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 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. 

older patient with a doctor at their house

‘Fundamental for all patients’: Exploring the benefits of palliative care for stroke survivors

Approximately 800,000 strokes occur each year in the United States alone. A majority of people survive, due in part to key advances in patient care over the years, but they often go forward without receiving the long-term help they need to recover and thrive. 

Edwards Evoque transcatheter tricuspid valve replacement TTVR

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement

Edwards Lifesciences sent a formal request to CMS in February after its Evoque TTVR device gained FDA approval. The agency is now accepting public comments for 30 days.

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.