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.
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.)
