U.S. Supreme Court

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

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Person filling syringe from vial.

The Beginning of the End of Federalism As We Know It Here on Earth One and Earth 616?

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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

The CMS Vaccine Mandate: The Nationwide Injunction and What It Means

By Kaitlynn Milvert

On November 30, 2021, a federal district court issued a nationwide preliminary injunction to block the Centers for Medicare and Medicaid Services (CMS) vaccine requirements for health care workers.

This ruling comes mere days before the December 6 deadline for employees of CMS-funded facilities to receive their first dose of a COVID-19 vaccine, and it casts uncertainty over upcoming deadlines for vaccination compliance.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Expanded Reimbursement Codes for Remote Therapeutic Monitoring: What This Means for Digital Health

By Adriana Krasniansky

New reimbursement codes for virtual patient monitoring may soon be incorporated into Medicare’s fee schedule, signaling the continued expansion and reach of digital health technologies catalyzed by the COVID-19 pandemic.

In July 2021, the Centers for Medicare & Medicaid Services (CMS) proposed adding a new class of current procedural terminology (CPT) codes under the category of “remote therapeutic monitoring” in its Medicare Physician Fee Schedule for 2022 — with a window for public comments until September 13, 2021. While this announcement may seem like a niche piece of health care news, it signals a next-phase evolution for virtual care in the U.S. health system, increasing access possibilities for patients nationwide.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Reforming How Medicare Pays for Digital Health

By Robert Horne and Lucia Savage

The Fourth Industrial Revolution, also known as the digital revolution, leverages technology to blur the lines between products and services. In the health insurance sector, this revolution offers policymakers unique opportunities to improve coverage and payment efficiencies while providing meaningful benefits to beneficiaries.

Medicare could lead this charge. Congress has an opportunity to reform Medicare in 2024, when the Trust Fund will become insolvent. Policymakers expect Congress to address this problem legislatively to prevent interruptions in coverage for seniors.

If past behavior is any indication, the legislation will also include reforms to improve how the program operates and spends money. Reforms to Medicare’s traditional coverage and reimbursement approaches that harness the digital revolution can help the program secure additional value. We know this because other sectors of the U.S. economy that have fully embraced this revolution have realized additional value.

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Map of the United States.

Health Reform via State Waiver

By Erin Fuse Brown and Chelsea Campbell

The path to systemic health reform in the U.S. may run through the states. To get there, the Biden/Harris administration should use its existing waiver authority under federal health care statutes to facilitate progressive state health reform efforts, including a state-based public option or single-payer plan.

One of the benefits of the United States’ federalist system, in which the power to enact policy and govern is divided between the national government and the states, is that we can test policies at the state level, and if we can establish a proof of concept there, it smooths the way for federal reform.

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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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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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Person typing on computer.

Telehealth Policy Brought to the Fore in the COVID-19 Pandemic

By Vrushab Gowda

The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity (e.g., minimizing infection risk, conserving thinly stretched healthcare resources, reducing cost) as well as of innovation.

Telehealth services have surged in recent months; in April alone, they constituted over 40 percent of primary care visits nationwide and over 73 percent of those in Boston. “Increasing Access to Care: Telehealth during COVID-19,” a recent publication in the Journal of Law and the Biosciences, dissects the issues that have accompanied the growth of telehealth and identifies further areas of potential reform.

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