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Center Implications Related to Bayesian . OPTN Utilization? CMS Utilization? SRTR Production? Your Focus? . OPTN Adoption. Public Comment ended 12/2013 Regional and Committee comments mixed Not voted on by BOARD Doesn’t appear to be on June agenda . CMS Adoption Position.
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Center Implications Related to Bayesian OPTN Utilization? CMS Utilization? SRTR Production? Your Focus?
OPTN Adoption • Public Comment ended 12/2013 • Regional and Committee comments mixed • Not voted on by BOARD • Doesn’t appear to be on June agenda
CMS Adoption Position May 12 2014 Final Rule May 15 2014 Proposed Rule ‘Proposed Changes to Enforcement Provisions for Organ Transplant Programs’ “Strengthen, clarify & provide additional transparency …for transplant centers requesting approval…when the center does not meet one or more of the COPs” • Reports to CMS • Transplant Outcome Review • Volume & Clinical Experience Requirement • Re-Approval Process • No ‘automatic reviews’ • Mitigating Factors can occur at any time for Conditional • Not ‘approved’ for three years • Added an ‘example’ to MF • And..some OPO stuff
May 15- ‘Proposed’ Rule Basis & Provisions in this Proposed Rule 1.Expansion of Mitigating Factors based on CMS experience (yep, 3 days later) 2.Coordination of Efforts with OPTN and HRSA (Bayesian thrown under the bus….)
It is Not Part of the ‘Proposed’ Rules • The OPTN and HRSA are ‘considering adoption’ of Bayesian however, CMS has inefficient experience data to determine an appropriate threshold for a Medicare Outcomes deficiency – therefore, we are not proposing any changes in our regulations regarding this new methodology. • Therefore, IF a program has been cited for an outcomes deficiency by CMS, but has not been flagged by the OPTN, CMS would take these facts into consideration IF the program had requested approval for Mitigating Factors.
If OPTN Adopts…….Your New Weekend Plans? • Centers with major outcome issues and larger volumes • Flag by MPSC/PSR & Flag by CMS • Small and moderate size centers without enough patients to reach a p<.05, or O-E >3 thresholds but with a significantly elevated O:E ratio • Flag by MPSC/PSR but not by CMS • No Flag on MPSC/PSR or CMS, but identification as less than expected • COE status in jeopardy
Other Considerations • Decision as to when “Bayesian results become public will be made by HRSA with guidance from the SRTR Technical Advisory Committee” • Impact on Centers of Excellence Criteria unclear? Which method will they use if both become publically available. • Will SRTR move from a 3 to a 5 tier system Higher/As/Lower than Expected to Excellent…Very Good…Good…Fair…Poor • Access to Tools for Current Performance
Bayesian (?) To Do List • Identify & remedy barriers to improving actual Outcomes • First year care team? • First year care environment? • Deploy RCA-like process • Root Cause • Contributory Cause • Frequency
Outcomes To Do List • Focus on ‘current’ performance analysis as much as PSRs • O/E at or below 1.3 to avoid COE issues
To Do List • Who is in Year One? • Exactly How Many Failures Can Your Center Tolerate