FDA Final Rule Reduces Radiological Devices Reporting Requirements and the End of the COVID PHE Will Bring Reimbursement Changes
FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation protection during medical procedures. It also does the same for certain records and reporting requirements for electronic products and performance standards for diagnostic x-ray systems and their major components, lasers and ultrasonic therapy products. The agency said the move is meant to reduce regulatory requirements that are outdated and duplicative. FDA’s new rule amends reporting requirements for manufacturers that incorporate a certified laser product to reduce reporting that is considered duplicative under certain conditions and repeals the performance standard for ultrasonic products because it is limited to a subset of physical therapy devices with an outdated standard.
The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards. IEC 81001-5-1 “Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle” addresses the challenges of software-related cybersecurity in medical devices, complementing the software life-cycle standard IEC 62304 “Medical device software – Software life cycle processes”. Manufacturers now have the option between UL 2900-x or IEC 81001-5-1 for 510(k) submissions and other regulatory clearances. IEC 81001-5-1 can be used as a Secure Product Development Framework according to the latest draft FDA guidance on cybersecurity and a method of answer to GSPR on cybersecurity of EU MDR and IVDR
(MD101 Consulting 1/9/2023)
Since the last week of 2022, the FDA announced it was classifying nine products as class II devices with special controls. The list of devices includes several software as a medical device (SaMD) products. The agency also issued classification orders identifying three devices as class II products during the first week of 2023: brain stimulation programming planning software, implantable post-surgical kinematic measurement knee devices and bone indentation devices. The list of SaMDs includes gastrointestinal lesion software detection systems, pediatric Autism Spectrum Disorder (ASD) diagnosis aids, interventional cardiovascular implant simulation software devices and adjunctive hemodynamic indicators with decision point.
The European Commission adopted a proposal to allow medical device makers more time to certify their products under the EU Medical Devices Regulation (MDR) amid concerns that the regulation could prompt shortages of lifesaving products. The proposal would also repeal the “sell-off” date provision under both MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Under the proposal, the transition period deadline is extended from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device. High-risk devices would be subject to the shorter transition period ending in 2027, while low- and medium-risk devices would have until the end of 2028 to complete a conformity assessment. The proposal will now be sent to the European Parliament and Council under an accelerated co-decision procedure to get final approval from legislators for the new deadlines.
The White House has announced the intend to end the COVID-19 Public Health Emergency (PHE) on May 11th. The PHE, which has been in place since March 2020, has temporarily provided coverage and payment for medical care including telehealth expansion. These benefits are set to expire 151 days after the PHE officially ends. Additional payments to hospital systems will also be discontinued and Medicare Advantage plans can begin charging for enrollees who receive care at out of network facilities.
The 2023 Physician Fee Schedule final rule was issued in early November with some significant changes, impacting remote monitoring and related topics. Remote Therapeutic Monitoring (RTM) has six CPT codes available that are billable by physicians, nonphysician practitioners and other qualified providers. The final rule eases supervision requirements, paving the way for an increase in RTM services. In addition, home health organizations have been asked to voluntarily report on telehealth and remote monitoring use through three non-reimbursable codes, signaling a potential for future reimbursement for home health Remote Patient Monitoring (RPM).
(Medical Economics 1/4/23)
The explosion in popularity of Medicare Advantage (MA) has triggered a discussion about how to calculate benchmarks that determine payment rates. As more and more MA plans become available and fee-for-service plan numbers decline, the use of standardized national spending is recommended as a benchmark for setting rates, reducing variation, and allowing more widespread availability of MA plans.
(Fierce Healthcare 1/26/23)
State Medicaid programs have become early adopters of digital therapeutics which normally face reimbursement challenges. Where there is a shortage of providers, digital therapeutics have improved access to care. Although new legislation providing guidance around coverage for DTx did not make it into this year’s funding, it defined what DTx coverage would look like and bodes well for the future.
(Behavior Health Business 1/6/23)
Clinical consults between primary care and specialty providers conducted via digital health means have received expanded coverage by Medicaid and Children’s Health Insurance Program. The new guidance means that specialists as well as primary care providers are now able to bill for these eConsults and primary care providers can expand care options to specialists while retaining more of their patients. This is especially helpful in rural areas where specialty care is scarce.
(Health Leaders 1/30/23)
CEO and cofounder of Force Therapeutics, Bronwyn Spira summarized new mechanisms for reimbursement for remote therapeutic monitoring in an interview. She states that the new CPT codes make it possible to manage high quality care at home, including to those in typically underserved populations, while providing tools and education along with an individualized approach for each patient. She stresses the importance of using a technology platform that provides the tracking and outcomes data that payers will require and that engages the patient such that they achieve at home the same or better outcomes as they would in a traditional care setting. To qualify for reimbursement the platform must be FDA approved as a Software as a Medical Device (SaMD).
(Healthcare IT News 1/30/23)
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 Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant. A story’s inclusion does not imply endorsement by Simbex.