Last revised date: January 23, 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 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
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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
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Workshop #1:
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Workshop #2:
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DRAFT ESRD Temporary Emergency Situation Exemption Rule (PDF)
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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)
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Workshop #3:
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Workshop #4:
Rule activities
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)
- NKC comments on January 16 Draft Rules (PDF)
- FMCNA comments on January 16 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 #4
Date:
January 4,2024 Time: 9 a.m. - 11 a.m. Virtual Access: Microsoft Teams meeting
Join meeting online via Microsoft Teams
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- 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 rulemaking petition 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.
Petition
Draft rules
- None at this time.
Rule activities
Public comment
- None at this time.
Rule workshops
The Certificate of Need program anticipates holding workshops to discuss potential rule changes beginning in March 2024. In the coming weeks, the Certificate of Need program will circulate a GovDelivery notice with dates for upcoming rule workshops on PCI rules. Prior to the first workshop, the Certificate of Need program will circulate draft rule language via GovDelivery for discussion at the first workshop.
Date:
To be determined
Time:
To be determined
Virtual Access:
- 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. 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
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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. See the Rules Activities section above.
- 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. 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
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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. 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
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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. 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
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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 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. 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
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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
Contact and connect
- CN program contact us
- To receive Certificate of Need information, subscribe for updates at the bottom of the page.