HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Thursday, December 29, 2011

The Nirvana Fallacy Among Health Care Cost Cutters

One of my fun little Christmas presents was the Gruber/Newquist/Schreiber comic book guide Health Care Reform: What It Is, Why It's Necessary, How It Works.   It's wonderfully illustrated and has a lot of good information.  It offers a very hopeful vision of what health reform can do.  It patiently explains the politics and policy that led to the ACA, portraying it as a compromise that both "left and right" should be able to support. 

Unfortunately, the authors have chosen to portray virtually anyone who opposes the ACA, on both left and right, as either angry, exasperated, selfish, or unreasonable.  (This animated penguin reminds me of several of the characters in the book.) There are also some questionable implications in various parts of the book.  For example, on p. 21, it's suggested that if employers didn't have to pay so much for health care, they'd just pay that in higher wages to employees.  But in an economy where corporate profits are capturing "88% of the growth in real national income while aggregate wages and salaries accounted for only slightly more than 1% of the growth in real national income," why should we assume that will happen? Workers' share of national income is declining; they have little bargaining power.  We can't extrapolate the economic projections of the "Great Moderation" era to today's Great Recession, where employers are exploiting the desperation caused by high unemployment to hold the line on wages and benefits.

One other objection: check out this graphic (my apologies for the poor camera-work), which suggests the deep problem in the US economy is that we're spending too little on military or homeland security expenditures, and too much on health care:

Continue reading

December 29, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, December 28, 2011

Mental Health Providers Target of Fraud and Other Complaints

By Thomas L. Hafemeister, J.D., Ph.D., Assoc. Prof., University of Virginia School of Law

A recent study published in the New England Journal of Medicine (here) examined the likelihood of being sued for malpractice by medical specialty.  The study, which examined nationwide malpractice data from 1991 through 2005 for physicians covered by a large professional liability insurer, found that out of twenty-five specialties, psychiatrists were the least likely of all physicians to get sued.

However, these and other mental health providers may face legal entanglements on other fronts, such as claims for fraudulent billing of Medicare and Medicaid.  While the number of these suits has dramatically increased in general in recent years (here), this increase may be particularly pronounced with regard to mental health professionals.  In addition, these or other federal complaints may be accompanied by criminal prosecutions of the officials involved or a loss of certification for facilities.  The following are recent related accountings focusing on mental health care.

Terri Langford, $90 Million Medicare Fraud Alleged: Clinic Owners Accused of Trying to Bill for Nonexistent Treatments, Hous. Chron., Dec. 15, 2011, at A1, 3 (here):

The owners of a Houston mental health program were arrested [December 14], charged with trying to bilk Medicare out of $90 million for treatments that amounted to little more than patients “watching movies, playing bingo or engaging in other activities,” federal authorities contend.

Mansour Sanjar, 78, and Cyrus Sajadi, 64, both physician owners of Spectrum Care in West Houston were charged in the alleged phony treatment scheme, which involved kickbacks to the owner of an assisted living facility in exchange for finding and funneling patients to the clinic.

Chandra Nunn, 33, the owner of the home, also was arrested Wednesday. All three are charged with conspiracy to commit health care fraud and conspiracy to pay and receive illegal health care kickbacks. Since 2006, Sanjar and Sajadi had been submitting bills to Medicare for supposed treatment at their “partial hospitalization program,” known as a PHP.

The arrests come just two months after a Houston Chronicle investigation uncovered hundreds of millions in Medicare dollars spent to shepherd mentally fragile Texans by ambulance to mental health clinics and PHPs where patients claimed they watched TV and ate junk food.

According to the indictment, the Spectrum Care owners submitted $90.4 million in claims starting in 2006 even though the PHP services "were not medically necessary, and in some cases, never provided."

Nunn's role was that of a patient broker, or what clinics call, a “marketer.” Sanjar is accused of paying Nunn with a $10,000 check in September 2010 to refer patients their way.

The indictment accused all three defendants of paying Medicare beneficiaries cash and cigarettes if they came to Spectrum.

Tom Brown, Miami Health Executive Gets Stiff Sentence for Fraud, Reuters, Dec. 9, 2011 (here):

A former Miami health care executive was sentenced to 35 years in prison for her role in a $205 million healthcare fraud scheme, authorities said on [December 9].

Judith Negron, the owner of American Therapeutic Corp, a chain of mental health care centers shut down after a raid on its Miami headquarters in October 2010, was convicted in August on charges that she helped mastermind what prosecutors described in court documents as “one of the largest and most brazen healthcare fraud conspiracies” in U.S. history.

Her sentencing in federal court on Thursday by U.S. District Judge James Lawrence King followed the sentencing in September of her co-defendants and co-owners. Lawrence Duran received a 50-year sentence and Marianella Valera received a 35-year sentence.

The prison sentences have been described by prosecutors as the harshest ever for defrauding Medicare, the federal insurance plan for the elderly and disabled.

Prosecutors said American Therapeutic, operating out of the southeastern city widely viewed by law enforcement officials as a central point for healthcare fraud in the United States, billed Medicare for more than $205 million in claims over eight years for mental health services that were either unnecessary or never provided to patients.

In addition to their time behind bars, Negron, Valera and Duran were ordered “jointly” or with other co-defendants to repay more than $87 million in restitution, covering the amount of fraudulent bills that Medicare actually paid out to American Therapeutic over eight years.

Todd Ackerman, Psychiatric Hospital Loses Medicaid/Medicare Contract, Hous. Chron., Dec. 15, 2011 (here):

[A] major inpatient psychiatric hospital[ in Houston, Texas,] has lost its Medicaid/Medicare certification in the wake of inspections that found “an immediate and serious threat to patient health and safety.”

The Centers for Medicare and Medicaid Services [CMS] has notified IntraCare Medical Center, a 148-bed acute-crisis care facility, that it is terminating its contract Dec. 23 because of the threat. The potential closing of the hospital represents a huge blow to the area’s overburdened mental health-care system.

* * *

The IntraCare deficiencies, not corrected over a series of CMS inspections from July to November, mostly involved the improper use of restraints and seclusion, used to secure the safety of patients or staff. They also included a suicide attempt that was not investigated.

* * *

CMS summaries of three inspections at IntraCare Medical Center make frequent references to patients being secluded or restrained, physically and chemically, without doctor's orders. The two practices have become an increasing focus of debate in the psychiatric community.

Jeffrey Anderson, D.C. Clinic Accused of Fraud in Reimbursement Bid: Corners Were Cut, Fired Staffer Says, Wash. Times, Dec. 13, 2011 (here):

A mental health clinic in Southeast Washington stands accused of defrauding Medicaid and the D.C. Department of Health Care Finance (DHCF) by counseling patients without first doing proper diagnostic examinations, cutting corners when it conducts the exams and manipulating requests for reimbursement . . . .

Family Preservation Services (FPS) . . . has pressured employees to engage in such practices to recoup $500,000 in mental health service reimbursements that otherwise would have been denied, according to a former billing specialist, Patrice Lancaster, who recently was fired.

* * *

. . . [T]he written complaint filed by Ms. Lancaster, . . . contains seven additional complaints, including failure to conduct 90-day follow-up visits with mental health patients and continuation of services billed to Medicaid where patients no longer needed services, but [a spokeswoman for the D.C. Department of Mental Health] said they could not be substantiated.

December 28, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, December 21, 2011

Guest Blogger James T. O'Reilly - Fed-Mal: Revenge of Healthcare Policy Wonks

Oreilly06Wonks like us lack the bling of “big time courthouse lawyers.” For those plaintiff’s attorneys whose billboards and phone book cover ads have annoyed us as quietly competent health law gurus, our day of retribution is coming. You slogged through our classes in administrative law, struggled with adjudication processes and burned the midnight oil learning the difference between a regulation and a guidance document. Revenge is sweet.

In my forthcoming text on the new medical malpractice environment, I explain how the administrative law student has a field day under PPACA while the dramatic Perry Masons of the Bar will slump into (relative) silence. As a result of the 2014 inclusion into the health care system of approximately 42 million uninsured persons [this number varies and time will tell the totals], the health care system is likely to face a bolus of postponed and untreated medical conditions as the new entrants appear on the doorstep to be diagnosed, treated, surgically corrected or otherwise healed.

A majority of the 42 million will be “working poor” whose care will come from either “community health centers” or “free clinics,” which now treat about 23 million patients annually. These descriptors are terms of art for lower cost sites at which medical care has been subsidized by charities and/or federal funding. Overcrowding, stress, lower paid staff, records confusion, etc. make these facilities somewhat more challenged to deliver perfect patient outcomes with every patient visit. That’s the right way to predict that medical malpractice claims will rise as the diagnostic and treatment roles of these funded clinics are pushed beyond their current capacity. Mistakes are made everywhere in the healthcare system, of course, but the stage is set for a medical malpractice scenario in the rural, rust belt and inner city clinic environment.

Aha! Plaintiff’s lawyers might salivate … did you say lots more med-mal claims are possible? Too bad, you who skipped administrative law; you have never seen an SF-95 and don’t understand HRSA’s PAL on FTCA roles of HHS-GC. You’ll be DOA!

In briefest terms, the clinics are immune from state tort med-mal claims; specialists in administrative claims will be invaluable to injured victims; Assistant U.S. Attorneys will easily remove and dismiss any state med-mal cases; of the administrative claimants anticipated, a small number will emerge as Federal Tort Claims Act litigants; FTCA cases are tried by the federal magistrate judge with no jury, a cap on attorney fees and a limitation on judicial awards to the specific dollar amount of the filed administrative claim. Money comes not from the doctor or clinic but from a federal fund whose appropriations are fixed in advance; awards late in the summer cannot be paid until the fund’s new fiscal year begins October 1st.

 Stay tuned for later blog entries as I expound on the impact of the PPACA on the glittering hubris of the plaintiff’s jury masters!

- James T. O' Reilly

December 21, 2011 | Permalink | Comments (0) | TrackBack (0)

Monday, December 19, 2011

Essential health benefits

Tim Jost, here, on HHS's "Bulletin" guidance. Politico's take is here. [NPT]

December 19, 2011 | Permalink | Comments (0) | TrackBack (0)

Sunday, December 18, 2011

Five Recent Cuts from the Media: Health & Popular Technological Devices

compiled by Thomas L. Hafemeister, J.D., Ph.D., Assoc. Prof., Univ. of Virginia School of Law

Matt Richtel, As Doctors Use More Devices, Potential for Distraction Grows, N.Y. Times, Dec. 15, 2011, at A1 (here):

Hospitals and doctors’ offices, hoping to curb medical error, have invested heavily to put computers, smartphones and other devices into the hands of medical staff for instant access to patient data, drug information and case studies.

But like many cures, this solution has come with an unintended side effect: doctors and nurses can be focused on the screen and not the patient, even during moments of critical care.  And they are not always doing work; examples include a neurosurgeon making personal calls during an operation, a nurse checking airfares during surgery and a poll showing that half of technicians running bypass machines had admitted texting during a procedure.

This phenomenon has set off an intensifying discussion at hospitals and medical schools about a problem perhaps best described as “distracted doctoring.”  In response, some hospitals have begun limiting the use of devices in critical settings, while schools have started reminding medical students to focus on patients instead of gadgets, even as the students are being given more devices.

* * *

Doctors and medical professionals have always faced interruptions from beepers and phones, and multitasking is simply a fact of life for many medical jobs.  What has changed, doctors say, especially younger ones, is that they face increasing pressure to interact with their devices.

The pressure stems from a mantra of modern medicine that patient care must be “data driven,” and informed by the latest, instantly accessible information.  Annual investment in gadgets and other technology by hospitals and doctors has soared into the billions of dollars.

By many accounts, the technology has helped reduce medical error by, for example, providing instant access to patient data or prescription details.

Dr. Peter W. Carmel, president of the American Medical Association, a physicians group, said technology “offers great potential in health care,” but he added that doctors’ first priority should be with the patient.

* * *

Scott J. Eldredge, a medical malpractice lawyer in Denver, recently represented a patient who was left partly paralyzed after surgery.  The neurosurgeon was distracted during the operation, using a wireless headset to talk on his cellphone, Mr. Eldredge said.

“He was making personal calls,” Mr. Eldredge said, at least 10 of them to family and business associates, according to phone records.  His client’s case was settled before a lawsuit was filed so there are no court records, like the name of the patient, doctor or hospital involved.  Mr. Eldredge, citing the agreement, declined to provide further details.

Others describe multitasking as relatively commonplace.

Matt Richtel, Reframing the Debate Over Using Phones Behind the Wheel, N.Y. Times, Dec. 17, 2011, at A25 (here):

For years, policy makers trying to curb distracted driving have compared the problem to drunken driving.  The analogy seemed fitting, with drivers weaving down roads and rationalizing behavior that they knew could be deadly.

But on Tuesday, in an emotional call for states to ban all phone use by drivers, the head of a federal agency introduced a new comparison: distracted driving is like smoking. 

The shift in language . . . opened a new front in a continuing national conversation about a deadly habit that safety advocates are trying desperately, and with a growing sense of futility, to stop.

[This] new tack also echoes a growing consensus among scientists that using phones and computers can be compulsive, both emotionally and physically, which helps explain why drivers may have trouble turning off their devices even if they want to.  In effect, they are saying that the running joke about BlackBerrys as “CrackBerrys” is more serious than people think.

. . .

In a study conducted last year and released this month by the federal government, about 120,000 drivers were estimated to be sending text messages or physically manipulating phones at any given time during the day, up 50 percent from 2009.

And according to the research, from the National Highway Traffic Safety Administration, 660,000 drivers were holding phones to their ears at any moment last year.

Part of the lure of smartphones, [David Greenfield, a psychologist and assistant professor of psychiatry,] said, is that they randomly dispense valuable information.  People do not know when an urgent or interesting e-mail or text will come in, so they feel compelled to check all the time.

“The unpredictability makes it incredibly irresistible,” Dr. Greenfield said. “It’s the most extinction-resistant form of habit.”

. . .

The lure of multitasking may be, in at least one respect, more powerful for drivers than for other people, said Clifford Nass, a sociology professor at Stanford University who studies electronic distraction.  Drivers are typically isolated and alone, he said, and humans are fundamentally social animals.

The ring of a phone or the ping of a text becomes a promise of human connection, which is “like catnip for humans,” Dr. Nass said.

“When you tap into a totally fundamental, universal human impulse,” he added, “it’s very hard to stop.”

But see Amy Norton, Studies May Have Overestimated Cellphone Crash Risk, Reuters Health, Dec. 13, 2011 (here): 

Increased risk of having a car crash attributed to cellphone use may have been overestimated in some past studies, a new analysis suggests.

So-called “distracted driving” has become a big public health issue in recent years. The majority of U.S. states now ban texting behind the wheel, while a handful prohibit drivers from using handheld cellphones at all (though many more ban “novice” drivers from doing so).

But studies have reached different conclusions about how much of an added crash risk there is with cellphone use.

In the new report, Richard A. Young of Wayne State University School of Medicine in Detroit finds that two influential studies on the subject might have overestimated the risk.

The problem has to do with the studies’ methods, according to Young.  Both studies -- a 1997 study from Canada, and one done in Australia in 2005 -- were “case-crossover” studies.

The researchers recruited people who had been in a crash, and then used their billing records to compare their cellphone use around the time of the crash with their cell use during the same time period the week before (called a “control window”).

But the issue with that, Young writes in the journal Epidemiology, is that people may not have been driving during that entire control window.

Such “part-time” driving, he says, would necessarily cut the odds of having a crash (and possibly reduce people's cell use) during the control window -- and make it seem like cellphone use is a bigger crash risk than it is.

Genevra Pittman, “Virtual Visits” Unpopular Among Cancer Survivors, Reuters Health, Dec. 15, 2011 (here): 

In a new survey of breast cancer survivors, few people said that having a follow-up appointment with a doctor or nurse over the phone or online instead of in person would ease their stress and worry.

* * *

“When patients first hear, ‘Oh, we can do a follow-up from your house, you don’t even have to come in,’ it might seem like they’re not getting as good care,” said Dr. Christine Hill-Kayser, a radiation oncologist at the Hospital of the University of Pennsylvania in Philadelphia, who was not involved in the new study.

Kristina Fiore, Violent Video Games May Alter Brain Function, MedPage Today, Nov. 28, 2011 (here):

CHICAGO -- Men who can’t pry their fingers off the controllers when it comes to shoot-em-up video games may have changes in areas of the brain associated with emotional and cognitive function, researchers said here.

In a small fMRI study, men who took aim at video game characters for about 10 hours during one week had diminished activity in areas of the brain associated with control of aggressive behavior, Vincent Mathews MD, of Indiana University in Indianapolis, reported at the Radiological Society of North America meeting here.

“We found that gamers showed reduced activity in areas of the brain involved in attention, inhibition, and decision making,” Mathews said in an interview with MedPage Today.  “This explains what others have observed in behavioral studies that when people are exposed to violent video games, they may show more aggression.”

Though researchers have long questioned whether violent video games can change brain structure, there’s limited evidence as to whether gaming has any long-term neurological effects.

December 18, 2011 | Permalink | Comments (0) | TrackBack (0)

An Additional Thought On Coercion

Nicole Huberfeld continues her series this month on the Medicaid cases pending before the U. S. Supreme Court over at Concurring Opinions with the following post:

Recently I wrote about the coercion question posed by Florida et al. in the PPACA litigation.  I have a quick follow up thought: I wonder if those advocating a more robust read of coercion recognize that their position could backfire if the goal is broadening federalism protections.  An expanded coercion doctrine ostensibly would introduce the possibility of judicially enforcing states’ rights against the congressional power to spend.  But the states should not assume that they are the only parties that could enforce federalism principles.  Just last term in Bond v. United States, Justice Kennedy wrote that individuals can have standing to enforce the principles of the Tenth Amendment against the federal government because federalism protects not just the states but also individuals.  In Bond, the conclusion was foreseeable, as a criminal defendant should be able to challenge the constitutionality of the statute under which she is charged.  But the idea is muddied in a conditional spending program, wherein individual beneficiaries are often at odds with the state and contest its compliance with the federal government’s statutory conditions. 

States have sought to prevent private enforcement of conditional spending statutes, and they have been more and more successful in closing the courthouse doors.  For example, the Court has limited implied rights of action as well as actions under civil rights law 42 U.S.C. § 1983, decisions that narrow state exposure in federal court.  In fact, this type of question is before the Court now in Douglas v. ILC, which confronts private enforcement of the Medicaid Act against states via the Supremacy Clause.

If the coercion theory is expanded, then private plaintiffs could be reintroduced into the federal courts, the very thing that states have been trying to prevent.  And, individuals engaging in coercion analysis may have different goals than states.  Further, it is possible that coercion could inaugurate a new theory by which those conditions, and the ways in which they are or are not executed by states, can be challenged by private plaintiffs.  So, not only is state coercion by the federal government an inherently sticky question, but it also may not produce results that states desire.


December 18, 2011 | Permalink | Comments (0) | TrackBack (0)

Saturday, December 17, 2011

More Erosion of PPACA

Two months ago, the Obama Administration dropped the PPACA provisions for long-term care insurance. Yesterday, the administration announced it would let each state define its own package of "essential health benefits." The politics are understandable--the administration now can deflect Republican charges that Washington is imposing a rigid, one-size-fits-all health care system on every state. However, we know from the country's experience with Medicare and Medicaid that state variations in government health care programs disserve the public. Perhaps, HHS can limit state discretion enough to ensure that PPACA still will provide good coverage throughout the country.


December 17, 2011 | Permalink | Comments (0) | TrackBack (0)

Friday, December 16, 2011

Guest Blogger Vickie J. Williams: More Coverage, Fewer Jobs


It has been widely reported in the mainstream news media that 2.5 million young adults who were uninsured are now insured because of the Patient Protection and Affordable Care Act (PPACA)’s requirement that children be allowed to stay on the parents’ health insurance until they are 26.  As reported in USA Today, the Department of Health and Human Service (HHS) states the rise in coverage is attributable to the PPACA, because there was no such rise in the age group of 26-35-year olds, and no increase in Medicaid coverage for adults in the 19-25-year-old age group.   HHS also noted that the timing of this increase (much of it in the spring) indicates that many young people took advantage of the law’s provisions as they graduated from school.

While the increase in coverage for this age group is good news, the fact that there was no increase in insurance coverage in the slightly older 26-35 year old group, and the timing of the increase for the 19-25 year old group, highlights the continued stagnation in the job market as much as it highlights a “success” of PPACA.  The fact that a great many 19-25 year olds needed to get onto their parents’ health insurance upon graduating from high school or college is not a sign of a robust private insurance market, it illustrates that young adults either have no jobs, or they have jobs that do not come with health insurance benefits.  As the parent of a college freshman and a high-school senior, I can tell you that the prospect of my kids being able to remain on my insurance plan until they are 26, so I can pay for their premiums (as well as likely welcoming them and their piles of dirty laundry home after they finish college and can’t find full-time jobs) does not exactly fill me with joy, although it does allow me to breathe a sigh of relief when they go rock-climbing or bungee-jumping or whatever high-risk activity they engage in.

If any good thing can come out of this tough job market, it may be a realization that continuing to tie health insurance to employment has outlasted its usefulness.  As I wrote in my 2008 article, The Health Washington Initiative:  Blue Ribbon Process, Red-Herring Result  the employment-based health insurance system is a vestige of World-War II-era wage controls and has continued because of favorable tax treatment given to amounts spent by employers and employees for employer-based health insurance.  In the 1940’s, and for many years afterwards, the prevailing model of a successful career was full-time employment with the same company for 35 years, with a gold watch and a pension upon retirement.  Now, for those under 35, self-employment, temporary employment, and part-time employment often prevail over traditional full-time employment, sometimes by choice and sometimes by necessity.  We applaud these efforts at creative productivity, to strike work/life balance, and to be entrepreneurial, but the employment-based health-insurance system works against the efforts of young people to forge their own productive paths.

An alternative to employment-based health insurance system does not have to be a single-payor system.  Changes to tax policy that provided tax benefits for purchasing health insurance on individuals rather than employers, significant non-monetary incentives for people to purchase health insurance (like “no driver’s license without proof of insurance”), and strong regulation of the private insurance market on either the state or federal level to ensure level playing fields, affordable rates,  and appropriate levels of expenditures by private insurers on the actual delivery of health care could ensure broad availability and purchase of individual health insurance.

By instituting a requirement that Medicaid programs cover childless adults, PPACA (provided it survives the current challenges in the U.S. Supreme Court) has taken a giant step towards debunking the notion that if you are an adult, you are somehow unworthy of receiving health care unless you work, or have a an excuse for not working that we deem “worthy” as a society.  Now we need to take the next step and de-link health insurance from employment entirely.  What are we really afraid of?  That people will choose not to work if they can get health insurance without working?  When PPACA’s individual mandate becomes effective, would it really be a disaster if purchasing individual health insurance became more attractive than employer-based insurance?  Or would it allow people the freedom to change jobs, take risks in their employment, and innovate?  And what could be more important to our economy in these times than allowing today’s  “slackers” who are unable to find full-time jobs, to be tomorrow’s innovators, as long as they are not derailed by the inability to access quality health care when they need it?

- Vickie J. Williams


December 16, 2011 | Permalink | Comments (0) | TrackBack (0)

Michael Jackson's Death Exposes Danger of Over-Broad Physician Prescribing Powers

This just in from Professor Jennifer S. Bard who will be returning as a guest blogger in the first part of the new year:

BardA jury in California has imposed criminal responsibility for Michael Jackson's death on a doctor who administered, in Mr. Jackson’s bedroom, a highly dangerous and potent drug never intended to be used outside of an operating room even though he had no training or experience in anesthesiology.  This, thank goodness, is an unusual event. Perhaps lost in the saturation coverage of the trial is something that’s not unusual: Dr. Conrad Murray’s actions in prescribing and administering the drug were completely legal.

Every day, every hour, that medicine is practiced in the United States a physician is most likely prescribing a drug to someone in a dose, for a condition or to a patient never contemplated by the Food and Drug Administration (FDA) which has the sole authority of approving drugs for sale.  There are many reasons for this, and most of them good ones, but if anything positive can ever can come out of another’s death, Michael Jackson’s could make us all safer by revisiting this outdated potentially highly dangerous situation.  No one wants to hamper physicians’ efforts to relieve the pain and suffering caused by illness and injury nor would it be fair to place undue restrictions on the majority of doctors who prescribe responsibly based on the extremely poor judgment of the few, but there is no reason why every physician should be able to prescribe every drug. 

The problem of unrestricted prescription powers is amplified by the explosion of available drugs.  We are a nation of drug takers.  Fifty-nine percent of all Americans, man, woman and child, and eighty-six percent of all seniors, take a prescription drug every day.  In large part, this is a problem that comes from an over-abundance of innovation.  In fact, there is no completely reliable count of the number of prescription drugs available to physicians but close estimates suggests between 10,000-20,000.  We all benefit from remarkable drugs that ward off cancer, maintain normal heart function, and strengthen fragile bones.  

Equally, no one would want to return to the days when few appreciated the importance of pain management and many lived, and died, in unnecessary agony, but the result, according to the Centers for Disease Control (CDC) is “at least a 10-fold increase in the medical use of opioid painkillers during the last 15 years.”  Prescription drugs have surpassed illegal street drugs in terms of unintended injury and death.  According to the CDC, "[d]rug overdose deaths were second only to motor vehicle crash deaths among leading causes of unintentional injury death in 2006 in the United States."  Scientific America reports that in that same time period, there has been a 65% increase in hospitalizations due to prescription drug overdose. 

The reason for providing unrestricted medical licenses is historical.  One hundred years ago when states started licensing physicians, there were far fewer drugs available and physicians were far less specialized.  As the number of drugs available has expanded and medicine has grown infinitely more complex, however, there has been no corresponding change to the medical licenses granted by each individual state.  Without exception, they bestow a general privilege to practice any kind of medicine and, within, the confines of laws intended to control the street sale of narcotics, prescribe any kind of drug.

Keeping hospital based drugs in the hospital is a reasoned and measured first step towards promoting greater safety.  Indeed, the current health care financing system which relies heavily on drug formularies has effectively already imposed for reasons of cost-cutting the kinds of limits proposed here for reasons of safety.  Almost every measure to limit the prescribing powers of physicians is met by dire predictions of what would happen if “the government” tried to interfere with the doctor-patient relationship.  But this makes no more sense than to speak of unwarranted government interference with the food-supplier/consumer relationship.   There is no physician who needs the immediate ability to prescribe any drug on the market.  Placing limits on the availability of some of the most dangerous is a measured response to prevent future tragedies.

- Jennifer Bard


December 16, 2011 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Wednesday, December 14, 2011

Secret Medical Prices: Free Market Triumph or Tragedy?

Can a market work when buyers are kept in the dark about the prices they’ll pay? That’s an increasingly urgent question for fans of consumer directed health care. In vogue during the administration of Bush fils, CDHC is reemerging as Obamacare’s opponents seek a standard to rally around (other than “laissez mourir“). In theory, consumers could force doctors and hospitals to compete by shopping around for services. But when the rubber hits the road, informed consumption is easier said than done, asJosh Barro describes:

Recently, my employer switched to a high-deductible health insurance plan, which means I’m paying at the margin for most of my health care. As a result, I have become more aware of the true cost of the care I receive—and more aware of how difficult it is to figure out that cost. . . . if you ask doctors how much a service costs, they tend not to know. I once had an argument with my doctor, who did not want to give me a blood test for fear that my insurer would deny the claim for the expensive test. I later found out that this test costs all of $9.48 at my insurer’s negotiated rates, despite a list price of $169. When I got orthotics, my podiatrist told me they would cost nearly $600. But that was the list price; the actual insured price was less than $250. . . .

It doesn’t have to be this way. We could legally obligate hospitals and medical practices to disclose their full price lists—both the inflated list prices and the rates negotiated with each insurer that the practice accepts.

A commenter on Barro’s blog retorts:

I’m a little surprised to see a blogger at the [National Review Online] suggest that the government “require” price disclosure from private market participants. This goes well beyond the market interference that some other odious “mandates” require. Why don’t we mandate that everyone disclose exactly what they pay each employee? . . . If you have an HSA or High-deductible policy, I would suggest it’s incumbent on the insurance provider to help you figure it out. If consumers want it enough the system should respond, right? Why not switch to an HDP that is more transparent?

The problem, of course, is that lots of parties have to agree to provide transparency, and there is a great deal of inertia. If all the other insurers aren’t transparent, there’s little reason for one of them to try to distinguish itself if it already has a steady customer base. And when it stirs itself to do so, it will find a wall of resistance from providers, who say “why should we give all this information to you—no one else is demanding it?” (Moreover, the “prices” don’t really exist except on paper on a “chargemaster,” and they’re practically meaningless (except as opportunities to gouge the unlucky). The real price is the negotiated price, and that’s generated out of iterative interactions.) Moreover, many interventions involve multiple providers, as a reader of Andrew Sullivan’s blog explains:

I am a pediatric subspecialist at a major academic medical center in New York City. Many times, patients call to find out the costs of procedures if we are outside of their network. As ridiculous as it sounds, we are universally unable to tell them. The prices are so opaque that no one at my institution will admit to being able to produce them.

For example, a pulmonary function test (really a group of tests) will involve a physician’s fee and a technical fee. The MD fee is generated from my practice and I have a list of fees that most patients are charged (though their insurances all pay different rates if they have insurance). The hospital owns the technical fee. A colleague of mine once spent three months trying to get an answer to the question of what the price is for a group of tests for a research grant she was planning. No one could or would tell her.

Perhaps the “free market advocate” would like to see a coalition of insurers band together to get enough bargaining power to demand transparency. (Query the point at which that consolidation becomes so great that it approaches monopolization, another enemy of free markets.) But the record of Group Purchasing Organizations in other parts of the health care marketplace is not promising. Such intermediaries are often tempted to put their own profits ahead of the entities they’re ostensibly serving.

It’s a bit like food nutrition labeling, which almost everyone now agrees is a good idea, but could only be catalyzed on a large scale by government intervention. The government may also need to limit the complexity of contracts in the area. As Uwe Reinhardt documented,

Relative to hospitals paid under the much simpler national health insurance schemes in other countries, the contracting and billing departments of U.S. hospitals . . . are huge enterprises, often requiring large cadres of highly skilled workers backed up by sophisticated computer systems that can simulate the revenue implications of the individual contract negotiations.

You’d think that, when US doctors’ administrative costs are four times that of Canada’s, consumers would at least get a clear picture of the financial landscape here. But instead, as with the labyrinth of self-serving complexity that constitutes the over-the-counter derivatives market, the complexity mainly serves to protect insiders. I predict that if CDHC advocates ask hospitals to reveal more, a plaintive chorus will respond that true prices are, in the words of Alan Greenspan, “irredeemably opaque.” For what is market freedom if it doesn’t include the freedom to contract into a dynamically multivariate payment scheme where the present value (or cost) or any given service cannot be calculated because it depends on a hundred other variables?

Doctors and insurers are not the only ones obscuring health care costs. As Steve Pearlstein noted recently, the prescription drug market “is renowned for its lack of transparency. Drug companies not only refuse to reveal their wholesale prices, but in contracting with pharmacy chains and PBMs they insist on contracts that prohibit either party from revealing prices to anyone else.” As Annemarie Bridy shows, a medical device manufacturer has claimed that “the actual prices its hospital customers pay for implantable devices, including cardiac pacemakers and defibrillators, are protectable as trade secrets under the Uniform Trade Secrets Act.” The B2B side of the business is shrouded in secrecy, as Reinhardt shows:

Whatever an insurer’s base for paying hospitals might be, the dollar level of payments is negotiated annually between each insurer and each hospital. Under a DRG system, for example, the item to be negotiated is the monetary conversion factor for the year and, possibly, some of the DRG weights. These actual dollar payments have traditionally been kept as strict, proprietary trade secrets by both the hospitals and the insurers. Recently Aetna announced that it will make public the actual payment rates it has negotiated with physicians in the Cincinnati area.20 That this small, tentative step toward transparency made national news speaks volumes about the state of price-transparency in U.S. health care. It remains to be seen whether that first step will trigger a larger industrywide move toward removing, at long last, the veil that has been draped for so long over the actual prices paid in the U.S. health system.

Fortunately for advocates of transparency, the Affordable Care Act has some provisions that require transparency. The ultimate solution is all-payer rate setting, which radically simplifies the negotiation games that are the root cause of so much health care opacity. Such rate setting may also pave the way to moreintegrated delivery systems, already contemplated in the parts of the ACA devoted to Accountable Care Organizations. When primary care doctors, specialists, imagers, etc., are all part of one organization, it’s much easier to estimate costs than when they are all independent actors.

But we should note that the problems here are much broader than health care. I predict a split in free market theory between those who enthusiastically endorse the propertization of prices, and those who see open information about them as a key to real competition.

X-posted: Health Reform Watch.


December 14, 2011 | Permalink | Comments (0) | TrackBack (0)

Saturday, December 10, 2011

Jumping Ahead to Coercion

The following is the second post in Professor 's month-long series on the Medicaid cases pending before the United States Supreme Court over at Concurring Opinions:

I had intended to address Douglas next, as it is a nice gateway for discussing Florida v. HHS, but a defense of the coercion argument just published in the New England Journal of Medicine Online inspired me to address the latter first.  I will begin by discussing why I think the Court granted the petition for certiorari then turn to the Medicaid coercion question. 

The Rehnquist Court excluded the Spending Clause from its federalism revolution inasmuch as that would have meant limiting the power to spend by the Tenth Amendment.  When Chief Justice Rehnquist authored South Dakota v. Dole, the evidence is that he believed it was an easy and relatively inconsequential case.  For those sane enough not to engage in the reading of tea leaves that is deciphering the spending power, a quick review.  Dole articulates typical Rehnquist categories for evaluating the constitutionality of conditions placed on federal spending:  the spending must be for the general welfare; the conditions must be clear and unambiguous (as modified by Arlington Central School District Board of Education v. Murphy); the conditions must have a nexus with the federal spending (“germaneness”); and the conditions cannot themselves be unconstitutional.  After providing this test, Rehnquist noted that “in some circumstances the financial inducement offered by Congress might be so coercive as to pass the point at which ‘pressure turns into compulsion.’”  No theory or constitutional provision was cited, but the opinion indicated that coercion would depend on the amount of money or percentage of money withheld if the state violates the conditions.  It seems that the Court meant that coercion would be a Tenth Amendment, state sovereignty problem.  But, Dole also explicitly stated that the Tenth Amendment was not implicated in the bar on unconstitutional conditions.  So, while Dole provides the test for conditional spending, it is undertheorized and a bit self-contradictory.  Nevertheless, the Rehnquist Court reiterated that the Spending Clause is not limited by the Tenth Amendment in New York v. U.S. and held to that position in subsequent cases, disappointing many who believed spending to be the next front in judicially-enforced federalism.

The Roberts Court has given hints now as to its approach to spending as well as federalism, and members of the Court have signaled interest in revisiting both topics.  For example, Justice Kennedy’s concurrence in Comstock stated: “The limits upon the spending power have not been much discussed, but if the relevant standard is parallel to the Commerce Clause cases, then the limits and the analytic approach in those precedents should be respected.”  Justice Kennedy also addressed broader federalism concerns in that concurrence, which were given free rein in his opinion for the Court in Bond v. U.S. as well.  Likewise, Justice Alito’s opinion in Arlington was written as a spending power decision rather than a limited statutory interpretation, which I have written elsewhere resulted in a narrower clear statement rule for the second element of the Dole test.

Additionally, even though the Court seems to dislike hearing both spending and healthcare cases, it already has heard Douglas this term, so spending, federalism, and Medicaid are fresh in the justices’ minds.  And, what could be a better vehicle for considering coercion than the largest grant-in-aid program that also constitutes the second largest portion of states’ budgets?  (Education is first.)  Further, numerous lower federal courts have attempted to construe coercion, but none have struck down federal legislation under the doctrine, making the issue ripe for the Court’s consideration.

Despite the idea of coercion arising repeatedly in federalism cases over the last thirty-ish years, its contours are unknown.  At what point is the money being offered too much? And is the offer really the issue, or is the problem the amount or percent of money a state stands to lose if it does not comply with the conditions?  (Dole indicated the latter, as South Dakota was not coerced because it would lose only 5% of its federal highway funding if it refused to comply with the minimum drinking age that the federal government sought to impose.)  Can coercion only apply to an existing conditional spending program that a state could not leave because it has become dependent on the program?  Or is there some federal program that would offer so much money that no state could turn it down, even at the outset, such that the new program would be coercive?  If it is the former, then clear statement rules also need to be revisited, because they seem to assume some kind of regular restatement of the rules of the program to which a state actively agrees.  That simply does not occur in a long-standing program like Medicaid, making me think that clear statement rules are almost meaningless in that context.  Additionally, states inherently relinquish some sovereignty when they agree to the terms of a cooperative federalism program, highlighting tensions between dual sovereignty and cooperative federalism.

So, what is the upshot for the Medicaid expansion?  [more after the jump]

Continue reading

December 10, 2011 | Permalink | Comments (0) | TrackBack (0)

Friday, December 9, 2011

The Denial of Cert. in Blackstone

 is guesting this month over at Concurring Opinions and is writing a very interesting series about the Medicaid cases pending before the United States Supreme Court this term. This is Professor Huberfeld's first post in the series:  

Many were watching this morning’s conference to see if the petition for certiorari would be granted in Blackstone Medical, Inc. v. U.S. ex rel. Hutcheson, but it was not.  The issue in Blackstone was whether a medical device company that paid illegal kickbacks to prescribing physicians could be liable under the False Claims Act (FCA) for causing false claims to be submitted to Medicare.  The FCA is the rare statute that is what it sounds like – basically, if you submit claims for federal monies, the claims cannot be false or fraudulent.  If they are, the federal government can recover large fines for each false claim as well as treble damages.  The statute includes a qui tam relator provision that encourages whistleblowers to come forward with information about false claims; if they are successful, they share in the government’s bounty.  The civil FCA has become the DOJ weapon of choice for fighting healthcare fraud, and circuit splits abound regarding the interpretive details of this statute.  In part, this is because whistleblowers tend to push the envelope of false claims theory.  To wit, in this case, the claim is not “factually false” (which would indicate that the services were not actually provided), it is “legally false,” which means the services are provided as claimed, but another law for which the filer has certified compliance is being violated.

A grant in Blackstone would have been notable, as the Roberts Court has decided five False Claims Act cases in five terms (October Term 2006-2010), as compared to four such decisions in the eleven years of the natural Rehnquist Court, making this potentially the sixth in seven terms.  It is hard to say if the Court is hearing so many FCA cases organically, or if something more is afoot.  But, the FCA decisions illustrate at least four big picture issues. 

First, separation of powers.  The Court is having a conversation with Congress that seems to further a clear statement rule project.  The Court has consistently read the FCA narrowly, forcing Congress to include the language it wants to see in the statute.  Twice Congress has responded, and quickly, by re-expanding the scope of the FCA, and in a third case, PPACA had already addressed the issue.  (Seems fraud is one of the few things Congress can agree on these days…)  The problem is that such rules are lost on whistleblowers, who dominate FCA prosecutions.  Second, the cases seem to support the theory that the Roberts Court is business-friendly, as a glance at the amicus briefs reveals.  The problem is that “business friendly” does not necessarily inform meaningfully or even predict outcomes.  For instance, the Chamber of Commerce often sides with healthcare providers, and it advocated for narrowing the scope of the FCA in the cases before the Court, which keeps whistleblowers out of court.  But in Douglas v. ILC (to which I’ll return in my next post) the Chamber advocated for hospitals, which would keep the courthouse doors open.  Third, the five cases reveal a docket clearing exercise that is consistent with the theory that the courthouse doors are being closed by the Roberts Court, irrespective of the business-friendly question.  Fourth, the Court’s interpretation of the FCA, and Congress’s response to the Court, will likely facilitate an increase rather than a decrease in the number of whistleblower actions brought under the FCA.  PPACA will increase the number of claims flowing through federal healthcare programs, and federal money flowing into the state insurance exchanges will be subject to the FCA too. 

So, even if the Court does not grant the petition in the other FCA case on the docket (Amgen, Inc. v. New York), it’s a safe bet the Roberts Court will be telling us more about the FCA soon.


December 9, 2011 | Permalink | Comments (0) | TrackBack (0)

Thursday, December 8, 2011

Local 6's Integrated Delivery System

Robert Kuttner has an excellent article on the Local 6 Union's health plan in the American Prospect.  The plan's success at reducing costs and improving quality may make it a good model for those who claim we need to go beyond ACO's to integrate delivery.  A few quotes from the piece:

Insurance costs generally are increasing at 9 percent to 10 percent a year, according to the Kaiser Foundation. By contrast, the costs of the hotel workers’ plan have been increasing at about 1 percent a year for the outpatient services that it provides directly and about 10 percent per year for inpatient services that are contracted with area hospitals. So the plan’s overall costs have been going up at about 3.5 percent a year. . . . 

[B]y dispensing with insurance-company middlemen, the plan eliminates a whole layer of costs. A doctor treats the patient according to his or her best medical judgment. There is no army of staffers dealing with patient billing, claims, and insurance reimbursement; no arguing with insurance--company case reviewers.  Second, doctors are all on salary. So there is no incentive to undertreat or overtreat . . . .

Further, the plan’s core principle is unlimited access to primary care, with all of the prevention and early--detection benefits that approach brings. . . .All doctors are salaried, with general practitioners being paid slightly more than specialists, in order to reward primary care. The scale for GPs ranges from $85 to $115 an hour, or around $200,000 a year or more. The plan has no trouble enlisting good doctors, since the conditions of medical practice elsewhere have been deteriorating under relentless pressure from insurers to cut costs and justify their medical decisions. . . .

The article also mentions tense negotiations with the RAPER specialties (Radiologists, Anesthesiologists, Pathologists, and ER doctors), which apparently have a good deal of bargaining power: 

Most New York hospitals now contract out these services to specialists’ groups who charge whatever the market will bear. In recent bargaining with one of its hospitals over a proposed rate increase, the hotel workers were told that the increase partly reflected higher charges billed by anesthesiologists. Greenspan [a union negotiator] requested the hospital to push back. Not our problem, the hospital contended; we don’t control these costs. “We told them, OK, next week our members stop using your hospital,” Greenspan says. The costs came down.

The plan's success may be complete when robots can reduce the cost of radiology and pathology.


December 8, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, December 7, 2011

Politics Trumps Science

Even in science-friendly administrations, politics can override the assessment of medical experts. Today, HHS Secretary Kathleen Sebelius announced her decison to reject the FDA's view that the morning-after pill can be purchased by minors without a prescription. (Thanks to Maurice Bernstein for flagging this.)


December 7, 2011 | Permalink | Comments (0) | TrackBack (0)

Central Line Infections

Interesting report from The Commonwealth Fund, here, on models for reduction of a major cause of HAIs. [NPT]

December 7, 2011 | Permalink | Comments (0) | TrackBack (0)

Monday, December 5, 2011

Introducing Guest Blogger Professor James T. O'Reilly

The Health Law Prof Blog team extends a big welcome to guest blogger Professor James T. O'Reilly. Below is his short bio. Read more here.

Oreilly06University of Cincinnati Law Prof. Jim O'Reilly has authored 45 texts and 180 articles over 32 years of teaching. His work has been quoted as "The expert" by the Supreme Court and many federal and state appellate courts. His most recent text, West's Healthcare Rulemaking Guide, will be followed in 2012 with a text on the impacts of PPACA healthcare reform on medical malpractice.




December 5, 2011 | Permalink | Comments (0) | TrackBack (0)

Caffeinated Alcoholic Drinks & the Law (just in time for the Holidays?)

By Thomas L. Hafemeister, J.D., Ph.D. Assoc. Professor, University of Virginia School of Law

On July 18, 2008, in Largo (Pinellas County), Florida, at about 2 a.m., a motorcycle driven by John Prado, 21, collided with a pickup truck, the driver of which had run a stop sign.  On the back of the motorcycle was Heather Lynn Cook, 20.  Prado was killed instantly, while Cook was thrown from the motorcycle and badly injured, with her leg ultimately amputated.  A police officer at the scene of the crash said cans of Icehouse beer came tumbling out of the pickup onto the street.  The driver of the pickup was subsequently arrested and charged with DUI manslaughter.  It appears the driver ultimately was convicted of a felony and given a prison sentence.  An account of the accident and subsequent criminal proceedings involving the driver of the pickup are here, while access to the germane court records can be gained here.   

However, apparently the driver of the pickup was not the only person involved in this accident who had previously been drinking.  Cook filed a related suit against the Estate of Prado and Millercoors, LLC, which manufactured, marketed, and sold “Sparks,” an alcoholic beverage containing caffeine and other stimulants.  [For a brief history of Sparks, its unique marketing history, and its cult following prior to its purchase by Millercoors, see here.]  

Cook argued that alcoholic beverages such as Sparks contained stimulants that are “uniquely dangerous” and appeal to younger drinkers.  Further, while the addition of caffeine enables one to drink more alcohol without feeling as intoxicated as one normally would, the stimulants do not reduce alcohol’s negative effects on motor skills and reaction times.  She asserted that consumers of these beverages are more likely to “engage in dangerous behavior such as driving,” and that her companion, Mr. Prado, after consuming Sparks, neither felt nor appeared to be impaired, although his blood alcohol level was 0.10 at the time of the crash.  [In Florida, at 0.08 the law presumes impairment, see here.] 

Cook’s complaint asserted that: (1) the combination of alcohol and stimulants created a latent inherent danger and MillerCoors failed to warn Mr. Prado of that inherent danger; (2) the addition of stimulants to the alcoholic beverage constituted a design defect; and (3) MillerCoors negligently manufactured Sparks, knowing that it was unreasonably dangerous and that inexperienced drinkers would be more likely to drink to excess due to the addition of stimulants. 

MillerCoors countered that there is no cause of action against a manufacturer of alcoholic beverages for injuries resulting from their consumption because the effects of alcohol consumption are well known.  Cook responded that these holdings apply to “conventional” alcoholic beverages, not to an alcoholic beverage mixed with stimulants designed to suppress the consumer’s awareness of alcohol’s well-known effects.

Just over a month ago, a federal district court in Florida granted Millercoors’ motion to dismiss Cook's lawsuit. 

With regard to the failure to warn claim, the court found that such a duty only arises with regard to dangers of which consumers are unaware, not to dangers which are obvious or commonly known.  The court determined that Cook had not alleged that Prado was unaware that he was drinking alcohol and thus it must be assumed that he did so with knowledge of its potential effects.  The court added that other courts have declined to impose a duty to warn on manufacturers of alcoholic beverages based upon a plaintiff’s perception or understanding of the risks involved with a particular product, citing rulings from Texas (regarding a belief that “Lite” beer was less intoxicating) and Tennessee (addressing Everclear grain alcohol), as they have noted the difficulty of devising a warning regarding the particular tolerance of an individual consumer. 

The court refused to be swayed by Cook’s evidence that state attorneys general and experts have expressed concern about the marketing and use of alcoholic energy drinks by young people, countering that she had not cited a case imposing related liability and that this was a policy question better left to the elected branches, not the courts. 

For the court's treatment of this and the other two counts targeting MillerCoors, as well as Cook's auto negligence claim against Prado, see here.  

It should be noted that MillerCoors, under pressure from more than a dozen state attorneys general, agreed in December 2008 to remove the caffeine and other stimulants from these drinks (see here, here, here, and here).  However, such products continue to be distributed by other entities (for a November 2009 list compiled by the FDA of manufacturers of caffeinated alcoholic beverages, see here).

Also, for a recent article in Scientific American addressing the dangers of caffeinated alcoholic energy drinks, as well as a discussion of the prohibition of their sale in Michigan and Oklahoma, see here and here.  For an article describing the Oklahoma ban, see here

For a posting containing the concerns of the FDA regarding alcoholic beverages with added caffeine, as well as its November 2010 warning letters to four companies that make these beverages, see here.  For a related Fact Sheet published by the CDC in July of 2010, see here.  For a report that college students who consume energy-drink cocktails are three times more likely than alcohol-only drinkers to leave a bar drunk, see here

Relatedly, the Substance Substance Abuse and Mental Health Services Administration (SAMHSA) recently published a report (Nov. 22, 2011) that documented a sharp increase in the number of emergency department visits involving "energy drinks," with a tenfold increase between 2005 and 2009 (see here).

December 5, 2011 | Permalink | Comments (0) | TrackBack (0)

So Long, and Thanks for All the Fish

It's been a bittersweet few weeks as I have taught my last few classes at Saint Louis University. Next month I assume the position of Hall Render Professor of Law & Co-Director of the Hall Center for Law and Health at Indiana University Robert H. McKinney School of Law. I am leaving many talented friends behind but am massively excited to be be working with hugely talented Hall Center faculty members such as (fellow blogger and co-Director) David Orentlicher, Emily Morris, Priscilla Keith, and Rob Katz (and, of course, the amazing Eleanor Kinney will remain involved in things). If you have been following the news, here, you will know that this is a law school with great ambition and resources. The opportunities to further expand an already excellent health law program by working with so many talented scholars across a major research institution are almost limitless. It's going to be a lot of fun and we'll be sure to keep you posted! Nic Terry,


December 5, 2011 | Permalink | Comments (0) | TrackBack (0)

Friday, December 2, 2011

Guest Blogger Vickie J. Williams: Cannibals Getting to the Marrow

Williams_31First, I want to thank Katharine Van Tassel and the other moderators of the HealthLawProfs Blog for inviting me back as a guest blogger this month.  As I did in May, I hope to provide you with some much-needed distractions from your dreary grading duties this month.

As mentioned on this blog on December 2, in Flynn v. Holder the 9th Circuit Court of Appeals, apparently in a case of first impression in any court, decided that persons who undergo peripheral blood stem cell apheresis to allow for harvesting of hematopoietic stem cells can be paid for their donations.  According to the Court in Flynn, hematopoietic stem cells are “seeds from which white blood cells, red blood cells, and platelets grow.”  Most of these cells remain in the bone marrow cavity, but some escape into the blood stream before they mature, and can be harvested by the same technique as is used to collect plasma or platelets from a blood donor.  The process is more like a traditional blood donation than like the older method used to collect bone marrow for donation, which required sticking a needle into the cavities of an anesthetized donor’s hip bones.  This is apparently as painful as it sounds, and involves much higher risks to the donor.

The plaintiffs challenged the federal statutory ban on payment for bone marrow donations as a violation of the Equal Protection Clause, claiming that allowing compensation for blood, sperm, and egg donations, while disallowing compensation for bone marrow donations, had no rational basis.  The Court avoided reaching the constitutional issue by interpreting the National Organ Transplant Act’s definition of organs for which compensation is prohibited, which includes “bone marrow,” to exclude peripheral blood stem cells.  Therefore, it reasoned, neither the statute itself, nor the Department of Health and Human Services (through regulation), prohibits payment to people who undergo peripheral blood stem cell apheresis to allow for harvesting of hematopoietic stem cells. The Court in effect said that using the term “bone marrow transplant” as a synonym for “peripheral blood stem cell apheresis” is an “anachronism that will soon fade away,” and the Court is just ahead of the curve in this process.

In my opinion, this is an eminently sensible decision which interprets the law in such a way as to harmonize it with advances in medical science (a refreshing change from the way that law and science have interacted in past years).  However, as a health law teacher and scholar, I think the more interesting part of the opinion is where the Court holds that prohibiting payment for bone marrow donations by the older “aspiration” method (still used in 1/3 of bone marrow donations, according to the Court) does not violate the Equal Protection Clause.  In this section, the Court identifies “two classes of rational basis […] policy concerns and philosophical concerns.”  After listing the kinds of policy concerns that most of us are familiar with (concern about the rich inducing the poor to sell their organs, or potential donors extracting every last cent from a sick patient needing a transplant), the Court goes into a rather lengthy discussion of the kinds of philosophical reasons that Congress may have had for prohibiting compensation for organ donations.  Citing extensively from Dr. Leon Kass’ book Life, Liberty and the Defense of Dignity:  The Challenge for Bioethics, the Court explores what it calls an “instinctive revulsion” of “commodification” of removal of flesh from a human being for use by another.  The Court even cites Kass’ statement that organ transplantation can be viewed as “simply a noble form of cannibalism.” The Court concedes that these philosophical reasons for the law prohibiting compensation are “in some respects vague, in some speculative, and in some arguably misplaced.”  Yet it then goes on to hold that Congress’ distinctions between body parts that can be bought and body parts that cannot be bought, apparently based (at least in part) on these vague, speculative, and possibly misplaced philosophical arguments, have a “rational basis.”  I’m a little surprised to see the Court cite what it calls “taboos” as a “rational basis” for distinctions in what can and cannot be commercialized.  What’s next, a holding that a traditional “taboo” on homosexual conduct constitutes a rational basis for the Defense of Marriage Act?   But that argument is probably for a different blog.

There is really some good imagery in this opinion, including Judge Kleinfeld’s description of “marrow” as “what some people suck out of beef bones.”  I think it’s time for lunch.

- Vickie J. Williams


December 2, 2011 | Permalink | Comments (0) | TrackBack (0)