Grafton, Illinois, USA, June 1, 2019 -Car submerged under flood water in small river town, Grafton, Illinois, as Mississippi River floods roads, businesses and houses. vehicle under water, men in boat

Bail Out Humans

By Christina S. Ho

This past year has sensitized us politically to government’s affirmative obligations, especially the duty to backstop health catastrophes in order to dampen the risks that ordinary people must bear. 

Our government bails out large risks in so many other arenas. Yet we too often fail to backstop the most human risk of all — our vulnerability to suffering and death. 

Throngs of scholars have described our deep tradition of government-sponsored risk mitigation to nurture favored private activities and expectations, and relieve those favored actors from catastrophes beyond what they could be expected to plan for. I have characterized this distinctive political role figuratively as one of “government as reinsurer.”

The federal government provides standard reinsurance for private crop insurers, virtually full risk-assumption for private flood insurance, guarantees for employer pension benefits, robust backstops for bank liquidity risks, FHA mortgage insurance and a federal secondary market to absorb the risks of housing finance.

In these arenas and more, statistically correlated or high-magnitude catastrophic losses are shed onto the state in order to smooth out and shore up the underlying private risk market. We have yet to commit similarly in the health care domain. 

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People protesting with signs that say "healthcare is a human right" and "medicare for all."

A Long View on Health Insurance Reform: The Case for an Employer Public Option

By Allison K. Hoffman

Historically, job-based health insurance coverage was the gold standard. It was broadly available to workers and was comprehensive. It covered the lion’s share of most services someone might need. 

Yet, job-based private health coverage has been in decline. Employers are struggling to maintain plans in the face of escalating health care prices, and indicating the need for government involvement to solve this problem.  

Even before the pandemic, a decreasing share of workers, especially lower wage workers, had health benefits through their jobs. The majority of the currently uninsured are workers, either those whose jobs do not offer them coverage, such as gig workers and part-time workers, or those who are offered coverage but cannot afford their share of the cost. Ironically, some of these workers become ineligible for Affordable Care Act (ACA) marketplace subsidies because they are offered job-based coverage. 

Even for those who have job-based coverage, health benefits have become less generous over time, leaving households vulnerable to unmanageable health care expenses. The average deductible for a worker-only plan has increased 25% over the last five years and 79% over the last ten years. 

To help address these shortcomings and challenges of job-based coverage, the Biden administration should offer employers a Medicare-based public health insurance option for their employee coverage. It would simultaneously offer an out for employers who want it, and start to build the foundation for a simpler, more equitable financing system down the road.

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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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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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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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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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Symposium Introduction: Recommendations for a Biden/Harris Health Policy Agenda

By Erin C. Fuse Brown

This digital symposium explores recommendations for the Biden/Harris administration’s health policy agenda. We asked leading health law scholars to describe one health policy action the administration should pursue, beyond the pandemic response. Their recommendations make up this symposium. The responses range from concrete policy changes to broad reform ideas and can be grouped into three categories, those that (1) Reverse and Restore; (2) Reinforce; (3) Reform.

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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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gavel on top of a pile of bills and pills

Federal Court Halts Implementation of 340B Dispute Resolution Rule

By Sravya Chary

The U.S. District Court for the Southern District of Indiana’s recent decision to grant Eli Lilly’s motion for a preliminary injunction rightfully halted the implementation of a dispute resolution rule for the 340B Drug Pricing Program.

The Alternate Dispute Resolution Final Rule (“ADR Final Rule”), issued on December 10, 2020, attempted to settle oft-occurring battles between pharmaceutical manufacturers and 340B covered entities. A few weeks later, the Department of Health and Human Services (HHS) released a 340B advisory opinion defining the department’s understanding of the statute.

The 340B Drug Pricing Program was established by Congress in 1992 with the intent to stretch federal resources to serve the nation’s most vulnerable patients. In practice, however, the program has deviated from its original intent.

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