Friday, July 28, 2006
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
Thursday, July 27, 2006
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.
Wednesday, July 26, 2006
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"?
Tuesday, July 25, 2006
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 Senate bill is here and the roll-call vote is here.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.
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:
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.
Monday, July 24, 2006
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: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."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."
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."
Sunday, July 23, 2006
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:As Paduda points out, these numbers are consistent with a study led by Dartmouth's John Wennberg. As summarized by NewsTarget.com: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.
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.
Saturday, July 22, 2006
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 . . . .
Friday, July 21, 2006
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."
Thursday, July 20, 2006
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.