CDRH officially launches OPEQ and ONC’s proposed information blocking rule gets push back regarding fees

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Regulatory News

CDRH Announces Implementation of Office of Product Evaluation and Quality
OPEQ will integrate the premarket and postmarket program functions along products lines to help CDRH optimize decision making across the product lifecycle. This new, team-based structure consolidates and integrates current parts of product review, quality, surveillance and enforcement.
(MedTech Intelligence 5/3/19)

Old Operating Systems Place Healthcare Orgs at Higher Risk of Threats
A majority of hospital networks still use unsupported Microsoft Windows operating systems, including Windows 7, Windows 2008 and Windows Mobile. Microsoft support is planned to expire in January 2020, and health systems that run on unsupported systems could expose their vulnerabilities and hurt regulatory compliance. But updates to these systems are costly. Certain medical devices will not work on recent versions of Windows due to lack of support, compatibility and license schema issues.
(MedTech Boston 5/15/19)

FDA’s Proposal to Limit Device Predicates Fails to Garner Industry Support
A common theme across commenters on the proposal is: There appears to be no public health reason to support limiting the use of predicates to those that are 10 years old or less, nor does there seem to be a reason to make older ones ineligible for use in demonstrating substantial equivalence to existing medical devices. AdvaMed believes that publishing such a list will not drive anyone to develop devices with newer technology and may actually lead to well-established devices being unnecessarily removed from the market.
(RAPS 5/14/19)

FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
Synovasure Lateral Flow Test Kit is an aid for the detection of periprosthetic joint infection (infection around a joint replacement) in the synovial (lubricant) fluid of patients being evaluated for revision surgery, which is surgery performed to replace or compensate for a failed implant.
(FDA Press Release 5/23/19)

Final FDA Q-Submission guidance includes medical device cybersecurity coverage
Finalized FDA guidance for its Q-Submission (Q-Sub) Program whereby manufacturers solicit feedback from the agency prior to submitting their premarket applications now includes recommendations for cybersecurity-related issues.
(Emergo 5/7/19)

EC Explains What UDI Information to Provide for Eudamed
The European Commission on Friday released three documents, including two on the Medical Device Regulation (MDR) and the In Vitro Diagnotic Regulation (IVDR) and what data from the unique device identifier (UDI) needs to be included in the Eudamed database of devices and IVDs, and another document on the Eudamed device data dictionary.
(RAPS 5/3/19)

CDRH Outlines Vision for Good Machine Learning Practices
GMLP “would be analogous to good manufacturing practices (GMP)” in applying a quality system approach, though it would be “specifically focused on the unique challenges for machine learning”. The approach seeks to align the regulatory process with the natural lifecycle of software and to facilitate movement of these technologies in a safe manner to the public as timely as possible.
(RAPS 5/28/19)


Payment News

HITAC wrestling with fees for data sharing as part of information blocking rule
The Office of the National Coordinator for Health Information Technology (ONC) unveiled its information blocking rule back in February. ONC officials have noted that there were situations where cost was being used as a way to block the flow of information. The proposed rule aims to limit vendors’ ability to charge fees for access to certain electronic health data. The HITAC’s information blocking task force doesn’t agree with ONC’s language regarding fees, saying it goes too far to enact federal price controls.
(FierceHealthcare 5/14/19)

CMS Launches a website to prepare for upcoming DMEPOS competitive bidding process
CMS will add 16 types of spinal orthoses and 7 types of knee orthoses to its list of durable medical equipment included in the competitive bidding program. The new website will function to compile all of the information about this process in one location.
(O and P Edge 5/18/19)

Private health insurance plans paid an average of 240% over Medicare rates in 2017
According to a recent RAND report, the payment gap between private and public insurance payments is expanding. The study authors encouraged employees and employers to be smart consumers by pressuring private health insurance companies to maintain their rates at a fixed multiple of the Medicare fee schedule.
(Healthcare Finance news 5/10/19)


The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Research Engineer and Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation.  A story’s inclusion does not imply endorsement by Simbex.

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