FDA Detailed Expanded Use of Remote Regulatory Assessments in New Guidance and CMS Proposed Updates to Remote Therapeutic Monitoring in 2023 Fee Schedule
FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency. These remote assessments of an FDA-regulated establishment and/or its records can help determine compliance with applicable FDA requirements, inform regulatory decisions and verify information submitted to the agency. Over the last two years, FDA has performed more than 1,470 domestic and more than 600 foreign entity establishment RRAs. The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities. Except for RRAs for establishments required to comply with the Foreign Supplier Verification Programs (FSVP) regulation, an RRA does not function as an inspection.
(FDA Press Release 7/22/22)
FDA has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles. FDA defines consumer health products as “510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores.” Class I devices that do not meet the agency’s definition of consumer health products have been granted compliance deadline extension, to December 8, 2022.
The MDR states: “Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.” Only the most recent version of a published standard will qualify as state-of-the-art in the EU. State-of-the-art risk management and MDR Article 10 requires manufacturers to establish, document, implement and maintain a product safety risk management system. Discussing state-of-the-art risk management in medical devices must address similar and equivalent devices. To claim equivalence, manufacturers must have sufficient access to data relating to the equivalent device. For high-risk devices, a contract must be in place allowing full access to the technical documentation on an ongoing basis.
The National Institute of Standards and Technology (NIST) has updated its cybersecurity guidance for the healthcare industry. The new draft publication, “Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide (NIST Special Publication 800-66, Revision 2),” is designed to help the industry maintain the confidentiality, integrity and availability of electronic protected health information (ePHI). The revision was developed to better integrate ePHI cybersecurity guidance with other NIST cybersecurity guidance that did not exist when Revision 1 was published in 2008.
(MedTech Intelligence 7/25/22)
The Centers for Medicare and Medicaid Services (CMS) released the proposed 2023 physician fee schedule on July 7. Multiple changes to the Remote Therapeutic Monitoring code set were included in the proposal. These changes clarify the types of providers using the codes by dividing the monitoring into codes billed by physicians and those billed by therapists and other non-physician healthcare professionals. A new supply code was introduced for cognitive behavioral therapy monitoring technology.
(JD Supra 7/12/22)
Pioneering digital therapeutic companies have now been on the market for around 5 years and still haven’t been able to generate significant revenue. Forrester Researcher interviewed employees of digital therapeutic companies and identified the lack of clear reimbursement pathway as a significant headwind. It was the most commonly discusses topic among interviewees and the process of achieving payer approval was described as “arduous and ill-defined”. However, interviewees are looking to recent additions of billing codes that cover remote therapy as a potential lifeline for the industry.
(MedTech Dive 7/15/22)
Beginning on July 1st, health insurers must publicly post their itemized pricing lists for healthcare services. The requirements are the result of a 2019 executive order and are expected to increase pricing transparency for customers and businesses in the healthcare industry. The rule specifies the inclusion of 500 “shoppable” services that patients should be able to schedule ahead of time, making informed cost-based decisions.
Telehealth reimbursement flexibilities were introduced in 2020 as a temporary measure during the COVID19 public health emergency. As a result, use of Telehealth services skyrocketed during the pandemic and although it has somewhat subsided, it has remained higher than pre-pandemic levels. The telehealth reimbursement rules are currently due to reset in October. A proposed bill from the House Rules Committee, called the “Advancing Telehealth Beyond COVID-19 Act” would extend reimbursement flexibilities through December 2024.
(Fierce Healthcare 7/26/22)
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.