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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Medicare Part B Lab Spending Hits $8.4 Billion as Genetic Testing Captures 43% of Dollars

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.

Attorney Alissa D. Fleming, a shareholder at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, told The Dark Report that federal audit risks have increased because of the OIG’s genetic test findings. The Dark Report is a sibling brand to Dark Daily.

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.

—Janette Wider

Rising Healthcare Costs May Change How Patients Use Clinical Lab Testing

A new KFF Health Tracking Poll shows healthcare costs are now the top economic worry for U.S. households—raising concerns that patients may skip screenings or shop more aggressively for lab tests, reshaping utilization and revenue patterns in 2026.

Healthcare costs are now the top economic concern for US households—and that anxiety is likely to ripple directly into clinical laboratories, according to a new KFF Health Tracking Poll released January 29.

Roughly one-third of the public (32%) say they are “very worried” about their ability to afford healthcare, a higher share than those most concerned about food, housing, utilities, or transportation. More broadly, 56% expect healthcare to become less affordable for their families in the coming year, signaling sustained pressure on patients’ willingness and ability to engage with the health system.

For clinical laboratories, that concern translates into two distinct, and potentially competing, patient behaviors.

Rising Costs Could Reshape Patient Testing Behavior

In one scenario, patients worried about out-of-pocket costs may delay or skip preventive screenings and fail to follow through on physician-ordered diagnostic testing. KFF found that about one in five respondents said their healthcare costs have risen faster than basic necessities like utilities or groceries. That perception alone can be enough to discourage patients from completing tests they view as optional, even when those tests are clinically indicated.

Photo credit: Image by Andreas Breitling from Pixabay.

In another scenario, cost-conscious patients may still pursue testing but do so more selectively. Rather than abandoning care altogether, these patients may “shop around,” comparing prices, turnaround times, and service offerings across clinical laboratories. This trend could increase demand for clearer test pricing, stronger patient-facing communication, and more transparent billing practices—areas where some labs may find both challenges and opportunities.

The poll also suggests that cost concerns are not confined to any single demographic or political group. Healthcare costs ranked as the top economic worry among Democrats, independents, and Republicans alike. More than four in ten voters (44%) say healthcare costs will have a “major impact” on whether they vote in the upcoming midterm elections, underscoring how personally felt the issue has become.

Policy Shifts Add New Pressure to Coverage and Affordability

Recent policy changes may be amplifying these anxieties. Congress allowed enhanced Affordable Care Act (ACA) tax credits to expire, a move that two-thirds of the public (67%) say was “the wrong thing” to do. The expiration is expected to increase premium payments for many marketplace enrollees, potentially leaving patients with less discretionary income for lab testing and other medical services.

While most Americans still view the ACA favorably—58% overall—that support has softened since last fall, reflecting ongoing uncertainty about coverage stability and affordability. For labs, fluctuations in insurance coverage can complicate reimbursement, increase patient self-pay balances, and add friction to pre-test counseling and billing workflows.

Taken together, the findings point to a year in which clinical laboratories may see uneven test utilization patterns. Some patients may disappear from the testing pipeline altogether, while others arrive armed with questions about cost, necessity, and alternatives.

As financial anxiety increasingly shapes patient decision-making, labs that can clearly communicate value—clinical relevance, quality, speed, and cost transparency—may be better positioned to maintain trust and test volume in an environment where affordability is front of mind.

—Janette Wider

Funding Standoff Jeopardizes PAMA Relief as Medicare Lab Cuts Loom

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.

Dark Daily last reported on this in November.

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.

—Janette Wider

Temporary Delay in PAMA Reductions Provides Labs More Time to Plan

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.

According to an article from our sibling publication G2 Intelligence, under the Protecting Access to Medicare Act (PAMA) of 2014, laboratories face up to 15% cuts in reimbursement rates for approximately 800 commonly ordered diagnostic tests.

“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.

Photo credit: “Capitol Hill – Washington, DC” by VinothChandar is licensed under CC BY 2.0.

Technical Revisions Clarify the Phase-in Schedule

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.

—Janette Wider

Shutdown Puts RESULTS Act and Lab Relief on Hold Until Congress Reopens

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.”

—Janette Wider

Extended Government Shutdown Squeezes Clinical Labs as Payment Delays Mount

With the government shutdown now stretching beyond two weeks, clinical laboratory leaders are beginning to feel the pinch. Experts warn that delays in Medicare payments could soon create cash-flow crunches and backlog claims well into November.

As the federal government shutdown stretches into its third week, laboratory leaders are warning of mounting financial pressure and potential payment delays that could disrupt operations and strain cash flow.

While clinical laboratories can continue to submit Medicare and Medicaid claims, the timing of reimbursements could soon become unpredictable. According to William Baus, a laboratory revenue cycle expert, who shared a visual on LinkedIn, “a government shutdown doesn’t stop you from submitting claims—but it can affect when you get paid.”

In his Oct. 11 post, Baus outlined the timeline of expected payment impacts. If the shutdown lasts fewer than 14 days (at the time this piece was written, the government shutdown entered its 17th day), Medicare reimbursements would have remained unaffected, since the Centers for Medicare and Medicaid Services (CMS) typically maintains a 14-day payment floor. But if the shutdown continues beyond that window (which it now has), the system begins to back up quickly.

For a 20-day shutdown, for instance, “payments are delayed about five business days,” Baus noted. Claims submitted October 1 would not pay out until October 21, creating a rolling backlog into November. “Bottom line,” he wrote, “a short shutdown = no impact. A longer shutdown = temporary cash-flow crunch.”

White House” by Diego Cambiaso is licensed under CC BY-SA 2.0.

Ripple Effects for Lab Cash Flow

For independent laboratories and pathology groups, especially those with thin operating margins, these delays could create significant short-term liquidity challenges. Many smaller or privately owned labs depend on steady reimbursement cycles to cover payroll, reagents, and lease expenses. Even a week-long delay in large Medicare payments can tighten available cash.

Hospital and health-system labs may have more flexibility, but even they face potential ripple effects if system-wide financial operations slow down or if supply purchases and contractor payments need to be deferred.

Medicaid and ACA Impacts

Ann Lambrix, vice president of revenue cycle management at Lighthouse Lab Services, echoed those concerns in a LinkedIn post of her own, warning that providers should brace for payment delays as the shutdown continues. “Healthcare providers should prepare for potential delays in claim processing and payments from Medicare,” Lambrix wrote. She noted that while “Medicaid [is] funded through Q1 of next year,” proposed cuts to enhanced subsidies “may threaten ACA coverage for individuals choosing to obtain health insurance through marketplace plans.” Lambrix thanked William Baus for his visual summary of the shutdown’s financial ripple effects, underscoring how even temporary disruptions in federal operations can upend reimbursement timelines across the healthcare sector.

Operational Preparedness

Lab leaders should prepare contingency plans, including:

  • Closely monitoring accounts receivable aging reports for delayed remittances.
  • Reviewing cash reserves and establishing short-term credit options if needed.
  • Communicating with vendors and staff about possible timing issues.
  • Staying in contact with billing vendors and clearinghouses to track any system backlogs.

“Claims can still be submitted and processed electronically,” Baus emphasized, “but the payment cycle may slip depending on how long the shutdown lasts.”

The Takeaway

In the short term, laboratories should brace for administrative slowdowns rather than outright denials. Yet as the shutdown continues, payment backlogs could cascade, especially for labs heavily reliant on Medicare revenue.

For now, experts recommend vigilance, conservative spending, and clear communication with financial teams. As the shutdown persists, even well-run labs could feel the pinch of delayed federal payments before November begins.

—Janette Wider

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