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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AI-powered platform for heart failure detection gains FDA clearance

According to data submitted to the FDA, the platform has been linked to an accuracy of 90%, sensitivity of 87.8% and specificity of 83%.

VIDEO: Impact of the 2023 Medicare cuts on radiology

Ed Gaines, JD, vice president of regulatory affairs and industry liaison, Zotec Partners, discussed the impact of the 2023 Medicare Fee Schedule on radiology at RSNA 2022 in Chicago last week. RSNA and several other medical societies say the cuts are not sustainable.

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Healthcare groups react to prior authorization proposed rule

Healthcare groups are largely excited by a new proposed rule from the Centers for Medicare and Medicaid Services (CMS) that aims to streamline prior authorization and reduce burden on healthcare providers.

Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the No Surprises Act on radiology at the Radiological Society of North America (RSNA) 2022 meeting. Gaines works with RSNA on billing and Medicare issues and spoke in sessions at the RSNA 2022 meeting. Insurance companies have weaponized the No Surprises Act in an effort to cut their costs, he said.

VIDEO: Insurance companies have weaponized the No Surprises Act, may impact patient care

Ed Gaines, JD, CCP, vice president of regulatory affairs and industry liaison, Zotec Partners, discusses the impact of the No Surprises Act on healthcare and medical imaging at the RSNA 2022 meeting

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CMS proposes rule on prior authorization

Prior authorization, which requires healthcare providers to get approval from insurance providers before giving certain treatments to patients, has been long-hailed as extremely burdensome to physicians, even causing delays in patient care.

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Integra LifeSciences to acquire SIA in deal worth up to $140M

Integra LifeSciences Holding Corporation, a global medical technology company, has agreed to acquire Surgical Innovation Associates (SIA), which is known as the manufacturer of monofilament mesh for plastic and reconstructive surgery. The deal is valued up to $140 million.

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Amazon’s $3.9B acquisition of One Medical under review in Oregon

The state of Oregon is taking a hard look at the proposed acquisition of One Medical by Amazon. The deal is valued at $3.9 billion.

As FDA approaches decision on Alzheimer's drug, 2 deaths raise concerns

Japanese pharmaceutical company Eisai has denied that two deaths that have sparked concerns about a new Alzheimer's disease drug treatment are attributed to its trials.

Around the web

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.

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. 

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.