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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U.S. Capitol Building at Night

A Legislative Override Could Save the ACA (and Fix Other Misapplications of Health Laws)

By John Aloysius Cogan, Jr.

The Congressional Democrats and the Biden administration need not wait for the Supreme Court to determine the fate of the Affordable Care Act (ACA) in California v. Texas; they can take charge of the case today by enacting and signing into law overriding legislation. 

Since the threat to the ACA is based on the interpretation of a federal statute — the ACA’s “inseverability clause” — Congress is within its rights to take charge of the case. Why? Because courts are not the final word on the meaning of a statute, Congress is.

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Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

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Medical bill and health insurance claim form with calculator.

Price Transparency: Progress, But Not Yet Celebration

By Wendy Netter Epstein

Price transparency has long eluded the health care industry, but change — fueled by rare bipartisan support — is afoot. 

The Trump Administration promulgated new rules relating to health care price transparency, and the Biden Administration seems poised to keep them. Though patients have grown accustomed to going to the doctor and agreeing to pay the bill — whatever it ends up being — they aren’t happy about it. The majority of the public (a remarkable 91%) supports price transparency. And lack of access to pricing has long been a significant glitch in a system that relies on markets to bring down prices. 

Though recent rulemaking looks like progress, it is still too soon to celebrate. Questions remain about consumer adoption, the role that providers will be willing to play, and the impact that transparency will have on pricing. The possibility that transparency will worsen existing inequities also requires careful observation.

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Illustration of fetus, DNA, lab supplies

Assisted Reproductive Technologies: A Bioethical Argument for Medicaid Coverage

By Sravya Chary

Assisted reproductive technologies (ARTs) such as artificial insemination, egg retrieval, and in-vitro fertilization (IVF) have revolutionized the landscape for people facing reproductive obstacles. Disappointingly, none of these technologies are covered under Medicaid — an insurance program for low-income adults and children, and people with qualifying disabilities.

Given the high prices of ARTs, those on Medicaid, which includes a disproportionate number of BIPOC individuals, are left behind in sharing the benefits of advancements in reproductive technologies. It is vital for ARTs to be covered under Medicaid to uphold reproductive justice and autonomy for this patient population.

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Emergency department entrance.

Be a Transformational President, Mr. Biden: Launch a Commission to Create an Ethical Health Care System

By William M. Sage

My message for President Joe Biden and his administration is a simple one. Invite physicians to create an ethical health care system. Demand that physicians take seriously that mission and work closely with other health professions and the public, sharing their power and authority.  

Physicians’ silence in the face of massive health injustice, inefficiency, and waste must be called out by leaders of the medical profession for what it is: complicity. Commitment to an ethically indefensible status quo has made much-needed reform proposals seem morally threatening, rather than representing opportunities for ethical introspection and improvement. All those who profit from the current system — a large group, given $4,000,000,000,000 of annual U.S. health care spending — use physician complacency to justify their own resistance to change.

The U.S. health care system will not change without permission from health professionals, especially America’s physicians. Permission must be built on principle, and it should take the form of re-envisioning and reaffirming medical ethics. The need to do so has been evident for over two decades, but COVID-19 has increased its urgency.

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