Government

FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021.  In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared for the transition. The deadline for labeling most Class I and Class II devices is Sept. 24.

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An in-depth look at the FDA’s refurb docket

Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA

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FDA announces public workshop to discuss third-party refurb docket

Now that the commenting period has ended, the FDA plans to host a two-day public workshop for stakeholders to discuss the questions raised in its third-party service and refurbished medical device docket.

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OMB receives CMS rules overhauling Medicaid

The CMS has sent a sweeping finalized rule that will overhaul the managedMedicaid program to the Office of Management and Budget for review. The 653-page proposed version of the rule suggested the biggest changes in Medicaid managed-care regulations in more than a decade. It would cap insurer profits, require states to more rigorously supervise the adequacy of plans’ provider networks, encourage states to establish quality rating systems for plans, allow more behavioral healthcare in institutional settings and encourage the growth of managed long-term care.  
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CMS Administrator Announces End of EHR Meaningful Use Program

Monday, January 18, 2016, Last week, Centers for Medicare & Medicaid Services (CMS) Administrator Andy Slavitt announced that the Electronic Health Records (EHR) Meaningful Use program will “effectively” end and be “replaced with something better.”

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Medical Device Tax Suspended for Two Years

President Barak Obama signed a nearly $2 trillion spending package into law on Friday that included provisions to suspend the sales tax on medical devices through 2017. The suspension of the 2.3% tax was part of a larger spending bill that will fund the government through September 2016.

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Medical device tax repeal included in proposed $1.1T spending bill

A two-year suspension of the 2.3% medical device excise tax is included in a $1.1 trillion spending bill that is expected to receive a vote in the House this week, to the delight of industry and med tech associations.

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BREAKING: Health spending growth surges to highest rate since 2007

The Affordable Care Act expanded health coverage to millions of Americans in 2014. Because more people had insurance to pay for healthcare services, demand and spending predictably went up more quickly.

But the important question for the future remains the same: Will healthcare be able to avoid large spending spikes and move to a more sustainable payment system?

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CMS pushes back deadline for imaging decision support

The U.S. Centers for Medicare and Medicaid Services (CMS) has postponed its January 1, 2017, deadline for physicians to start ordering advanced imaging studies with clinical decision-support (CDS) software that is based on appropriate use criteria (AUC).

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Retooled two-midnight rule gets mixed reviews

Providers and policy experts are split on the Obama administration’s proposal to salvage the controversial two-midnight rule with a series of modifications intended to mollify its many critics.

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