HealthLawProf Blog

Replacing the Affordable Care Act?

With the future of the Affordable Care Act in doubt after last week’s hearing before the U.S. Supreme Court, Republican lawmakers are busily preparing back-up legislation. New options should not be necessary—the government should prevail against those challenging its interpretation of the Act’s premium subsidy provisions. But it is prudent to consider alternatives in the event that the Court rules against the government.

While most of the ideas being floated would do little to bring health care insurance to the uninsured, there is an option that really could expand access to coverage while also containing health care spending. And it could be attractive to Republicans and Democrats alike on Capitol Hill.

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Why Sen. Elizabeth Warren's Memoir is of Special Interest to Health Profs

I'm a guest over at prawfsblog this month--come visit-and my posting today was about why law professors should be interested in Sen. Elizabeth Warren's new memoir.  You can read the whole pitch below--it includes that it's a funny, warm, well-written and interesting account of a remarkably successful career.  I also noted how important her efforts at fixing student loan debt are as a platform on which to build needed change in higher education.  Finally, she has very interesting things to say about balancing work and family as well as going beyond the classroom to help the individuals affected by the law she studied.   At a recent executive board meeting of the AALS Section on Law, Medicine and Health Care, current chair Dr. Ani Satz noted that there are not many mechanisms for recognizing that kind of service.  (side note--consider yourself warmly invited to the terrific panels our chair elect, Dr. Thad Pope, has organized for us to present and co-sponsor, more information to come).

But for a health prof audience, I'd also point out that she discusses her empirical work (with a team of top social scientists--she didn't do the math herself) that finally demonstrated the major flaw in our employer based health insurance system.  Medical bills turned out to be the leading cause of bankruptcy--and very often among families already insured.  Either their insurance was inadequate (maybe we should get these folks together with the people who are upset they can't keep their "old" plans) or, worse, their illness meant they could no longer work.  Whether the debt came directly from medical bills or from using credit cards and home equity loans to pay the bills--the results were equally catastrophic.

That this actually happens--that medical bills are a leading cause of bankruptcy--is as far as I know not currently disputed.  But I'd be remiss in this context not to point out that as part of the opposition research arising from her running to Senate-the Breitbart blog has made available a series of angry accusations from the 1990's of misconduct about that study.

 It will be a while before we see if the Affordble Care Act is going to do much to fix this problem--and predictions are mixed.  See this as opposed to this.   There's a federal study finding bankruptcies down in Massachusetts following Romneycare.   Common sense suggests that changes like no exclusions for pre-existing conditions and the lift of lifetime caps will make things better (for people with plans bound by those provisions).

But although certainly not usually described as such, Sen. Warren is, if not a Health Law Prof, certainly one whose work is very important to us. 

 

Continued Skepticism re "Wellness Programs"

A big part of the job of being a Health Law Prof is to help students understand the intersection of the many legal specialties that comprise the big tent of "Health Law."  Wellness Programs are a good way of doing that because one of the key features of the Affordable Care Act is the flexibility it provides employers to link the cost their employees pay for health insurance with the individual employee's participation in a company sponsored "welleness program."  Here's an article I wrote explaining how PPACA went about doing that.  Here's a link to the Department of Labor's summary of the current rules and a good overview by the law firm Nixon-Peabody.  This report from Rand is an overview of what these programs are and how companies have increasingly fallen in love with them.   At this point just about every insurance company is offering to create one--here's some information from Aetna.  

The problem is, there's very little evidence that these programs do anything to demonstrably improve health (whatever that may mean).  And quite a bit that they may promote many different kinds of social injustice.

 This article in the Harvard Business Review does a great job describing the kinds of programs that are now descending on employees and how they are creating disatsifaction without any scientifically supportable improvement in "health."

There is also a growing literature suggesting that these programs may disproportionately discourage workers who employers aren't that unhappy to see go--but might not legally be able to actually fire.  Here is some very interesting testimony by Jennifer Mathis Director of Programs, Bazelon Center for Mental Health Law
On Behalf of the Consortium of Citizens with Disabilities.

Michelle Mello at Harvard has coined the term "life-style discrimination" to describe the ways Wellness Programs may target individuals employers may perceive as undesirable because they are obese, smoke or have other non-job related characteristics.

Studying Wellness Programs--and the issues they raise--can be an accessible entry point for students who can easily be intimated by the regulatory complexity of health law and can also be a bridge to understanding how fundamentally the Affordable Care Act has affected the way health care will be paid for and delivered as our students begin their careers in advising those struggling to implement these new regulations.

 

 

 

 

Of Data Challenges

Challenges designed to spur innovative uses of data are springing up frequently.  These are contests, sponsored by a mix of government agencies, industry, foundations, a variety of not-for-profit groups, or even individuals.  They offer prize money or other incentives for people or teams to come up with solutions to a wide range of problems.  In addition to grand prizes, they often offer many smaller prizes or networking opportunities.  The latest such challenge to come to my attention was announced August 19 by the Knight Foundation:  $2 million for answers to the question "how can we harnass data and information for the health of communities?"  Companion prizes, of up to $200,000, are also being offered by  the Robert Wood Johnson Foundation and the California Healthcare Foundation. 

Such challenges are also a favorite of the Obama administration.  From promoting Obamacare among younger Americans (over 100 prizes of up to $30,000)--now entered by Karl Rove's Crossroads group--to arms control and identification of sewer overflows, the federal government has gone in for challenges big time.  Check out challenge.gov to see the impressive list.  Use of information and technological innovation feature prominently in the challenges, but there is also a challenge for "innovative communications strategies to target individuals who experience high levels of involuntary breaks ("churn") in health insurance coverage" (from SAMHSA), a challenge to design posters to educate kids about concussions (from CDC), a challenge to develop a robot that can retrieve samples (from NASA), and a challenge to use technology for atrocity prevention (from USAID and Humanity United).  All in all, some 285 challenges sponsored by the federal government are currently active, although for some the submission period has closed.

These challenges are entertaining, call on crowdsourcing for knowledge production, find new sources of expertise way beyond the Beltway or even US borders, encourage private sector groups rather than government to bear costs and risks of development (or failure), and may bring novel and highly useful ideas to light.  So what's not to like?  I may be just grumpy today, but I have some serious worries about the rush to challenges as a way to solve persistent or apparently intractable problems. 

Challenges may be more hype than achievement, more heat than ultimate light.  They may emphasize the quick and clever--the nifty over the difficult or profound.  They may substitute the excitement of awarding and winning a prize for making real progress on a problem. Most troubling to me, however, is the challenge strategy's potential to skew what government finds interesting and what it is willing to do.  Many challenges have private partners in industry, appear likely to result in for-profit products, or set aside values that may be more difficult to quantify or instantiate.

Take the HHS Datapalooza, for example.  Now entering its fifth year, the Datapalooza is an annual celebration of innovations designed to make use of health data available from a wide variety of sources, including government health data.  "Data liberation" is the watchword, with periodic but limited references to data protection, security and privacy.  A look at the 2013 agenda reveals a planning committee representing start-ups and venture capital.  It also reveals a $500,000 prize awarded by Heritage Provider Network, a managed care organization originally located in Southern California but now expanding in markets in Arizona and New York and serving many Medicare Advantage patients.  The prize was for a model to predict hospitalizations accurately and in advance--so that they could be avoided.   The winning team, powerdot, didn't reach the benchmark needed to win the full $3m prize.  So . . . Heritage is continuing the competition, making more (and apparently no longer deidentified) data available to a select set of leading competitors in the original competition in order to improve the accuracy of the modeling.  (A description of deidentification methods for the data made available to all entrants in the original competition is available here.)  There are of course real advantages in developing a good predictive model--for patients in avoiding hospitalizations, and for Heritage in saving money in patient care.  This is potentially a "win win"--as Mark Wagar, the executive awarding the prize stated, "it's not just about the money; it's personal."  But "it's not just about the money" is telling: the risk of these challenges is that they are about the money, and that the money will come to dominate personal or other values unless we are careful.

Solutions, if my concerns are well-founded?  Trying to turn back the disruptive clock and fight the appeal of challenges is probably futile--although perhaps some of the initial enthusiasm may wane. One solution is to join in--after all, challenges are infectious and potentially innovative--encouraging more challenges aimed at different problems--say, challenges for privacy or security protection alongside challenges for data liberation and use.  Or, challenges for improving patient understanding of their health conditions and informed consent to strategies for managing them--as some of the challenges aimed at patients with diabetes illustrate.  Another solution is to watch very carefully what challenges are offered, who funds them, who wins them, and what is ultimately achieved by them.

[LPF]

Another ACA Delay--and a Proposed Solution

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.

[LPF]

Our Not-So-Exceptional System of Employer-Sponsored Health Insurance

In yesterday's New York Times, Ross Douthat joined the chorus that criticizes employer-sponsored health care insurance. According to Douthat, this "unsustainable relic" is a "burden on businesses, a source of perverse incentives for the health care market and an obstacle to more efficient, affordable and universal coverage."

In fact, the United States is not unusual in the extent to which it relies on companies to fund health care coverage. Indeed, employers in France, Germany and Japan shoulder a higher percentage of their countries' national health spending than do U.S. employers. Government-run systems must find sources of funding for their programs, and employers are an obvious place to look.

To be sure, there are problems with employer-sponsored coverage, but the Affordable Care Act (ACA) takes care of a very important one. Employer-sponsored coverage has promoted "job lock" in the United States. Many would-be entrepreneurs have been reluctant to start their own companies because they would lose their employer-sponsored coverage and have to pay for insurance out of their own pocket. For people with pre-existing medical conditions, insurance might not be available. Under ACA, the new entrepreneur will be able to find an affordable health care plan on an insurance exchange.

The abandonment of employer-sponsored coverage would reduce the burden on businesses only if health care costs overall were lower under the replacement system. Many health care policy experts observe that costs are lower in government-run systems overseas because the governments can exercise greater negotiating leverage with doctors and hospitals than can insurance companies in the United States. In short, the high cost of U.S. health care and its burden on business seems to be not so much a problem of relying on employers rather than individuals to purchase coverage but a problem of relying on private insurers rather than government to operate the system.

[DO]

 

Lessons About Medical Error Learned Watching I Love Lucy.

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. 

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Evidenced Based Practice: When will Law Catch up with Medicine?

 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.