Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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Person smoking cigarette.

Graphic Warnings on Cigarettes: Public Health vs. Corporate Speech

By Laura Karas

The latest attempt of the U.S. Food and Drug Administration (FDA) to make a dent in the country’s intractable tobacco problem is a set of color graphic warnings that will appear on cigarette packages and advertisements beginning in June of 2021.

The legal battle surrounding the graphic warnings and other attempts to regulate commercial speech in the food and drug context illustrate the courts’ enduring failure to appreciate the full extent and substantiality of the government’s interest in promoting public health.

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doctor holding clipboard.

The Inherent Value of Patient Safety Reports as Key Educational Tools

By John Tingle

Many patient safety adverse events across the National Health Service (NHS) in England have common causes, which exist regardless of clinical specialty, such as failures in communication, poor record keeping, and poor staffing levels.

This commonality of cause means that patient reports emanating from various clinical areas can have general, health system-wide value, relevance, and application. From these reports, it is possible to extrapolate generally applicable patient safety themes that can apply in a wide range of health care settings.

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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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Supreme Court of Mexico.

How Does the Mexican Constitution Regulate Crisis?

By David García Sarubbi

When the Mexican Constitution was issued in 1917, one of its main concerns was to regulate how democracy must deal with crisis, that is, with exceptional situations that demand the exercise of powers outside the Constitution’s regular limits to suppress potential dangers.

There is not an “off switch” available for political powers to put the Constitution to rest while solving urgent issues. Instead, there are complex rules to govern decisions in extraordinary circumstances.

The Constitution’s Article 29 has a Suspension Clause, which contains a detailed regulation for such cases. Moreover, in Article 73, Section XVI, there is another regulation relating to pandemics like the one we are experiencing currently.

Thus, from the founding era, the Mexican constitution has upheld the value of the rule of law, even in extraordinary circumstances.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Regulation of Access to Clinical Data in Chile’s New Constitution

By Gabriela Y. Novoa and Alexis M. Kalergis

As Chileans prepare to vote on whether or not to create a new Constitution, an issue worth considering relative to this reform concerns access to clinical data.

The Political Constitution of the Republic of Chile dates back to 1980, and, in the past decades, has undergone several amendments, including key reforms in August 1989, August 2005, and August 2019. As part of this last modification, it was agreed to organize a plebiscite to democratically decide whether or not to elaborate an entirely new constitutional text. If the alternative of generating a new constitution is adopted, it will consist of a constitution written from square one, rather than a modification to the existing text.

As part of the public discussion relative to the potential approval of the need for a new constitution, an open debate has taken place about which issues should or should not be incorporated into this new text.

Among several important themes, the need to regulate the access to clinical data of patients, also called “interoperability,” arises as a major one. Such an issue is linked to the rights to life, to health and privacy protection, individual honor and personal data and property, which are currently established as constitutional guarantees by Article 19 of the current Constitution. Further, the legal framework dealing with this issue is currently mainly found in Law No. 20,584, which regulates the Rights and Duties of individuals in connection with actions associated to their health care, and in Law No. 19,628 (on the protection of the privacy of individuals).

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Map of United States made up of pills.

The Opioid Multidistrict Litigation, Federal Rule 23, and the Negotiation Class

By Laura Karas

A recent Sixth Circuit decision dashed hopes of a faster resolution to the federal opioid multidistrict litigation (MDL).

The MDL (In re National Prescription Opiate Litigation, Docket No. 1:17-md-02804) consolidated many thousands of suits against opioid makers and distributors.

Thus far, action in the MDL has presaged the enormity of corporate responsibility for the opioid crisis. Roughly one year ago, the first bellwether trial in the MDL, involving two Ohio counties, was averted due to a last-minute settlement by Teva Pharmaceuticals and the “Big Three” drug distributors (AmerisourceBergen, Cardinal Health, and McKesson). A $465 million verdict last year against Johnson & Johnson “abated” one year’s worth of damage to the state of Oklahoma from the opioid crisis, which was held to be a public nuisance under Oklahoma law. And another bellwether trial involving pharmacy chains including Walgreens and CVS is scheduled to take place next year, despite the pharmacy chains’ strong pushback.

As part of the MDL, the U.S. District Court for the Northern District of Ohio had certified a new kind of class, distinct from a litigation or settlement class — a “negotiation class” of cities and counties throughout the United States — under Federal Rule of Civil Procedure 23, the Federal Rule that governs class actions.

But on September 24, a decision by the U.S. Court of Appeals for the Sixth Circuit reversed this decision.

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WHO flag.

A Dose of Perspective on World Patient Safety Day

By John Tingle

The second World Health Organization (WHO) World Patient Safety Day was held on September 17th, 2020.

WHO made a call for global support, commitment, and collective action by all countries and international partners to improve patient safety. The theme for the year is “health worker safety: a priority for patient safety.”

The annual WHO World Patient Safety Day campaign is a welcome one, especially in the context of the COVID-19 pandemic.

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Man in hospital.

Following the Yellow Brick Road Toward Hospital Price Transparency

By Laura Karas

The Center for Medicare and Medicaid Services (CMS) scored a victory on the price transparency front in June of this year with the D.C. Circuit decision in American Hospital Association v. Azar, No. 1:19-cv-03619-CJN.

The CMS final rule at issue in the suit requires price transparency for hospital items and services. The legal victory will begin to remedy the information asymmetry that has kept patients in the dark about hospital prices for far too long.

As the final rule states, its aim is to empower patients to become “active consumers” of health care “so that they can lead the drive towards value.” The rule is part of a federal effort to improve the ability of patients to make informed choices based on price and gain leverage to negotiate unreasonable hospital charges.

The American Hospital Association, the Association of American Medical Colleges, and several other groups brought suit to contest the CMS final rule mandating that hospitals make public and update annually certain “standard charges” for hospital “items and services.”

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