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.

FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death
The devices are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.
New recall includes nearly 23K bottles of triglycerides drug used to treat heart disease
New Jersey-based Zydus Pharmaceuticals has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness.
Medicare contractor proposes denying coverage for AI-based brain MRI technology
If finalized, the decision would impact radiology providers across Illinois, Minnesota, Wisconsin, Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont.
FTC settles lawsuit against Express Scripts in deal that includes TrumpRx support
The Federal Trade Commission was suing the pharmacy benefit manager over allegations it was deliberately inflating the price of insulin. Per the agreement, Express Scripts has agreed to end business practices that involved taking manufacturer rebates on wholesale drug costs without passing them on to patients.
OIG audit of hospital’s cybersecurity finds vulnerabilities in common web applications
Neither the health system nor the applications were named. Investigators with the U.S. Department of Health and Human Services Office of the Inspector General said they were able to perform a successful phishing attack and breach a portal lacking firewall support. The agency released a report containing the full details.

Walmart workers sue over tobacco fees levied for health plan trust

The class action lawsuit argues employees cannot escape the fees even after they stop using tobacco, a violation of labor regulations.

HHS awards $75M for addiction and maternal health services in rural areas

The funds will be used to expand services and improve the financial stability of existing healthcare organizations located in underserved regions of the South.

Lawmakers likely to delay Medicare doc fix until after election

Scheduling conflicts and “lingering disagreements” are delaying potential changes to the MPFS, along with a radiologist-supported bill to modify the No Surprises Act.

FDA announces Class I recall for compounding inlets due to risk of death

Baxter’s disposable inlets for automated compounding systems could pose a serious risk to patients if not properly inspected before use.

Watchdog group, fearful of fraud, wants more oversight for remote patient monitoring

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Biden administration urges Supreme Court to uphold ACA mandate requiring cost-free cancer screenings

A recent "mixed bag" ruling from the Fifth Circuit Court of Appeals threw the mandate into question, potentially jeopardizing imaging services for millions of Americans.

Q&A: Healthcare attorney skeptical of California’s new private equity regulation

AB 3129 grants the Attorney General of California oversight of private equity transactions in healthcare. An attorney with Holland & Knight is concerned about the unintended consequences of the proposed law.

Erin R. Stevens, CNMT, NCT, director of nuclear medicine at Oregon Heart Center, said training physicians for what is needed in cardiac PET documentation is key for preventing issues with prior authorizations. ASNC photo

Good documentation is the key to cardiac PET prior authorizations

Knowing what, exactly, is needed in cardiac PET documentation is one of the best ways to limit prior authorization issues.

Policy & Regulations

FDA announces recall of Johnson & Johnson devices after multiple injuries, 1 death

New recall includes nearly 23K bottles of triglycerides drug used to treat heart disease

Medicare contractor proposes denying coverage for AI-based brain MRI technology

FTC settles lawsuit against Express Scripts in deal that includes TrumpRx support

OIG audit of hospital’s cybersecurity finds vulnerabilities in common web applications