Stacks of books against a burgundy wall

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 November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Doctor, DNA, microscope concept illustration.

Legislative Success in FL Suggests Time is Ripe for Further Genetic Nondiscrimination Protections

By Anna C F Lewis and Anya E R Prince

On July 1, a law banning the use of genetic information by life, long-term care, and disability income insurers took effect in Florida.

Florida’s success marks a potential turning point of bipartisan appeal for this issue.

The passage of this law, which we explore in a recent article published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), was propelled by a campaign that argued that an individual’s DNA should not be weaponized against them, that affordable insurance shouldn’t just be for the genetic elite, and that an individual should be able to keep their genetic data private.

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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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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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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

A calculator, a stethoscope, and a stack of money rest on a table.

Telemedicine is No Cure for Fraud and Abuse

By Vrushab Gowda

The exponential growth of telehealth in recent years has revolutionized the delivery, access, and cost of care. Unfortunately, it is not immune to the fraud and abuse that divert nearly $70 billion from the health care system annually.

A rise in suspect practices has been accompanied by a concomitant escalation of Department of Justice (DOJ) enforcement, sending a clear signal to would-be fraudulent actors.

The ongoing Operation Rubber Stamp is one such enforcement thrust. A joint initiative of the of the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS), it targeted an extensive network of telemedicine fraud totaling over $4.5 billion in false claims and yielding thirty guilty pleas to date.

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a stethoscope tied around a dollar bill, with a bottle of pills nearby

Can We Expect Legislation on Surprise Medical Billing? I’d Be Surprised

By Abe Sutton

Surprise medical billing has emerged as a top political priority amid a torrent of complaints about expensive balance billing.

Despite leaders such as President Trump, former Vice President Biden, and members of the 116th Congress pledging to address surprise medical billing, federal legislation is unlikely, due to powerful health associations’ divergent interests. To shake legislation loose, the President would need to publicly take a side and expend political capital on a creative solution.

In this piece, I walk through why federal legislative action has been stymied to date, and what it would take to get surprise medical billing legislation over the line.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Great Responsibility: Navigating Moral Hazards During COVID-19

By Jacqueline Salwa

Younger people may be driving the COVID-19 pandemic in part because they perceive the costs of complying with public health measures as higher and the expected benefits as lower compared with older individuals.

”Indemnifying Precaution: Economic Insights for Regulation of a Highly Infectious Disease,” a paper recently published in the Journal of Law and the Biosciences, explores how to align costs and benefits so that individuals of all ages adhere to precautions.

Younger people tend to experience less severe symptoms from COVID-19 infection, and may be disproportionately affected by other aspects of the pandemic.  These include depression from lack of social interaction, stifled career advancement, and difficulties with providing for dependents.  Compared to younger people, older people have a greater chance of being settled down, retired, and not responsible for dependents. As a result, those that  receive the least benefit from taking precautions, and incur the greatest personal costs for abiding by these precautions, have a lack of incentive to follow precautionary public health measures. This is known, in economic terms, as a moral hazard.

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Young male doctor in telehealth concept

Telehealth amid COVID-19: What Health Care Providers Should Know

By Adriana Krasniansky

COVID-19 stands to be a watershed moment for telehealth adoption within the U.S. healthcare system.

In response to the COVID-19 pandemic, the Trump administration and the Centers for Medicare & Medicaid Services (CMS) (part of the Department of Health and Human Services, or HHS) announced expanded Medicare telehealth coverage for over 80 health services, to be delivered over video or audio channels. Additionally, the HHS Office for Civil Rights (OCR) announced it would waive potential Health Insurance Portability and Accountability Act (HIPAA) penalties for good faith use of telehealth during the emergency. Both measures are designed to enable patients to receive a wider range of health care services remotely, reducing clinical congestion and limiting transmission of the virus. 

In the midst of this emergency situation, health care providers can take measures to consider the ethical and legal aspects of tele-practice as they get started. This article is a short primer to help medical professionals understand telehealth in this moment, navigate regulations and technology practice standards, and choose technologies to support quality patient care. Read More

New technologies are empowering persons with disabilities. But are they Assistive?

Consumer tech has reduced daily friction for countless individuals, making it easier to control households, shop for groceries, and connect with loved ones. These technologies can be especially empowering for persons with disabilities, increasing accessibility and resolving frustrations of everyday activities. You may have seen related news in press releases and popular headlines: “Alexa is a Revelation to the Blind,” “Disabled Americans Deserve the Benefit of Self-Driving Cars,” “Amazon Alexa Can Help People With Autism Do More On Their Own.”

But are these technologies assistive? Disability nonprofit Understood.org defines assistive technology as “any device, software, or equipment that helps people work around their challenges.” Classifying a device or software as assistive technology (and/or related regulatory labels) can lead to insurance coverage and tax incentives. It can change how devices are viewed in healthcare settings and impact product research and design. In this article, we speak with bioethicist and disability scholar Dr. Joseph Stramondo about how to define assistive technologies in today’s consumer tech revolution. 

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