LDT Advocacy: What You Should Know

• Laboratory-Developed Test Oversight
• Take action to stop the FDA Final Rule
• Watch Webinar 1: Understand and Prepare for the Impact of the FDA's LDT Final Rule
• Register for the "Understand and Prepare for the Impact of the FDA's LDT Final Rule" Webinar Series
• Share your story with legislators about how FDA’s laboratory-developed test rule will impact your laboratory and patients in your community.

Brittani Riddle:

Hello and welcome to the latest edition of the College of American Pathologists' CAPcast. I'm Brittani Riddle, manager for advocacy, communications, and production at the CAP. The Food and Drug Administration's Laboratory Developed Test Final rule outlines new regulations for tests developed and used within a single laboratory. In this episode, we'll discuss the newly proposed rule and the CAP's ongoing advocacy efforts to protect pathologists and ensure patients have access to the test they need for quality care. Before we get into the topic, I'd like my guest to introduce himself, Dr. Saad.

Dr. A. Joe Saad:

Thank you, Brittani, and it's a pleasure to be here today doing this podcast with you. My name is Joe Saad. I'm the chair of pathology for the Methodist Health System in Dallas, Texas, in private practice in Dallas, and I also serve as chair of the Council on Government Professional Affairs for the CAP, and I'm a member of the Board of Governors of the CAP.

Brittani Riddle:

Thank you so much again, Dr. Saad, for joining me today. So we're talking all things laboratory developed tests and the FDA oversight of the LDTs has been a very hot topic this year. Can you provide the listeners with a basic understanding of what LDTs are and where the issue currently stands regarding FDA oversight?

Dr. A. Joe Saad:

The FDA has its own definition, but an LDT is essentially a test designed manufacturers and use within a single laboratory. By definition, an LDT is a high complexity test, and so the laboratory must be certified under CLIA to do high complexity testing. These tests are sometimes referred to as in-house tests, and they could be offered in community laboratories, independent laboratories, and even some larger commercial companies offer LDTs. Historically, the tests have posed lower risks than commercial test kits and therefore were exempt from LDT oversight, or at least the FDA was using enforcement discretion to oversee these tests. An example of a simple test like this could be for a single analyte for rare disease when there are no other approved tests. Over the past 40 years, some of these tests have become more complex and some have recently been developed for diagnosing infectious diseases like COVID-19, HPV, Zika, OCX, and Genetic Abnormalities in Cancer.

Some of the tests that we use often in our laboratories, such as immunochemical stains and flow cytometry are considered to be LDTs in some circumstances. On the question of oversight, the FDA has long maintained that under the medical device of 1976, they have had the authority to regulate LDTs, but have used enforcement discretion recently in order to clarify that authority, the FDA released the final rule on the Regulational laboratory developed tests, and they have essentially added to the definition of a medical device in vitro diagnostic test, including when the manufacturer of these products is a laboratory. As I'm sure the listeners know, the final rule was published on May 6th. It was released a week earlier, but May 6th of 2024 is essentially the date to which everything going forward is tied. And so over the course of the next four years, the FDA intends to exert full oversight of new laboratory developed tests under the existing authority that's outlined in the final rule. There are a couple of exceptions tests that have been offered prior to May 6th will remain under enforcement discretion for at least the stages four and five. But these tests still have to comply with stages one, two, and part of stage three.

So I think the second part of your question was also about oversight. So you know the FDA, like I said, has long maintained that they have the authority, but they have always said that they prefer that Congress gives 'em a framework by which to regulate LDTs. For the past 15 years, we have worked with Congress, we have worked with the FDA and recognize that some of these tests, they're becoming increasingly complex and some of them do pose a higher risk to patients, although it's a small subset, in our opinion, do pose a high risk to patients and there needs to be a regulatory framework for oversight.

We believe that the medical device amendments of 1976 do not provide that appropriate oversight, so it goes back to Congress. There've been several attempts in Congress most recently starting in 2018, to provide a regulatory framework for LDTs, a legislative framework that will allow regulation. And that 2018 effort evolved into the verifying accurate leading IVCT Development Act. The legislation did provide an appropriate oversight in our opinion with a role for the FDA. It had many exemptions for tests and guardrails around the FDA that would allow flexibility to offer innovation. Sadly, the legislation did not pass in 2022 and the FDA went ahead and exercised its authority to regulate LDTs under the medical devices amendments of 1976. So this is where we are right now.

Brittani Riddle:

Thank you for that. So the College of American Pathologists has been doing a lot of advocacy work around LDTs and recently had a really big push during the month of August for a recess rally. Can you explain a little bit more about the rally and how CAP members engaged with their local legislators during the August recess?

Dr. A. Joe Saad:

Yes, of course. The August recess rally was a grassroots effort where CAP members were active and responded to a CAP action alert to engage with their local representatives and senators in Congress. August is actually one of the best times to advocate and engage with local legislatures while they're home during the August recess, and it's a time when they want to hear from their constituents about the critical issues back home. This year is an election year, so they're particularly interested in hearing from constituents. So if the CAP uses time to speak with legislators on important issues that are needed to protect our laboratories and our patients from regulatory overreach and advocate to stop payment cuts to pathology services, we took the advantage to educate the legislators on top issues, including the issue of laboratory developed tests. During the rally, 500 CAP members took action. We reached 349 members of Congress and sent over 1500 messages. This effort included 48 members who became new advocates for the CAP. So we're very excited about the momentum that we've achieved and we hope to continue this effort going into the fall. We will build on it and in October we plan another rally. And so watch, please watch for a message from CAP encouraging you to encourage your lawmaker to act. In addition, I'd like to say that over the August recess, our president-elect, Dr. Jim Zhai, met with Senator Cassidy of Louisiana and several members from Arkansas, Kansas, and Missouri met with legislators as well.

Brittani Riddle:

That's terrific. And I was going to ask this a little later, but since we're talking about the August recess rally, you were able to host the laboratory tour with the congressional representative that represents your office. Could you talk a little bit more about how you were able to get the tour organized and what are some of the benefits of inviting representatives and senators to tour the laboratory?

Dr. A. Joe Saad:

I think honestly, the best way to kickstart a relationship with your legislator is to visit them in person, and that would either be in your district, in their home state town, or participate in the Pathologist Leadership Summit in Washington DC where you would have the opportunity to go to the hill with many of your colleagues and meet legislators and or their staff. So the most recent effort was a result of the PLSI attended the PLSI visited several congressional offices and an invitation to each of the staff and or congressperson to come visit the laboratory. I did have some interest, so I followed up with an email and it took a couple of different tries, but we were eventually able to get a mutually appropriate date for a legislator to come visit our laboratory. And so Congressman Veasey came and visited the Methodist, Dallas Medical Center, probably spent about an hour and 15, an hour and 20 minutes here, and he was willing to spend much longer except he had another commitment that he had to attend.

But we toured the lab and he was actually amazed at the complexity of what he saw, the instrumentation, the professionalism of all the technology, the technologists that we have in the laboratory. We took him upstairs, he toured the gross room, and then we sat down at a multi-headed scope and looked at a few cases together. I really think it was eye awakening for him. He expressed a lot of gratitude and expressed that he had a deeper of an understanding of what pathologists do, why we're concerned about reimbursement issues, and why we're concerned about issues such as laboratory developed tests and an appropriate regulatory oversight.

Brittani Riddle:

That sounds really exciting. I'm so glad you were able to do the tour and hopefully some more of our members will be able to do them in the future. Going back to the LDTs, there are two organizations, the American Clinical Laboratory Association and the Association for Molecular Pathology have filed lawsuits in the courts to vacate the FDA's final LDT rule. Can you talk a little bit more about those cases and what the CAP may plan to do with those lawsuits?

Dr. A. Joe Saad:

Of course, the ACLA, I think it was May 29th, filed a lawsuit in the Eastern District of Texas, and that was followed up by, in mid August, the Association for Molecular Pathology or AMP filed a lawsuit in the Southern District of Texan. The CAP had been working on an amicus brief to file in support of the ACLA lawsuit when AMP dropped their lawsuit as well. And so we pulled back, we had it almost ready to go. This was the end of August. We pulled back a little in an effort to study the AMP lawsuit more thoroughly, and eventually these two lawsuits were consolidated to be heard in a single court in the Eastern District of Texas. By the same judge, they will be heard simultaneously, but somewhat independently. We anticipate that a ruling will be given to incorporate both lawsuits. So the CAP pulled back on our amicus brief and decided to reword it to incorporate elements of both lawsuits in our filing with the court where currently in the final stages of working on that with the attorneys for CAP, and it will be filed on or before October 7th, we are asking the court to vacate the FDA final rule because the agency failed to adequately justify the rules, unsustainable costs, which will hinder the development of LDTs and ultimately harm patients.

The costs will burden laboratories and make it so expensive that we will have to discontinue. Many laboratories will have to discontinue offering and developing essential and innovative laboratory developed tests. For this reason, we believe that patients will have a harder time accessing tests. They will be more expensive and there will be less of them and less timely new tests developed, which ultimately harms patients.

Brittani Riddle:

I'm glad you brought up the patients because I'd love to hear a little bit more about the patient perspective and what you think they should know when they hear about the CAP and why our advocacy work around LDTs is so critical for quality patient care.

Dr. A. Joe Saad:

Our ultimate goal is to protect patients safety is of utmost importance above everything else. However, we believe this rule has a potential to harm patients as much as it does to protect patients. There are currently tens of thousands, if not over a hundred thousand laboratory developed tests that are being offered. The vast, vast majority of those are well characterized and safe and they benefit patients. The final rule is going to be so disruptive to the tests that are offered that many patients will be unable to access these tests. Some they won't be able to access at all, and many, they'll be significant delays in increased costs in accessing these tests, we are particularly concerned about rural hospitals and underserved areas that may not have the resources to offer these tests, and ultimately that's bad for patients. We share the FDA's concern over patient safety, but we believe that there's a better way to ensure patient safety and access the tests.

Brittani Riddle:

How will the FDA's LDT rule impact your laboratory and patients? Share your story with us. Your story could be used to help legislators understand how the oversight of tests should be based on protecting patients and providing access to safe diagnostic tests with the framework that is the least burdensome for laboratories. Click the tell us your story link and this week show notes and fill out the form to tell us more. Are there questions or things that a patient should be aware of for future doctor visits as we continue our advocacy efforts around LDTs?

Dr. A. Joe Saad:

I would emphasize that we need to talk to patients, and patients need to talk to us if they have any questions or concerned about a test that they're being asked to have done, if they have any concerns about the interpretation of that test or what it means, what the limitations are. We encourage patients to reach out to their physician and their pathologist, who's obviously also a physician and knows best about the benefits and limitations of the test. We urge patients to reach out to us. Ultimately, we all have the same goal in mind. We want to protect patients and we want 'em to have access to timely, important, and in some instances, lifesaving tests.

Brittani Riddle:

Absolutely. So we talked a little bit about the amicus brief. What are some of the additional advocacy efforts that the CAP will be taking part in moving forward this fall?

Dr. A. Joe Saad:

As the lawsuit moves forward and we don't expect any kind of decision until at the very earliest, around the middle of next year, perhaps even later, as the lawsuit moves forward, we are committed to working with the pathologists, the pathology and laboratory community to ensure that the laboratories are preparing for the possibility that the final rule may go into effect. It may not be blocked or vacated by the court, so it'd be irresponsible of us to put our heads in the sand and put all our eggs in one basket. So we must prepare our members for the LDT final rule. So the CAP has launched a six part webinar series entitled Understanding and Prepare for the Impact of FDA's LDT Final Rule. The first webinar was offered last week on September 18th, and it covered risk classification. They will be offered at a cadence of approximately every other month. So please go to the CAP website and register for this webinar series. Secondly, we'll continue our grassroots advocacy efforts into this fall. As I mentioned previously, including a virtual fly-in with CAP members and legislators and more information on this effort will be forthcoming in the next few weeks.

Brittani Riddle:

Okay. And earlier you also mentioned attending the Pathologist Leadership Summit this past spring, so we'll be sharing some information around that for this coming April as well. Is there anything else you want to share with fellow pathologists about what to know about our advocacy on LDTs?

Dr. A. Joe Saad:

Yes, I mean, I would also encourage pathologists to attend our annual meeting. It's next month. It begins on October the 18th in Las Vegas. There will be a very robust advocacy program, including a discussion on laboratory developed tests with an opportunity to engage and ask questions of the CAP leadership. So I encourage all our members to consider attending the annual meeting. We'll be talking about payment issues. We'll be talking about laboratory developed tests. We'll be talking about workforce and many other issues that I'm sure our members will find of interest and importance.

Brittani Riddle:

Thank you again, Dr. Saad, for joining me today. Can you tell our listeners who are fellow pathologists, how they can join the CAP?

Dr. A. Joe Saad:

Go to our website and click on join CAP. There's a very simple application to fill out, so if you're not a member of the CAP, I would encourage you to go to the website and join as soon as possible. If you need any help, please reach out to our membership division or reach out to any current member, could probably help you navigate how to join.

Brittani Riddle:

Thank you for listening to this edition of the College of American Pathologists' podcast. I'd like to thank today's guests, Dr. Joseph Saad for joining me. Be sure to subscribe to CAPcast where podcasts are available. To learn more about the CAP, visit our website at cap.org or download the MyCAP app.

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