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.

House passed three bills in the fight against opioids

The House has passed three bills aimed at reducing opioid addiction in an overwhelming 410-1 vote, reports The Hill.

May 11, 2016

U of C’s $269M hospital expansion, trauma center approved despite criticism of cost

The plan had been criticized in an April by the Illinois Health Facilities and Services Review Board, which said the projected cost was about $18 million too high.

May 11, 2016

CMS seeks insurers to share ACA successes for June forum

Insurers finding success on the Affordable Care Act’s insurance exchanges are being asked to share what they’ve learned at a June CMS forum.

May 11, 2016

Will erasing state lines improve healthcare insurance?

The first in a series of videos from the Kaiser Health Network looks at the proposal to allow sales of policies across state lines.

May 11, 2016

Cybersecurity experts conduct hacker test on medical devices

Cybersecurity experts tested the vulnerability of software and medical devices at a group of hospitals, and they found hacking into the healthcare system is a lot easier than expected, reports WUSA9.    

May 10, 2016

Missouri governor vetoes $500K bill for HIT

Gov. Jay Nixon has vetoed a $500,000 bill that would’ve gone to a health information exchange program because he believes it would have favored one vendor over another.

May 9, 2016

GAO appoints three new members to Health IT Policy Committee

Comptroller General of the United States and head of the U.S. Government Accountability Office (GAO), Gene L. Dodaro, has announced James S. Ferguson, Carolyn Petersen and Karen L. Caulil as the newest members on the Health Information Technology (HIT) Policy Committee. 

May 9, 2016

ACLU: Reproductive health denied at Catholic hospitals

A report by the American Civil Liberties Union (ACLU) and MergerWatch found that one in six hospitals in the U.S. are operated in accordance with Catholic religious rules, leading to the reproductive health of women being left unattended.

May 9, 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.