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.
Diagnostic laboratories must dig into where their suppliers source their items to avoid surprises
Clinical laboratories in the US are under additional financial and operational pressure because of tariff fluctuations from the federal government among global trading partners. This brief overview explores clinical lab tariff strategies that may help organizations better prepare for difficult stretches.
Across the overall laboratory industry—including diagnostics settings—average duties on imported lab equipment and consumables hover around 23%, with personal protective equipment, lab instruments, and supply chains facing even higher tariffs depending on their origin, according to a report from Lab Manager, a sibling brand to Dark Daily.
“Don’t assume that just because something is made in the United States that it will be tariff free because many of the components are not,” Drew Kevorkian, founder and CEO at ARES Scientific, told Lab Manager. ARES Scientific maintains a useful online tariff guide.
These nuances can escalate costs, complicate budgeting, and squeeze margins, all of which pose a risk to financial viability for clinical labs.
When it comes to clinical lab tariff strategies, the starting point is clear. “Assume costs are going up one way or another. The best thing to do is be well informed,” Drew Kevorkian, founder and CEO at ARES Scientific, told Lab Manager. (Photo copyright: Ares Scientific.)
Tariff-Influenced Areas for Clinical Labs to Consider
Managers and others who oversee budgeting or product procurement should think about the following aspects as they plan out their clinical lab tariff strategies:
Component audits. Labs should undertake an audit of their consumables down to the stock-keeping unit (SKU), which is an alphanumeric descriptor that identifies a product. The goal is to identify the source of the products to determine if they come from tariff-affected countries, Kevorkian noted. This exercise allows clinical lab professionals to forecast cost scenarios and make informed procurement decisions.
Reused lab instruments. Tariffs introduce an opportunity to think about acquiring certified refurbished lab equipment. Such items, often already in the US, can offer meaningful savings and avoid import duties, according to Lab Manager.
Investigate in vitro diagnostics (IVD) sourcing. Clinical labs should look into where their IVD suppliers get their components, according to The Dark Report. Even if a lab buys from American-based suppliers, the IVD companies a laboratory works with might have ties overseas that aren’t immediately obvious. “All IVD companies get components from China,” Rob LaCroix, executive director of global strategy at LTC LLC, told attendees at the 2025 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. “Just-in-time [purchasing] with tariffs is a problem,” he noted.
Clinical Lab Tariff Strategies Should Model Various Budget Scenarios
Lab Manager suggested that laboratories build tiered budget models that consider various tariff scenarios:
Baseline case assumes stable tariffs (around 23% as noted earlier).
Worst case simulates escalation or new restrictions.
Optimistic case explores tariff relief or exemptions.
These forecast ranges enable clinical labs to develop contingency plans, such as temporarily reducing discretionary spending or exploring ways to pass on incremental costs.
Insurers continued receiving payments even after beneficiaries moved to other states, the paper reported
As Congress considers cuts in Medicaid funding, The Wall Street Journal reported that Medicaid managed care plans received at least $4.3 billion in duplicate payments over a three-year period, due to recipients who moved from one state to another.
Centene, the largest private Medicaid insurer, collected $620 million in duplicate payments between 2019 and 2021, while Elevance Health received $346 million and UnitedHealth Group took in $298 million, The Journal reported on March 26.
All told, more than 270 insurers received duplicate payments. The paper noted that private insurers handle coverage for 70% of the 72 million Medicaid recipients.
“We may be paying premiums on behalf of an individual who might have moved, and we don’t know that they have moved,” healthcare consultant Caprice Knapp, PhD, told the newspaper. “It definitely is wasteful.”
The reporting was based on an analysis of the Transformed Medicaid Statistical Information System (T-MSIS), a database of beneficiary information maintained by the Centers for Medicare and Medicaid Services (CMS).
In response to a Wall Street Journal article about managed care plans receiving billions in duplicate Medicaid payments, Craig Kennedy, chief executive of Medicaid Health Plans of America, noted how heavily regulated the health insurance industry is. (Photo copyright: LinkedIn.)
Multiple States Paid Double Payments to Medicaid Insurers
“Government guidelines stipulate that if Medicaid recipients move to another state, they are supposed to cancel their coverage in their former state when signing up in the new one, which often gives them a different insurer,” The Journal reported. “But the recipients don’t always cancel, leaving states to play catch-up.”
States paying the highest rates of duplicate payments include Georgia, Florida, and Indiana, according to The Wall Street Journal’s report.
To illustrate how this works, the story used the hypothetical example of a Medicaid recipient in Florida. There, the state pays $291 per month to the private Medicaid insurer. The individual moves to Georgia and enrolls in that state’s Medicaid program. Georgia begins paying an insurer $339 per month. But Florida continues to pay the monthly fee even though the recipient is now receiving medical care in Georgia. (The payment amounts are estimates based on averages in each state, the paper said.)
The state might not know that a beneficiary has moved until it conducts an annual eligibility check, the story noted. In the meantime, insurers “can collect months of payments before a patient is dropped from the rolls.”
To determine if a patient had moved, the analysis looked at where they received medical care. “The data don’t indicate where recipients are actually living or reflect all adjustments later made to payments,” the story noted.
Some insurers criticized the analysis. Most of the three-year period overlapped with the COVID-19 pandemic, when emergency rules made it difficult to disenroll beneficiaries, insurers told The Wall Street Journal. A Centene spokesman said the analysis “ignores the financial safeguards in place to address potential overpayments.” The insurer told the paper that it had repaid $2 billion to the states between 2019 and 2021.
The duplicate payments amounted to $800 million in 2019, then jumped to $1.3 billion in 2020 and $2.1 billion in 2021, the paper reported. KFF, citing CMS data, reported that states spent an estimated $880 billion on Medicaid programs in fiscal year 2023.
Craig Kennedy, chief executive at Medicaid Health Plans of American—an industry group that represents managed care organizations—told The Journal that insurers are closely watched by regulators.
“[Health insurance is] a heavily regulated industry,” Kennedy said. “Following rules and regulations is the No. 1 priority here.”
Office of Inspector General Weighs In
The Wall Street Journal analysis followed an earlier report from the US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG). The OIG report, issued in September 2022, was based on an audit covering Medicaid managed care capitation payments in August 2019 and August 2020. It was also based on data from T-MSIS.
“All 47 States reviewed made capitation payments on behalf of Medicaid beneficiaries who were concurrently enrolled in two States,” the OIG reported. “Specifically, capitation payments were made on behalf of 208,254 concurrently enrolled beneficiaries in August 2019 and 327,497 concurrently enrolled beneficiaries in August 2020. The Medicaid program incurred costs of approximately $72.9 million in August 2019 and $117.1 million in August 2020 for capitation payments associated with beneficiaries in one of the two concurrently enrolled States.”
OIG advised CMS to provide state agencies with T-MSIS enrollment data. CMS dismissed the recommendation, claiming that the Public Assistance Reporting Information System (PARIS), designed to deter improper public assistance payments, was sufficient, and that T-MSIS would add inefficiency and confusion. However, current and former state Medicaid officials told The Wall Street Journal that PARIS “doesn’t always include up-to-date or complete information.”
KLAS Research characterized partnership and responsiveness as key drivers of customer satisfaction
Epic Systems has bolstered its status as the dominant player among vendors of electronic health records (EHR) software, winning nearly 70% of new hospital contracts in 2024. Most, if not all, of these rollouts will include clinical laboratory data imported into the EHR system.
According to a recent market share report from KLAS Research, Epic added a net 176 acute care multispecialty hospitals in 2024, marking its largest-ever annual net gain, KLAS reported. Meanwhile, Epic’s largest rival, Oracle Health, saw a net loss of 74 hospitals during the year. Meditech, the No. 3 EHR vendor, saw a net decline of 57 hospitals.
The report, titled, “US Acute Care EHR Market Share 2025,” was based on interviews with healthcare organizations as well as data from vendors and other sources, KLAS said.
“Across all vendors, the level of partnership has emerged as a key differentiator,” KLAS stated in its report. “A vendor’s reputation for listening to customers, taking feedback, and implementing requested changes greatly impacts customer satisfaction—often translating to gains in overall market share.”
In their KLAS report, authors Bradley Hunter (left) and Paul Warburton (right) wrote, “Though still high overall, acute care EHR purchase energy slightly cooled in 2024. Health systems continued to drive most of the decisions.” Photo copyrights: KLAS Research.)
Drivers of Epic’s Success
Among large health systems—defined as those with more than 10 hospitals—KLAS noted the following market share for EHR vendors:
Epic—48%.
Oracle—27%.
Meditech—15%.
All other EHR vendors—10%.
Among all acute care hospitals, Epic’s market share is 42.3% compared with 22.9% for Oracle and 14.8% for Meditech.
Epic also dominates in terms of percentage of hospital beds, with a 54.9% market share compared with 22.1% for Oracle and 12.7% for Meditech.
Overall, acute care EHR purchases declined in 2024, as 272 hospitals bought an EHR system, compared with 319 in 2023, KLAS reported.
The report attributed Epic’s success to “the stability and interoperability capabilities of the product as well as generally high satisfaction among current customers. Beyond strictly technological considerations, Epic’s reputation for customer partnership has brought them to the forefront of most EHR considerations.”
Oracle’s Market Decline
For the first time, Oracle declined to offer a list of new contracts, KLAS reported. To arrive at its estimates for the company, KLAS said it used “publicly available resources and our standard internal research methods.”
What accounts for Oracle’s market decline? “As has been the case historically, healthcare organizations continue to cite poor partnership and a lack of follow-through on promises as some of their biggest concerns,” KLAS reported, adding, “While many Cerner customers hoped the 2022 acquisition by Oracle Health would lead to relationship improvements, the vendor’s loyalty and relationship ratings have dropped over 10 points since November 2021 (just before the announced acquisition).”
On the other hand, current and potential Oracle customers have expressed “cautious optimism” due to recent technology developments, KLAS reported, including rollouts of Clinical AI Agent, Seamless Exchange, and Oracle Cloud Infrastructure, plus announcements of a new EHR system and patient portal.
“More than one-third of customers report that over the last six months, there has been a positive change in the vendor’s execution/delivery,” KLAS reported. “This represents a notable change from the overall sentiment during the last couple of years.”
Even a 10% decline in vaccination rates would cause cases to skyrocket, leading to massive increase in demand for clinical laboratory MMR testing
As policymakers consider revisions to the current childhood vaccination schedule, a simulation model developed at Stanford University projects that declines in vaccination rates could lead to a dramatic resurgence of measles and other preventable infectious diseases over the next 25 years. Even at current vaccination rates, measles could once again become endemic in the US within two decades, the researchers reported.
The model suggests that clinical laboratories could one day find themselves testing millions of children for diseases once thought to be nearly eliminated in the US.
“With measles, we’re right on the cusp,” said senior author Nathan Lo, MD, PhD, assistant professor of infectious diseases, in a Stanford Medicine press release. “Increasing vaccination levels by just 5% brings the number of measles cases down, safely away from returning to endemic levels.”
“We’ve seen a worrisome pattern of decreasing routine childhood vaccinations,” said study senior author Nathan Lo, MD, PhD, in a Stanford Medicine press release. (Photo copyright: Stanford University.)
Millions of Measles Cases Predicted if Vaccinations Drop
To complete their study, the researchers looked at four infectious diseases:
“We used a large-scale epidemiological model to simulate all individuals living in the US and assigned them an age, vaccination status, immunity, state of residence, etc.,” Lo explained. “We then simulated how infections would spread under different vaccine conditions.”
Each state was modeled independently to account for variations in risk, noted lead author Mathew Kiang, ScD, assistant professor in the department of epidemiology and population health at Stanford. For example, Massachusetts is considered low risk due to high vaccination rates, whereas Texas and California are “higher risk because vaccination rates in both have dropped and there’s a lot of travel to those states,” he said.
The model assumed that infections would not cross state lines, “so the numbers could be an underestimate,” Kiang said.
He painted a grim picture of the scenarios projected by the model.
“If vaccination were to fall by even 10% today, measles cases would skyrocket to 11.1 million over the next 25 years,” he said. “If vaccination rates were cut in half, we’d expect 51.2 million cases of measles, 9.9 million cases of rubella, 4.3 million cases of polio, and 200 cases of diphtheria over 25 years. This would lead to 10.3 million hospitalizations and 159,200 deaths, plus an estimated 51,200 children with post-measles neurological complications, 10,700 cases of birth defects due to rubella, and 5,400 people paralyzed from polio.”
Lo suggested a more hopeful scenario in which “some fraction of the unvaccinated population seeks vaccination” as the diseases spread over the next decade. However, “if that were to happen, you can’t just flip a switch—once these diseases get unleashed, it would take time eliminate them again,” he said.
As of May 22, 2025, 1,046 cases of measles have been reported in the US this year, according to the Centers for Disease Control and Prevention. This year has been among the most active for measles since 2000. For the whole of 2024, 285 cases were reported.
More Contagious than COVID-19
All four diseases are far more contagious than COVID-19, Lo said, but measles “is in a different ballpark” as one of the most infectious diseases known to medicine. In a fully susceptible population, he said, one person can infect up to 20 individuals, but for the purposes of the simulation, they used a more conservative estimate of 12.
“There was a disruption to healthcare services during the pandemic, but declines preceded this period and have accelerated since then for many reasons,” he noted. “People look around and say, ‘We don’t see these diseases. Why should we vaccinate against them?’ There’s a general fatigue with vaccines. And there’s distrust and misinformation about vaccine effectiveness and safety.”
Another concern with measles is that the MMR vaccine “has become particularly controversial, partly due to a history of fraudulent medical research that raised safety concerns,” Lo said.
He added that compared to the other diseases, measles is more prevalent globally.
“Travelers importing a disease are like matches, and US under-vaccination is the tinder,” Kiang said. “With measles, you’re throwing a lot of matches in, and eventually something is going to happen.”
With public trust in healthcare organizations dropping, clinical laboratories worldwide must work doubly hard to provide competent, secure services to their patients
Is the UK’s National Health Service hurting people? About 10% of NHS patients said yes in a recent survey conducted by the London School of Hygiene and Tropical Medicine (LSHTM) and the University of Oxford. And those findings are a public stain on the physicians and clinical laboratories in an already strained healthcare system.
Of the 10,000 people interviewed, nearly 1,000 “reported they had experienced harm caused by the NHS in the previous three years. Of those, 6.2% cited their treatment or care and 3.5% blamed the harm on a lack of access to NHS services,” according to an LSHTM news release.
While the definition of “hurt” within the confines of the survey wasn’t specified, what is clear is that public trust in the UK’s healthcare system is decreasing. Fallout from the survey may affect the public’s trust in clinical labs that are facing unfavorable feedback from slow test result delivery times or rare instances of incorrect results.
“I’ve been studying patient safety and working in and with the NHS, including as a GP, for many years. It’s a complex challenge to pinpoint the cause of the problem and solve it,” said study author Helen Hogan, PhD, MBBS, a general practitioner and associate professor in the department of Health Services Research and Policy at LSHTM, in the news release.
“These findings indicate that healthcare harm affects a considerable number of the general public. It shows that there is still some way to go to improve safety across the NHS,” said study author Helen Hogan, PhD, MBBS, general practitioner and associate professor in the department of Health Services Research and Policy at LSHTM, in a news release. (Photo copyright: London School of Hygiene and Tropical Medicine.)
Of the 9.7% that reported NHS harm, 6.2% claimed it was from the actual treatment or care given and 3.5% from the access to care. Severity ranged from 37.6% reporting moderate impact to 44.8% reporting severe impact, and the majority claimed the impact occurred at hospitals, the authors wrote in BMJ Quality and Safety.
Women led the respondents in reports of harm, and more severe harm or higher rates of harm were reported from those in disadvantaged groups or lower social grades and those with disabilities or long-term illness, according to the researchers.
Though 60% got professional support for their troubles, including 11.6% contacting the NHS’ Patient Advice and Liaison Service (PALS), only 17% made a formal complaint. A small percentage, 2.5%, sought financial compensation, the survey showed.
Poor Patient Service Experience
Further, the patients reported poor results when they sought relief from the harm. Some (44.4%) desired treatment or care to help with the harm, while others (34.8%) wanted an explanation for the harm. Two-thirds said their incidents were not dealt with well and only half reported a positive PALS experience, the survey noted.
“Those harmed by healthcare are looking for a compassionate and caring response from services. What they really want is to be listened to, to have their harm acknowledged, and get an explanation,” noted Michele Peters, PhD, fellow survey author and associate professor at Oxford Population Health, University of Oxford, in the LSHTM news release.
Loss in Confidence
To make matters worse for the UK’s publicly run healthcare system, an unrelated patient satisfaction survey published contemporaneously found that NHS satisfaction hit record lows. According to The Guardian, the annual patient survey found a 24% decrease in satisfaction among adults in Britain in how NHS is run (now at a mere 21%). Dissatisfaction rose from 52% to 59% in the past year.
General practice, accident and emergency, and dental care were the areas of biggest disappointment, the study revealed.
“It is by far the most dramatic loss of confidence in how the NHS runs that we have seen in 40 years of this survey,” said Mark Dayan, a policy analyst at the Nuffield Trust who was engaged by The King’s Fund to analyze the survey data.
“There is a need to better understand the patient perspective following harm and for further consideration of what a person-centered approach to resolution and recovery might look like,” the researchers noted in BMJ Quality and Safety.
These types of findings can contribute to public mistrust of healthcare organizations worldwide, including clinical laboratories and pathology groups. It’s worth watching how the NHS resolves these issues.
