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Ensuring Medicare rates are based on actual, adjudicated claims instead of outdated 2016 data.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 Senate’s government funding proposal includes a 30-day delay in PAMA cuts, giving clinical labs more time to prepare for reduced Medicare reimbursement rates.
Tucked into the Senate’s government funding proposal is a modest yet impactful measure that gives clinical laboratories a brief reprieve from PAMA reimbursement cuts.
On Nov. 10, the Senate amended and passed a version of a House funding bill, H.R. 5371, designed to reopen the government and allocate funding across multiple agencies. Among its 394 pages is a 30-day stopgap measure delaying PAMA reimbursement cuts, pushing the effective date from January 1 to January 31, 2026.
“While this 30-day reprieve provides welcome relief and demonstrates growing awareness of the impact these cuts have on laboratories and patient access, our work is far from done,” said Clarisa Blattner, senior director of revenue and payor optimization at XiFin, who was among the first to publicly note the extension via a LinkedIn post.
The Senate provision references updates to Section 1834A of the Social Security Act, known internally as Section 6209. The amendment modifies how CMS phases in payment reductions based on private payer data:
The 2026 calendar year is divided into two periods: January 1–30, 2026, and January 31–December 31, 2026, rather than treating the entire year as a single implementation period.
Reporting windows for private-sector payment data, which inform Medicare rates, are also extended. Instead of ending December 31, 2025, the next reporting period will run from February 1 through April 30, 2026.
These changes give laboratories additional time to prepare, gather, and validate private payer data while adjusting to new reimbursement rates—a key operational relief, especially for smaller and independent labs.
Extra Time to Advance the RESULTS Act
G2 Intelligence also reported that the temporary delay also offers the clinical lab industry a critical window to rally support for the RESULTS Act (Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act). The bill aims to reform PAMA by reducing reimbursement rate cuts, using an independent database for commercial payer reporting, and lengthening intervals between reporting windows.
Industry observers had warned that Congress was unlikely to again delay PAMA cuts, which have been postponed periodically since the pandemic. The 30-day extension is therefore notable, giving laboratories a short but meaningful buffer to continue advocacy and prepare for upcoming rate adjustments.
Looking Ahead
Laboratory leaders can use this window to assess financial impacts, adjust operational plans, and ensure compliance with updated reporting requirements. As CMS continues to refine its private-payer-based payment system under PAMA, this modest delay offers a critical opportunity to stabilize lab operations and maintain patient access to essential diagnostic services.
The IVD industry’s consolidation surge continues unabated, as advances in AI-driven genomics and a flurry of private equity deals reshape the sector for a data-driven decade ahead.
The in vitro diagnostics (IVD) market is entering a new phase of transformation, defined by innovation at the technology level and consolidation at the corporate level, as strategic buyers and investors reshape the competitive landscape.
In the latest move, QIAGEN announced plans to acquire Parse Biosciences for up to $280 million, a deal that will expand QIAGEN’s Sample technologies into the rapidly growing single-cell sequencing market. The acquisition gives QIAGEN access to Parse’s Evercode technology and massive-scale datasets—critical assets as AI-driven drug discovery and predictive biology become central to life sciences. The move underscores QIAGEN’s bet that future diagnostic and therapeutic breakthroughs will hinge on scalable, data-rich technologies rather than traditional instrument-based models.
The Dark Report noted recently in its ranking of top IVD companies that Qiagen was #10, a jump of three spots up from its prior ranking.
Alex Rosenberg, PhD, CEO and co-founder of Parse Biosciences added, “As our team joins QIAGEN, we want to accelerate that mission and extend the reach of our technology to more customers around the world. QIAGEN’s strong commitment to Sample technologies and its global infrastructure make it an ideal partner for our next stage of growth.” (Photo credit: Parse Biosciences)
M&A Highlights
The QIAGEN–Parse deal follows months of high-profile M&A activity reshaping the diagnostics sector.
In October, Hologic agreed to an $18.3 billion buyout by Blackstone and TPG, marking one of the largest private equity transactions in healthcare this year. The move takes a top-15 IVD and imaging company private, reflecting both investor confidence in the steady revenues of women’s health diagnostics and a broader pattern of capital consolidation in the space. Analysts suggest that private equity firms are seeking predictable, cash-generating platforms while large corporations increasingly focus on growth through specialization or divestment.
That strategy is on display at Siemens Healthineers, which is reportedly exploring a $7 billion divestiture of its diagnostics division to firms including Blackstone, KKR, and CVC Capital Partners. Such a sale would streamline Siemens’ portfolio around imaging and oncology technologies, while potentially placing one of the world’s largest IVD suppliers under new ownership.
Taken together, these deals highlight a defining moment for the diagnostics industry. Major corporations are repositioning their portfolios around data, AI, and precision medicine, while investors are moving aggressively to capture value in an industry that proved its resilience during and after the pandemic.
For laboratory leaders, the implications are clear: consolidation is accelerating, supply chains and vendor relationships may shift, and innovation is increasingly concentrated among fewer, but more powerful, players.
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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.”
A new KFF poll shows Americans’ trust in the CDC has dropped to its lowest point since COVID-19, creating an opportunity for clinical laboratories to become trusted local voices in public health.
An article from CIDRAP recently reported that public trust in the Centers for Disease Control and Prevention (CDC) has fallen to its lowest level since the start of the COVID-19 pandemic, according to a KFF poll. The decline comes amid renewed misinformation about vaccines and autism and reflects growing skepticism toward the agency from both sides of the political spectrum.
The survey, conducted September 23–29 among more than 1,300 adults, found that only 18% of respondents have “a great deal” of trust in the CDC to provide reliable vaccine information, and 32% have “a fair amount.” That means just half of Americans have at least some trust in the CDC—down from 63% in 2023 and 57% as recently as mid-2025.
The findings followed remarks by President Donald Trump linking acetaminophen use in pregnancy to autism and calling for the measles, mumps, and rubella (MMR) vaccine to be split into three separate shots, claims that lack scientific evidence.
The erosion of trust, however, extends beyond political statements. While conservatives have long viewed the CDC with suspicion over perceived government overreach during COVID-19, many liberals now express frustration with what they see as inconsistency and political influence within the agency.
Higher Trust in Professional Medical Organizations
Interestingly, trust remains higher in professional medical organizations. Sixty-nine percent of parents polled said they trust the American Academy of Pediatrics, and 64% said they trust the American Medical Association.
“It’s encouraging, if far from ideal, that as trust in our nation’s scientific agencies crumbles, the public does trust the professional associations who have stepped forward,” said KFF president and CEO Drew Altman, PhD, in the organization’s press release. (Photo credit: KFF)
Support for Health and Human Services Secretary Robert F. Kennedy Jr. and his “Make America Health Again” (MAHA) movement was also low, with 62% disapproving of his handling of vaccine policy and 59% disapproving of his overall job performance.
What Labs Can Do
Amid this erosion of trust in federal health leadership, local clinical and public health laboratories may be poised to fill an emerging gap. Because labs are often the first to detect spikes in testing volume or positive results, they have a front-line view of disease trends—sometimes days or weeks before such patterns are visible nationally. If skepticism toward the CDC continues to grow, local labs could play an increasingly vital role in identifying and communicating outbreaks, especially during flu season or in the event of a new respiratory virus surge.
Beyond surveillance, labs can also help rebuild confidence in science by engaging their communities directly. Educational outreach, transparent data sharing, and collaboration with local healthcare providers can position laboratories as trusted sources of public health information, at a time when trust in national institutions is faltering.
As the CDC works to rebuild its credibility, laboratories across the country have a unique opportunity to step into the information void by translating data into understanding, and helping restore the link between diagnostics, public awareness, and trust in science.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Lawmakers are renewing efforts to tackle the national clinical lab staffing crisis with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025, a bipartisan bill that would expand training grants and loan forgiveness programs to strengthen the medical laboratory workforce.
Efforts to address the nation’s clinical laboratory staffing crisis have regained momentum with the reintroduction of the Medical Laboratory Personnel Shortage Relief Act of 2025. The bipartisan legislation, introduced by Rep. Jen Kiggans (R-VA-02) and Rep. Deborah Ross (D-NC-02), seeks to bolster recruitment and retention across a profession facing severe shortages.
According to a September press release from Kiggans and Ross, the bill is designed to “address the nationwide shortage of clinical laboratory professionals” by expanding eligibility for the National Health Service Corps (NHSC) to include medical laboratory personnel and establishing new federal grants for accredited colleges and universities to train future lab workers.
“Across the country, clinical laboratories face vacancy rates as high as 25%,” the release stated. “These shortages strain healthcare delivery, lead to longer wait times for patients, and contribute to burnout among existing lab staff.” The lawmakers noted that laboratory professionals are essential to healthcare operations, as “doctors depend on the diagnostic work done by laboratory professionals for nearly 70% of their medical decisions.”
“As a nurse practitioner, I know that access to quality healthcare depends on having the right professionals in place at every level,” said Congresswoman Kiggans in the press release. “That’s why I’m proud to join Congresswoman Deborah Ross on the Medical Laboratory Personnel Shortage Relief Act. This important legislation will add medical laboratory professionals to the National Health Service Corps and provide grants to accredited institutions to train more laboratory scientists and technicians.
Rep. Jen Kiggans (R-VA-02) said, “Our nation faces a severe shortage of clinical laboratory professionals—a problem that will only worsen as our population ages. Without enough trained experts, our clinical labs cannot keep pace with the growing demand and complexity of medical testing, which is essential for diagnosing and treating patients. Investing in our medical laboratory workforce strengthens our health system, supports patients, and ensures we are prepared to meet future challenges.” (Photo credit: https://kiggans.house.gov/)
Medical Laboratory Personnel Shortage Relief Act of 2024
The proposal is built upon the Medical Laboratory Personnel Shortage Relief Act of 2024, introduced the previous year before the November elections, as reported by G2 Intelligence. The updated version continues provisions that would amend the Public Health Service Act (42 U.S.C. 254e) to direct the Health and Human Services Secretary to identify areas suffering from shortages of qualified laboratory professionals and deploy NHSC members to those locations.
The act would also establish a Medical Laboratory Personnel Education Program, operated through grants and contracts awarded to accredited nonprofits, allied health schools, and hospitals. These funds would expand training capacity, support internships required for certification, and help recruit qualified faculty which have been longstanding barriers to increasing the pipeline of lab professionals.
In an interview with G2 Intelligence, Jim Flanigan, CAE, executive vice president of the American Society for Clinical Laboratory Science (ASCLS), said the act offers two major advantages: “the establishment of a federal grant program that would allow educational programs to expand the number of students they can train at a given time” and the inclusion of laboratory professionals in the NHSC, which would make them eligible for student loan forgiveness. “Both efforts will help in attracting individuals to the lab career path,” he said.
Rodney Rohde, PhD, MS, SM(ASCP)CM, SVCM, MBCM, FACSC, chair and professor of clinical laboratory science at Texas State University, told G2 Intelligence that he “cannot overemphasize the impact that establishing a program for lab personnel loan repayment will have for building our pipeline in recruiting and retention of students interested in the medical laboratory major and career path.” He added, “Laboratory testing follows patients throughout their lives, from cradle to grave, and it drives about two-thirds of all medical decisions made by doctors and other healthcare professionals.”
Despite the strong backing from organizations such as ASCLS, the Association for Diagnostics and Laboratory Medicine, and the American Clinical Laboratory Association, the bill’s path forward remains uncertain amid fiscal restraint on Capitol Hill. “All programs that incur significant costs are going to face challenges in getting passed,” Flanigan noted.
Still, as G2 Intelligence reported, supporters see the act as a vital “investment in our public health and our invaluable laboratory workforce.”
