The Good News is that Health Care Spending is Down

The bad news is that the country’s too broke to be sick. The New York Times reports that health care spending rose just 3.9% in 2010, totaling $2.6 trillion or 17.9% of the Gross Domestic Product. The information was derived from the latest report from the government’s National Health Expenditure Accounts (NHEA), which are, according to the Center for Medicare & Medicaid Services, “the official estimates of total health care spending in the United States. Dating back to 1960, the NHEA measures annual U.S. expenditures for health care goods and services, public health activities, government administration, the net cost of health insurance, and investment related to health care. The data are presented by type of service, sources of funding, and by type of sponsor.”

The Times notes:

Health spending normally grows much faster than the economy. But in 2010 growth rates were similar, so that health care accounted for the same share of total economic output in 2009 and 2010.

“U.S. health spending grew more slowly in 2009 and 2010″ than at any other time in the 51 years the government has been collecting such data, said Anne B. Martin, an economist in the office of the actuary at the Department of Health and Human Services.

How bad is it? The data is, well, record-breaking.

The Times:

In 2010, the study said, hospitals reported a decline in admissions and slower growth in emergency room visits and outpatient visits. Likewise, it said, doctor’s office visits declined, and spending for doctors’ services grew just 1.8 percent, to $416 billion in 2010. Total health spending averaged $8,402 a person, up 3.1 percent from 2009, the report said.

Doctors often prescribe drugs during office visits, and the decline in visits helped slow the growth of drug spending, as did the use of lower-cost generic medications. The number of prescriptions filled rose just 1.2 percent in 2010, and total retail spending on prescription drugs also grew 1.2 percent, to $259 billion, the slowest rate of growth in a half-century, the report said.

Those numbers of slowed growth are even more incredible given the context of a slowed generation of aging baby boomers.

But in the inimitable words of R. Hunter and J. Garcia,

Talk about your plenty, talk about your ills
One man gathers what another man spills

The Times notes:

For the first time in seven years, total private health insurance premiums grew faster than insurers’ spending on health care benefits, the administration said. Premiums totaled $849 billion in 2010, while spending on benefits totaled $746 billion. The difference includes administrative costs and profits.

There are a number of other interesting points to be found in the New York Times article, not the least of which is the growth in federal expenditures. It’s well worth a read.

Vermont and Single Payer, Laboratory for the States?

Law Professor Kevin Outterson, Health Law, Bioethics and Human Rights, at Boston University School of Law (as well as Editor in Chief of the Journal of Law, Medicine & Ethics and Faculty Advisor to the American Journal of Law & Medicine), gives a good account of the implications of Vermont’s recent declaration that it will be instituting  a single payer health care plan (yes, if you haven’t heard, that Single Payer Plan) on WNYC’s Brian Lehrer Show.

Professor Outterson observes that  implementation “will require multiple steps,” but that the formal decision to move forward was “a significant step,” and that “if Vermont is able to control costs better than their neighboring states, than they will be a magnet for employment.” He also notes that adjustments will need to be made by the federal authorities in order for Vermont’s plan to mesh with PPACA, Medicare and Medicaid, and addresses conflicts of interest in medicine, as presently financed and practiced, which add to the costs of healthcare.

The Single Payer segment starts at 3:48

Veterans and Mental Health Care, The Court Speaks

As Memorial Day comes to a close and we ready ourselves for a return to work and all that brings, let’s take a moment, after this single day dedicated to the ultimate sacrifices made by American military men and women, to consider our part of the bargain.

These are the opening paragraphs from an Associated Press article which ran two weeks ago:

Noting that an average of 18 veterans a day commit suicide, a federal appeals court on Tuesday ordered the Department of Veterans Affairs to dramatically overhaul its mental health care system.

In the strongly worded ruling, the 9th U.S. Circuit Court of Appeals said it takes the department an average of four years to fully provide the mental health benefits owed veterans.

The court also said it often takes weeks for a suicidal vet to get a first appointment.

The “unchecked incompetence” in handling the flood of post-traumatic stress disorder and other mental health claims is unconstitutional, the court said.

And, one might add, unconscionable. The AP notes that

The court said a 2007 report by the Office of the Inspector General found significant delays in timely referrals from VA doctors for treatment of PTSD and depression. Fewer than half of the patients received same-day mental evaluations while others had to wait as long as two months for a counseling session.

But wait, there’s more.  A questioning attempt at cover up in an email from a high ranking VA official–which begins with an imperative for quiet: The AP notes:

“Shhh!” began a Feb. 13, 2008, e-mail from Dr. Ira Katz, a VA deputy chief. “Our suicide prevention coordinators are identifying about 1,000 suicide attempts per month among the veterans we see in our medical facilities. Is this something we should (carefully) address ourselves in some sort of release before someone stumbles on it?”

Katz wrote in another e-mail that 18 veterans kill themselves daily on average.

And then, an attempt to have VA counselors purposefully misdiagnose. AP reports

After the trial another e-mail surfaced that was written by VA psychologist Norma Perez suggesting that counselors in Texas make a point to diagnose fewer post-traumatic stress disorder cases. The veterans’ lawyers argued that e-mail showed the VA’s unwillingness to properly treat mental health issues.

Judge Stephen Reinhardt wrote for the court:

“No more veterans should be compelled to agonize or perish while the government fails to perform its obligations. Having chosen to honor and provide for our veterans by guaranteeing them the mental health care and other critical benefits to which they are entitled, the government may not deprive them of that support through unchallengeable and interminable delays.”

On Memorial Day we rightly honor our dead. But let’s not forget the sacrifices of the living– or our part of the bargain.

A Biography of Cancer and Other Interesting Interviews

As I’m sure the great majority of our readers don’t get the regular joy of hearing Leonard Lopate at NPR’s WNYC, I thought I’d offer up these recent archive interviews for your pleasure and/or edification. Lopate’s interviews are generally extraordinary– and these are no different, except perhaps even better than the norm.

This is how they describe the show– recent favorite interviews– on the WNYC website:

Oncologist Siddhartha Mukherjee discusses his deeply personal biography of what he calls “the emperor of all maladies:” cancer. Yvonne Thornton talks about her long road to become the first African American woman board certified in the obstetrical sub-specialty of maternal-fetal medicine. Douglas Starr tells the true crime story that led to the birth of forensic medicine. And Anand Giridharadas gives us an intimate portrait of India’s remaking.

Enjoy.

“The King Has No Clothes!” and Other Useful Truths in the Health Care Setting

Two recent  articles in the Wall Street Journal’s Health Blog are well worth considering. The one article discusses the efficacy of the “aviation model” for medical practice safety. Noting that the surgical checklist is itself cockpit inspired, the article considers a report which questions whether other aviation safety models might be also effective in a health care setting. WSJ writes:

A paper published recently in the Milbank Quarterly, a peer-reviewed population-health and health-policy journal, suggests extracting even more lessons from the aviation world, offering 15 examples of error-reduction policies that aren’t always routinely used in the health-care setting.

The surgical checklist has proved effective. In a post entitled Surgical Checklist Said to Save Lives & Money, we noted the following:

The use of a basic checklist was shown to be associated with a substantial decrease in surgical deaths and complications. In what the A.P. referred to as a “a large international study of how to avoid blatant operating room mistakes,” researchers found a 47 per cent decrease in death and a more than one third decrease in complications-from 11% to 7%- concomitant with the use of a 19 point checklist designed by the World Health Organization.

A few aviation examples the WSJ noted in the article mentioned above involve communication and they, I believe, are worth considering for a moment:

The “sterile cockpit” rule. During certain critical phases of flight, pilots and crew aren’t supposed to chat idly or do anything else not essential to their jobs. Similarly, nonessential activities might be prohibited during certain phases of medical practice, which would depend on the practice (incision during surgery, for example.)

First-names only rule. Regardless of rank or seniority, cockpit personnel address each other by their first names in order to “flatten the social hierarchy” and “foster a culture in which colleagues feel more comfortable questioning one another,” the authors write. Doing the same for surgical or medical teams might promote a similar culture, though the issue is made “complex” by the fact that patients prefer “formality” in their relationships with their doctors.

These examples, much like the surgical checklist, stand out for being common sensical and one would imagine, relatively easy to implement.

Anyone involved in a moderately complex task should be able to relate to the benefit of a “no chatter zone” during the portions of the task which require greater concentration or present greater risk or more dire ramifications. Much of what I do on any given day, because I do it so often, is largely rote. But some moments are crucial; it helps to then not be listening to a co-worker recount the latest misadventure involving cute children, a puppy and some potato salad.

The First-names only rule is perhaps a bit more attenuated, but perhaps even more important. People make mistakes; it is crucial that one has colleagues or friends willing to point them out. The failure to be informed of one’s own errors can have critical impact. History and literature are filled with examples. Think of King Lear and his Fool–someone at court able to tell the King the truth– lest the ruler find himself, like that other famously fabled King, parading through town without clothes. A more modern, and real, example is President Kennedy, his Cabinet and the Bay of Pigs fiasco–a room full of men who thought better but engaged in “groupthink” to the point that they ultimately functioned as rubber stamp sycophants to the President– keeping their misgivings to themselves. After the disaster which was the Bay of Pigs, Kennedy removed himself from Cabinet meetings to allow his counsel to do just that. And for the boxing afficianado (boxing is not sport so much as life distilled– Classical Tragedy, with only the how and when to be resolved) it is an oft repeated tale in which after years of hard and driven work with a dedicated trainer a new Champion with new money is found by new friends–or “hangers-on” as they are most often called in the trade. These omnipresent “friends” with no visible means of support beyond the boxer tend to say things like “You’re right Champ” and  ”You’re the Champion Of The Entire World! You don’t have to train if you don’t want to.” The results are often brutal in their reckoning. Ask Mike Tyson.

But in a more recent article, “Report: Communication Breakdowns Lead to Hospital Errors,” the Wall Street Journal gives us other cause for concern–more concrete, more direct to the topic at hand. The Journal writes:

According to a two-pronged survey of operating-room and critical-care nurses conducted by their professional associations and VitalSmarts, a global training and consulting firm, 85% of 2,383 nurses surveyed said they’d been in a situation where measures put in place to reduce errors -  including checklists or hand-off protocols - warned them of a problem that would have otherwise harmed a patient.

That’s the good news. The bad is that 58% of the nurses said they’d been in situations where it was “either unsafe to speak up or they were unable to get others to listen.”

The report focuses on what causes this type of communication breakdown, including three concerns that are rarely discussed by health-care teams: dangerous shortcuts, incompetence and disrespect. Among respondents to a separate survey of 4,235 nurses, 84% reported working with people who take potentially dangerous shortcuts, such as not washing hands for long enough, with 34% saying shortcuts had led to near misses and 26% saying they caused harm to patients. Some 19% say incompetence or lack of required skills have harmed patients and 20% say that disrespect is making them seriously consider leaving their profession.

Despite all this, concerns “are often left undiscussed,” the report says.

This Film is Rated “R” for… Smoking?

Earlier this month, the Wall Street Journal Health Blog reported on several anti-smoking groups waging a campaign against Rango, a Paramount Pictures animation about animal characters in a Wild West town.  In one scene, a character swallows a cigar and burps fire into the face of another character.  Seemingly harmless fun in the world of animation, right?  Well, not everyone thinks so… and the burping fire and possible physical scarring isn’t the issue here.

Smoke Free Movies, the American Legacy Foundation, the Campaign for Tobacco-Free Kids, and the American Academy for Pediatrics have rallied against the portrayal of smoking in Rango and other films marketed to children.  (SceneSmoking provides a tally of the number of “smoking incidents” - over 50 - in Rango.)  The groups maintain that exposing children to smoking on the silver screen leads to smoking in real life; thus, such films should have an R-rating.  Rango is rated PG “for rude humor, language, action, and smoking.”

In response to the release of Rango, Cheryl Healton, CEO of the American Legacy Foundation, stated that

[t]he public health community has made great progress in making every studio aware of the harm to America’s youth when they release films with smoking and animated films are no exception….  Even the cartoon Joe Camel has long been barred from reaching children to sell cigarettes. So it is a mystery why Hollywood’s masters of storytelling and visual effects have not found a better way to depict their characters without the danger of influencing young people to light up.

Similarly, Smoke Free Movies took out a one-page advert in Variety and The Hollywood Reporter criticizing Paramount Pictures and the film industry for the depiction of tobacco use in Oscar-nominated films and citing National Cancer Institute research connecting silver screen exposure to an increased likelihood of real-life smoking.  Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California-San Francisco (and head of Smoke Free Movies), said “[a] lot of kids are going to start smoking because of this movie.”  On the other side, Virginia Lam, a Paramount Pictures spokeswoman, replied that “[t]he images of smoking in the film, which primarily involves the animals, are portrayed by supporting characters and are not intended to be celebrated or emulated. Rango [the title character] is never depicted as smoking.”

So are these anti-smoking groups overreacting or must the Motion Picture Association of America (MPAA) reevaluate its ratings system?  In August 2010, the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report printed some research that found “[e]xposure to onscreen smoking in movies increases the probability that youths will start smoking.  Youths who are heavily exposed to onscreen smoking are approximately two to three times more likely to begin smoking than youths who are lightly exposed.”  (Note Prof. Glantz contributed to that report.)  USAToday has reported that “[o]f more than 2,500 movies rated from May 2007 to May 2010, nearly three-fourths of those that depicted smoking were rated R, and instances of smoking in films not rated R have declined” though this is not enough for the anti-smoking groups.

So what is the difference between a PG-rated film and an R-rated film?  According to the MPAA, a PG-rated film requires

investigat[ion] by parents before they let their younger children attend.  The PG rating indicates… that parents may consider some material unsuitable for their children, and parents should make that decision.  The more mature themes in some PG-rated motion pictures may call for parental guidance.  There may be some profanity and some depictions of violence or brief nudity.  But these elements are not deemed so intense as to require that parents be strongly cautioned beyond the suggestion of parental guidance.  There is no drug use content in a PG-rated motion picture.

(Emphasis added.)  On the other hand, an R-rated film will

contain some adult material.  An R-rated motion picture may include adult themes, adult activity, hard language, intense or persistent violence, sexually-oriented nudity, drug abuse or other elements, so that parents are counseled to take this rating very seriously.  Children under 17 are not allowed to attend R-rated motion pictures unaccompanied by a parent or adult guardian. Parents are strongly urged to find out more about R-rated motion pictures in determining their suitability for their children.  Generally, it is not appropriate for parents to bring their young children with them to R-rated motion pictures.

(Emphasis added.)  Elizabeth Kaltman, a spokeswoman for the MPAA, told TheWrap that

underage smoking has always factored into movie ratings, but as of May 2007, all smoking is included as a ratings factor, along with language, nudity and other adult content. Kaltman adds that movies depicting smoking in a fantastical rather than realistic manner are more likely to receive slack on the ratings front.

As for Smoke Free Movies’ suggestion that smoking and the PG rating don’t mix? Kaltman notes that the purpose of the ratings system is to provide parents with information, not to service activists.

People younger than 18 years can’t buy cigarettes.  Tobacco companies should not target children and teenagers.  Should the same rules apply to tobacco use in films?  How much responsibility should be imposed on the MPAA (whose rating system has been called into question by This Film Is Not Yet Rated and others) and how much responsibility should rest with parents who can choose not to take their children to a film with smoking in it?  What about re-runs of television shows from the 1950s, 1960s and 1970s which show people smoking?  Should Popeye, Maxwell Smart, and Lieutenant Columbo lose their pipe, cigarette, and cigar?  As a kid, I saw re-runs of shows with these characters and I didn’t become a smoker.  Should such shows be banned from television all-together so children aren’t exposed to smoking or only aired after 9pm to limit the chance of exposure?  Where and when do we draw the line?

Health Care and You.org, Simply Well Done

There’s a new resource in town– and it’s both informative and refreshingly easy to use. It’s called healthcareandyou.org and it allows a user to click on their state, and find out what the health reform law means to them– personally. By clicking on New Jersey, I got this:

What You Need to Know About Health Care in New Jersey

• In 2011, those in the Medicare Part D “doughnut hole” will automatically receive a 50 percent discount on certain name-brand drugs and a 7 percent discount on generic drugs.
• Young adults up to age 26 can now stay on their parent’s health plan.
• NJ Protect is available for adults who have been uninsured for at least 6 months and have been denied coverage because of a pre-existing condition. Also, children up to age 19 can’t be denied coverage because of pre-existing conditions. (By 2014, insurance companies will not be able to deny coverage to anyone with pre-existing conditions.)
• Some small businesses can get tax credits to help pay for the cost of covering their employees.
• Insurance companies can’t put dollar limits on the care that is covered in your lifetime.

It will also allow further refinement by under/over 65 years old and small business owner– tailoring the pertinent information accordingly. Beyond that, the glossary is a major league help.There’s also an implementation timeline.

In case you were wondering, the site is the result of a partnership among AARP, American Academy of Family Physicians, American Cancer Society, American College of Physicians, The American Medical Association (AMA), American Nurses Association, Catholic Health Association of the United States, and the National Community Pharmacists Association.

In addition to the link in this post, the site will be listed on this blog going forward in Resources. It simply is.

Senate Votes Against Repeal: Out of the Woods but for How Long?

Last Wednesday, the Senate voted 47-51 against the “Repealing the Job-Killing Health Care Law Act.”  50  Democrats and one Independent voted against the Act while all 47 Republicans voted in favor of it (click here to view results).  No surprises there… but where do we go from here?

The Washington Post and the New York Times report that pro-repeal Senators and activists remain energetic and optimistic.  Senator John Cornyn (R-Texas) observes “[t]hese are the first steps in a long road that will culminate in 2012.”  Marilyn Shachter, a tea party activist, predicts a repeal “definitely will happen. It may take until 2012, or after 2012, when we get rid of Mr. Obama and a lot of these borderline senators that are up for reelection are replaced.”  Keith Hennessey, former Assistant to the President for Economic Policy and Director of the National Economic Council, outlines a two-year “path to repeal” the Patient Protection and Affordable Care Act (PPACA):

• Keep up the pressure in 2011 and 2012:
  • maintain and strengthen Republican unity toward full repeal;
  • repeatedly attack the bill legislatively on all fronts, knowing that most votes will pass the House and fail in the Senate;
  • continue legal pressure through the courts; and
  • tee up repeal as a key partisan difference in the 2012 Presidential and Congressional elections;
• In 2012 win the White House, hold the House majority, and pick up a net 3 Republican Senate seats to retake the majority there; and
• In 2013, use reconciliation to repeal ObamaCare, requiring only a simple majority in the Senate.

ABC News notes that the latest repeal attempt “was just one of three ways the Republicans are trying to kill the health care law.”  The second way involves the constitutional challenges filed in the courts.  The third way involves Senator Lindsey Graham (R-SC) and Senator John Barrasso’s (R-WY) proposed legislation allowing states to opt out of certain PPACA provisions, such as the individual mandate.

I would add a fourth way: good ol’ public relations (see my previous post on renaming/rebranding PPACA).  For instance, last Thursday Alaska Governor Sean Parnell announced that he had asked the state attorney general whether implementing and enforcing PPACA would violate his oath of office.  The Governor described himself as being “caught between a federal government that says, ‘You must pursue this, you must pursue this,’ and I have the duty to uphold the rule of law.”  There’s some solid, dramatic PR right there.

Be that as it may, the Senate has spoken.  The lower courts have spoken.  Senators Graham and Barrasso have spoken.  Governor Parnell has spoken.  Members of this blog have spoken.  Must we wait until Mr. Hennessey’s two year “path to repeal” has been successfully implemented or foiled before the Supreme Court chimes in?

Spinal Fusion Controversy Underscores Extent of Conflicts of Interest

The Wall Street Journal recently published a report that outlines the extensive financial benefits that surgeons are receiving for spinal fusion surgeries. The “bounty” — a term used by the WSJ — comes from Medicare reimbursement as well as royalties for the intellectual property contributed by the surgeons to the spinal fusion procedures. Presumably the surgeons also receive money from speaking and training fees.

In short, spinal fusion is a surgical procedure whereby two or more vertebrae are fused together. The fusion is accomplished by creating a bridge between the vertebrae that is usually constructed out of bone taken from other parts of the body. The bone is inserted between the vertebrae, and is secured by rods, screws, and plates. This reduces the movement of each vertebrae that is connected to the bridge, thereby relieving stress on the injured vertebrae, disks, and nerves. Spinal fusion may be a necessary treatment in the face of trauma or debilitating diseases affecting the spine, such as scoliosis. However, the application of spinal fusion to treat certain types of back pain has been questioned.

In light of the dearth of comparative effectiveness research regarding nearly all surgical procedures, why then is spinal fusion so controversial? There appear to be two factors: the high price of the surgery, and  the strong ties between the surgeons performing the spinal fusions and the medical device manufacturers that produce the hardware used in the procedure.

In particular, the royalty payments are staggering. In the first three quarters of 2010, the WSJ reports that each of five spinal surgeons at Norton Hospital in Louisville Kentucky received more than $1.3 million from Medtronic — the leading manufacturer of spinal fusion devices. Norton Hospital — and its surgeons — are certainly not alone in profiting from the procedures.

Though the device manufacturers like Medtronic pay out large sums to physicians that develop, utilize, and promote spinal fusion treatments, the manufacturers clearly come out ahead after taking into account the price they charge hospitals for the spinal fusion devices. Not surprisingly, this money often comes from Medicare reimbursement.  According to the WSJ’s analysis of Medicare claims, spinal fusion went from costing Medicare $343 million in 1997 to $2.24 billion in 2008.  And as the Journal points out, the screws used in spinal fusion implants can cost between $1,000 to $2,000 a piece for reimbursement but actually turn out to cost less than $100 to make. Spinal surgeon Charles Rosen is quoted as stating that “You can easily put in $30,000 worth of hardware in a person during a fusion surgery.” A Los Angeles Times report in 2010 found that complex spinal fusion surgeries can end up costing $80,888 in hospital charges as compared to $23,724 for spinal decompression surgery — the latter referring to a group of procedures that can relieve painful pressure on the spine, but without the extensive implantation required by spinal fusion.

Nevertheless, it is true that there there are many expensive surgical procedures wherein the value to the patient justifies the high price. But it is more than the wise allocation of resources that is at issue. In the Journal of the American Medical Association’s April 2010 issue, Dr. Eugene Carragee M.D., professor of spinal disease and orthopaedic surgery at Stanford University School of Medicine summarized the clinical difficulties facing complex spinal fusion surgery, especially in older individuals:

…the complex reconstruction of spinal deformity in older patients remains a difficult and dangerous enterprise. Complication rates have declined but remain concerning (30%-40%) and the reoperation rates, in a population for whom there is a high risk of both medical and anesthetic complications with additional surgery, remains at 10% to 20% in the most optimistic reports. Moreover, despite these major interventions, this approach is still not effective in 30% to 40% of patients.

When asked about the need for spinal fusion surgeries, Dr. Steven Glassman — one of the Norton Hospital surgeons that has received millions to implant spinal fusion devices — stated that he and his colleagues were “leaders among spine surgeons nationally in comparative effectiveness research.” This is a troubling statement, precisely because of the significant royalty agreements between Dr. Glassman and Medtronic that are described in the WSJ report. Dr. Glassman is therefore incentivized — at least economically speaking — to interpret research findings in such a way that maximizes the contexts in which spinal fusion surgery can be recommended.

To combat these conflict of interest claims, Medtronic claims that it refrains from paying out royalties to the collaborating surgeons on the devices they personally use in their patients. This would appear to reduce the incentive for Dr. Glassman to personally churn out spinal fusion operations in the hope that he will get royalties for those instances where he implants hardware in which he holds a royalty agreement with Medtronic. This certainly helps to combat violations of the Federal Anti-Kickback Statute, which prohibits Medtronic from inducing surgeons to purchase their devices. But this policy does little to curb the general conflicts of interest of the general spinal surgery community when determining whether to recommend complex spinal fusion surgery. Even if a contributing surgeon does not receive royalty payments for the specific surgeries where his manual contributions are utilized, they still have an incentive to keep Medtronic “happy” by increasing demand for the spinal fusion hardware. And certainly one can envision a scenario in which a surgeon so situated might suggest such a surgery but then refer the procedure itself to a colleague, thereby allowing the royalty payments to flow unencumbered by the guise of propriety.  What does appear certain is that demand for complex spinal fusion operations has increased. Citing a study by Deyo and colleagues in the same JAMA issue, Dr. Carragee points out that:

…the rate of spinal stenosis surgery in the Medicare population has remained more or less stable, but the rate of complex surgery for this disease has increased from negligible levels in 2002 to nearly 15% of all spinal stenosis surgeries in 2007. These more complex surgeries are also reported to be independently associated with increased perioperative mortality, major complications, rehospitalization, and cost.

The findings do not provide explanations for the increase in complex surgery that has occurred during the past 6 years. Ideally, because the complex surgical techniques are used to treat complex deformities, the data should show that patients undergoing these procedures usually have these complex deformities. The diagnoses reported, however, do not support this “ideal” explanation; 50% of these new complex fusion operations were performed in patients with spinal stenosis alone and no deformity. Spinal stenosis with scoliosis by coding, accounted for only 6% of the complex fusions performed.

In other words, there has been an increase in the rate of a complex surgical procedures prone to severe complications, but with no concomitant increase in the rate of the severe conditions that would ostensibly warrant such surgery. Regardless, this demand pays dividends in the royalty agreements that the surgeons receive when the U.S. spinal surgery community implant the hardware that the contributing surgeons developed– and dividends to the manufacturer.

Currently, there appears to be little, if any, countervailing force that militates against the doctors recommending this complex and expensive procedure. By conducting the complex fusion operation, the surgeon and the hospital both make money through the handsome reimbursement from Medicare and private insurance, while Medtronic is handsomely paid by selling more devices. Those hurt, financially speaking, are the taxpayers in terms of Medicare, and those insureds in private plans whose premiums have risen because of the increased costs of this procedure. Private insurance plans are unable to combat this, as any limit on spinal fusion surgery will be framed as corporate greed coming at the expense of treatment. This is precisely what has occurred after Blue Cross and Blue Shield of North Carolina announced that it would place tighter restrictions on spinal fusion surgery. In response to the restrictions, Dr. John Wilson, a neurosurgeon at Wake Forest University Baptist Medical Center and president of the North Carolina Neurological Society stated that “If this intrusion into the physician-patient relationship goes unchallenged, other insurers will follow suit…It will be a progression of ever-more restrictive policies that will handcuff us as we try to treat patients.” Dr. Wilson was one of nine physicians to write a letter to Blue Cross urging the insurer to alter the new rules. Interestingly, the letter repeatedly supports its position by citing the studies of Dr. Daniel Resnick, a spine surgeon who is listed by the Congress of Neurological Surgeons as receiving grant money from Medtronic.

Interviews with Virginia Attorney General and White House Health Reform Director

In case you missed it: courtesy of PBS, a minute and 45 seconds of recap and then interviews with White House health reform director Nancy-Ann DeParle and Virginia Attorney General Ken Cuccinelli on the constitutionality (or lack thereof) of the individual mandate. Attorney General Cuccinelli brought the suit against the mandate that won in Virginia federal court last week. (It takes a moment or two to buffer).

Medicare, Hospitals, Serious Harm and Death

The Inspector General of the Department of Health and Human Services, Daniel R. Levinson, published an Op-ed in USA Today that is well worth considering.  The column, entitled “Medical mistakes plague Medicare patients,” speaks volumes. Levinson writes:

Today’s hospitals are modern-day marvels of healing, and we expect them to be models of patient safety as well. But a just-released report from my office shows that medical care is falling short for too many hospitalized Medicare patients. A decade after an Institute of Medicine study placed preventable medical errors among the leading causes of death in the United States, our latest study found that a disturbing number of hospitalized patients still endure harmful consequences from medical care, 44% of them preventable. These instances, which the report calls “adverse events,” include infections, surgical complications and medication errors

Such occurrences are not always preventable, particularly since many Medicare patients are elderly and have complicated health problems. But enough patient harm is avoidable to make a strong case for action. Hospitals must improve, but they need the help of lawmakers, medical professionals and patients to do so.

We’ve written about this issue before here on HRW (in the context of various calls for medical malpractice reform as part of health care reform and studies that show hospital staff neither washing their hands regularly nor utilizing the simple but effective surgical checklist). The Institute of Medicine study Inspector General Levinson referred to estimated 98,000 deaths per year. Last year I wrote:

Bloomberg reports that “The U.S. Institute of Medicine found a decade ago that medical errors kill 98,000 Americans a year” according to Les Weisbrod, president of the Washington-based trial lawyers’ group, the American Association of Justice.

According to Medical News Today, the medical error fatality figures above were supported by “Dr. Chunliu Zhan and Dr. Marlene R. Miller in a research study published in the Journal of the American Medical Association (JAMA) in October of 2003. The Zhan and Miller study supported the Institute of Medicine’s (IOM) 1999 report conclusion, which found that medical errors caused up to 98,000 deaths annually and should be considered a national epidemic.

A study by HealthGrades found more than twice that number in “potentially preventable deaths.”

And now this study. Look at the numbers; they aren’t pretty–and they cast some present doubt on the 98,000 number if one considers the rubric, “contributed to their deaths.” Levinson writes:

Errors prolonged hospital stays

This study began in response to a congressional mandate to determine the number of harmful medical events Medicare patients experienced, and the cost to taxpayers. My office arranged for physician reviewers to examine a random sample of 780 Medicare patients discharged from hospitals around the country during the month of October 2008.

Physicians determined that about one in seven patients (13.5%) experienced at least one serious instance of harm from medical care that prolonged their hospital stay, caused permanent harm, required life-sustaining intervention, or contributed to their deaths. Projected to the entire Medicare population, this rate means an estimated 134,000 hospitalized Medicare beneficiaries experienced harm from medical care in one month, with the event contributing to death for 1.5%, or approximately 15,000 patients.

That’s per month. Some quick math will give us the yearly death figure: 15,000 x 12 months = 180,000 per year. And that’s just Medicare patients.

The “seriously harmed” equals 1,608,000 per year. Again, just Medicare.

Levinson continues:

Strikingly, medication errors factored in more than half the patient fatalities in our sample, including use of the wrong drug, giving the wrong dosage, or inadequately treating known side effects. Such events were commonly caused by hospital staff diagnosing patients incorrectly or failing to closely monitor their conditions.

Less serious harm also occurred. An additional one in seven hospitalized Medicare patients experienced temporary problems, such as allergic reactions or injuries from falls. And many experienced multiple events, including an elderly heart patient who had six separate events during a single hospital stay. Obviously, this situation is unacceptable — and expensive, costing taxpayers more than $4 billion a year due to the need for additional treatment or longer hospitalizations (and even more if you add costs for follow-up care).

I’ve said it before and I’ll say it again. “Seemingly, one would define “defensive medicine” as that which a doctor [or hospital] does, which he or she would not do, if solely exercising his or her [or its] discretion without the fear of being sued. Therefore, might I suggest that “defensive medicine” is only excessive if the doctor’s [or hospital's] best estimation of the situation is correct.”

You can read the rest of Inspector General Levinson’s Op-ed here. He offers some direction– much needed direction.

Two Courts Interpret Regulations to Expand Medicare Coverage

As first reported by the New York Times, two Federal District Courts have rendered decisions within the past six weeks that expand Medicare coverage for skilled nursing care (”SNC”).  According to the rulings, Medicare beneficiaries are entitled to such coverage without, as the government contends, proof that their condition will improve as a result of treatment.

In both cases, Medicare beneficiaries appealed final decisions of the Secretary of the Department of Health and Human Services (”Secretary”) denying Medicare coverage under, individually, Part A and Part C (a Medicare Advantage plan) of the Medicare Program.  Since Medicare Part A and Medicare Advantage plans are required to cover the same medical services under 42 C.F.R. § 422.101, the courts’ frameworks of analysis should be the same.  However, each court relied on various administrative provisions to support of the principle that Medicare beneficiaries are entitled to SNC to maintain stable health and prevent deterioration of capabilities.

Papciak v. Sebelius, 2010 U.S. Dist. LEXIS 102801

In Papciak, the eighty-one-year-old Plaintiff received seventeen days of inpatient SNC shortly after hip replacement surgery.  Medicare denied coverage for the last ten days of care, on the ground that she “had been determined to have met her maximum potential” after the first seven days, and therefore, only qualified for “custodial care” for the rest of her inpatient stay.

The US District Court for the Western District of Pennsylvania agreed with the plaintiff that the administrative decisions had failed to consider whether the plaintiff needed SNC to maintain her level of functioning.  The Medicare Skilled Nursing Facility Manual Chapter 2 §214.3 states that skilled nursing care “must be provided with the expectation that… [1] the condition of the patient will improve materially in a reasonable and generally predictable period of time, or [2] the services must be necessary for the establishment of a safe and effective maintenance program.”  Furthermore,

The Secretary’s regulations state that “[t]he restoration potential of a patient is not the deciding factor in determining whether skilled services are needed. Even if full recovery or medical improvement is not possible, a patient may need skilled services to prevent further deterioration or preserve current capabilities.” 42 C.F.R § 409.32(c) (emphasis added).

In light of the foregoing, the Court reversed the Secretary’s decision.  Because the Secretary had failed to consider the alternative reason for rehabilitative SNC, the decision could not be affirmed as a matter of law.

Anderson v. Sebelius, 2010 U.S. Dist. LEXIS 113550

In Anderson, the sixty-year-old Plaintiff required 24-hour supervision to remain safe in her home after a second stroke rendered her incontinent, cognitively impaired, and immobile.  Her physician certified six times that Anderson needed SNC for a 60-day period; however, she was denied coverage after the first of six physician-certified periods.  The US District Court for the District of Vermont held that the ALJ had incorrectly concluded that SNC is “not covered when a patient’s condition is stable and unlikely to change.”

To the contrary, “a patient’s chronic or stable condition does not provide a basis for automatically denying coverage for skilled services.”  The court cited the Medicare Benefit Policy Manual, which states:

The determination of whether a patient needs skilled nursing care should be based solely upon the patient’s unique condition and individual needs, without regard to whether the illness or injury is acute, chronic, terminal, or expected to extend over a long period of time. In addition, skilled care may, depending on the unique condition of the patient, continue to be necessary for patients whose condition is stable. § 40.1.1 (emphasis added).

Furthermore, a physician’s decision as to whether SNC was reasonable and necessary is to “be viewed from the perspective of the condition of the patient when the services were ordered and what was, at that time, reasonably expected to be appropriate treatment for the illness or injury throughout the certification period.”  § 40.1.2.1.  The Court held that the ALJ’s hindsight determination that the patient remained stable and did not improve during the certification period was inappropriate.  “The fact that skilled care has stabilized a claimant’s health does not render that level of care unnecessary. An elderly claimant need not risk a deterioration of her fragile health to validate the continuing requirement for skilled care.” (quoting Folland ex rel. Smith v. Sullivan).

Looking Ahead…

These rulings will likely benefit those with chronic conditions and disabilities.  Representative Joe Courtney, Democrat of Connecticut, led a group of seventeen House Democrats in objecting to the administration’s interpretation of the law.  According to their letter:

Beneficiaries are frequently told that Medicare will not cover skilled services if their underlying condition will not improve. For example, as people with multiple sclerosis are often not likely to improve, skilled services such as physical, occupational and speech therapies that are necessary to slow the progression of the disease, or maintain current function, are denied. As a result, these individuals’ conditions deteriorate — frequently leading to more intense, more expensive services, hospital or nursing home care.

The government has not announced whether it will challenge the decision.

The Ethics of Modern Drugs and Clinical Trials

A recent article in the New York Times raised an interesting question: are traditional, randomized, controlled trials of new genetically targeted cancer drugs unethical?

The piece recounts the story of two cousins, both diagnosed with melanoma.  After enrolling in the last phase of clinical study, the computer lottery selected one cousin to receive PLX4032, experimental “superpills.” The second cousin, now deceased, was relegated to a “notoriously ineffective” course of chemotherapy.

Randomized, controlled trials have become the gold standard in clinical research, comparing competing treatments to determine which extends life most.  The structure of the trial, with an experimental group and control group, is premised on the idea that the comparative effectiveness of the experimental treatment is unknown.  Therefore, one half of the participants in the clinical trial receive a believed to be less effective therapy for a greater good: researchers come to know definitively which treatment is more effective and future patients benefit from that knowledge.

Critics point out that these new drugs are so much more effective than prior treatments that time-consuming clinical trials are futile: the Phase III trial for PLX4032 would cost $100 million and take at least two years before possibly receiving F.D.A. approval.  That is a huge cost, in terms of lives and money, to “prove” what has already been demonstrated in early clinical testing.  Physicians are forced to forego an opportunity “to give patients symptomatic relief, even if the drug turned out not to prolong life.”

Dr. Paul B. Chapman of Sloan-Kettering, a medical oncologist at Memorial Sloan-Kettering Cancer Center and leader of the trial states in the article:

My goal is to find out as quickly as possible in as few patients as possible whether this works.  If we never know, then we’re never going to be able to build on anything.

Making patients’ tumors go away is gratifying.  But that’s not the businss I’m in.  I’m in the business of making people live longer.  That’s what I want to do.

In contrast, Dr. David E. Fisher, a leading melanoma biologist at Massachusetts General  said of the controlled trial:

My personal view is it’s nuts.  I don’t know anyone who hasn’t shuddered at the concept that we can’t let patients on the control arm cross over because we need them to die earlier to prove a point.

The trend towards more targeted and effective drugs changes the framework for evaluating the ethics of clinical trials.  Promising new treatments however, have sometimes been proven to be less effective.  Therefore, the question remains for medical researchers and the F.D.A.: when will early clinical results be so persuasive that a traditional, controlled trial is unnecessary?

Health Care and Disparity in a “Post-Racial” Era

Seton Hall Law School recently hosted the Third National People of Color Conference, which was convened to “address critical national and global issues through the lens of legal scholarship that explicitly and implicitly examines contemporary racial context.”

The conference brought together over 400 judges, law professors, lawyers and students to our campus over the course of  four days and featured panels and speeches by people such as the Reverend Jesse Jackson; the Honorable Cory Booker, Mayor of Newark, New Jersey; Professor Derek Bell, Visiting Professor at New York University School of Law; Kathleen Martinez, Assistant Secretary of Labor for Disability Employment; The Honorable Joseph A. Greenaway, U.S. Court of Appeals, Third Circuit; Gay McDougall, United Nations Independent Expert on Minority Issues; Keith Harper, former Appellate Justice of the Mashantucket Pequot Tribal Nation; and just too many other smart and interesting people to list here. (A good account of the Conference in Diverse Magazine can be found here).

Involved in some of the on site prep work, I was unable to attend nearly as much as I would have liked. But I did have the opportunity to listen to a number of thought provoking presentations, including speeches by Jesse Jackson, Mayor Booker, Keith Harper and Katleen Martinez.

In considering the theme of the conference, “Our Country, Our World in a ‘Post-Racial’ Era,” it was made clear time and time again that despite the rhetoric that has bounced about our nation since President Obama took office, when looking at numerical indicators for well being in the United States racial identity, ethnicity, gender, sexual identity, and disability status matter.

I realize that I am saying nothing new here–nor am I saying it as well as I heard it. But I think it also bears repeating.

It is also worth noting, when looking at the disparity in health care access, utilization, and quality of received care, that here in New Jersey as a response to a budget crisis, the state recently summarily stripped over 12,000 legal immigrants of their right to health care through Medicaid. Our Center for Social Justice here at Seton Hall Law has sued the State of New Jersey for doing so as a violation of both the state and federal constitutions as a matter of, among other things, equal protection. Such actions by the state assuredly do not bode well for the health care variance numbers below; and maybe, when considering the disparities in health care, “equal protection,” in the largest sense of the word, is the appropriate lens through which to view this.

But it is also, within the context of anyone’s verbal meanderings about a supposed “post-racial” society, important to note that news of the suit was featured in the Wall Street Journal, Star Ledger, Asbury Park Press, The Record, The Daily Record, The Courier Post, Home News & Tribune, The Jersey Journal, MSNBC, PolitickerNJ, Newsday, Immigration Prof Blog and other media throughout New Jersey, New York, Pennsylvania, and Connecticut.

Reader’s comments were decidedly not kind. Having done a great deal of work with and for immigrant communities, the urban disenfranchised, Guantanamo Detainees, and others unpopular and unjustly treated, we’re used to it here at Seton Hall Law. But I invite anyone entertaining delusions about a “post-racial” era to take a look at the comments. Or, for that matter, the comments on almost any newspaper article that deals with immigration– or race.

Having said that, I also invite you to take a look at the following numbers and study results from HHS’ Agency for Healthcare Research and Quality. Below that, you’ll find a really interesting lecture from a Health Care Disparities Class at Case Western Reserve University from Professor Insoo Hyun. The video is courtesy of the Case Center for Reducing Health Disparities and their well produced blog and resource center.

As for the studies and numbers, though just a small sampling, I’ll let them speak for themselves:

Identifying Disparities in Care

Access to Primary Care

Primary care is the underpinning of the health care system, and research studies have shown that having a usual source of care raises the chance that people receive adequate preventive care and other important health services. Data from AHRQ’s Medical Expenditure Panel Survey (MEPS) reveal that:

• About 30 percent of Hispanic and 20 percent of black Americans lack a usual source of health care compared with less than 16 percent of whites.
• Hispanic children are nearly three times as likely as non-Hispanic white children to have no usual source of health care.
• African Americans and Hispanic Americans are far more likely to rely on hospitals or clinics for their usual source of care than are white Americans (16 and 13 percent, respectively, v. 8 percent).

Diagnosis and Treatment

Race and ethnicity influence a patient’s chance of receiving many specific procedures and treatments. Of nine hospital procedures investigated in one study, five were significantly less common among African American patients than among white patients; three of those five were also less common among Hispanics, and two were less common among Asian Americans. Other AHRQ-supported studies have revealed additional disparities in patient care for various conditions and care settings including:

• Heart disease. African Americans are 13 percent less likely to undergo coronary angioplasty and one-third less likely to undergo bypass surgery than are whites.
• Asthma. Among preschool children hospitalized for asthma, only 7 percent of black and 2 percent of Hispanic children, compared with 21 percent of white children, are prescribed routine medications to prevent future asthma-related hospitalizations.
• Breast cancer. The length of time between an abnormal screening mammogram and the followup diagnostic test to determine whether a woman has breast cancer is more than twice as long in Asian American, black, and Hispanic women as in white women.
• Human immunodeficiency virus (HIV) infection. African Americans with HIV infection are less likely to be on antiretroviral therapy, less likely to receive prophylaxis for Pneumocystis pneumonia, and less likely to be receiving protease inhibitors than other persons with HIV. An HIV infection data coordinating center, now under development, will allow researchers to compare contemporary data on HIV care to examine whether disparities in care among groups are being addressed and to identify any new patterns in treatment that arise.
• Nursing home care. Asian American, Hispanic, and African American residents of nursing homes are all far less likely than white residents to have sensory and communication aids, such as glasses and hearing aids. A new study of nursing home care is developing measures of disparities in this care setting and their relationship to quality of care.

Looking Beyond Income and Insurance

Disparities in health care are often ascribed to differences in income and access to insurance. Research has shown these to be important, but by no means the only factors. For instance, the proportion of Hispanic Americans with a usual source of care has declined substantially over the past decade (from 80 percent in 1986 to 70 percent in 1996). Insurance coverage has also declined, and the lack of insurance in some groups is dramatic (among Hispanic men, for instance, 37 percent have no health insurance). Nonetheless, declines in insurance coverage explained only one-fifth of the change in access to a usual source of care.

In another recent study, AHRQ-funded researchers in Boston examined the quality of care provided to hospital patients with congestive heart failure or pneumonia. Quality of care was measured both by physician review and by adherence to standards of care. The researchers found no difference in quality of care for patients from poor communities compared with other patients, after adjusting for other factors. They did find, however, that African American patients received a lower quality of care than white patients.

Physician Decisionmaking

A small study of physicians’ decisions about whether to refer patients for cardiac catheterization, a diagnostic procedure for heart disease, provides supportive evidence that factors other than insurance and income can influence the quality of care people get. This study, which used actors portraying similar economic backgrounds, found that black women were significantly less likely than white men to be recommended for referral, despite reporting the same symptoms. (Differences between other groups studied were not statistically significant.)

Hospital Characteristics

In the Boston study of the quality of care, quality for African American patients was lower in nonteaching than in teaching hospitals. In another study, white patients were more likely than Hispanic and African American patients to receive invasive cardiac procedures in hospitals performing a high volume of such procedures, a factor strongly associated with the quality of cardiac care.

The Ultimate Ends of Health Care

“I don’t want to achieve immortality through my work,’ Woody Allen said, “I want to achieve it through not dying.” The “Singularity University” is attracting Silicon Valley glitterati who think along the same lines:

[T]he Singularity — a time, possibly just a couple decades from now, when a superior intelligence will dominate and life will take on an altered form that we can’t predict or comprehend in our current, limited state . . . [will lead to a world where] human beings and machines . . . so effortlessly and elegantly merge that poor health, the ravages of old age and even death itself will all be things of the past.

Some of Silicon Valley’s smartest and wealthiest people have embraced the Singularity. They believe that technology may be the only way to solve the world’s ills, while also allowing people to seize control of the evolutionary process. For those who haven’t noticed, the Valley’s most-celebrated company — Google — works daily on building a giant brain that harnesses the thinking power of humans in order to surpass the thinking power of humans.

Ezra Klein skewers the techno-utopianism, toying with the idea that we may well be robotized before we get electronic medical records:

Right now, one of the top stories on the New York Times site is about how human beings are going to become people-computer hybrids and live forever and that vision actually seems semi-plausible until you realize that all the information about the operation to download your memories into a Macintosh will probably be kept in a manila folder in a large filing cabinet, and then it doesn’t seem so likely.

But Klein neglects the trends toward tiering in the medical system, which may well continue forking into “upper decks” where anything is possible and nether realms of penury. As Andrew Orlowski comments, “The Singularity is . . . . rich people building a lifeboat and getting off the ship.” I think that progress in bioethics depends on a rejection of that kind of thinking in favor of a more solidaristic orientation toward the needs of the worst off. As I stated in 2002,

We are all disturbed by hypothetical dystopias like Huxley’s Brave New World. But their most important flaws - the inequality, degradation, and moral irresponsibility of their inhabitants - are already apparent in [some aspects of life in the] world’s wealthiest nations[, which] spend hundreds of millions of dollars on elaborate technologies of life-extension, while contributing much less to efforts to assure basic medical care to the poorest. Public debate on regenerative medicine must acknowledge this inequality. Societies and individuals can invest in it in good conscience only if they are seriously committed to extending extant medicine to all.

If “Singularity University” turns out to be a prime philanthropic initiative of the Google guys, while the Bill and Melinda Gates Foundation sticks to “progress in fighting hunger and poverty,” I know which tech company I’ll be rooting for.

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