- Being Specific About Race-Specific Medicine
Health Affairs, Vol. 25, 2006
Jonathan D. Kahn and Pamela Sankar, Hamline University - School of Law and University of Pennsylvania - School of Medicine
Date Posted: August 30, 2006
Last Revised: August 30, 2006 Accepted Paper Series - Counterfeit Drugs: The Good, the Bad and the Ugly
Albany Law Journal of Science and Technology, Vol. 15, 2006
Kevin Outterson and Ryan Smith, West Virginia University - College of Law and West Virginia University - College of Law
Date Posted: August 30, 2006
Last Revised: August 30, 2006 Accepted Paper Series
2 downloads - Deciding Who We Are: The Relational Self and Tyranny of Atomistic Autonomy
David E. Guinn, DePaul University
Date Posted: August 30, 2006
Last Revised: September 1, 2006
Working Paper Series
8 downloads - Mental Health Tribunals: A Significant Medico-Legal Change
Medico-Legal Journal of Ireland, Vol. 10, p. 84, 2004
Darius Whelan, University College Cork - Faculty and Department of Law
Date Posted: August 30, 2006
Last Revised: August 30, 2006
Accepted Paper Series - Defining Constitutional Parameters: The Forced Drugging of Civilly Committed Mental Patients
Southern California Interdisciplinary Law Journal, Vol. 1, pp. 57, 1992
Lisa Litwiller, Chapman University - School of Law
Date Posted: August 29, 2006
Last Revised:August 29, 2006
Accepted Paper Series - Maryland's Wal-Mart Act: Policy and Preemption
Cardozo Law Review, forthcoming
Edward A. Zelinsky, Cardozo Law School
Date Posted: August 29, 2006
Last Revised:August 29, 2006
Accepted Paper Series
1 downloads - New Terms for an Old Debate: Embryos, Dying and the 'Culture Wars'
Hofstra Univ. Legal Studies Research Paper No. 06-23, Houston Journal of Health Law & Policy, Vol. 6, p. 251, 2006
Janet L. Dolgin, Hofstra University - School of Law
Date Posted: August 29, 2006
Last Revised: August 29, 2006
Accepted Paper Series
5 downloads - The Beginning and End of the Life Cycle
Hong Kong Law Journal, Vol. 35, No. 2, p. 277, 2005
Elizabeth Butler-Sloss, University of Hong Kong - Faculty of Law
Date Posted: August 29, 2006
Last Revised:August 29, 2006
Accepted Paper Series - Toward Healing and Restoration for All: Reframing Medical Malpractice Reform
Connecticut Law Review, Vol. 39, Winter 2006-2007
Jonathan Todres, New York University School of Law
Date Posted: August 29, 2006
Last Revised: August 29, 2006
Accepted Paper Series - What Should California Law Be on Doctor-Assisted Suicide
Los Angeles Daily Journal, Vol. 106, No. 7, 1993
Jeremy M. Miller, Chapman University - School of Law
Date Posted: August 29, 2006
Last Revised: August 29, 2006
Accepted Paper Series - Human Genetics Studies: The Case for Group Rights
Duke Science, Technology & Innovation Paper No. 10, Journal of Law, Medicine & Ethics, Vol. 35, 2006
Laura Underkuffler, Duke University - School of Law Date
Posted: August 24, 2006
Last Revised: August 24, 2006
Accepted Paper Series
2 downloads - Abortion and Original Meaning
Jack M. Balkin, Yale University - Law School
Date Posted: August 21, 2006
Last Revised: August 25, 2006
Working Paper Series
541 downloads - Defining Life from the Perspective of Death: An Introduction to the Forced Symmetry Approach
Arizona Legal Studies Discussion Paper No. 06-29, University of Chicago Legal Forum, 2006
Kirsten Rabe Smolensky, University of Arizona - James E. Rogers College of Law
Date Posted: August 18, 2006
Last Revised: August 18, 2006
Accepted Paper Series
13 downloads - Governing the Body: Examining EU Regulatory Developments in Relation to Substances of Human Origin
Journal of Social Welfare and Family Law, Vol. 27, Nos. 3-4, pp. 427-437, 2005
Anne-Maree Farrell, University of Manchester
Date Posted: August 15, 2006
Last Revised: August 15, 2006
Accepted Paper Series
Law, Religion and Biomedicine: Consensus or Conflict?
Sydney Law School Research Paper No. 06/12, Macquarie Law Symposium - Law, Religion and Medical Science, Vol. 1, pp. 59-66, 2006
Roger Magnusson, University of Sydney - Faculty of Law
Date Posted: August 15, 2006
Last Revised: August 24, 2006
Accepted Paper Series
7 downloads - The Design and Experience of Health Regulation in Colombia
Revista de Economía Institucional, Vol. 7, No. 12, First semester 2005
Jairo Humberto Restrepo Zea and Sandra Rodríguez Acosta, Universidad de Antioquia and Universidad de Antioquia
Date Posted: August 12, 2006
Last Revised: August 12, 2006
Accepted Paper Series - Improving Medical Malpractice Liability by Allowing Insurers to Take Charge
Harvard Law and Economics Discussion Paper No. 556
David Rosenberg and Kenneth Reinker, Harvard Law School and Criterion Economics, LLC
Date Posted: August 10, 2006
Last Revised:August 31, 2006
Working Paper Series
23 downloads - The Idea of a Right to Genetic Privacy
Torben Spaak, Uppsala University - Law
Date Posted: August 10, 2006
Last Revised: August 10, 2006
Working Paper Series
7 downloads - The Ills of America's Health Care System: Root Causes and Potential Cures
Networks Financial Institute Policy Brief No. 2006-PB-12
Sidney Taurel, Eli Lilly and Company - Lilly Corporate Center
Date Posted: August 9, 2006
Last Revised:August 9, 2006
Working Paper Series
3 downloads - Schiavo: The Road Not Taken
University of Miami Law Review, Vol. 61, No. 20, 2007
Mary Irene Coombs, University of Miami - School of Law
Date Posted: August 8, 2006
Last Revised: August 18, 2006
Accepted Paper Series
3 downloads - Human Rights as a Contingent Foundation: The Case of Physicians for Human Rights
Journal of Human Rights, Forthcoming
Neve Gordon, Ben-Gurion University of the Negev
Date Posted: August 7, 2006
Last Revised: August 22, 2006
Accepted Paper Series - Hospital's Activity-Based Financing System and Manager-Physician Interaction
CORE Discussion Paper No. 2006/29
David Crainich, Hervé Leleu and Ana Mauleon, Catholic University of Lille - Faculté Libre des Sciences Economiques (FLSE) , Catholic University of Louvain - Center for Operations Research and Econometrics (CORE) and Facultés universitaires Saint-Louis à Bruxelles - CEREC
Date Posted: August 4, 2006
Last Revised: August 22, 2006
Working Paper Series
4 downloads - Medical Error as Reportable Event, as Tort, as Crime: A Transpacific Comparison
Widener Law Review, Vol. 12, June 2006
Robert B. Leflar and Futoshi Iwata, University of Arkansas School of Law and Sophia University - Faculty of Law
Date Posted: August 3, 2006
Last Revised: September 3, 2006
Accepted Paper Series
4 downloads - New Estimates of the Demand for Physical and Mental Health Treatment
Chad D. Meyerhoefer and Samuel H. Zuvekas, Agency for Healthcare Research & Quality (AHRQ) and Agency for Healthcare Research and Quality
Date Posted: August 2, 2006
Last Revised: August 2, 2006
Working Paper Series
17 downloads
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Tuesday, September 05, 2006
SSRN roundup: health law (August 2006 additions)
Monday, September 04, 2006
Krugman: Why is health policy malpractice a conservative disease?
What explains the VA's success? Here's Krugman's version:
The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life.
This means that the V.A. can easily keep track of a patient’s medical history, allowing it to make much better use of information technology than other health care providers. Unlike all but a few doctors in the private sector, V.A. doctors have instant access to patients’ medical records via a systemwide network, which reduces both costs and medical errors.
The long-term relationship with patients also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.
The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient.
You might think that the government would be happy to see more veterans receive more of their care within the VA system, but you'd be wrong:
The irony isn't lost on Krugman: "Think about that: they won’t let vets on Medicare buy into the V.A. system, not because they believe this policy initiative would fail, but because they’re afraid it would succeed."Not surprisingly, hundreds of thousands of veterans have switched from private physicians to the V.A. The commander of the American Legion has proposed letting elderly vets spend their Medicare benefits at V.A. facilities, which would lead to better medical care and large government savings.
Instead, the Bush administration has restricted access to the V.A. system, limiting it to poor vets or those with service-related injuries. And as for allowing elderly vets to get better, cheaper health care: “Conservatives,” writes Time, “fear such an arrangement would be a Trojan horse, setting up an even larger national health-care program and taking more business from the private sector.”
Meanwhile, the subsidies to lure private insurers into the Medicare managed care market push the costs to the government 11 percent higher than traditional Medicare and mortality rates are 40 percent higher than those of elderly veterans in the VA system. Krugman's conclusion:
I don't really have a quarrel with Krugman's argument. Okay, maybe a nit to pick here or there (for example, the better comparison of costs-per-patient would have been between Medicare managed care, on the one hand, and the VA on the other -- Krugman implies that the VA's costs are lower than Medicare managed care, but he never actually says it. And research schlub that I am, I don't know where to go to get that missing piece of his argument.)On one side, then, the administration and its allies in Congress oppose expanding the best health care system in America, even though that expansion would save taxpayer dollars, because they’re afraid that allowing a successful government program to expand would undermine their antigovernment crusade and displease powerful business lobbies.
On the other side, ideology and fealty to interest groups make them willing to waste billions subsidizing private H.M.O.’s.
Also, I know it's dangerous to try to make policy on the basis of anecdote, but every medical student I know who rotates through the VA hospital here in Dallas comes back with horror stories of poor care (with respect to the technical component, the interpersonal component, and the amenities). It's just one hospital in a vast system, and the examples of bad care are likely to make more of an impression than the virtually silent and invisible examples of care that is provided well, but everyone I know rolls their eyes at the mention of the VA hospital. And yet, the VA stats speak for themselves, don't they?
Sunday, September 03, 2006
Post-grad opportunity at Harvard
The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School
2007-2009 Post-Graduate and Mid-Career Fellowship Program
Call for Applications: Deadline October 16, 2006
The Petrie-Flom Center is an interdisciplinary research program at HarvardLaw School dedicated to the scholarly research of important issues about the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research, and bioethics.
The Center is now accepting applications for its second group of post-graduate/mid-career fellowships starting in August 2007. These are two-year full-time academic research fellowships paying $60,000 per year, plus benefits.
Applicants must hold a degree in law or some other graduate discipline that they intend to apply to issues of health law policy or bioethics. The Center particularly encourages applications by those who intend to pursue careers as law professors, but will consider any applicant who demonstrates an interest and ability to produce cutting-edge scholarship in the areas of health policy, biotechnology or bioethics during the term of the fellowship.
Fellows chosen for the 2007-09 term will join an outstanding inaugural group of fellows who started in August 2006, as well as senior fellow Frances Kamm, one of the world's leading moral philosophers, who will be in residence at the Center during the 2007-08 academic year. Detailed information about the fellowship program, our
current fellows, and how to apply is available at
www.law.harvard.edu/programs/petrie-flom/.Applications are due no later than October 16, 2006. Please note that this deadline is several months earlier than last year's.
Will Christian Science health plan count in Massachusetts?
When Gov. Mitt Romney signed the Massachusetts' health care law in April, it was hailed as a watershed moment.
Under the new law, Massachusetts is the first state to require all residents to have health insurance by July 2007.
The poorest will receive subsidized care, while everyone making more than three times the federal poverty level will be required to have private insurance, either through their employer or on their own.
To encourage employers to offer insurance, the law imposes an annual $295 per-worker fee on employers that don't offer insurance but employ 11 or more workers.
Christian Scientists want to make sure the new regulations recognize the church's own health plan, based on spiritual healing instead of medications and surgery, as a legitimate health care plan both for employers and individuals. . . .
[Jane Warmack, head of the church's legislative division] said the church wants to make sure other health care plans that don't rely on invasive medical care are put on an equal legal footing with other insurance plans.
"The legislative intent behind the law was to ensure that Massachusetts residents would be provided health care," she said. "It wasn't to dictate a particular kind of health care."
She said she also wanted to make sure that individuals who opt for alternative plans would not be penalized.
"What's at stake is people's access to the type of health care they want and for some people that is spiritual healing," she said.
The church already has testified before the state Division of Health Care Finance and Policy, which will write the final regulations. Those are expected sometime in early September, according to Dick Powers, spokesman for the Executive Office of Health and Human Services.
"We listened and read everyone's testimony and all of it will be taken into consideration," Powers said.
Powers also pointed to a portion of the law that would allow individuals to avoid tax penalties if they file an affidavit with their income tax returns stating "sincerely held religious beliefs" were the basis of their refusal to obtain "creditable coverage."
AHLA's Health Lawyers Weekly (Sept. 1)
September 1, 2006 Vol. 4, Issue 34
Top Stories
- Specialty Hospitals Associated With Increased Utilization, MedPAC Finds
Physician-owned heart hospitals are associated with a significant increase in the rate of cardiac surgeries in the market where the hospital is located, according to a Medicare Payment Advisory Commission (MedPAC) 2006 Report to Congress, Physician Owned Specialty Hospitals Revisited. According to the report, the entrance of a physician-owned cardiac hospital into a market was associated with a 6% increase in the number of cardiac surgeries per 1,000 Medicare beneficiaries. Full Story - Schering-Plough Will Pay $435 Million To Settle Allegations Of Illegal Marketing, Fraud
Schering-Plough Corp. and one of its subsidiaries have agreed to a $435 million global settlement to resolve criminal charges and civil claims that they engaged in illegal sales and marketing schemes and defrauded Medicaid, U.S. Attorney for the District of Massachusetts Michael Sullivan announced August 29.The settlement stems from allegations that the company marketed its drug Temodar and Intron A for so-called "off label" uses that had not been approved by the Food and Drug Administration (FDA). Full Story
Articles & Analyses
- Final Stark Exception And Anti-Kickback Safe Harbor For Electronic Health Records And E-Prescribing, By Jill M. Girardeau, Womble Carlyle Sandridge & Rice, PLLC
Current Topics
- Criminal Law
Fourth Circuit Vacates Physician's Drug Trafficking Conviction Citing Improper Jury Instruction - EMTALA
U.S. Court In Alabama Finds CMS Investigation Report Admissible In EMTALA Action - ERISA
Eleventh Circuit Applies Supreme Court's Sereboff Decision To ERISA Plan Subrogation Claims - Food and Drug Law
FDA Issues Draft Guidance, Schedules Hearing On Emergency Research - Fraud and Abuse
1. BCBSA Says Anti-Fraud Efforts Saved $249 Million In 2005
2. Update
3. OIG Approves Charitable Organization's Proposed Subsidization Of Medicare Part D Premiums For Certain Patients With Kidney Disease
4. Michigan Appeals Court Finds Sufficient Evidence Of Wrongful Intent To Sustain Medicaid Fraud Charges
5. U.S. Court In Illinois Dismisses Second Amended Qui Tam Complaint Against Pharmacy Benefit Services Company - Healthcare Access
California Governor Announces New Initiative To Reduce Drug Costs - Hospitals and Health Systems
JCAHO Issues Revised Medical Staff Standard For Comment - Insurance
Census Bureau Finds Number Of Uninsured Grew Between 2004 And 2005 - Long Term Care
North Dakota Supreme Court Finds Wife May Be Liable For Nursing Home Bills Of Institutionalized Spouse If She Had A Valid Contract With Home - Managed Care
Pennsylvania Supreme Court Finds HMO Is Exempt From Complying With Anti-Subrogation Provision Of State Automobile Insurance Law - Medicaid
CMS Issues Interim Final Rule On Medicaid, SCHIP Improper Error Rate Estimation - Medical Malpractice
Minnesota Appeals Court Finds Lower Court Erred In Directing Verdict For Radiation Therapy Center In Negligence Action - Medicare
1. Public Interest Group Sues CMS Alleging Part D Marketing Guidelines Violate Free Speech
2. OIG Finds Oncology Demonstration Data Unreliable
3. Lieberman Says Senate Must Address Impending Medicare Physician Payment Cuts
4. CMS Plans To Review Its Medicare Payment Codes For Inhalation Drugs
5. CMS Proposes Prohibition On Midyear Benefit Enhancements By MA Plans
6. CMS Announces FY 2007 Update To Hospice Wage Index
(c) 2006, AHLA. Reprinted with permission.
U.S. research: running on empty?
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?
Tuesday, August 29, 2006
"Medically inappropriate treatment" - how do we decide?
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?
Friday, August 25, 2006
AHLA's Health Lawyers Weekly (Aug. 25)
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
Thursday, August 24, 2006
Why is 16% of GDP too much to spend on health care?
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.
Wednesday, August 23, 2006
New technique for deriving embryonic stem cells that doesn't destroy the embryo
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.")
Sunday, August 20, 2006
Internet prescribing legislation introduced in U.S. Senate
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
Saturday, August 19, 2006
Latest from AHLA's Health Lawyers Weekly (18 Aug 2006)
(c) 2006. Reprinted by permission 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 StoryArticles & 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 GroupCurrent 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
Friday, August 18, 2006
It's a good time to be in cardiology
- 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.
Wednesday, August 16, 2006
Medical liability insurers profiting handsomely in wake of Texas tort reform
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."
Tuesday, August 15, 2006
More on emergency room practices
ER sends nonemergency patients packing
Sunday, August 13, 2006
Kaiser fined for mismanagement of its kidney-transplant program
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
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
Latest from AHLA's Health Lawyers Weekly (11 Aug 2006)
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
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?
Thursday, August 10, 2006
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
- GAO Releases Survey Results Of Nonprofit
- 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
Tuesday, August 08, 2006
FDA, Barr Pharmaceuticals, reach accord over Plan B contraceptive sales
Thursday, August 03, 2006
NH's medical board agrees: doc has 1st Amendment right to be a jerk
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).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.