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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Health system announces new plan to refund patients if expectations aren't met

The Pennsylvania-based Geisinger Health System has unveiled its ProvenExperience program, which offers refunds to patients who don’t have their expectations met while receiving care. 

Healthcare leaders spanning the globe urge U.S. presidential hopefuls to back openness on clinical trials

Close to 60 physicians, medical researchers and public-health experts from around the world are imploring American presidential candidates to state whether they support access to all clinical trial data held by U.S. federal agencies—regardless of the trials’ topics, findings, sponsors or geographical settings. 

Lumenis Acquires Israeli-Based Pollogen Strengthening and Expanding Its Aesthetic Division

Lumenis Ltd., the world's largest energy-based medical device company for aesthetic, surgical and ophthalmic applications, announced today that the company has completed the acquisition of Pollogen Ltd. 

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CMS reports smooth ICD-10 transition to date

The transition to ICD-10 is going well, according to the first numbers released by the Centers for Medicare & Medicaid Services. 

Senators introduce bipartisan bills to expedite FDA approval for medical devices

Republican senator Cory Gardner (Colorado) and Democrat senator Joe Donnelly (Indiana) introduced two bills on Oct. 21 to accelerate the FDA approval process for medical devices.

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The transition finally happens

After years of debate, several delays and lots of preparation, the big news this week was that it's finally time to start using the ICD-10 codeset. 

Lawmakers join groups urging MU delay

A bipartisan group of congressional leaders has joined other calls for a delay in the Meaningful Use program. 

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New AHIMA tool ready to help with accurate coding

With the clock ticking down to the Oct. 1 deadline to transition to the ICD-10 dataset, the American Health Information Management Association (AHIMA) has introduced a new tool to help providers succeed with the transition.

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Around the web

Cardiovascular Business
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.

AI in Healthcare
From Capitol Hill to a hospital near you? 5 federal recommendations for healthcare AI policy

The 24 members of the House Task Force on AI—12 reps from each party—have posted a 253-page report detailing their bipartisan vision for encouraging innovation while minimizing risks. 

Cardiovascular Business
Merck spends up to $2B to license new weight loss drug with potential heart benefits

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.