For 2011, the CMS standardized base rate of the bundle is $229.63, prior to the adjustments to case-mix and the wage index. CMS adopted four patient-level case-mix adjustors: age, body mass index, body surface area and new patients. It also includes six comorbidity categories, down from 11 in the proposed rule. The bundle encompasses 52 lab tests, listed by CMS in the final rule, which are specifically related to ESRD care.

The bundling of lab tests and drugs into a single reimbursement rate comes with a reduction in payment.

“In MIPPA of 2008, Congress basically changed a quarter of a century reimbursement policy by combining all these income streams into a single stream and then also mandating that the total reimbursement be reduced by 2 percent,” says Dolph Chianchiano, senior VP for health policy and research with the National Kidney Foundation.

Much of the concern expressed by key industry players is centered on the inclusion of Medicare Part D prescription drugs into the bundle and an unexpected CMS calculation that may deepen the 2 percent dent in revenue for dialysis providers nationwide.

Bundling of drugs
In the first draft of its rule, CMS included all renal-related oral drugs without an injectable equivalent into the bundled payment, drawing much criticism from the industry. In the final rule, CMS decided to hold off from including the oral-only drugs into the bundle until 2014.

“It was very much in response to comments and our recognition that we need a lot more data and background before actually bundling [the oral-only drugs] in,” says CMS’ Griffith. “In principle, they are included, but we’re not implementing that until the end of the transition period.”

The delay of the oral-only drugs into the bundle will enable CMS to conduct additional research on the ability of dialysis facilities to provide ESRD drugs and facilities to develop the infrastructure to offer the drugs to patients.

Providers commend CMS for holding off on the inclusion of the drugs until 2014, but also recognize the administrative challenges that lie ahead.
Marc Chow, director of government affairs with Satellite Healthcare, a 47-center nonprofit kidney dialysis service provider, says facilities will have to change their operational models — seek out pharmaceutical partners and navigate state pharmaceutical laws —unprecedented hurdles for dialysis facilities.

The transition of facilities into the role of drug providers also raises concerns about the fragmentation of care. Gary Cellini, VP of strategic planning with Satellite Healthcare, says shifting the responsibility to providers may exacerbate the already complicated medication management process among dialysis patients.

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