HealthLawProf Blog

Happy Fourth of July

The Declaration of Independence:         When in the Course of human events it becomes necessary for one people to dissolve the political bands which have connected them with another and to assume among the powers of the earth, the separate and equal station to which the Laws of Nature and of Nature's God entitle them, a decent respect to the opinions of mankind requires that they should declare the causes which impel them to the separation. We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. — That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed, — That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness. Prudence, indeed, will dictate that Governments long established should not be changed for light and transient causes; and accordingly all experience hath shewn that mankind are more disposed to suffer, while evils are sufferable than to right themselves by abolishing the forms to which they are accustomed.

Medical Malpractice Reform as a part of Health Reform

RollCall reports on the push to make medical malpractice reform part of the overall health reform legislation:

The Senate Health, Education, Labor and Pensions Committee’s markup of health care legislation is just the latest skirmish in what has been a long-standing partisan battle — the fight to change medical malpractice laws. The issue has long been a fixture of legislative fights over health care policy....

Republicans have long argued that the system is weighted against doctors. They say that limitless damage awards lead to crushing insurance costs for doctors, who pass them along to patients, and that physicians are practicing defensive medicine, which drives up health care costs through unnecessary treatments. Sen. Judd Gregg (R-N.H.) argues that reforming this system will help drive down health care costs and expand coverage.  “We cannot possibly reduce the cost of health care in this country without reducing defensive medicine,” he said....

Democrats reject this argument, countering that the current system is necessary to protect patients from medical mistakes that can cause them irreparable harm.  “I honestly really don’t see this as a health care issue,” said Sen. Sheldon Whitehouse (D-R.I.). Instead, the Senator, a former Rhode Island attorney general, argued that medical malpractice is more of an “intruder” into the debate to protect insurance companies, hospitals and doctors from being accountable for their mistakes....

Some observers say the American Medical Association and other doctors’ groups could put pressure on Democrats to accept some sort of reform in exchange for their support of health reform. However, Gregg said, “Medical providers have never been able to organize enough of an offensive” to force change.

A Republican Senate aide agreed. If the reform bill includes changes to medical malpractice, it will infuriate trial attorneys. A better way to go might be to focus on changing doctors’ Medicare reimbursement rates, the aide said. Doctors have also fought to increase these rates and, unlike tort reform, there is no powerful lobby opposing that issue....

However, the White House has shown some willingness to explore the issue. Obama told AMA members in June that some medical malpractice reforms were necessary as part of health reform.

“I recognize that it will be hard to make some of these changes if doctors feel like they’re constantly looking over their shoulders for fear of lawsuits,” Obama said.

Meanwhile, the AMA is moderating its goals for reform beyond caps on damages, given Democratic control of Congress....

Insurance Concentration

Steven Benen of the Washington Monthly reports on the concentration in the insurance industry:

Zachary Roth has a very good piece today pointing to a HCAN report documenting the fact that most Americans don't enjoy "anything like a competitive marketplace for health care."

The report, released by Health Care for America Now (HCAN), uses data compiled by the American Medical Association to show that 94 percent of the country's insurance markets are defined as "highly concentrated," according to Justice Department guidelines. Predictably, that's led to skyrocketing costs for patients, and monster profits for the big health insurers. Premiums have gone up over the past six years by more than 87 percent, on average, while profits at ten of the largest publicly traded health insurance companies rose 428 percent from 2000 to 2007.

Far from healthy market competition, HCAN describes the situation as "a market failure where a small number of large companies use their concentrated power to control premium levels, benefit packages, and provider payments in the markets they dominate."

So extreme is the level of consolidation, in fact, that one former top Federal Trade Commission official working with HCAN has sent a letter to the Justice Department's Antitrust Division, asking for an investigation into the health insurance marketplace.

Specifically, the Justice Department considers a marketplace "highly concentrated" if a company's market share tops 42%. HCAN found 10 states in which one or two companies control 80% or more of the market. In Alabama, home to Sen. Richard Shelby (R), one of the strongest opponents of reform, Blue Cross Blue Shield controls 83% of the statewide market.

Individual insurance companies enjoy practical monopolies in many parts of the country, which keeps prices high, profits high, and consumers screwed. It's why the public option is seen as such a serious threat -- it would introduce at least some competition, and offer consumers some choices. . . .

Congressional Budget Office on the Cost of Health Reform - New Numbers

Ezra Klein points out the new budget numbers on the Senate's HELP bill:         

The big news of the morning is a new version of the Senate HELP Committee's health-care reform bill that seems to have everyone confused. The short version is this: CBO estimates that by 2019 the bill will cover 21 million people at a cost of $597 billion. But -- and this is important -- the HELP Committee's bill doesn't include the Medicaid expansion, because Medicaid is under the sole jurisdiction of the Finance Committee. But if Medicaid is expanded to 150 percent, it will cover an additional 20 million at a cost of about $1 trillion. Add in the savings that Finance is expected to get from reforming Medicare and you're looking at a bill that will cost $1 trillion to $1.3 trillion and cover 42 million people (which would mean 97 percent of the legal population in 2019 would have health insurance) by 2019.

The importance of this set of numbers can be understood only in terms of the catastrophe that was the last set of numbers. On June 15, the Congressional Budget Office scored an incomplete version of this bill. The office estimated that it would cost $1 trillion over 10 years and cover 16 million people. It would've cost, in other words, 70 percent more and covered 20 percent fewer people. The big question, then, is what accounts for the change? And luckily, there's a simple answer: the employer mandate. ...

But oh, what a difference a mandate makes: The new version of the HELP bill includes an employer mandate for firms with more than 25 workers. Every full-time worker who isn't given health-care coverage triggers a penalty of $750. Every part-time employee not given coverage costs $375. Doesn't seem like very much, does it? But it's enough. In Massachusetts, the employer mandate has been a success with a piddling $295 penalty. Indeed, the evidence we have suggests that the small penalty creates a massive change in behavior. ...

FDA Panel Recommends Ban on 2 Painkillers

The New York Times:

A federal advisory panel voted narrowly on Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States....

The panel’s 20-17 vote to recommend a ban on the combination drugs was one of 11 it took at a meeting called to advise the F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American consumers bought 28 billion doses of products containing the ingredient.  While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.

In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams.

But they voted 20 to 17 against limiting the number of pills allowed in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains.    “We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation. ...

Still, some doctors predicted that the recommendation would put extra burdens on physicians and patients.  “More people will be suffering from pain,” said Dr. Sean Mackey, chief of pain management at Stanford University Medical School. “More people will be seeing their doctors more frequently and running up health care costs.”

In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” like Advil and aspirin.

Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe. “I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.

The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36 to 1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents.  “I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the acting chairman. . . .

Today's Diane Rehm Show has a further discussion of the FDA panel's recommendation:

PainKiller Safety:   An update on recommendations to the Food and Drug Administration to restrict acetaminophen and ban the popular painkillers Percocet and Vicodin because of possible risks of overdose and liver damage.  Guests:    Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen; editor of WorstPills.org;  Dr. Andrew Putnam, director, palliative care program at Lombardi Comprehensive Cancer Center at Georgetown University Medical Center; Linda Suydam, president, the Consumer Healthcare Products Association;      Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs.

Drug Resistant Swine Flu

The Associated Press reports,   

For the first time, a case of swine flu has proven resistant to Tamiflu — the leading pharmaceutical weapon against the new virus, international health officials said Monday.    The resistance was seen in a patient in Denmark, who has recovered.  "The goods news is they just found one," said Dr. Carolyn Bridges of the U.S. Centers for Disease control and Prevention. . . .

Until an effective vaccine is developed, the drugs Tamiflu and Relenza have been considered the best available defense against the swine flu virus, which has caused nearly 28,000 reported illness in the United States, including more than 3,000 hospitalizations and 127 deaths.

The Danish case was isolated, however, and guidelines from the CDC and the World Health Organization continue to recommend Tamiflu as a treatment. No details were released on the patient's age or gender, or on when the patient was sick.   "It is possible to see occasional reports of resistance while a drug remains largely effective," said Terry Hurley, a Roche spokesman.

Diane Rehm on Primary Care Doctors

Diane Rehm discusses the need for more primary care doctors today:    

10:00     Primary Care Doctors

The role of primary care doctors in the U.S. health care system and efforts to address what some believe is a crisis in primary care.

Guests

Dr. Atul Grover, Association of American Medical Colleges

Dr. Fitzhugh Mullan, Murdock Head Professor of Medicine and Health Policy, George Washington University School of Public Health and Health Services

Dr. Walker Ray, Vice President for The Physicians Foundation, and retired after 38 years as pediatrician in Atlanta

Healthy Americans Against Health Reform: New AD

I find these ads quite funny, hope others to do - click here (HARRM.ORG) for their latest.   For more health reform humor, check out Tom Tomorrow's latest cartoon here.

The Public Plan: A Discussion

Several scholars discuss and debate the pros and cons of a public plan option at The American Prospect.   Here is a brief excerpt:

In "The Perils of the Public Plan," Paul Starr warns that a public-insurance option could turn into exactly the opposite of what progressives want. Here he discusses the problems with the Prospect's two other co-founders, Robert Kuttner and Robert Reich.

Paul Starr:
The far bigger question is how those exchanges work:

Are they open to all employers and individuals -- required, in fact, for employers below a given size -- or open only to the individual and small-group market?

Do the exchanges have the power to risk-adjust the premiums paid to health plans?

Can they regulate the marketing strategies and benefit designs of private insurers?

The public plan will likely end up as a dumping ground for high-cost, mostly low-income people if the exchanges are open only to the individual and small-group market and have inadequate power to risk-adjust premiums or to regulate private insurers' marketing and benefit design. In other words, we could get a public plan that instead of "disciplining" private insurers, as the president said last week, actually buttresses their dominance of the system. Watch what you wish for.

Robert Kuttner:
The public option, as it is evolving, is even more dubious than Paul Starr's apt critique suggests. Under the House leadership bill, people who have coverage through their employers are ineligible. So the proposed, head-to-head competition between the public plan and private competitors is left to employers, not individuals.

What's distressing is that progressives have put all their eggs in this leaky basket. It's clear that Jacob Hacker's original inspiration -- that over time the superior efficiencies of a true public plan would crowd out private alternatives -- is being undermined by the politics of compromise. Even Sen. Max Baucus, not exactly a lefty, remarked the other day that he wished that single-payer hadn't been taken off the table, if only for tactical reasons.

In public opinion polls and in liberal advocacy, the badly flawed public option has become a kind of proxy for what most Americans really want -- national health insurance. . . .

Robert Reich:
Paul Starr worries that the public plan would end up a dumping ground for the sicker and more expensive. If that were the likely outcome, private insurers, the pharmaceutical lobby, and the American Medical Association would be all in favor of it. But they're apoplectic about a public option because they fear exactly the opposite, which also seems to me more likely: By virtue of its scale and scope, a public plan would have the bargaining power to get lower drug prices and better deals with health providers, thereby eating into their profits. And they worry that the lower administrative costs of a public plan that doesn't have to show a profit, or spend on marketing and advertising, will further erode their margins. Of course we need to pay attention to the precise organization of the risk exchanges, but that's mainly to make sure the public plan is allowed to exert full competitive pressure on the private plans. . .      .

Krugman on Health Reform

Oxdown Gazette has an excellent post discussing Paul Krugman's response to George Will's (Washington Post) and Greg Mankiw's (New York Times) editorials on healthcare.   The blogger writes,

Fortunately, Paul Krugman had similar concerns, but expressed them more clearly, and after all, he's a decent economist. In Health Care is Not a Bowl of Cherries, he responds to Mankiw:

Both George Will and Greg Mankiw basically argue that we don’t need a government role because we can trust the market to work — hey, we do it for groceries, right?

Um, economists have known for 45 years — ever since Kenneth Arrow’s seminal paper — that the standard competitive market model just doesn’t work for health care: adverse selection and moral hazard are so central to the enterprise that nobody, nobody expects free-market principles to be enough. To act all wide-eyed and innocent about these problems at this late date is either remarkably ignorant or simply disingenuous.

Those who follow Krugman, DeLong and other economist blogs know that in several posts over recent months, Krugman and DeLong have been rolling their eyes at economists succumbing to talking points and what they call "The Great Ignorance," in which prominent economists appear to have forgotten what their predecessors figured out decades ago. This began during the stimulus debates.

Working to Prevent Painkiller Damage

The Associated Press reports on the FDA's renewed focus on painkillers and their damaging side effects. The article provides,

Tylenol, Excedrin, NyQuil. These household brands and others have come to symbolize safe, convenient relief from the aches and pains of everyday life. But this week the Food and Drug Administration is focusing on a seldom-discussed side effect of the medications: severe liver damage. Since the drugs first became widely available in the 1950s, the FDA has tried to minimize the risks of acetaminophen — the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Acetaminophen overdoses send an estimated 56,000 people to the emergency room each year, according to the FDA.  Despite decades of educational campaigns, bolstered warnings and other federal actions, acetaminophen continues to be the leading cause of liver failure in the U.S. . .  .   

The FDA does not have to follow the group's advice, though it usually does. Individual companies already are sparring in an effort to influence the FDA's decision.   Panelists will be asked to vote on a range of options: adding a "black box" warning label to the products, lowering the drug dosage in some products, or pulling certain types of medications off the market — which could cost manufacturers millions in sales.  The drugs that could be pulled off store shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which combine acetaminophen with other ingredients that treat cough and runny nose....

Coverage for Autism

The National Law Journal reports on a settlement in Michigan involving payment for autism treatments by  insurance companies.  Tresa Baldas writes,

In what plaintiffs lawyers are calling a landmark autism case, a Michigan insurance company has agreed to reimburse at least 100 families for costs involving treatments for their autistic children.

The $1 million class action settlement from Blue Cross Blue Shield of Michigan comes amid a legislative wave in which a growing number of a states are passing laws that require insurance companies to pay for autism treatments and screenings. To date, 13 states have such laws, the most recent being Connecticut, Colorado and Nevada. New Jersey is currently considering an autism bill, and Pennsylvania's law goes into effect July 1.

The June 17 Michigan settlement, meanwhile, has autism advocates hopeful that insurance companies will stop claiming that behavioral therapy for autistic children is experimental, and start paying for it.

"It is a significant victory for the families, obviously, and it marks a trend, hopefully, that insurance companies will start to look at autism treatment differently," said Areva Martin, an attorney at Los Angeles-based Martin & Martin who is currently handling about 30 autism cases. She believes the labeling of autism treatments as experimental is "absurd." ...

In the case, Johns v. Blue Cross Blue Shield of Michigan, filed in the Eastern District of Michigan, the family of an autistic child sued Blue Cross for allegedly failing to acknowledge that a treatment known as applied behavioral analysis is scientifically valid. ABA therapy attempts to change behavior through positive and negative reinforcements.   In the suit, the plaintiffs alleged that Blue Cross' pattern and practice of characterizing ABA as "experimental" was arbitrary, capricious, illegal and contradicted by many years of scientific validation.   Blue Cross sought dismissal of the case, but a judge permitted it to go forward.

The case settled shortly after plaintiffs counsel obtained a court order requiring Blue Cross to produce documents that validated the effectiveness of ABA. Among the documents obtained was a draft of a 2005 Blue Cross Blue Shield medical policy, which stated: "Applied behavioral analysis (ABA) is currently the most thoroughly researched treatment modality for early intervention approaches to autism spectrum disorders and is the standard of care recommended by the American Academy of Pediatrics, National Academy of Sciences Committee and the Association for Science in Autism Treatment, among others."

Blue Cross' documents also stated: "The earlier the disorder is diagnosed, the sooner the child can be helped through treatment interventions." ...