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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CMS finalizes outpatient payment system

The final rule updated the OPPS payment rate by 3.8% for calendar year 2023, which CMS based on the 4.1% projected hospital market basket percentage increase and adjusted for 0.3 percentage points for productivity. 

 

Medicare money payment physician

CVS, Walgreens settle opioid lawsuits for $10B

CVS Health will pay $5 billion over the next 10 years, and Walgreens will pay $4.95 billion over the next 15 years.

Providers face ‘ominous reality’ of payment cuts as CMS finalizes 2023 Physician Fee Schedule

Physicians are now bracing for payment cuts after the Centers for Medicare and Medicaid Services (CMS) published its final rule for the 2023 Physician Fee Schedule.

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Two Florida women sentenced to prison for falsifying clinical records

Two women in Florida have been sentenced to prison for their roles in a conspiracy to falsify clinical trial data.

Sutter Health to pay $13M in settlement over improper billing

The healthcare provider allegedly billed for toxicology tests performed by outside labs for government health programs. 

 

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FDA, DOJ go after e-cigarette companies for breaking the law

“Today’s enforcement actions represent a significant step for the FDA in preventing tobacco product manufacturers from violating the law,” one FDA official said. 

 

Claire Ernst, director of government affairs, Medical Group Management Association (MGMA), explains the list of priorities for the association. These include staving off the large, planned 2023 Medicare reimbursement cuts, fighting for continuation of reimbursements for telehealth, and revamping prior authorizations.

VIDEO: MGMA explains why the COVID-19 public health emergency extension is critical

Claire Ernst, director of government affairs for the Medical Group Management Association, talked to us about why extending the federal COVID-19 health emergency was so important for healthcare providers.

Left, HeartFlow's RoadMap analysis enables cardiac CT readers to identify stenoses in the major coronary arteries. The AI provides visualization and quantification of the location and severity of anatomic narrowings. Right image, HeartFlow's Plaque Analysis AI algorithm automates assessment of coronary plaque characteristics and volume on CCTA exams to greatly reduce the time it takes to manually assess and quantify these features.

HeartFlow gains FDA clearance for 2 new AI-powered imaging assessments

The solutions, Plaque Analysis and RoadMap Analysis, both use coronary CT angiography to provide clinicians with a noninvasive look at patients who present with coronary artery disease and face a heightened myocardial infarction risk.

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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.