FDA releases new EMC draft guidance and CMS increases home health reimbursement for 2021
Medical device manufacturers have new draft guidance on electromagnetic compatibility from FDA. The new 20-page guidance delves into much more detail than the six pages of the 2016 final guidance it is destined to replace. The guidance gives detailed instructions for sponsors about how to depict and describe the electromagnetic characteristics of devices, including the presence of any wireless technology and radiofrequency transmitters in the device. Risk assessment should take in account what would happen if EMI occurred, and categorize each harm to patient, user or operator according to the severity of potential harm.
(RAPS-16 Nov 2020)
Participating MDSAP regulatory bodies (US FDA, Health Canada, Australia’s TGA, Brazil’s ANVISA, and Japan’s MHLW and PMDA) published a new consolidated guidance into a single source of information detailing the process for auditing the quality management systems of medical device manufacturers. The MDSAP Council also added annexes providing further details and guidance on assessing conformity for each audited process; and giving deadlines for submitting adverse events reports and advisory notices.
Software continues to be the top reason for a recall (it has been the top issue for 17 out of the 18 past quarters), with 50 recalls during Q3, affecting nearly 5 million units of all recalled units. Meanwhile, quality came in second in terms of reason for a recall, but it impacted 6.2 million units.
(Medtech Intelligence 11/30/20)
MHRA states that international standards will continue to be used. The Usability Engineering standard IEC62366 is recognized by Notified Bodies and is certain to be carried over into the CABs. Manufacturers should continue to use IEC62366-1 as the ”go-to” standard for applying Usability Engineering methods. Fortunately, there are strong links between the activities recommended in IEC62366-1 and the usability requirements inherent in the European Medical Devices Regulation (MDR). MHRA produced their own human factors guidance which recommends an approach to human factors that aligns closely with the US FDA, and also with the requirements in IEC62366-1. MHRA is not expected to update this guidance any time soon, so for the foreseeable future it will be the most current guidance from MHRA.
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)
The $1.9M boost for home health reimbursement is smaller than the original 2.6% increase that was proposed by Centers for Medicare and Medicaid Services (CMS) in June 2020. The increase will take effect in 2021. The final rule also contains provisions intended to promote the use of telecommunication technology. This will allow home health agencies to provide remote patient monitoring services as needed in response to COVID-19 and beyond.
(RevCycle Intelligence 11/4/20)
In an opinion piece, Andrey Ostrovsky, former Chief Medical Officer of the US Medicaid program commented on the proposed MCIT rule. He highlighted the high number of fatalities among Medicare beneficiaries due to COVID-19 and stated that the Centers for Medicare and Medicaid Services (CMS) should consider the pressing need for new digital therapeutics to deliver socially distanced care. He stated that the proposed MCIT rule, which would expedite CMS coverage for breakthrough devices, might not address the lack of coverage for digital therapeutics because they do not fit into a recognized benefit category. In order to address this issue, he suggested that CMS should expand their current interpretation of what constitutes durable medical equipment to include digital devices.
(STAT News 10/19/20)
Medical device company CVRx has received Centers for Medicare and Medicaid Services (CMS) approval for a New Technology Add-on Payment (NTAP) for its implantable device, Barostim Neo. The NTAP payments will provide up to 65% of the device cost added to the Medicare payments for the procedure. As a technology that received breakthrough designation from the FDA in 2016, the Barostim Neo also falls under Medicare’s proposed MCIT rule that would provide immediate national coverage for new breakthrough devices. The Barostim Neo has already been widely reimbursed via a claim-by-claim basis, but the new rule would provide coverage without the need for the adjudication process.
(Mass Device 11/3/20)
The Centers for Medicare and Medicaid Services (CMS) released the latest End-Stage Renal Disease Prospective Payment System in early November 2020. The rule expands transitional add-on payments for new and innovative dialysis machines, including those used for home dialysis. Access to home dialysis is considered a key option to reduce exposure for patients who are at higher risk of requiring hospitalization due to COVID-19.
(RevCycle Intelligence 11/3/20)
The recent Telehealth boom resulting from precautions surrounding COVID-19 has changed the face of US healthcare delivery. A panel of experts discussed the opportunities and challenges surrounding health disparities and Telehealth in the light of these recent changes. Issues mentioned include working with patients who are not “digital natives” and considering the differences in rural versus urban communities. One panelist, Dr. Tom Brazelton, recommends “listen to your champions – those rare early adopters, innovators…there are a lot of champions within any organization, ones with great ideas – start with them.” The article contains a link to the full panel discussion.
(Becker Hospital Review 11/3/20)
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)
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)
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.