Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

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Drawing inspiration from the World War II “Why We Fight” campaign that rallied support for the U.S. war effort, American Medical Association (AMA) President Jesse M. Ehrenfeld, MD, MPH, drew comparisons with the uphill battles physicians are facing today with dwindling reimbursements, physicians shortages, burnout and administrative fights against prior authorization burdens and attempts to preserve access to telehealth. #AMA #AMAHOD24 #AMAHOD2024 #HOD #HOD24 #HOD2024

AMA president calls for physicians to take war-time footing in fight over reimbursement, care quality

Drawing inspiration from the World War II “Why We Fight” campaign that rallied support for the U.S. war effort, AMA President Jesse  Ehrenfeld, MD, spoke on the uphill battles physicians are facing today.

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California bill: Private equity firms must seek AG approval for healthcare buyouts

California Assembly bill AB-3129 requires private equity investors to send an application to the state attorney general 90 days before they purchase a hospital or provider group.

FDA panel recommends new COVID-19 booster

Booster uptake rates remain low. To date, only 22.5% of Americans received an annual COVID-19 shot from 2023.

Moon Surgical gets FDA approval for mission launch of surgery robot

The Maestro robot aids surgeons by holding tools and providing real-time analysis of a surgery.

FDA announces recall of Medtronic brain surgery support systems

Medtronic has issued a recall affecting several versions of its StealthStation S8 due to a software error that puts patients at risk of serious injury or death.

Heart Rhythm Society (HRS) President Kenneth Ellenbogen, MD, FHRS, director of clinical cardiac electrophysiology and pacing, Virginia Commonwealth University, discussed two key initiatives for 2024-25 with Cardiovascular Business. These include helping create a new, independent cardiovascular medicine board, and supporting the movement toward more outpatient procedures being performed in office-based labs (OBL) and ambulatory surgical centers (ASC). #EPeeps #HRS #HRS24 #HRS2024

Heart Rhythm Society shows support for new cardiovascular board, outpatient EP centers

Cardiovascular Business spoke with HRS President Kenneth Ellenbogen, MD, about two key initiatives the group is focused on this year.

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Q&A: Healthcare cybersecurity advocate fears damage from Change Healthcare breach has only begun

Richard Staynings says the breach of Change Healthcare’s systems stems from consolidation, and the impact may devastate independent providers.

HHS: ‘Who is responsible for ensuring that individuals affected by the Change Healthcare breach receive notification?’

HHS’s Office for Civil Rights (OCR) has confirmed UnitedHealth Group can send out HIPAA-required notifications about the breach but stopped short of saying the company will be responsible for doing so.

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Around the web

Cardiovascular Business
FDA says years-long tirzepatide shortage is resolved, will give limited leeway to compounders

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.