MDR Officially Delayed and Telehealth is Here to Stay
MDR delay official as industry calls to push back IVDR
The European Council voted 27-0 to adopt an amendment to delay the application of the Medical Devices Regulation by one year and allow for EU-wide derogations for certain medical devices needed in the response to the coronavirus disease (COVID-19) pandemic. The delay was made official with the publication of the amendment in the Official Journal of the European Union. (RAPS 4/24/20)
User fee-related reviews on schedule amid COVID-19
FDA user fee funded reviews of drugs, biologics and medical devices are progressing according to schedule despite the disruption caused by the coronavirus disease (COVID-19) pandemic. In addition to shifting resources in its response to COVID-19, much of FDA’s staff has been directed to work remotely during the crisis. CDRH has worked to convert previously scheduled meetings through May into teleconferences and further extended response due dates by 90 days for 510(k)s, PMAs, HDE and De Novo classification requests on hold. (RAPS 4/16/20)
Has FDA relaxed its human factors expectations in response to the COVID-19 pandemic?
FDA’s HF representatives have communicated to some manufacturers that its fundamental expectations for HF engineering activities have not changed in response to the COVID-19 pandemic. If you wish to take a remote (or other alternative) approach to HF validation testing, you should develop a test protocol and, most importantly, engage with FDA in a Q-Sub review to seek its agreement on the proposed approach before proceeding. If you are testing a medical software application that has no physical interface or interactions, conducting the test remotely might pose few differences compared to testing in-person. (Emergo 4/6/20)
FDA Eases Guidelines for New mHealth, Telemental Health Treatments
Earlier this month, the FDA issued new guidance in the wake of the COVID-19 emergency that relaxes pre-market certification on certain Class 2 prescription-only connected health tools, such as apps and devices, that are designed to treat depression, anxiety, insomnia and other conditions. FDA is keeping some requirements in place – including verification, validation and hazard analysis – so that digital health companies can’t simply create something from scratch and push it onto the market. The guidance also clarifies the agency’s rules on low-risk devices aimed at health and wellness on a more permanent basis beyond the end of this COVID 19 emergency. (mHealth Intelligence 4/21/20)
MDCG posts five new guidances
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. The aim of the new guidance on legacy devices is to explain how to generate sufficient clinical evidence to demonstrate conformity to the relevant general safety and performance requirements (GSPR) for legacy devices CE marked in accordance with the MDD and AIMDD. In two separate guidances, the MDCG provides templates for postmarket clinical follow-up plans and evaluation reports. (RAPS 4/28/20)
IMDRF finalizes guidances on cybersecurity, personalized devices and conformity assessment bodies
The International Medical Device Regulators Forum (IMDRF) finalized four technical documents covering cybersecurity, personalized devices and conformity assessment bodies. The cybersecurity document explains that medical device cybersecurity should follow a total product lifecycle (TPLC) approach with different principles and elements considered at different stages. On the premarket end, the document discusses security requirements and design, risk management principles, security testing, labeling and considerations for regulatory submissions. For the postmarket side, the document provides insights on devices in their intended use environment, information sharing, vulnerability disclosures and legacy devices. (RAPS 4/23/20)
FCC Unveils More Telehealth Grants, New 5G Fund for Rural America
The FCC has announced plans to distribute as much as $9 billion through the Universal Service Fund to establish 5G wireless broadband connectivity in rural parts of the country, giving healthcare providers and consumers a better foundation for telehealth and mHealth. They have also adopted rules opening up the 1,200 megahertz of spectrum in the 6 GHz band available for unlicensed use, giving healthcare providers and others more room to expand Wi-Fi networks and bolster the Internet of Things to support mHealth devices and uses. (mHealth Intelligence 4/23/20)
Should telehealth adoption be a part of the “new normal”?
Rapid increases in virtual primary care appointments were seen across the US throughout March and April as a result of relaxed restrictions during the COVID-19 pandemic response. Now key option leaders are starting to consider how to sustain those services after the emergency subsides. Among the talk are ideas to use economic stimulus funds to permanently expand telehealth capabilities and a need to develop a standard reimbursement system for virtual evaluation and monitoring payment codes. (Fierce Healthcare, 4/17/20)
Ventilators are removed from CMS competitive bidding program in response to COVID-19
The Centers for Medicare and Medicaid Services (CMS) announced that non-invasive ventilators have been taken off the list of devices in the durable medical equipment (DME) competitive bidding program. This move will allow any Medicare-enrolled DME supplier to provide any type of CMS-covered ventilator. Ventilator manufacturing has ramped up in response to increase demand, and the removal of reimbursement barriers may help to improve patient access. (MedTech Dive, 4/14/20)
Robotic exoskeleton company ReWalk finalizes agreement with German health insurance companies
Two top German health insurance companies have agreed to begin covering the cost of the ReWalk robotic exoskeleton for qualifying patients with spinal cord injuries. ReWalk reports that this decision will directly affect 20 individuals with cases pending review for the equipment. If approved, the reimbursement will be applied toward personal purchase of the ReWalk, which will allow beneficiaries to obtain the device for home and community use. (Biospace 4/23/20)
Congress asks CMS to reconsider telehealth coverage for therapy services
The Centers for Medicare and Medicaid Services (CMS) has extended telehealth reimbursement concessions to multiple medical professions amid the COVID-19 crisis, but providers such as physical and occupational therapists, speech language pathologists and audiologists have been excluded thus far. An April 14 letter from a group of congressional representatives asks CMS to reconsider, stating: “Current stay at home orders and social distancing protocols are leaving many beneficiaries with underlying conditions without access to the services they need. We cannot continue to put older and health compromised Medicare beneficiaries at risk by forcing them to choose between forgoing regular care or risking exposure to the virus.” (mHealth intelligence 4/15/20)
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.