Rules in Progress-Certificate of Need

Last revised date: December 1, 2023

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 rulemaking process, the department will address petitions including:

• Home health methodology
• Percutaneous coronary intervention exception criteria.

Department of Health Rules Page

Current rules in progress

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. The CN program is considering creating a new section to implement Substitute Senate Bill (SSB) 5569 (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.

Draft rules

• Workshop #1:

  • DRAFT ESRD Temporary Emergency Situation Exemption Rule (PDF)

• Workshop #2:

  • DRAFT ESRD Temporary Emergency Situation Exemption Rule (PDF)

  • The goal of this draft workbook is to consolidate public comments, draft rule language, and any updates made to rule language based on comments. DRAFT ESRD Temporary Emergency Situation Rule Workbook (PDF)

Rule activities

• WSR 23-16-038 CR-101 (PDF)

Public Comment

ESRD Rulemaking Comments on SSB 5569

• August 2023 (PDF)
• September 2023 (PDF)
• Fresenius comments on November 1 Draft Rules (PDF)
• DaVita comments on November 1 Draft Rules (PDF)
• NKC comments on November 1 Draft Rules (PDF)

Rule Workshops

The CN program has committed to hosting two public rules workshops to discuss draft rule language. The second public rule workshop will be hosted virtually. The workshop will consist of reviewing/editing draft rule language, taking comment, and answering questions.

Meeting information included below:

Workshop #1

Date:	September 28, 2023 - completed

Workshop #2

Date:	October 19, 2023
Time:	9 a.m. - 11 a.m.
Virtual Access:	Microsoft Teams meeting Join on your computer, mobile app or room device Click here to join the meeting Meeting ID: 271 596 920 151 Passcode: kqxW4M Download Teams | Join on the web Or call in (audio only) +1 564-999-2000,,714030822#   United States, Olympia Phone Conference ID: 714 030 822# Find a local number | Reset PIN Learn More | Meeting options

 

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

• January 4, 2023 Proposed draft changes to WAC 246-310-720 and WAC 246-310-745 by Harborview Medical Center (PDF)
• May 27, 2022 Initial proposed draft changes to WAC 246-310-720(2) (PDF)

Rule activities 

• Draft language for WAC 246-310-720(2) - proposal withdrawn based on feedback received during Workshop #1.

Rule petition documents

• Harborview Medical Center rule amendment (PDF)

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

• December 2, 2022 CR-103 adopted rule change to WAC 246-310-290(8)(e) (PDF) 
• July 6, 2022 Updated proposed draft changes to WAC 246-310-290(8)(e) (PDF) 
• June 22, 2022 Updated proposed draft changes to WAC 246-310-290(8)(e) (PDF)
• May 27, 2022 Initial proposed draft changes to WAC 246-310-290(8)(e) (PDF)

Rule activities 

• August 25, 2022 Written comment provided by Dennis Barnes (PDF)
• August 25, 2022 Written comment provided by Susan Young (PDF)
• August 25, 2022 Written comment provided by Carollynn Zimmers (PDF)
• Sample methodology reflecting proposed change of July 6, 2022 (PDF)
• Draft language received for WAC 246-310-290(8)(e), as of June 21, 2022 (PDF)
• Sample methodology reflecting proposed change (PDF)

Rule petition documents

• None received at this time.

Stakeholder meetings

Agenda and other relevant material will be provided prior to each meeting. Meetings 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. See the Rules Activities section above. 

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. Meetings 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. Meetings 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

• November 1, 2022 Written comments submitted by Fresenius Medical Care (PDF)
• October 13, 2022 Written comments submitted by Kaiser Permanente (PDF)

Stakeholder meetings

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

• Written comments submitted by the Home Care Association of Washington (PDF). 

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. Meetings 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)