Is 'Cookbook Medicine' Crippling the U.S. Health System?
By now, the case of Nataline Sarkisyan has garnered so much media attention that there's likely few people who haven't heard the story of the 17 year-old California girl who died five days before Christmas after her insurance company refused to approve her liver transplant.
Sarkisyan, who was diagnosed with Leukemia when she was 14, was undergoing treatment at UCLA Medical Center when Philadelphia-based Cigna HealthCare ruled her much-needed transplant "experimental, investigational and unproven."
Sarkisyan spent three weeks in a vegetative state before Cigna bowed to pressure from the girl's doctors and offered to pay for the transplant itself. But by then it was too late.
Whether a transplant would have ultimately saved Sarkisyan's life we will never know. But that's not really the point. After all somebody has to say no; the problem, says David Senoff -- a Pennsylvania attorney who represents patients who have been denied care by their insurance company -- is that the people saying no are the very same people who profit from the answer.
"Health insurance by definition covers some things, and not other things it's the same as any other policy: there are some things that are in and some things that are out and somebody has to be the one who's outside of coverage; but you don't want those people who decide to be the ones who are in the company making additional money by denying care," Senoff said.
"The last person on earth that should be making a determination [on coverage] is the person that's going to be making money off of the decision," echoes Steffie Woolhandler, an associate professor of medicine at Harvard University. "No one that's involved in that decision should stand to gain or lose based on the decision."
Woolhandler, a vocal proponent of a single-payer, universal health care system, recently co-authored a study on the U.S. health care system for the British Medical Journal that exposed the failings of America's managed care system.
"The U.S. health care system is failing because we have adopted a for-profit, market-driven model," Woolhandler said. "Americans die younger and pay more for their care than people in nations with non-profit national health insurance."
For Senoff, profit motive aside, the very nature of managed care is like putting the "fox in charge of the hen house."
"I'm not a person who's against companies making profits, the problem for me is the management portion of the insurance," he said. "When I was a kid this idea of managed care with the insurance company being the manager was unthinkable."
Judging by industry data, the fox has had a very good run of it. Since the Health Maintenance Organization Act of 1973 created the managed care system, the industry has become a virtual profit machine. According to Fortune magazine, the top-ten managed care companies -- ranked by revenue -- made roughly $12 billion in profits in 2007. The ten highest paid HMO chief executives collectively made nearly $170 million last year.
Meanwhile, the industry spent more than $150 million lobbying the government over the past five years, according to the Center for Responsive Politics, and has managed to secure an entrenched position that makes challenging insurance companies difficult if not impossible.
Senoff attributes this to two primary characteristics: a shift in the way claims are classified and processed, and a decades-old federal law that gives HMOs virtual immunity from liability for negligence.
The Best Evidence?
There are two primary rationales managed care organizations use when refusing to cover a specific treatment: one is to say the treatment is in itself experimental or investigational; the other -- as happened in the Sarkisyan case -- is to say it's experimental or investigational for a particular patient's diagnosis.
This second rationale, which is becoming more common, is reliant on a concept called "evidence-based medicine" (EBM) -- a trend that is finding an eager proponent in managed care companies.
Under EBM, medical treatment decisions are made primarily using guidelines from existing literature rather than a doctor's own expert opinion. Advocates of the practice say such guidelines limit variation in physician practice thereby improving quality of care.
But critics dismiss a reliance on such standardized treatment protocols as "cookbook medicine" and argue that EBM not only takes the individuality out of case management, but stifles innovation by removing insurance companies' obligation to pay for treatments they may deem "experimental."
Health insurers began developing guidelines in the 1990s to identify inappropriate medical care and reduce unnecessary utilization of services, according to a 2005 report on evidence-based medicine published by the Minnesota-based patient advocacy group Citizens Council on Health Care (CCHC).
"Insurance companies needed a name and a process that they could call scientific; they dressed it up to look like something different but the whole point still is just to ration health care but to do it from what would be perceived as science," said Twila Brase, a former ER nurse who now heads the CCHC. "It's a fallacy...there's no doctor out there today practicing medicine without evidence."
"What they say is we're going to scour all the journals to find out if this is appropriate with that kind of condition," explained Senoff. "The problem is that the science is always ahead of the literature -- it takes time to get this stuff published. So they might be relying on journal articles that are a year to three years old, which in [today's medical environment] is ancient."
On the federal side, since 1997 the Agency for Healthcare Research & Quality has run a pilot program on evidence-based practice for application to Medicaid and Medicare. In Oct. 2007 the agency announced the third award of five-year contracts to 14 evidence-based practice centers around the country. Commercial HMOs started implementing EBM around the same time and rely heavily on two guideline developers: Seattle-based Milliman USA and the Institute for Clinical Systems Improvement (ICSI), based in Minnesota. Underscoring the synergy between insurance companies and EBM centers, ICSI lists its top-three financial sponsors as Blue Cross/Blue Shield, HealthPartners and Medica -- all managed care firms.
A former Cigna claims manager, who asked that he not be identified because he still works in the medical field, said during his ten years with company, Cigna used guidelines produced by Milliman USA.
"I had cases where they would alter the guidelines a little bit, often with younger patients to give them the benefit of the doubt," he said, "but generally speaking the guidelines were pretty rigid and people had to meet them."
According to Milliman's own assessment, one in three Americans is managed using the company's care guidelines and nine of the eleven largest managed care organizations in the nation are Milliman clients. In 2006, Dr. James M. Schibanoff, editor-in-chief of the Milliman Care Guidelines, was named one of the "50 Most Powerful Physician Executives" in the nation by Modern Physician and Modern Healthcare magazines.
Milliman has had its share of controversy over the years; in the 1990s, for example, the company issued guidelines recommending that mastectomies be performed on an outpatient basis, and drew considerable criticism when it suggested that elderly patients be limited to cataract surgery in just one eye -- presumably because two-eyed sight was unnecessary.
Dr. Craig Umscheid, who helps run the Center for Evidence-Based Practice at the University of Pennsylvania, said EBM often gets a bad rap, primarily because it's either misunderstood or misapplied.
"It's a mistake to say EBM equals a standardized approach; if it were that then you wouldn't even need physicians to practice medicine; experience is important -- but somebody's got to make the decision what to cover and what not to cover -- there's a lot of very expensive snake oil out there."
Dr. Umscheid says his group does not take any funding from health care companies, and can understand why there would be concerns about conflicts of interest with guideline developers that do. But he says when it comes down to it, he believes EBM can be a valuable tool in the health care arsenal if properly utilized.
"Nothing is black and white -- like most things if EBM is practiced appropriately I feel that it's the best way to practice," he said. "I think EBM is a foundation but it's not the end in itself; it's a means to an end. When you have evidence suggesting one treatment may be better than another it's prudent to do what the evidence says is true."
Harvard's Woolhandler says she agrees with that concept in theory, but adds that the very nature of America's health care system often calls the motivation behind EBM into question.
"It's important to figure out what's effective and what's not but the caveat I would add is that there's a problem in that you are very dependent on somebody funding the research to prove the remedy," she said. "In the United States you have a system where often the funding is driven by commercial priorities."
Beyond controversial management practices, in most cases, existing federal law serves as a barrier to holding managed care companies accountable for their actions -- even when they result in death.
A year after the HMO Act, Congress passed the Employee Retirement Income Security Act (ERISA) in response to rampant pension fraud and mismanagement. The statute was designed to protect employees from having their benefits plundered by setting out requirements for the management of all employee benefits, including health care, and placing all legal matters involving benefits under federal jurisdiction.
In practice, when applied to HMOs, ERISA preempts state jurisdiction over tort claims against insurance companies and severely limits an enrollee's legal recourse. Most notably, although enrollees can sue their HMO for denying a claim, under ERISA they can only recoup the costs of the initial test or treatment; the law prohibits additional compensation, such as lost wages, medical expenses to treat an injury, punitive damages for pain and suffering, or wrongful death.
ERISA applies to all self-insured employer-sponsored benefit plans, which comprise roughly 70 percent of the insured public. Only government workers and employees of religious organizations are exempt.
"The ERISA standard so favors the insurance company, I don't even take ERISA cases anymore," said Senoff. "If you win the case, you can petition the court to pay your attorneys fees, but even that's not automatic and the cases take a long time."
Some states, including Pennsylvania and Texas, have attempted, unsuccessfully, to litigate around ERISA. In 1998, the PA Supreme Court concluded that Congress never intended ERISA to bar negligence claims against HMOs just because they are subject to federal employee benefits law. But a federal court subsequently overturned that ruling, and in 2004 the U.S. Supreme Court settled the issue by barring all states from letting patients sue managed care companies whose refusal to pay for treatment resulted in death or injury.
Since then, a legislative effort led by the late congressman Charlie Norwood (R-GA) has continued to push for reforms to the legislation. Norwood first took up the cause in 1997 with the Patient Access to Responsible Care Act, and has reintroduced a similar measure in nearly every Congress since.
Norwood died on Feb. 13, 2007; the day after the most recent version of his bill -- The Bipartisan Consensus Managed Care Improvement Act of 2007 -- was reintroduced by its co-sponsor, John Dingell (D-MI). Last summer, the Norwood/Dingell bill was referred to the House Subcommittee on Health, Employment, Labor, and Pensions, where it sits today.
If the insurance industry gets it's way, that's where it will stay. In November, managed care went on the attack, and together with more the 50 of the nation's largest corporations formed the innocuous sounding National Coalition on Benefits to aggressively lobby against any ERISA changes.
The article originally appeared in The Philadelphia Tribune.