Since Alexa is now programed to be compliant with HIPAA privacy rules, it’s likely similar voice assistance technologies will soon become available in US healthcare as well
Shortages of physicians and other types of caregivers—including
histopathologists
and pathology
laboratory workers—in the United Kingdom (UK) has the UK’s National Health Service (NHS) seeking alternate
ways to get patients needed health and medical information. This has prompted a
partnership with Amazon to use the Alexa virtual assistant to
answer patients healthcare inquiries.
Here in the United States, pathologists and clinical
laboratory executives should take the time to understand this development.
The fact that the NHS is willing to use a device like Alexa to help it maintain
access to services expected by patients in the United Kingdom shows how rapidly
the concept of “virtual clinical care” is moving to become mainstream.
If the NHS can make it work in a health system serving 66-million
people, it can be expected that health insurers, hospitals, and physicians in
the United States will follow that example and deploy similar virtual health
services to their patients.
For these reasons, all clinical laboratories and anatomic
pathology groups will want to develop a strategy as to how their
organizations will interact with virtual health services and how their labs
will want to deploy similar virtual patient information services.
Critical Shortages in Healthcare Services
While virtual assistants have
been answering commonly-asked health questions by mining popular responses on
the Internet for some time, this new agreement allows Alexa to provide
government-endorsed medical advice drawn from the NHS website.
By doing this, the NHS hopes to reduce the burden on
healthcare workers by making it easier for UK patients to access health
information and receive answers to commonly-asked health questions directly from
their homes, GeekWire
reported.
“The public needs to be able to get reliable information
about their health easily and in ways they actually use. By working closely
with Amazon and other tech companies, big and small, we can ensure that the
millions of users looking for health information every day can get simple,
validated advice at the touch of a button or voice command,” Matthew Gould, CEO of NHSX, a division of the NHS that focuses
on digital initiatives, told GeekWire.
The
Verge reported that when the British government officially announced
the partnership in a July press
release, the sample questions that Alexa could answer included:
Alexa, how do I treat a migraine?
Alexa, what are the symptoms of the flu?
Alexa, what are the symptoms of chickenpox?
“We want to empower every patient to take better control of
their healthcare and technology like this is a great example of how people can
access reliable, world-leading NHS advice from the comfort of their home,
reducing the pressure on our hardworking GPs (General Practitioners) and
pharmacists,” said Matt
Hancock, Secretary of State for Health and Social Care, in the press release.
MD
Connect notes that the NHS provides healthcare services free of charge to
more than 66-million individuals residing in the UK. With 1.2 million
employees, the NHS is the largest employer in Europe, according to The
Economist. That article also stated that the biggest problem facing the
NHS is a staff shortage, citing research conducted by three independent
organizations:
Their findings indicate “that NHS hospitals, mental-health
providers, and community services have 100,000 vacancies, and that there are
another 110,000 gaps in adult social care. If things stay on their current
trajectory, the think-tanks predict that there will be 250,000 NHS vacancies in
a decade,” The Economist reported.
“This idea is certainly interesting and it has the potential
to help some patients work out what kind of care they need before considering
whether to seek face-to-face medical help, especially for minor ailments that
rarely need a GP appointment, such as coughs and colds that can be safely
treated at home,” Professor
Helen Stokes-Lampard, Chairman at the Royal
College of General Practitioners, and Chair of the Board Of
Directors/Trustees at National
Academy of Social Prescribing, told Sky News.
“However,” she continued, “it is vital that independent
research is done to ensure that the advice given is safe, otherwise it could
prevent people seeking proper medical help and create even more pressure on our
overstretched GP service.”
Amazon has assured consumers that all data obtained by Alexa
through the NHS partnership will be encrypted to ensure privacy and security,
MD Connect notes. Amazon also promised that the personal information will not
be shared or sold to third parties.
Alexa Now HIPAA Compliant in the US
This new agreement with the UK follows the announcement in April
of a new Alexa
Skills Kit that “enables select Covered Entities and their Business
Associates, subject to the US Health
Insurance Portability and Accountability Act of 1996 (HIPAA), to build
Alexa skills that transmit and receive protected
health information (PHI) as part of an invite-only program. Six new Alexa
healthcare skills from industry-leading healthcare providers, payors, pharmacy
benefit managers, and digital health coaching companies are now operating in
our HIPAA-eligible environment.”
Developers of voice assistance technologies can freely use
these Alexa skills, which are “designed to help customers manage a variety of
healthcare needs at home simply using voice—whether it’s booking a medical
appointment, accessing hospital post-discharge instructions, checking on the
status of a prescription delivery, and more,” an Amazon
Developer Alexa blog states.
The blog lists the HIPAA-compliant Alexa skills as:
Express
Scripts: Members can check the status of a home delivery prescription and can
request Alexa notifications when their prescription orders are shipped.
Cigna
Health Today by Cigna (NYSE:CI): Eligible employees with one of Cigna’s
large national accounts can now manage their health improvement goals and
increase opportunities for earning personalized wellness incentives.
Swedish
Health Connect by Providence St.
Joseph Health, a healthcare system with 51 hospitals across seven states
and 829 clinics: Customers can find an urgent care center near them and
schedule a same-day appointment.
Atrium
Health, a healthcare system with more than 40 hospitals and 900 care
locations throughout North and South Carolina and Georgia: Customers in North
and South Carolina can find an urgent care location near them and schedule a
same-day appointment.
Livongo,
a digital health company that creates new and different experiences for people
with chronic conditions: Members can query their last blood sugar reading,
blood sugar measurement trends, and receive insights and Health Nudges that are
personalized to them.
HIPAA Journal notes: “This is not the first time that Alexa skills have been developed, but a stumbling block has been the requirements of HIPAA Privacy Rules, which limit the use of voice technology with protected health information. Now, thanks to HIPAA compliant data transfers, the voice assistant can be used by a select group of healthcare organizations to communicate PHI without violating the HIPAA Privacy Rule.”
Steady increases associated with the costs of medical care
combined with a shortage of healthcare professionals on both continents are
driving trends that motivate government health programs and providers to
experiment with non-traditional ways to interact with patients.
New digital and Artificial
Intelligence (AI) tools like Alexa may continue to emerge as methods for
providing care—including clinical laboratory and pathology advice—to healthcare
consumers.
When patients use telehealth, how do they choose medical laboratories for lab test orders their virtual doctors have authorized?
Doctors On Demand is expanding the nation’s primary care services by launching a virtual care telehealth platform for health insurers and employers. This fits into a growing nationwide trend toward increased use of remote and virtual doctor’s visits. But how should clinical laboratories and anatomic pathology groups prepare for fulfilling virtual doctors’ lab test orders in ways consistent with current scope-of-practice laws?
The rise of virtual care is made possible by innovations in digital
and telecommunication technology. Driven by studies showing more patients are
opting out of conventional primary care visits that take too much time or are
too far away, the healthcare industry is responding by bringing medical
services—including pathology and clinical laboratory—closer to patients through
retail settings and urgent care clinics.
Many pathologists and clinical laboratory managers are unaware of how swiftly patients are becoming comfortable with getting their primary care needs met by other types of caregivers, including virtually. Recently, the Health Care Cost Institute (HCCI) published data showing that visits to primary care physicians declined 18% from 2012 to 2016 among adults under 65 who had employer-sponsored insurance. However, during these same years, visits with nurse practitioners and physician’s assistants increased by 129%!
Another way that providers are making it easier for patients to access healthcare is through the Internet.
Doctor On Demand, a San Francisco-based virtual care provider, is targeting insurers and employers with its Synapse telehealth platform, which integrates into existing health plan networks and enables virtual primary care, according to a news release.
How Synapse Works
Humana is using Synapse in its new On Hand virtual primary
care plan, the news release states. Humana said its members have no copay for
the virtual doctor visits and $5 copays for standard medical laboratory tests
and prescriptions. Synapse’s “smart referrals” function sends referrals to
in-network clinical laboratories, imaging providers, and pharmacies, Healthcare
Dive reported.
“Humana has a deep footprint, and this is a payer looking to create a virtual primary care network as a way to contain cost and thinking about how care is coordinated and delivered,” Josh Berlin, a Principal and Healthcare Co-Practice Leader with advisory firm Citrin Cooperman, told FierceHealthcare.
Changing Primary Care Relationships
Another insurer advancing telehealth is Oscar Health, which offers its own Doctor on Call telehealth platform. The New York City-based health plan reported in a year-end review that 82% of its members had set up a profile that gave them access to a concierge care team and 24/7 telemedicine services, including clinical laboratory test results.
During 2018, Oscar’s concierge teams addressed 1.2 million
questions from 77% of its members, the insurer said.
Becker’s Hospital Review reports that telehealth usage by Oscar’s members is five times higher than the average for the healthcare industry.
Will Clinical Laboratories Receive Virtual Referrals?
In a way, it has never been easier for patients to see a
primary care doctor or research symptoms. Additionally, the Internet makes it
possible for patients to self-diagnose, though not always to the benefit of
healthcare providers or the patients.
So, how should clinical laboratories respond to this growing expansion of virtual care doctors? Experts advise lab leaders to reach out to health plans soon and determine their inclusion in virtual healthcare networks. Labs also may benefit by making test scheduling and reporting accessible and convenient to insurance company members and consumers choosing telehealth.
During his keynote presentation at the 24th Annual Executive War College in May, Ted Schwab, a Los Angeles area Healthcare Strategist and Entrepreneur, said, “If you use Google in the United States to check symptoms, you’ll find 350 different electronic applications that will give you medical advice—meaning you’ll get a diagnosis over the Internet. These applications are winding their way somewhere through the regulatory process. (See Schwab’s expanded comments on this trend in, “Strategist Explains Key Trends in Healthcare’s Transformation,” The Dark Report, October 14, 2019.)
Schwab advises that in this “time of change” it’s critical
for labs to take proactive measures. “What we know today is that
providers—including clinical laboratories and pathology groups—who do nothing
will get trampled. However, those providers that do something proactively will
most likely be the winners as healthcare continues to transform.”
Online reputation management is increasingly becoming a critical function that all providers, including clinical laboratories, must address or risk losing revenue
Recent surveys cite growing evidence that Facebook (NASDAQ:FB) and online review sites such as Yelp (NYSE:YELP) are swiftly becoming healthcare consumers’ preferred sources for researching doctors, hospitals, medical laboratories, and other medical service providers.
Healthcare consumers are using the Internet to review information
on healthcare providers prior to visits. More important, data show a majority
of Americans share their healthcare experiences publicly online following
visits with providers.
This should serve as a wakeup call for clinical laboratories and anatomic pathology groups that have not developed effective social media strategies, as they are clearly among the health services being evaluated.
More than half of Americans (51%) reported sharing their healthcare experiences online, an increase of 65% over just one year ago;
Among Millennials (people born between 1981 and 1996) that number jumps to 70%, a 94% increase over last year;
70% of Americans overall say online ratings and reviews influenced their choices of physicians and facilities;
More than 40% of respondents admitted they researched doctors online even after being referred to them by another healthcare professional.
Healthcare Dive also noted that Millennials are likely to consider online reviews and ratings of healthcare professionals to be trustworthy.
97% of 24- to 34-year-olds report believing
online comments are reliable;
While 100% of the 18- to 24-year-olds surveyed felt
similarly.
Pathologists and clinical laboratory administrators should
consider the two findings above as evidence that a major change has already
happened in how the younger generations look for—and select—their hospitals,
their physicians, and their clinical laboratory providers. Thus, every
pathology group and clinical laboratory should have a business strategy for
managing the Internet presence of their labs. Failure to do so means that
competing labs that do a good job of managing their Internet presence will be
more successful at winning the lab testing business of Gen Xers (born
1965-1980), Millennials (Gen Y, born 1981-1996), and Gen Z (born 1997-2009).
In addition, the survey discovered that the most important
qualities consumers look for in a doctor are:
Friendly and caring attitudes;
Physicians’ ability to answer questions; and
Thoroughness of examinations.
Those polled reported the most frustrating issues when
dealing with healthcare professionals were:
Office wait times;
Cost and payment concerns;
Wait times for exam and medical laboratory
results; and
Scheduling appointments.
It’s All in a Word
Earlier this year, Healthcare Dive also reported on research that examined online reviews and their content conducted by Penn Medicine. Researchers at the University of Pennsylvania used digital tools and data analytics to help healthcare providers better understand and improve the patient experience.
The researchers analyzed 51,376 online reviews about 1,566
hospitals posted on Yelp over a 12-year period. They published their findings in
the Journal
of General Internal Medicine (JGIM).
They concluded the word most often found in positive Yelp
reviews was “friendly.” Their example of how positive review writers used this word:
“The doctors, nurses, and X-ray technician who helped me out were all so cool
and friendly. It really restored my faith in humanity after I got hit on my
bike.”
Other words the researchers commonly found in good online
reviews include “great, staff, and very.”
“Told” was the word most often found in negative reviews. The
researchers’ example: “I constantly told them that none of that was true and
the nurse there wouldn’t believe me.” It appears from the JGIM study
that Millennials often felt healthcare professionals did not listen to them.
The researchers identified “worst, hours, rude, said, no and
not” as other words often found in negative reviews.
Half of Millennials Prefer Internet Research and Online
Virtual Healthcare
Another survey conducted by Harmony Healthcare IT, a health data management firm based in South Bend, Ind., found that more millennials are researching the Internet for medical advice in lieu of actual doctor visits.
PC Magazine reported Harmony Healthcare IT’s survey found:
73% of Millennials reported following medical
advice found online instead of going to a doctor; and
93% reported researching medical conditions
online in addition to a doctor visit.
The survey also found that 48% of millennials trust online
resources for medical information and that 48% prefer virtual doctor office
visits over in-person visits.
In addition, 24% of this age group have gone five or more years without a physical and 57% prefer high-deductible health plans (HDHPs).
“With an emphasis on convenience, low cost, and technology, it will be interesting to see how this generation helps shape the future of health and how both patients and providers will adapt to those changes along the way,” Harmony Healthcare IT wrote in a blog post.
The results of these surveys illustrate why clinical laboratories
and anatomic pathology groups must have a social media strategy for managing
their reputations and presence on the Internet, especially where Millennials
are concerned.
That strategy should include easy and informative ways for
patients to learn about medical laboratory services, pricing of lab tests,
quality of work, and methods consumers can use to leave online feedback and
receive responses to their comments.
This CMS pilot program is another opportunity for clinical laboratories to provide medical lab test services and collect specimens outside of traditional sites of healthcare services
Clinical laboratories and anatomic pathology groups are once again reminded to develop strategies that support the increasing number of physicians providing medical care in nontraditional outpatient settings. Now in its seventh year, the Medicare Independence at Home program is reviving the tradition of healthcare providers making house calls to elderly patients who have certain chronic illnesses, and so far, the results are promising.
Primary care teams at the 14 participating healthcare
providers include physicians, nurse practitioners, physician assistants,
pharmacists, social workers, and other staff.
Hospital networks participating in the federal Centers for Medicare and Medicaid Services (CMS) primary care pilot program are saving the government millions of dollars, while improving healthcare outcomes for their chronically ill patients and earning millions in return.
A CMS fact sheet states that to qualify for incentive payments, participating providers must meet performance thresholds of at least three of the following six measures:
Follow-up contact within 48 hours of a hospital
admission, hospital discharge, and emergency department visit;
Medication reconciliation in the home within 48
hours of a hospital discharge and emergency department visit;
Annual documentation of patient preferences;
Hospital admissions for ambulatory care
sensitive conditions; and
Emergency department visits for ambulatory care
sensitive conditions.
Northwell Health House Calls a Model of Success
The Independence at Home (IAH) demonstration project from the federal Center for Medicare and Medicaid Innovation (CMMI) was established in 2010 as part of the Affordable Care Act. In 2018, Congress extended the pilot for another two years and increased the number of eligible participants from 10,000 to 15,000.
Northwell Health House Calls has been a model of success within the federal IAH demonstration project. The New York-based healthcare provider has annually reduced costs while improving health outcomes for participating patients.
Results from the fifth year of the program (Oct. 1, 2016 through Sept. 30, 2017) show Northwell Health reduced per-beneficiary-per-month (PBPM) expenditures to $2,703, compared to a spending target of $3,874, according to the most recent CMS Fact Sheet. In return, Northwell Health received an incentive payment of more than $1.82 million. That’s the largest payout among the eight practices that met incentive payment quality benchmarks and savings requirements.
According to the news release, patients in Northwell’s House Calls program receive comprehensive, coordinated care, that includes ultrasounds, radiology, electrocardiograms, sleep studies, clinical laboratory work, physical exams, occupational and speech therapy, and social services, as well as intravenous fluids and prescription refills.
Physicians, nurse practitioners, and other clinicians are
available for urgent, same-day visits during the work week. The team also is
accessible 24/7 to answer clinical questions from patients and caregivers, or
to arrange urgent services.
In an interview with Crain’s New York Business, Karen Abrashkin, MD, Medical Director of Northwell Health House Calls, said, “We’ve achieved cost savings by providing really good primary care and ongoing care for medical illnesses. We’re responsive to patients whenever they have a change in condition.”
How Patients Qualify for Medicare’s IAH Program
To qualify for the Independence at Home pilot, patients must:
Currently be Medicare beneficiaries with two or
more chronic health conditions;
Need help with activities of daily living; and
Have had a hospital admission and rehab stay
within the past year.
Though he praises the House Calls program’s success, Kristofer Smith, MD, Senior Vice President of Population Health Management at Northwell Health stated that the program should be expanded slowly and only extended to those who would benefit most from in-home care.
“We need to be thoughtful about making sure we’re not expanding beyond the populations for whom we know it works because [it would] dilute the results,” he told Modern Healthcare.
Will Medicare’s Primary Care at Home Program Continue
Beyond the Pilot?
The Independence
at Home pilot is scheduled to end Dec. 31, 2020. What happens next is
uncertain. Efforts in Congress to create a permanent home-based primary care
program under Medicare have not yet gained traction despite bipartisan support.
Thomas Cornwell, MD, CEO, Home Centered Care Institute (HCCI), a national non-profit organization focused on advancing home-based primary care, is skeptical the primary care provider workforce could meet increased demand. He told Home Health Care News that question is “the greatest unknown.”
Nevertheless, the apparent success of Medicare’s
Independence at Home pilot program should be a wakeup call to clinical
laboratories and anatomic pathology groups that the trend of providing medical
services in lower-cost settings will likely continue.
That means medical laboratory leaders should be developing
strategies to support providers who are delivering medical care in nontraditional
healthcare environments.
Medical laboratories that develop appropriate clinical strategies may find opportunities to leverage several new technologies expected to have a big impact on providers
Industry experts often speculate how developing technologies will impact healthcare. However, clinical laboratory leaders may be surprised by how much blockchain, medical malls, and Uber Health are expected to alter healthcare delivery in the next decade.
An article in FierceHealthcare states that “Healthcare is on the cusp of a technology revolution. Technology is primed to disrupt healthcare more explosively than it has any other industry.”
Medical advancements certainly impact clinical laboratories
and anatomic pathology groups, and any acceleration in these developing
technologies applied to healthcare will certainly be of interest to lab leaders
who want to ensure their labs are ready.
Blockchain Provides Healthcare Security, Privacy, and
Interoperability
Authored by Sloan Gaon, CEO, PulsePoint, the FierceHealthcare article predicts that blockchain will be an important feature in the future of healthcare. It will allow patients to have an online, accurate health record that is accessible only to necessary parties in real time. Consumers will be able to maintain, control, and share their data as they wish while increasing the security, privacy, and interoperability of their health information.
“A primary care physician could access a complete medical history of the member, while the radiologist could be limited to only the specifics he or she needs to perform the task at hand. For each, it’s about accessing the right data at the right time, and the blockchain technology could enable this type of specific ‘need-to-know’ medical history access,” wrote Bruce Broussard, President and CEO of Humana in a LinkedIn article.
The blockchain records can be shared among a network of
computers and kept secure via cryptography. And the
technology allows for easy transferability among different networks, improving
performance and outcomes for patients. Broussard also stated that blockchain
technology will provide more efficient payment for insurance claims.
“With transparency and automation, greater efficiencies will
lead to lower administration costs, faster claims, and less money wasted.
Blockchain enables claims to be paid without an intermediary, since health plan
members are connecting directly with their providers. These consumers can also
access their permanent electronic health records in a secure fashion, enabling
them to have a real-time understanding of their health,” he wrote.
Should blockchain achieve widespread adoption as a platform
for patient health information, the clinical laboratory industry will need to
address the problem of different test methodologies and different reference
ranges for test results. If blockchain makes it feasible to bring all pieces of
a single patient’s cumulative health data into a single record, then clinical
labs will need to address that problem in an effective way.
Medical Malls a Win-Win for Healthcare Providers and
Retail Locations
With big shopping malls dying due to economic recessions and the emergence of online retail destinations, property owners are seeking new tenants. In the summer of 2017, there were still about 1,100 malls remaining in the US, however, a quarter of them were at a risk of closing within five years, Time noted that year.
As healthcare organizations expand, there is an overwhelming
need for suitable space that is accessible for consumers at a reasonable price.
Fading shopping malls with their convenient locations, sturdy foundations, and
large parking lots could fill that gap.
In February of 2017, Avita Health System opened a boutique hospital in a space once occupied by an anchor store in a mall located in Ontario, Ohio. The healthcare provider purchased a 185,000 square-foot space that was formerly a Lazarus department store.
Mansfield News Journal reported that when the hospital opened, it included a walk-in clinic, an emergency room, surgical suites, pre-operative and post-operative areas, an onsite pharmacy, imaging services, a clinical laboratory, and 30 acute care beds.
Other services, including a Level II Cath lab, a maternity center, and the installation of a 3T Magnetic Resonance Imaging (3T MRI) machine, have been added since the facility opened. And there’s room for more expansion at the site.
Vanderbilt Medical Group (VMG) now occupies the entire second level of One Hundred Oaks Mall, in Nashville, Tenn. Their services at the once-struggling retail shopping center include 22 specialty clinics in 450,000 square feet of space designed by architecture firm Gresham Smith.
Patients can pick up a pager at the VMG facility and then
shop on the lower level while waiting to be paged to see a healthcare
professional or receive test results.
“More important than the significant increase in our available clinical space is the overall concept and design which is focused on providing our patients, faculty, and staff with a new paradigm for health and wellness. The convenience, accessibility, and innovative ways of providing care for our patients are a true transformation of both the architecture and the way our patients experience healthcare,” said Cyril Stewart, former Director of Facility Planning for Vanderbilt University Medical Center (VUMC) in a testimonial on the Gresham Smith website.
Non-Emergency Medical Transportation and Uber Health
Kaiser Family Foundation (KFF) reported in 2016 that “Medicaid’s non-emergency medical transportation (NEMT) benefit facilitates access to care for low income beneficiaries who otherwise may not have a reliable affordable means of getting to healthcare appointments. NEMT also assists people with disabilities who have frequent appointments and people who have limited public transit options and long travel times to healthcare providers, such as those in rural areas.”
The Hospital and Healthsystem Association of Pennsylvania (HAP) reported that an average of 3.6 million Americans miss their healthcare appointments annually due to lack of or unreliable transportation. These missed appointments can cause an avalanche of future problems, including increased visits to emergency rooms, extended hospital stays, and higher costs for providers.
“If there are people who are missing their appointments because they’re using an unreliable bus service to get to and from their healthcare provider, this is a great solution for them,” Christopher Weber, General Manager and Senior Project Manager at Uber Health, told The Verge. “The types of individuals this is valuable for really is limitless.”
Uber health’s mobile device application (app) enables patients and healthcare providers to schedule non-emergency medical transportation for medical appointments within a few hours or up to a 30-day notice. It is also available both as an online dashboard and as an application-programming interface (API) for software developers to integrate the service into their proprietary healthcare tools.
An Uber
(NYSE:UBER) account is not required, as notifications about rides can be sent
to patients via text messages.
Clinical laboratory leaders may want to develop strategies
around these three predictions to increase business and maximize profits. Since
more healthcare organizations will soon be linked via blockchain, and an
increased number of consumers could start using non-emergency medical
transportation, such as Uber Health, to get to medical appointments, becoming
familiar with these technologies could prove to be beneficial to labs.
In addition, medical facilities cropping up in former mall
spaces will require medical laboratories to be onsite to support care and
provide lab test results within an acceptable turnaround time.
Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts
Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it tough for labs to get paid for the tests they perform.
Clinical laboratory leaders can expect continued scrutiny of
their labs’ operations and financials as government and commercial payers move
forward with invasive programs and policies designed to ferret out fraud and
bad actors.
Federal officials are focusing their investigations on healthcare providers who mismanage or inappropriately use Medicare and Medicaid programs, while commercial payers are closely scrutinizing areas such as genetic testing prior authorization, say healthcare attorneys with Cleveland Ohio-based McDonald Hopkins, LLC.
“The government is looking at fraud, waste, and abuse, and all the different ways they come into play,” said Elizabeth Sullivan, Esq., a Member and Co-Chair of the firm’s Healthcare Practice Group, in an exclusive interview with Dark Daily. “We anticipate there will be more enforcement [of fraud and abuse laws] centered around different issues—anything that can be a false claim.”
Specifically, government officials will key in on violations of the Stark Law, EKRA (the Eliminating Kickback in Recovery Act of 2018), and other anti-kickback statutes and laws, Sullivan said.
“And clinical laboratories, by virtue of the type of
services and service arrangements they offer, will continue to be a target,” she
added.
Medical laboratory leaders also must prepare for aggressive tactics by insurance companies. “On the commercial side, payers are getting more aggressive and more willing to take things to ligation if they don’t get what they want and don’t see a settlement that satisfies their concerns over issues,” said Courtney Tito, Esq., also a Member with McDonald Hopkins, in the Dark Daily interview.
Current Investigations Likely to Impact Clinical
Laboratories
Sullivan and Tito advise clinical labs to be aware of the
following issues being fast-tracked by government and private payers:
EKRA (Eliminating Kickback in Recovery Act of 2018).
The TPE audits program, according to CMS, is focused on providers with high claim error rates or unusual billing practices. During a TPE, a Medicare administrative contractor (MAC) works with a provider to identify and correct errors.
“The TPE audits are real hot right now. We are seeing a lot
of clients go through this,” Tito said.
Feds Crack Down on Genetic Testing Fraud Schemes
Genetic testing is another “hot button” issue for
enforcement by government and private payers, Sullivan and Tito state.
CMS is taking action against testing companies and
practitioners who submitted more than $1.7 billion in claims to Medicare, the
statement added.
The scheme involved medical laboratories conducting the genetic tests, McDonald Hopkins noted in an Alert about the DOJ investigation. The alert described how the scam operated:
Scam recruiters approached Medicare
beneficiaries at health fairs;
In exchange for a DNA sample (in the form of a
cheek swab) and a copy of the victim’s driver’s license, the “representative”
offered a free genetic test;
Representatives allegedly asked the seniors’
doctors to sign-off on test orders. If the seniors’ physicians refused, the
scammers offered kickbacks to doctors already in their group;
Clinical laboratories that performed the tests
were reimbursed from Medicare and, allegedly, shared the proceeds with the scammers.
“Although these opportunities may seem appealing as an
additional revenue source for providers, it is always important to review the
regulatory requirements as well as the potential anti-kickback statute and
Stark implications for any new arrangement,” Sullivan and Tito wrote in the McDonald
Hopkins Alert article.
Criminal Behavior in CMS Programs
Effective Nov. 4, 2019, CMS issued a final rule intended to stop fraud before it happens by keeping “unscrupulous providers” out of the federal healthcare programs in the first place, states a CMS news release.
Additionally, EKRA establishes “criminal penalties for unlawful payments for referrals to recovery homes and clinical treatment facilities,” Dark Daily recently reported. However, as the e-briefing points out, it is unclear whether EKRA applies to clinical laboratories.
Nevertheless, Sullivan points out that, “Even without EKRA,
the anti-kickback statute applies to any arrangement between individuals. And,
it is good to have an attorney look at those arrangements. What your sales reps
are doing in the field, how they are communicating, and their practices warrant
oversight. EKRA just makes it all the more important.”
Clinical Laboratories Need Compliance Plan, Focus on
Payers
With so many legal requirements and payer programs, Sullivan
advises medical labs and pathology group practices to work with resources they
trust and to have a compliance plan at the ready. “Have resources in place,
including but not limited to a compliance officer, a committee, and someone who
is spending time on these issues. Monitoring government enforcement and payer
activity is the most critical,” she said.
To assist labs in remaining fully informed on these critical
compliance topics, and the federal government’s latest legislation to combat
fraud, Dark Daily is offering a webinar on November 20th at 1pm Eastern
time. Sullivan and Tito will offer their insights and advice on how labs should
prepare for CMS’ battle to reign in fraud and commercial payers’ increased
scrutiny into prior authorizations.
Clinical laboratory leaders, compliance officers, and
finance staff will benefit greatly from this crucial resource.