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
Sunday, November 16, 2003
"For Middle Class, Health Insurance Becomes a Luxury"
That's the title of a good article, dateline Dallas, by Stephanie Strom in today's New York Times. The article reports that the folks without health insurance are, increasingly, folks like you and me -- middle class, often with decent jobs, but priced out of the market. Without meaning to sound too unfeeling, this is precisely the development that is needed for there to be any lift under the wings of health care reform. Remember the old saying that a recession is when your neighbors lose their jobs and a depression is when you lose yours? The same principle seems to apply to health care: a health care problem is when 43 million neighbors lack health insurance, and a health care crisis is when you lack it, too. I've yet to read anything about the massive Medicare reform package that includes the new prescription drug benefit (see below) that will do anything to make health care benefits more available to these 43 million Americans.
Medicare prescription drug benefit deal approved in principle by conferees.
The deal was struck between "top Republicans in Congress and two Democratic senators" and was announced on Saturday. See article in today's New York Times.) I guess it remains to be seen whether other top Democrats can be persuaded to go along. This has become one of the all-time "Christmas tree" bills, with a little light or gew-gaw for everyone:
Besides adding drug benefits to Medicare, the bill would inject competition and market forces into Medicare and establish a new mechanism to help hold down Medicare costs. It would also offer tens of billions of dollars in subsidies and other aid to employers to encourage them to continue providing health benefits, including drug coverage, to retirees.So scuttling this bill would require members to explain to the folks back home not just why the drug benefit got killed (and apparently "because we can't afford it" just isn't a good answer these days), but also why this or that favorite provision also had to be killed. Will this make the bill bulletproof? We'll see . . . .
Schiavo case is prompting experts to ask: Could it happen in my state?
The Stamford (Ct.) Advocate reports today that an expert on living wills believes Connecticut's living will law is too narrow and wouldn't necessarily protect against the nightmare scenario that is presently playing itself out in Florida. Offhand, Connecticut's doesn't sound that different than Texas' law, except that the expert believes a patient is not in a terminal condition if there's even a 0.1% chance of survival. That's a pretty useless standard, if true, but it's not how Ct. Stat. § 19a-570 (requires WestLaw subscription) defines "terminal condition." Our own law in Texas clearly gives the spouse of an incompetent patient with no advance directive the authority to consent to the withholding or withdrawal of life-sustaining treatment, including artificial nutrition and hydration, once the patient is diagnosed as having a terminal or irreversible condition. Permanent unconsciousness clearly qualifies as the latter.
Saturday, November 15, 2003
New play based on the trial of Carrie Buck.
According to an article in the Sioux City Journal, Northwestern College's Jeff Barker, a professor of theater and speech, has written a play, "Kin," based on the trial of Carrie Buck, the central figure in the famouse Supreme Court case of Buck v. Bell. This was the case in which the Court, in an opinion written by Oliver Wendell Holmes, Jr., upheld the Commonwealth of Virginia's decision to sterilize Carrie Buck. As the opinion states: "Carrie Buck is a feeble minded white woman who was committed to the State Colony above mentioned in due form. She is the daughter of a feeble minded mother in the same institution, and the mother of an illegitimate feeble minded child." The court's rationale was simple enough: "[t]hree generations of imbeciles are enough." Research in the late 20th century discovered the extent of Virginia's eugenics program: 8,300 persons sterilized, 4,000 at the Lynchburg facility where Carrie and her sister were sterilized. The research was summarized in an essay by Stephen Jay Gould ("Carrie Buck's Daughter") in The Flamingo's Smile. An excerpt appears here.
Wednesday, November 12, 2003
False Claims Act recoveries at all-time record level.
As reported by Modern Healthcare, the Justice Department says it has collected $2.1 billion under the False Claims Act for the fiscal year that ended September 30, $1.7 billion of which came from health-care fraud settlements. This includes "$641 million by HCA, $382 million by Abbott Laboratories, $280 million by AstraZeneca and $51 million by Tenet Healthcare Corp." Relevant sources on the federal government's fraud-fighting efforts include:
Wednesday, November 05, 2003
SCOTUS' take on the Supreme Court's grant of certiorari in the Texas ERISA/HMO case.
SCOTUS is a terrific blog run out of the Goldstein Howe law firm that tracks the US Supreme Court's docket and various related comings and goings. Here's SCOTUS' post on the Court's recent grant of cert in the HMO case out of the 5th Circuit. And here's SCOTUS' link to the NY Times' coverage of the case.
Tuesday, November 04, 2003
HealthSouth's CEO Scrushy indicted on 85 counts this morning.
Federal prosecutors in Alabama claim he masterminded the plot, to which several executives have already pleaded guilty, to cook HealthSouth's books to the tune of $2.5 billion.
A Catholic priest and bioethicist takes on the Governor and legislature of Florida.
There's a good article in this morning's Miami Herald in which Fr. Kevin O'Rourke disputes the ethics of keeping Terri Schiavo alive.
''For Christians, it is a blasphemy to keep people alive as if you were doing them a favor, to keep people alive in that condition as if it benefits them. It doesn't benefit them,'' O'Rourke argues. ``I know it is wrapped up in the pro-life, antiabortion activity, and while I am antiabortion, I also know there is eternal life and that we should not confuse or equate the antiabortion effort with the notion of withdrawing life support from dying people.
``They act as though the most important thing is to lead a long life and Christians who read the Gospel seriously believe that it is a good life you are pursuing, not a long life. But this notion of having a long life has become the watchword for these groups. Life is terminal. Life by definition is going to have an end.''
Monday, November 03, 2003
Human research then and now.
Interesting article in the Th Daily Pennsylvanian - UPenn's campus paper, about the University's decision to give a lifetime achievement award to dermatologist and professor emeritus Albert Kligman. In addition to his pioneering work on Retin-A, Dr. Kligman entered into numerous contracts with pharmaceutical companies to test their drugs, which he often did on the inmates of Holmesburg Prison and the elderly residents of the Riverview Home. An article in the same paper last Friday quotes Art Caplan, the head of the bioethics program at Penn, as saying:
Our attitude is that in some ways his experiments from current standards... don't pass muster. . . But according to the standards of the day, doing experiments on prisoners was common. . . . There's no doubt that scientifically and medically he did pioneering and important work . . . At the same time, I think it's appropriate in acknowledging him to comment that some of the things that happened in the time were immoral. . . . Science has advanced and, in fact, ethics have advanced. . . . You have this problem that comes up all the time of holding people [to today's standards when evaluating their past actions] . . . There's been a shift in attitudes from the '50s to today in terms of research on prisoners and the rights of people to be informed . . . I think it's fine and appropriate to say to people [that] what we did then we've learned is wrong, and we are committed to doing better . . . I think that's owed the people. I think that's appropriate for the University to say.
U.N. to Consider Whether to Ban Cloning of Human Embryos
Supreme Court to Rule on ERISA Preemption Question in Suits Over Patients Denied Treatment.
As reported by the AP earlier today (here's the Chicago Tribune link to the story, but there are millions of others out there), the Supreme Court of the United States ("SCOTUS") granted review this morning in an HMO-reform/ERISA case out of Texas. Two cert. petitions were granted in the case: Aetna Health Inc. v. Davila, No. 02-1845, and Cigna Healthcare of Texas Inc. v. Calad, No. 03-83. In the U.S. Court of Appeals for the Fifth Circuit, the case was styled as Roark v. Humana, 307 F.3d 298 (5th Cir. 2002) (here are links to the Westlaw version of the case [requires subscription] and the FindLaw version [free PDF]). In the interest of time, I will post the first two paragraphs of the Fifth Circuit's opinion and add my own commentary later:
This suit consolidates multiple district court actions and appeals for consideration of common issues. Ruby Calad, Walter Thorn, Juan Davila, and Gwen Roark sued their respective health maintenance organizations ("HMO's") for negligence under Texas state law: They alleged that although their doctors recommended treatment, the HMO's negligently refused to cover it. The HMO's removed to federal court, arguing that because each plaintiff received HMO coverage through his employer's ERISA plan, the claims arose under ERISA. The plaintiffs moved to remand.The Roarks' claims are the only ones held by the court to have been partially preempted under section 502 of ERISA (the complete preemption provision); thus the district court properly denied their motion to remand. After that, the district court ruled the remaining claims were preempted by section 514 of ERISA (the ordinary preemption provision of the federal law), which the Fifth Circuit affirmed on the bas sis of its earlier Corcoran case, which it found to be indistinguishable. More later . . .
The respective district courts denied Calad, Davila, and Roark's remand motions and dismissed their claims under Fed.R.Civ.P. 12(b)(6), citing ERISA preemption. The district court granted Thorn's remand motion. Roark, Calad, and Davila appeal the refusal to remand and, in the alternative, the dismissal. Thorn's HMO appeals the remand. We affirm the judgments in Roark's and Thorn's cases and reverse with respect to Calad and Davila.
Sunday, November 02, 2003
Palm Beach editorialist weighs in on the Schiavo case.
Randy Schultz, editor of the editorial page of the Palm Beach Post has a great editorial in today's paper. Schultz carefully reviews the judicial history of the case and the opinions filed by judges, observing along the way:
"It is likely that no guardianship court," the judges said, "has ever received as much high-quality medical evidence in such a proceeding." The appeals court looked at the full-length videotapes of Ms. Schiavo, not the excerpts on TV news programs. The judges examined brain scans. The conclusion: Terri Schiavo is in a permanent vegetative state.Saving the best for last, Schultz concludes: "It should have ended there. The courts have spent years on Terri Schiavo's case and acknowledged the difficulty. The governor and Legislature spent two hours and proclaimed themselves saviors. So who's being reckless and uncaring?"
But as Judge Altenbernd noted in June: "Each of us, however, has our own family, our own loved ones, our own children... we understand why a parent who had raised and nurtured a child from conception would hold out hope that some level of cognitive function remained. If Mrs. Schiavo were our own daughter, we could not but hold to such a faith."
So the court sees Terri Schiavo as a person. The court knows the tragedy, of her condition, the family fight, the unpleasant decision. "It is a thankless task," Judge Altenbernd wrote, "and one to be taken with care, objectivity and a cautious legal standard designed to promote the value of life.
"But it is also a necessary function if all people are to be entitled to a personalized decision about life-prolonging procedures independent of the subjective and conflicting assessments of their friends and relatives... the law currently provides no better solution that adequately protects the interests of promoting the value of life."
Stem cells and President Bush.
There is a nice 1-2-3 sequence of articles in The Washington Post over the past week concerning stem-cell research and President Bush.
(1) The series started with a column by syndicated Post columnist Michaeld Kinsley that appeared on October 24 (One Reason Not to Like Bush (washingtonpost.com)). In this piece, Kinsley argued that Bush's policy on federal funding was "unexpectedly restrictive" and was based upon two factual assumptions that turn out not to be true: (1) there are 60 viable stem cell lines available for stem cell research (turns out it's more like 10) and (2) there is hope for the process by which adult stem cells could be switched on to behave like pluripotential embryonic stem cells, a claim that has been authoritatively debunked by an article in the scientific journal Nature.
(2) The Bush administration replied with an Op-Ed in the Washington Post on October 30 by Jay Lefkowitz, who was chair of the White House Domestic Policy Council until last month. Lefkowitz asserted that the president "made the first-ever offer of federal aid to support the research" and responds to Kinsley's attack on the two bedrock assumptions that underlay the president's policies.
(3) Kinsley's reply ("Kabuki and Stem Cells") appeared on October 31. He yields no points to Lefkowitz, and his arguments on the merits of the stem-cell debate are worth reading. Of greater interest to some will be Kinsely's critique of Lefkowitz' response "as an illustration of modern Washington dishonesty":
(1) The series started with a column by syndicated Post columnist Michaeld Kinsley that appeared on October 24 (One Reason Not to Like Bush (washingtonpost.com)). In this piece, Kinsley argued that Bush's policy on federal funding was "unexpectedly restrictive" and was based upon two factual assumptions that turn out not to be true: (1) there are 60 viable stem cell lines available for stem cell research (turns out it's more like 10) and (2) there is hope for the process by which adult stem cells could be switched on to behave like pluripotential embryonic stem cells, a claim that has been authoritatively debunked by an article in the scientific journal Nature.
(2) The Bush administration replied with an Op-Ed in the Washington Post on October 30 by Jay Lefkowitz, who was chair of the White House Domestic Policy Council until last month. Lefkowitz asserted that the president "made the first-ever offer of federal aid to support the research" and responds to Kinsley's attack on the two bedrock assumptions that underlay the president's policies.
(3) Kinsley's reply ("Kabuki and Stem Cells") appeared on October 31. He yields no points to Lefkowitz, and his arguments on the merits of the stem-cell debate are worth reading. Of greater interest to some will be Kinsely's critique of Lefkowitz' response "as an illustration of modern Washington dishonesty":
I do not assert that Republicans are more dishonest than Democrats -- only that this document is a choice example of the state of the art.Kinsley then nicely skewers Lefkowitz' points, 1 by 1, 1-2-3.
The distinguishing feature of modern Washington dishonesty is that it is almost transparent, barely intended to deceive. It uses true-ish factoids to construct an implied assertion about reality that is not just false but preposterous. Modern Washington dishonesty is more like a kabuki ritual than a realistic, Western-style performance. The goal is not to persuade but merely to create an impression that there are two sides to the question without actually having to supply one of them.
Saturday, November 01, 2003
Schiavo developments.
- The ACLU's brief on behalf of Michael Schiavo "as guardian of Terry Schiavo" against the Florida legislation can be found here (52 pp., PDF).
- Newsday, the L.A. Times, and others are reporting that Jay Wolfson, a University of South Florida professor and "expert on health care financing, has been appointed to independently investigate the case . . . . A judge on Friday named [him] as Terry Schiavo's guardian." Prof. Wolfson's web site is here.
- Today's Pittsburgh Post-Gazette has an excellent piece on the case, with useful observations from Alan Meisel, whom I think of as the Magister Ludi of "the right to die," and neurologist Ron Cranford.
Sunday, October 26, 2003
Growth in ER use fueled by insured patients, not uninsured.
The nonprofit, nonpartisan Center for Health System Change reports that most of the increase in ER use in recent years has been the result of increased E use by insured patients:
U.S. hospital emergency department (ED) visits increased to almost 108 million annually in 2000 and 2001, an increase of about 16 percent from 1996-97. Emergency department visits between 1996-97 and 2000-01 increased 24 percent for privately insured people, 10 percent for Medicare beneficiaries, 10 percent for self-pay or no-charge—typically uninsured—patients but were unchanged for Medicaid beneficiaries, according to the study based on data from the Centers for Disease Control and Prevention's (CDC) National Hospital Ambulatory Medical Care Survey.A news release and a link to the full report are here.
Together, privately insured and Medicare beneficiaries accounted for almost two-thirds of the overall increase in ED visits. In contrast, self-pay or no-charge patients accounted for about 11 percent of the increase in ED visits. People with other sources of coverage—worker's compensation, for example—or unknown coverage accounted for the remaining increase.
For privately insured people, the 24 percent increase in ED visits paralleled an across-the-board increase in ambulatory care use, including a 29 percent increase in physician office visits between 1996-97 and 2000-01, the study found. In contrast, for uninsured people, the 10 percent increase in ED visits was accompanied by a 37 percent decrease in physician office visits, resulting in uninsured people relying on emergency departments for an even greater part of their medical care. One-fourth of all doctor visits by the uninsured now take place in emergency departments, compared with 17 percent in 1996-97.
"Uninsured people clearly are not a major factor in increased crowding at most hospital emergency departments, but uninsured people's growing reliance on emergency care indicates decreased access to other sources of care, including physician's offices. Getting medical care outside of the emergency department is definitely becoming more difficult for uninsured people," said HSC Senior Health Researcher Peter Cunningham, Ph.D., who co-authored the study with HSC Research Assistant Jessica May.
GAO report on specialty hospitals.
The article in this morning's NY Times on the rise of specialty hospitals (see below) mentions a report from the Government Accounting Office on the phenomenon. As today's "Health Law Highlights" from American Health Lawyers Association points out, the report "notes that specialty hospitals are largely for-profit and, in many cases, are owned in part by physicians. Specialty hospitals as a group tended to be less likely to have emergency departments, with 72% of cardiac hospitals, 50% of women's hospitals, 39% of surgical hospitals, and 33% of orthopedic hospitals having emergency departments. In contrast, 92% of general hospitals have emergency departments."
From this morning's NY Times: More on Schiavo, PVS, Medicare.
The NY Times is filled with stuff today:
- Schiavo I: article in "The Week in Review" about brain-damage and family decision making by Dudley Clendinen;
- Schiavo II: good piece by Sheila Dewan on the practical aspects of ethics consultations in cases like the Schiavo imbroglio (warning: this link will only last a few days);
- Schiavo III: an informative article about the American Academy of Neurology's guidelines for diagnosing permanent vegetative state (you can read them for yourself here);
- a front-page piece about the dramatic rise of specialty hospitals and the Medicare reimbursement scheme that has contributed to it.
Friday, October 24, 2003
FDA eases stance on importing medicines
The FDA has softened the official (hard) line against importing drugs from Canada, according to an article in today's Boston Globe: "'We're not considering legal action against cities or states,' said William K. Hubbard, associate commissioner for policy and planning at the FDA." The FDA isn't giving up its suits against the major suppliers to these state and local programs, however:
Hubbard said the FDA would continue its court battles against "businesses that sell commercial quantities of drugs" from overseas. The agency sent a cease-and-desist letter last month to CanaRx, the company that arranges for Canadian drugs to be shipped to Springfield. The Justice Department is awaiting a ruling after suing in Oklahoma to shut down a chain of stores that provide Canadian drugs under the names Rx Depot and Rx of Canada.Presumably the cities and states are free to negotiate with Canadian pharmacies for discounted prices and employees would then be able to place their orders directly from the Canadian firms.
Slate opinion piece on the Schiavo case
There was a very good column by Dahlia Lithwick over at Slate. It builds on Alta Charo's point that this is case is mostly about who should decide and when should the state overrule that person's choices (and why).
Schiavo case reviewed by Florida's medical ethics community.
There's a good article in the Gainesville Sun today that contains the analysis of medical ethicists and legal experts in Florida. The commentary seems focused primarily upon Terry Schiavo's desire to avoid unwanted invasive treatments, but Alta Charo, quoted in an article in the Post-Crescent (Appleton-Neenah-Menasha, Wisc.) makes the more generally useful point that Schiavo is about the ability of a surrogate decision maker to make his or her decision stick in the event of a family dispute. "Once an individual has lost the ability to speak for herself, somebody must speak for her,” and once that happens, legal questions abound: who can speak for her? does the answer to that question change when the family disagrees about the outcome? what are the evidentiary standards and substantive rules that constrain the surrogate's choice? Of course, all those issues have been litigated for the better (or worse) part of 7 years: Terry's husband has been found to be the lawful surrogate and the choice he's made has been found to be consistent with the law of Florida for such choices, which makes the intervention by the legislature and the governor appallingly bad and shockingly opportunistic.
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