As one partner at my firm puts it, “If it makes good business sense, in the health care business, it’s probably illegal.” As a practicing junior health care attorney it did not take long for me to learn this reality of the regulatory scheme I learned as a law student. As snarky as the sentiment may seem, the restrictions on profit-sharing, referrals, and reduced-cost or free goods and services imposed by Stark and Anti-Kickback laws (while well-intended) can stifle some creative thinking in health care delivery.
What is not always as salient in the daily grind of my practice focusing on transactions and system-level compliance issues, are the ways in which the regulatory scheme can limit a physician’s acts of generosity and kindness. Whether we think our regulations intended to align incentives with cost-effective and quality health care delivery are good, bad or otherwise, I found this article in the New York Times by Abigail Zuger to be a thought-provoking moment of pause to consider how the complex scheme plays out in the day-to-day delivery of primary care and the physician-patient relationship.
As public health concerns over obesity and diabetes continue to rise, physicians, public health organizations, and medical educators are thinking out of the box — and into the kitchen and grocery store. Two stories done by NPR this week feature programs aimed to increase physician influence in patient dietary choices. The first article describes Wholesome Wave, a program in which a physician writes a “prescription” for fruits and vegetables in the form of a voucher for overweight or diabetic children (and their families). The second article reports on a collaboration between Tulane University School of Medicine and Johnson & Wales University College of Culinary Arts. The hope for the two schools is for both groups of students to learn more about nutrition.
Hearing these two stories reminded me of work I did as a student at the Harvard Legal Services Center, working with the Mississippi Food Policy Council to get food stamps accepted at farmers’ markets and improve access to fruits and vegetables. Most would agree (including Michelle Obama) that providing access to fruits and vegetables in “food deserts” is a laudable goal, but I’m struck by the way in which “prescriptions” for healthy foods versus providing access to healthy food changes the level of autonomy patients have in choosing what they eat.
Couple programs like Wholesome Wave with the ACA’s increased incentives for wellness programs, and I wonder how much a doctor, employer, or insurance plan may dictate consuming that one apple (or bunch of kale) per day. As Professor Matt Lamkin described in his work last year, some employer insurance plans contain high deductibles ($4,400 in the example he describes) that are much lower ($400) if a wellness plan is followed, which often includes following a doctor’s recommendations. In the example Lamkin uses, a patient must choose between continuing unpleasant chemotherapy or paying thousands dollars more to satisfy the obligations of a higher deductible. What if patients want to toss out a doctor’s “prescription” for kale and grab a KitKat instead?
While combating obesity and diabetes is of tantamount importance, how much outside influence over what we eat (or what our children eat) is too much influence? I’m not sure where I come down on this issue, but it gives those of us simultaneously concerned with public health and patient autonomy something to chew on . . .
by Katie Kraschel
Mitt Romney’s anecdote about the binders of women he relied upon in selecting members of his cabinet when he was Governor has fueled criticism from feminist groups and filled my Facebook feed with a plethora of Halloween pictures featuring costumes depicting his unfortunate choice of words. People generally have an instinctive aversion to being summarized into a page in a loosely bound, plastic-covered book. However, this level of summary and (arguably) downright objectification happens every day when individuals peruse IVF clinic and cryobank catalogs shopping for sperm or eggs. And while many of us worry that a Romney win next week would result in four years of presidential leadership that is clueless and insensitive to the plight of women in the workforce, the ASRM decision to remove the experimental label from oocyte cryopreservation is likely to literally increase the number of “women in binders,” which presents a different set of concerns.
Oocyte retrieval — the process of harvesting eggs that allows a woman to place her age, weight, height, eye color, S.A.T. score, college major, baby picture and perhaps even celebrity look-a-like into a gamete catalog — has long been a topic of bioethical debate and criticism due to the risks associated with the high level of hormones involved in the process and the accompanying high level of compensation frequently offered for women’s eggs. The likely increases in demand and number of oocytes produced presents a unique opportunity to revisit these issues and reconsider what regulations may be necessary to keep all parties involved respected and protected.
It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week. Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics? I think this may be the case.
Perhaps most importantly, frozen oocytes will not implicate personhood laws. Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses. However, IVF clinics and clinicians should also be concerned. It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos. There have been no such criminal proceedings brought against an IVF clinic — yet. Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist. Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.
Last week NPR covered a story highlighting how medical education is morphing in order to adapt to the unmet demand for primary care physicians driven (at least in part) by the increased access to primary care that will be ushered in under the ACA. It may be surprising to some to learn that many of the most prestigious medical schools like Johns Hopkins and Harvard do not have a primary care program; however, as reported by NPR, medical schools may soon rethink this hole in their curriculum in the face of changing demands upon the health care system and its accompanying incentives for young physicians to enter primary care. Mount Sinai School of Medicine is leading the way in this regard by launching a new department of family medicine in June.
Intuitively, changing the medical education system to produce more primary care physicians will further goals of the ACA by increasing access to primary care, and therefore improving overall public health and diminishing cost by decreasing emergency room care for conditions that could have been treated less expensively or avoided altogether by increasing access to preventative services. These are the arguments we’ve heard repeatedly by the champions of the ACA and by the Obama administration, particularly through its vision for the Prevention and Public Health Fund which was intended to bolster the pipeline of primary care physicians before being gutted earlier this year.