Findings could reduce the need for self-reporting in future nutritional studies and lead to new clinical laboratory testing
Clinical laboratory testing may one day influence whether a person snacks on a bag of chips every day or chooses to eat healthy foods instead.
Researchers at the National Institutes of Health (NIH) reported that they have identified biomarkers in blood and urine that can indicate an individual’s consumption of ultra-processed foods (UPF).
Scientists discovered a signature that is predictive of a dietary pattern that’s high in ultra-processed food, study leader Erikka Loftfield, PhD, MPH, epidemiologist and principal investigator with the NIH, told the Associated Press (AP).
Using data on the biomarkers—metabolites left after the body breaks down food—the researchers devised a “poly-metabolite score” that could potentially “reduce the reliance on, or complement the use of, self-reported dietary data in large population studies,” according to an NIH press release.
This will be helpful because, according to the AP, “Typical nutrition studies rely on recall: asking people what they ate during a certain period. But such reports are notoriously unreliable because people don’t remember everything they ate, or they record it inaccurately.”
“Limitations of self-reported diet are well known. Metabolomics provides an exciting opportunity to not only improve our methods for objectively measuring complex exposures like diet and intake of ultra-processed foods, but also to understand the mechanisms by which diet might be impacting health,” said Loftfield in the press release.
Thus, it’s conceivable that one day clinical laboratory testing could affect people’s food choices and help to improve their health.
“There’s a need for both a more objective measure and potentially also a more accurate measure,” Erikka Loftfield, PhD, MPH, epidemiologist and principal investigator with the NIH, told the Associated Press. (Photo copyright: National Cancer Institute.)
Study Methodology
The findings were based in part on an earlier study of 718 AARP members, aged 50-74, who agreed to submit blood and urine samples. The participants also completed dietary recall reports.
“The researchers found hundreds of metabolites that correlated with the percentage of energy from ultra-processed foods in the diet,” the NIH press release noted. “Using machine learning, researchers identified metabolic patterns associated with high intake of ultra-processed foods and calculated poly-metabolite scores for blood and urine separately.”
To test their findings, the researchers referred to a 2019 NIH study involving 20 adults aged 18 to 50. Under carefully controlled conditions, these participants spent two weeks consuming high levels of ultra-processed foods, followed by two weeks consuming no ultra-processed foods. As with the AARP cohort, they also submitted blood and urine samples. The poly-metabolite score proved to be an accurate measure of which diets they had consumed, the researchers reported.
The researchers acknowledged limitations in the study that will necessitate further research. “Study participants were older US adults whose diets may vary from other populations,” the authors noted. “Poly-metabolite scores should be evaluated and iteratively improved in populations with diverse diets and a wide range of UPF intake.”
Ultra-Processed Foods Defined
The NIH defines ultra-processed foods as “ready-to-eat or ready-to-heat, industrially manufactured products, typically high in calories and low in essential nutrients.” Diets high in these foods have been associated with “increased risk of obesity and related chronic diseases, including some types of cancer,” the press release noted.
In identifying these foods, the researchers cited a 2019 paper published in the journal Public Health Nutrition (PHN). The paper relied on the NOVA classification system, which makes a distinction between “processed” and “ultra-processed” foods. The latter typically contain “food substances never or rarely used in kitchens,” or cosmetic additives “whose function is to make the final product palatable or more appealing,” the PHN paper noted.
“From sugary cereals at breakfast to frozen pizzas at dinner, plus in-between snacks of potato chips, sodas and ice cream, ultra-processed foods make up about 60% of the US diet,” the AP reported in an earlier story. “For kids and teens, it’s even higher—about two-thirds of what they eat.”
The federal agency says it will mandate randomized, controlled clinical trials for vaccination of younger, healthy individuals
It’s been a confusing past few weeks in terms of what the general public’s access to COVID-19 vaccinations will be like in the future.
Public health experts have been verbally jousting with the federal Department of Health and Human Services (HHS) about moves its health officials made recently regarding the vaccines. This could put clinical laboratories on the front lines to help determine whether COVID cases—particularly severe ones—eventually rise as a result.
Food and Drug Administration (FDA) commissioner Martin A. Makary, MD, MPH, and Vinay Prasad, MD, MPH, who leads the agency’s vaccine oversight, announced on May 20 that the agency will require randomized, controlled clinical trials before approving COVID vaccines for healthy individuals under age 65.
“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe COVID-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” Makary and Prasad wrote in NEJM.
Under the new framework, they noted, the agency expects that it will continue to approve vaccines for adults over 65 as well as younger people with health conditions that put them at high risk of severe outcomes from COVID-19.
The range of diseases is “vast, including obesity and even mental health conditions such as depression,” they wrote. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner.”
In their NEJM commentary, FDA commissioner Martin Makary, MD (left), and Vinay Prasad, MD (right), wrote, “Moving forward, the FDA will adopt the following COVID-19 vaccination regulatory framework: On the basis of immunogenicity—proof that a vaccine can generate antibody titers in people.” (Photo copyrights: Wikimedia Commons.)
Former CDC APIC Member Pushes Back
The announcement drew criticism from public health and medical experts.
“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for COVID-19 vaccine licensure,” wrote pediatrician and vaccinologist Kathryn M. Edwards, MD, in a commentary for STAT. Edwards is a former member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the agency.
On June 9, in an opinion piece for The Wall Street Journal, HHS Secretary Robert F. Kennedy Jr. announced that he’s removing all 17 current members of ACIP.
“The FDA mandate is to ensure safe and effective vaccines based on the clinical studies performed, but not to develop specific recommendations for their use,” Edwards added. “Providing recommendations on vaccine use for the civilian population is the mandate of the ACIP.”
Edwards contended that extensive data is already available on the safety and effectiveness of COVID-19 vaccines. She stated that “there is no precedent for mandating continued placebo-controlled randomized clinical trials for vaccines that have already been licensed.”
New Policy Announcement Raises Questions
The New York Times notes that many questions remain about the specifics of the new policy and how broadly the vaccines will be available.
A likely scenario, the paper reported, is that health insurers will play a role as “gatekeepers by demanding medical documentation of an underlying condition before agreeing to cover the cost.” Without insurance coverage, people would likely pay approximately $140 per shot out of pocket.
This stands in contrast to European countries, where outreach campaigns target specific populations based on public health recommendations. according to Forbes. However, “in virtually all instances, COVID-19 vaccines can be gotten free of charge across Europe regardless of health or age status,” the article notes.
In their NEJM commentary, Prasad and Makary noted that adoption of the annual COVID-19 booster shot is already low. The CDC reported that 23% of Americans 18 and older received vaccinations in the 2024-2025 season, up slightly from 21.6% in 2023-2024.
Kennedy Steps In
On May 27, Kennedy announced in a video on X that the CDC would remove the COVID-19 vaccine from the recommended immunization schedule for healthy children and healthy pregnant women. Previously, the CDC recommended the vaccine for everyone ages six months and older.
Kennedy was joined in the video by Makary and National Institutes of Health director Jay Bhattacharya MD, PhD.
However, CDC staffers were “blindsided” by the announcement, NPR reported, citing an agency official who requested anonymity.
“Hours after the post on X, CDC staffers received a directive from Secretary Kennedy—dated May 19, but sent May 27—rescinding the department’s 2022 acceptance of the CDC’s recommendations for the use of COVID shots in children and during pregnancy,” NPR reported.
It now appears that HHS has at least partially backtracked on Kennedy’s announcement.
The CDC’s immunization schedule now states that vaccination of healthy children should be a matter of “shared clinical decision-making” between the doctor and parent or patient.
“After confusing, mixed messages from leaders at HHS earlier this week, we are relieved to see today that the CDC updated its schedules for child and adolescent immunizations to allow families to maintain the choice to immunize their children against COVID in consultation with their doctor,” American Academy of Pediatrics president Susan Kressly said in a statement from the organization.
In a June 1 interview with the CBS News program “Face the Nation,” Makary confirmed that the recommendation to vaccinate “should be with the patient and their doctor.”
However, he also criticized ACIP as a “kangaroo court where they just rubber stamp every single vaccine put in front of them.”
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.”
