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. 

Lehigh Valley Hospital

Lehigh Valley Health admits to controlled substances violations in $2.75M settlement

The Pennsylvania-based health system reported drug diversion incidents to authorities involving a pharmacy technician who used employee passwords to steal pills from one of its hospitals.

the words "FDA recall" on a board

Sanitation issue forces FDA recall of ventilator suction systems

Ballard Closed Suction Systems will need to be returned to the manufacturer for a refund due to the high risk of a potentially fatal infection stemming from their use.

An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.

Medicare now covers TriClip procedures for patients with symptomatic tricuspid regurgitation

CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development.

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CVS hit with $949M judgment over fraudulent Omnicare prescriptions

The pharmacy chain said it plans to appeal the ruling. The complaint was brought by a former employee turned whistleblower who alleged that Omnicare had billed the government for millions of unnecessary prescriptions.

UnitedHealthcare HQ Sign

Report: DOJ questioning doctors linked to possible Medicare fraud at UnitedHealth

According to the Wall Street Journal, the OIG and FBI are also involved in the DOJ's criminal probe into alleged incidents of upcoding by the Medicare Advantage insurer. UnitedHealth denied any wrongdoing. 

FDA issues Class I recall on infant heated wire circuits prone to disconnect

The faulty adapters must not be used. The devices, manufactured under the brand name AirLife, must be identified and quarantined because of the high risk of severe injury or death associated with the malfunction.

AMA continues fight against scope of practice creep

The American Medical Association had 180 scope of practice victories around the country, opposing incidents of groups practicing medicine without the proper background and training. However, its efforts to clamp down are being challenged. 

VA halts mass layoffs, still shedding 30,000 jobs by 2026

Veterans Affairs said plans to reduce its workforce by 85,000 have been called off. It has instead undertaken other efforts to improve efficiency. As for the 30,000 jobs it expects to lose by the end of 2025, those will come from early retirements.

Around the web

Heartflow, known for its AI-based CCTA evaluations, appears to be going public. The news follows years of momentum for the California-based company, including improved Medicare reimbursements for cardiac CT and a new Category I CPT code for its Plaque Analysis software.

Suman Tandon, MD, an American Society of Nuclear Cardiology board member, explains the group's call on Congress to update a number of healthcare policies. 

The 2026 MPFS proposed rule includes higher conversion factors across the board. However, some cardiology groups remain concerned about a series of reimbursement reductions for high-value cardiology services.