Rule-Making Activities

Last revised date: March 25, 2025

The department has filed a CR-101 to open the entire chapter of Certificate of Need (CN) rules (246-310 WAC) to clarify, streamline, develop progressive enforcement tools, and modernize language.

As part of the rule-making process, the department will address petitions including:

  • Home health methodology
  • Percutaneous coronary intervention exception criteria.

Department of Health Rules Page

Current Rules in Progress

Proviso Report

Background

The Department of Health was allocated funds to analyze the Certificate of Need program and report findings to the legislature and Governor by June 30, 2025. The report will explore other states' strategies, healthcare access, cost management, equity, and methods for identifying service needs. A research firm with expertise in healthcare economics and data analytics has been contracted with to assist with research and recommendations.

Preliminary Findings Presentations

BerryDunn presented on the preliminary findings for modernizing the CN program on three separate dates. A recording of these presentations is available upon request. 

You may also view the Preliminary Findings Presentation (PDF)

Presentation Date and Time
#1 Wednesday, November 13, 2024; 9 a.m. - 11 a.m.
#2 Tuesday, November 19, 2024; 2 p.m. - 4 p.m. 
#3 Wednesday, November 20, 2024; 10 a.m. - 12 p.m.

Past Workshops

To access comments related to this work email the Certificate of Need rules team.
Workshop Date and Time
#1 Tuesday, July 30, 2024, 9 a.m. - 11 a.m.
#2 Thursday, August 1, 2024, 4 p.m. - 6 p.m.
#3 Wednesday, August 7, 2024, 9 a.m. - 11 a.m.
#4 Thursday, August 8, 2024, 4 p.m. - 6 p.m.
#5 Thursday, September 19, 2024; 11 a.m. - 1 p.m.
#6 Tuesday, October 1, 2024; 9 a.m. - 1 p.m.
#7 Wednesday, October 8, 2024; 10 a.m. - 12 p.m.
Percutaneous Coronary Intervention (PCI) Rules 2024-2025

Background

The Department of Health (department) is considering changes to requirements for adult elective PCI programs in response to rule-making petitions.

In October 2023, the department received a petition (PDF) for rulemaking to amend WAC 246-310-720 Hospital volume standards. WAC 246-310-720(1) requires hospitals with elective PCI programs to perform at least 200 adult PCIs per year by their third year. WAC 246-310-720(2) only allows new elective PCI programs to enter a planning area if there are unmet volumes sufficient to establish another program and all existing elective PCI programs meet the minimum volume standard. The petition requests amendment of WAC 246-310-720(2), to eliminate the requirement that existing PCI programs in the planning area must meet the minimum volume standard before a new elective PCI program may be approved.

In 2019, a separate rule-making petition (PDF) was approved by the department that also requested amendment of WAC 246-310-720, as well as WAC 246-310-745. The department opened the CN rule chapter to address the petition, as well as other changes to CN rules. Ultimately, the department determined addressing CN rule amendments by facility type would be preferable to addressing the entire chapter at once. This rulemaking project will consider both petition requests.

The department will consider amendments proposed in petitions to WAC 246-310-720 and WAC 246-310-745. The department will also consider amendments to other PCI rules, WAC 246-310-700 through WAC 246-310-755, as part of this rule project.

Petitions

Correspondence with UW Harborview regarding the 2019 Petition

Draft Rules and Workbooks

Rule Activities

Public Comment

Comments specific to a workshop topic are in the Past Workshop section below, along with articles and presentations provided by participants.

Rule Workshops, Presentations, and Documents

Upcoming Workshops

Workshop Date, Time, and Topics Workshop Materials
#11 Tuesday, April 22, 2025, 1:30 p.m. - 4:30 p.m.
Register for April 22 Workshop		 To be distributed in early April
#12 Friday, May 16, 2025, 9:30 a.m. - 12:00 p.m.
Register for May 14 Workshop
Note: this workshop may be cancelled if deemed not needed		 To be distributed in early May

Past Workshops

Workshop Date, Time, and Topics Materials Received
#1

Monday, June 10, 2024, 9 a.m. - noon

Topics:

General Provisions
  • 700 – Adult elective PCI without on-site cardiac surgery
  • 705 – PCI definitions
  • 710 – Concurrent review
 None
#2

Tuesday, July 9, 2024, 9 a.m. - 1 p.m.

Topics:

Methodology Presentations by Petitioners
  • UW Harborview
  • Providence
  • MHS
Need Methodology
  • 745 – Need forecasting methodology
  • 750 – Tiebreaker
  • 755 – Ongoing compliance with standards

Presentations:
#2.5

Wednesday, July 24, 2024, 9 a.m. - 11 a.m.

Topics:

  • Publicly available data sources
  • Consider updates to planning areas identified in WAC 246-310-705(5)
  • Guiding principles for rulemaking
 Journal of the American Heart Association, Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights from the Washington State Cardiac Care Outcomes Assessment Program (PDF)
#3

Tuesday, August 6, 2024, 9 a.m. - 1 p.m.

Topics:

Rule-making processes Guiding Principles Need Methodology, continued
  • 745 – Need forecasting methodology
  • 750 – Tiebreaker
  • 755 – Ongoing compliance with standards

Guiding Principle Submissions:
#4

Tuesday, September 3, 2024, 9 a.m. - 1 p.m.

Topics:

Presentation by Corazon Review Workshop #3 Defining PCI Identifying Data Source Methodology Review
  • 745 - Need Forecasting Methodology
  • 750 - Tiebreaker
  • 755 - Ongoing Standards Compliance

PCI Presentations, Definition Submissions, and Meeting Notes:
#5

Tuesday, October 1, 2024, 9 a.m. - 1 p.m.

Topics:

Presentation by COAP on PCI Data Presentation by COAP on Article (PDF) Presentation by External Stakeholder Group

PCI Presentations and rulemaking proposals:
#6

Tuesday, October 29, 2024, 9 a.m. - 1 p.m.

Topics:

  • Presentation by External Stakeholder Group
  • Alternative need models

PCI Presentations and materials:

#7

Thursday, December 5, 2024, 1p.m. - 3 p.m.

Topics:

  • Community Presentations

PCI Presentations: 
#8

Tuesday, December 17, 2024, 9 a.m. - noon

Topics: 

  • Community Presentations
  • PCI Definition
  • Data Source 

PCI Presentations:
#9

Thursday, February 20, 2025, 9 a.m. - 11:30 a.m.

Topics:

  • WAC 246-310-705 through 246-310-740

PCI Presentations:
#10

Friday, March 21, 2025, 9:30 a.m. - 11:30 a.m.

Topics:

  • Need Methodology
  • Concurrent review
  • Tiebreaker

PCI Presentations and Materials:

Past Rules Projects

Kidney Dialysis Temporary Emergency Situation Exemption

Background

The Certificate of Need (CN) program filed a CR-101 on July 24, 2023 under WSR: 23-16-038 (PDF). The CN program is considering creating a new section to implement Substitute Senate Bill (SSB) 5569 (PDF) (chapter 48, Laws of 2023) that creates exemptions from certificate of need requirements for kidney disease centers due to a temporary emergency situation. The department is also considering amending kidney disease treatment center rules, WAC 246-310-800 through WAC 246-310-833, based upon the effects of creating a new exemption for kidney disease centers pursuant to SSB 5569.

Rule Activities

Comments on CR-102 Proposed Rule Language

Draft Rules and Rules Workshops

Public Comment

ESRD Rule-making Comments on SSB 5569

Percutaneous Coronary Intervention (PCI) Volume Standards

The purpose of opening WAC 246-310-715, 246-310-720, and 246-310-745 is to update the PCI standards by incorporating stakeholder input gained through various rules workshops and comment opportunities.

Draft rules

Rule activities

  • Draft language for WAC 246-310-720(2) - proposal withdrawn based on feedback received during Workshop #1.

Rule petition documents

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Hospice Need Forecasting Methodology and Standards

The purpose of opening WAC 246-310-290 and 246-310-295 is to update the need forecasting methodology and standards for hospice services by incorporating stakeholder input gained through various rules workshops and comment opportunities.

Draft rules

Rule activities

Rule petition documents

  • None received at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. All meetings will be held virtually via Microsoft Teams, unless otherwise indicated

Kidney Dialysis Need Forecasting Methodology and Standards

The purpose of opening WAC 246-310-800, 246-310-803, 246-310-806, 246-310-809, 246-310-812, 246-310-815, 246-310-818, 246-310-821, 246-310-824, 246-310-827, 246-310-830, and 246-310-833 is to review standards and need forecasting methodology for kidney dialysis facilities by incorporating stakeholder input through various rules workshops and comment opportunities.

Draft rules

  • None at this time.

Rule activities

  • None at this time.

Rule petition documents

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Nursing Home and Need Forecasting Methodology and Standards

The purpose is to review standards and need forecasting methodology for nursing home facilities by incorporating stakeholder input through various rules workshops and comment opportunities.

Draft rules

Rule activities

  • None at this time.

Rule petition documents

  • None at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. All meetings will be held virtually via Microsoft Teams, unless otherwise indicated

Rulemaking Kickoff Presentation

May 25, 2022, Rulemaking Kickoff Presentation (PDF)

More agency rule resources

Contact and connect

  • CN program: contact us
  • To receive Certificate of Need information, subscribe for updates at the bottom of the page.