Medical Device Industry Braces for Life After Brexit and Silicon Valley Conference Focuses on Future of DTx Reimbursement
Regulatory
UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul
The UK is currently in the midst of an 11-month transition period ending 31 December 2020, during which it will continue to follow EU law. The UK government introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry. The bill delegates powers to update the existing regulatory frameworks for human and veterinary medicines, medical devices and clinical trials after the transition period. For medical devices, the bill would consolidate and expand the government’s enforcement authority by disapplying the Consumer Protection Act and the amendments to the Medical Devices Regulations 2002. (RAPS: 02/13/2020)
UK regulator offers conditional grace period for medical device companies changing Notified Bodies
MHRA will provide grace periods on a case-by-case basis to manufacturers either based in the UK, or whose Authorized Representatives are based in the UK, and that hold valid CE Mark certificates under one or more of the current European Medical Devices Directives (MDDs). MHRA’s new policy acknowledges significant challenges concerning Notified Body capacity faced by manufacturers seeking to maintain access to European markets during the transition to the Medical Devices Regulation (MDR) in May 2020. (RAPS 02/04/20)
FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions
FDA finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) waivers for their tests or conduct studies to support dual 510(k) and CLIA waiver by application submissions. The guidance on CLIA Waiver Application provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver. The guidance also explains how to submit a dual submission and the study design considerations an IVD developer should make to support both applications. (RAPS: 02/25/2020)
Acutus secures FDA clearance for new real-time heart mapping algorithm
Acutus Medical has secured an FDA clearance for a heart mapping algorithm designed for its AcQMap 3D imaging system. The SuperMap program was cleared to help guide electrophysiologists in the diagnosis and treatment of stable and transient arrhythmias, by providing high-resolution, whole-chamber maps of the heart’s left or right atria. This allows physicians to map the heart’s chambers, perform an ablation, and then quickly re-map the atria to confirm the effects—while also identifying regions of slow electrical conduction or irregular activity, as well as focal points. (FierceBiotech- 02/19/2020)
FDA to Pilot Interactive 510(k) Template
As part of its commitments under the Medical Device User Fee Amendments (MDUFA IV), the FDA announced a pilot to test a new, interactive, PDF-based 510(k) template. The electronic Submission Template and Resource (eSTAR) features automation, integration with other resources and a structure that is more aligned with the CDRH’s internal review templates. (RAPS 02/26/20)
Payment
Digital Therapeutics conference discussed medical device reimbursement issues
Reimbursement was a heavily discussed topic at the Digital Therapeutics conference held in February in Silicon Valley. This marked a shift from previous years where the emphasis was primarily on evidence generation and regulatory pathways. Advancements in medical devices have outpaced the traditional payment models and companies are seeking solutions for “sustainable reimbursement” on which to base their business models. Outcomes data are being collected continually by connected medical devices, providing unprecedented opportunity to demonstrate value, which may include facilitating treatment efficiency or improving patient adherence to treatment plans. Suggestions for problem solving included the expansion of the FDA “breakthrough” device program to impact payment models, or the addition of a new medical device category for digital therapeutics. (Forbes 2/23/20)
6 Prosthetic HCPCS Codes now require prior authorization
CMS announced the inclusion of several high-end prosthetic devices will be subject to prior authorization as a Medicare condition of payment. The Healthcare Common Procedural Codes (HCPCS) Codes included in this list (L5856, L5857, L5858, L5973, L5980, L5987) describe microprocessor knee and ankle components as well as prosthetic feet. This new policy will require prosthetists to obtain insurance authorization before providing these components to patients. There is concern that this may cause delay in medical care, but it may also reduce payment uncertainty. CMS is rolling the program out initially in four states throughout the spring and summer before expanding to apply it nationwide in October. (NAAOP 2/18/20)
Budget impact of Exoskeletons in spinal cord injury treatment
A new journal article published in the Journal of NeuroEngineering and Rehabilitation compares the budget impact of physical therapy using robotic exoskeletons for gait training on individuals with spinal cord injuries. The robotic therapy costs were compared to standard treatment in the following key measures: device costs, training costs for personnel, human capital costs, device demand and the number of training sessions. The findings were that hospitals using robotic exoskeletons to deliver gait training in 10% of the therapy sessions had an annual net savings of between $1114-$4784. The researchers conclude by saying “The assessment of economic efficiency-with robotic exoskeleton is in its infancy.” (Journal of NeuroEngineering and Rehabilitation, 1/10/20)
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, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, Mohammed Kazi, MS, Simbex Quality Systems Coordinator, and Laura Bleyendaal, MBA, Simbex Centers Fellow. A story’s inclusion does not imply endorsement by Simbex.
