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Administration’s Guidance on State Innovation Waivers under the ACA Violates the Act’s Statutory Guardrails

By Joel McElvain

This post was originally published on Take Care. 

The Affordable Care Act reformed the individual health insurance market to protect persons with pre-existing conditions. Insurers who participate in this market must sell plans with a standard set of comprehensive benefits, and may not deny coverage to, or impose higher premiums on, persons with pre-existing conditions.

Through legislative, regulatory, and litigation efforts, the Trump Administration has sought to depart from the ACA’s regime to allow the sale of plans that are medically-underwritten, offer more limited health benefits, or both.

The Administration’s latest such effort comes in the form of guidance by the Departments of Treasury and Health and Human Services that adopts a broader reading of the Act’s provision for state innovation waivers. Read More

Successful HIV Criminalization Reform in California: Q and A with Sen. Scott Wiener

The majority of states have laws that criminalize activities engaged in by HIV-positive people that are not criminalized when engaged in by the rest of the population.

Many of these laws improperly single out HIV over other infectious diseases and reflect a lack of understanding of both how HIV spreads and how it can be treated.

In 2017, California passed legislation which modernized and improved California’s HIV criminalization law. One of the authors of the law was State Senator Scott Wiener. I recently had a chance to ask Sen. Wiener some questions about that process.

His responses are given here in hopes of supplying useful information for legislators, lobbyists, and activists in other states who are interested in starting the reform process in their own states or other jurisdictions around the world. This interview has been edited for clarity.

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Ebola… again: What have we learned?

By Alicia Ely Yamin

As Susan Sontag eloquently noted decades ago, illness conjures metaphors that reveal a great deal about how we think about, and, in turn, address them. None more so than the lethal Ebola, which monstrously disfigures bodies before killing the infected person and spreading rapidly through the routines of everyday life.

In the West, Ebola evokes images of illness as a deadly foreign invasion, while in the West African pandemic we know that first those who were afflicted—and later those who survived—were stigmatized as possessing demons.

The growing outbreak in the DRC has produced calls for greater physical and financial involvement from the US government by a number of health law scholars, citing the potential for exponential spread if it reaches highly populated areas, and underscoring it as a global health security issue.  Thus far, WHO’s Director General has not declared it a “Public Health Emergency of International Concern” (PHEIC), which triggers consideration of both trade and travel restrictions, as well as international assistance and under the International Health Regulations. Read More

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Abbe Gluck, Michael Froomkin, Nicholson Price on ‘The Week in Health Law’ Podcast

I am joined by Abbe Gluck, Professor of Law and the Faculty Director of the Solomon Center for Health Law and Policy at Yale Law School.

In November 2018 her team pulled together an excellent roundtable on “The Law and Policy of AI, Robotics, and Telemedicine in Health Care.”

This episode of TWIH is the first of two taking a deeper dive into just a few of the  issues that were so well presented at the roundtable.

Here we were joined by Michael Froomkin, the Laurie Silvers and Mitchell Rubenstein Distinguished Professor of Law at the University of Miami School of Law and by Nicholson Price, Assistant Professor of Law at The University of Michigan Law School. Topics ranged from consent in the next generation of healthcare research to data protection, and appropriate regulatory models. Read More

Public Charge and the Expressive Effects of Immigration Law

In early October, the Department of Homeland Security published a proposed redefinition of the Immigrant and Nationality Act’s “public charge” provision, stirring serious concern among health-care and immigrant advocacy groups.

The “public charge” provision of the INA currently allows immigration officers to deny green cards to legal immigrants who are likely to become “primarily dependent on the government for subsistence.”

DHS’s proposed rule would widen the scope of “public charge” to include any legal immigrant who uses cash or non-cash government benefits. In expanding the scope of the public charge inadmissibility determinations, DHS would empower immigration officers to consider immigrants’ current or prior use of programs like Medicaid and SNAP in evaluating applications. Read More

A row of colored medical records folders

The Troubling Prevalence of Medical Record Errors

With plenty of potential healthcare concerns and complications arising out of medical diagnoses and treatments themselves, errors in medical records present an unfortunate additional opportunity for improper treatment.

A recent article from Kaiser Health News (KHN) discussed several examples of dangerous medical record errors: a hospital pathology report identifying cancer that failed to reach the patient’s neurosurgeon, a patient whose record incorrectly identified her as having an under-active rather than overactive thyroid, potentially subjecting her to harmful medicine, and a patient who discovered pages someone else’s medical records tucked into in her father’s records. In addition to incorrect information, omitting information on medications, allergies, and lab results from a patient’s records can be quite dangerous.

The goal of “one patient, one record” provides a way to “bring patient records and data into one centralized location that all clinicians will be able to access as authorized.” This enables providers to better understand the full picture of a patient’s medical condition. It also minimizes the number of questions, and chances of making errors, that a patient must answer regarding their medical conditions and history when they visit a provider.

Other benefits, such as cost and care coordination, also add to the appeal of centralized records.

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hand reaching for blue pills

Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim?

Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.

Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.

In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More

Science and ethics experts still reeling from #CRISPRbabies fallout

Watching David Baltimore open the #GeneEdit Summit last week brought back a memory of the last time I saw the Nobel laureate in such a role. The 2015 #GeneEditSummit concluded with a Q&A about the summit’s statement — which many considered was a moratorium on gene editing of embryos.

An audience member, with a sense of the promise of the science but concern for buy-in from a distrustful public, asked whether the statement might be translated into clearer language for those hard-pressed to understand CRISPR even with the acronym spelled out for them. To which Baltimore replied: “You mean it isn’t?”

That exchange convinced me that even gene editors need an editor. Especially gene editors. Indeed, if He Jiankui read that 2015 moratorium before he altered his own future in unintended ways, he did not see it as a red light.

In a tweet, director Francis Collins (@NIHdirector) clarified that the National Institutes of Health considers the light red: “The work of Dr. He Jiankui presented at #GeneEditSummit is profoundly disturbing & tramples on ethical norms. We need to develop binding international consensus on limits for this research. #NIH does not support the use of gene-editing in human embryos.”

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