Health Law Pulse

Posted by: John Culhane on Friday, January 1st, 2010; also available at WordInEdgeWise.org

Sorry to bring your “Happy New Year” to a screeching halt, but yesterday’s decision by the Montana Supreme Court in a physician-assisted suicide case (Baxter v. State)  is too rich a source to ignore. And too personal.

In a case that focused on a nice question of statutory interpretation, the court ruled that a terminally ill patient’s consent to die formed a valid defense to a homicide charge, where the doctor supplied the lethal drug.

In general, one may consent to what would otherwise be a criminal act unless such consent would violate public policy. The court found that, while consent to violent breaches of the peace (such as in an earlier case involving aggravated assault) is against public policy, physician-assisted suicide is not. As one judge stated in a concurring opinion, the logic of the court’s opinion isn’t limited to doctors. A friend might be able to hand the dying patient the instruments of death, as long as there was valid consent. (Of course, the court might rule that such an informal arrangement, as opposed to a prescription for drugs that cause death, does violate public policy.)

The court wisely avoided deciding the case on constitutional grounds, thereby throwing the issue back to the legislature, which can now decide whether to allow the practice to continue.

Predictably, right-to-life groups denounced the decision. They have a point, but not for the reasons they advance. One  wants the “right to die” to be clearly set forth in a law that spells out what’s permissible, and what isn’t. Otherwise, it’s fair to worry that the law will be used too broadly in cases involving the poorest and most powerless citizens.

The deeper philosophical objection, though, is to allowing anyone to actively bring about, or even facilitate, the death of another. For some moral philosophers, there’s a great difference between doing nothing (as by acceding to a patient’s wishes to refuse nutrition and hydration) and doing something (as is the case with doctor-assisted suicide). If it’s hard to see the distinction in this case, consider another: We might feel quite differently about using extraordinary means to keep a fetus alive, for example, than we would about actively aborting it (especially where doing so wouldn’t pose a grave danger to the mother). Whether this intuitive distinction should be translated into law is an understandably debated question.

And the gulf between law and practice in this area is well-known, but perhaps insufficiently aired. The common case that the court didn’t discuss is the one that many a care-giver to a dying family member could relate, even though it stands outside the formal law. When my grandmother was dying of a stroke a few years ago, everyone understood and respected her living will, and my mother’s power of attorney:  Only comfort measures were to be taken. Yet death in these cases can take longer than you’d imagine. Even a woman in her 90’s, as she was, can survive for well over a week in a condition that is painful to call to mind, even today.

So when I returned to the nursing home on about the tenth day of my parents’ relentless, loving, and exhausting vigil, I knew something had to be done to bring matters to a merciful conclusion. I phoned a doctor friend, who gave me some magic words to utter in order to get the morphine cranked up to the level that would finally get her the peace, and final rest, that she — and my parents — deserved. Once that happened, death followed quickly.

This isn’t the case that the Montana Supreme Court had in mind; the one where  a mentally competent patient asks for a prescription that the patient then self-administers. But it’s the case that’s familiar to many, and it’s time we had a transparent conversation about it.

Opinions expressed in posts on this blog are not necessarily those of Widener University or its Law School.

Prof. Michele Forzley recently represented Widener at a healthcare symposium in China.  She posts:

Forzley China Blog post

December 15, 2009

China is in the midst of a massive health reform with a proposed budget of some 124 billion dollars.  As with many countries including the US low rates of access, the high cost of drugs, poor health statistics and the effects of these on the economy have made health reform a high priority.   All countries in health reform do so without the benefit of a successful model.    There is however substantial evidence from the field of public health about what health systems must do to function optimally. We know how to measure their performance and their failure but we have less certainty on how to fix or reform them.  Historically health systems have been viewed as the domain of the medical field and to their credit; great advances have been achieved in clinical interventions.  We know how to cure disease but this knowledge does not apply to the operation of the health systems in which these clinical interventions occur.

In the last five years the social determinants of health have received attention.  The WHO issued a report on the Social Determinants of Health naming cultural, political, economic and other sectors as important as clinical interventions.  Even with this broader view of what it takes to achieve health the law has yet to be understood as an explicit determinant of health.

There is no peer reviewed literature assessing the association between law and desired health system functions or reform outcomes.   With regards to the health sector among public health and development professionals, the consensus is that good governance is effective, equitable, anticipatory, accountable, transparent, responsive, and inclusive and follows the rule of law. Exactly how the rule law is involved in health sector functioning let alone its reform is as yet to be studied.

Thus there is what could be described as a gap and thus a new field of legal epidemiology or the study of the association between law and an outcome.   While preparing this talk I noted that rule of law had been made a key national goal and basis of development in the 1999 amendments of the constitution of China and its 11^th National 5 Year Plan.  It seemed a wonderful opportunity to explore how rule of law concepts might guide China and other developing countries in achieving health reform goals. To that goal, this lecture presents the early version of a methodology to apply rule of law and to the development of a comprehensive body of law and regulation of health systems.

After professor Pope and I presented we listened to professors from SWUPL present several topics such as organ donation, public health emergencies and the law including the IHR and on whether health law is public or private law or a new category of oblique law. Oblique law was likened to equity in the common law system as the form  of law that solved what the professor saw as a conflicts in emerging concepts in Chinese health law.   This for me was the most intriguing talk as it reflected the difficulties in the nascent Chinese legal system.

I was impressed with the level of sophistication and worldliness of the staff and students. Perhaps China is regarded as a developing country but with everything I saw and experienced, it is on a fast run that will leapfrog much of the learning curve before we know it.  There is good reason to enhance the relationship with SWUPL, a school with excellent reputation, high bar pass rates, by student and professor exchanges and a continuation of  a symposium series on health law and the education of health lawyers.

So the fix provided by the proposed new Senate Amendment to its Patient Protection and Affordable Care Act (”Act”) with respect to annual insurance coverage limits (see my December 13 blog entry) is to retain the notion of allowing annual limits, but only “restricted annual limits” where “essential health benefits” (as defined in the Act and as determined by the Secretary of HHS) are involved, at least until 2014. Let’s parce that out just a bit.  Health insurance policies can contain annual limits, but until 2014 restrictions on those limits will be imposed. Those restrictions will apply only to “essential health benefits”. Gone is the open-ended reference to “unreasonable” limits, and the curious reference to provisions in the tax code relating to health savings accounts. In their place the Act clarifies that the Secretary (not state insurance commissioners or others) will have some discretion to determine which are essential health benefits, but any such discretion will be rooted in the definition of that term in 1302(b) of the Act.

Section 1302(b) of the Act defers to the Secretary again, except that the following must be included among “essential health benefits”: Ambulatory, emergency and hospital care; maternal and newborn care; mental health and substance abuse; prescription drugs; rehab; lab; prevention and wellness and chronic disease management; and pediatric care, including oral and vision care. (What’s missing?) One more mandate: the Secretary must certify that the scope of “essential health benefits” is equal to that of a typical employer plan, as determined by survey. (Is it getting a little self-referential here?)

This would seem to address the concerns of those who may have feared the prior version was an invitation to insurers to beat up on their insureds with annual limits. There is a standard to which annual coverage limits will be held, and the Secretary, not individual insureds, will be doing the negotiating with insurers to establish any permissible limits – at least until 2014.

Views expressed in posts on this blog are not necessarily those of Widener University or its School of Law.

Tags: coverage limits, insurance

CNN, Associated Press and others are now focusing on language in the Senate’s Patient Protection and Affordable Care Act to the effect that the vaunted provisions of the House bill prohibiting lifetime and annual caps on health insurance coverage have been revised in the Senate version with respect to annual caps: The Senate bill would prohibit only unreasonable limits. The Act goes on to cross-reference IRC § 223 for the definition of unreasonable annual coverage limits.

The objectors, for the moment, are those who suspect a deal has been made with insurance companies further to gut the Act. First the public plan goes, and now the prohibition on annual coverage limits. Some of the news coverage of this revelation implies that the “reasonableness” modifier was sneaked into the Senate bill, but in fairness, it has been there since the bill was first introduced, and it is in the first sentence of the first section of the bill.

When I first read the applicable language I thought the reasonableness limitation may have been inserted to clarify that policies not purporting to offer “essential health benefits” (§ 1302(b) of the Act) or “minimal essential coverage” (IRC 5000A(f)) could still have appropriate limits. The Act is intended to apply to basic health insurance, after all, and not specialty policies intended from the outset for limited purposes. Coverage for a dancer’s legs, to go to an extreme case to make the point, could still have limitations under the Act. But that clarification was already present in the next following subsection of the Act, so my initial reading was probably wrong.

But then other questions began to flow. Why allow a reasonableness limit on annual but not lifetime benefits? From the insurer’s vantage point, given sufficient actuarial data and a large enough risk pool, would an annual limit not become the economic equivalent of a lifetime limit anyway? And from the patient’s vantage point, a similar result:  Anyone unable to finish an expensive battle against cancer in year 1 may not live long enough for a lifetime cap to become relevant.  And how is the “reasonable” amount to be determined? Did the Act intend to leave it to the Secretary of HHS – or Treasury or state insurance commissioners – to set an amount? If so, why cross-reference IRC § 223 for a definition of reasonableness instead of expressly delegating the matter to a regulatory authority?

And what are we to make of that curious reference to IRC § 223? I’m still looking for anything in that section that addresses the reasonableness of insurance coverage limits, annual or otherwise, so I would be grateful for any clues readers may offer. As I read it, § 223 deals with the permitted limitations on the deductions allowable for amounts paid into health savings accounts, and such amounts – $2,600 for individual and $5,150 for family coverage – are certainly not reasonable as coverage limits.

So at this point, unless a reader can enlighten me, I am falling back on my experience as a contract negotiator, which tells me that the apparently innocuous and inherently reasonable word “reasonable” is inserted when the parties concerned want to leave the matter open to later contest, including litigation. You put the word “reasonable” into a document when you are willing to let a court decide what it means. At that point, “reasonable” is only reasonable if the contesting parties are reasonably matched. If the future contest as to what is a reasonable coverage limit is to play out between the Secretary of HHS or state insurance commissioners on one hand and insurers on the other, that is one thing, though not a pretty thing. Politics will probably be involved. But if the contest will be between insurers and the insured, heaven will have to help the insureds.

My experience also tells me that the insertion of the word “reasonable” in the Senate bill was probably not casual or accidental. There is probably a backstory. Based on comments Sen. Tom Harkin has made, he probably knows the story, and it probably had something to do with limiting the cost of the bill. Compromise with insurers is a likely scenario, but other possibilities exist. I wonder, for instance, if the CBO was encouraged by advocates of the bill to take the language into account when estimating the bill’s cost.

There is another possibility, which I mention for the sake of provoking more thought and not because I know any backstory. (After all, if we’ve learned one thing about statutory construction since someone first discovered death panels in a healthcare reform bill, it is that first reactions are not always the best.) Allowing for reasonableness in annual but not lifetime coverage limits would be consistent with a position long advocated by ethicist Daniel Callahan, co-founder of The Hastings Center. The position is generally that that expensive medical care could be rationed based on a patient’s age. I won’t go any further, both because I am likely to misrepresent Mr. Callahan’s argument and because I think you can see where it goes for present purposes. Given a “reasonable” annual cap, a policy could limit the kinds of care given in the last stages of life and remain in compliance with the Act. Conversely, without the reasonableness limitation, any such rationing would not be possible. Under the Senate’s bill as now written, the Secretary could promulgate regulations allowing limits on the dollar value of particular kinds of benefits for particular age groups.

It always comes down to this, doesn’t it? A truly limitless financial obligation to health is not affordable, no matter how far and wide we spread the risk. Something’s gotta give. But in the meantime, let’s check our first impulses at the door as we work through this document.

Views expressed in posts on this blog are not necessarily those of Widener University or its School of Law.

Our good friend Catherine Reynolds calls our attention to this story, and follows with these comments:

No doubt a tragedy but is City Council really the forum or knowledgeable body to investigate such a case?  I doubt Patient Safety experts would agree.  What are the drivers for bringing this situation to this  level, the fact that it happened to prominent community leader?  Generally in like situations the Joint Commission or the State Dept of Health would address sentinel safety events.

What effect will this have on transparency and/or defensive clinical practice?

I remember working as a nurse in the ED in a hospital, and sometimes doing triage, when the story broke (2006 Illinois) about a woman who died in an ED waiting room from a heart attack after being directed to wait after evaluation by the triage nurse.  There was talk of homicide charges against the individual triage nurse based on the coroner’s ruling of homicide citing that a reasonable person would have acted differently in like situations.  The immediate ripple effect throughout ED nursing staffs alone was quite worrisome and may have provoked a non-transparent and very defensive mindset – the opposite of where we want professional conduct to go.  Some of my fellow nurses stated then that “they are just gonna bring everybody right back (from wait room to treatment area but not necessarily prioritizing for acuity and maintaining a safe flow of patients through the door) as long as they wanna charge nurses with homicide”.  I guess the tightrope can be accountability vs culture killer.

Catherine Reynolds RN, BSN, MJ, DL

Views expressed in posts on this blog are not necessarily those of Widener University or its School of Law.

Here is a (timely) link to some recent pieces in the Lancet linking climate and health, and another to the publications my colleague Dave Hodas, who can really open the subject.

Tags: climate and health

At an address recently given at Widener, Princeton Professor Paul Starr made the point that the health reform plans currently being promoted by House and Senate Democrats are essentially the plans that were proposed in the past by Presidents Nixon, Reagan and Bush I. Contemporary Democrats have in effect compromised with a Republican party that no longer exists.

One example is the position taken on the House bill in favor of the purchase and sale of insurance across state lines. This was an element in Republican thought as recently as Sen. John McCain’s Presidential bid. He proposed insurance sales across state lines, for which he was roundly criticized by progressives. Sen. McCain believed the measure would stimulate competition and unleash market forces that would make affordable coverage more available. Opponents argued that allowing insurers to sell their products across state lines would trigger a “race to the bottom” in terms of coverage quality, while diverting the young and healthy away from the risk pools of the sick and needy. For a good primer on the issue, see Kaiser Health News.

Other evidence that Republicans have shifted grounds is not hard to find. In the ’90s, as President Clinton was attempting a more radical system overhaul, Sen. Bob Dole and others advocated reform measures intended to keep our existing employer-based arrangement intact by subsidizing private insurance. That is ground upon which Democrats now stand. Even the idea of mandating individual coverage – features in both House and Senate bills and now opposed by Republicans –  has its roots in Republican policy.

Prompting the following question:  Have Republican ideas changed so much, or is it rather that the Republican party is being consistent in opposing anything favored by Democrats?

Postings on this blog do not necessarily reflect the opinions of Widener University or Widener University School of Law.

New Guidelines

With reference to the recommendations for breast cancer screening released last week by the U.S. Preventive Services Task Force (a non-governmental, independent panel of physicians and scientists), and for that matter with reference to the guidelines for Pap tests coincidentally released a few days later by the American College of Obstetricians and Gynecologists (also non-governmental), we pause to recall the 1974 Washington Supreme Court decision in  Helling v. Carey. The plaintiff suffered from open angle glaucoma, a disease which, in the absence of a simple and inexpensive pressure test, can go undetected until irreversible loss of vision has occurred. Defendants were the plaintiff’s ophthalmologists, who had not administered the pressure test, but who had adhered to the standards of their profession in not doing so. The plaintiff had been 32 at the time at issue, and the applicable standards did not require tests for patients under the age of 40.  The incidence of glaucoma among people under the age of 40 was 1 in 25,000.

As the Washington Supreme Court framed it, the issue was whether adherence to professional standards insulated the defendants from liability for negligence. The Court held that it did not. The Court, citing Justice Holmes,  held that where it is a matter of deciding what constitutes reasonable prudence for purposes of assessing negligence liability, legal process (courts, juries, etc.) determines the outcome, not a professional standard: “What usually is done may be evidence of what ought to be done, but what ought to be done is fixed by a standard of reasonable prudence, whether it usually is complied with or not.”

Such notions of liability are not hospitable to evidence-based medicine, which generally seeks to use outcome data to direct provider decision making. If the evidence shows that testing persons under 40 for glaucoma has no measurable benefit, or that the benefit of mammography screening for women under 50 does not sufficiently advance positive outcomes, standards of practice may conform, and may yet conflict with negligence doctrine.

Unless, of course, legislators were to fix the limits of professional liability to coincide with professional standards. There are serious risks either way. On the one hand, we may not want courts exercising their judgment to determine medical professional conduct, and we may not want to rely solely on common law negligence liability to determine how we allocate healthcare resources. The result (and arguably the effect of the Helling decision) could be to drive the cost of healthcare upward as providers perform screening tests defensively.  On the other hand, we may not want to license professionals to insulate themselves from liability simply by agreeing collectively to standards of conduct.

One way to look at this is to view tort law and professional practice guidelines based on outcome research as two approaches to assuring quality in medicine, and then see if we can decide between the two on that basis. Tort law seeks to motivate providers to avoid mistakes by applying punitive consequences. It’s proponents even make a claim to cost reduction on the grounds that tort law deters negligence. The counterclaim is that tort claims motivate defensive medicine, and consequently drive costs upward.

Practice guidelines - the end product of outcome or evidence-based medical research – purport to induce practitioners to improve the quality of care, not just to avoid error. And there are many who argue this approach can bend the cost curve downwards, or at least that cost-effectiveness can be built into evidence-based practice models. But for this to work, (i) there will have to be line-drawing of the kind offered by the U.S. Preventive Services Task Force, and to which the defendants in Helling appealed; and (ii) there should be some form of limitation of tort liability for those practitioners adhering to the guidelines.

To this end it will be interesting to see what proceeds from various provisions of the House and Senate bills that invite reconsideration of this issue. Both bills have provisions to encourage comparative effectiveness research, and to implement its findings through accountable care organizations (ACOs). Section 6801 of the bill currently being debated in the Senate, entitled “Sense of the Senate Regarding Medical Malpractice”, encourages state experimentation with alternatives to civil litigation as a means of controlling healthcare quality. Put together, all these provisions could lead to limitations of liability in certain contexts for providers adhering to guidelines generated from outcome research and seen from a broad public health vantage. One can imagine legislative grants of immunity to physicians in ACOs to the extent they follow guidelines. Helling v. Carey could be overruled as a consequence of healthcare reform legislation, at least in certain settings. What kind of settings? If we are going to experiment with practice models that limit provider liability for providers who adhere to evidence-based guidelines, it would make sense to do so in settings in which fully-informed patients agree to this paradigm from the get go.

Postings on this blog do not necessarily reflect the opinions of Widener University or Widener University School of Law.

Tags: Evidence-based medicine

Posted by: John Culhane

on Friday, November 20th, 2009

“I can’t believe they would put an economic value over the lives of fifteen or more people.” (Statement of a woman whose father died as a result of eating raw oysters that contained a deadly bacteria.)

“Let the rationing begin.” (Rep. David Camp, Ranking Republican on House Ways and Means Committee, responding to U.S. Preventive Services Task Force Report that recommends women delay routine mammograms until age 50).¹

Public health takes a beating again.

In the first case, the FDA has had to eat crow. Just last month, the agency trumpeted its “public health” duty to prevent a predictable number of deaths each year by banning the sale of untreated, raw oysters during the summer months. But now the FDA has been shut up by the industry and by too-powerful Louisiana Sen. Mary Landrieu. (She can pretty much get anything she wants, including her own Mardi Gras Float, at least while the health care reform bill is pending.) The agency has slunk away, murmuring something about studying “feasibility and costs.”

In the second case, the jumpy recommendation against routine mammograms (and self-examinations) to detect breast cancer has brought a howl of protests. The objection: “Yes, the test only picks up one cancer case out of every 1,900 — but what if you’re the one?” For opportunists in the Camp camp, this cold-blooded calculation serves as a timely, exploitable proxy for everything  that’s wrong about health care reform. Never mind that the proposed legislation does a dismal job at controlling anything — costs or procedures — and that rationing is a fact of life now under managed care.

And when it comes to the battle against breast cancer, stirring outrage is a pink breeze.  Anything that would lead to even one more death — period — will be decried as the heartless elevation of population-based data over real lives.

It’s not clear that federal authorities, here representing a population-based, public-health perspective, were right in either case. Perhaps they could have continued efforts at education in the first case (which the FDA said it had tried, without success for a decade), rather than requiring irradiation (which has its own PR cost). In the second case, even public health authorities are split on whether the evidence justifies the new recommendations. At least this was a non-binding task force, easily overcome by political outrage.

There are two issues here. First, public health works best when it can explain and justify its position in a way most reasonable people will find at least defensible. Even then, though, its recommendations — or even coercive steps — can be defeated when other forces (like the oyster lobby or the breast cancer survivor community) are more powerful.

But the more important point — and the one no one wants to discuss — is that we do make safety and efficiency trade-offs, all the time. We couldn’t function without doing so, either in our own lives, or societally. Would routine mammograms be cost-justified if, say, they saved one life in one million? One can always say: “What if you’re that one person?”

Postings on this blog do not necessarily reflect the opinions of Widener University or Widener University School of Law.

Tags: Evidenced-based medicine

Posted by: John Culhane on Saturday, November 14th, 2009, at WordinEdgewise.org.

China’s political and environmental challenges are often chronicled, but less attention has been paid to the public health issues that the nation’s move to developed nation status has caused.

That’s starting to change. In a good summary article in Yale Public Health, (pdf. of Fall issue on right side of linked homepage), Christina Larson offers a succinct account of the many issues confronting public health researchers and policy-makers in a nation with more than 170 cities of at least one million people (that’s right). As in any rapidly developing nation, China finds itself with a spike in chronic disease problems, while infectious disease issues have to an extent been dealt with. Today, the country is dealing with a high incidence of lung cancers (caused by a just silly smoking rate and by environmental toxins); diabetes; and — yes — obesity. Those iconic Beijing bikes are quickly giving way to cars, with the host of predictable negative health consequences you might expect.

The article goes on to explain that China is really a host of sub-populations, flung over a vast expanse and with wildly different problems. Interventions need to be carefully targeted to stand any chance of improving public health outcomes, but that targeting is itself challenging because of the dynamic, quickly changing nature of the nation and its people. Trying to glean useful data that screens out the “noise” is always a challenge for epidemiologists, but even more daunting under these conditions.

Steps are being taken, including the bellwether move of banning smoking in certain bars, but it will be vital for local, state, and global public health officials to “get smart” about the challenges they face, and soon. Time’s not on their side.

With these issues in mind, a contingent of health law professors from our law school is traveling to Southwest University in Chongqing next month, there to discuss, among other topics, global public health. Our expert on these issues, Michele Forzley, is a global public health expert with ties to WHO and the U.S. Department of Commerce; she is to speak on training legal and public health experts on confronting emerging issues. Her work is vital.

Postings on this blog do not necessarily reflect the opinions of Widener University or Widener University School of Law.

Tags: China