Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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Suboxone.

Eliminating Barriers to Opioid Use Disorder Treatment

By Jennifer D. Oliva, Taleed El-Sabawi, and Shelly Weizman

The tragedy of the ever-worsening drug poisoning and overdose crisis in the United States is compounded by a simple fact: We know how to prevent overdose deaths, and yet, the overwhelming majority of individuals with opioid use disorder (OUD) lack access to the lifesaving, standard of care treatment.

Research demonstrates that the opioid agonist medications methadone and buprenorphine are the safest and most effective treatments for OUD. As the National Academy of Sciences explained in a 2019 report, these two medications reduce risk of death by up to 50 percent and are associated with numerous other benefits, including improved quality of life, reduced rates of use of other opioids, and reduced risk of contracting illnesses including HIV and hepatitis C.

However, during the worst drug poisoning crisis in U.S. history, which is now killing more than 100,000 people a year, the country’s outdated and restrictive federal regulatory schemes that pertain to methadone and buprenorphine present a pernicious and persistent barrier to accessing OUD medications.

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Mushrooms containing psilocybin grow in the forest.

Washington Psilocybin Bill Would Legalize Supported Adult Use

By Mason Marks

On Tuesday, Washington State legislators filed SB 5660, a bill that would legalize the supported adult use of psilocybin by people 21 years of age and older.

Sponsored by Senators Jesse Salomon and Liz Lovelett, the bill, known as the Washington Psilocybin Wellness and Opportunity Act, includes many innovative features including a Social Opportunity Program to help address harms caused by the war on drugs, a provision to support small businesses, and accommodations for people with certain medical conditions to receive the psychedelic substance at home.

I had the privilege of helping to draft the Washington Psilocybin Services Wellness and Opportunity Act with input from the Psychedelic Medicine Alliance of Washington and my colleague John Rapp of the law firm Harris Bricken. We had previously collaborated on the psychedelic decriminalization resolution adopted unanimously by the Seattle City Council.

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Chicago, IL, USA - October 18 2021: BinaxNOW Covid-19 Antigen Self Test. Results in 15 minutes at home.

The Devil is in the Details with Biden’s Free COVID Testing Plan

By David A. Simon

Yesterday, President Biden announced a new requirement that private insurers must reimburse purchases of at-home COVID-19 tests.

This represents a significant departure from current policy, which only requires insurance companies to pay for testing at the direction of a healthcare provider. The new policy has yet to take effect — the Department of Health and Human Services (HHS) will release formal guidance for private insurers by January 15th.

Removing the need for clinician approval to access free COVID-19 testing is a noteworthy step; however, the new policy raises a host of questions that remain to be addressed, which are discussed briefly below.

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A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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Busy Nurse's Station In Modern Hospital

Call Your Senator and Help Give Doctors a Break

By Jacob Madden

Want to help make a big change for our nation’s overworked doctors? Call your senator and tell them to hire more.

In March of this year, Senators Robert Menendez (D-N.J.), John Boozman (R-Ark.), and Chuck Schumer (D-N.Y.) introduced S.834, the Resident Physician Shortage Reduction Act to confront the country’s growing shortage of doctors.

The proposed legislation will increase the number of resident physician positions supported by Medicare by 2,000 each year from 2023 to 2029, for a total of 14,000 newly supported positions.

This legislation could make a small but significant dent in the nation’s physician shortage. By 2034, the Association of American Medical Colleges expects a shortage ranging from 17,800 to 48,000 primary care physicians, and 21,000 to 77,100 non-primary care physicians. Take both worst-case scenarios, and we are short 125,100 doctors.

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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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Kirkland, WA / USA - circa March 2020: Street view of the Life Care Center of Kirkland building, ground zero of the coronavirus outbreak in Kirkland.

The PREP Act and Nursing Homes’ Fight to Move COVID Claims to Federal Court

By Kaitlynn Milvert

As nursing homes face wrongful death claims amid the COVID-19 pandemic, they increasingly have pursued a common litigation strategy: attempting to reroute state tort lawsuits to federal court.

A recent ruling in the Third Circuit Court of Appeals rejected this tactic. As the first court of appeals ruling on this issue, the decision avoids extending a federal statute limiting pandemic liability into unprecedented areas and defines at least some limits on the statute’s effect on state tort suits. Read More

Police car.

New Data Highlights Complexity of Good Samaritan Overdose Law Landscape

By David Momjian

Since 1999, over 800,000 people have died from a drug overdose in the United States, with more than half of those deaths (500,000) resulting from opioid overdose.

Additionally, all 50 states have experienced a spike in overdose deaths in the wake of the COVID-19 pandemic. In the 12-month period ending in May 2020, 81,000 drug overdose deaths occurred in the United States; the highest number of overdose deaths ever recorded in a 12-month period.

To combat the rising death toll from drug overdoses, 47 state legislatures and the District of Columbia have passed Good Samaritan laws (GSLs) to protect bystanders from criminal prosecution if they call for medical assistance during a drug overdose. Bystanders to a drug overdose are often worried that by calling for help, they could be arrested for drug possession or evicted by the police, who often arrive first at the scene of a 911 call, even if it is a medical emergency.

A new dataset built by the Center for Public Health Law Research at Temple University’s Beasley School of Law and funded by Vital Strategies, covers the evolution of GSLs in the United States from January 1, 2007, to June 1, 2021.

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