Category Archives: Certificate of Need

11/7+ WA DOH ESRD Listening Session Postponed

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The WA DOH Certificate of Need Listening Session on ESRD scheduled for November 7, 2022 has been cancelled. The Session scheduled for January 10, 2023 will be held as scheduled, but it will focus on discussing suggestions made in the September and October Sessions. DOH continues to encourage written feedback emailed to CNRulemaking@doh.wa.gov. For more information, click on “Kidney Dialysis Need Forecasting Methodology and Standards” at https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/certificate-need/rule-making-activities. Register for the Microsoft Teams January Session at https://teams.microsoft.com/registration/F-LQEU4mCkCLoFfcwSfXLQ,BBAH3n6VPECO3MVQUjgblQ,vGeM3yDv3U6DPwOdGzAjOQ,MQCmGfFZhEOvTBzEH5N5cw,Yde-jczsu0-eUoa3-rb1Ng,EDeXZX-YtUSp7M2uzTRaxw?mode=read&tenantId=11d0e217-264e-400a-8ba0-57dcc127d72d&webinarRing=gcc&skipauthstrap=1.

9/15+ WA CoN Listening Sessions

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The Washington State Department of Health will hold Listening Sessions to collect information about any changes that stakeholders want to Certificate of Need rules, to be held on September 15, October 12, and November 7, 2022, and January 10, 2023. For more information, click on “Kidney Dialysis Need Forecasting Methodology and Standards” at https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/certificate-need/rule-making-activities. Register for the September 15 session at https://us02web.zoom.us/webinar/register/WN_PoX97gk4Rr-aRphWgWzEtg. Links to future sessions will be posted at the doh website above.

8/28+ WA Only: FAQ re End of COVID CofN Waivers

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Certificates of Need and Construction Reviews for ESRD facilities in Washington State were waived to allow a faster response to the COVID-19 pandemic. On August 1, 2022, Washington DOH announced that those waivers would end, and provided a timeline for that process, as described at https://nwrnbulletins.wordpress.com/2022/08/03/8-4-wa-only-covid-cofn-waivers-to-end/. Washington DOH has added a web page of Frequently Asked Questions about the process, at https://doh.wa.gov/sites/default/files/2022-08/FAQ-COVID-19WaiverOffboarding.pdf. The timeline includes August 28 deadlines.

8/4+ WA only COVID CofN Waivers to End

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Urgent information about COVID waivers: Early in the COVID-19 pandemic, Governor Inslee issued Proclamation 20-36 which waived certain certificate of need (CN), construction review (CR), and facility licensing requirements to allow health care facilities to rapidly adapt and expand to meet the demands for surge capacity. The Governor has announced his intent to rescind Proclamation 20-36 on October 27, 2022. Facilities that utilized the waivers to address surge must either revert their operations or take immediate action to move toward compliance by October 27, 2022. WA DOH will provide health care facilities a glide path to come into compliance, but you must act quickly to submit letters of intent and applications as described below. If your health care facility took advantage of the waivers in Proclamation 20-36 and you plan to maintain these changes beyond October 27, 2022, you must comply with state law applicable to your license type. This could include obtaining a certificate of need, obtaining construction review approval, and/or updating your license.

For those facilities requiring a Certificate of Need:

  1. By August 28, 2022, facilities must submit a Letter of Intent to WA DOH conforming to WAC 246-310-080. Letters of Intent must describe the increase in capacity and/or new locations the facility wants to maintain and be accompanied by a patient transition plan should DOH not approve the application. Send the Letter of Intent to COVIDwaiver@doh.wa.gov.  
  2. By October 27, 2022, facilities must submit a CN application and the appropriate fee to WA DOH following existing CN application processes and requirements. Facilities must also submit applications to modify their facility license within this same timeframe, as appropriate. If your CN application is denied, you must execute your patient transition plan and revert your operations to your previously approved CN.
  3. Exception: Health care facility types on a concurrent review cycle for CN applications (including ESRD facilities) will be required to submit a second Letter of Intent, CN application, and appropriate fee in compliance with WA DOH’s published schedule the next time the application cycle opens. Facilities must also submit applications to modify their facility license within this same timeframe, as appropriate. If your CN application is denied, you must execute your patient transition plan and revert your operations to your previously approved CN.

For those facilities requiring Construction Review:

  1. By August 28, 2022, facilities must submit a construction review application to COVIDwaiver@doh.wa.gov and appropriate fee. Applications must include a clear description of the scope of work (physical changes, additions, renovations) made to the facility.
  2. By October 27, 2022, facilities must submit formal engineering plans, functional programs, and associated documentation needed to evaluate compliance with the state licensing rules OR submit a technical assistance application to WA DOH to confirm the scope of work and establish documentation requirements. Facilities must respond quickly and in good faith to correct non-compliant construction, eliminate hazards within the environment and complete the review project.
  3. By January 25, 2023, and every 90 days after that until the project is fully approved, submit to WA DOH quarterly progress reports that address project status, updates since the last report, and planned completion date.

Following the process above will not adversely affect a facility’s CN, CR, or license application. Failure to follow the steps outlined above will be considered non-compliance and the department may take appropriate enforcement action. If you have any questions about what actions you should take now, technical assistance is available at COVIDwaiver@doh.wa.gov.

Informational Webinars: WA DOH will also host webinars about the glide path described above on the following dates:

7/26 Survey re COVID Expansion

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Washington State Governor’s Proclamation 20-36 waived portions of the CoN statutes and rules to allow providers to expand and/or establish new services to meet COVID-19 treatment and quarantine needs. Washington State DOH has now requested that Washington providers respond to a Survey if they changed their services as a result of this Proclamation. No date has been set for rescinding the Proclamation, but DOH is currently planning how and when to return to CoN-approved services, and needs to know how many facilities were involved, and the nature of their involvement, so they can coordinate their rescission plan. Find the Survey at https://fortress.wa.gov/doh/opinio/s?s=CoNPandemicTransitionPlan. The Survey must be completed by July 26, 2021.

8/1 WA CoN Waiver Extension

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The Washington State dialysis facility Certificate of Need waiver has been extended to August 1, 2020 or the end of the declared COVID-19 State of Emergency, whichever comes first.  Find details at https://www.governor.wa.gov/sites/default/files/proclamations/20-36.3%20-%20COVID-19%20HCF %20Ext%20%28tmp%29.pdf.

NW16 WA Suspension of CoN until 4/29

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Governor Inslee’s Proclamation 20-36 has waived Washington State Certificate of Need requirements for new health care infrastructure until April 29, 2020.  Dialysis facilities can without prior approval add stations where needed to help with isolation clinics, or to build out capacity at clinics that are not isolation clinics in order to move patients around to have the capacity needed at the isolation clinics.  For details see https://www.governor.wa.gov/sites/default/files/proclamations/20-36%20-%20COVID-19%20-%20DOH%20Health%20Care%20Facilities-Hand%20Sanitizer%20%28tmp%29.pdf.

4/1 NW16 WA Revised CoN Application Form

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Washington State DOH has revised the application form that providers and potential providers must use to request a Certificate of Need to build a new or expand an existing dialysis facility in Washington State.  Find a copy of the revised application at https://www.doh.wa.gov/Portals/1/Documents/2300/2019/ESRDApp2019.pdf.  Letters of Intent for the 2019 “Special Circumstances, Cycle One” review of CoN applications must be filed by April 1, 2019.  Call 360-236-2955 or email DOH at FSLCON@doh.wa.gov if you have questions.  For more information on Washington CoN, see https://www.doh.wa.gov/LicensesPermitsandCertificates/FacilitiesNewReneworUpdate/CertificateofNeed.

NW16 WA 2/15 CoN Data Submission

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Dialysis providers that wish to be considered during 2019 in Concurrent Review situations for Washington State dialysis facility applications must file specific information with the WA Department of Health Certificate of Need Program before February 15, 2019.  WA DOH has already downloaded information on Home Training, Shift Beginning After 5pm, SMR, and SHR from your DFC or DFR, and TPS from your QIP PSR.*  The additional information providers need to submit by February 15 includes:

  • From the DFR:
    • Nursing Home Patients from Table 1
    • Average Number of Comorbid Conditions from Table 12
  • From the Medicare Cost Report (MCR)
    • Net Patient Revenues from Worksheet F-1
    • Total Provider Treatments from Worksheet C

DOH encourages submission earlier than February 15 if possible.  Submission after February 15 will disqualify a provider from 2019 Concurrent Review Applications.

The applicable pages from these reports, for each dialysis facility owned or operated in Washington State, and for any out-of-state facilities that may potentially be used as a comparable facility, should be emailed to fslcon@doh.wa.gov in PDF format.  Though not required, a cover page that identifies which facilities are included is strongly recommended.

If any of the data elements above (from any of the DFR, DFC, MCR, or QIP) are unavailable for any reason, an exemption request can be submitted until February 28, 2019.  Valid reasons for an exemption could include, but are not limited to, any of:

  • A facility has opened too recently and data has not yet been published
  • Volumes at the facility are insufficient to generate a score
  • A change of ownership has taken place and valid data under your ownership and control does not yet exist

Regardless of the reason for your exemption request, it must be clear that absence of data is not a result of failure to report to CMS, and you must provide any applicable documentation.

Call DOH CoN at 360-236-2955 if you have any questions.

*PS: See our Acronyms table at https://nwrnbulletins.wordpress.com/abbreviations/ if we ever use abbreviations you don’t recognize.