IHA Daily Briefing: September 23

White House Issues Proclamation Changing the H-1B Visa Program

A Sept. 19 proclamation signed by President Trump increases the fee to $100,000 for new H-1B petitions filed by employers, and implements additional restrictions on the entry of certain nonimmigrant workers. These restrictions began on Sept. 21 and will expire after 12 months if not extended.

An FAQ webpage maintained by the U.S. Citizenship and Immigration Services said the proclamation does not apply to any previously issued H-1B visas or any petitions submitted prior to Sept. 21. The proclamation does not change any payments or fees required to be submitted in connection with any H-1B renewals.

According to the proclamation, application fees can be waived at the discretion of the Secretary of Homeland Security if it is determined that the hiring of these workers is in the national interest. It is currently unclear if healthcare workers could qualify for the exemption process.

IHA is reviewing the memo from the U.S. Dept. of Homeland Security and will continue to advocate for exemptions. IHA will work with the American Hospital Association as we evaluate the potential impact of these policy changes on hospitals and health systems and the patients and communities you serve.

FDA Initiates Acetaminophen Label Change Citing Use Concerns for Pregnant Women

On Monday, the Food and Drug Administration (FDA) initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence the FDA says suggests that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children, according to an FDA news release. The agency also issued a related letter alerting physicians nationwide.

"The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen," said FDA Commissioner Marty Makary, MD, MPH. "Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don't require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios."

The FDA statement noted that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children. Aspirin and ibuprofen are not approved, with the FDA emphasizing they, "have well-documented adverse impacts on the fetus."

In response to the FDA announcement, several medical, research and autism advocacy groups decried the claims.

The American Academy of Pediatrics (AAP) said the White House event announcing the action was "filled with dangerous claims and misleading information." The AAP also emphasized, "Studies have repeatedly found no credible link between life-saving childhood vaccines and autism. This research, in many countries, involving thousands of individuals, has spanned multiple decades. Any effort to misrepresent sound, strong science poses a threat to the health of children."

To view the FDA news release, click here. To view the full statement from AAP, click here.

IDPH Stresses Tick Bite Protection, Points to Recent Powassan Illness

The Illinois Dept. of Public Health (IDPH) sent a public statewide announcement yesterday encouraging Illinoisans to take appropriate precautions against tick bites after an Illinois resident became seriously ill with Powassan-a tickborne illness that had not previously been detected in this state. IDPH and the local health department are currently investigating whether the resident was exposed to the illness through a tick bite here in Illinois or in a different state.

Powassan cannot be spread human-to-human through casual contact, and IDPH emphasized although ticks can spread other serious illnesses, including Lyme Disease and Rocky Mountain Spotted Fever, the risks associated with tick bites are low if appropriate precautions are taken. Click hereto view the IDPH communication, which includes resources with information on how to protect against tickborne illnesses.

TJC, Coalition for Health AI Releases AI Healthcare Guidance

The Joint Commission (TJC) and the Coalition for Health AI (CHAI) recently released guidance on the responsible use of artificial intelligence (AI) in healthcare, intended to assist hospitals and health systems in safely using AI technology. The guidance document outlines seven recommendations on AI policies, including oversight, deployment and monitoring of AI while ensuring patient safety, data security and transparency. The guidance identifies seven elements of responsible AI use in healthcare, including AI policies and governance structures; patient privacy and transparency; data security and data use protections; ongoing quality monitoring; voluntary, blinded reporting of AI safety-related events; risk and bias assessment; and education. CHAI and TJC plan to release further guidance and a playbook by year's end.