By collecting data on MS patients’ activities and abilities, parent company Roche Group hopes to create new drugs and diagnostics to combat this deadly disease
Biotechnology company Genentech, a subsidiary of multinational pharmaceutical/diagnostics company Roche Holdings AG, has developed a smartphone application (app) that enables patients with Multiple Sclerosis (MS) to monitor and track their illness in real-time and provide data and insight to their doctors.
Clinical laboratories may be able to help in the collection, storing, analysis, and reporting of the data obtained by the app. Dark Daily has reported on many mobile health apps that provided medical laboratories with similar opportunities going back to 2010.
Till now, those innovations mostly came from healthcare developers and providers looking to leverage big data for precision medicine and telemedicine. However, big pharmaceutical companies also are developing ways customers can use smartphones to track their chronic conditions and medication usage.
Seeing the ‘Big
Picture’ in Chronic Disease
Smartphone applications (AKA, mobile apps) continue to find their way into the hands of healthcare providers, patients with chronic diseases, and active people who want to monitor their health goals. Clinical laboratories have many opportunities to provide services to physicians and health networks leveraging mHealth at the point-of-care and in rural or resource-strapped regions.
Genentech’s “Floodlight” mobile app, which can be downloaded for free from Apple’s iTunes app store, is part of Floodlight Open, a global MS study that hopes to “understand the effects of MS on mental and physical functioning in a real-world setting.”
The data collected enables researchers to “see ‘big picture’ trends in the data that could help improve understanding of the disease and how it may lead to disability over time,” notes Genentech’s website.
Floodlight enables MS patients with smartphones to monitor
the progression of their illness by measuring mobility, hand motor function,
and cognition. Its passive self-monitoring also helps patients understand
fluctuations in their condition.
To join the study, patients must download the free Floodlight app (shown above) and read and sign the consent form. They then can begin performing the simple tasks described in the app to self-monitor their MS symptoms and disease progression. All data collected is anonymized and shared with the Floodlight Open online community, physicians, and scientists. (Photo copyright: Bloomberg/Marthe Fourcade.)
People using the app can choose to automatically share their
personal information with their physicians via a private ID number.
The tasks MS patients are asked to perform via the app
include:
Matching
symbols to measure how quickly the patient processes information;
Squeezing
a tomato on the screen to measure motor skills and any changes in hand-eye
coordination;
Drawing
shapes to measure speed and accuracy of hand and finger movements;
Performing
a U-turn while walking to discern ability to change direction;
Completing
a two-minute walk to measure stamina and mobility; and,
Standing
still for 30 seconds to measure posture, balance, and stability.
“I am particularly excited about these ways that we can potentially advance the understanding of MS. We hope that this investigation will get the field closer to realizing this better understanding of MS for both patients and providers,” Laura Julian, PhD, Principal Medical Science Director at Genentech, told Multiple Sclerosis News Today. Click here to view the video above and learn more about Floodlight Open and the technology behind it. (Photo copyright: Neurology Live.)
There are currently more than 400 MS patients using the
Floodlight app. Genentech hopes to enroll 10,000 patients in the program within
the next five years. Among the current Floodlight users, there is a 76.5%
adherence to the active tests and an 83.2% adherence to passive monitoring,
such as walking and mobility throughout the day.
When questioned about their satisfaction with the app, study
participants gave it a good to excellent rating of a 73.3 average out of 100
possible points.
Other mHealth Apps
Mobile health applications are becoming a preferred way for
diagnostics developers to gather data for their research. Many apps similar to
Floodlight are currently in development or available for free download.
One such example is FocalView by Novartis. It enables ophthalmological patients to remotely participate in clinical trials, track data about their ocular diseases, and share that information with their physicians. The app was designed to assess visual function, visual acuity, and contrast sensitivity in patients.
Another is Quitter’s Circle, a mobile app developed by Pfizer and the American Lung Association to help individuals quit smoking. The online support community currently has over 165,000 members and offers tips, information, resources, and live conversations for those interested in smoking cessation.
Applications for mHealth are gaining in popularity with both patients and healthcare providers. As the medical community strives to provide more personalized medicine and improve patient outcomes, the data obtained through real-time monitoring can assist doctors and medical laboratory professionals work together to determine the best treatment options for individual patients with chronic diseases.
SMARTChip biosensor undergoing clinical trials in England could pave way for clinical laboratories to provide additional diagnostic tests for monitoring patient progress
Emergency medical workers and mobile clinical laboratory technicians may soon have a point-of-care blood test that can identify patients having a stroke from its earliest moments. Currently being developed by Sarissa Biomedical at the University of Warwick in England, the SMARTChip is a finger-prick blood test that reportedly could cut diagnostic time to under five minutes.
Such a device could be a lifesaver for stroke victims. It would speed treatment decisions, ensure more patients receive treatment, and provide medical laboratories with an opportunity to play a crucial role in saving stroke victims’ lives and monitoring the progress of their recovery.
Development in
Detecting Stroke Lags Behind Other Major Killers
Currently, there is no quick way to diagnose a stroke. Time-consuming CT and MRI scans and other tests must be used to evaluate the type of stroke a patient has had and to rule out other possible causes of symptoms that mimic a stroke. Every minute a major stroke is left treated, the brain loses an estimated 1.9 million neurons.
SMARTChip may change that. If the portable SMARTChip proves
its diagnostic abilities in additional trials, it means stroke patients in the
future may be able to begin receiving treatment sooner, perhaps while in an
ambulance to the hospital.
The biosensor’s arrays measure compounds in blood called purines, which are produced within cells that are deprived of oxygen. During an ischemic stroke, purine levels surge when a blood clot blocks blood flow to the brain.
“Survival rates for heart attack victims have risen dramatically over the last 20 years,” noted Nicholas Dale, PhD, a neuroscientist and professor at the University of Warwick in Coventry, England. “In part, this has come from faster diagnostic tools such as ECG monitors, and rapid biochemical tests. By comparison, stroke patients have got a raw deal. No equally simple biochemical tests exist in stroke. For neuroscientists, this is depressing.”
Neuroscientist and University of Warwick professor Nicholas Dale, PhD, is shown above holding the SMARTChip biosensor. “The key to getting the best recovery is rapid recognition of the stroke followed by prompt action to implement brain-saving treatment,” he told The Guardian in a 2017 profile that outlined his 20-year quest to develop the SMARTChip stroke-detecting biosensor. “This is where SMARTChip is most likely to be transformative.” [Photo copyright: The Guardian/Antonio Olmos for the Observer.]
Clinical trials at University Hospitals Coventry and Warwickshire (UHCW) NHS Trust followed 375 stroke patients who were administered the SMARTChip blood test when admitted to the hospital and again 24 hours later.
Chris Imray, PhD, a professor and vascular surgeon at UHCW NHS Trust, told MidTECH, an organization supporting healthcare innovation in NHS West Midlands, that the device has passed its first hurdle.
“SMARTChip has been developed to address the need for rapid diagnostic tests to inform clinical decision making in the early critical period following a stroke …,” Imray stated in a 2019 MidTECH case study.
“We were able to prove that on the onset of a stroke the
brain releases a detectable quantity of purines into the blood,” he continued.
“SMARTChip is able to measure these purines in the blood and help diagnose the
symptoms of a stroke faster, which means that our patients get the care that
they need as quickly as possible.”
Dale notes the next step for the SMARTChip device will be a
“multicenter paramedic-led clinical trial in early 2019 for the evaluation of
diagnostic accuracy.”
Identifying Type of
Stroke Critical to Correct Treatment
Stroke is the fifth leading cause of death in the US, according to the US Centers for Disease Control and Prevention (CDC). Strokes are also one of the primary causes of serious disability among Americans.
“Use of rapid blood tests to identify patients with stroke is a very important and exciting area of research, and the results of this trial are awaited with keen interest by the stroke community,” Richard Perry, MD, a consultant neurologist at University College London Hospitals, told the Daily Mail.
However, Perry adds a word of caution regarding the SMARTChip’s potential, telling the Daily Mail it is unclear whether tracking purine-release levels will enable doctors to distinguish between an ischemic or hemorrhagic stroke. Most strokes (87%) are ischemic strokes, which occur when blood flow through an artery becomes blocked. This is typically caused by a blood clot in the brain. A hemorrhagic stroke happens when an artery in the brain leaks blood or ruptures.
“These two types of stroke require very different treatment
strategies, so distinguishing them early is another important goal for blood
biomarker studies,” Perry said.
According to ClinicalTrials.gov, the SMARTChip Stroke Study’s estimated completion date is June 2019. If this device ultimately makes it way to the commercial market, clinical laboratories will be looking for ways to build on its leading-edge technology with value-add testing for the monitoring of stroke patients.
These new additions to the Synaptic Health Alliance demonstrate an increasing belief among insurers that blockchain will improve the accuracy and exchange of critical healthcare data
Is blockchain technology ready for widespread use within healthcare? New developments show a growing interest among major health insurers to incorporate blockchain technology into their ongoing operations. As this happens, clinical laboratories will need a strategy, since a large proportion of all health data is made up of medical laboratory test results.
Dark Daily previously reported on how blockchain technology—with its big data and systemwide integration to existing healthcare provider directories—could alter how clinical laboratories obtain/store testing information and bill/receive payment for services rendered. We also covered how blockchain could enable insurers to instantly verify beneficiary’s coverage and attain interoperability between disparate electronic healthcare record (EHR) systems, including laboratory EHRs.
Now, insurers Aetna and Ascension have joined founding members UnitedHealthcare,Multiplan, Quest Diagnostics, Optum, and Humana in the Synaptic Health Alliance (SHA). These organizations formed SHA last year to “leverage [blockchain] technology to facilitate reaching across industry and competitive lines, creating a provider data exchange—a cooperatively owned, synchronized distributed ledger to collect and share changes to provider data,” according to the organization’s website.
What should be on the
minds of every hospital and independent medical laboratory administrator is
what will be required to engage in information exchange with such a
distributed, non-centralized provider ledger.
What is Blockchain and How Does it Apply to Healthcare and Diagnostic
Providers?
The SHA defines
blockchain as “a shared, distributed digital ledger on which transactions are
chronologically recorded in a cooperative and tamper-free manner [such as a] spreadsheet
that gets duplicated multiple times across a network of computers, which is
designed to regularly update the spreadsheet.”
Though the SHA’s efforts are still being tested, medical laboratories and pathology groups should note how Quest’s “physical relationship” with healthcare providers—as Jason O’Meara, Senior Director of Architecture at Quest Diagnostics describes it—gives the blood company an advantage. “The first day a practice opens up, they need internet, a telephone provider, and they have to have a diagnostics provider,” he told FierceHealthcare.
“Each of our organizations expends a tremendous amount of
energy and effort trying to get this data as good as it can be,” O’Meara
continued. “The challenge is—when we’re doing this in independent silos—it
leads to duplication of efforts.”
O’Meara notes that while health plans collect needed
information for months after a new practice opens, Quest often knows of these
new locations “several weeks in advance” because new locations need supplies
and the capability to order diagnostic tests from day one.
This physical-relationship advantage applies to all clinical
laboratories, because they often are the first to know—and provide supplies
to—new provider offices.
This informative video describes three ways blockchain will change healthcare. Click here to view the video or click on the image above. (Photo/video copyright: The Medical Futurist.)
Trimming Costs
through Redundancy Elimination
Federal regulations require healthcare providers and payers
to maintain frequently updated directories of care providers and services. These
directories are then used across and between health networks to determine
service availability, coverage options, and other critical elements related to obtaining
care and reimbursements.
“Who weren’t accepting new patients despite the
directory saying that they were; and,
“Incorrect or disconnected phone numbers.”
In other words, CMS found that in its own MAO directories, about
half of the information enrollees need to make important healthcare choices is either
incorrect or out of date!
The SHA intends to change that by using blockchain to create
a shared, up-to-the-minute accurate resource with interoperability between all
participating providers.
By allowing alliance participants to consolidate directory
updates, the system could eliminate silos and drastically reduce time and money
spent applying updates to directories individually at each provider.
“We want this to be a public utility that every health plan
and provider can participate on,” O’Meara
told FierceHealthcare. “There’s no
other technology we’re aware of that would allow for that type of robustness.”
Other Efforts to use
Blockchain in Healthcare
In January, HealthPayerIntelligence (HPI) outlined another strategic initiative similar to the SHA involving Aetna, Anthem, Health Care Service Corporation (HCSC), IBM, and PNC Bank to create a “health utility network” using blockchain technology “to improve data accuracy for providers, regulators, and other stakeholders, and give our members more control over their own data.”
Lori Steele, Global Managing Director for IBM Healthcare and Life Sciences, told HPI that“blockchain’s unique attributes make it suitable for large networks of members to quickly exchange sensitive data in a permissioned, controlled, and transparent way.”
She continued, “The fact that these major healthcare players
have come together to collaborate indicates the value they see in working
together to explore new models that we think could drive more efficiency in the
healthcare system and ultimately improve the patient experience.”
As medical laboratories continue to endure the financial pressures of healthcare reform, blockchain appears to offer yet another way to increase efficiencies, improve accuracy and accountability, and exchange data between disparate information systems.
While many possible uses for this technology remain in
proof-of-concept and pilot-testing phases, pathologists and medical laboratory
administrators looking to stay ahead of trends will want to keep up with
blockchain as it continues to mature.
Medicare officials are including most hospital laboratories in this PAMA data reporting cycle, but hospitals face $10,000/day federal penalties for not filing, filing late, or filing incomplete or inaccurate data
Clinical laboratories operated by hospitals and health systems could prove to be a game changer for the lab industry in this upcoming PAMA private payer lab test price reporting cycle. But that upside comes with risk.
For this reporting period, the federal Centers for Medicare and Medicaid Services (CMS) has defined any hospital laboratory that uses the CMS 1450 14X to bill for Medicare Part B clinical laboratory tests as an “applicable laboratory” under the Protecting Access to Medicare Act of 2014 (PAMA). That means a majority of hospital labs in the United States are required to report the prices they were paid by private health insurers to CMS.
This makes the current PAMA reporting period a high-stakes
endeavor, because unprepared clinical laboratories could face federal fines of
$10,000/day. The reporting eligibility requirements are broad and may leave unprepared
clinical laboratories at significant risk.
“Receive more than 50% of their Medicare revenues from laboratory and physician services during a data collection period.
“Laboratories will collect private [payer] data from January
1, 2019, through June 30, 2019, and report it to CMS by March 31, 2020.”
In addition to shrinking margins, increased competition,
reduced reimbursement rates, and ever-changing regulations, clinical
laboratories now face new fines that could prove financially catastrophic for
even the largest, most efficient labs.
New Rules and
Reporting Requirements Threaten Unprepared Labs
Healthcare reform continues to reshape how healthcare is both delivered and billed across the country. GenomeWeb reported in 2017 that CMS expects PAMA to save the government $3.93 billion by 2028.
While medical laboratories continue to grapple with the
impact of reduced reimbursement rates under PAMA’s revised CLFS final rule, the
new rules for what constitutes an “applicable lab” and the new reporting
requirements that started January 1, 2019, add yet another level of complexity
to reporting and compliance concerns.
Rodney Forsman, Assistant Professor Emeritus of Lab Medicine and Pathology at the Mayo Clinic College of Medicine, in Rochester, MN, told Dark Daily that “Laboratories must work to identify reporting concerns, billing and IT limitations, and identify current statutes and limitations to present to compliance officers and stakeholders. Failure to do so could leave labs liable for fines of up to $10,000 per day.”
Compliance Will Be a
Team Effort
He further emphasizes that compliance with reporting
requirements will involve a range of stakeholders within the hospital and its
laboratory. Information technology (IT) teams, compliance officers, laboratory C-suite
executives, and billing departments all will play a role in implementing the
changes needed and reporting the data required.
Therefore, understanding exactly what regulations require—and
what is at stake—is crucial to not only implement critical changes, but to ensure
that the lab understands and is on-board with said changes.
Considerations include:
Understanding the new collection and reporting
periods;
Assessing billing and IT limitations in relation
to reporting requirements; and,
Implementing proper data capture and validation
systems ahead of data submission.
Rodney Forsman (left), Assistant Professor Emeritus of Lab Medicine and Pathology at the Mayo Clinic College of Medicine, and Brian Kemp (right), Vice President of Change Healthcare, stress that a current understanding of PAMA’s impact is crucial and that clinical laboratories are at considerable risk if they are not compliant with the latest PAMA requirements. (Photo copyright: Dark Daily.)
This important webinar will include:
A brief overview of PAMA;
The latest updates to PAMA reporting
requirements; and,
Actionable information for applicable labs
required to meet them.
The speakers will also cover concerns for hospital outreach programs and specific CMS 1450 14X Type of Bill (TOB) billing changes to help hospital COOs, CFOs, CIOs, contract officers, and compliance officers understand the latest implications of ongoing PAMA requirements.
Laboratory directors, managers, administrators, and IT and
billing staff will want to attend this critical webinar to learn essential PAMA
reporting considerations and pitfalls to avoid.
(To register for this
critical Feb. 20th webinar, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/pama-in-2019-what-labs-need-to-know-to-collect-data-report-on-time-and-avoid-10000-per-day-penalties/.)
With a now-estimated price tag of $16.1 billion, federal regulators and government representatives question the VA’s replacement for their VistA medical records system
Originally estimated to cost $10 billion, a contract to
replace the federal Department of Veterans
Affairs (VA) electronic
health record (EHR) system will now cost $16.1 billion, according to new
estimates, and this has drawn increased scrutiny from regulators and the media.
ProPublica reports that the initial
deal signed in May 2018 between the VA and Cerner,
one of the nation’s largest vendors of laboratory
information systems (LIS) and anatomic pathology information systems,
included a $10-billion ‘no-bid’ contract to replace the VA’s aging VistA medical records system
over 10 years. Since then, that estimate has ballooned to $16 billion, and with
this latest increase, is now at $16.1 billion.
One ongoing challenge facing clinical
laboratories and anatomic
pathology groups is maintaining interfaces to the plethora of disparate EHR
systems implemented in healthcare networks across the country. It’s a costly
undertaking that has nearly bankrupted many healthcare providers.
Thus, these developments could impact how medical
laboratories and pathology groups work and communicate with the VA in the
future and are worth paying attention to.
In response, John Windom,
Executive Director of the federal government’s Office of Electronic Health Record Modernization (OEHRM), told the House Committee that the VA’s
original estimate failed to include roughly $35 million/year for VA government employee
costs over the decade-long Cerner contract.
“We have to have highly qualified subject matter experts to
grade the implementation efforts of Cerner. Those people in the industry cost
money,” noted Windom, Health Data Management reported.
This review hearing came just after ProPublica reported on a progress report where Cerner had assigned
an alert rating of “yellow trending toward red” to the VA’s EHR implementation efforts.
“It scares the hell out of me,” Ken Kizer, MD, MPH, CEO of health information technology (HIT) developer Medsphere Systems, and former Under Secretary for Health at the VA, told ProPublica. “I don’t think the VA, given other issues, has the luxury to have something that doesn’t work.” (Photo copyright: UC Davis Health.)
Deploying a new EHR in a system as large as the VA is a
highly complex operation. Adding in government oversight—and coordinating
development and deployment between all the parties involved—further complicates
the VA and Cerner’s efforts.
One complication not receiving much coverage is the fact
that EHR systems designed primarily for insurance billing purposes may be
incompatible with the needs of the VA and other federal agencies that do not
bill insurance companies.
“VA is different. The focus of the VA’s electronic medical
record is never about clinical documentation to support billing. It’s about
giving the information to the provider at the right time to inform the best
care. There are true risks to patients if they don’t do this right,” Heather
Woodward-Hagg, PhD, former National Program Director (Acting), Veterans
Engineering Resource Centers (VERC) and Founding Director, Veterans Affairs
Center for Applied System Engineering (VA-CASE), told ProPublica.
Nevertheless, according to coverage of the Review Committee
hearing by MeriTalk, Windom remains hopeful
that the project’s financials will improve. “There are going to be efficiencies
gained we can’t forecast at this point,” he told the Committee members.
According to MeriTalk, the original deal between
the DoD, Cerner, and Leidos in 2015 was estimated
at $4.3 billion. However, in July 2018, the DoD increased the project budget by
$1.2 billion—bringing the total estimate to $5.5 billion.
Still, this falls far short of the VA estimate of $16.1
billion leaving regulators and media outlets questioning the health and
oversight of the Cerner/VA project.
The VA estimate also is well above the cost of other notable
EHR implementations—such as the development and deployment of Kaiser
Permanente’s HealthConnect EHR.
Speaking with InfoWorld in 2013, Philip Fasano, then CIO
of Kaiser Permanente, noted
that it cost roughly $4 billion to build a system alongside Epic to serve their
9-million members. When asked what it would take to implement a similar system
nationally, he estimated costs in the “tens of billions.”
The Hidden Costs of
EHR Implementation
Speaking with Becker’s Hospital Review in 2016, Eric Helsher, Vice
President of Client Success at Epic, highlighted
how difficult it is to budget for such upgrades. “It’s misleading to say, ‘A
hospital is undergoing a $X million Epic
implementation,’ because the install includes far more than simply the Epic
software,” he said. “An EHR from any vendor requires technology like servers
and storage to house the software—be it on-premise
or in the Cloud—and laptops and mobile devices to access it. That would be like
if you go buy a fully loaded laptop and attribute that full cost to Microsoft
Word. You needed the computer to get Word.”
Whether the VA and Cerner can determine ways to bring the
contract in line with budgets remains to be seen. However, while healthcare
reform highlights EHR implementation and interoperability as major concerns in
the modern US healthcare landscape, the VA’s latest attempts at replacing their
VistA medical records system serves as a reminder of the complexity and hidden
costs facing healthcare providers working to meet healthcare reform
requirements and offer a more personalized care experience.
This, of course, applies equally well to clinical
laboratories.
While clinical laboratories may not be directly affected by copay accumulators, anything that affects patients’ ability to pay for healthcare will likely impact lab revenues as well
Here’s a new term and strategy that some big employers are
deploying in an attempt to control the choice of health benefits provided to
their employees. The term is “copay accumulator” and it is intended to offset
efforts by pharmaceutical companies to minimize what consumers must pay
out-of-pocket for expensive prescription drugs.
Clinical laboratory managers and pathologists will have a front row seat to watch this next round in the struggle between industry giants for control over how patients pay for drugs and treatment regimes.
Pharmaceutical companies on one side and health insurers and employers on the other side have played brinksmanship over medication copays for years. Now at the center of this struggle are copay accumulators, a relatively new feature of plans from insurers and pharmacy benefit managers (PBMs) on behalf of the large employers they serve.
More than 41-million Americans use copay accumulators, and about nine million use similar though limited copay maximizer programs, Zitter Health Insights, a New Jersey-based pharma and managed care consultancy firm, told Reuters.
Now, big employers are getting in on the game. Walmart
(NYSE:WMT) and Home Depot (NYSE:HD) are among a growing number of companies using
copay accumulators and copay maximizers to keep their healthcare costs down and
encourage employees to seek lower-cost alternatives to expensive brand
prescriptions (generic drugs).
About 25% of employers currently use such programs, and 50% of employers are anticipated to be doing so in just two more years, the National Business Group on Health told Reuters.
What Are Copay
Accumulators and How Do They Work?
In response to popular drug company discount cards,
insurance companies developed the “copay accumulator.” Here’s how it works.
Typically, patients’ insurance plan deductibles can be thousands
of dollars. Thus, even after plan discounts, patients often pay hundreds, even
thousands of dollars each month for prescribed medications. Insurance companies
see a beneficial side to this, stating the cost encourages patients to be aware
of their medications and motivates them to try lower-cost non-branded
alternatives (generic drugs), all of which saves insurance plans money.
However, many patients with high-deductibles balk at paying
the high cost. They opt to not fill prescriptions, which costs pharmaceutical
companies money.
To encourage patients to fill prescriptions, drug companies
provide discount cards to help defray the cost of the drugs. The difference
between the discounted payment and the full price of the drug is paid by the
pharmaceutical company. But these discount cards interfere with insurance
companies’ ability to effectively track their enrollees’ drug usage, which
impacts the payers’ bottom lines.
When a patient uses a drug discount card at the point-of-sale, the sale is noted by the patient’s health insurer and the insurer’s copay accumulator program kicks in. It caps the total accumulated discount an enrollee can take for that medication and prevents any patient payments to apply toward the plan’s deductible. Once the drug company’s discount card threshold is reached, the patient bears the full cost of the drug, a ZS Associates Active Ingredient blog post explained.
Critics of copay accumulators point out that patients could
end up paying full price for extremely expensive prescriptions they previously
accessed with discount cards, while simultaneously making no progress toward
fulfilling their insurance deductibles. Or, they will simply stop taking their
medications altogether.
“A medication which previously cost $7 may suddenly cost hundreds or even thousands of dollars because the maximum amount of copay assistance from the [drug] manufacturer was reached,” noted Ken Majkowski, Pharm.D, Chief Pharmacy Officer at FamilyWize (a company that offers its own prescription savings programs), in a blog post. “Since the health plan will no longer allow the copay amounts to contribute to the patient’s deductible, the cost of the medication remains very high.”
Major Employers Implement
Their Own Copay Accumulator Programs
Enter the next goliath into the fray—the large employer. Executives
at Walmart and Home Depot say discount drug coupons drive up healthcare costs
and give their employees and their family members no incentive to explore lower
cost alternatives, Reuters reported.
Walmart’s pharmacy benefits are managed by Express Scripts, a prescription benefit plan provider that fills millions of prescriptions annually, according to the company’s website. Meanwhile, Home Depot’s pharmacy benefits are operated by CVSHealth, which focuses on therapies for cystic fibrosis, hepatitis C, cancer, HIV, psoriasis, pulmonary arterial hypertension, and hyperlipidemia, Reuters noted.
Insurance Associations
Weigh-In
Health insurance company representatives say the need for copay accumulators begins with the high price of pharmaceuticals. Insurers are not the only ones concerned about these costs. The American Hospital Association (AHA), the Federation of American Hospitals (FAH), and the American Society of Health-System Pharmacists (ASHP) recently released a report showing total drug spending per hospital admission increased by 18% between 2015 and 2017, and some drug categories rose more than 80%.
“The bigger question is why do we need copay coupons at all? It’s very important to recognize the problem starts with the [drug] price. This is the real underlying problem,” Cathryn Donaldson, Director of Communications, America’s Health Insurance Plans (AHIP), told the Los Angeles Times.
In their blog post, ZS Associates advised drug companies to
“push-back” on the copay accumulators. The Evanston, Ill.-based consultancy
firm recommends pharma executives change the way they run the discount cards—such
as paying rebates directly to patients instead of working through pharmacies.
Medical laboratory leaders need to be aware of programs,
such as copay accumulators, and the associated issues that affect patients’
ability to pay for their healthcare. Because large numbers of patients struggle
to pay these high deductibles, it means clinical laboratories will be competing
more frequently with hospitals, physicians, imaging providers, and others to
get patients to pay their lab test bills.
