Lawmakers Debate New Reimbursement System for ESAs

Lawmakers debated whether to change Medicare’s reimbursement system for erythropoiesis-stimulating agents (ESAs) over concerns that the current program encourages physicians to overprescribe the drugs, risking patient health.

The FDA recently issued a public health advisory and required manufacturers to include a black box warning for ESAs because of the increased risk of death and serious life-threatening side effects. The warning tells physicians to use the lowest possible dosage of ESAs to reach the patient’s ideal hemoglobin level, FDA’s Office of New Drugs Director John Jenkins said.

Witnesses at a House Ways and Means Subcommittee on Health hearing June 26 debated changing Medicare’s reimbursement program for ESAs to a ‘bundled’ system. The subcommittee held a similar hearing last December.

A bundled system would change the incentives for ESA use by establishing a fixed payment amount for ESRD services given to a patient, ostensibly eliminating the potential for overdosing, Centers for Medicare & Medicaid Services (CMS) Acting Administrator Leslie Norwalk, said.

The CMS is ‘generally supportive’ of shifting to a system of bundled prospective payments instead of paying for treatments and drugs separately, she added.

However, some witnesses expressed concern with a bundled system, saying it may lead physicians to underprescribe the drugs and may not give physicians the flexibility necessary to deal with individual patient needs. A bundled system should include safeguards against underprescribing, according to Norwalk.