CHICAGO – As Octavia Peck Palmer wrapped up her tenure this week as president of the Association for Diagnostics and Laboratory Medicine, the organization's focus will continue to home in on reimbursement for diagnostic testing and the US Food and Drug Administration's final rule governing the use of laboratory-developed tests, she told 360Dx.
Speaking on the sidelines of ADLM's annual meeting this week, Peck Palmer emphasized three key areas of focus for the organization's advocacy efforts — developing appropriate pediatric reference intervals for diagnostic tests, ensuring adequate reimbursement for testing, and raising awareness of the impact of the FDA's final rule on its members while advocating against the rule's implementation.
According to Peck Palmer, the FDA's final rule on LDTs will "severely impact" patient access to tests, and ADLM is aiming to both ensure that its members are knowledgeable about the ruling and what it will mean for their laboratories by providing educational resources as well as "equipping them to also be advocates" within their own institutions. Additionally, ADLM plans on having its members explain to lawmakers what impact the FDA's decision will have on public health.
In ADLM's view, the FDA has "overstepped its authority" and will stifle innovation by requiring LDTs to go through the FDA approval process, she said, adding it's unclear what problem the FDA is attempting to address with the final rule, as "lab professionals are well trained to develop the tests, to interpret the tests."
Laboratories in the US are already governed by an extensive regulatory apparatus led by the Centers for Medicare and Medicaid Services, and the focus should be on modernizing and improving that process via CMS rather than going through the FDA, Peck Palmer noted.
If the final rule is implemented, laboratories will have to follow rules set out by two separate regulatory authorities and will likely have to outsource some of the burden of trying to meet regulatory requirements to others, since many laboratories do not regularly submit tests to the FDA and may not understand the requirements or have the resources, she said.
The time it takes to get approval for a test is also a big concern for ADLM, since it can take more than a year for tests to be approved by the FDA. "We need these tests now, and that's why we have laboratory-developed tests now," Peck Palmer said. These tests are "developed to meet the needs of the [laboratory's] patient population."
On a more basic level, ADLM is seeking answers to questions that many of its members have about the final rule, such as how the FDA will help laboratories adhere to the requirements, Peck Palmer said.
Another key focus for the organization is reimbursement as laboratories are continuously seeing cuts to their reimbursements as there is "really nothing else to cut" without eliminating the testing being performed altogether, she said. ADLM is encouraging decision makers to look at pricing and costs in community laboratories to understand what is going on in those laboratories and across the industry as a whole, rather than deferring only to large reference laboratories.
For example, the Protecting Access to Medicare Act, which routinely requires certain price cuts for laboratory tests based on the average price of those tests, has faced pushback and calls for reform partially due to its focus on data from large reference labs. Because those price cuts don't reflect the costs that smaller labs face, "we really need to go back to the drawing board and have that input from those hospitals and clinical laboratories for us to be able to set accurate pricing and reimbursement for our testing," Peck Palmer said.
Another priority for ADLM is developing appropriate pediatric reference intervals for diagnostic tests to ensure physicians can interpret results correctly for children. Right now, most reference intervals for tests that pediatric patients are using are based on adults, and those intervals may not be appropriate or accurate for children, Peck Palmer said. Many tests, such as those that measure cancer markers to detect abnormalities, don't have pediatric-specific reference intervals, which can lead to those abnormalities getting missed in pediatric patients.
Having specific pediatric reference intervals would allow not only for early detection of any abnormal changes but also for timely access to therapeutics for cancer treatment, she added.
Peck Palmer also emphasized ADLM advocacy for equity and diversity in healthcare, noting that the organization has been encouraging its members to think about the communities they serve and how treatment can be more equitable. For example, there may be cultural differences when it comes to how patient samples are collected or language barriers that impact how results are received and interpreted. Labs, she said, must take such factors into consideration in the communities they serve to ensure treatment is fair and accessible for anyone.
Data science and artificial intelligence are areas of interest for the diagnostics community at large, and ADLM is no exception. The organization is particularly interested in how to harness existing data and translate it into information that laboratories can use to identify and fill healthcare gaps, which can also help improve healthcare for underserved populations. Data science and AI can be used to both identify problems in healthcare and to develop and identify solutions to those problems, Peck Palmer added.
Lastly, the impact of the COVID-19 pandemic is still being felt by ADLM and its members. COVID-19 "reshaped how laboratory medicine is even described or thought about," Peck Palmer said. It may also end up helping with the widespread laboratory workforce shortage, since more people know about laboratory medicine and diagnostics than they did pre-pandemic, she added.