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Recent Headlines

21st Century Cures Act unlikely to move until after election

Legislation aiming to speed up the regulatory approval process for medical devices and drugs and boost research funding will have to wait until after Election Day.

PuraPly products now available for Medicare reimbursement in 10 states

Following the decision by the National Government Services to end its local coverage determination for both cellular and tissue-based products, Organogenesis’s PuraPly and PuraPly Antimicrobial products for wound management will be eligible for Medicare coverage and reimbursement in 10 states.

FDA recalls the INRatio and INRatio2 PT/INR monitoring systems

The FDA has announced that Alere has recalled their INRatio and INRatio2 PT/INR monitoring systems.

EpiPen's 400 percent price increase has consumers and Congress confused and concerned

U.S. lawmakers are joining concerned parents in demanding to know: What is up with the sudden increase in the price of an EpiPen?

 
Device companies agree to pay $1 billion in user fees to FDA

Medical device companies will pay the FDA nearly $1 billion in user fees for five years beginning in October 2017 under the fourth reauthorization of the Medical Device User Fee & Modernization Act (MDUFA).

Duke professors argue ACOs haven’t worked

Duke University professors Kevin Schulman, MD, and Barak Richman, JD, PhD, called on the CMS Innovation Center to focus on telemedicine and wearable devices, rather than accountable care organizations (ACOs) which integrate hospitals, to reduce the cost of care.

Pathway Health to get a tech upgrade through Virtual Health partnership

Pathway Health, a post-acute consulting firm, and Virtual Health, a population health management technology provider, have entered into a partnership that will provide Pathway with strategic consulting services to improve technology and payment models.

FDA guidance addresses when device makers need to report changes

Draft guidance from the Food and Drug Administration is seeking to clarify when medical device manufacturers need the agency’s approval to make changes to their products, potentially replacing guidance that had remained unchanged since 1997.

Study: Only 15% of device companies ready for Sept. 24 UDI compliance deadline

A September 24 deadline set by the Food and Drug Administration is looming for Class II medical devices, such as condoms or wheelchairs, to be outfitted with unique device identifier (UDI) barcodes, but in a survey of device makers, only a few said their companies were currently compliant with the standard.

Q&A with AMDIS Award winner Peter Basch

Recently, the Association of Medical Directors of Information Systems (AMDIS) held their annual awards to recognize leaders in healthcare IT. Among those recipients was Peter Basch, MD, MACP, Senior Director for IT Quality and Safety, Research and National Health IT Policy at MedStar Health.

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