8/1 WA CoN Waiver Extension

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.

5/26+ CMS Shareholder Engagement Calls

CMS is hosting weekly Stakeholder Engagement sessions to share information related to the agency’s response to COVID-19.  These sessions are open to the healthcare community and provide updates, share best practices, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.  Conference lines are limited so we encourage you to join via audio webcast on your computer or smartphone web browser.  You are welcome to share this invitation with your colleagues and professional networks, but these calls are not intended for the press.  Call recordings and transcripts are posted on the CMS podcast page at: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.

Targeted Updates for Dialysis Organizations on the agency’s latest COVID-19 guidance, also featuring leaders in the field sharing best practices, with an opportunity to ask questions if time allows.  Wednesday May 27, 2020, 2:30-3:00 pm PDT, toll-free 833-614-0820, passcode 6152699, audio webcast link https://engage.vevent.com/index.jsp?eid=5779&seid=2123#/main/simplify.

COVID-19 Office Hours Calls are an opportunity for providers to ask questions of CMS officials about temporary actions that allow increased capacity, expanded workforce, patient priority, and telehealth.  Tuesday May 26, 2020, 2-3pm PDT, toll-free 833-614-0820, passcode 8977438, audio webcast link https://engage.vevent.com/index.jsp?eid=5779&seid=2012#/main/simplify.

Lessons from the Front Lines with representatives from CMS, FDA, and the Coronavirus Task Force, along with front-line clinicians.  Friday May 29, 2020, 9:30-11:00 am PDT,  toll-free 877-251-0301, passcode 6350189, audio webcast link https://engage.vevent.com/index.jsp?eid=5779&seid=2075#/main/simplify.

6/1 Comments Due on CMS Flexibility Rules Change

CMS has published an Interim Final Rule with Comment Period on the Flexibility changes in Medicare rules made on March 31, 2020.  The Comment Period will expire June 1, 2020.  For details and comment see Medicare and Medicaid Programs: Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency at https://www.regulations.gov/document?D=CMS-2020-0032-0013.

CMS 4/8 Press Release on Infection Control Guidance

CMS has published an April 8, 2020 press release, on CMS Issues New Wave of Infection Control Guidance Based on CDC Guidelines to Protect Patients and Healthcare Workers from COVID-19 (1), that emphasizes dialysis facilities, but does not link to ESRD Guidance directly, instead linking to general pages on Current Emergencies (2), and on Coronavirus Waivers and Flexibilities (3).  The relevant document on the Waivers page, ESRD Facilities: CMS Flexibilities to Fight COVID-19 (4), is up to date.  The relevant document on the Emergencies page is now up to date; it’s labeled April 8, but it’s the current, revised (March 30) version of the ESRD survey guidance document (5), Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Dialysis Facilities.  This document includes FAQs for Special Purpose Renal Dialysis Facilities on pp.7-9.

Links:

  1. April 8 press release – https://www.cms.gov/newsroom/press-releases/cms-issues-new-wave-infection-control-guidance-based-cdc-guidelines-protect-patients-and-healthcare.
  2. CMS Current Emergencies page – https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page.
  3. CMS Coronavirus Waivers and Flexibilities page – https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.
  4. Current, March 28, version of ESRD Flexibilities documenthttps://www.cms.gov/files/document/covid-19-esrd-facilities.pdf.
  5. Current, March 30, version of Survey Guidance document – https://www.cms.gov/files/document/qso-20-19-esrd-revised.pdf.

NW16 WA Suspension of CoN until 4/29

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.

CMS Survey Reprioritization

On March 23, 2020, CMS published a summary of their inspection of a Kirkland WA SNF and the changes they are making to Survey priorities as a result.  Find:

New CDC HAN and COVID-19 News

  • CDC has issued a new HAN Health Alert on the COVID-19 Coronavirus, titled Updated Guidance on Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19).  Find it at https://emergency.cdc.gov/han/2020/han00429.asp.  See next post for more information.

>2/21 Revised CMS State Operations Manual

CMS has published revisions to the State Operations Manual, including Appendix H – ESRD Facilities, Appendix X – Organ Transplant Program, and Appendix Z – Emergency Preparedness.  Find the revised Manual, which is effective as of February 21, 2020, at https://www.cms.gov/files/document/r200soma.pdf.  The 700-page manual lacks page numbers or other indications of which appendix you’re reading, but online PDF readers provide page counts in the upper left-hand corner, or at the top of the screen.  Changes include:

  • pp. 175ff: Appendix H – ESRD Facilities.  Guidance to Surveyors in Appendix H is extensively revised throughout, including updates to the regulatory text based on requirements set forth in the 2008 Conditions for Coverage and revisions based on recent Federal Fire Safety Requirements.
  • pp. 614ff: Appendix X – Organ Transplant Programs.  Revisions include Survey Protocol Tasks, and occasional other revisions scattered throughout.
  • pp. 657ff: Appendix Z – Emergency Preparedness.   Major revisions are included throughout.

CMS Coronavirus Prevention Preparations

CMS has advised that, in response to the Wuhan Coronavirus threat, it will be taking steps to assure that infection control procedures are up to date, and being followed, by all Medicare-asssociated healthcare facilities in the US, and by the State Survey Agencies that monitor them.  Find details at https://www.cms.gov/newsroom/press-releases/cms-prepares-nations-healthcare-facilities-coronavirus-threat.