Medicare Fee Schedules Show Cuts To Physician Services

US Medicare payments for services provided in physician offices will fall by nearly 4% in calendar 2022; elsewhere, the agency granted pass-through payments to three devices and maintained additional telehealth services.

Dollar bill cut in many pieces.

More from Policy & Regulation

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
• By 

International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Commission Needs To Prioritize Devices Agency Above All Else

 

Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.

Shuren Expects Longer CDRH Review Times

 
• By 

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

More from Medtech Insight

Shuren Expects Longer CDRH Review Times

 
• By 

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?