Stethoscope with blue suitcase on a table with American flag as background.

Is a Federal Medical License Constitutional?

By Timothy Bonis

Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize.

This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legislative approaches, and speculate on how the late Roberts Court might respond to reform attempts.

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Medical student textbooks with pencil and multicolor bookmarks and stethoscope isolated on white.

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

By Ameet Sarpatwari, Alexander Egilman, andAaron 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 the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

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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.

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

By Ameet Sarpatwari, Liam Bendicksen, Alexander Egilman, andAaron 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 August. The selections feature topics ranging from a discussion of opportunities for improving the use of U.S. Food and Drug Administration (FDA) advisory committees, an analysis of the key patents covering drugs recently approved by the FDA, and an examination of high-risk cardiovascular devices approved by the FDA for use in children and adolescents. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, D.C. skyline with highways and monuments.

COVID-19 as Disability Interest Convergence?

By Jasmine E. Harris

Some have suggested that the COVID-19 pandemic could be a moment of what critical race theorist Derrick Bell called “interest convergence,” where majority interests align with those of a minority group to create a critical moment for social change.

It would be easy to think that interests indeed have converged between disabled and nondisabled people in the United States. From education to employment, modifications deemed “unreasonable” became not only plausible but streamlined with broad support.

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3d render, abstract fantasy cloudscape on a sunny day, white clouds fly under the red gates on the blue sky. Square portal construction.

A Different Future Was Possible: Reflections on the US Pandemic Response

By Justin Feldman

The inadequacies of the early U.S. pandemic response are well-rehearsed at this point — the failure to develop tests, distribute personal protective equipment, recommend masks for the general public, protect essential workers, and take swift action to stop the spread.

But to focus on these failures risks forgetting the collective framing and collective policy response that dominated the first few months of the COVID-19 pandemic. And forgetting that makes it seem as though our current, enormous death toll was inevitable. This dangerously obscures what went wrong and limits our political imagination for the future of the COVID-19 pandemic and other emerging crises.

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2020 San Pedro California April 30: Federal Correctional Institution Terminal Island prison. Half the inmates there were infected with coronavirus.

Carceral Health Care Is Designed to Fail

By Andrea C. Armstrong

COVID-19 is not the first pandemic within prisons. Modern history is littered with examples of disease outbreaks in carceral spaces, including tuberculosis, influenza, and MRSA. Like these earlier carceral pandemics, the over 620,000 COVID-19 infections and 3,100 related deaths among incarcerated individuals to date simply expose how U.S. health law and policy fails to protect people in custody.

Only incarcerated people have a constitutional right to healthcare in the United States. That right, however, is rendered toothless when supplied through a punitive system that lacks meaningful standards and robust oversight.

Here is what we know — despite the secrecy that shields penal institutions — about carceral health care.

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Bill of Health - A worker gives directions as motorists wait in lines to get the coronavirus (COVID-19) vaccine in a parking lot at Dodger Stadium, Friday, Jan. 15, 2021, in Los Angeles, covid vaccine distribution

Countercyclical Aid Is Not Enough to Fix the Broken US Approach to Public Health Financing

By Philip Rocco

In the last month, the U.S. Centers for Disease Control and Prevention’s failed responses to COVID-19, ranging from “testing to data to communications,” have prompted a call to reorganize the agency.

Yet restructuring the CDC will have little effect on pandemic preparedness if the decentralized American approach to health finance remains in place. This structure was already stripped bare by decades of state and local austerity even before the first cases of COVID-19 were identified, and has been further worn down since 2020.

If the pandemic has taught us anything about public policy, it is that the model of countercyclical federal aid — which expands at the onset of an economic crisis but abates as that crisis is resolved — is fundamentally inadequate when applied to the realm of public health.

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

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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 April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

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Pill pack.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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Waiting area in a doctor's office

Churntables: A Look at the Record on Medicaid Redetermination Plans

By Cathy Zhang

The COVID-19 Public Health Emergency (PHE) expires at the end of this week, with Department of Health and Human Services (HHS) Secretary Xavier Becerra expected to renew the PHE once more to extend through mid-July.

When the PHE ultimately expires, this will also trigger the end of the Medicaid continuous enrollment requirement, under which states must provide continuous Medicaid coverage for enrollees through the end of the last month of the PHE in order to receive enhanced federal funding. This policy improves coverage and helps reduce churn, which is associated with poor health outcomes.

After the PHE, states can facilitate smooth transitions for those no longer eligible for Medicaid by taking advantage of the full 12- to 14- month period that the Centers for Medicare & Medicaid Services (CMS) has established for redetermining eligibility.

In August 2021, CMS released guidance giving states up to 12 months following the end of the PHE to redetermine whether Medicaid enrollees were still eligible and renew coverage. Last month, CMS released new guidance specifying that states must initiate redeterminations and renewals within 12 months of the PHE ending, but have up to 14 months to complete them. The agency is encouraging states to spread its renewals over the course of the full 12-month unwinding period, processing no more than 1/9th of their caseloads in a month, in order to reduce the risk of inappropriate terminations.

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