Health Lawyers News, June 22

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

• OIG Finds Sale Of Part Of Physician-Owned ASC To Hospital Could Trigger Sanctions. The sale of part of an ambulatory surgery center (ASC) to a nonprofit hospital could potentially generate prohibited remuneration under the Anti-Kickback Statute and could lead to the imposition of administrative sanctions, according to Department of Health and Human Services Office of Inspector General (OIG) Advisory Opinion No. 07-05 posted June 19. Full Story


• President Bush Vetoes Stem Cell Bill, Calls For Expanding Alternative Research. President Bush vetoed June 20 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells. The measure cleared by a vote of 247-176 in the House and 63-34 in the Senate, short of the two-thirds majorities needed to override the veto. Full Story

Articles & Analyses

• Impact Of IRS’s Draft Redesigned Form 990 On Tax-Exempt Healthcare Organizations, By James R. King and Gerald M. Griffith, Jones Day


• Physician Quality Reporting Initiative Begins July 1, 2007, By Timothy J. Cahill, Porter Wright Morris & Arthur, LLP

Current Topics

• Antitrust
  1. DOJ Reaches Settlement With Federation Of Physicians And Dentists Resolving Allegations Of Antitrust Violations
  2. Illinois AG Alleges Clinics Conspired To Turn Away Medicaid Patients In Effort To Increase Reimbursement Rates


• Criminal Law
  Sixth Circuit Upholds Medicare Fraud Convictions, But Remands For Evidentiary Hearing On Documents Withheld By Government


• ERISA
  U.S. Court In Texas Remands Hospital's Action Against Managed Care Firm To State Tribunal, Finding ERISA Did Not Completely Preempt Claims


• Food and Drug Law
  1. U.S. Court In New York Upholds Plavix Patent, Enjoins Marketing Of Generic
  2. U.S. Court In Minnesota Allows Product Liability Claims Against ICD Device Manufacturer To Proceed To Trial


• Fraud and Abuse
  1. Update
  2. D.C. Circuit Finds Renal Physicians Association Lacks Standing To Bring Lawsuit Challenging Stark Safe Harbor Rule
  3. OIG Withdraws Proposed Rule On Exclusion Authority For Entities Submitting Claims Containing Excessive Charges
  4. OIG Approves Texas’ False Claims Act


• Healthcare Access
  Study Finds 689,000 Low-Income Children Eligible For SCHIP, DHHS Says


• Healthcare Spending
  Senate Budget Panel Considers Options For Controlling Healthcare Costs


• Hospitals and Health Systems
  1. Grassley Urges CMS To Collect Better Data From Hospitals On Uncompensated Care
  2. Baucus Questions CMS About Standards Of Safety And Care At California Hospital


• Insurance
  Connecticut Appeals Court Finds Liability Insurer Obligated To Cover Claim Made During Required Extension Period


• Medicaid
  CMS Releases Timeline For Implementing New AMP-Based FULs For Medicaid Prescription Drug Reimbursements


• Medical Malpractice
  Florida Appeals Court Finds Expert Opinion That Surgery Unnecessary Was Sufficient To Create Triable Issue


• Medicare
  1. Health Insurers Agree To Suspend Marketing Of Medicare PFFS Plans
  2. MedPAC Recommends Ways To Improve Efficiency In Medicare
  3. U.S. Court In New Jersey Refuses To Reconsider Its Previous Decision Affirming Finding That Provider Was Overpaid By Medicare
  4. Baucus, Grassley Oppose Speculative Cuts In Proposed Medicare Payment Rule
  5. Medicare To Expand Testing Of Personal Health Records Tools
  6. OIG Finds Medicare Beneficiaries Have Broad Access To Retail Pharmacies That Participate In Medicare Part D Program
  7. CMS Extends Timeline For Publication Of Provider Appeals Rule
  Study Examines Impact Of Medicare Part D On Nursing Homes And LTCPs


• News in Brief
  1. CHA Releases Draft "Vision" For Healthcare Reform
  2. CMS Enhances Hospital Compare Website

Table of Contents © AHLA, 2007. Reprinted by permission.

Bush vetoes stem-cell-funding bill

As promised, the President dropped S. 5 into the trash today.

• S. 5, the “Stem Cell Research Enhancement Act of 2007"


• President's veto message


• President's comments about his veto

As predicted, Bush made adult-stem-cell research the linchpin of his argument.

Amazing. Or not.

New Orleans grand jury moving in on Memorial Medical Center doctor

Disturbing news from CNN out of New Orleans:

(CNN) -- Two nurses accused in the post-Katrina deaths of four patients at New Orleans' Memorial Medical Center have been offered immunity to testify before a special grand jury, sources close to the investigation tell CNN.

Sources also told CNN the grand jury has been told as many as nine patients may have died after being administered what Louisiana's attorney general called a "lethal cocktail" of medications by hospital staff.

Family members said staffers used the drugs to kill patients so caregivers could flee appalling conditions inside the hospital after the storm.

Dr. Anna Pou and nurses Cheri Landry and Lori Budo were arrested in July 2006 after a 10-month investigation. Louisiana Attorney General Charles C. Foti charged them with second-degree murder.

Sources close to the investigation told CNN the two nurses are expected to testify before the grand jury in the next two weeks, which could signal a possible wrapping up of the case. It could also signal the main target of the investigation is Pou, a physician who was under contract with Memorial Medical Center when Katrina struck.

It's extremely important not to rush to judgment in this case. The report says "Family members said," and we don't know what the nurses are going to say when they testify. The offer of immunity is no doubt a worrisome turn of events for Dr. Pou, because the offer wouldn't have been made unless the DA thought they had something to give in exchange. But the last I heard (in her interview on "60 Minutes"), Dr. Pou persuasively denied that she killed patients at Memorial during Katrina. (Thanks to Dr. Mo Bernstein at USC for alerting me to this story.)

Happy Father's Day

Pain treatment and the fine line between therapy and felony

In this morning's NY Times Magazine:

When Is a Pain Doctor a Drug Pusher?
By TINA ROSENBERG
Published: June 17, 2007
Those treating pain make subjective choices about dosage. When a doctor gets it wrong, is it a mistake or a felony?

For a variety of reasons, and for a variety of patients (not only patients who have chronic and severe pain) and their doctors, the article includes some important facts, e.g.:

[F]or many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.

It’s a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction — which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful — occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn’t mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. “Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older,” says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.

The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)

It's a well-balanced article that discusses all the reasons why 50% of patients who experience serious chronic pain remain undermedicated: poor medical school training, physicians who are as uninformed as the general public, well-intentioned but counter-productive laws such as Washington's, medical licensing boards that don't understand that high-dose opioids do not equal abuse or malpractice, and fear of criminal prosecution.

Ellen Goodman on stem cells

Ellen Goodman's column on the stem-cell breakthrough (a "breakthrough" if you're a mouse anyway) today in the Boston Globe hit just the right notes:

• Congress' bill to increase federal funding for stem-cell research (S. 5) is heading to the President, who -- if he keeps his promise, and who thinks he won't? -- veto the bill in order to protect the embryos that would otherwise be destroyed for their stem cells. The research report on reprogramming mouse skin cells to act like pluripotent stem cells, writes Goodman, will surely be a part of the president's spin ("see, told you so, we don't actually need to use human embryos").


• That's possibly good politics (unless everyone sees through it) but bad science. First, we don't know how to do this in humans, or even whether we can do this in humans. "Second, this breakthrough actually began with scientists studying the genes in mice embryos. Anybody who wants to repeat the work in humans will have to use human embryos to learn the same mechanics."

So this well-timed announcement about the switchability of skin cells in mice shouldn't for a minute provide cover for a presidential veto of this bill.

In health care, high cost not necessarily the same as high quality

Just an excellent article in today's NY Times about a study that shows significant disparities between health care charges and health care quality. This is a must read for teachers of health care law survey courses. Here's a bit from the early paragraphs:

Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a hospital study set for release today.

In a Pennsylvania government survey of the state’s 60 hospitals that perform heart bypass surgery, the best-paid hospital received nearly $100,000, on average, for the operation while the least-paid got less than $20,000. At both, patients had comparable lengths of stay and death rates.

And among the 20 hospitals serving metropolitan Philadelphia, two of the highest paid actually had higher-than-expected death rates, the survey found.

Hospitals say there are numerous reasons for some of the high payments, including the fact that a single very expensive case can push up the averages.

Still, the Pennsylvania findings support a growing national consensus that as consumers, insurers and employers pay more for care, they are not necessarily getting better care.

Expensive medicine may, in fact, be poor medicine.

“For most consumers, the fact that there is no connection between quality and cost is one of the dirty secrets of medicine,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that provide health care coverage for workers.

Some Pennsylvania employers said the state’s findings, based on data from 2005, might put more pressure on insurance carriers and hospitals to start demonstrating the value of care. “It now provides us a tool to have a serious dialogue with our carriers,” said Mark Dever, a benefits consultant for Duquesne Light, a regional utility in Pittsburgh.

“We have to question,” he said. “There’s a big difference in price — why?”

The report by the Pennsylvania Health Care Cost Containment Council, a state agency, provides a rare public glimpse of detailed information about hospital payments and patient outcomes. And the seemingly random nature of the payments is striking.

Although federal Medicare payments are largely fixed, they varied somewhat among the Pennsylvania hospitals surveyed. The far greater disparity involved commercial insurers, which must negotiate their rates hospital by hospital.

And the survey found that good care can go unrewarded. One Philadelphia area hospital, Main Line Health’s Lankenau center, which performs a large number of bypass surgeries and has a high success rate, according to the survey, was paid an average of $33,549 by private insurers. That was less than half the nearly
$80,000 in average payments received by the other hospitals, with poorer track records.

“It doesn’t make sense,” said Marc P. Volavka, the executive director of the Pennsylvania Health Care Cost Containment Council. “Certain payers are paying an awful lot for poor quality.”

He points to some of the experiments to change how hospitals are paid, like Geisinger Health System in central Pennsylvania, which is trying to demonstrate its commitment to high-quality care by offering a 30-day warranty on its cardiac surgery.

“The current reimbursement paradigm is fundamentally broken,” said Dr. Ronald Paulus, an executive with Geisinger, who says there is no current financial incentive
for a hospital to provide the kind of care that leads to better outcomes and lower payments.

What's up when the rich and well-insured can't get standard-of-care? You could teach an entire health law course on the basis of this one article, if you wanted to explore the in's and out's of this article.

The study is here and the press release about the study is here.

SCOTUS: Home health workers not entitled to overtime pay

The Supreme Court has held that home healthcare workers are not entitled to overtime pay (Long Island Care at Home, Ltd. v. Coke).

Here's AHLA's excellent media review of the Court's decision:

• In a unanimous decision in Long Island Care at Home, Ltd. v. Coke (pdf), the Supreme Court found that home healthcare workers employed by a private company or employer are not covered by laws on overtime pay or the minimum wage because they are "companion workers." ABC World News (6/11, story 9, 0:20, Gibson) noted that the decision "has implications for the nation's one million home healthcare workers and the people for whom they care."


• The Washington Post (6/12, D2, Barnes) reports that yesterday the Supreme Court ruled "that workers in the fast-growing home-care industry are not entitled to overtime pay." The court's decision upheld "a 1975 Labor Department regulation," which exempts "workers paid by third parties from minimum-wage and maximum-hour rules." The high court said the regulation "was a valid exercise of the power given to the agency by Congress."


• The Chicago Tribune (6/12, Rose) adds, "The decision came in a test case by Evelyn Coke, a 73-year-old Jamaican immigrant who, with union backing, sued a Long Island, N.Y.-based home-care agency."


• The AP (6/12) writes, "Lawyers for Coke challenged the Labor Department regulation, and the 2nd U.S. Circuit Court of Appeals in New York City ruled in the workers' favor," saying "it was 'implausible' that Congress would have wanted the Labor Department to wipe out protection for an entire category of workers."


• The Los Angeles Times (6/12, Savage) reports, "With an estimated 1 million workers now assisting the elderly and the injured in their homes, unions and civil rights groups had urged the justices to repeal the rule because it deprives many of the nation's lowest-paid workers of a decent wage. These employees tend to be women and minorities and often work all night, but they do not earn enough to rise above the poverty level, the advocates said."


• However, UPI (6/12) reports, "The issue is not that home-care agencies do not want to pay better wages, said New York State Association of Health Care Providers President Phyllis Wang, but because Medicare and Medicaid rates are set by the government, home healthcare agencies cannot raise rates like more traditional businesses in order to provide higher wages and benefits."


• Also, a separate AP (6/12, Yost) story notes that "Coke's former employer, Long Island Care at Home Ltd., says it would experience 'tremendous and unsustainable losses' if it had to comply with federal overtime requirements."


• Moreover, the New York Times (6/12, B3, Greenhouse) adds, "The Bloomberg administration filed an amicus brief in the case, arguing that a victory for Ms. Coke could force the city, state and federal governments, which finance home care through Medicaid, to pay $250 million more a year to the 60,000 home-care attendants in the city." The Times continues, "The main question in the case was whether several 1974 amendments to the Fair Labor Standards Act (FLSA) exempted home-care aides employed by agencies from minimum-wage and overtime protections. In contrast, all sides agreed that those amendments exempted aides hired directly by the elderly or infirm." Writing for the court, Justice Stephen G. Breyer "acknowledged that the Labor Department had issued conflicting regulations. One says that home-care aides employed through agencies or other third parties are exempt from protections under the Fair Labor Standards Act, and another that aides should not be exempt from minimum-wage and overtime protections unless they work in the home of their employer."


• USA Today (6/12, Biskupic) reports, "AARP lawyer Sarah Lock said the decision would make it more difficult for families to find attendants to undertake personal care of the ill and elderly, such as bathing and dressing. Lock called the decision a 'great disappointment' for AARP members of the baby-boom generation who are caring for aging parents and also concerned with their own needs." The "Service Employees International Union (SEIU), which backed Coke, and other advocates for home-care aides said they would push for federal legislation to lift the exemption or encourage a new administration to interpret the FLSA to cover the attendants." Ruling won't affect every state.


• Meanwhile, Bloomberg (6/12, Stohr) reports, "At least 10 states impose their own minimum-wage and overtime requirements on providers that employ home-care workers."


• For example, the Philadelphia Inquirer (6/12, Von Bergen) notes that "yesterday's decision will have little bearing on two local overtime cases involving home-care workers," because "Pennsylvania wage laws do not have the same ambiguities as the federal law. ... Philadelphia-area home-health employees, working with the Service Employees International Union, have filed lawsuits against two nonunion home-care agencies -- Lee's Industries Inc., of Germantown, and Total Health Home Care Corp., of Upper Darby."


• The Wall Street Journal (6/12, A12, Bravin, Anderson) also notes the Supreme Court's decision.

"Boarding" in EDs on the rise, according to survey

The number of uninsured (and underinsured) continues to rise. Where do these patients go for their health care? The most obvious answer is emergency departments, which are required by Medicare to screen for emergency conditions and to stabilize any they find, regardless of ability to pay. Even those without an emergency condition may get their sore throat and fever treated, or perhaps they will be triaged to the ambulatory care clinic down that hallway and to your left. Meanwhile, hospitals continue to close their emergency rooms after years of struggling to provide care for those uninsured patients, reducing the emergency-care capacity of one community after another.

One of the consequences of this pattern is that the remaining emergency rooms operate at or near capacity for far more hours of far more days than ever before -- over capacity, too, forcing emergency room personnel to treat patients in hallways while they wait for an examining room or in-patient room to open up. The practice is called "boarding," and according to a recent survey of doctors in NY, NJ, and CT conducted by the American College of Emergency Physicians, "boarding has increased significantly in recent years." Yesterday's NY Times had the story, which explored the quality-of-care implications of the practice.

New dispute over frozen embryos

Just in time for Monday's 4th Bioethics class, here's a Dallas Morning News article on the dispute in Austin over the disposition of frozen embryos, involving a divorcing couple and their interrupted plans for an IVF pregnancy. (The article exemplifies one of my pet peeves about journalists' tangential (at best) understanding of legal process. In its last paragraph, the article states, "Arguments before the Texas Supreme Court in the Roman case have not yet been set," but nowhere this statement does the reporter ever say what the outcome was at the trial court level (Family Court? Probate Court? In what county?) or the intermediate appellate level.)

This is a replay of the famous Tennessee Supreme Court case, Junior Davis v. Mary Sue Davis, which was the first case to say that, absent extraordinary circumstances, the ex-spouse who wants to avoid parenthood should ordinarily be allowed to do so:

In summary, we hold that disputes involving the Disposition of preembryos produced by in vitro fertilization should be resolved, first, by looking to the preferences of the progenitors. If their wishes cannot be ascertained, or if there is dispute, then their prior agreement concerning Disposition should be carried out. If no prior agreement exists, then the relative interests of the parties in using or not using the preembryos must be weighed. Ordinarily, the party wishing to avoid procreation should prevail,
assuming that the other party has a reasonable possibility of achieving parenthood by means other than use of the preembryos in question. If no other reasonable alternatives exist, then the argument in favor of using the preembryos to achieve pregnancy should be considered. However, if the party seeking control of the preembryos intends merely to donate them to another couple, the objecting party obviously has the greater interest and should prevail.

Most courts have followed the Tennessee court's lead in this arena.

As for the Texas case, here is the appellate court' s opinion (the husband won: "We hold that the embryo agreement provides that the frozen embryos are to be discarded in the event of divorce. By awarding the frozen embryos to Augusta, the trial court improperly rewrote the parties’ agreement instead of enforcing what the parties had voluntarily decided in the event of divorce. Accordingly, the trial court abused its discretion in not enforcing the embryo agreement. ") and a link to the Supreme Court's docket sheet in Roman v. Roman. Petitioner's reply brief on the merits is due June 15th, though the parties in this case have received many extensions of time during their year at the Supreme Court; all told, the case has been kicking around for almost 5 years (nearly as long as the Romans' marriage lasted). More to follow . . . .

Health Lawyers News, June 8

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

• More Questions Surface About FDA's Response To Avandia Risks
  The House Oversight and Government Reform Committee held a hearing June 6 to probe the Food and Drug Administration’s (FDA's) role in evaluating the safety of the diabetes drug Avandia. Full Story
• House Passes Stem Cell Bill
  The House cleared June 7 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells in a 247-176 vote. The Senate cleared the measure in April by a vote of 63-34. Full Story

Articles & Analyses

• The Medicare Competitive Bidding Program For Durable Medical Equipment, Prosthetics, Orthotics, And SuppliesBy Carol Loepere, Elizabeth Carder-Thompson, Bob Hill, and Debra McCurdy, Reed Smith LLP
• Proposed Inpatient PPS Rule To Impact Specialty Hospitals: CMS Continues To Implement Its “Strategic And Implementing Plan For Specialty Hospitals”, By Thomas E. Dowdell and Lara E. Parkin, Fulbright & Jaworski, LLP

Current Topics

• Antitrust
  U.S. Court In Tennessee Refuses To Dismiss Nurses’ Claims Alleging Hospitals Conspired To Depress Wages
• Arbitration/Mediation
  Arkansas High Court Upholds Denial Of Medical Corporation’s Motion To Compel Physician To Arbitrate Claims In Employment Dispute
• EMTALA
  U.S. Court In Virginia Holds State Hospital's Agreement To Comply With EMTALA Did Not Waive Virginia's Sovereign Immunity
• ERISA
  1. U.S. Court In Missouri Finds ERISA Preempts Plan Beneficiaries' Suit Against HMO For Charging Copays In Violation Of State Law
  2. Eighth Circuit Reverses Lower Court Decision Upholding Health Plan Insurer’s Retroactive Rescission Of Plan Participant’s Coverage
• Food and Drug Law
  1. FDA Creates Communications Advisory Committee
  2. Health Subcommittee Will Mark Up Pharmaceutical, Device Bills Next Week
• Fraud and Abuse
  1. Eleven Arrested In Alleged $5 Million Billing Scheme For HIV Infusion Treatments
  2. Update
  3. U.S., Texas Reach $15 Million Settlement With Hospital District To Resolve FCA Claims
• Health Information Technology
  New Coalition Will Lobby For Immediate Deployment Of Health Information Technology
• Health Policy
  Business Roundtable Releases Principles For Healthcare Reform
• Healthcare Spending
  NGA-NASBO Reports Stable Fiscal Conditions For States In FY 2007, But Projects Increasing Strain On Budgets In FY 2008
• Hospitals and Health Systems
  Texas Supreme Court Finds Hospital May Not Maintain Lien Against Patient For Charges Not Covered By Workers Comp
• Individual/Patient Rights
  Sixth Circuit Strikes Down Michigan Abortion Law
• Insurance
  Maine High Court Rejects Payors’ Challenge To Calculation Of “Cost Savings” From Health Program Used To Set Offset Payments
• Medicaid
  OIG Finds AMPs For Most Drugs Remained Fairly Stable In Quarterly Comparison
• Medicare
  U.S. Court In District Of Columbia Stays Hospitals’ Action Seeking Reopening Of Medicare Cost Reports
• News in Brief
  AMA Consortium Approves 10 New Physician Quality Measures
• Physicians
  1. Physician Survey Finds Medicare Payment Cuts Will Affect Access, Care, AMA Says
  2. Oklahoma High Court Reinstates Physician’s Suit Against Hospital, Finding Peer Review Statute Does Not Provide Blanket Immunity
• Quality of Care
  Study Shows Pay-For-Performance Initiative Did Not Result In Significant Improvement For Heart Attack Patients
• Tax
  1. Ohio High Court Finds Provider Of Hospice And In-Home Nurse Services Entitled To Property Tax Exemption
  2. Indiana Tax Court Finds Taxpayer Failed To Show Medical Facility Was Used Predominantly For Charity, Denies Property Tax Exemption

Table of Contents © AHLA, 2007. Reprinted by permission.

On the day before the House passed the stem-cell funding bill (S. 5 passed in the Senate on April 11), which Pres. Bush has promised to veto, there was interesting, potentially revolutionary (but potentially not) news on the stem-cell science front: Skin cells from mice have been reprogrammed to act as stem cells. If that carries over to humans and the results are consistently reproducible, we're looking at a way to avoid using embryonic stem cells, thus mooting the pro-life objection against destroying an embryo (even one you created as a clone of yourself) to obtain a fresh supply of stem cells. Here are some links and summaries from AHLA:

• NBC Nightly News (6/6, lead story, 3:05, Williams) led its broadcast with "an amazing piece of science" having to do "with medicine," as well as "with a hugely divisive political issue, embryonic stem cells and their potential to cure the sick and disabled." NBC (Bazell) added, "This is indeed an astounding and elegant piece of scientific research. It's not going to end the debate about embryonic stem cells, but it could be a big step in that direction."


• The CBS Evening News (6/6, story 3, :30, Couric) noted that "researchers say they have found a way to make stem cells out of ordinary skin cells in mice. If the technique works in humans, scientists might using human embryos. Experts believe stem cells could be used to treat diseases ranging from diabetes to Parkinsons."


• The Chicago Tribune (6/6, Kaplan) reports, "If the discovery applies to human cells -- and researchers are optimistic that it will -- it would offer a straightforward method for creating a limitless supply of cell lines tailor-made for patients without any ethical strings attached. ... 'This is truly the Holy Grail -- to be able to take a few cells from a patient, say a cheek swab or some skin cells, and turn them into stem cells in the laboratory,' said Dr. Robert Lanza, an embryonic stem-cell researcher and head of scientific development at Advanced Cell Technology Inc. in Worcester, Mass., who was not involved in the research. 'It would be like turning lead into gold.'"


• In a front-page article, USA Today (6/7, 1A, Vergano) says that "the findings, by three teams publishing in the journals Nature and Cell Stem Cell, mean the reprogrammed cells may offer a non-controversial way...to make rejection-free tissues for transplant patients. But research still hasn't shown that the same cells will work in humans too, the study's authors say."


• The Wall Street Journal (6/7, Naik) runs a similar report under the headline "Stem-Cell Breakthrough May Ease Ethical Debate." On its front page, the New York Times (6/7, A1, Wade), meanwhile, says that "the technique seems likely to be welcomed by many who have opposed human embryonic stem cell research. It 'raises no serious moral problem, because it creates embryoniclike stem cells without creating, harming or destroying human lives at any stage,' said Richard Doerflinger, the United States Conference of Catholic Bishops' spokesman on stem-cell issues."


• The Christian Science Monitor (6/6, Spotts) adds, "many researchers say that progress in the U.S. has been hampered by limits...Bush imposed on federally funded human embryonic stem-cell research nearly six years ago." But "the limits also have prompted some labs to hunt for alternate ways to derive cells."


• In a front-page article, the Washington Post (6/7, A1, Weiss) reports, "Acutely aware that their new work could undermine that key political goal, the scientists cautioned that their success with mouse cells does not guarantee quick success with human cells." They "called for Congress to pass the bill, which would give federally funded researchers access to embryos slated for destruction at fertility clinics. 'A human is not a mouse, so a lot more work has to be done,' said Marius Wernig, who led one team with Rudolf Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Mass."
  
• Along those lines, the New York Times (6/7, A32, Pollack) runs another story titled: "A Long, Uncertain Path For New Cell Technique."

TB quarantines are usually a local matter, rarely federal

That's what last night's AP story on Drew Speaker reported. True enough, and this case illustrates that local authority is still pretty much hit-or-miss. Maryland officials claimed not to have the authority to detain or quarantine him, but as the AP reports, many state and local jurisdictions do. Speaker was being kept in quarantine pursuant to a federal order -- the first in 44 years -- but that order lapsed Saturday night, when it was replaced by a local Denver order.

• CDC's Division of Tuberculosis Elimination has some good information about the case.


• The ACLU has published some comments on the Speaker case. Although it says there is no indication that federal law has been violated by his quarantine, the group emphasizes the need to get judicial review of Speaker's continued detention. It also has links to its comments on the CDC's proposed rule on quarantining travelers (70 Fed. Reg. 71892-71948 (Nov. 30, 2005)).

Top SSRN downloads in public health law

Here are the top 10 SSRN downloads in public health law as of the end of May:

• Why Evolutionary Biology is (So Far) Irrelevant to Law
  U of Texas Law, Public Law Research Paper No. 89, U of Texas Law, Law & Econ Research Paper No. 81
  Brian Leiter and Michael Weisberg , University of Texas at Austin - School of Law & Department of Philosophy and University of Pennsylvania Date
  Posted: March 23, 2006Last Revised: February 7, 2007
  Working Paper Series 844 downloads
• Privacy's Other Path: Recovering the Law of Confidentiality
  George Washington University Law School Public Law Research Paper No. 249, Washington University School of Law Working Paper No. 07-03-02, Georgetown Law Journal, 2007
  Neil M. Richards and Daniel J. Solove , Washington University School of Law and George Washington University Law School
  Date Posted: March 13, 2007
  Last Revised: April 5, 2007
  Accepted Paper Series
  758 downloads
• Tort Reform and Accidental Deaths
  Emory Law and Economics Research Paper No. 05-17, Emory Public Law Research Paper No. 05-29
  Paul H. Rubin and Joanna Shepherd , Emory University - Department of Economics and Emory University - School of Law
  Date Posted: August 11, 2005
  Last Revised: February 27, 2006
  Working Paper Series
  600 downloads
• Toward a Theory of a Right to Health: Capability and Incompletely Theorized Agreements
  Yale Journal of Law & the Humanities, Vol. 18, pp. 273-326, 2006
  Jennifer Prah Ruger , Yale University - School of Medicine
  Date Posted: September 28, 2006
  Last Revised: March 30, 2007
  Accepted Paper Series
  589 downloads
• The Case Against Smoking Bans
  U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-11, Missouri Environmental Law and Policy Review, Vol. 13, 2006
  Thomas Andrew Lambert , University of Missouri at Columbia - School of Law
  Date Posted: April 24, 2006
  Last Revised: July 7, 2006
  Accepted Paper Series
  562 downloads
• Does Medical Malpractice Reform Help States Retain Physicians and Does it Matter
  Jonathan Klick and Thomas Stratmann , Florida State University College of Law and George Mason University - Buchanan Center Political Economy
  Date Posted: November 19, 2003
  Last Revised: December 19, 2005
  Working Paper Series
  527 downloads
• Database of State Tort Law Reforms (DSTLR 2nd)
  Northwestern Law & Econ Research Paper No. 06-08
  Ronen Avraham , Northwestern University - School of Law
  Date Posted: May 17, 2006
  Last Revised: December 8, 2006
  Working Paper Series
  488 downloads
• Rethinking Equal Access: Agency, Quality, and Norms
  Global Public Health, Vol. 2, No. 1, pp. 78-96, 2007
  Jennifer Prah Ruger , Yale University - School of Medicine
  Date Posted: January 18, 2007
  Last Revised: March 30, 2007
  Accepted Paper Series
  343 downloads
• Stem Cell Research and the Law
  UCLA School of Law Research Paper No. 06-05
  Russell B. Korobkin and Stephen R. Munzer , University of California, Los Angeles - School of Law and University of California, Los Angeles - School of Law
  Date Posted: January 28, 2006
  Last Revised: February 8, 2006
  Working Paper Series
  324 downloads
• Toward a Human Rights Framework for Intellectual Property
  Vanderbilt Public Law Research Paper No. 06-03, U.C. Davis Law Review, Vol. 40, p. 971, 2007
  Laurence R. Helfer , Vanderbilt University - School of Law
  Date Posted: March 21, 2006
  Last Revised: April 12, 2007
  Accepted Paper Series
  318 downloads

Groopman on medical error: it's not all about systems

There's an interesting blog post by Rob Cunningham over at Health Affairs, ostensibly about Jerome Groopman's new book, How Doctors Think. Here's a sample:

[T]he subtlety of the cognitive biases associated with diagnostic error in Groopman’s work and other studies suggests a daunting re-education challenge. Greater reciprocity in doctor-patient relations is a part of the answer that is consistent with many IT champions’ vision of patient-centered care. Other problems are not nearly as well recognized. Mark Graber and colleagues, cited above, found “premature closure,” or the inclination of physicians to settle on a diagnosis before they have gathered enough information or considered all the alternatives, to be the single most common source of cognitive failure. But there are a whole slew of other mental and behavioral weaknesses that may enter into the clinical encounter and drive it into a ditch.

The bottom line, according to Groopman, is that doctors often don’t ask the right questions and don’t listen carefully enough when the patient answers. . . .

It's an interesting problem, and not just for medical schools and training programs. Earlier in the blog post, Cunningham referred to "rushed patient encounters and imperious, overconfident practitioners [as] merely the most obvious symptoms of what can go wrong." I don't know what legislators and regulators can do about imperious and overconfident practitioners, but it's certainly worth asking what systemic conditions have contributed to the rushed patient encounters, as well as other health-care ills -- e.g., "an apparent decline in physicians’ clinical skills, driven at least in part by increasing dependency on high-tech diagnostic tools and financial incentives to see more and more patients."

When we get the health care system we deserve, we also get the practitioners (and practices) we deserve, as well.

Meanwhile, Groopman made an appearance on the Colbert Report recently. Here are the (somewhat predictable) results:

Shouldn't someone at his publisher's have told Dr. Groopman he was going onto a comedy show?

Art Caplan on Dr. Death's release and legacy

I'm glad Art sees this guy the same way I do. Here are some nuggets:

• I believed Kevorkian was a very dangerous killer [in 1994], and I still believe it now. He helped dozens of depressed and disabled people die without trying very hard to convince them to live.


• Kevorkian believes in suicide on demand. He thinks that doctors have an obligation to help anyone who decides that their life is not worth living, whatever their reason. Some of the 130 people he helped die had no terminal illnesses. Some were clearly depressed. Others had histories of mental illness. Only a few got any counseling. Kevorkian helped them all to die.


• Kevorkian’s problem was and is that he likes death way too much. The enthusiasm he brought to his cause was always deeply troubling. No doubts, no ambivalence, ever seemed to cross his mind as he dispatched his victims. The fact that he helped some to die within hours of meeting them, the fact that he would turn a disabled man’s death into a national spectacle by giving a tape of his murder to "60 Minutes" — never mind that they used it! — and the fact that he never seemed to try particularly hard to talk those who came to him out of their decision to die made him morally suspect then and hardly worth hearing from now.

As Caplan points out, the carefully crafted Oregon Death with Dignity Act has resulted in relatively few actual suicides, while at the same time providing the encouragement to develop more effective (and available) palliative care programs. On balance, I am still against legalizing physician-assisted-suicide, but public opinion is slowly swinging in favor of legalization and Oregon has demonstrated that, at least in a state like Oregon, it's possible to avoid the abuses that people like me have worried about.

SSRN: Top health law downloads

End-of-month (or beginning-of-month) recap of the top 10 SSRN downloads in health law (look for public health law rankings tomorrow):

• Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
  Yale Law School, Law & Economics Working Paper No. 237
  John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
  Date Posted: May 22, 2000
  Last Revised: June 10, 2002
  Working Paper Series
  9111 downloads


• Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
  Yale Law & Economics Research Paper No. 254
  John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
  Date Posted: May 16, 2001
  Last Revised: June 5, 2001
  Working Paper Series
  6030 downloads


• Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
  Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005, Columbia Law and Economics Working Paper No. 287, U Illinois Law & Economics Research Paper No. LE05-002, U of Texas law, Law and Econ Research Paper No. 030
  Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage University of Texas at Austin - School of Law , University of Texas at Austin , University of Illinois College of Law and University of Texas at Austin
  Date Posted: October 25, 2005
  Last Revised: March 19, 2007
  Accepted Paper Series
  1682 downloads


• Abortion and Original Meaning
  Yale Law School, Public Law Working Paper No. 119
  Jack M. Balkin , Yale University - Law School
  Date Posted: August 21, 2006
  Last Revised: October 2, 2006
  Working Paper Series
  1485 downloads


• What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
  Stanford Law Review, Vol. 52
  Jonathan Zittrain , University of Oxford - Oxford Internet Institute
  Date Posted: March 9, 2000
  Last Revised: March 26, 2007
  Accepted Paper Series
  1300 downloads


• TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
  U Chicago Law & Economics, Olin Working Paper No. 140
  Alan O. Sykes , Stanford Law School
  Date Posted: February 19, 2002
  Last Revised: March 7, 2002
  Working Paper Series
  1250 downloads


• 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
  971 downloads


• 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
  901 downloads


• Incentives in Nonprofit Organizations: Evidence from Hospitals
  Simon School of Business Working Paper No. FR 00-02
  James A. Brickley and R. Lawrence Van Horn , University of Rochester - Simon School and Owen Graduate School of Management, Vanderbilt University
  Date Posted: February 14, 2000
  Last Revised: April 2, 2002
  Working Paper Series
  826 downloads


• The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
  FSU College of Law, Public Law Working Paper No. 36 and QUNO Occasional Paper No. 7
  Frederick M. Abbott and Florida State University College of Law and Illinois Institute of Technology - Chicago-Kent College of Law
  Date Posted: October 8, 2001
  Last Revised: October 15, 2001
  Working Paper Series
  744 downloads

Tubercular lawyer's world-wide travel raises public health questions

"Drew" Speaker, and every public-health office and official he encountered in the past couple of weeks, are now at the center of a serious controversy. The best single story that summarizes what we know so far appeared in this morning's New York Times. In addition to a full account of Speaker's travels and discussions with public-health officers, John Schwartz asks all the right questions:

1. "Why would a well-informed person aware of medical concerns get on an airplane after receiving a diagnosis of a disease that could be fatal to others?"
   
2. "Why would he flee from health authorities once the diagnosis became even more grave?"


3. "How could the man’s father-in-law, an expert in tuberculosis at the C.D.C., accede to the trip?"


4. What does this saga tell us about the legal and practical gaps in our ability to limit the public's exposure to an infected individual, especially one with a motive -- whether benign or malicious -- to be evasive?


5. How much freedom -- of movement, from surveillance -- will Americans tolerate in order to limit their exposure to infectious disease?

One of the more interesting lessons of this story revolves around Speaker's decision -- which he admits, "In hindsight, maybe it wasn't the best decision" -- to ignore the CDC's instruction not to fly home from Rome on a commerical airliner:

He said that when he was contacted by a representative of the Centers for Disease Control in Rome, he was told that he could not fly home unless he chartered a plane — at a cost of $100,000 — and that he should check into a local hospital. “I felt very abandoned,” he said, emphasizing that he firmly believed he could not infect others. He said he feared he might end up “stuck in an Italian hospital indefinitely, where I could die.”

As Michael Osterholm, an epidemiologist who directs the Center for Infectious Disease Research and Policy at the University of Minnesota, observed:

“Short of a military state where you have 24/7 surveillance on someone, you have to count on the good will of the individual.

He called this a fact of life in an open society, one that could lead to major problems in an outbreak of pandemic influenza, in which many people would probably be boarding planes knowing they were sick to get away from an epidemic. “They would say, ‘I want to make sure I get out,’ ” whatever the risk to others. In that kind of situation, he said, the public health system would inevitably be unable to keep up.

There are a couple of AP stories today that add to what we know about Speaker:

• TB Lawyer Called 'Pillar' of Community photo
  ATLANTA (AP) - The story of how Andrew Speaker met his future bride still draws laughs from his friends. The young attorney met Sarah Spence Cooksey, an aspiring lawyer, at an Atlanta pub and handed her his fancy business card. When she called, she asked for "Mr. Speaker." But the man she ended up...


• TB Patient Faces 2 Months in Hospital photo
  DENVER (AP) - The man quarantined with a dangerous strain of tuberculosis will likely spend up to two months in a hospital while he receives a battery of antibiotics and is evaluated for possible surgery, his doctors said. Andrew Speaker is the first infected person quarantined by the U.S....

The most comprehensive coverage of this story seems to be over at the Harvard Public Health School's World Health News site. Here are the stories they've featured:

• Man With TB Apologizes for Putting Others at Risk
  Lawrence K. Altman and John Holusha (The New York Times, June 1, 2007)
  "The Atlanta lawyer who flew on crowded airplanes while infected with a dangerous form of tuberculosis said today he did not think he presented a danger when he flew and he apologized to his fellow passengers." See also: TB Treatment a 'Challenge,' Doctor Says (The Atlanta Journal-Constitution, June 1, 2007)


• Agent at Border, Aware, Let In Man With TB
  Lawrence K. Altman (The New York Times, June 1, 2007)
  "The man with a dangerous form of tuberculosis who flew to Europe for his wedding and honeymoon was identified yesterday as a 31-year-old Atlanta lawyer. Department of Homeland Security officials said he re-entered the country from Canada when a customs agent let him pass despite knowing that the man was being sought by health authorities." Free registration required.
  
• Case of TB Traveler Reveals Holes in Global Disease Control
  Elisabeth Rosenthal (International Herald Tribune, May 31, 2007)
  "The U.S. health authorities failed to notify their Italian counterparts that an American tourist with an extremely dangerous form of tuberculosis was staying in a Rome hotel this month until he was leaving the country, Italian officials said Thursday. That time lapse allowed him to leave Rome and fly to Prague and Montreal, potentially exposing dozens of people to an often lethal germ."


• TB Patient's Father-in-Law a CDC Microbiologist
  (Associated Press, May 31, 2007)
  "The honeymooner quarantined with a dangerous strain of tuberculosis was identified Thursday as a 31-year-old Atlanta personal injury lawyer whose new father-in-law is a CDC microbiologist specializing in the spread of TB and other bacteria."


• Near Misses Allowed Man With Tuberculosis to Fly
  Lawrence K. Altman and John Schwartz (The New York Times, May 31, 2007)
  "A series of 'understandable' near misses accounted for a Georgia man’s odyssey to Europe in which he might have exposed fellow passengers on a series of commercial flights to an exceptionally dangerous form of tuberculosis, federal officials said [Wednesday]." Free registration required.


• Isolating an Evasive TB Patient
  Editorial (The New York Times, May 31, 2007)
  "Congressional oversight committees ought to examine whether health officials dropped the ball -- and what steps can be taken to ensure that patients infected with deadly contagious diseases protect others from infection." Free registration required.


• Earlier:
  CDC May 29 Media Relations Telebriefing Transcript
  Atlantan Quarantined with Deadly TB Strain (The Atlanta Journal-Constitution, May 30, 2007) Free registration required.
  CDC Warns of Possible TB Exposure on Atlanta-Paris Flight (The Atlanta Journal-Constitution, May 29, 2007) Free registration required.

Dr. Death out of prison

I can't let the moment pass without acknowledging the release -- after 8 years in the Michigan prison system -- of Jack Kevorkian, a former pathologist who performed active euthanasia (a/k/a "murder") on a patient, filmed it, and allowed "60 Minutes" to air the event (AP, courtesy of Forbes). ("60 Minutes" will broadcast an interview with Mike Wallace this Sunday.)

He's a ding-bat, to be sure. Even many proponents of physician-assisted suicide cringe at the mention of his name. In the name of physician-assisted suicide ("PAS"), he helped strangers, not patients, kill themselves without ensuring that they were terminally ill, without assessing their mental state, and without seriously exploring less drastic means of addressing the concerns that led these citizens to seek out Kevorkian's services. Most, if not all, of the safeguards built into the Oregon Death With Dignity Act were routinely ignored in his quest for publicity for his cause. He shone a spotlight on an issue that needed to be examined and debated, but the way he did it might well have set the PAS movement back years, if not more. The New York Times has a good article on Kevorkian and the status of PAS around the country.

Dutch reality tv program -- "Big Donor Show" -- a hoax

Wouldn't you know: One of the stories that lured me out of semi-retirement and back to HealthLawBlog -- the one about the Dutch tv network that was about to air a show featuring a terminally-ill patient interviewing three candidates in kidney failure to decide which one would get her kidney -- turns out to be a hoax by the network, designed to pressure government officials to reform organ-transplantation laws in the Netherlands. According to the AP (courtesy of The Washington Post), the terminally-ill patient was simply a role played by a Dutch actress (Leonie Gebbink, looking none-too-ill in her publicity shot).

It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:

• there are currently 96,047 registered patients on various waiting lists


• over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:

[click to enlarge]

Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.