At least one portion of the Medicare Part B proposed rule for the bundling of drugs and services related to end stage renal disease treatment - the inclusion in the bundle of oral ESRD drugs without an I.V. equivalent - will be drawing a challenge from Amgen.

The proposed rule, posted by CMS Sept. 15 in advance of publication in the Federal Register, stems from requirements in the Medicare Improvements for Patients and Providers Act of 2008, which required the agency to develop a bundled payment system.

The proposed prospective payment system will offer a base payment rate per dialysis treatment representing "the average Medicare allowable payment per treatment for composite rate and separately billable services, including training and home dialysis costs, laboratory services and all ESRD-related Part B and former Part D drugs," the agency said in a fact sheet about the proposed rule. The base rate would be adjusted to reflect patient- and facility-specific differences in case mix and other modifiers as required by MIPPA.

"The dialysis community, including Amgen, opposes including orals that do not have an I.V. equivalent in the bundle because of the adverse impact on access to important treatments for patients and also because of the difficulty that dialysis providers may have in implementing this requirement," an Amgen spokeswoman said. "We don't believe that Congress intended for oral drugs without I.V. equivalents to be included in the bundle."

Amgen markets an oral drug, Sensipar (cinacalcet), for treatment of secondary hyperparathyroidism in chronic kidney disease patients on dialysis.

The language in MIPPA calls for bundling to include "other drugs and biologicals that are furnished to individuals for the treatment of end stage renal disease and for which payment was (before the application of this paragraph) made separately under this title, and any oral equivalent form of such drug or biological."

One interpretation of this clause could be that it is strictly referring to drugs other than erythropoiesis-stimulating agents (which are separately identified in MIPPA as being part of the bundle) that are intravenously administered as part of the dialysis treatment and their oral equivalents.

The proposed rule is scheduled to be published in the Federal Register on Sept. 29. Comments on the proposed rule will be due Nov. 16.

-Gregory Twachtman (g.twachtman@elsevier.com)

Amgen To Challenge Inclusion Of Oral ESRD Drugs With No I.V. Equivalent In Medicare Payment Bundle

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