Last revised date: November 6, 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
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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.
Winter Workshop Sessions
A second set of workshops is anticipated for Winter 2024. More information on these workshop dates, times, and registration will be announced via GovDelivery.
Past Workshops
To access comments related to this work email the Certificate of Need rules team.Workshop Date and Time #4 Thursday, August 8, 2024, 4 p.m. - 6 p.m. #3 Wednesday, August 7, 2024, 9 a.m. - 11 a.m. #2 Thursday, August 1, 2024, 4 p.m. - 6 p.m. #1 Tuesday, July 30, 2024, 9 a.m. - 11 a.m. - Kidney Dialysis Temporary Emergency Situation Exemption
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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
- WSR 23-16-038 CR-101 (PDF)
- WSR 24-10-087 CR102 (PDF)
- WSR 24-18-006 CR103P (PDF)
- Concise explanatory statement (PDF)
Comments on CR-102 Proposed Rule Language
Draft Rules and Rules Workshops
- Workshop #1:
- 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)
- Workshop #3:
- Workshop #4:
Public Comment
ESRD Rule-making Comments on SSB 5569
- Percutaneous Coronary Intervention (PCI) Rules 2024
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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
- 07/08/2019 Harborview's petition to amend WAC 246-310-720 and 246-310-745 (PDF)
- 10/06/2023 Providence's petition to amend WAC 246-310-720 (PDF)
Correspondence with UW Harborview regarding the 2019 Petition
- 09/03/2019 Department's response to Harborview's petition (PDF)
- 01/04/2023 Harborview's letter to the department (PDF)
- 01/04/2024 Harborview's letter to Dr. Shah (PDF)
- Attachment to 01/04/2024 letter, Harborview's Mission Statement (PDF)
- Attachment to 01/04/2024 letter, National Cardiovascular Data Registry Heat Map (PDF)
- 01/18/2024 Department's response to Harborview (PDF)
Draft Rules and Workbooks
- 09/03/2024 Draft rules (PDF) and workbook (PDF)
- 05/24/2024 Draft rules (PDF)
Rule Activities
Public Comment
- 06/07/2024, from MultiCare Health System (PDF)
- 06/07/2024, from Providence (PDF)
- 10/25/2024, from MultiCare Health System (PDF)
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:
- Presentations
- Meeting 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:
- Presentations
- Proposal
#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:
- Presentations
- Definition suggestions
- Meeting Notes (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:
- 07/24/2024, from Health Facilities Planning and Development (PDF)
- 08/05/2024, from MultiCare Health System (PDF)
#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
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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
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
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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. 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
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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
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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
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None at this time.
Rule activities
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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
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- Ambulatory Surgery Rule-making Activities
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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
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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
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- Kidney Dialysis Need Forecasting Methodology and Standards
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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. 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
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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
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None at this time.
Rule activities
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None at this time.
Rule petition documents
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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
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- Home Health Need Forecasting Methodology and Standards
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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
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None at this time.
Rule activities
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None at this time.
Rule petition documents
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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.
Listening session #3- CanceledNovember 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
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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
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None at this time.
Rule petition documents
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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
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- Rulemaking Kickoff Presentation
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May 25, 2022 Rulemaking Kickoff Presentation (PDF)
- Chapter 246-310 WAC Certificate of Need
- Tribal Notification
More agency rule resources
- Department of Health Rule Making
- State Board of Health rules
- Other Department rules in Washington Administrative Code Title 246
Contact and connect
- CN program contact us
- To receive Certificate of Need information, subscribe for updates at the bottom of the page.