Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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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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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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Medical bill and health insurance claim form with calculator.

Price Transparency: Progress, But Not Yet Celebration

By Wendy Netter Epstein

Price transparency has long eluded the health care industry, but change — fueled by rare bipartisan support — is afoot. 

The Trump Administration promulgated new rules relating to health care price transparency, and the Biden Administration seems poised to keep them. Though patients have grown accustomed to going to the doctor and agreeing to pay the bill — whatever it ends up being — they aren’t happy about it. The majority of the public (a remarkable 91%) supports price transparency. And lack of access to pricing has long been a significant glitch in a system that relies on markets to bring down prices. 

Though recent rulemaking looks like progress, it is still too soon to celebrate. Questions remain about consumer adoption, the role that providers will be willing to play, and the impact that transparency will have on pricing. The possibility that transparency will worsen existing inequities also requires careful observation.

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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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NHS building

When Will the NHS Get Its Complaints System Right?

By John Tingle

The National Health Service (NHS) in England has been trying to get an effective, fit-for-purpose complaints system for at least 28 years, and it has still not succeeded.

This has been one of the NHS’s perpetual and intractable problems. History has not served the NHS well here, despite the publication of countless reports on patient safety and NHS complaint handling, and several major crises happening, such as Mid Staffordshire.

More often than not, the reports into patient safety crises and NHS complaints system reform all say the same (or similar) thing, and point to the same issues.

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ANDOVER,HAMPSHIRE/UNITED KINGDOM-NOVEMBER 6 2019:A district nurse visits a ninety-four year old patient at his home to treat for pulmonary edema and head/brain injury.

Challenges Facing Home Health Caregivers During COVID-19 Pandemic

By Vicki Hoak

The pandemic has emphasized the value of home health caregivers. Their contribution has been overshadowed for decades, but now it is very clear how important their work is to the well-being of older Americans, people with disabilities, and medically-fragile children.

As families were urged to stay at home to stop the spread of COVID-19, home care agencies and their staff became all the more important for preventing the spread of COVID-19 and protecting the most vulnerable from the disease. Home health aides offer clients one-to-one care and continual monitoring of changes in conditions — all in the safety of one’s own home.

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Field hospital in NY during COVID-19 pandemic.

Ethical and Legal Challenges Faced by Hospitals in New York’s First COVID-19 Surge

By Zachary E. Shapiro

After COVID-19 reached the United States, New York City quickly became the epicenter of the pandemic. Clinicians at New York Presbyterian Hospital-Weill Cornell Medical Center turned to the Clinical Ethics Consultation Service to help meet the ethical challenges that arose. During the surge, the Ethics Team saw a marked increase in the volume of consultations for individual patients in the hospital, and took part in over 2,500 informal consultations with caregivers. Discussions centered around a wide range of ethical issues distinct from those that come up in routine practice. As one of the only lawyers in the Division of Medical Ethics at Weill Cornell Medical College, I encountered a myriad of legal concerns presented by the pandemic.

During the height of the surge in New York, there was no formal legal guidance available to clinicians concerning medical practice during a pandemic. Questions about legal immunity abounded, as unclear state and federal guidance left many doctors worried that they were taking personal and professional risks by providing care to COVID-19 patients.

The pandemic forced doctors to shift away from traditional standards of care in terms of resuscitation, patient care, and surrogate decision-making. The ethics team had to take new dynamics into account, such as the risk of infection to doctors and staff, and balance these factors in the risk/benefit calculations for treatments and interventions. Undertaking these shifts without federal or state guidance caused significant distress and concern. It often seemed that the law was not only not helpful, but an active hindrance to medical practice, as many health care workers were consumed by worry about the prospect of future liability. This concern persisted, even though the deviations in the standard of practice were necessitated by the realities of the pandemic overwhelming our health care system.

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NHS building

Health Care Providers’ Legal Duty to Be Open and Honest with Patients

By John Tingle

Last September, the first ever prosecution of a National Health Service (NHS) trust for failure to comply with the regulation concerning duty of candor was adjudicated.

University Hospitals Plymouth NHS Trust was ordered to pay a total of £12,565 after admitting it failed to disclose details relating to a surgical procedure and to apologize following the death of a 91-year-old woman.

Duties of candor require that patients be informed of adverse events as soon as possible after they occur. These duties serve as mechanisms to help balance power dynamics in health care and to advance patient rights. In England, duties of candor are contained in the professional codes of ethics of doctors and nurses, and in statutory regulations.

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Russia, Saint-Petersburg, village of Telman - August 2015: a plant for the production of meat products. a worker walks down the hall of meat production in Russia, the village of Telman.

Performance Analysis of OSHA During COVID-19

By Zoey Binder

The United States Occupational Safety and Health Administration (OSHA) was highly criticized this year for an alleged lack of enforcement and failure to protect workers from unsafe working conditions related to COVID-19.

Of particular concern has been its failure to exert authority over the meatpacking industry, whose workers have been disproportionately harmed by the pandemic.

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