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.

UnitedHealthcare sues national dialysis chain for fraud

UnitedHealthcare is suing a national dialysis company, claining American Renal Associates has been exploiting the insurance provider and its own poorer patients for money collected from dialysis treatment.

July 5, 2016

Senate committee discusses changes to physician self-referral law

The Stark law, which prohibits physician referrals for Medicare services to entities with which they share a financial relationship, is due for an overhaul, according to a report released by Senate Finance Committee Chairman Orrin Hatch, R-Utah.

July 5, 2016

FDA-approved stomach-draining device may face lawsuit

The Food and Drug Administration has approved several new weight loss interventions in the past year, but one in particular seems to be raising eyebrows among physicians.

July 5, 2016

NIH-funded study will track Zika infections on U.S. Olympic team

Athletes, coaches and staff traveling to Brazil as part of the 2016 Summer Olympics and Paralympics will be monitored by researchers for potential exposure to the Zika virus.

July 5, 2016

Largest generic drug company may join PhRMA

The trade association for brand-name drug manufacturers could soon count the largest generic drug maker among its members—and the brand-name companies aren’t entirely comfortable with the idea.

July 5, 2016

Nearly 600 U.S. clinics could be selling unregulated stem cell treatments

The risks of “stem cell tourism” might be overplayed, according to a new paper published June 30 in the journal Cell Stem Cell. But only because the real risks of unregulated stem cells might actually be within the U.S. 

July 1, 2016

1.6 million ACA exchange customers dropped out by March

Nearly 13 percent of the 12.7 million people who bought coverage on the Affordable Care Act’s health insurance marketplaces for 2016 had dropped out by the end of March.

July 1, 2016

AstraZeneca takes on FDA over Crestor patent

AstraZeneca’s cholesterol medicine Crestor’s patent protection is set to expire July 8, according to FDA standards, but the company has other plans for the drug. 

June 30, 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.