“Hijacking, evidently, is this year’s broccoli”

By Gregory M. Lipper

Linda Greenhouse has another must-read column about the Supreme Court contraception cases, and she predicts that the religious objectors will reject the compromise proposed by the Court in Tuesday’s order requesting supplemental briefing:

Would opt-out-without-notice serve just as well? If women would still get their coverage, probably it would. Will the religious interests resist taking “yes” for an answer, as they have from the beginning of this litigation?

Probably they will, because they are after bigger game: getting the Supreme Court to interpret the Religious Freedom Restoration Act to mean anything they say it means.

Relatedly, I discussed (along with Jeffrey Rosen and Michael Moreland) both the Zubik oral argument and supplemental-briefing order, on the National Constitution Center’s We the People podcast; you can listen here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5

This week we interviewed Christopher Robertson, a professor and associate dean at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute.

We mainly discussed Robertson’s new book with past TWIHL guest Aaron Kesselheim, Blinding as a Solution to Bias:  Strengthening Biomedical Science, Forensic Science, and Law. The book is a tour de force collection of approaches to improving our knowledge of optimal medical, legal, and forensic practices.

We also discussed some of Robertson’s recent contributions to insurance law and policy, including Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, as well as A Randomized Experiment of the Split Benefit Health Insurance Reform to Reduce High-Cost, Low-Value Consumption. The latter work, combined with Episode 47’s discussion with Mark Hall about employer-based exchanges, may well signal a gradual transition toward defined contribution (rather than defined benefit) health insurance plans.

FDA’s Relationship with Marijuana: It’s Complicated

By Elizabeth Guo

Marijuana and marijuana-derived products are top of mind for state legislatures these days. On March 10, the Virginia state legislature passed a bill legalizing cannabidiol oil, a marijuana-derived product, for patients who suffer from epilepsy. Other legislatures are actively debating measures to legalize cannabis-related products in their states, and many of these legislative proposals would allow cannabis-use for patients suffering from specific medical conditions. Last week, the Alabama state legislature debated a bill that would allow people to take cannabidiol to treat certain conditions, and Utah recently defeated a bill that would have allowed people with certain debilitating conditions to use a marijuana-related extract.

As more states pass bills allowing patients to use marijuana-derived products, will state laws clash with federal policies implemented by the Food and Drug Administration (FDA)?

Marijuana is complicated. Marijuana refers to the dried leaves and flowers of the cannabis plant. All marijuana plants contain a mixture of molecules, including cannabinoids. Different cannabinoids can have different effects, and scientists have identified more than 200 different cannabinoids from marijuana plants. Some of the most well known cannaboids in marijuana include tetrahydrocannibonol (THC), cannabidiol (CBD), and archidonoyl ethanolamide (anandamide). Read More

Little Sisters’ Case: A Forgotten Voice

By: Matthew Ryan

I love the Little Sisters of the Poor. As an undergraduate student, I fulfilled my public health program’s service requirements by volunteering at their nursing home in St. Louis. Each week, I would drive from my pristine, Jesuit college campus to the neglected part of the city. The sisters’ home was on an abandoned block without a street sign. The sister’s “neighbors” were a few burnt-out homes and mostly over-grown lots.

Inside, the nuns housed and loved the most vulnerable. I volunteered on the floor with residents suffering from dementia. I remember one nun in particular, Sister Isabella, who had given her entire life to caring for our elderly poor. Every hour or so, Sister Isabella would greet one resident who could no longer speak audibly nor open her eyes. Sister Isabella would hug her, sing to her, and often take her outside to feel the sunshine. This, in addition, to cleaning up after the residents, leading prayer before meals, and ensuring each resident got out of his or her bed each day.

Sister Isabella—and the Little Sisters in general—have remained imprinted in my memory. They have been a tremendous example to follow. When the rest of society, many Catholic churches included, had given up on the “least of our brothers and sisters,” the Little Sisters quietly went about doing the work of God. My admiration for them has made the recent Supreme Court case—and the battle over the Affordable Care Act’s contraceptive coverage—all the more difficult. Read More

Health Care Politics in the US South

by Emma Sandoe

Courtesy of Vanderbilt Center for Medicine, Health, and Society http://www.vanderbilt.edu/mhs/the-politics-of-health-in-the-u-s-south/

This month I attended the Politics of Health Care in the US South conference held at Vanderbilt. This conference was cosponsored by the Anna Julia Cooper Center at Wake Forest. Instead of a lengthy conference summary, I’ll attempt to capture some of the key lessons I learned to better understand the politics of the South.

What is the South?

There is no other region of the country with such a strong personal identification and complex emotional reaction as the South. Californians don’t identify as “Westerners;” “New Englander” inspires connotations of sleepy scenes of snow and hot chocolate; and while you may get a rare character that strongly identifies as a “Midwesterner,” there is a clear difference in the passion that a Minnesotan speaks of their homeland compared to a Tennessean. But despite the fact that the words “the South” strikes passion in its residents, historical and modern important moments in our nations conversation on race, and a specific cultural identity, there is really no common definition of the geographic South. Modern politics make the inclusion of Maryland and DC counter to our understanding of the deep red political vote. Texas and Florida have their own unique identities and their vast populations often skew any analysis of the region. Each unique issue in the South first requires a definition of what geographic region you are discussing.

Read More

About that Order for Supplemental Briefing in Zubik v. Burwell

Photo: Pen & Parchment
Flickr/Creative Commons—Christa Uymatiao

By Gregory M. Lipper

This afternoon the Supreme Court requested supplemental briefing in Zubik v. Burwell and the other challenges to the contraceptive-coverage accommodation, as follows: “The parties are directed to file supplemental briefs that address whether and how contraceptive coverage may be obtained by petitioners’ employees through petitioners’ insurance companies, but in a way that does not require any involvement of petitioners beyond their own decision to provide health insurance without contraceptive coverage to their employees.”

And in so doing, the Court offered a proposal of its own (I’ve added paragraph breaks and numbering):

[1] For example, the parties should consider a situation in which petitioners would contract to provide health insurance for their employees, and in the course of obtaining such insurance, inform their insurance company that they do not want their health plan to include contraceptive coverage of the type to which they object on religious grounds.

[2] Petitioners would have no legal obligation to provide such contraceptive coverage, would not pay for such coverage, and would not be required to submit any separate notice to their insurer, to the Federal Government, or to their employees.

[3] At the same time, petitioners’ insurance company—aware that petitioners are not providing certain contraceptive coverage on religious grounds—would separately notify petitioners’ employees that the insurance company will provide cost-free contraceptive coverage, and that such coverage is not paid for by petitioners and is not provided through petitioners’ health plan.

Although it’s foolish to read tea leaves, read them I shall:

1. I think that this is a decent sign for the government. It was clear from last week’s argument that four Justices would vote to uphold the accommodation; but the potential fifth vote, Justice Kennedy, seemed to be skeptical of the government’s arguments. This order suggests that at least five Justices (including Justice Kennedy) seem to think that the challengers’ proposed alternatives to the accommodation (create separate, contraceptive-only policies and require women to seek them out; expand Title X clinics; and other Rube Goldberg-schemes) harm women by preventing them from receiving seamless and convenient coverage. If the Court thought that those other alternatives were sufficient, then it wouldn’t be looking for a way to ensure that women retained accommodation-style seamless coverage.

Read More

The Unintended Uninsured: The Affordable Care Act’s Coverage Gap

[Cross posted from the Harvard Law and Policy Review]

By Julian Polaris

This is a golden age for access to healthcare in America. In 2015, over 90% of Americans had health coverage, the highest insurance ratein the 50 years the federal government has collected insurance data. This astonishing progress is due in large part to the Affordable Care Act (ACA): President Obama recently announced that 20 million people are covered thanks to the ACA. The victory is bittersweet, however: had the ACA been implemented as designed, an additional three million people would have insurance today. This is the story of the “coverage gap,” a crack in the ACA created by the Supreme Court and left unrepaired in nineteen states. A crack so wide that three million low-income people have fallen through it.

The ACA, as originally passed, aimed to increase access to health coverage in two main ways. First, the Act expanded Medicaid, the public health plan for people with low income. Previously, most states had limited Medicaid eligibility to specific groups like children and pregnant women. The ACA enlarged and standardized the Medicaid program to cover all people who earn up to 138% of the federal poverty level (FPL). The federal government picks up 90% of the cost of healthcare services for newly eligible beneficiaries, whereas costs in traditional Medicaid are split closer to 50-50.

Second, the ACA established the health insurance “exchanges,” portals in each state where consumers can shop for standardized plans that aren’t tied to a particular employer. Federal tax credits are available to subsidize exchange coverage for those earning 100 to 400% of the FPL. Read More

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Read More

The Economist on Contraceptive Coverage and Misleading Metaphors

By Gregory M. Lipper

The Economist is not buying the challengers’ claim that the provision of contraceptive coverage—by third parties—is an act of “hijacking”:

When the government arranges for contraceptive coverage with the insurance company used by the religious charity, it is not commandeering anybody’s property. Nor is it taking metaphorical control of the group’s health insurance plan. Instead, the government is seeking to fulfil Obamacare’s near-universal guarantee to female employees by working with the same insurance company or third-party plan administrator that provides the rest of the employee’s health benefits. Neither the insurance company nor the plan is the property of the religious charity: Aetna is not a wholly owned subsidiary of Catholic Charities. The non-profit and the insurer are independent entities.  When a school brings a child to a playground that his parents (for some reason) opt to avoid, the teachers are not “hijacking” the swingset. They are using a resource for the child’s benefit. The parents may be displeased about the school trip to the forbidden playground, but any complaint they raise would necessarily have a paternalistic flavour. Employers do not have such a role vis-a-vis their employees.

Read the full essay here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

Regulating genetically modified mosquitoes

By Dalia Deak

Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in the United States, pending a public comment process on a draft environmental assessment submitted by Oxitec. It should be noted that a final approval for the trial will not be made until the FDA completes the public comment process.

The genetically modified insects, which are male Aedes aegypti mosquitoes, are designed to breed with the female Aedes aegypti mosquito (primarily responsible for transmitting zika, dengue fever, and other diseases) and contain a gene lethal to their offspring. The female mosquitoes lay eggs but the larvae die well before adulthood. Oxitec claims that recent tests have shown up to a 90% decrease in the population of the Aedes aegypti mosquito, with a recent test in Piracicaba (~100 miles from Sao Paulo in Brazil) showing an 82% decline. Tests have also been conducted in the Cayman Islands and Malaysia.

In the United States, Oxitec is in the process of waiting for FDA approval to conduct trials in the Florida Keys. However, this is relatively unclear and uncharted territory for the federal government in terms of what group should be responsible for the review, and the decision for the CVM jurisdiction in this case remains hotly debated. Jurisdictional debate exists between the U.S. Department of Agriculture and the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).

Read More