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.

Mangione now faces federal charges, death penalty in murder of UHC CEO
After Luigi Mangione, the man accused of killing UnitedHealthcare CEO Brian Thompson, was extradited to New York, federal prosecutors unsealed a new set of murder charges.
FDA issues Class I recall on counterfeit infusion pump batteries
ICU Medical alerted customers to knockoff batteries being circulated by suppliers. Due to a risk of the batteries not holding a charge, the recall has been given the FDA’s most serious designation.
FDA issues alert on PCNL sheath safety after patient death
Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture.
DOJ sues CVS over unlawful opioid prescriptions and reimbursement
The U.S. Department of Justice said policies at CVS Health forbade pharmacists from discussing patients and providers who may be prescribing opiates in violation of the Controlled Substance Act.
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.

Patients receiving big discounts for paying in cash

A recent story in the Wall Street Journal examined this trend, providing numerous examples of patients saving more than $500 on procedures by simply paying in cash up front instead of going through insurance. 

February 24, 2016

What’s on TV? Ads for expensive drugs to fight rare conditions

Americans who watch at least a few hours of TV each week are used to getting urged to ask their doctors about all sorts of medications that, chances are, they really don’t need.  

February 23, 2016

Coalition outlines 6 steps to innovate U.S. healthcare system

The Healthcare Leadership Council (HLC), a coalition of executives representing health providers, insurers, manufacturers and patient advocacy groups, has issued six recommendations it believes can be implemented today to improve healthcare in the U.S.

February 18, 2016

Scalia's death will affect ACA-related Supreme Court case

A recent question-and-answer article prepared by the Associated Press and published by the Chicago Tribune (and others) examined the impact Supreme Court Justice Antonin Scalia’s death  could have on existing cases in 2016. 

February 16, 2016

CMS publishes final rule on overpayments for Medicare Parts A and B

CMS has published a final rule that requires healthcare providers and suppliers receiving funds from Medicare Part A and Part B to report and return overpayments within 60 days of first identifying them. 

February 11, 2016

Burwell has faith remaining states will embrace Medicaid expansion

HHS Secretary Sylvia Mathews Burwell spoke to reporters last week about the Affordable Care Act’s 2016 open enrollment figures and the future of healthcare in the U.S. 

February 10, 2016

Longer hours show no significant impact on resident satisfaction or patient care

Surgical residents who are allowed to work longer hours than currently allowed so that they can stay with or stabilize patients do not show any signs of putting their patients at risk, according to a recent study published by the New England Journal of Medicine. 

February 4, 2016

State of California fines hospital more than $86,000 for towel left inside of a patient

The California Department of Public Health fined the Community Regional Medical Center $86,625 after a hospital employee left a towel inside a patient following abdominal surgery, the Fresno Bee reports. This is the hospital’s fourth penalty since 2007.

February 1, 2016

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.