FDA Misses MDUFA V Deadline After Months Of Contentious Talks

 In Blog, Regulatory & Reimbursement Update


FDA misses MDUFA V deadline after months of contentious talks

FDA has failed to send the final Medical Device User Fee Amendments V agreement to Congress by the Jan. 15 deadline. The missed deadline follows months of talks that showed the FDA and industry were at odds over critical elements of the MDUFA program. Disruption caused by the COVID-19 pandemic meant negotiations over MDUFA V got off to a late start. Yet, negotiations between FDA and other parts of the life science industry wrapped up months ago — the agency published its commitment letter to the pharmaceutical sector in August — and meeting minutes reveal points of major disagreement over a deal that could be worth $1.2 billion. Whatever the cause of the delay, FDA is staying tight-lipped for now.

(MEDTECHDIVE: 19 Jan 2022)

Digital health tech in clinical investigations: FDA issues draft guidance

The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.  Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in late December 2021. Not only does the use of DHT offer the opportunity to collect data on a near-continuous basis, but remote data collection may also be less burdensome when travel to clinical trial sites is difficult. Also, DHTs can allow direct recording of data from individuals such as infants and some people with cognitive impairment who otherwise could not provide direct report of their clinical experience.

(RAPS: 05 Jan 2022)

FDA temporarily halts inspections due to omicron

As the US and other countries grapple with record-high COVID-19 cases driven by the omicron variant, the US Food and Drug Administration (FDA) has once again halted many of its domestic and foreign inspections. Just before the New Year, on 29 December, FDA “implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant.” FDA said it will continue conducting “mission-critical” work through 19 January but will postpone other inspections for the time being. The agency said it will continue to conduct mission-critical foreign inspections and “reassess plans as needed” based on travel conditions abroad. The agency said it hopes to resume its routine inspectional activities “as soon as possible.”

(RAPS: 05 Jan 2022)

US FDA lays out post-COVID EUA transition plans for medical devices

The US Food and Drug Administration has published transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency but that will require full regulatory registration to remain legally commercialized. New draft guidance from FDA cover transition plans for devices granted EUA designations during the coronavirus pandemic; the guidance provides more clarity regarding how device manufacturers whose devices were made available via pandemic-era EUAs will be affected once the public health emergency abates. Industry and other stakeholders have 90 days to comment on FDA’s approach.

(EMERGO: 11 Jan 2022)


APTA practice advisory for Remote Therapeutic Monitoring

The American Physical Therapy Association (APTA) has issued a practice advisory for the use of the new Remote Therapeutic Monitoring (RTM) reimbursement codes. Five new RTM codes were issued as a part of the 2022 Medicare physician fee schedule and were available for billing as of January 1st. RTM codes are used to describe the monitoring of patients’ musculoskeletal or respiratory status and their response and adherence to therapy. Data for RTM can come from a medical device or can be provided via patient reported outcome measures. The ability to bill for remote monitoring is new to physical and occupational therapists, and the practice advisory explains the correct requirements and procedures.

(APTA 1/20/22)

Digital health reimbursement is “better than ever with a long way to go”

The state of the reimbursement landscape for digital health was summarized in an article by Robert Jarrin and Brian Scarpelli. They note that funding for the digital health sector doubled in 2021 compared to 2020. Reimbursement development is lagging behind this rapid growth, although it has taken off in the last five years. Because many payment policies are retrofit into a system that was created long before digital health, the results are “a very complex area that isn’t necessarily user friendly.” Medical device entrepreneurs are looking to administration leadership for acknowledgement and endorsement of how digital health tools can help to provide care to underserved communities and can be used for more than just telehealth.

(Mobihealth News 1/21/22)

CMS is boosting chronic care management in 2022

Chronic care management reimbursement was first established in 2015 by the Centers for Medicare and Medicaid Services (CMS). The goal of chronic care management is to provide improved care and reduce the cost of treatment to patients with complex medical needs, including diabetes, cancer, cardiovascular disease, and pulmonary disease. The Covid-19 pandemic has highlighted the need for this and has shown that chronic care management has real value for patients and for the healthcare system. The increased reimbursement rates for chronic care management in CMS’ 2022 physician fee schedule reflect this fact.

(MedCity News 1/26/22)

iRhythm sees the impact of doubled Medicare reimbursement rate

Novitas, a regional Medicare contractor, raised payment rates for cardiac monitoring in 2022. In some instances, the new rates are more than twice the 2021 payment levels. The new rates apply to cardiac monitoring for 7-15 days and for monitoring from 48hrs to 7 days. iRhythm and other cardiac monitoring companies had engaged with Novitas and other Medicare rate setters to help underscore the value of continuous ECG monitoring after a dramatic rate cut in 2021 had cast uncertainty over the feasibility the business. The 2022 rate hikes appear to have come as a surprise and the impact could be seen immediately in a 28% jump of iRhythm stock after the announcement.

(MedTech Dive 1/11/22)

Balancing personalized care with remote patient management

New digital solutions are bridging the gap between diagnostics and therapeutics, meaning that the patient can be evaluated and treated using the same tools. Telehealth adoption increased in 2020 and stabilized in 2021, but was used mostly by the young, educated, and wealthy. One area where digital tools may fall flat is in building the patient/provider relationship. Another roadblock is moving from a fee-for-service environment to a value-based and preventative care system. This has left a patchwork of reimbursement options and unanswered coding, coverage, and payment questions around digital health. The author’s prediction: “We’ll see a range of digital versus human-led interventions emerge that are both asynchronous and synchronous based on patient complexity and patient progress.”

 (Forbes 1/28/22)

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 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.

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