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.

2019 DFR Preview Schedule

The University of Michigan Kidney Epidemiology and Cost Center (UM-KECC) has announced the DFR Quarterly Update schedule for the rest of FY2020 (CY2019).  Facilities will preview their FY2020 annual DFR (for 2015-2018) during July 15-August 15, 2019, their Q1 2019 Quarterly DFR Update (for January-March 2019) during November 1-15, 2019, their Q2 Quarterly DFR Update (for January-June 2019) during February 1-15, 2020, and their Q3 Quarterly DFR Update (for January-September 2019) during May 1-15, 2020.  The DFRs and facility comments will be released to state surveyors on September 1 and December 1, 2019, and March 1 and June 1, 2020, respectively.

The DFR and Quarterly Updates will be available for preview and comment on http://www.dialysisdata.org.  Authorized users may submit comments about the report on the Dialysis Data secure website by using the forms “Comments on DFR for UM-KECC” and  “Comments on DFR for State Surveyor.”  All comments submitted for state surveyors will be appended to the DFR and made available to surveyors.  Do not include questions for UM-KECC in comments intended for the state surveyors.  All Dialysis Data website MAH passwords were reset, and all user accounts were disabled in December 2018.  If you haven’t already, facility MAHs must log into their master account to re-enable facility user accounts and grant permissions prior to July 15, 2019.

The Dialysis Data Helpdesk welcomes questions and comments about the DFRs and suggestions for future reports of this type, at 1-855-764-2885 or DialysisData@umich.edu.

New CMS Transplant Center Survey Protocol Manual

CMS has added a new Appendix X to their State Operations Manual, detailing Interpretive Guidance and Survey Protocols for Organ Transplant Program Conditions for Participation, effective May 24, 2019.  Find a copy at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R189SOMA.pdf.

4/1 NW16 WA Revised CoN Application Form

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

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.