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
Friday, June 11, 2004
U.S. won't appeal jury verdict in St. David's case.
Thursday, June 10, 2004
Should Doctors Help With Executions?
About 25 states allow or require doctors to be present at executions. But information on the number of doctors who participate in executions is hard to come by, as states generally refuse to name anyone who does so, citing security and privacy concerns. . . .The AMA Code provision in question is E-2.06.
Many of the states that encourage doctors to participate in executions have seemingly contradictory laws that allow doctors to be disciplined by state medical boards for violating codes of medical ethics. Those codes almost universally forbid participation in executions.
The American Medical Association's ethics code, for instance, says that "a physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution."
The code forbids doctors to perform an array of acts at executions, including prescribing the drugs, supervising prison personnel, selecting intravenous sites, placing intravenous lines, administering the injections and pronouncing death.
"They're not allowed to determine that the execution has been unsuccessful so that the execution can be repeated," said Dr. Stephen H. Miles, a professor of medicine at the University of Minnesota and author of "The Hippocratic Oath and the Ethics of Medicine."
But a survey of doctors in 2001 found that more than 40 percent would be willing to perform at least one of the forbidden activities.
Scholars who have studied the matter said they knew of no state board action against a doctor for aiding in a lawful execution. . . .
At least eight states . . . also seek to shield doctors from professional discipline through laws saying that aiding in executions is not the practice of medicine.
Interestingly, the Supreme Court may be heading toward a position that the absence of a physician's involvement in lethal injections may contribute to the execution's unconstitutionality. As the Times article points out:
In a unanimous decision on May 24 allowing a death row inmate to challenge lethal injections as cruel and unusual punishment, the United States Supreme Court appeared to suggest that a doctor should be required for at least some procedures.The case in question is Nelson v. Campbell, No. 03-6821.
The inmate in that case, David L. Nelson, had badly damaged his veins by long-term drug use, and went to court to fight a plan by Alabama prison officials to make a two-inch incision in his arm or leg to allow his execution to proceed. "There was no assurance," Justice Sandra Day O'Connor wrote in the decision, "that a physician would perform or even be present for the procedure."
Doctors getting feisty: are there any ethical limits?
A South Carolina doctor is asking the American Medical Association to approve as ethical a policy that would permit doctors to refuse treating medical malpractice lawyers. The proposal demonstrates how heated the debate over medical malpractice has become.At 4 minutes and 2 seconds, it's well worth a listen. When the transcript becomes available, I'll offer some salient excerpts (in the spirit of Fair Use). For now, here's the gist: Fed up with the perceived effect of allegedly frivolous lawsuits, this physician believes he is so biased against plaintiffs' attorneys that he can't trust himself to provide competent medical care.
The Charleston (S.C.) Post & Courier ran a story about this physician's quest in its May 29 edition (requires free registration):
Tucked among the stacks of resolutions to be debated at the American Medical Association's annual meeting next month will be one that, if approved, is sure to inflame the already white-hot debate over medical malpractice liability reforms. It also may sound familiar to South Carolinians: The proposal urges the AMA to inform doctors that it is not unethical to stop treating attorneys and their families in non-emergency cases.
The man behind the idea is prominent Charleston surgeon Dr. Chris Hawk. In March, he urged doctors at the South Carolina Medical Association meeting to quit treating plaintiffs' lawyers and their families in an effort to soften trial lawyers' resistance to malpractice reform.
That call ignited a firestorm, leading to intense criticism from lawyers and some doctors who called it unethical and said it takes the debate over malpractice premiums too far. . . .
When the AMA's House of Delegates meets June 12, various AMA committees will sift through hundreds of resolutions that delegates will vote on over the course of the three-day meeting. . . .
The resolutions are typically filed by either medical specialty societies or state associations like the South Carolina Medical Association. In this case, Hawk, an AMA delegate, introduced the proposal himself -- a rare occurrence that happens just once or twice a year, an AMA official said.
How well Hawk's proposal will fare is far from certain. In March, when Hawk made similar comments at the SCMA meeting pushing doctors to drop attorney patients, the association's board made it a point to insist that it didn't endorse the idea.
One board member called Hawk's position "totally off the wall."
Hawk said that in his view, it's not unethical to deny care to patients as long as the doctor is not dealing with a medical emergency and as long as the patient is given 30 days' notice.
Here's the text of Hawk's Resolution 202 (Word file):
Fort Worth Star-Telegram editorial writer Linda Campbell has an eminently sensible response to Dr. Hawk's crusade:AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES
Resolution: 202
(A-04)
Introduced by: J. Chris Hawk, III, MD, Delegate, South Carolina
Subject: Reform of Civil Justice System
Referred to: Reference Committee B
(Michael J. Fischer, MD, Chair)
Whereas, Tort reform has been our number one legislative priority; and
Whereas, Our American Medical Association has been concentrating on MICRA-like reform, particularly a cap on non-economic damages, when in fact we need major reform of the entire civil justice system; and
Whereas, Our current efforts at tort reform have failed at a national level; and
Whereas, We need to get beyond tort reform to other issues that are vital to medicine and our patients; and
Whereas, Patients’ access to medical care has diminished progressively and is likely to continue to do so, due to high malpractice insurance premiums forcing physicians to reduce their scope of practice, relocate, and retire early; and
Whereas, Our Principles of Medical Ethics IX states, “A physician shall support access to medical care for all people”; and
Whereas, If trial attorneys were given the opportunity to experience the access problems caused by the professional liability crisis, then perhaps they would be willing to help change the system; and
Whereas, Our Principles of Medical Ethics VI states, “A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care” therefore be it
RESOLVED, That our American Medical Association notify physicians that, except in emergencies and except as otherwise required by law or other professional regulation, it is not unethical to refuse care to plaintiffs’ attorneys and their spouses (New HOD Policy); and
RESOLVED, That our AMA organize a national task force, forum, or town meeting to reform the civil justice system, or get medical professional liability moved to an alternate dispute system, with report back by the 2005 Annual Meeting (Directive to Take Action); and
RESOLVED, That our AMA continue our efforts to reform the US health care system.
This jaw-dropping measure, presented as a means of addressing diminishing access to health care, laments the medical profession's inability to impose a $250,000 national cap on pain and suffering damages in medical malpractice lawsuits - as though that were the magic antidote for chronically bloated insurance premiums.She ends with a comment that gets to the nub of the problem:
Among its whereases, the resolution suggests that "if trial attorneys were given the opportunity to experience the access problems caused by the professional liability crisis, then perhaps they would be willing to help change the system."
So, Hawk believes, the AMA should "notify physicians that, except in emergencies and except as otherwise required by law or other professional regulation, it is not unethical to refuse care to plaintiffs' attorneys and their spouses."
Forget about that Hippocratic oath.
Let's indulge in discrimination according to livelihood - not to mention guilt by marital association.
Hawk told The Post and Courier in Charleston, "My obligation now is to try to improve the system, because we already have patients not getting care."
It requires truly warped logic to imagine that this tactic would advance that cause in any fashion.
If anyone thinks that Hawk's effort is merely an aberration, consider that the Christian Coalition of Alabama recently asked candidates for judicial office whether they would pledge to spurn campaign funding from personal injury trial lawyers, The Birmingham News reported. The organization considers Roe v. Wade an "activist" decision, and judges backed by trial lawyers tend to be "judicial activists," and so, of course, you see the connection.
What all this really accomplishes is to distract from meaningful debate about daunting problems.
Forty-three million Americans remain without health insurance. Many suffer for want of treatment. Someone has to pay to treat them when they get sick. But the cost of medical care climbs.
Medical malpractice insurance companies continue to hike premiums even in states that have limited awards for non-economic damages.
Texas voters last fall approved a constitutional amendment capping non-economic damages, but it hasn't immediately translated into lower malpractice insurance rates for many physicians.
Texas Medical Liability Trust reduced its rates by 12 percent, as promised.
But, late last year, the Joint Underwriting Association asked to raise rates 35 percent for physicians, surgeons and other health care providers and almost 68 percent for hospitals, a request denied by Texas Insurance Commissioner Jose Montemayor.
Yet another insurer, General Electric Medical Protective, switched to an unregulated type of insurance so that it could increase premiums by 10 percent.
In Ohio, malpractice premiums are expected to go up 10 percent to 40 percent this year, even though the state adopted pain-and-suffering caps, "The Advocate" newspaper in central Ohio reported in February.
Brooklyn Law School professor Anthony J. Sebok wrote in December that the usual suspects with the loudest voices on America's "liability crisis" miss the point about what needs reforming in the tort system.
"It is so expensive to litigate that few deserving victims sue, and many blameless defendants settle just so they can escape the expense and uncertainty of the civil justice system," he wrote on findlaw.com.
That can't be corrected with simplistic solutions or absurd ethical practices.
Dylan, poet redux.
Wednesday, June 09, 2004
Getting the bad news with the good news about a drug.
A doctor is thinking of trying a new drug on a 67-year-old patient because a study shows it works well in men only slightly younger. But the doctor doesn't know about a clinical trial that found serious side effects in older patients. Those results were never published.
John Schneider, a doctor of internal medicine and a member of the American Medical Association's Council on Scientific Affairs, fears that that scenario happens all too often.
Because drug companies often do not reveal the contents of studies that make their drugs look bad, he said, many doctors are frustrated because they sometimes prescribe medications without knowing all the information about them and possible side effects.
Now, the AMA is considering asking the federal government to open up this secretive world. The group's House of Delegates will vote during a meeting that starts Saturday on a resolution urging the U.S. Department of Health and Human Services to create a registry of all clinical trials and their results.
The power of a front-page story in The Times.
Bob Dylan -- master poet.
Organ trafficking.
Tuesday, June 08, 2004
A prescription for healthcare.
The U.S. health care system is in bad shape. Medical services are restricted or rationed, many patients receive poor care, and high rates of preventable medical error persist. There are wide and inexplicable differences in costs and quality among providers and across geographic areas. In well-functioning, competitive markets, such outcomes would be inconceivable. In health care, these results are intolerable. Competition in health care needs to change, say the authors. It currently operates at the wrong level. Payers, health plans, providers, physicians, and others in the system wrangle over the wrong things, in the wrong locations, and at the wrong times. System participants divide value instead of creating it. (And in some instances, they destroy it.) They shift costs onto one another, restrict access to care, stifle innovation, and hoard information--all without truly benefiting patients. This form of zero-sum competition must be replaced by competition at the level of preventing, diagnosing, and treating individual conditions and diseases. Among the authors' well-researched recommendations for reform: Standardized information about individual diseases and treatments should be collected and disseminated widely so patients can make informed choices about their care. Payers, providers, and health plans should establish transparent billing and pricing mechanisms to reduce cost shifting, confusion, pricing discrimination, and other inefficiencies in the system. And health care providers should be experts in certain conditions and treatments rather than try to be all things to all people. U.S. employers can also play a big role in reform by changing how they manage their health benefits.
HHS OIG publishes draft revised hospital compliance guidance.
According to the preamble,
When the final version of this document is published, it will supplement the OIG’s prior compliance program guidance for hospitals issued in 1998. This draft contains new compliance recommendations and an expanded discussion of risk areas. The draft takes into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance.Among other things, the draft revises the OIG's list of compliance "risk areas":
This section addresses the following areas of significant concern for hospitals: (A) Submission of accurate claims and information; (B) the referral statutes; (C) payments to reduce or limit services; (D) the Emergency Medical Treatment and Labor Act (EMTALA); (E) substandard care; (F) relationships with Federal health care program beneficiaries; (G) HIPAA Privacy and Security Rules; and (H) billing Medicare or Medicaid substantially in excess of usual charges. In addition, a final section (I) addresses several areas of general interest that, while not necessarily matters of significant risk, have been of continuing interest to the hospital community.Final section (I) discusses (1) discounts to uninsured patients, (2) preventive care services, and (3) professional courtesy.
Pfizer pleads guilty to marketing drug illegally.
Monday, June 07, 2004
Pediatric deaths due to error - Report.
Thousands of children die unnecessarily in hospitals because of medical errors stemming from patient-safety lapses, and the extra cost of care for pediatric patients exposed to 20 types of safety problems exceeds $1 billion annually, according to a study in the June Pediatrics. The study confirmed that medical errors are a significant problem for children as well as adults, and it identified the very young and the very poor as more vulnerable than children in general. Researchers from the department of pediatrics at Johns Hopkins University, Baltimore, said the figures on patient deaths were conservative. The methods used to identify 4,483 unnecessary deaths from an analysis of 5.7 million records in 2000 "can detect only a small portion of the types of patient safety events that actually happen in hospitals," according to the article.The abstract concludes: "Patient safety problems for hospitalized children occur frequently and with substantial impacts to our health care industry. Unmeasurable by this study are the additional "costs" and "burdens" of safety events that our patients are forced to handle. Additional work to describe and quantify better these outcomes in addition to ones measured here can help solidify the "business case" for patient safety efforts."
More than 51,000 cases of medical error were discovered, and four of the 20 types of treatment failure occurred at a rate exceeding 100 per 10,000 discharges. Those were failure to rescue a patient suffering from a threatening event, postoperative sepsis, and obstetric trauma with and without the use of instrumentation. The study also recorded the financial cost of each of the 20 types of treatment failure. For example, each case of sepsis resulted in an average of 26 extra hospital days and $118,000 in extra charges.
Washington Post analyzes Kerry's health plan.
Sunday, June 06, 2004
How Private Is My Medical Information?
50-state rundown on gay-marriage laws.
Stem cell research ethics debated.
Friday, June 04, 2004
Indigent care: Texas Attorney General Op. No. GA-0198.
In this case, the [Indigent Health Care and Treatment] Act does not contemplate that a health care provider may require an applicant for indigent health care to obtain insurance through the applicant's employer in certain circumstances. Section 61.007(5) of the Health and Safety Code, requiring an applicant to provide information regarding the "existence of insurance coverage," is phrased in the present tense. Tex. Health & Safety Code Ann. § 61.007(5) (Vernon 2001). It is concerned with an applicant's coverage at the time of the application, not the availability of coverage or the potential for coverage in the future. The Department's [i.e., the Department of State Health Services'] rule requiring an applicant to list information about any medical insurance household members "receive," see 25 Tex. Admin. Code § 14.101(a)(3)(E) (2004), similarly focuses on whether the applicant is insured at the time he or she applies for indigent health care. No other provision in chapter 61 of the Health and Safety Code or in the Department's rules expressly or implicitly authorizes a hospital district to require an applicant to purchase health insurance as a prerequisite to receiving indigent health care.
Moreover, absent a provision in the special law creating it, a hospital district has no authority to require an applicant to obtain insurance before the applicant is eligible for indigent health care. "A hospital district has only such authority as is expressly conferred on it by statute or necessarily implied from the authority expressly conferred to effectuate the express powers." Tex. Att'y Gen. Op. No. JC-0068 (1999) at 1. Without express authority, a hospital district may not adopt a standard for determining an applicant's income and resources that is stricter than the Department's standard. See Tex. Health & Safety Code Ann. § 61.052(a)(2) (Vernon 2001); see also id. § 61.052(e) (stating that, if the Department changes its income and resources requirements so that the hospital district's standards become stricter than the Department's, the hospital district must change its standard to at least comply with the Department's requirements). Because neither the statute nor the Department's rules permit a requirement that an applicant purchase insurance, any such hospital district requirement would be more restrictive than the state requirements and, absent express authority, would be impermissible under the statute.
Schiavo case on fast track to Florida Supreme Court.
Meanwhile, Terri's parents are again contesting her husband's right to make medical decisions for her -- an issue that has been litigated and re-litigated and always comes out the same way every time - in favor of the husband. The Second District Court of Appeal's opinion from last June neatly summarizes the issue. Apparently "finality" is a foreign concept in Florida's court system.
For more on the lower court's opinion and other recent developments in this case go here and here.
Wednesday, June 02, 2004
Additional thoughts on late-term abortions.
The absence of these two simple features suggests a number of possibilities:
- Maybe Congress and the Administration were more interested in a confrontation with the federal courts over partial-birth abortion than they were in enacting any meaningful legislation.
- Or perhaps Congress and the Administration were more interested in creating a campaign issue for the summer and fall of 2004 than they were in banning a procedure that is so rarely used but has such potent political symbolism.
- Finally, it is possible that the Administration and both houses of Congress truly believe that if this loose thread can be successfully pulled away from the body politic, the entire fabric of Roe v. Wade will surely follow.
Health insurance coverage and the kindness of strangers.
In other words, poorer and less urban states, with a less skilled workforce and fewer high-end and skilled jobs, can't do much to raise the rate of ESI, short of attracting more skilled jobs, more high-end employers, etc. And that means simultaneously granting tax breaks and spending more on improving public services, paying attention to public education and public health, all of which requires a stronger tax base. How does a comparatively poor state dig itself out of this hole?
Working In Communities With Greater Number Of ‘Advantaged’ Workers
Increases Likelihood Of Employer-Sponsored Coverage
BETHESDA, MD — Although there is wide variation across the country in the rate of employer-sponsored insurance, almost all of the variation can be accounted for by variation in individual demographic characteristics, employment characteristics, and a community effect, according to a new paper published today by Health Affairs and the California HealthCare Foundation.
Author Richard Kronick, a professor with the University of California, San Diego, and two colleagues use Current Population Survey data to demonstrate that community characteristics exert a strong “contextual effect” on employer-sponsored coverage. . . .
According to Kronick, all individual and job characteristics being equal, workers are more likely to receive employer-sponsored coverage in communities with a large proportion of high-income adults and greater numbers of manufacturing and public administration jobs, rather than those whose economy is weighted toward low-income adults, minority workers, and small-business jobs.
Kronick and colleagues conclude that the demographic characteristics of a community have more bearing on rates of employer-sponsored insurance (ESI) than do state policies aimed at reducing the number of uninsured, such as small-group market reform or elimination of benefit mandates.
“In almost all states the actual rate of ESI is within one or two percentage points of the level that would be expected based on demographic and employment characteristics and the contextual effect,” Kronick says.
“Other than Hawaii, there is very little that states have done to move the rate of ESI either substantially above or below the rate that would be expected based on the demographic and employment characteristics of the people who live in the state. The only effective action that any state has taken to substantially increase the level of ESI among workers is to require employers to offer insurance,” as Hawaii has, Kronick says.
The authors find that a worker with a given set of characteristics (age, race/ethnicity, income, family structure, size of employer, industry, health status, home ownership, and union membership) is 3.5 percentage points more likely to have employer-sponsored insurance if they live in a metropolitan area with a high-wage, high-skill economy than if the workers lives in an average metropolitan area.
“There is a strong contextual effect on coverage rates,” Kronick says. “Although there are wide variations across states in the rate of (employer-sponsored insurance), almost all of the variation can be accounted for by the combination of individual characteristics and the contextual effect.”
The authors offer three potential explanations for the “contextual effect”:
In areas where there are the types of workers who expect to have ESI (well-educated, higher-income, native-born Anglos), employers will be more likely to offer coverage. As a result, the search costs for a marginal worker to find a job offering insurance will be lower than in areas where there are fewer employers offering insurance Total compensation, including ESI and other benefits, is more likely to higher in areas with larger numbers of higher-skilled workers Workers in high-coverage areas may prefer to search longer for jobs with ESI, while workers in low-coverage areas may find it more acceptable to go without coverage
The skewed politics of assisted suicide.
Tuesday, June 01, 2004
NY Times' extensive coverage of life and death under Oregon's PAS law.
More on partial-birth abortion ruling.
1. The partial-birth abortion law is unconstitutional in three respects.
a. The statutory definition of the procedure could apply to previability D&E procedures as well as inductions. It could also apply to the interventions performed by physicians who treat a woman experiencing a spontaneous second-trimester miscarriage. Physicians may face criminal prosecution under the statute for procedures than cannot always be predicted when they begin to treat their patients. This could reduce the availability of such procedures and could have an adverse impact on the physicians who continue to do the procedures. All of this amounts to an "undue burden," as that phrase has been explained in Casey and Stenberg: the law "has the effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus." The Nebraska law at issue in Stenberg was struck down for the same reason.
b. The law is unconstitutionally vague in two material respects: "partial-birth abortion has little if any medical significance; "living fetus" adds to the vagueness of the law because it does not pertain to viability or to the framework of Roe and Casey; and neither the "overt act" nor the scienter requirements of the statute save the law from unconstitutional vagueness.
c. Notwithstanding the extensive findings of Congress to the contrary, the Court concluded that the intact D&E procedure (referred to in Stenberg as "D&X" or "dilation and extraction") is relatively safe, and it may be safer than any of the alternative procedures under some circumstances. Therefore banning the procedure could endanger women's health. The Nebraska law at issue in Stenberg was struck down for the same reason.
2. The extensive Congressional findings in support of Congress' conclusion that intact D&E is never necessary for the health of the mother were reviewed by the court under an intermediate review standard, neither de novo (as the plaintiffs argued) nor with the extreme deference sought by the government's lawyers. Applying a standard akin to a "hard look," the court concluded that these findings were "unreasonable and . . . not supported by substanttial evidence [that] was available to Congress at the time."
Federal court declares partial-birth abortion law unconstitutional.
As reported this morning by the San Francisco Chronicle:
The ruling applies to the nation's 900 or so Planned Parenthood clinics and their doctors, who perform roughly half of all abortions in the United States.
U.S. District Judge Phyllis Hamilton's ruling came in one of three lawsuits challenging the legislation President Bush signed last year. . . .
Federal judges in New York and Nebraska also heard challenges to the law earlier this year but have yet to rule. . . .
Late last year, Hamilton, a Clinton appointee, and federal judges in New York and Lincoln, Neb., blocked the act from being enforced pending the outcome of the court challenges. They began hearing testimony March 29. . . .
The Nebraska and New York cases are expected to conclude within weeks. The outcomes, which may conflict with one another, will almost certainly be appealed to the Supreme Court.
The New York case was brought by the National Abortion Federation, which represents nearly half the nation's abortion providers. The Nebraska case was brought by a few abortion doctors.
Monday, May 31, 2004
Alan Morrison . . . living greatly in the law.
Morrison's bold attempt to get Scalia out of the Cheney case is illustrative of his career:
The episode captures an essential truth about Morrison, one of the nation's top public interest lawyers, as he looks back over his 32 years with the Ralph Nader-founded Public Citizen Litigation Group. He is fearless about challenging government and corporate interests, yet also has no fear of befriending -- or at least being cordial to -- their advocates and icons.For my students, the closing words of the article are memorable:
"There's no reason not to deal with people in a civil manner," Morrison says. "I don't consider myself a rebel. I like having people return my phone calls."
Even in his parting, a range of luminaries returned his phone calls and formed a host committee for a June 3 farewell dinner for Morrison that will also fund a fellowship in his name. The list spans the spectrum of the legal establishment -- from former Whitewater Independent Counsel Kenneth Starr to Harvard Law School professor Laurence Tribe, Reagan Solicitor General Charles Fried to Clinton SG Seth Waxman, Reagan White House Counsel Fred Fielding to Clinton Chief of Staff John Podesta. "Alan Morrison is deeply respected throughout the entire Washington community," says Starr, now partner in the D.C. office of Kirkland & Ellis. "His conservative friends may not always agree with him, but they know he is a person of complete intellectual honesty."
Throughout his career, Morrison says, he was never tempted by the astronomically higher salaries he could have made if he had put his tenacity and litigating skills to work for a private firm. At Public Citizen he was paid no more than $80,000 a year, he says, and even when he supplemented that with an adjunct law school teaching gig, "I'm still making less than a first-year associate at a New York firm."
But Morrison says the rewards have been incomparable. Pointing to Craig's book about the litigation group's early days, he says, "I hope young people read it and say to themselves, 'You know, there's a better way to spend my life.' You work here, and there's no competition, you don't have to make partner." One young lawyer on his staff once told him the job was so fulfilling and fun, "I don't think we should get paid."
Morrison recalls the words of his friend the late public interest activist Joseph Rauh Jr., who once said, "They made all the money; we had all the fun."
Sunday, May 30, 2004
New Texas Supreme Court case on workers' comp.
In 1989, the Legislature enacted a new Workers’ Compensation Act in response to rising medical costs and increasing insurance premiums. The Legislature created the Texas Workers’ Compensation Commission and gave the agency broad powers to adopt rules necessary for the implementation and enforcement of the Workers’ Compensation Act. TEX. LAB. CODE § 402.061. One of TWCC’s new functions was to establish fee guidelines for reimbursements to health care providers who treat injured workers. Id. § 413.011. To this end, the agency promulgated the Texas Workers’ Compensation Commission Medical Fee Guideline 1996, adopted by reference in Rule 134.201 of the Texas Administrative Code. See 28 TEX. ADMIN. CODE § 134.201 (indicating that copies of the Guideline may be obtained from TWCC’s publication department). The Guideline contains the maximum allowable reimbursements (MARs) for thousands of medical procedures. The MARs establish upper limits on the amount of reimbursements payable to health care providers for the listed treatments or services. TWCC also promulgated a set of rules, now commonly referred to as the “Dispute and Audit Rules,” which establish a process for insurance carriers to review and audit bills submitted by health care providers. Id. §§ 133.301-.305.2 The rules also set up dispute resolution procedures to resolve disagreements over the necessity of medical procedures and the amount of reimbursements. Id. § 133.305. Requests for medical dispute resolution must be filed not later than one year from the date of the medical service. Id. § 133.305(d).The Supreme Court concludes "that TWCC complied with the statutory requisites for promulgating the fee guidelines and acted within its designated powers in limiting specified medical fee reimbursements and the time to seek medical dispute resolution. We affirm the court of appeals’ judgment on these issues. Because we conclude that TWCC did not delegate its power to private entities, we reverse the portion of the court of appeals’ judgment that is contrary to this conclusion. We also overrule the constitutional challenge to TWCC’s fee reimbursement guidelines and time limitations for commencing medical dispute resolution."
TWCC’s adoption of the Guideline and the Dispute and Audit Rules are at the base of this dispute. Patient Advocates of Texas and Allen J. Meril, M.D. (collectively PAT) initiated this lawsuit claiming that TWCC did not follow the rulemaking procedures required by statute when promulgating the Guideline. Additionally, PAT asserts that TWCC exceeded its rulemaking authority by setting a ceiling on many medical fee reimbursements and limiting the time for a party to seek medical dispute resolution to one year from the date the medical service was provided. PAT also challenges the validity of the Dispute and Audit Rules alleging that TWCC illegally delegated its audit and fee-setting authority to private insurance carriers. Lastly, PAT raises constitutional challenges to the rules on the grounds that the MARs and the one-year time limitation constitute a taking of their property without due process and just compensation. In response, TWCC argues that its enactment of the Guideline meets statutory procedural requirements and the limits placed on medical payments are consistent with the agency’s authority to establish medical policies and guidelines pursuant to section 413.011 of the Labor Code. TWCC claims that it retains its power to audit workers’ compensation participants and establish medical fees, and that the Dispute and Audit Rules are simply a means to facilitate insurance carriers’ review of the medical claims submitted by health care providers.
Radicalized elders turn to drug smuggling.
Harvard Medical amends conflict-of-interest policies
Under the policy, Harvard faculty cannot own more than $30,000 in stock from public companies that benefit from their research, a $10,000 increase from the previous limit. They cannot have any stock from companies with which they have ongoing research collaborations. In addition, faculty members cannot own stock in private companies related to their research. But faculty can receive up to $20,000 in consulting fees from companies tied to their research, also a $10,000 increase from the previous limit. . . .The Office of Public Health and Science at HHS published its own guidance on this subject on May 12.
Until now, faculty could not hold upper management jobs in firms. The new policy extends this prohibition to include the positions of chief scientific officer and chief medical officer, slots Harvard faculty occasionally accept.
The new policy was crafted by Harvard medical dean Dr. Joseph B. Martin, in consultation with several faculty committees. He noted that some faculty members argued for looser rules that would foster increased interaction with Boston's vibrant biotechnology and pharmaceutical communities.
''The issues that some individuals raised were set aside for two reasons: that we need to protect human subjects in research . . . and that there not be any perception of bias in research work," he said.
But of faculty collaborations with industry, Martin said: ''We encourage it in every possible way." The increase in the stock and consulting limits, said Martin, reflected what he thought ''responsible people ought to be able to take in."
Saturday, May 29, 2004
Monkey business affects waiting times on transplant list in Albany.
Maternal-fetal conflicts: a moving target.
Interesting intersection of universal health care coverage, same-sex marriage, and domestic-partners' benefits
As pointed out in the article, however, same-sex couples may decide to remain unmarried in order to adopt children in countries than ban adoptions by married same-sex couples. And Springfield's three-month phase-out may leave out in the cold those couples that cannot (or choose not to) get their marital act together that quickly. Mayor Charlie Ryan (who was also mayor during my high school days, 37 years ago, and whom I always regarded as an exceptionally straight shooter) says his new order will bring the city into compliance with state insurance laws, though that didn't seem to be a high priority until now.
As for cost: Cambridge Vice-mayor Marjorie Decker is quoted as saying, "It’s an interesting debate for any city or town," she said. "We’re at the crossroads of what happens when you don’t have some universal form of health care." Cambridge, as well as other employers, is confronting the same choices:
Decker expects the city will eventually debate the issue. She predicts that some will argue that domestic-partnership benefits should be extended to all couples who are in long-term committed relationships, rather than forcing them to marry in order to access health benefits. . . .Stay tuned . . . .
Among Boston-area employers, Beth Israel Deaconess Medical Center and Babson College will discontinue domestic-partner benefits at the end of the year.
Employers including Massachusetts Institute of Technology, Brigham and Women’s Hospital, Massachusetts General Hospital, Fidelity Investments, Gillette Co. and EMC Corp. will maintain the benefits. Harvard University plans to maintain them for the immediate future, but will revisit the issue in the next two years.
Physician-Assisted Suicide.
In sum, the CSA was enacted to combat drug abuse. To the extent that it authorizes the federal government to make decisions regarding the practice of medicine, those decisions are delegated to the Secretary of Heath and Human Services, not to the Attorney General. The Attorney General’s unilateral attempt to regulate general medical practices historically entrusted to state lawmakers interferes with the democratic debate about physician assisted suicide and far exceeds the scope of his authority under federal law. We therefore hold that the Ashcroft Directive is invalid and may not be enforced.The irony in all this is that this most avowedly pro-State, anti-federalist administration hasn't hesitated to try to impose its will on the states when it perceived a hint of political mileage that might be gained with the far right, even when it means shamelessly trampling individual liberties and the traditional role of the states in regulating the practice of medicine.
Prisoner Abuse and Doctors' Duty.
Monday, May 17, 2004
Texas Supreme Court decides informed-consent case.
(A) Limitation of movement of shoulder and arm.This opinion is consistent with those of four Texas courts of appeals. The Supreme Court emphasized that the negligent diagnosis or prognosis could give rise to a negligence claim, but in this case the plaintiff had waived those claims over the course of the litigation. It probably doesn't need to be emphasized that the consent process may be flawed, irredeemably so, when the practitioner affirmatively misleads the patient with statements that are known to be false, simply to procure a consent.
(B) Swelling of the arm.
(C) Loss of the skin of the chest requiring skin graft.
(D) Recurrence of malignancy, if present.
(E) Decreased sensation or numbness of the inner aspect of the arm and chest wall.
None of the risks listed for this or any other procedure on List A include the risk that the physician's diagnosis or prognosis that supports his or her recommendation that the procedure be performed is or may be incorrect. If a physician told a patient that she had cancer and was therefore recommending a hysterectomy, the risks enumerated by the Texas Disclosure Panel do not include the risk that the surgery may be unnecessary. The risk that a physician may have erroneously made a diagnosis or prognosis as a predicate to recommending surgery is not inherent in any particular surgery or procedure or medication. That is a general risk of consulting a physician.
Saturday, May 08, 2004
IRS ruling a template for hospital-physician deals.
The five-page revenue ruling offers a template for how not-for-profit hospitals can protect their tax-exempt status and avoid paying unrelated-business income taxes in joint ventures with physicians or for-profit companies. . . .
[A] tax-exempt university asked for IRS guidance on its plan to offer training programs for elementary and secondary schoolteachers. The university would team up with a for-profit, interactive-video company in a 50-50 joint venture, with each partner naming three directors to the board. The governance agreement would prohibit activities contrary to the university's tax-exempt status, require the university to remain at arm's length in negotiations for contracts and other transactions, and establish fair-market value as a benchmark for prices.
The IRS said those stipulations would protect the university's tax-exempt status, and there would be no unrelated-business income taxes because the venture was an extension of the university's educational mission and insubstantial compared with its overall activity.
Friday, May 07, 2004
Schiavo timeline and significant documents.
Thursday, May 06, 2004
"Terri's Law" declared unconstitutional by Florida court.
- First, the court held that the law effects an unconstitutional delegation of legislative power to the governor, in violation of Art. II, sec. 3, of the Florida Constitution and separation-of-powers principles. The gist of this holding is that the legislature provided Gov. Bush with virtually no standards to guide his exercise of discretion as to whether to order the reinstatement of life-sustaining measures and for how long.
- Second, the court held that statute violates Terri Schiavo's right of privacy, a right that was added to the Florida Constitution in 1980 (Art. I, sec. 23). Section 23 provides: "Every natural person has the right to be let alone and free from governmental intrusion into the person's private life except as otherwise provided herein. This section shall not be construed to limit the public's right of access to public records and meetings as provided by law. "
- The court also found that the law was retroactive legislation and an unconstitutional intrusion into the judicial function.
Limits on Stem-Cell Research Re-emerge as a Political Issue.
As reported in today's New York Times, the question of the federal government's funding policies is emerging as an issue in Campaign 2004. Stay tuned . . .
Wednesday, May 05, 2004
Quality of care lacking in a majority of communities in US.
- "Profiling The Quality Of Care In Twelve Communities: Results From The CQI Study," by Eve A. Kerr, Elizabeth A. McGlynn, John Adams, Joan Keesey and Steven M. Asch.
Abstract: Health care quality falls far short of its potential nationally. Because care is delivered locally, improvement strategies should be tailored to community needs. This analysis from the Community Quality Index (CQI) study reports on a comprehensive examination of how effectively care is delivered in twelve metropolitan areas. We find room for improvement in quality overall and in dimensions of preventive, acute, and chronic care in all of these communities; no community was consistently best or worst on the various dimensions. Having concrete estimates of the extent of the gap in performance should stimulate community-based quality improvement efforts. (Full text requires subscription to journal.)
Americans get substandard care for their ailments about half the time, even if they live near a major teaching hospital, the first comprehensive study of health care provided in metropolitan areas has found.
The inadequate treatment leads to "thousands of needless deaths each year," said Dr. Elizabeth A. McGlynn, a researcher at the RAND Corporation . . . .
The study's conclusions were based chiefly on a review of the medical records of nearly 7,000 people in 12 metropolitan areas, including Newark, Miami and Orange County, Calif. On average, the authors found, patients received substandard care, as defined by leading medical groups, 50 percent to 60 percent of the time. There was little variation among the metropolitan areas, randomly selected from 60 with populations of at least 200,000. The areas included cities and their suburbs.
Texas Leads Nation in Percentage of Uninsured Workers.
The full report (Characteristics of the Uninsured: A View from the States (May 2003), from the Robert Wood Johnson Foundation) is here.
Tuesday, May 04, 2004
Two must-read articles in the current issue of Health Affairs.
- "How Does the Quality of Care Compare in Five Countries?," by Peter S. Hussey, Gerard F. Anderson, Robin Osborn, Colin Feek, Vivienne McLaughlin, John Millar and Arnold Epstein -- 23(3):89-99.
Abstract: International data on quality of medical care allow countries to compare their performance to that of other countries. The Commonwealth Fund International Working Group on Quality Indicators collected data on twenty-one indicators that reflect medical care in Australia, Canada, New Zealand, England, and the United States. The indicators include five-year cancer relative survival rates, thirty-day case-fatality rates after acute myocardial infarction and stroke, breast cancer screening rates, and asthma mortality rates. No country scores consistently the best or worst overall. Each country has at least one area of care where it could learn from international experiences and one area where its experiences could teach others. - "U.S. Health Care Spending In An International Context," Uwe E. Reinhardt, Peter S. Hussey and Gerard F. Anderson -- 23(3):10-25.
Abstract: Using the most recent data on health spending published by the Organization for Economic Cooperation and Development (OECD), we explore reasons why U.S. health spending towers over that of other countries with much older populations. Prominent among the reasons are higher U.S. per capita gross domestic product (GDP) as well as a highly complex and fragmented payment system that weakens the demand side of the health sector and entails high administrative costs. We examine the economic burden that health spending places on the U.S. economy. We comment on attempts by U.S. policy-makers to increase the prices foreign health systems pay for U.S. prescription drugs.
HHS/CMS effort to silence CMS' chief actuary probably violated federal law.
The Congressional Research Service on Monday concluded that Bush administration officials "appear to have violated federal law" by barring CMS chief actuary Richard Foster from sharing with lawmakers his cost estimates for the Medicare legislation, the Wall Street Journal reports (Rogers, Wall Street Journal, 5/4). CRS is a branch of the Library of Congress and provides nonpartisan analysis and research to lawmakers (Pugh, Philadelphia Inquirer, 5/4). The analysis comes more than one month after Foster told members of the House Ways and Means Committee that he had shared with Doug Badger, President Bush's health policy adviser, and James Capretta, associate director of the Office of Management and Budget, his analysis that the Medicare legislation would exceed its target spending goal. According to OMB estimates released after Congress passed the legislation, the Medicare law will cost $534 billion over the next 10 years, $134 billion more than estimated by the Congressional Budget Office. Foster has said that the higher cost projection was known before the final House and Senate votes on the legislation in November but that former CMS Administrator Tom Scully told him, "We can't let that get out." In an e-mail to colleagues at CMS, Foster indicated he believed he might lose his job if he revealed his cost estimates for the Medicare legislation. Scully has said that he did not threaten to fire Foster if the higher estimates were released. Scully also said that he "curbed Foster on only one specific request" made by Democrats at the time of the first House vote on the Medicare bill (Kaiser Daily Health Policy Report, 3/25).Analysis Details. In a nine-page memo to Rep. Charles Rangel (D-N.Y.), ranking member of the Ways and Means Committee, CRS said that federal officials "do not have the right to prevent or prohibit" employees from sharing information concerning "relevant public policy issues" to congressional members (Goldstein, Washington Post, 5/4). Further, Congress' "right to receive truthful information from federal agencies to assist in its legislative functions is clear and unassailable," the analysis states. According to CRS, since 1912, federal laws have protected federal employees' rights to communicate with lawmakers, and more recent laws have "reaffirmed and strengthened" those rights (Pear, New York Times, 5/4). Jack Maskell, a legislative lawyer at CRS, said that in 1997, "when some lawmakers felt that the Clinton administration threatened the candor of federal health experts, House and Senate appropriations conferees wrote into health care legislation" that the CMS Office of the Actuary serves both the administration and the Congress, the Inquirer reports. In addition, the legislation states that the actuary's independence to provide data to Congress is "vital," according to the Inquirer (Philadelphia Inquirer, 5/4). Thus, Scully's order "would appear to violate a specific and express prohibition of federal law," according to CRS (New York Times, 5/4). However, CRS said that such an act "may not rise to level of a criminal violation" (Heil, CongressDaily, 5/3). According to the Inquirer, Scully probably could not be prosecuted because "only individual lawmakers sought Foster's estimates." Scully could not be reached for comment Monday (Philadelphia Inquirer, 5/4).
Democrats' Response. The CRS report prompted Rangel, who requested the analysis, and Rep. Pete Stark (D-Calif.), House Ways and Means Health Subcommittee ranking member, to request a new committee hearing on the estimates (CongressDaily, 5/3). According to the Journal, some House Democrats "seized the nine-page memo" to reaffirm their argument for subpoenas to make Scully and Badger testify regarding their knowledge of the "alleged 'gag order'" (Wall Street Journal, 5/4). Scully and Badger declined to appear before the House panel when it considered the estimates last month (Kaiser Daily Health Policy Report, 4/2). In a letter, Rangel and Stark reminded House Ways and Means Committee Chair Bill Thomas (R-Calif.), who has declined previous requests to subpoena Scully or Badger, that he has said he would support a subpoena "if it was clear that laws had been broken," CongressDaily reports. In the letter, Rangel and Stark said, "It is clear that laws were broken. ... Indeed, the administration's steadfast refusal even now to release the requested information raises serious questions as to the ongoing violations of the spirit, if not the letter, of these laws" (CongressDaily, 5/3). HHS Secretary Tommy Thompson last week said he would not release additional documents related to Bush administration cost estimates for the Medicare law, despite a formal request from Democrats on the House Government Reform Committee (Kaiser Daily Health Policy Report, 4/29).
Administration Reaction According to the Journal, CRS "is respected by the administration" and therefore, the CRS analysis "makes it harder to isolate the complaints as driven by election-year politics and Democrats who opposed the bill" (Wall Street Journal, 5/4). However, HHS spokesperson Bill Pierce on Monday said that the department is "focusing on instituting the new Medicare law and not on the Scully-Foster controversy" (Philadelphia Inquirer, 5/4). Pierce added that "we are looking to the future, not the past" (New York Times, 5/4).
Friday, April 30, 2004
U of Wash update.
The Seattle Times has updated its story, to reflect the actual settlement announcement this morning.
The complaint, which was filed under seal in 1999 and released today, is here.
Qui tam action against Univ. of Washington teaching hospital settles for $35 million
[W]hen [a 1996 compliance] program was put into place, auditors found rampant errors. Doctors were routinely overbilling Medicare and Medicaid, charging for more expensive services than those they had performed. According to the lawsuit, auditors found evidence of this in nine out of 10 departments at the Children's University Medical Group, the billing group for UW doctors who practice at Children's Hospital and Medical Center.Best of all, "UW Physicians destroyed the old reports, the lawsuit said, and wrote new, sanitized versions."
When UW Physicians found out, according to the lawsuit, it hid the practice by changing the compliance policy, making it acceptable to round up, meaning doctors could charge for a treatment that was one rung higher on the billing chart than the treatment they had actually provided.
With the new rules in place, UW Physicians began a second audit for 27 specialty departments. Even under the more permissive rule, though, the errors poured in, according to the lawsuit. The majority of errors came from doctors who were charging for services two or more rungs higher than the services performed. In the dermatology department, 90 percent of the cases reviewed were incorrectly billed. Rates were 57 percent for infectious-diseases, 21 percent for pulmonary and 22 percent for craniofacial.
Tuesday, April 27, 2004
Bioethics novels.
Monday, April 26, 2004
ER care being triaged at University of Colo. Hosp. in Boulder.
To begin with: "As the provider of last resort, hospital emergency departments across America have for decades accepted thousands of truly non-urgent cases and swallowed the cost. For the most part, the patients have nowhere else to go, no insurance and no money." In other words, ER patients with subacute conditions typically got triaged over to the nonemergent ER desk, where their sore throats and sprains were handled. If the bill was never paid, that was just a fact of life. No more. Now they are triaged out to another facility.
Beyond this change, the ERs are treating nonemergent ferently depending upon their financial ability to pay. Nonemergent cases will continue to be seen, as long as there's insurance coverage for that service or -- because most health plans will deny coverage of nonemergency services in the ER -- the patient has cash.
Whether this is a good thing (i.e., hospitals finally taking control of their emergency departments and running them a little more like a business) or not remains a hotly debated issue.
At least judging from the article, there is a chance that patients who present to the ER with a request for emergency services will get a cursory review, rather than a "medically appropriate screening," as required by the federal Emergency Medical Treatment and Active Labor Act (EMTALA). Federal officials say that isn't happening at the Univ. of Colo. hospital, but it is obviously a risk. And, apart from the legal liability that flows from an EMTALA violation, there is the added health costs: "'If we tell people don't come to the emergency department unless you're dying, that's exactly what they'll do,' said Arthur Kellermann, a professor at Emory University School of Medicine and chairman of the emergency medicine department at Grady Memorial Hospital in Atlanta. 'If no one else is willing to take care of that diabetic, then we are very unwise to turn that person away,' because chronic conditions tend to worsen if left untreated."
One of perhaps unintended patient benefits of EMTALA was precisely this: patients with chronic or sub-emergent conditions got seen by a doctor or nurse-practitioner/physician's assistant somewhere within the system, and conditions that could have worsened were treated sooner rather than later. The problems with this fix are (1) some ERs are stretched beyond their limits by such cases, which necessitates the diversion of true emergencies away from the ERs, and (2) from a cost standpoint, about the only more expensive (and less appropriate) hospital setting for these subacute patients is the ICU.
The message of the unsurprising story in today's paper is that our country's ER "fix" for unfunded patients (EMTALA) was an admirable attempt to fix the patient of "patient dumping" but was not a good solution -- nor was it really intended to be -- for the problem of inequitable access to health insurance, and it has become unsustainable. This was the message of a Wall Street Journal article last year about similar efforts to cut back on uncompensated care at the University of Texas Medical Branch (UTMB) at Galveston (Bernard Wysocki Jr., "At One Hospital, A Stark Solution For Allocating Care," WSJ, September 23, 2003, at A1) (may require paid subscription). In fact, the WSJ has done a good job on this issue with a series of pieces, from September to December 2003, including:
• Six Prescriptions to Ease Rationing, 12/22/03Meanwhile, a quite useful analysis of the "hidden costs" in the Canadian health care system appeared last week in the WSJ and should be required reading for anyone who thinks health-care financing woes are subject to a quick fix.
• Universal Care Has a Big Price: Patients Wait, 11/12/03
• Longer Dialysis Raises Hopes, but Poses Dilemma, 10/02/03
• Stark Choices at a Texas Hospital, 09/23/03
• Lilly Fuels Debate Over Rationing, 09/18/03
• An Invisible Web of Gatekeepers, 09/16/03
• Health Care's Big Secret: Rationing Is Here, 09/12/03
Sunday, April 25, 2004
The New York Times: "Administration Says a `Zone of Autonomy' Justifies Its Secrecy on Energy Task Force"
Do poets die young(er)?
"Poets produce twice as much of their lifetime output in their twenties as novelists do," he said.Good. Now we can go back to worrying about real health threats, like SARS and the environmental policies of George Bush.
So when a budding novelist dies young, few people may notice.
"A great novelist or nonfiction writer who dies at 28 may not have yet produced her or his magnum opus."
Kaufman said poets should not worry, but should perhaps look after their health.
"The fact that a Sylvia Plath ... may die young does not necessarily mean an Introduction to Poetry class should carry a warning that poems may be hazardous to one's health," he said.
Gov. Romney won't let gay outsiders wed in Massachusetts.
It seems unlikely that any state would be able to say that at the moment. Thirty-nine states have passed so-called defense-of-marriage acts, which stipulate that marriage is between a man and a woman. Three other states — Maryland, New Hampshire and Wyoming — have laws precluding same-sex marriage. And seven states, including New York, New Jersey and Connecticut, make no specific reference to same-sex couples in their laws.By my count, that's 49 states that will not recognize same-sex marriage. (Where's D.C. in all this?)
Described by various news reports as "obscure" and "little-known," the 1913 law is easily found in Chapter 207 ("Marriage") of the Domestic Relations Law of the Commonwealth of Massachusetts. The first part of Chapter 207 is entitled "Certain Marriages Prohibited," and Section 11 (of 14 sections) lays it out for all to see:
Section 11. No marriage shall be contracted in this commonwealth by a party residing and intending to continue to reside in another jurisdiction if such marriage would be void if contracted in such other jurisdiction, and every marriage contracted in this commonwealth in violation hereof shall be null and void.I don't know of many other states with a similar provision, probably because most states are happy to marry 'most anyone who meets the legal requirements of their own state and leave it to the happy couples' home states to figure out whether they will recognize the union or not (depending on whether the marriage violates the public policy of the state). Gov. Romney, on the other hand, is not concerned with enforcing other states' rules about who can marry whom. His worry is that Massachusetts will "become the Las Vegas of same-sex marriage." Considering that all states are perfectly capable of protecting their own interests in traditional marriage without the help of the Commonwealth of Massachusetts, one wonders whether this is really about the proliferation of tacky little white marriage chapels or plain, old-fashioned discrimination.