DC Medical Malpractice & Patient Safety Blog

Many Medicare recipients delay getting hospice services because they must agree to cease curative treatments such as chemotherapy. So by the time they do enter hospice, their condition is much more dire, and many often have mere days to live. Some never make it to hospice at all, and spend their final days in a hospital intensive care unit.

So three years ago, Congress directed Medicare to test an expanded hospice program. It would enable beneficiaries to continue potentially lifesaving treatments, possibly to improve their quality of life, while saving money by avoiding expensive hospital care. But, as told in a story by Kaiser Health News and PoliticoPro, the program has yet to begin.

The Affordable Care Act (“Obamacare”) required Medicare to subsidize hospice care while also paying for treatment—for children. It’s called concurrent care, and most states have such a program for low-income residents. The ACA also said 15 sites should be chosen to test concurrent care for Medicare patients, which covers disabled people and those older than 65.

What’s taking so long? Dr. Randall Krakauer, an Aetna executive instrumental in establishing its concurrent care program for private coverage, told KHN/PP that Medicare “is missing an opportunity. Our own experience is when you do liberalize the hospice benefit, it does not cost you extra and it may actually cost you less."

Krakauer said Aetna asked for permission to expand concurrent care to the 448,000 elderly people enrolled in its Medicare Advantage plan. Aetna even said it would cover any extra costs, but Medicare never responded.

Officials at the Centers for Medicare & Medicaid Innovation, which is responsible for managing the expanded program, declined to discuss the delay with the news organizations, issuing only a news release expressing its commitment to “allow beneficiaries to receive both palliative and curative care at the same time … "

Apparently, CMS has commitment issues.

According to KHN/PP, hospice is one of the fastest growing parts of Medicare. In 2011, 1.2 million Medicare beneficiaries used the benefit, double the number who did so only a decade earlier. Medicare spent $13.8 billion on hospice; the average per-patient cost was $11,342.

Palliative care, as opposed to curative care, focuses on a patient’s comfort, not on prolonging life. Hospice advocates say that palliative care has the dual virtue of being more humane and less expensive. A study published in Health Affairs, “Hospice Enrollment Saves Money For Medicare And Improves Care Quality Across A Number Of Different Lengths-Of-Stay," found that patients who were enrolled in hospice at least three months before they died cost Medicare less than those who never used the benefit.

The average cost to Medicare of hospice patients enrolled between 53 and 105 days was $22,083 compared with $24,644 for patients who never enrolled.

You can’t know for sure if hospice patients who get both palliative and curative care would cost less until you establish the program. (The ACA forbids Medicare to spend more money on the patients in the demonstration project than it otherwise would have.) But Aetna told KHN/PP that it saved an estimate 22% on patients younger than 65 in its concurrent program.

According to the news organizations, some health policy experts ascribe the delay in implementing the program to … politics. End-of-life care is a sensitive subject—remember how some ignorant demagogues liked to invoke the scary term “death panels” during the robust debate before passage of the ACA?

To learn more about palliative and hospice care, and to locate hospice services near you, visit the website of the National Hospice and Palliative Care Association.

To learn about health care power of attorney and living wills, see our newsletter “Talking to Your Doctor When You Can't Speak.”

A federal judge this week upheld a jury verdict against the American Academy of Orthopedic Surgeons, finding sufficient evidence for the jury's decision that the AAOS acted with "reckless disregard for the truth" in publicizing its discipline of an orthopedic surgeon who had testified that another surgeon had committed malpractice.

The decision was written by U.S. District Judge Joel Slomsky, who was nominated to the federal bench by George W. Bush and sits in Philadelphia. Read the judge's decision against the orthopedic surgeons' society here.

The surgeon who successfully sued the AAOS is Steven Graboff, MD, whom the AAOS suspended for two years after he testified against an AAOS member. The jury found that the AAOS report about its disciplinary action cast Dr. Graboff in a "false light" because of various errors. The AAOS report remains on its publicly accessible website.

The AAOS is one of a number of doctor organizations with "peer review" programs for reviewing expert testimony against members. The programs exercise vast economic power over the members' testifying activities, as the court found. Responding to an argument from the orthopedic surgeon group that the expert witness had not shown enough economic harm from its slam of him, the judge wrote:

The AAOS is well aware of its clout in the profession of orthopaedic surgeons and created its compliance program and standards to control the occupation of its members as experts.16 It is also aware that its enforcement program and standards would affect the income of doctors because the loss of AAOS accreditation has a substantial impact on the ability of an expert to work in that industry. Further, the presence of the standards alone, however noble they are as a mission statement, can have a chilling effect on orthopaedic surgeons who serve as expert witnesses against other orthopaedic surgeons.

The ostensible goal of these expert witness "review" programs is "truth" in testifying, but the judge's decision summarizes the evidence at trial supporting the jury's verdict that AAOS did not run an unbiased review system.

The bias started with the doctor the orthopedic surgeons picked to set up and run its testimony review program: Dr. Peter Mandell, an orthopedic surgeon who had stopped treating patients and focused his practice on testifying for insurance companies in workers' compensation cases (i.e., testifying against patients).

Dr. Mandell, as Judge Slomsky found, is the head of the AAOS Committee on Professionalism, the first body to hear charges that an orthopedic surgeon has testified in violation of the AAOS expert witness standards.

(By the way, only members of the AAOS are eligible to start complaint proceedings against an orthopedic witness; that means that any patient who feels aggrieved by a surgeon's testimony against the patient -- like Dr. Mandell's testimony against a worker's comp claimant -- has no recourse.)

Dr. Mandell is also head of the AAOS Council on Advocacy, which lobbies in Washington for "tort reform" to curb malpractice lawsuits.

Hmm. Coincidence?

The expert witness review program, Dr. Mandell testified (with admirable candor) in the Graboff lawsuit, came about because orthopedic surgeons were upset about high jury verdicts against orthopedists in malpractice cases.

Any scientist knows that biased decision makers produce biased outcomes. That's why medical research usually requires "double blinded" studies so that doctors studying a new drug or device don't subconsciously tilt the results one way or the other from knowing which way something should come out.

But in this case, the old doctors' joke may hold true. Q: What's the definition of a double-blind study? A: Two orthopedic surgeons examining the same patient.

Medical malpractice reform is a political football in a game that serves no one well. Not patients, not their legal representatives, not medical professionals, not insurance interests.

OK, we've said that before, but we'll keep saying it as long as the flat-earthers press their misguided "reforms." And here are some new facts:

A recent article by David A. Hyman, a doctor and a lawyer, and Charles Silver, a lawyer, in Chest Journal, (the publication of the American College of Chest Surgeons) identifies five myths of medical malpractice that persist in doctor circles. Hyman and Silver want to set the record straight.

Myth No. 1: Malpractice crises are caused by spikes in medical malpractice lawsuits.

This bogus belief spreads when juries give large awards to patients with claims that sound, in the media accounts, questionable or frivolous. But research indicates that such stories of “runaway” jury verdicts, when they're not completely apocryphal, do not represent the norm. And rarely are they paid in full.

“Because the overwhelming majority of payments to plaintiffs are the result of voluntary settlements,” the writers point out, “one must study closed claims (rather than jury verdicts) to get a full picture of what is going on.”

Closed claims databases show that both the frequency of malpractice claims and the payments per claim were either stable or declining at the beginning of this century. The writers conducted a study using the National Practitioner Databank. They found that the frequency of paid medical malpractice claims per physician has been dropping steadily since 1992, and is now less than half the level it was that year.

The decline is largest in states that recently capped damages awarded because of medical malpractice, but there are large declines in states with no damage caps as well.

An earlier study using the National Practitioner Databank data found that average payments grew by about half from 1991 to 2004, roughly in line with increases in health-care spending.

“The finding that the latest malpractice crisis was not caused by spikes in malpractice claims or payouts should not be surprising,” say Hyman and Silver. “Although hot spots can occur, the liability system primarily responds to (and lags) the frequency of serious medical injuries.

Because the frequency of serious medical injuries changes slowly, the litigation rate should not be prone to dramatic spikes in claiming.”

Even the big payouts in the rare, headline-grabbing jury verdicts often are slashed by judges. And more than 9 in 10 cases are resolved, and the overwhelming majority of payouts are made as a result of voluntary settlement.

Myth No. 2: The tort system delivers “jackpot justice.”

This charge means, basically, that the system doles out compensation randomly. Uninjured patients take home millions, and people who suffer grievously receive little or nothing at all.

This seems so especially if you’re focusing on patients who experience bad outcomes and can’t tell whether they’re victims of negligent treatment or bad luck. (See our blog “The Difference Between Medical Negligence and Complication.” ) Many patients who received appropriate care file claims.

But the larger problem, say the writers, “is that an enormous fraction of patients who are harmed by medical negligence either make no effort to recover damages or cannot find lawyers willing to take their cases. (See our blog, “How Tort Reform Continues to Victimize the Victims”.) These patients, who are entitled to compensation, never initiate claims. “So the liability system is simultaneously beset by overclaiming and underclaiming.”

If you focus on people who initiate claims, the liability system is pretty good at separating the worthy from the unworthy. Patients who were treated negligently recover damages far more often than patients who weren’t. And except for patients who die, payments increase with injury severity. “Unfortunately,” the writers say, “most patients are undercompensated, and those with the most severe injuries suffer the biggest gap between provable injuries and the amounts they recover.”

Objective data for this comes from the Texas Department of Insurance. Texas adopted tort reform in 2003. Before then, in a state with a population of almost 25 million, there were only 7,650 malpractice claims per year. After tort reform, the number of claims declined to 5,300 per year.

Both pre-reform and post-reform, more than 8 in 10 claims closed without payment. When there was a payment, it was almost always the result of a voluntary settlement—that is, trials were rare.

The average payout was $609,000 during the pre-reform period and $419,000 post-reform. Jury verdicts were substantially higher, but they typically got cut a lot before they were paid. And physicians rarely paid anything out of pocket.

Here’s how the severity of injury is quantified. Data from the Illinois Department of Insurance show that from 2005 to 2008, the average payout was $626,827, but the amount paid wasn’t as much for less-severe injuries. Patients got the most money only if they suffered at least significant permanent injury. Their average award was $1.25 million.

Myth No. 3: Physicians are one malpractice verdict away from bankruptcy.

Physicians’ fear that a malpractice verdict will wipe out their savings is proved unfounded, the writers say, when you consider that jury trials are uncommon and plaintiff victories even less common. Most malpractice cases are settled or dismissed; only about 2 in 100 claims go to trial, where providers win about 3 in 4 cases.

If you compare actual payments to jury awards, “many patients who win turn out to be losers as well,” the writers say. Awards often fail to cover patients’ actual losses. As we said, you hear about huge verdicts because they are so unusual.

“Any verdict, blockbuster or otherwise, that exceeds the limits of a provider’s insurance coverage is quite unlikely to be paid in full,” the writers note. In Texas, the larger the
verdict, the more likely it was to be reduced because policy limits served as a functional cap on patients’ recoveries.

And you might be surprised to learn that when payments above the policy limits were
made, whether the case had gone to trial or was settled, the money almost always came from insurers. Out-of-pocket payments by physicians were extraordinarily rare. “Most physicians have effectively no personal exposure on malpractice claims (other than the obvious and unavoidable side effects of litigation, e.g., the emotional and time-related costs of being deposed),” the writers say.

Generally, plaintiffs’ lawyers don’t go after physicians’ personal assets, as a study once documented. In other words, it’s not about vengeance; it’s about justice.

“The only physicians who should worry about personal exposure are those who grossly underinsure,” the writers conclude, “and even they should not worry too much.”

Myth No. 4: Physicians move to states that adopt malpractice damages caps.

“If physicians relocate because of liability risk,” the writers note, “damages caps are an obvious strategy for attracting more physicians, particularly in lawsuit-prone specialties.”

This strategy works only if some states do not have caps. But plenty of states lack caps, and researchers have found that damages caps may draw a small number of physicians especially to rural areas or particular specialties. But there’s not much evidence to suggest increases in statewide physician counts.

Before Texas capped damages in 2003, proponents of tort reform claimed that physicians were deserting the state in droves. After caps were imposed, proponents claimed that there had been a dramatic increase in physicians moving to Texas because of the improved liability climate. But Hyman and Silver’s study found no evidence to support either claim. Hyman and Silver write:

“Physician supply was not measurably stunted prior to reform, and it did not measurably improve after reform, whether one focused on all patient-care physicians in Texas, on high-malpractice-risk specialties or on rural physicians. Thus, although damages caps may play a small role in attracting and keeping physicians practicing in rural areas and in high-risk specialties, the evidence is mixed, and some studies have found no effect.”

Myth No. 5: Tort reform will lower health-care spending dramatically.

The writers ask how much the malpractice system costs, and how much tort reform will reduce the cost of the malpractice system, including its effect on health-care spending.

Direct costs include malpractice awards and settlements and all costs associated with defending against such claims, including the administrative costs of medical malpractice insurers. Indirect costs often are referred to as “defensive medicine,” which is when doctors overprescribe or overtest to avoid the claim of having been negligent—it’s the cover-your-hiney strategy.

“Because tort reforms make lawsuits less likely and less expensive, they may reduce defensive medicine,” the writers suggest, “and thereby reduce health-care spending.” The direct costs of the malpractice system are only about 2% of health-care spending. Still, proponents claim that tort reform can reduce indirect costs by $100 billion to $650 billion per year.

Uh…no. One study of the impact of tort reforms on health-care spending found that damages caps and other reforms that limited liability directly reduced post-treatment medical spending by 4% - 5%.

A Congressional Budget Office review “found no evidence that restrictions on tort liability reduce medical spending.” A follow-up Congressional Budget Office study estimated that a cap on noneconomic damages would reduce Medicare spending by a statistically insignificant 1.6%.

Several other studies showed similarly modest reductions.

Hyman and Silver’s analysis of Texas’ damages caps showed in a dramatic decline in claim frequency and payout per claim, reducing overall payouts by about 75%. But this dramatic change in the malpractice environment did not result in significant changes in health-care spending levels. After reforms were enacted, they even found evidence of increased physician spending in counties where medical malpractice risk was high. They concluded that there was no evidence that Texas’s tort reforms bent the cost curve downward.

In summary, although “tort reform” doesn’t do much for Hyman and Silver, they still acknowledge problems with the medical malpractice system.

For one, it’s slow. “On average,” they say, “it takes about two years from the date of injury to the date a lawsuit is filed and roughly the same amount of time for the case to be settled. But the time period required can be much longer, particularly if minors are involved or if the case goes to trial.

“It is unrealistic to expect the malpractice system to provide much in the way of useful
feedback if it takes at least four years to get an answer.”

They also call the malpractice system extremely expensive. The cost of defending paid medical malpractice claims has roughly doubled since 1988. “In part,” they say, “high costs are ‘baked into’ the third-party fault-based process for determining who gets paid by the malpractice can serve as an expert because decreased supply translates into higher prices.”

Also, the malpractice system is perceived by everyone as unpleasant, unjust and/or unfair. “Providers who were not negligent resent being dragged into lawsuits and having their competence questioned. Patients who were injured (whether negligently or not) are usually unable to find out what happened to them unless they find a plaintiffs’ lawyer willing to take their case, and then they must wait several years for the process to be completed.”

But none of the above is an argument for limiting awards. Although damages caps “can dramatically reduce claims frequency, payouts per claim and insurance premiums, they do not make health-care safer, reduce health-care spending, compensate those who are negligently injured or make the liability system work better.

“The best reforms are patient safety initiatives that reduce the frequency and severity of medical mistakes. Ideally, the liability system would encourage providers to adopt patient-protecting innovations. Its effect in that regard is limited, however, partly because tort reforms insulate providers from many of the costs of medical errors.”

Someone old enough to be a consenting adult is also, presumably, someone who understands what he or she is being asked to consent to. But not in one Florida appeals court.

A recent court decision in Florida concerning a 92-year-old woman’s signature on her nursing home contract changes the basic premise of what it means to consent.

As Kaiser Health News (KHN) reports, a mandatory arbitration agreement is a common document in a package of admissions documents at many nursing homes these days. They’re often overlooked but can have an outsized impact if something goes wrong.

Signing an arbitration agreement means that if something goes wrong—the patient falls on a wet floor and breaks her hip, or wanders off the premises and gets hit by a car—you agree to bring the dispute before a professional arbitrator instead of suing for negligence in court.

Consumer advocates are not fans of arbitration agreements. They can be expensive—in addition to hiring a lawyer, the patient or family generally must pay a share of the arbitrator's fee. Proceedings are not public, and arbitrators that have a reputation for siding with the patient usually lose their place on corporate lists of potential arbitrators. In other words, the deck often is stacked against the patient before anything bad even happens.

We’ve expressed our opposition to arbitration agreements before.

Promoters of arbitration agreements—typically corporations keen to avoid class-action suits and exert maximum power over individuals who buy their wares—say arbitration saves the months or years it can take to resolve a lawsuit. They never say how it also saves everyone the trouble of protecting your rights.

In the recent Florida case, Spring Lake v. Holloway, the patient had a fourth-grade education, memory problems and was increasingly confused. When she was admitted to the nursing home, she was asked to sign a typically dense contract full of legal terminology no one who isn’t a lawyer understands. It also included an arbitration clause.

The court had to address whether her signature was legally binding.

The U.S. Supreme Court has ruled that arbitration must be a matter of "consent"; parties are forced into arbitration only if they voluntarily agree to arbitrate. You can’t voluntarily agree to something you don’t understand.

The Florida appeals court didn’t dispute that the elderly woman was in no position to consent to the nursing home’s terms—it agreed with the trial court that “the contracts were so complex that she could not possibly have understood what she was signing.”

But her inability to “consent” wasn’t a problem for that court. "For better or worse,” it wrote, “her limited abilities are not a basis to prevent the enforceability of this contract."

Here’s the court’s justification for allowing the agreement to stand, even though to the woman it might as well have been written in Swahili:

“Our modern economy simply could not function if a ‘meeting of the minds’ required individualized understanding of all aspects of the typical standardized contract that is now signed without any expectation that the terms will actually be negotiated between the parties. Without suggesting that the contract in this case is abusive in any fashion, the law must address abuses in standardized contracts by rules other than the ‘meeting of the minds.’"

Do you find it comforting that those entrusted with protecting your legal rights can force you to honor an agreement you don’t understand, simply because it’s good for commerce?

When a corporation can force an individual to agree to an arbitration clause, it is forcing a person into judicial subservience. When a court says it doesn’t matter if a vulnerable, powerless person couldn’t have understood what she was signing, the concept of consent becomes meaningless.

The sad ruling in Florida has implications for basic patient safety. Informed consent requires evidence of actual, knowing, competent consent, but medical advocates of what they call a "professional custom" standard of care ignore that by promoting standards only they understand. The fair standard for care should be a "patient's reasonable expectations"—that’s something an informed person can understand, and a court should defend.

Another recent tale of a nursing home and an arbitration agreement involved a patient who signed the agreement and later died, allegedly through the nursing home’s negligence. The patients’ survivors sued for wrongful death. The issue the court had to decide was whether the agreement required the patient’s estate and heirs to arbitrate the wrongful death claim. The court ruled that it did because the patient signed with full mental capacity to enter into a contract.

As noted by KHN, you can avoid being forced into arbitration: Don't sign the arbitration agreement. If you don’t, nothing happens because it’s not a condition of admission to the facility. The American Health Care Association doesn't support requiring people to sign an arbitration agreement as a condition of admission, said a KHN source, although practices may vary at individual nursing homes.

If you do sign, then regret it, typically you have a 30-day "opt-out" period to change your mind and retain your rights to sue.

Thanks to Paul Bland of Public Justice, a public-interest law firm, for keeping us apprised of the Florida ruling and for keeping such abuses of justice front and center.

When Laurie Sanders lost her 6-year-old son Christopher to a malpractice incident at a North Carolina hospital, she refused the hospital's offer of settlement that would have required her to keep quiet about what happened.

"I didn't know how everything would end as far as the lawsuit, but I did know that it wouldn't end in this way. And that would be Christopher's mommy taking hush money and saying, 'I won't talk about what happened to my son,'" Sanders told Raleigh TV station WTVD. "I wanted to make a difference, to try to prevent people from ever experiencing preventable medical errors."

So Sanders spoke out. And now Steve Daniels, WTVD reporter, is taking up the issue of whether defendants in North Carolina should be legally allowed to demand secrecy when they pay to settle lawsuits out of court, even if that means covering up public health issues that could affect other consumers.

It's an important issue across the country. "Confidentiality" provisions in settlement agreements have saved defendants a lot of embarrassment over the years, but they have also let repeat offenders continue to harm people under the cloak of secrecy. Witness the Firestone tire failures that came to light many years after product liability suits were settled. Witness also the clergy sex abuse scandal.

At Patrick Malone & Associates, we take a stand against secrecy in settlements, agreeing only to keep the amount of money paid confidential, because that protects our clients.

I have written and lectured to lawyer groups around the country advocating a stand against secret settlements because they often violate the attorneys' ethics code. Read my article on the ethics of secret settlements here.

Connie Spears has the bad luck to live in Texas. Her story, as recounted by the New York Times/Texas Tribune is another sad reminder of how the powerful forces behind so-called “tort reform” continue to deprive people harmed by medical mistakes of their rights. And Texas leads the way.

In 2010, Spears arrived at a Christus Santa Rosa hospital emergency room with severe leg pain. She told the medical staff about her history of blood clots. They diagnosed a less serious disorder and sent her home. Within days, Spears landed in another hospital with a severe clot and extensive tissue damage. To save her life, they amputated both of her legs.

But thanks to Texas’ tort reform laws, Spears is not only unable to be compensated for her damaged health, she’s liable for paying the legal bills of the defendants she sued for malpractice.

As The Times explains, Texas law caps noneconomic damages that a plaintiff—Spears, in this case—can receive for medical malpractice at $250,000. Of course, no amount can compensate for the loss of one’s legs, but at least it’s an acknowledgment of error.

But the law also establishes a “willful and wanton” negligence standard for emergency care, which means that the patient must prove that he or she was harmed almost intentionally.

The law also requires that medical witnesses for the plaintiff must practice or teach in the same specialty as the defendant. If plaintiffs don’t supply these expert reports within 120 days of filing their cases, they’re on the hook for defendants’ legal fees.

Many potential lawyers rejected Spears’ case because they were afraid they wouldn’t be able to meet the state’s negligence standard. It took her two years find someone.

Then, her lawyer couldn’t find an expert witness by the report deadline, so the judge ordered her to pay thousands of dollars to cover some defendants’ legal bills. Spears had exhausted her retirement savings, and now she might lose her home. And she’s the one who lost her legs because somebody else screwed up.

How is this justice, much less mercy?

Tort reform proponents sing the same off-key tune—they say it prevents “frivolous” lawsuits that clog the system and raise the costs for everybody. In Texas, they say such pro-business measures attract more medical professionals to a state that desperately needs them.

That’s bunk. As noted on Pop Tort, a civil justice website sponsored by the Center for Justice & Democracy, such laws protect “the ‘psychic’ damage to physicians (who have well-paid insurance lawyers defending them, by the way), than the horrifying actual damage caused by negligent care, killing 98,000 people every year (at least), plus brain injury, blindness, quadriplegia, misdiagnosed cancer, the death of a child, … How about the fact that the vast majority of preventable errors that physicians commit never result in a claim at all? … Shouldn't we be far more concerned about what happens to patients like Ms. Spears in states like Texas?”

As Pop Tort says, more than 8 in 10 doctors have never had a medical malpractice payment. So the vast majority of good doctors get lumped in with the few repeatedly poor practitioners in order to achieve an "average" that tort reformers suggest reflects the real world. Consumers—and lawmakers—are misled into believing that all doctors fear spending valuable time fighting claims.

“Nothing today prevents insurers from settling legitimate claims with patients before they file a court case or from paying valid claims expeditiously,” says Pop Tort. “Yet they do not. Insurers hold onto money as long as possible. They deny, delay and defend claims even when their clients are clearly at fault. And why shouldn’t they in states like Texas, where patients will never win?”

As people become more aware of the waste associated with overdiagnosis and overtreatment and as the government strives to make the delivery of high quality health care more efficient and responsive, measures to connect patient satisfaction with provider payment are becoming popular. (See our blog about doctor rating services.)

But one practitioner, writing on KevinMd.Com, has written a thoughtful essay inviting people to reconsider the equation of Satisfaction=Higher pay. Such a model, he suggests, actually might punish the best health-care providers and work against better patient outcomes.

“I hope my patients are satisfied,” Dr. John Mandrola, a cardiologist, writes. “Improving the lives of people is why doctors do what they do. How much we help our patients is the metric. It’s the peg we hang our self-esteem on.”

“So yes, of course, patient satisfaction is really important.”

But, he says, “on a list of well-meaning but really dumb reform ideas, linking compensation of hospitals (or doctors) to patient satisfaction scores ranks near the top. Let me tell you why I think this way. It involves an important baddie—overtreatment.”

“Medical care,” Mandrola writes, “is not the same as customer service. For instance, I believe strongly in the importance of explaining and then implementing TLC—therapeutic lifestyle changes. … Asking or expecting patients to take care of themselves risks converting them quickly to the ranks of dissatisfied. A much easier road for the doctor is to avoid the elephant in the room—and simply write the prescription, order the MRI or refer the patient on to another specialist. This behavior will only worsen if we dis-incentivize doctors to speak the truth. We already have too much care.”

The problem becomes acute when there are two treatment approaches—one involving a well-reimbursed procedure and the other involving a discussion between doctor and patient about lifestyle changes (or other conservative measures) that, if the patient commits to them, might avoid ever needing the more invasive procedure. As Mandrola says, the problem with the conservative approach is the risk of a poor satisfaction score by the patient. “Not doing in our system is far harder than doing,” he says.

“Bigger care, more care, riskier care–these are the reasons why I oppose using satisfaction scores to pay hospitals and doctors.”

One of his patients went to the ER. The problem, Mandrola recounts, was the patient’s inability to follow his earlier advice, as a first-line defense against his heart issues, not to use caffeine and nicotine. Mandrola had also discussed with the patient the importance of adhering to a medically sound regimen of an inexpensive generic medicine. At the ER, Mandrola reminded the patient that “his health depended on him—not me.”

Mandrola’s ER visit confirmed that his patient’s experience was common: The ER was overflowing with patients who had strayed, in Mandrola’s words, “far from ‘the program.’” But the ER staff still had to address their problems as emergencies, possibly serious ones. As one ER doc told Mandrola, “ …[N]ow, with patient satisfaction scores, we have to be extremely careful not to make patients mad.”

Readers of this blog know that while we never defend practitioners who are lazy, uncommunicative or negligent, we also make clear that patients have a huge responsibility in securing their own best care. Being satisfied with your health care is partly up to you.

The use of opioid drugs is another area ripe for a misguided application of Satisfaction=MoreBucks. Sometimes patients aren’t happy with the amount or type of pain medicines they’re prescribed. Sometimes that’s the doctor’s oversight or error, and some patients are deprived of pain meds they need. But sometimes, it’s the patient making an unreasonable demand, one that has contributed to the overuse and abuse of opioids in this country. (See our blog, “FDA to hold hearings on misuse of powerful pain pills.”)

If you don’t give patients the medicine they want, they might not be satisfied with your care, even when it’s appropriate. Satisfying them can be dangerous.

Mandrola ends his essay “with this warning—from the real world of health care–to policy makers:

“What you incent with dollars will happen.”

Accountability for preventable mistakes has now been officially recognized as an important part of the effort to make medical care safer for everyone.

The Agency for Healthcare Research and Quality (AHRQ) is the lead agency in the federal HHS department charged with improving the quality, safety, efficiency and effectiveness of health care. It supports research that helps people make more informed decisions and develops partnerships among different groups to make such improvements happen.

Accountability is part of that effort. To that end, the AHRQ is seeking approval from the Obama administration for a prototype system for patients to report medical mistakes and unsafe practices by health-care providers.

The New York Times described the plan, and said that even hospitals were receptive to the idea, despite some concerns about malpractice liability and possible financial penalties for poor performance.

Consumers have several options for reporting medical errors; last year we blogged about how to complain about unsafe medical care. The FDA’s MedWatch program is another channel for reporting adverse event about drugs and devices, but not practitioners. Individual states’ medical licensing boards field complaints, but their effectiveness and responsiveness vary widely.

And mistakes often go unreported anyway.

The AHRQ director, Dr. Carolyn M. Clancy, told The Times, “Currently there is no mechanism for consumers to report information about patient safety events.”

“Patient reports could complement and enhance reports from providers and thus produce a more complete and accurate understanding of the prevalence and characteristics [of medical errors].”

Common errors are drug mix-ups (the wrong medicine is given, or the wrong dose), surgical mistakes (surgery on the wrong body part, for example,) radiation overdoses and procedures (or the lack of them) that cause infections.

The Times story referred to research suggesting that 1 in 4 patients experiences adverse events; some were not even recorded in their medical records.

The system proposed by the AHRQ enables patients and their family members to report medical errors and near errors via a Web site and telephone interviews. The information would include:

1. details of the medical mistake;


2. the date and location of the adverse event, and whether it resulted in harm;


3. the type of harm;


4. contributing factors; and


5. whether the adverse event was reported and to whom.

The information submitted in the reports would be analyzed by researchers from the RAND Corporation and the ECRI Institute, a not-for-profit organization that investigates medical errors.

The feds would like to begin collecting data in May. Questionnaires would be available in hospitals and doctors’ offices. Information about the reporting program would be distributed to pharmacies and mailed to patients’ homes.

If the plan gets the go-ahead, and if patients volunteer to describe their adverse experiences with regularity, an important new data base should contribute mightily to recognizing how mistakes happen, and to a broad-based response to preventing them.

With all the political angst over the future of Medicare and how to fund it, we have to ask: Why not start with eliminating the redundancies -- the repeats on tests when no repeat is needed?

A new study published in the Archives of Internal Medicine suggests that Medicare patients frequently undergo repeated diagnostic tests. The researchers called such repetitive interventions a “major determinant” in the ability to contain health-care costs.

“We examined repetitive testing for six commonly performed diagnostic tests in which repeat testing is not routinely anticipated,” they wrote. “Although we expected a certain fraction of examinations to be repeated, we were struck by the magnitude of that fraction: one-third to one-half of these tests are repeated within a three-year period. This finding raises the question whether some physicians are routinely repeating diagnostic tests.”

Nearly three-quarters of a million older adults with fee-for-service Medicare coverage were studied. Within three years, the tests and their repeat numbers out of 100 Medicare patients were:

• echocardiography (heart), 55;


• imaging stress tests (heart), 44;


• pulmonary function tests (lungs), 49;


• chest computed tomography, 46;


• cystoscopies (bladder), 41;


• upper endoscopies (digestive tract), 35.

So nearly half (or more) of Medicare patients who had heart, chest, stomach or bladder tests had them again within three years. And the average time between repeat testing was four to 14 months.

Two different heart tests were analyzed. Echocardiography is an ultrasound of the heart, and is less invasive than imaging, or nuclear stress test, which tracks radioactive dye through the bloodstream to create the image while the patient works out on a treadmill or stationary bike, and again at rest.

As noted on Reuters, such procedures usually aren't supposed to be repeated routinely. And the routine use of some (echocardiography, stress tests) are specifically contraindicated.

As Reuters makes clear, the tests studied are for diagnostic purposes; that is, they’re generally performed on people with symptoms to help doctors make a diagnosis, then decide how to treat the problem. They cost from about $200 to more than $1,000.

As the lead research told Reuters, "Either these patients continually develop new problems or there are doctors who routinely repeat tests. … The fact is, we are paid more to do more."

Cost is not the only factor in having unnecessary tests; overuse can reduce the time available for practitioners to see new patients. As many Medicare beneficiaries are aware, it can be difficult already to find a doctor who accepts new Medicare patients. And as we’ve previously noted, unnecessary tests can lead to unnecessary and possibly complicating treatment for conditions that are harmless or relatively so.

As the researchers concluded, “Although the tests themselves pose little risk, repeat testing is a major risk factor for incidental detection and overdiagnosis

In an editorial accompanying the research study, Dr. Jerome P. Kassirer of Tufts University School of Medicine and Dr. Arnold Milstein of Stanford University School of Medicine wrote that “After decades of attention to unsustainable growth in health spending and its degradation of worker wages, employer economic vitality, state educational funding and fiscal integrity, it is discouraging to contemplate the fresh evidence … of our failure to curb waste of health care resources.”

To address unnecessary redundancies, the commentators suggest implementing peer-designed electronic systems to coordinate clinical information and eliminating incentives for fee-for-service procedures. The former would communicate a patient’s history more efficiently and the latter would pull the plug on the notion that more treatment means better treatment.

“No matter what future payment system is implemented,” wrote Kassirer and Milstein, “intercession in clinical decision making will be required to protect patients from too many tests and from too few tests. We have not come close to getting it right.”

If your doctor has prescribed a diagnostic test, either for the first time or especially as a repeat procedure, ask why; ask what would happen if you didn’t have the test, what it might show and what treatments might be prescribed for those hypothetical results.

You can also visit Choosing Wisely, an initiative to help providers and patients communicate better with the aim of more efficient delivery of health-care services. The site, produced by nine medical professional organizations, identifies procedures patients should question and discuss.

Now that President Obama has won a second term, the Affordable Care Act (ACA, commonly called “Obamacare”) has gained renewed attention and urgency.

As Kaiser Health News reminds, “[T]he law will have sweeping ramifications for consumers, state officials, employers and health care providers, including hospitals and doctors.” Courtesy of KHN, here’s a refresher about the ACA’s key features and the timetable for implementing the remaining provisions of the law.

It’s uncertain whether you will pay more or less for the new coverage. It includes incentives to control costs via, for example, more coordinated care. Such measures take time to register bottom-line results, and some provisions remain under Congressional scrutiny.

But new taxes and fees should offset some costs. Next year individuals earnings more than $200,000 and married couples earning more than $250,000 will pay a higher Medicare payroll tax, and higher-income earners pay more on unearned income, such as dividends and interest.

New taxes and fees will be levied on several major health industries. Next year, medical device manufacturers and importers must pay more sales tax. Fees will rise on health insurers and brand name drugs. The higher cost of doing business probably will be passed onto consumers via more expensive premiums.

Some aspects of the ACA already are in force:

• Parents may keep children as old as 26 on their health plan.


• Health plans no longer may impose lifetime coverage limits.


• Many preventive services are covered with no out-of-pocket costs. (See our blog post, “Health Care Reform: New Coverage for Women”.)


• Medicare now covers many preventive services without cost to beneficiaries.


• Insurance coverage may not be canceled after you get sick unless you committed fraud on your original application.


• Children with pre-existing conditions may not be denied coverage.

Some key features of the new law won’t be in force until 2014, when most people must have health insurance or pay a fine. Some states have passed laws barring the requirement to be insured, but they don’t override federal law.

Some existing health plans that haven't changed significantly since passage of the law are excused from certain parts of the law. Called “grandfathered” plans, they are allowed to charge beneficiaries part of the cost of otherwise fully subsidized preventive services.

If your plan is one of these but your employer changes it substantially—for example, by raising co-pays—it’s no longer protected by grandfather status.

As of 2014:

• Adults with pre-existing conditions may not be denied coverage.


• Individual penalties for not having health insurance start at $95 a year or as much as 1 percent of income, whichever is greater. The penalty increases to $695 or 2.5 percent of income by 2016. Penalties for uninsured families would be the greater of $2,085 or 2.5 percent of household income.

  The requirement can be waived for reasons including financial hardship or religious belief.



• Millions more people will qualify for federal subsidies to purchase insurance. Millions more will qualify for Medicaid.

  Individuals who earn as much as four times the federal poverty level (as much as $44,680) may qualify for help paying for their premiums. A family of four earning as much as $92,200 may qualify. Medicaid eligibility includes anyone whose income is lower than 133 percent of the federal poverty level ($14,856 for an individual and $30,656 for a family of four).

  The Supreme Court ruled in June that states, which administer Medicaid programs, may not be forced to accept this expansion, but the election results may influence governors who have said they will resist.



• Insurance exchanges, state-based programs to market insurance plans for people shopping for health coverage (primarily individuals and small businesses) will become operational. In addition to offering plan comparisons, they will assist consumers who may be eligible for federal subsidies.


• People who have insurance through their employer may retain that coverage if their employers keep those plans. They are not required to do so. They may change premiums, deductibles, co-pays and network coverage.

Businesses with at least 50 employees that don't provide health-care coverage but have at least one full-time worker who receives subsidized coverage in the health insurance exchange must pay a fee of $2,000 per full-time employee. The first 30 workers would be excluded from the fee. Companies with 50 or fewer employees are not assessed penalties.

Tax credits will be available to small business owners to help cover insurance costs.


• Medicare beneficiaries will see a gradual narrowing of the gap in prescription drug plans (the so-called “doughnut hole”). Seniors still will pay 25 percent of their prescription drug costs, but since the ACA was passed, according to the Department of Health and Human Services, 5.6 million seniors have saved $4.8 billion on prescription drugs.


• There is less subsidy for Medicare Advantage plans, which are private plans offered as an alternative to traditional Medicare. They’re more expensive, but often include extras such as free eyeglasses and hearing aids.

Aspects of the reform could be curtailed if Congress chooses to reduce some subsidies, KHN says, to address the budget deficit. Taxes on device manufacturers could be rolled back as part of a budget deal.

Whether President Obama’s re-election was a resounding vote for the ACA or only an invitation to keep diddling with its provisions will become apparent soon. But there is no doubt that it has already had an impact on how we think about providing medical care for people who need it now, and will need it later. That’s pretty much everyone.

As the health-care landscape continues to be reconfigured through legislative reform, greater consumer awareness, technological advances and evolving provider business models, an entrepreneurial niche has been carved out to help patients find the best, most efficient care. It’s called patient advocacy, and although the business is in its infancy, already there are a couple hundred members of the National Association of Healthcare Advocacy Consultants (NAHAC), as reported on Marketplace.

The organization’s self-described purpose is “to improve the way people interact with and experience the health care system by supporting public education to foster effective self-advocacy.”

We have repeatedly described the role of a patient advocate and explained why every patient who is hospitalized and all patients unable to fully inform themselves and act in their own interests should have a patient advocate.

The Marketplace story describes this function as a profession. It told the story of William Roach, who was diagnosed with brain cancer and faced multiple important decisions. He needed help. "It's not hard to find people who are sympathetic," Roach told Marketplace. "It is hard to find people that are both sympathetic and can provide information that can actually be helpful."

It’s sort of like asking your sister-in-law, who is good at math, to help with your financial portfolio. When you win the lottery, however, you need professional advice about what to do with all that money.

Roach contacted Elisabeth Schuler Russell, president of NAHAC and a private health-care consultant. Her line of work is so new, she said, sometimes doctors don’t understand her role. "They’re a little skeptical at first," she told Marketplace. "Because you’re not a family member, so why are you here? But once we explain to them that we’re there to help manage all the moving parts and to benefit the patient, they’re usually fine with that."

Her fees are $125 an hour. That’s a lot, but, according to her, most people need only a few hours of her time to help patients locate the right providers and supply them with relevant research so that they can “become their own best advocate."

Obviously, for some people this service isn’t affordable. And it shouldn’t be necessary if high-quality, cost-effective medical care routinely were delivered efficiently. We all know that doesn’t always happen.

Health-care consultant James Unland believes Baby Boomers will juice the patient advocate market for help choosing doctors, treatments, medications and dealing with billing, which is a whole other branch of the business.

But Les Funtleyder, author of "Health Care Investing: Profiting from the New World of Pharma, Biotech, and Health Care Services,” raises a warning flag. Because patient advocates so far aren’t licensed, accredited or otherwise certified, anyone can call himself a patient advocate even if he lacks qualifications. "You see this at the beginning of almost any new industry," Funtleyder told Marketplace. "There are always good ones and bad ones, and hopefully the bad ones get weeded out."

Roach apparently got the flower and not the weed. He said the $2,500 he spent on a patient advocate saved him money because it helped him spend fewer hours under a specialist’s care. And he’s fortunate that his screening tests lately have all been clear and he hasn’t required follow up.

The Deloitte Center for Health Solutions, a research arm of the business consulting firm Deloitte LLP, recently surveyed consumers, physicians and employers about the U.S. health-care system. Although these groups often have competing interests and agendas, they shared a low opinion about health care in America.

As reported on MedCity News, 63 percent of consumers, 65 percent of physicians and 65 percent of employers gave the U.S. health-care system a grade of C or lower. The poor grades, the thinking goes, is due to the perception that the system is wasteful and lacks value—only 1 in 4 respondents to an earlier consumer survey said they got the best value for their money.

There were differences, however, among the survey groups. When asked if they agreed that health-care reform (commonly referred to as “Obamacare”) was a step in the right direction, 44 in 100 physicians said yes, 38 in 100 consumers did and 30 in 100 employers. Only 4 in 10 mid-sized and large companies said they were “well prepared” to implement the Affordable Care Act reforms of 2014.

Asked who was to blame as the single largest contributor to health-care costs, 8 in 10 employers and nearly 6 in 10 consumers said “hospital costs;” 7 in 10 physicians said “consumer behavior.” There's a credibility gap that needs exploring. Because physicians are the ones writing the orders for drugs, tests and procedures, it's a little hard to swallow the idea that insistent consumers are browbeating doctors into wasting money on unnecessary medical stuff.

If only Dr. Marty Makary could be everybody’s doctor. He’s a surgeon at Johns Hopkins Hospital and associate professor of Health Policy at the Johns Hopkins School of Public Health. Unlike many of his fellow professionals, he’s vocal about the deficiencies in the delivery of health care, and openly discusses the problems of medical malpractice.

Makary led the effort of the World Health Organization (WHO) to measure hospital complications and co-developed the life-saving checklist for surgeons that’s become best practice to reduce infection and mistakes and to improve patient outcomes. As author of “Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Healthcare,” he’s often quoted about medical error, and his informed opinions widely reproduced.

We think highly of his work, and are sharing some excerpts from his book. Our selections come from a long story recently published on The Daily Beast.com/Newsweek, but he’s been widely quoted in other media, including The Wall Street Journal.

On Overtesting and Overdiagnosing
“A host of new studies examining the current state of health care indicates that approximately one in every five medications, tests, and procedures is likely unnecessary. What other industry misses the mark that often? Others put that number even higher. Harvey Fineberg, M.D., president of the Institute of Medicine and former dean of the Harvard School of Public Health, has said that between 30 percent and 40 percent of our entire health-care expenditure is paying for fraud and unnecessary treatment.”
…
“Politicians debate different ways to pay for our broken system. But if we are going to get serious about reducing health-care costs—and improving health-care outcomes—we need to address the 20 percent of medical care that is unnecessary and dangerous. The public should demand disclosure of a hospital’s patient-outcome statistics. After all, we have information on a car’s safety record to inform our decision about which car to buy. But when it comes to choosing medical care, the consumer is left to walk in blind. While we currently have a free market for health care, the competition is at the wrong level. Many patients tell me they choose their medical care based on parking. For an industry that represents one sixth of the U.S. economy, we can do better than that.”

See our blog, “Overtested, Overtreated, Overcharged.”

On Hospital Competency
“While patients are encouraged to think that the health-care system is competent and wise, it’s actually more like the Wild West. The shocking truth is that some prestigious hospitals participating in a national collaborative to measure surgical complications have four to five times more complications as other hospitals. And even within good hospitals, there are pockets of poorly performing services.”
…
“The wide disparity in the quality of medical care is no secret among hospital staff. In a study I conducted in 2006, we asked hospital employees, ‘Would you feel comfortable receiving medical care in the unit in which you work?’ While there were hospitals where 99 percent said yes, at more than half of the hospitals we surveyed, the majority of health-care workers said no. And to the question of whether their hospital gives priority to what’s best for the patient, again, in more than half of the hospitals surveyed, the majority of health-care workers said no.

“In other words, everyone who works in medicine knows about this problem but few talk about it. A cardiovascular anesthesiologist once described to me a colleague who was one of four heart surgeons at his well-known heart hospital. This surgeon had six consecutive deaths during routine bypass surgery. Half the operations of his last 10 surviving patients took several hours longer than the norm, often requiring the patient to be put back on the heart-lung bypass machine after having come off it. I asked my friend if he ever thought about reporting this surgeon to someone. He laughed and asked, “Like who?” The hospital administration loved this young doctor and was making a mint off his work. The senior partners were very protective of him—he covered their holiday shifts and happily tended to whatever the senior surgeons did not like to do. Whenever one of his complications was discussed at a peer-review conference, they cut him tremendous slack, attributing the death to some extenuating patient circumstance.”

See our blog, “An Insider Dishes About Hospital Ratings.”

On Hospital Transparency
“A new generation of doctors has been developing fair and simple ways to measure how well patients do at individual hospitals. In hospital-speak, we call the information “sensitive data”—data that would tell you which hospitals have much worse outcomes than others.

“It’s the kind of data that, if you had access to it, would help you know just where to find the best care. But you don’t. And that is precisely the problem with the entire system: because a hospital’s outcomes are hidden from the public, neither consumers nor payers have any way of measuring whether the medicine they provide is good, adequate, or even safe. Much as the financial crisis was incubated when bank executives turned a blind eye to the ugly details about their mortgage-backed securities, so too does medicine’s lack of accountability create an institutional culture that results in overtreatment, increased risk, and runaway costs.”

See our blog, “Rating Hospitals by Readmission Is Not Simple.”

On Dangerous Doctors
“Years ago, one of my favorite public-health professors, Harvard surgeon Dr. Lucian Leape, opened the keynote speech at a national surgeons’ conference by asking the thousands of doctors there to ‘raise your hand if you know of a physician you work with who should not be practicing because he or she is too dangerous.’ Every hand went up. Doing the math, I figured that each one of these dangerous doctors probably sees hundreds of patients each year, which would put the total number of patients who encounter the dangerous doctors known to this audience alone in the hundreds of thousands. If, say, only 2 percent of the nation’s 1 million doctors are seriously impaired or fraudulent (and most experts agree that 2 percent is a low estimate), that would mean 20,000 impaired or fraudulent doctors are practicing medicine. If each one of these doctors typically sees 500 patients each year, then 10 million people are seeing impaired or fraudulent doctors annually. Incredulous at the numbers, I took to asking the same question whenever I spoke at conferences. And the response was always the same.”
…
“[T]he National Practitioner Data Bank collected by the U.S. Department of Health and Human Services … is also known as the national “blacklist” of doctors. The public has absolutely no access to it. When I requested the list, I was given a version with the doctors’ names deleted; the only groups that can query the list are state medical boards or human-resources departments doing background checks. Ironically, sex offenders’ names are broadcast to the community when they move into town, but doctors who lose their license in one state because of sexual misconduct with a patient are shielded by name in the database if their license is later restored or if they continue to practice medicine in another state.”

See our blog, “Minnesota Tells Dangerous Doctors: We Won’t Punish You.”

On Preventable Medical Errors
A 2010 New England Journal of Medicine study concluded that as many as 25 percent of all hospitalized patients will experience a preventable medical error of some kind, and 100,000 will die annually because of errors. If medical error were a disease, it would be the sixth-leading cause of death in the country. My research partner lost his father due to a medical error. My medical partner lost his younger sister due to a medication error. My best friend’s mom had her breast removed unnecessarily because she was mistakenly told she had stage-III breast cancer. My grandfather died at age 60 from a preventable infection following a surgery he didn’t need. Andy Warhol died prematurely of a mistreated gallstone at 54; “Saturday Night Live’s” Dana Carvey had open-heart bypass surgery on the wrong vessel; and the singer Kanye West’s mother recently went to a surgery center for a routine plastic surgery, developed a rare complication, and died.”

See our blog, “Medical Mistakes That Led to a Greater Good.”

Last month, Kaiser Health News published a story about mandatory arbitration agreements in nursing home contracts. Such agreements are common when signing up for services such as credit cards and cell phones. Increasingly, medical consumers are asked to sign arbitration agreements at doctors’ appointments (see our post about binding arbitration ).

Essentially, agreeing to arbitrate disputes denies your right for a grievance to heard by a court of law. Arbitration agreements are promoted as saving the protracted time it can take to resolve a lawsuit, and, by saving legal fees, to reserve for the patient a larger percent of any award. Never mind that many people still retain counsel in arbitrated disputes, and are responsible for their share of the arbitrator fees.

Consumer advocates dislike arbitration agreements because although arbitrators are selected jointly by the parties involved, their objectivity can be suspect: Arbitrators with a reputation for patient awards might find their names lopped from the industry’s list of suitable candidates.

In the case of a dispute with a doctor, or as in the KHN story, a nursing home, consumers who sign arbitration agreements are not able to file a medical malpractice or wrongful death lawsuit.

Unlike court proceedings, which are public and whose public records inform industry practice and help develop case law, arbitration hearings are conducted in private. The proceedings and documents usually are protected by confidentiality rules.

And if there is an award, it’s often less if it’s determined by an arbitrator than it would be if the case went to trial. No wonder businesses want consumers to agree to arbitration in case they mess up.

According to KHN, Aon Global Risk Consulting analyzed 1,449 closed claims involving long-term care providers (such as nursing homes) between 2003 and 2011. No money was awarded in nearly 1 in 3 claims for which a valid arbitration agreement was in place. But no money was awarded in only 1 in 5 claims for which there was no arbitration agreement or the agreement was determined to be unenforceable.

Nearly 12 in 100 claims without arbitration agreements resulted in awards of $250,000 or more, versus 8.5 in 100 with arbitration agreements.

The study was conducted by the American Health Care Association, which represents long-term care facilities. Greg Crist, the association’s spokesman, said increasing liability costs for providing care has prompted the popularity of arbitration agreements, which help to reduce them.

The news story pointed out that consigning someone to a long-term care facility is an anxious ordeal; a mandatory arbitration agreement is often overlooked within the reams of admissions documents many nursing homes require to be signed.

Of course you should always read the fine print in any contract. Crist told KHN that if people don’t want to be forced into arbitration in the event of a future dispute, they shouldn’t sign the arbitration agreement. "It's not a condition of admission to the facility," he said.

The KHN article concluded that rather than invoking the 30-day "opt-out" provision that allows you to change your mind about arbitration and retain your rights to sue, “Better yet, experts agree, is not to sign in the first place.”

Whoa Nelly! “On what planet?” asked the Center for Justice & Democracy’s Pop Tort blog. “These folks have obviously never had to deal with the misfortune of trying to find a decent nursing home for a family member.”

“[Y] ou cannot ‘not sign’ what a nursing home is asking you to sign,” said Pop Tort. “Nursing homes aren’t things families leisurely shop around for like condos or summer vacation rentals. Usually, families are dealing with a situation where a family member is being thrown out of hospital after suffering some terrible illness or injury. If the family is lucky, they’ll quickly find a facility with a decent reputation, not too many state violations and hopefully accepts Medicaid. … If you refuse to submit to a nursing home's terms, good luck getting in.”

Pop Tort also called out the KHN story for suggesting that if an arbitration clause is buried in the paperwork you’ve unwittingly signed, and then something actionable happens to your loved one, you can sue the nursing home, the judge will find fault with the arbitration clause and throw it out, as one judge did in one case the story mentioned.

Hardly. “Even the U.S. Supreme Court has spoken on this topic,” said Pop Tort, “and how do I put it: They don’t care!” (Read about its ruling on arbitration clauses here.) In a further indictment of the objectivity of arbitration, Pop Tort noted, the court ruled that it was OK for arbitrators themselves to decide if their own system was fair.

Arbitration is stacked against people whose loved ones have been harmed. The U.S. has a perfectly good legal system to adjudicate medical disputes. What’s unconscionable is denying medical consumers its remedies before the process even starts.

Health-care business writer Merrill Goozner recently analyzed a report from the National Institute for Health Care Management (NIHCM). It showed that in 2009, half the U.S. population (150 million people) spent an average of $236 per person on health care, or $36 billion of the $1.3 trillion in personal health-care expenditures.

Only 5 percent of the population (about 15 million people) spent about half of all personal health-care dollars ($623 billion). That’s about $41,000 per patient. The top 1 percent of health-care spenders (usually people battling life-threatening or chronic illnesses such as heart disease, diabetes, cancer or dementia) average more than $90,000 per patient per year. These 3 million people represent more than 20 percent of the total U.S. health-care tab.

Goozner makes the point that “eliminating waste” and giving “consumers a greater financial stake” in health-care decisions are reasonable goals and popular political buzzwords, but they’re not the key to curbing rising health-care costs. Most people, as the NIHCM figures show, are not on a wild health-care spending spree.

The vast majority of big spenders were older and often had multiple chronic conditions (heart disease, diabetes, asthma, arthritis) that were associated with obesity. Medicare-eligible patients 65 and older composed 13 percent of the population, but represented 40 percent of the high-spending group.

Working people with private insurance and large health-care expenses also suffered disproportionately from multiple chronic conditions. A previous study cited in the NIHCM report showed that only 7 percent of people in the highest spending 5 percent had no previous chronic condition; in other words, they were stricken without warning by cancer or had a bad accident.

Like the best prescription for treating health problems, the best way to treat skyrocketing costs is to prevent them in the first place. Said Ken Thorpe, professor of preventive medicine at Emory University and chairman of the corporate-backed Partnership to Fight Chronic Disease, “If you look at what’s driving the growth in health-care spending, half is due to the increase in chronic health conditions. Prevention is crucial to holding down costs long-term.”

Thorpe’s organization promotes prevention strategies, such as a diabetes prevention program that has been shown to reduce the number of people who move into the high-cost category. But, Goozner writes, prevention strategies don’t curb costs in the short term; once someone joins the high-spending ranks, he or she probably will remain there.

The who-spends-what scenario makes implementing the Affordable Care Act -- the health care reform legislation that the Supreme Court recently ruled was, with notable exceptions, constitutional -- more challenging. The key argument in favor of the individual health insurance mandate is that everyone uses health care eventually. So it’s only fair that everyone pays into the insurance pool. Without a mandate, some people will wait until they get sick before buying coverage.

For the NIHCM, the new study means that the ACA’s new state insurance exchanges, which are intended to provide broader access to affordable coverage, either must guarantee that high-cost patients are evenly distributed among competing plans or must “risk adjust” the size of payments to insurers. That means if one plan covers a disproportionately large number of seriously and/or chronically ill people, it must cost more.

“If you’re an organization with a great reputation for treating diabetics, guess who you’re going to get? Lots of diabetics,” said NIHCM President Nancy Chockley. “There has to be adequate risk adjustment.”

As of this month, an estimated 47 million women covered under a variety of health plans gain access to eight more preventive health-care services. We previewed this aspect of the Affordable Care Act (ACA) last year.

Of course, it’s not just women who are benefiting from the ACA—in the last couple of years, everyone has been able to receive free preventive services including flu shots and other immunizations, and screenings for cancers high blood pressure, cholesterol and depression.

Before the most recent mandate kicked in, some insurance companies did not cover certain preventive services for women, and others required them to pay deductibles or co-pays for what, in many cases, is essential care. Now, these preventive services are free of charge:

• well-woman visits;


• gestational diabetes screening that helps protect pregnant women from one of the most serious pregnancy-related diseases;


• domestic and interpersonal violence screening and counseling;


• FDA-approved contraceptive methods, and contraceptive education and counseling;


• breastfeeding support, supplies and counseling;


• HPV DNA testing for women 30 or older;


• sexually transmitted infections counseling for sexually-active women;


• HIV screening and counseling for sexually active women.

But be aware that people covered by plans with grandfathered status—that is, plans that were in effect prior to enactment of the legislation on March 23, 2010—are not required to cover these services. Grandfathering is complicated, however, so contact your insurance company to determine if your plan qualifies; even if it existed before 2010, if certain changes have been made to it, it might have lost grandfathered status.

Also, some nonprofit religious organizations, such as churches and schools, are not required to cover the services; most of the issues surrounding those decisions concern opposition to contraceptives and counseling.

It’s a heated issue in many quarters; the Obama administration recently addressed it with this limp explanation: “The Obama administration will continue to work with all employers to give them the flexibility and resources they need to implement the health care law in a way that protects women’s health while making common-sense accommodations for values like religious liberty.”

Preventive services currently offered for women covered by Medicare include annual wellness visits, mammograms, diabetes screening and bone mass measurement for people at risk of osteoporosis. Nearly 25 million women with Medicare used at least one free preventive service in 2011.

To learn all 22 preventive services for women that are covered for free, link here. To find out about the health-care services for which anyone might be eligible at no extra charge, link here.

The advent of Medicare’s Part D drug plan introduced everyone to the concept of the “donut hole.” That’s the point at which prescription drug coverage ceases for a period during which the plan member pays full price. The gap closes when the patient has spent a set amount for drugs, and subsidies resume. As reported by Reuters Health, research has shown that this gap prompts seniors to stop taking medications for heart problems, diabetes and, now, depression.

According to the researchers of a new study published in the Archives of General Psychiatry, when these patients stop taking antidepressants, their risk of relapse increases. Such behavior, they said, “poses a serious risk.”

Once beneficiaries pay a deductible of a few hundred dollars, Part D drug plans usually cover 75 percent of drug costs until the threshold figure is reached. This year, for standard coverage, that amount is nearly $3,000. Then patients must shell out another $3,700 (amounts vary according to plan) before coverage resumes.

If the Affordable Care Act survives the current political upheaval, the donut hole will expire in 2020, when the legislation mandates that drug coverage be constant. But that’s a long time away, especially if you’re a senior citizen.

We’ve discussed how the insurance coverage options available to supplement Medicare are so confusing that seniors are less likely to enroll for additional coverage. But the study makes clear, however, that they are less likely to forgo their drugs if they have it.

The study involved more than 22,000 Medicare beneficiaries who had been diagnosed with depression and were prescribed antidepressants. Data was collected starting in 2007, the year after the Part D plan was initiated. Nearly 3,000 study subjects had supplemental insurance that filled the gap for generic drugs. Another 11,500 had complete coverage from other sources, including low-income subsidies. But more than 7,500 were stuck paying the gap amount.
Nearly 7 in 100 people who had generic drug gap coverage ceased taking their antidepressant meds, but more than 12 in 100 with no coverage did.

As the study notes, depression affects 13 in 100 Medicare beneficiaries 65 years or older. Many have additional chronic physical conditions. Treating and maintaining treatment of late-life depression with antidepressants prevents recurrent episodes of major depression. Caregivers generally recommend these patients take antidepressants for two years.

It’s a bad idea to stop taking these drugs cold turkey. As the lead researcher wrote, "If patients discontinue their appropriate medication therapy abruptly, they could be placing themselves at risk for medication withdrawal effects [including include dizziness, gastrointestinal distress, disturbing dreams, fatigue and irritability] and for (depression) relapse or recurrence."

Although the study didn’t find that rates of hospitalization were higher for the no-gap coverage group than the others in the study, the depressed elderly population remains vulnerable to the Part D donut hole.

If you or a loved one is in this situation, help is available. Contact the manufacturer of the relevant drug—they often have coupons or rebate/subsidy programs for the financially pinched. That link also includes contact information for other prescription assistance organizations, as well as general resources for seniors. For general information about Medicare’s prescription drug coverage, link here.

One component of the changing U.S. medical industrial complex is a greater awareness on the part of physicians that superior health care isn’t only about science and practice management. It’s also about the efficient and fair delivery of medical care.

There is, perhaps, no better example of this awareness than a recent report that issued from an annual meeting of the American Medical Association (AMA). As the largest medical professional organization, and publisher of the Journal of the American Medical Association (JAMA) and its several specialty publications, the AMA’s pronouncements carry heft not only for members, but for anyone interested in medicine.

Last month, the AMA’s principle policy-making body, the House of Delegates, declared that the provision of effective medical care includes an “obligation” to manage health-care resources well (p. 180). As reported on MedPage Today, the statement reinforced the notion that physicians are obliged primarily to serve the interest of individuals, and that too often, caregivers make decisions that don’t consider the welfare of the patient.

That includes recognition of the cost of care.

In our monthly newsletter, we’ve discussed the idea of transparency in health care, of how medical consumers usually have little idea of what treatment costs because its purchase is clouded in bureaucracy and a sliding standard, depending on whether insurance underwrites care, and if so, to what extent. It’s refreshing to see the organization that represents so many practitioners calling for the same clarity of cost.

The report cited several cost pressures under which caregivers work, some of which are beyond their control—drug prices, for one example. “Other cost drivers, however, such as extensive use of new technologies and high intensity of services provided at each patient encounter, are influenced by physician choices,” the report read.

Doctors must refrain, the report said, from ordering medically unnecessary tests, and to provide treatments of clear patient benefit. “Wise stewardship,” the report says, is what should shape decisions about care. “More intensive and/or costlier services do not necessarily lead to better health outcomes.” Readers of this blog have heard that before.

Some doctors practice defensive medicine—that is, they overtreat because they’re afraid of getting sued for malpractice if they don’t order many tests and something goes wrong. Unfortunately, however, instead of acknowledging that bogus premise and that good care and the immediate acknowledgment of responsibility in the event of an error have been proved to thwart lawsuits, the AMA statement said only that doctors should work harder for medical liability reform in order to fully implement its vision of “wise stewardship.”

Although some doctors were concerned that cost-consciousness would make patient well-being a secondary consideration, most were in favor of what the report specifically recommended:

• Base medical recommendations on patients' medical needs using scientifically grounded evidence.


• Help patients and their families form realistic expectations about whether a particular intervention is likely to achieve its goals.


• Choose the course of action that demand fewer resources if alternatives offer similar prospective outcome and anticipated benefit compared with anticipated harm.


• Be transparent about the medical alternatives, including disclosing when a constraint on resources played a role in decision-making.


• Try to resolve disagreement if a patient feels a costly intervention is worthwhile. This could include consulting other professionals.

• encouraging health-care administrators and organizations to make cost data transparent;


• ensuring that physicians have the training they need to be informed about health-care costs
  and how their decisions affect overall health-care spending.

The legal attack on "Obamacare" -- the Affordable Care Act -- often asks the question: If the government can make you buy medical insurance, couldn't it also make you buy broccoli? A lot of us chafe at this glib analogy, which masks the free rider problem with uninsured patients who drive up the costs of health care for everybody who is responsible enough to have insurance.

But here's the best answer I've read about why the broccoli analogy is false and misleading. It comes from a physician, H. Jack Geiger, a retired professor of community medicine at City University of New York Medical School, writing a letter to the New York Times editorial page.

[P]eople who choose not to buy (or cannot afford to buy) broccoli do not drive up its cost and make it unaffordable to those who need and want it.

But all of us who need and want health insurance pay for those who do not have it. Everyone, sooner or later, gets seriously ill or injured.

The uninsured patient comes to the hospital and in many cases incurs costs running to the hundreds of thousands of dollars. The hospitals, unable to absorb those costs and survive financially, shift costs to those who are insured by raising their rates for everything from room charges to every diagnostic and therapeutic procedure. The health insurance company, faced with paying for those claims, raises its premiums.

Whether we are publicly or privately insured, we all pay more, and the national cycle of escalating health care costs goes on. That’s not broccoli; it’s interstate commerce.

At its root, the use of this false broccoli argument is an attack on the concept of a common good, the reality that we are all in this together, and the idea that the government has a legitimate stake in the health of our population.

Here’s another arrow for the quiver of people exasperated with government.

As part of its health-care reform, the Obama Administration proposed that drug companies be made to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. The rationale, as reported by The New York Times, was evidence that such payments can influence treatment decisions and boost costs by encouraging the use of more expensive drugs and medical devices.

Disclosure, the thinking goes, would make doctors more disposed toward making decisions in the best interests of patients instead of their bottom lines. As we’ve reported, drug and device company largess can be ripe for conflicts of interest.

According to The Times, about 1 in 4 doctors takes cash payments from drug or device makers; nearly 2 in 3 accept routine gifts of meals for themselves and their staff. The Times also concluded that doctors who take money from drug makers often practice medicine differently from those who do not—they’re more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Some companies have begun posting some payment information on their web sites, sometimes as the result of legal settlements with the federal government. Under the new proposal, if a company has even one product covered by Medicare or Medicaid, it must disclose all payments to doctors other than its own employees. The federal government will post the information on a public Web site.

The penalty for noncompliance could be $10,000 for failure to report. A company that knowingly fails to report payments could be subject to a $100,000 penalty for each violation, to a maximum of $1 million a year.

Comments about the proposal were accepted until Feb. 17, then Medicare officials were to issue final rules with the force of law.

Here’s where the archers among us start to take aim. As reported on FDA Law Blog, earlier this month the Centers for Medicare & Medicaid Services (CMS) announced “that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before Jan. 1, 2013.”

The regulation requires the first report to be submitted by March 31, 2013 for payments made in this calendar year, but CMS already has exceeded one deadline--under the Patient Protection and Affordable Care Act (ACA), payment-reporting procedures were supposed to be established by of Oct. 1, 2011.

The postponement gives CMS time to review more than 300 comments about the proposed rule, and also affords manufacturers additional time to prepare for the disclosure reports. Although the CMS didn’t expressly say the March deadline was extended, it’s implicit in the delay.

On news of the extension, Sen. Charles Grassley, R-Iowa, one of the sponsors of the Physician Payments Sunshine Act, said, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

We’d like to believe him. But when it comes to excuses in Washington, supply always
seems to exceed demand.

What with the uncertainty of the Obama Administration’s health-care reform and the increasing cost of medical care, few areas of U.S. commerce are as volatile as health insurance. But one segment of that industry is decidedly popular, although it’s fraught with “what-ifs.”

In one year, between January 2010 and January 2011, high-deductible insurance plans grew by more than 1 million customers. According to a story aired on PBS Newshour, in collaboration with Kaiser Health News, last year, nearly 3 in 10 workers covered by employer insurance were offered a high-deductible option. Enrollment in such plans has tripled in five years. A survey by the Kaiser Family Foundation (not affiliated with the health-care provider) showed that half of all covered workers in small businesses (as many as 199 employees) had a high-deductible plan.

Deductibles for these plans range from at least $1,200 for an individual to more than $10,000. Before the insurer begins to cover the costs, the consumer must pay the deductible out of pocket. The tradeoff is that the monthly premiums are lower for both employers and consumers than other plans—they average, for an individual, about $1,000-$2,000 a year.

Many employers offering these plans also create health savings accounts (HSAs), a sort of rainy-day fund to which employers and/or employees may contribute money tax-free for use in medical emergencies. The money accumulates year to year, and can be rolled over into a new employer’s plan.

Thanks to the Patient Protection and Affordable Care Act (ACA), even bare-bones, high-deductible plans must cover certain basic, preventive services for free, such as vaccinations. But they’re still risky, even for the young, healthy people for whom they make the most sense.

The PBS story profiled a young ballet dancer who opted for his dance company’s high-deductible coverage. Dennis Adams, in his mid-20s, had never had surgery, had never broken a bone, had never been in an ambulance, had never been to the hospital. He signed up for a $2,500 deductible plan.

Then he tore a knee ligament during a dance performance. The MRI needed to show the extent of the damage cost $1,600, and the provider required that it be paid up front. Adams didn’t have the money.

Lucky for him, the injury was work related, so workers’ compensation insurance covered his cost.

Whether you’re older, infirm or young and robust, high-deductible plans are designed to make you likelier to take care of yourself, and more attentive to how your health-care dollars are spent. In theory, that’s a good thing—the overuse of medical services has fueled an out-of-control medical industrial industry and increased patient harm.

But there’s a black side here, and it’s not just about lacking the cash to cover your deductible.
It’s about the inability for even the most conscientious consumer to price medical services (see Patrick Malone's newsletter this month on "The Unknowable Cost of Medical Care," and what you can do), and the withholding of even needed care. In the PBS story, Dr. Alison Galbraith of Harvard Medical School said that people in high-deductible plans had “a much higher prevalence of delayed or foregone care due to cost” compared with those in more traditional plans.

People are rationing their own care, which is fine for many people who otherwise would overuse the system. It’s not fine if you’re ill or have a chronic condition that can be managed with regular, sometimes minimal care.

One high-deductible plan member allowed as much. “I do get headaches about once a month,” she said, “and they can get really bad. And I still haven't gone to see a doctor about it. … It's like, I'm kind of trying to cheat the system a little bit, because it's like, if I don't go and it's not really serious, then I'm saving money.”

But at what cost?

As Dr. Drew Altman, President and CEO of the Kaiser Family Foundation, put it, “We really need to have a national discussion about whether this is a good thing or this is a bad thing. … I think what it really means is, this is OK for some people if you are pretty healthy. But we have to worry about what these very high deductibles, $2,000, $3,000, $4,000, $5,000 deductibles, is that really even insurance coverage?”

If you’re considering insurance coverage with a high deductible, remember:

• Out-of-pocket costs generally include the deductible, the patient's co-pay to see a doctor, prescription medicines and/or hospital costs.


• Often, the number of office visits allowed for only the co-pay is limited. If you exceed that number within a calendar year, generally you are expected to pay the caregiver’s out-of-network (or unsubsidized) rate.


• HSAs allow beneficiaries to contribute, tax-free, as much as $3,100 for an individual and $6,250 for a family.


• The plans are problematic for low-income individuals, especially those with chronic conditions, such as diabetes. People with health problems often have the toughest time meeting the high deductible because their illnesses can keep them from working.


• The IRS determines what medical expenses qualify toward the deductible. Recently, the agency dropped over-the-counter medications from its list.

In medicine, a culture shift may be underway in venture capital, which subsidizes the cutting-edge technology that keeps a culture moving forward.

As reported by Kaiser Health News (KHN) in conjunction with NPR and KQED, for venture capitalists, the bloom is fading from expensive medical gee-whizzery. These days, such deep-pocketed supporters are more in favor of improving medical efficiency than in staking a claim to such glitzy endeavors as robotic surgery, whose questionable benefits we recently covered.

Hospitals love boasting about their amazing new machines and surgeons love using them. Insurance companies don’t love paying for them, so their enormous costs are passed along to employers and patients.

As the recession took hold, however, and the Affordable Care Act (ACA) was passed, the financial engine behind high-tech R&D began to reassess where to put its fuel. As one Silicon Valley venture capitalist told KHN, “If you come in with [a device] that’s 10 percent better and twice as expensive, it’s hard to get anyone to care.”

Venture capitalists look for opportunity wherever it occurs, and these days it’s in areas such as helping hospitals figure out how to reduce readmissions. It’s expensive when a recently released hospital patient must be readmitted because of complications, and under the ACA, readmissions carry financial penalties.

Because the ACA will increase the number of people who are covered by high-deductible insurance plans, venture capital is funding a technology company that helps them choose the least expensive care. Another less-than-glamorous funding recipient, but one with an enormous impact, addresses the often torturous process of health-care billing.

“There’s a half a person per hospital bed on average that sits in the hospital doing coding and collections and trying to get paid,” according to one venture capitalist. His solution is to replace the labor-intensive manual coding with software that can understand repetitive charges and devise efficiencies that minimize repetitious functions.

That doesn’t mean new medical developments are all about process instead of product, but the products are simpler. Infections, notoriously borne by the widespread use of catheters, are being controlled better through the venture-capital development of a plastic device that kills microbes. The DualCap catheter costs less than a dollar.

Sometimes, the most thoughtful investment isn’t about the sexiest new surgical tool that helps 10 rich people find a place in medical history; it’s about helping millions of average patients gain access to competent, affordable care for the long run.

Watch this video from the floor of the U.S. House of Representatives today. Rep. Bruce Braley explains why the bill under debate to make it harder for patients to win malpractice lawsuits won't heal any of the medical industry's troubles. And it certainly won't help improve patient safety.

These "reform" bills turn up like bad pennies every year. Nobody likes to be held accountable for carelessness and negligence. But sometimes that's the only fair thing to do. And in the case of medical malpractice, lawsuits unfortunately are the only effective system for making care providers work harder to avoid hurting patients.

If you suffer a terrible injury from taking a generic prescription drug, you have no legal recourse. So ruled the U.S. Supreme Court last year in a case that divided along political lines with five conservative justices throwing a new lifeline of legal protection to the generic drug industry.

Now the consequences of that decision are being borne out as hundreds of patients injured by generic drugs are finding their lawsuits thrown out of court. Some of their stories are gathered by the New York Times in a new report on this arbitrary distinction between generic drugs without legal recourse but brand names where the injured consumer still can sue.

Since the Supreme Court's ruling is not based on the Constitution but just its own interpretation of the wording of the Food and Drug Act and the regulations of the Food and Drug Administration, either Congress or the FDA could fix this problem. But that means politics, and the powerful drug industry will fight hard to protect its advantages. Stay tuned to see if anything happens legislatively to reverse this unfair decision.

If it takes a village to raise a child, it takes a whole culture to ensure adequate health care for all. One Idaho obstetrician recently explained to his state’s legislators how he thinks it can be done.

Dr. Loel Fenwick, as reported by the Idaho Reporter, said in order to curb the rising cost of health care and address the U.S. propensity to overtreat, consumers must become more involved in health-care decisions. These aren’t new ideas, and readers of this blog will recognize the echoing refrain. The point is not only to lower costs, but improve outcomes.

Instead of the standard, but now diminishing, group health coverage by employers, Fenwick supports the idea of health savings accounts (HSAs) for private sector employees. HSAs are insurance plans with two basic elements:

• a tax-preferred savings account where money is set aside by the consumer (employers may also contribute) to pay for medical expenses and prescription drugs;


• a high-deductible health insurance plan.

Fenwick’s idea is for the state to develop these accounts for private sector employees, and for insurance carriers to house the policies. Employers would deposit insurance premiums into the accounts, which could be tapped only for health-care expenditures.

Like all HSAs, the cash accounts are coupled with high-deductible insurance coverage for things beyond relatively modest procedures and treatments, such as vaccinations, and check-ups.

Fenwick’s plan would require doctors and hospitals to list the cost of treatments and procedures so that consumers could be informed about what stuff actually costs, instead of knowing only what is their share of an otherwise unknowable cost. Comparison shopping for medical needs! What a concept! This idea is gaining traction, and we wrote about one such program a few months ago.

Fenwick says Idaho would save as much as $1,350 per year, per resident in otherwise state-subsidized care.

One legislator expressed support for Fenwick’s idea, noting that the current health-care mind-set is to secure as many medical services—diagnosis, testing, treatment—as one’s insurance policy will permit, rather than to think about them as a commodity with resources that must be shared. “When something is free, people will take more than they need,” he said. “When you don’t have any skin in the game, you don’t care what it costs.”

To encourage participants to be careful medical consumers, the cash accounts permit withdrawals of a certain percentage of the funds each year. If you think there’s a financial reward for not using medical services you might not need, the thinking goes, chances are better that you won’t.

Fenwick’s plan isn’t a panacea for all the ills that render health care in the U.S. less than robust. But at least somebody on the front lines is proffering an alternative that people without high-maintenance and/or chronic health problems should be considering.

So much about the health insurance industry is wrong, so much compromises good care and patient safety, that when an underwriter makes the right decision it deserves attention.

WellPoint Inc., according to a recent AP story, plans to boost primary care reimbursement and initiate payment for care management, a patient-protective practice it previously did not cover. The bottom line should be that patients with WellPoint plans will get more quality time with their doctors.

The WellPoint plan will debut later this year and should be implemented throughout its primary care network by the end of 2014.

Primary care practices often receive such low insurance reimbursements that they’re forced to jam as many patient visits as possible into a workday simply to stay financially afloat. We’ve detailed the plight of primary care practitioners, as well as the value of coordinated care.

Care management includes practices such as preparing care plans for people with complex medical problems. It includes simpler practices as well, such as developing an exercise plan for overweight patients, and following up to ensure adherence to it. Care management is a matter of enabling providers to work for patients all along the health continuum instead of addressing only acute needs, of treating people only when they’re sick.

Spending more time with patients facilitates communication, and when patients and doctors communicate well, outcomes improve.

Best practices like these aren’t just about altruism, they’re about saving money, and WellPoint will offer doctors a share in some of the savings realized when better care results in lower costs. Wellpoint officials said the reformulated payments and coverage should reduce some of the most expensive medical care, such as emergency room visits and hospital admissions.

Similar efforts are underway elsewhere in the health-care industry.

Accountable care organizations (ACOs) are becoming more popular as coordinators of care among multiple providers that reduce redundant testing and minimize medical errors. ACOs also afford professional participants a piece of the savings pie.

Insurers are examining the notion of patient-centered medical homes, which are similar to ACOs but focus more on individual practices. Primary care doctors monitor patients between visits and serve as the nexus of communication among specialists and ancillary caregivers, such as nutritionists and physical therapists.

WellPoint has tested the medical home concept and reported that such programs resulted in an 18 percent decrease in hospital admissions and 15 percent decrease in emergency room visits. The company’s new primary care reimbursement plan, AP reported, plans to build on those pilot programs.

Well done, WellPoint. But the effort will have to be embraced by all other insurers in order to become the cultural norm instead of a curiosity.

Electronic health records (EHRs) hold much promise for reducing medical errors and improving quality of care, but the prospect that patient advocates can use EHRs to do an autopsy of where a patient's care went wrong has some in the medical industry sounding an alarm.

Last week a story (actually a press release, on closer scrutiny) in the Wall Street Journal's Market Watch talked about "Crippling Access to Physician's Actions" allowed by tattle-tale Electronic Health Records. Among the horrors described by IT consultant Dr. Sam Bierbock:

EHRs ... can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

And this is a bad thing?

Fortunately there are patient advocates in the medical informatics industry. One is Scot Silverstein, MD, of Drexel University, who trained as a doctor in intensive care units, which have heavy demands for up-to-the-second monitoring information on the desperately ill patients they care for. Dr. Silverstein wrote a well-informed blog post on the real problems with EHRs and why it won't wash to make plaintiff attorneys and malpractice lawsuits the whipping boy for the industry's troubles.

Our firm represented a patient's family last year in a particularly tragic malpractice case where we used the hospital's "audit trial" of EHR records to show that a nurse was claiming to be in two places at one time. Her neglect led to the stillbirth of our family's child.

The alarm of IT consultants like Dr. Bierbock over the ease of auditing health care brought about by EHR's is really a false alarm. Yes, there will be closer scrutiny of medical decisions. But audit trails will lead to more accurate understanding of what happened in any tragic injury, and that should lead to better care for all.

First published on Technorati.

What is the essential core of a health insurance policy that every insurer should have to offer its customers? The federal government is struggling to come up with a definition, but it's proving to be not so easy.

Most people know that the Affordable Care Act (ACA), the health reform plan that was passed in 2010 and remains under political attack, imposes a series of requirements on health insurers. But most people also remain confused about what’s required of the companies that insure them.

Kaiser Health News helps interpret a recent document released by the Department of Health and Human Services previewing what most health plans must offer by way of insurance-covered services beginning in 2014.

Individual states have some latitude in defining “essential benefits” that must be part of coverage for individuals or small businesses, but the law is clear that 10 benefit categories must be included. States can decide, for example, how many doctor visits are allowed.

The HHS released a list of insurance plans names and network types that states may follow, but the feds’ document doesn’t include the benefits covered by those plans. And it doesn’t express a preference for what it would like to see covered.

Consumer advocates, of course, find that rather wanting.

As quoted by Kaiser Health News, Stephen Finan of the American Cancer Society-Cancer Action Network said that without the complete package, “we remain completely in the dark.” Late last year, consumer groups including the Cancer Society were signatories to a letter to HHS seeking advice about which health plans states could choose as benchmarks.

The list offered last week by the department isn’t exactly what they had in mind.

“We know a little more than we knew yesterday, but we still do not have basic documents to see if the plans are good or not so good for cancer patients, or any other kind of patient,” Finan told Kaiser Health News.

HHS lists the insurance plans in each state with the largest enrollments in the small group market. It also lists the three nationally available health plans with the largest enrollments open to federal employees. The document reads, “Under the state’s intended approach, states would have the flexibility to select an existing health plan to set the ‘benchmark’ for the items and services included.” If the selected plan doesn’t include benefits in the federally defined categories, the state must supplement the benchmark.

States may select a benchmark from four types of plans, but if you don’t know what’s in the plan, how do you make an informed decision? It’s like ordering a full course dinner from a brand name restaurant without looking at the menu.

If you’d like to make your feelings known, contact The U.S. Department of Health and Human Services at 200 Independence Avenue, S.W., Washington, D.C. 20201. The phone number is (877) 696-6775.

It's been known for a while that Minnesota ranks dead last in the nation in the frequency with which its doctors are disciplined by the state licensing board for harming patients. Now we know why.

A new investigative series by the Minneapolis Star Tribune has some dizzying quotes from state officials who are charged with protecting the public.

For example, when asked why Minnesota so seldom took action against a doctor's license when authorities in another state had already done so, Ruth Martinez, supervisor of the board's complaint review unit, replied:

"What's the point of piling on?"

(Earth to Ms. Martinez: If your state is the only one that hasn't restricted a doctor's license to practice after some horrendous harm to patients, where do you think that doctor is going to end up practicing?)

Perhaps even more revealing are the words of the board's executive director, Robert Leach, who is quoted as follows by the Star Tribune:

"I'm satisfied the public is protected in Minnesota -- very satisfied. And remember that part of public protection is ensuring an adequate supply of health care practitioners to the public. You can't take everybody out of practice just because they had a problem. That's why we're not in the business of removing credentials unless absolutely necessary. We want to be remedial."

When the board declines to act against a doctor, patients have no way of finding out that that doctor might be a problem -- because by law in Minnesota, only public discipline is disclosable. So there's a real Catch 22 for patients trying to make sure they are seeing a top notch doctor.

Kudos to Public Citizen's Health Research Group for its compilation of the discipline statistics state by state, on which the Minneapolis newspaper report was based.

Rick Santorum is not the first politician to be caught in a "Do as I say, not as I did" moment. So when it came out this weekend that Santorum had asked for more damages in his wife's medical malpractice lawsuit than the legal limit he would like to impose on all malpractice victims, it would be easy to shrug off the story as the usual politicians behaving badly. But that would miss the bigger and more interesting story.

All the Republican presidential candidates, this year and stretching back for many campaigns, propose damage caps and other rollbacks to the public's right to sue when injured by medical mistakes.

The idea of imposing a uniform national limit on the amount that victims could sue for -- no matter how bad their injury -- has always been a head scratcher to anyone looking for some minimal level of consistency in their politicians. After all, Republicans are often the first to decry "big government Washington solutions" to local issues best handled by each of the 50 states in their own ways. And with medical malpractice, there has been no shortage of state experiments with damage caps and other ideas that are supposed to make medical care more affordable and accessible, despite the lack of evidence that they do either.

But the Santorum story is interesting for another reason that exposes the Achilles heel in the damage cap idea. Every state already has a mechanism for cutting back on high jury awards when plaintiffs like Santorum's wife overreach, and it worked very nicely in the Santorum case.

Karen Santorum sued a Virginia chiropractor in 1999, asking for $500,000 for a back injury she claimed his manipulation caused, with allegedly permanent restrictions on her ability to move. After a jury gave her $350,000, the presiding trial judge, Arthur Vierreg, noted that she only had $18,000 in actual medical bills. Most of the award was for the kind of general damages that Santorum would like to cap for other victims.

Judge Vierreg said the jury's award was "excessive" and a product of "undue sympathy." He cut the verdict by half to $175,000. That's a power he shares with every trial judge in America. It's called "remittitur," and it's an ancient common law power of judges, who see the actual evidence unfold at trial, to curb the occasional over-enthusiastic jury.

It's one of those small-government, local-control ideas that the GOP is supposed to champion.

Those states that have imposed the kind of cap that Santorum advocated -- a $250,000 limit on all "non-economic damages", other than lost wages and medical bills -- have not seen their medical costs go down. Texas, the most recent state to follow a path first walked by California in 1975, has the same medical cost problem as the rest of the country, and its small towns are just as under-served by doctors as they were before the "reforms" were implemented in 2003. Texas actually added doctors to its population faster before the 2003 law than after, as PolitiFact pointed out recently when it rated as "false" the claim of then GOP candidate Rick Perry that tort reform had boosted its number of doctors dramatically.

There's another problem with damage caps besides that they don't work. They hit hardest at the malpractice victims with the worst injuries, like brain damage and paralysis, that can justify high verdicts. Caps do little to curb middling claims like Mrs. Santorum's; she and her husband testified that she had some numbness in a leg and persistent back pain because of the chiropractor's manipulation.

A White House memo on possible medical malpractice reforms was made public last Friday (courtesy of the New Yorker's Ryan Lizza), making the same point. According to the memo sent to President Obama in July 2009 by two top aides on health care policy, "Evidence shows that caps reduce average damage awards by 20 to 30 percent but do not reduce the frequency of medical malpractice claims. Although some argue that caps may reduce the growth of malpractice premiums, there is no evidence that they improve quality of care or reduce health care costs. Finally (and not surprisingly), caps appear to adversely affect the most severely injured patients."

The Santorums are not alone in thinking that damage caps may be a good idea for other people, but not so much at home. Saddled with a bad injury, most people would rather take their shot with a jury and judge, and not have big brother impose a one-size-fits-all limit on their case.

There are plenty of other reasonable ideas to speed up the malpractice system, improve patient safety and cut health care costs. This just isn't one of them. So isn't it time to inter damage caps into the policy grave that they deserve? Somebody give Rick Santorum a shovel.

First published on Huffington Post.

Somewhere between scary false terms such as “death panel,” voiced by opponents of the Obama administration’s health care reform (the Affordable Care Act, or ACA), and the truly scary increase in the cost of health care lies a reasoned, enlightened conversation about what is appropriate care, and what it costs.

Often, the last people to endeavor to defuse the rhetoric and reality of medical care in America are the people who provide it. After all, consumers and insurers want and expect doctors and other caregivers to be, first and foremost, scientist-artists who can diagnose individual problems and treat them. We don’t expect them to be actuarial types, who perform cost-benefit analyses, and make treatment decisions based on numbers.

Do we?

Kinda. But not because we want to. We have to, because everyone is affected when people needing health care go without, when subsidizers pay too much and when the corruption in publicly funded programs gobbles up taxpayer resources.

So the American College of Physicians recently took the no-win bull by the horns and weighed in on whether doctors should consider cost when making decisions on how to treat patients. In its latest edition of ethical guidelines, published in the Annals of Internal Medicine, the ACP said, yes they should.

As recounted in a story on National Public Radio, topics that once were deemed unseemly for a caregiver to consider are an important part of health-care reform. Topics such as:

* Is a breast cancer drug worth its $100,000 cost if it adds only a few months to a woman’s life?

* Should certain tests, such as those for prostate cancer and mammograms, be routine for everyone if they’ve been shown to cause more suffering for a lot of people than the woe they’re trying to prevent?

These thorny issues are hardly news, and we’ve written about them many times—here and here, for example. But when a major medical group not only chews them over but also codifies them in its ethical guidelines, that’s a provocative act. That means that the discussion no longer is a polarized screed between clearly defined camps. It means these issues transcend political expedience and must become public health policy.

The ACP represents 132,000 internists. Their president, Virginia Hood, told NPR, “The cost of health care in the United States is twice that of every other industrialized country. We're not providing care to as many people as they do in other places and we don't even have as good outcomes.”

One way to promote better outcomes, she said, is for doctors to think harder about the tests they order and the treatments they prescribe. “Every time you prescribe something for a patient or subject them to some kind of investigation,” Hood said, “there's a risk of harm, so the concept of doing less is actually a really good concept.”

One bioethicist told NPR that as soon as “cost” becomes a part of “care,” the notion of rationing enters the picture. And no one’s comfortable with that. Which makes some people wonder how many individual doctors will follow the ethics manual’s guidance—they already make the tough decisions that become only more difficult when patients demand an extra test or drug, patients who might be desperate for something, anything, that will restore their health or save their lives.

In that circumstance, yes, it is difficult to concentrate on an individual patient’s needs and simultaneously consider the well-being of the community at large. It’s difficult to remember that the whole is greater than the sum of its parts.

Which makes the ACP’s new guidelines so remarkable.

The Obama administration’s effort at health-care reform—known as the Affordable Care Act, or ACA—has an image problem. Virtually every poll asking Americans what they think of its provisions demonstrates not only widespread disapproval, but widespread ignorance.

Some pundits attribute our collective misunderstanding to the administration’s inept efforts to publicize the program’s features, some attribute it to GOP mischaracterizations of its features and some say Americans just aren’t paying attention.

One recent poll, however, was categoric in what Americans like about the ACA: the demand that health-care plans clearly communicate their benefits, coverage and exclusions. The popularity of what seems so simple—transparency—underlies the questionable instincts so common among U.S. commercial interests, whether they’re large financial institutions, Big Pharma or insurance underwriters: You can fatten your bottom line by making consumer safety secondary to obscuring the facts about your product.

The monthly Kaiser Health Tracking Poll examines public opinion and knowledge about specific provisions of the ACA. In November, the “runaway” favorite element of the reform plan was the transparency requirement for health plans. Six in 10 Americans gave this provision a "very favorable" rating, the only such element of the ACA to score that high among more than half the public. Eighty-four in 100 ranked this provision "favorable."

Overall, the plan garnered an "unfavorable" review from 44 in 100 respondents; 37 in 100 gave it a "favorable" rating.

Several better-known aspects of the ACA generated these responses:

• preventing insurers from denying people coverage if they have pre-existing conditions: "very favorable," 47 in 100; "favorable," 67 in 100;


• closing the Medicare doughnut hole for drug coverage: "very favorable," 46 in 100; "favorable," 74 in 100;


• providing tax credits to individuals and small businesses to help pay for coverage: "very favorable," 44 in 100 and 45 in 100, respectively; "favorable," 75 and 80 in 100, respectively;


• the individual mandate (the requirement that everyone purchase health insurance coverage that is subject to Supreme Court review): "very unfavorable," 43 in 100.

In reviewing the poll results, an analyst with Kaiser, which has no relationship to the health-care company of the same name, opined, “It is no huge surprise that people are confused by their health benefits. And, unlike many elements of the health reform law, there is no apparent downside to the public from requiring health plans to be more up front about what they do and do not cover; although employers and insurers have objected to the rule as a costly and unnecessary new regulatory burden. What is a surprise, though, is that people feel so lost in the health insurance system that they chose a requirement that insurance companies explain their benefits in plain language as the most popular element of the giant health reform law, and by such a wide margin over the many others we asked about.

“But, our polling shows people don’t know much about its more consumer friendly provisions which are popular even across partisan lines. As long as that remains the case, people will not perceive the ACA as part of the solution to their everyday problems and public opinion will remain split along the familiar partisan divide.”

Unless the patient needs really intensive, round-the-clock care, most hospital-type care can be done in the patient's home -- where it's safer, more comfortable and less expensive. That lesson is so well accepted that it was written into the federal health care reform law -- to provide financial incentives for outfits called Independence at Home Organizations.

The problem is that the rules for the new home care organizations are supposed to go into effect on January 1, 2012, but Medicare is behind on writing the rules. So there will be delay in getting this started. The current rules discourage moving hospital-style care home because, among other things, Medicare won't pay for home visits.

An internist named Jack Resnick, M.D., writing an op-ed in the New York Times, talks about his own practice on New York City's Roosevelt Island, caring for infirm and elderly patients. He makes a persuasive case for the home care organizations, writing:

Patients who are treated at home by a doctor and nursing staff who know them intimately and can be available 24/7 are happier and healthier. This kind of care decreases the infections, mistakes and delirium, which, especially among the elderly, are the attendants of hospital care. And it is far more efficient.

Patients’ rights advocates lost a valuable team member this month.

Dr. Donald Berwick resigned as administrator of the Centers for Medicare and Medicaid Services (CMS) for reasons wholly political. The respected, forward-thinking medical professional opted to leave rather than continue in the role for which President Obama sought Congressional approval, but resorted to a so-called “pocket” appointment when Senate Republicans blocked his nomination last year.

The appointment, which Obama made when the Senate was in recess, was in effect until the end of this year. Berwick, a pediatrician, has served 17 months and is leaving, as opposition among Republicans remains strong. They claim Berwick is a fellow traveler with Obama’s health-care reform movement—the Affordable Care Act, or ACA—and all too willing to ration health care.

They’re not completely wrong, but they’re not right.

As recounted on Medscape.com, when Obama nominated Berwick in April last year, he had headed the Institute for Healthcare Improvement, and various organizations supported the move, including the American College of Physicians, AARP, Walmart and Consumers Union.

In his temporary tenure at CMS, Berwick helped implement several elements of the ACA pertaining to the Medicare and Medicaid programs. Among them were regulations for accountable care organizations (ACOs). Those groups of health-care providers improve outcomes and reduce costs by coordinating the care of Medicare patients and, as a reward, get a cut of the money saved.

Berwick also shepherded a pilot program to effect essentially the same change—and benefits—for physicians, rewarding them for providing better quality versus higher quantity of care for the quality as opposed to the quantity of their services. Known as the Comprehensive Primary Care Initiative, the program assists primary care doctors in:

• helping patients with serious or chronic diseases follow personalized care plans;


• giving patients 24-hour access to care and health information;


• delivering preventive care;


• engaging patients and their families in their own care; and


• working together with other doctors, including specialists, to provide better coordinated care.

Among them are the president and chief executive officer of the American Medical Group Association and the chief executive officer of the American College of Cardiology. The latter, Dr. Jack Lewin, applauds Dr. Berwick for listening to physicians while trying to reform the health-care system. As Medscape notes, when organized medicine initially gave a thumbs-down to the ACO rules, Berwick "went back and changed them significantly," Lewin said.

"CMS is trying to do its job as a regulatory agency, but facilitate innovation at the same time," Lewin said. "They're partnering with us. That's clearly part of Don's legacy."

"It's been a great era. It's too bad we don't have a few more years of it."

Because of his willingness to accept the limitations of modern health-care delivery, Berwick was scorned in Congress and all over the conservative blogosphere as "Dr. Death Panel," referring to his past statements supporting Britain’s National Health Service and accepting that rationing of healthcare is inevitable.

"The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open," Berwick is quoted as saying in Biotechnology Healthcare magazine in 2009. "And right now, we are doing it blindly."

For people more concerned about the quality, accessibility and cost of health care more than who wins political points making it happen, Lewin summarized Berwick’s situation for Medscape: "Unfortunately, he's been a scapegoat for Republicans who are mad about the ACA."

Here's an interesting interview with Dr. Berwick in the New York Times, where he gets off some parting shots about what's wrong with the politics of our health care system.

A primary consumer benefit of free enterprise is competition. Not happy with the service/quality/price of something you want to purchase? Compare one merchant’s offer with that of another, and take your business where it makes most sense to you.

A few months ago, we wrote about a Florida law requiring urgent care clinics to post prices. Unfortunately, knowing the cost of a medical service in advance generally isn’t possible in the health-care market. As noted by Merrill Goozner on his GoozNews blog,

“

For all the talk about consumer driven medicine …, why doesn’t anyone talk about pricing transparency in health care? Did you ever walk into a doctor’s office where the prices of various services were posted? A hospital? At the drug store’s pharmacy counter?”

But enabling medical consumers to contrast and compare isn’t as easy as, say, simply legislating that prices be posted wherever people are buying health-care products and services. Goozner says that although that’s a place to start, it’s inherently confusing because the U.S. system of health care is so fragmented. It’s not like buying a pair of jeans, where the only differences might be cost and whether or not you get free shipping.

When you’re buying treatment for a heart attack, as Goozner so deftly describes one hypothetical hospital emergency room patient, “You look up on the wall to learn that Insurance Company A pays $30,000 for angioplasty. Insurance Company B pays $28,000. Medicare pays $26,000. Medicaid pays $24,000. And (for) you, the customer right in off the street without coverage, the charge is $32,000. Don’t want to pay our rack rate? You might want to try down the street at Mother Mercy of the Poor. We understand their rack rate is $26,000, the same as Medicare.”

You still need to compare apples with apples. How many providers are involved in each of these options, what are their credentials, what’s the record for each hospital in terms of infection control and readmission rates? Every price listing begs another question.

Holy sliding scale!

“Pricing transparency” helps medical consumers understand the high cost of medical care, and the inefficiencies and inequities of a multipayer system of financing it, as Goozner notes, and that’s critical to effecting any meaningful change. But unless and until U.S. medical care is priced the same for everybody receiving the same service or product, he says, it won’t address the problem of why Americans pay more for medical care than residents of other countries.

Jason Shafrin, writing on the Healthcare Economist blog, is also a believer in pricing transparency. He promotes a tool consumers can use to help them shop for care. The Healthcare Blue Book, which is recommended by Consumer Reports, estimates costs for specific medical problems.

Armed with pricing information, consumers—especially the uninsured—are then empowered to negotiate, to ask for charges comparable to others they can quantify.

As stated on the Blue Book website, the resource “is a free consumer guide to help you determine fair prices in your area for healthcare services. If you pay for your own healthcare, have a high deductible or need a service your insurance does not fully cover, we can help. The Blue Book will help you find fair prices for surgery, hospital stays, doctor visits, medical tests and much more.”

Shafrin looked into how the Blue Book sourced its pricing information. Using claims and billing data, it averages prices paid by insurance companies to providers in a given market.

If you’re faced with a medical expense, either in full or as a contribution to what your insurance pays, inform yourself if the cost seems reasonable. If not, speak out. When it comes to fair health care costs, ignorance is not your friend.

A Kansas neurosurgeon who has been sued at least 16 times for malpractice has been able to enlist one important ally in protecting his privacy: the federal agency that runs the data bank that is supposed to keep track of dangerous doctors so they don't drift from hospital to hospital without their track record becoming known to hospitals who hire them.

The National Practitioner Data Bank (NPDB) is run by the U.S. Health Resources and Services Administration. It has both a public mission and a confidential one. The confidential mission is to allow hospitals to query the data base to obtain the track record of lawsuit payouts and disciplinary actions against doctors so they can make an intelligent decision about whether to bring a doctor onto their staff. The data bank also publishes aggregate data, without individual identifiers, about the doctors it keeps an eye on, so the public can see that it is doing its job.

A reporter for the Kansas City Star used the public data on the NPDB, among other resources, to figure out the lawsuit record of neurosurgeon Robert Tenny.

As shown by newly released documents, Dr. Tenny responded with a flurry of letters to the federal agency, which responded with:

* A threat against the newspaper reporter to punish him with fines for misusing the data bank. (This was later withdrawn.)

* Stern letters to all the 28 hospitals who had queried the data bank about Dr. Tenny to warn them that the information they had obtained on him was confidential and not to be disclosed.

* Shutting down the public access portion of the data bank.

The shutdown of all public data from the data bank has caused the most outcry, with a bunch of journalist organizations demanding that it be reinstated.

Senator Charles Grassley of Iowa released documents this week showing the cozy relationship between Dr. Tenny and the federal agency. You can read the documents by clicking here.

Article first published as Federal Health Agency Takes Side of Multi-Sued Surgeon on Technorati.

Last week, the Federal Trade Commission (FTC) released a report with the boring title “Agreements Filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement and Modernization Act of 2003.”

But the story it tells is hardly dull, and it has implications for anyone who takes prescription medicine. If you want to read the whole report, spoiler alert! It concludes “pharmaceutical companies continued a recent anticompetitive trend of paying potential generic rivals to delay the introduction of lower-cost prescription drug alternatives for American consumers.”

The Washington Post was less than impressed with Big Pharma’s “pay-for-delay settlements.” As analyzed by FDA Law Blog, there were 43 more of these unsavory brand/generic settlements in fiscal year 2011 than 2010; 28 final settlements involved 25 different branded Big Pharma drugs that both compensated the generic manufacturer and restricted it from marketing the less expensive version of the brand med.

In 2004, the FTC didn’t find a single settlement in a patent litigation matter involving drug makers that raised pay-for-delay concerns.

The commission concluded that fiscal year 2011 “witnessed the continued trends of (a) record numbers of brands and generics resolving patent litigation prior to a final court decision on the merits and (b) significant numbers of such settlements potentially involving pay-for-delay.”

It seems obvious that, as The Post notes, “Such pay-for-delay arrangements hurt consumers and increase costs for federal programs such as Medicare and Medicaid,” but the Generic Pharmaceutical Association (“GPhA”) disagrees. It said that “the FTC continues to miss the fundamental point: Patent settlements speed up the availability of less costly generic drugs and save money for everyone; banning settlements and forcing drugs makers to continue lengthy litigation with uncertain outcomes will be costly.”

It’s saying that when generic companies litigate drug patent cases to conclusion (as opposed to settling the case earlier), the generic drugs are delayed from entering the market at least until the brand patent expires.

This expensive, consumer-averse mess would be eliminated by enacting the Preserve Access to Affordable Generics Act. It would effectively ban patent settlement agreements and empower the FTC to challenge suspicious deals. It would accept certain deals if “clear and convincing evidence” supports the notion that the “pro-competitive benefits outweigh the anti-competitive harms.” The nonpartisan Congressional Budget Office estimates that the government would save $3 billion over 10 years by eliminating pay-for-delay deals.

The FTC and the Obama administration have urged the Joint Select Committee on Deficit Reduction (the “super committee” charged with trying to find federal budgets cuts by the end of November) to include the legislation in its deficit reduction plan.

You wonder if all the zealots keen to limit patients’ right by unreasonably capping medical malpractice awards (euphemistically referred to as “tort reform”) are as eager to put a stop to what looks awfully like pharmaceutical company collusion.

Stephen Colbert knows a thing or two about hypocrisy in the USA and how to get a laugh out of it. In this segment on his show, he interviews Susan Saladoff, director of the HBO documentary, Hot Coffee, about the myth of frivolous lawsuits.

Why mention this on a patient safety blog? Because the medical industry continues to do its best to dismantle the only way that Americans can demand accountability when they've been injured by unsafe and unethical medical treatment. They call it tort reform, but it's really tort deform, as Susan Saladoff tells Colbert.

PS: The segment starts at 15:15 on the timer.

The conservative Cato Institute is out with a new study arguing that putting limits on malpractice verdicts could be doubly bad for patients. It could result in both inadequate compensation for victims of malpractice, and could reduce the incentives of malpractice insurance carriers to hit malpracticing doctors with financial penalties to encourage better and safer care.

Here's a quote from the executive summary of the study done by Shirley Svorny, professor of economics at California State University, Northridge:

First, caps on awards may result in some patients not receiving adequate compensation for injuries they suffer as a result of physician negligence. Second, because caps limit physician liability, they can also mute incentives for physicians to reduce the risk of negligent injuries. ...

This paper reviews an existing body of work that shows that medical malpractice awards do track actual damages. Furthermore, this paper provides evidence that medical malpractice insurance carriers use various tools to reduce the risk of patient injury, including experience rating of physicians’ malpractice premiums. High-risk physicians face higher malpractice insurance premiums than their less-risky peers.
In addition, carriers offer other incentives for physicians to reduce the risk of negligent care. ...

If the medical malpractice liability insurance industry does indeed protect consumers, then policies that reduce liability or shield physicians from oversight by carriers may harm consumers. In particular, caps on damages would reduce physicians’ and carriers’ incentives to keep track of and reduce practice risk.

The malpractice liability system is the sole means by which consumers can bring some measure of accountability to health care providers who cause harm to patients. So the new Cato study provides important support for the idea that tinkering with the system, which the medical industry claims would produce more affordable health care, could be exactly the wrong approach for patient safety.

... goes to Skip Lockwood, head of a prostate cancer advocacy group called Zero. When the US Preventive Services Task Force recommended against routine screening of men with the PSA blood test, Lockwood said the PSTF's advice "condemns tens of thousands of men to die this year and every year going forward..."

Prostate cancer kills about 30,000 American men a year, so if Lockwood is right, that means the PSA test would have prevented MOST of those deaths. If it was that obviously beneficial, why would so many doctors and health care leaders have such doubts? Last year, in a less publicized statement based on the same research studies, the American Cancer Society also pulled the plug on its advice for screening with the PSA test.

The fact is that fears of just this kind of over-the-top reaction caused the PSTF to delay its advice for two and a half years after definitive studies came out from Europe and the US showing that PSA testing just doesn't do the job of putting any measurable dent in the death rate from prostate cancer. The PSTF was cowed by the blowback to its last big recommendation: that the numbers don't justify routine mammograms for women in their 40s.

PSA testing has generated a billion dollar industry of urologists doing surgery on men, with high rates of impotence and incontinence in their wake. At the risk of making a bold statement in the opposite direction of Mr. Lockwood's, it's almost malpractice now to put men into routine prostate cancer screening when the odds are much greater for harm than help.

Even the inventor of PSA testing came out last year against its routine use in low-risk men. The test is best reserved for high-risk men who need monitoring after they've already had prostate cancer and need to know if it's coming back.

But don't try to confuse the advocates with scientific facts. They'd rather play on emotions.

Article first published as The Award for Most Fear-Mongering Health Care Statement of the Year ... on Technorati.

The scourge of cervical cancer -- a leading cancer killer of women in the third world without access to Pap smears and HPV vaccinations -- is being whipped with an unlikely low-tech, low-cost preventive treatment: Ordinary vinegar plus freezing of the cervical warts before they turn cancerous.

The vinegar is brushed on the cervix by a nurse and any areas of abnormality turn white. It's not perfectly accurate -- sometimes spots turn white and they are totally benign. But the treatment of the white spots is low-pain and cheap -- and highly effective: freezing of the white spots with a metal rod dipped in liquid carbon dioxide (available from the nearest Coca Cola plant).

Read more about this public health innovation that was co-invented by American and Indian doctors, and spread in Thailand, in this New York Times article.

At a time when the cost of health care represents nearly one-fifth of the U.S. gross domestic product, it is reasonable and necessary to discuss the notion of “appropriate care.” But a fair and conscientious examination of what measures, personnel and technologies should be employed to diagnose and treat medical problems must get past such inflammatory terms as “death panel,” “rationed care” and “tort reform” (that is, malpractice lawsuits). That kind of language does not advance or inform the discussion.

A recent commentary in the New England Journal of Medicine grappled with the topic, and the breadth of comments by its readers indicated how all of us – providers and consumers – must drive meaningful health-care reform.

Victor R. Fuchs, Ph.D., is an economist affiliated with Stanford University and an expert on health policy. His commentary, “The Doctor’s Dilemma – What Is ‘Appropriate’ Care?”, discusses the difference between what is “ethical” and what is “appropriate.”

“How can a commitment to cost-effective care be reconciled with a fundamental principle of primacy of patient welfare?” he asks.

We are a nation that celebrates the individual and enables development of expensive drugs, devices and procedures. Our default position is that if something is new! and improved! it should be widely used. But, Fuchs notes, “[T]echnologies that may provide high value for carefully selected patients are often used indiscriminately for a much larger cohort of patients.”

Nine in 10 medical bills are paid by health insurance (public or private), not by the patient. That distances individuals from the reality that even the newest (and often hideously expensive) procedure or gizmo isn’t always the best prescription. For example, U.S. patients average almost three times as many magnetic resonance imaging scans as Canadians. But there are no significant differences in our respective health outcomes.

Fuchs argues that if we didn’t have widespread insurance coverage, fewer physicians would order expensive procedures unless the chance of substantial benefit was demonstrable; that is, unless it was cost-effective. U.S.-style insurance is cost-insensitive, and that can undermine “appropriate.”

The insured patient, he says, usually wants any and all care that might possibly help, regardless of cost. And although the physician might know that it’s probably not going to help in certain cases, that it isn’t cost-effective, might recommend it anyway because he or she:

• wants to keep the goodwill of the patient;


• believes he or she is protecting against a malpractice claim;


• assumes that denial is “inappropriate” and “unethical.”

No one here – not patient, not provider – is ill-intentioned or looking for anything other than a solution to a medical problem. We aren’t the problem, Fuchs says, our system is.

The solution isn’t forcing patients to put “more skin in the game” – that is, subsidizing more costs of their care. The need for an annual cap on patients’ payments, above which insurance pays, is widely accepted. But today, 5 out of 100 patients account for 50% of annual health-care costs. That means the most expensive procedures go to patients whose costs have exceeded the cap.

Nor is the answer eliminating so-called “unnecessary” care, which is desirable, but which Fuchs says accounts for smaller potential savings than is usually claimed. If some procedures turn out to be useless or even harmful for some patients, that’s because the diverse nature of patient populations make it difficult or impossible to determine in advance who will benefit by a procedure and who won’t.

If a physician is paid on a fee-for-service basis and the patient has open-ended insurance, the default is more likely to fall to the “possible” than the “cost-effective” side of care. If so, the benefit other patients might get from the resources saved with cost-effective medicine isn’t necessarily clear.

Physicians who are paid on an annual fee-per-enrollee basis in a defined population are more likely to practice cost-effective medicine. The resources saved in those practices are used for the benefit of the defined population, which includes the physician’s patient.

Per capita health-care spending in Canada is nearly half what it in the U.S. Canadians have universal care, a defined budget and a default for the prudent expenditure of resources.

“In short,” Fuchs summarizes, “when physicians are collectively caring for a defined population within a fixed annual budget, it is easier for the individual physician to resolve the dilemma in favor of cost-effective medicine. That becomes ‘appropriate’ care. And it is an ethical choice … because if all physicians act the same way, all patients benefit.”

But we don’t have a Canadian-style health-care system, and as one physician pointed out in the online comments to Fuchs’ article, for people who are uninsured, there is no context for “appropriate.”

Another physician commented that by cultivating superior clinical skills, remaining current on medical developments and establishing honest rapport with patients, physicians can bypass the scorched-earth approach to treatment, resulting in lower costs.

A particularly articulate physician said, “Americans have come to expect unlimited health care resources while assuming little to no individual responsibility for paying for it. … The differences between American health care and other systems have been identified for years by Dr. Fuchs and others…. There is no system, not the market, not single payer, that can bridge the gap between this expectation and a diminishing ability of society to meet it. The hope for political compromise and develop a rational means to modifying our system so as to maximize benefit and minimize harm is unlikely until we come to accept this fact as a people.”

Ouch. But, he’s right – you can’t treat the festering sore until you yank off the bandage and examine, without political agenda, the problems that created it.

Another clarion call to simplify a program so critical to the welfare of so many Americans was sounded earlier this month in a report published online by Health Affairs. It concluded that when faced with numerous Medicare Advantage plans, older Americans were less likely to enroll than if their choice of plans was more limited. It also found that seniors whose mental faculties were impaired were less likely to enroll than others when the Advantage plans offered more generous benefits.

Medicare Advantage plans, a form of supplemental insurance administered by private companies, pay providers more for treating Medicare beneficiaries. They frequently offer more generous drug benefits than those that are available in Medicare Part D plans.

The findings suggest that many Medicare beneficiaries are unable to access or process information, so if they’re faced with numerous, complicated insurance plans, they make enrollment decisions that aren’t in their best interests.

The three-year study looked at 21,815 enrollment decisions made by 6,672 participants. In comparing enrollment decisions among participants with different mental capabilities and plan offerings, if 15 or fewer plans were available, there was usually an increase in Medicare Advantage enrollment. When the number of options surpassed 30, as it did in one-quarter of U.S. counties, enrollment in the program decreased.

Last November, the FDA ruled that tobacco manufacturers must include on their packaging graphic depictions of the horrors smoking can wreak. The new packaging was to take effect in autumn 2012.

Five tobacco companies now have taken the FDA to federal court, challenging the regulations. Among other things, they claim that the depictions:

• would unfairly dissuade adults from using a legal product;


• would cost millions;


• violate the First Amendment;


• “do not further any compelling governmental purpose”; and


• “would have few if any benefits.”

“A decade of experience in more than 30 other countries has demonstrated that such graphic warnings lead to an array of public health benefits. The warnings are more likely to be noticed than text-only labels, are viewed as more effective in communicating health risks to smokers and are associated with increased motivation on the part of smokers to quit smoking.”

Dr. Koh is assistant secretary for health in the U.S. Department of Health and Human Services. So he's defending his own decision. But knowing what we know about how tobacco poisons work throughout the human body, is this even a close question?

To see a slide show of the text and images for the new packaging, click here.

And if you want to harken back to the olden days before we had any warnings on cigarette packs, and when the manufacturers liked to use doctors to promote their smoky poisons, check out this tour through nostalgia.

The news that health insurers will be required to cover contraception and related counseling, courtesy of the Affordable Care Act (ACA) passed last year, received a lot of media attention and political blowback.

Because some people find that provision of preventive care for women objectionable, it overshadowed other elements of the new guidelines, which pertain to insurance policies whose plan years begin on or after Aug. 1, 2012. Such policies are referred to as “nongrandfathered” because they represent only new plans; a health plan in effect now cannot be “grandfathered” into this coverage, although some might include it anyway.

As defined by the U.S. Department of Health and Human Services, the mission of the ACA is to promote prevention of health problems in the hope of reducing the need to treat them. It also aims to make care affordable and accessible for everybody by requiring health plans to cover preventive services and eliminating cost sharing.

Although “preventive services” covers a lot of territory that can include marginally appropriate, cost-inflating measures, those required by HHS demonstrate strong scientific evidence of their health benefits, per research conducted by the Institute of Medicine (IOM). Not only must plans cover them, they may not charge a copayment, coinsurance or deductible if the services are delivered by a network provider.

In addition to the birth control measures, from which plans are exempt for certain religious employers, the following preventive services for women are mandatory and must be provided by insurers without cost sharing to policyholders for policies beginning on or after Aug. 1, 2012:

• well-woman visits;


• screening for gestational high blood sugar;


• human papilloma virus (HPV) DNA testing for women 30 and older;


• sexually transmitted disease counseling;


• human immunodeficiency virus (HIV) screening and counseling;


• breastfeeding support, supplies and counseling; and


• family violence screening and counseling.

The U.S. faces a growing shortage of the low-profit but vital generic drugs that cancer patients and other desperate folks rely on. These drugs are made in places like India and China in plants that the Food and Drug Administration lacks power to inspect.

Meantime, Big Pharma focuses on new high-profit but low-benefit drugs. The latest examples of new FDA approvals: Provenge, a drug for prostate cancer which on average extends life by four months at a cost of $93,000, and Yervoy, a melanoma drug with a price tag of $120,000 for a similar average benefit of four more months of life.

As reported by Gardiner Harris in the New York Times, a lot of solutions are being proposed to the crisis that has been brewing for the last few years, ranging from creation of a government stockpile of drugs to a requirement that drug makers give an early warning to the FDA of inability to keep up with demand for drugs.

Good luck getting any of these passed by a Congress whose loudest members reflexively say the government is the problem, not the solution. But as many Times readers noted in comments on the new article, this story is another example of why we need smart government, not no government, to address the many failures of the free market when it comes to vital services like health care.

If you follow patient safety news, you've seen this headline before. Why should you care? Apart from retaining an attorney to represent you in the event of medical malpractice, what stands most prominently between medical consumers and the bad behavior of health-care providers is their states' medical boards.

These government agencies are charged with licensing medical practitioners, monitoring their practices and punishing those who make serious mistakes or who commit crimes. Sometimes, this oversight is lacking. We’ve written here before about states that fail to discipline doctors whose own hospitals find their behavior wanting, and about how one state—Washington—took the lead in addressing its board’s deficiencies.

A recent study by consumer watchdog Public Citizen has ranked states’ effectiveness in protecting their citizens from substandard physicians. Thanks primarily to shrinking budgets and also to flagging political will and leadership, residents of many states have a lot to be concerned about.

Most states, the study concludes, do not live up to their obligations to protect patients from doctors who practice substandard medicine.

The report analyzed data from the Federation of State Medical Boards on all disciplinary actions taken against doctors in 2010. It calculated the rate of serious disciplinary actions (revocations and surrenders of licenses, suspensions and probation/restrictions) taken by state medical boards. The rate was slightly lower than that in 2009 and “significantly” lower than the peak for the last 10 years.

Some of the worst states have been consistently poor performers. Nationally, in 2010 state medical boards took 2.97 serious actions per 1,000 physicians – down 3% from the last period and 20% from the peak rate of discipline in 2004 of 3.72 per 1,000 physicians.

Had the national rate of doctor discipline repeated the 2004 peak rate, there would have been 745 additional serious disciplinary actions in 2010 against U.S. physicians. “With a typical doctor having between 500 and 1,000 or more patients in their practice,” the report reads, “the positive impact of this on the large number of patients going to these doctors would be enormous.”

Minnesota was the worst state when it came to disciplining doctors. South Carolina and Wisconsin also have been consistently among the bottom 10 states for each of the last eight rankings. Connecticut has been in the bottom 10 for the last five rankings, and for the third consecutive ranking, Florida, at no. 7, is among the 10 states with the lowest rates of serious disciplinary actions. It’s a highly populated state with a lot of older people who use more health-care services than other demographic segments.

Filling out the bottom 10 are: Massachusetts, Rhode Island, New Hampshire, Utah and Vermont.

States whose rank has declined the most since their peak are: Vermont (8 to 42), Utah (10 to 43), Massachusetts (23 to 47), Montana (8 to 32) and Georgia (15 to 40).

Louisiana ranked highest in disciplining doctors, taking 5.98 serious actions per 1,000 physicians. Five states – Alaska, Arizona, Colorado, Ohio and Oklahoma – have been in the top 10 for all eight rankings. Other states in the top 10 are: Wyoming, North Dakota, New Mexico and Nebraska.

States whose rank has improved the most since their nadir: Hawaii (51 to 11), Delaware (50 to 13), Maine (46 to 19), North Carolina (41 to 16), Washington (42 to 18) and Arkansas (45 to 23). There are 51 rankings because the District of Columbia was also included (no. 37).

“One reason for medical boards’ declining rate of discipline is likely tighter state budgets,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The ability of certain states to rapidly increase or decrease their rankings … can only be due to changes in practices at the board level. The prevalence of physicians eligible for discipline cannot possibly change so rapidly.”

Most boards do not perform satisfactorily in disciplining physicians. Public Citizen called for legislative action and public pressure to kick them into action and, by extension, improve patient protection.

The organization said medical boards are more likely to address physician misbehavior if:

• they receive adequate funding (all money from license fees going to fund board activities instead of into the state’s general fund);


• they have adequate staffing;


• they engage in proactive investigations, rather than only reacting to complaints;


• they use all available/reliable data from other sources such as Medicare and Medicaid sanctions, hospital sanctions and malpractice payouts;


• they have excellent leadership;


• they have independence from state medical societies;


• they are independent from other state agencies; and


• a reasonable legal framework exists for disciplining doctors (the “preponderance of the evidence” rather than “beyond reasonable doubt” or “clear and convincing evidence” as the legal standard for discipline).

You have lupus, the chronic inflammatory disease in which the body's immune system attacks its tissues and organs. Sometimes the symptoms resemble the joint stiffness and swelling of arthritis; sometimes they present as skin rashes; sometimes your kidneys malfunction. There are four different kinds of lupus whose treatment might involve a variety of behavioral interventions and so many drug options you need a scorecard to keep track.

Even medical professionals specializing in auto-immune disorders can’t keep up with the research and vast body of knowledge required to be expert in such a complicated disease, not to mention scores of other disorders whose treatment is situational and varied.

In these days of government that can seem to do no right, one federal program is planning to improve access to the body of medical research knowledge. Established by Congress via the 2010 Patient Protection and Affordable Care Act, the Patient-Centered Outcomes Research Institute (PCORI) is tasked with identifying the best available information to help patients and their health-care providers make informed decisions about their care.

PCORI, an independent, nonprofit entity, is all about the science.

As noted by Kaiser Health News in collaboration with Philly.com, "'comparative effectiveness research'" is a relatively new concept in the United States. In fact, the U.S. health system, which largely follows a model that pays doctors and hospitals for any service provided, generally has not embraced comparative effective research.”

If PCORI brings a much-needed objective, science-based standard to the health-care landscape, that doesn’t mean there aren’t challenges to its success. After all, it was created by the political process, and when does that ever yield a purely feel-good result?

KHN/Philly.com enumerates several obstacles for the new agency:

• identifying research priorities for patients based on the study of hundreds of medical conditions and the questions they pose;


• avoiding political criticism from opponents who argue that PCORI will ration care, some even calling it a "death panel";


• maintaining support from medical device makers and drug companies concerned that the institute will be simply a cost-control mechanism; and


• devising strategies for conducting studies to provide meaningful results.

PCORI is reviewing past comparative effectiveness research in the hope of making several grants by the end of this year to identify what it needs to find out from patients. For example, should it use social media to ask people what kind of information they want to have before making decisions?

It also wants to warm up the cold, bureaucratic face public programs often present. “[I]in addition to enhancing the quality of the research,” said KHN/Philly.com, “reaching out to patients can help the institute shed concerns about rationing that were raised by opponents in the health care debate.”

To protect its objectivity, PCORI is forbidden to consider the cost of different treatments as part of setting its research agenda or drawing conclusions. That makes medical device manufacturers and drug companies, who always are concerned about discussions of cost, more comfortable.

PCORI leaders are highly and widely respected, which also helps solidify its neutrality and depth. The nonpartisan Government Accountability Office selected most of its board members; directors of the National Institutes of Health and the Agency for Healthcare Research and Quality chose the others. The board chairman is vice chancellor health sciences at UCLA and dean of its medical school.

“The basic mission is to insure that patients are well-informed and can have informed conversations with doctors,” Dr. Harold C. Sox, former editor of the Annals of Internal Medicine told KNH/Philly.com . “Shared decision-making is not a blue-red issue.”

PCORI wants and needs consumer input throughout its mission. This month, it’s soliciting input from the public about initial topics for pilot projects. To learn more, link here. To stay informed about what PCORI wants to know from consumers, and to contribute to the conversation, link here.

A favorite whipping boy of the medical industrial complex is the alleged wave of lawsuits that need to be squashed for freedom to reign once more in America. Now, a new documentary airing on HBO exposes the truth behind so-called "tort reform."

The documentary is called "Hot Coffee" -- after the infamous case of spilled McDonald's coffee that turns out to have a lot more merit, and a far more serious injury, than the Chamber of Commerce would like the public to realize.

The documentary airs Monday, June 27th at 9 pm EDT on HBO. It's done by trial lawyer Susan Saladoff, former DC resident who now practices in Oregon. Check it out.

Here's a good preview piece in the New York Times.

Too often, patients and families with a serious complaint about an incompetent or unethical medical doctor will write their concerns to the state licensing board and then see their case drop into a black hole. But now, thanks to the work of one crusading family, the state of Washington has a new law to make its board more responsive.

Consumers shuld hope that more of these disciplinary bodies around the country sign on for the basic changes in board conduct now required by the state of Washington. For instance, the new law requires the board to give families a report of the final disposition of any complaint, with reasons for the board's action.

These bodies are important upholders of patient safety because they have the legal power to pull or place restrictions on a doctor's or nurse's license to practice -- yet they seldom do.

In malpractice actions brought by the Patrick Malone law firm, we have often experienced the black hole first hand when we have tried to bring dangerous practitioners to the attention of state licensing authorities.

In one case, we sent a thick pile of medical records to a state licensing board about a plastic surgeon who overdosed a patient with so much local anesthetic that her heart stopped, causing her to go into a vegetative state.

The board responded a year later with a notice that the surgeon had been given a "private reprimand." When we asked them to explain what that meant, they said it was "private."

Oh.

In another case, we sent records, expert reports and other data to a state board demonstrating how a nurse had mishandled Pitocin, causing a woman's uterus to rupture with tragic consequences for her unborn baby. Two years later, we received a one-sentence notice that the board had decided not to do anything. The board advised us with pro forma language that we could send them more information. We pointed out in response that not knowing what else they might need, we felt stymied. The board said that was our problem.

Washington state has acted thanks to the efforts of Yanling Yu and Rex Johnson. Three years ago, Yu's father, Xingxun Yu, 81, died after being given a drug his daughter says triggered a fatal allergic reaction. They filed a complaint with the state's Medical Quality Assurance Commission about the doctor. When the board proved non-responsive, they enlisted the help of two state senators.

The new Washington law, which was signed by the governor a week ago, requires a disciplinary authority to promptly respond to inquiries about a complaint's status and provide the person complaining with a report on its final disposition. The law also gives family members the right to tell boards how a medical injury has affected them or their loved ones.

Yu told the Seattle Times: "I think it will make a difference, at least make them more responsive. I think it is a great step forward from what I call the dark ages in the process."

Lisa McGiffert, campaign manager for Consumer Union's Safe Patient Project, said she hoped the new Washington law would become a national model.

Article first published as Plugging the "Black Hole" in Medical Licensing Boards on Technorati.

The push to make hospitals and doctors more accountable for health care quality means more attention must be paid to the accuracy and reliability of measures used to evaluate caregivers, according to Johns Hopkins patient safety expert Peter Pronovost.

There is little consensus as to which measures are scientifically valid and accurate assessments of quality, and this risks misinforming patients who may make decisions based on metrics that poorly reflect the state of health care, Pronovost wrote in the April issue of Health Affairs.

Pronovost supports the bipartisan effort to pay for value rather than volume with health care, but says serious work needs to be done to create a “whole library of outcome measures” such efforts require. Failure to create such measures “could ultimately lead to a failure to make improvements in hospitals where quality is judged to be better than it is,” he says.

Pronovost maintains that despite the substantial, persistent shortcomings in the quality of care that causes needless patient harm and increases health care costs, fixes can’t be put in place until rigorous scientific data show exactly where systems are broken, and until hard comparative evidence points to what types of repairs work best.

In the absence of such safety and efficacy science, he says, there will remain little consensus among hospitals and physicians about the best methods to judge quality or improvement. He points to overall hospital death rates as an example of an imperfect reflection of quality of care that in many cases is the only measure used.

Pronovost notes that physicians typically support the use of outcome measures if they are valid and reliable enough to enable conclusions to be drawn about the quality of care. Unfortunately, too often they aren’t.

For example, he says, some states penalize institutions for what they deem are preventable complications contracted by patients during their hospital stays, even though the hospitals don’t know exactly what they are being judged on because those states use a proprietary algorithm (commonly referred to as a "black box") created by a private company to determine which hospitals are “successful” and which ones should be sanctioned. Clinicians and the public end up not knowing how accurate the measures are or how they were calculated.

Source: The Johns Hopkins University Gazette

You can read the abstract of the article in Health Affairs here.

Washington state lawmakers have proposed a bill that would give more rights to people who file licensing complaints alleging medical mistakes. Up to now, when something terrible happens to a patient in a hospital or under a doctor's care, families often file complaints with the Medical Quality Assurance Commission (MQAC) - the state's medical disciplinary board - but hear nothing for months or even years, only to finally be told that the official finding is "insufficient evidence" or "no cause for action." Not surprisingly, this leaves many families wondering if the physician and/or hospital have covered up what really happened to the patient.

Last year, nearly 1,400 Washington families filed complaints with the MQAC. Like most state medical boards, the MQAC typically closes most without action - of the 1,400 complaints, 950 were investigated and disciplinary action taken in only 94 cases, says its legal manager, Michael Farrell. Current Washington state law doesn’t require MQAC to divulge evidence during investigations or to detail its reasoning, Farrell says, and for the most part, it doesn’t.

But Lisa McGiffert, director of Consumers Union's Safe Patient Project, a national patient-safety effort, says that “many patients who file complaints end up getting frustrated because they feel like their report disappears into a bureaucratic black hole." Under the proposed law, which has already been passed by the House and is currently before a Senate committee, patients would have a "better opportunity to be heard."

The proposed law, which is being touted as model legislation for other states, would require a health profession's disciplinary board to promptly respond to complainants' queries about the status of an investigation, provide copies of files on request once a case is closed and, when deciding whether to reconsider its original finding because of new evidence, provide an explanation of its reasoning. For the first time, families would be given the right to tell board members how they've been affected - in writing or in person and before a case is closed - and recommend sanctions.

Source: The Seattle Times

Backers of a Nevada bill that would give plaintiffs a 45-day “time cushion” to obtain and file an expert witness affidavit call it an issue of fairness. At a hearing before the state’s Assembly Judiciary Committee, witnesses noted that in some cases, affidavits become separated from lawsuits or cannot be obtained within the 1-year statute of limitations.

Opponents of the bill say that if the time cushion became law, it would erode provisions of a 2004 initiative passed by voters to cap malpractice awards and reduce so-called frivolous litigation. They maintain that 1-year statute of limitations allows enough time for those with meritorious claims to find an attorney, secure medical records and a medical expert affidavit..

However, the Committee heard differently from witness Sandra Payan, who testified that her mother’s death following a hernia operation was later determined to have been caused by a punctured colon which then ruptured. After more than 2 years, the malpractice suit filed by the family was dismissed just weeks before trial after defense attorneys successfully argued the affidavit was not filed along with the suit but instead was filed separately a few days later.

After Payan’s testimony, one member of the Assembly agreed that dismissing a suit because an affidavit may have gotten lost in a clerical error was a harsh penalty and said the 45-day window would be “beneficial to both parties.”

Source: Businessweek

If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group?

"Protect Patients Now!" It has a nice ring, doesn't it?

However, the people behind this campaign, which was launched in Washington to advocate for the H.R. 5 "tort reform" bill in Congress, are anything but patient advocates.

The campaign comes from a group called the Health Coalition on Liability and Access. A list of the coalition's members can be found on its website, and includes:

* Major medical malpractice insurance carriers (Pro Assurance, The Doctors' Company, Medical Protective);

* Doctors' lobbying organizations, especially those who have been active in political efforts to curb lawsuits (the AMA, plus neurosurgeons' and orthopedic surgeons' societies and others);

* Long-time "players" in the legal "reform" space, particularly the American Tort Reform Association, which got much of its seed money from the tobacco industry.

The coalition calls itself a "grassroots advocacy organization" but conspicuously absent from its membership are any of the consumer groups — Consumers Union and Public Citizen, to name two — who have been pushing the medical industry to make health care safer (and thereby solve its lawsuit problem).

H.R. 5 was sent to the floor of the U.S. House of Representatives this week by a party line vote of the House Judiciary Committee. The bill gives special breaks in the form of damage "caps" and other special treatment not only to all physicians, nurses and other individual caregivers, but also to drug manufacturers, nursing homes and hospitals.

The idea of H.R. 5 is that by making the medical industry less legally accountable for the harms it causes, Congress will free up the industry to become safer and provide cheaper care to more Americans.

I did not make that up.

The American Association for Justice (of which I am a member) has an online petition for concerned consumers to send a message to their Member of Congress about this bill.

Article first published as George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group on Technorati.

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’

...

“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

One of the main arguments made by proponents of malpractice reform is that physicians would order fewer medical tests if patients could receive only a limited amount of money in a potential lawsuit. But that assumption may not be true, according to a recent study published in the journal Health Affairs. In that study, researchers from the University of Iowa found that not only does reducing malpractice costs not make physicians less concerned about being sued, it also doesn't necessarily result in them ordering fewer tests.

The study evaluated physicians’ perceptions about malpractice claims in states where more objective indicators of malpractice risk, such as malpractice premiums, varied considerably. It found high levels of malpractice concern among both generalists and specialists in states where objective measures of malpractice risk were low. The study also found relatively modest differences in physicians’ concerns across states with and without common tort reforms. These results suggest that many policies aimed at controlling malpractice costs may have a limited effect on physicians’ malpractice concerns.

Proponents of malpractice reform, including lawmakers, assume that physicians order unnecessary tests because they fear being sued, and this so-called "defensive medicine" is one of the main factors driving up health care spending.

However, opponents of malpractice reform argue that although some physicians request unneeded tests to avoid potential lawsuits, in many cases, physicians order tests because they're trying to do a thorough job with patients, while others order tests to exploit the “fee-for-service” system, which allows physicians to bill more when they perform more services or provide more care.

Source: Des Moines Register editorial

You can read the abstract of the University of Iowa study here.

Half of all graduating medical residents or fellows trained in Illinois are leaving the state to practice elsewhere, according to a new study, which seems to indicate that as many as 50% of the state’s medical school graduates are turned off by the “toxic” malpractice environment. Critics, however, say the study is just another attempt by the health care industry to blame its problems on malpractice claims.

The study, which was funded by the Illinois Hospital Association and the Illinois State Medical Society, asked 561 medical students where they intended to practice after graduation and why. Students who said they planned to leave Illinois cited salary, opportunities to work in their specialty and proximity to family as the most important factors driving their decision. The survey also found that for nearly 70 percent of these students, their perception of Illinois' liability environment -- based on the state's high medical malpractice insurance premiums compared to its neighbors, as well as the Illinois Supreme Court's recent decision to remove caps on damages for medical lawsuits -- also played a role.

But are malpractice claims really driving new physicians from Illinois?. Patrick Salvi, a Chicago-based malpractice attorney, doesn’t think so. “There could be many reasons to explain an impending physician shortage in Illinois, including a general population shift, so it's utterly wrong to say it's solely because of medical malpractice claims,” Salvi says. “The fact is that medical negligence litigation comprises a very small fraction of costs within the health care industry, and those costs would not have been accrued if a physician had not made a terrible mistake that led to the injury or death of a patient.”

Salvi also points to a report by the American Association for Justice which, using data from the American Medical Association, showed that the number of physicians per 100,000 residents was 21 percent higher in states without caps on medical liability damages than in states with caps.

Source: Chicago Sun-Times

You can view or download a PDF of the complete Northwestern Report here.

Go here for more on the critique of the Northwestern report's conclusions.

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It was nearly a year ago that the U.S. Preventive Services Task Force caused a huge uproar with the mildest imaginable recommendation about mammograms, and now two physician researchers say it might be time to point out that certain emperors are wearing no clothes.

In their Sounding Board article in the New England Journal of Medicine, Drs. Kerianne Quanstrum and Rodney Hayward note that some of the harshest cries against the Preventive Services Task Force came from those doctors with the highest vested self-interest in maintaining the importance of mammograms: radiologists with the Society for Breast Imaging. Yet nobody seemed to notice the obvious conflict of interest.

As the authors note:

When a given service is successfully extended to more people with more intensity, the profession providing that service tends to grow in importance and profitability. In the United States, where medical specialists often enjoy an exalted status in the minds of the public, if experts shout loudly that every woman 40 years of age or older must be screened annually for breast cancer, then breast cancer must be important, screening must be a basic human right, and doctors who provide this service must have great value and authority.

But what if those experts are basing their recommendations on more than the interest of patients alone? In any other industry, we accept the idea as natural that those providing a service or product hold their own and their shareholders' interests as a primary objective. Why have we failed to acknowledge that the same phenomenon occurs in health care? Although it is true that individual medical providers care deeply about their patients, the guild of health care professionals — including their specialty societies — has a primary responsibility to promote its members' interests. Now, self-interest is not in itself a bad thing; indeed, it is a force for productivity and efficiency in a well-functioning market. But it is a fool's dream to expect the guild of any service industry to harness its self-interest and to act according to beneficence alone — to compete on true value when the opportunity to inflate perceived value is readily available.

The objective facts, as Quanstrum and Hayward point out, are that the well known economics law of diminishing marginal returns applies in health care as much as anywhere. In mammograms, as the rareness of the tested condition increases, the hidden costs of the test goes up and the value goes down.

So for women between ages 60 and 69, you can save one life by subjecting only 400 women to mammogram screening (in the process of 5,000 screening visits and 400 false alarms in the same group over 13 years of follow-up). That's enough of a benefit to encourage everybody in the age group to get annual screening.

But in women between ages 40 and 49, the data show that to save a single life, you need to subject 1,900 women to screening and endure 20,000 screening exams with 2,000 false alarm tests during eleven years of follow-up. That puts the risk-benefit equation in more of a gray area where you cannot say definitely that no one should have it, or that no one should not have the screening.

And that was exactly the point of the Preventive Services' recommendation: To put the issue into the hands of individual doctors and patients and let them decide if family history or individual anxiety are enough to make the patient want to have the test. That's not a cop-out, it's a prudent bow to individual self-determination.

Here's another quote from Drs. Quanstrum and Hayward:

We must acknowledge that just as in any other profession or industry, self-interest is unavoidably at work in health care. Rather than even acknowledging practice guidelines offered by vested experts, we ought to borrow from the wisdom of sound governance and implement a system of checks and balances when it comes to the interpretation and application of medical evidence. At the same time, we need to recognize that these two tasks are distinct. Although the interpretation of medical evidence is (or ought to be) a scientific exercise, the application of that evidence, as in guideline formation, is ultimately a social exercise.

Decisions regarding practice guidelines can, and certainly should, be informed by evidence. But they will always require value judgments regarding how much evidence is sufficient to dictate care, for example, or whether and to what degree costs should be considered. By separating the processes of evidence review and guideline formation, fair disagreements about the quality or substance of the evidence can occur separately from, and before, disagreements about the implications for clinical care.

Hundreds of patients appear to have received cardiac stents that they didn't need from Dr. Mark Midei, a cardiologist at St. Joseph's Hospital in Towson, Maryland. So why did no one at the hospital blow the whistle? And why did the patients not realize that Midei was rushing them into unwise and risky surgery?

Heart surgery is highly profitable, and there are no incentives for doctors or hospital administrators to rock the boat by raising questions when one cardiologist is putting stents into far more patients than his colleagues.

As for the patients, we Americans have a bias toward dramatic action. If one doctor tells us we need a stent to prop open the coronary arteries in the heart, and another doctor says all we need to do is take a pill every day, most of us will tilt toward the big intervention. Which can be a big mistake, because we then get a piece of metal permanently implanted in a blood vessel, and we have to take medicines anyway for the rest of our life to avoid getting blood clots from the metal that could cause a devastating stroke or more heart damage.

Recently in this blog, I pointed readers toward an excellent review by the Harvard Medical School of the scientific evidence on who should -- and shouldn't -- get the balloon and stent treatment for opening their heart arteries. Many studies have found that unless a patient is having repeated symptoms, the stent treatment does nothing to extend his or her life, even if an artery looks dramatically narrowed.

In the case of Dr. Midei, it appears that outright fraud might have been involved. You have to have a significant narrowing of the artery, 70 percent or more, to even start to qualify for stent treatment, and Midei aggressively over-read his own X-ray studies of the heart's blood vessels to make it seem that patients had much worse narrowing than they really did, according to the published allegations about his practice.

This raises a Fox/Henhouse issue: How is it that a cardiologist can do his own testing to see if someone needs treatment, and then be the one to profit mightily if the decision is yes, they need it? Should second opinions be mandatory on any patient with blood vessel narrowing?

Dr. Bob Wachter, a patient safety pioneer at UCSF medical school in San Francisco, wrote a thoughtful blog on this topic. I'm reprinting part of it below, and urge readers to read the whole article here.

Dr. Wachter writes:

Obviously, the Mideis of the world could be caught by requiring that every cath [blood vessel X-ray] undergo an independent second reading. Some insurers in New Jersey now require such readings before they authorize a stent, and at least one SoCal Kaiser hospital mandates that each cath be presented at a conference before a treatment decision is rendered, analogous to what many tumor boards do for cancers.

Such required peer review might have benefits beyond simply preventing the rare case of fraud. If done well, it might also ensure that other conflicts of interest and non-evidence-based decisions are avoided to the degree possible. For example, a meta-analysis in last month’s Annals of Internal Medicine illustrates the limited value of percutaneous coronary interventions – whereas older studies found that PCI was more effective than medical therapy in treating angina, more recent studies show that these differences have narrowed or even vanished. I’d guess that, when recommending a treatment for a patient with mild angina and a 60% LAD lesion, a peer review group is more likely to pay attention to this kind of evidence than the average cath jock – who may not only be staring at his kid’s private school tuition bill but also at a patient whose bias is to see a stent as a more intuitively satisfying solution than “just medications.”

Some will argue that mandating second opinions for every cath is the equivalent of hitting a nail with a sledgehammer, and they might well be right. However, I do favor at least random over-reads of a sample of catheterization studies. Something like this already happens in a few specialties. In many teaching hospitals, a random sample of pathology studies is reviewed by a second provider. In a few forward-thinking practices, radiologists re-read a sample of x-rays, looking for discrepancies. In response to this case, in fact, St. Joseph’s now requires that 5% of its cath cases undergo a random and blinded re-review. Random audits won’t catch every case of fraud, any more than IRS audits catch every tax scofflaw. But they do help keep people honest, particularly if the audits are coupled with a culture in which the docs welcome feedback and strive for continuous improvement.

Speaking of which, the Midei case made me wonder about the institutional culture at St. Joseph’s. Was Midei a rogue interventionalist working in isolation? Perhaps so – it's common for no other doc to be looking over the shoulder of a cardiologist and his cath readings. But cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents.

And what about the hospital administrators? Stents are big business. When Johnson & Johnson first launched their drug coated Cypher stent in 2003, Dr. Midei told the Baltimore Sun, “This is the hottest thing in cardiology in years.” And it was: Maryland hospitals chalked up nearly $250 million in stent business in 2009, and St. Joseph’s stent revenues were $38 million, up more than 50% in 5 years. Before the case broke, St. Joseph’s advertised itself as the busiest cath hospital in Maryland, averaging nearly 20 interventional cases daily. While it is possible that no St. Joe’s leader knew precisely what was happening, I'm guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when.

Cases like this one are terribly troubling, not just because they harm individual patients but because they do violence to the trust that is so fundamental to the physician-patient relationship. Part of the solution must be more robust oversight procedures, such as mandatory second readings of randomly selected cath films.

But these cases also force us to consider the kind of culture that could allow such a fraud to take root and go on for years – a culture that likely prized the hospitals’ and physicians’ financial health over the clinical health of their patients. If the allegations are true, the penalties should be severe, not only for Dr. Midei but also for leaders who knew – or should have known – what was going on, yet remained silent.

Patients need to know that this is not just an issue of a few rogue bad apples. Medicine's fee-for-service payment system pushes doctors toward advocating for more aggressive and profitable interventions. The only way to find out what your body really needs is to shop for second and third opinions, every time. I have more on this subject in chapter 9 of my book, "The Life You Save."

The chapter title says it all: "The Second Opinion: Always Your First Choice."

It's helpful to look at the actual facts, not supposition, about so-called "tort reform" and medical malpractice, because so many medical leaders persist in arguing that curbing victims' rights to accountability for medical injuries would make the health care system better.

The following discussion is courtesy of Joanne Doroshow, the head of Center for Justice & Democracy, and based on a submission she made to the Medicare payment review board.

No serious economist believes that medical malpractice litigation is a major driver of health care costs. In over 30 years, medical malpractice premiums and claims have never been greater than 1% of our nation’s health care costs.

Senator Orrin Hatch asked the Congressional Budget Office to look into the cost issue. CBO responded in an October 9, 2009 letter, trying to determine health care cost savings if Congress enacted a menu of extreme tort restrictions advocated by the medical lobbies, the insurance industry and a lot misinformed doctors. CBO could go no further than to find an extremely small percentage - about 0.5% - of health care savings by wiping out most litigation, legitimate and otherwise (which is what these measures would do – see the Texas example, below). This is far lower than the highly exaggerated numbers thrown around by those who would like to restrict patients’ rights. Alexander C. Hart, “Medical malpractice reform savings would be small, report says,” Los Angeles Times, October 10, 2009;

To reach the 0.5% savings figure, CBO determined that 0.3% was specifically due to defensive medicine. That’s it. Moreover, CBO found little evidence of this “defensive medicine” phenomenon except in studies of Medicare, not studies of private managed care systems. Obviously doctors operate under the same liability rules no matter the system of payment or the age of the patient, so the explanation for this disparity cannot lie with the legal system. Rather, according to CBO, the problem is Medicare’s emphasis on “fee-for-service” spending, whereas private managed care “limit[s] the use of services that have marginal or no benefit to patients (some of which might otherwise be provided as ‘defensive medicine’).” In other words, CBO suggests that to the extent defensive medicine exists at all, it can be controlled through simply managing care correctly as opposed to taking away patients’ rights and possibly killing and injuring more people.

As far as medical malpractice premiums, CBO attributed 0.2% to this cost. This insurance industry continuously fights its own figures on this, but I think they speak for themselves. (See, e.g, a New York Times article.) And here’s what the figures say:

• Medical malpractice premiums, inflation-adjusted, are nearly the lowest they have been in over 30 years. The periodic premium spikes that doctors experience, as they did from 2002 until 2005, are not related to claims, which have been steady or dropping for many years, but to the economic cycle of insurers and to drops in investment income. In fact, medical malpractice claims, inflation-adjusted, are down 45 percent since 2000.

• Medical malpractice insurer profits are higher than the rest of the property casualty industry, which has been remarkably profitable over the last five years.

• Many states that have resisted enacting severe restrictions on injured patients’ legal rights experienced rate changes (i.e., premium increases or decreases for doctors) similar to those states that enacted severe restrictions on patients’ rights, i.e., there is no correlation between “tort reform” and insurance rates for doctors.

All the data backing up these statistics can be found here: For more information, contact the study’s main author, actuary J. Robert Hunter, former Federal Insurance Administrator under Presidents Carter and Ford, former Texas Insurance Commissioner, and now Director of Insurance for the Consumer Federation of America.

Finally, you may be familiar with the widely-read and cited June 1, 2009, New Yorker magazine article by Dr. Atul Gawande, “The Cost Conundrum; What a Texas town can teach us about health care,” which explored why the town of McAllen, Texas, “was the country’s most expensive place for health care.” The following exchange took place with a group of doctors and Dr. Gawande:

“It’s malpractice,” a family physician who had practiced here for thirty-three years said. “McAllen is legal hell,” the cardiologist agreed. Doctors order unnecessary tests just to protect themselves, he said. Everyone thought the lawyers here were worse than elsewhere.

That explanation puzzled me. Several years ago, Texas passed a tough malpractice law that capped pain-and-suffering awards at two hundred and fifty thousand dollars. Didn’t lawsuits go down? “Practically to zero,” the cardiologist admitted.

“Come on,” the general surgeon finally said. “We all know these arguments are bullshit. There is overutilization here, pure and simple.” Doctors, he said, were racking up charges with extra tests, services, and procedures.

This is true for all states that have enacted "caps" and other restrictions on patients' rights. Moreover, CBO noted that “imposing limits on [the right to sue for damages] might be expected to have a negative impact on health outcomes” and cites one study finding such tort restrictions would lead to a 0.2 % increase in the nation’s overall death rate. If true, that would be an additional 4,853 Americans killed every year by medical malpractice, or 48,250 Americans over the ten-year period CBO examines. This should be unacceptable to us as a nation.

The free meals, trinkets and other goodies now lavished on doctors by the prescription drug industry will soon be a matter of public record for each doctor in the United States, under a provision of the new health care reform law. A searchable database goes into effect in 2013 that will let anyone plug in a doctor's name and find out how much largesse that doctor received in the past year. This is a positive development for patient safety in the United States.

Readers of this blog know from past reports that even small "gifts" from manufacturers are highly effective in influencing doctors' prescription writing habits. The industry spends about $1 billion a year in free meals for doctors and many more dollars in countless free pens, scratch pads, textbooks and other trinkets branded with the names of various drugs being promoted. (As we reported in another post, deep-sea fishing trips and golf junkets are also part of the blandishments.)

Do small gifts matter? Yes, as the Pew Prescription Project points out in an excellent fact sheet that summarizes the studies on how doctors' decisions about drugs are influenced by manufacturers. As the Pew researchers write:

[T]he evidence is clear: gifts, even small ones, change behavior. Such marketing drives up drug costs and sometimes puts patients at risk. Social science research ... shows that a gift of any size imposes on the recipient a sense of indebtedness. This need for reciprocity is a deep-seated human reaction. It creates in the recipient, whether consciously or not, a sense of obligation to repay favors, gifts, invitations, etc. Research shows that it takes extraordinarily little to bias an individual’s interpretation and processing of information. Such bias is both subtle and unintentional.

Now, that's "subtle and unintentional" bias on the part of the doctor receiving the gift. Most doctors will deny heatedly -- and honestly -- that drug freebies have any role in how they prescribe medicines. The manufacturers, who study this closely, know otherwise. There is nothing "unintentional" about the way they spend money on seemingly innocuous trinkets like pens.

The new reporting law requires the drug manufacturers to report to the government everything of value given to any doctor or teaching hospital, starting January 1, 2012 (and the government web site has to be up by September 30, 2013).

Manufacturers do not have to report gifts worth less than $10, but if the total of those gifts in one year to any doctor reaches $100, then all gifts have to be reported. There are a few other exemptions and other details worth reading in this "Sunshine" fact sheet from Pew.

Free samples of drugs also will be covered by another part of the law. As I have reported before, thoughtful doctors don't even accept free samples because that can bias their prescriptions away from "tried-and-true" medicines toward newer drugs with uncertain safety records.

I have a chapter in my book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, educating consumers on how to use prescription drugs safely. One of my key points is that people need to realize that the first few years a new drug is on the market -- during the time of its heaviest promotion by the manufacturer -- is also the most dangerous time for the patient to try the drug, because early users are basically guinea pigs.

This new law infringes no doctor's freedom to accept gifts from industry, and doesn't impact any patient's freedom to patronize such doctors. But with education and "sunshine" about how these gifts create conflicts of interest for the doctor, we can hope that the torrent of freebies will start to slow. All patients will be better off if the education doctors get about new drugs is not influenced by industry gifts.

That question is now on trial in a small west Texas town, where a nurse stands accused of a felony for reporting a doctor whom she thought was guilty of malpractice on patients. Even if the nurse is acquitted, the case could have a chilling effect on nurses' willingness to act as whistle blowers when they see sub-standard medical care.

The defendant, Anne Mitchell, R.N., was indicted for "misuse of official information," a felony, because she reported to the state medical board her concerns about the quality of care delivered by Dr. Rolando G. Arafiles Jr.

Nurse Mitchell worked in quality of care issues for the Winkler County Memorial Hospital where both she and Dr. Arafiles worked.

The case is being followed closely by the Texas Nurses Association, which raised money for the defense of Ms. Mitchell. Click here for case updates.

When the indictment was first reported last summer against Ms. Mitchell and a second nurse (whose charges were recently dropped by the local prosecutor), the American Nurses Association also spoke out strongly.

“ANA wants Winkler County to know the world is watching – we will be monitoring this case closely in the hope that the apparent abuse of prosecutorial discretion will be corrected,” said ANA President Rebecca M. Patton, MSN, RN, CNOR. “It is outrageous to file criminal felony charges against these nurses based on allegations that they raised concerns over a physician’s actions. This undermines one of the basic tenets of the nurse’s Code of Ethics – nurses have a duty to advocate for the health and safety of their patients, and that is what these nurses were doing.”

The New York Times detailed Ms. Mitchell's concerns with Dr. Arafiles' practices in a recent article by Kevin Sack, which also discusses the bigger picture for quality of medical care.

Nurses are traditionally seen as patient safety advocates. That role needs to be nourished, not threatened, for the sake of all patients.

The best measure for understanding what Americans spend on health care is the health care share of GDP (Gross Domestic Production). When that share crossed the 10 percent thershold in the early 1980s, plenty of economists sounded the alarm that ruin was ahead if we couldn't somehow make that share stable, so the rise in health care spending kept pace with the economy but didn't take a bigger and bigger piece of the pie.

So how are we doing? Health care's share of the economic pie went up to 17.3 percent of GDP in 2009, according to a new report in the respected journal Health Affairs. It's the biggest single-year increase since 1960.

The Wall Street Journal's Health Blog crunched some numbers and reported:

The U.S. spent $2.472 trillion on health care last year, according to a paper out today in the journal Health Affairs. That’s $282 million an hour.

Health spending as a percent of GDP — a key metric that shows how much of all U.S. spending goes to health care — rose from 16.2% in 2008 to 17.3% in 2009, far higher than any other industrialized country. That’s the largest one-year increase since 1960, when the feds started closely tracking national health expenditures.

The figure went up so much because health spending continued to rise, even as the overall economy shrank. The aging population accounted for a small part of this rise, but two other factors were more important: rising prices and increasing use. Health-care prices rose by 3.2% in 2009, according to the Health Affairs paper, significantly faster than prices rose for the overall economy. Utilization, which includes both volume and intensity of health-care services, rose by 1.5%.

The share of health-care spending paid for by the government (through programs such as Medicare and Medicaid) is also rising, and is projected to cross the 50% threshold soon.

The share of the economy for health care will be close to 20 percent within the next 10 years, according to government forecasters.

These sobering numbers show the urgency of "bending the cost curve down," as the pundits like to say. Unfortunately the urgency of reforming the safety and quality of health care has taken a far back seat to the money discussion. They actually are compatible goals. One thing we've learned in the health care reform debate is the huge overspending in health care caused by widespread use of new technologies before their benefit is proven, driven in part by conflicts of interest by those pushing the new technologies.

Measured by results -- preventable deaths and injuries due to malpractice, medical errors, preventable infections, misdiagnosis and other events that shouldn't happen -- American health care has a lot of problems. Millions of patients are injured every year, and upwards of 200,000 patients die annually from preventable errors and hospital-acquired infections. The United States also lags far behind other developed countries in basic health outcome measures like life expectancy and infant death rates.

But when U.S. hospitals measure themselves with a different yardstick -- the "process" measures of how often certain important things get done for commonly treated diseases -- the results are astoundingly good. An annual report from the Joint Commission, the agency that inspects and accredits hospitals, finds steady improvement in the "process" quality measures that it looks at -- with most hospitals now performing in the 99% range on things like how often heart attack patients get standard treatments in the ER like aspirin and beta-blocker drugs.

The Joint Commission now measures 31 quality indicators. They cover the most common hospitalizable conditions: heart attack, heart failure (when the pump isn't pumping effectively), pneumonia, surgical care, and children's asthma. You can go to this website to look up information about a particular hospital.

The problems with the report are:

* Data is reported voluntarily by the hospitals, with no independent audit from anyone other than the Joint Commission. The Joint Commission says it's independent from the hospital industry but is often seen by critics as a cheerleader.

* Outcome measures -- deaths and injuries -- are not included in the report. Even infection rates, which could have required reports if Congress ever passes health care reform, are not yet reported.

Consumers Union has a Safe Patients Project. CU says it's high time for the U.S. health care industry to be required to report its results. Patient advocates like me agree wholeheartedly.

The deadly MRSA infection, estimated to kill 19,000 Americans every year (more than the toll from AIDS), has been virtually wiped out in Norway, with three simple steps:

As described in a recent Associated Press article:

Norway's model is surprisingly straightforward.

-- Norwegian doctors prescribe fewer antibiotics than any other country, so people do not have a chance to develop resistance to them.

-- Patients with MRSA are isolated and medical staff who test positive stay at home.

-- Doctors track each case of MRSA by its individual strain, interviewing patients about where they've been and who they've been with, testing anyone who has been in contact with them.

Step No. 1, ratcheting back on antibiotic prescriptions and relying more on the old tried-and-true ones, won't go over well in America, where the prescription drug industry pushes all of us into a newer-is-better and more-is-better approach.

But step No. 2 -- test and isolate -- has been proven to work by itself to virtually wipe out the spread of MRSA once it gets into a hospital, by isolating people who are carriers.

The problem is that people can carry the bug on their skin without harm; a deadly infection only happens when it gets into the body of an already vulnerable patient. The answer: do nasal swabs of all incoming patients when admitted to the hospital to see if they are carriers, and if so, isolate them in special units.

Does your hospital do this? If not, you should ask why not. The safest hospitals in the United States do nasal swabs of all incoming patients at the time of admission. It's for their safety and everyone else's.

Actor James Woods' brother Michael died of a heart attack three years ago in an emergency room hallway in Rhode Island because no one was paying attention. Now, something good will come from Michael Woods' death, thanks to a settlement reached between the Woods family and Kent Hospital in the middle of a jury trial.

The settlement creates a new institute to help teach hospital staff how to pay better attention to patients and develop a more "human-centered" standard of care.

An impasse between the two sides in the trial was broken when the president of the hospital, Sandra Coletta, called James Woods the night before the actor was going to testify about his brother's death. As reported in the Providence Journal:

In that call, he said he heard something he’d never heard from Kent Hospital before, someone saying she was sorry for his family’s loss. ... Woods said the family’s peace of mind about the agreement was helped when Coletta met his mother, Martha.

“Sandra and my mother had a very personal moment, a mother-to-mother conversation,” Woods said, calling it a “sweet and dear way to express sorrow.”

“It was all I ever needed to see in my life,” Woods said, “one human being saying to another human being ‘I’m sorry for your loss.’ ”

In announcing the new Michael J. Woods Institute, which will be funded by $1.25 million of the hospital's money, hospital president Coletta said:

"We know we're not perfect at Kent Hospital. Mistakes were made. We can do better. The Michael J. Woods Institute will help establish a leadership role in promoting patient safety and developing new ways to improve the patient experience and clinical outcomes."

This is one often-overlooked benefit of the civil justice system: producing positive safety reforms to try to reduce the toll of medical error. An actor's celebrity helped make that a reality in Rhode Island. On a quieter level, similar positive events happen at the end of many lawsuits, where families who have lost a loved one insist that part of the settlement go toward education and system reforms to make hospitals safer places. Patient safety advocates like me believe this is one of our highest callings.

How is our medical care system like American agriculture before the era of modern food-growing practices? Pretty similar, argues Dr. Atul Gawande in the New Yorker. Both were expensive, wasteful of human resources and completely fragmented. And the cures for their problems could be similar too.

What reformed American farming and turned it into a world leader in producing low-cost food was the "extension" system that the government set up for teaching farmers, one county at a time, what worked and what didn't work.

Dr. Gawande argues that the 2,000-page health care reform bill now in Congress has an optimistic prospect for using many pilot projects in funding health care to figure out what works to lower costs and increase safety and quality. It's a fascinating argument, and I hope he is right.

I only differ from Gawande on one thing: he takes swipes at malpractice attorneys and the lawsuit system as contributing to the waste. That has not been borne out by careful studies. Moreover, patients need a robust system of advocacy for when preventable injuries have occurred. So far, no better system has been developed for getting to the bottom of what happened, to try to prevent it from happening again, and to give the patient fair compensation.

A piece by a doctor in Salon.com puts the lie to claims from the medical industry that a dose of "tort reform" to curb medical malpractice lawsuits will lower medical costs and make for safer health care. Quite the opposite, as pediatrician Rahul K. Parikh, M.D. explains. Two short excerpts below from his article, which is worth reading in its entirety:

Their refrain [of the AMA leaders] is familiar to anybody following the healthcare reform debate. The only problem is that it's not true. There's nothing "sure or quick" about changing medical liability laws that will improve healthcare or its costs. Defensive medicine adds very little to healthcare's price tag, and rising malpractice premiums have had very little impact on access to care.

...

Tort reformers neglect the fact that malpractice reform won't save one extra life. To make that difference, insurers, doctors and their lobbyists like the AMA need to find ways to improve patient safety. So for those who push tort reform as a panacea for a sick healthcare system, working to prevent injuries is a much more noble pursuit than writing up baseless arguments for the back pages of a newspaper [in this case, the Wall Street Journal].