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.

Hospitals, physicians want ACA to remain unchanged

Hospitals, physicians and health insurers are hoping the Supreme Court rules in favor of the defendant in the King v. Burwell case, NPR reports.

March 4, 2015

Overview of the King v. Burwell Supreme Court case

With the Supreme Court hearing oral arguments in the King v. Burwell case on March 4, the Washington Post reports the case is the biggest challenge to the Patient Protection and Affordable Care Act in three years.

March 3, 2015

Federal government sends erroneous tax information to 800,000 people buying insurance

The federal government made mistakes in sending tax information to 800,000 people who received subsidies to help pay for their health insurance, the Associated Press reports.

March 2, 2015

Ruling in the King v. Burwell Supreme Court case may cause millions to lose insurance

On March 4, the Supreme Court will hear arguments in the King v. Burwell case, which could affect millions of people.

March 2, 2015

WEDI offers ICD-10 testing guidance for small providers

A new white paper serves as an instructional guide to ICD-10 testing for small providers.

March 2, 2015

Former employee sues hospital operator for unnecessary procedures and illegal billing

A former claims director filed a lawsuit against HCA Holdings alleging the company performed unnecessary cardiology procedures and submitted false claims, the Wall Street Journal reports.

February 27, 2015

Nearly 9 million people sign up for coverage through health insurance marketplace

During the open enrollment period that ended on Feb. 22, more than 8.8 million people signed up for coverage through HealthCare.gov.

February 27, 2015

CMS updates hospital outpatient rates and ambulatory surgical center payments

The Centers for Medicare & Medicaid Services made changes to outpatient rates and ambulatory surgical center payments for 2015, Healthcare Finance reports.

February 27, 2015

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.