While healthcare reform takes center stage and dominates congressional activity, the Centers for Medicare and Medicaid Services (CMS) has released the end-stage renal disease (ESRD) Medicare prospective payment system (PPS) proposed rule, which was required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The long-awaited proposed bundled payment system, unveiled on September 15, will replace the current payment system beginning January 1, 2011. According to the proposed rule, all items and services currently included in the composite rate would be included in the bundled payment system. Erythropoiesis-stimulating agents (ESAs) in oral and injectable form and all ESRD-related drugs and biologicals that had been separately payable under Medicare Part B and Part D regardless of route of administration, would also be included in the bundled payment system. All laboratory tests, including those ordered by a physician who receives monthly capitation payments for treating ESRD patients that are separately billed by independent laboratories, would also be included in the bundle. The proposed rule excludes vaccines from the bundled payment rate. In the proposed rule, CMS determined that the unit of payment continue to be per treatment, saying that facilities would be paid for up to three treatments per week, unless medical necessity justified more than three treatments. CMS proposes to include payment for all home dialysis services in the bundled system, including home support services. CMS proposed continuing to use age, body surface area, body mass index, and pediatric status as adjustors under the bundled payment system and proposed additional case-mix adjustments for patient sex and 11 comorbidities. The agency also suggested a “new patient adjustment” that would recognize patients that have higher costs in their first four months of maintenance dialysis. The proposed rule did not include an adjustment for patient race or ethnicity. The proposed rule also included a payment adjustment for low-volume facilities, which are defined as a facility that furnishes less than 3,000 treatments in each of the three years preceding the payment year and has not opened, closed, or received a new provider number due to a change in ownership during the three years preceding the payment year. CMS proposed a 20.2 percent increase to the base rate for facilities that are considered to be low-volume. As required by statute, CMS would allow facilities to elect to phase into the new bundled payment system over a four-year period or to be paid entirely under the new payment system beginning on January 1, 2011. In the proposed rule, CMS estimated that 36% of facilities will choose to be excluded from the transition and that 64% will choose to be paid the blended rate during the phase-in period. CMS proposed that a transition budget neutrality adjustment factor of negative 3 percent be applied to all payments during the four-year phase-in period. CMS also proposed to apply a $14.00 per treatment adjustment to the composite rate portion of the bundled payment amount to reflect ESRD-related Part D drugs. The proposed rule also addressed home dialysis (Method I and Method II) and self-dialysis training. CMS proposed to include payment for all home dialysis services, excluding physicians' services, in the bundled payment system. This would include home dialysis supplies, equipment, and home support services. CMS also proposed to discontinue Method II, which would send all reimbursements through a facility, which would then pay the suppliers. In the proposed rule, CMS described the potential components of the Quality Incentive Program (QIP), mandated by MIPPA, but said the agency intends to issue a separate proposed rule to provide the details for QIP. CMS proposed using three existing Dialysis Facility Compare measures focusing on anemia management and hemodialysis adequacy. CMS suggested that the quality reporting period would be all or portions of 2010 because it is required to begin implementing the 2 percent payment reduction on January 1, 2012. When CMS announced the proposed bundled payment rule it requested comments from those in the kidney care community. The agency set a deadline to submit comments of 5:00 p.m. ET on November 16. The agency added that it will issue the final rule in 2010.