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. 

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FDA issues recall on infusion pump parts due to risk of uncontrollable drug flow

Due to a risk of fatal overdose, the recall is labeled as the most serious of its type. While no patients have died, two have reportedly been injured. 

Shockwave Medical, a Johnson & Johnson MedTech company, has officially launched its Shockwave E8 Peripheral IVL Catheter in the United States. Shockwave’s E8 catheter was designed specifically to treat patients with calcified femoropopliteal and below-the-knee (BTK) peripheral artery disease (PAD), including those diagnosed with complex chronic limb-threatening ischemia (CLTI).

Shockwave Medical launches new FDA-approved IVL catheter for PAD, CLTI

The new device, already cleared by the FDA, was designed to treat femoropopliteal and below-the-knee PAD. 

Biotronik has received U.S. Food and Drug Administration (FDA) approval to make its Solia S lead and Selectra 3D catheter available for a new indication: left bundle branch area pacing (LBBAP).

FDA approves Biotronik lead, catheter for left bundle branch area pacing

LBBAP is a relatively new alternative to biventricular pacing. The FDA's decision was based largely on data from the BIO-CONDUCT clinical trial.

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Lawmakers introduce radiologist-supported bill to punish payers that fail to pony up under NSA

Rep. Greg Murphy, MD, R-N.C., unveiled the No Surprises Enforcement Act on Sept. 13, joined by Reps. Raul Ruiz, MD, D-Calif., and John Joyce, MD, R-Penn. 

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Physician burnout has become ‘widespread,’ Radiology Partners warns Medicare program

Continued declines in reimbursement and mounting administrative burdens are combining to weigh down members of the specialty, RP wrote in recent comments. 

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Social media ads led 200K patients to unwittingly drop their insurance

Users on Facebook and Snapchat clicked on ads promising free cash, only to find out their health plan changed.

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AMA study shows four pharmacy benefit managers control 70% of the market

The study from the American Medical Association is based on data from commercial and Medicare Part D plans. The analysis found market share for PBMs is heavily concentrated, leading to higher drug costs. 

CTC colonography colon cancer colonoscopy

ACR concerned pay cap on CT-based colon cancer screening could make service ‘untenable’

Medicare wants to limit the technical component for the exam to the HOPPS rate, which would represent an 81% reduction to the MPFS amount of $459.92. 

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