HealthLawProf Blog

Editor: Katharine Van Tassel
Creighton University School of Law

Saturday, February 21, 2009

The Office of Health Reform - Still Happening?

Ezra Klein contemplates whether President Obama will still pursue the creation of the Office of Health Reform.  He writes,

To calm my e-mailers down: The fact that the White House might dump the Office of Health Reform does not mean they're dumping health reform. Quite the opposite, in fact.

The White House Office of Health Reform was an agency created at Tom Daschle's request to carry out Tom Daschle's vision of health reform. . . . .

That vision, crucially, relied on the authority vested in him by the President of the United States. The health czar only matters if he's understood to have Obama's ear on the issue. And Daschle did have Obama's ear. Obama trusted Daschle. He trusted him to be the administration's point of contact with the Senate, he trusted his knowledge and instincts on the issue, he trusted his ability to manage a large bureaucracy. But the administration has not found a suitable replacement. Daschle has not -- and will not -- be replaced. And if he's not replaced, then the structure built around his person has to change.

Indeed, there's a strong argument that filling that spot with someone else would actually undermine the original intent of the office. Daschle presided over the early conversations on health reform. His authority on the issue was understood and respected by the other players in the room. But his withdrawal did not derail the administration's internal health policy process. The room simply changed. Other players stepped into larger roles. Peter Orszag and his health deputy Zeke Emanuel emerged as key participants. Jason Furman and Diana Farrell at the National Economic Council. Jeanne Lambrew and Mark Childress retain significant roles. Larry Summers, of course, has influence, though it's not clear if he's directly involved at this juncture. . . .

Which calls into question the need for a new agency called the Office of Health Reform: No one wants a department that was supposed to streamline the process to instead add to the clutter. If they decide to dump the Office of Health Reform, it's not because they've abandoned health care reform. It's because they haven't, and they're building a post-Daschle strategy.

February 21, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, February 20, 2009

Flu Trends

Here is a link to the Google's Flu Trends website that allows you to track the flu in your state.  Thanks to DemfromCt for the update on flu season.

February 20, 2009 | Permalink | Comments (0) | TrackBack (1)

Suing Medical Device Manufacturers . . . .

Last year, in Riegel v. Medtronic, the United States Supreme Court barred patients from suing in tort makers of medical devices if the Food and Drug Administration had approved them. Now several lawmakers consider legislation to overturn that ruling.  The New York Times reports,

But now, some members of Congress want to give potential plaintiffs . . . a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.  A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.  The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

“Consumers face the worse of all possible worlds,” said David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. “The F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.” . . .

Mr. Pallone says he also expects the House Energy and Commerce Committee to hold hearings this session to question whether the F.D.A. process for approving devices is adequate. “The F.D.A. has limited resources and can’t assess all the risks that a device poses once it gets on the market,” he said.

Medical device producers and some conservative legal groups have lined up to oppose the legislation, which is supported by plaintiffs’ lawyers. Last year, at a Congressional hearing, the Advanced Medical Technology Association, a device industry trade group, said that the F.D.A. was the appropriate body to set nationwide safety standards and that allowing juries to second-guess such decisions would stifle product innovation.  “We are clearly very troubled by this legislation,” Christopher White, the trade group’s general counsel said in an interview. “Our concern is that it would undermine the F.D.A. process.”

The Supreme Court, in a case argued last fall, is now weighing whether to give the same type of legal protections to drug manufacturers. In that case, like the one decided in February 2008, the Bush administration supported pre-empting many product liability suits against F.D.A.-approved products . . . .

February 20, 2009 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 19, 2009

Kansas Governor Top Pick For HHS

The New York Times reports today that Governor Kathleen Seblius is President Obama's top pick for Secretary of HHS.   Peter Baker and Robert Pear write,

Gov. Kathleen Sebelius of Kansas, an early Obama ally with a record of working across party lines, is emerging as the president’s top choice for secretary of health and human services, advisers said Wednesday.  Should she be nominated, Ms. Sebelius would bring eight years of experience as her state’s insurance commissioner as well as six years as a governor running a state Medicaid program.

But with President Obama about to begin a drive to expand health coverage, an issue on which the two parties have deep ideological divisions, her strongest asset in the view of the White House may be her record of navigating partisan politics as a Democrat in one of the country’s most Republican states. . . .   With his economic recovery plan signed into law, Mr. Obama plans to turn his attention more to health care next week with a fiscal blueprint that will begin to advance his ideas about covering the uninsured, advisers said. He may also make health care a theme of his prime-time address to a joint session of Congress on Tuesday night, they said. . . .

If she becomes health secretary, she will be the fourth woman in the 15-member cabinet, overseeing 65,000 employees and a $700 billion budget. But she is unlikely to also wear the second hat that Mr. Daschle negotiated for himself as White House health czar, a position that could be influential in setting health care policy. . . .

As Kansas insurance commissioner, Ms. Sebelius helped draft a proposed national bill of rights for patients and blocked the sale of Blue Cross and Blue Shield to an out-of-state company because it would have raised premiums. She served as president of the National Association of Insurance Commissioners and often testified before Congress. . . .

February 19, 2009 | Permalink | Comments (0) | TrackBack (1)

Human Rights for Fertilized Eggs

The Associated Press reports on the North Dakota House's new law providing human rights for fertilized eggs.  The story states,

A measure approved by the North Dakota House gives a fertilized human egg the legal rights of a human being, a step that would essentially ban abortion in the state. . . . It now moves to the North Dakota Senate for its review.  The bill declares that "any organism with the genome of homo sapiens" is a person protected by rights granted by the North Dakota Constitution and state laws.

The measure's sponsor, Rep. Dan Ruby, R-Minot, said the legislation did not automatically ban abortion. . . . "This is very simply defining when life begins, and giving that life some protections under our Constitution — the right to life, liberty and the pursuit of happiness."  Critics of the measure say it will cost millions of dollars to defend. Ruby said the state has been willing to go to bat for other principles that were less important.

In Oklahoma, meanwhile, a state House committee Tuesday approved legislation that would prohibit physicians from performing abortions solely on account of the gender of a woman's fetus, even though the measure's author said there is no evidence the practice has ever occurred in the state. . . .

February 19, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 18, 2009

Howard Dean Speaks on Comparative Effectiveness Research

The Huffingtonpost runs a brief editorial by Howard Dean (whose name has been mentioned as a potential HHS Secretary) concerning comparative effectiveness research and its opponents.  He writes,

Opponents of fixing our broken health care system are at it again, attempting to use their same old scare tactics and falsehoods to kill a common-sense health care provision is the economic recovery package. . . . Under attack is a provision that is in the package that will help your doctor be better informed and more effective at the job they signed up to do in the first place - taking care of you and your family.   

Comparative Effectiveness Research:   At issue is something called "Comparative Effectiveness Research" which basically means giving your doctor access to the latest research on what treatments and therapies work and which don't. This also helps doctors know which treatments are more expensive than others, and helps both patients and doctors decide if there is a cheaper treatment that is just as effective. As a doctor and the husband of a doctor, I know how important it is to have solid scientific research to make critical decisions for my patients.  This research will help doctors choose the best treatment for their patients' situation and help them make more informed choices rather than risk prescribing less effective or even potentially harmful treatments.

Essentially, in order to control costs and provide patients with better care as we reform health care, the Federal Government will fund and disseminate research that evaluates the effectiveness of different treatments and medicines. This research will give doctors and patients better choices, and most importantly better health care for their money. . . .

Medicine is and should always be science based - not driven by ideology.

Mr. Limbaugh and his cohorts would have you believe that this research will be used to deny needed care to your great Aunt May and be run by the politburo. But the Bill passed by Congress states right up front that the Government can not make coverage decisions based on this research . . . .

This claptrap is really about the far right laying the ground work for a far greater and more sustained attack on the Democrats' attempt to fix our health care system. As we move forward with the American people to finally fulfill the promise of Harry Truman, who over sixty years ago suggested that every American ought to have a reasonable health care plan, we will rely on the voters to remind the right wing that change is what we promised, and change is what we will deliver. . . .

February 18, 2009 | Permalink | Comments (0) | TrackBack (0)

Number of Uninsured Rising By 14,000 per day . . .

Thinkprogress reports on the increasing number of uninsured as more and more people lose their jobs - in fact, 14,000 each day.  The story states,

Since spring 2007, 3.5 million Americans have lost their health benefits and are now uninsured. And while the stimulus begins to address the skyrocketing health costs and lack of access to coverage, the ranks of the uninsured will only grow as the recession persists. In fact, according to a forthcoming analysis by The Wonk Room’s James Kvaal and Ben Furnas, approximately 14,000 people a day are losing their health coverage . .

The Wall Street Journal's Health Blog reports on the Stimulus Bill and notes that it contains some wins and some losses for those interested in health reform. 

The version of the economic stimulus bill that’s come out of the congressional conference committee has wins and losses for advocates of universal health care.  House Democrats in particular had tried to use the stimulus bill as a step toward universal coverage, pushing for expansions of laid-off workers’ access to Cobra coverage and Medicaid. Republicans had complained about some proposals, saying the Dems were using the stimulus bill to jump the gun with costly health-reform proposals that didn’t belong there. . . .   For gobs of detail on how the Senate and House proposals melded into the compromise version, click here. Health care is toward the end of the document. A much briefer summary of the bill is here. The Kaiser Family Foundation also offers a summary of health provisions.

February 18, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 17, 2009

Medicare Privacy Ruling

AmNews reports on the D.C. Circuit's ruling that HHS is not required to turn over Medicare claims data to a consumer group wishing to use the data to provide patients with selected physician information.  The case is:  Consumers' Checkbook/Center for the Study of Services v. U.S. Dept. of Health and Human Services.  Chris Silva provides a brief overview of the case and writes,

A federal appeals court said physician privacy dictates that a consumer group is not entitled to receive and publicize Medicare physician claims data. The court added that the information would not be of use to patients anyway.

Consumers' Checkbook/Center for the Study of Services [a nonprofit that rates firms and services for subscribers] sued, in 2006, the Dept. of Health and Human Services under the Freedom of Information Act to obtain selected physician claims data. The organization hoped to provide patients information on the number of major procedures performed in 2004 by each Medicare physician in four states -- Illinois, Maryland, Virginia and Washington -- and the District of Columbia.

The appeals court's Jan. 30 decision reverses a district court ruling of August 2007. It prevents both the data release and the publication of a free public resource that Checkbook/CSS had planned to produce using the information. The American Medical Association was successfully added to the case as an additional appellant after it urged HHS to challenge the lower court's ruling. While the appeal was pending, the release of the claims data was put on hold. . . .

"We are in favor of patients having information that's evidence-based and statistically balanced, but the problem with the request by Consumers' Checkbook is that it's raw billing data, which could be misleading to society," said Jeremy A. Lazarus, MD, a psychiatrist from Denver and speaker of the AMA House of Delegates. "Unless it's tied to quality measures and an adequate patient size, then it could be damaging."

Checkbook/CSS anticipated that a patient could use the information when seeking a physician for a specific procedure. A patient could find out how many of these procedures a given doctor performed over the course of a year and choose a more experienced physician . . . .

The information requested by Checkbook/CSS "does not serve as a ratings system," said K. Edward Shanbacker, the Medical Society of the District of Columbia's executive vice president.

"It would have been misleading to patients if they had tried to extrapolate data from the Medicare program on a per-procedure basis. It doesn't speak anything about the physician's competence or quality," he said.

The U.S. Court of Appeals for the D.C. Circuit agreed in a 2-1 decision. The court weighed the "nonexistent public interest against every physician's substantial privacy interest" and concluded that exposure of the data "would constitute a clearly unwarranted invasion of personal privacy." . . .

An HHS spokesperson said the department has no comment on the court's Jan. 30 ruling because the pending suit has not yet been dismissed. But the department has stated a commitment to making Medicare claims data available as allowable by the law. In challenging the suit, it cited a 1979 ruling by the U.S. District Court for the Middle District of Florida that prohibited it from disclosing Medicare pay data that would have identified individual doctors.

February 17, 2009 | Permalink | Comments (0) | TrackBack (0)

Food Policy and Health Policy

Ezra Klein has some interesting thoughts on our current food policies.  He writes,

To put some of the recent conversations over chronic disease and diet into economic perspective, consider the hackneyed statistic that we spend more on health care than on food. The stat is true: We spent $2.26 trillion on health care in 2007 and about $845 billion on food. Those numbers are not strangers to one another. To some degree, we spend more on health care because we spend less on food. Cheap food tends to be nutritionally hollow and purchased in spectacular quantity. Neither quality makes HoHos friendly to arterial health.

But the sobering corollary to talking about the public costs of bad diet is that we don't really know how to change the way people eat. Diansheng Dong and Biing Hwan-Lin recently conducted a study for the USDA's economic research service modeling the likely impact of a 10 percent discount on fruits and vegetables for low-income Americans (defined here as incomes below 130 percent of the poverty line). They concluded that the policy, which would cost $580 million, would increase the consumption of fruits by 2.1-to-5.2 percent and vegetables by 2.1-to-4.9 percent. It's not nothing, but it's not much.  . . .

And cost is just one barrier. Many people lack access to decent produce. . . .  More than that, it's foolish to imagine that poor eating habits are the simple outcome of inadequate nutritional education, incomes, and access. . . .   Cooking takes time, and when you're working multiple jobs and feeding a family, the undeniable ease of fast food is a powerful lure. And fast food is tasty!  . . .  So this isn't a question with easy answers. Even if you could get the political system to focus on it, the policies are not obvious and the payoff would not be quick.

February 17, 2009 | Permalink | Comments (0) | TrackBack (0)

Monday, February 16, 2009

Medical Marijuana and the California DMV

The LA Times reports on a lawsuit filed by citizens of California prescribed marijuana for medical purposes against their state's Department of Motor Vehicles for targeting them.

When Matt Vaughn was pulled over for speeding on Interstate 5 in Northern California early on a Sunday morning, he had a bag of marijuana on the passenger seat.  The California Highway Patrol officer smelled the weed, searched the car, took the marijuana and pipe and gave Vaughn a sobriety test, which he passed. An angry Vaughn showed the officer his doctor's recommendation to use marijuana for glaucoma. The officer was unimpressed. 

"He said, in Glenn County, they don't recognize those kinds of things," said Vaughn, 55, who has a long ponytail, mustache and beard. "He was not very friendly about it." The 2005 incident cost Vaughn a speeding ticket, his 1 1/4 ounce of pot and his driver's license -- and nine months of fighting the California Department of Motor Vehicles -- before he prevailed.

As a result of that and other encounters involving medical marijuana, an advocacy group has sued the DMV, asking for a written policy that says medical marijuana should be treated the same as prescription drugs. The suit contends that the DMV has a pattern of investigating and suspending the driver's licenses of people who use pot on the recommendation of their doctors.  It happens a disturbing amount," said Joseph D. Elford, chief counsel for Americans for Safe Access, which promotes legalizing marijuana for medicinal purposes and research. .  .  .

The DMV can obtain medical information about someone if an investigation is launched into the person's fitness to drive.  In Vaughn's case, the CHP officer sent the DMV a report about Vaughn, along with a medical journal article saying marijuana was not the choice drug for treating glaucoma.  In another case, Rose Johnson, 53, the plaintiff named in the pending suit, used medical marijuana for back and neck injuries and lost her license after a DMV worker referred her for an investigation.  The worker had noted that Johnson had difficulty moving when she went in to renew her driver's license. Despite her perfect driving record, the DMV cited the Merced woman's marijuana use last year in revoking her license, the suit said.

Elford said the DMV also learns of medical marijuana patients from law enforcement officers who ask drivers if they have used drugs in the 24 hours before a traffic stop. Medical marijuana users usually answer truthfully, thinking they are protected by law, Elford said. He added that he does not advise them to lie because defrauding a police officer is a misdemeanor in California.  State officials said in interviews that it is not their policy to take away licenses from marijuana patients. . . . Although medicinal weed is not automatic grounds for revoking a license, conditions that impair safe driving, including "poor judgment, aggressive behavior, impaired decision making, slowed motor functions, impaired coordination . . . and drowsiness" could result in license removal, he said.

Not even marijuana advocates recommend driving under pot's influence. California has convicted drivers of being under the influence of marijuana when they failed field sobriety tests, Elford said.  Studies on the effects of marijuana on driving have reached varying conclusions. Some found that experienced users are likely to compensate for their deteriorated state by being especially cautious -- but are prone to getting lost -- while others showed significant debilitating effects from THC, the main mind-altering ingredient in marijuana. . . .

February 16, 2009 | Permalink | Comments (0) | TrackBack (0)

Comparing Medical Treatments

The New York Times highlights a provision of the stimulus bill that will provide funding for comparing the effectiveness of different medical treatments for the same health problem. 

Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.

The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments. Supporters of the research hope it will eventually save money by discouraging the use of costly, ineffective treatments.

The soaring cost of health care is widely seen as a problem for the economy. Spending on health care totaled $2.2 trillion, or 16 percent of the nation’s gross domestic product, in 2007, and the Congressional Budget Office estimates that, without any changes in federal law, it will rise to 25 percent of the G.D.P. in 2025. . . .

As Congress translated the idea into legislation, it became a lightning rod for pharmaceutical and medical-device lobbyists, who fear the findings will be used by insurers or the government to deny coverage for more expensive treatments and, thus, to ration care. In addition, Republican lawmakers and conservative commentators complained that the legislation would allow the federal government to intrude in a person’s health care by enforcing clinical guidelines and treatment protocols.

The money will be immediately available to the Health and Human Services Department but can be spent over several years. Some money will be used for systematic reviews of published scientific studies, and some will be used for clinical trials making head-to-head comparisons of different treatments.

For many years, the government has regulated drugs and devices and supported biomedical research, but the goal was usually to establish if a particular treatment was safe and effective, not if it was better than the alternatives.  Consumer groups, labor unions, large employers and pharmacy benefit managers supported the new initiative, saying it would fill gaps in the evidence available to doctors and patients.

“The new research will eventually save money and lives,” said Representative Pete Stark, Democrat of California. The United States spends more than $2 trillion a year on health care, but “we have little information about which treatments work best for which patients,” said Mr. Stark, who is the chairman of the Ways and Means Subcommittee on Health.  In the absence of information on what works, Mr. Stark said, patients are put at risk, and billions of dollars are spent each year on ineffective or unnecessary treatments. . . .

Lawmakers and lobbyists agree that researchers should compare the clinical merits of different treatments. Whether they should also consider cost is hotly debated. Representative Charles Boustany Jr., a Louisiana Republican who is a heart surgeon, said he worried that “federal bureaucrats will misuse this research to ration care, to deny life-saving treatments to seniors and disabled people.” . . .

Congress did not say exactly how the findings should be used. Private insurers can use the data in deciding whether to cover new drugs and medical procedures, but it is unclear how Medicare will use the information. Under existing law, Medicare generally covers any treatment that is “reasonable and necessary for the diagnosis or treatment of illness or injury,” and the agency does not have clear legal authority to take costs into account when deciding whether to cover a particular treatment. . . .

February 16, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 15, 2009

Executive Order on Stem Cells Soon

The Huffingtonpost reports on David Axelrod's recent announcement concerning an executive order on stem cell research.  The article provides,

Expect an executive order soon from President Barack Obama on federal funding for embryonic stem cell research.  That's the word from White House adviser David Axelrod.

Under President George W. Bush, federal money for research on human embryonic stems cells was limited to those stem cell lines that were created before Aug. 9, 2001. No federal dollars could be used on research with cell lines from embryos destroyed from that point forward. . . .  Axelrod tells "Fox News Sunday" that Obama right now is considering an executive order lifting the federal ban on funding.

February 15, 2009 | Permalink | Comments (0) | TrackBack (0)