Until then, clinical laboratory professionals must push the proposed legislation forward to achieve PAMA reform.
Officials from one of the key groups behind the proposed RESULTS Act stated earlier this month that the goal is to have the legislation attached to a year-end spending bill in Congress.
That leaves approximately 10 months for the clinical laboratory industry to mount enough momentum to bring the proposal to a vote.
“It is never easy to get anything done on Capitol Hill,” noted Joyce Gresko, legal counsel for the American Clinical Laboratory Association (ACLA) and an attorney at Alston & Bird.
Gresko spoke during a Feb. 11 webinar hosted by ACLA about the current lab operating environment under the Protecting Access to Medicare Act of 2014 (PAMA). PAMA-related cuts to clinical lab test reimbursement rates have been delayed until Jan. 1, 2027. However, in the nearer term, an important reporting milestone under PAMA begins on May 1.
Joyce Gresko, legal counsel for the ACLA and an attorney at Alston & Bird, urged clinical laboratories to contact members of Congress about passing the RESULTS Act. (Photo credit: Alston & Bird)
The RESULTS Act—more formally the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act of 2025—calls for PAMA reform by permanently capping reimbursement cuts to 5% annually and identifying an independent claims database to help the federal government set Medicare rates for lab test claims. Currently those rates are set through lab-based reporting, an approach that has been largely criticized by the diagnostics industry.
Gresko noted that ACLA is eyeing the idea of the RESULTS Act becoming part of an end-of-year spending package in December, which could allow the proposal to pass as part of a larger vote. Such packages are typical in Congress.
Lawmakers Need to Hear about Support for the RESULTS Act
The ACLA has been among the loudest voices in the clinical laboratory industry supporting passage of the RESULTS Act. The bill was introduced in September 2025, as reported by Dark Daily.
Through a special ACLA website, StopLabCuts.org, 190,000 messages have been sent to Congress from lab industry professionals, Gresko said. She urged others to let their opinions be heard by lawmakers.
“Please weigh in with your members of Congress,” she said.
PAMA cuts have costs the diagnostics industry $3.8 billion over the last decade, noted Susan Van Meter, president of the ACLA.
For labs, those cuts “have had a negative impact on being able to maintain access to a whole level of [diagnostic] services,” Van Meter added.
New PAMA Reporting Window Starts on May 1 for Clinical Labs
While the RESULTS Act gets debated, clinical laboratories will need to prepare for their next reporting window under PAMA, which begins on May 1 and ends on July 31.
PAMA requires affected labs to submit information about tests they perform to the Centers for Medicare and Medicaid Services, including what private payers reimbursed labs for each test. This data establishes Medicare reimbursement rates under the Clinical Laboratory Fee Schedule.
In a twist, Congress revised that data collection to include 2025 commercial rates for labs, not 2019 data as was originally mandated.
Laboratories that have not started preparing for this reporting window need to begin now.
The trade association is publicly promoting the benefits of biomarker testing and AI’s benefits to diagnostics
One of the core tenets to getting federal lawmaker support for business is to tell them what an industry does. In that vein, the American Clinical Laboratory Association (ACLA) has released a new promotion that highlights applications of companion diagnostics, rapid whole genome sequencing, drug screening, biomarker testing, and infectious disease management.
One of the end goals? To sway Congress to take action against proposed reimbursement cuts to clinical lab test rates.
The ACLA campaign, known as the “Power of Knowing,” took center stage during a panel discussion at the ACLA Annual Meeting, held Feb. 27 in Washington, DC. One objective, panelists said, is to draw attention to the profession’s role in prevention and early detection of diseases, according to report from Medtech Insight.
“The association is working hard to demonstrate to policymakers the value of clinical laboratory testing through the Power of Knowing as they make policy decisions on reimbursement and clinical laboratory infrastructure that’s necessary for robust patient access to these innovative diagnostics,” said panel moderator Elyse Oveson, according to Medtech Insight. Oveson serves as ACLA chief of advocacy operations.
In March 2024, ACLA released digital ads urging Congress to pass the Saving Access to Laboratory Services Act (SALSA), which would have prevented a 15% cut in Medicare reimbursement for approximately 800 laboratory tests.
“A sustainable reform of the Medicare payment system for clinical laboratory services is vital to protect and enhance patient care, foster innovation, and ensure the stability of clinical laboratories nationwide,” ACLA president Susan Van Meter said at the time.
“If patients don’t have their biomarkers profiled for them at diagnosis and again at progression, there’s a very real chance that they would be put on the incorrect therapy that could lead to them having real harm in their health. So, we view biomarkers as critical,” said Nikki Martin (above), senior director of precision medicine initiatives for the LUNGevity Foundation, during the 2025 ACLA Annual Meeting. (Photo copyright: LinkedIn.)
Martin told attendees that biomarker tests should be part of the standard of care in lung cancer diagnosis, Medtech Insight reported. These tests analyze blood or other patient samples to identify molecules associated with specific diseases.
“For patients with non-small cell lung cancer, biomarkers are everything,” said Martin during the panel discussion. Many patients with advanced metastatic cancer, she said, “are not receiving comprehensive biomarker testing, and if they’re not, then they’re at risk of having much worse outcomes.”
Edelmayer discussed progress in developing biomarker tests for early diagnosis of Alzheimer’s disease. “The momentum is palpable among the research community,” she said. “We’re now starting to see the shift into implementation and more types of tools and technologies being available to clinicians to help patients.”
However, Edelmayer acknowledged that progress in developing Alzheimer’s tests and treatments has been slow.
“There’s never going to be a single test to help diagnose Alzheimer’s disease,” she said. “We recognize that it’s going to be a combination approach.”
New Video Campaign
The campaign’s latest advertising is summed up in a 90-second sizzle reel in which clinical laboratory leaders discuss various ways in which the profession supports healthcare.
One theme in the video is the growing use of artificial intelligence (AI) in the profession. “AI-enabled diagnostics are tools that use machine learning to analyze vast amounts of data from patient records to genomic profiles,” said Kate Sasser, PhD, chief scientific officer of Tempus, in the video. “These systems can recognize patterns in the data that humans may not easily see and help clinicians detect diseases earlier and more accurately.”
“By harnessing these cutting-edge tools, we can move closer to a world where treatments are no longer one size fits all but are instead tailored to the unique genetic and molecular profile of each patient,” said Elias Zerhouni, MD, president and vice chairman of OPKO Health, in a recent video produced as part of the ACLA’s Power of Knowing campaign.
The campaign website includes additional videos as well as downloadable graphics that can be shared on social media.
Clinical laboratories should closely watch the Trump administration as it contemplates a court appeal, a revised LDT rulemaking, or abandoning the rule altogether
With a US District Court judge’s decision to vacate the Food and Drug Administration’s (FDA) rule on laboratory-developed tests (LDTs), perhaps the most intriguing aspect for clinical laboratories is what the next move will be by the federal government.
It’s hard to predict whether the administration of President Donald Trump will either appeal the judge’s decision, direct the FDA to come up with a new version of the rule that passes legal muster, or simply back off further scrutiny of LDTs.
Let’s look more closely at the options for clinical laboratory professionals to monitor.
US District Court Judge Sean Jordan, JD (above), vacated the federal Food and Drug Administration’s final rule to regulate laboratory-developed tests (LDTs) on March 31, 2025. In a lawsuit, the Association for Molecular Pathologists and the American Clinical Laboratory Association accused the FDA of overstepping its legal authority in issuing the LDT rule in 2024. The outcome of this ruling will affect clinical laboratories’ future development their own tests. (Photo copyright: Jackson Walker LLP.)
Will the Trump Administration Appeal the LDT Decision?
The FDA’s final rule—which came out in 2024 and was about to hit its first compliance milestone on May 6, 2025—had been discussed for at least 10 years prior, covering multiple presidential administrations. Because the final rule was published by the FDA under former President Joe Biden, it surprised some observers to see Trump’s Department of Justice defend the FDA’s right to implement the rule during oral arguments in February before Judge Sean Jordan in US District Court for the Eastern District of Texas.
That hearing was the culmination of a combined lawsuit from American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) challenging the LDT rule. The suit sought summary judgment on the matter, which Jordan granted on March 31 in his decision to vacate the FDA’s rule.
“The Court vacates and sets aside, in its entirety, the FDA’s final rule titled Medical Devices; Laboratory Developed Tests,” Jordan wrote. “The Court remands this matter to the secretary of Health and Human Services for further consideration.”
Trump’s legal team set a precedent early in the president’s second term to aggressively challenge any court decisions that buck his authority. From that perspective, an appeal of the LDT judgment seems probable, although there is no official word yet about that.
Trump ran on an anti-regulatory, smaller government platform. In that sense, the DOJ’s defense of the FDA’s standing to carry out the LDT rule was a surprise.
Will the FDA Create a Revised Version of the LDT Rule?
The court sent the rule back to the FDA, which leaves the door open for the agency to construct and issue a new rule.
The clinical laboratory industry argued that LDTs should not be classified as medical devices, which the rule instead emphasized. That could be an area where a new version of the rule bends.
Congress could also step in here. For many years, a proposed bill known as the VALID Act (formally the Verifying Accurate Leading-Edge IVCT Development Act) was filed in the House of Representatives to increase LDT oversight.
But then—after the FDA’s LDT rule came out—the VALID Act looked to be the lesser of two evils to lab professionals. It’s possible labs and lawmakers could work out a new version of the VALID Act to avoid another potentially onerous FDA-issued rulemaking.
Will Trump and the FDA Do Nothing?
Even though it would go against the current pattern of challenging court decisions, the Trump administration could simply step back and choose to do nothing with the FDA’s vacated rule.
In that case, presumably LDTs would continue to be overseen by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The medical lab industry has long preferred to see CLIA reform as the pathway to regulating LDTs in the future rather than formal FDA involvement. The FDA referred to this arrangement as “enforcement discretion,” as LDT oversight has always been on the books at the FDA, but the agency deferred to CLIA for many years.
Of related interest was a news release last week from the federal Department of Health and Human Services (HHS) announcing a sweeping number of layoffs under its individual agencies. The FDA is slated to lose 3,500 employees, although the “reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors,” HHS noted in a fact sheet.
Revisiting an LDT rule that will require more reviewers and inspectors seems at odds with a shrinking FDA.
Clinical Labs Must Monitor the Near-term Future of LDTs
After coming out ahead in one of the biggest court showdowns in clinical lab history, medical laboratory scientists and industry leaders now must keep their eyes on the various avenues that LDT regulation could head down in the near future.
Watch for further analysis of the business implications of this court decision in The Dark Report.
“Previously … CDC developed tests for emerging pathogens and then shared those tests with others, and then after that, commercial labs would develop their own tests,” Shah told CNN. “That process took time. Now with these new arrangements, commercial labs will be developing new tests for public health responses alongside CDC, not after CDC.”
In a news release announcing the contract, ARUP Laboratories also characterized the move as a shift for the agency.
“The new contract formalizes ARUP’s relationship with the CDC,” said Benjamin Bradley, MD, PhD, medical director of the ARUP Institute for Research and Innovation in Infectious Disease Genomic Technologies, High Consequence Pathogen Response, Virology, and Molecular Infectious Diseases. “We continue to expand our capabilities to address public health crises and are prepared to scale up testing for H5N1, or develop other tests quickly, should the need arise.”
“To be clear, we have no evidence so far that this [bird flu] virus can easily infect human beings or that it can spread between human beings easily in a sustained fashion,” Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at Brown University School of Public Health, told CNN. “If it did have those abilities, we would be in a pandemic.” Clinical laboratory leaders will recall the challenges at the CDC as it developed its SARS-CoV-2 test early in the COVID-19 pandemic. (Photo copyright: Brown University.)
Missouri Case Raises Concerns
The first human infection of HPAI was reported in late March following a farmer’s “exposure to dairy cows presumably infected with bird flu,” the CDC stated in its June 3, 2024, bird flu Situation Summary. That followed confirmation by the USDA’s Animal and Plant Health Inspection Service (APHIS) of an HPAI outbreak in commercial poultry flocks in February 2022, and the CDC’s confirmation of the first known infections in dairy herds reported on March 25, 2024.
Concerns about the outbreak were heightened in September following news that a person in Missouri had been infected with the virus despite having no known contact with infected animals. CNN reported that it was the 14th human case in the US this year, but all previous cases were in farm workers known to be exposed to infected dairy cattle or poultry.
In a news release, the Missouri Department of Health and Senior Services (DHSS) revealed that the patient, who was not identified, was hospitalized on Aug. 22. This person had “underlying medical conditions,” DHSS reported, and has since recovered and was sent home. Both DHSS and the CDC conducted tests to determine that the virus was the H5 subtype, the news release states.
At present, the CDC states that the public health risk from the virus is low. However, public health experts are concerned that risks could rise as the weather gets cooler, creating opportunities for the virus to mutate “since both cows and other flu viruses will be on the move,” CNN reported.
Concerns over CDC Testing and FDA Oversight
In the months immediately following the first human case of the bird flu virus, Nuzzo was among several public health experts sounding an alarm about the country’s ability to ramp up testing in the face of new pathogens.
“We’re flying blind,” she told KFF Health News in June, due to an inability to track infections in farmworkers. At that time, tests had been distributed to approximately 100 public health labs, but Nuzzo and other experts noted that doctors typically order tests from commercial laboratories and universities.
KFF reported that one diagnostics company, Neelyx Labs, ran into obstacles as it tried to license the CDC’s bird flu test. Founder, CEO, and lead scientist Shyam Saladi, PhD, told KFF that the federal agency had promised to cooperate by facilitating a license and a “right to reference” CDC data when applying for FDA authorization but was slow to come through.
While acknowledging the need for testing accuracy, Greninger contended that the CDC was prioritizing caution over speed, as it did in the early days of the COVID-19 pandemic. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he told KFF.
Another problem, KFF reported, related to the FDA’s new oversight of laboratory developed tests (LDTs), which is causing labs to move cautiously in developing their own tests.
Jennifer Nuzzo, DrPH (above), Director of the Pandemic Center and Professor of Epidemiology at the Brown University School of Public Health co-authored a June 2024 analysis in Health Affairs that called on the CDC to develop “a better testing playbook for biological emergencies.” The authors’ analysis cited earlier problems with the responses to the COVID-19 and mpox (formerly known as monkeypox) outbreaks.
If global surveillance networks have detected a novel pathogen, the authors advise, the US should gather information and “begin examining the existing testing landscape” within the first 48 hours.
Once the pathogen is detected in the US, they continued, FDA-authorized tests should be distributed to public health laboratories and the CDC’s Laboratory Response Network (LRN) laboratories within 48 hours.
Advocates of this approach suggest that within the first week diagnostics manufacturers should begin developing their own tests and the federal government should begin working with commercial labs. Then, within the first month, commercial laboratories should be using FDA-authorized tests to provide “high throughput capacity.”
This may be good advice. Experts in the clinical laboratory and healthcare professions believe there needs to be improvement in how novel tests are developed and made available as novel infectious agents are identified.
Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.
“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”
“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)
Arguments For and Against FDA LDT Regulation of LDTs
Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.
Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.
In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.
“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.
“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.
Actions Clinical Laboratory Managers Can Take
Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:
Contact their representatives in Congress.
Find out whether any trade associations they belong to have taken a position on the VALID Act.
Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.
Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs.
