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Editor’s take – Health care and life sciences: The war in Ukraine, the next phase of the pandemic and the No Surprises Act

Medicine being stored in a warehouse for distribution in Ukraine
(Image credit: Getty Images)

The reading habits of SmartBrief’s health care and life science audiences provide a unique window into the priorities and interests of professionals across these industries, and our newsletter engagement data sheds light on what intrigues our readers along with the challenges they face. We serve health care insurers, clinicians and IT professionals, as well as audiences in pharma and medtech. Here’s what was top of mind for all of them in Q1, plus a look at what’s next.

War in Ukraine

As war broke out in Europe, the effects of Russia’s invasion of Ukraine reverberated throughout the global biopharmaceutical industry, with operations on hold at Kyiv-based Enamine and clinical trials in Ukraine in question. Over 400 biotech CEOs, executives and biopharma investors signed an open letter condemning Russia’s actions in Ukraine and urged the industry’s “immediate and complete economic disengagement.” Readers of all types mobilized to help, from scientists to veterinarians.

What’s next:

War boosts demand for some drugs and medical products but can also devastate pharmaceutical markets of sanctioned countries and their suppliers, allowing counterfeit drugs to fill voids and fund continuing conflict. Drugmakers may also be targets for cyberwarfare and security experts have warned that health care is among the US business sectors that could face an increased risk of cyberattacks if the US or NATO becomes more involved in the Russia-Ukraine conflict.

The next phase of the pandemic

Early in the 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 expect more new variants to appear. Already, researchers have identified a hybrid coronavirus dubbed “Deltacron” that combines the Delta and Omicron variants’ genes. Last month, experts warned the US could experience surges similar to those seen in Europe, possibly driven by 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, along with some immunocompromised individuals, at least four months after their initial booster. The CDC said it would include that action in its vaccine guidance. The CDC also significantly relaxed nationwide mask guidelines during the first quarter, advising that Americans residing in areas with low or medium community levels do not need to use masks in public or indoor settings.

In another step into the next phase of the pandemic, the FDA decided to restart routine domestic surveillance inspections and continues to proceed with previously planned foreign surveillance inspections that have received country clearance and are within the CDC’s Level 1 or Level 2 COVID-19 travel recommendation. The FDA said it will take a risk-based approach to prioritizing inspections and will continue recognizing assessments made by regulatory bodies in countries with which it has mutual recognition agreements. It will also continue conducting remote interactive evaluations.

What’s next:

Epidemiologists who have created COVID-19 pandemic modeling for government officials in the UK say it’s possible the future will bring significant waves of infection, depending on factors like new variants and waning population immunity, and that “a steady, predictable pattern … may be many years away.”

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

No Surprises Act

A new law went into effect in January that prohibits surprise medical bills for patients with medical emergencies who are treated at hospital emergency departments or urgent care centers or by health care providers that are outside 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 HHS’ rule governing settlement of payment disputes over unexpected out-of-network medical bills. The court objected to a provision stating that arbiters should assume the correct amount for payment is the median payment typically provided for the service in that geographic area.

What’s next:

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

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More top news

Check out a snapshot of more top health care and life sciences stories from Q2 below.

Califf confirmed by Senate to lead FDA a 2nd time

CMS to penalize 764 hospitals for high complications

FDA warns Eli Lilly over Trulicity Instagram post

FDA rescinds approval of 29 new drug applications

CDER unveils list of guidances for release this year

FDA offers final guidance on combination products

Ciox Health breach affects 32 hospitals, health systems

CMS updates health worker vaccine rule in 24 states

Primary care shortage among hospital CEOs’ top concerns

AI predicts next coronavirus animal hosts

CMS releases OTC COVID-19 testing guidance for insurers

Biden announces COVID-19 antiviral treatment program

CDC: Boosters can prevent COVID-19 hospitalization

Rules require coverage of 8 home COVID-19 tests monthly