and align rules with the Washington Medical Commission (WMC).

The Occupational Therapy Practice Board and the Department of Health are considering amending rules and establishing fees for temporary practice permits in response to the Washington Military Spouse Employment Act.

The Department of Health is considering amending radioactive material licenses and licensee's fees to cover operating costs for the following: Small business discount provision and optional fee payment schedule applicable to radioactive materials licensees; Fees for specialized radioactive material licenses; Fees for medical and veterinary radioactive material use Fees for industrial radioactive material licenses; Fees for laboratory radioactive material licenses; and Fees for licensing and compliance actions.

The Department of Health is considering updates to rules regarding acute care and private psychiatric hospital fees to address funding needs under WAC 246-322-990. An update may be necessary to adequately fund the hospital inspection, investigation, and licensing programs to protect patients.

The Department of Health is considering amendments to the birth doula certification requirements in WAC 246-835-040, Applicants currently certified in other states or territories, to comply with Second Substitute House Bill (2SHB) 1724 (chapter 425, Laws of 2023).

The Board of Osteopathic Medicine and Surgery is considering amending WAC 246-853-080 to update the continuing education (CE) requirements for licensure renewal of osteopathic physicians to clarify Washington-specific mandated CE requirements.

The Department of Health is considering amending, repealing, or creating new sections in chapter 246-809 WAC, to establish: a directory to help mental health counselor, marriage and family therapist, and social worker associates find supervisors; minimum standards for supervision of associates; and a stipend program to offset some costs of supervision for associates.

The Department of Health is considering amending requirements for respiratory care practitioner application, examination licensure, and out of state credentialing and temporary practice permits.

The Department of Health is considering amending fees in WAC 246-358-990 to cover operating costs in the Temporary Worker Housing program. The department will consider updating or restructuring existing fees and creating new fees. Rulemaking is being considered because the department conducted an initial assessment of the program and determined the current fee is not generating sufficient revenue to cover the program’s costs.

The Veterinary Board of Governors is considering updates and revisions to WAC 246-935-050 animal health care tasks, WAC 246-935-040 responsibilities of a Veterinarian supervising a licensed Veterinary Technician or unregistered assistant, WAC 246-935-010 definitions (Veterinary Technicians), and WAC 246-937-010 definitions (registered Veterinary Medication Clerks).

The Washington State Board of Health is considering amending the auditory screening sections of chapter 246-760 WAC, Auditory and Visual Standards – School Districts, to align with current national evidence-based practices and assess potential options regarding whether to include otoacoustic emission (OAE) screening technology in the Board’s rules. The Board may also consider other technical or editorial changes as needed.

The Department of Health is considering amendments to genetic counselor licensure requirements in WAC 246-825-080 Licensure by endorsement, to comply with Second Substitute House Bill (2SHB) 1724 (chapter 425, Laws of 2023) to make disciplining authorities review and adjust licensure requirements to remove barriers to entering and remaining in the health care workforce, and to streamline and shorten the credentialing process.

The Department of Health is considering adding a new section of rule to address the medication administration requirements for the medical assistant-registered credential to align with recent legislation and considering updating the medical assistant-certified training and certification requirements to expand the types of apprenticeship programs accepted to meet the training requirements to allow experienced medical assistants to enter the Washington workforce more easily. Engrossed Substitute House Bill (ESHB) 1073 (Chapter 134, Laws of 2023). WAC 246-827-0010, 246-827-0200, and 246-827-0240, new section WAC 246-827-0340.

The Board of Osteopathic Medicine and Surgery is considering amendments to update the examination requirements for licensure of osteopathic physicians in response to Second Substitute House Bill (2SHB) 1724 (chapter 425, Laws of 2023) and to reduce potentially unnecessary licensure barriers.

2SHB 1724 requires regulatory authorities to review licensure standards for health professionals in other states to determine substantial equivalency to Washington licensure standards in order to streamline and expedite credentialing processes. In response to this requirement, and to reduce potentially unnecessary licensure barriers, the board is considering amendments to the osteopathic physician examination requirements.

The Department of Health is considering requiring acute care hospitals to report hospital maintenance and operation data to the department through the Washington Healthcare Emergency and Logistics Tracking Hub (WA HEALTH), a statewide data management system. The department will also consider requiring behavioral health agencies and facilities to report hospital maintenance and operation data to the department through WA HEALTH.

WAC 246-918-076 (Physician Assistants) and WAC 246-919-397 (Physicians), How to obtain a temporary practice permit—Military spouse. The Washington Medical Commission will consider amending these WACs in response to Second Substitute House Bill (2SHB) 1009 (chapter 165, Laws of 2023), Military spouse employment act.

Rule making notices will be delivered via GovDelivery. To receive notices, interested persons may sign up for any or all of the lists. Please go to: https://public.govdelivery.com/accounts/WADOH/subscriber/new. After signing in, please click open the box labeled "Health Systems Quality Assurance." Next click open the box labeled "Health Professions." From there, check the Medical Cannabis Program box. You may also check any other box of the professions listed that you may be interested in.

Shannon Angell

PO Box 47860

Olympia, WA 98504-7860

Phone: 360-236-2820

Email: shannon.angell@doh.wa.gov

The Department of Health is considering updating public water system fees to generate sufficient income to cover costs of the program. This may include updating or restructuring existing fees or creating new fees.

The Pharmacy Quality Assurance Commission is considering amending WAC 246-945-055 to remove fenfluramine from the list of Schedule IV substances and adding a new section to chapter 246-945 WAC to establish a list of schedule IV exemptions. Fenfluramine is a medication used in the treatment of seizures associated with certain syndromes and as an appetite suppressant and was removed from the Drug Enforcement Administration’s (DEA) federal Controlled Substances Act (CSA) in December of 2022.

The Board of Physical Therapy is considering amendments to update initial licensure and endorsement requirements in consideration of Second Substitute House Bill (2SHB) 1724, (chapter 425, Laws of 2023). The board will also consider making general updates to the licensing and endorsement process, examine the jurisprudence examination requirement, and review for housekeeping changes.

Section 8 of 2SHB 1724 requires boards and commissions to waive any examination requirements in an effort to expedite the licensing process for applicants who meet the requirements under 2SHB 1724. The board will review the initial licensure and endorsement requirements to bring them into alignment with 2SHB 1724, and review the current license requirements for consistency and relevancy. The board will consider additional housekeeping updates.

The Department of Health is considering amending existing rules WAC 246-225-020 and 246-225-030 and creating new rules in chapter 246-225 WAC, X-Rays in the Healing Arts, to address technological advances in radiation therapy and fluoroscopic X-ray, establish machine performance and quality control standards, and to address plan review shielding requirements. Amendments to radiation therapy rules considered by the department will apply only to machine generated ionizing radiation, and not radiopharmaceuticals or radioactive materials.

The Department of Health is considering amending WAC 246-10-501 to include applicants for interstate license compacts, milk banks, and 988-line crisis call centers to the list of applicant types who are eligible for brief adjudicated proceedings as a due process recourse if their application is denied.

Shad Bell

360-236-4711

The Occupational Therapy Practice Board is considering amendments to implement Second Substitute House Bill (2SHB) 1724 (Chapter 425, Laws of 2023) to remove barriers to licensure and endorsement. Additionally, the board will consider amendments to align with the national certifying board and standards of ethics and professional conduct.

Section 8 of 2SHB 1724 directs boards and commissions to waive certain requirements to licensure for specific types of applicants. The intent of the bill was to change licensure requirements to remove barriers to entering and remaining in the health care workforce, and to streamline and shorten the credentialing process. Rulemaking may be necessary to amend licensure requirements to align with the new legislation. Additionally, the board consistently receives inquiries on whether an OT can work off the evaluation of another profession such as a physical therapist. The board is considering adding rule language that makes it clear that an OT must complete their own evaluation of the client, and will consider adding language that aligns continued competency rules with the national certifying board.

Amelia Boyd

The Board of Hearing and Speech is considering amendments to WAC 246-828-020, WAC 246-828-510, and WAC 246-828-617 to update requirements for speech-language pathology assistant certification. The board may also consider making related updates or new sections to clarify and streamline licensure in chapter 246-828 WAC.