The American Hospital Association (AHA) is pushing back on a proposed FDA rule to regulate diagnostic tests developed in hospital and health system laboratories, claiming it would “pose nearly unsurmountable burdens and costs” for both the labs and the agency.

The rule, which the FDA proposed in September 2023, would allow the agency to regulate laboratory developed tests, or LDTs, in the same manner it regulates medical devices. The FDA says it needs to regulate the tests to make sure they’re safe and accurate, while the hospital trade group claims FDA regulation would be exceedingly costly and stifle innovation.

“While we support the need for additional oversight of the development and use of some LDTs and in-vitro diagnostics (IVDs) offered as LDTs, the FDA’s proposal to apply its device regulations to hospital and health system LDTs is misguided,” Stacey Hughes, EVP of government relations and public policy at the AHA, wrote in a letter sent to Senator Bill Cassidy, a Louisiana Republican and ranking member of the Health, Education, Labor, and Pensions Committee, on April 1.

What exactly are LDTs? Hospitals and health systems sometimes have in-house labs that develop tests for conditions for which there are no commercially distributed tests, like cancer or rare diseases, according to the AHA.

Keep reading here.—MA

Do you work in healthcare or have information about the industry that we should know? Email Maia at [email protected]. For confidential conversations, ask Maia for her number on Signal.

Clinicians thrive with the right competency development, which is why they need individualized training. After all, one-size-fits-all doesn’t exactly fly for, well, all.

That’s why the HealthStream Competency Suite+ helps meet each of your clinicians’ specific needs. Their competency development experience cultivates the ability to:

• Identify knowledge and clinical judgment strengths and opportunities.
• Target development and validate skills.
• Measure competency-based performance.
• Build next-level preceptors.

HealthStream even has a Competency Management for the Next Generation webinar to help you dig into the details of clinical competency development—especially with the help of AI.

Tune in to their on-demand webinar to see how you can leverage AI to accelerate, individualize, and maximize learning time.

Connect to better competency management.

In what could either be a very elaborate April Fools prank or just plain bad news for employers looking to sponsor health workers from abroad, the US Citizenship and Immigration Services (USCIS) raised fees for employment-based visa applications on April 1.

Sadly, unlike with the Empire State Building’s Rainforest Café announcement, it doesn’t feel like USCIS is about to come out with a “Haha, gotcha!” anytime soon.

One affected visa in particular may spell consequences for the healthcare industry: the H-1B, the most commonly used visa for foreign workers. Under the new USCIS rule, the petition fee for the H-1B (known as Form I-129) jumped to $780 from $460, a 70% increase, and the H-1B registration process fee increased from $10 to $215—a 2,050% hike.

Keep reading here.—QS

Do you work in healthcare or have information about the industry that we should know? Email Quinn at [email protected]. For confidential conversations, ask Quinn for their number on Signal.

A new digital platform from Kenvue, the spinoff company of brands that previously were part of the Johnson & Johnson consumer division, includes content that helps readers know what to expect beyond hot flashes. Articles on the site address topics including why dry skin or acne may increase among people going through menopause, how those with ADHD may find that menopause worsens the symptoms, and a buying guide for lubricants for those with the common symptom of vaginal dryness.

Visitors to the site also can book video appointments with physicians and nurse practitioners who specialize in menopause and who, along with suggesting lifestyle changes and other care, can write prescriptions for hormonal treatments and other medications.

The appointments, which cost $92 for an initial video visit and $54 for follow-ups, are enabled by a partnership between Kenvue and Wheel, the telehealth startup that launched in 2018.

Keep reading at Retail Brew.—AAN

The prescription for better reach. Health and pharma brands know how challenging it is to reach the right audience—but CMI Media Group might have the cure. Their Empower™ operating system uses proprietary audience tools to foster 100% media reach with always-on, trigger-based plans that are precise, personalized, and cost effective. Expand your reach.