HealthLawProf Blog

False Claims Act Recoveries, 1999-2003

From the Jan. 30, 2006, issue of MANAGED CARE WEEK:

False Claims Act recoveries have surpassed $17 billion since 1986, according to Taxpayers Against Fraud (TAF). Nearly $1 billion was recovered in the first quarter of fiscal year 2006 alone, the organization says. . . . Large False Claims Act cases involving health care in the first three months of FY 2006 include a $704 million settlement with Serono Inc. for the allegedly illegal marketing of Serostim, a $124 settlement with King Pharmaceuticals, a $40 million settlement with Erlanger Medical Center in Tennessee and a $62.55 million settlement with Tenet Healthcare. According to a report released last year by TAF, the federal government's net recoveries from civil health care fraud cases were $5.21 billion between 1999 and 2003.

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Top 10 SSRN Downloads: Health Law

Little or no change since the last SSRN/Health Carelisting (Jan. 15). "Unintended Consequences of Medical Malpractice Damages Caps" and "Incentives in Nonprofit Organizations" traded places; all others stayed locked in place:

1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 22, 2000
   Last Revised:June 10, 2002
   Working Paper Series
   8846 downloads
2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 16, 2001
   Last Revised:June 5, 2001
   Working Paper Series
   5606 downloads
3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
   Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
   Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
   University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
   Date Posted:October 25, 2005
   Last Revised:January 23, 2006
   Accepted Paper Series
   1582 downloads
4. What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
   Stanford Law Review, Vol. 52
   Jonathan Zittrain
   Oxford University
   Date Posted:March 9, 2000
   Last Revised:June 30, 2000
   Accepted Paper Series
   1187 downloads
5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
   Alan O. Sykes
   University of Chicago Law School
   Date Posted:February 19, 2002
   Last Revised:March 7, 2002
   Working Paper Series
   908 downloads
6. Unintended Consequences of Medical Malpractice Damages Caps
   NYU Law Review, Vol. 80, pp. 391-512, May 2005
   Catherine M. Sharkey
   Columbia University - Columbia Law School
   Date Posted:February 17, 2005
   Last Revised:June 1, 2005
   Accepted Paper Series
   764 downloads
7. Incentives in Nonprofit Organizations: Evidence from Hospitals
   James A. Brickley and R. Lawrence Van Horn
   Simon School, University of Rochester and Simon School, University of Rochester
   Date Posted:February 14, 2000
   Last Revised:April 2, 2002
   Working Paper Series
   752 downloads
8. Bayh-Dole Reform and the Progress of Biomedicine
   Law and Contemporary Problems, Vol. 66, No. 1
   Arti K. Rai and Rebecca S. Eisenberg
   Duke University School of Law and University of Michigan Law School
   Date Posted:November 23, 2002
   Last Revised:February 6, 2003
   Accepted Paper Series
   744 downloads
9. Medical Problems and Bankruptcy Filings
   Norton's Bankruptcy Adviser, May 2000
   Elizabeth Warren , Teresa Sullivan and Melissa B. Jacoby
   Harvard Law School , University of Texas at Austin - Office of the Vice President and Dean of Graduate Studies and University of North Carolina at Chapel Hill - School of Law
   Date Posted:May 9, 2000
   Last Revised:July 29, 2000
   Accepted Paper Series
   604 downloads
10. The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
    Frederick M. Abbott
    Florida State University College of Law
    Date Posted:October 8, 2001
    Last Revised:October 15, 2001
    Working Paper Series
    542 downloads

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Ethics Code for QIOs

From Modern Healthcare (Fri., 01/27/2006):

The American Health Quality Association, the trade group for Medicare quality improvement organizations, released a code of conduct addressing board structure, board and executive compensation, conflicts of interest and travel reimbursement. The AHQA asked members to promptly adopt the code, approved by its board last month. So far, 17 of 40 QIOs in the group have done so, an official said. According to the code, "consumer representation is essential" on QIO boards, and organizations should seek mechanisms to "continuously infuse" board deliberations with new and different perspectives. In addition, at least one-third of board members should not be compensated by the QIO or contractors of the organization.

Click to read the press release from AHQA and the AHQA Policy. [tm]

Health Care and the Bush Administration

Last week, it was reported (Washington Post, 1/25/06) that "President Bush will propose [in the FY 2007 budget, due out in about two weeks] that Americans be allowed to take tax deductions on more of their out-of pocket medical expenses, as part of an initiative the White House believes will rein in soaring health costs by shifting responsibility toward individuals."  The tax break is part of a three-pronged approach described as follows:

• The new tax breaks for personal health spending, to be included in the 2007 budget Bush will release in less than two weeks, are designed to help the uninsured and to allow people with insurance to write off a greater portion of the money they spend on co-payments, deductibles and care that is not covered. Under current tax rules, people can deduct medical expenses only if they exceed 7.5 percent of their adjusted gross income.
• The president also plans to call for an expansion of health savings accounts, an idea long favored by conservatives and approved by Congress slightly more than two years ago, in which people who buy bare-bones insurance policies are allowed to put money into tax-free accounts for their medical expenses.
• In addition, Bush intends to propose changes to allow people to keep their insurance, without extra cost, if they change jobs or decide to start a business, building on a decade-old law that was designed to make health coverage more "portable."

According to the Post article,

The idea of tax breaks for out-of-pocket medical expenses is borrowed from a recent book by three academics, including two with whom Hubbard has close ties: R. Glenn Hubbard, a former chairman under Bush of the White House Council of Economic Advisers, and John F. Cogan, a White House economic adviser when Ronald Reagan was president. Their book, "Healthy, Wealthy & Wise," calls for all such spending to become tax-deductible. The authors estimate that the revision in tax law would cost $28 billion a year when phased in completely, although they predict much of that lost revenue would be regained through ripple effects the change would create in the health care system.

Several outside health policy experts, both Democrat and Republican, speculated yesterday that the president is unlikely to make such a large financial commitment at a time when the administration has pledged to halve a $400 billion budget deficit during the next several years. Joseph R. Antos, a scholar at the conservative American Enterprise Institute, predicted that Bush will "open this particular door. But how far does it open? We'll see."

When this report first appeared, I wondered how they could possibly control cost increases.  All of the proposals should increase demand for health care services, which can be expected to fuel increases in cost, not decreases.  And expanding the existing tax subsidy for health insurance to include the self-insured and out-of-pocket expenditures would continue the "masking effect" that shields consumers from the true costs of their health-care decisions, not the other way around, as claimed by the President's people.

On Sunday, the New York Times' Robert Pear offered some additional reporting on the President's State of the Union address (scheduled for Tuesday evening) and picked up on some expert opinions that express doubts similar to mine.  [tm]

$10 Million from Gates Foundation to U of Toronto

Ethics in the third world got a shot in the arm last week in the form of a $10 million grant to the University of Toronto.  Here's the news from the Bioethics.net blog:

The University of Toronto has launched a new effort in the developing world, the product of their continuing effort to expand bioethics - considerably - in terms of its focus on the world's health at large. The program is funded by the Bill and Melinda Gates foundation and others for $10 million. Toronto has become the leading program in the world in executing large-scale initiatives in bioethics and this is another great example.

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Cartoon Roundup

The Supreme Court's decision in Gonzales v. Oregon (04-623, 01/17/06) seems to have captured the imagination of political cartoonists the past couple of weeks.  Copyright considerations militate against reproducing the cartoons here, but Slate (presumably under license) has loads of 'em, including 'toons by Jack Ohman (The Portland Oregonian), Dana Summers (Orlando Sentinel), Gary Varvel (Indianapolis Star), and Chuck Asay (Colorado Springs Gazette Telegraph).

Bid flu is still popular, too, and has taken a (suprise) decidedly political turn in recent week, e.g.: Steve Breen (San Diego Union-Tribune), Eric Allie (Cagle.MSNBC.com), Bon Gorrell (National/Syndicated), Jack Ohman (The Portland Oregonian), and 3 from Stephane at Bangkok's The Nation (1-2-3).

And the Medicare prescription drug plan pulled down its fair share of ridicule: M.E. Cohen (humorlink.com), Jimmy Margulies (The New Jersey Record), Jeff Parker (Florida Today), and Mike Keefe (Denver Post).

Let's end with one on U.S. health care policy and the Iraq war from Bulgaria's Christo Komarnitski.  [tm]

Docs Are Urged to Reject Gifts from Pharma

As reported in the on-line N.Y. Times, physican-authors in JAMA this week are calling for an end to the pharmaceutical companies' largesse, claiming that "[t]he free gifts, drugs and classes that pharmaceutical and medical device makers routinely give doctors undermine good medical care [and] hurt patients. . . .  But Dr. David Blumenthal, one of the article's co-authors, said it was 'not very likely' that many in medicine would listen to the group." 

The article provides a non-exclusive list of the kinds of inducements "that must be addressed":

gifts, even of relatively small items, including meals; payment for attendance at lectures and conferences, including online activities; CME for which physicians pay no fee; payment for time while attending meetings; payment for travel to meetings or scholarships to attend meetings; payment for participation in speakers bureaus; the provision of ghostwriting services; provision of pharmaceutical samples; grants for research projects; and payment for consulting relationships. 

The link the the JAMA article (which requires a subscription to view the full piece) is here.  [tm]

Add Switzerland to List of PAS-Friendly States?

There's an oldish BBC report (Aug. 12, 2002) that reports on a group (Dignitas) that helps patients commit suicide with the full knowledge and acquiescence of Swiss authorities.The story hit the AP and Bioethics.net in December 2005, and then the BMJ in its January 7, 2006, issue, when a Swiss hospital, Vaud University Hospital Center, announced that it would allow another of Switzerland's four assisted-suicide organizations (Exit Society) to assist in the suicides of patients who have been admitted to the hospital and can no longer go home.  [tm]

GAO on Nursing Home Quality and Safety

"Nursing Homes: Despite Increased Oversight, Challenges Remain in Ensuring High-Quality Care and Resident Safety." GAO-06-117, December 28.

• Report - http://www.gao.gov/cgi-bin/getrpt?GAO-06-117
• Highlights - http://www.gao.gov/highlights/d06117high.pdf

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SCOTUS Disallows DEA Action Against Oregon Physicians

The Supreme Court this morning handed down a 6-3 decision in Gonzales v. Ashcroft (No. 04-623), the closely followed case that considered whether DOJ and DEA could penalize Oregon physicians who prescribe drugs under the Death With Dignity Act to patients who have stated their intent to commit suicide.  The Justices concluded that the "Ashcroft Memo" rested upon ""authority claimed by the attorney general [that] is both beyond his expertise and incongruous with the statutory purposes and design."  Chief Justice Roberts and Justice Thomas joined the dissenting opinion of Justice Scalia, who wrote, "If the term 'legitimate medical purpose' has any meaning, it surely excludes the prescription of drugs to produce death."

• Justice Kennedy's opinion for the majority.
• Justice Scalia's dissenting opinion.
• Justice Thomas' separate dissent. 
• Press summaries:
  • Bloomberg
  • BBC News
  • Reuters
  • AP

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Another Case of Fabricated Data

Last month, the esteemed journal Science learned it was punked by Korean stem-cell researcher Hwang Woo-suk, two of whose articles were "unconditionally retracted" by the journal when it was learned that his "breakthroughs" were in fact pure fiction.

Now comes "[a] Norwegian cancer researcher [who] has admitted fabricating data published in a renowned international medical journal, officials in Norway said Saturday." [AP/MyWay]  The strategy director of Norway's Comprehensive Cancer Center states: "'All of it was fabricated. It was not manipulation of real data - it was just complete fabrication.'"  The journal (Lancet) in which the article was published in October 2005 has not yet responded to the story. If the article in question is "Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control study" (abstract) [The Lancet 2005; 366:1359-1366], there are 14 co-authors of this piece, including researchers from M.D. Anderson and Weill Medical College of Cornell University.  This is going to get very messy. [tm]

Diabetes: Series in The NY Times

Last week, the Times ran a 4-day series on diabetes.  In addition to some public-health insights and patient stories, the series included a fascinating article on reimbursement policy and the perverse incentives it creates for practitioners who treat this disease.  Here are the titles and links:

• East Meets West, Adding Pounds and Peril
  By MARC SANTORA
  Asians are acutely susceptible to diabetes, a factor that is compounded by recent immigrants' collision with American diet.
  Slide Show: The Gathering Storm
• In the Treatment of Diabetes, Success Often Does Not Pay
  By IAN URBINA
  Doctors and hospitals profit by treating complications of diabetes but lose money when they try to prevent them.
  Graphic: Good Care, Bad Business
• Living at an Epicenter of Diabetes, Defiance and Despair
  By N. R. KLEINFIELD
  In East Harlem, an invisible web of diabetes stretches throughout the neighborhood, touching nearly every life with its menace.
• Diabetes and Its Awful Toll Quietly Emerge as a Crisis
  By N. R. KLEINFIELD
  An estimated 800,000 adult New Yorkers now have diabetes, and city health officials describe the problem as an epidemic.
• By the Numbers: One Scourge in 2 Forms
  Type 1 and Type 2 diabetes are diseases in which the amount of sugar in the blood rises to dangerous levels. Neither is truly curable.

Speaking of health policy and incentives, Paul Krugman does a good job of parsing the numbers in today's op-ed.  [tm]

Top 10 SSRN Downloads

The rankings haven't changed much:

1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 22, 2000
   Last Revised:June 10, 2002
   Working Paper Series
   8836 downloads
2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 16, 2001
   Last Revised:June 5, 2001
   Working Paper Series
   5589 downloads
3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
   Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
   Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
   University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
   Date Posted:October 25, 2005
   Last Revised:December 5, 2005
   Accepted Paper Series
   1569 downloads
4. What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
   Stanford Law Review, Vol. 52
   Jonathan Zittrain
   Oxford University
   Date Posted:March 9, 2000
   Last Revised:June 30, 2000
   Accepted Paper Series
   1181 downloads
5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
   Alan O. Sykes
   University of Chicago Law School
   Date Posted:February 19, 2002
   Last Revised:March 7, 2002
   Working Paper Series
   904 downloads
6. Incentives in Nonprofit Organizations: Evidence from Hospitals
   James A. Brickley and R. Lawrence Van Horn
   Simon School, University of Rochester and Simon School, University of Rochester
   Date Posted:February 14, 2000
   Last Revised:April 2, 2002
   Working Paper Series
   750 downloads
7. Unintended Consequences of Medical Malpractice Damages Caps
   NYU Law Review, Vol. 80, pp. 391-512, May 2005
   Catherine M. Sharkey
   Columbia University - Columbia Law School
   Date Posted:February 17, 2005
   Last Revised:June 1, 2005
   Accepted Paper Series
   745 downloads
8. Bayh-Dole Reform and the Progress of Biomedicine
   Law and Contemporary Problems, Vol. 66, No. 1
   Arti K. Rai and Rebecca S. Eisenberg
   Duke University School of Law and University of Michigan Law School
   Date Posted:November 23, 2002
   Last Revised:February 6, 2003
   Accepted Paper Series
   730 downloads
9. Medical Problems and Bankruptcy Filings
   Norton's Bankruptcy Adviser, May 2000
   Elizabeth Warren , Teresa Sullivan and Melissa B. Jacoby
   Harvard Law School , University of Texas at Austin - Office of the Vice President and Dean of Graduate Studies and University of North Carolina at Chapel Hill - School of Law
   Date Posted:May 9, 2000
   Last Revised:July 29, 2000
   Accepted Paper Series
   602 downloads
10. The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
    Frederick M. Abbott
    Florida State University College of Law
    Date Posted:October 8, 2001
    Last Revised:October 15, 2001
    Working Paper Series
    540 downloads

[tm]

Health Affairs: Hospitals & Their Mission

Starting the new year off with a bang, Health Affairs' Jan./Feb. issue is full of material that will keep the rest of us busy reading and digesting.  The theme of the issue is "U.S. Hospitals: Mission vs. Market."  Here is editor John Iglehart's introduction to the contents:

. . . Although hospitals have been remarkably successful in navigating the shoals of the ever-changing U.S. health care system, new pressures lie ahead. Two of the most formidable are multiple forces that seek to eliminate the cross-subsidies sustaining hospitals’ less profitable services and an increasing number of physicians who are shifting their patients to freestanding ambulatory care centers and specialty hospitals in which they often have an investment. The first seven papers in this thematic issue on hospitals are a primer on the issues surrounding cross-subsidization and the way hospitals price their services. . . . No issue has the U.S. hospital community more exercised than the increase in the number of specialty hospitals. These are the latest in a wave of accelerating efforts by physicians to break out of the traditional hospital setting in search of more income and greater autonomy. Four papers here address the issues surrounding for-profit specialty hospitals, which are proliferating particularly in states without certificate-of-need laws.

Four of the articles are free-access:

• The Precarious Hospital Pricing System
  Christopher P. Tompkins, Stuart H. Altman &
  Efrat Eilat
• Hospital Pricing: Chaos Beyond A Veil Of Secrecy
  Uwe E. Reinhardt
• Hospital Quality Reporting & Medicare
  Charles N. Kahn III & Colleagues
• Specialty Hospitals: Problem Or Symptom?
  Stuart Guterman

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Bird Flu Pandemic Teleconf

We've missed one of five installments, but perhaps the best is yet to come.  Here's the straight dope:

Pandemic Flu Teleconference Series. The American Health Lawyers Association, CDC, and others will host "Planning for Pandemonium: Preparing for Pandemic Flu and Other Disasters," a five-part teleconference series. Parts I through IV will be held from 1:00-2:30 p.m. EST on January 4, 12, 23, and 31, 2006. Part V will be held from 12:30-2:00 p.m. EST, on February 24, 2006. For more information, visit here.

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Should We Create a Market for Transplantable Organs?

The question has been debated endlessly.  My colleague Greg Crespi's tenure piece (more than 10 years ago) suggested a futures market for organs might work nicely.  Many others have chimed in over the years. This month, Chicago's Gary Becker and the Seventh Circuit's Richard Posner make the case nicely over at their blog. There isn't much new in their discussion, though I like Posner's extended analysis of why donation rates are higher in opt-out countries than in opt-in countries. 

For those who are aghast at the classical economic analysis of organ shortages and the beneficial effects of a monetary market in organs, one commenter offers this tip:

A legal non-monetary market for organs exists in the United States. It's called LifeSharers. Anyone can participate for free at http://www.lifesharers.org.

When you join LifeSharers you agree to donate your organs when you die, and you also agree to offer them first to fellow members. In return you get preferred access to the organs of all other members.

This is an excellent trade. By giving up your organs after you can't use them anymore, you increase your chances of getting an organ if you ever need one. Given that more than half of the people who need a transplant die before they get one, this is a significant benefit.

By creating a pool of organs available first to members, LifeSharers creates an incentive for non-donors to donate and to join LifeSharers. This incentive gets more powerful as the number of members increases.

LifeSharers uses a form of directed donation that is legal under federal law and under the laws of all 50 states. Parents can enroll their minor children. No one is excluded because of any medical condition.

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Article III Groupie Is Back

"Underneath Their Robes" is just about what it sounds like: a snappy, irreverent blog that actually has some of the most up-to-date info on what's happening on the federal bench (including nuggets of clerkship news), delivered by a babe named Article III Groupie.  She (A3G, that is, not her alter ego, former AUSA David Lat) disappeared from view after a New Yorker profile let the proverbial cat out of the bag, but she's back, sassy as ever.  Give her blog a try: You'll be in good company (Circuit Judge Richard Posner, for example, is a fan).

(OK, this has nothing to do with health law, except that federal judges occasionally have to decide health-law issues.  Close enough.  You can thank me later.)  Back to health law.  [tm]

D.C.'s Drug Pricing Act Held Unconstitutional

From the Jan. 2 issue of AIS's Managed Care Week:

U.S. District Judge Richard Leon on Dec. 22 blocked Washington, D.C.’s Prescription Drugs Excessive Pricing Act. The law would have made it illegal for pharmaceutical companies to sell patented medicines at an excessive price, defined as 30% more than the prices in four other developed countries. In the case of Pharmaceutical Research and Manufacturers of America (PhRMA) v. District of Columbia, et al., Leon ruled that the act went against the will of Congress and violated constitutional protections of interstate commerce. D.C. Council member David Catania (I) had sponsored the bill, which the D.C. council passed unanimously and was signed by D.C. Mayor Anthony Williams (D). Catania’s office said he “is eager to continue to press the issue” of controlling drug costs. Billy Tauzin, PhRMA president and CEO, said the organization was pleased with the judge’s ruling (news release here).

Opinion is here.  The D.C. ordinance is identified in the opinion as D.C. Act 16-174 in the opinion, but all I could find on-line was two versions of D.C. Act 16-114 and an unnumbered "Enrolled Original."  I am linking to the latter; this should give you at least an idea of what the law says.  And it is something of a disgrace that the D.C. City Council doesn't provide a legislative page that gives users easy access to the Council's session laws. Very few states have failed to meet this basic obligation of democratic governments . . . . [tm]

NJ Medical & Dental School Placed Under Federal Monitor

The NY Times reported this week that the University of Medicine and Dentistry of New Jersey agreed to place its finances and management under the control of a federal monitor in order to avoid criminal charges in connection with Medicaid improprieties going back years.  Herbert Stern, a former federal prosecutor and district judge, will fill the role and collect $500 per hour for his trouble, according to a sidebar article. [tm]

Harvard Public Health School: 2005 was "The Year of Bird Flu"

That was the top story in 2005, according to Harvard's World Health News.  HWHN tracks the major developments, as reported in the pages of the Atlanta Journal-Constitution, Washington Post, International Herald Tribune, the New York Times, and the Guardian (London). [tm]