Jul 11, 2018 | Laboratory News, Laboratory Operations, Management & Operations
New healthcare fraud prevention partnership white paper outlines the most common abuses and the reasons clinical laboratories are susceptible to fraudulent practices
When it comes to questionable marketing and billing practices for lab testing, clinical laboratory companies can expect increased scrutiny and enforcement actions by federal healthcare authorities. That’s one message in a recently-issued white paper that was jointly authored by the Centers for Medicare and Medicaid Services (CMS) and the Healthcare Fraud Prevention Partnership (HFPP).
Systemic Challenges That Put Clinical Labs at Risk
According to the CMS/HFPP report: “Examining Clinical Laboratory Services: What You Need to Know, How You Can Avoid its Consequences, and What to Do if You Are a Target of This Enforcement,” clinical laboratories face systemic challenges that can lead to the potential for fraud and abuse. Those include the:
- Number and variability of laboratories;
- High-volume, low-dollar nature of ordering, providing, and billing for clinical laboratory services; and,
- Technical complexity and continuing evolution of clinical laboratory services.
While HFPP, a public-private partnership of healthcare payers and allied organizations, notes it is difficult to put a price on the cost of laboratory fraud and abuse, it concludes, “[Fraud] can negatively impact patient care and outcomes, cause financial harm to legitimate service providers and drive up the cost of care for all.”
The CMS/HFPP white paper points out that fraud within the clinical laboratory industry typically is related to abuse of billing standards, improper laboratory relationships, and medically unnecessary testing, such as:
- Improper use of Current Procedural Terminology Code Modifier 91, which indicates when a test needs to be repeated on the same day;
- Unbundling of laboratory panels;
- Pass-through billing schemes;
- Rural health pass-through billing;
- Physician partial ownership of laboratories and co-referral networks;
- Use of exclusively large panels;
- Standing orders for laboratory tests;
- Excessive or improper urine drug testing;
- Sober living facilities (Sober Homes) that profit from urine drug testing; and,
- Excessive or improper genetic testing.
As the spotlight intensifies on an industry ripe for potential abuse, criminal and civil penalties for fraudulent and/or improper billing for medical laboratory services skyrocket as well.
This means clinical laboratory managers and pathologists can no longer simply rely on written compliance programs. They must implement compliance procedures that can stand up to investigations and enforcement actions and keep pace with frequently changing laws and regulations.
Diagnostic laboratories that fail to comply with healthcare fraud and abuse regulations face increasing legal risk. The Bipartisan Budget Act of 2018 (BBA) doubled many healthcare fraud and abuse penalties. The maximum penalties under U.S. Code § 1320a–7a—the Civil Monetary Penalties Law (CMPL)—for knowingly filing an improper claim jumped to $20,000; $30,000; or $100,000, depending on the violation.
Similarly, the maximum financial penalty related to payments to induce the reduction or limitation of services increased from $2,000 to $5,000. Criminal penalties for felony convictions of the Anti-Kickback Statute (AKS) also were substantially increased. Previously, a provider who violated the AKS could be fined as much as $25,000 and receive a maximum five-year prison sentence. As of February 9, 2018, AKS violations now can result in a maximum fine of $100,000 and up to a 10-year prison term.
Since 2015, monetary penalties for non-compliance with CMPL and AKS regulations have included an annual inflation adjustment, making the recently enacted increases less dramatic than they first appeared. Nonetheless, the BBA has upped the ante for clinical laboratories.
Protecting Your Clinical Laboratory Against Compliance Violations
“The BBA contained key changes to federal healthcare fraud statutes that, on the whole, reflect ongoing Congressional efforts to heighten penalties for healthcare fraud infractions. The revisions to the AKS and CMPL will, in Congress’s view, raise the stakes companies and individuals face in healthcare fraud cases,” noted law firm Hogan Lovells of Washington, D.C.
To help clinical laboratories and pathologists understand the significance of the CMS/HFPP white paper, and to navigate the increasingly treacherous regulatory and legal landscape, Dark Daily will be presenting a July 18 webinar titled “The New CMS White Paper on Healthcare Fraud Prevention: What You Need to Know, How You Can Avoid its Consequences, and What to Do if You Are a Target of This Enforcement.”
Melissa Jampol (left) and Charles Dunham, IV (right), are with Epstein Becker and Green, P.C., a national law firm with decades of experience focusing on healthcare and life science regulatory and enforcement issues that impact clinical and anatomic pathology laboratories, hospitals and health systems, and physician group practices and networks. (Photo copyrights: Epstein Becker and Green.)
During this valuable webinar, you will hear from two legal experts—Charles Dunham, IV, (above right) and Melissa Jampol (above left)—both of Epstein Becker and Green, P.C. (EBG). They have extensive healthcare industry regulatory experience and understand the enforcement process. They will provide diagnostic laboratories with a critical understanding of:
- Department of Justice operations, procedures and techniques for fraud enforcement, as well as laboratory actions that could be viewed as signs of potential fraud or abuse;
- Non-governmental enforcement procedures and techniques used by private health insurers;
- Tools for dealing with enforcement procedures or actions;
- How to build a compliance program that becomes infused in the culture of a clinical laboratory’s operations; and,
- Best practices designed to protect your lab from compliance violations or to mitigate potential problems, and more.
First to speak will be Charles Dunham, who is a partner at EBG. His national practice includes representation of healthcare providers and health-related entities. He has a particular focus on clinical and anatomic pathology laboratories, hospitals and health systems, and physician group practices and networks. His national clientele provides him with a wide view of the latest and most important developments in how laboratories, hospitals, and physicians need to comply with state and federal laws.
Clinical lab managers and pathologists participating in the webinar will get a unique, insider’s perspective from the co-presenter. Melissa Jampol is a former Assistant U.S. Attorney now at EBG. In this role, she has significant experience interacting with a range of federal and state law enforcement agencies on cases involving healthcare fraud and abuse. Her earlier experience includes more than six years as an Assistant District Attorney at the New York County District Attorney’s office.
To register for this crucial webinar and see essential details about discussion topics, use this link (or copy and paste this URL into your browser: https://pathologywebinars.com/current/the-new-cms-white-paper-on-healthcare-fraud-prevention-what-you-need-to-know-how-you-can-avoid-its-consequences-and-what-to-do-if-you-are-a-target-of-this-enforcement/).
While only a small percentage of labs engage in fraudulent business practices, all laboratory organizations today are subject to increased scrutiny and potential enforcement action. This essential webinar will provide in-depth information for laboratory managers and pathologists seeking practical advice on how to decrease non-compliance risks.
Don’t miss this unique opportunity to proactively protect your lab or pathology group from future problems, and learn how to respond if you are the subject of a payer audit, served with a Civil Investigative Demand letter, a subpoena, or other action. Register today!
—Andrea Downing Peck
Related Information:
Examining Clinical Laboratory Services: A Review by the Healthcare Fraud Prevention Partnership
Health Care Program Penalties Rise with Bipartisan Budget Act of 2018
Global Clinical Laboratory Services Market: Growing Demand for Quick Results and High Prevalence of Seasonal Infections Remain Important Drivers, Says TMR
Examining Clinical Laboratory Services Infographic
The New CMS White Paper on Healthcare Fraud Prevention: What You Need to Know, How You Can Avoid its Consequences, and What to Do if You Are a Target of This Enforcement
Jul 9, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Testing, News From Dark Daily
Could biometrics increase security and safety of clinical laboratory patient identification and specimen tracking processes as well?
Positive patient identification is a common problem for all healthcare providers, including medical laboratories. That is why there is strong interest in developing technologies that use biometric data to identify patients. The challenge has been to find a biometric solution that has acceptable accuracy and can make the positive identification in a speedy fashion, particularly when the patient presents for service or to provide a clinical laboratory specimen.
One Canadian company believes it has a biometrics-based solution almost ready to bring to market. AceAge, Inc., a Canadian healthcare technology company, recently added facial recognition software to their Karie at-home medication dispensing appliance, according to Biometric Update. The Ver-ID facial recognition authentication application they chose was developed by Ontario-based Applied Recognition, Inc.
Karie (above right) is designed to help patients accurately schedule, monitor, and take their medications. The companion facial recognition software—one of several security features—will enable homebound individuals who use mobile devices or the Internet to electronically sign-in and notify caregivers that medication was taken as ordered, an AceAge news release noted. “Now, our end users can dispense their prescriptions at a glance and without worry that, for example, a child might inadvertently get access. This will help bring security to medication in people’s homes,” Spencer Waugh, AceAge’s CEO (above), stated in the news release. (Image copyright: AceAge.)
The new Karie automated solution, is expected to launch later this year. Developers anticipate that the facial recognition feature also could be of value to researchers in late-stage clinical trials, where documentation of medication adherence is critical.
How Does Facial Recognition Software Work?
According to Applied Recognition, Ver-ID uses an algorithm that is more than 99% accurate in detecting and recognizing faces. Here’s how it works:
- A patient registers his or her face using the camera on a mobile device or camera-enabled computer;
- The patented Ver-ID algorithm matches 75 points and creates a “facial print” or “signature,” capturing unique features;
- Then, as the person uses their mobile device or computer, the facial signature is authenticated against the registered signature to control access to the app or device.
AceAge’s Karie device would authenticate the patient’s facial image against a stored facial signature in the same manner.
Fingerprint Readers Give People Identity, Care Access in Africa
Danny Thakkar, co-founder of Bayometric of San Jose, Calif., a global provider of fingerprint scanners and biometric software, says biometrics improves patient identification and is faster and more reliable than manual identification of patient records in a master patient index.
“The process of patient enrollment and admission becomes fast and hassle-free as a simple biometric scan is all it takes to identify and admit a patient,” Thakkar noted in a blog post.
In fact, biometrics technology has made it possible for residents of developing countries, without driver licenses or credit cards, to secure identity and access to healthcare services, according CNN.
COHESU, a Kenyan community health charity, is reportedly working with Simprints, a nonprofit technology company in the UK that makes fingerprint scanners for mobile platforms and charities worldwide, to implement biometrics for patient identification.
After having their fingerprints registered by the Simprints biometric scanner, Kenyan patients receive a unique identifier that can be matched to their healthcare records. Caregivers use mobile apps to access their patients’ health records and review or update them, CNN reported.
“Biometrics as a technology has completely changed our way of thinking. Without it, they would probably stay at home and accept their fate,” Nicholas Mwaura, a systems and database administrator with COHESU told CNN.
Hospitals Have Outdated Patient ID Methods, Says HealthsystemCIO Survey
Meanwhile, 42% of hospital CIOs acknowledged in an Imprivata/HealthsystemCIO.com survey that patient matching is a top priority at their organizations, according to a news release. Another 24% of CIOs surveyed said patient matching is not a priority, but it should be.
“Many hospitals still rely on methods that do not guarantee accurate patient identification, such as a person’s date of birth or a health insurance card. By implementing a registration solution—such as biometric identification technology—that accurately identifies patients and matches them with their correct EMPI (enterprise master patient index) and EHR (electronic health record) records, hospitals can reduce the very real risks highlighted in this survey,” Sean Kelly, MD, Imprivata’s Chief Medical Officer, told EHR Intelligence.
Clinical laboratory leaders already use processes and software to identify patients and match them with records and specimens. In the near future, biometric facial recognition might provide additional patient identification, safety, and medical laboratory security.
—Donna Marie Pocius
Related Information:
Medication Delivery Device Maker Adds Ver-ID for Biometric Patient Verification
AceAge Selects Applied Recognition to Provide Face Recognition Technology for Biometric Identity Authentication
Biometrics for Accurate Patient Identification
How Biometrics is Giving Identities to ‘Invisible Citizens’
Mismatched Patient Records: An Under-Recognized and Growing Problem at Most Hospitals, Imprivata CIO Survey Finds
42% of Healthcare CIOs List Patient Matching Issues a Top Priority
Jul 6, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Analysis performed by this new biosensor could help identify inflammatory bowel diseases, cancer, and other chronic diseases, and contribute to influencing the best treatment options, a critical aspect of personalized medicine
Anatomic pathologists and clinical laboratories have long known that disease, as the saying goes, “is written in the blood.” How to spot the disease has been the challenge.
Now, researchers at Finland’s Aalto University have developed a cutting-edge plasmonic biosensor that uses the intense light absorption and reflective properties of plasmonic materials to discern refractive changes between healthy and diseased exosomes—even with the naked eye!
This opens the door to a plethora of non-invasive health tests similar to home pregnancy tests. Should such tests prove accurate and affordable, medical laboratories could have new tools in their fight to end chronic disease.
New Rules for Differentiating Healthy and Diseased Human Exosomes
The Aalto researchers produced the biosensor by depositing plasmonic metaparticles (hypothetical particles that always move faster than light, such as Tachyons) on a black metal surface capable of absorbing electromagnetic radiation. With it, abnormalities can be distinguished by the color generated when the plasmons impact the black surface.
“We exploited it as the basis of new design rules to differentiate diseased human serum exosomes from healthy ones in a simple manner with no need [for] any specialized equipment”, Dr. Abdou Elsharawy, PhD, Postdoctoral Researcher at Kiel University in Kiel, Germany, stated in an Aalto University news release.
Researchers at Aalto University in Finland have developed a method for “visualizing the specular reflection color by a blackbody substrate. The carriers containing Ag nanoparticles [shown above] are covered with various dielectrics of AlN [aluminum nitride], SiO2 [silicon dioxide], and the composites thereof that are placed on a black background to enhance the reflectivity contrast of various colors at a normal angle of incidence.” This has resulted in a tool that medical laboratories could use to differentiate between healthy and diseased exosomes in human blood. (Photo and caption copyrights: Aalto University.)
Dr. Mady Elbahri, PhD, Professor, Nanochemistry and Nanoengineering, Department of Chemistry and Materials Science at Aalto University, indicated that there is no need to use sophisticated fabrication and patterning methods with the biosensor as bulk biodetection of samples can be seen with the naked eye.
“It is extraordinary that we can detect diseased exosomes by the naked eye. The conventional plasmonic biosensors are able to detect analytes solely at a molecular level. So far, the naked-eye detection of biosamples has been either rarely considered or unsuccessful,” Elbahri noted in the news release.
Exosomes Critical to Many Human Bodily Processes
Exosomes are cell-derived vesicles that are present in many and perhaps all eukaryotic fluids, including blood, urine, and cultured medium of cell cultures. These small bundles of material are released by the outer wall of a cell and contain everything from proteins to ribonucleic acid (RNA) and Messenger RNA (mRNA). They are important indicators of health conditions.
There is mounting evidence that exosomes have exclusive functions and perform a significant role in bodily processes like coagulation, intercellular signaling, and waste management.
Interest in the clinical applications of exosomes is increasing, along with their potential for use in prognosis, development of therapies, and as biomarkers for diseases. But, exosomes are rare and distinguishing them among all other elements located in bodily fluids has proven difficult.
Thus, the Aalto study has strong implications for clinical laboratories and anatomic pathology groups. More research and regulatory approval will be needed before use of this new tool comes to fruition. However, any method that accurately and inexpensively identifies chronic disease biomarkers will impact the medical laboratory and anatomic pathology professions and is worth watching
—JP Schlingman
Related Information:
Plasmonic Biosensors Enable Development of New Easy-to-use Health Tests
Plasmonic Biosensor to Detect Exosomes with Naked Eye
Plasmonic Metaparticles on a Blackbody Create Vivid Reflective Colors for Naked‐Eye Environmental and Clinical Biodetection
Plasmonic Biosensors
Jul 2, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Growing interest in more transparency for the prices of prescription drugs is reflected in a study published in the Journal of the American Medical Association (JAMA) that highlights disparities in pharma prices for patients, pharmacies, and payers
Consumer demand for increased transparency in the prices patients, health insurers, and others pay for healthcare services continues. The Kaiser Family Foundation (KFF) reports that patients are facing higher deductibles, higher premiums, and increasingly complex—and opaque—pricing for everything from medical laboratory tests and routine checkups to prescriptions and out-of-network care. (See Dark Daily, “KFF Study Finds HDHPs and Increased Cost-Sharing Requirements for Medical Services are Making Healthcare Increasingly Inaccessible to Consumers,” April 20, 2018.)
However, while reference pricing and pricing databases help savvy patients compare prices across a range of procedures, much about pharmaceutical pricing remains shrouded in mystery. This is why calls for greater transparency in how prescription drugs are priced are increasing as well.
The Trump administration, state governments, and advocacy groups have each targeted drug costs as a problem in the current healthcare system. And a March 2018 study published in the Journal of the American Medical Association (JAMA) may further fuel the fires facing big pharma.
Overpayments and the Silence Behind Them
Analyzing 9.5 million claims from Optum’s Clinformatics Data Mart over the first half of 2013, researchers found that approximately 23% of all claims involved overpayments—situations in which the co-pay charged to the patient exceeded what the insurer paid the pharmacy to fill the prescription.
While data from 2013 might not reflect the current state of pharmaceutical pricing, the study brings exposure to trends in both politics and media coverage surrounding the industry.
The study authors found that overpayments totaled $135-million in 2013. Generic medications saw a higher portion of overpayments with more than one in four generic prescriptions costing patients more than what payers paid the pharmacy. However, in the 6% of claims involving branded medication, overpayments were nearly twice as high with an average overpayment of $13.46 per claim.
The researchers also cited data from a National Community Pharmacists Association (NCPA) survey of 628 pharmacies in which 49% claimed to have seen 10-50 occurrences of “clawback fees” in the past month. A further 35% reported seeing more than 50 clawback fees in the past month. These “fees” are part of contractual obligations that payers can use to recoup such overpayments to pharmacies.
Other contractual arrangements, such as “gag clauses” (AKA, non-disclosure agreements), wherein pharmacists cannot disclose to patients when their copay exceeds the cost of filling the prescription without coverage, have garnered coverage in the media.
The Hill recently outlined efforts from senators to stop this practice for both traditional insurance plans and Medicare Advantage and Part D participants. “Americans have the right to know which payment method—insurance or cash—would provide the most savings when purchasing prescription drugs,” Senator Susan Collins (R-Maine) told The Hill.
Rebates, Secretive Deals, and Red Tape in Government Crosshairs
Rebates are another contested aspect of current pricing models. Traditionally, pharmacy benefit managers (PBMs) serve as a middleman between pharmaceutical companies and pharmacies to negotiate prices and maintain markets. PBMs negotiate deals for insurers in the form of rebates. Insurers, however, are using these savings to offer lower premiums, rather than forwarding the savings directly to the customer.
UnitedHealthcare unveiled plans to pass these rebates directly to consumers in early March, The Hill reported.
In a press release, Department of Health and Human Services (HHS) Secretary Alex M. Azar II stated, “Today’s announcement by UnitedHealthcare is a prime example of the movement toward transparency and lower drug prices for millions of patients that the Trump Administration is championing. Empowering patients and providers with the information and control to put them in the driver’s seat is a key part of our strategy … to bring down the price of drugs and make healthcare more affordable.” (Photo copyright: Washington Post.)
The Trump Administration also recently outlined their new “American Patients First” plan for reducing drug prices and out-of-pocket costs for patients.
Key elements of their proposed approach include:
- Eliminating gaming of regulations, such as the Risk Evaluation and Mitigating Strategies (REMS) requirements manufacturers use to avoid sending samples to creators of generics;
- Promoting biosimilars;
- Allowing greater substitution in Medicare Part D;
- Including list prices in pharma advertising;
- Restricting rebates through Anti-Kickback Statue revisions; and,
- Eliminating gag clauses or clawback fees.
However, pharma industry coverage of the plan is mixed. MarketWatch sees little to worry about, predicting, “[the plan] isn’t expected to hurt drug makers or pharmacy-system middlemen.” Meanwhile, Forbes claims, “[the plan] represents a sea of change in pharmaceutical pricing policy, one that will have a significant effect on drug prices in the future.”
Anatomic pathology groups, medical laboratories, and other diagnostics providers can view this as yet another example of healthcare providers trying to shore up financials and protect profits by protecting sensitive pricing information, as the industry faces increasing scrutiny. Nevertheless, regardless of the outcome, these latest trends emphasize the role that transparency is likely to play—and how clinical laboratories will be impacted—as healthcare reform progresses, both in terms of public relations and regulatory requirements.
—Jon Stone
Related Information:
Frequency and Magnitude of Co-payments Exceeding Prescription Drug Costs
Impact of Direct and Indirect Remuneration (DIR) Fees on Pharmacies and PBM-Imposed Copay Clawback Fees Affecting Patients
Copay Exceeds Drug Cost in 23% of Claims: JAMA Research
You’re Overpaying for Drugs and Your Pharmacist Can’t Tell You
Oregon, the Latest State to Tackle High Drug Prices, Pushes through Transparency Law
Governor Brown Signs HB 4005, Creating New Transparency in Drug Pricing
UnitedHealthcare Will Pass Drug Rebates Directly to Consumers
Senators Target ‘Gag Clauses’ That Hide Potential Savings on Prescriptions
FDA Commissioner Says ‘Rigged’ System Raises Drug Costs for Patients, Discourages Competition
FDA Puts Drug Supply Chain on Notice
The FDA Commissioner Just Laid Out How ‘Everybody Wins’ in the US Healthcare System except the Patients
Your Guide to the Trump Drug Price Plan: Who It Affects and How
The Trump Plan to Reduce Prescription Drug Prices Will Have a Major Impact
American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
Secretary Azar Statement on UnitedHealthcare Drug Discount Announcement
Reference Pricing and Price Shopping Hold Potential Peril for Both Clinical Laboratories and Consumers
Consumers Now Use Medical Cost Websites to Price Shop for Clinical Pathology Laboratory Tests and Other Medical Procedures
KFF Study Finds HDHPs and Increased Cost-Sharing Requirements for Medical Services Are Making Healthcare Increasingly Inaccessible to Consumers
Jun 29, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
While consolidation is a common trend across many sectors—including anatomic pathology groups and hospital systems—UnitedHealth Group is the latest example of the payer-provider consolidation trend impacting medical laboratories nationwide
Pending the successful completion of a $4.9-billion acquisition of DaVita Medical Group, UnitedHealth Group (UNH) will be poised to become the largest single employer of doctors in the U.S., according to numbers reported by leading sources.
Clinical laboratories, anatomic pathology groups, and other service providers that service those doctors should already be taking a serious look at their revenue flows and efficiencies to maintain margins and weather the shift into a model of value-based reimbursement.
Controlling Costs with Direct Care
According to a press release, UnitedHealth Group’s (NYSE:UNH) direct-to-patient healthcare subsidiary, OptumCare, currently employs or is affiliated with 30,000 physicians. And, DaVita Medical Group, a subsidiary of DaVita Inc. (NYSA:DVA), lists 13,000 affiliated physicians on their website. Should acquisition of DaVita Medical Group go forward, OptumCare would have approximately 43,000 affiliated or employed physicians—roughly 5,000 more physicians than HCA Healthcare and nearly double Kaiser Permanente’s 22,080 physicians—thus, making OptumCare’s parent company UNH the largest individual employer of physicians in the U.S. The acquisition is reportedly to reinforce UNH’s ability to control costs and manage the care experience by acquiring office-based physicians to provide services.
OptumCare has seen significant growth over the past decade. OptumHealth, one of three segments of UNH’s overall Optum healthcare subsidiary, includes OptumCare medical groups and IPAs, MedExpress urgent care, Surgical Care Affiliates ambulatory surgery centers, HouseCalls home visits, behavioral health, care management, and Rally Health wellness and digital consumer engagement.
“We have been slowly, steadily, methodically aligning and partnering with phenomenal medical groups who choose to join us,” Andrew Hayek, CEO of OptumHealth (above), told Bloomberg. “The shift towards value-based care and enabling medical groups to make that transition to value-based care is an important trend.” (Photo copyright: Becker’s ASC Review.)
Acquisitions of Doctors on the Rise; Clinical Lab Revenues Threatened
Independent physicians and practices have been a hot commodity in recent years. A March 2018 study from Avalere Health in collaboration with the Physicians Advocacy Institute (PAI) showed that the number of physicians employed by hospitals rose from 26% in July 2012 to 42% in 2016—a rise of 16% over four years.
By acquiring physicians of their own, insurance companies like UnitedHealth Group believe they can offset the cost and shifts in service of these prior trends. “We’re in an arms race with hospital systems,” John Gorman of Gorman Health Group told Bloomberg. “The goal is to better control the means of production in their key markets.”
According to Modern Healthcare, the acquisition of DaVita Medical Group is UnitedHealth’s third such acquisition in 2017. Other acquisitions include:
Along with Surgical Care Affiliates came a chain of surgery centers that, according to The New York Times (NYT), OptumCare plans to use to perform approximately one million surgeries and other outpatient procedures this year alone, while reducing expenses for outpatient surgeries by more than 50%.
NYT also noted that acquisition of DaVita Medical Group doesn’t bring just physicians under the OptumCare umbrella, but also nearly 250 MedExpress urgent care locations across the country.
By having physicians, clinical laboratories, outpatient surgery centers, and urgent care centers within their own networks, insurance providers then can steer patients toward the lowest-cost options within their networks and away from more expensive hospitals. This could mean less demand on independent clinical laboratories and hospitals and, with that, reduced cash flows.
According to NYT, Optum currently works with more than 80 health plans. However, mergers such these—including those between CVS Health (NYSE:CVS) and Aetna (NYSE:AET), and the proposed agreement between Humana (NYSE:HUM) and Walmart (NYSE:WMT) to deliver healthcare in the retailers’ stores—indicate that insurers are seeking ways to offer care in locations consumers find most accessible, while also working to exert influence on who patients seek out, to generate cost advantages for the insurers.
This consolidation should concern hospitals as payers increasingly draw physicians from them, potentially also taking away their patients. The impact, however, may also reach independent medical laboratories, medical imaging centers, anatomic pathology groups, and other healthcare service providers that provide diagnoses and treatments in today’s complex healthcare system.
Deep Payer Pockets Mean Fewer Patients for Clinical Labs and Medical Groups
As this trend continues, it could gain momentum and potentially funnel more patients toward similar setups. Major corporations have deeper pockets to advertise their physicians, medical laboratories, and other service providers—or to raise public awareness and improve reputations. Such support might be harder to justify for independent healthcare providers and medical facilities with shrinking budgets and margins in the face of healthcare reform.
Shawn Purifoy, MD, a family medicine practitioner in Malvern, Ark., expressed his concern succinctly in The New York Times. “I can’t advertise on NBC [but] CVS can,” he noted.
While further consolidation within independent clinical laboratories and hospitals might help to fend off this latest trend, it remains essential that medical laboratories and other service providers continue to optimize efficiency and educate both physicians and payers on the value of their services—particularly those services offered at higher margins or common to menus across a range of service providers.
—Jon Stone
Related Information:
With 8k More Physicians than Kaiser, Optum Is ‘Scaring the Crap Out of Hospitals’
30,000 Strong and Counting, UnitedHealth Gathers a Doctor Army
CVS’s Megadeal to Change U.S. Health Care Faces Stiff Challenges
Updated Physician Practice Acquisition Study: National and Regional Changes in Physician Employment 2012–2016
The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care
UnitedHealth’s Optum to Buy DaVita Medical Group for $4.9B: 6 Things to Know
UnitedHealth Buys Large Doctors Group as Lines Blur in Healthcare
UnitedHealth’s Optum to Buy DaVita Medical Group for $4.9 Billion
UnitedHealth Is Buying a Major Doctor Group on the Heels of the CVS-Aetna Deal
DaVita Medical Group to Join Optum
Jun 27, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Using GPIIb/IIIa inhibition, and ion chelation, researchers have developed a “universal” method for preserving blood up to 72 hours while keeping it viable for advanced rare-cell applications
Through microfluidics and automation, clinical laboratories and anatomic pathologists have been able to detect ever-smaller quantities of biomarkers and other indicators of chronic disease.
However, preserving sample quality is an essential part of analytical accuracy. This is particularly true in precision oncology and other specialties where isolating rare cells (aka, low abundance cells), such as circulating tumor cells (CTCs), is a key component to obtaining information and running diagnostics.
Publishing their finding in Nature, researchers at Massachusetts General Hospital Center for Engineering in Medicine (MGH-CEM) have developed a whole blood stabilization method that is ideal for rare-cell applications, and which preserves sample integrity for up to 72 hours.
Should further testing validate their findings and methodology, this change could allow greater use of central laboratories and other remote testing facilities that previously would not be available due to distance and sample travel time.
Keeping Blood Alive Is Not Easy
“At Mass. General, we have the luxury of being so integrated with the clinical team that we can process blood specimens in the lab typically within an hour or two after they are drawn,” stated lead author Keith Wong, PhD, former Research Fellow, MGH-CEM, and now Senior Scientist at Rubius Therapeutics, Boston, in a Mass General press release. “But to make these liquid biopsy technologies routine lab tests for the rest of the world, we need ways to keep blood alive for much longer than several hours, since these assays are best performed in central laboratories for reasons of cost-effectiveness and reproducibility.”
Study authors Wong and co-lead author Shannon Tessier, PhD, Investigator at MGH-CEM, noted that current FDA-approved blood stabilization methods for CTC assays use chemical fixation—a process that can result in degradation of sensitive biomolecules and kill the cells within the sample.
Without stabilization, however, breakdown of red cells, activation of leukocytes (white blood cells), and clot formation can render the results of analyzing a sample useless, or create issues with increasingly sensitive equipment used to run assays and diagnostics.
“We wanted to slow down the biological clock as much as possible by using hypothermia, but that is not as simple as it sounds,” says Tessier. “Low temperature is a powerful means to decrease metabolism, but a host of unwanted side effects occur at the same time.”
Researchers started by using hypothermic treatments to slow degradation and cell death. However, this created another obstacle—aggressive platelet coagulation. By introducing glycoprotein IIb/IIIa inhibitors, they found they could minimize this aggregation.
Keith Wong, PhD (left), a former Research Fellow, MGH-CEM, and now Senior Scientist at Rubius Therapeutics in Boston; and Shannon Tessier, PhD (right), Investigator at MGH-CEM, co-authored a study to develop a whole blood stabilization method that preserves sample integrity for up to 72 hours, making it possible to transport blood specimens further distances to central clinical laboratories for processing. (Photo copyrights: LinkedIn.)
Prior to microfluidic processing of their test samples, researchers applied a brief calcium chelation treatment. The result was efficient sorting of rare CTCs from blood drawn up to 72 hours prior, while keeping RNA intact and retaining cell viability.
“The critical achievement here,” says Tessier, “Is that the isolated tumor cells contain high-quality RNA that is suitable for demanding molecular assays, such as single-cell qPCR, droplet digital PCR, and RNA sequencing.”
Their testing involved 10 patients with metastatic prostate cancer. Sample integrity was verified by comparing CTC analysis results between fresh samples and preserved samples from the same patients using MGH-CEM’s own microfluidic CTC-iChip device.
Results showed a 92% agreement across 12 cancer-specific gene transcripts. For AR-V7, their preservation method achieved 100% agreement. “This is very exciting for clinicians,” declared David Miyamoto, MD, PhD, of Massachusetts General Hospital Cancer Center in the press release. “AR-V7 mRNA can only be detected using CTCs and not with circulating tumor DNA or other cell-free assays.”
Methodology Concerns and Future Confirmations
“Moving forward, an extremely exciting area in precision oncology is the establishment of patient-specific CTC cultures and xenograft models for drug susceptibility,” the study authors noted. “The lack of robust methods to preserve viable CTCs is a major roadblock towards this Holy Grail in liquid biopsy. In our preliminary experiments, we found that spiked tumor cells in blood remain highly viable (>80%) after 72 hours of hypothermic preservation.”
Despite this, they also acknowledge limitations on their current findings. The first is the need for larger-scale validation, as their testing involved a 10-patient sample group.
Second, they note that further studies will be needed to “more completely characterize whole-transcriptome alterations as a result of preservation, and to what extent they can be stabilized through other means, such as further cooling (e.g., non-freezing sub-zero temperatures) or metabolic depression.”
Researchers also note that their approach has multiple advantages for regulatory approval and further testing—GPIIb/IIIa inhibitors are both low-cost and already approved for clinical use, implementation requires no modification of existing isolation assays, and cold chain protocols are already in place allowing for easy adaptation to fit the needs of pathology groups, medical laboratories, and other diagnostics providers handling samples.
While still in its early stages, the methods introduced by the researchers at MGH-CEM show potential to allow both the facilities collecting samples and the clinical laboratories processing them greater flexibility and increased accuracy, as high-sensitivity assays and diagnostics continue to power the push toward personalized medicine and expand laboratory menus across the industry.
—Jon Stone
Related Information:
Whole Blood Stabilization for the Microfluidic Isolation and Molecular Characterization of Circulating Tumor Cells
Improved Blood Stabilization Should Expand Use of Circulating Tumor Cell Profiling
Genentech Scientists Zero In on “Liquid Biopsies” as a Way to Replace Tissue Biopsies in Breast Cancer
University of Michigan Researchers Use “Labyrinth” Chip Design in Clinical Trial to Capture Circulating Tumor Cells of Different Cancer Types
Super-Fast Microscope Captures Circulating Tumor Cells with High Sensitivity and Resolution in Real Time
