Hospital Buyer

The FDA has fined the American Red Cross (ARC) to the tune of $5.7 million over three years for failure to comply with a 2003 agreement meant to make sure the organization would amend its unsafe practices. The Adverse Determination Letter (ADL) (pdf with redacted non-public information) sent by the administration on November 21 states that inspections of the ARC’s New York Penn Region’s Blood Services facility done between August and December 2005 revealed many violations of the law, regulations, and the amended consent decree of permanent injunction entered in April 2003. In a statement the ARC answers it will review the ADL and prepare a plan of action to address the FDA’s concerns within 20 days. The Red Cross, which supplies about 45 percent of the blood used in the U.S., pays all imposed fines from Biomedical Services operating funds rather than from monetary donations.

Meanwhile, the LA Times reports CMS is cutting funding for two small heart transplant programs in North Carolina and New York while St. Louis University Hospital agreed to withdraw its heart transplant program from the Medicare program. According to the LA Times, these three programs failed to perform the minimum number of surgeries (12 per year) the federal government thinks is necessary to maintain proper skills. Montefiore in NY and St. Louis University performed no heart transplants last year, and Wake Forest in NC did only two. Earlier this year the Californian newspaper questioned the United Network for Organ Sharing’s (UNOS) transparency and decisiveness to enforce rules. The LA Times found numerous facilities that failed to meet Medicare standards, an issue Senator Chuck Grassley expressed concern about.

For reference, here are the basic Medicare transplant regulations and Conditions for Coverage (CfCs) & Conditions of Participations (CoPs) for transplant centers.

November 30, 2006 Related topics: Legal & legislative, Ethics & Scandals