FDA Increases User Fees for 2020 and CMS Increases Payments for FDA Breakthrough Devices

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Regulatory News

US FDA medical device user fees increase six percent for 2020
FDA medical device user fees for 510(k) premarket notifications, Premarket Approvals (PMAs) and other market registration applications will increase by about six percent for the agency’s 2020 fiscal year. FDA’s 2020 user fee schedule takes effect October 1, 2019 and entails six-percent increases for both standard and small-business rates. The agency’s 2020 fiscal year increases are slightly higher than for 2019, which saw four-percent increases for most user fees. Manufacturers have until September 30, 2019 to submit premarket applications to FDA and pay lower 2019 user fees. (EMERGO- 08/05/2019)

MHRA Expands Guidance on Assistive Technology to Help Device Industry
MHRA published guidance on the definition and safe use of assistive technologies, provided examples of assistive technologies that are classed as medical devices, and gave an overview of the safety issues associated with the class of products. The expanded guidance now includes information to help developers of assistive technologies determine whether a product would be classed as a medical device for regulatory purposes. (RAPS 8/22/19)

FDA to Roll Out Modernization Plan in Push for Data Interoperability
FDA’s plan for data interoperability seeks to make use of application programming interfaces to create efficiencies around regulatory review processes and track medical products throughout their life cycle by leveraging data sources like electronic health records (EHRs) to create a totality of evidence that better informs benefit-risk profiles. The goal is to determine what happens when a data element traverses from the EHR all the way through the process into clinical research. (RAPS 8/23/19)

Payment News

CMS launching pilot program to give providers direct access to claims data
The Data at the Point of Care pilot program will use Medicare’s Blue Button to provide access to claims data to fill in the data gaps for providers by giving them access to information like previous diagnoses, past procedures and medication lists, CMS officials said. Providers participating in the DPC pilot program will, once their health IT is properly configured, be allowed to request a Medicare beneficiary’s Medicare claims data from CMS via HL7’s FHIR standard. (FierceHealthcare 7/30/19)

Autonomous AI Device Receives Historic CPT Code
AMA Current Procedural Terminology (CPT) Editorial Panel created a Category 1 CPT code for retinal imaging with automated point-of-care, which includes IDx-DR, an FDA-cleared autonomous AI system that detects diabetic retinopathy without the need for physician interpretation. This can be considered the first step in a process to lead to payments for autonomous AI in general.(MDDI 7/31/19)

CMS increases payment for breakthrough devices
CMS has outlined a new technology add-on payment for devices designated with FDA breakthrough status. This new rule lightens the need to demonstrate substantial clinical improvement, instead placing emphasis on meeting particular cost criteria. The intent is to provide additional payment for technologies that are depending on the emergence of real-world evidence. The changes will take effect in fiscal year 2021. (MedTechDive 8/5/19)

A CMS fact sheet proposes rule to streamline DMEPOS payments
A “comparable item analysis” is the proposed CMS solution to add “transparency and predictability” to the process of establishing fees for new durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). New DMEPOS items would be compared against existing devices in 5 major categories, including: physical components, mechanical components, electrical components, function/intended use and “additional attributes and features”. New DMEPOS items that are determined to be the same/similar to existing devices will be assigned a fee from the existing fee schedule. If no existing comparison is available, CMS will determine the payment after considering invoice pricing. (PT News 7/31/19)

New Hampshire’s state Medicare will cover telehealth starting in 2020
New Hampshire has added a new law that creates definitions for remote patient monitoring and “store-and-forward” (or asynchronous) telehealth, which will enable an increase in healthcare beyond the walls of the clinic. The hope is that this new law will increase access to care for New Hampshire residents who have difficulty reaching primary care providers and specialists. (Mhealth Intelligence 8/13/19)

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, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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