International Regulators Talk of Phased Implementation & Telehealth Coverage Extends, But Usage Still Falters

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Regulatory News

FDA plans phased approach to restarting surveillance inspections

FDA is working with the CDC to formulate a process for “how and where” to begin those inspections in the future in line with White House guidelines to ensure inspections are carried out safely. Agency expects this to be a phased approach driven by scientific data. (RAPS 5/12/20)

Eudamed update: Phased implementation planned for European medical device, IVD database

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has indicated that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022. Manufacturers will be able to start uploading data into Eudamed within a year, as Actor Registration modules, UDI/Device Registration module and the Certificate/Notified Body modules will be available in 2021. (Emergo 5/12/20)

European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies

Implementing Regulation (EU) 2020/666 targets Notified Bodies whose MDD and AIMDD designations are set to expire before the MDR’s date of application (May 26, 2021). Affected NBs may forego on-site audits and assessments by their designating authorities during this timeframe, but must still undergo surveillance and monitoring by said authorities. By amending Implementing Regulation (EU) 920/2013, the European Commission aims to mitigate NB capacity issues and help manufacturers of CE Marked medical devices maintain their European market access during the new 12-month transition period to MDR. (Emergo 5/26/20)

Multinational efforts build framework for real-world and observational COVID-19 data

International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic. Recent US-based efforts to bolster real-world data collection and analytics include a partnership between the FDA and Aetion, Inc., a New York-based health technology firm. That agreement will use Aetion’s data platform to assimilate and analyze disparate real-world sources such as electronic health record data, insurance claims data, and existing patient registries. (RAPS 5/21/20)

IMDRF medical device cybersecurity guidance recommends UL 2900 compliance

Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. The IMDRF guidance cites UL 2900-1:2017 covering software cybersecurity for network-connected medical devices, as well as UL 2900-2-1:2017 for requirements particular to network-connectable healthcare and wellness system components. (EMERGO- May 19, 2020)

FDA pulls together all COVID-19-related Guidances

FDA recently created a single site of all COVID-19-related guidance documents for easier accessibility by Industry, FDA Staff, and Other Stakeholders. (FDA 5/27/20)

Patients tapping into digital physical therapy see improvements in pain

Each participant was mailed a computer tablet with the Hinge Health app and two Bluetooth wearable motion sensors, which are used during exercise. The Hinge program includes digital in-app exercise-therapy, where the patient’s sensors were able to indicate if the participant was in the correct range for each exercise. Every participant was also assigned a personal coach to text with. Subjects were also put into support groups where they could help each other with tech questions. Participants were instructed to participate in the sensor-guided therapy up to three times a week and on average reported a 68% decrease in pain. (MobiHealthNews 5/14/20)

Payment News

Telehealth coverage is extended to cover audio-only sessions

The last few months have seen an unprecedented rise in telehealth services throughout the United States. Video conference tools have been pressed into service to allow for consultation between patients and providers. However, many of the most vulnerable patients – especially older adults, do not have access or prefer not to use video calling. In response to this, CMS has increased the payments for audio-only telehealth visits to match those of in-office or video evaluation and treatment services. (Health Payer Intelligence, 5/25/20)

 Decline in patients seeking care for serious health conditions

A report by insurance company Cigna in late April showed that patients have been deferring care for high-risk conditions, not just for elective procedures. Hospitalizations were down across the board in the months of January, February, and March as patients avoided seeking care for fear of exposure to COVID-19. The report authors warn that the sharp decline in potentially lifesaving treatments for conditions such as appendicitis, acute coronary syndromes, and seizures will have serious consequences. (Fierce Healthcare, 4/24/20)

Hospitals are suffering financially due to altered procedural mix

High-paying procedures such as total joint replacements, colonoscopies, and radiology tests are the “cash cows” of hospital systems due to favorable reimbursement rates. The Coronavirus response necessitated that these appointments be delayed or canceled to make way for non-procedural admissions and expensive intensive care. Add to this the cost of procuring supplies including personal protective equipment and ventilators, and the financial danger to hospitals becomes clear. Although the situation is aggravated by the special circumstances of the pandemic, the underlying problem can be attributed to imbalances within the reimbursement system. (STAT News, 5/26/20)

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.

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