Monday, February 10, 2014
Where does one start with AOL CEO Armstrong's ridiculous and unfeeling justifications for changes in his company’s 401(k) plan. Cable TV and Twitter came out of the blocks fast with the obvious critiques. And the outrage only increased after novelist Deanna Fei took to Slate to identify her daughter as one of the subjects of Armstrong’s implied criticism. Armstrong has now apologized and reversed his earlier decision.
As the corporate spin doctors contain the damage, Armstrong’s statements likely will recede from memory, although I am still hoping The Onion will memorialize Armstrong’s entry into the healthcare debate (suggested headline, "CEO Discovers Nation's Healthcare Crisis Caused by 25 Ounce Baby”). But supposing (just supposing) your health law students ask about the story in class this week. What sort of journey can you take them on?
February 10, 2014 in Affordable Care Act, Cost, Coverage, Employer-Sponsored Insurance, Health Care, Health Care Costs, Health Care Reform, Health Economics, Health Law, HIPAA, privacy | Permalink | Comments (0) | TrackBack (0)
Monday, January 20, 2014
What are We Learning About Brain Death from the McMath and Munoz cases?
By Jennifer S. Bard, J.D., M.P.H., Ph.D.
With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on. Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.
Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32 in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity. In legal terms, a person declared “brain dead” has the same status as any other dead person. Each state is entitled to make its own decision of whether or not to adopt a brain death statute. California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity. The declaration of death is, in all states, a legal act. Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors. A declaration of death cuts off any rights of the individual. The family of someone declared dead is no longer a surrogate decision maker. Rather, they have something like property rights to the disposal of the remains. More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare. If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.”
When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so. Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function. However, there is never any legal need for a declaration of brain death in order for a family to withdraw life sustaining treatment. In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.” And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.
Many families in the McMath’s situation would have, even in their shock, heeded the doctors advice and stopped treatment. Although we do not, yet, know what actually happened, I suggest that it is possible that cases like the McMath’s can arise when hospitals and doctors seek to pressure families into withdrawing treatment by, essentially, taking away their right to receive care. This can be a lot more direct than the often times consuming and complex process of withdrawing "futile" care. Indeed, in the actual absence of all brain function there are no interventions that can replace the complex functions of the human brain and deterioration and decay are inevitable.
Although it is easy enough to say that Jahi’s family’s refusal to accept reality stems from ignorance or grief, it is not fair, as some have done, to call them crazy for mistrust of a diagnoses that is based in theory, not reality. Jahi may be irrevocably brain injured, but there are increasing signs that she may indeed have some brain function. Her thrashing movements may be reflex, not purposeful—but corpses do not have reflexes. This week, neonatologist Dr. Paul Burn notes, without citation so we do not know if it is true, that Jahi, has regained sufficient hypothalamus function to regulate her own body temperature. A corpse does not regulate its own body temperature.
This is not to suggest that the doctors are wrong about the amount of brain damage she has sustained or her chances of even retaining a sliver of consciousness—but that is not the same as “complete cessation” of all brain activity.
In contrast to the case in California, Marlize’s family, in Texas, want to let her go. The hospital is invoking a provision of the Texas Advanced Directives Act law which prohibits a hospital from withdrawing life sustaining treatment from a pregnant women. It may be, as bioethics experts law Tom Mayo at SMU explain, that this law does not apply after a declaration of death, but only when the mother is in a permanent coma. But, again, this points out the limits of using the legal concept of brain death to describe the medical condition of any particular person. Marlize may well be dead, but her fetus certainly is not. But until Marlize’s family gets clarification in the case it has filed in Tarrant County, or, ultimately, the Texas Supreme Court this distinction does not change their situation.
So where does that leave a health law professor? One of the reasons brain death is so hard to define is that we know relatively little about how the brain works. As the American Academy of Pediatrics Guidelines Determination Of Brain Death In Infants And Children,“ No randomized control trials examining different strategies regarding the diagnosis of brain death exist.” It even seems increasingly likely that we are not even sure where all of what we consider to be brain function happens—it turns out-—as folk wisdom has always believed—that a lot of it may happen in our guts. .
It may be that these two cases spur changes to the law—although other equally publicized situations have not-but for teaching purposes they both are helpful in exposing law students to how much we actually do not know about the human body and, especially, our brains.
Wired Magazine, in August 2011, ran a fascinating article called, “7 Creepy Experiments That Could Teach Us So Much (if they weren’t so wrong). These “7 Creepy Experiments” include some truly creepy things like using “a synthetic virus” to insert into an embryonic cell a “reporter” gene (green fluorescent protein, for example) in order to track embryonic development throughout the life cycle or deliberately separating twins at birth in order to study them.” I use it in my Human Subject Research Law class to get students thinking about the limits of consent, but more generally it and these cases tell us something about the reality that we need to make and enforce law in the face of limited information.
Thursday, October 17, 2013
The Dartmouth Institute has just published its Atlas of areal differences in utilization of prescription drugs by Medicare Part D recipients. The Atlas--unsurprisingly but disturbingly--details significant differences. Pharmaceutical interventions are classified as effective, discretionary (where there is diagnostic or therapeutic uncertainty), and likely to be harmful in the patient population at issue. A caveat, however, is that the report measured prescriptions filled and thus may underestimate actual provider behavior.
An initial variation involved sheer numbers of prescriptions, with a high average of 63 per year in Miami and a low average of 39 per year in Colorado (overall, the average was 49 standardized 30 day prescriptions filled per year per Part D beneficiary). In general, the Mountain West had the lowest prescription average and the Rust Belt and Appalachian states the highest. These differences could not be explained primarily by overall burden of disease but instead appear to reflect variations in provider prescribing practices. For example, the American Heart Association recommends use of beta blockers in heart attack patients for three years post-attack. However, rates of prescriptions for these drugs in the first six months ranged from highs of 94% to lows of under 68%, and persistence in the next six months was only slightly lower, ranging from highs of 92% to lows of under 68%. Variations in statin use were even greater, ranging from just over 91% in Ogden, Utah, to below 45% in Abilene, Texas. Interestingly, there was little correlation between effective use of beta blockers and effective use of statins.
The other two therapies analyzed in the Atlas were treatment of diabetes and treatment of patients with fragility fractures. Diabetic patients fared somewhat better than heart attack patients, albeit still with significant variations. Osteoporotic patients, however, fared dismally, receiving a high of 28% and a low of 7% with filled prescriptions for drug to combat osteoporosis after fragility fractures in sites other than the hip (such treatment is recommended to decrease the risk of future hip fractures).
Most interesting of all, there was no correlation between drug expenditures and measures of effective care. In other words, patients in some regions may be spending a great deal on their drugs (paid for under Part D), but receiving far less benefit that patients in other regions who spend a great deal less.
October 17, 2013 in Access, Chronic Care, CMS, Consumers, Cost, Drug and Device, Health Care, Health Care Costs, Medicare, Prescription Drugs, Quality, Spending | Permalink | Comments (0) | TrackBack (0)
Monday, September 23, 2013
Chilmark Research produces evidence-based reports of health IT and market trends in the health IT industry.
A recently issued Chilmark report, 2013 Clinical Analytics for Population Health Market Trends Report, which I have not read because it costs $4500, details the conflicting interests of clinicians and payers with respect to insights gleaned from data analytics. The hope of EHRs in combination with data analytics is better patient health, for example through alerts about needed preventive measures or care management strategies. But different payment may reimburse categories of care differently--so a diabetic covered by one type of payment structure might get reminders when her counterpart with different coverage might not. Even worse, patients whose prognosis is seen as "hopeless" through the predictive lens of analytics might get very different treatment recommendations under cost-conscious reimbursement structures.
Cora Sharma's post on the Chilmark blog details these likely conflicts with chilling precision.
September 23, 2013 in Access, Accountable Care Organizations, Chronic Care, Consumers, Cost, Coverage, Disparities, Electronic Medical Records, Health Care Costs, Insurance, Prevention, Private Insurance | Permalink | Comments (0) | TrackBack (0)
Saturday, August 17, 2013
This past week, the New York Times published a story about yet another delay in the implementation of the Affordable Care Act. Earlier this summer, NPR also reported the delay, which concerns total limits on out of pocket costs that consumers can be required to pay. Under ACA, beginning in 2014 consumers were supposed to have to meet only one out of pocket limit--$6,350 for an individual and $12,700 for a family--including all deductibles and co-payments. But the Times story reports that insurers have been granted a year's grace in implementing this requirement and quotes an administration official as attributing this decision to the inability of insurance plans to communicate with each other in determining out of pocket costs.
Both stories emphasize the plight of patients who are covered under separate medical and pharmacy benefit plans. Pharmacy plans in particular may have very high copayments, without annual limits. Patients with expensive drug needs for diseases such as multiple sclerosis are especially hard hit by these benefit structures.
As I ruminated on this delay, it occurred to me that the problem of the plans' inability to communicate with one another is the plan's problem, not the patient's. To say the least, it does seem rather unfair to have patients bear all of the costs of the delay.
Moreover, there is a model that could have been used to implement the single limit: submission of claims for out-of-network care. Patients do this all the time and receive reimbursement to the extent covered by their plans. The payer has a record of the claim and can credit it against the patient's deductible. Why couldn't this model have been applied to the problem of multiple plans for patients? It would be simple. These are primarily patients with employer-provided plans. All that would be needed would be to stipulate which plan is primary for the purpose of maintaining the single out of pocket total. Medical plans are used to maintaining such totals. If the medical plan were stipulated to be the primary plan, all the patient would need to do would be to submit records of out of pocket payments under their pharmacy plans. When patients meet the out of pocket total for the year, they would no longer be responsible for copays or deductibles from the primary plan. How would other plans know about this? Patients will receive records from their primary plans that they have met their deductible for the year. They would then be responsible for submitting these records to their other plans--after which the other plans would no longer be able to charge copays or deductibles.
This approach, to be sure, puts the burden on patients to solve the communication problem. But I'm surprised notbody seems to have entertained this suggestion, in a health care climate that heralds patient responsibility. Perhaps the difficulty instead is that the multiple-plan structure emerged as a way to limit health care costs for payers by shifting costs to consumers.
August 17, 2013 in Accountable Care Organizations, Affordable Care Act, Consumers, Cost, Employer-Sponsored Insurance, Health Care Costs, Insurance, Payment, Reform, Spending | Permalink | Comments (0) | TrackBack (0)
Saturday, May 25, 2013
It's no secret that the night staff of a hospital are both over-worked and over-tired. Nor is it any secret that many medical errors occur at night. But until we look at the totality of the human factors making up medical error, we are unlikely to make significant headway in addressing it. A review of the literature suggests that the reason isn't a lack of understanding about the factors which cause human errors, it's concern about the cost of addressing them.
The authors of a recent study in the Journal of the American Medical Association titled, Relationship Between Occurrence of Surgical Complications and Hospital Finances conclude that not only aren’t hospitals doing all they can to reduce medical errors, they actually have no financial incentives to do so.
I'd suggest that financial incentives are behind ineffective efforts to address the issues of staff over-work and the inherent dangers of intermittent shift work.
It's no surprise that another widely reported recent study has found that reductions in the hours medical residents work has not resulted in increased patient safety. The study authors conclude that this is because although residents worked less hours, they did not have a reduced work load. So, like Lucille Ball in the chocolate factory, the trying to cram more work in the same amount of time increased resident error.
The findings of that study need to be seen in combination with the vast amount of scientific research on the increase in errors caused during night shifts. A recent study of nurses working night shifts showed that “on average, the error rate increase 6% after the second night shift in a row, 17% after the third successive night shift and an astounding 35% higher on the fourth night shift.” See also this and this article by the Joint Commission. Although no one disputes the reality that human beings perform best in the day time, every hospital must be fully staffed 24 hours a day. The information is both anecdotal and research based. But no one seems to be listening.
An article in Nursing World does an excellent job of using available research to describe the scope of the problem, but implies that it can be effectively addressed by nurses proactively paying more attention to their sleep patterns. It advises nurses working the night shift to “take control of sleep.” In fact the NSF “recommends that nurses wear wrap around sunglasses when driving home so the body is less aware that it is daylight.” This advice ignores the scientific reality that humans are not as effective or alert at night as they are in the day time. Nor does it consider the human reality that medical shift workers do not have the luxury of using their days to sleep. Like everyone else living in a diurnal world, they must cope with the tasks of family and daily living.
Techniques like wearing dark glasses may work in making a shift to a new rhythm--like travelling to another time zone. But given the unlikeliness of medical staff to convert to a permanent change in their circadian rhthyms, as if they were working in a submarine (and that doesn’t work very well either) the answer is to address the reality that humans are less effective at recognizing problems and completing complex tasks at night. But that’s not where the problem solving is going.
May 25, 2013 in Cost, Effectiveness, Health Care, Health Care Costs, Health Care Reform, Health Economics, Health Law, Hospital Finances, Hospitals, Insurance, Medical Malpractice, Nurses, Patient Safety, Payment, Physicians, Policy, Public Health, Quality, Quality Improvement, Reform, Research, Science and Health, Substance Abuse | Permalink | Comments (0) | TrackBack (0)
Friday, May 17, 2013
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)