Ongoing increases in the global number of prostate cancer cases expected to motivate test developers to deliver better screening tests to pathologists and clinical lab scientists
No less an authority than the peer-reviewed healthcare journal The Lancet is drawing attention to predictions of increasing prostate cancer cases across the globe, triggering calls for the development of cheaper, faster, and more accurate assays that pathologists and medical laboratories can use to screen for—and diagnose—prostate cancer.
Swift population growth and rising life expectancy will cause the prostate cancer death rate to nearly double in the next 20 years, according to a new study that has led scientists to call for immediate, critical improvements in clinical laboratory testing for cancer screening, Financial Times (FT) reported.
“Low- and middle-income countries need to prepare to prevent a sharp rise in fatalities while richer nations should pay more attention to young men at higher risk of the disease,” FT noted. The study, titled, “The Lancet Commission on Prostate Cancer: Planning for the Surge in Cases,” predicts cases will jump from 1.4 million in 2020 to 2.9 million by 2040.
“Prostate cancer is the most common cancer in men in 112 countries, and accounts for 15% of cancers. In this Commission, we report projections of prostate cancer cases in 2040 on the basis of data for demographic changes worldwide and rising life expectancy. … This surge in cases cannot be prevented by lifestyle changes or public health interventions alone, and governments need to prepare strategies to deal with it,” the study authors wrote.
“The findings in this Commission provide a pathway forward for healthcare providers and funders, public health bodies, research funders, governments, and the broader patient and clinical community,” the authors noted. In their Lancet paper, the researchers define clear areas for improvement.
Given the shortage worldwide of pathologists—especially highly-trained pathologists—the gap between the demand/need for expanded prostate cancer testing as screens (along with prostate biopsies) and the available supply of pathologists will encourage companies to develop screening and diagnostic tests that are accurate and automated, thus increasing the productivity of the available pathologists.
“As more and more men around the world live to middle and old age, there will be an inevitable rise in the number of prostate cancer cases. We know this surge in cases is coming, so we need to start planning and take action now,” said Nick James, PhD (above), Professor of Prostate and Bladder Cancer Research at The Institute of Cancer Research, in a press release. Pathologists and medical laboratories worldwide will want to monitor progress of The Lancet Commission’s recommendations. (Photo copyright: Institute of Cancer Research.)
“Evidence-based interventions, such as improved early detection and education programs, will help to save lives and prevent ill health from prostate cancer in the years to come. This is especially true for low- and middle-income countries (LMICs) which will bear the overwhelming brunt of future cases,” he said in a press release.
Communication is key. “Improved outreach programs are needed to better inform people of the key signs to look out for and what to do next,” James N’Dow, MD, Professor and Chair in Surgery and Director of the Academic Urology Unit at the University of Aberdeen in the UK, told the Financial Times. “Implementing these in tandem with investments in cost-effective early diagnostic systems will be key to preventing deaths,” he added.
Capitalizing on artificial intelligence (AI) analysis to help translate results was another area The Lancet Commission researchers focused on, Financial Times noted.
AI could “subdivide disease into potentially valuable additional subgroups to help with treatment selection. In environments with few or no pathologists, these changes could be transformational,” the study authors wrote.
High Income Countries (HICs) would benefit from AI by empowering patients. “Linking cloud-based records to artificial intelligence systems could allow access to context-sensitive, up-to-date advice for both patients and health professionals, and could be used to drive evidence-based change in all settings,” the study authors added. Such a trend could lead to specialist prostate cancer pathologists being referred cases from around the world as digital pathology systems become faster and less expensive.
Effective treatment strategies and bolstering areas of need is also key, the study notes. “Many LMICs have urgent need for expansion of radiotherapy and surgery services,” the study authors wrote. The researchers stress the need to immediately implement expansion programs to keep up with anticipated near-future demand.
Cancer drug therapy should follow suit.
“Research and the development of risk-stratified regulatory models need to be facilitated,” the study authors noted, citing a focus on drug repurposing and dose de-escalation. “Novel clinical trial designs, such as multi-arm platforms, should be supported and expanded,” they added.
Unique Needs of LMICs, HICs
The Lancet Commission researchers’ recommendations shift depending on the financial health of a specific area. HICs are experiencing a 30-year decline in the number of deaths resulting from prostate cancer, presumably from additional testing measures and public health campaigns that may be lacking in LMICs, Financial Times reported. And as population growth soars, low-to-middle income populations “will need to be prepared for the strain the expected surge in cases will put on health resources.”
For HICs, the study dissected the limitations of prostate-specific antigen (PSA) testing. The researchers pointed out that PSA’s inaccuracies in screening symptomless patients can pinpoint “cancers that may never cause symptoms and need no treatment,” Financial Times reported.
Missing high-risk cases was also a cause for concern. “Diagnostic pathways should be modified to facilitate early detection of prostate cancer while avoiding overdiagnosis and overtreatment of trivial disease,” the study notes.
Screenings for high-risk younger men, and continuing public campaigns about prostate cancer, should be a focus for HICs, the study authors noted. “These would include people who have a family history of the disease, are of African ancestry, or carry a genetic mutation known as BRCA2,” Financial Times reported.
While the undertaking may sound intimidating—there is already such a heavy impact worldwide from prostate cancer—the researchers are optimistic of their recommendations.
“Options to improve care are already available at moderate cost. We found that late diagnosis is widespread worldwide, but especially in LMICs, where it is the norm. Early diagnosis improves prognosis and outcomes, and reduces societal and individual costs, and we recommend changes to the diagnostic pathway that can be immediately implemented,” the study authors wrote.
What Comes Next
“More research is needed among various ethnic groups to expand understanding of prostate cancer beyond the findings from studies that were largely based on data from white men,” The Lancet Commission told the Financial Times.
Astute pathologists and medical laboratories will want to monitor efforts to develop assays that are inexpensive, more accurate, and produce faster answers. Demand for these tests will be substantial—both in developed and developing nations.
With FDA clearance already approved, hospital infection control teams and their clinical laboratories may have another diagnostic tool for diagnosing blood infections
Controlling sepsis in hospitals continues to be a major concern in nations around the world, including in the United States. Now, a new 10-minute clinical laboratory blood test that uses artificial intelligence (AI) and digital images to spot biomarkers of the potentially fatal condition may soon be available for use in hospitals. The test, which was approved to be marketed in the US in 2022 by the federal Food and Drug Administration (FDA), may be “one of the most important breakthroughs in modern medical history,” according to US researchers, Good News Network (GNN) reported.
“Early detection of sepsis is an invaluable capability for healthcare professionals. Quickly identifying sepsis is critical to saving lives, but until now, we’ve lacked a reliable tool to either recognize the condition or explore alternate diagnoses,” said O’Neal in an LSU press release.
“IntelliSep is truly a game changer,” said Hollis O’Neal, MD (above), Associate Professor of Medicine at Louisiana State University Health Sciences Center in Baton Rouge. “The test provides hospital staff with information needed to identify and treat septic patients efficiently and reduce the financial and health burdens of overtreatment for hospitals and patients.” Clinical laboratories may have a new blood test for sepsis by the end of the year. (Photo copyright: Louisiana State University.)
How IntelliSep Works
The IntelliSep test analyzes blood samples extracted from emergency room patients who present with sepsis symptoms by squeezing white blood cells through a tiny tube to determine how the cells react and if they change shape. White blood cells in patients with sepsis are softer and spongier and their shape compresses and elongates, increasing the likelihood of developing sepsis.
Images are taken of the cells using an ultra-high-speed camera that can capture up to 500,000 frames per second. The images are the analyzed by an AI-powered computer which calculates the total number of elongated white blood cells to determine if sepsis is present.
IntelliSep then separates patients into three bands of risk for developing sepsis:
Band 1 (low)
Band 2 (medium)
Band 3 (high)
Results of the test are available to emergency room personnel in less than 10 minutes.
“Sepsis is notorious as the ‘silent killer’ because it is so easily missed early on, when a patient’s symptoms can often be mistaken for other less serious illnesses,” Michael Atar, PhD, DDS, Associate Professor, Pediatric Dentistry at New York University told Good News Network. “Rapid diagnosis and treatment is crucial to a good outcome, but there has never been a single, reliable diagnostic test available to doctors, costing precious time and people’s lives.”
Atar is a lead medical technology investor and an advisor to Cytovale.
‘Holy Grail’ of Sepsis Diagnosis
To complete the IntelliSep study, researchers enrolled 1,002 ER patients who presented with signs of sepsis. IntelliSep correctly identified patients who did not have sepsis with an accuracy rate of 97.5%. The technology showed an accuracy rate of 55% for positive sepsis results. Researchers also used IntelliSep to quickly diagnose and assess the severity of a sepsis infection.
There were no sepsis deaths reported in patients with low-risk scores. This indicates the test could help physicians rule out sepsis and seek other diagnoses for those patients.
“Cytovale’s IntelliSep device is, by any objective measure, the ‘holy grail’ that the medical community has been so desperate to find,” Atar told Good News Network. “The technology behind it is genuinely groundbreaking and it has the real-world, tried-and-tested potential to save millions of lives, year on year, across the planet.”
The technology is currently being used in a few hospitals in Louisiana and the inventors hope to have it available in at least 10 other hospitals by the end of the year.
Our Lady of the Lake Regional Medical Center, a not-for-profit Catholic healthcare ministry located in Baton Rouge, was one of the first hospitals to implement IntelliSep.
“Cytovale’s innovative technology will help drastically decrease the number of sepsis-related deaths in hospital settings, and we are honored that, since day one, we have been a part of the research that led to this technology,” said Chuck Spicer, President of Our Lady of the Lake Health in a news release.
Saint Francis Medical Center in Monroe, La., announced on September 3 that it has started using the IntelliSep test in its emergency rooms and staff are impressed by the impact on hospital efficiency.
“If it turns out negative then you don’t have to treat as many patients as you did before, which runs up costs, hospital bills and causes people to be in the hospital for longer periods of time,” said pulmonary disease physician Thomas Gullatt, MD, President, St. Francis Health, told KNOE News.
Patient Expectations for Treatment
Sepsis, also known as septicemia or blood poisoning, is a serious medical condition that occurs when the body improperly reacts to an infection or injury. The dangerous reaction causes extensive inflammation throughout the body and, if not treated early, can lead to organ failure, tissue damage, and even death.
The Centers for Disease Control and Prevention (CDC) reports at least 1.7 million adults develop sepsis annually in the US and at least 350,000 die as a result of the condition. It also states sepsis is one of the main reasons people are readmitted to hospitals.
Clinical laboratories should be aware of developments in the use of this new diagnostic assay and how it is aiding the diagnosis, antibiotic selection, and monitoring of patients with this deadly infection. Patients often learn about new technologies and come to their hospital or provider expecting to be treated with these innovations.
Program is open to providers that exclusively offer telehealth services, and those providers that offer the telehealth services to other hospitals
In another sign that telehealth is now an established presence in the healthcare marketplace, The Joint Commission recently implemented a new Telehealth Accreditation Program. The initiative, which took effect on July 1, 2024, aims to provide “updated, streamlined standards” enabling “safe, high-quality” delivery of telehealth services to patients, according to a press release. The organization announced the program in April.
Dark Daily has regularly commented on the importance for clinical laboratories to recognize this trend and add the necessary services to meet the expectations and needs of telehealth/virtual doctor visits where the physician orders medical laboratory tests for the patient.
“The use of telehealth in the United States increased 154% during early stages of the COVID-19 pandemic and stabilized at levels 38 times higher than levels in 2019,” said Joint Commission President and CEO Jonathan B. Perlin, MD, PhD, in the press release.
“As telehealth continues to evolve, it was imperative to create a new accreditation program to provide a framework to support the integrity of patient safety regardless of the care setting,” he added.
The accrediting organization is reacting to market demand. Patient and doctor acceptance of virtual doctor visits and telehealth consults is now an established fact.
[PHOTO OF PERLIN HERE]
“Our new Telehealth Accreditation Program helps organizations standardize care and reduce risk so that all patients, including those obtaining services remotely, receive the safest, highest-quality care with outcomes consistent with traditional settings,” said Jonathan B. Perlin, MD, PhD (above), President/CEO, The Joint Commission, in a press release. Clinical laboratory accreditation nationwide is also handled by the not-for-profit organization. (Photo copyright: International Hospital Federation.)
Eligibility
The Joint Commission describes itself as “the nation’s oldest and largest standards-setting and accrediting body in healthcare.” The not-for-profit organization certifies more than 22,000 healthcare providers in the US, according to its website, including hospitals and medical laboratories. Its evaluations are based on surveys in which qualified experts conduct inspections of the facilities to ensure compliance with patient safety and quality standards.
Accreditation is not mandatory, however many states have licensing, certification, or contracting requirements that mandate accreditation by The Joint Commission or other accrediting bodies.
The program is open to providers that exclusively offer healthcare services “via telehealth or remote patient monitoring, with no in-person visits or encounters,” according to The Joint Commission website. This can include organizations that provide:
Primary care, specialty care, or urgent care,
Medical or behavioral consultation,
Remote patient monitoring, and
TeleICU, telestroke, telepsychiatry, or teleimaging services to hospitals.
Hospitals or other healthcare providers can also apply if they have contracts to offer “care, treatment, and services via telehealth to another organization’s patients,” The Joint Commission states. Examples include acute care or psychiatric hospitals that provide telehealth services to other facilities. In this case, the hospitals can obtain telehealth accreditation for the contracted services while maintaining their current accreditation for services provided onsite.
Requirements for Certification
The requirements for accreditation are similar to those in other Joint Commission programs, the organization says. This includes “requirements for information management, leadership, medication management, patient identification, documentation, and credentialing and privileging.”
In addition, it includes requirements specific to telehealth. For example, emergency management requirements have been streamlined to account for services provided remotely. It also contains standards related to telehealth equipment as well as provider and patient education about use of the technology.
“Additionally, the program’s standards may be filtered based on the telehealth modality or service provided,” the organization’s website notes.
Other Accrediting Organizations
The Joint Commission is not the only organization that offers telehealth accreditation or certification. The Utilization Review Accreditation Commission (URAC) provides accreditation programs for telehealth and remote patient monitoring, as well as a certification program for telehealth support services.
The telehealth accreditation program consists of three modules accounting for different forms of delivery:
Provider-to-provider (one provider offers services such as consultation to another provider).
The accreditation process takes up to four months, URAC says.
The Accreditation Commission for Health Care (ACHC) offers what it describes as a telehealth “Distinction” for certain kinds of healthcare providers that it has accredited, including:
Additionally, in April 2022, ACHC announced a telehealth certification program open to “any healthcare provider or organization that delivers health-related services via electronic information and telecommunication technologies,” regardless of whether they are accredited, according to a press release.
“The pandemic really pushed healthcare providers to adopt and grow telehealth services to maintain access for patients and, as a result, many of our clients were seeking ways to optimize this offering in the context of providing quality services,” said program director Teresa Hoosier, RN, in the press release. “ACHC Telehealth Certification establishes national standards. It promotes best practices for digital healthcare services. Certification confirms quality, safety, and consistency—strengthening trust in an organization and assuring patients that they are receiving the best care possible.”
This development is a reminder that clinical laboratory managers need a consumer/patient focused strategy and operational capability to collect specimens and provide medical laboratory tests for telehealth visits when the doctors order tests. It confirms that the trend of consumers/patients using remote healthcare is real, robust, and has legs.
Another report finds nearly half of all healthcare systems planning to opt out of Medicare Advantage plans because of issues caused by prior authorization requirements
Prior-authorization is common and neither healthcare providers (including clinical laboratories) nor Medicare Advantage (MA) health plans are happy with the basic process. Thus, labs—which often must get prior-authorization for molecular diagnostics and genetic tests—may learn from a recent KFF study of denial rates and successful appeals.
“While prior authorization has long been used to contain spending and prevent people from receiving unnecessary or low-value services, it also has been [the] subject of criticism that it may create barriers to receiving necessary care,” KFF, a health policy research organization, stated in a news release.
Nearly all MA plan enrollees have to get prior authorization for high cost services such as inpatient stays, skilled nursing care, and chemotherapy. However, “some lawmakers and others have raised concerns that prior authorization requirements and processes, including the use of artificial intelligence to review requests, impose barriers and delays to receiving necessary care,” KFF reported.
“Insurers argue the process helps to manage unnecessary utilization and lower healthcare costs. But providers say prior authorization is time-consuming and delays care for patients,” Healthcare Dive reported.
“There are a ton of barriers with prior authorizations and referrals. And there’s been a really big delay in care—then we spend a lot of hours and dollars to get paid what our contracts say,” said Katie Kucera (above),Vice President and CFO, Carson Tahoe Health, Carson City, Nev., in a Becker’s Hospital CFO Report which shared the health system’s plan to end participation in UnitedHealthcare commercial and Medicare Advantage plans effective May 2025. Clinical laboratories may want to review how test denials by Medicare Advantage plans, and the time cost of the appeals process, affect the services they provide to their provider clients. (Photo copyright: Carson Tahoe Health.)
Key Findings of KFF Study
To complete its study, KFF analyzed “data submitted by Medicare Advantage insurers to CMS to examine the number of prior authorization requests, denials, and appeals for 2019 through 2022, as well as differences across Medicare Advantage insurers in 2022,” according to a KFF issue brief.
Here are key findings:
Requests for prior authorization jumped 24.3% to 46 million in 2022 from 37 million in 2019.
More than 90%, or 42.7 million requests, were approved in full.
About 7.4%, or 3.4 million, prior authorization requests were fully or partially denied by insurers in 2022, up from 5.8% in 2021, 5.6% in 2020, and 5.7% in 2019.
About 9.9% of denials were appealed in 2022, up from 7.5% in 2019, but less than 10.2% in 2020 and 10.6% in 2021.
More than 80% of appeals resulted in partial or full overturning of denials in the years studied. Still, “negative effects on a person’s health may have resulted from delay,” KFF pointed out.
KFF also found that requests for prior authorization differed among insurers. For example:
Humana experienced the most requests for prior authorization.
Among all MA plans, the share of patients who appealed denied requests was small. The low rate of appeals may reflect Medicare Advantage plan members’ uncertainty that they can question insurers’ decisions, KFF noted.
It’s a big market. Nevertheless, “between onerous authorization requirements and high denial rates, healthcare systems are frustrated with Medicare Advantage,” according to a Healthcare Financial Management Association (HFMA) survey of 135 health system Chief Financial Officers.
According to the CFOs surveyed, 19% of healthcare systems stopped accepting one or more Medicare Advantage plans in 2023, and 61% are planning or considering ending participation in one or more plans within two years.
“Nearly half of health systems are considering dropping Medicare Advantage plans,” Becker’s reported.
Federal lawmakers acted, introducing three bills to help improve timeliness, transparency, and criteria used in prior authorization decision making. Starting in 2023, KFF reported, the federal Centers for Medicare and Medicaid Services (CMS) published final rules on the bills:
Rule One (effective June 5, 2023), “clarifies the criteria that may be used by Medicare Advantage plans in establishing prior authorization policies and the duration for which a prior authorization is valid. Specifically, the rule states that prior authorization may only be used to confirm a diagnosis and/or ensure that the requested service is medically necessary and that private insurers must follow the same criteria used by traditional Medicare. That is, Medicare Advantage prior authorization requirements cannot result in coverage that is more restrictive than traditional Medicare.”
Rule Two (effective April 8, 2024), is “intended to improve the use of electronic prior authorization processes, as well as the timeliness and transparency of decisions, and applies to Medicare Advantage and certain other insurers. Specifically, it shortens the standard time frame for insurers to respond to prior authorization requests from 14 to seven calendar days starting in January 2026 and standardizes the electronic exchange of information by specifying the prior authorization information that must be included in application programming interfaces starting in January 2027.”
Rule Three (effective June 3, 2024), requires “Medicare Advantage plans to evaluate the effect of prior authorization policies on people with certain social risk factors starting with plan year 2025.”
KFF’s report details how prior authorization affects patient care and how healthcare providers struggle to get paid for services rendered by Medicare Advantage plans amid the rise of value-based reimbursements.
Clinical laboratory leaders may want to analyze their test denials and appeals rates as well and, in partnership with finance colleagues, consider whether to continue contracts with Medicare Advantage health plans.
Request for money upfront comes at a time when many patients already struggle with medical debt
In its reporting of healthcare trends gathering momentum, a national newspaper caused quite a stir this spring when it published a story documenting how some hospitals now require patients to pay in advance of specified surgeries and procedures. Hospitals are recognizing what clinical laboratories have long known—a larger proportion of Americans do not have the cash to pay a medical bill.
Hospitals and surgery centers are requesting advanced payment for elective procedures such as knee replacements, CT scans, and childbirth procedures, according to an Advisory Board daily briefing.
“In some cases, they may also have a contract with an insurance company. And in that contract are terms that stipulate hospitals need to collect deductibles or co-insurance before a procedure,” Evans added.
According to Bankrate’s 2024 Annual Emergency Savings Report, nearly half of all American’s would be unable to pay cash for an unplanned $1,000 bill. Therefore, one wonders why hospitals would attempt to extract payments from patients in advance of medical visits and clinical laboratory testing. Wouldn’t that just reduce the number of patients electing to undergo needed surgeries and other costly procedures? Nevertheless, it appears that many hospitals struggling financially are doing just that, according to The Wall Street Journal.
Genetic testing laboratories have a similar problem because of high-deductible health plans ($5K/year for individual, $12K/year for family). It means that many patients, even with insurance, struggle to pay a $1,000 to $5,000 bill for a genetic test.
Requesting payment from patients before healthcare visits is not new. However, the practice is on the rise and comes at a time when consumers are already struggling to make ends meet.
“Hospitals collected (in Q1 2024) about 23% of what patients owed them before they set foot in a hospital or doctor’s office. That’s up from about 20% in the same period a year earlier,” said reporter Melanie Evans (above) of The Wall Street Journal, referring to data from 1,850 hospitals analyzed by Kodiak Solutions. Genetic testing laboratories experience similar challenges getting paid due to many people struggling with high deductible health plans. (Photo copyright: LinkedIn.)
Price Transparency Behind Upfront Payments
According to a recent KFF survey of US families, “about half of adults would be unable to pay an unexpected medical bill of $500 in full without going into debt.”
Regardless, asking for payment for nonemergency care has become more common as people increasingly choose health plans with high-deductibles and amid the push for greater price transparency, according to Richard Gundling, Senior Vice President, Content and Professional Practice Guidance at Healthcare Financial Management Association (HFMA), in an interview with Advisory Board.
“It’s very common if not the norm” for hospitals to give patients a cost estimate and ask for advance payment, Gundling stated during the interview.
In fact, healthcare providers and insurers are required to shared charges and estimates as part of newly implemented federal rules. According to the American Hospital Association (AHA) those statutes and rules include:
The Hospital Price Transparency Final Rule (effective January 2021) which requires hospitals to publicly post “standard charges” via machine readable files.
The No Surprises Act which mandates the sharing of “good faith estimates” with uninsured/self-pay patients for most scheduled services and also requires insurers to provide explanation of benefits to enrollees.
According to Consumer Reports, hospitals are finding consumers less reliable payers than insurance companies. “No one would say, ‘Pay up or we won’t treat you.’ But we’re saying that, ‘You have a large out-of-pocket cost, and we want to know how are you going to pay for it,’” explained Jonathan Wiik, Vice President of Health Insights at FinThrive, a revenue cycle management company.
Razor Thin Hospital Margins
For their part, hospitals, health systems, and medical practices wrote off $17.4 billion in bad debt in 2023, Kodiak Solutions, an Indianapolis-based healthcare consulting and software company, reported in a news release.
“With the amounts that health plans require patients to pay continuing to grow, provider organizations need a strategy to avoid intensifying pressure on their already thin margins,” said Colleen Hall, Senior Vice President, Revenue Cycle, Kodiak, in the news release.
“Patient collections have become an increasingly difficult challenge for hospitals due primarily to a shift in payer mix. Because of rising deductibles and increased patient responsibility, the percentage of healthcare provider revenue collected directly from patients increased to more than 30% from less than 10% over 10 years,” the HFMA noted.
Thus, the financial tension being experienced by both patients and providers, and the need for patients to prepay for some treatment, are extreme challenges. The situation may call for clinical laboratory leaders to not only focus on quality testing and efficient workflow, but also affordability and access to services.
