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Patient Rights Group Says Too Many Hospitals Are Not Complying with CMS Price Transparency Rules

Only about a third of the hospitals surveyed are in full compliance with giving public access to prices, the watchdog group contends, but the AHA disputes its methodology

It’s been almost four years since the Centers for Medicare and Medicaid Services (CMS) enacted its Hospital Price Transparency rule which requires hospitals—including their medical laboratories—to make their prices available and easily accessible to the public. But according to a 2024 report from PatientRightsAdvocate.org (PRA), just 34.5% of reviewed hospitals are fully compliant with the transparency rule. That’s a slight decrease from the 36% compliance rate the PRA listed in its 2023 report, the watchdog group stated in a blog post.

Released on Feb. 29, this was the group’s sixth semi-annual hospital price transparency report since the CMS rule took effect in 2021.

The rule “requires hospitals to post all prices online, easily accessible and searchable, in the form of (i) a single machine-readable standard charges file for all items, services, and drugs by all payers and all plans, the de-identified minimum and maximum negotiated rates, and all discounted cash prices, as well as (ii) prices for the 300 most common shoppable services either as a consumer-friendly standard charges display listing actual prices or, alternatively, as a price estimator tool,” the report states.

The required viewable prices are to be for, among others, medical imaging, clinical laboratory testing, and outpatient procedures such as a colonoscopies, etc.

“With full transparency, consumers can benefit from competition to make informed decisions, protect from overcharges, billing errors, and fraud, and lower their costs,” the report states. “Employer and union plans can use pricing and claims data to improve their plan designs and direct members to lower cost, high-quality facilities. However, continued noncompliance impedes this ability.”

At any time, the US Department of Justice (DOJ) could decide to file charges against a hospital or a clinical laboratory for not posting their prices on their websites in compliance with the federal rule. Such an action by DOJ officials would be to specifically put the entire industry on notice that there will be consequences for non-compliance.

The PRA’s report provides hospitals and clinical laboratories with a reminder that consumer watchdogs are also monitoring compliance.

“Our comprehensive study of 2,000 hospitals indicates nearly two-thirds (65.5%) of hospitals reviewed continue failing to fully comply with the rule, yet the Centers for Medicare and Medicaid Services (CMS) has only fined fourteen hospitals for noncompliance out of the thousands found to not be meeting all of the rule’s requirements. When hospitals don’t post their prices, they can charge whatever they want,” wrote PRA Founder and Chairman Cynthia Fisher (above) in a letter to President Biden. Hospital medical laboratories are also required to post their prices for tests. (Photo copyright: PatientRightsAdvocate.org.)

Increasing Penalties for Non-compliance

In a March 18 Health Affairs blog post on price transparency, two healthcare policy experts—David Muhlestein, PhD, JD, Chief Research Officer at Leavitt Partners, Washington, DC, and Adjunct Assistant Professor of The Dartmouth Institute (TDI) at the Geisel School of Medicine at Dartmouth College; and Yuvraj Pathak, PhD, Associate Director at West Health—argued that CMS should increase penalties for non-compliance, so the dollar amounts are greater than the cost of compliance.

To compile their report, PRA analysts examined the websites of 2,000 US hospitals between September 3, 2023, and January 13, 2023, and found that 1,311, or 65.5%, were not in full compliance, mostly due to “missing or significantly incomplete pricing data,” the report states.

More than 6,000 licensed hospitals operate in the US, the report notes. The group said it focused on hospitals owned by the largest US health systems.

Among the notable findings:

  • The 2023 report found that 98% of Kaiser Permanente’s 42 hospitals were in full compliance with the rule, but in the 2024 study, none were compliant because the hospitals began posting multiple files instead of a single file.
  • In total, 103 hospitals rated as noncompliant in the previous report were found to be compliant in the new analysis. Conversely, 135 hospitals previously rated as compliant were listed as noncompliant in the 2024 report.

The report lauded three hospitals for posting “exemplary files” that were “easily accessible, downloadable, machine-readable, and including all negotiated rates by payer and plan.” Those were Cape Cod Hospital in Hyannis, Mass.; Christus Santa Rosa Medical Center in San Antonio; and UW Health University Hospital in Madison, Wis.

In its discussion of the findings, PRA called on CMS to step up enforcement of the pricing transparency rule. The group also wants the government to close what it describes as the “estimator tool loophole,” which allows hospitals to list non-binding price estimates and price ranges instead of concrete prices.

“Price estimator tools do not achieve the goals of price transparency policy and fundamentally undermine the intent of the regulations,” the PRA’s report contends.

AHA Pushes Back on PRA Assessment

The American Hospital Association (AHA) took issue with PRA’s methodology, as Dark Daily reported in “CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups.”

In response to the 2023 PRA report, AHA Group Vice President for Public Policy Molly Smith issued the following statement, “Once again, Patient Rights Advocate has put out a report that blatantly misconstrues, ignores, and mischaracterizes hospitals’ compliance with federal price transparency regulations. The AHA has repeatedly debunked point-by-point Patient Rights Advocate’s intentionally misleading ‘reports’ on price transparency.”

Citing CMS data, Smith said that as of 2022, 70% of US hospitals had complied with two key federal rules:

  • One requiring hospitals to post machine-readable files with pricing information.
  • The other mandating a list of prices for at least 300 “shoppable” services.

More than 80% of hospitals had complied with at least one of the rules, she contended in an AHA press release.

Speaking to the New Orleans Times-Picayune, PRA Founder and Chairman Cynthia Fisher said her group performs a more in-depth study of pricing data compared with CMS.

“They did not do a comprehensive review,” she told the publication. “We do a deep dive for full compliance.”

The PRA study came on the heels of a January report from Turquoise Health that offered a rosier assessment of hospital compliance, albeit with different criteria. According to the Turquoise report, as of Dec. 15, 2023:

  • 90.7% of 6,357 US hospitals had posted machine-readable files,
  • 83.1% posted information about negotiated rates, and
  • 77.3% posted cash rates.

The Turquoise Health end-to-end price transparency platform uses a 5-point system to rate the quality of hospitals’ machine-readable files and said that more than 50% scored five stars. Clinical laboratory managers and pathologists may find it timely to review their lab organization’s compliance with this federal price transparency rule.

—Stephen Beale

Related Information:

Just 34.5% of Reviewed Hospitals Fully Compliant with Federally-Mandated Price Transparency Rule

Sixth Semi-Annual Hospital Price Transparency Compliance Report

Improving Hospital Compliance with Price Transparency Rules

Only Half of LA Hospitals Publish Prices as Required by Law, Hindering Patient Choice

34.5% of Hospitals Complying with Price Transparency Rule, Report Says

Little Progress Made with Hospital Price Transparency Compliance

CMS Releases Tool to Validate Price Transparency File Compliance

Hospital Price Transparency Compliance Dips: Report

Hospitals Backslide on Price Transparency Test

Moving into 2024: State of Price Transparency

Hospitals Finally Reached Widespread Price Transparency Compliance in 2023

More Hospitals, Payers Compliant with Price Transparency Laws

New Zealand Blood Service Workers and Junior Doctors Hit the Picket Line Once Again to Fight against Pay Disparities and Poor Working Conditions

As before, the ongoing strikes continue to cause delays in critical clinical laboratory blood testing and surgical procedures

After seven months of failed negotiations, New Zealand’s blood workers, clinical laboratory technicians, and medical scientists, are once again back on strike. According to Star News, hundreds of lab workers walked off the job on May 31, 2024, with another longer walkout planned for June to protest pay disparities.

New Zealand Blood Service (NZBS) workers, who are represented by the Public Service Association or PSA (Māori: Te Pūkenga Here Tikanga Mahi), collect and process blood and tissue samples from donors to ensure they are safe for transfer.

“Our colleagues at Te Whatu Ora [Health New Zealand] are being paid up to 35% more than us and we want to be paid too. We want fair pay,” Esperanza Stuart, a New Zealand Blood Service scientist, told Star News.

“The stall in negotiations is largely attributed to a lack of movement from NZBS on the principal issue of parity with Te Whatu Ora laboratory workers rates of pay. There is currently a 21-28% pay differential between NZBS and Te Whatu Ora laboratory workers, despite both groups of workers performing essentially the same work,” NZ Doctor noted.

Health New Zealand is the country’s government-run healthcare system.

The first strike took place on May 31 from 1-5 pm. A second 24-hour strike is planned for June 4. The strikers outlined the rest of their strike schedule as follows:

  • No work outside paid hours (5/29-6/6)
  • Refusal to conduct duties associated with processing AHF [antihemophilic factor] plasma (5/29-6/6)
  • No overtime or extra shifts (6/6-6/19)

The PSA union claims that the pay disparity workers are experiencing is pushing veteran workers out and complicating recruitment of new workers.

New Zealand Blood Service workers and junior doctors are once again back on the picket line to protest wage cuts and pay disparities. “I think it should be a signal that things are not right in our health system when there are multiple groups of workers going on strike simultaneously,” said PSA union organizer Alexandra Ward. Clinical laboratory workers in the US are closely monitoring the goings on in New Zealand as pressure over staff shortages and working conditions continue to mount in this country as well. (Photo copyright: RNZ.)

Clinical Laboratory Worker Strikes Ongoing in New Zealand

This is far from the first time New Zealand lab workers have hit the picket line.

In “Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand,” Dark Daily reported on a medical laboratory workers strike that took place in 2023 in New Zealand’s South Island and Wellington regions. The workers walked off the job after a negotiated agreement was not reached between APEX, a “specialist union representing over 4,000 allied, scientific, and technical health professionals,” according to the union’s website, and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

And in “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered a series of walkouts in 2022 sparked by an unprecedented surge in PCR COVID-19 testing that pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.

This latest strike is likely to cause delays in vital surgeries and risk the nation’s critical blood supply. All of these strikes were spurred on by low pay, negative working conditions and worker burnout. Similar issues have caused labor actions in the United Kingdom’s National Health Service in recent years.  

Junior Doctors Join Blood Service Workers on Picket Line

Blood service workers aren’t the only healthcare employees in New Zealand’s medical community taking action. In May about half of the nation’s junior doctors walked off the job for 25 hours to protest proposed pay cuts, NZ Herald reported.

In a letter to the nation’s public hospitals, Sarah Morley, PhD, NZBS’s Chief Medical Officer, “warned [that] even high priority planned surgeries should be deferred because they did not meet the definition of a ‘life-preserving service,’” and that “only surgeries where there is less than a 5% risk that patients may need a transfusion should be carried out,” RNZ reported.

According to an internal memo at Mercy Ascot, NZBS “did not consider cancers and cardiac operations in private hospitals to be a life-preserving service,” RNZ noted.

The situation may be more dangerous than officials are letting on, NZ Herald noted. A senior doctor at Waikato Hospital told reporters, “There are plenty of elective services cancelled today—clinics, surgery, day stay procedures etc. … And although I can only speak for my department, we are really tight for cover from SMO [senior medical officers] staff for acute services and pretty much all elective work has been cancelled. So, it’s actually pretty dire, and if next week’s planned strike goes ahead it’s going to be worse. I’d go as far as to say that it’s bordering on unsafe.”

The strike did take place, and the junior doctors went back on strike at the end of May as well, according to RNZ.

Support from Patients

Eden Hawkins, a junior doctor on strike at Wellington Hospital told RNZ that patient wellbeing is a top concern of striking workers and that patients have shown support for the doctors.

“When patients have brought it up with me on the wards or in other contexts there seems to be a bolstering sense of support around us, which is really reassuring and heartening because there’s obviously a conflict within ourselves when we strike, we don’t want to be doing that,” she said. Hawkins also makes the argument that striking workers can improve patient wellbeing in the long run. Improvement of pay and conditions could lessen staff turnover and overall improve the standard of care.

New Zealand healthcare workers haven’t been shy when it comes to fighting for the improved working conditions and fair pay. And their problems are far from unique. American healthcare workers have been struggling with worker burnout, pay disparities, high turnover as well. Clinical laboratory and other healthcare professionals in the US would be wise to keep an eye on their Kiwi counterparts.

—Ashley Croce

Related Information:

Fed-Up Blood Service Workers Go on Strike

NZ Blood Workers Plan 24-Hour Strike for Pay Parity

New Zealand Blood Service Laboratory Workers to Strike after 7 Months of Stalled Pay Negotiations

Significant Risk to Blood Supply as Blood Service Lab Workers Strike

Junior Doctors to Strike for 25 Hours, May Postpone Treatments

‘Pretty Dire’ Situation for Patients as Junior Doctors Strike Over Pay Cuts

Junior Doctors Go on Strike Again, More Surgeries Deferred

Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand

Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions

Ex-Theranos Founder and CEO Elizabeth Holmes Reduced Her Prison Sentence by Nearly Two Years

Good behavior in federal prison by the disgraced founder of the now-defunct clinical laboratory company earned her the reduction in her original sentence of 11 years

Elizabeth Holmes, founder of failed clinical laboratory blood analysis company Theranos, continues to serve a lengthy term in prison after being convicted of multiple counts of fraud in 2022. However, now comes news that good behavior at her federal prison has shortened her sentence by nearly two years, according to NBC News.

The latest reduction took Holmes’ release from December 2032 to August 2032 in her “11-plus-year (135 month) prison sentence for wire fraud and conspiracy,” NBC reported, adding that Holmes, though Theranos, “defrauded investors out of hundreds of millions of dollars.”

Holmes entered FPC Bryan, a federal prison camp in Bryan, Texas, to begin serving her term in May 2023.

“Holmes had her sentence computation done within the first 30 days of arriving at Bryan,” Forbes reported. Given Good Conduct Time (GCT), Holmes was given 608 days off calculated from the start of her sentence. “If she were to incur a disciplinary infraction, some of those days can be taken away. Most all prisoners receive 54 days per year of GCT based on the sentence imposed,” Forbes added.

The Federal Bureau of Prisons (BOP) can additionally shave off up to a year through its Residential Drug Abuse Program (RDAP). “To qualify, the prisoner must not have a disqualifying offense, such as terrorism or gun charge, and voluntarily provided information that they had a drug or alcohol problem prior to their arrest. This disclosure has to be done prior to sentencing during the pre-sentence interview and must be also documented in the Presentence Report, a detailed report used by the BOP to determine things like classification and programming for the prisoner,” Forbes noted.

Additionally, the federal First Step Act, which President Trump signed into law in 2018, enables Holmes to “earn up to 365 days off any imposed sentence by participating in prison programming such as a self-improvement classes, a job, or religious activities,” Forbes reported.

Given the opportunities to shave time off her sentence, Holmes may ultimately serve just 66 months of her original 135 month sentence in federal prison.

Elizabeth Holmes (above) taken backstage at TechCrunch Disrupt San Francisco 2014 when Holmes was at the height of her fame and popularity. At this point, Theranos’ Edison blood testing device had not yet been shown to be a fake. But evidence was mounting as clinical laboratory scientists and anatomic pathologists became aware of the technology’s shortcomings. (Photo copyright: Max Morse/Wikimedia Commons.)

Fall of a Silicon Valley Darling

Theranos boasted breakthrough technology and became an almost overnight sensation in Silicon Valley when it burst onto the scene in 2003. Holmes, a then 19-year-old Stanford University dropout, claimed Theranos would “revolutionize the world of blood testing by reducing sample sizes to a single pin prick,” Quartz reported.

The height of the company saw Theranos valued at $9 billion, which came crashing down when the Wall Street Journal reported in 2015 that questionable accuracy and procedures were being followed by the company, CNN reported.

In “After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology,” Dark Daily’s Editor-in-Chief Robert Michel reported on Holmes’ presentation at the American Association of Clinical Chemistry (AACC) annual meeting in 2016, after which the clinical laboratory scientists in attendance were highly skeptical of Holmes’ claims.

“From the moment Holmes concluded her presentation and stepped off the podium on Monday afternoon, she, her company, and her comments became the number one subject discussed by attendees in the halls between sessions and in the AACC exhibit hall,” Michel wrote, adding, “The executive team and the investors at Theranos have burned through their credibility with the media, the medical laboratory profession, and the public. In the future, the company’s claims will only be accepted if presented with scientific data developed according to accepted standards and reviewed by credible third parties. Much of this data also needs to be published in peer-reviewed medical journals held in highest esteem.”

A follow-up Dark Daily ebriefing concerning Theranos covered a fraud settlement with the Securities and Exchange Commission (SEC), sanctions from the Centers for Medicare and Medicaid Services (CMS), investor lawsuits, consumer lawsuits, and a settlement with Walgreens over claims about Theranos’ Edison portable blood analyzer. Theranos’ web of lies was unraveling.

Theranos Saga Continues

Ultimately, investors who had jumped in early with financial support for Theranos were defrauded of hundreds of millions of dollars and Holmes was sentenced to 11 years/three months behind bars. 

“Theranos had only ever performed roughly a dozen of the hundreds of tests it offered using its proprietary technology, and with questionable accuracy. It also came to light that Theranos was relying on third-party manufactured devices from traditional blood testing companies rather than its own technology,” CNN added.

The company shut down in 2018.

And so, the Elizabeth Holmes saga continues with reductions in her prison sentence for “good behavior.” The irony will likely not be lost on the anatomic pathologists, clinical laboratory scientists, and lab managers who followed the federal trials.

—Kristin Althea O’Connor

Related Information:

Elizabeth Holmes Sees More Months Trimmed from Prison Release Date

Theranos Founder Elizabeth Holmes’ Prison Sentence Keeps Getting Shorter

Hot Startup Theranos Has Struggled with Its Blood-Test Technology

Elizabeth Holmes Shaves More Time Off Her Sentence

The Infatuation with Elizabeth Holmes’ Prison Term

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

NIH Scientists Develop New Clinical Laboratory Assay to Measure Effectiveness of ‘Good’ Cholesterol

Clinical studies show that new ‘cell-free’ test can predict cardiovascular disease risk better than standard HDL cholesterol test

Researchers from the National Institutes of Health (NIH) have developed a diagnostic assay that measures how well high-density lipoprotein (HDL)—the so-called “good” cholesterol—is working in the body. And their findings could lead to new clinical laboratory tests that supplement standard HDL level testing to better determine a person’s risk for heart disease.

Cholesterol tests are among the most commonly performed assays by clinical laboratories. A new test that reveals how well HDL is working in the body would certainly boost a medical laboratory’s test requisition volume.

The researchers are with the NIH’s National Heart, Lung, and Blood Institute (NHLBI).

“Measuring HDL function is limited to research labs and isn’t conducive to large-scale testing by routine clinical laboratories. To try to solve that problem, researchers from NHLBI’s Lipoprotein Metabolism Laboratory created a new diagnostic test,” noted an NHLBI news release.

“This is going to quicken the pace of basic research,” said Edward B. Neufeld, PhD, who along with guest researcher Masaki Sato, PhD, developed the test. “It increases the number of samples that you can study. It increases the number of experiments you can do.”

The researchers published their findings in The Journal of Clinical Investigation titled, “Cell-Free, High-Density Lipoprotein–Specific Phospholipid Efflux Assay Predicts Incident Cardiovascular Disease.” They have also patented their test and plan to work with a company on licensing and manufacturing it.

Such a new cholesterol test would quickly become one of the most commonly performed clinical lab tests because just about every American who has a physical gets cholesterol tests as part of that process.

“Other people may modify this or come up with better versions, which is fine with us,” Edward Neufeld, PhD (above), NHLBI Staff Scientist, said in a news release. “We just really wanted to tackle this problem of evaluating HDL function.” Clinical laboratories may soon have a new cholesterol test to supplement standard HDL level testing. (Photo copyright: ResearchGate.)

Faster Answers Needed about HDL 

According to the NIH, the goal should go beyond measuring level of HDL as part of a person’s annual physical. What is also needed is finding out whether HDL cholesterol is effectively doing certain tasks, such as removing extra cholesterol from arteries and transporting it to the liver.

The NHLBI’s new cell-free test may make it possible to step up large-scale clinical testing of HDL function, according to the news release. As it stands now, HDL function study has been limited to research labs where testing involves “harvesting cells in the lab [which] can take days to process,” according to NIH Record.

“Most studies to date that have assessed CAD (coronary artery disease) risk by HDL functionality still use the CEC (cellular cholesterol efflux capacity) in vitro assay and are based on the use of radioisotopes (3H-cholesterol) and cultured cells, which is very labor intensive and impractical to do in a clinical laboratory,” the researchers wrote in The Journal of Clinical Investigation. They also pointed out that CEC batch-to-batch variability does not fit clinical laboratories’ need for standardization.

Advantages of NHLBI’s Test  

To overcome these barriers, the NHLBI researchers created an HDL-specific phospholipid efflux (HDL-SPE) assay that has certain advantages over current HDL function assessments done in research labs.

According to the NIH, the HDP-SPE assay:

  • Is easy to replicate in clinical labs.
  • Is more suited to automation and large samples.
  • Offers up results in about an hour.
  • Is a better predictor of cardiovascular disease risk than HDL cholesterol testing for CAD risk.

“We developed a cell-free, HDL-specific phospholipid efflux assay for the assessment of CAD risk on the basis of HDL functionality in whole plasma or serum. One of the main advantages of the HDL-SPE assay is that it can be readily automated, unlike the various CEC assays currently in use,” the authors noted in their paper.

Here is how the test is performed, according to the NIH:

  • Plasma with HDL is separated from the patient’s blood.
  • “Plasma is added to donor particles coated with a lipid mixture resembling plaque and a fluorescent-tagged phospholipid” that only HDL can remove.
  • The fluorescent signal by HDL is then measured.
  • A bright signal suggests optimal HDL lipid removal function, while a dim light means reduced function.

The test builds on the scientists’ previous findings and data. In creating the new assay they drew on data from:

  • A study of 50 severe CAD and 50 non-CAD people.
  • A Japanese study of 70 CAD and 154 non-CAD participants.
  • Examined association of HDL-SPE with cardiovascular disease in a study of 340 patients and 340 controls.

“We have established the HDL-SPE assay for assessment of the functional ability of HDL to efflux phospholipids. Our combined data consistently show that our relatively simple HDL-SPE assay captures a pathophysiologically relevant parameter of HDL function that is at least equivalent to the CEC assay in its association with prevalent and incident CAD,” the researchers concluded in The Journal of Clinical Investigation

Test May Be Subject to New FDA Rule

While HDL cardiovascular-related research is moving forward, studies aimed at the therapeutic side need to pick up, NIH noted.

“Someday we may have a drug that modulates HDL and turns out to be beneficial, but right now we don’t have that,” said Alan Remaley MD, PhD, NHLBI Senior Investigator and Head of the Lipoprotein Metabolism Laboratory, in the news release.

It may be years before the HDL-SPE test is used in medical settings, the researchers acknowledged, adding that more studies are needed with inclusion of different ethnicities.

Additionally, in light of the recently released US Food and Drug Administration (FDA) final rule on regulation of laboratory developed tests (LDT), the company licensed to bring the test to market may need to submit the HDL-SPE assay to the FDA for premarket review and clearance. That could lengthen the time required for the developers to comply with the FDA before the test is used by doctors and clinical laboratories in patient care.

—Donna Marie Pocius

Related Information:

FDA Takes Action Aimed at Helping Ensure Safety and Effectiveness of Laboratory Developed Tests

Cell-free, High-Density Lipoprotein-Specific Phospholipid Efflux Assay Predicts Incident Cardiovascular Disease

An Updated Test Measures How Well “Good Cholesterol” Works

NHLBI Refines Test for Good Cholesterol Function

Measles Cases in the US, Europe, and Other Countries are Increasing, Slowing Progress on Efforts to Eliminate the Disease

Clinical laboratory managers should prepare for an increase in demand for measles testing, especially for children

Clinical laboratory managers should be on the alert for new cases of measles. The US Centers for Disease Control and Prevention (CDC) has reported a surge in the highly infectious disease. Public health experts pointed to declining vaccination coverage as the primary cause. Officials in other countries have also reported outbreaks.

In 2000, the US declared that measles had been eliminated, meaning it “is no longer constantly present in this country,” the CDC stated on its website. However, the agency noted travelers can still bring the disease into the country and that there have been sporadic outbreaks since then.

In a new study, published April 11, 2024, in the CDC’s Morbidity and Mortality Weekly Report (MMWR), the agency reported that it was notified of 97 confirmed cases in the first quarter of 2024. That compares to an average of five cases during the first quarters of 2020 through 2023, the agency stated. In total, 338 cases were reported to the CDC between Jan. 1, 2020, and March 28, 2024, so the latest outbreaks amount to 29%—nearly a third—of the total.

“While the risk for measles for the majority of the US population still remains low, it’s crucial that we take the necessary steps now to prevent the continued spread of measles and maintain elimination in the US,” Adria D. Mathis, MSPH, lead author of the CDC report, told Healthline. Mathis is affiliated with the CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases (NCIRD).

“We have seen, in the region, not only a 30-fold increase in measles cases, but also nearly 21,000 hospitalizations and five measles-related deaths. This is concerning,” Hans Henri P. Kluge, MD (above), WHO Regional Director for Europe, told BBC News. “Vaccination is the only way to protect children from this potentially dangerous disease.” Clinical laboratories in the US that identify a case of measles from a positive test must report that result to public health labs. Thus, wise lab managers will track the rise in measles cases and prepare for increased demand for measles testing. (Photo copyright: World Health Organization.)

Renewed Threat to the US, Other Countries

The recent cases “represent a renewed threat to the US elimination status,” and “underscore the need for additional efforts to increase measles, mumps, and rubella (MMR) vaccination coverage, especially among close-knit and under-vaccinated communities,” Mathis told Healthline.

The MMWR report notes that most of the new cases were in persons under age 20, and that almost all were “in persons who were unvaccinated or whose vaccination status was unknown.” Most of the importations, the report states, were “among persons traveling to and from countries in the Eastern Mediterranean and African WHO [World Health Organization] regions; these regions experienced the highest reported measles incidence among all WHO regions during 2021–2022.”

In the US, vaccination coverage has been below 95% for three consecutive years. That is the “estimated population-level immunity necessary to prevent sustained measles transmission,” according to the federal agency. In 12 states and the District of Columbia, the coverage rate is below 90%. In total, “approximately 250,000 kindergarten children [are] susceptible to measles each year,” the CDC report states.

Measles vaccination coverage has declined globally, “from 86% in 2019 to 83% in 2022.” This left nearly 22 million children under the age of one susceptible to the disease, the report notes.

Earlier Measles Outbreaks in the US

The CDC performed its latest analysis following two larger measles outbreaks in 2019 among under-vaccinated populations in New York state.

The Associated Press (AP) reported that the 2019 epidemic, which totaled 1,274 cases nationwide, “was the worst in almost three decades and threatened the United States’ status as a country that has eliminated measles by stopping the continual spread of the measles virus.”

A vaccine for the disease first became available in 1963. Prior to its availability, “there were some three million to four million cases per year,” AP reported. Most people recover, but “in the decade before the vaccine was available, 48,000 people were hospitalized per year. … About 1,000 people developed dangerous brain inflammation from measles each year, and 400 to 500 died,” AP noted, citing CDC data.

US Not Alone in Fight against Measles

Other countries also are reporting spikes in measles cases. In a recently published rapid risk assessment, the Canadian government reported a total of 29 cases as of March 15, 2024, of which 21 were reported since Feb. 28.

“That’s already the largest annual total since 2019 and more than double the number of cases reported last year, as medical experts fear the number will rise while more Canadians travel in and out of the country this month for March break,” CBC News reported.

“New projections from a team at Simon Fraser University (SFU) in British Columbia show the grim possibilities,” CBC News reported. “The modelling suggests that vaccine coverage of less than 85% can lead to dozens of cases within small communities—or even hundreds if immunization rates are lower.”

Numbers are far worse in parts of Europe. In a February 2024 news release, the World Health Organization reported that in 2023, more than 58,000 people in its European region were infected by the disease, “resulting in thousands of hospitalizations and 10 measles-related deaths.”

According to WHO epidemiological data, countries in Central Asia, which is part of WHO’s European region, reported some of the highest numbers:

  • 15,111 in Kazakhstan,
  • 13,735 in Azerbaijan, and
  • 7,044 in Kyrgyzstan.

The Russian Federation reported 12,723 cases and Turkey reported 4,559.

A WHO European Region Measles and Rubella Monthly Update notes that more than half of the regionwide cases—31,428—were reported in the last three months of 2023. More than 15,000 cases were reported in December. That compares to just 163 cases reported in 2021 and 942 in 2022. Nearly half of the cases were among children under the age of five.

Lack of Vaccinations among Children Blamed for Outbreaks

One factor that has led to the increase in measles cases was the disruption to immunization services caused by the COVID-19 pandemic. “This has resulted in a significant accumulation of susceptible children who have missed their routine vaccinations against measles and other vaccine-preventable diseases,” the WHO reported.

Among the region’s 53 member states, 33 had eliminated measles, WHO reported, but “this achievement remains fragile. To retain this status, a country must ensure that transmission of the virus following any importation is stopped within 12 months from the first reported case.”

In the UK, which reported 231 cases last year, the National Health Service has launched a campaign to improve vaccination rates, the BBC reported, noting that “more than 3.4 million children aged under 16 are unprotected and at risk of becoming ill.”

However, a public health campaign built on vaccination is successful only if a high rate of individuals get vaccinated. The Baby Boomer and Gen X generations had high rates of vaccination for smallpox, polio, etc. because the parents saw individuals in their family and neighborhood who became infected and suffered lifechanging consequences. They recognized that vaccination was a simple thing to provide protection from a potentially deadly infection.

Clinical laboratory managers and pathologists will want to follow the CDC’s ongoing reports of the number of cases of measles in this country. Today, the absolute number of new measles cases is relatively small. At the same time, in communities experiencing an outbreak of even a few measles cases, physicians may want to increase the volume of measles tests they order for their patients.

—Stephen Beale

Related Information:

Canada Heading Toward Major Measles Outbreak without Vaccine Boost, New Modelling Suggests

A Review of the Resurgence of Measles, a Vaccine-Preventable Disease, as Current Concerns Contrast with Past Hopes for Measles Elimination

Alarming 45-Fold Rise in Measles in Europe-WHO

US Declared Measles Gone in 2000—New Outbreaks May Change That

US Measles Cases Are Up in 2024. What’s Driving the Increase?

CDC Warns That Measles Spike Poses A ‘Renewed Threat’ To the Disease’s Elimination

Measles Vaccine Campaign Targets Unprotected Millions

Pennsylvania’s WellSpan Health Announces New Medical Drone Delivery Service

Drone company Zipline delivers medical supplies and clinical laboratory specimens on four continents and is used in the US by several major healthcare networks and retail organizations

Unmanned aerial vehicles (UAVs), commonly referred to as drones, continue to demonstrate their value in the medical industry. In February, WellSpan Health announced it will soon begin using drones to deliver prescriptions to patients and to transport medical supplies and clinical laboratory specimens between its facilities located in Pennsylvania.

WellSpan Health, one of the leading healthcare systems in Southern Pennsylvania and Northern Maryland, is partnering with Zipline, a supplier of drone logistic services, in the endeavor.

“We’re making our [healthcare] system lower cost, faster, and more sustainable by bringing this exceptional technology to South Central Pennsylvania,” said Roxanna Gapstur, PhD, RN, President and CEO, WellSpan Health, in a news release. “We know the easier it is to access care the healthier people can be. With Zipline, we’re connecting healthcare straight to your front door.”

Zipline’s Platform 2 (P2 Zip) drone will be used for the venture. The drone is designed to fly in almost all weather conditions. If true, this would be a boon to the drone delivery service industry.

Previous attempts to implement drone delivery services have been hampered by a typical drone’s low performance in bad weather such as heavy rain and high winds. This seems to be what has held back wide adoption of drone delivery in the US.

“WellSpan continues to reimagine what healthcare can look like for our patients. With Zipline, we’re creating a future for our patients, where getting a prescription filled is as simple as pressing a button,” said Roxanna Gapstur, PhD, RN (above), President and CEO, WellSpan Health, in a news release. WellSpan Health’s drone delivery customers will be able to receive text notifications tracking the progress of their medical supplies and clinical laboratory specimens on their smartphones. (Photo copyright: WellSpan Health.)

Delivery of Medical Supplies Direct to Patients’ Front Door

ABC27 reported that “WellSpan will be the first health service in the state of Pennsylvania that will introduce this type of technology and delivery system.”

According to the drone company’s website, Zipline:

  • Serves more than 4,000 health centers worldwide and more than 45 million people.
  • Has completed more than one million deliveries.
  • Plans to operate more flights annually than almost all the major US airlines by next year.
  • Delivers 75% of Rwanda’s blood supply outside Kigali, the country’s capital city.

Additionally, Zipline’s all-electric, zero-emission drones reduce carbon emissions by an average of 97% when compared to gas-driven vehicles. 

Each P2 Zip drone features Zipline’s autonomous airspace Detect and Avoid (DAA) deconfliction technology and contains fully redundant flight systems.

“This acoustic system is composed of a series of small, lightweight acoustic microphones and onboard processors used to navigate airspace and grant 360-degree awareness with a range of up to 2,000 meters,” DRONELIFE reported. “This innovative onboard system enables the aircraft to autonomously detect and maneuver around other aircraft and obstacles in real-time, making large scale autonomous commercial operations more feasible.”

According to a fact sheet, the P2 Zip drone can carry loads up to eight pounds and has a cruising speed of 70 miles/hour. It’s service range is either a 10-mile radius or a one-way trip of 24 miles. It only requires two feet of open space to execute a delivery and can hover at more than 300 feet above the ground while delivering a package.

“Zipline has been improving access to healthcare for eight years. Together with WellSpan Health we will bring prescriptions and medical products right to patients’ doorsteps with fast, sustainable, and convenient delivery,” stated Keller Rinaudo Cliffton, co-founder and CEO of Zipline, in the news release. 

Other Healthcare Drone Delivery Services

Dark Daily has published many ebriefs about drones being used for medical supply and clinical laboratory specimen deliveries.

In “Dr. Risch Laboratory Group in Switzerland Partners with Drone Company to Deliver Medical Laboratory Specimens in a Unique Way,” we reported how the medical laboratory group was testing drone delivery of specimens to 14 clinical laboratories and eight sample collection locations throughout Switzerland. What makes this service unique is that the Jedsy drone they used can deliver packages directly to windows, regardless of where the window is located on the building.  

In “Oregon-based Interpath Laboratory Launches Pilot Program to Explore Delivering Biological Specimens by Drone from Yellowhawk Tribal Health Center,” we covered how Interpath Laboratory in the Pacific Northwest launched a drone delivery pilot program for delivering clinical laboratory test specimens from Yellowhawk Tribal Health Center to Interpath’s medical laboratory in Pendleton, Ore.

And in “California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda,” we reported how Zipline drones were being used in Rwanda and Tanzania for the transportation of medical supplies and blood products, and how delivery times had been reduced from four hours to just 30 minutes.

As drone delivery technology continues to improve, UAVs are more likely to be used in healthcare situations. If the issue of bad weather has been resolved, it’s reasonable to assume that within a short period of time clinical laboratories may begin receiving many more samples to test via drones.

—JP Schlingman

Related Information:

WellSpan Will Bring Innovative Medical Drone Delivery to PA with Logistics Leader Zipline

WellSpan Health to Bring Medical Drone Delivery to Pennsylvania

The Essential Guide to Implementing Drone Delivery in Healthcare

Dr. Risch Laboratory Group in Switzerland Partners with Drone Company to Deliver Medical Laboratory Specimens in a Unique Way

Oregon-based Interpath Laboratory Launches Pilot Program to Explore Delivering Biological Specimens by Drone from Yellowhawk Tribal Health Center

California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda

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