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 warning alert exclamation computer

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. 

Sahajanand Medical Technologies (SMT) Hydra TAVR

Hydra TAVR valve gains key approval as global reach continues to grow

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

congress money medicare washington DC senate house

Physician Medicare pay fix in jeopardy following criticism from Donald Trump, Elon Musk

UPDATE: Congress on Friday, Dec. 20, passed a slimmed down version of the original continuing resolution with no physician Medicare pay fix. 

Blue Cross Blue Shield BCBS

Blue Cross Blue Shield affiliate rejects MRI contrast coverage, labeling it ‘investigational’

The BCBS decision pertains to gadopiclenol, a gadolinium-based product sold under the brand names Elucirem and Vueway. 

New York Albany capitol

Radiologists push governor to veto bill that would produce ‘staggering’ increase in liability premiums

ACR noted that the state already is struggling to recruit and retain physicians, with the policy potentially exacerbating the problem. 

CVS Health announces $10.6B acquisition of Oak Street Health

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. 

artificial intelligence pharmaceutical industry

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.

artificial intelligence AI in healthcare

Industry Watcher’s Digest

Nurses are making their peace with workplace AI.