Evaluation of technologies approved for supplemental payments in the United States

Judson, Timothy; Dhruva, Sanket S.; Redberg, Rita F.

doi:10.1136/bmj.l2190

Cited by 11 publications

(10 citation statements)

References 23 publications

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“…A recent study raised concerns that many NTAP technologies may not provide substantial clinical benefit. 3 Drawing from other countries’ experiences, others highlighted the need for broad US policy reform that aligns technology prices with value. 4 Our study adds to this ongoing discussion by raising questions regarding adequacy of reimbursement of these technologies and whether, despite recent increases, NTAP payments will be sufficient to incentivize hospitals to offer these therapies to patients in need.…”

Section: Discussionmentioning

confidence: 99%

The Changing Characteristics of Technologies Covered by Medicare’s New Technology Add-on Payment Program

2020

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Section: Discussionmentioning

confidence: 99%

The Changing Characteristics of Technologies Covered by Medicare’s New Technology Add-on Payment Program

2020

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“…The Centers for Medicare and Medicaid (CMS) services subsequently authorized supplemental payment to facilitate device utilization. 21,22 Recent study of postmarket experience reveals that the device was rapidly adopted into clinical practice, but did not result in significant reduction in post-TAVR stroke or transient ischemic attack. 21,23 This saga illustrates the need for more rigorous evidentiary standards, which could help minimize clinical opportunity costs and wasteful healthcare spending that result from the adoption of ineffective devices.…”

Section: Discussionmentioning

confidence: 99%

Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

Johnston

Dhruva

Ross

et al. 2020

Preprint

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Importance: In recent years, the US Food and Drug Administration (FDA) and manufacturers have increasingly sought to expedite patient access to first-of-a-kind devices via the De Novo premarket review pathway. Understanding the strength of clinical evidence supporting FDA clearance through this pathway can help guide clinical adoption of novel devices and ongoing regulatory development of the postmarket surveillance infrastructure. Objective: Our primary objective was to characterize the strength of clinical evidence supporting FDA clearance of therapeutic De Novo devices. Key secondary objectives were 1) characterization of FDA post-marketing requirements for De Novo devices and 2) study of the use of these devices as the basis for devices subsequently cleared via the 510(k) process. Design: Retrospective cross-sectional analysis Setting: Publicly available online FDA databases, including the De Novo database, the 510(k) clearance database, the 522 Post Market Surveillance database, and the Recalls of Medical Devices database Participants: All moderate-risk therapeutic devices cleared via the De Novo pathway between January 1, 2011, and December 31, 2019. Main Outcome Measures: (1) proportion of De Novo devices cleared based on evidence from a pivotal clinical study, (2) proportion of pivotal study primary effectiveness endpoints that were met, (3) proportion of De Novo devices subject to FDA-required postmarket studies, and (4) proportion of De Novo devices serving as the basis for at least one subsequently cleared 510(k) device (i.e., new models or competitor products). Results: There were 63 (of 65; 96.9%) moderate-risk therapeutic devices cleared by FDA via the De Novo pathway between 2011 and 2019 for which decision summary documentation was publicly available. Of the 63 devices, 51 (81.0%) were supported by pivotal clinical studies (n=54 studies); the remainder (n=12; 19.0%) were not supported by a pivotal clinical study. The majority of pivotal studies were randomized (57.4%), multi-armed (61.1%), and used an active (25.9%) or sham (35.2%) comparator arm; 17 (31.5%) failed to meet at least one primary effectiveness endpoint. Among the 63 devices cleared via the De Novo pathway, one (1.6%) was subject to an FDA-required posttmarket study and 32 (47.8%) served as a predicate device for new models or competitor devices subsequently cleared through the 510(k) process. Conclusions: Between 2011 and 2019, the FDA cleared the majority of first-of-a-kind moderate-risk therapeutic devices via the De Novo pathway based on premarket evidence from pivotal clinical studies. However, 43% of devices were cleared without clinical evidence from pivotal studies or based on pivotal studies that failed to meet at least one primary effectiveness endpoint. The FDA rarely required postmarket studies of these devices, which often served as the basis for new models and competitor products subsequently cleared via the 510(k) process.

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“…Analysis of impact is required; particularly as recent studies have raised concern about some NTAP technologies that may not have provided the anticipated clinical benefit. 17 The first approved NTAP for stroke triage AI: The specific strategies employed A stroke AI system company was granted the first NTAP effective for Medicare discharges occurring between 1 October 2020 and 30 September 2021. 3 It used software that automatically stratifies patients with and without a LVO stroke, then triggers automated alerts and graphical data to the treating physicians intended to accelerate the identification of such patients, reducing the number of phone calls and wait times to assess images and clinical data.…”

Section: Why Ntap and Stroke Ai?mentioning

confidence: 99%

“…Analysis of impact is required; particularly as recent studies have raised concern about some NTAP technologies that may not have provided the anticipated clinical benefit. 17…”

Section: Why Ntap and Stroke Ai?mentioning

confidence: 99%

Insurance payment for artificial intelligence technology: Methods used by a stroke artificial intelligence system and strategies to qualify for the new technology add-on payment

et al. 2022

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The first ever insurance reimbursement for an artificial intelligence (AI) system, which expedites triage of acute stroke, occurred in 2020 when the Centers for Medicare and Medicaid Services (CMS) granted approval for a New Technology Add-on Payment (NTAP). Key aspects of the AI system that led to its approval by the CMS included its unique mechanism of action, use of robotic process automation, and clear linkage of the system’s output to clinical outcomes. The specific strategies employed encompass a first-case scenario of proving reimbursable value for improved stroke outcomes using AI. Given the rapid change in utilization of AI technology in stroke care, we describe the economic drivers of stroke AI systems in healthcare, focusing on concepts of reimbursement for value added by AI to the stroke care system. This report reviews (1) the successful approach used by the first NTAP-approved AI system, (2) economic variables in insurance reimbursement for AI, and (3) resultant strategies that may be utilized to facilitate qualification for NTAP reimbursement, which may be adopted by other AI systems used in stroke care.

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Evaluation of technologies approved for supplemental payments in the United States

Abstract: Supplemental payment programmes can increase access to new technologies, but Timothy Judson and colleagues find that some payments are made without clear evidence of safety and effectiveness

Cited by 11 publications

References 23 publications

The Changing Characteristics of Technologies Covered by Medicare’s New Technology Add-on Payment Program

The Changing Characteristics of Technologies Covered by Medicare’s New Technology Add-on Payment Program

Clinical Evidence Supporting FDA Clearance of First-of-a-Kind Therapeutic Devices via the De Novo Pathway Between 2011 and 2019

Insurance payment for artificial intelligence technology: Methods used by a stroke artificial intelligence system and strategies to qualify for the new technology add-on payment

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