Rule-Making Activities-Certificate of Need

Last revised date: November 22, 2024

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; 9a.m. - 11a.m.
#2 Tuesday, November 19, 2024; 2p.m. - 4p.m. 
#3 Wednesday, November 20, 2024; 10 a.m. - 12p.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; 11a.m. - 1p.m.
#6 Tuesday, October 1, 2024; 9a.m. - 1 p.m.
#7 Wednesday, October 8, 2024; 10a.m. - 12p.m.
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) Rules 2024

Background

The Department of Health (department) is considering changes to requirements for adult elective PCI programs in response to rulemaking 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
#7

Date and time TBD

  

Past Workshops

Workshop Date, Time, and Topics Materials Received
#6

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

Topics:

  • Presentation by External Stakeholder Group
  • Alternative need models

PCI Presentations and materials:
#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:
#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:
#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:
#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)

#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:
#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
  

Past Rules Projects

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. Meeting may end early if all business is concluded earlier than the end time.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
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. Meeting may end early if all business is concluded earlier than the end time.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
Tertiary Health Services

The Certificate of Need Program is conducting a review of tertiary services in WAC 246-310-020(1)(d)(i). The purpose of the review is to decide if any changes are necessary to the tertiary services list. Changes could be either additions to or deletions from the list. The current list of tertiary services includes:

  • Specialty burn services
  • Intermediate care nursery and/or obstetric services Level II
  • Neonatal intensive care nursery and/or obstetric services Level III
  • Transplantation of specific solid organs
  • Open heart surgery and/or elective therapeutic cardiac catheterization, including percutaneous coronary interventions generally and elective percutaneous coronary angioplasty (PTCA), specifically
  • Inpatient physical rehabilitation services Level I
  • Specialized inpatient pediatric services

A provider must get Certificate of Need-approval before starting any of these services the hospital has not provided in the preceding 12 months.

Draft rules

  • None at this time.

Rule activities

  • Based on feedback received during the listening sessions, work on tertiary health services will be incorporated in the workgroups for hospital rules.

Rule petition documents

  • None at this time.

Stakeholder meetings

No future meetings are planned.

Acute Care and Psychiatric Bed Need

The purpose of these rules is to develop standards and an acute care hospital and psychiatric bed need rules 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

  • None at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. If you do not see your meeting information, scroll down. Meeting may end early if all business is concluded earlier than the end time.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
Ambulatory Surgery Rule-making Activities

The purpose of opening WAC 246-310-020 and 246-310-270 is to update the need forecasting methodology and standards for Certificate of Need-approved ambulatory surgery facility (ASF) by incorporating stakeholder input gained through various rules workshops and comment opportunities.

Draft rules

  • None at this time.

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. If you do not see your meeting information, scroll down. Meeting may end early if all business is concluded earlier than the end time.

All meetings will be held virtually via Microsoft Teams or Zoom, unless otherwise indicated.

Date and Location Meeting Documents

TBD
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. If you do not see your meeting information, scroll down. Meeting may end early if all business is concluded earlier than the end time.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
General Certificate of Need Rules

The purpose is to review general standards that generally impact all 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

  • None at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. If you do not see your meeting information, scroll down.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
Home Health Need Forecasting Methodology and Standards

The purpose is to review standards and need forecasting methodology for home health 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

  • None at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. If you do not see your meeting information, scroll down.

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

Listening session #4

January 31, 2023, 4:30 p.m. to 6 p.m.

Via Microsoft Teams

Listening session #3 - Canceled

November 17, 2022, 5 p.m. to 6:30 p.m.

Via Microsoft Teams

Listening session #2

October 26, 2022, 10:30 a.m. to noon

Via Microsoft Teams

Listening session #1

September 20, 2022 1:30 p.m. to 3 p.m.

 Listening session (PDF)
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. If you do not see your meeting information, scroll down. Meeting may end early if all business is concluded earlier than the end time

All meetings will be held virtually via Microsoft Teams, unless otherwise indicated.

Date and Location Meeting Documents

TBD
Rulemaking Kickoff Presentation

May 25, 2022 Rulemaking Kickoff Presentation (PDF)

Chapter 246-310 WAC Certificate of Need

CR-101 filed December 18, 2019 (PDF)

Tribal Notification

Notice of Rulemaking Tribal Notification (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.