FDA Releases New Biocompatibility Draft Guidance and CMS provides further comment on “reasonable and necessary”

 In News, Regulatory & Reimbursement Update


FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for nitinol-containing devices. In the draft guidance, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made from common polymers and fabrics that come in contact with intact skin. The draft guidance outlines the criteria for certain devices made from materials with “very low biocompatibility risk” and a “long history of safe use in medical devices” to bypass biocompatibility testing. RAPS: 15 October 2020

US FDA publishes trio of final guidances for Accreditation Scheme for Conformity Assessment (ASCA) program

As the US Food and Drug Administration formally launches the pilot for its Accreditation Scheme for Conformity Assessment (ASCA) program to streamline testing requirements in medical device premarket reviews, the agency has published three final guidances addressing ASCA program goals, scope and acceptable testing standards. FDA intends for the ASCA program to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. Utilizing accredited testing labs would help make medical device and IVD premarket reviews more consistent and efficient, according to the regulator. EMERGO: 6 October 2020

CDRH FY 2021 guidance slate includes post-EUA transition plan

CDRH anticipates finalizing guidance documents on clinical decision support software and device-specifics guidances for safety and performance-based pathway implementation. Among the dozen topics to be covered in CDRH’s A-list draft guidances are postmarket surveillance under section 522 of the Federal Food, Drug & Cosmetic Act (FD&C), unique device identification enforcement policies for certain Class I devices, and how to handle post-approval studies that were imposed by premarket approval application orders. The agency also plans to tackle premarket submissions for software contained in medical devices in FY 2021; device manufacturers will also receive guidance on premarket submissions for management of medical device cybersecurity. An electronic submission template for 510(k) submissions is also slated to be covered in a draft guidance. RAPS 10/19/20

Eudamed: EC posts info on actor registration module

The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. The EC’s newly posted webpage on the actor registration module provides information on obtaining a single registration number (SRN), the actor registration request process and the process for granting additional users access to an actor’s profile. An infographic is provided for each of the three topics. The page also explains the documentation required to submit a registration request and provides a user guide for economic operators and technical documentation for the module. RAPS 10/20/20

US FDA updates final guidance on ISO 10993 for medical device biocompatibility 

FDA released a clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices. Notably, the guidance contains an updated FDA-modified matrix to identify and determine biocompatibility endpoints for evaluations of devices and manufacturer considerations when device labels include claims that a device is free (“-Free”) of a particular substance. (EMERGO- 9/15/20)


CMS provides further comment on efforts to define “reasonable and necessary”

The Centers for Medicare and Medicaid services (CMS) uses the phrase “reasonable and necessary” to describe the criteria for coverage of medical products and services. These terms have never been formally defined, but in September 2020, it was announced that CMS would propose a definition as part of MCIT (85 Fed, Reg 54327CMS). Senior Official Tamara Syrek Jensen stated in October that the proposed definition would consider an item or service to be appropriate for coverage if it is already being covered by a commercial insurer. Comments to the proposed rule are due by 11/2/20. (MedTech Dive 10/6/20)

Former CMS Chief Medical Officer recommends big changes to digital therapeutics reimbursement

In an article written in Stat News, Andrew Ostrovsky, former Chief Medical Officer for the Centers for Medicare and Medicaid services (CMS) shared his opinion on CMS coverage of digital therapeutics. He wrote about the complexity of the current coverage determination system and warned that there is a “pressing need” for safe and effective socially distanced digital therapeutics. The problem is that the outdated CMS benefit categories do not account for new technologies, and thus coverage of these services is not possible, even through the recently announced automatic coverage of “breakthrough technologies”. He stated that there are two potential fixes for this issue: congress could establish a Medicare benefit category for digital therapeutics, or CMS could use the Medicare Coverage for Innovative Technology rule to clearly establish that the existing benefit category of durable medical equipment includes digital therapeutics and software-based medical devices. Although the legislative solution would be preferable, it would take a long time to get passed and the coverage of digital therapeutics is an important and urgent issue in the current healthcare environment. (Stat News 10/19/20)

Germany opens doors to prescription digital health apps

As of the 5th of October, doctors in Germany can now prescribe digital health applications to their patients. Two apps have already been approved for this new program, Kalmeda – and app that helps patients deal with tinnitus and Velibra – an app that provides a therapy for anxiety. Costs for the apps will be covered by the German statutory health insurance (GKV). (Healthcare IT News 10/29/20)

Dr. Hugh Herr discusses the reimbursement challenges of advanced prostheses

In an interview with Industrial Robot Journal, MIT researcher and entrepreneur Dr. Hugh Herr discussed the joys and challenges of developing and commercializing robotic prosthesis. He noted that reimbursement is one of the most formidable barriers to the development of bionic limbs. Using the example of the Empower ankle, a powered ankle prosthesis, Dr. Herr stated that although a reimbursement code exists, it has not been assigned a price or coverage. This puts the $50,000 prosthesis out of reach for most patients in the US. Dr. Herr sold his company BionX to Ottobock in 2017, which has allowed the technology to be sold internationally. (Robotics Business Review 9/29/20)

CMS announces effort to codify the definition of “reasonable and necessary” 

CMS has long used the phrase “reasonable and necessary” to describe its coverage criteria. CMS is seeking to formalize the meaning of this phrase to include the following: the item or service is safe and effective, not experimental or investigational, and is appropriate for Medicare patients. More specifically, the item or service must be furnished in accordance with accepted standards, in appropriate settings, by qualified personnel. The item or service must meet but not exceed the patient’s medical need and be at least as beneficial as existing alternatives.  (HME News 9/1/20)

Health insurance provider Centene provides smartphones to rural and underserved patients 

Centene Corporation has partnered with Samsung to send Galaxy smartphones to patients who do not have other means to access virtual visits. About 13,000 members in rural and underserved areas received the phones and 90 days of free coverage. Centene CEO stated that this program demonstrates the insurer’s belief that telehealth solutions have the potential to significantly improve access to care. (Becker’s Hospital Review 9/14/20)

Digital therapeutic products added to list of standard covered benefits 

reSET and reSET-O, two products by Pear Therapeutics, were added to the list of standard medical benefits by health insurance company PreferredOne. Inclusion in this list will enable PreferredOne members to access the digital therapeutic products like another other medication or treatment. Both reSET and reSET-O are adjunctive to outpatient counseling and are used to treat substance use and opioid use disorders.  (Businesswire 9/21/20)

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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