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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United States Capitol Building - Washington, DC.

Congress Should Insulate the Indian Health Service from the Next Government Shutdown

By Matthew B. Lawrence

Contributors to Bill of Health’s symposium on Recommendations for a Biden/Harris Health Policy Agenda have made a number of excellent suggestions. I have one more policy suggestion to add and endorse: Congress should adopt the Biden Administration’s recent proposal to insulate the Indian Health Service from future government shutdowns.

A service population of 2.5 million American Indians and Alaska Natives rely on the federally-funded Indian Health Service (IHS). The IHS is one of several trust obligations that the U.S. government owes Native peoples as a result “of Native Americans ceding over 400 million acres of tribal land to the United States pursuant to promises and agreements that included providing health care services,” as the U.S. Commission on Civil Rights put it.

Yet the IHS is dependent entirely on annual one-year appropriations from Congress. That means that the House and the Senate must come together, on time, every single year on an appropriations package, for the IHS to continue all its operations.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Dementia Care: Lessons for the Future

By Marie Clouqueur, Brent P. Forester, and Ipsit V. Vahia

Alongside the COVID-19 epidemic in the U.S., the country faces another public health epidemic: dementia, and particularly Alzheimer’s disease.

Currently one in nine older adults in the U.S. — 6.2 million — have Alzheimer’s disease. The number of adults with Alzheimer’s in the U.S. will increase rapidly as the Baby Boomers age — it is expected to double by 2050.

The COVID-19 pandemic has exacerbated the situation. Acute, surging demand for dementia care services will turn into a persistent problem if we do not increase our capacity for services and better support our frontline workers. We have a chance now to reflect and take action to prepare for what is coming.

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doctor holding clipboard.

Learning from Clinical Negligence Claims: The New NHS Patient Safety Syllabus

By John Tingle

As part of its patient safety strategy, the National Health Service (NHS) in England has created the first system-wide patient safety syllabus, training, and education framework.

Education and training are fundamental prerequisites for creating a patient safety culture in any health care system. This new patient safety syllabus is both innovative and reflective, combining systems and human factors thinking.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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

Fixing Prices: Immigration and Physician Competition

By Jill Horwitz and Austin Nichols

The Biden administration is off to a roaring start. It is expanding and maintaining coverage during the pandemic by shoring up subsidies, paying premiums for laid-off workers, and otherwise working to reverse the growth in the uninsured (and underinsured) population caused by the last administration. Now it’s time to tackle another, cost.

Not only are health expenditures a large and growing share of GDP, crowding out other spending, costs have been increasingly shifted to patients in the form of premiums and ever-growing deductibles, which together have grown much faster than wages over the past decade. Moreover, out-of-pocket spending often hits all at once; about a third of high-spending patients incur half of their annual out-of-pocket spending in a single day. Increasingly, even people with insurance cannot afford to use it, so high cost is undercutting access even for the insured

We can tackle the primary drivers of cost, prices, by dismantling market power. The most salient case is cartel prices charged by physicians, and the natural solution is expanding the supply of physicians. Congress has taken some steps in this direction by expanding Medicare graduate medical education (GME) by 1,000 positions last December. The administration can unilaterally increase supply by via immigration. As others have suggested, increasing immigration of physicians who would accept somewhat lower compensation than current market rates would put “downward pressure on” physician pay.

These steps are important because expenditures for physician and clinical services are key drivers of spending and spending growth. In 2019 they accounted for $772.1 billion or 20% of total health care expenditures, representing a growth rate of 4.6% over 2018. Overuse drives some of these cost increases, but prices are the main story.

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U.S. Capitol Building.

Possibilities and Pitfalls of Health Reform Through Budget Reconciliation

By Nicole Huberfeld

The Biden administration entered office promising health reform. But the evenly-split Senate means ten Republican votes are necessary to move major legislation — cooperation that seems unlikely after years of Republican attempts to repeal and obstruct the Affordable Care Act (ACA).

Still, expanding health insurance coverage may be on the menu through budget reconciliation. A budget reconciliation bill progresses with a simple majority vote: special rules limit debate and make filibuster impossible.

The Biden administration has already navigated budget reconciliation to enact speedy health policy measures in response to the pandemic. Signed March 11, the American Rescue Plan Act of 2021 (ARPA) is a reconciliation bill which, among other things, offers federal money to support states’ and localities’ public health needs; facilitates economic recovery; increases tax subsidies provided through health insurance exchanges to expand affordability; and builds on the ACA and 2020 COVID relief bills by offering Medicaid non-expansion states an enhanced federal match of 5% for each enrollee to encourage expansion and counterbalance costs. The ARPA also addresses determinants of health and health equity, for example by extending the option of maternal Medicaid coverage for a year after the 60-day post-partum period and creating a new child tax credit. Most provisions last no more than two years.

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