Oct 30, 2017 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Indicted on charges related to 124 genetic cancer tests performed between 2013 and 2014, former Hershey Medical Center Research Technologist Floyd Benko pleads guilty to charges with a maximum sentence of up to five years in prison
Wake up calls don’t come any clearer. False reporting of clinical laboratory test results will not be tolerated and anyone engaged in it will pay hefty fines and go to jail. Medical laboratories and anatomic pathology groups were put on notice when in July, nearly two years after he was indicted for healthcare fraud, Floyd Benko, of Palmyra, Penn., pled guilty in State District Court to charges of making false statements.
Benko, a 60-year old former research technologist at the Hershey Medical Center (HMC) in Hershey, Penn., surrendered to authorities on July 31, 2015, according a 2015 news release from The United States Attorney’s Office for the Middle District of Pennsylvania. The charges centered on 124 genetic diagnostic tests he performed at HMC between 2013 and 2014. Repeat testing conducted at HMC’s expense resulted in 60 tests results returned from two outside laboratories that differed from Benko’s reported results. No civil charges related to those 60 patients have been filed at the time of writing. And while sentencing is not yet scheduled, part of Benko’s plea requires restitution to HMC in the amount of approximately $70,000.
According to a Department of Justice (DOJ) press release, “The maximum penalty for false statements in healthcare matters is five years’ imprisonment, a term of supervised release following imprisonment, and a fine.” Coverage of the case at PennLive adds, “That agreement also cites a stipulation between the prosecution and defense that the advisory guidelines for Benko’s case call for a prison term of up to one and a half years.”
A Brief History of the Case and Charges
Details in media coverage regarding the case remain scant. However, case filings highlight a few details that help to establish a timeline of the alleged wrongdoing.
According to filings found at Leagle, charges stem around results to a range of genetic diagnostics, including:
· Epidermal Growth Factor Receptor (EGFR);
· KRAS gene mutation; and,
· BRAF gene mutation tests.
Documents show Benko had more than two decades of experience working with HMC. He also helped to define standard operating procedures (SOPs) for the tests in question. This is key to the case as charges stem from failing to follow the SOPs he helped to put in place.
Between April 9, 2013, and November 10, 2014, Benko performed 124 of these procedures for HMC. The SOPs required use of a NanoDrop 2000 spectrophotometer and preservation of tissue samples and specimens involved in all procedures.
Court filings note, “In late 2013, a treating physician observed that a patient’s HMC test results were at odds with the patient’s clinical profile. Defendant had performed the particular test in question. The treating physician ordered the same test from an outside laboratory, which reached a different result than the results reached by Defendant on the same patient’s tissue.”
Penn State Milton S. Hershey Medical Center (above) where in 2013 to 2014 Floyd Benko, a 60-year-old research technologist, improperly conducted 124 gene mutation clinical laboratory tests and then lied about it to cover up his lack of following standard operating procedures. (Photo copyright: PennLive/Paul Chaplin.)
When these results were brought to the attention of HMS supervisors, they requested Benko repeat the test. His results, again, differed from those of outside laboratories. This led to a request to access the tissues used in the test. Benko could not provide them.
Upon further investigation, the samples for 124 tests were missing. Court filings note, “[Benko] had no explanation for the missing DNA and tissue slides at that time.” HMS ordered retests for the tests with outside laboratories at a loss of more than $102,000. The 2015 DOJ press release breaks down these losses further, separating the figure into “$65,000 for outside laboratory testing and $37,406 for assay refunds.”
Of the 124 results, 60 returned discordant with Benko’s findings. This led to Benko sending two letters to HMS supervisors—one in April 2014 and another in October 2014, following his termination—attempting to explain the discordant results. Neither mentioned the NanoDrop 2000 spectrophotometer or provided reasons for failing to preserve tissue samples.
In July 2015, a federal grand jury returned an indictment on three counts related to the questioned testing. The court filing lists charges as follows:
“In Count I, the indictment charges Defendant with healthcare fraud in violation of 18 U.S.C. § 1347. According to the indictment, Defendant defrauded HMC in connection with the delivery of healthcare services by:
1. Failing to use the NanoDrop 2000 spectrophotometer in conducting the assays;
2. Failing to preserve the leftover patient tissue samples;
3. Failing to disclose his actions to his supervising physician or HMC management; and,
4. By providing false statements about the manner in which he performed the tests.
Counts II and III charge Defendant with making false statements to HMC. Counts II and III are predicated on the letters Defendant wrote to HMC in April and October of 2014.”
Critical Considerations for Medical Laboratories
The criminal charges levied at Benko directly result from his work in a clinical laboratory. And while the guilty plea does not include the healthcare fraud charge, it highlights the potential criminal liability risks pathology and medical laboratory workers face when tests prove inaccurate due to user error.
Because of discordant test results, an individual worker of a clinical laboratory was held liable for damages. Ensuring protocol adherence and accuracy of test results—particularly as new genetic assays and diagnostics reach laboratory test menus—can help to identify potential problems before they become a legal concern.
Maintaining rigorous records and following protocols for required samples and specimens also can help to establish evidence and resolve concerns should they arise.
—Jon Stone
Related Information:
Former Hershey Medical Center Research Technologist Charged with Healthcare Fraud
Former Hershey Medical Center Research Technologist Pleads Guilty to Making False Statements About Cancer Tests
Former Hershey Med Center Research Technologist Indicted for Fraud
Former Hershey Medical Center Worker Pleads Guilty to Lying About Cancer Testing Procedure
Hospital Staffer Admits to Lying About Genetic Cancer Tests
Former Hershey Med Tech Pleads Guilty to Lying About Fudging Cancer Testing
U.S. v. Benko No. 1:15-cr-00159
United States of America v. Floyd A. Benko, Defendant
Oct 18, 2017 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
The Joint Commission opposed the Medicare proposal, and patient advocate groups say rescinding it is a setback for hospital transparency
Powerful interests arrayed against greater transparency in the performance of hospitals, physicians, and medical laboratories have stopped a proposed Medicare program that would have allowed the public to see the results of hospital inspections.
Stopped in its tracks was an effort by the Centers for Medicare and Medicaid Services (CMS) to make hospital accreditation inspection reports available for public viewing. Opposition to this program led CMS to withdraw its plan for heightened transparency.
CMS originally called the proposal “groundbreaking” in a National Public Radio (NPR) article. That’s because it would have enabled consumers to view reports that private accreditation organizations, such as The Joint Commission, complete after each inspection. Inspection reports contain information on errors and problems found during hospital surveys. CMS’ push for more transparency in hospital inspections is consistent with the healthcare industry’s trend toward open sharing of healthcare quality, price, and other data.
“We are proposing changes relating to transparency of accrediting organizations survey reports and plans of correction of providers and suppliers,” CMS officials wrote in a proposed rule published on April 28.
CMS Pulls Back Proposal to Make Hospital Survey Reports Public
But it was not to be. After receiving comments, CMS officials stated in early August that the agency had pulled back the proposal.
“CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care,” noted a CMS fact sheet.
Agencies Find Problems in Hospitals That Accreditors Do Not, CMS Declares
It’s against federal law for CMS to release data related to hospital inspections, Becker’s Hospital Review reported. And, as part of the Clinical Laboratory Improvement Amendments (CLIA), clinical laboratories must participate in inspections to ensure they qualify for Medicare and Medicaid payments. However, the inspection reports of the nation’s medical laboratories are not made public.
So, what motivated CMS to make healthcare organizations’ inspection information public? CMS noted that private accreditation organizations miss serious provider problems that state inspectors find in follow-up visits to hospitals, ProPublica explained.
In fact, state agency reviews of 103 hospitals in 2014 found 41 serious deficiencies, including 39 missed by the accreditors, noted the NPR article.
The chart above based on Johns Hopkins research was compiled by the National Center for Health Statistics and reported by The Washington Post. It shows that medical errors are now the third leading cause of death in the US. (Photo copyright: The Washington Post.)
“Right now, the public has very little information about the places where they’re putting their life on the line, and that’s just not acceptable. If [they are] a good place, what are they afraid of?” Rosemary Gibson, Senior Advisor at The Hastings Center, stated in the NPR article.
Reaction from Accreditors and Consumer Groups Differs
The Joint Commission opposed the CMS proposal. And, now, patient safety advocacy groups are disappointed about the decision by Medicare officials to rescind the proposed program.
“We believe the proposal will have significant detrimental consequences on our nation’s ability to continually improve the delivery of healthcare services,” stated Mark Chassin, MD, FACP, MPP, MPH, Joint Commission President and Chief Executive Officer, in a June letter to CMS published partially in an HCPro blog post.
HCPro, a firm that aids organizations in accreditation, credentialing, and other needs, noted the following Joint Commission concerns about publicly shared survey reports in the blog post:
- Providers may be less likely to be open about opportunities for improvement;
- Accreditors could struggle to create new standards;
- The number of non-accredited facilities may increase;
- Accreditation may be devalued; and,
- Costs to providers and accreditors would likely rise.
The Center for Improvement in Healthcare Quality (CIHQ), another accreditation option for hospitals, also expressed concerns with the CMS proposal, according to the ProPublica report.
“Knowing that survey [inspection] reports are public knowledge will only incentivize hospitals and other healthcare entities to go back to the days of ‘hiding’ quality of care issues from accreditors, rather than working with us to improve the quality and safety of care rendered to patients,” CIHQ advised in the ProPublica article.
The Leapfrog Group, which bills itself as an advocate of hospital transparency, called the reversed proposal “a disappointing setback for healthcare transparency.”
In a statement, Leah Binder, President and Chief Executive Officer of The Leapfrog Group, noted, “We are disappointed to learn that the agency that runs Medicare (CMS) has reversed course on its proposal to require private accrediting organizations, such as the Joint Commission, to publicly release reports of problems they found in hospitals and other healthcare facilities. The public deserves full transparency on how the healthcare industry performs.”
Clearly the public is calling for increased transparency in healthcare. As are many organizations and industry journals, such as the Association of Health Care Journalists (AHCJ), which presented a national award to Ellen Gabler, an investigative reporter for the Milwaukee Journal Sentinel, for her work covering weaknesses in inspections for clinical laboratories. (See Dark Daily, “Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry,” May 16, 2016.)
Some Accreditation Information Available Online
So, for the time being, it appears that what is found during hospital inspections will stay within the inspection report and will not become available to the general public. However, with consumers expecting greater transparency and higher levels of service in all aspects of healthcare, the interest in public access to the quality performance of hospitals, physicians, clinical laboratories, and anatomic pathology groups will only increase.
Meanwhile, for patients interested in existing resources about provider quality, The Joint Commission has an online “find a gold star healthcare organization” quality check. Also, the American College of Surgeons publishes an online search for accredited facilities. And, the Centers for Disease Control and Prevention (CDC) offers an online search for CLIA accredited labs.
—Donna Marie Pocius
Related Information:
Secret Data on Hospital Inspections May Become Public At Last
Proposed Centers for Medicare and Medicaid (CMS) Rule
Changes to the Application and Reapplication Procedures for National Accrediting Organizations
CMS Backs Off Proposal to Make Hospital Accredited Investigations Public; Five Things to Know
Accreditors Can Keep Their Hospital Inspection Reports Secret, Feds Decide
Joint Commission Comments on Proposed CMS Transparency Rule
Disappointing Setback for Healthcare Transparency
Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry
Oct 11, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Free-standing device eliminates need for special pickups and dangerous disposal of any type of medical waste, including biohazard waste generated by medical laboratories
Clinical laboratories generate a substantial amount of regulated medical waste (RMW) including needles, collection supplies, gloves, sample tubes, and sample storage containers. RMW, also known as biohazardous or infectious medical waste, must be disposed of properly per federal and state regulations, including the Medical Waste Tracking Act of 1988.
There are currently several ways to discard of medical waste, but those methods can be dangerous, costly, and time-consuming. They usually involve chemicals, gases, irradiation, or incineration, and the waste often has to be hauled away in hazardous waste vehicles.
Thus, a revolutionary new machine that enables the disposal of medical waste in a harmless, effective, low-cost, and on-demand basis would be a boon for medical laboratories, pathology groups, blood labs, as well as all other healthcare practices that handle medical waste.
Safe, On-demand, Onsite, Point-of-Care Medical Waste Disposal a Reality
Such a device has been created by Sterilis LLC, a privately-held company headquartered in Boxborough, Mass. The patented, device utilizes steam sterilization and grinding technologies to convert dangerous medical waste into a safe confetti-like material. It is about the size of a large office copier and can handle up to 15 lbs. of biomedical waste at a time. Sterilis is charging $50,000 for the machine or it may be leased for $1,000 per month.
“The regulated medical waste industry has seen little innovation and still operates under an archaic approach of ‘haul and burn.’ Therefore, the industry is ripe for disruption with Sterilis’ new, safer, and more sustainable approach to treat and safely dispose of regulated medical waste, when and where it is generated,” stated Robert Winskowicz, Chief Executive Officer of Sterilis in a Medical Design Technology article.
To operate the Sterilis device (above), users simply place up to 15 lbs. of medical waste (containers and all) into the top compartment of the machine and turn it on. In less than one hour the waste is transformed into a sterile material that is automatically deposited into a proprietary collection bag, which can be placed into a regular trash container. (Photo copyright: Sterilis LLC.)
“Most people in the medical profession would tell you the best way to treat medical waste is as close to the point of generation as possible, and take care of it immediately,” noted Winskowicz in a Fox25News article. “And our machines give you that on-demand capability.”
The free-standing machine is about 36” by 24” by 47” making it similar in size to an office photocopier. It runs on standard electricity, requires no plumbing or set-up, and is completely portable. Depending on usage, the steam reservoir gets refilled with water a few times a week. The device lets users know when it needs water.
“We created the Sterilis device to address a burning need for more sustainable and safer disposal of medical waste,” stated Jeffrey Bell, Sterilis’ founder, President, Chief Financial Officer, and Chairman of the Board of Directors in a Sterilis news release. “The Sterilis method for infectious waste disposal disrupts the RMW industry by allowing facilities to safely remediate waste onsite and at the point-of-care using steam sterilization and grinding technologies, which reduces the waste volume by about 80%. Not only does this create a smaller waste footprint, but it protects the environment by preventing the need for waste incineration, which has been cited by the EPA as a major contributor to climate change.”
Device Designed for All Types of Medical Practices, including Clinical Labs
The apparatus was designed to be used in a variety of settings including medical centers and hospitals, clinics, medical laboratories, nursing facilities, dialysis centers, urgent care centers, dermatology facilities, pathology offices, oral surgery centers, and even corrections facilities, military sites, and veterinary clinics. Sterilis is also experiencing a demand for the device among facilities involved in community needle exchange programs. Among the 40 early adopters of the device are hospitals, HIV treatment centers, community needle-drop facilities, prisons, airports, and nursing homes located throughout the US and Canada.
“The Sterilis device makes handling medical waste safer, protects healthcare professionals, reduces costs, time and labor, and reduces the need to incinerate medical waste. We’re excited by the response and customer demand for the Sterilis device as we enter a more aggressive growth phase and expand our sales and distribution footprint nationwide,” Winskowicz stated in the press release.
The machine also includes software that monitors and captures sterilization parameters for compliance and tracking purposes. That data is automatically transmitted to and stored in the Cloud where it can be easily retrieved and viewed.
The medical waste management market reached $10.3 billion globally in 2015 and is expected to reach $13.3 billion by 2020, according to research firm MarketsandMarkets. Thus, the handling of biomedical waste is becoming a critical issue for medical facilities and clinical laboratories due to limited space, costs, and increasing regulations and requirements. As the medical waste management market continues to grow, it is probable that more technological advances will emerge to better serve laboratory, medical, and research professionals.
—JP Schlingman
Related Information:
Sterilis Introduces Approach to Treating Medical Waste
Sterilis, LLC Named Technology for a Better Future Finalist in MassTLC’s Tech Leadership Awards
This Needle Grinder Can Mash Up Medical Waste in an Hour
Sterilis Device: How It Works
Sterilis, LLC Wins 2017 Top Product of the Year Award for Green Medical Waste Disposal Device by Environmental Leader
New Technology Helps Clean up Areas Littered with Heroin Needles
Oct 9, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Mobile point-of-care (POC) smartphone-based nucleic acid assay allows for quick turn arounds and accurate information in any healthcare setting, including resource limited and remote environments
DNA detection might soon be accomplished with the use of a smartphone. That’s the goal of a research effort at the University of California Los Angeles (UCLA). If this effort succeeds, it would give medical laboratories a new tool to use in genetic testing.
Clinical laboratory equipment is becoming more effective even as it shrinks in size and cost. One such device has been developed by Ozcan Laboratory Group, headed by UCLA professor Aydogan Ozcan, PhD. It is a portable, smartphone-based mobile lab with sensitivity and reliability on par with large-scale medical laboratory-based equipment.
Ozcan Lab’s portable DNA detection system, according to a UCLA press release, “leverages the sensors and optics of cellphones” and adapts them to read and report the presence of DNA molecules. The sensor uses a new detector dye mixture and reportedly produces a signal that is 10 to 20 times brighter than previous detector dye outputs.
This new system improves upon the optical detection abilities of current point-of-care nucleic acid tests (POCTs) and, according to a study published in the American Chemical Society’s ACS Nano, the device is able to “retain the same robust standards of benchtop lab-based tests.”
Go Anywhere Technology Improves POC Testing
Nucleic acid detecting assays are crucial tools anatomic pathologists use to identify pathogens, detect residual disease markers, and identify treatable mutations of diseases. Due to the need for amplification of nucleic acids for detection with benchtop equipment, there are challenges associated with providing rapid diagnostics outside the clinical laboratory.
The device developed by Ozcan Labs (above) is a “field-portable and cost-effective mobile-phone-based nucleic acid amplification and readout platform [that] is broadly applicable to other real-time nucleic acid amplification tests by similarly modulating intercalating dye performance. It is compatible with any fluorescence-based assay that can be run in a 96-well microplate format, making it especially valuable for POC and resource-limited settings.” (Caption and photo copyright: American Chemical Society.)
In an article published in Future Medicine, Ozcan and Hatice Ceylan Koydemir, PhD, a post-doctoral researcher in electrical engineering at UCLA, comment on the growing interest in mobile POC diagnostics, stating that smartphone-based devices and platforms have the potential “to be used for early detection and prevention of a variety of health problems.”
According to the article, smartphone-based sensing and imaging platforms have been developed to:
- Analyze chemicals and biological specimens;
- Perform advanced cytometry and bright-field/fluorescence microscopy;
- Detect bacterial contamination;
- Image nano-sized specimens;
- Detect antimicrobial drug resistance; and
- Analyze enzyme-linked immunosorbent assay (ELISA)-based testing.
Smartphones, according to Ozcan and Koydemir, have been adapted to a range of biomedical measurement tools, “have the potential to transform traditional uses of imaging, sensing, and diagnostic systems, especially for point-of-care applications and field settings,” and can provide speedy results.
A ‘Highly Stable’ and Sensitive System
The proof-of-concept study of Ozcan Lab’s new smartphone-based detection system and new detector dye mixture was led by Janay E. Kong, PhD in bioengineering at UCLA, with the help of Ozcan and fellow professors Dino Di Carlo, PhD, professor of bioengineering and mechanical and aerospace engineering at UCLA, and Omai Garner, PhD, associate professor of clinical microbiology at the David Geffen School of Medicine at UCLA.
According to an article in Bioscience Technologies, the new smartphone DNA detection system addresses issues with detection of light emitted from intercalator dyes, which are normally “too subtle and unstable for regular cellphone camera sensors.” The new system uses loop-mediated isothermal amplification (LAMP) to amplify DNA in connection with a newly developed dye that uses hydroxynaphthol blue (HNB) as an indicator.
The inclusion of HNB into the dye, according to the original research study, “yields 20 times higher fluorescent signal change over background compared to current intercalating dyes,” making the results bright enough for smartphone camera sensors without “interfering with the nucleic acid amplification process.” The original study reports that the digital LAMP system and use of the HNB intercalating dye, in fact, provided “significantly enhanced performance compared to a benchtop reader with standard LAMP conditions.”
Ozcan labs shows no signs of slowing down their development of mobile POC diagnostic devices. The development of these smartphone-based tools may provide unique and much-needed equipment for clinical pathologists given the rising interest in mobile healthcare worldwide.
— Amanda Warren
Related Information:
UCLA Researchers Make DNA Detection Portable, Affordable Using Cellphones
Mobile Phones Create New Opportunities for Microbiology Research and Clinical Applications
Highly Stable and Sensitive Nucleic Acid Amplification and Cell-Phone-Based Readout
Cellphone System Makes DNA Detection Affordable and Portable
UCLA Device Enables Diagnosis of Antimicrobial Resistance in Any Setting; Could Save Lives Lost to Antimicrobial Resistant Bacteria
UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere
Smartphone “Dongle” Achieves Capabilities of Big Clinical Laboratory Analyzers: Diagnoses Three Diseases at Once from Single Drop of Blood
New Fast, Inexpensive, Mobile Device Accurately Identifies Healthcare-Acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers
Pathologists and Researchers Predict Development Trajectory for Biomarker-based Molecular Diagnostics in Support of Translational Medicine
Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology
Oct 6, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Identification of 144 elevated phosphoproteins indicative of cancer shows one possible path forward in the use of liquid biopsies for early detection of cancer and monitoring patients in remission
While precision medicine and a growing menu of medical laboratory assays and diagnostics are increasing the number of treatment methods available to cancer patients, early detection is still key to improving outcomes and increasing the odds of survival.
In February 2017, a Dark Daily ebriefing titled, “British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection,” showcased the EarlyCDT-Lung test. In a University of Dundee press release, researchers noted the non-invasive test promised detection of lung cancer “potentially up to five years” earlier than traditional scans.
Now, researchers from Purdue University are testing a non-invasive blood test for detection of all types of cancer using phosphoproteins as biomarkers that could detect cancer even before the onset of any symptoms. This could lead to non-invasive therapies, and ways to monitor them, that could be applied while the patient’s body is still strong and able to respond well to treatment.
Speaking with New Atlas, researcher W. Andy Tao, PhD, Chief Scientific Officer of Tymora Analytical Operations, stated, “This is definitely a breakthrough, showing the feasibility of using phosphoproteins in blood for detecting and monitoring diseases.”
Extracellular Vesicles as the Key to Isolating Phosphoproteins
Protein phosphorylation—particularly mutations in phosphatases and kinases—are already known to play roles in cancer development as noted in the OncLive article “Phosphorylation: The Master Switch of the Cell.”
However, as the liver uses phosphatase to dephosphorylate proteins, identification of phosphoproteins in the blood has remained difficult for researchers.
Isolating phosphoproteins from tissue samples is equally difficult. “Assays of phosphoproteins from tissues face tremendous challenges because of the invasive nature of tissue biopsy and the highly dynamic nature of protein phosphorylation during the typically long and complex procedure of tissue biopsy,” noted I-Hsuan Chen, PhD Candidate, and W. Andy Tao, PhD, in their study published in Proceedings of the National Academy of Sciences of the United States of America (PNAS).
As shown in the illustration above, extracellular vesicles are basically blobs of cellular cytosol that contain microRNA (miRNA) Messenger RNA (mRNA) and proteins, which some researchers believe potentially could compete with stem cell-based therapeutics. (Image copyright: BioProcess Intl.)
In their attempts, researchers instead focused on the biomarker discovery potential of extracellular vesicles (EV)—in particular microvesicles and exosomes—citing strong evidence in the ability to use EV-based disease biomarkers well before symptoms appear.
“The ability to detect the genome output (active proteins, and in particular phosphoproteins) can provide more direct real-time information about the organism’s physiological function and disease progressions, particularly in cancers,” the PNAS study authors noted.
Researchers isolated nearly 2,400 phosphoproteins across 30 samples from breast cancer patients. They then compared these to six control samples and identified 144 specific proteins commonly elevated when cancer was present.
In a Purdue University press release, Timothy Ratliff, PhD, Director of Purdue University Center for Cancer Research expanded on the findings of the study, stating, “The vesicles and exosomes are present and released by all cancers, so it could be that there are general patterns for cancer tissues, but it’s more likely that [W. Andy Tao, PhD] will develop patterns associated with different cancers.”
Monitoring Cancer with a Blood-Based Cartridge Diagnostic
The Purdue University press release highlights the potential of the process, noting, “A simple blood test for cancer would be far less invasive than scopes or biopsies that remove tissue. A doctor could also regularly test a cancer patient’s blood to understand the effectiveness of treatment and monitor patients after treatment to see if the cancer is returning.”
The ability to capture EV phosphoproteins appears to be stable over time. The samples used in the Perdue University study were taken nearly five years ago by the Indiana Biobank.
While the stability of samples is a boon to researchers, they note that there are still many improvements to be made to the methods used before some medical laboratories could attempt to replicate their results.
Current methods require using differential high-speed and ultra-high-speed centrifugation. Study authors note this makes it less than ideal for clinical laboratory use due to lack of access and lower specificity.
However, the Purdue press release also notes plans for future improvements. Tymora Analytical Operations is developing technologies to use the biomarkers in a cartridge-based system. This could mean that pathology groups and medical laboratories might one day add an automated test to their menus for the second leading cause of death in the United States.
Until then, medical laboratories can help further efforts by collecting samples and working with biobanks, such as the one used in the Purdue study. Clinical laboratories already power much of the diagnostic tools driving innovation and discovery in oncological precision medicine. With the addition of a way to detect cancers, both while in remission or before symptoms appear, laboratories could further increase their role in fighting this worldwide killer.
—Jon Stone
Related Information:
Protein Discovery Points to Potential Blood Test for All Cancers
Phosphoproteins in Extracellular Vesicles as Candidate Markers for Breast Cancer
Breakthrough Discovery May Make Blood Test Feasible for Detecting Cancer
Phosphorylation: The Master Switch of the Cell
Overview of Protein Phosphorylation
Extracellular Vesicles Commercial Potential as Byproducts of Cell Manufacturing for Research and Therapeutic Use
Extracellular vesicles: An Introduction
British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection
Oct 4, 2017 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
To help patients pay their clinical laboratory test bills, Sonora Quest Laboratories partners with CarePayment to provide patients with no-interest loans
With tens of millions of Americans now covered by a high-deductible health plan (HDHP), hospitals, physicians, and clinical laboratories now share a common problem: how to collect the full amount due for a patient who may have an annual deductible of $5,000 (individual) or $10,000 (family).
This is a significant problem for healthcare providers and Dark Daily has reported on this trend several times, most recently in “Hospitals, Pathology Groups, Clinical Labs Struggling to Collect Payments from Patients with High-Deductible Health Plans,” September 6, 2017.
Thus, many pathologists and clinical laboratory managers will be interested in a new solution that the largest commercial laboratory company in Arizona is using to help cope with the need to collect larger amounts of money from patients with a high-deductible health plan. Recently, Senora Quest Laboratories announced an innovative collaboration with healthcare finance company CarePayment to ensure cost is not a barrier to clinical laboratory and pathology patients needing medical tests.
Sonora Quest Laboratories, which performs more than 60-million diagnostic tests per year in Arizona, has established a new partnership with CarePayment of Nashville to provide no-interest loans to any Sonora Quest patient whose testing bill exceeds $100.
David Dexter, Chief Executive Officer at Sonora Quest Laboratories, believes patients have a right to “affordable access to much-needed laboratory testing.” In a statement, Dexter notes, “Across Arizona, rising out-of-pocket medical costs are impacting families’ budgets, and ultimately, their health. No one should delay having clinical testing done because they are worried about costs.
“Sonora Quest Laboratories understands the importance of making healthcare services affordable to consumers,” he added. “We are working with CarePayment to do our part to provide affordable access to much needed laboratory testing. We believe this will help improve testing compliance and lead to better outcomes for patients managing chronic disease or monitoring their overall wellness.”
Annual Deductibles Rise 153% for Workers
The annual deductible that patients must cover is climbing, not just in Arizona, but nationally. According to the Kaiser Family Foundation 2016 Employer Health Benefits Survey, the average worker’s annual deductible has gone up 153% from 2009 to 2016. In addition, after meeting their annual deductibles, most workers face additional cost sharing for hospital admission or outpatient surgery.
To address the problem of collecting these larger deductibles from patients and to avoid racking up patient bad debt, Healthcare Finance News (HFN) points out that hospitals and healthcare providers are looking for financial solutions that “benefit both sides of the patient-provider relationship.”
As the graph above illustrates, more workers each year find themselves enrolled in high-deductible health plans (HDHPs) they can barely afford. That’s why hospitals, medical laboratory companies, and financial services organizations are partnering to develop programs patients can use to make affordable payments on their healthcare bills. (Image copyright: Kaiser Family Foundation/Obeo Health.)
To fill this need, a new type of company is popping up: third-party finance companies. CarePayment is one example. These new companies want to partner with hospitals and other healthcare organizations to identify patients who need assistance with out-of-pocket expenses. After a patient’s insurance company pays its portion of a bill, patients are referred to the healthcare finance company, which charges the hospital or provider a “discount factor” on the accounts it establishes.
Helping Clinical Laboratories, Pathology Groups Collect from Patients
According to CarePayment, enrollment in its programs is voluntary, requires no application, and has no impact on a patient’s credit score. CarePayment states that providers “double net collections on average” when patients use its financing solutions.
Craig Hodges, CEO of CarePayment, maintains innovative payment solutions are necessary because of the increased consumer responsibility for healthcare costs. “There’s evidence out there that asking a consumer to pay interest on top of their out-of-pocket expense is impractical,” Hodges stated in the HFN article. “Consumer responsibility for the [the total] bill has grown from sub 5% to 25%. There’s a lot of sticker shock out there.”
Third-party healthcare finance companies are not the only alternative financing option open to healthcare providers. Healthcare Finance News points out that Docpay offers automated clearinghouse payment plans, which require the patient to preauthorize a payment schedule from their bank account or credit card, guaranteeing payments are made each month. A service fee is charged to the patient that covers credit card processing fees as well as payment plan fees. According to the company’s website, a healthcare practice receives a higher net collection percentage than if they used a third-party financing company or processed credit card payments in-house.
Banks Get into the Act to Help Physicians, Hospitals, Medical Laboratories
NBC News adds that some hospitals are partnering with banks to offer patients no-interest or low-interest loans as well, with the goal of offering patients more affordable payment options while increasing payment rates.
David and Nicole Rayman of Chatham, Ill., told NBC News a zero-interest hospital loan saved them from high-interest financing after they were hit with an unexpected $2,800 bill to remove a benign growth from David’s neck. Under terms of the loan, they paid $80 a month for 36 months.
“That’s going out to dinner one time a month, so that’s definitely something we could cut out,” Nicole Rayman stated in the NBC News article.
Failure to Collect Bills Directly from Patients
While Hodges predicts that healthcare financing could potentially be a $70-billion industry, he also notes that growth has been fueled by providers’ difficulty communicating costs with consumers and collecting bills directly from them.
“As those high-deductible health plans grew over time, providers realized they didn’t have the infrastructure to deal with that,” Hodges noted in the HFN article. “The portion of the bill the patient was responsible for used to be small. As that grew, providers didn’t have the experience, in-house, to interact with the consumer in a consumer-like environment.”
While medical laboratories and other providers have been slow to embrace price transparency, Hodges believes simplified and transparent financial responsibility will fuel healthcare consumerism and improve the provider-patient relationship.
“My theory is that we have to evolve to total transparency,” he told Healthcare Finance News. “Here’s what the service is going to cost you from an out-of-pocket perspective—that’s the first step.”
This development is another sign HDHPs are creating financial challenges for clinical laboratories and pathology groups as more patients are unable to pay out-of-pocket cost for testing services. In this environment, medical laboratory managers and pathology practice administrators will need a strategy for collecting payments from patients at the time of service.
—Andrea Downing Peck
Related Information:
Sonora Quest Laboratories Partners with CarePayment to Help Patients Pay for Clinical Testing
Kaiser Family Foundation 2016 Employer Health Benefits Survey
Healthcare Turns to Zero-Interest Loans to Give Patients a Better Reason to Pay
Some Hospitals Will Now Offer You an Interest Free Loan
To Handle Increased Bad Debt by Patients in High-Deductible Health Plans, Hospitals Are Offering Loan Programs
Hospitals, Pathology Groups, Clinical Labs Struggling to Collect Payments from Patients with High-Deductible Health Plans
