This is the second of a three-part series on revenue cycle management for molecular testing laboratories and pathology practices, produced in collaboration with XiFin, Inc.
Second of a 3-part series, this article will detail what molecular diagnostics and pathology groups need to understand about coding, billing, and denial management to maximize revenue and cash flow successfully.
In the first article, we discussed how molecular diagnostics and pathology groups can enhance the patient experience, physician engagement, and payer relations. Now, we will detail how denial management can successfully maximize revenue and cash flow. As we discussed in the last article, revenue cycle management (RCM) is much more than billing.
Today’s rapidly changing environment of directives and expectations from payers, patients, and health systems require deeper understanding, great agility, and strategy in every aspect of business. Creating opportunities to provide better service, adopt state-of-the-art technologies, and build robust processes and partnerships can make or break the long-term success of a laboratory or pathology practice.
Technical assessments are often required to establish clinical validity and utility to achieve payer coverage for novel genetic tests. Achieving payer coverage requires a deep understanding of how-to code tests compliantly and to facilitate reimbursement.
“We recommend that molecular diagnostics laboratories consult with coding experts to fully understand the coding requirements for each genetic test,” says Clarisa Blattner, XiFin Senior Director, Revenue and Payor Optimization. “Ensuring reimbursement requires knowing payer policies and to track denial trends by payer over time to identify changes.”
Blattner noted that payer policies and behavior are constantly changing. Labs, and their billing partners must stay abreast of changes to avoid lengthy delays that denials and subsequent appeals can cause. Understanding the documentation that is required with claims is invaluable. Knowing these requirements up front and submitting complete claims with all required medical records and documentation of medical necessity goes a long way toward facilitating reimbursement.
Payers are adopting increasingly rigid policies that are often inconsistent with others. Reimbursements continue to be cut while quality reporting requirements rise.
Diagnostics laboratories that conduct genetic testing must also overcome four common challenges:
Achieving and expanding payer coverage with coverage determination that defines reasonable and medically necessary services and tests.
Knowing how to code the tests correctly with medical nomenclature to report services and/or tests to a payer.
Ensuring payment/reimbursement for services/tests based on services/tests rendered and coverage determination.
Maintaining compliance and keeping abreast of billing compliance and having a voice in reform
“We also recommend that laboratories conduct internal audits that reconcile laboratory information system (LIS) data with RCM system data,” Blattner continued. “Labs with a robust business intelligence (BI) solution can proactively identify outliers, such as accessions that exist in one system but not the other.”
Maintain Your Billing System and Maximize Clean Claim Submissions
Laboratories should be sure that these four payer services are being handled appropriately, whether it is by the lab or an RCM partner:
1. Payer relations: An effective payer relations team monitors denials and coordinates with payers. This team reviews front-end payer rejections, coordinates with clients (i.e., ordering physicians), and identifies and updates edits based on payer policies and behavior changes.
2. Electronic data interchange (EDI) enrollment: This team handles monitoring and proactive enrollment for electronic submissions and helps ensure bidirectional transaction automation.
3. EDI analysts: Experts in healthcare EDI who investigate errors, participate in standards development and testing, as well as payer education and coordination.
4. EDI operations: These specialized technicians configure files and ensure the reconciliation of claim-level submissions.
Efficiently Upload and Store Medical Records and Documentation
Although laboratories do not directly control patient medical records, it is essential to understand that diagnosis codes alone are generally insufficient.
Laboratory sales representatives must work with clients and ordering physicians to ensure medical records have all the information required for payment. Ensuring that the payers expedite payment requires efficient uploading and storing of medical records and documentation:
Align with payers on clinical utility evidence requirements, current billing policies, and preferred coding approach.
Leverage the support and advocacy of key opinion leaders (KOLs).
Collaborate with clinicians on the prior authorization process.
Select an RCM partner that helps you maximize process automation and front-end edits.
Leverage a business intelligence (BI) system that simplifies the tracking of key performance indicators (KPIs), helps identify payer policy and behavior changes early, and highlights changes in key business trends.
The RCM system must be able to upload and store medical records and documentation. The required medical information typically includes the following:
Who? Ordering/referring provider.
What? What service(s)/test(s) is/are being ordered?
Where? Where is the specimen being sent?
When? What is the date of service (DOS)?
Why? What are the patient’s signs/symptoms, or what prompted the test to be ordered?
How? How are the test results used to manage the patient’s medical condition?
But even after including all of the correct medical information, denials are inevitable. There are important steps labs can take to streamline denial management.
The Importance of Patient Engagement in Maximizing Reimbursement
Patient engagement plays an essential role in facilitating reimbursement and maximizing cash collection. Patients expect transparency and ease of information access from their healthcare encounters, just as they experience in all other areas of their lives. Because most laboratory, pathology, and molecular encounters are not directly patient-facing, proven payment accelerating engagement tools are essential. Dynamic portals, electronic statements, and text messages are essential, especially when it comes to communication regarding errors and patient financial responsibility.
XiFin customer data show a substantive increase in patient payments received in the first 30 days of the dunning cycle after integrating texting and automated calls into the traditional process. For example, a XiFin customer collected 26.6% more of the revenue in the first 30 days after implementing a text reminder between the first and second paper statements. Prior to implementation, the customer followed a traditional three-statement dunning cycle:
42.6% of total payments received occurred after the first statement (within the first 29 days of the dunning cycle).
34.8% occurred after sending the second statement (between days 30-59 of the dunning cycle).
22.6% were received after sending the third and final statement (during days 60-90 of thedunning cycle).
The convenience of text messaging allows patients to connect to the call center or to the patient portal, where a payment can be made immediately. XiFin customers can customize their dunning cycle, depending on how their specific patient population responds to texts, paper statements, and the timing between billing cycles. Studying the behaviors of patient interactions at the client level, rather than only referencing the status quo of macro-level trending, empowers a more strategic approach to engagement and improving overall patient satisfaction.
Denial Trends Driving Reduced Revenue and Higher Costs
Denials extend time in accounts receivable, contributing to bad debt on services already rendered and laboratory expenses absorbed. Denials also often require the most attention from staff – increasing the cost of billing. Hard denials, such as Medical Necessity, make up the most challenging revenue to collect, comprising about 5-10% of total denials received. In addition to creating delays and revenue loss, denials illustrate how payers administer their policies, even when those policies are unpublished.
Fundamentally, an effective RCM process is rooted in the ability to file clean claims to the degree that is possible. Improving those outcomes requires focus on the exceptions – the dirty claims – the denials.
“At XiFin, we invest in front-end configurations and workflows to catch denials prior to submitting the claim to the payer,” continued Blattner. “As we monitor denial trends, we build more robust front-end workflows and add automation (such as integrating with insurance discovery and prior authorization vendors) to reduce the associated burden on billing teams.”
In addition, molecular testing coverage continues to expand, reducing non-covered denials. The stabilization of these medical policy-related denials is positive. The jump in demographic denials, however, requires additional consideration.
Paid vs. Denied by Payer Group
Denial patterns vary among payers. The percentage of claims denied also differs by segment, largely due to the type of testing performed.
Of the claims XiFin processes annually (approximately $50 billion in charges), 22.5% are denied. The graphs below demonstrate molecular testing’s higher propensity for denial (27.5% of claims billed), driven by non-covered, medical necessity, and prior authorization requirement challenges.
Routine pathology has closer to a 20% denial rate overall. The average percentage of billed claims that are denied by segment are:
■ Clinical: 13.62%
■ Molecular: 27.19%
■ Pathology: 19.82%
Molecular testing has a higher propensity for denial (27.5% of claims billed), driven by non-covered, medical necessity, and prior authorization requirement challenges. Routine pathology has closer to a 20% denial rate overall.
Clinical laboratory denial rates averaged 13.62% in 2021. As seen in the table below,clinical laboratories saw a significant decline in experimental/investigational denials between 2018 and 2021.
Denial Type
Molecular % of Total Denied 2018
Clinical % of Total Denied 2021
Variance (% change 2021 vs. 2018)
Benefit Maximum Reached
39.3%
29.7%
-24.4%
Claim Specific Negotiated Discount
17.6%
18.1%
2.8%
Coordination of Benefits
4.1%
16.3%
298%
Coverage Terminated
6.6%
13.4%
103%
Diagnosis Not Covered
11.3%
6.4%
-43.4%
Duplicate Denial
8.3%
3.4%
-57.8%
Experimental Investigational
0.1%
2.7%
2600%
HSA
2.1%
2.4%
14.3%
Incorrect Payer
0.9%
1.6%
77.8%
Non-Covered
2.2%
1.1%
-50.0%
Patient Cannot be Identified
0.7%
0.8%
14.3%
Patient Enrolled in Hospice
0.5%
0.5%
0.0%
Prior Authorization
0.2%
0.2%
0.0%
Procedure Code Inconsistent with the Modifier Used or a Required Modifier is Missing
1.6%
0.1%
-87.5%
Procedure Not Paid Separately
0.5%
0.1%
-60.0%
Service Not Payable per Managed Care Contract
0.1%
0.0%
-100%
Molecular claims continue to experience the highest denial rates of any laboratory segment. With an average denial rate of 27%, molecular continues to be arevenue recovery workflow heavy on the back-end. As a percentage of the total denial population, between 2018 and 2021, XiFin experienced increases in patient-coverage denials, such as coordination of benefits (298%), coverage terminated (103%), and experimental/investigational (2600%). Decreases in diagnosis not covered denials (-43.4%) and duplicate denials (-57.8%) are also recognized.
Exome/Genome Testing must be administered by specialized technicians with specificcredentials, creating potential backlogs. They can take 8, 12, or even 16 weeks to complete, depending on testing methodologies. This presents a high risk of timely filing denials for the many payers that have adopted 90-day timely filing limits. XiFin recommended practice: Explore amending your payer contracts to extend timely filing limits on these tests.
Denial Type
Pathology % of Total Denied 2018
Pathology % of Total Denied 2021
Variance (% change 2021 vs. 2018)
Prior Authorization
28.9%
36.1%
24.6%
Duplicate Denial
21.5%
21.2%
-1.9%
Non-Covered
14.1%
10.1%
-27.7%
Services Not Prov. By Network/Primary Care Provider
8.8%
8.5%
-3.4%
Procedure Not Paid Separately
4.4%
5.1%
15.9%
Services Not Authorized by Network/Primary Care Provider
3.6%
3.8%
5.6%
Procedure Code Inconsistent with the Modifier Used or a Required Modifier is Missing
1.5%
3.3%
120%
Coverage Terminated
2.2%
2.6%
18.2%
Coordination of Benefits
3.8%
2.4%
-34.2%
Patient Cannot Be Identified
3.1%
2.3%
-25.8%
Remark Code
5.9%
2.1%
-64.4%
Experimental Investigational
1.0%
1.2%
20.0%
Benefit Maximum Reached
0.4%
1.0%
175%
Patient Enrolled in Hospice
0.4%
0.1%
-75.0%
Incorrect Payer
0.0%
0.1%
100%
Service Not Payable per Managed Care Contract
0.2%
0.0%
-100%
Anatomic pathology denials have increased by approximately 5% from 2018 to 2021.As a percentage of the total denial population, the lack of prior authorization is the highestcontributor to this increase, having grown 24.6%. There was an increase inprocedure code inconsistent with modifier denials (120% increase) and a decreasein non-covered denials (-27.7%).
Importance of an Efficient and Effective Appeals Process
Front-end edits and configurations help mitigate backend denials. Capturing potential denial-related issues proactively are the most effective way to maintain a manageable AR and improve the propensity to pay. For example, payers that observe National Correct Coding Initiative (NCCI) and Medically Unlikely Edits (MUEs) will consider all Current Procedural Terminology (CPT) codes billed for that patient for the same Date of Service (DOS), even when not billed on the same claim form.
Denials are inevitable if your current billing process does not have edits in place to perform a historical review of charges for the same patient on the same DOS.
Denials are unavoidable, and not all known issues can be addressed on the front end of the process. An example of this is denial code CO252, which is an additional information denial. It indicates the payer is requesting additional documentation (i.e., clinical information, medical records, and test results) before issuing payment – essentially performing an audit to ensure the services billed are reasonable and necessary and medical necessity is justified and documented.
“These are not always complex molecular tests; they can be routine pathology claims,” said Blattner “Each time we receive a CO252 denial it has to be appealed with additional documentation found in the patient’s medical records. Though it is inevitable, we must wait on the denial before we can take action.”
Segment
Appeal-Payments as % of Total Insurance Payments Received
Average Payment Amount per Appeal
Clinical
0.11%
$121
Molecular
6.56%
$1,420
Pathology
1.12%
$327
Industry Average
3.39%
$623
Payment collection per appeal continues to be stable in the pathology (averaging 1-2%) and clinical segments, where appeals are less prolific. Revenue recovered by corrected claims is excluded since these claims follow a separate process and impact denial codes such as CO97 (Procedure or service isn’t paid for separately), CO18 (Duplicate), and CO234 (Procedure not paid separately). Further, a single appeal process is not sufficient. A robust appeals process here becomes critical. Specifically in molecular testing, appeals carry a heightening impact on revenue collection. In 2020, appeals accounted for 5% of the total revenue generated by XiFin customers. In 2021, that increased to 6.5%.
Appeal Success Rates by Payer Group by Segment
The next four charts show appeal success rates by payer group for 2021, overall and by market segment for clinical, molecular, and pathology. The fifth chart illustrates the incremental impact of multiple appeal attempts by market segment.
This assessment only includes activity related to revenue recovery through an appeals process. Some denials can be addressed by filing of a corrected claim and can be a much more efficient process. Although ideal, corrected claims are not always possible, depending on denial type and individual payer preferences.
% of Total Appeals Filed
% of AppealsPaid after 1st Attempt
% of AppealsPaid after 2nd Attempt
% of AppealsPaid after 3rd Attempt
Avg Paymentper Appeal
Clinical
17.4%
17.8%
9.9%
$ 276
Additional Information
70.1%
20.9%
20.3%
10.0%
$ 258
COVID Medical Necessity
8.9%
3.9%
50.0%
$ 78
Medical Necessity
4.8%
30.4%
18.4%
$ 553
Out of Network
6.9%
4.4%
2.4%
$ 594
Prior Authorization
0.0%
14.3%
0.0%
$ 421
Underpayment
9.3%
6.9%
6.3%
$ 10
The clinical laboratory segment maintains the lowest volume of denials. But this does not negate the need for robust editing processes. Implementing robust front-end logic and leveraging intelligent automation to correct potential issues dramatically streamlines the process from submission to payment, especially in the high-volume clinical laboratory segment.
% of Total Appeals Filed
% of AppealsPaid after 1st Attempt
% of AppealsPaid after 2nd Attempt
% of AppealsPaid after 3rd Attempt
Avg Paymentper Appeal
Molecular
21.4%
17.2%
19.4%
$1,420
Additional Information
47.7%
23.9%
20.7%
23.3%
$1,285
Medical Necessity
23.0%
17.6%
14.0%
12.8%
$1,518
Prior Authorization
11.4%
18.9%
11.7%
13.1%
$1,944
Experimental and Investigational / Non-Covered
5.6%
13.2%
9.0%
9.0%
$4,234
COVID Underpayment
3.8%
44.7%
24.6%
10.7%
$52
Timely Filing
3.5%
10.1%
8.3%
18.9%
$551
Out of Network
3.5%
14.0%
10.8%
8.4%
$2,513
Underpayment
1.1%
31.2%
17.8%
15.3%
$2,154
COVID Medical Necessity
0.4%
46.4%
27.0%
0.0%
$124
Appeal Trends: Molecular and Genomic Testing At $1,420, the average payment per appeal for molecular testing is more significant due to the high-dollar value of the testing. Additional information appeals account for 47% of the total appeals filed in 2021 in the molecular segment and have an average success rate of 23%. Another 23% of appeals are for claims denied for medical necessity, followed by prior authorizations at 11.4% of total appeals filed. Prior authorization appeal volumes have remained consistent year-over-year in this segment, averaging 10% in 2020, despite a higher volume of prior authorization requirements than pathology or clinical laboratory.
XiFin’s RCM platform has integrated automation with prior authorization partners, allowing claims meeting prior authorization criteria to be submitted to a prior authorization solution automatically. Utilizing “real-time data exchange” via application programming interfaces (API) without partners, XiFin can more quickly acquire the necessary prior authorization number and update the patient’s information in XiFin RPM upon those values being returned.
% of Total Appeals Filed
% of AppealsPaid after 1st Attempt
% of AppealsPaid after 2nd Attempt
% of AppealsPaid after 3rd Attempt
Avg Paymentper Appeal
Pathology
22.6%
20.6%
21.8%
$327
Additional Information
33.4%
28.8%
23.4%
27.9%
$337
Medical Necessity
19.0%
23.5%
23.4%
27.6%
$398
Out of Network
17.9%
17.6%
12.4%
17.7%
$318
Prior Authorization
12.2%
21.5%
32.9%
36.5%
$350
Experimental and Investigational / Non-Covered
9.2%
17.8%
8.9%
3.1%
$195
COVID Underpayment
5.8%
9.0%
3.4%
16.7%
$31
Timely Filing
2.5%
20.5%
15.6%
13.3%
$191
Underpayment
0.1%
52.2%
0.0%
$177
Appeal Trends: Pathology
Approximately 2% of the pathology accessions received into XiFin RPM require an appeal. Those appeals will be responsible for approximately 1-2% of the pathology practice’s revenue. As noted above, the revenue reclaimed is largely attributed to the first attempted appeal. A robust process that includes multiple attempts is critical in revenue recovery in the event the first appeal is not overturned.
If Not Documented, It Did Not Happen
Payer edits and guidelines can be difficult to follow, particularly if physicians, coders, or billing staff are expected to memorize those requirements.
Making the situation even more challenging is the fact that edits vary widely among payers and are constantly changing. RCM platforms should be updated routinely (XiFin RPM is updated monthly) with payer edit updates, while remaining configurable so that custom edits can be easily built to accommodate specific payer requirements.
Whether it is a payer audit or packaging an appeal, documentation in the pathology report and/or clinical notes should clearly outline the services provided and the medical necessity of those services. If it is not documented, it did not happen. Further, understand the various programs that drive payer edits and guidelines. These edits drive an increased need for discipline and documentation. Be conscious of payer-specific requirements. Cigna, Aetna, and UHC require proprietary forms to be completed when appealing claims.
Benchmarking Productivity
Proactively preventing a denial and avoiding the need to submit a corrected claim or file an appeal reduces the time to reimbursement by four to eight weeks, depending on the payer and type of denial. If denials are not addressed properly and manual workflows persist, diagnostic labs will continue to experience a loss of revenue, and staffing will be insufficient to keep up.
Productivity rates for anatomic and molecular billing teams historically average between 12,000-15,000 accessions per person per full-time equivalent (FTE) per year (clinical laboratory is often much higher). However, with the increases in denials, the resulting demands on back-end teams have increased substantially and impacted productivity rates. This holds particularly true for particularly non-covered, medical necessity, and prior authorization denials.
Further, speed to payment is also improved. By automating appeals, the turn-around-time on submitting back to the payer is reduced, on average, from 45 days to 1-3 days, as seen in the blue bar in the chart above.
By installing front-end edits to help maximize clean claims, up to an additional 54 days can be saved, moving from 135 days to just 30 days for full adjudication.
Automating Workflows with AI
Opportunities to automate the process will reduce time and labor and make decisions more consistent. Once there is a deep understanding of coding, billing, denial management, and strategic appeals, there is the ability to automate the important processes across the RCM process. Automation and AI-powered workflows pave the way for consistent, optimized molecular diagnostics and pathology RCM.
Part 3 will demonstrate how AI can be used in RCM to inform, accelerate, automate, validate, and generate.Watch for updates here at DarkDaily.
Former Vice President received an exclusive tour of a completely fake medical testing laboratory within Theranos, which he found “most impressive”
One thing clinical laboratory leaders and pathologists may still be curious about concerning the whole Theranos affair is how the company founder Elizabeth Holmes could fool so many high-ranking individuals—including then Vice President Joe Biden—into endorsing a completely fraudulent medical laboratory test process.
But it was the lengths to which Holmes and Balwani went to “trick” Joe Biden into endorsing Theranos—and subsequently receive the positive press that followed—that MSN found most intriguing.
According to MSN, in July of 2015 Holmes and Balwani procured Biden’s endorsement by giving the VP a tour of a “completely fake, staged lab.”
“What’s most impressive to me is you’re not only making these lab tests more accessible, you’re charging historically low prices, which is a small fraction of what is charged now, while maintaining the highest standards, and empowering people whether they live in the barrio or a mansion, putting them in a position to help take control of their own health,” stated then VP Joe Biden (above with Elizabeth Holmes) in a Theranos press release. Sadly, many clinical laboratory leaders who were skeptical and outspoken about Theranos’ claims were ignored by the press. (Photo copyright: ABC News.)
Wall Street Journal Reporter Exposes Theranos Fraud
According to a 2018 article by John Carreyrou which was part of his expose´ of Theranos published in The Wall Street Journal, “Ms. Holmes and Mr. Balwani wanted to impress Vice President Biden with a vision of a cutting-edge, automated laboratory. Instead of showing him the actual lab with its commercial analyzers, they created a fake one, according to former employees who worked in Newark. They made the microbiology team vacate a room it occupied, had it repainted, and lined its walls with rows of [Theranos] miniLabs stacked up on metal shelves.”
And the ruse worked. A 2015 Theranos press release outlined the visit at the time and stated that Biden found the facility inspiring and was impressed by the work being done by the company.
“I just had a short tour and I’m glad because you can see first-hand what innovation is all about just walking through this facility. This is the laboratory of the future,” Biden said in the press release.
In 2015, then Vice President Joe Biden toured the Theranos facility with Elizabeth Holmes, observed their supposedly innovative finger stick test system, and met with several Theranos employees. Later reports exposing the fraud stated that Holmes and Balwani were desperate to obtain Biden’s approval as it would provide positive press for Theranos, a good reputation within the industry, and lure potential investors. Theranos later tweeted a photo (above) of the visit showing Biden and Holmes walking amongst numbered blood-testing machines with a huge Theranos logo banner in the background. (Photo copyright: Connor Radnovich/The Chronicle.)
Biden’s visit occurred just a few months before Carreyrou’s Wall Street Journal report questioned the efficacy of Theranos’ blood testing technology and alleged the lab testing company tried to cover up its failures and mislead investors and patients.
Prior to that hard-hitting exposé, Holmes was heralded by the media as a star in the field of medicine. She was even prominently featured on magazine covers of influential business periodicals such as Fortune, Forbes, and Inc.
Others Who Were Bamboozled by Holmes and Balwani
Biden was not the only high-profile individual who was fooled by Holmes, Balwani and their billion-dollar con job. Other high-profile people included:
Theranos ceased operations in September of 2018 amidst the exposing of the fraud and inability to locate a buyer for the company. The shutdown rendered all investments in the company worthless.
Holmes to Receive New Hearing in Federal Court
In January of this year, Holmes was found guilty of three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors about Theranos products. She faces up to 20 years in prison and a fine of $250,000 plus restitution for each count.
And so, clinical laboratory leaders and pathologists now have a better idea as to how Joe Biden was hoodwinked and endorsed a completely fake blood testing laboratory at Theranos. Can he be blamed for his ignorance of clinical laboratory test technology? Probably not. But it makes for interesting reading.
Liquid biopsy tests hold much promise. But inconsistencies in their findings provoke scrutiny and calls from researchers for further development before they can be considered reliable enough for diagnostic use
Many commercial developers of liquid biopsy tests tout the accuracy and benefits of their diagnostic technology. However, there are an equal number of medical laboratory experts who believe that this technology is not yet reliable enough for clinical use. Critics also point out that these tests are being offered as Laboratory Developed Tests (LDTs), which are internally developed and validated and have not undergone regulatory review.
Dark Daily has published several e-briefings on researchers who have sent the same patient samples to different genetic testing labs and received back materially different test results. Now, a new study by Johns Hopkins University concludes that liquid biopsy technology “must improve” before it should be relied upon for diagnostic and treatment decision making.
‘Certification for Medical Laboratories Must Improve’
Liquid Biopsy is the term for drawing whole blood and looking for cancer/tumor cells circulating in the blood stream. This is one factor in the imprecision of a liquid biopsy. Did the blood sample drawn actually have tumor cells? After all, only a limited number of tumor cells, if present, are in circulation.
Gonzalo Torga, MD (above left), and Kenneth J. Pienta, MD (above right), are the two Johns Hopkins Medicine doctors who conducted the recent study into the efficacy of liquid biopsy laboratory developed tests (LDTs) offered by different medical laboratory companies. They published their findings in JAMA Oncology. (Photos copyright: Johns Hopkins.)
In reporting the DNA findings and results from the two medical laboratory companies, researchers discovered that the results completely matched in only three of the 40 patients! The Johns Hopkins researchers are concerned that patients could be prescribed certain cancer treatments based on which lab company’s liquid biopsy test their physician orders, instead of an accurate identification of the unique mutations in their tumors.
“Liquid biopsy is a promising technology, with an exceptional potential to impact our ability to treat patients, but it is a new technology that may need more time and experience to improve,” Gonzalo Torga, MD, Postdoctoral Fellow and Instructor at Johns Hopkins, and the lead author of the study, told Forbes. “We can’t tell from these studies which laboratory’s panel is better, but we can say that certification for these laboratories must improve.”
Unlocking New View of Tumors
Two commercial tests were used for the study:
Guardant360 from Guardant Health, Inc., uses digital sequencing to analyze genomic data points at the single molecular level. It examines 73 genes, including all National Comprehensive Cancer Network (NCCN) listed genes. The test searches for DNA fragments among billions of cells and digitally tags each fragment. This process unlocks a view of tumors that is not seen with tissue biopsies, which helps doctors prescribe the best treatment options for a particular patient.
“As a simple blood test, it provides physicians with a streamlined, cost-effective method to identify genomic alterations that can comprehensively influence a patient’s therapy response,” Helmy Eltoukhy, PhD, co-founder and Chief Executive Officer at Guardant Health, told MDBR.
“The only way of keeping ahead of those diseases and tracking those mutations has been through surgery, through doing a tissue biopsy and physically cutting a piece of the tumor out and sequencing it,” Eltoukhy noted in an interview with Xconomy. “What we’re able to do is essentially get the same, or sometimes better performance to tissue biopsy, but through two teaspoons of blood.”
According to the Guardant Health website, it takes just 14 days for a full report from Guardant360 to reach the ordering physician. In addition, the blood test provides samples with an adequate level of cell-free DNA to test 99.8% of the time and reduces errors and false positives found in standard sequencing methods by 1,000 times. It is common for samples used for tissue sequencing to have insufficient DNA for testing 20% to 40% of the time.
“We believe that conquering cancer is at its core a big data problem, and researchers have been data-starved,” explained Eltoukhy in VentureBeat. “Our launch of the world’s first commercial comprehensive liquid biopsy sparked a boom in cancer data acquisition. Every physician who orders one of our tests, and every patient whose tumor DNA we sequence, adds to this larger mission by improving our understanding of this complex disease.”
PlasmaSELECT-R64, manufactured by Personal Genome Diagnostics (PGDx), evaluates a targeted panel of 64 genes that have biological and functional relevance in making treatment decisions. PGDx announced the expanded version of its PlasmaSELECT assay in March of 2017.
“We are proud to launch the revolutionary PlasmaSELECT 64 expanded assay just six months after we introduced the most accurate, clinically actionable liquid biopsy tumor profiling assay to the market,” said Doug Ward, Chief Executive Officer at PGDx, in a press release. “This update is the first liquid biopsy assay that includes MSI (microsatellite instability) testing as a biomarker for high tumor mutational load, thereby providing cancer patients and their oncologists with information on whether they might be candidates for immuno-oncology therapies. The ability to generate DNA tumor profiling non-invasively using blood or plasma offers many advantages and makes genomic testing more accessible and usable.”
Regulations of LDTs Could be Needed to Improve Liquid Biopsy Tests
There are pathologists and clinical laboratory professionals who believe the technology behind liquid biopsies is not yet reliable enough for clinical use. The tests are being offered as LDTs, which are internally developed and validated, and the Food and Drug Administration (FDA) allows LDTs to be sold without regulatory reviews at this time. However, there are discussions regarding if and how to regulate LDTs, the outcome of which could impact how clinical laboratories are allowed to market the LDTs they develop.
Clearly, liquid biopsies are still in their relatively early stages of development. More testing and evaluation is needed to determine their efficacy. However, their potential to revolutionize cancer detection and care is obvious and a strong motivator for LTD developers, which means there will be future developments worth noting.
Digital Therapeutics combined with clinical laboratory oversight testing could help chronic disease patients avoid surgeries and expensive drug therapies
One area of technology that has fundamentally changed the healthcare industry involves mobile devices. But those early “wellness” tools have evolved. Today’s modern mobile health devices feature software applications (apps) designed to remotely treat chronic conditions by helping modify patient behavior, as well as monitoring drug intake and physical condition biomarkers. These devices are dubbed “Digital Therapeutics,” and they present opportunities for anatomic pathology groups and clinical laboratories.
For if mobile apps are going to be used to monitor patients’ adherence to therapy—including prescription drugs—there will be a need for clinical laboratory tests that work in harmony with these apps. Otherwise, how will providers and insurers know for certain patients’ biomarkers have improved or regressed?
Massive Investments in Digital Therapeutics Companies
Today’s digital therapeutics (AKA, software for drugs) can be tailor to specific treatments of chronic conditions, such as:
· diabetes mellitus;
· cardiovascular disease;
· hypertension; and,
· chronic obstructive pulmonary disease (COPD).
Forbes states that the “future of healthcare will be app based.” That seem likely given the massive influx of capital being directed at the mobile healthcare industry.
The graphic above is taken from a 2015 report by PricewaterhouseCoopers Health Research Institute (PwC), which sourced the data from the 2014 clinician workforce and consumer surveys. Since then, the demand for mHealth products has increased exponentially. Today’s digital therapeutics market includes clinical laboratory and pathology group treatments and drug therapies. (Graphic copyright: PwC.)
The global digital therapeutics market is projected to grow to about $9 billion by 2025. That’s up from $1.7 billion last year, according to a report by Grand View Research. Driving the popularity of digital therapeutics are the benefits it affords patients, explained the report’s summary. They include:
· Continuous monitoring of vital signs;
· Medication management; and,
· Current healthcare reminders.
This is where pathologists and clinical laboratories come in. The medical laboratory can be the source for baseline blood tests before apps are used. And then, ongoing testing can determine if patients are taking drugs according to treatment guidelines and making the appropriate lifestyle changes.
Start-ups Raise Millions, Define Digital Therapeutics Space
One unique aspect of digital therapeutics is its ability to promote health improvements through behavioral changes alone. And millions are being invested in the concept.
For example, Virta Health Corp. raised $37 million in funding for an app that coaches diabetics on a diet to reverse their condition without drugs or surgery, according to MIT Technology Review.
“[Digital therapeutics] is still a fluid space that everyone is trying to categorize,” Peter Hames, co-founder and Chief Executive Officer of Big Health noted in the MIT Technology Review article. Among other programs, Big Health developed Sleepio, a sleep improvement program or insomnia app. Hames says most apps fall into two categories: “medication augmentation” or “medication replacement.”
Omada Health secured $127 million to conduct a clinical trial with Humana that investigates prediabetes, noted Forbes.
The study findings, which appeared in the Journal of Aging and Health, suggest that Omada Health’s digital behavior change program can help people to reduce chronic disease risk, noted a Humana news release.
The study involved Humana Medicare Advantage insurance members, who were enrolled in Omada Health’s Diabetes Prevention Program. The app enabled them to partake in online courses, use wireless scales, and tap other digital health tools as they worked to improve health and reduce risk of type 2 diabetes. Human coaches also were accessible.
“Few efforts have explored the feasibility and effectiveness of using technology to deliver diabetes prevention programs specifically for older adults,” the study researchers wrote.
According to the researchers:
· 501 people with average weight of 208 pounds participated;
· Hour-long lessons were made available and expected to be completed by smartphone, laptop, or tablet;
· Coaches monitored the information participants provided and their requests for counseling;
· 92% of participants completed at least nine of the 16 core online courses, which focused on topics such as changing food habits and increasing physical activities;
· People lost 7.5% of body weight after 12 months, or 13 to 14 lbs.;
· A subsample (69 individuals) who had lab tests performed improved glucose control as evidenced by a -0.14% reduction in glycosylated hemoglobin, and a decrease of -7.08 mg/dL in total cholesterol.
“These results support the clinical validity of the program with Medicare-eligible, at risk older adults. They are added evidence that chronic disease risk reduction is achievable through a variety of modalities, including digital-based programs with human coaching,” the researchers noted.
And because digital therapeutics amasses data that can be leveraged, Omada Health’s program acts as a “continuous learning system,” Sean Duffy, Omada Health’s co-founder and Chief Executive Officer, noted in Undark.
App Tracks People After Heart Attack
Johns Hopkins Medicine’s Corrie Health app is aimed at helping patients recover from heart attacks. A study at Johns Hopkins Bayview Medical Center in Baltimore explored the effectiveness of app-enabled information and resources made available to patients early in the heart attack recovery process, according to Corrie Health’s Website.
Results from the clinical study of 50 patients show no one was readmitted to hospital in the first 30 days, Undark reported.
“We can actually enroll patients who are six or seven hours out of having a stent placed in the ICU. We’re giving [the Corrie Health app] to patients when they have the time to spend watching the videos and asking questions about their medications … We’re getting them to buy-in and learn the skills while they care the most,” Francoise Marvel, MD, an internist affiliated with Johns Hopkins Bayview Medical Center, told Undark.
A Role for Medical Laboratories
So, is there a role for medical laboratories where digital therapeutics are being used? We think so. Pathologists and lab leaders may even want to reach out to venture capitalists working on mobile apps that combine adherence to therapies with medical lab tests.
As our population ages and the shortage of physicians becomes more evident, digital therapeutics may be a smart way to address select patient needs in a quality and cost-effective manner.
Researchers find shopping for medical laboratory tests increased by nearly 50%, and people are saving more than a million dollars annually by shopping for blood tests
Each year, more consumers use online healthcare price-shopping tools to find hospitals, physicians, and clinical laboratories that have the lowest prices. And medical laboratory tests is among the top services on their lists!
Researchers at Vitals of Lyndhurst, NJ, a company that publishes online physician ratings, analyzed how consumers were using its price and quality transparency tools. They confirmed that shopping for medical laboratory tests/blood work is one of the top healthcare procedures checked by consumers.
According to a recent Vitals press release, approximately 46% more people shopped for blood tests in 2015 than the year before, and they saved $1,149,682 by doing so. That’s because their health plans reward them for selecting good quality and low-price providers, as well as adopting healthy behaviors, such as losing weight, exercising more, and lowering high cholesterol scores. (more…)
