CMS Issues Memo on Revised Guidelines for Solid Organ Transplant Program Outcomes Thresholds

Monday, May 16, 2016
CMS released a memo on Friday, May 13, 2016 to outline Revised Guidelines for Solid Organ Transplant Program Outcomes Thresholds. The memo is available for your review on the CMS website. Highlights include:
  1. The CMS regulation sets the outcomes threshold at 150% (1.5 times) the risk-adjusted expected number of one-year post-transplant patient deaths or graft failures.
  2. While the regulation is unchanged, CMS issues survey & certification guidance to interpret the regulations.
  3. CMS Survey and Certifications operations make a distinction between serious (“condition level”) and less serious (“standard level” deficiencies).
  4. Programs are generally NOT at risk of losing Medicare if the only deficiency is a standard level deficiency.  No mitigating factors approval is necessary if that is the only deficiency.
  5. Previously, a condition-level outcomes deficiency was cited if the 1.5 threshold was crossed over in the most recent SRTR report and 1 or more additional SRTR reports in the past 2.5 years (i.e., “two-flags”), provided the outcomes are also statistically significant (p <.05) and numerically meaningful (O – E > 3)
  6. With the change announced in this Memorandum, effective immediately, the condition level deficiency will apply only if there are two or more flags (“two -flags”), including outcomes from the most recent SRTR report, with outcomes higher than 1.85 . There are a variety of situations in which a program might be flagged for outcomes that are above the 1.5 threshold, but where only a standard level deficiency would apply.  For example, for programs that have outcomes above 1.5 (with results also statistically and numerically significant), there will generally only be a standard level deficiency (rather than condition level) when the only deficiency is an outcomes deficiency, and there is:
  • One flag between 1.5 and 1.85;
  • Two-flags between 1.5 and 1.85 and all other flags in the period are lower than or equal to 1.85;
  • One-flag above 1.85 in the past 2.5 years (i.e., which could include the most recent SRTR report where the number of one-year patient deaths or graft failures was greater than 1.85), or
  • One or more flags above 1.85 but the flag in the most recent SRTR report is between 1.5 and 1.85, or lower.
Please take some time to consider the charts in the memo, which seek to offer a clear, concise description of this guidance.
CMS citation thresholds have consistently, and purposely, been set to flag fewer programs, and with a CMS citation occurring only after 2 flags, compared with the flagging thresholds of the OPTN Membership & Professional Standards Committee.  This has been done in order to leave considerable space for the OPTN peer review processes to work, or at least allow the transplant programs a head start on program improvements before any significant CMS involvement on the outcomes dimension of the CMS regulation.