Improving Organ Transplantation in the United States—A Regulatory Perspective
Article first published online: 6 OCT 2008
© 2008 The Author Journal compilation © 2008 The American Society of Transplantation and the American Society of Transplant Surgeons
American Journal of Transplantation
Volume 8, Issue 12, pages 2503–2505, December 2008
How to Cite
Hamilton, T. E. (2008), Improving Organ Transplantation in the United States—A Regulatory Perspective. American Journal of Transplantation, 8: 2503–2505. doi: 10.1111/j.1600-6143.2008.02446.x
- Issue published online: 11 NOV 2008
- Article first published online: 6 OCT 2008
During the next 3 years, survey teams under Centers for Medicare and Medicaid Services (CMS) guidance will visit each hospital transplant center in the United States for an on-site review to assess the extent to which the transplant center fulfills key expectations set forth in regulation. The regulation itself was recently promulgated through a 3-year public process. As the surveys are underway now, it is appropriate to step back and seek perspective on both the challenges and opportunities inherent in these developments.
The wellspring of regulation is a failure. Usually repeated, systemic failure. Whether it is the Enron-WorldCom collection of overconfident, extralegal excesses or the recent subprime mortgage market mess in the United States, when a system experiences failure in serious form, uncorrected by any internal self-righting process, then public opinion tends to coalesce in the conclusion that external regulatory processes ought to be imposed or strengthened.
The organ transplantation failures recounted in the American Society of Transplant Surgeons (ASTS) article do not, by any means, indicate systemic problems of the magnitude suggested by the Enron or subprime mortgage examples above. Nonetheless, they were serious failures. The failures directly affected the well-being of many patients. They undermined public confidence. They caused CMS, Congress and payors to question safety, judgment and effectiveness. And they threatened to undermine the vital contributions of donors, families and friends, as donors questioned both fairness and efficacy of the system.
Will these publicized failures—and CMS' regulatory response—lead to a better system or to a sluggish and more costly system of lowered effectiveness? These are important questions, for regulatory systems themselves may fail. This is why the very active participation of the ASTS in CMS' development and implementation of the transplant center regulation has been so important. The consistently constructive ASTS input has been, unquestionably, invaluable. We sincerely thank ASTS members for their countless hours devoted to improving regulatory oversight as we work toward the shared goal of an improved health care system.
One hallmark of failed systems is the lack of an effective feedback mechanism that regularly streams the system performance and analysis back to practitioners and management. A second hallmark is the failure of management to design and support such feedback systems, or the failure of management to take advisable and timely corrective action. Why did a California hospital fail to inform applicants that the hospital was turning away organs and not performing transplants? Why did it do so for an extensive period of time? Why did it require an outside party (CMS) to act before the nonfunctioning program was discontinued? And why have other transplant centers continued to operate for long periods with poor transplant or survival outcomes, apparently without effective efforts to address the sub-par performance?
The above observations lead directly to a very important aspect of CMS' new transplant regulations—the requirement that every transplant center maintain a data-driven ‘Quality Assessment and Program Improvement (QAPI)’ system to monitor and improve performance. It is an action-oriented requirement. It obliges each transplant center to ‘take actions that result in performance improvement and track performance to ensure that improvements are sustained’ (1). As a key element of any learning organization, the QAPI system can help fulfill the old adage ‘If you lose the patient, don't lose the lesson’. In this spirit, the regulation requires ‘a thorough analysis of…any adverse event’, as well as use of that analysis ‘to prevent repeat incidents’ (2). In this spirit, CMS and State surveyors ask, of any serious failing, whether the transplant center's QAPI system has analyzed the phenomenon and whether the hospital management has made use of the QAPI analysis to affect system improvement. It is striking how many of the well-publicized organ transplant failures have involved the lack of an effective internal feedback and analysis system, or management's failure to heed and act on important information.
CMS oversight ought to strengthen the role of internal, self-correcting systems in today's hospitals, particularly the Quality Assessment and Program Improvement system.
Ironically, self-governing systems tend to work better if there is an objective external enforcer whose actions are viewed by participants as worse than self-government. CMS plays the role of external reviewer whose potential enforcement actions make self-governed alternatives quite attractive. This layered strategy—internal QAPI and governing body expectations on the part of hospitals combined with external oversight—is an important aspect of CMS' regulatory approach.
Effective internal learning systems can make external quality assurance less necessary. Our hope is to make CMS' survey & certification system as unnecessary as possible. Expect surveyors, therefore, to inquire about the transplant center's internal QAPI system and management's response to the findings and feedback. The functioning of QAPI systems, together with outcomes data, will also influence the frequency of federal surveys once the initial 3-year phase-in of the new regulations is accomplished.
Table 3 of the ASTS article conveys some of the most frequently cited deficiencies found in the first 6 months of CMS surveys. These citations match up well against many of the well-publicized issues found in recent years, such as verification of ABO, adherence to selection criteria and QAPI deficiencies.
In the next 6 months we can expect the issue of poor outcomes to become more salient. With certain exceptions (3), risk-adjusted 1-year patient and graft survival data that evidence outcomes below a specified tolerance limit (e.g. observed deaths 50% greater than expected deaths at a one-sided p-value less than 0.05) (4), represent serious findings that will generally lead to a notice of proposed disapproval of an initial application (or proposed, prospective termination from Medicare participation for a currently participating program) subject to appeal. CMS may also consider ‘mitigating factors’ (5), if the outcome requirements are not met, such as the effect of factors beyond the control of the hospital, the extent of the outcomes deficiency, the outcomes trendline and evidence that QAPI and management actions are having a substantial positive effect on that trendline. We will post more information on the ‘mitigating factors’ provision, on the CMS website at: http://www.cms.hhs.gov/CertificationandComplianc/20_Transplant.asp.
With the above perspective in mind, we may consider the ASTS concern that CMS regulations may lead to excessive time spent on documentation in the medical record. The regulation's emphasis on documentation derives from a desire for objectivity and systems improvement. Surveyors base their reviews on actual observation and evidence (rather than hearsay, theory or supposition). Surveyors therefore review a sample of medical records to determine the extent to which policies are actually followed. But they also interview transplant recipients, and we instruct surveyors to be open to other evidence that may be supplied by the transplant center to show that a policy was indeed followed.
If the regulations lead to increased documentation, whether such increased documentation is a concern and leads to increased and unwarranted net cost will depend on (a) the hospital's internal efficiency in capturing data and (b) the extent to which the data can and are used for internal management and systems improvement—such as in the hospital's QAPI system. Data used internally to improve outcomes or satisfaction (e.g. by donors, recipients, staff) may create offset savings that can at least mitigate any added expense. We accept the criticism about documentation and note the value of tracking this concern over time to see the actual net effect.
One irony of the well-publicized problems cited in the ASTS article is that they have occurred in the larger context of remarkable successes in organ donation and organ transplantation throughout the United States. More people are benefiting from organ transplants than ever before. More lives are being saved (or extended) than ever before. Certain organ transplants are effectively accomplished today that never would have been possible (or even attempted) in any recent period called ‘yesterday’. Such irony makes it even clearer that we ought hasten toward a day of increased confidence and assurance that we have the fairest, most just, most accessible and most effective organ transplant system in the United States that our collective efforts can sustain. We look forward to continuing work with ASTS, the Health Resources and Services Administration (HRSA), the Organ Procurement Transplantation Network (OPTN) and the dedicated transplant professionals throughout the country to achieve this goal.
- 142 CFR 482.96(a), CMS CoP Final Rule Section Headings; Title 42—Public Health, Chapter IV—Centers for Medicare and Medicaid Services, Department of Health and Human Services, Part 482—Conditions of participation for hospitals, Quality Assessment and Performance Improvement (QAPI).
- 242 CFR 482.96(b)(2), CMS CoP Final Rule Section Headings; Title 42—Public Health, Chapter IV—Centers for Medicare and Medicaid Services, Department of Health and Human Services, Part 482—Conditions of participation for hospitals, conditions of participation for hospitals, Quality Assessment and Performance Improvement (QAPI).
- 342 CFR 482.80(c),(d), CMS CoP Final Rule Section Headings; Title 42—Public Health, Chapter IV—Centers for Medicare and Medicaid Services, Department of Health and Human Services, Part 482—Conditions of participation for hospitals, heart-lung, intestine, and pancreas transplant programs. Data submission, clinical experience, and outcome requirements for initial approval of transplant centers.
- 442 CFR 482.82(c), CMS CoP Final Rule Section Headings; Title 42—Public Health, Chapter IV—Centers for Medicare and Medicaid Services, Department of Health and Human Services, Part 482—Conditions of participation for hospitals, data submission, clinical experience, and outcome requirements for re-approval of transplant centers.
- 542 CFR 488.61(a)(4), 488.61(b)(2), and 488.61(c)(4), CMS CoP Final Rule Section Headings; Title 42—Public Health, Chapter IV—Centers for Medicare and Medicaid Services, Department of Health and Human Services, Part 482—Conditions of participation for hospitals, special procedures for approval and re-approval of organ transplant centers.