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
  U.S. Court In Missouri Says Medical Group's Antitrust Suit Against Hospital Failed To Allege Relevant Geographic Market
• EMTALA
  U.S. Court In Missouri Dismisses EMTALA Claim, Finding No Evidence That Uninsured Patient Was Treated Differently
• Food and Drug Law
  GlaxoSmithKline Agrees To Pay $70 Million To Settle AWP Dispute
• Fraud and Abuse
  1. U.S. Court In Nevada Finds No Fact Issue Regarding Whether Government Knew Of FCA Defendant's Billing Practices
  2. U.S. Court In Nevada Finds Government Failed To Establish FCA Claims Alleging Physician Improperly Billed Medicare For Tests
• Health Policy
  Tommy Thompson Issues Paper Urging Medicaid Program Reform
• Hospitals and Health Systems
  1. Uninsured Settle Pricing Lawsuit With Sutter Health
  2. CMS Issues Final Report Outlining Its Strategic Plan For Specialty Hospitals
• Long Term Care
  1. Sixth Circuit Affirms Civil Money Penalty Imposed On Nursing Home
  2. Nursing Home Care Continues To Fall Short, New Report Finds
• Managed Care
  1. U.S. Court In Maryland Grants Class Certification For Lawsuit Against HMO For Collecting Subrogation Claims
  2. U.S. Court In Michigan Finds HMO Had Rational Basis For Denying Out-Of-Network Provider's Reimbursement Claim
  3. Kaiser Agrees To Pay $5 Million For Lack Of Oversight Of Transplant Facility
• Medicaid
  Group Dismisses Lawsuit Seeking To Enjoin D.C. From Enforcing Medicaid
  Proof-Of-Citizenship Requirements
• Medical Malpractice
  New Jersey Supreme Court Says Psychiatrist Can Be Liable For Abandonment Even Absent Duty To Warn
• News in Brief
  FDA Seeks Comments On UDI System For Medical Devices
• Physicians
  U.S. Court Of Federal Claims Dismisses Physician's Action Against U.S. Stemming From Loss Of Medical Licenses

(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.

Should prisoners be enrolled in riskier drug studies?

The New York Times has an interesting article on this question, spurred by a recent report of the Institute of Medicine that recommends altering the "minimal risk" standard that now applies to prisoners as long as the greater risks are accompanied by the potential of some benefit to the prisoners themselves. The IOM's press release on the report and recommendations is here.

AHLA Health Lawyers Weekly (04 Aug 2006)

With the permission of the AHLA, here's the TOC for last week's HLW [members only] (which came in while I was on vacation); this week's TOC should be available tomorrow.

• Top Stories
• CMS Issues Final IPPS Rule That Phases-In Move To Cost-Based System
  The Centers for Medicare and Medicaid Services (CMS) issued August 1 the
  much-anticipated inpatient prospective payment system (IPPS) final rule for
  fiscal year (FY) 2007 that seeks to improve the accuracy of hospital payments by moving from a charge to cost-based system and by accounting more fully for patient severity.
• CMS, OIG Release Final Health IT Rules
  The Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (DHHS) Office of Inspector General (OIG) released final rules August 1 to speed the adoption of electronic prescribing and electronic health records.
• Articles & Analyses
• OIG Publishes Report Of Claims Billed By Independent Diagnostic Testing
  Facilities
  By Marla P. Spindel, Powers, Pyles, Sutter & Verville, P.C.
• 2005-2006 Long Term Care Year In Review
  Compiled by Health Lawyers' Long
  Term Care Practice Group
• 2005-2006 Medical Staff, Credentialing, and Peer Review Year In
  Review
  Compiled by Health Lawyers' Medical Staff, Credentialing, and Peer
  Review Practice Group
• Current Topics
• Corporate Governance
  
  • GAO Releases Survey Results Of Nonprofit
    Hospitals' Executive Compensation Practices
• ERISA
• Eleventh Circuit Upholds Dismissal Of State Law Claims Against Insurer Of ERISA-Governed Health Plan That Failed To Disclose Lapsed Plan
• Food and Drug Law
• FDA Announces Plans For OTC Marketing Of Plan B
• Enzi, Kennedy Introduce Drug Safety Bill
• Fraud and Abuse
• First Circuit Vacates Three-Month Prison Sentence For Executive Convicted Of Conspiring To Defraud Medicare Of Over $5 Million
• Update
• Health Information Technology
• DHHS Recognizes CCHIT Criteria For EHRs, Releases Certification Guidance Document
• Hospitals and Health Systems
• Grassley, Baucus Question Whether CMS' Specialty Hospital Study Is Flawed
• HSC Study Discusses Implications Of Growth In ASCs And Rising Specialty-Service Competition
• Managed Care
• Florida Appeals Court Overturns Dismissal Of Hospital's Action Seeking Reimbursement For Emergency Services Rendered To HMO Subscriber
• Medical Records
• California Appeals Court Finds Health Plan May Disclose To Its Attorney Medical Records Of Potential Malpractice Complainants
• Medicare
• GAO Sees Promise In CMS' New Cost-Based Approach Under IPPS
• CMS Announces First Contract For Payment Of Medicare Part A And B Claims
• Grassley, Baucus Introduce Bill To Improve Accuracy Of Medicare Payments To Hospitals
• OIG Finds Medicare Part B Drug Costs Would Have Been Cut By $16 Million Had CMS Applied Authorized Price Adjustment
• CMS Issues Final Rule Updating Payment Rates For IRFs In FY 2007
• CMS Issues Final Rule On Accreditation Of DME Suppliers
• CBO Researcher Says Medicare Spending Per Beneficiary Has Slowed In Recent Years
• OIG Releases Reports On Medicare Beneficiary Access To Home Health Agencies And Skilled Nursing Facilities
• Report Says Medicare Beneficiaries With HIV/AIDS Face High Out-Of-Pocket Costs Under Part D
• News in Brief
• JCAHO Will Test Measures For Inpatient Psychiatric Services
• NCQA Adds Two New Standards To Its 2007 Accreditation Standards For Managed Care Plans
• Physicians
• New York Court Finds Physician Not Required To Exhaust Administrative Remedies To Sue For Contract Breach
• Quality of Care
• Report Makes Recommendations For Improvement Of Current Flawed Healthcare System

FDA, Barr Pharmaceuticals, reach accord over Plan B contraceptive sales

In Wednesday's paper, the NY Times reports that the FDA and the manufacturer of the Plan B contraceptive have reached an agreement that may lead to OTC sales (at least to customers 18 years of age and up; under-18's will still need a prescription) within weeks. The story doesn't refer to an earlier report that the FDA offered the deal to Barr last week, on the eve of hearings on the nomination of acting Commissioner Andrew C. von Eschenbach, apparently in response to the announced opposition of Sen. Hillary Clinton and other Senate Dems, who had vowed to delay a vote on the nomination until the FDA cleared its apparently unprecedented derailing of the OTC application. Pro-life groups regard the drug as an abortifacient, despite FDA's official classification of Barr's Plan B drug as an emergency contraceptive, so we can expect this latest development to produce the usual ripple effect of abortion politics.

NH's medical board agrees: doc has 1st Amendment right to be a jerk

As reported here earlier, a local NH court ruled that Terry Bennett's rude and crude comments to his patients were protected by the First Amendment and couldn't be the basis of a disciplinary case against the doctor. Apparently the New Hampshire State Board of Medicine agrees. As reported by Modern Healthcare today, the Board

will not appeal a court decision that blocked a disciplinary case over comments made by Rochester, N.H., physician Terry Bennett to patients in his private practice. The board sought to determine whether Bennett's comments, which at least three patients characterized as offensive, breached professional ethics standards.

This has to be the right result, from a constitutional perspective. Too bad it will probably only encourage the good doctor in his boorish and racist comments. The AP story is here (courtesy of the Boston Globe).

Vacation: what a concept (Part Deux)

Now it begins . . . .

AHLA's Health Lawyers Weekly

With AHLA's permission, here's the Table of Contents of today's issue of Health Lawyers Weekly:

I. Top Stories:

• House Clears HIT Legislation
• FDA To Improve Transparency Of Advisory Panel Conflicts, Official Says

II. Articles & Analyses:

• A Discussion About Alternative Dispute Resolution In The Healthcare Field
• 2005-2006 In-House Counsel Year In Review
• 2005-2006 Labor And Employment Year In Review

III. Current Topics:

A. Criminal Law

• Seventh Circuit Says Dentist May Not Withdraw Guilty Plea To Medicaid Fraud

B. Employment and Labor

• New Jersey Supreme Court Says Shareholder-Director Of Radiology Practice Not An "Employee" Under State's Whistleblower Protection Statute

C. ERISA

• U.S. Court In Pennsylvania Says ERISA Pre-Empts Hospital’s Contract Claims Against Insurers

D. Fraud and Abuse

• Update

E. Health Information Technology

• CDC Finds Increasing Percentage Of Office-Based Physicians Using Electronic Medical Records

F. Hospitals and Health Systems

• Oregon Health System Settles Charity Care Lawsuit
• U.S. Court In New Jersey Rejects Lawsuit Against Health System For Overcharging Uninsured
• Labor Union Ordered To Pay $17.3 Million For Defaming Hospital System
• Long Term Care OIG Finds State Survey Agencies Failed To Investigate Serious Complaints At Nursing Homes Within Required Timeframes

G. Managed Care

• California Governor Issues Executive Order To End "Balance Billing"
• Medicaid Sixth Circuit Upholds Dismissal Of Most § 1983 Claims Against Michigan Officials For Failure To Provide Services Mandated By Medicaid Act
• States To Receive $1.75 Billion To Offer Alternative Long Term Care Options Under Medicaid
• CMS Announces New Policies For Medicaid Asset Transfers, Improved Coordination Of Care
• CMS OKs Landmark Massachusetts Healthcare Reform Plan

H. Medical Malpractice

• Texas Appeals Court Finds Error In Dismissal Of Malpractice Action Against Laboratory

I. Medicare

• House Panel Considers Medicare Physician Payment Fixes
• GAO Finds Few Major Access Problems Reported By Medicare Beneficiaries For Physician Services
• CMS Announces Payment Updates For Home Health Services, Nursing Homes

J. News in Brief

• CMS Announces $150 Million In Transformation Grants For State Medicaid Programs
• CMS Issues Final Part D Marketing Guidelines
• CMS Awards Contracts To Test Transfer Of Medicare Data To PHRs For Online Use

K. Physicians

• California Appeals Court Rejects Physician's Retaliatory Eviction And Suspension Claims Against Hospital
• California Supreme Court Holds Hospital Could File Anti-SLAPP Motion To Strike Complaint Arising From Peer Review Proceedings

Vacation: what a concept!

HealthLawBlog will be on vacation for the next two weeks.

With random exceptions, don't expect anything new here before August 10th.

Stay cool. Be happy.

Yates: Not guilty by reason of insanity

Finally . . . .

NOLA murder arrests: further reflections

Today's CDC Public Health Law Newsletter has a link to a Chicago Tribune article that explores the ethics of triage and its applicability vel non to the NOLA cases previously discussed (here, here, and here):

“Disaster plan: Time to think unthinkable?”
Chicago Tribune (07/19/06) Ronald Kotulak

Last week, two nurses and a doctor were arrested in New Orleans on charges that they gave lethal doses of drugs to four hospital patients in the aftermath of Hurricane Katrina. The second-degree murder charges have led ethicists to begin debating what actions taken by medical personnel are permissible in similar situations, such as catastrophic weather events, deployments of weapons of mass destruction, or even widespread influenza epidemics. In such situations, medical care might be limited. “What do you do if you had no way to treat people and they were ill and there was no power and the ventilation had gone down and the machines that had kept them alive were failing? That is an astonishingly important ethical problem, given the realities we face with disaster planning,” said Laurie Zoloth, director of the Center for Bioethics, Science and Society at the Northwestern University Feinberg School of Medicine. Zoloth compared such scenarios to doctors triaging wounded soldiers on the battlefield. Dr. Mark Siegler of the University of Chicago’s MacLain Center for Medical Ethics said there is sometimes a fine line between giving a patient morphine for pain and a dose high enough to cause death. But Dr. Joshua Hauser, a palliative care expert, said doctors have specific guidelines to follow to avoid a morphine-related death. “There’s significant consensus in the medical community that giving a dose of morphine with the intent of ending someone’s life is unacceptable,” he said.

Further thoughts on the Senate abortion bill

As previously noted, the Senate has passed a bill that would impose criminal penalties on anyone who helps a minor travel across state lines from a state that has a parental-notification or -consent law in order to obtain an abortion in a state that has no such restrictions. As the map on my post illustrates, 6 states have no restrictions on minors: Washington, Oregon, Vermont, New York, Massachusetts, and Hawai'i. The House previously passed a similar bill [H.R.748; roll call #144], and news reports today say the president has said he will sign a bill if the two houses of Congress can agree on language in conference [NY Times].

Maybe my brain isn't firing on all 8 cylinders this morning. But -- quite apart from whether you think a restriction like this is good social policy -- when was the last time Congress criminalized two perfectly legal acts, one of which the Supreme Court has decided is Constitutionally protected as a "fundamental right"?

Senate passes prohibition on interstate travel for abortion

The Washington Post has the story. The Senate has passed a a bill (S.403) "to prohibit taking minors across State lines in circumvention of laws requiring the involvement of parents in abortion decisions [preamble]," thus (according to The Post) handing a long-sought victory to the Bush administration and abortion opponents":

The bill would help about three dozen states enforce laws that require minors to notify or obtain the consent of their parents before having an abortion. It would bar people -- including clergy members and grandparents -- from helping a girl cross state lines to avoid parental-involvement laws. Violations could result in a year in prison.

Most states have passed such laws, but courts
have invalidated at least nine of them, advocacy groups say. . . . The Senate voted 65 to 34 to approve the bill, which is similar to one the House has approved before, including last year.

The Senate bill is here and the roll-call vote is here.

Juvenile court orders teen to accept chemo, reversed by circuit court

Starchild Abraham Cherrix has Hodgkin's disease, and when the disease returned after his initial round of chemo, he refused a second round, opting instead for "a sugar-free, organic diet and take herbal supplements under the supervision of a clinic in Mexico" [Washington Post]:

A social worker asked a juvenile court judge to require the teen to continue conventional treatment, and the judge on Friday ordered Abraham to report to a hospital Tuesday. But Accomack County Circuit Court Judge Glen A. Tyler suspended the judge's order. . . . Tyler [also] agreed to a stay and set a trial date of Aug. 16 [and] ended joint custody of Abraham between his parents and social services officials.

In a similar case last year, the parents of 13-year-old Hodgkin's disease patient Katie Wernecke won the right in November to make all her medical decisions after a court fight with Texas child welfare officials. Doctors had recommended chemotherapy and radiation; her father favored a program of intravenous vitamin C.

The 'Net is ablaze with coverage of this story, as well as commentary. Here is a sampling:

• Treatment should be patients' choiceMSU State News, MI - 52 minutes ago... illnesses? Starchild Abraham Cherrix, who goes by Abraham, a 16-year-old from Virginia, has been dealing with this question lately....
• Is That Freedom Ringing?Hammer of Truth - 1 hour agoGood news from the Abraham Cherrix saga! Accomack County Circuit Court Judge Glen A. Tyler ruled that Abraham does not have to report ...
• Statements on Abraham Cherrix chemotherapy court decision by Mike ...Newstarget.com, Taiwan - Jul 21, 2006"The court's demand that Abraham Cherrix, a clear-thinking young man ... It is the ultimate misuse of power and equivalent to a death sentence upon Mr. Cherrix.". ...
• His say-so was boycottedWashington Times, DC - 12 minutes ago... On July 21, juvenile court Judge Jesse E. Demps ruled that the boy's parents, Jay and Rose Cherrix of Chincoteague, were neglectful and must continue to share ...
• Teen's court battle gains national attentionChincoteague Beacon, VA - Jul 20, 2006... it probes at what age a minor is old enough to make personal medical choices -- is drawing remarkable media attention for 16-year-old Abraham Cherrix and his ...

Art Caplan is one of the few voices in the wilderness who questions the wisdom of letting young Mr. Cherrix decide his fate:

• Medical Neglect? The Abraham Cherrix Case
  This is an especially tough case since the child involved is older and seems very mature. Still it is hard to deny an efficacious treatment based on the views of a sixteen year old who is still strongly under his parents influence when it comes to attitudes about standard medical care.

The American Way of Death IV

While we're talking about patient and family perceptions of end-of-life care in the hospital -- we were talking about that, weren't we? just yesterday? -- Pamela Winnick's essay in the Wall Street Journal on July 21 is well worth considering. She talks about a resident nicknamed "Dr. Death" who pursues family members down the hall to harangue them about her father's alleged desire to be allowed to die a dignified death. She continues:

"Dr. Death" was just one of several. A new resident appeared the next day, this one a bit more diplomatic but again urging us to allow my father to "die with dignity." And the next day came yet another, who opened with the words, "We're getting mixed messages from your family," before I shut him up. I've written extensively about practice of bioethics -- which, for the most part, I do not find especially ethical -- but never did I dream that our moral compass had gone this far askew. My father, 85, was heading ineluctably toward death. Though unconscious, his brain, as far as anyone could tell, had not been touched by either the cancer or the blood clot. He was not in a persistent vegetative state" (itself a phrase subject to broad interpretation), that magic point at which family members are required to pull the plug -- or risk the accusation that they are right-wing Christians.

I complained about all the death-with-dignity pressure to my father's doctor, an Orthodox Jew, who said that his religion forbids the termination of care but that he would be perfectly willing to "look the other way" if we wanted my father to die. We didn't. Then a light bulb went off in my head. We could devise a strategy to fend off the death-happy residents: We would tell them we were Orthodox Jews.

"My little ruse," she reports, "worked. During the few days after I announced this faux fact, it was as though an invisible fence had been drawn around my mother, my sister and me. No one dared mutter that hateful phrase 'death with dignity.'" Eventually her father was well enough to be transferred out of the ICU and then out of the long-term respiratory care unit. "A day later he was off the respirator, able to breathe on his own. He still mostly slept, but then he began to awaken for minutes at a time, at first groggy, but soon he was as alert (and funny) as ever. A day later, we walked in to find him sitting upright in a chair, reading the New York Times."

This a good reminder for all of us who work with ethics committees and through them with the families of (apparently) dying patients: The "death with dignity" mantra needs to be applied cautiously, patiently, and with sensitivity and a healthy dose of humility.

The HCA deal is done

The closing probably won't be till the 4th quarter, assuming the federal regulators bless it and the board doesn't get a better offer, but HCA's board has approved the sale of the company to an aglomeration of investment bankers and the founding Frist family. Of course, no one can quite agree whether the deal is worth $21 billion, $31 billion, or $33 billion, but what's a few billion here or there?

• HCA Agrees to $21.3B Leveraged Buyout Washington Post, United States - By Daniela Deane. HCA Inc., the country's largest for-profit hospital operator group founded by the family of Senate Majority Leader ...
• HCA Goes For The Record Forbes - HCA, the huge for-profit hospital operator, agreed on Monday to be taken private by a consortium that will pay $33 billion in cash and assumed debt, the ...
• US hospital operator faces $41b private equity buyout Sydney Morning Herald, Australia - THREE private equity firms will offer to buy America's biggest hospital operator, HCA, for about $US31 billion ($41 billion) including debt, people familiar ...

The biggest disparity in the reported figures is probably attributable to the $10.6 billion of debt that's being assumed. Once the reporting settles on the value of the deal, it will be in the $31-33 billion range. As Forbes is reporting, their estimate of $31.6 billion would make this the largest leveraged buyout in U.S. history, exceeding KKR's $31.1 billion purchase of RJR Nabisco in 1989. (KKR is also involved in the HCA deal.)

From a health policy perspective, I expect the pundits to ask the question whether for-profit health care ought to be so profitable that it would lead savvy business people to shell out this kind of money. Forbes' title for one of its on-line stories this morning unintentionally sums it up nicely: "Health Is Wealth." When a health care provider can throw of this amount of wealth for private investors, it's bound to fuel questions about whether patients and payers, including the federal government, are paying too much for what they receive.

The investors are also giving us their take on the long-term future of health care in this country. From Forbes: "Apart from betting that economic conditions in the U.S. will remain stable, the suitors will be hoping that the aging American population continues to prompt higher spending on health care, and that the government eventually resolves the problem of uninsured patients."

HCA close to $21 billion buyout

After coming oh so close to closing a deal last weekend, it looks like the board is on the verge of approving a $21 billion deal tonight. As reported by the NY Times, "HCA, the nation’s largest for-profit hospital operator, was close to a deal last night to sell itself to a consortium of private equity investors for about $21 billion, people involved in the talks said. The investors would also take on about $10.6 billion of HCA’s debt, making the deal the largest leveraged buyout in history." For-profit healthcare is looking rosy (or, at a minimum, HCA insiders and some savvy investment bankers think HCA's stock is 'way undervalued by the market).

• Bain, Merrill, KKR to Bid $21 Bln for HCA, People Say (Update1) Bloomberg - July 24 (Bloomberg) -- Bain Capital LLC, Merrill Lynch & Co. and Kohlberg, Kravis Roberts & Co. will offer to buy HCA Inc., the ...
• HCA (HCA) Near $21B Deal with Investor Group WSJ StreetInsider.com (subscription), MI - According to reports from the Wall Street Journal, HCA Inc. (NYSE: HCA) is in advanced takeover talks with an investor group that could be worth $21 billion. ...
• Big Private Hospital Chain May Be Close to Record Sale New York Times, United States - HCA, the nation’s largest for-profit hospital operator, was close to a deal last night to sell itself to a consortium of private equity investors for about ...