DEPARTMENT OF HEALTH

[Filed January 19, 2021, 1:14 p.m., effective January 19, 2021, 1:14 p.m.]

Effective Date of Rule: Immediately upon filing.

Purpose: WAC 246-310-710 Percutaneous coronary intervention (PCI) services concurrent review cycles. The department of health (department) is adopting an emergency rule to extend deadlines for PCI services concurrent review cycle. This existing rule sets the deadlines for each step of the concurrent review process based on identified need for PCI services in Washington state. The amendments in this emergency rule are necessary due to the coronavirus disease 2019 (COVID-19) pandemic response.

Citation of Rules Affected by this Order: Amending WAC 246-310-710.

Statutory Authority for Adoption: RCW 70.38.135.

Other Authority: None.

Under RCW 34.05.350 the agency for good cause finds that immediate adoption, amendment, or repeal of a rule is necessary for the preservation of the public health, safety, or general welfare, and that observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest.

Reasons for this Finding: The amendment of these existing rules is necessary for the preservation of public health, safety, and general welfare. This rule is necessary to amend the specific deadlines in rule for submitting and reviewing applications for PCI services to give applicants time and capacity to submit quality applications that satisfy regulatory requirements and identified community need. The report that these systems and facilities rely on to determine their ability to fill need and request review was impacted by technology challenges that occurred because of the COVID-19 response updates. The resources needed to correct the output have been limited due to the more immediate need for COVID-19 response support. Changing the deadlines in rule will create the flexibility needed to produce the needed materials and preserve the time needed for complete applications in a time when the applicants are also strained in their own COVID-19 responses resources. This change will limit the impact on resources currently needed in the communities. Observing the time requirements of notice and opportunity to comment upon adoption of a permanent rule would be contrary to the public interest. Extending the next PCI services start cycle will allow time for applicants to receive and respond to identified need for services as well as responding to current needs.

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 0, 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 1, 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 1, Repealed 0.

Date Adopted: January 19, 2021.

for Umair A. Shah, MD, MPH

AMENDATORY SECTION(Amending WSR 09-01-113, filed 12/19/08, effective 12/19/08)

WAC 246-310-710Concurrent review.

The department shall review new adult elective percutaneous coronary intervention (PCI) services using the concurrent review cycle according to the following table:

Concurrent Review Cycle:

Application Submission Period	Letters of Intent Due	First working day through last working day of ((January))February of each year.
	Receipt of Initial Application	First working day through last working day of ((February))March of each year.
	End of Screening Period	Last working day of ((March))April of each year.
	Applicant Response	Last working day of ((April))May of each year.
Department Action	Beginning of Review Preparation	((May))June 1 through ((May))June 15
Application Review Period	Public Comment Period (includes public hearing if requested)	60-Day Public Comment Period	Begins ((May))June 16 of each year or the first working day after ((May))June 16.
	Rebuttal Period	30-Day Rebuttal period	Applicant and affected party response to public comment.
	Ex parte Period	45-Day Ex parte period	Department evaluation and decision.

(1) If the department is unable to meet the deadline for making a decision on the application, it will notify applicants fifteen days prior to the scheduled decision date. In that event, the department will establish a new decision date.

(2) The department may not accept new applications for a planning area if there are any pending applications in that planning area filed under a previous concurrent review cycle, or applications submitted prior to the effective date of these rules that affect any of the new planning areas, unless the department has not made a decision on the pending applications within the review timelines of nine months for a concurrent review and six months for a regular review.

(3) If the department determines that an application does not compete with another application, it may convert the review of an application that was initially submitted under a concurrent review cycle to a regular review process.