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. 

Novartis sues FDA over ‘unlawful’ approval of generic heart failure drug

The drugmaker argues that the FDA's recent approval of a generic version of Entresto should not be allowed for multiple reasons. Novartis sent multiple requests to the agency hoping to stop the approval, but the FDA denied each one. 

Stark Law Kickback Erlanger

DOJ suing health system in alleged kickback scheme

Three years after a pair of former hospital C-suite executives blew the whistle on their own institution, the U.S. Department of Justice has acted on the complaint.

AMA survey: Prior authorization causes many patients to abandon care, raises healthcare costs

Prior authorization is frustrating to clinicians, but a new survey from the American Medical Association shows it also frustrates patients to the point of abandoning care. The survey showed many more insights regarding PA impact on care.

Insurance telemarketing CEO sentenced to 25 years in federal prison for lying to consumers

The owner of a health insurance telemarketing company was sentenced to 25 years in federal prison for selling limited indemnity health insurance plans using false and deceptive practices. The FTC had the courts liquidate the companys assets earlier this year. 

hospital ransomware cybercrime hacking

North Korean hospital hacker indicted in the US

A North Korean national who may or may not still reside in his home country has been indicted for allegedly leading ransomware attacks against U.S. hospitals.

wisconsin baldwin rural healthcare

Senate bill would protect rural residents from shock of healthcare service shutdowns

Calling the legislation the Hospital Stability and Health Services Act, Sen. Tammy Baldwin (D-Wis.) suggests she wrote the bill with rural communities in mind.

Dana H. Smetherman, MD, MPH, MBA, FACR, the new CEO of the American College of Radiology (ACR), explains with the ongoing 2024 election, it is very unlikely there will be any serious reform to the Medicare payment system this year. She said further Medicare cuts set for 2025 also further threaten patient access to care.

Meaningful Medicare reform unlikely in 2024

New American College of Radiology CEO Dana Smetherman, MD, discusses the impact of reimbursement cuts, issues with staffing costs and prior authorization. 

Medicare money payment physician

Cardiology groups push for Medicare reform in face of ‘unsustainable’ payment cuts

Nearly 130 healthcare groups are urging Congress to pass legislation that would provide relief to U.S. physicians struggling to keep up with wave after wave of payment reductions.

Around the web

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.

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. 

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.