CMS Staff Discuss ADLTs

 CMS staff discuss ADLTs @ meeting.

##

AI RE WRITE

Understanding the ADLT Application Process

Jason Bennett, who oversees the office of new technology coding and pricing at Medicare, provided insights into the Advanced Diagnostic Laboratory Tests (ADLT) application process. He emphasized the relatively low application volume, with approximately 20 to 22 products reviewed over time. Bennett noted that about two-thirds of these applications meet the criteria for approval.

A key challenge in the ADLT application process, as Bennett described, is demonstrating the uniqueness and clinical utility of the test compared to existing options. The evaluation team, which includes clinicians, focuses on understanding the new information the test provides and its implications for patient care. Bennett advises applicants to clearly articulate how their test delivers unique, actionable insights that can improve patient outcomes.

Bennett also mentioned that some applications are denied for straightforward reasons, such as not being conducted in a single laboratory. However, the primary challenge remains proving the test's unique value and clinical relevance.

Addressing Timelines and Resource Constraints

Bruce Quinn, a consultant specializing in Medicare technology, raised concerns about delays in the ADLT decision-making process. Bennett acknowledged that FDA-based decisions tend to be more streamlined due to fewer criteria. He highlighted the broader issue of resource constraints at CMS, noting the contrast with the FDA's user fee system that supports its operations.

Bennett explained that the Medicare Trust Fund does not provide the same level of resource flexibility for CMS, which relies on annual appropriations. These budgetary constraints, combined with the need to prioritize tasks and manage a growing workload against flat or limited resources, lead to variability in review timelines. He stressed that current environmental factors might increase this variability, underscoring the challenges of managing the agency's mission within these constraints.

CONCLUSION

In conclusion, Bennett's discussion sheds light on the complexities of the ADLT application process and the impact of resource limitations on CMS's ability to maintain timely reviews. Applicants are advised to focus on clearly demonstrating their test's unique value and clinical utility to navigate these challenges successfully.

 

###

AUTO TRANSCRIPT (LOW QUALITY, UNEDITED)

Speaker 1  11:33 

Well, that's helpful. No, thank you. So, Jason, you know, I know and part of your work is in review of the advanced diagnostic laboratory tests, ADLT  and can you help us understand that process, and market stakeholders can do to, in your view, would be a better approach to going to apply for a ADLT? And perhaps some tips, and then also maybe what some mistakes to avoid? In your view? Yeah,

 

Speaker 3  12:01 

there's not been a lot of application for the pathway. We've had around 2022 or so products, I think we've seen over the years. So it's not a high utilization, or kind of kind of high approach pathway. And I think we've had around two thirds or so that have met the criteria for it's really important to, to take the time to look at the criteria and assess how how the test relates to those criteria.

 

And then really be prepared to help us understand your perspective or your business's perspective on that.

 

One of the complexities that I think we see is around that kind of concept of telling us what new information there is that the test is bringing to market relative to other tasks.

 

And the team that will look at it will include clinicians who are kind of trying to understand how to interpret those results as they would in clinical practice. And so it's important to be able to kind of describe, in many respects, what the test is saying about the patient. And then how is that supposed to affect the care that the decision right that the physician is making? Or, or, or sort of what that's why there isn't somewhere else, they would have gone to receive that same type of information.

 

So that's probably you know, at a high level, the area where we see the most complexity, and often where there's most engagement back and forth, as we tried to kind of refine our understanding of that and and hear from your from the laboratories about what was behind that test and why they're there other issues that that have occurred, but that resulted in denials. But those are usually more straightforward.

 

For instance, if it's not a single laboratory, that that can be a disqualifying reason. But the primary one tends to come around that aspect of what's unique what's different about this test? And how is that clinically useful to to improve the patient's outcomes or potential for for future outcomes?

###

Hi, my name is Bruce Quinn, I work full time on Medicare technology consulting. . Jason, I work with different companies in the lab industry. And I've been hearing where people have been talking that the ADL T decisions seem to be coming out on a longer timetable than they used to. And I just wondered if that was true? 

And if so, are the FDA based ADLT still a fairly clean decision?

Speaker 3  41:32  

Certainly the FDA ones are the cleanest decision, I think that we that we have. There's there's the fewest criterion. So that's a more straightforward decision. You know, one of the things that I think is helpful for everyone to understand, and it's timely, right, because we're potentially a week away from our annual budget, having that many of you work with the FDA, and they have a user fee system that helps support them and helps them have a robust agency to stay on top of the technologies. Think a lot of people assume that the trust fund the Medicare trust fund does the same thing for us from a resource standpoint. It did you hear your Tamarack? chuckling it does not. A lot of folks, I think think that we just have from that and pull the resources that the agency wants or needs to do the mission that we've been called to do by statute. And that's not the case. So we, most of our staff, are very much funded out of a primary administration appropriation line that is annually funded. And as we all see the environment that we're in, we know that the environment that we're in, and that's not different for CMS, as it is for many other federal agencies. So we have to take the workforce that we have and stretch them across everything that we possibly can do. We have to prioritize between the musters by certain dates, the really like to dues and the other commitments that we've made as an agency. And, and so there will be variability in that. And I do think that this immediate time is one of those with which the variability is probably going to increase relative to maybe the last few years as we, as we sort of see where, where our final appropriation comes in. But, but as you all know, if you work from a flat budget, you still have inflation. So that that means that there are in our appropriations lines notionally fund the types of things you would think of people are contracts, and our facilities.

 And so you have to make adjustments to to accommodate that. And if the workload is growing, at the same time, your resources are flat, or otherwise, you have to make trade offs.