LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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doctor holding clipboard.

Transformation of Behavioral Health Care Through Section 1115 Waivers

By John Jacobi

As the Biden administration works to improve health access and transform health delivery, behavioral health reform should be at the front of the queue.

People with severe mental illness and opioid use disorder are dying young for lack of routine health care. Much of the work that needs to be done in behavioral health is developed or developing at the state level. But the Biden administration has a powerful tool for encouraging state-level innovation in the § 1115 Medicaid waiver process.

Reform through state waivers

Section 1115 waiver authority permits the Department of Health and Human Services to approve pilots and demonstrations if they are found likely to promote the objectives of the Medicaid program. Waivers, which do not require Congressional or formal regulatory enactments, permit relatively rapid cycling of innovation, in contrast to the lumbering pace of legislative or regulatory change.

While applications for waivers originate with the states, presidents have set the agenda by signaling what categories of waivers will be looked upon favorably, offering the administration the ability to put its stamp on the development of care for low-income and disabled people.

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A pile of three surgical masks.

Public Health Law vs. Individual Advice: Why Discarding Indoor Mask Mandates Is a Mistake

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) announced today that fully vaccinated individuals no longer need to wear masks indoors or outdoors in most cases.

The agency has emphasized that this is merely guidance, and is not intended to affect public policy or to change practices of private companies. But it is naïve to imagine that health departments and private organizations will not make changes in response to the announcement.

There is a growing public wish to put COVID-19 behind us by eliminating visible signs that it still exists (e.g., mask wearing). But guidance driven by this magical thinking will cause unnecessary harm. Public health measures should protect the larger population, including those who cannot be or have not yet been vaccinated. This CDC guidance proffers individual advice at the expense of the goals of public health.

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Biden’s Early Focus: Durable and Attainable Private Insurance

By Zack Buck

Though health policy debates during the 2020 presidential primaries centered around expanding access to public health insurance programs (e.g., “Medicare-for-All”), the focus of the nascent Biden administration has been on making private health insurance more durable, not deconstructing it.

While these changes are likely to make private insurance plans more affordable and attainable, choosing to reinforce private insurance plans puts global systemic reform, the goal of many advocates, further out of reach.

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Hand holding pencil drawing a path.

Roll Back Harmful Section 1115 Waivers: Charting the Path Forward

By Sidney D. Watson

On March 18, 2021, the U.S. Department of Health and Human Services (HHS) sent formal notices to Arkansas and New Hampshire that it was withdrawing their Section 1115 waivers that allowed the states to require poor adults to work as a condition of Medicaid coverage.  

This appears to be the first time that HHS has invoked its authority to rescind an approved 1115 waiver. It won’t be the last. 

Waiver withdrawals provide a path forward for the Biden administration to end a grab bag of Trump-era Section 1115 waivers that create a risk of loss in coverage and harm to Medicaid beneficiaries.  

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Close up of a Doctor making a vaccination in the shoulder of patient.

The Legality and Feasibility of COVID-19 Vaccine Mandates for Children

By Dorit Rubinstein Reiss

On May 10, 2021 the U.S. Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include children aged 12-15.

The vaccine was previously authorized for use in those aged 16 and older. The company has announced it will seek emergency use authorization for younger children by September.

Now that children over the age of 12 can get vaccinated against COVID-19, will immunization against SARS-CoV-2 become a requirement for the return to public schools this fall?

My answer: In the near term, we probably will not see COVID-19 vaccine mandates for school children. And in the longer term, it depends.

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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

Now Is the Time for a Sex-Based Civil Rights Movement in Health Care

By Valarie K. Blake

The Biden administration and all three branches of government are poised to finally deliver a sex-based civil rights movement in health care that generations have waited for.

Sex discrimination is prevalent in health care, but especially so for LGBTQ people. Combine this with other forms of discrimination that LGBTQ people experience, and the result is a population that suffers from serious health disparities, including heightened risks of mental health conditions, substance use disorders, and suicide.

A much needed ban on sex discrimination in health care finally passed in 2010, as part of the Affordable Care Act (ACA). Section 1557 of the ACA prohibits health care entities that receive federal money from discriminating on the basis of sex, along with race, age, and disability. Specifically, Section 1557 bans sex discrimination in health care by way of extending Title IX, which previously applied to educational entities only. Section 1557 reaches most hospitals, providers, and insurers. Sex equality in health was a long time coming. Similar bans on discrimination by recipients of federal money had passed decades earlier: race discrimination in 1964, disability discrimination in 1973, and age discrimination in 1975.

Despite its historic nature, Section 1557 has yet to deliver on its promise, owing to delays and volatility in rulemaking and near-constant litigation. The statute was barebones, requiring interpretation, but the Obama administration only promulgated a rule and began full enforcement six years after the passage of the ACA. The Obama rule broadly banned gender identity and sexual orientation discrimination, but the part of the rule banning gender identity discrimination was judicially stayed only months later in Franciscan Alliance v. Burwell.

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Hand arranging wood block pyramid with health icons on each block.

ERISA Preemption Reform: Unlocking States’ Capacity for Incremental Reform

By Elizabeth McCuskey

For the past 46 years, the Employee Retirement Income Security Act (ERISA) has preempted state regulation that “relates to” employer-sponsored health benefits. 

Much has changed in health care and society over that time; but ERISA’s preemption abides — widely maligned, yet unaltered. An ERISA preemption waiver thus presents a long-overdue update to health care regulation with a lot to recommend it to the Biden Administration’s health care agenda: it enables states to “strengthen and build on the Affordable Care Act,” it offers a modest incremental step that could pave the way for bigger structural change, it prompts no federal spending, and it has bipartisan political support. 

The preemption provision in 1974 was supposed to entice multistate employers to offer benefits by creating some federal uniformity in benefit regulation. For health benefits, however, that uniformity has been largely deregulatory.

ERISA preemption currently prevents states from fully enforcing a wide variety of health reforms, ranging from claims data collection to state-level employer mandates. And it casts a pall of private litigation challenges over even the ones that should be enforceable, like surprise billing regulation, prescription drug pricing measures, and state and local public option plans.  

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Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

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stethoscope, pills, ampules, and notepad with "claim denied" written on it.

Preserving Meaningful External Review Despite Insurers’ Rulification of Medical Necessity

By Daniel Schwarcz and Amy B. Monahan

Increasingly, health insurers are crafting their coverage terms in ways that undermine a vital consumer protection created by the Affordable Care Act (ACA): the right to appeal health plan claim denials that are based on medical judgments to an independent, external reviewer. The ACA extended this right to all health plans to protect consumers against the risk of unreasonable coverage determinations — a risk that is all too familiar given insurers’ financial incentives to deny claims.

Yet, as revealed by our new article, Rules of Medical Necessity, this essential consumer protection is becoming increasingly illusory as health insurers shift from broad standards to concrete rules for defining when care is medically necessary. For that reason, this post proposes that the Biden/Harris administration should promulgate rules allowing external reviewers to set aside insurers’ rules of medical necessity even when they are contained in insurance policies or formal health plan documents. Instead, federal regulations should make clear that the ACA requires external reviewers to apply traditional, standard-based, definitions of medical necessity when reviewing denials of coverage that are premised on medical judgments.

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