CMS Regulatory Changes: How Transplant Programs Are Reviewed

We were pleased to have Dr. Daniel Schwartz from CMS present at CEoT 2017 as part of our “Transplant Value- How to Survive the Next Decade” session. Dr. Schwartz focused his presentation on valuing the public payor perspective in transplantation. As part of his talk, he provided an overview of the recent CMS regulatory changes regarding how transplant programs outcomes requirements are reviewed. I asked Dr. Schwartz to write a blog on this topic to ensure that this information is reaching our members who were unable to join us in Phoenix for the CEoT meeting, as it impacts all of us.

The Centers for Medicare and Medicaid Services (CMS) Survey and Certification Group specified changes to policy for enforcing the transplant center outcomes regulation at CFR 42 482.82  in its S&C Memo 17-13-Transplant released on December 16, 2016.  As of January 2017, CMS no longer looks at outcomes from any previous Scientific Registry of Transplant Recipients (SRTR) reports to determine compliance with the regulation.  Beginning with the January 2017 SRTR report, programs with observed/expected outcomes (O/E) greater than 1.85, O-E of greater than 3, and a one-sided p value of less than 0.05 (outcomes non-compliance), are now notified of their outcome results by CMS.  Simultaneously, CMS will request more recent data from the SRTR to determine if the program outcomes are improving or declining, and:

•  If the subsequent SRTR report shows that program to be back in compliance, no further action will be taken. 
•  If, however, the next SRTR report (two consecutive reports) shows outcomes non-compliance, CMS will again review more recent data to determine if the program outcomes are improving or declining.

If a transplant program’s outcomes are not improving, CMS will consider the program to be non-compliant at a Condition level, and an on-site survey may be scheduled to review/identify associated process requirement concerns.  Outcomes non-compliance, as well as any additional deficiencies identified at the time of the on-site survey, will be cited upon completion of the survey.  If an on-site survey is not conducted, the program will be notified of its outcomes non-compliance by letter, with findings documented on form CMS-2567.

There are multiple ways these changes will impact transplant programs, including:

• Programs must be out of compliance on two consecutive SRTR reports to be at risk of being cited for outcomes non-compliance.
• Programs with more current SRTR data showing improved outcomes will no longer be automatically cited at a Condition level if their outcomes are not in compliance on two consecutive SRTR reports. 

These changes place a premium on a program’s ability to monitor their outcomes data and make necessary improvements to prevent recurrent adverse events. 

If you have any feedback on the updated regulations, please feel free to share your thoughts in the comments section.