The U.S. FDA’s device user fee schedule doubled for both the third and fourth user fee agreements over the prior iterations, but the pressure against another doubling for the fifth iteration of the user fee program is mounting. The Medical Imaging & Technology Alliance (MITA) said it sees a need to retain the user fee programs that are working and to jettison any underperforming programs, adding that user fees “should be stabilized around current funding levels.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
The U.S. Centers for Medicare and Medicaid Services (CMS) has moved incrementally to date on the Medicare inpatient-only (IPO) list for a number of procedures, but the agency recently proposed to eliminate the IPO list altogether by 2024. The Advanced Medical Technology Association (Advamed) cautioned that the elimination of the entire IPO list should at the least be accompanied by a monitoring of outcomes to ensure that quality of the services is not affected, but also said the translation of payment codes for outpatient performance of these procedures might lead to inadequate reimbursement rates.
The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.
The U.S. FDA has a number of draft guidances in queue thanks to the COVID-19 pandemic, but released two final guidances in mid-July, including the guidance for clinical investigations for prostate tissue ablation devices. Stakeholders pressed the agency to avoid a fixed period of follow-up for such studies due to variability in the elapsed time for device-related adverse events, but the agency stuck to the draft’s mandate for at least a year of follow-up.
The comment period has closed on the U.S. FDA’s discussion draft for artificial intelligence (AI) in medical devices, a paper that attracted the attention of medical societies and regulated industry. One of the questions posed by industry was whether the FDA is in a position to deal with the massive volumes of data developers would have to disclose to the agency, creating concern that such disclosures would amount to little more than an obligatory and useless data dump.
The Dec. 9, 2019, FDA draft guidance spelling out performance criteria for magnetic resonance coils seemed to take up a relatively simple matter, but industry’s response suggested otherwise. The Medical Imaging & Technology Alliance (MITA) recommended that the agency undertake nearly two dozen changes to the draft, including a change to the title to indicate that the scope of the guidance is limited to receive-only MRI coils.
The U.S. FDA’s attempt to use objective performance criteria for class II devices offers several advantages for device makers. However, the Advanced Medical Technology Association (Advamed) said in comments to the docket for two such sub-guidances that the documents are too narrowly scoped to be of much use in many instances.
