Congress included lab relief in its latest funding bill, signaling growing awareness of PAMA’s impact. Here’s what lab leaders should do next.
During a Nov. 12 webinar hosted by Dark Daily, the discussion centered on why a small laboratory provision ended up in the massive continuing resolution (CR) to reopen the federal government, and what it signals about congressional awareness of the urgent issues surrounding PAMA.
Panelists Susan Van Meter, president, American Clinical Laboratory Association (ACLA) and Jay Weiss, PhD, president and co-owner, Allermetrix explained that the inclusion reflects years of coordinated, persistent advocacy by ACLA, NILA, laboratorians, and industry partners, who have made the case that impending cuts on January 1 would be devastating. Although Congress has repeatedly delayed PAMA cuts and reporting requirements—five and six times respectively—stakeholders emphasized that this should never be taken for granted.
Both speakers highlighted that many lawmakers were initially unaware that laboratories were facing up to 15% reductions on roughly 800 codes beginning in 2026, with ripple effects extending to private insurers because their rates are indexed to Medicare. As Congress searched for a bipartisan path to reopen the government, advocates successfully argued that a short-term delay of the PAMA “cliff” needed to be included in the CR. That delay now runs only until January 30.
“We have been working very deliberately around the clock since the beginning of this year to encourage Congress to move forward legislation that would reform PAMA and address the reductions. It’s been a complicated legislative year,” said Susan Van Meter, president, ACLA. (Photo credit: ACLA)
RESULTS Act
The panel then outlined the RESULTS Act, a bipartisan proposal intended to fix structural flaws in PAMA. Its main provisions include:
Replacing lab-reported commercial rates with data from a nonprofit claims database for widely available tests
Requiring labs to report only for low-volume codes (100 or fewer labs)
Reducing reporting burden significantly
Eliminating three years of up to 15% cuts
Capping future reductions at 5% annually
Ensuring Medicare rates are based on actual, adjudicated claims instead of outdated 2016 data.
Speakers noted that commercial plans already submit claims data to independent entities such as FAIR Health, so the framework is neither novel nor untested. Claims would be reported only after full adjudication, typically six months post-submission.
On timing, the panel acknowledged that passing the RESULTS Act before Jan. 30 is ambitious, especially after weeks of congressional inaction during the shutdown fight. Still, they characterized the inclusion of lab relief in the CR as a strong signal that lawmakers view PAMA reform as legitimate and urgent. A Congressional Budget Office score has not yet been issued for the RESULTS Act, though preliminary scoring requests have been made.
What Lab Leaders Can Do
Both speakers urged labs to prepare dual budgets—one assuming RESULTS Act passage, another reflecting full PAMA implementation. Contingency planning may include staff reductions, automation investments, operational cuts, and pursuing non-payer revenue streams. They also emphasized that PAMA cuts would affect far more than Medicare because commercial payers peg rates to the CLFS.
Finally, both panelists stressed that advocacy in the next few weeks is critical. They encouraged labs to contact lawmakers through email, phone, or in-person visits—and especially to invite members of Congress to tour their laboratories. The StopLabCuts.org campaign has already generated 150,000 messages to Capitol Hill; speakers urged the audience to double that volume. With strong bipartisan sponsorship in both chambers, they said the RESULTS Act has momentum—but is not guaranteed without significant grassroots pressure.
If you missed the live webinar, view it on demand, here.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
The bipartisan RESULTS Act, designed to overhaul Medicare’s payment system for clinical laboratory testing, is on hold amid the ongoing government shutdown. With cuts of up to 15% set to hit 800 common lab tests in 2026, laboratory leaders warn that the delay threatens patient access and lab stability nationwide.
Efforts to reform how Medicare pays for clinical laboratory testing have hit a standstill as the ongoing federal government shutdown freezes legislative progress on Capitol Hill, delaying long-awaited relief for labs facing steep payment cuts in 2026.
The bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act—introduced in September by Senators Raphael Warnock (D-GA) and Thom Tillis (R-NC)—was gaining momentum as a fix to long-standing problems in the Medicare Clinical Laboratory Fee Schedule (CLFS). But with Congress largely at a standstill, the bill and several other healthcare measures are now in limbo, leaving labs anxious about their financial outlook heading into next year.
At stake are payment reductions of up to 15% for more than 800 commonly ordered laboratory tests, scheduled to take effect on January 1, 2026. Laboratory organizations warn that without swift action, the cuts could destabilize the nation’s diagnostic infrastructure, threaten patient access, and further weaken community and hospital outreach laboratories already strained by workforce shortages and inflation.
Organizations Pen Letter
In a letter sent to congressional leaders on October 30, more than two dozen healthcare and laboratory organizations, including the American Clinical Laboratory Association (ACLA), the College of American Pathologists (CAP), the American Hospital Association (AHA), and the American Medical Association (AMA), urged Congress to pass the RESULTS Act to “protect patient access to clinical laboratory services.”
“Timely access to innovative clinical laboratory tests is critical to the prevention, early detection, therapy selection, and effective management of chronic and life-threatening diseases,” the coalition wrote. “Without action, around 800 laboratory tests will be subject to payment cuts of up to 15% on January 1, 2026, threatening patient access to routine and life-saving diagnostics.”
The letter highlights a decade-long problem stemming from the Protecting Access to Medicare Act (PAMA) of 2014. That law aimed to align Medicare reimbursement with private market rates but relied on limited data reporting—less than 1% of lab data nationwide—resulting in artificially low payment rates. In its first three years alone, PAMA implementation cut nearly $4 billion from the CLFS. Congress has since delayed those cuts five times, but advocates say temporary fixes are no longer sustainable.
“The time for permanent reform is now,” the coalition urged.
Shutdown Leaves Critical Medicare Lab Payment Fix Hanging in the Balance
The RESULTS Act seeks to overhaul the payment process to ensure rates reflect the full diversity of the laboratory market, including independent, hospital outreach, and physician office laboratories. It would reduce administrative burdens on both labs and the Centers for Medicare & Medicaid Services (CMS), cap annual payment reductions at 5% instead of 15%, and extend data reporting cycles to every four years. The bill would also empower CMS to work with an independent third party to collect more representative market data and make rates subject to administrative or judicial review.
Supporters say these reforms would promote innovation and stabilize Medicare reimbursement. Industry groups agree that without reform, continued cuts could push smaller community and regional labs, particularly those serving rural or underserved populations, to close their doors.
ACLA president Susan Van Meter underscored the importance of laboratories in guiding medical decisions. “Clinical laboratories deliver essential information that individuals need to better understand their own health status, while also serving as the backbone of our healthcare system, providing the results that inform 70% of medical decisions,” she said.
ACLA president Susan Van Meter noted, “As our industry continues to innovate and tailor healthcare solutions through personalized medicine, the RESULTS Act is a critical step to safeguard access to these life-saving tools, reinforce our healthcare infrastructure, and support continued innovation in laboratory medicine.” (Photo credit: ACLA)
However, with the government shutdown halting normal committee business and delaying budget negotiations, the RESULTS Act—along with various other bipartisan healthcare bills—remains stuck in legislative limbo. For laboratory leaders, that means more uncertainty and a narrowing window for action before the 2026 cuts take effect.
The coalition letter concluded, “We stand ready to help advance the RESULTS Act to achieve fundamental reform of the flawed Medicare clinical laboratory payment system.”
Lab leaders warn that without the RESULTS Act, up to 800 common tests could see steep Medicare payment cuts, threatening patient access and community laboratory stability.
Clinical laboratory leaders have been expressing concern over looming Medicare payment cuts they say could destabilize their operations, threaten patient access, and undermine preparedness for future public health crises. With reductions of up to 15% scheduled to take effect in 2026, the introduction of the bipartisan Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act is being hailed by lab organizations as a lifeline to preserve financial stability and ensure seniors continue to receive timely, high-quality diagnostic testing.
US Senators Raphael Warnock (D-GA) and Thom Tillis (R-NC), along with a bipartisan coalition of House members, introduced the RESULTS Act on Sept. 10, 2025, to reform how Medicare pays for clinical laboratory services, a move aimed at protecting seniors’ access to essential diagnostic tests and stabilizing the nation’s lab infrastructure.
The legislation seeks to overhaul the payment system established under the Protecting Access to Medicare Act (PAMA) of 2014. While PAMA was intended to align Medicare rates with private insurers, laboratory groups argue that the way the law was implemented resulted in steep, unsustainable cuts. Without reform, payment reductions of up to 15% are scheduled to hit more than 800 commonly ordered tests starting January 1, 2026, and again in subsequent years.
“Access to quality clinical labs is essential to keeping our seniors living long, healthy lives,” said Warnock. “I’m proud to partner with my colleague Senator Tillis to put forward this legislative fix that will help ensure Georgia seniors will continue to have access to high-quality diagnostic services.”
Tillis emphasized that the bill is about long-term stability. “It is critically important that seniors have uninterrupted access to innovative diagnostic tests,” he said. “The RESULTS Act is a necessary step toward ensuring this access and supporting seniors’ healthcare needs. I’m proud to work with my colleagues to permanently fix flawed data collection and reporting methods which will allow Medicare beneficiaries to continue receiving quality and affordable lab services.”
CAP: Current Cuts Would “Undermine” Lab Operations
“The CAP supports congressional efforts to improve the PAMA rate-setting process for clinical lab services and reduce unnecessary burdens on laboratories,” said CAP president Donald S. Karcher, MD, FCAP.
Donald S. Karcher, MD, FCAP, CAP president noted, “Under the current structure dictated by PAMA, the severity of fee reductions would undermine the operational infrastructure of clinical laboratories throughout the United States. The RESULTS Act will mitigate these cuts, avert needless loss in access to care, and allow laboratories to continue providing timely, high quality clinical services for patients. We urge Congress to pass the RESULTS Act before cuts take effect on January 1, 2026.” (Photo credit: CAP)
ACLA: Nearly $4 Billion Cut Already
The American Clinical Laboratory Association (ACLA) also praised the legislation, calling it essential to protect access to both routine and advanced diagnostics. The group noted that implementation of PAMA slashed nearly $4 billion from the Medicare Clinical Laboratory Fee Schedule in just three years.
“When PAMA was implemented, this goal was not achieved, as CLFS [Clinical Laboratory Fee Schedule] rates were set based on data collected from less than 1% of all laboratories, resulting in artificially low payment rates,” ACLA said. Without intervention, “about 820 laboratory tests’ CLFS rates will be cut by up to 15% beginning January 1, 2026, threatening patient access to routine and life-saving diagnostics.”
ACLA president Susan Van Meter underscored the importance of laboratories in guiding medical decisions. “Clinical laboratories deliver essential information that individuals need to better understand their own health status, while also serving as the backbone of our healthcare system, providing the results that inform 70% of medical decisions,” she said. “As our industry continues to innovate and tailor healthcare solutions through personalized medicine, the RESULTS Act is a critical step to safeguard access to these life-saving tools, reinforce our healthcare infrastructure, and support continued innovation in laboratory medicine.”
“NILA applauds the bipartisan introduction of the RESULTS Act and urges Congress to quickly pass this vital legislation to strengthen our nation’s clinical laboratory infrastructure,” said NILA’s executive director Mark S. Birenbaum, PhD. “Our members are facing up to 15% in cuts to many of the most common laboratory tests; without immediate reform to PAMA this year, regional and community clinical laboratories could be forced to close their doors, leaving patients without access to critical laboratory testing.”
Birenbaum added that continued cuts could also erode preparedness for future public health emergencies. “PAMA cuts have weakened our nation’s community and regional clinical laboratories by leaving them without the necessary resources to continue providing essential services to people across the country,” he said. “Further cuts would continue to harm this infrastructure and threaten the ability of clinical laboratories to be prepared for a future pandemic or public health emergency.”
What the Bill Would Do
The RESULTS Act proposes several key reforms:
Adjust data reporting requirements and allow CMS to work with an independent third-party to collect more representative data
Exclude Medicaid managed care organizations from the definition of private payors
Cap annual Medicare payment cuts at 5% instead of 15%, while allowing increases with no cap
Extend the reporting cycle to every four years
Make payment rates subject to administrative or judicial review
Both widely available and more specialized tests would be covered under the new structure, using a mix of independent claims databases and targeted lab reporting to set accurate rates
Supporters say these changes would reduce administrative burden, stabilize Medicare reimbursement, and protect seniors’ access to vital testing.
“Congress has an opportunity this year to ensure long-term stability for the nation’s clinical laboratories,” ACLA’s Van Meter said. “We look forward to working with lawmakers to deliver this urgently needed reform.”
A more in-depth look at the RESULTS Act will be featured in the next edition of The Dark Report. (If you’re not a Dark Report subscriber, check out our 14-day free trial.)
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.
“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.
