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A consumer suit seeking access to Medicare documents that show an alleged error in the administration of a drug could turn into a boon for the medical malpractice plaintiffs’ bar. In response to the suit, federal officials have proposed clarifying language to ensure complainants’ access to reports — a move that could reveal doctors and hospital errors, thus helping personal injury medical malpractice suits. The suit was brought by Alan Levine, the son of a Florida woman who unexpectedly died in a Jacksonville, Fla., hospital after suffering an asthma attack in 1998. Levine v. Department of Heath and Human Services, No. No. CA 00-731 (Dist. Ct., Washington, D.C.). AN ISSUE OF CONSENT According to federal statute, Medicare complaints must be reviewed by a peer review organization (PRO), which, if it concludes that there was a breach of the standard of care, can take action against the doctors through fines, remedial education or other remedies. After Mary Levine’s death, her son wrote to Florida Medical Quality Assurance Inc., the PRO responsible for monitoring the delivery of Medicare services in Florida. The group completed a review but declined to disclose the results to Levine because the attending doctor had refused to give consent. The agency cited federal regulations and the Peer Review Organization Manual of the Health Care Financing Administration (HCFA), which say that PROs must keep the results of a review confidential unless the doctor involved consents to their release. Levine’s lawyer, Amanda Frost, with the nonprofit, Washington, D.C.-based organization Public Citizen, filed a suit arguing that the amendment to the 1982 law enabling PROs to oversee Medicare complaints specifically requires the PROs to disclose the final dispositions of their investigations. Peer Review Improvement Act, at 42 U.S.C. 1320c-3(a)(14). Frost argued that in 1989, HCFA, a division of the Department of Health and Human Services, took steps to bring the regulations into line with the statute, but that the changes were never made final. After Frost filed a motion for summary judgment, the government requested a stay of the proceedings until Jan. 17. Government lawyers asserted that they would provide Levine with the documents he had requested and would bring the agency’s manual into compliance. They added that this would render the action moot. Levine did receive the report, which indicated that his mother’s standard of care was breached when she was given a drug to which she had a known allergy. But those doing the review concluded there was no indication that she had had a fatal reaction to the drug. A spokesman for the federal agency said that its policy of disclosing the results of peer reviews has not changed and that reviewers have always been required to inform patients of the final disposition of their case, without naming names. But Frost disputes that the regulations are in line with the statute. “All we know is what they’ve done so far, which is to give information that explicitly and implicitly identified a doctor,” she said. “So I don’t know why they would say their policy doesn’t do that. Unless they consider Alan Levine is an exception.” Frost also brought the suit on behalf of Public Citizen members, in an effort to assure that the policy would be amended permanently via the regulations. She said that she will pursue the lawsuit if it is not undertaken by the Health Care Financing Administration. Its officials said that they know of some other peer review organizations that are not adhering to the regulation but that a clarification of the manual is all that is needed.

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