Regulatory Policy

Payment Bundle Integrity

The Medicare program must protect the integrity of the ESRD bundle. First, KCP supports efforts to clarify what items and services are intended to be included in the current ESRD PPS. The scope of the bundle should be limited to those items and services that have been defined in rulemaking. In 2014, guidance resulted in an inappropriate expansion of the bundle, which led Part D plans not to provide medically necessary medication to patients. It is important that only drugs and biologicals that are part of renal dialysis services be included in the bundle and that Part D plans provide beneficiaries with oral medications that are outside of the ESRD bundle. CMS released clarifications in late November and early December. KCP will continue to monitor the situation to ensure that Part D plans provide medically necessary medications to patients when appropriate. In addition, KCP believes that adding any new items or services to the bundle requires statutory changes. CMS also must add new funds to the payment rate to cover the cost of providing new items or services. KCP has identified 7 core principles that CMS should use to establish the appropriate framework for adding new items or services to the bundle.

KCP Comment Letters: