https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807906
August 4, 2023
Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies
Zachary A. Sexton, MS1; Juliana R. Perl, MS1; Henry R. Saul1; et alArtem A. Trotsyuk, PhD1,2; Jan B. Pietzsch, PhD1,3; Sandra Waugh Ruggles, PhD1,4; Margaret C. Nikolov, PhD5; Kevin A. Schulman, MD5,6; Josh Makower, MD1,7,8
JAMA Health Forum. 2023;4(8):e232260. doi:10.1001/jamahealthforum.2023.2260
Key Points
Question How long does it take to establish Medicare coverage for novel medical technologies?
Findings In this cross-sectional study, 64 devices and diagnostics authorized by the US Food and Drug Administration through premarket approval and de novo pathways between 2016 and 2019 required establishment of new Medicare coverage; at least nominal explicit or implicit Medicare coverage supportive of patient access was achieved by 28 (44%) within a median of 5.7 years.
Meaning Lengthy processes to establish Medicare coverage warrant attention; timelines for coverage achievement can be used to inform new policy strategies.
Abstract
Importance A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies.
Objective To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway.
Design, Setting, and Participants In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022.
Main Outcome Measurement Time from FDA authorization to the first coverage milestone.
Results Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40).
Conclusions and Relevance In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.
ChatGPT3.5 summary
This study, published in JAMA Health Forum and conducted by Zachary A. Sexton and colleagues, investigates the time required to establish Medicare coverage for medical devices and diagnostics authorized by the US Food and Drug Administration (FDA). The main question addressed by the study is: how long does it take to establish Medicare coverage for novel medical technologies?
For their research, Sexton et al. utilized a cross-sectional design. They screened public databases to associate each technology with billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. The main outcome measurement was the time from FDA authorization to the first coverage milestone.
Their findings revealed that of the 281 technologies authorized by the FDA between 2016 and 2019, 64 were novel and required establishment of a new reimbursement process. For these novel technologies, only 28 (or 44%) reached at least nominal coverage by the conclusion of the study period. The median time to at least nominal coverage for this group was 5.7 years. The study also found considerable variability in time to coverage milestone achievement. While the strength of clinical evidence did not show a significant difference in time to coverage, manufacturer size and type of technology did. Larger manufacturers and diagnostic assays reached coverage more rapidly than other types of devices and smaller manufacturers.
The study is important in that it underscores a significant gap between FDA authorization and Medicare coverage. It shows that the process of establishing Medicare coverage for novel medical technologies can be lengthy, which may have implications for patient access to these technologies. This finding is particularly relevant given the increasing pace of medical technology development.
The authors argue that this substantial coverage gap warrants attention and suggest that timelines for coverage achievement can be used to inform new policy strategies. They highlight the need for more efficient and timely reimbursement processes for novel FDA-authorized medical devices and diagnostics.
They discuss the potential reasons for the gap, such as the complex nature of the reimbursement process, the financial ability of larger manufacturers to hire individuals with expertise in navigating the path to milestones, and the need for additional clinical evidence for the Medicare population. They also point to possible solutions, such as the development of acceleration programs designed to close the gap between FDA authorization and new Medicare coverage. However, they note that current programs such as the Coverage with Evidence Development (CED), the FDA Payer Communication Task Force, and Parallel Review have been underutilized and have not achieved their intended goals.
The authors acknowledge several limitations of their study, such as the potential bias introduced by industry experts, the limited scope of FDA 510(k) technologies included in the sample, and the exclusion of technologies requiring a new Medicare benefit category. They also note that their analysis adopted the perspective that access to FDA-authorized technologies is a desirable objective, but acknowledge that additional postauthorization clinical evidence collection might be necessary and take time.
In conclusion, this study provides valuable insights into the length of time it takes to establish Medicare coverage for novel medical technologies. The findings could inform future policy strategies aimed at improving patient access to these technologies. The study also highlights the need for further research and potential changes to current acceleration programs to facilitate a more efficient and timely reimbursement process for novel FDA-authorized medical devices and diagnostics.
Haiku
Novel tech advances,
Coverage lags in its wake,
Patients wait in vain.
FDA approves fast,
Yet Medicare's slow to act,
Access gap persists.
VIDEO VERSION
[Opening Slide: Time From FDA Authorization to Medicare Coverage]
"Hello and welcome. Today we're discussing an important study published in the JAMA Health Forum by Zachary A. Sexton and colleagues. This study delves into the timeline from FDA authorization to Medicare coverage for novel medical technologies.
[Slide: Research Objective]
The objective was to measure the time from FDA authorization to Medicare coverage for technologies requiring a new reimbursement pathway. This is a critical issue, as it's not enough for a medical technology to be deemed safe and effective by the FDA; it also needs to be covered by insurance providers for patients to have access to it.
[Slide: Methodology]
The team conducted a cross-sectional study that included new product applications authorized by the FDA through various pathways from January 1, 2016, to December 31, 2019. The main outcome measurement was the time from FDA authorization to the first coverage milestone.
[Slide: Findings]
The researchers found that out of 281 technologies authorized by the FDA during this period, 64 required the establishment of a new reimbursement process, and these were considered novel. However, only 44% of these novel technologies achieved at least nominal Medicare coverage by the conclusion of the study period. The median time to at least nominal coverage was 5.7 years.
[Slide: Factors Affecting Time to Coverage]
Interestingly, the study found considerable variability in time to coverage milestone achievement. While the strength of clinical evidence did not significantly influence the timeline, manufacturer size and the type of technology did. Larger manufacturers and diagnostic assays reached coverage more rapidly than other types of devices and smaller manufacturers.
[Slide: Implications]
This substantial gap between FDA authorization and Medicare coverage for novel medical technologies underscores a need for more efficient and timely reimbursement processes. It's crucial because this gap can affect patient access to novel medical technologies.
[Slide: Potential Solutions]
The authors suggest acceleration programs designed to close the gap between FDA authorization and new Medicare coverage. However, they also note that current programs have fallen short of their intended goals and are underutilized.
[Closing Slide: Conclusion]
In conclusion, this study highlights a significant issue in the healthcare sector: the time gap between FDA authorization and Medicare coverage for novel medical technologies. Future policy strategies could utilize these findings to improve patient access to these technologies. This research also underscores the need for further studies and potential changes to current acceleration programs to make the reimbursement process for novel FDA-authorized medical devices and diagnostics more efficient and timely.
Thank you for joining us today. Stay tuned for more updates on healthcare research."
[End of Video]
###
Original JAMA Abstract (Sexton 2023)
375 words
ChatGPT3.5 Summary
(Requested 600 words)
Importance A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies.
Objective To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway.
Design, Setting, and Participants In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022.
Main Outcome Measurement Time from FDA authorization to the first coverage milestone.
Results Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40).
Conclusions and Relevance In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.
375 words.
This study, published in JAMA Health Forum and conducted by Zachary A. Sexton and colleagues, investigates the time required to establish Medicare coverage for medical devices and diagnostics authorized by the US Food and Drug Administration (FDA). The main question addressed by the study is: how long does it take to establish Medicare coverage for novel medical technologies?
For their research, Sexton et al. utilized a cross-sectional design. They screened public databases to associate each technology with billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. The main outcome measurement was the time from FDA authorization to the first coverage milestone.
Their findings revealed that of the 281 technologies authorized by the FDA between 2016 and 2019, 64 were novel and required establishment of a new reimbursement process. For these novel technologies, only 28 (or 44%) reached at least nominal coverage by the conclusion of the study period. The median time to at least nominal coverage for this group was 5.7 years. The study also found considerable variability in time to coverage milestone achievement. While the strength of clinical evidence did not show a significant difference in time to coverage, manufacturer size and type of technology did. Larger manufacturers and diagnostic assays reached coverage more rapidly than other types of devices and smaller manufacturers.
The study is important in that it underscores a significant gap between FDA authorization and Medicare coverage. It shows that the process of establishing Medicare coverage for novel medical technologies can be lengthy, which may have implications for patient access to these technologies. This finding is particularly relevant given the increasing pace of medical technology development.
The authors argue that this substantial coverage gap warrants attention and suggest that timelines for coverage achievement can be used to inform new policy strategies. They highlight the need for more efficient and timely reimbursement processes for novel FDA-authorized medical devices and diagnostics.
They discuss the potential reasons for the gap, such as the complex nature of the reimbursement process, the financial ability of larger manufacturers to hire individuals with expertise in navigating the path to milestones, and the need for additional clinical evidence for the Medicare population. They also point to possible solutions, such as the development of acceleration programs designed to close the gap between FDA authorization and new Medicare coverage. However, they note that current programs such as the Coverage with Evidence Development (CED), the FDA Payer Communication Task Force, and Parallel Review have been underutilized and have not achieved their intended goals.
The authors acknowledge several limitations of their study, such as the potential bias introduced by industry experts, the limited scope of FDA 510(k) technologies included in the sample, and the exclusion of technologies requiring a new Medicare benefit category. They also note that their analysis adopted the perspective that access to FDA-authorized technologies is a desirable objective, but acknowledge that additional postauthorization clinical evidence collection might be necessary and take time.
In conclusion, this study provides valuable insights into the length of time it takes to establish Medicare coverage for novel medical technologies. The findings could inform future policy strategies aimed at improving patient access to these technologies. The study also highlights the need for further research and potential changes to current acceleration programs to facilitate a more efficient and timely reimbursement process for novel FDA-authorized medical devices and diagnostics.
616 words.
Bonus Haiku Summaries
Novel tech advances,
Coverage lags in its wake,
Patients wait in vain.FDA approves fast,
Yet Medicare's slow to act,
Access gap persists.
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