Top Stories
- More Questions Surface About FDA's Response To Avandia Risks
The House Oversight and Government Reform Committee held a hearing June 6 to probe the Food and Drug Administration’s (FDA's) role in evaluating the safety of the diabetes drug Avandia. Full Story- House Passes Stem Cell Bill
The House cleared June 7 a bill (S. 5) aimed at expanding research opportunities on embryonic stem cells in a 247-176 vote. The Senate cleared the measure in April by a vote of 63-34. Full StoryArticles & Analyses
- The Medicare Competitive Bidding Program For Durable Medical Equipment, Prosthetics, Orthotics, And SuppliesBy Carol Loepere, Elizabeth Carder-Thompson, Bob Hill, and Debra McCurdy, Reed Smith LLP
- Proposed Inpatient PPS Rule To Impact Specialty Hospitals: CMS Continues To Implement Its “Strategic And Implementing Plan For Specialty Hospitals”, By Thomas E. Dowdell and Lara E. Parkin, Fulbright & Jaworski, LLP
Current Topics
- Antitrust
U.S. Court In Tennessee Refuses To Dismiss Nurses’ Claims Alleging Hospitals Conspired To Depress Wages- Arbitration/Mediation
Arkansas High Court Upholds Denial Of Medical Corporation’s Motion To Compel Physician To Arbitrate Claims In Employment Dispute- EMTALA
U.S. Court In Virginia Holds State Hospital's Agreement To Comply With EMTALA Did Not Waive Virginia's Sovereign Immunity- ERISA
1. U.S. Court In Missouri Finds ERISA Preempts Plan Beneficiaries' Suit Against HMO For Charging Copays In Violation Of State Law
2. Eighth Circuit Reverses Lower Court Decision Upholding Health Plan Insurer’s Retroactive Rescission Of Plan Participant’s Coverage- Food and Drug Law
1. FDA Creates Communications Advisory Committee
2. Health Subcommittee Will Mark Up Pharmaceutical, Device Bills Next Week- Fraud and Abuse
1. Eleven Arrested In Alleged $5 Million Billing Scheme For HIV Infusion Treatments
2. Update
3. U.S., Texas Reach $15 Million Settlement With Hospital District To Resolve FCA Claims- Health Information Technology
New Coalition Will Lobby For Immediate Deployment Of Health Information Technology- Health Policy
Business Roundtable Releases Principles For Healthcare Reform- Healthcare Spending
NGA-NASBO Reports Stable Fiscal Conditions For States In FY 2007, But Projects Increasing Strain On Budgets In FY 2008- Hospitals and Health Systems
Texas Supreme Court Finds Hospital May Not Maintain Lien Against Patient For Charges Not Covered By Workers Comp- Individual/Patient Rights
Sixth Circuit Strikes Down Michigan Abortion Law- Insurance
Maine High Court Rejects Payors’ Challenge To Calculation Of “Cost Savings” From Health Program Used To Set Offset Payments- Medicaid
OIG Finds AMPs For Most Drugs Remained Fairly Stable In Quarterly Comparison- Medicare
U.S. Court In District Of Columbia Stays Hospitals’ Action Seeking Reopening Of Medicare Cost Reports- News in Brief
AMA Consortium Approves 10 New Physician Quality Measures- Physicians
1. Physician Survey Finds Medicare Payment Cuts Will Affect Access, Care, AMA Says
2. Oklahoma High Court Reinstates Physician’s Suit Against Hospital, Finding Peer Review Statute Does Not Provide Blanket Immunity- Quality of Care
Study Shows Pay-For-Performance Initiative Did Not Result In Significant Improvement For Heart Attack Patients- Tax
1. Ohio High Court Finds Provider Of Hospice And In-Home Nurse Services Entitled To Property Tax Exemption
2. Indiana Tax Court Finds Taxpayer Failed To Show Medical Facility Was Used Predominantly For Charity, Denies Property Tax ExemptionTable of Contents © AHLA, 2007. Reprinted by permission.
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
Saturday, June 09, 2007
Health Lawyers News, June 8
Thursday, June 07, 2007
- NBC Nightly News (6/6, lead story, 3:05, Williams) led its broadcast with "an amazing piece of science" having to do "with medicine," as well as "with a hugely divisive political issue, embryonic stem cells and their potential to cure the sick and disabled." NBC (Bazell) added, "This is indeed an astounding and elegant piece of scientific research. It's not going to end the debate about embryonic stem cells, but it could be a big step in that direction."
- The CBS Evening News (6/6, story 3, :30, Couric) noted that "researchers say they have found a way to make stem cells out of ordinary skin cells in mice. If the technique works in humans, scientists might using human embryos. Experts believe stem cells could be used to treat diseases ranging from diabetes to Parkinsons."
- The Chicago Tribune (6/6, Kaplan) reports, "If the discovery applies to human cells -- and researchers are optimistic that it will -- it would offer a straightforward method for creating a limitless supply of cell lines tailor-made for patients without any ethical strings attached. ... 'This is truly the Holy Grail -- to be able to take a few cells from a patient, say a cheek swab or some skin cells, and turn them into stem cells in the laboratory,' said Dr. Robert Lanza, an embryonic stem-cell researcher and head of scientific development at Advanced Cell Technology Inc. in Worcester, Mass., who was not involved in the research. 'It would be like turning lead into gold.'"
- In a front-page article, USA Today (6/7, 1A, Vergano) says that "the findings, by three teams publishing in the journals Nature and Cell Stem Cell, mean the reprogrammed cells may offer a non-controversial way...to make rejection-free tissues for transplant patients. But research still hasn't shown that the same cells will work in humans too, the study's authors say."
- The Wall Street Journal (6/7, Naik) runs a similar report under the headline "Stem-Cell Breakthrough May Ease Ethical Debate." On its front page, the New York Times (6/7, A1, Wade), meanwhile, says that "the technique seems likely to be welcomed by many who have opposed human embryonic stem cell research. It 'raises no serious moral problem, because it creates embryoniclike stem cells without creating, harming or destroying human lives at any stage,' said Richard Doerflinger, the United States Conference of Catholic Bishops' spokesman on stem-cell issues."
- The Christian Science Monitor (6/6, Spotts) adds, "many researchers say that progress in the U.S. has been hampered by limits...Bush imposed on federally funded human embryonic stem-cell research nearly six years ago." But "the limits also have prompted some labs to hunt for alternate ways to derive cells."
- In a front-page article, the Washington Post (6/7, A1, Weiss) reports, "Acutely aware that their new work could undermine that key political goal, the scientists cautioned that their success with mouse cells does not guarantee quick success with human cells." They "called for Congress to pass the bill, which would give federally funded researchers access to embryos slated for destruction at fertility clinics. 'A human is not a mouse, so a lot more work has to be done,' said Marius Wernig, who led one team with Rudolf Jaenisch of the Whitehead Institute for Biomedical Research in Cambridge, Mass."
- Along those lines, the New York Times (6/7, A32, Pollack) runs another story titled: "A Long, Uncertain Path For New Cell Technique."
Monday, June 04, 2007
TB quarantines are usually a local matter, rarely federal
- CDC's Division of Tuberculosis Elimination has some good information about the case.
- The ACLU has published some comments on the Speaker case. Although it says there is no indication that federal law has been violated by his quarantine, the group emphasizes the need to get judicial review of Speaker's continued detention. It also has links to its comments on the CDC's proposed rule on quarantining travelers (70 Fed. Reg. 71892-71948 (Nov. 30, 2005)).
Top SSRN downloads in public health law
- Why Evolutionary Biology is (So Far) Irrelevant to Law
U of Texas Law, Public Law Research Paper No. 89, U of Texas Law, Law & Econ Research Paper No. 81
Brian Leiter and Michael Weisberg , University of Texas at Austin - School of Law & Department of Philosophy and University of Pennsylvania Date
Posted: March 23, 2006Last Revised: February 7, 2007
Working Paper Series 844 downloads - Privacy's Other Path: Recovering the Law of Confidentiality
George Washington University Law School Public Law Research Paper No. 249, Washington University School of Law Working Paper No. 07-03-02, Georgetown Law Journal, 2007
Neil M. Richards and Daniel J. Solove , Washington University School of Law and George Washington University Law School
Date Posted: March 13, 2007
Last Revised: April 5, 2007
Accepted Paper Series
758 downloads - Tort Reform and Accidental Deaths
Emory Law and Economics Research Paper No. 05-17, Emory Public Law Research Paper No. 05-29
Paul H. Rubin and Joanna Shepherd , Emory University - Department of Economics and Emory University - School of Law
Date Posted: August 11, 2005
Last Revised: February 27, 2006
Working Paper Series
600 downloads - Toward a Theory of a Right to Health: Capability and Incompletely Theorized Agreements
Yale Journal of Law & the Humanities, Vol. 18, pp. 273-326, 2006
Jennifer Prah Ruger , Yale University - School of Medicine
Date Posted: September 28, 2006
Last Revised: March 30, 2007
Accepted Paper Series
589 downloads - The Case Against Smoking Bans
U of Missouri-Columbia School of Law Legal Studies Research Paper No. 2006-11, Missouri Environmental Law and Policy Review, Vol. 13, 2006
Thomas Andrew Lambert , University of Missouri at Columbia - School of Law
Date Posted: April 24, 2006
Last Revised: July 7, 2006
Accepted Paper Series
562 downloads - Does Medical Malpractice Reform Help States Retain Physicians and Does it Matter
Jonathan Klick and Thomas Stratmann , Florida State University College of Law and George Mason University - Buchanan Center Political Economy
Date Posted: November 19, 2003
Last Revised: December 19, 2005
Working Paper Series
527 downloads - Database of State Tort Law Reforms (DSTLR 2nd)
Northwestern Law & Econ Research Paper No. 06-08
Ronen Avraham , Northwestern University - School of Law
Date Posted: May 17, 2006
Last Revised: December 8, 2006
Working Paper Series
488 downloads - Rethinking Equal Access: Agency, Quality, and Norms
Global Public Health, Vol. 2, No. 1, pp. 78-96, 2007
Jennifer Prah Ruger , Yale University - School of Medicine
Date Posted: January 18, 2007
Last Revised: March 30, 2007
Accepted Paper Series
343 downloads - Stem Cell Research and the Law
UCLA School of Law Research Paper No. 06-05
Russell B. Korobkin and Stephen R. Munzer , University of California, Los Angeles - School of Law and University of California, Los Angeles - School of Law
Date Posted: January 28, 2006
Last Revised: February 8, 2006
Working Paper Series
324 downloads - Toward a Human Rights Framework for Intellectual Property
Vanderbilt Public Law Research Paper No. 06-03, U.C. Davis Law Review, Vol. 40, p. 971, 2007
Laurence R. Helfer , Vanderbilt University - School of Law
Date Posted: March 21, 2006
Last Revised: April 12, 2007
Accepted Paper Series
318 downloads
Sunday, June 03, 2007
Groopman on medical error: it's not all about systems
[T]he subtlety of the cognitive biases associated with diagnostic error in Groopman’s work and other studies suggests a daunting re-education challenge. Greater reciprocity in doctor-patient relations is a part of the answer that is consistent with many IT champions’ vision of patient-centered care. Other problems are not nearly as well recognized. Mark Graber and colleagues, cited above, found “premature closure,” or the inclination of physicians to settle on a diagnosis before they have gathered enough information or considered all the alternatives, to be the single most common source of cognitive failure. But there are a whole slew of other mental and behavioral weaknesses that may enter into the clinical encounter and drive it into a ditch.
The bottom line, according to Groopman, is that doctors often don’t ask the right questions and don’t listen carefully enough when the patient answers. . . .
It's an interesting problem, and not just for medical schools and training programs. Earlier in the blog post, Cunningham referred to "rushed patient encounters and imperious, overconfident practitioners [as] merely the most obvious symptoms of what can go wrong." I don't know what legislators and regulators can do about imperious and overconfident practitioners, but it's certainly worth asking what systemic conditions have contributed to the rushed patient encounters, as well as other health-care ills -- e.g., "an apparent decline in physicians’ clinical skills, driven at least in part by increasing dependency on high-tech diagnostic tools and financial incentives to see more and more patients."
When we get the health care system we deserve, we also get the practitioners (and practices) we deserve, as well.
Meanwhile, Groopman made an appearance on the Colbert Report recently. Here are the (somewhat predictable) results:
Shouldn't someone at his publisher's have told Dr. Groopman he was going onto a comedy show?
Art Caplan on Dr. Death's release and legacy
- I believed Kevorkian was a very dangerous killer [in 1994], and I still believe it now. He helped dozens of depressed and disabled people die without trying very hard to convince them to live.
- Kevorkian believes in suicide on demand. He thinks that doctors have an obligation to help anyone who decides that their life is not worth living, whatever their reason. Some of the 130 people he helped die had no terminal illnesses. Some were clearly depressed. Others had histories of mental illness. Only a few got any counseling. Kevorkian helped them all to die.
- Kevorkian’s problem was and is that he likes death way too much. The enthusiasm he brought to his cause was always deeply troubling. No doubts, no ambivalence, ever seemed to cross his mind as he dispatched his victims. The fact that he helped some to die within hours of meeting them, the fact that he would turn a disabled man’s death into a national spectacle by giving a tape of his murder to "60 Minutes" — never mind that they used it! — and the fact that he never seemed to try particularly hard to talk those who came to him out of their decision to die made him morally suspect then and hardly worth hearing from now.
As Caplan points out, the carefully crafted Oregon Death with Dignity Act has resulted in relatively few actual suicides, while at the same time providing the encouragement to develop more effective (and available) palliative care programs. On balance, I am still against legalizing physician-assisted-suicide, but public opinion is slowly swinging in favor of legalization and Oregon has demonstrated that, at least in a state like Oregon, it's possible to avoid the abuses that people like me have worried about.
SSRN: Top health law downloads
- Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
Yale Law School, Law & Economics Working Paper No. 237
John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
Date Posted: May 22, 2000
Last Revised: June 10, 2002
Working Paper Series
9111 downloads - Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
Yale Law & Economics Research Paper No. 254
John R. Lott Jr. and John E. Whitley , State University of New York - Department of Economics and University of Adelaide - School of Economics
Date Posted: May 16, 2001
Last Revised: June 5, 2001
Working Paper Series
6030 downloads - Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005, Columbia Law and Economics Working Paper No. 287, U Illinois Law & Economics Research Paper No. LE05-002, U of Texas law, Law and Econ Research Paper No. 030
Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage University of Texas at Austin - School of Law , University of Texas at Austin , University of Illinois College of Law and University of Texas at Austin
Date Posted: October 25, 2005
Last Revised: March 19, 2007
Accepted Paper Series
1682 downloads - Abortion and Original Meaning
Yale Law School, Public Law Working Paper No. 119
Jack M. Balkin , Yale University - Law School
Date Posted: August 21, 2006
Last Revised: October 2, 2006
Working Paper Series
1485 downloads - What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
Stanford Law Review, Vol. 52
Jonathan Zittrain , University of Oxford - Oxford Internet Institute
Date Posted: March 9, 2000
Last Revised: March 26, 2007
Accepted Paper Series
1300 downloads - TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
U Chicago Law & Economics, Olin Working Paper No. 140
Alan O. Sykes , Stanford Law School
Date Posted: February 19, 2002
Last Revised: March 7, 2002
Working Paper Series
1250 downloads - Unintended Consequences of Medical Malpractice Damages Caps
NYU Law Review, Vol. 80, pp. 391-512, May 2005
Catherine M. Sharkey , Columbia University - Columbia Law School
Date Posted: February 17, 2005
Last Revised: June 1, 2005
Accepted Paper Series
971 downloads - Bayh-Dole Reform and the Progress of Biomedicine
Law and Contemporary Problems, Vol. 66, No. 1
Arti K. Rai and Rebecca S. Eisenberg , Duke University School of Law and University of Michigan Law School
Date Posted: November 23, 2002
Last Revised: February 6, 2003
Accepted Paper Series
901 downloads - Incentives in Nonprofit Organizations: Evidence from Hospitals
Simon School of Business Working Paper No. FR 00-02
James A. Brickley and R. Lawrence Van Horn , University of Rochester - Simon School and Owen Graduate School of Management, Vanderbilt University
Date Posted: February 14, 2000
Last Revised: April 2, 2002
Working Paper Series
826 downloads - The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
FSU College of Law, Public Law Working Paper No. 36 and QUNO Occasional Paper No. 7
Frederick M. Abbott and Florida State University College of Law and Illinois Institute of Technology - Chicago-Kent College of Law
Date Posted: October 8, 2001
Last Revised: October 15, 2001
Working Paper Series
744 downloads
Saturday, June 02, 2007
Tubercular lawyer's world-wide travel raises public health questions
- "Why would a well-informed person aware of medical concerns get on an airplane after receiving a diagnosis of a disease that could be fatal to others?"
- "Why would he flee from health authorities once the diagnosis became even more grave?"
- "How could the man’s father-in-law, an expert in tuberculosis at the C.D.C., accede to the trip?"
- What does this saga tell us about the legal and practical gaps in our ability to limit the public's exposure to an infected individual, especially one with a motive -- whether benign or malicious -- to be evasive?
- How much freedom -- of movement, from surveillance -- will Americans tolerate in order to limit their exposure to infectious disease?
He said that when he was contacted by a representative of the Centers for Disease Control in Rome, he was told that he could not fly home unless he chartered a plane — at a cost of $100,000 — and that he should check into a local hospital. “I felt very abandoned,” he said, emphasizing that he firmly believed he could not infect others. He said he feared he might end up “stuck in an Italian hospital indefinitely, where I could die.”
“Short of a military state where you have 24/7 surveillance on someone, you have to count on the good will of the individual.
He called this a fact of life in an open society, one that could lead to major problems in an outbreak of pandemic influenza, in which many people would probably be boarding planes knowing they were sick to get away from an epidemic. “They would say, ‘I want to make sure I get out,’ ” whatever the risk to others. In that kind of situation, he said, the public health system would inevitably be unable to keep up.
There are a couple of AP stories today that add to what we know about Speaker:
- TB Lawyer Called 'Pillar' of Community photo
ATLANTA (AP) - The story of how Andrew Speaker met his future bride still draws laughs from his friends. The young attorney met Sarah Spence Cooksey, an aspiring lawyer, at an Atlanta pub and handed her his fancy business card. When she called, she asked for "Mr. Speaker." But the man she ended up... - TB Patient Faces 2 Months in Hospital photo
DENVER (AP) - The man quarantined with a dangerous strain of tuberculosis will likely spend up to two months in a hospital while he receives a battery of antibiotics and is evaluated for possible surgery, his doctors said. Andrew Speaker is the first infected person quarantined by the U.S....
- Man With TB Apologizes for Putting Others at Risk
Lawrence K. Altman and John Holusha (The New York Times, June 1, 2007)
"The Atlanta lawyer who flew on crowded airplanes while infected with a dangerous form of tuberculosis said today he did not think he presented a danger when he flew and he apologized to his fellow passengers." See also: TB Treatment a 'Challenge,' Doctor Says (The Atlanta Journal-Constitution, June 1, 2007) - Agent at Border, Aware, Let In Man With TB
Lawrence K. Altman (The New York Times, June 1, 2007)
"The man with a dangerous form of tuberculosis who flew to Europe for his wedding and honeymoon was identified yesterday as a 31-year-old Atlanta lawyer. Department of Homeland Security officials said he re-entered the country from Canada when a customs agent let him pass despite knowing that the man was being sought by health authorities." Free registration required. - Case of TB Traveler Reveals Holes in Global Disease Control
Elisabeth Rosenthal (International Herald Tribune, May 31, 2007)
"The U.S. health authorities failed to notify their Italian counterparts that an American tourist with an extremely dangerous form of tuberculosis was staying in a Rome hotel this month until he was leaving the country, Italian officials said Thursday. That time lapse allowed him to leave Rome and fly to Prague and Montreal, potentially exposing dozens of people to an often lethal germ." - TB Patient's Father-in-Law a CDC Microbiologist
(Associated Press, May 31, 2007)
"The honeymooner quarantined with a dangerous strain of tuberculosis was identified Thursday as a 31-year-old Atlanta personal injury lawyer whose new father-in-law is a CDC microbiologist specializing in the spread of TB and other bacteria." - Near Misses Allowed Man With Tuberculosis to Fly
Lawrence K. Altman and John Schwartz (The New York Times, May 31, 2007)
"A series of 'understandable' near misses accounted for a Georgia man’s odyssey to Europe in which he might have exposed fellow passengers on a series of commercial flights to an exceptionally dangerous form of tuberculosis, federal officials said [Wednesday]." Free registration required. - Isolating an Evasive TB Patient
Editorial (The New York Times, May 31, 2007)
"Congressional oversight committees ought to examine whether health officials dropped the ball -- and what steps can be taken to ensure that patients infected with deadly contagious diseases protect others from infection." Free registration required. - Earlier:
CDC May 29 Media Relations Telebriefing Transcript
Atlantan Quarantined with Deadly TB Strain (The Atlanta Journal-Constitution, May 30, 2007) Free registration required.
CDC Warns of Possible TB Exposure on Atlanta-Paris Flight (The Atlanta Journal-Constitution, May 29, 2007) Free registration required.
Dr. Death out of prison
Dutch reality tv program -- "Big Donor Show" -- a hoax
It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:
- there are currently 96,047 registered patients on various waiting lists
- over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:
Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.
Friday, June 01, 2007
Health Lawyers News, June 1
Top Stories
- CMS Implements New Marketing, Education Requirements For PFFS Plans
Abby L. Block Director of the Centers for Medicare and Medicaid Services’ (CMS’) Center for Beneficiary Choices sent a memo May 29 to Medicare Advantage (MA) Private fee-for-service (PFFS) plans reminding them that CMS is requiring new outreach processes to ensure beneficiaries and providers are informed about the distinctive features of Medicare PFFS plans. Full Story- Baucus, Grassley Urge IRS To Update Reporting Forms For Nonprofits
Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) sent a letter May 25 to Treasury Secretary Henry Paulson urging him to update Form 990 and Form 990 PF that nonprofits file with the Internal Revenue Service (IRS) in order to gain greater transparency into the workings of tax-exempt organizations including charities. Full StoryArticles & Analyses
- Unionized Hospital Denied Antitrust Exemption In Nurses’ Suit, by Mark A. Hutcheson, Douglas C. Ross, Mary E. Drobka, and Charles S. Wright, Davis Wright Tremaine, LLP
Current Topics
- Criminal Law
D.C. Circuit Upholds Restitution Order Against Podiatrist Who Pled Guilty To Medicare Fraud- Fraud and Abuse
Sixteen Individuals Charged With Defrauding Medicare Of $101 Million In DME Billing Scheme- Update
- Healthcare Access
California Appeals Court Voids County’s Income Eligibility Cap For Subsistence Medical Care- Hospitals and Health Systems
1. Florida High Court Finds Hospital Has No Duty To Ensure Staff Physicians Have Malpractice Insurance
2. Florida Appeals Court Finds Hospital Owed No Duty of Care To Man Who Fainted After Viewing His Wife’s Emergency Treatment- Individual/Patient Rights
Second Circuit Finds Intended Organ Recipient Had No Property Right In Donated Kidney Because Of Incompatibility- Long Term Care
House Panel Investigating Deceptive Practices In Long Term Care Insurance Market- Medicaid
1. President Signs Supplemental War Spending Bill With SCHIP Funding And Moratorium On Medicaid Rule
2. CMS Issues Final Rule On State Medicaid Financing Arrangements
3. Ninth Circuit Upholds Oregon Plan Charging Individuals In Medicaid Expansion Group Higher Copays Than Other Medicaid Recipients- Medicare
1. CMS Proposes Non-Coverage Of LADR For Medicare Recipients Over 60
2. CMS Releases Measures For Evaluating Financial Health Of Suppliers Participating In New DMEPOS Competitive Bidding Program
3. CMS Clarifies Policy Relating To Part D Special Transition Period For Retroactive Enrollment
4. GAO Finds Most Employers Continued Retiree Drug Coverage, Opted For
Subsidy- News in Brief
1. PhRMA Adds Drug Safety Information To Its Website
2. AHRQ Adds New Web Tool For Healthcare Quality Report Cards- Patient Safety
Baucus,Grassley Introduce Bill Directed At Improving Research On Pharmaceutical Safety And Effectiveness- Physicians
1. Tennessee High Court Holds Information Otherwise Available From Original Sources Is Discoverable But Not From Peer Review Committee
2. Ohio High Court Strikes Down Rule Barring Anesthesiologist Assistants From Performing Epidural And Spinal Procedures- Tax
Eleventh Circuit Holds Medical Residents May Qualify For FICA Exemption
Thursday, May 31, 2007
NIH creates and confers new AID research awards
A joint award to Robert Yarchoan, M.D. and Hiroaki Mitsuya, M.D., Ph.D. of the National Cancer Institute — for their individual and combined achievements, groundbreaking discoveries and innovative and original scientific contributions that have significantly advanced HIV treatment research. Their landmark clinical studies, demonstrating that AZT could result in partial restoration of the immune response and temporary clinical benefit, established the first treatment for HIV infection and launched the era of effective therapy for HIV/AIDS. Their work significantly advanced this field, directly impacting on the development of new and better strategies to prevent and treat HIV disease in this country and around the world.
Wednesday, May 30, 2007
China's ex-regulator of food and drug gets death penalty
China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system targeting unsafe food products.
The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods -- from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.
The Beijing No. 1 Intermediate People's Court convicted Zheng Xiaoyu for taking bribes in cash and gifts worth more than $832,000 when he was director of the State Food and Drug Administration, the official Xinhua News Agency said. The court then issued the death penalty, the report said.
Tuesday, May 29, 2007
Dutch reality tv: who will get my kidney?
Monday, May 28, 2007
Emergency research protocols expand
Saturday, March 31, 2007
California health reform
Saturday, March 24, 2007
Living with an incurable genetic disease
Fen-phen lawyers defrauded plaintiffs, court rules
There's more, and it's all ugly. Shameful.W. L. Carter knew there was something fishy going on when he went to his lawyers’ office a few years ago to pick up his settlement check for the heart damage he had sustained from taking the diet drug combination fen-phen.
The check was, for starters, much smaller than he had expected. And his own lawyers threatened to retaliate against him if he ever told anyone, including his family, how much he had been paid. “You will be fined $100,000, you will go to jail and you will be sued,” Mr. Carter recalled them saying.
Mr. Carter was right to have been suspicious. The lawyers defrauded their clients, a state judge has ruled in a civil case, when they settled fen-phen lawsuits on behalf of 440 of them for $200 million but kept the bulk of the money for themselves. Legal experts said the fraud might be one of the biggest and most brazen in legal history.
This week, several clients testified before a federal grand jury that has begun to investigate potential criminal wrongdoing arising from the settlement.
“It enrages me,” said Sonja Pickett, a retail manager, who testified Thursday before the grand jury. “They robbed us.”. . .
The basic facts are not in dispute. When the clients sued the drug maker, they agreed to pay the lawyers 30 percent to 33 percent of any money that was recovered, plus expenses. In this case, that would have left the 440 clients to divide perhaps $135 million.
But the clients received only $74 million. An additional $20 million went to a questionable “charitable fund.” The rest — $106 million — went to lawyers. Though amounts of the individual settlements remain sealed, court papers suggest they were from $100,000 to $5 million. On average, plaintiffs received less than 40 percent of what the settlement agreement specified, instead of the roughly 70 percent to which they were entitled.
Had the lawyers merely taken what they were contractually entitled to, they would have become very rich men, said Tracy Curtis, a mortgage loan officer who is also suing her former lawyers. “They could have taken the high road,” Ms. Curtis said. “They would have made plenty of money.”
Federal bill prohibiting genetic discrimination analyzed by Congressional Budget Office
- Amends the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act to expand the prohibition against discrimination by group health plans and health insurance issuers in the group and individual markets on the basis of genetic information or services to prohibit: (1) enrollment and premium discrimination based on information about a request for or receipt of genetic services; and (2) requiring genetic testing. Sets forth penalties for violations.
- Amends title XVIII (Medicare) of the Social Security Act to prohibit issuers of Medicare supplemental policies from discriminating on the basis of genetic information.
- Extends medical privacy and confidentiality rules to the disclosure of genetic information.
- Makes it an unlawful employment practice for an employer, employment agency, labor organization, or training program to discriminate against an individual or deprive such individual of employment opportunities because of genetic information. Prohibits the collection and disclosure of genetic information, with certain exceptions.
- Establishes a Genetic Nondiscrimination Study Commission to review the developing science of genetics and advise Congress on the advisability of providing for a disparate impact cause of action under this Act.
For a more detailed discussion of the bill, go to H. Rept. 11-28 (Part I), March 5, 2007. Also, a number of states already have similar laws on their books. The National Conference of State Legislatures has a handy list of such laws (last updated Nov. 2006 (employment) and June 2005 (insurance)).
Yesterday, the CBO published its cost estimate for H.R. 493. Over 10 years, the federal treasury would be out about $2 million (because premiums for some of the new insureds would be tax-deductible) and the CBO estimates increased outlays of about $2 million (assuming appropriations are approved) for the Departments of Labor, Treasury, and HHS. There will be additional state and private-sector mandates in connection with the anti-discrimination law, but CBO figures the cost will be low for the states and below the threshold in the Unfunded Mandates Reform Act for the private-sector actors.
If there's a surprise in any of this, it might be in the estimated number of citizens expected to benefit from this law: 600. Is there any chance this is a typo?
Thursday, March 22, 2007
NEW MEDICARE HOSPITAL CONDITIONS OF
PARTICIPATION FOR TRANSPLANT CENTERSThe Centers for Medicare & Medicaid Services (CMS) issued a final rule today setting forth the requirements that transplant centers must meet to participate in the Medicare program that moves Medicare covered transplant programs toward an outcome-focused system.
This final rule will move Medicare-covered transplant programs toward an outcome-focused system that reflects the clinical experience, resources and commitment of the transplant program. The rule contains comprehensive conditions of participation for transplant programs serving Medicare beneficiaries.
It will ensure effective oversight of transplant centers by advancing coordination between CMS, State survey agencies, the Health Resources and Services Administration, the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.
“This is a major milestone in our efforts to make sure that people needing transplants get the best possible care, while giving transplant centers and physicians comprehensive and reliable guidance,” said Leslie V. Norwalk, CMS acting administrator. “This rule both improves the current transplant outcome measure requirements and strengthens the protection of the health and safety of patients and living donors.”
In recent decades, remarkable strides in transplantation technology and pharmacology have turned organ transplantation into a mainstream treatment for many patients in end stage organ failure. CMS issued coverage decisions related to heart transplants in 1987, liver transplants in 1991, lung transplants in 1995, and intestine transplants in 2001 and updated in 2006. Kidney transplant centers have been regulated in the Code of Federal Regulations since 1976. This rule will consolidate all transplant center requirements into one regulation.
All transplant centers that continue to participate in Medicare, including kidney transplant centers, are required to submit a request for initial approval. Once approved by Medicare, transplant centers are eligible for re-approval every 3 years.
Transplant centers with current Medicare approval, that have applied for initial approval within 180 days from the effective date of the final rule may continue to provide transplant services and receive payment from Medicare until CMS makes a decision on the transplant center’s request for approval.
The final rule went on public display today at the Office of the Federal Register for publication on Friday, March 23, 2007.
Tuesday, March 20, 2007
IRS releases "Good Governance Practices" for charitable organizations
The IRS seems to be saying that adoption of these good governance practices is not a criterion for obtaining or retaining exempt status, but that an organization that departs to a significant degree from them is more likely to engage in practices that put its exempt status in jeopardy. Interestingly, if somewhat bizarrely, the Service inserted a comment about board size into its introduction that doesn't appear -- either implicitly or explicitly -- in the Good Governance Practices themselves. It's the trite-but-true "Goldilocks" principle that boards that are too small have difficulty representing "a public interest" and boards that are too large "may be less attentive to oversight duties." Presumably boards that are "just right" are more likely to see that their duties are carried out in a manner that promotes, in the case of exempt hospitals, community benefits.
Monday, March 05, 2007
GAO testimony on DOD/VA care problems for injured soldiers, vets
It may be true, as Paul Krugman writes in today's op-ed (paid TimesSelect subscription required) in the N.Y. Times, that the worst of the worst in terms of quality care (or the lack thereof) is in the military hospitals, which are separate and distinct from the VA. And the VA may still be the exemplar of quality that it's been touted to be for the past 10 years (although that's not what I hear from the medical students who rotate through the VA hospital here, and that's not the message from vets in today's Post article by Hull and Priest). But the testimony of the GAO witness documents some of the ways that the care in the VA system breaks down when a patient is handed off from the military's hospital system to the VA's.
To be middle-class and uninsured
The article offers a good illustration of the problems encountered by the uninsured.[T]he uninsured are not necessarily the poor, the unemployed and the undocumented. Solidly middle-class people like Ms. Readling are one of the fastest growing subgroups.
And that is one reason, according to a recent New York Times/CBS News poll, that the problems of the uninsured have jumped to the top of the domestic political agenda in Washington and on the campaign trail.
Today, more than one-third of the uninsured — 17 million of the nearly 47 million — have family incomes of $40,000 or more, according to the Employee Benefit Research Institute, a nonpartisan organization. More than two-thirds of the uninsured are in households with at least one full-time worker.
Undertreatment and general mismanagement of chronic conditions will, in the long run, result in more expense, not less, but if short-term cash flow makes the cost of care prohibitively expensive, where's the safety net for patients like Ms. Readling? It doesn't exist.To save money, Ms. Readling said, she defers visits to the doctor and stretches out her cancer medication, which costs her about $300 a month. She takes the tiny pills three or four times a week, rather than seven days a week as prescribed.
“I really try to stay away from the doctor because I am so scared of what everything will cost,” said Ms. Readling, who is divorced and has twin 18-year-old sons. Before every doctor’s visit and test, she asks, “How much are you going to charge me?” She says she tries to arrange “the best deals I can.”
But in many cases, the price is still unaffordable, and “I have to do without.”