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 ...

Criminal Law III: More on the NOLA murder prosecutions

AP/Yahoo has an article today entitled, "Many see accused New Orleans MD as hero." State AG made much of the fact that both morphine and Versed were found in the the bodies of the four patients whose deaths were the basis for his order to arrest Dr. Pou and the two nurses. Contrary to his assertion that the two drugs together can mean only one thing -- that the health care workers' intent was to produce the patients' death -- "Dr. Daniel Nuss (Dr. Pou's department head at LSU) and other doctors said the morphine and Versed that investigators found in the patients' bodies are commonly given to relieve suffering and anxiety. 'If you didn't find sedatives and analgesics in these people, I would think that was inhumane,' [Dr. Ben] deBoisblanc[, director of critical care at Charity Hospital] said. 'The very fact that you found these drugs means nothing.'"

The American Way of Death III

NPR's Studio 360 program has a wonderful item this week on Emily Dickinson and her iconic poem, "Because I Could Not Stop For Death." The program is available as an MP3 file here.

We read this poem every year in Law, Literature & Medicine, where third-year law students from SMU and fourth-year medical students from UT-Southwestern wrestle with Dickinson's verses, among many others.

Because I could not stop for Death –
He kindly stopped for me –
The Carriage held but just Ourselves –
And Immortality.

We slowly drove – He knew no haste
And I had put away
My labor and my leisure too,
For His Civility –

We passed the School, where Children strove
At Recess – in the Ring –
We passed the Fields of Gazing Grain –
We passed the Setting Sun –

Or rather – He passed us –
The Dews drew quivering and chill –
For only Gossamer, my Gown –
My Tippet – only Tulle –

We paused before a House that seemed
A Swelling of the Ground –
The Roof was scarcely visible –
The Cornice – in the Ground –

Since then – 'tis Centuries – and yet
Feels shorter than the Day
I first surmised the Horses' Heads
Were toward Eternity –

courtesy of the Academy of American Poets

The American Way of Death II

Thanks to Joe Paduda's "Managed Care Matters" for pointing me to this story in the Minneapolis-St. Paul Business Journal about a recent article in Mayo Clinic Proceedings: "Adult Intensive Care Unit Use at the End of Life: A Population-Based Study," by Seferian and Afessa [abstract; full text available in 6 months]. As reported in the business journal:

Intensive care costs comprise 30 to 40 percent of hospital spending and may continue to grow as the population ages, according to a new Mayo Clinic study. Older people with chronic illnesses have the highest rates of intensive-care-unit (ICU) use at the end of their lives, the study found. The country's aging population has an increased prevalence of chronic diseases, signaling that ICUs may treat more and more people in the years ahead. . . .

The study was set in Olmsted County, home of Rochester-based Mayo Clinic, and looked at 818 residents who were admitted to an ICU in 1998. Of those people, one in five died after having received ICU care in the last six months of life. Patients in the last year of their lives accounted for one-fourth of the ICU days used by county residents.

As Paduda points out, these numbers are consistent with a study led by Dartmouth's John Wennberg. As summarized by NewsTarget.com:

The Dartmouth Atlas Project studied the records of 4.7 million Medicare enrollees who died from 2000 to 2003 and had at least one of 12 chronic illnesses. The study demonstrates that even within this limited patient population, Medicare could have realized substantia savings — $40 billion or nearly one-third of what it spent for their care over the four years — if all U.S. hospitals practiced at the high-quality/low-cost standard set by the Salt Lake City region.

The American Way of Death I

Back in the day, the phrase "The American Way of Death" invoked Jessica Mitford's classic expose of the funeral industry. In bioethics and law, however, it has a more immediate connotation. With 80% of all Americans dying in an insitutional setting, what is the meaning of "a good death"? And is it possible to achieve in a hospital? Palliative care services notwithstanding, the standard of care for a dying patient typically leaves a lot to be desired. Just how much is well illustrated in an article in the June 21 issue of JAMA (subscription required): "At Face Value" by Karen Donley-Hayes. In discussing her best friend Ashley's death at 36 of breast cancer, she described a process all to familiar to those of us who hang around hospitals:

In Ashley's care (with which I have no quarrel), there was no focus on dying until — reluctantly — she went into hospice two weeks before the end of her life. Fortunately, hospice did give us all some preparation for what was to come, but I recall no substantive discussion with the oncologist, or the nursing staff, or the surgeons about what to expect as Ashley died, how to handle it, and what to do — only discussions about how to fight the cancer, until it was clear that fighting was over. Then, it seemed, the entire oncology department removed itself from the picture; even the pain management center seemed to fall short of helping. No one, no organized section of the medical community, came forward to help in the transition from aggressively treating the cancer to helping the patient die. Hospice stepped up to the plate within the scope of its purview, but the medical community, in retrospect, seemed to have hit a wall, as if their jurisdiction to help Ashley in any way ended when it was clear that she would die.

Ashley liked and respected her physicians, liked the nurses who helped with her chemotherapy; for the year and a half of her illness, these people had become, in a way, a part of her family. They knew her by name, knew about her life, what she did, what she liked, her family. For a while, she saw and talked to them nearly as much as the rest of her family. And suddenly, they were gone. Out of the picture. Part of her past. One nurse came to Ashley's memorial service, a gesture that showed us that Ashley had been important to them too; other than that, I did not see any of the members involved in her medical care again. While they were trying to beat this cancer, to win the battle, they were there en masse. When no more chemotherapy or radiation would be administered, they were gone. Looking back, I see this as a sad departure, almost an abandonment. They were there to help her try to live, but they were not there to help her die. . . .

Ashley's situation was unique, because she had several people in her immediate family and close circle of friends who were able to devote themselves to her during her illness and dying process. As time has passed since her death, and I have studied medical ethics and end-of-life issues, it has become clearer to me that there is a gap in the scope of medical care for terminally ill persons: How does the medical community help people die? Can the physicians who govern the treatment of an illness also embrace the care of the patient and the patient's family in the dying process? The disconnect that happens when the "fight" is over is a disservice to the patient. And it's a disservice to the health care professionals as well. They're out of touch with part of the course of the patient's illness, even if they can't cure the illness.

Ashley was very fortunate in so many ways. But what happens to patients who don't have family and friends with the ability or willingness to help them weather the rigors of treatment, or help them die when and if the time comes? Who supports these patients? Who helps their families and friends, who must try and manage this with little or no training or guidance?

Hospice can be a huge help, but it's still a blunt separation from the medical teams that were treating the patient. The transition in care might be the flick of a light switch, but the transition in terms of spirituality, psychology, acceptance for the patient — or the patient's family — cannot be so simple.

If the act of dying isn't shuttled into the closet, if the medical community could embrace it as a natural part of life, the process could be an easier one on everyone — less frightening, less painful, less lonely and rudderless. Death is ugly, scary, and final. But I doubt that any of us want to die feeling impotent, abandoned, no longer in the embrace of the physicians who cared for us when they hoped we might live. A natural part of death for everyone is grief, anxiety, fear, maybe anger. But it can also be a time of growth and enlightenment.

Ashley wasn't timid about dying. The medical profession shouldn't be either.

Criminal Law II: follow-up on the Memorial Hospital case

Now that the Louisiana Attorney General has had his day (see my earlier post), the extent of AG Foti's grandstanding is starting to come to light. You'd never know it from his office's press release on this case, but consider the following:

• the state attorney general has no power to indict or prosecute for these alleged crimes;
• the physician and nurses involved have not been charged with any crime, only arrested, which is the extent of the state AG's authority;
• there has been no grand jury investigation into the deaths at Memorial hospital;
• there is not yet an official medical examiner's report into the cause of death of the four patients whose deaths lead the AG to arrest the health care workers;
• the Orleans Parish D.A., Eddie Jordan, has the prosecutorial authority in these cases, and he's taking a wait-and-see attitude; and
• there is at least some feeling among Louisiana lawyers that the AG's aggressive grandstanding crosses the line into unethical behavior and is related to his plan to run for reelection in 2008.

There's a good article from the L.A. Times on all this.

Criminal Law I: promoting off-label uses of approved drugs

Today's New York Times has an article about the recent arrest and prosecution of Dr. Peter Gleason for promoting use of the drug Xyrem, which is approved by the FDA for the treatment of narcolepsy, for the off-label treatment of depression and pain.

Now, it's horn-book law that physicians can use approved drugs for off-label uses. And it's equally well-settled, though perhaps a little less well-known, that pharmaceutical companies cannot themselves promote their approved drugs for nonapproved (or "off-label") uses without formal FDA approval; they have to limit their claims for the drug's safety and efficacy to those uses for which they submitted data to the FDA and received that agency's marketing approval. (Max Mehlman has a good essay on this. The FDA's rule is here.)

But it is apparently perfectly okay for a pharmaceutical company to pay a physician to promote the off-label use of the company's approved drug or, as the Times article puts it: "Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor 'continuing medical education' sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies."

So how did Dr. Gleason get into so much trouble? It's not that clear. Perhaps the FDA decided to rein him in because it viewed his claims concerning Xyrem's safety -- i.e., that it was as safe as table salt and safe for children -- extravagant and dangerous, considering that its active ingredient is GBH (the "date rape drug"). Or perhaps it's because Dr. Gleason did not agree to cooperate with the government's investigation of his former benefactor, Jazz Pharmaceuticals, which has not yet been charged with anything. What is clear is that the FDA's rules don't provide much guidance for this practice and the basis for a criminal prosecution in Dr. Gleason's case is shaky at best. Stay tuned . . . .

Texas hospitals and immigration

There was a terrific article in The New York Times this past week on the different approaches taken by the public hospitals in Dallas County (Parkland) and Tarrant County (JPS), separated by about 40 miles and a river and a very different view of their missions. This country isn't close to figuring out a humane and sensible approach to immigrant health care, and the conflicts and contradictions are illustrated well by this story. For my money, the approach of the Parkland CEO, Dr. Ron Anderson, is best: "I don’t want my doctors and nurses to be immigration agents."

House fails to override presidential veto

The House failed to override Pres. Bush's veto of H.R.810 by a vote of 235-193, almost the identical vote when it was originally passed by the House in May. Not exactly earth-shattering news, but I offer it for the sake of closure if nothing else.

An excellent primer on the stem cell issue

Everything a reporter might need to know to cover this story intelligently -- and the rest of us will find helpful as well -- has been collected, organized, linkified, synthesized, and analyzed by Al Tompkins at the Poynter Center in last Friday's edition of Al's Morning Meeting. Thanks to AJOB's blog for the tip.