Call from unknown number on iPhone.

The Surprising Shape of COVID Fraud

By James Toomey

When the world went into lockdown in March 2020, many commentators noticed that social isolation could offer scammers an unprecedented opportunity to take advantage of people’s fear and loneliness. But they didn’t anticipate that fraud would generally affect a range of age groups. Indeed, much like the virus itself, the risks of frauds and scams related to the COVID pandemic were thought primarily to affect older adults.

This assumption seems to have been wrong. Recently, I conducted a study on the prevalence of scam-victimization during the pandemic across age groups. Specifically, I recruited two populations — one of adults between 25 and 35 and one of adults over than 65—and asked whether they had been contacted by people making specific fraudulent promises during the pandemic, and whether they’d engaged with the scammer by giving personal information, sending money, or clicking a link. In the study populations, the younger group engaged with scammers three times more frequently than the older group — a disparity that was statistically significant and persisted regardless of how I sliced the data.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

What Democrats’ Drug Pricing Plan Means for Consumers

By Cathy Zhang

At the start of the month, Democrats announced a new drug pricing plan, detailed in the House’s Build Back Better Act (H.R. 5376). In the immediate short term, the drug pricing plan has enabled the $1.75 trillion bill to go forward through the House. If ultimately enacted, it will generate savings for consumers, some more directly than others, and at a more modest pace and magnitude than many had hoped.

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Senior citizen woman in wheelchair in a nursing home.

The Barriers to Aging in Place

By Renu Thomas and John Roth

The COVID-19 pandemic has highlighted the risks associated with institutionalized care for the elderly, and has further shifted sentiments toward a preference for aging in place. But most seniors and their loved ones don’t realize the barriers that make aging in place a difficult proposition until a crisis occurs and they’re faced with finding services.

Take our family, for example. My father was diagnosed with Parkinson’s disease and it was after his first fall and discharge from the hospital that our family realized my parents’ independence was severely limited. We knew their house was not wheelchair or walker accessible, but we also needed to address other issues as well; neither of them could drive anymore, so how would we get them to appointments, how would their prescriptions and groceries get picked up, and how could we prevent them from being socially isolated? Like many families, we do not live nearby, let alone in the same state, which made coordinating these services even more challenging.

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Glasses, case for contact lenses and eye test chart on mint background, top view

Medicare Poised to Expand Vision, Hearing, and Dental Benefits

By Bailey Kennedy

Though Pres. Biden’s expansive infrastructure and social spending bills remain mired in Congress, it still seems likely that his administration will preside over one of the most dramatic revisions in America’s public safety net since the Great Society.

One of the most discussed provisions in the omnibus bill would expand Medicare benefits to include hearing, vision, and dental care. Currently, millions of Americans are forced to go without the types of care that the proposed Medicare expansion would address. And seniors, in particular, are likely to deal with vision and hearing-related health care issues, which pose a high financial burden.

While the proposed expansion has met pushback, including these aspects of health care in standard insurance plans is significantly overdue.

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Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

There’s More to Decision-Making Capacity than Cognitive Function

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. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By James Toomey

The doctrine of capacity is a mess.

From Britney Spears’s high-profile struggles to establish her own capacity to the countless, quiet challenges of so many older adults, the doctrine of capacity, which requires people to have the cognitive functioning to understand the nature and consequences of a decision in order for it to be recognized in law, is vague, normatively and medically challenging, and inconsistently applied.

This is a big deal — at stake in every capacity case is whether, on the one hand, an individual may access the legal rights most of us take for granted, to enter into contracts, buy or transfer property, or get married or divorced; or, on the other, whether the legal system will ratify a decision the “real person” never would have made.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, 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 July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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Map of remote execution requirements for advance directives.

Advance Care Planning in an Online World: State Law Activity and Challenges Since COVID-19

By Nikol Nesterenko, Jonathan Chernoguz, and Sarah Hooper

Advance care planning — the process by which an individual documents their wishes for health care in the event that they become incapacitated — has become particularly urgent during the COVID-19 pandemic.

However, individuals that wish to engage in advance care planning, and specifically to document their plans in a written form (i.e., advance directives), have faced significant hurdles due to legal execution requirements. State advance directive law often requires or presumes live, in-person witnessing or notarization, actions which were prohibited by social distancing orders or simply unsafe during the pandemic.

In this piece, we summarize the state of remote execution requirements for advance directives before and during the COVID-19 pandemic. Broadly speaking, while many states took some action in this regard, most did not enact comprehensive changes, and therefore failed to meaningfully facilitate remote execution of advance directives.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

The Current COVID-19 Surge, Eugenics, and Health-Based Discrimination

By Jacqueline Fox

COVID has shown us that the burdens and inequities that characterize everyday life for many Americans are not merely vestiges of an older time, but an honest reflection of our unwillingness to treat everyone with dignity and respect.

We have undergone an ethical stress test in the last 18 months. While many people have exhibited heroic commitments to their fellow citizens, much of our governmental response is indefensible in a society that professes to care for all of its members. This implies we are not such a society.

Rather, we are a society riddled with healthism — discrimination based on health status — and eugenics — a pseudo-science that arbitrarily elevates some human traits over others, much as we do with breeding dogs and horses.

As a result, although we are armed with the power to prevent much harm, we lack the will or inclination to use that power for our most vulnerable. Instead, we place different values on people’s lives using arbitrary definitions of quality, and treat people differently based on their health status. Examples include placing a lower value on a life because a person is older, disabled, or overweight.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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