Regulatory

FDA adds transition period to electromagnetic compatibility final guidance

(RAPS 6/6/22)

FDA finalized its Electromagnetic Compatibility (EMC) of Medical Devices guidance. The guidance outlines what sponsors need to consider about potential electromagnetic interference and immunity from or with their device and will supersede the June 2016 guidance titled Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices after the 60-day and 1-year implementation period for IVDs and other medical devices, respectively.

 

US FDA finalizes guidance on machine learning for medical devices

(Emergo 6/23/22)

In its Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions, the agency outlines the information manufacturers must include in premarket submission applications for radiological devices with quantitative imaging functions. FDA now requires manufacturers submitting a device for market approval to include a technical description of the quantitative imaging functions of the device with enough detail for regulators to understand how it works. FDA asks sponsors to include documentation that explains how the software used in the algorithm works, especially for the quantitative imaging functions. Manufacturers are asked to consider conducting a sensitivity analysis to determine all the potential areas where data could be problematic, including image acquisition, image processing and patient features.

AdvaMed Releases New Resource on Diversity in Clinical Research

(MedTech Intelligence 6/8/22)

AdvaMed) has released “Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities”, a new document intended to outline considerations and approaches to improving representation in clinical research with the goal of reducing and eliminating health disparities. Key Recommendations include: Be aware of historical biases that exist in clinical research and potential mistrust of the healthcare system by underrepresented populations. Use a variety of available tools to adequately define the targeted patient population, including leveraging RWD sources. Be prepared to go to the patient by broadening the types and locations of the trial sites and diversity of investigators.

AHRQ Releases Technical Brief on Evaluation of Mental Health Apps

(MedTech Intelligence 5/31/22)

The brief proposes a framework to assess the apps called The Framework to Assist Stakeholders in Technology Evaluation for Recovery (FASTER) to Mental Health and Wellness, which assesses the risk/safety, technical functionality and mental health features of apps. FASTER can be used by advocacy organizations, payers, healthcare systems and others to inform selection of mental health mobile apps. They identified gaps in the assessment of risks that users may face from apps, such as privacy and security disclosures and regulatory safeguards to protect the users. Key informant discussions identified priority criteria to include in the framework, including safety and efficacy of mental health apps.

HHS offers guidance for HIPAA-compliant audio telehealth

(Medical design and Outsourcing 6/13/22)

The Office for Civil Rights at the U.S. Department of Health and Human Services today issued guidance on providing audio-only telehealth services in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The HIPAA Security Rule does not apply to audio-only telehealth services provided via landline, but does apply to calls over cellular and internet connections.

Payment

Digital health startups tend to lack robust clinical data 

Analysis by Rock Health consultants (full article published in JMIR), shows that digital health start-ups have no universal standards for the level of efficacy evidence required to get to market. The researchers measured “clinical robustness” by counting the number of clinical trials and regulatory filings for each company and compared this against the number of claims related to prevention, diagnosis, or treatment.  There was no clear relationship between the robustness of the clinical evidence and the number of claims made.  About 40% of the companies investigated had no clinical trials or regulatory filings and about 20% of the companies investigated had more than 5 trials/filings. The clinical robustness was not related to the age or funding level of the company, but there were trends of more robust evidence for digital health products that address cardiovascular disease and diabetes. The researchers highlight the importance of their findings in the light of the ongoing reimbursement struggle around digital health, they point out that innovators should “rigorously demonstrate the impact of their solutions” with a mix of clinical, economic and engagement claims that will resonate with payers.

 (Rock Health 6/22/22)

MDMA comments to CMS on benefit category determination 

The Medical Device Manufacturers Association (MDMA) submitted a comment letter to the Center for Medicare and Medicaid Services (CMS) in response to the June 2022 HealthCare Common Procedure Coding System Public Meeting. The letter points out the inadequacies of the current benefit determination process and states that the current system leaves Medicare beneficiaries and medical device stakeholders in limbo by effectively blocking access to innovative new technologies. New devices that do not fall into an existing benefit category often wait for multiple years while CMS decides on category assignment. Two of the devices mentioned in the letter are the ReWalk and MyoPro exoskeletons, which MDMA suggest should be categorized as orthotics and prosthetic items.

(MDMA 6/8/22)

Researchers outline a “reimbursement framework” for AI in Healthcare 

An article published in Nature states that Artificial Intelligence (AI) can reduce costs and care access issues that contribute to inequity in healthcare. However, providers are heavily influenced by financial incentives for services, and reimbursement will be a key factor in adoption of these technologies.  Existing reimbursement frameworks are limited in scope and most only cover inpatient treatment. The research team suggested their own framework of “Access maximizing value” which operates in the context of alternative treatment costs and stays within guardrails of oversight from stakeholder such as the FDA, commercial insurance companies and professional societies.

(Healthcare Analytics 6/20/22)

CMS fines hospitals for lack of price transparency  

The Centers for Medicare and Medicaid Services (CMS) has issued its first penalties to hospitals 18 months after enacting the final rule on price transparency. Two hospitals in Georgia received fines of up to $300/day, with the amount calculated based on hospital size and length of time that the hospital websites were non-compliant. In January 20221 CMS began requiring hospitals to post a comprehensive price list. CMS says it has issued a total of 352 warning letters this month, 157 of which remained non-compliant after receipt of the letters.

(Fierce Healthcare 6/9/22)

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, and Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation.  A story’s inclusion does not imply endorsement by Simbex.