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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DOJ recovers $2.3B in false claims

The Department of Justice has recovered $2.3 billion from alleged healthcare fraud schemes during fiscal year 2014, reports Modern Healthcare. 

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CMS launches new data and analytics office

The Centers for Medicare & Medicaid has formed a new Office of Enterprise Data and Analytics, which will help the agency better harness its vast data resources, reports Clinical Innovation + Technology.

HHS proposal would expand clinical trial data disclosure requirements

The Department of Health & Human Services has released a proposed rule that would require companies to report summary results for drugs and devices that are never approved and not just for products that reach the marketplace, reports the American Association for the Advancement of Science. 

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New coalition hopes for no further ICD-10 delays

A group of 15 professional organizations sent a letter to congressional leaders asking them not to issue any further delays to the current ICD-10 implementation date of Oct. 1, 2015.

HealthCare.gov attracts steady traffic on first live weekday

The first weekday of the sign-up season for HealthCare.gov attracted plenty of traffic, although some users did encounter a few minor bumps, reports ABC News.

Cost of small physician office ICD-10 conversion overestimated

New data suggests that the costs and efforts related to ICD-implementation for small physician offices have been overestimated, according to a study in the Journal of the American Health Information Management Association.

Early praise for Healthcare.gov

Healthcare.gov opened for browsing over the weekend, and users are offering some early praise on the design improvements, reports Bloomberg Businessweek.  

Feds lower expectations for open enrollment period

The Department of Health & Human Services has lowered its prediction for the number of enrollees from 13 million to 9-9.9 million for coverage through state and federal exchanges for 2015, reports Modern Healthcare. 

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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.