Is the Health Care Financing Administration changing its policy on disclosure of medical errors to Medicare beneficiaries? The issue is causing a tremendous amount of confusion among physicians and health plans. To HCFA, however, the fuss is much ado about nothing.
Several recently published reports say that HCFA is reversing its long-standing policy of keeping a lid on medical errors if physicians object to disclosure. One publication suggested the feds were going to finally publish a "list of bad docs." Not true, according to a HCFA spokesman: "We're not changing any rules, no matter what the New York Times says."
The Times and other media, he says, misinterpreted HCFA's intent. "What we are doing is clarifying the existing instructions in the peer review organization [PRO] manuals about disclosure," he says.
Currently, PROs are required to provide beneficiaries with information on the final disposition of a complaint, but they may not explicitly or implicitly identify individual practitioners without their consent.
Yet, change could be in the offing, the HCFA spokesman admits. "Several people are considering proposing regulations that could change that. We're issuing a notice of rule-making later this year." So, while reports of the death of the existing disclosure policy have been greatly exaggerated, one should watch for future developments.
What has happened is that a lawsuit was filed in the U.S. District Court for the District of Columbia against HCFA and the Department of Health and Human Services by Public Citizen and Alan Levine, challenging the federal government's policy of prohibiting PROs from releasing the results of investigations of complaints about the quality of health care services as a violation of federal regulations. Levine wrote to Florida Medical Quality Assurance (FMQA), a PRO, in 1999 to request a review of the quality of care his Medicare-beneficiary mother received while at Memorial Hospital in Jacksonville, Fla.
Mrs. Levine died seven days after being admitted. FMQA replied that it would conduct a complete review, but six months later told Levine that it could not inform him of the results because his mother's physician didn't consent to the disclosure.
Levine's lawyer then requested release of the investigation. FMQA's response: It couldn't, because of existing federal law and regulations. Public Citizen and Levine then filed suit against HHS and HCFA last April.
Amanda Frost, a lawyer with the Public Citizen Litigation Group, says the plaintiffs demanded that HHS change its regulations and policy manual to comply with federal laws, which, she contends, actually provide for release of the information.
Now, Frost reports, at the end of a three-month stay, HHS has told the PRO to release the information to Levine — but still hasn't changed its regulations. "It appears something has changed. HHS has sent a letter" to Levine and proposed changes to its policy manual, she says, but she hasn't been given a copy of the letter or seen the proposed changes.
Medical errors garnered public interest after the release of the Institute of Medicine's 1999 report that argued for a comprehensive approach to improving patient safety, but admitted there is no "magic bullet" that would reduce errors. The fuss has renewed debate about what the goal of disclosing medical errors should be.
Melinda Hatton, chief legal counsel of the American Hospital Association, says the objective has been — and should continue to be — allowing professional health care practitioners to look at what they and their colleagues are doing to improve patient care.
No opposition there. The rub comes when changes in policy could result in additional litigation. Mohit Ghose, of the American Association of Health Plans, explains: "Our board of directors has endorsed the concept of disclosure to help improve patient care. We do not agree with opening the liability system — that doesn't make sense."
Practitioners worry that disclosing too much could make it more difficult to improve patient treatment and safety. "There's not always agreement on treatment matters," one medical professional notes. "You need to be able to talk about what was done, why it was done, what happened, and what might have been done differently. But you don't need to put all that in the hands of some lawyer."
Douglas Hastings, a partner in Epstein, Becker & Green and president-elect of the American Health Lawyers Association, says that the debate points up the need to refine the system for reporting medical errors, so as to prevent misinterpretation of what's been reported.
Hastings says HCFA's change "had to do with a more effective way of disclosing information already required — not changing policy regarding identification of specific physicians in hospitals." He says that the confusion demonstrates the necessity of finding ways "to balance confidentiality with the need for improving quality.
"This is an area where it all comes down to a balance between competing good things," he continues. "One good thing is quality review by professionals in confidential settings that allow for careful review. The other good thing is open information to patients about their care, or a loved one's care. The whole issue of medical errors puts these good goals in conflict."
Hastings says it underscores the problems lawmakers face on patient rights issues.
How quickly Congress and the Bush administration will begin serious work on any health care initiative is still a matter of speculation. One long-time Senate staff member predicts health care issues won't be at the top of the agenda for the new president or the new Congress, but that tax cuts and education will take precedence.
John Stone, press secretary to Republican Rep. Charles Norwood of Georgia, who has been one of the most active members on health care matters in the past several sessions, argues that Bush has the chance to combine cutting taxes with promoting increased health insurance coverage.
"The last thing we heard is that they wanted to move forward in the first 100 days with some health care initiative," Stone says — a patients bill of rights, Medicare prescription drug benefits, or dealing with the problem of the uninsured. Bush officials appeared to be leaning toward dealing with that third issue, Stone says — and that could be done by providing a $2,000 instant tax credit, as Norwood has proposed.
One simple — but extremely significant — change in committee voting procedures may affect the movement of health care issues through this Congress. With Senate committee membership divided evenly among Republicans and Democrats, the change provides that tie votes will be considered a "yes" vote rather than a "no" vote — meaning that bills can move out of committee this year on tie votes.
"One party or the other won't automatically have a veto over legislation," a staff member explains. "Now a tie is a win, whereas before a tie was a loss." That rule change — unlike the medical errors-disclosure brouhaha — seems perfectly clear.