FDA creates new category for OTC hearing aids and CMS no longer requiring CMNs for some DMEPOS
FDA finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for hearing exams or fittings. The rule only applies to certain air conduction hearing aids for adults who have mild to moderate hearing loss. At the same time, it also published a final guidance titled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” While hearing aids and PSAPs often look very similar and work in the same way, the guidance delineates when a PSAP will be considered a hearing aid and hence have to meet more stringent regulatory requirements.
Innovation in the medical device industry has increased in a great manner as seen by the 693 breakthrough designations granted by the FDA since 2015. The majority of these designations have been submitted through the FDA’s Center for Devices and Radiological Health. In a further breakdown, breakthrough cardiovascular medical devices had the highest number of approvals of the 693 devices which were submitted.
The European Commission’s Medical Device Coordination Group (MDCG) has listed a slew of actions to help streamline the work of notified bodies (NB), including encouraging notified bodies to conduct hybrid audits when doing so would speed conformity assessments. In order to avoid unnecessary duplication of work, the MDCG encourages notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the directives for the purpose of conformity assessment procedures under the regulations. The MDCG said there should be flexibility given to the review of legacy products as long as they are deemed relatively safe and effective. The MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants and ensure access of SMEs and first-time applicants to notified bodies for conformity assessment.
EPA announced plans to propose an air pollution rule later this year to address emissions of ethylene oxide at commercial sterilizers. As part of its proposal, the EPA has conducted a risk assessment which identified 23 commercial sterilizers in several states that were found to emit high levels of ethylene oxide.
The FDA shares concerns about the release of ethylene oxide at unsafe levels into the environment. FDA has been proactively working with medical device sterilizers to reduce the amount of EtO they use while still effectively sterilizing products to help ensure they meet the EPA’s standards for ethylene oxide emission levels. To that end, FDA is equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations. FDA’s supply chain program is ready to work with industry to help prevent and mitigate potential shortages due to reduced supply of certain ethylene oxide sterilized medical devices.
(FDA press release 8/3/22)
The Centers for Medicare and Medicaid Services (CMS) announced in Mid-August that it will discontinue the requirement of some documentation aspects in the coverage process of some types of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). The change seeks to lessen provider burden and provide a quicker path to care for patients in need of DMEPOS items. It was determined that the previous requirements of physician documentation of medical necessity and prior authorization often caused a delay of care that could risk to the life or health of the patient. This new rule goes into effect April 13, 2023, and applies to specific DEMOPOS items under certain circumstances. Examples of HCPCS codes effected by these changes include knee and back orthoses such as: L0648, L0650, L1832, L1833, L1851.
FIGUR8, a digital health company based in Boston, MA announced that the American Medical Association (AMA) issued a new Category III CPT code for the use of their sensor system. The system measures muscle function through a combination of surface mechanomyography and inertial measurement. FIGUR8’s CEO Nan-Wei Gong, PhD noted that this is the first example of the AMA recognizing a digital physical examination procedure in the CPT code set. The new code goes into effect on January 1, 2023.
(PR Newswire 8/22/22)
It has been nearly five years since the first US regulatory clearance of a prescription digital therapeutic (PDT), but currently the only public coverage for PDTs is via individual state-by-state contracts with Medicaid plans. Private payers also remain hesitant to cover PDTs widely, citing concern with lack of long-term efficacy evidence. Although a bill was introduced in the Senate in 2022 to establish a designated benefit category for PDTs, it has yet to be enacted. New payment codes have been introduced gradually, but the billing process still consists largely of ad hoc contracts. Reimbursement through procedural codes has become more common, using the remote monitoring code sets. A new level II HCPCS code (A9291) was introduced in April 2022, but pricing has not yet been established. Alternative payment methods such as bundling PDTs into episodes of care is another possibility that is being explored through performance-based innovation models. The current pace of PDT innovation is outpacing the reimbursement mechanisms. Establishing clear standards for evidence requirements is one suggested way to improve coverage.
(Health Affairs Forefront 8/10/22)
Medicare Advantage programs are growing rapidly, about 48% of Medicare beneficiaries currently are on a Medicare Advantage plan. University of Pennsylvania researchers found substantially higher expenses in treating patients with four chronic conditions when those patients were enrolled in traditional Medicare versus Medicare Advantage. The cost disparities are attributed to performance-based payments and improved vertical integration in Medicare Advantage systems. This indicates that Medicare Advantage plans have more “levers” to control costs and improve quality of care.
(Fierce Healthcare 8/25/22)
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, Amit Guruprasad, Simbex Quality Engineer, and Angela Smalley, PhD, Simbex Senior Commercialization Consultant. A story’s inclusion does not imply endorsement by Simbex.