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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CMS finalizes decision to limit coverage for controversial Alzheimer’s drug, related imaging

The agency has maintained the same pay restrictions in its final policy, only covering PET scans if required by a clinical trial protocol. 

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American College of Radiology, patient advocacy groups urge feds to fix CTC coverage gap

ACR and others have submitted a formal national coverage determination request, asking the agency to address payment gaps for virtual colonoscopies. 

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CMS delays start of Radiation Oncology Alternative Payment Model yet again

The mandatory bundled payment initiative was slated to kick off Jan. 1, 2023, following numerous delays, but will now launch on a to-be-determined date.

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FDA clears Aidoc artificial intelligence solution for flagging suspected brain aneurysm cases

This marks the ninth 510(k) clearance for the company, which has offices in Israel and New York, and second in the past 10 days. 

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UnitedHealth, Change Healthcare extend merger agreement, adding $650M breakup fee if DOJ suit prevails

The two companies said the agreement reflects their commitment to combining and desire to fight the Department of Justice's "meritless legal challenge to this merger." 

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US Senate passes bill to bolster access to breast cancer screening services and related care

If approved by the House, the MAMMO Act would launch a telemammography pilot program to broaden offerings for vets in rural areas, among other changes.

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DBT coverage mandates increase use but have no impact on patients’ out-of-pocket costs

More than a dozen states have required private payers to cover digital breast tomosynthesis, producing a $39 decrease in average price for the exam. 

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High-profile, $100M mammography trial touts new enrollment milestone

TMIST just recently reached 65,000 participants, surpassing the halfway mark toward its current goal of 128,905, organizers announced recently. 

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Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
GE HealthCare moves PET/CT scanner production to United States

The all-in-one Omni Legend PET/CT scanner is now being manufactured in a new production facility in Waukesha, Wisconsin.