HealthLawProf Blog

Worth Reading This Week

Amy Monahan, Fairness Versus Welfare in Health Insurance Content Regulation, SSRN/Ill. L.Rev.

Alex Stein, Toward a Theory of Medical Malpractice, SSRN/Iowa L.Rev.

Pieter Cohen, Assessing Supplement Safety — The FDA's Controversial Proposal, NJEM

Sharon Long et al, Massachusetts Health Reforms: Uninsurance Remains Low, Self-Reported Health Status Improves As State Prepares To Tackle Costs, Health Affairs

[NPT]

 

Health Law Headlines of the Week (1/15-1/21)

Sam Baker, Court Angst for Left Over Healthcare, The Hill, Jan. 18, 2012 (here).

Supporters of President Obama’s healthcare reform have lost the high level of confidence they once displayed that the Supreme Court would throw out constitutional challenges to the law’s individual mandate.

Many liberals and some Democratic leaders initially waved off lawsuits challenging the law’s individual mandate, saying the suits were “frivolous” political stunts.

But that tone has shifted significantly since the Supreme Court devoted nearly six hours to arguments in the case—a modern record.  That the high court would set aside so much time for the landmark case suggests that the justices certainly don’t see the challenges as a waste of time.

The law’s critics were also encouraged that the justices agreed to hear arguments against its Medicaid expansion.  That part of the suit does not meet the criteria the court usually uses when deciding which cases to consider.

David Sherfinski, Bill Would Add Virginia to Health Care Opponents, Wash. Times, Jan. 17, 2012 (here).

A Virginia lawmaker is pushing legislation to add the state to an interstate compact that would exempt members from President Obama’s health care overhaul—a budding movement that’s providing states across the country with another constitutional weapon to combat the landmark law.

. . . [U]nder [the bill] Virginia would join other states collectively seeking to create their own health care policies through federal block grants and shield themselves from any conflicting federal law or regulation. . . .

Four other states — Georgia, Texas, Oklahoma and Missouri — already have approved measures that put the compact into law, and legislation is pending in at least 12 others . . . .  For a compact to take effect, it needs at least two member states and congressional approval.

Enabled by the “Compact Clause” in Article 1 of the Constitution, interstate compacts generally are used to solve cross-border problems such as transportation.  About 200 compacts are currently in effect.  In the Washington area, the Metrorail system is one example.  But the health care compact would be the first to explicitly protect states from federal law.

Jonathan D. Rockoff & Mia Lamar, Medivation, Pfizer End Work on Alzheimer’s Drug, Wall St. J., Jan. 18, 2012 (here).

Pfizer Inc. and partner Medivation Inc. are abandoning development of an experimental Alzheimer's drug, a decision that underscores the risks that Big Pharma faces in trying to bolster drug pipelines with expensive deals.

The companies decided to end the program for developing the compound, called Dimebon, after it failed to meet two primary endpoints in a phase 3 trial studying its use with the existing treatment Aricept in patients with mild-to-moderate Alzheimer's. The failure was Dimebon's second in a phase 3 trial.

Finding a treatment for Alzheimer's, a brain disease that progressively robs sufferers of their memory, is a priority of many drug makers.  Some 5.4 million people in the U.S. and 18 million world-wide are estimated to have Alzheimer's.  Analysts say sales of effective treatments could reach $25 billion a year.

Seeking an edge in that market, in 2008 Pfizer agreed to pay Medivation $225 million upfront—and up to $500 million more if milestones were met—for development rights to Dimebon. . . .

Skeptics on Wall Street, however, questioned the drug's prospects and size of the deal.  The drug was originally a common-cold remedy in Russia.  No one could fully explain how an antihistamine might slow the progression of Alzheimer's, although clinical trials conducted in Russia suggested it could. . . .

Announcing the failure of the latest trial Tuesday, the two companies said they would halt development of Dimebon for all indications and cease an ongoing open-label extension study in Alzheimer's disease.  The companies also said they would terminate an agreement to codevelop and market the drug.

Robert Pear, U.S. to Force Drug Firms to Report Money Paid to Doctors, N.Y. Times, Jan. 17, 2012, at A1 (here).

To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.

Many researchers have found evidence (here) that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices. . . .

Large numbers of doctors receive payments from drug and device companies every year—sometimes into the hundreds of thousands or millions of dollars—in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.

The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees.  The federal government will post the payment data on a Web site where it will be available to the public. . . .

Companies will be subject to a penalty up to $10,000 for each payment they fail to report.  A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year. . . .

Manuel Roig-Franzia, After the Death of Jack Kevorkian, Lawrence Egbert Is the New Public Face of American Assisted Suicide, Wash. Post, Jan. 19, 2012 (here).

[Lawrence] Egbert[, a retired anesthesiologist,] estimates he has been present for 100 suicides in the past 15 years, a figure that puts him in the same league with the famed assisted-suicide maverick Jack Kevorkian, who claimed to have helped more than 130 people die.  Egbert calls Kevorkian a “radical” because the latter took an active role in some suicides, building a machine to administer lethal doses and sometimes injecting patients himself.  Egbert sees his work as a calling, a vocation aimed at ending suffering.  But he says he provides only guidance and support.

Egbert says he approved applications for about 300 suicides, most as medical director of the Final Exit Network, a loosely knit group that claims 3,000 dues-paying members.  Even within his own organization, Egbert is controversial.  The vast majority of the network’s members suffer from painful physical ailments such as late-stage cancer, he says.  But unlike the group’s current leadership, Egbert is also willing, in extreme cases, he says, to serve as an “exit guide” for patients who have suffered from depression for extended periods of time.

. . . [W]ith Kevorkian gone—he died in June—two indictments of Egbert, one in Arizona and another in Georgia, have transformed [Egbert] into the public face of American assisted suicide . . . .

Egbert has been acquitted in Arizona, but the Georgia case looms, trudging slowly through the court system toward a possible trial that could further shape national opinion about assisted suicide.

Denise Grady, Scientists to Pause Research on Deadly Strain of Bird Flu, N.Y. Times, Jan. 21, 2012, at A3 (here).

The scientists who altered a deadly flu virus to make it more contagious have agreed to suspend their research for 60 days to give other international experts time to discuss the work and determine how it can proceed without putting the world at risk of a potentially catastrophic pandemic.

Suspensions of biomedical research are almost unheard of; the only other one in the United States was a moratorium from 1974 to 1976 on some types of recombinant DNA research, because of safety concerns.

A letter explaining the flu decision (here) is being published in two scientific journals, Science and Nature, which also plan to publish reports on the research, but in a redacted form, omitting details that would let other researchers copy the experiments. The letter is signed by the scientists who produced the new, more contagious form of the flu virus, as well as by more than 30 other leading flu researchers.

(th)

Lombardo on Legal Archaeology

Paul A. Lombardo published an essay "Legal Archaeology: Recovering the Stories behind the Cases" in the Fall 2008 issue of the Journal of Law, Medicine, and Ethics.  It reminded me of the wonderful chapters in this volume of "health law stories."  Here are some excerpts that may be of interest: 

 Every lawsuit is a potential drama: a story of conflict, often with victims and villains, leading to justice done or denied. Yet a great deal, if not all, that we learn about the most noteworthy of lawsuits — the truly great cases — comes from reading the opinion of an appellate court, written by a judge who never saw the parties of the case, who worked at a time and a place far removed from the events that gave rise to litigation.

Rarely do we admit that the official factual account contained in an appellate opinion may have only the most tenuous relationship to the events that actually led the parties to court. The complex stories — turning on small facts, seemingly trivial circumstances, and inter-contingent events — fade away as the “case” takes on a life of its own as it leaves the court of appeals.

How can a law professor correct this bias?  Here are some of Lombardo's suggestions: 

The best starting point for doing legal archaeology is the case record itself. We all begin our investigation of cases by reading an appellate opinion. With some extra effort, we can retrieve the records and briefs that the judges relied on as they wrote that opinion. Of course, the case record that is printed for submission to an appellate tribunal will include only a small portion of the documents that make up the lawsuit’s paper trail.

Much of the material contained in the case record is now filed electronically, and for recent cases, may be available on the Web. But even for most pre-Internet cases, finding the proper repository for all these records is not difficult. A visit to your school’s reference librarian with copies of the articles referenced here should get you started.

Lombardo also suggests consulting newspapers and magazines, professional journals, and material generated by the parties and their lawyers.  Though some students may complain of "reading overload," skillful editing can make the effort to contextualize the cases well worth everyone's while.  I also anticipate that internet archives of particular helpful case studies will accumulate over time.

Selected References from Lombardo

P. Brooks and P. Gewirtz, eds., Law’s Stories: Narrative and Rhetoric in the Law (New Haven: Yale University Press, 1997).

J. L. Maute, “The Value of Legal Archaeology,” Utah Law Review 2000, no. 2 (2000).

D. L. Threedy, “Legal Archaeology: Excavating Cases, Reconstructing Context,” Tulane Law Review 80, no. 4 (2006)

C. Geertz, “Thick Description: Toward an Interpretive Theory of Culture,” in The Interpretation of Cultures: Selected Essays.

[FP]

Worth Reading This Week

Ashutosh Avinash Bhagwat, Sorrell v. IMS Health: Details, Detailing, and the Death of Privacy, SSRN/Vermont L.Rev.

James Bennett, Pandering for Profit: The Transformation of Health Charities to Lobbyists, SSRN

Andrew Koppelman, Bad News for Everybody: Lawson and Kopel on Health Care Reform and Originalism, SSRN/Yale Journal Online 

Reza Mirnezami et al, Preparing for Precision Medicine, NEJM

[NPT]

 

Is the Cost Curve Bending?

Perceptive analysis by Karen Davis over on the Commonwealth Fund Blog, here.

While the recession has played an important role in the reduced utilization of health care services, the efforts made over the last decade to transform health care delivery may also have contributed to slower spending growth. Private sector initiatives have been encouraging hospitals and physicians to adopt improved safety methods, reach performance benchmarks, and reorganize care to achieve greater value. Private insurers and Medicaid have begun to pay for care differently, creating opportunities for new models of health care delivery.

Difficult questions abound. How much of this shift can be credited to the Affordable Care Act? Will the Act be able to control expected insurance cost increases? Is this the beginning of cost bending or the end?

[NPT]

Disclosing Gifts from Industry to Physicians

Robert Pear reports in the New York Times about the recently proposed rules that will require drug and device manufacturers to disclose payments and gifts to physicians. The Centers for Medicare & Medicaid Services released the proposed regulations in December, and comment is due by February 17.

Disclosure often is an important first step in discouraging inappropriate payments from industry, but it is rarely an adequate step. Indeed, some physicians respond to disclosure requirements with a greater willingness to accept gifts from drug and device companies. The government needs to follow up with additional steps, including prohibitions on certain kinds of payments.

And the government can look to professional guidelines that have been in effect for more than twenty years in formulationg stricter regulations. For the AMA guidelines that were subsequently adopted by PhRMA, see the original guidelines and an update that were published in the Food and Drug Law Journal. 

[DO]

MLK's Legacy at a South Carolina Hospital

From MLK’s Legacy: The Charleston Hospital Workers’ Strike of 1969:

During the year after her husband’s assassination, Coretta Scott King made several visits to Charleston, S.C., where hospital aides at what was then the Medical College of South Carolina were involved in a protracted fight for decent wages. After a 113-day strike, the union won an agreement that led to wage increases and new grievance procedures.

The campaign was led by Mary Moultrie, a South Carolina native . . . In Moultrie’s telling, the gains that the union won lasted only for a few years. Because South Carolina is a right-to-work state, the union couldn’t manage to maintain much strength. But Moultrie didn’t give up: She was still organizing as recently as 2008.

A fascinating story, with historical documents at the link. [FP]

AALS Panel on Teaching Health Law: A Tour de Force

The health law section at AALS put on a truly outstanding program.  Jennifer Bard posted on the speakers and topics here, and I'd wanted to do a post reporting on the program.  But there was so much there that I'll try to draft a post on each speaker, or at least a column from the Journal of Law, Medicine, and Ethics that reflects her or his approach.  Fortunately, as Bard reported, "the Indiana University Robert H. Mckinney School of Law’s Health Law Review has agreed to print pieces about these programs as well as the proceedings of the panel in a Spring 2012 volume."

The first speaker was Prof. Charity Scott,  Catherine C. Henson Professor of Law and Director of the Center for Law, Health & Society at Georgia State University College of Law.  Her presentation, "Collaborating with the Real World: Opportunities for Developing Skills and Values in Health Law," was a terrific mix of high level observation, on-the-ground experiences, practical examples from her own health law program, and articles she edited as editor of the Teaching Health Law column of the JLME.  Scott noted that experiential learning can happen in time slots ranging from an hour to a day to a semester or year, so any committed professional can fit some opportunities into their schedule at some point.  She particularly focused on how students could help attorneys, doctors, and community members solve pressing problems.  In coming weeks, I'll blog on some of the particular programs she mentioned.

[FP]; Simulposted at Health Reform Watch.

Guest Blogger Jeff Hammond: How Sustainable is the Sustainable Growth Rate?

Thanks to Katharine and the other editors here at the Health Law Profs Blog for having me as a guest blogger this month.  During the month, I look forward to sharing a few thoughts with you about health care delivery and finance.  As an initial foray, take a look at these two posts, one from KevinMD.com about how prospective application of the Medicare Sustainable Growth Rate (SGR) will affect the take home pay of physicians, and the other from Chicago health lawyer Scott Becker’s Orthopedic, Spine, and Pain Management Review about broader policy issues involved with the application of the SGR.  As you might be aware, when President Obama signed the Temporary Payroll Tax Cut Continuation Act on December 23, 2011, the imposition of SGR was stayed for only two months.  Unless once again modified by Congress, its formula is set to ratchet down physician payments at the beginning of March this year.

If there is one idea I’d like for you to get from this post, it’s that: sometimes the law erects barriers that can inhibit people from doing the very things that the law (and lawmakers) really want that person to do.  In the case of health care, the SGR is such a barrier.  It’s the infamous and very complicated “governor” on the growth of physician’s fees paid for by Medicare.  Its formula is based, in part, on the growth (or lack thereof) of gross domestic product in the broader economy.  Because Medicare payment rates are already thought to be low, Congress has consistently delayed the application of the Sustainable Growth Rate, which if applied, would downwardly adjust doctors’ fees.  To be fair, SGR theoretically could generate a positive update if the variables in its formula lined up just right.  Nevertheless, SGR is distinctive in that it “remembers” past cuts that its formula generated, yet Congress postponed.  Thus, if they were ever to be imposed, the cuts mandated by SGR would be massive.    

However, at the same time that Congress wants to manage the growth of physician fees, it really wants Americans to have better access to primary care physicians.  For example, Congress knew that primary care physicians are both valuable to Americans’ health, yet they are underpaid.  Hence, it provided in the Affordable Care Act for a significant (yet temporary) 10% upward adjustment in fees for certain primary care services (see ACA § 5501(a)(1)).

Congress is playing a grand game of chicken with its contracted doctors.  Congress has enticed physicians to keep playing the game with a 10% fee increase, yet it consistently swerves at the last minute when it pulls back the SGR cuts.  Physicians have every right to be skittish about such gamesmanship from Congress.  It is no wonder that groups like the AARP and the AMA couch the SGR as a healthcare access issue.  They know that doctors will discontinue their participation in Medicare if the SGR is ever imposed.

It is therefore time for Congress to bite the proverbial bullet and fix the SGR once and for all.  Two commentators recently estimated that it will cost upwards of $300 billion to set Medicare physician reimbursement on the right track.  (see Mark Harkins and Erica Stocker, “Congressional Dysfunction Imperils Health Care System,” BNA Health Care Policy Report, January 6, 2012).  Although the right thing to do, it seems implausible in an age of eye-popping deficits and breathtaking defense cuts that the doctors would get $300 billion.  Without such a fix, they are forced to be content with their heads being saved from the guillotine every few months.

It would be irresponsible to lay all of physicians’ money woes at the feet of the SGR.  As an article from CNNMoney pointed out last week, there are several factors that complicate doctors’ quests for profitability: hassles with private payers, overhead costs, and the nature of fee-for-service reimbursement, in which payers are incentivized to package many services into one.  In fact, it would probably be irresponsible for any particular physician to blame real time, balance-the-ledger, pay the employees right now(!!!) woes on the possibility of SGR being imposed and thus driving the fees so low that she will have to declare bankruptcy or go out of business.  No, SGR is contingent.  It looms in the shadows.  It lurks in the corners scaring doctors of what might come next.  But, if imposed, it will be disastrous for doctors’ practices, as ably described by Dr. Matthew Mintz in his KevinMD.com post.  But it hasn’t been imposed since 2002, as Bob Herman points out in the Becker article.  One wonders, though, when the infamous other shoe will drop.  And if it ever does, one must also soberly wonder how many doctors will leave Medicare and the practice of medicine altogether.

- Jeff Hammond

  

Introducing Guest Blogger Jeff Hammond

The Health Law Prof Blog extends a warm welcome to our guest blogger for January, Professor Jeff Hammond. Here is his short bio:

Jeff Hammond is an Associate Professor of Law at Faulkner University’s Thomas Goode Jones School of Law in Montgomery, Alabama.  He received his B.A. in English from Harding University in 1997.  Jeff is an alumnus of Emory University’s joint-degree program in law and religion, earning the Master of Theological Studies degree from Emory’s Candler School of Theology and the Doctor of Law degree from Emory’s School of Law in 2001.  From 2001 to 2007, Jeff practiced exclusively in the area of health law while working for two large firms in Nashville, Tennessee.  Jeff’s research interests in health law include finance and delivery issues and fraud and abuse issues.  He’s also written in the area of law and bioethics, with an article about legal protections due to persons in the minimally conscious state.  Jeff is also interested in the intersection of law and Christian theology.  Jeff’s other published articles include one about the reemerging trend of “cash only” physicians and another about compliance norms for chronically diseased Medicare beneficiaries.  His current projects include pieces about the Stark Law, the federal Anti-Kickback Statute, and a companion piece to the “cash only doctors” article about private contracting in the Medicare program.

[KVT]

Article on the Fate of the PPACA Appears in the NEJM

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

An interesting article just appeared in the New England Journal of Medicine that asserts that “[a]lthough major components of [The Patient Protection and Affordable Care Act of 2010 (ACA)] do not go into effect until 2014, the fate of the ACA depends on the outcome of four key events in 2012.” 

Provided by the Department of Health Management and Policy and the Department of Political Science at the University of Michigan, the four identified events are (1) 2012 state legislative sessions, “the vast majority of which” will occur between January and June, (2) the Supreme Court ruling on the constitutionality of the ACA, expected by the end of June, (3) “the June 29 deadline for applications for the final federal grant that states can obtain to support establishment of a health insurance exchange,” and (4) the Presidential, Congressional, and state elections (including the heads of the departments of insurance in three states) on November 6. 

The article proceeds to anticipate various potential outcomes associated with these events.  Of particular note, comments in response to this article may be posted through January 18.  The article can be found here.

Establishing a Clearinghouse for Summer Teaching Positions: Call for Hiring Chair Announcements

Although many law schools, both in the United States and to a lesser extent abroad, hire faculty members other than their own to teach summer school, this has always been a haphazard process.  Given the success of sharing information about entry level teaching jobs over at Prawfs Blawg, establishing a general clearinghouse for law school summer teaching positions is likely to provide a great benefit for both law faculty and law schools across the country and the world. The Health Law Prof Blog has agreed to host the clearinghouse by posting all of the notices of teaching opportunities, in all subjects, for the Summer of 2012.

I hope this becomes a valuable resource for law professors and law schools.  

Jennifer S. Bard

Associate Dean for Faculty Research and Development 

Texas Tech University School of Law

Please share the following information in your announcement and send it for posting on the Health Law Profs Blog to either Jennifer Bard at jennifer.bard@ttu.edu or Katharine Van Tassel at kvantassel@stu.edu:

(a) the name of your school; (b) the name of the chair of your summer hiring committee and that person's contact information; (c) any particular subject areas in which your school is looking to hire; (d) the dates that the summer class(es) will be taught; and, (e) any other information you think might be relevant.

 [KVT]

Worth Reading This Week

Glenn Cohen, Selling Bone Marrow — Flynn v. Holder, NEJM

Karen Sokol, The Underrecognized Role of Tort Law in the U.S. Healthcare System, SSRN/Hamline J. Pub. Policy

Elizabeth Weeks Leonard, The Rhetoric Hits the Road: State Resistance to Affordable Care Act Implementation, SSRN/U. Rich. L.Rev.

Einer Elhauge, The Irrelevance of the Broccoli Argument against the Insurance Mandate, NEJM

[NPT]

 

AALS Annual Meeting Panel - "Reaching Out Beyond the Classroom: Health Law Professors Interacting with the Real World"

The AALS Section on Law, Medicine and Healthcare invites all who are attending the AALS Annual Meeting to come to the Section's panel entitled "Reaching Out Beyond the Classroom: Health Law Professors Interacting with the Real World" which is being presented in close cooperation with the Section on Clinical Legal Education.

Health Law professors have long utilized the principles of experiential learning in their classes. This panel presents a sampling of the many different ways that health law professors are reaching out of the classroom and helping their students experience the real world.

The Call for Papers associated with this panel generated so many interesting and innovative programs that the Indiana University Robert H. Mckinney School of Law’s Health Law Review has agreed to print pieces about these programs as well as the proceedings of the panel in a Spring 2012 volume. The Panel includes the following:

Moderator and Speaker: Jennifer S. Bard, Alvin R. Allison Professor of Law, Director, Health Law and J.D./M.D. Program, Associate Dean for Faculty Research and Development, Texas Tech University School of Law.

Speaker: Charity Scott, Catherine C. Henson Professor of Law, Director, Center for Law, Health & Society, Georgia State University College of Law. “Collaborating with the Real World: Opportunities for Developing Skills and Values in Health Law.”

Speaker: Marshall B. Kapp, Director, Center for Innovative Collaboration in Medicine & Law, Professor, Department of Geriatrics. Florida State University College of Law. “Innovative Collaboration in Medicine and Law: The Ivory Tower as a Strategic Advantage.”

Speaker: Wendy E. Parmet, Northeastern University School of Law, Assoc. Dean for Academic Affairs & Matthews Distinguished University Professor of Law. “Health Law Coops -Views from Inside & Outside the Law School.”

Speaker: JoNel Newman, University of Miami School of Law, Associate Professor of Clinical Education, Director, Health and Elder Law Clinic. “Medical-Legal Partnerships in an Academic Setting.”

Speaker: Sallie T. Sanford, University of Washington School of Law. “Hyenas at the Gates: Teaching Problem-Based Health Care Law and Ethics in Rural Ethiopia.”

The Program will be held on Saturday, January 7, 2012 at 8:30 -- 10:15 a.m. and is currently scheduled to be in the Maryland Suite A, Lobby Level, Washington Marriott Hotel. The LMH Section's Business Meeting will be held at the conclusion of the Program.

- Jennifer S. Bard

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 "The Nirvana Fallacy Among Health Care Cost Cutters"

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.

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

Wonks 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 1^st.

 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

Essential health benefits

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

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.

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.

[KVT]