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CMS and OPTN Changes

CMS and OPTN Changes. Esther-Marie Carmichael, MT(ASCP), CLS, PHM Quality Assurance Manager, Transplant Institute. May 16, 2012. Federal Register, Change #8 – TC Process Amend the blood type and other vital data verification and documentation procedures (§ 482.92)

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CMS and OPTN Changes

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  1. CMS and OPTN Changes Esther-Marie Carmichael, MT(ASCP), CLS, PHM Quality Assurance Manager, Transplant Institute

  2. May 16, 2012 • Federal Register, Change #8 – TC Process • Amend the blood type and other vital data verification and documentation procedures (§ 482.92) • Removed requiring transplant team to verify blood type before organ recovery • Rationale: (redundancy) • OPO rule requires donor verification (§ 486.344(d)(2)(ii) and § 486.344(e) • Intended recipient can change before transplant • December 10, 2013,OPTN released recommended forms for living donor and recipient – CMS reviewed

  3. February 7, 2013 FR Publication • Goal is to promote: • Streamlined, effective and efficient regulatory framework • Economic growth, innovation, job-creation and competitiveness • Ongoing retrospective review to identify rules that can be eliminated as obsolete, unnecessary, burdensome or counterproductive.

  4. February 7, 2013 FR Publication • Transplant Centers (TC) and OPO reports to CMS • TC outcome review • TC volume and clinical experience requirements • TC re-approval

  5. February 7, 2013 FR Publication • OPO technical corrections to the CoPs • OPO service area size designation and documentation requirements • Designation of one OPO for each service area • Evaluation and management of potential donors and organ placement and recovery

  6. February 1, 2013 CMS/OPTN Crosswalk • Summary • Development of Transplant Policy Crosswalk between CMS, HRSA and OPTN contractor, UNOS • Ongoing effort to address survey process and overlap • Material is informational designed to assist surveyors to better understand OPTN requirements and the manner in which CMS and OPTN requirements mesh

  7. February 1, 2013 CMS/OPTN Crosswalk • OPTN and CMS review the transplant programs with separate and unique • Intent • Criteria • Responsibilities • to the transplant community and the public

  8. February 1, 2013 CMS/OPTN Crosswalk • Advisory Committee on Transplantation (ACOT) in 2011 focused on alignment between CMS and OPTN • Regulatory • Policy changes • Process changes • Standardized documentation • The transplant crosswalk was the first deliverable

  9. February 1, 2013 CMS/OPTN Crosswalk • Requirements are divided into four types • Administrative – program operations, infrastructure and management • Clinical – patient care • Human Resources – staffing • Quality Assessment and Performance Improvement (QAPI) – quality improvement

  10. February 1, 2013 CMS/OPTN Crosswalk • Crosswalk Guide to OTN and CMS Reviews of Transplant Programs http://optn.transplant.hrsa.gov/content/policiesAndBylaws/evaluation_plan.asp • Crosswalk Guide to OPTN & CMS Transplant Programs Oversight http://optn.transplant.hrsa.gov/ContentDocuments/CMS-OPTN_Crosswalk_Attachment.pdf

  11. April 16, 2013 Evaluation Plan Updated • Evaluation Plan http://optn.transplant.hrsa.gov/ContentDocuments/Evaluation_Plan.pdf • Change Log http://optn.transplant.hrsa.gov/ContentDocuments/Evaluation_Plan.pdf#nameddest=Change_Log

  12. February 1, 2013 OPTN Living Donor Policy 12.0 (revised) • Policy expanded from 11 pages to 19 • Living Donation (12.1 to 12.6) • Packaging of organs, vessels and tissue typing materials, including transportation (12.7) • Reporting requirements living donor (12.8) • Long-term Care or Support of Living Donors (12.9) • Required protocols for kidney recovery hospitals (12.10) • Required protocols for liver recovery hospitals (12.11)

  13. April 5, 2012 Survey and Certification Letter – Sequestration Effect • Summary • Sequestration took effect March 1, 2013 • Priority is to maintain public protection and State survey agency (SA) functions are central to that priority • Memo describes adjustment made that affect SA operations intended to accommodate sequestration

  14. April 5, 2012 Survey and Certification Letter – Sequestration Effect • Protect SA ability to continue onsite complaint investigations and surveys of existing providers • Complaint investigations • Only when allegations, if substantiated would lead to condition-level or immediate jeopardy findings.

  15. April 5, 2012 Survey and Certification Letter – Sequestration Effect • Allowed • Reducing expenses • Suspending workload additions • Reducing time spent on low risk areas • Reducing CMS Central Office services • MCS budget reduction 5% from FY 2012 $19 million

  16. April 5, 2012 Survey and Certification Letter – Sequestration Effect • Transplant Programs • Reducing frequency of onsite recertification from 3 years to 4 to 6 years, while maintaining CMS continuous monitoring of PSR • SA survey work will transition to a National Contractor • No mention of effect on OPO

  17. May 10, 2013 Survey and Certification Letter – SRTR Delay • January and July SRTR PSR delayed • CMS and SSA need to address availability of Social Security Mater Death File (SSMDF) used to calculate PSR reports. • Regulations require CMS to use the most recent PSR for determining compliance with outcome requirements. • July 2012 will be used to determine compliance until further notice • Mitigating Factor approval prior to prospective termination date for programs with condition-level deficiencies

  18. April 2013 UNOS Forum Survey Process Changes • Presented by Healthcare Management Solutions, LLC • Report to CMS Central Office • State Agencies report to CMS Regional Offices • Also perform Federal monitoring surveys

  19. Rational for Change • Improve efficiency • Provide consistency • Provide a more in-depth meaningful survey that integrates transplant outcomes data and Quality Assessment and Performance Improvement (QAPI) • Increase surveyor confidence in performing transplant surveys • Move from a paper driven process to active investigation

  20. Change Goal • Provide focused observations and interviews to find the real issues within a transplant program • Provide opportunities for surveyors to spend time in areas that yield results • Reduce sample size for record reviews

  21. Survey and Certification Group Internet Link http://www.cms.hhs.gov/SurveyCertificationGenInfo/

  22. Survey and Certification Group Internet Link http://www.cms.hhs.gov/SurveyCertificationGenInfo

  23. CMS Transplant Website • Transplant Regulations http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/transplantcenters.html • Transplant http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Transplant.html

  24. Conclusion • Change is inevitable and unpredictable • Change tests our • Nimbleness • Willingness • Readiness • “Ever Ready” for survey with a robust QAPI program. Are YOU Ready?

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