More Remote Monitoring Devices Added to FDA’s EUA and a Step Forward for Digital Therapeutics Reimbursement

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Regulatory News

FDA expands guidance on remote monitoring devices for COVID-19

Device categories covered by the guidance now include both diagnostic and monitoring spirometers and peak-flow meters, apnea monitors, telephone ECG transmitting and receiving equipment, EEGs and non-EEG seizure monitoring systems, biofeedback sleep assessment devices, audiometers, vestibular analysis apparatuses, and computerized cognitive assessment aids. In the context of the COVID-19 public health emergency, the leveraging of current non-invasive patient monitoring technology will help eliminate unnecessary patient contact and ease the burden on hospitals, other health care facilities, and health care professionals. Additionally, the guidance now contains an expanded of resources outlining FDA’s digital health policies, including a guidance for radio frequency wireless technology in medical devices, and guidance regarding interoperable medical devices.

(RAPS 6/8/20)

FDA explains COVID-19 impact on MDUFA goals, meetings

FDA concedes that it may miss some of its MDUFA performance goals, including those for biologics license application (BLA) devices, as a result of the pandemic, citing the increased workload related to emergency use authorizations (EUAs) and developing policies related to COVID-19. In the case of a missed MDUFA goal, FDA says it will follow the missed MDUFA decision procedures laid out in its guidances for various submission types’ review clock and goals. FDA explains that it will give device sponsors an additional 90 days to respond to major deficiency letters for premarket approval (PMA) and humanitarian device exemption (HDE) applications and to additional information letters for 510(k)s and de novo requests for submission and applications on hold as of 16 March 2020.

(RAPS 6/22/20)

FDA issues final guidance on inspections of medical device establishments

The US Food and Drug Administration (FDA) published finalized guidance on inspections of medical device establishments. The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspections.

(RAPS- 26 June 2020)

Medical Device Cybersecurity in the Age of IoMT

Healthcare 4.0, which is represented by the Internet of Medical Things (IoMT) and big data analysis, brings connectivity and data-driven decision making to everyday healthcare practices. The proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks. FDA views cybersecurity as a shared responsibility among companies, clinics, HCPs and patients. Therefore, medical device companies must consider cybersecurity as an indispensable requirement to their products and deliver education, training and support to customers and end-users to create and maintain a safe and secure ecosystem.

(MedTech Intelligence 6/29/20)

European Commission issues decision on harmonized standards for MDR, IVDR

The total number of standards harmonized under the Medical Devices Directive 93/42/EC (MDD) is 264, while the total number of standards for the MDR is 63. Standards relating to products are not to be harmonized under the MDR or IVDR. Most standards relating to processes are harmonized under the MDR/IVDR.

(Emergo 6/16/20)



Payment News

Pear Therapeutics announces coverage through RemedyOne formulary

RemedyOne, a formulary optimization company, will offer and administer benefit coverage of Pear Therapeutics products reSET and reSET-O, digital therapeutics for the treatment of substance use disorder and opioid use disorder. The coverage decision was made in the context of the stress and isolation caused by COVID-19, circumstances which can negatively impact the recovery process.

(Pear Therapeutics 6/24/20)

Coalition advocates for insurance coverage of digital therapeutics that treat substance use disorder

The Recovery Access Coalition was formed to address barriers to potentially life-saving digital therapeutics that are used in the treatment of substance use disorder. The Coalition includes multiple key opinion leaders and organizations and is sponsored by Pear Therapeutics. Coverage and policy changes by CMS and private insurance companies are main goals of the Coalition.

(Business Wire 6/25/20)

New CMS advisory article – correct coding for lower extremity prostheses 

Three prosthetic foot codes (L5973, L5980, L5987) and three knee-shin prosthesis system codes (L5856, L5857, L5858) will require prior authorization effective 1/1/2021. Coding guidelines and a list of qualifying devices has been issued for these six codes by the CMS Pricing, Data Analysis and Coding (PDAC) contractor in order to add clarity for manufacturers and suppliers.

(Palmetto PDAC 6/26/20)

AHA & AMA encourage self-measured blood pressure monitoring

The American Heart Association and American Medical Association joined forces to address the barriers to implementation of self-measured blood pressure (BP) monitoring. The organizations agree that home monitoring is important for patients who have high office BP, especially in this time of COVID, when patients are having fewer in-person medical visits. In order to facilitate self-measuring of BP, the organizations are advocating for improvements in patient education, provider training, and insurance reimbursement.

(AHA Newsroom 6/22/20)


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, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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