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 releases plan for improving medical device safety

“Although medical devices provide great benefits to patients, they also present risks,” said FDA Commissioner Scott Gottlieb, MD. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

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Hospitals have the most to lose from healthcare’s blurring lines

The wave of megamergers involving health insurers could place the greatest pressure on both not-for-profit and for-profit hospitals, according to a report from Moody’s Investors Service, if these new combinations steer patients away from hospital-owned facilities.

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What pharma fears about Trump’s upcoming speech on drug prices

President Donald Trump will deliver a speech on April 26 focused on ways to lower prescription drug prices, but the pharmaceutical industry doesn’t expect it to include the more dramatic reforms Trump espoused on the campaign trail.

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Amazon won’t sell drugs to hospitals, but may still compete with pharma in other ways

Amazon has reportedly shelved plans to sell and distribute pharmaceuticals to hospitals and health systems through its Amazon Business unit, a move which analysts said illustrates the difficulty outside companies face in disrupting the existing healthcare supply chain.

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Healthcare price growth hits 6-year high

Prices across the healthcare sector rose 2.2 percent year-over-year in March 2018, the highest annual growth rate recorded by Altarum since January 2012, with the report warning rapid price growth is likely to continue.

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Chicago’s Rush calls off merger with suburban hospital

The Rush hospital system based in Chicago has ended plans to acquire Little Company of Mary of Evergreen Park, Illinois, which would’ve merged 12 facilities with Rush University Medical Center and its 2,500-student health sciences college.

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Drug competition didn’t stop sharp increase in MS spending

The report from the Health Care Cost Institute (HCCI) examined claims for people with multiple sclerosis (MS) from 2009 to 2015 covered by individual market, employer-sponsored or Medicare Advantage plans. It found total spending per MS patient rose from around $23,900 to $39,628 by 2015. During the same time period, the share of spending spent towards injectable and oral disease modifying therapies (DMTs) rose from 39 percent to 53 percent.

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5 things to know about the final ACA rule for 2019

In a final rule that CMS said would help customers “suffering from high Obamacare premiums,” the agency’s 2019 rule for the Affordable Care Act (ACA) exchanges would give states more power on how plans cover required benefits and widen exemptions to the law’s individual mandate in the final year customers can be penalized for not having ACA-compliant insurance.

Around the web

Boston Scientific has announced another significant M&A deal, scooping up an Israeli medtech company focused on RDN technology. 

Harvard’s David A. Rosman, MD, MBA, explains how moving imaging outside of hospitals could save billions of dollars for U.S. healthcare.

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.