Editor’s Note – Health Care and Life Sciences: The War in Ukraine, the Next Phase of the Pandemic, and the Law with No Surprises

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SmartBrief’s reading habits of healthcare and life sciences audiences offer a unique window into the priorities and interests of professionals in these industries, and our newsletter engagement data shines a light on what’s intriguing. our readers and the challenges they face. We serve healthcare insurers, clinicians and IT professionals, as well as audiences in the pharmaceutical and medical industries. Here’s what was on top for each of them in Q1, plus a look at what’s next.

War in Ukraine

When war broke out in Europe, the effects of Russia’s invasion of Ukraine rippled through the entire global biopharmaceutical industry, with operations suspended at Kyiv-based Enamine and clinical trials in Ukraine in question. More than 400 biopharmaceutical CEOs, executives and investors have signed an open letter condemning Russia’s actions in Ukraine and urging “immediate and complete economic disengagement” from the industry. Readers of all types have stepped up to help, from scientists to veterinarians.

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War stimulates demand for some drugs and medical products, but can also devastate the pharmaceutical markets of sanctioned countries and their suppliers, allowing counterfeit drugs to fill voids and fund lingering conflicts. Drugmakers could also be targets of cyberwars and security experts have warned that healthcare is among US business sectors that could face an increased risk of cyberattacks if the US or NATO steps in. involved more in the Russian-Ukrainian conflict.

The next phase of the pandemic

Earlier this year, President Joe Biden extended the national public health emergency for the COVID-19 pandemic past March 1, and World Health Organization officials said they will expected more new variants to appear. Already, researchers have identified a hybrid coronavirus dubbed “Deltacron” which combines the genes of the Delta and Omicron variants. Last month, experts warned that the United States could experience surges similar to those seen in Europe, likely due to the BA.2 subvariant.

To mitigate the ongoing effects of the pandemic, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, as well as some immunocompromised individuals, at least four months after their initial booster. The CDC said it would include this action in its vaccine guidelines. The CDC also significantly relaxed nationwide mask guidelines in the first quarter, advising that Americans residing in low- or mid-level community areas do not need to use masks in public or indoor settings.

In another step in the next phase of the pandemic, the FDA has decided to restart routine domestic surveillance inspections and continues to conduct previously scheduled overseas surveillance inspections that have received country clearance and are compliant. CDC Level 1 or 2 COVID-19 travel recommendations. . The FDA said it will take a risk-based approach to prioritizing inspections and will continue to recognize assessments performed by regulatory agencies in countries with which it has mutual recognition agreements. It will also continue to conduct interactive remote assessments.

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Epidemiologists who created the modeling of the COVID-19 pandemic for government officials in the UK say it is possible the future will bring significant waves of infection, depending on factors such as new variants and waning population immunity, and that “a stable and predictable pattern…may be many years from now.

National Institute of Allergy and Infectious Diseases Director Anthony Fauci has warned that there are five stages of a pandemic, with the whole world negatively affected, as it is now, being the first stage. . The following phases consist of deceleration, control, elimination and finally eradication.

law without surprise

A new law came into effect in January that prohibits surprise medical bills for patients with medical emergencies who are treated in hospital emergency departments or urgent care centers or by health care providers who are not part of their insurance networks. Patients will not be responsible for costs beyond their normal cost sharing.

However, in February, Texas Judge Jeremy Kernodle struck down part of the HHS rule governing the settlement of payment disputes over unexpected out-of-network medical bills. The court objected to a provision stating that arbitrators should assume that the correct payment amount is the median payment generally provided for service in that geographic area.

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It is possible that the February decision will be appealed and similar lawsuits are pending. Meanwhile, the American Hospital Association has asked CMS to delay enforcing the rule until the process of providing cost estimates can be automated. He also asked CMS to eliminate the procedure-specific insurance verification requirement, submit invoices to the dispute resolution process only if they are 10% higher than good faith estimates, and align the rule on other federal price transparency mandates. More broadly, all signs point to continued efforts to improve price transparency.

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More news

Check out an overview of the top Q2 healthcare and life sciences stories below.

Califf confirmed by Senate to lead FDA for second time

CMS will penalize 764 hospitals for high complications

FDA warns Eli Lilly against Trulicity Instagram post

FDA cancels approval of 29 new drug applications

The CDER unveils the list of guidelines to be published this year

FDA proposes final guidelines on combination products

Ciox Health breach affects 32 hospitals and health systems

CMS updates health worker vaccination rule in 24 states

Primary care shortage among top concerns for hospital CEOs

AI predicts next animal hosts of coronavirus

CMS issues OTC COVID-19 testing guidance for insurers

Biden announces COVID-19 antiviral treatment program

CDC: Recalls may prevent COVID-19 hospitalization

Rules require coverage of 8 at-home COVID-19 tests per month

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