Anaemia drug profiteering investigations continue

Since the Centers for Medicare & Medicaid Services issued new reimbursement rules that limit the use and dosage for anaemia drugs (ESAs), further recent findings that ESA medications were being over-prescribed for profit under the current billing rules have come back to haunt manufacturers Amgen and J&J.

On 10 May 2007, Amgen received a subpoena from the New York attorney general seeking documents related to "promotional activities, sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements and corporate communications," according to its 22 May 2007 SEC filing.

The best-selling EPAs are sold under the brand names Procrit, Epogen, and Aranesp. J&J manufactures Procrit, while Amgen manufactures the rest. Around 50 per cent of Amgen's total revenue for FY06 was earned by Epogen and Aranesp, bringing in combined sales of USD 6.6bn. Procrit was J&J's second best selling drug in FY06 at USD 3.2bn, according to Forbes in March 2007.

A June 2007 report on an investigation by the US Department of Health and Human Services Office of Inspector General found dialysis facilities could acquire the anaemia drugs for as much as 10 per cent below Medicare reimbursement levels. Acquisition costs also varied greatly, according to the report, with chain-owned freestanding clinics often paying less than non-chain freestanding and hospital-based facilities.

In a 9 March 2007 safety alert, the FDA reported that there were five clinical trials that demonstrated decreased survival time in cancer patients receiving ESA's compared with those receiving blood transfusions.

On 26 June 2007, regional inspector general for evaluation and inspections in Philadelphia at the US Department of Health and Human Services' Office of Inspector General, Robert Vito, testified at a hearing before the House Ways and Means Committee and described cases where dialysis centres have been found to be submitting false claims for payment to Medicare involving the anaemia drugs.

Vito revealed that Dialysis Clinic agreed to pay USD 1.8m to resolve liability under the False Claim Act, with the majority of the settlement associated with the administration and billing of ESAs when it was medically unnecessary.