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.
Genetic tests make up just 5% of volume but now drive 43% of Medicare Part B lab spending, according to OIG’s latest report.
Medicare Part B spending on clinical laboratory testing rose to $8.4 billion in 2024, a 5% increase over the previous year, according to the Department of Health and Human Services’ Office of Inspector General (OIG). For laboratory professionals, the headline is not just rising spending—it’s where the money is flowing.
Although genetic tests accounted for only 5% of all Part B tests performed in 2024, they represented 43% of total lab spending—$3.6 billion. In contrast, the far larger volume of routine chemistry, hematology, and other non-genetic tests generated $4.8 billion. Spending on non-genetic testing has generally declined since 2021, while genetic testing expenditures climbed 20% between 2023 and 2024 alone.
Utilization trends help explain the shift. The number of genetic tests paid under Part B increased 160% between 2018 and 2024, reaching 18 million tests last year. Meanwhile, non-genetic testing volume declined 12% over the same period. More enrollees are receiving at least one genetic test per year, and per-enrollee payments for those services are rising sharply.
Genetic Testing Drives Revenue Growth
In 2024, Medicare paid an average of $794 per enrollee for genetic testing—a 26% jump from 2023. By comparison, per-enrollee spending for non-genetic testing remained relatively stable at just over $200 annually. Even as overall Part B enrollment receiving clinical lab services declined 15% since 2018, spending per genetic-testing patient increased, amplifying the financial impact of molecular diagnostics on lab revenue.
OIG suggests the decline in Part B enrollees receiving lab tests may reflect migration to Medicare Advantage plans. For independent labs heavily dependent on traditional fee-for-service Part B volume, this shift adds another layer of financial pressure and underscores the need to monitor payer mix closely.
High-Dollar Molecular Codes Dominate the Top 25
The concentration of revenue in high-priced molecular assays is intensifying. In 2024, 346 laboratories received more than $1 million in Medicare payments for genetic tests; 55 labs exceeded $10 million. The top 25 laboratory procedure codes accounted for nearly half of all Part B lab spending—more than $4.1 billion.
Genetic tests dominated the fastest-growing segments. CPT code 87798—used for infectious agent detection by nucleic acid when no organism-specific code exists—generated $443 million in 2024, a 51% increase over 2023, making it the highest-paid lab test under Part B. An epilepsy genomic panel (CPT 81419) posted a fivefold spending increase year over year. Several oncology liquid biopsy assays remain among the highest-reimbursed tests, with median payments reaching into the thousands of dollars.
Routine Testing Holds Volume—but Not Spending Power
In contrast, routine tests familiar to every clinical laboratory—comprehensive metabolic panels (80053), CBCs (85025), lipid panels (80061), thyroid testing (84443), and A1C (83036)—either declined or remained flat in spending. Comprehensive metabolic panel spending has dropped 25% since 2018 and fell from the top spending position in 2023 to second place in 2024. These high-volume, low-margin tests continue to anchor daily lab operations but represent a shrinking share of total Medicare dollars.
Importantly, OIG notes that these shifts are not driven by changes in the Clinical Laboratory Fee Schedule, which has remained largely frozen since 2020 under provisions from the Protecting Access to Medicare Act. Instead, spending growth reflects changes in utilization, test mix, and per-enrollee costs.
For clinical laboratory leaders, the message is clear: Medicare’s lab dollars are increasingly concentrated in molecular diagnostics. That shift brings opportunity—but also heightened regulatory scrutiny. OIG’s history of fraud alerts and audits in genetic testing suggests that compliance, documentation, and medical necessity controls will remain critical as high-complexity testing continues to expand within the Medicare population.
This article was created with the assistance of generative AI and has undergone editorial review before publishing.
Clinical laboratories face renewed Medicare payment uncertainty as a congressional funding impasse threatens to derail temporary PAMA relief, with new CLFS cuts scheduled to take effect in days unless lawmakers act.
Clinical laboratories are once again facing near-term Medicare payment uncertainty as congressional negotiations over a must-pass spending package stall, putting temporary relief from PAMA-driven cuts at risk just days before new reductions are scheduled to take effect.
The American Clinical Laboratory Association (ACLA) is closely tracking bipartisan, bicameral negotiations tied to a broader government funding deal that includes provisions to delay further cuts to the Medicare Clinical Laboratory Fee Schedule (CLFS). The proposal would push back additional PAMA-related reductions until Jan. 1, 2027, and update the private payor data CMS uses to set future Medicare rates. Without action, lab test reimbursement rate cuts are scheduled to go into effect on Jan. 31.
ACLA Backs PAMA Relief but Warns Structural Flaws and Imminent CLFS Cuts Remain
ACLA President Susan Van Meter said lawmakers appear increasingly aware of the structural flaws baked into PAMA’s rate-setting framework.
“ACLA appreciates that lawmakers on both sides of the aisle recognize the serious and ongoing problems posed by PAMA,” Van Meter said in a statement provided by the organization. (Photo credit: ACLA)
She emphasized that shifting the data collection period to more recent market information would represent a meaningful, though incomplete, step forward.
Under the legislative language outlined in the bill, Congress would revise the PAMA phase-in schedule by extending payment reduction caps through 2029, rather than allowing steeper cuts to resume sooner. The bill would also replace the 2019 private payor data CMS is currently set to rely on with data from 2025, addressing longstanding concerns from laboratories that Medicare rates are being calculated using outdated and unrepresentative commercial payment information.
“Updating the data collection period from 2019 to 2025 would move Medicare payment rates away from reliance on seven-year-old market data that would otherwise be used to set 2027 rates,” Van Meter said, according to the statement from ACLA. However, she cautioned that even with updated timelines, “CMS is unlikely to receive comprehensive and representative commercial data needed to set accurate Medicare rates.”
The stakes for laboratories are immediate. Without congressional action, new CLFS cuts of up to 15 percent on roughly 800 tests are scheduled to take effect on Jan. 31, adding to what ACLA described as “three previous rounds of reductions.” Lab professionals have repeatedly warned that cumulative cuts threaten the sustainability of community-based testing and could restrict patient access, particularly in rural and underserved areas.
PAMA Relief Tied to High-Stakes Funding Fight, Leaving Labs in Legislative Limbo
The PAMA provisions are embedded in a larger government funding package that now faces political headwinds. As reported in The Washington Post, Senate Democrats have indicated they will block the broader spending deal unless it is restructured, raising the possibility of a partial government shutdown. While the dispute centers on Department of Homeland Security (DHS) funding, failure to advance the package would also stall health-related provisions, including laboratory payment relief. There has been discussion about separating votes for DHS and Health and Human Services (HHS) spending, but it is not clear yet whether that will happen. The PAMA delays are tied into the HHS spending package.
That linkage is raising concern across the laboratory sector, where advocates argue that PAMA relief has long enjoyed bipartisan support and should not become collateral damage. Van Meter urged lawmakers to move quickly, calling the proposal “a down payment toward lasting PAMA reform” and pressing Congress to advance the bipartisan RESULTS Act this year.
For lab professionals, the outcome of the funding negotiations will determine whether temporary relief materializes—or whether another round of PAMA cuts proceeds as scheduled, further reshaping the Medicare testing landscape just as laboratories continue to adapt to tightening margins and rising operational costs.
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.)
