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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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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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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Steps 1, 2, 3, 4 signpost.

The Ongoing Step Therapy Debate

By Laura Karas

Senator Lisa Murkowski’s (R-AK) reintroduction this February of a federal bill, the Safe Step Act, has revived the debate over the prudence of step therapy protocols.

Step therapy is an insurer utilization-management tool imposed in response to high drug prices. As its name implies, step therapy requires “steps” before a patient can receive his preferred medication (i.e., the one his provider has prescribed). Typically, a patient must “try and fail” a less costly medication or series of medications before becoming eligible for insurance coverage of the medication in question. In effect, step therapy allows an insurer’s “preferred therapy” to supersede patient and provider preference.

The need for step therapy is closely bound to the problem of high drug prices. But the crux of the step therapy debate boils down to the following: Who should decide which pharmaceutical drugs your health plan covers? You and your doctor, or your insurer?

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U.S. Capitol Building at Night

How a Public Option Would Lead to Single Payer

By Abe Sutton

This past Democratic Party presidential primary season highlighted the differences between the health policy approaches championed by Senator Sanders and President Biden.

But, despite short-term distinctions and differences in services covered between Medicare For All’s single payer and a public option built on the Affordable Care Act, I believe that in the long run, these approaches are indistinguishable. This is because a public option would lead to single payer over time.

In this post, I walk through three ways that many public option proposals would pave the way for single payer.

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U.S. Capitol Building at Night

Advantages of Using the Congressional Review Act to Revoke Health Care Waivers

By Matthew B. Lawrence

The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.

Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.

Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).

In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.

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image of the US Supreme Court

What the Supreme Court’s ACA Ruling Might Mean for Nonprofit Hospitals

By Jacob Madden

California v. Texas, a pending Supreme Court case that concerns the constitutionality of the Affordable Care Act (ACA)’s individual mandate, could have profound implications for the standards to which nonprofit hospitals are held.

The ACA’s individual mandate requires people to have health insurance or otherwise pay a penalty. While the Court previously upheld the individual mandate as being constitutional under Congress’ taxation power in the 2012 case National Federation of Independent Business v. Sebelius, it may not do so again. For one, the 2017 Trump tax cuts effectively eliminated the individual mandate’s penalty, raising the question of whether the individual mandate is still a valid exercise of Congress’ taxation power. And conservative Judge Amy Coney Barrett’s confirmation, filling the late Justice Ruth Bader Ginsburg’s seat, has significantly changed the composition of the court.

If the Court strikes down the individual mandate, the rest of the ACA could be in jeopardy, depending on the specifics of the ruling. The Court has several options: sever the individual mandate from the ACA and keep the ACA alive, strike down the ACA in part, or strike down the ACA entirely.

The immediate concern, should the Court strike down the ACA entirely, is that tens of millions of Americans likely would lose their health insurance and other protections afforded by the law. Another, albeit lesser known concern, is that we would lose § 501(r).

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Illustration of a family and large clipboard with items in a list checked off. All are underneath a large blue umbrella

Private Law Alternatives to the Individual Mandate: Video Preview with Wendy Netter Epstein

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Wendy Netter Epstein gives a preview of her paper, “Private Law Alternatives to the Individual Mandate,” which she will present at the Health Law Policy workshop on November 2, 2020. Watch the full video below:

Close-up Of Stethoscope On Us Currency And American Flag.

Short-Term, Limited-Duration Insurance May Be Here to Stay

By Abe Sutton

Short-term, limited-duration insurance (STLDI) may be here to stay despite legal attacks, poor branding, and a potential Democratic victory in the upcoming Presidential election.

Though the Obama administration curtailed STLDI, it is now likely to endure due to black letter administrative law and changes in circumstance since 2016.

In light of this, a potential Biden administration should package legislation codifying the current regulations with legislation increasing individual market subsidies. A package along these lines could appeal to both sides of the aisle.

In this post, I provide an overview of what STLDI is, explain why administrative law precedents complicate the reversal of current regulations, and propose a path forward for a potential Biden administration. Read More