Norwegian researchers reviewed large clinical trials of six common cancer screenings, including clinical laboratory tests, but some experts question the findings
Cancer screenings are a critical tool for diagnosis and treatment. But how much do they actually extend the lives of patients? According to researchers at the University of Oslo in Norway, not by much. They recently conducted a review and meta-analysis of 18 long-term clinical trials, five of the six most commonly used types of cancer screening—including two clinical laboratory tests—and found that with few exceptions, the screenings did not significantly extend lifespans.
The 18 long-term clinical trials included in the study were randomized trials that collectively included a total of 2.1 million participants. Median follow-up periods of 10 to 15 years were used to gauge estimated lifetime gain and mortality.
“The findings of this meta-analysis suggest that current evidence does not substantiate the claim that common cancer screening tests save lives by extending lifetime, except possibly for colorectal cancer screening with sigmoidoscopy,” the researchers wrote in their published paper.
The researchers noted, however, that their analysis does not suggest all screenings should be abandoned. They also acknowledged that some lives are saved by screenings.
“Without screening, these patients may have died of cancer because it would have been detected at a later, incurable stage,” the scientists wrote, MedPage Today reported. “Thus, these patients experience a gain in lifetime.”
Still, some independent experts questioned the validity of the findings.
Gastroenterologist Michael Bretthauer, MD, PhD (above), a professor at the University of Oslo in Norway led the research into cancer screenings. In their JAMA Internal Medicine paper, he and his team wrote, “The findings of this meta-analysis suggest that colorectal cancer screening with sigmoidoscopy may extend life by approximately three months; lifetime gain for other screening tests appears to be unlikely or uncertain.” How their findings might affect clinical laboratory and anatomic pathology screening for cancer remains to be seen. (Photo copyright: University of Oslo.)
Pros and Cons of Cancer Screening
The clinical trials, according to MedPage Today and Oncology Nursing News covered the following tests:
Mammography screening for breast cancer (two trials).
As reported in these trials, “colorectal cancer screening with sigmoidoscopy prolonged lifetime by 110 days, while fecal testing and mammography screening did not prolong life,” the researchers wrote. “An extension of 37 days was noted for prostate cancer screening with prostate-specific antigen testing and 107 days with lung cancer screening using computed tomography, but estimates are uncertain.”
The American Cancer Society (ACS) recommends certain types of screening tests to detect cancers and pre-cancers before they can spread, thus improving the chances for survival.
The ACS advises screenings for breast cancer, colorectal cancer, and cervical cancer regardless of whether the individual is considered high risk. Lung cancer screenings are advised for people with a history of smoking. Men who are 45 to 50 or older should discuss the pros and cons of prostate cancer screening with their healthcare providers, the ACS states.
A CNN report about the University of Oslo study noted that the benefits and drawbacks of cancer screening have long been well known to doctors.
“Some positive screening results are false positives, which can lead to unnecessary anxiety as well as additional screening that can be expensive,” CNN reported. “Tests can also give a false negative and thus a false sense of security. Sometimes too, treatment can be unnecessary, resulting in a net harm rather than a net benefit, studies show.”
In their JAMA paper, the University of Oslo researchers wrote, “The critical question is whether the benefits for the few are sufficiently large to warrant the associated harms for many. It is entirely possible that multicancer detection blood tests do save lives and warrant the attendant costs and harms. But we will never know unless we ask,” CNN reported.
Hidden Impact on Cancer Mortality
ACS Chief Scientific Officer William Dahut, MD, told CNN that screenings may have an impact on cancer mortality in ways that might not be apparent from randomized trials. He noted that there’s been a decline in deaths from cervical cancer and prostate cancer since doctors began advising routine testing.
“Cancer screening was never really designed to increase longevity,” Dahut said. “Screenings are really designed to decrease premature deaths from cancer.” For example, “if a person’s life expectancy at birth was 80, a cancer screening may prevent their premature death at 65, but it wouldn’t necessarily mean they’d live to be 90 instead of the predicted 80,” CNN reported.
Dahut told CNN that fully assessing the impact of cancer screenings on life expectancy would require a clinical trial larger than those in the new study, and one that followed patients “for a very long time.”
“From its title, one would have expected this paper to be based on analysis of individual lifetime data. However, it is not,” he wrote in a compilation of expert commentary from the UK’s Science Media Center. “The paper’s conclusions are based on arithmetic manipulation of relative rates of all-cause mortality in some of the screening trials. It is therefore difficult to give credence to the claim that screening largely does not extend expected lifetime.”
He also questioned the inclusion of one particular trial in the University of Oslo study—the Canadian National Breast Screening Study—“as there is now public domain evidence of subversion of the randomization in this trial,” he added.
Another expert, Leigh Jackson, PhD, of the University of Exeter in the UK, described the University of Oslo study as “methodologically sound with some limitations which the authors clearly state.”
But he observed that “the focus on 2.1 million individuals is slightly misleading. The study considered many different screening tests and 2.1 million was indeed the total number of included patients, however, no calculation included that many people.”
Jackson also characterized the length of follow-up as a limitation. “This may have limited the amount of data included and also not considering longer follow-up may tend to underestimate the effects of screening,” he said.
This published study—along with the range of credible criticisms offered by other scientists—demonstrates how analysis of huge volumes of data is making it possible to tease out useful new insights. Clinical laboratory managers and pathologists can expect to see other examples of researchers assembling large quantities of data across different areas of medicine. This huge pools of data will be analyzed to determine the effectiveness of many medical procedures that have been performed for years with a belief that they are helpful.
Clinical laboratory leaders are aware that reference pricing is a tool employers and health insurer can use to reduce the wide variation different providers charge for the same clinical service. In 2016 our sister publication, The Dark Report, devoted an entire issue to the subject of reference pricing. (See TDR, “The Newest Threat to Lab Revenues: Reference Pricing in Healthcare,” September 6, 2016.)
The Dark Report wrote about the reference pricing pilot conducted by Safeway, the grocery chain, in collaboration with Anthem, Inc. (NYSE:ANTM), the large health insurance company. The reference pricing program had these elements:
When Safeway employees and their beneficiaries chose a lab that priced its tests below the 60th percentile, the patient qualified for the health plan’s benefits. But if the patient chose a lab with test prices above the 60th percentile, that patient was responsible for the full cost of the test.
Safeway employees and their beneficiaries were given a real-time price checking tool that they could access by web browser and smart phone. This app, developed by Castlight Health, Inc., of San Francisco, showed the prices each lab in the Safeway/Anthem network charged for the same lab test, along with the percentile price of that test.
As reported in JAMA Internal Medicine, Safeway introduced reference pricing into its health insurance design for 15,000 employees in 2011. Three years later, the company and its employees were spending 32% less for clinical laboratory tests and saved $2.57 million during the years 2011 to 2013.
The reference pricing program at Safeway, which focused
primarily on clinical laboratory testing, succeeded because of the large
variability in how different labs price the same tests. For example, as TDR
reported:
For a basic metabolic panel, which was the most
commonly prescribed test, prices among different labs ranged from $5.75 to
$126.44; and
Prices for a lipid panel ranged from $8.85 to
$74.92.
The graphic above, taken from the Safeway/Anthem observational study of “changes in laboratory pricing and selection by employees … before and after a reference pricing policy for laboratory services,” illustrates the wide range of prices Safeway paid for the 10 most common clinical laboratory tests. (Graphic copyright: American Medical Association/JAMA Internal Medicine.)
Typically, a reference pricing arrangement is done to lower
costs, decrease disparities in pricing for similar medical services, and make
health plans more attractive to employers. This is why state health plans are
looking at implementing reference price reimbursement models as a way to reduce
healthcare costs for state employees and other beneficiaries.
North Carolina Providers Respond Negatively to State Reference
Pricing Plan
North Carolina’s State Health Plan encountered resistance
from the state’s medical community when it attempted to implement a similar
reference-price reimbursement model.
The state’s health plan covers more than 727,000
beneficiaries, including teachers, state employees, retired employees, and
their dependents. It is overseen by the State Treasurer and administered by BlueCross
BlueShield of North Carolina (Blue Cross NC).
In October 2018, North Carolina’s state health plan board of
trustees unanimously approved the Clear
Pricing Project, a reference-pricing program championed by State Treasurer Dale Folwell. A 2019 Blue
Cross NC State Health Plan Network Master Reimbursement Exhibit document
states, beginning in 2020, most hospitals would get 160% of the Medicare rate
for inpatient services and 230% for outpatient services; rural providers would
get more.
Pricing for medical lab and pathology services also was set
at 160% of the Medicare rate. The document states, “Except for services
identified by Medicare as CLIA Excluded or CLIA Waiver,
In-Office Laboratory Service fees will be limited to those services for which
you have provided Blue Cross and Blue Shield of North Carolina with evidence of
CLIA
certification.”
North Carolina’s healthcare providers had no choice but to
agree to the pricing to be included in the state’s provider network, but they
were not happy about the arrangement.
NCHA Warns Hundreds of Providers Could Be Pushed Out of
Network
Hospitals countered with a public relations and lobbying
campaign through the North Carolina Healthcare
Association (NCHA). Soon after Folwell’s announcement, the NCHA issued a
statement claiming that his plan “could force hundreds of providers out of
the State Health Plan network or out of business.” The NCHA estimated the
potential losses to hospitals and health systems at “upwards of $400 million.”
In the statement, NCHA President Steve
Lawler said, “We believe the treasurer is not being transparent about what
this proposal will do to state health plan members and their families.”
As an alternative, the NCHA proposed that the state examine
value-based approaches such as “case management, outcomes-based payment models,
and member education as ways to manage costs.”
The organization established a web page explaining its opposition
to the state’s plan and pushed for legislation that would delay its
implementation. House
Bill 184, which sought to delay implementation of the state’s healthcare
reimbursement plan, passed the state House of Representatives in April, before
stalling in the Senate in May, North
Carolina Health News reported.
Many providers simply refused to sign the necessary
contracts, Modern
Healthcare reported, even after Folwell agreed to increase the average
rate to 196%. In August, he relented and announced that for 2020, the provider
network will consist of the North Carolina State Health Plan Network—28,000
providers that had signed on to the Clear Pricing Project—plus the Blue Options
PPO Network, which includes providers that had not agreed to the new pricing.
That makes for a total of more than 68,000 providers, states
a news
release from the treasurer’s office. After the change was announced,
providers in the State Health Plan Network were permitted to revert to the Blue
Options PPO Network rates.
States may approach implementing reference pricing in
different ways, which will likely lead to a distinct disparity in outcomes. Nevertheless,
whatever approach is used, medical laboratories and pathology groups will want
to understand how reference pricing works and how it may be implemented in
their states.
Armed with that understanding, they may want to pursue a
proactive strategy of aligning the prices of their lab tests to be at the 50th percentile
or lower to avoid being the highest-priced labs in their communities and
regions.
Medical laboratories that develop appropriate clinical strategies may find opportunities to leverage several new technologies expected to have a big impact on providers
Industry experts often speculate how developing technologies will impact healthcare. However, clinical laboratory leaders may be surprised by how much blockchain, medical malls, and Uber Health are expected to alter healthcare delivery in the next decade.
An article in FierceHealthcare states that “Healthcare is on the cusp of a technology revolution. Technology is primed to disrupt healthcare more explosively than it has any other industry.”
Medical advancements certainly impact clinical laboratories
and anatomic pathology groups, and any acceleration in these developing
technologies applied to healthcare will certainly be of interest to lab leaders
who want to ensure their labs are ready.
Blockchain Provides Healthcare Security, Privacy, and
Interoperability
Authored by Sloan Gaon, CEO, PulsePoint, the FierceHealthcare article predicts that blockchain will be an important feature in the future of healthcare. It will allow patients to have an online, accurate health record that is accessible only to necessary parties in real time. Consumers will be able to maintain, control, and share their data as they wish while increasing the security, privacy, and interoperability of their health information.
“A primary care physician could access a complete medical history of the member, while the radiologist could be limited to only the specifics he or she needs to perform the task at hand. For each, it’s about accessing the right data at the right time, and the blockchain technology could enable this type of specific ‘need-to-know’ medical history access,” wrote Bruce Broussard, President and CEO of Humana in a LinkedIn article.
The blockchain records can be shared among a network of
computers and kept secure via cryptography. And the
technology allows for easy transferability among different networks, improving
performance and outcomes for patients. Broussard also stated that blockchain
technology will provide more efficient payment for insurance claims.
“With transparency and automation, greater efficiencies will
lead to lower administration costs, faster claims, and less money wasted.
Blockchain enables claims to be paid without an intermediary, since health plan
members are connecting directly with their providers. These consumers can also
access their permanent electronic health records in a secure fashion, enabling
them to have a real-time understanding of their health,” he wrote.
Should blockchain achieve widespread adoption as a platform
for patient health information, the clinical laboratory industry will need to
address the problem of different test methodologies and different reference
ranges for test results. If blockchain makes it feasible to bring all pieces of
a single patient’s cumulative health data into a single record, then clinical
labs will need to address that problem in an effective way.
In his FierceHealthcare article, Sloan Gaon, CEO of PulsePoint, said “Technology will drive innovation, automation, transparency and efficiency, rendering the current healthcare landscape unrecognizable. As technology garners healthcare’s gold seal of approval, its effects will upend the industry, shrinking costs and improving outcomes.”
Medical Malls a Win-Win for Healthcare Providers and
Retail Locations
With big shopping malls dying due to economic recessions and the emergence of online retail destinations, property owners are seeking new tenants. In the summer of 2017, there were still about 1,100 malls remaining in the US, however, a quarter of them were at a risk of closing within five years, Time noted that year.
As healthcare organizations expand, there is an overwhelming
need for suitable space that is accessible for consumers at a reasonable price.
Fading shopping malls with their convenient locations, sturdy foundations, and
large parking lots could fill that gap.
In February of 2017, Avita Health System opened a boutique hospital in a space once occupied by an anchor store in a mall located in Ontario, Ohio. The healthcare provider purchased a 185,000 square-foot space that was formerly a Lazarus department store.
Mansfield News Journal reported that when the hospital opened, it included a walk-in clinic, an emergency room, surgical suites, pre-operative and post-operative areas, an onsite pharmacy, imaging services, a clinical laboratory, and 30 acute care beds.
Other services, including a Level II Cath lab, a maternity center, and the installation of a 3T Magnetic Resonance Imaging (3T MRI) machine, have been added since the facility opened. And there’s room for more expansion at the site.
Vanderbilt Medical Group (VMG) now occupies the entire second level of One Hundred Oaks Mall, in Nashville, Tenn. Their services at the once-struggling retail shopping center include 22 specialty clinics in 450,000 square feet of space designed by architecture firm Gresham Smith.
Patients can pick up a pager at the VMG facility and then
shop on the lower level while waiting to be paged to see a healthcare
professional or receive test results.
“More important than the significant increase in our available clinical space is the overall concept and design which is focused on providing our patients, faculty, and staff with a new paradigm for health and wellness. The convenience, accessibility, and innovative ways of providing care for our patients are a true transformation of both the architecture and the way our patients experience healthcare,” said Cyril Stewart, former Director of Facility Planning for Vanderbilt University Medical Center (VUMC) in a testimonial on the Gresham Smith website.
Non-Emergency Medical Transportation and Uber Health
Kaiser Family Foundation (KFF) reported in 2016 that “Medicaid’s non-emergency medical transportation (NEMT) benefit facilitates access to care for low income beneficiaries who otherwise may not have a reliable affordable means of getting to healthcare appointments. NEMT also assists people with disabilities who have frequent appointments and people who have limited public transit options and long travel times to healthcare providers, such as those in rural areas.”
The Hospital and Healthsystem Association of Pennsylvania (HAP) reported that an average of 3.6 million Americans miss their healthcare appointments annually due to lack of or unreliable transportation. These missed appointments can cause an avalanche of future problems, including increased visits to emergency rooms, extended hospital stays, and higher costs for providers.
“If there are people who are missing their appointments because they’re using an unreliable bus service to get to and from their healthcare provider, this is a great solution for them,” Christopher Weber, General Manager and Senior Project Manager at Uber Health, told The Verge. “The types of individuals this is valuable for really is limitless.”
Uber health’s mobile device application (app) enables patients and healthcare providers to schedule non-emergency medical transportation for medical appointments within a few hours or up to a 30-day notice. It is also available both as an online dashboard and as an application-programming interface (API) for software developers to integrate the service into their proprietary healthcare tools.
An Uber
(NYSE:UBER) account is not required, as notifications about rides can be sent
to patients via text messages.
Clinical laboratory leaders may want to develop strategies
around these three predictions to increase business and maximize profits. Since
more healthcare organizations will soon be linked via blockchain, and an
increased number of consumers could start using non-emergency medical
transportation, such as Uber Health, to get to medical appointments, becoming
familiar with these technologies could prove to be beneficial to labs.
In addition, medical facilities cropping up in former mall
spaces will require medical laboratories to be onsite to support care and
provide lab test results within an acceptable turnaround time.
Latest research provides new opportunities for clinical laboratories to demonstrate how testing can help curb hospital-acquired infections
Pathologists, microbiologists, and other healthcare providers have long been aware that hospital patients taking antibiotics are at higher risk of contracting the potentially deadly Clostridium difficile infection (C. diff). But new research adds an interesting twist to this issue.
Recent research indicates that being a “second user” of a bed may be another risk factor for acquiring the disease. This will give clinical laboratory professionals, microbiologists, and others on the front lines of hospital infection control programs another factor to consider when working to halt the spread of hospital-acquired infections (HAIs).
The recent study was published online in JAMA Internal Medicine. It shows that patients put in a hospital bed previously occupied by someone given antibiotics are 22% more likely to develop the C. difficile infection, even if they do not themselves receive antibiotics. (more…)
Recent studies indicate that high readmission rates often may be due to patient demographics, giving clinical laboratories an opportunity to use lab test results in ways that minimize the need for specific patients to be readmitted
Medicare’s efforts to reduce hospital readmission rates have left most hospitals facing reductions in Medicare payments. However, a recent ranking of hospitals by the Modern Healthcare Data Center indicates that influences other than inferior care—such as patient demographics—can affect 30-day readmission rates.
These findings are noteworthy for pathologists and clinical laboratory managers operating medical laboratories in hospitals and health systems. That’s because readmission rates impact a hospital’s budget. Thus, less revenue can cause hospital administrators to reduce spending for clinical laboratory and anatomic pathology services. (more…)
