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.”
The federal government shutdown has suspended key scientific operations—including FDA application processing, EPA inspections, NIH and NSF grant reviews, CDC reporting, and OSHA enforcement—resulting in significant delays for laboratories.
As of October 1, 2025, a lapse in federal funding has forced many U.S. science-relevant agencies to curtail nonessential operations, leaving laboratory leaders to manage uncertainty, delays, and compliance risks.
What’s Happening Across Agencies
Lab Manager reported that the FDA warned that “new drug, biologics, and device applications that require user fees are not being accepted during the shutdown.”
In an official message, FDA Commissioner Marty Makary, MD, MPH, stated that while “many employees will be furloughed during the lapse period,” the agency will “continue to fully execute our public health mission to the extent permitted by law.”
FDA Commissioner Marty Makary, MD, MPH, noted in the FDA’s official message, “I am disappointed that Congress failed to reach a budget agreement. As a result, the FDA is now faced with a lapse in appropriations and will be forced to shut down certain operations of the agency.” (Photo credit: FDA)
The Los Angeles Times reported that EPA will see a sweeping reduction in capacity, with nearly 90 % of its workforce being furloughed.
Lab Manager also reported that new permits, inspections, and compliance enforcement are largely frozen.
HHS Contingency Plan
Under the HHS contingency plan, which covers NIH, CDC, and other health agencies:
Out of ~79,717 employees, 32,460 are estimated to be furloughed under the plan.
HHS will continue only “exempt or excepted” activities, such as outbreak monitoring by CDC and “core functions” at the FDA.
All non-exempt NIH extramural research, grant oversight, and data collection will be suspended.
The Occupational Safety and Health Administration (OSHA) has largely ceased routine enforcement and consultation activities during the shutdown, with only emergency inspections continuing. According to Lab Manager, the agency has suspended “most programmed inspections and compliance assistance,” retaining only personnel necessary to respond to “imminent danger situations” and fatalities. This means laboratory safety programs will receive no regular oversight until funding is restored, placing greater responsibility on lab leaders to maintain compliance and documentation internally.
Key Impacts for Laboratory Leaders
While grant proposals may still be submitted in some cases, their review and processing are stalled, according to Lab Manager. Further, labs awaiting FDA approvals or oversight (e.g. for devices, reagents, protocols) may see deliverables and timelines move unpredictably.
Without regular EPA permitting, inspections, or enforcement, labs that rely on environmental permits must sustain internal compliance vigilance in the absence of federal oversight.
Agencies that supply routine safety, epidemiological, or environmental data are scaling back to minimal essential operations, potentially leaving labs with delayed access to critical datasets.
In many agencies, core capabilities are cut to only those functions required to protect human life or property.
What Lab Leaders Should Do Now
Revisit project timelines: Recognize that regulatory submission dates, funding disbursements, and permit cycles may shift.
Document internal compliance: Maintain logs, audits, and safety checks independent of federal interaction.
Communicate with stakeholders: Funders, collaborators, and regulatory bodies should be notified of possible delays.
Prioritize essential operations: Identify which experiments, sample storage, or assays must continue even under constrained oversight.
Monitor agency updates: Shutdowns evolve, and agencies may alter which functions are considered “essential” or “excepted.”
Recent laws in California, Utah, and Texas define new compliance standards for clinical laboratories employing AI in diagnostic and clinical messaging.
When it comes to oversight of artificial intelligence (AI) use in clinical laboratory, it behooves lab leaders to watch what is happening on the state level. In some cases, disclosure of AI use is a threshold states are monitoring.
For example, California Assembly Bill 3030, which went into effect Jan. 1, 2025, mandates transparency when generative AI is used in healthcare. Any health facility, laboratory, clinic, physician’s office, or group practice that employs generative AI to create patient communications about clinical information must include:
A prominent disclaimer stating the content was AI-generated.
Clear instructions that inform patients how to speak directly with a human clinician.
If a licensed provider reviews and approves the AI-generated communication, these requirements are waived. AB 3030 applies only to clinical—not administrative—messages. Non‑compliance can result in disciplinary actions from state regulators.
Laboratories using AI in patient-facing contexts should ensure their workflows include AI‑disclaimers, human‑review triggers, and clear ways for patients to contact providers.
“Symposium Cisco Ecole Polytechnique 9-10 April 2018 Artificial Intelligence & Cybersecurity” by Ecole polytechnique / Paris / France is licensed under CC BY-SA 2.0.
AI Disclosure in Utah
Meanwhile, Utah Senate Bill 226 updates its Artificial Intelligence Policy Act, tightening rules around how healthcare entities—including clinical labs—use generative AI in patient interactions. The rules went into effect May 7, 2025.
Under the state’s law, labs must disclose AI use only when:
A patient explicitly asks whether they’re interacting with AI, or
The lab uses AI in high-risk communications, such as delivering test interpretations, diagnostic results, or clinical advice.
Routine AI use in back-end operations or non-clinical messaging does not require disclosure.
A safe harbor provision protects labs from penalties if the AI system clearly identifies itself as non-human at the beginning and throughout the interaction.
Labs that use AI-generated content in patient portals, chatbots, or outreach must ensure compliance or face consumer protection penalties.
New Texas Law on AI
Texas passed a law in June that goes into effect Sept. 1, 2025, the regulates how AI is used within electronic health records (EHRs).
According to the law, providers that use AI for recommendations on diagnosis or treatment based on a patient’s medical record must review all information obtained through AI to ensure its accuracy before entering the information into a patient’s EHR.
The law also “imposes a strict data localization mandate, prohibiting the physical offshoring of electronic medical records,” law firm Holland & Knight noted. “This requirement applies not only to records stored directly by healthcare providers but also to those maintained by third-party vendors or cloud service providers.”
Federal investigations into UnitedHealth’s Medicare billing could impact clinical labs and reshape diagnostic workflows.
The intensifying federal investigation into UnitedHealth Group’s Medicare Advantage billing practices is making headlines in both major outlets and industry-specific trade publications. Clinical laboratories have the potential to soon feel the effects. As questions grow around how the insurance giant gathers and codes medical diagnoses, labs that play a role in confirming those diagnoses could see heightened regulatory oversight, increased documentation requirements, and a more complex reimbursement landscape.
According to an article from The Associated Press, on July 24, UnitedHealth Group, the largest U.S. provider of Medicare Advantage (MA) plans, revealed in a Securities and Exchange Commission (SEC) filing that it is now cooperating with both criminal and civil investigations by the Department of Justice (DOJ). The probes are centered on allegations that the company inflated patient diagnoses in order to receive larger payments from the federal government. These investigations, which were first surfaced in reports by The Wall Street Journal earlier this year, are now confirmed.
UnitedHealth Comments on Investigation
UnitedHealth said it initiated contact with the DOJ after the reports came to light and is already responding to information requests. The company also announced it has launched a third-party review of its business policies and performance metrics, which is expected to conclude by the end of the third quarter, according to comments made to CNBC.
“UnitedHealth has full confidence in its practices and is committed to working cooperatively with the Department throughout this process,” the company stated in its filing.
The DOJ’s criminal investigation reportedly includes interviews with doctors about whether they were pressured to submit claims for certain diagnoses that would lead to higher MA payments. A civil inquiry into the company’s billing practices has been underway since February. Both investigations center around suspicions that UnitedHealth used retrospective chart reviews and in-home health assessments—often carried out by clinicians contracted through its Optum unit—to bolster patient risk scores and inflate payments from Medicare.
What this Might Mean for Clinical Labs
Clinical laboratories may be affected, as lab-generated diagnostic data is frequently used to support or validate the conditions coded for reimbursement. If regulators demand greater transparency or auditing of how diagnostic data is linked to MA billing, labs could face increased scrutiny on test utilization, data accuracy, and coding practices.
CNBC reported that UnitedHealth has pushed back against some of the scrutiny. The company noted that Centers for Medicare & Medicaid Services (CMS) audits have found its practices to be “among the most accurate in the industry.” It also cited a special master’s recommendation in March in an ongoing legal case stemming from a whistleblower complaint that accused the company of withholding $2 billion in Medicare payments. In that case, the special master concluded that the DOJ had insufficient evidence to proceed.
As for the timing of the DOJ confirmation, UnitedHealth has had a challenging year. The company has endured stock volatility, leadership upheaval, and broader reputational risks. In May, CEO Andrew Witty abruptly resigned, and earlier in the year, the firm dealt with the fatal shooting of UnitedHealthcare CEO Brian Thompson in New York City. UnitedHealth is also still recovering from a massive cyberattack that disrupted operations across its network.
“This all sounds logical as it moves forward with a new CEO,” wrote Jared Holz, healthcare strategist at Mizuho Securities, in a note to clients July 24, while noting that UnitedHealth had previously denied being under federal investigation.
Jared Holz, Mizuho healthcare sector strategist, said UnitedHealth’s choice to acknowledge the probes and cooperate with the department “all sounds logical as it moves forward with a new CEO.”
The Medicare and Retirement division, which includes the Medicare Advantage business, brought in $139 billion in revenue last year, making it UnitedHealth Group’s largest segment. But medical costs have surged, particularly among new MA enrollees. UnitedHealth suspended its 2025 forecast and withdrew guidance altogether in May due to financial uncertainty.
For clinical labs, payers, and providers, the situation underscores a growing federal focus on Medicare Advantage oversight, potentially reshaping not only billing practices but also the data and diagnostics behind them.
Clinical laboratory genetic testing labs and telemedicine groups among those charged
In the largest healthcare fraud bust in US history, the US Department of Justice (DOJ) announced it had levied criminal charges against 324 defendants for allegedly participating in various fraudulent healthcare schemes—including clinical laboratory genetic testing and telemedicine fraud—totaling over $14.6 billion in losses.
A DOJ press release states the agency’s 2025 National Health Care Fraud Takedown represents an unprecedented effort to alleviate fraud in healthcare that exploits patients and taxpayers.
The defendants include 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals. The cases are being prosecuted by Health Care Fraud Strike Force teams from the Criminal Division’s Fraud Section, 50 US Attorneys’ Offices, and 12 State Attorneys’ General Offices.
“This record-setting Health Care Fraud Takedown delivers justice to criminal actors who prey upon our most vulnerable citizens and steal from hardworking American taxpayers,” said Attorney General Pam Bondi in the press release. (Photo copyright: US Department of Justice.)
49 Clinical Lab Defendants Charged
The takedown relied on coordinated investigations from several agencies, including the:
Health Care Fraud Unit of the DOJ Criminal Division’s Fraud Section,
Department of Health and Human Services Office of Inspector General,
Federal Bureau of Investigation,
Drug Enforcement Administration, and,
Multiple US Attorneys’ Offices.
Clinical laboratory testing fraud was addressed in the takedown. Forty-nine defendants were charged with telemedicine and genetic testing fraud schemes where deceptive telemarketing campaigns targeted Medicare beneficiaries, resulting in $46 million in fraudulent claims being submitted to Medicare for durable medical equipment (DME), genetic tests, and COVID-19 tests.
“Make no mistake—this administration will not tolerate criminals who line their pockets with taxpayer dollars while endangering the health and safety of our communities,” said Attorney General Pam Bondi in the press release.
Other High-Profile Cases
The most prominent cases include a $10 billion urinary catheter scheme where foreign straw owners secretly purchased medical supply companies and then used stolen identities and personal health data of more than one million Americans to file erroneous Medicare claims. Known as Operation Gold Rush, the hoax resulted in the arrests of nineteen defendants, including four in Estonia and seven individuals attempting to avoid capture at US airports and at the Mexican border.
In another case involving foreign influence, owners and executives in Pakistan were charged in connection with a $703 million scheme where artificial intelligence (AI) was allegedly used to create fake recordings of Medicare recipients consenting to receive various products. The data was then sold to clinical laboratories and DME companies to fraudulently submit false claims to Medicare. In addition, some of these defendants allegedly conspired to conceal and launder proceeds from US bank accounts to overseas bank accounts.
Also, a defendant who owned a billing company allegedly planned a sham in which Arizona Medicaid was fraudulently billed $650 million for addiction treatment programs where services were never rendered or patients received substandard care. The defendant, who is based in Pakistan and the United Arab Emirates, supposedly received at least $25 million from the scheme and is also charged with a money laundering offense.
“It’s not done by small time operators,” said Mehmet Oz, MD, who leads the Centers for Medicare and Medicaid Services (CMS). “These are organized syndicates who are designing to hurt America.”
Other notable cases include a scam involving $1.1 billion in fraudulent claims for unnecessary amniotic wound allografts for elderly patients resulting in defendants receiving millions in illegal kickbacks. In another scheme, 74 defendants were charged with the illegal distribution of prescription opioids and other controlled substances.
DOJ Property Seizures
As a result of the fraud bust, the US government seized over $245 million in cash, luxury vehicles, cryptocurrency, and other assets and prevented an additional $4 billion from being paid out by CMS due to false and fraudulent claims.
“These criminals didn’t just steal someone else’s money. They stole from you,” Matthew Galeotti, JD, who leads the DOJ Criminal Division, told the Associated Press. “Every fraudulent claim, every fake billing, every kickback scheme represents money taken directly from the pockets of American taxpayers who fund these essential programs through their hard work and sacrifice.”
This latest bust demonstrates the DOJ’s increased resolve to pursue healthcare fraud, including cases involving clinical laboratory testing. Look for further coverage of this aspect in the 7-14-2025 issue of The Dark Report.
Clinical laboratories should take a proactive approach to ensure compliance with current price transparency regulations
Price transparency in healthcare continues to be a focus of the Centers for Medicare and Medicaid Services (CMS). As of this ebrief, the agency has cited nearly a dozen hospitals this year that failed to, wholly or in part, follow through with federal legislation due to technical issues.
The citations, paired with President Trump’s executive order from February on price transparency, demonstrates a growing trend toward costly enforcement.
It’s not clear from the documentation posted by CMS if any of this involves price transparency with clinical laboratory tests. Labs that operate within hospitals or health systems are subject to the executive order; thus, diagnostic test pricing estimates are subject to transparency mandates.
Based on enforcement actions posted online by CMS, it’s clear that the agency is looking into technical issues of price transparency requirements that have little to do with diagnostic medicine. From that perspective, clinical laboratory teams may want to pass this Dark Daily ebrief along to their IT department and business analysts, whose work is drawing criticism from CMS at some hospitals.
The entire lab team should be proactive on the issue of price transparency.
“Imagine how a one-on-one conversation with a patient would go if a physician explained that a routine cholesterol test sent to Lab A would cost five times that of Lab B. Anyone think the patient would choose Lab A?” wrote Bryan Vaughn, senior vice president, health systems and mid-America division, Labcorp, in an article he penned for the lab company’s website. (Photo copyright: Labcorp.)
Hefty Fines and Warnings from CMS
According to CMS, already in 2025, 10 hospitals have received civil monetary penalty (CMP) notices of hefty fines for non-compliance. They include:
Arkansas Methodist Medical Center, Paragould, Ark. $309,738
Northlake Behavioral Health System, Mandeville, La. $257,180
Lawrence Rehabilitation Hospital, Brick, N.J. $120,120
Community Care Hospital, New Orleans, La. $93,214
Hill Hospital of Sumter County, York, Ala. $84,216
Bucktail Medical Center, Renovo, Pa. $75,582
D.W. McMillan Memorial Hospital, Brewton, Ala. $71,852
First Surgical Hospital, Bellaire, Texas $62,016
CCM Health, Montevideo, Minn. $55,611
Southeast Regional Medical Center, Kentwood, La. $32,301
Payments for citations are due 60 days after receiving the CMP notice.
Trump’s Executive Order
CMS’ price transparency focus comes alongside President Trump’s Executive Order 14221, “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information,” which the administration put out in February of this year, CMS noted.
As covered in the March 31 issue of The Dark Report, a sister publication to Dark Daily, Trump’s order is an expansion of his previous price transparency ruling, which went into effect at the start of 2021.
At that time, hospitals were required to “provide clear, accessible pricing information online about the items and services they provide” that was easy understand and to use, and machine-readable files listing all services and items available, CMS noted.
Impact on Clinical Laboratories
CMS’ updated requirements and refreshed reinforcement against healthcare organizations remain pertinent to hospital laboratories mostly due to extreme variations in test pricing.
“Reports continue to point out wide differences in the prices of routine laboratory testing across settings. Yet, routine lab testing may be some of the most comparable procedures in healthcare, with minimal differences in methods or quality,” wrote Bryan Vaughn, senior vice president of health systems and the mid-America division at Labcorp, in an article he penned for the lab company’s website.
Vaughn cited as much as a $600 difference found between metabolic or lipid panels and other standard lab tests.
It behooves clinical labs to verify that the information they provide to consumers online about test prices is indeed easy to understand and meets the spirit of the executive order and CMS. Failure to do so could be costly to a health system or hospital.
