• Compliance;
  • Medicaid;
  • Medicare;
  • regulatory issues;
  • transplant

Two concerns expressed by the American Society of Transplant Surgeons (ASTS) are that (1) the new Medicare regulations for transplant hospitals take a ‘punitive’ approach and that (2) the outcome requirement may thwart innovation by not including certain risk factors into the risk adjustment used to calculate expected outcomes. This article explains efforts by the Centers for Medicare & Medicaid Services (CMS) to encourage quality improvement. CMS limits outcomes-related enforcement to situations where failure rates exceed certain substantial ‘tolerance limits’, ensuring opportunity for quality improvement to be effective prior to enforcement. Transplantations involving a disproportionate share of risk factors not incorporated into the risk-adjustment methodology can also be raised through CMS’‘mitigating factors’ process. Of the 22 mitigating factor requests completed through March 10, 2009, 7 raised issues of risk adjustment (none involved experimental protocols). Four of the seven requests were approved for other reasons (evidence of effective program changes and improved outcomes). CMS concluded that none of the seven made a persuasive case based on risk factors. The early data indicate that program deficiencies may outweigh risk adjustment issues. CMS agrees to consider the ASTS suggestions for future action and continues to monitor the situation in case a different pattern emerges.