Thomas Cleary, M.D., doesn't mince words when describing the proposed pediatric-care guidelines he was asked to review in mid-1998.
"I said, `They're outrageous. They're dangerous. Kids could die because of these guidelines,' " recalls Cleary, professor of pediatric infectious diseases at the University of Texas Medical School in Houston.
But to his disbelief, the next time Cleary saw the guidelines, in fall 1999, they had been published nationally with his name listed among the "contributing authors."
"I was angry as hell," Cleary says.
The controversy has thrust Cleary and a former colleague, William Riley, M.D., to the forefront of a growing backlash against the guidelines' publisher, Milliman & Robertson. They have filed a fraud and defamation lawsuit against the Seattle-based consulting and actuarial firm. Riley was also listed as a contributing author of the pediatric-care guidelines without his permission, according to the lawsuit.
Milliman & Robertson is considered the nation's most influential producer of manuals designed to cut healthcare costs. Insurers and HMOs serving more than 50 million people use its guidelines to help determine the length of hospital stays and whether to pay for treatments.
Milliman & Robertson maintains that its "best practices" guidelines are designed only as reference tools for doctors and should never be used to deny treatment. Many physicians, though, insist the recommendations are dangerous because they emphasize saving money more than patients' lives.
Milliman & Robertson officials did not return repeated phone calls seeking comment on the lawsuit.
Tough restrictions. The latest manual, a $1,000, 400-page document, sets tight length-of-stay goals for children. Recommendations include one day in the hospital for a diabetic coma, two days for a bone infection and three days for bacterial meningitis.
"Some of the guidelines don't come near the standard of care," says Cleary, noting that those illnesses often require weeks-long hospital stays.
Cleary is just the latest to join a growing insurrection against what's been dubbed "medicine-by-numbers." Insurers Humana and Prudential HealthCare both face class-action lawsuits blaming them for relying too heavily on Milliman & Robertson guidelines.
In the lawsuit against Prudential, for instance, the lead plaintiff alleges the insurer denied her proper medical care after she was admitted to the hospital with a chronic bowel disorder. Though her doctor wanted to keep her overnight to run tests, a Prudential review nurse refused coverage based on a best-practices manual.
Cleary's and Riley's lawsuit, however, is the first to directly challenge the credibility of such guidelines as well as the methods used to write them.
In addition to claiming that Milliman & Robertson's recommendations have no basis in sound medical practice, the suit contends the company tried to buy scientific legitimacy by giving $100,000 to the University of Texas' pediatrics department in exchange for the school's stamp of approval. It also questions whether the department manipulated its own faculty into becoming "contributing authors" in order to accept the money.
Milliman & Robertson has managed to dodge the liability bullet until now because it has always left the actual coverage decisions to outside experts.
According to its Web site, writing its guidelines "involves clinicians, healthcare management consultants, practicing physicians in managed-care environments, medical school physicians, specialty societies, client site visits, data sources from hospitals and health plans, and input from (guideline) users" as well as a review of 75,000 patient charts.
But Cleary challenges this claim, arguing that he was acknowledged as one of 17 contributors to the pediatric guidelines even though he had told the project director that they were unsafe and needed to be changed. Riley, an endocrinologist, and four other physicians have made similar complaints.
Offer to settle refused. Cleary and Riley offered to settle the case if Milliman & Robertson recalled all pediatric manuals sold; sent apologies to buyers admitting wrongdoing; bought full-page ads in every major U.S. newspaper apologizing and announcing the recall; and donated all the money earned from sales of the book to pediatric charities.
The company declined. It did, however, send letters to those who had already bought the guidelines, announcing that Cleary, Riley and two other doctors did not wish to have their names associated with the book.
A trial is set for January 2001.
Milliman & Robertson is no stranger to controversy. It drew sharp criticism a few years ago when it recommended that women be discharged from hospitals one day after having a baby and undergo mastectomies on an outpatient basis. Once, it even suggested that elderly people with cataracts should receive surgery in one eye only because seeing with both eyes wasn't essential. After a public outcry, the guidelines were amended.
But despite their notoriety among most patients and doctors, Milliman & Robertson's guidelines have worked their way into the policies of most hospitals and health insurers. Even Kaiser Permanente, the nation's oldest and arguably most physician-focused HMO, makes use of them.
"Our physicians call the shots," says Kathy Antis, Kaiser's director of quality resource and risk management. "The guidelines are more for the nurses and the rest of the healthcare team so that everyone is on the same page. We clip a copy to the patient's chart so that the team can see what a typical case looks like, so they know basically what to expect."
Patients, she adds, are never discharged simply because a guideline has been exceeded. "They're just a reference tool. That's all they are."