- James C. Robinson, Biomedical Innovation In The Era Of Health Care Spending Constraints, Health Affairs
- Susan M. Wolf et al, Forty Years of Work on End-of-Life Care — From Patients’ Rights to Systemic Reform, NEJM
- Leslie P. Francis, Patient Registries: Patient Consent When Children Become Adults, SSRN/SLU JHLP
- Eric S. Lander, Cutting the Gordian Helix — Regulating Genomic Testing in the Era of Precision Medicine, NEJM
- Lawrence O. Gostin, Law, Ethics, and Public Health in the Vaccination Debates: Politics of the Measles Outbreak, JAMA
Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.
This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale
- David Orentlicher, Employer-Based Health Care Insurance: Not So Exceptional after All, SSRN/UALR L.Rev.
- Daniel Polsky et al, Appointment Availability after Increases in Medicaid Payments for Primary Care, NEJM
- Jordan Paradise, The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the U.S. Healthcare System, SSRN/AJLM
- Lindsay F. Wiley, Health Law as Social Justice, SSRN/Cornell JL&Pub Pol
Given the increasing numbers of health data breaches, including this week’s announcement from Anthem (potentially exposing 80m records, mine included) a brief review on the subject may be appropriate.
At the federal level both the Security Rule and the Breach Notification Rule are in play. In large part the Security Rule requires covered entities and their business associates to base their security precautions on risk assessment. Required precautions include administrative, physical, and technical safeguards. Many of these are required, for example unique user identities for access and tracking. Some precautions, however, are only “addressable.”
This latter is the case with data encryption, defined in the Security Rule as “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” In practical terms data may need to be encrypted end-to-end (during transmittal) or while stored (at rest). Being only ‘addressable,’ the question whether to encrypt stored data depends on the data custodian’s assessment whether that technology “is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information.” If the risk assessment goes against encryption that decision must be documented and a reasonable and appropriate alternative safeguard implemented. Continue reading
Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.
Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.
The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”
The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.
- Chana A. Sacks & Celestine E. Warren, Foreseeable Risks? Informed Consent for Studies within the Standard of Care, NEJM
- Kyle Brothers & Mark A. Rothstein, Ethical, Legal and Social Implications of Incorporating Personalized Medicine into Healthcare, SSRN/Future Medicine
- Wendy K. Mariner, Health Insurance is Dead; Long Live Health Insurance, SSRN/AJLME
- David Hyman et al, Insurance Crisis or Liability Crisis? Medical Malpractice Claiming in Illinois, 1980-2010, SSRN
- Wendy K. Mariner, Paternalism, Public Health, and Behavioral Economics: A Problematic Combination, SSRN/Conn. L.Rev.
- Nicole Huberfeld, The Universality of Medicaid at Fifty, SSRN/Yale Journal of Health Policy, Law, and Ethics
- Nicholas Bagley et al, Predicting the Fallout from King v. Burwell — Exchanges and the ACA, NEJM
- Linda C. McClain, Corporate Conscience and the Contraceptive Mandate: A Dworkinian Reading, SSRN/Forthcoming in the Journal of Law and Religion
- S. Rosenbaum and C. Hurt, How States Are Expanding Medicaid to Low-Income Adults Through Section 1115 Waiver Demonstrations, Commonwealth Fund
- Christopher T. Robertson, David V. Yokum, The Burden of Deciding for Yourself: The Disutility Caused by Out-of-Pocket Healthcare Spending, SSRN/Indiana Health L. Rev.
- Jonathan Oberlander, Unraveling Obamacare — Can Congress and the Supreme Court Undo Health Care Reform? NEJM
- Elizabeth Sepper, Reports of Accommodation’s Death Have Been Greatly Exaggerated, SSRN/Harv. L. Rev. Forum
- Fredric Blavin et al, An Early Look At Changes In Employer-Sponsored Insurance Under The Affordable Care Act, Heath Affairs
Health reform may have signaled the shift from hospital-based “sick” care to primary care and “wellness” but the ACA failed to provide a detailed roadmap. All we know for sure is that primary care (PC) will be hugely important. Increasingly it also seems that it will look quite different. “Old” PC is being battered; Medicaid primary care physicians (PCP) saw their the two-year ACA bonuses expire in December, the OIG just reported that way too many Medicaid-listed doctors are not taking new patients, and the coverage-doesn’t-equal-access mantra is born out by persistent reports of PCP shortages. If PC as we have known it is not going to step up to the plate, what is the “new” model and who will end up owning it?
The ACA gave hospitals both good (fewer uninsureds in ERs, Medicaid expansion) and bad news (fewer profitably occupied beds because of HAC and readmission penalties). Not surprisingly there was a sharp increase in hospitals buying PCP practices. In part this was just hospitals following the money as usual, looking to roll these practices into their new ACOs. But, longer term strategies also persisted, such as strengthening networks, intercepting patients before they turn up in ERs, and creating local or regional dominant positions. Smaller PCP practices have also been more willing to sell as they faced financial regulatory disincentives (such as meaningful use penalties) if they continued as independents.
However, we are seeing hospitals doing more than increasing the number of hospital-based clinics. Many are also opening their own free-standing urgent care clinics, the “new” PC. There are several models, including full ownership as with the Intermountain Healthcare group or, perhaps for those late to the game, strategic partnerships with urgent care specialists like Premier Health or MedSpring. Continue reading
- Sara Rosenbaum, Medicaid Payments and Access to Care, N Engl J Med
- Mark A. Rothstein, Ethical Issues in Big Data Health Research, SSRN/JLME
- David A. Hyman & Shirley Svorny, If Professions are Just ‘Cartels by Another Name,’ What Should We Do About it? SSRN/U. Pa. L.Rev.
- Cassandra Burke Robertson, Private Ordering in the Market for Professional Services, SSRN/B.U. L.Rev.
- Marshall B. Kapp, Getting Physicians and Patients to Choose Wisely: Does the Law Help or Hurt? SSRN/Toledo L.Rev.
- Cass R. Sunstein, Behaviorally Informed Health Policy? Patient Autonomy, Active Choosing, and Paternalism, SSRN/JHU Press
- Nicole Huberfeld & Jessica L. Roberts, An Empirical Perspective on Medicaid as Social Insurance, SSRN/Toledo L.Rev.
- Christine K. Cassel et al, Getting More Performance from Performance Measurement, NEJM
- I. Glenn Cohen, Regulating the Organ Market: Normative Foundations for Market Regulation, SSRN/Law & Contemp. Prob.
The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.
As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks? Continue reading
- Mark A. Rothstein, From SARS to Ebola: Legal and Ethical Considerations for Modern Quarantine, SSRN/Indiana Health L.Rev.
- R. Alta Charo, The Supreme Court Decision in the Hobby Lobby Case; Conscience, Complicity, and Contraception, JAMA Intern. Med.
- W. Nicholson Price II, Incentives, Intellectual Property, and Black-Box Personalized Medicine, SSRN/Harv. J. L. & Tech
- Mark William Osler, 1986: AIDS, Crack, and C. Everett Koop, SSRN/Rutgers L.Rev.
- Amanda Zibners Naprawa & Dorit Rubinstein Reiss, Medical Advice and Vaccinating: What Liability? SSRN
- Michele Goodwin, Fetal Protection Laws: Moral Panic and the New Constitutional Battlefront, SSRN/California L Rev
- Anna B. Laakmann, When Should Physicians Be Liable for Innovation? SSRN/Cardozo L Rev
- Caroline Sayer & Thomas H. Lee, Time after Time — Health Policy Implications of a Three-Generation Case Study, N Engl J Med
Today’s order from Chief Judge LaVerdiere is available here. It removes restrictions on Kaci Hickox’s movements and essentially orders her to comply with the latest CDC guidelines that she was already following on a voluntary basis. According to this report the state troopers that had been posted outside her house have left. Two paragraphs at the end of the order are worth quoting in full.
First, we would not be here today unless Respondent generously, kindly and with compassion lent her skills to aid, comfort, and care for individuals stricken with a terrible disease. We need to remember as we go through this matter that we owe her and all professionals who give of themselves in this way a debt of gratitude.
Having said that, Respondent should understand that the court is fully aware of the misconceptions, misinformation, bad science and bad information being spread from shore to shore in our country with respect to Ebola. The court is fully aware that people are acting out of fear and that this fear is not entirely rational. However, whether that fear is rational or not, it is present and it is real. Respondent’s actions at this point, as a healthcare professional, need to demonstrate her full understanding of human nature and the real fear that exists.…
An interview with Ms Hickox suggested she was taking the judge’s advice, “I am sensitive… I don’t want to make anyone uncomfortable.” However, according to this recent report Governor LePage believes, “we don’t know what we don’t know about Ebola” and does not trust Ms. Hickox.
The enormity of the tragedy in West Africa remains hard to appreciate even as Ebola begins to migrate into developed countries. In the U.S. mindless panic stoked by the 24 hour news cycle and fear-mongering politicians are not the only familiar phenomena. In important ways our “Ebola crisis” is only tangentially related to a malicious virus and has much more to do with the state of our health care system. Consider the following “Ebola issues”
- Ebola has been marked by uncertainty as to federal and state responsibilities for infectious disease policy, prevention and reaction. Sadly, first impressions have been confirmed by the appointment of an Ebola “czar”, a sure sign that various branches of government have not been playing well together. Such regulatory fragmentation and lack of coordination is not new. Health care is our most regulated industry emanating from a bewildering array of legislation and regulation enforced by innumerable and frequently dysfunctional federal and state agencies.
- That lack of coordination has been replicated at the local level between agencies and healthcare institutions and between multiple institutions. Regional or local planning appears to be missing or only reactive. In a post-Katrina, post-swine flu world it seems extraordinary that there were not cogent plans waiting to be executed. Of course “There are only four in the U.S. with special isolation units designed to contain biohazards like Ebola” but why weren’t there plans to utilize them? Even now how many localities have a plan to handle, say, a major outbreak by using a centralized, tertiary care facility? Continue reading
Recent speculation about healthcare disruption seems to have moved away from HIT to mHealth (discussed here). Apple has fueled this trend with its launch of sensor-laden iPhones and the new Apple Watch, iOS 8’s Health app and the HealthKit API framework. The future, we are told, is in mHealth provided by our phones and wearables notwithstanding that we have yet to solve data protection and other issues associated with the new devices.
Over the last few days leaks have suggested that web behemoths Facebook and Google may have their own takes on the future of healthcare. Reuters reports that Facebook is doing, lets face it, what you would expect—creating online “support communities” for patients with similar conditions and diseases.and creating “preventative care” applications. Now, Engadget reports that Google is testing a new service that offers chats with doctors when a user searches for symptoms. The service seems related to Google Healthcare Helpouts, a video telemedicine platform that launched a year ago to some on-line speculation about healthcare disruption but which today seems limited to a small number of mostly non-physician therapists, family counsellors, coaches or other advisors.
- Jorge L. Contreras, Narratives of Gene Patenting, SSRN
- Sharona Hoffman, Citizen Science: The Law and Ethics of Public Access to Medical Big Data, SSRN/Berkeley Tech LJ
- James Hodge & Kellie Nelson, Active Shooters in Health Care Settings: Prevention and Response Through Law and Policy, SSRN/JLME
- David Orentlicher, Abortion and Compelled Physician Speech, SSRN/JLME
- K. Rai, G. Rice, Use patents can be useful: The case of rescued drugs, SSRN/Sci. Transl. Med
- Seema K. Shah, Piercing the Veil: The Limits of Brain Death as a Legal Fiction, SSRN/Mich J L Ref
- Rebecca Haffajee, Wendy Parmet & Michelle Mello, What Is a Public Health “Emergency”? N Engl J Med
- Kristin Madison, Health Regulators as Data Stewards, SSRN/N.Carolina L.Rev.
- Tim Jost, Subsidies and the Survival of the ACA — Divided Decisions on Premium Tax Credits, N Engl J Med
- Andrea M. Sisko et al, National Health Expenditure Projections, 2013–23: Faster Growth Expected With Expanded Coverage And Improving Economy, Health Affairs,
- Craig B. Garner, Medicare: The Perpetual Balance between Performance and Preservation, SSRN/J Contemp L&Pol
- Larry Levitt, A To-Do List for the New CEO of the Federal Health Insurance Marketplace, JAMA