EC Cautions on MDR’s Impact on Device Availability and New Executive Order Requires Transparency for Out of Pocket Healthcare Costs

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Regulatory News

EC Cautions on MDR/IVDR Impact on Device Availability
The European Commission acknowledged that the EU’s MDR and IVDR “could have consequences for the availability of medical devices for health institutions,” with the potential for some devices to “become temporarily unavailable.” The EC noted that MDR reclassifies devices and has a wider scope than the current device directive. And the wider scope of IVDR will result in about 85% of all IVDs being subject to notified body (NB) oversight, up from 20% under the current directive. Yet while two NBs have been designated against MDR so far, and the EC still expects to designate 20 NBs under MDR by year’s end, no NBs have been designated for IVDR. (RAPS 6/17/19)

NESTcc Taps Apple Watch as First Wearable Project
NESTcc’s first test case to involve a wearable device comes as a result of its targeted request—issued in addition to the broader call in July 2018— to specifically look for projects that will be incorporating Patient Generated Data. The research with the Apple Watch ECG and irregular rhythm notification detection features will be a randomized, controlled trial and allocate either the Apple Watch or usual care to 150 patients with atrial fibrillation who will be followed for six months. It will inform apps’ effects on patient-reported outcomes and clinical use to then assess the Apple Watch’s ability to serve as a post-market ECG surveillance tool. (RAPS 6/5/19)

BrainBox Seeks to Bring TBI Detection Test to Market
FDA has granted breakthrough device designation for the BrainBox TBI test. The BrainBox TBI test is composed of a multiplex, fluorescence immunoassay using a panel of in-vitro diagnostic serum measurements, The BrainBox test, for use in point-of-care or clinical laboratory settings, provides physicians with a single score incorporating the data from all the test components and additional data useful for guiding treatment. (RAPS 6/6/19)

Health Canada Consults on New Proposed Device Regulations
Health Canada is proposing regulations that would require device makers to provide annual summary reports of adverse events and to notify Health Canada if there have been any changes to a device’s benefits and risks. The proposed regulations would also give the government authority to request safety assessments or order new safety testing for marketed devices, as well as to require device makers to provide analyses of the safety and effectiveness of their products to enable Health Canada to conduct postmarket safety reviews. (RAPS 06/18/2019)

FDA Clears MindMotion GO, Mobile Neurorehabilitation Product
MindMotion GO utilizes technology that is designed to be used by patients with mild to lightly severe neurological impairments, as well as in the recovery phase of rehabilitation. Produced by the Swiss neurogaming company MindMaze, the mobile rehabilitation product is an outpatient addition to its MindMotion PRO, which received FDA clearance in May 2017. (MD Magazine 06/12/2019)

CDRH Discusses Evolution of Q-Submission Program
The Q-submission program is intended to provide a mechanism for sponsors of medical device submissions to request early interactions with agency staff prior to reaching the submission phase. A common question to CDRH relates to the newly introduced two-tiered review timeline for goals on submission issue requests (SIRs) as pre-submissions are the only Q-submission type with set commitments and goals under the MDUFA IV. (RAPS 06/17/2019)


Payment News

Transparency and clarity needed for out of pocket healthcare costs
Hospitals could be required to provide prices in an “easy-to-read, patient-friendly format” before they provide services to patients under rules that will be proposed in an executive order signed by President Trump. The new movement toward hospital price transparency may be confusing to patients, who already have difficulty understanding what their out of pocket costs will be for each procedure. It’s hoped that increasing price transparency would encourage patients to behave like consumers and engage in shopping-like behavior to compare price and quality when selecting healthcare providers. However, this strategy will only work if the pricing information provided is clear and actionable. (KFF 6/25/19)

Are Americans the worst patients in the world?
In searching for ways to reduce healthcare spending, the focus is often on system reform. However, patient behavior is also an important factor in the expense and outcomes of medical treatment. American medical costs are at least somewhat rooted in cultural norms and lifestyle choices that lead to unhealthy habits such as smoking, poor nutrition and minimal exercise.  These are issues that policy-making and healthcare reform will not be able to effectively address unless the mind-set of the patients changes as well.  (The Atlantic July 2019 Issue)

CMS Patients over Paperwork Initiative is seeking input
A request for information has been issued by the Centers for Medicare and Medicaid Services (CMS) about next steps to reduce the amount of administrative burden on healthcare providers. The public is invited to provide recommendations of policy or procedure changes that would improve workflow and prioritize clinicians’ attention to the treatment of patients over documentation and paperwork. CMS has been attempting to “streamline regulations” and “cut the red tape” since the launch of this initiative in 2017, with the goal of saving over 40 million hours and 5.7 billion dollars throughout the healthcare system by 2021. (O&P Edge 6/13/19)


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 Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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