Post-grad opportunity at Harvard

From I. Glenn Cohen, a fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (Harvard Law School):

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School

2007-2009 Post-Graduate and Mid-Career Fellowship Program

Call for Applications: Deadline October 16, 2006

The Petrie-Flom Center is an interdisciplinary research program at HarvardLaw School dedicated to the scholarly research of important issues about the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research, and bioethics.

The Center is now accepting applications for its second group of post-graduate/mid-career fellowships starting in August 2007. These are two-year full-time academic research fellowships paying $60,000 per year, plus benefits.

Applicants must hold a degree in law or some other graduate discipline that they intend to apply to issues of health law policy or bioethics. The Center particularly encourages applications by those who intend to pursue careers as law professors, but will consider any applicant who demonstrates an interest and ability to produce cutting-edge scholarship in the areas of health policy, biotechnology or bioethics during the term of the fellowship.

Fellows chosen for the 2007-09 term will join an outstanding inaugural group of fellows who started in August 2006, as well as senior fellow Frances Kamm, one of the world's leading moral philosophers, who will be in residence at the Center during the 2007-08 academic year. Detailed information about the fellowship program, our
current fellows, and how to apply is available at
www.law.harvard.edu/programs/petrie-flom/.

Applications are due no later than October 16, 2006. Please note that this deadline is several months earlier than last year's.

Will Christian Science health plan count in Massachusetts?

As recently reported by the AP (courtesy of the Portsmouth (NH) Herald), health care regulators in Massachusetts are beset by a bevy of difficult issues in the wake of the Bay State's passage of a universal health care law:

When Gov. Mitt Romney signed the Massachusetts' health care law in April, it was hailed as a watershed moment.

Under the new law, Massachusetts is the first state to require all residents to have health insurance by July 2007.

The poorest will receive subsidized care, while everyone making more than three times the federal poverty level will be required to have private insurance, either through their employer or on their own.

To encourage employers to offer insurance, the law imposes an annual $295 per-worker fee on employers that don't offer insurance but employ 11 or more workers.

Christian Scientists want to make sure the new regulations recognize the church's own health plan, based on spiritual healing instead of medications and surgery, as a legitimate health care plan both for employers and individuals. . . .

[Jane Warmack, head of the church's legislative division] said the church wants to make sure other health care plans that don't rely on invasive medical care are put on an equal legal footing with other insurance plans.

"The legislative intent behind the law was to ensure that Massachusetts residents would be provided health care," she said. "It wasn't to dictate a particular kind of health care."

She said she also wanted to make sure that individuals who opt for alternative plans would not be penalized.

"What's at stake is people's access to the type of health care they want and for some people that is spiritual healing," she said.

The church already has testified before the state Division of Health Care Finance and Policy, which will write the final regulations. Those are expected sometime in early September, according to Dick Powers, spokesman for the Executive Office of Health and Human Services.

"We listened and read everyone's testimony and all of it will be taken into consideration," Powers said.

Powers also pointed to a portion of the law that would allow individuals to avoid tax penalties if they file an affidavit with their income tax returns stating "sincerely held religious beliefs" were the basis of their refusal to obtain "creditable coverage."

AHLA's Health Lawyers Weekly (Sept. 1)

Here's the table of contents from Friday's "Health Lawyers Weekly," a free member benefit from the American Health Lawyers Association (and reprinted here with their permission):

September 1, 2006 Vol. 4, Issue 34
Top Stories

• Specialty Hospitals Associated With Increased Utilization, MedPAC Finds
  Physician-owned heart hospitals are associated with a significant increase in the rate of cardiac surgeries in the market where the hospital is located, according to a Medicare Payment Advisory Commission (MedPAC) 2006 Report to Congress, Physician Owned Specialty Hospitals Revisited. According to the report, the entrance of a physician-owned cardiac hospital into a market was associated with a 6% increase in the number of cardiac surgeries per 1,000 Medicare beneficiaries. Full Story
• Schering-Plough Will Pay $435 Million To Settle Allegations Of Illegal Marketing, Fraud
  Schering-Plough Corp. and one of its subsidiaries have agreed to a $435 million global settlement to resolve criminal charges and civil claims that they engaged in illegal sales and marketing schemes and defrauded Medicaid, U.S. Attorney for the District of Massachusetts Michael Sullivan announced August 29.The settlement stems from allegations that the company marketed its drug Temodar and Intron A for so-called "off label" uses that had not been approved by the Food and Drug Administration (FDA). Full Story

Articles & Analyses

• Final Stark Exception And Anti-Kickback Safe Harbor For Electronic Health Records And E-Prescribing, By Jill M. Girardeau, Womble Carlyle Sandridge & Rice, PLLC

Current Topics

• Criminal Law
  Fourth Circuit Vacates Physician's Drug Trafficking Conviction Citing Improper Jury Instruction
• EMTALA
  U.S. Court In Alabama Finds CMS Investigation Report Admissible In EMTALA Action
• ERISA
  Eleventh Circuit Applies Supreme Court's Sereboff Decision To ERISA Plan Subrogation Claims
• Food and Drug Law
  FDA Issues Draft Guidance, Schedules Hearing On Emergency Research
• Fraud and Abuse
  1. BCBSA Says Anti-Fraud Efforts Saved $249 Million In 2005
  2. Update
  3. OIG Approves Charitable Organization's Proposed Subsidization Of Medicare Part D Premiums For Certain Patients With Kidney Disease
  4. Michigan Appeals Court Finds Sufficient Evidence Of Wrongful Intent To Sustain Medicaid Fraud Charges
  5. U.S. Court In Illinois Dismisses Second Amended Qui Tam Complaint Against Pharmacy Benefit Services Company
• Healthcare Access
  California Governor Announces New Initiative To Reduce Drug Costs
• Hospitals and Health Systems
  JCAHO Issues Revised Medical Staff Standard For Comment
• Insurance
  Census Bureau Finds Number Of Uninsured Grew Between 2004 And 2005
• Long Term Care
  North Dakota Supreme Court Finds Wife May Be Liable For Nursing Home Bills Of Institutionalized Spouse If She Had A Valid Contract With Home
• Managed Care
  Pennsylvania Supreme Court Finds HMO Is Exempt From Complying With Anti-Subrogation Provision Of State Automobile Insurance Law
• Medicaid
  CMS Issues Interim Final Rule On Medicaid, SCHIP Improper Error Rate Estimation
• Medical Malpractice
  Minnesota Appeals Court Finds Lower Court Erred In Directing Verdict For Radiation Therapy Center In Negligence Action
• Medicare
  1. Public Interest Group Sues CMS Alleging Part D Marketing Guidelines Violate Free Speech
  2. OIG Finds Oncology Demonstration Data Unreliable
  3. Lieberman Says Senate Must Address Impending Medicare Physician Payment Cuts
  4. CMS Plans To Review Its Medicare Payment Codes For Inhalation Drugs
  5. CMS Proposes Prohibition On Midyear Benefit Enhancements By MA Plans
  6. CMS Announces FY 2007 Update To Hospice Wage Index
  
  (c) 2006, AHLA. Reprinted with permission.

U.S. research: running on empty?

Today's N.Y. Times has a piece ("The State of Research Isn't All That Grand") discusses the implications for the U.S. economy of reduced R&D expenditures in both the public and private sectors. The balanced conclusion:

In global R.& D. rankings, the United States is still the clear leader in spending, with 34 percent of the total. In fact, about half of all such spending comes from just two nations: the United States and Japan.

But the United States falls down the list when it comes to more meaningful comparisons.

According to the Organization for Economic Cooperation and Development, the nation ranks seventh in R.& D. spending as a share of the economy, trailing Sweden, Finland, Japan, Switzerland, Iceland and South Korea. In spending on basic research as a share of R.& D., the United States ranks 11th. And when measuring nondefense research as a share of the economy, it’s 22nd.

Looking ahead, there is good reason to expect even greater pressure on R.& D spending in the United States. The federal government will be only more constrained in its ability to invest in research as large unfunded commitments like Social Security and Medicare come due. Corporate America will continue to face competitive global pressures, seeking investments that pay off in the short term. And fast-developing countries like China and India will strive to become even more powerful global forces.

It all leads to a question: Where will the innovation come from to drive the American economy of the future?

"Medically inappropriate treatment" - how do we decide?

There's a good piece in the NY Times today about dialysis, when and how it should be withheld, and who should decide: "Choosing a 'God Squad,' When the Mind Has Faded" by Barron Lerner, MD. Here's how it starts:

Would you want your tax dollars to pay for dialysis for a patient with irreversible brain damage? In 1972, when Congress agreed to use Medicare money to finance dialysis for patients with end-stage kidney failure, this question had never come up.

But now, new research shows, many patients on dialysis have severe mental impairment. Is it appropriate, or even possible, to refuse to give patients this treatment?

The article mentions Medicare's End-Stage Renal Dialysis program, which covers dialysis for all who are medically qualified to receive it; the article then takes a trip down the resource-allocation highway, followed by an abrupt turn down a more patient-centered boulevard:

But there were new problems. For one, the bill’s sponsors underestimated the demand for dialysis, now given to more than 300,000 patients a year, at a cost of more than $16 billion. It also became clear that the technology was, in some cases, being used indiscriminately.

In 2000, Dr. Alvin H. Moss, director of the Center for Health Ethics and Law at West Virginia University, led a committee of the Renal Physicians Association and the American Society of Nephrology that developed guidelines on the use of dialysis. It was found to be inappropriate for those with “irreversible, profound neurological impairment,” among others. The committee also said it was reasonable to consider withholding dialysis from patients with terminal illnesses unrelated to the kidneys. . . .

“The renal-care team has the right to refuse to offer dialysis when the expected benefits do not justify the risks,” Dr. Moss said. At his home institution, Dr. Moss is taking a more hard-line approach, saying no to families who request what he believes is inappropriate dialysis. At other times, he offers the dialysis, but if the patient doesn’t improve, it is stopped.

So far he has not been sued, he said, citing thoughtful discussions he has had with family members about what dialysis can and cannot achieve.

But the fear of lawsuits continues to worry many nephrologists who believe that it is safer to provide dialysis. And there remains that old American unwillingness to let people die, even when it is surely their time.

Dr. Valeri, of Columbia, knows this feeling well. If he suggests to relatives that dialysis be withheld for a gravely ill family member, they confuse it with euthanasia. “They think you are just another Kevorkian,” he said.

In a microcosm, this is exactly the discussion we've been having in Texas this year, as we debate the merits of Texas' so-called "futility law," which allows hospitals to stop life-sustaining treatment when a physician says the treatment is not appropriate and an ethics committee agrees (§ 166.046 of the Health & Safety Code). Are there limits beyond which otherwise appropriate care becomes inappropriate? What is the source of those limits: benefits/burdens ratio for the patient? benefits/burdens for society? a professional ethos among nephrologists (pulmonologists, cardiologists, intensivists, et al.)? Is the threat of litigation a good thing or a bad thing? What do we mean by good end-of-life care? If the technological imperative is resisted, is that euthanasia or the wise practice of medicine?

AHLA's Health Lawyers Weekly (Aug. 25)

Here's the table of contents from today's Health Lawyers Weekly, reprinted here with the kind permission of the AHLA:

Top Stories

• Bush Signs Executive Order Requiring Federal Agencies To Increase Price And Quality Transparency
  President George W. Bush signed August 22 an executive order directing federal agencies that administer or sponsor a healthcare program to increase price and quality transparency by January 1, 2007. Full Story
• OIG Publishes Guidelines For Evaluating State FCA Cases
  The Department of Health and Human Services Office of Inspector General (OIG) issued a notice in the August 21 Federal Register (71 Fed. Reg. 48552) announcing the publication of OIG’s guidelines for evaluating state False Claims Act cases. Full Story

Articles & Analyses

• Implementing A Trusted Health Information Exchange, By Zoë Baird, President Marke Foundation
• 2005-2006 Teaching Hospitals And Academic Medical Centers Year In Review, Compiled by Health Lawyers' Teaching Hospitals and Academic Medical Centers Practice Group

Current Topics

• Antitrust
  FTC Says IPAs Engaged In Anticompetitive Conduct
• Criminal Law
  Fourth Circuit Says Plaintiff Bound To Appeal Waiver In Plea Agreement
• Employment and Labor
  1. Eighth Circuit Finds Terminated Physician Did Not Qualify As Whistleblower
  2. U.S. Court In Tennessee Says Termination Of Tenured Faculty Members Violated Due Process
• EMTALA
  U.S. Court In Alabama Allows Pregnant Woman’s EMTALA Claim To Go Forward
• ERISA
  Fifth Circuit Holds ERISA Does Not Preempt Louisiana Assignment Statute
• Food and Drug Law
  1. U.S. Court In California Says Federal Law Preempts Pharmaceutical Failure-To-Warn Claims
  2. FDA Proposes Comprehensive Electronic Drug Registration List
  3. FDA Approves Plan B For OTC Use
• Fraud and Abuse
  1. DOJ Announces $20 Million Settlement Of FCA Charges
  2. Seventh Circuit Finds Qui Tam Relator Must Show Specific Claim That Was False
  3. North Carolina To Repay Federal Government $151.5 Million Of Medicaid Reimbursements
  4. Update
• Hospitals and Health Systems
  USC Seeks To Part Ways With Tenet Subsidiary
• Medicaid
  NASMD, APHSA Urges DHHS Not To Implement Proposed Medicaid Regulatory Changes
• Medicare
  1. CMS Posts Medicare Payment Data On Common ASC Procedures
  2. Eighth Circuit Says Hospital’s Classroom Costs Not Entitled To Pass-Through Treatment
  3. Study Finds Variation In Part D Plans’ Drug Coverage
• News in Brief
  CMS Solicits Proposals For New Risk Reduction Demonstration

(c) 2006, AHLA. Reprinted with permission.

OTC sales of Plan B approved for adults

After years of hassling over whether to approve over-the-counter sales of the Plan B contraceptives, the FDA has finally relented and announced yesterday that the "morning after" pill would become available for purchase by adults by the end of the year. (NY Times; Wall Street Journal; Washington Post; AP/MyWay) Compared to the original application three years ago, which sought approval for sales by under-18's as well, this is something of a compromise, and a disappointment to advocates for broader access. Much of the agency's foot-dragging was wrapped in official comments that questioned the adequacy of safety data for teenaged users, although critics of the agency believed the doubts were a smokescreen for the Bush administration, which appeared to opposed broadening the availability of this contraceptive on political grounds. Their bottom line -- on a number of issues -- seems to be that they are against anything that might make teen sex a little less dangerous and therefore a little more attractive: "Plan A (Abstinence) or the highway!" Could a government policy be more backward? At least yesterday's announcement is a start. Meanwhile, according to the AP, "[t]he Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue."

Why is 16% of GDP too much to spend on health care?

That will be one of my questions tomorrow in the first class in Health Law. I remember, back during the debate over the Clintons' plan, the tongue-in-cheek report that, at the then-current rate of health-care inflation, in 50 years 100% of our GDP would be health care ("every man, woman, and child would be in hospital beds administering IVs to one another"). Now, quite sensible people (e.g., Robert W. Fogel, a Nobel laureate at the University of Chicago's Graduate School of Business) predict that health care will account for 25% of GDP by 2030. It's less than 100%, but it's still the kind of number that makes you sit up and take notice.

It also made Gina Kolata sit up and take notice in Tuesday's New York Times. There is much to think about (and discuss in class) in this article, including this exchange:

Unless the current system is changed, most health care costs will continue to be paid by insurance, especially Medicare, which means that the taxpayers will foot the bill. But Dr. Fogel says he is not alarmed. Americans can afford it, he says, because the nation is so rich.

“It takes so little of household income to satisfy expenditures on food, clothing and shelter,” he explains. “At the end of the 19th century, food, clothing and shelter accounted for 80 percent of the family budget. Today it’s about a third.” Other economists agree. “We have to spend our money on something,” says Robert E. Hall, a Stanford University economist.

New technique for deriving embryonic stem cells that doesn't destroy the embryo

You would think that a technique that allows lab techs to grow embryonic stem cell lines without destroying the embryo would be the ultimate answer to the principal objection to embryonic stem cell research. But you would be wrong.

An on-line letter (1st paragraph only) at the journal Nature (requires subscription) describes the technique, as do articles posted this afternoon to the web sites of the New York Times and the Wall Street Journal (requires subscription). Researchers at Advanced Cell Technology report success borrowing the technique used for pre-implantation genetic diagnosis ("PGD") of embryos created at in vitro fertilization centers. The technique takes the fertilized egg at the point that it is an 8-celled organism. The cells are called blastomeres, and PGD removes one blastomere for genetic testing and screening. Now 10 years old, PGD produces no discernible harm to the remaining 7-cell organism, which appears capable of developing into a normal, health embryo and then fetus. It was reported last year that embryonic stem cells were derived from mouse embryos using this technique. The ACT letter appears to be the first report that the technique can be successfully performed on human embryos. ACT's press release is here. More details are also available from the statement issued by ACT's ethics advisory board.

Despite the head-on challenge this technique represents to current ethical objections to harvesting embryonic stem cells, both papers report that the news was met with different degrees of skepticism, dismay, and downright hostility by the U.S. Conference of Catholic Bishops ("gravely unethical" -- the bishops also oppose IVF and PGD), Glenn McGee ("this will please no one" -- McGee is described as a long-time critic of ACT), and the immediate past chair of the President's Council on Bioethics, Leon Kass ("'I do not think that this is the sought-for, morally unproblematic and practically useful approach we need.' He said the long-term risk of P.G.D. testing is unknown, and that the present stem-cell technique is inefficient, requiring blastomeres from many embryos to generate each new cell line. It would be better to derive human stem cell lines from the body’s mature cells, he said, a method that researchers are still working on.")

Internet prescribing legislation introduced in U.S. Senate

From the Federation of State Medical Boards:

New legislation designed to regulate the sale of prescription drugs and controlled substances over the Internet was introduced in the U.S. Senate on Aug. 10. The “Online Pharmacy Consumer Protection Act of 2006” (SB 3834)would:

• Prohibit the distribution of controlled substances and prescription drugs via the Internet without a valid prescription issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner
• Provide criminal penalties for unlawfully dispensing controlled substances and prescription drugs over the Internet
• Give state attorneys general a civil cause of action against violators
• Allow the federal government to take possession of property used illegally by online pharmacies
• Require online pharmacies to file an additional registration statement with the attorney general and meet additional registration requirements
• Report to the attorney general all controlled substances and prescription drugs dispensed over the Internet

Latest from AHLA's Health Lawyers Weekly (18 Aug 2006)

Herewith, the table of contents of this week's American Health Lawyers' Health Lawyers Weekly (a free member benefit of AHLA):

Top Stories

• CMS Issues Final Quality Standards For DMEPOS Suppliers
  The Centers for Medicare and Medicaid Services (CMS) released August 14 its final quality standards for suppliers of durable medical equipment, prosthetics, orthotics, supplies, (DMEPOS) and other items and services under the Medicare program. The standards have been scaled-back substantially from the draft version issued in September 2005, thereby reducing the standards document from 104 pages to fourteen pages. Full Story
• OIG Finds Some MA Marketing Materials Not In Compliance With CMS Requirements
  Some Medicare Advantage (MA) marketing materials for 2005 did not meet the Centers for Medicare and Medicaid Services' (CMS') requirements for marketing, the Department of Health and Human Services Office of Inspector General (OIG) found in a report issued August 14. Full Story

Articles & Analyses

• Impact Of Proposed Changes To The Medicare Physician Fee Schedule On Diagnostic Imaging Providers
  By Thomas W. Greeson and Heather M. Zimmerman, Reed Smith LLP, Falls Church, VA
• 2005-2006 Tax And Finance Year In Review
  Compiled by Health Lawyers' Tax and Finance Practice Group

Current Topics

• AIDS
  New Jersey Appeals Court Finds Hospital That Failed To Notify Patient Of Positive HIV Test Results Civilly Liable To Patient's Sexual
• Employment and Labor
  1. North Carolina Appeals Court Finds Covenant Not To Compete Valid
  2. Missouri Supreme Court Finds Home Healthcare Provider's Noncompetition Agreements Are Valid And Enforceable
• ERISA
  U.S. Court In Ohio Finds ERISA Does Not Preempt Hospital's State Law Claims Against Plan Administrator
• Food and Drug Law
  1. OIG Report Finds Deficiencies In FDA's National Drug Code Directory
  2. FDA Issues Warning Letters To Three Pharmacies Engaged In Compounding Mass Amounts Of Inhalation Drugs
• Fraud and Abuse
  1. Louisiana Hospital Agrees To Pay U.S. $3.8 Million To Settle Fraud Allegations
  2. Update
• Health Policy
  Many Americans Report Unsafe Or Wasteful Healthcare, New Survey Finds
• Healthcare Access
  Study Finds Fewer Physicians Accepting New Medicaid Patients
• Medicaid
  1. Nebraska Supreme Court Finds Longer Look-Back Period Applied To Medicaid Eligibility Decision Was Error
  2. House Members Urge CMS To Change Medicaid Citizenship Requirements
• Medical Malpractice
  1. Connecticut Appeals Court Finds Patient's Medical Malpractice Action Against Radiologist Time-Barred
  2. Louisiana Appeals Court Finds Lack Of Notation In Medical Record Created Material Issue Regarding Whether Treatment Recommendation Was Made To Patient
• Medical Records
  Mississippi Supreme Court Finds Health Insurer Did Not Owe Fiduciary Duty To Maintain Confidentiality Of Insured's Medical Records
• Medicare
  Part D Costs For 2007 Lower Than Predicted, CMS Says
• Physicians
  Iowa Appeals Court Finds Evidence Supports Medical Board's Disciplinary Action
• Quality of Care
  NCQA Seeking Input On Implementation Of Single Set Of Standards For All Health Plans

(c) 2006. Reprinted by permission of AHLA.

It's a good time to be in cardiology

Two items from the print press, courtesy of Modern Healthcare's "Daily Dose":

• In Philadelphia, heart-transplant centers abound (Philadelphia Inquirer)
  After a massive heart attack last year, doctors told David Kaminstein that he needed a transplant. He had the choice of five hospitals in the Philadelphia area that could do the complicated operation. That's a lot of choices -- some say too many. With the launch of two new heart-transplant centers in recent years, this region has the same number of programs as Los Angeles, though just half the population. Last year, only the Hospital of the University of Pennsylvania -- with 49 transplants -- performed more than 13 of the operations. Most healthcare experts say that the more patients a transplant team treats, the better the results.
  
• Angioplasty rates off the charts in Ohio city (New York Times)
  People with blocked coronary arteries can typically choose among drugs, bypass surgery and vessel-clearing procedures like angioplasty. But in Elyria, a small, aging industrial city in northeast Ohio, doctors are much more likely than those anywhere else in the country to steer patients toward angioplasty. No one has accused the doctors involved of any wrongdoing. But the statistics are so far off the charts -- Medicare patients in Elyria receive angioplasties at a rate nearly four times the national average -- that Medicare and at least one commercial insurer are starting to ask questions. And the hospital where most of the procedures take place says it plans to conduct an independent review.

Medical liability insurers profiting handsomely in wake of Texas tort reform

Three years after tort reform hit the books in Texas, the state's medical liability insurers have lowered premiums somewhat and added enormously to their bottom line, according to a story in the August 11 issue of the Austin Business Journal. The largest of them all -- Texas Medical Liability Trust -- has shown the greatest gains:

The state's largest medical malpractice insurer -- Texas Medical Liability Trust, which is based in Austin -- may have the best post-tort reform success story.

In its 2005 annual report, TMLT detailed how, in just five years since 2001, its surplus has gone from $22.9 million to $203.4 million -- an increase of almost 800 percent. Over the same period, its assets almost doubled, going from $333.9 million in 2001 to $588.7 million last year. During the same time, however, its insurance losses went down by almost half, from $137.2 million in 2001 to $73.2 million last year.

And, the article continues, "Texas' second-largest doctor insurer, Fort Wayne, Ind.-based Medical Protective Corp., is doing well enough that last year it was bought by Berkshire Hathaway Inc., the legendary company run by the world's second-richest man, Warren Buffett."

More on emergency room practices

This from the East Bay Business Times in California . . . . Sutter Delta Medical Center, among others in the region, has cut waiting times in its ER from 4-6 hours to 1-2 hours. They've done it by being imaginative in their triaging of patients, getting noncritical patients to doctors faster than before, for instance. The hospital's director of emergency services says, "People are still using the ER as their primary-care provider. Our challenge was what kind of mechanism could we use to treat the nonemergency patients." Beats the daylights out of a brochure and a boot to the butt.

ER sends nonemergency patients packing

This might be a case of "dog bites man," but the Jacksonville Business Journal reports that area HCA hospitals have adopted the practice of screening emergency room patients (as required by EMTALA) and showing nonemergency patients the door (as permitted by EMTALA) with a brochure listing area clinics in their hands. Is this news, exactly? In my limited urban ER experience, you can sit in the waiting room on a Saturday or Sunday morning and watch one person after another get screened by a nurse who shows the BP/temp/pulse data to a doc and then gently but firmly escorts the almost-a-patient back out to the street. The more humane or enlightened institutions have an ambulatory care clinic to which the a-a-p can be directed, though most ACC's seem to be open only during regular business hours Mon.-Fri. Another common practice is to triage nonemergency ER patients to a non-acute treatment room within the emergency department. The brochure is a nice touch, though the article does quote someone who says the brochure has several inaccurate phone numbers and facility names.

Kaiser fined for mismanagement of its kidney-transplant program

Considering how neurotic the organ-transplant industry is to maintain a squeaky-clean image, it's remarkable that Kaiser Permanente's been hit with a massive fine from California's Department of Managed Health Care [press release] for mismanaging its kidney-transplant program. Even more significant, for my money, is the lesson here.

How many times has a health care provider tried to minimize the imposition of civil penalties by characterizing its lapses as "mere" record-keeping or bureaucratic errors, insisting all the while that no patient was put at risk and quality care wasn't compromised? My take on such evasions is that paperwork snafu's are typically the tip of the iceberg or (to mix my metaphors) the regulator's low-hanging fruit. If a place can't keep the administrative details straight, you can bet there's more to the situation than misplaced files and incomplete reports. Kaiser's situation is a good example:

Kaiser suspended its Northern California kidney transplant program in May amid mounting regulatory pressure and patient lawsuits alleging that botched paperwork and administrative errors had imperiled lives.

Problems arose when Kaiser ordered Northern California kidney patients to transfer from University of California hospitals to its new transplant center in 2004.

Kaiser failed to discuss with regulators the transfer of up to 1,500 patients to the new center, delaying some patients' procedures, the Los Angeles Times reported. Only 56 transplants were performed at the Kaiser's San Francisco center in 2005, while twice that number of people died waiting for a kidney, the Times reported.

At other California transplant centers, more than twice as many people received kidneys than died.

Lucinda Ehnes, director of the managed care department, said Kaiser's administrative oversight was inadequate and it provided too few personnel to accomplish the transfers.

The company also failed to provide timely access to specialists and did not properly respond to patient complaints, she said.

Mary Ann Thode, president of Kaiser Foundation Health Plan and Hospitals in the Northern California region, said the HMO deeply regretted "any problems, difficulties or concerns we may have caused any of our patients as a result of their experience."

"Problems," "difficulties," and "concerns" are corporate euphemisms for the likely loss of lives of patients who placed their faith in Kaiser. But give Kaiser credit: it isn't engaging in the usual evasions about "mere errors in the paperwork," but is instead taking responsibility and vowing to do better in the future.

Costly Drugs Force Life-Death Decisions

From the AP, a good story about the costly, high-tech armamentorium of drugs and devices that offer the promise of extending life-spans once deemed to be "terminal," but at a price that's so high, some patients simply opt out:

More patients are confronting this wrenching decision, as the latest generation of pricier cancer drugs and heart implants stretches out the final months of advanced disease. Is the chance for several more months of life - maybe a year or more with luck - precious enough to spend a small fortune? This dilemma is also challenging governments, employers and insurers, who all help finance America's longer life spans and innovative technologies.

Extraordinary care for dying patients can make for inspiring medicine, but its extraordinary costs make it an increasingly debated choice to promote public health. Many economists, doctors, and ethicists say this care too often buys too little for too much - and that its expanding share of medical resources might better pay for screening and treating diseases in earlier stages.

Already, up to 30 percent of annual payments by federal Medicare insurance go to the 5 percent of members in their last year of life, research shows.

"People still have an underlying belief that there's an infinite amount of resources that can be invested in health care," says Dr. Harlan Krumholz, a Yale University heart specialist who studies quality of care. "But I think we're coming to a realization that we're going to need to confront these issues explicitly."

Maybe so, but any retreat from last-resort care still raises objections from many patients, doctors and medical companies. They denounce "rationing" of care and defend expensive treatments for the dying as a moral imperative.

More on non-heart-beating organ donors

"NHBD" is slowly being replaced by "DCD" ("donation after cardiac death"), but whatever name it goes by, these organ-donor protocols continue to get (deservedly) close scrutiny, most recently in the New Scientist. The move away from brain death and toward cardiopulmonary death is, contrary to the implications of this article, not evidence of a "new" standard for determining when death occurs, but rather is a return to the old way of determining death. Most states retained cardiopulmonary death when they adopted brain death, so no change in law is needed except in the few states that made neurological criteria the sole standard for determining when death occurs. The real concerns -- and this is brought out in the article -- are over whether the existing protocols run roughshod over the the requirement that the absence of cardiac and pulmonary function be irreversible and whether the administration of regitine and heparin cause the cessation of cardiopulmonary function. For more on all this, a good place to start is the 1997 IOM report, "Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement."

Latest from AHLA's Health Lawyers Weekly (11 Aug 2006)

With the permission of the American Health Lawyers Association, here's this week's Table of Contents for its Health Lawyers Weekly (free member benefit):

Top Stories

• CMS Projects 5.1% Reduction In Medicare Physician Payment Rates For 2007: The Centers for Medicare and Medicaid Services (CMS) is projecting a negative 5.1% update in the Medicare physician fee schedule for 2007 under the Sustainable Growth Rate (SGR) formula, according to a proposed rule released August 8.Under the proposal, CMS expects payments of roughly $61.5 billion to 875,000 physicians and other healthcare professionals in 2007. Full Story
• CMS Issues Proposed OPPS Rule Containing Significant Revisions To ASC Payment: Hospitals will receive an overall average increase in Medicare payments of 3% in calendar year (CY) 2007 for outpatient services under the proposed hospital outpatient prospective payment system (OPPS) rule issued August 8 by the Centers for Medicare and Medicaid Services (CMS). Full Story

Articles & Analyses

• New IRS Independent Contractor Test, By Sidney S. Welch and Tizgel K. S. Mark, Powell Goldstein LLP
• 2005-2006 Physician Organizations Year In Review, Compiled by Health Lawyers' Physician Organizations Practice Group
• 2005-2006 Regulation, Accreditation, And Payment Year In ReviewCompiled by Health Lawyers' Regulation, Accreditation, And Payment Practice Group

Current Topics

• Antitrust
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(c) 2006. Reprinted by permission of AHLA. All rights reserved.

Lawsuit Seeking to Discipline Georgia Physicians for Participation in Executions Dismissed

From the Federation of State Medical Boards:

A lawsuit seeking to require the Georgia Composite State Board of Medical Examiners to punish physicians who participate in executions was dismissed last week by a Fulton County Superior Court judge. Lawyers for seven physicians, including three physicians in Georgia, had sought to have the medical board uphold American Medical Association guidelines that prohibit physicians from involvement in executions.

Lawyers for the state argued that the physicians had no legal standing to sue because they could show no specific harm, and that state law is the determining factor in the administration of lethal injection in Georgia, not the AMA’s ethical guidelines. Complaints were filed with the medical board against a Georgia physician who assisted the department of corrections with executions, but the board declined to discipline him. The lawsuit, filed by a group of Atlanta-area lawyers, unsuccessfully sought to appeal the board’s decision.

In April, Georgia Gov. Sonny Perdue signed a bill (HB 57 [link]) that protects any physician licensed in Georgia from having their license challenged, revoked or suspended if the individual participates, in any way, in the state’s execution process. The Act became effective July 1, 2006, and applies to executions carried out on or after July 1, 2006.