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.”
During an upcoming Dark Daily webinar, attorneys Elizabeth Sullivan (left) and Courtney Tito (right) of McDonald Hopkins, LLC, will advise clinical laboratory leaders and financial staff on how to prepare for future aggressive payer audits, rigid enforcement of fraud and abuse laws, and more. (Photos copyright: LinkedIn/Dark Daily.)
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.
Medical laboratories may find opportunities guiding hospital telehealth service physicians in how clinical lab tests are ordered and how the test results are used to select the best therapies
Telehealth is usually thought of as a way for patients in remote settings to access physicians and other caregivers. But now comes a pair of studies that indicate use of telehealth in inpatient settings is outpacing the growth of telehealth for outpatient services.
This is an unexpected development that could give clinical laboratories new opportunities to help improve how physicians in telehealth services use medical laboratory tests to diagnose their patients and select appropriate therapies.
Dual Surveys Compare Inpatient and Outpatient Telehealth
Service Use
Definitive Healthcare (DH) of Framingham, Mass., is an analytics company that provides data on hospitals, physicians, and other healthcare providers, according to the company’s website. A survey conducted by DH found that use of telehealth solutions—such as two-way video webcams and SMS (short message service) text—has increased by inpatient providers from 54% in 2014 to 85% in 2019, a news release stated.
Meanwhile, a second Definitive Healthcare survey suggests
use of telehealth in outpatient physician office settings remained essentially
flat at 44% from 2018 to 2019, according to another news
release.
For the inpatient report, Definitive Healthcare polled 175 c-suite
providers and health
information technology (HIT) directors in hospitals and healthcare systems.
For the outpatient survey, the firm surveyed 270 physicians and outpatient
facilities administrators.
DH’s research was aimed at learning the status of telehealth
adoption, identifying the type of telehealth technology used, and predicting possible
further investments in telehealth technologies.
Most Popular Inpatient Telehealth Technologies
On the inpatient side, 65% of survey respondents said the most used telehealth mode is hub-and-spoke teleconferencing (audio/video communication between sites), Healthcare Dive reported. Also popular:
Fierce
Healthcarereports that the telehealth technologies showing the largest
increase by hospitals and health networks since 2016 are:
Two-way video/webcam between physician and
patient (70%, up from 47%);
Population health management tools, such as SMS
text (19%, up from 12%);
Remote patient monitoring using clinical-grade
devices (14%, up from 8%);
Mobile apps for concierge services (23%, up from
17%).
“Organizations are finding new and creative ways through telehealth to fill gaps in patient care, increase care access, and provide additional services to patient populations outside the walls of their hospital,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Managed Healthcare Executive.
DH believes investments in telehealth will increase at
hospitals as well as physician practices. In fact, 90% of respondents planning
to adopt more telehealth technology indicated they would likely start in the
next 18 months, the news releases state.
Most Popular Outpatient Telehealth Technologies
In the outpatient telehealth survey, 56% of physician
practice respondents indicated patient portals as the
leading telehealth technology, MedCity
News reported. That was followed by:
Hub-and-spoke teleconferencing (42%);
Concierge services (42%);
Clinical- and consumer-grade remote patient
monitoring products (21% and 12%).
While adoption of telehealth technology was flat over the
past year, 68% of physician practices did use two-way video/webcam technology
between physician and patient, which is up from 45% in 2018, Fierce
Healthcare reported.
The graph above, taken from the Definitive Healthcare 2019 survey, shows the percentage of telehealth use among surveyed outpatient settings. “The results show how telehealth continues to be one of the core linchpins for providers,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Healthcare Dive. (Graphic copyright: Definitive Healthcare.)
MedCity News reports that other telehealth technologies in
use at physician practices include:
Mobile apps for concierge service (33%);
Two-way video between physicians (25%);
SMS population management tools (20%).
Telehealth Reimbursement and Interoperability Uncertain
Why do outpatient providers appear slower to adopt
telehealth, even though they generally have more patient encounters than
inpatient facilities and need to reach out further and more often?
Definitive Healthcare reports that 20% of physician practice
respondents are “satisfied with the practice’s current solutions and services,”
and though telehealth reimbursement is improving, 13% are unsure they will be
reimbursed for telehealth services.
The Centers
for Medicare and Medicaid Services (CMS) states that Medicare
Part B covers “certain telehealth services,” and that patients may be
responsible for paying 20% of the Medicare approved amount. CMS also states
that, effective in 2020, Medicare
Advantage plans may “offer more telehealth benefits,” as compared to
traditional Medicare.
“There is not only a need for more clarity around reimbursement policies, but also a need for more interoperable telehealth solutions that can be accessed through electronic health record or electronic medical record systems, as well as a better understanding about what types of telehealth options are available,” said Jason Krantz (above), CEO, Definitive Healthcare, in the outpatient telehealth survey news release. (Photo copyright: Definitive Healthcare.)
The increase in telehealth use at hospitals—as well as its
increased adoption by physician offices—may provide clinical laboratories with opportunities
to assist telehealth doctors with lab test use and ordering. By engaging in telehealth
technology, such as two-way video between physicians, pathologists also may be
able to help with the accuracy of diagnoses and timely and effective patient
care.
EMPIs may help clinical laboratories ensure their patients and medical records are properly matched with medical laboratory test results and specimens
Mix-ups between patients and their medical records, known in
the healthcare industry as “patient mismatching,” happen far too frequently in
hospitals and clinics worldwide. When surgery is involved, such mismatches can lead
to deadly errors. However, clinical
laboratories and pathology
groups also must take steps to ensure patients, their medical records, and their
biological specimens remain properly matched.
Once horrific incident in 2016 involved Saint Vincent Hospital in
Worcester, Mass. Believing they were operating on a patient with a kidney
tumor, surgeons mistakenly removed a healthy kidney from the wrong patient. The
cause of the patient mismatch was a mix-up with CT scans. The two patients
shared similar names, Managed
Care reported.
Sadly, patient mismatching is not a new or rare problem. Patient
mismatches often lead to delays, extra costs to fix duplicate information, and
tragically, unnecessary surgery and inappropriate care, Healthcare
Dive noted.
According to Managed Care, organizations working on
solutions include:
“Incorrect matches could result in patients getting the
wrong medicine, and failure to link records could lead to treatment decisions
made without access to up-to-date laboratory test results,” Pew noted in an issues
brief.
Pew and the MAeHC interviewed 18 hospital, medical practice,
and health information technology exchange leaders. The respondents admitted
that they are uncertain about the extent of the matching problem.
“They don’t know all the records that should be related and
thus cannot understand what percentage of those are unlinked,” the researchers
wrote.
Nonetheless, the researchers found that patient/record match
rates fall “far below the desired level” for effective data exchange among
organizations, Healthcare Dive reported.
For pathologists and clinical laboratory managers, the
Pew/MAeHC study had several key takeaways, such as:
“Match rates are far below the desired level for
effective data exchange.
“An increased demand for interoperability—the
exchange of electronic data among different systems—is fueling the desire for
improvements.
“Match rates are difficult to measure.
“The methods in which records are received can
affect match results.
“Different types of healthcare providers vary in
their perspectives on the extent of the problem.
“Effective opportunities exist for organizations
to more accurately link individuals’ health records.”
About $1,950 in medical care costs per patient during a
hospital stay, and $1.5 million annually in denied claims per hospital, are
associated with inaccurate patient identification, reported a survey conducted
by Black
Book Research.
“Patient matching is a fundamental function of being able to get the right records, for the right person, at the right time, so that timely decisions can be made about his or her health. There has to be a mechanism to ensure that you’re actually getting a copy of the records for the right person,” Mariann Yeager (above), CEO of the Sequoia Project told Modern Healthcare. The Sequoia Project advocates for nationwide health information exchange (HIE). (Photo copyright: Value-based Care Summit.)
Why Patient-Matching is Difficult
Respondents to the Pew study reported that challenges to
correctly matching patients with their records include:
Receiving patient records that an organization
did not expect;
Urban health systems serving patients through
multiple sites;
High costs associated with matching solutions;
and
Differences in how organizations capture, use,
and link medical records.
When humans manually input patient data, Mary Elizabeth
Smith could be listed as M.E. Smith or Mary E. Smith or even Liz Smith. Such
data, when filed differently, can result in duplicate records for the same person,
or, as St. Vincent’s found out, patient mismatches that have dire consequences,
Managed Care noted.
“If there’s some kind of error in entering fields (name,
address, date of birth), either when the patient’s coming in or in a previous
entry, the matching can go awry,” Brendan Watkins,
Administrative Director of Enterprise Analytics at Stanford Children’s Health,
told Modern Healthcare.
Patient-Matching Solutions at Clinical Laboratories
Clinical laboratories also have tackled patient-mismatching
and have devised processing software solutions that ensure patients are
correctly identified and matched with the appropriate records and specimens.
Other solutions suggested by respondents to a previous 2018
Pew survey include:
Unique patient
identifier: Adoption of a patient identification number could help matching
efforts, though patients have expressed privacy concerns. The idea is to use
smartphones to validate patient data using digit codes. However, respondents
told Pew, not everyone has a smartphone.
Data
standardization: Respondents said standardization of data elements and
formatting could impact match rates. But agreement on which elements to use for
the match would be needed.
Referential
matching: Healthcare providers could follow the banking industry and use
outside sources, such as credit bureaus, to verify addresses and other data.
Respondents to the Pew survey balked at the cost.
With advancements in technology and interoperability,
medical laboratory leaders and other healthcare leaders may soon be expected to
achieve patient and record match rates of 100%. Pathology laboratories with
EMPIs and other solutions may be well prepared to meet those challenges.
“Pathologists and medical laboratories may have to demonstrate efficiency and effectiveness to stay in the insurer’s networks and get paid for their services
In recent years, Medicare officials have regularly introduced new care models that include quality metrics for providers involved in a patient’s treatment. Now comes news that a national health insurer is launching an innovative cancer-care model that includes quality metrics for medical laboratories and anatomic pathology groups that deliver diagnostic services to patients covered by this program.
Anatomic pathologists and clinical laboratories know that cancer patients engage with many aspects of healthcare. And that, once diagnoses are made, the continuum of cancer care for these patients can be lengthy, uncomfortable, and quite costly. Thus, it will be no surprise that health insurers are looking for ways to lower their costs while also improving the experience and outcomes of care for their customers.
To help coordinate care for cancer patients while simultaneously addressing costs, Humana, Inc., (NYSE:HUM) has started a national Oncology Model-of-Care (OMOC) program for its Medicare Advantage and commercial members who are being treated for cancer, Humana announced in a press release.
What’s important for anatomic pathologists and clinical
laboratories to know is that the program involves collecting performance
metrics from providers and ancillary services, such as clinical laboratory,
pathology, and radiology. These metrics will determine not only if doctors and
ancillary service providers can participate in Humana’s networks, but also if
and how much they get paid.
Anatomic pathologists and medical laboratory leaders will want to study Humana’s OMOC program carefully. It furthers Humana’s adoption of value-based care over a fee-for-service payment system.
How Humana’s OMOC Program Works
According to Modern Healthcare, “Humana will be looking at several measures to determine quality of cancer care at the practices including inpatient admissions, emergency room visits, medications ordered, and education provided to patients on their illness and treatment.”
As Humana initiates the program with the first batch of
oncologists and medical practices across the US, it also will test performance criteria
that anatomic pathologist groups will need to meet to participate in the
insurer’s network and be paid for services.
The insurer’s metrics address access to care, clinical status assessments, and patient education. Physicians can earn rewards for enhancing their patients’ navigation through healthcare, while addressing quality and cost of care, reported Health Payer Intelligence.
“The experience for cancer care is fragmented,” Bryan Loy, MD (above), Corporate Medical Director of Humana’s Oncology, Laboratory, and Personalized Medicine Strategies Group, told Modern Healthcare. Loy is board-certified in anatomic and clinical pathology, as well as hematology. “Humana wants to improve the patient experience and health outcomes for members. We are looking to make sure the care is coordinated.” (Photo copyright: National Lung Cancer Roundtable/American Cancer Society.)
Humana claims its OMOC quality and cost measurements are
effective in the areas of:
inpatient admissions,
emergency room visits,
medical and pharmacy drugs,
laboratory and pathology services, and
radiology.
To help cover reporting and other costs associated with
participation in the OMOC program, Humana is offering physician practices
analytics data and care coordinating payments, notes Modern Healthcare.
“The practices that improve their own performance over a one-year period will see the care coordination fee from Humana increase,” Julie Royalty, Humana’s Director of Oncology and Laboratory Strategies, told Modern Healthcare.
Value-Based Care Programs are Expensive
Due to the cost of collecting data and increasing staff capabilities to meet program parameters, participating in value-based care models can be costly for medical practices, according to Scottsdale, Ariz.-based Darwin Research Group (DRG), which studies emerging payer models.
Some of the inaugural medical practices in the Humana OMOC
include:
Southern Cancer Center, Alabama;
US Oncology Network, Arizona;
Cancer Specialists of North Florida;
Michigan Healthcare Professionals;
University of Cincinnati Physicians Company; and
Center for Cancer and Blood Disorders, Texas.
Other Payers’ Value-Based Cancer Care Programs
“Depending upon which part of the country you’re in,
alternative payment models in oncology are becoming the norm not the exception,”
noted the DRG study. “Humana is a little late to the party.”
Darwin Research added that Humana may realize benefits from
having observed other insurance company programs, such as:
Humana is not the only payer offering value-based cancer care programs. The Centers for Medicare and Medicaid Services (CMS) Oncology Care Model is a five-year model (2016 through 2021) involving approximately 175 practices and 10 payers throughout America (see above). The healthcare networks and insurers have made payment arrangements with their patients for chemotherapy episode-of-care services, noted a CMS fact sheet. (Graphic copyright: Centers for Medicare and Medicaid Services.)
Humana’s Other Special Pay Programs
Humana has developed other value-based bundled payment
programs as well. It has episode-based
models that feature open participation for doctors serving Humana Medicare
Advantage members needing:
total hip or knee joint replacement (available
nationwide since 2018); and
spinal fusion surgery (launched in 2019).
Humana also started a maternity episode-of-care bundled
payment program last year for its commercial plan members.
In fact, more than 1,000 providers and Humana value-based
relationships are in effect. They involve more than two-million Medicare
Advantage members and 115,000 commercial members.
Clearly, Humana has embraced value-based care. And, to
participate, anatomic pathology groups and medical laboratories will need to be
efficient and effective in meeting the payer’s performance requirements, while
serving their patients and referring doctors with quality diagnostic services.
Clinical laboratories could offer services that complement SDH programs and help physicians find chronic disease patients who are undiagnosed
Insurance companies and healthcare providers increasingly consider social determinants of health (SDH) when devising strategies to improve the health of their customers and affect positive outcomes to medical encounters. Housing, transportation, access to food, and social support are quickly becoming part of the SDH approach to value-based care and population health.
For clinical laboratory managers and pathologists this rapidly-developing trend is worth watching. They can expect to see more providers and insurers in their communities begin to offer these types of services to individuals and patients who might stay healthier and out of the hospital as a result of SDH programs. Clinical laboratories should consider strategies that help them provide medical lab testing services that complement SDH programs.
Medical laboratories, for example, could participate by offering
free transportation to patient
service centers for homebound chronic disease patients who need regular
blood tests. Such community outreach also could help physicians identify people
with chronic diseases who might otherwise go undiagnosed.
Anthem Offers Social
Determinants of Health Package
In fact, health benefits giant Anthem, Inc. (NYSE:ANTM) partly attributes its 2019 first quarter 14% increase of Medicare Advantage members to a new “social determinants of health benefits package” comprised of healthy meals, transportation, adult day care, and homecare, according to Forbes.
“Our focus on caring for the whole person is designed to deliver
better care and outcomes, reduce costs, and ultimately accelerate growth,” Gail Boudreaux,
Anthem President and CEO, stated in a call to analysts, Forbes reports.
An Anthem news release states that SDH priorities for payers, providers, and other stakeholders should focus on enhancing individuals’ access to food, transportation, and social support.
In the Anthem news release, which announced the publication of a white paper that “outlines key differences in how individuals and the public perceive social determinants of health,” Jennifer Kowalski (above), Vice President of the Anthem Public Policy Institute stated, “By better understanding how individuals view and talk about social determinants, payers and providers alike can identify new and improved ways to engage with them to more effectively improve their health and wellbeing and the delivery of healthcare.” (Photo copyright: LinkedIn.)
CMS Expands Medicare
Advantage Plans to Include Social Determinants of Health
The Centers for Medicare and Medicaid Services announced that, effective in 2019, Medicare Advantage plans can offer members benefits that address social determinants of health. Medicare Advantage members may be covered for services such as adult day care, meal delivery, transportation, and home environmental services that relate to chronic illnesses.
Humana’s ‘Bold Goal’
Humana, Inc. (NYSE:HUM) calls its SDH focus the BoldGoal. The program aims to improve health in communities it serves by 20% by 2020.
“The social barriers and health challenges that our Medicare Advantage members and others face are deeply personal. This requires us to become their trusted advocate that can partner with them to understand, navigate, and address these barriers and challenges,” said William Shrank, MD, Humana’s Chief Medical Officer, in a news release.
UnitedHealthcare
Investing More than $400 Million in Housing
Meanwhile, since 2011, UnitedHealthcare (NYSE:UNH) also has invested in affordable housing and social determinants of health, Health Payer Intelligence reported.
In a news release, UnitedHealthcare, the nation’s largest health insurer, described how it is investing more than $400 million in 80 affordable US housing communities, including:
$12 million, PATH Metro Villas, Los Angeles;
$11.7 million, Capital Studios, Austin;
$14.5 million allocated to Minneapolis military
veterans housing;
$7.9 million, New Parkridge (in Ypsilanti, Mich.)
affordable housing complex;
$21 million earmarked to Phoenix low- and moderate-income
families needing housing and supportive services;
$7.8 million, Gouverneur Place Apartments, Bronx,
New York; and
$7.7 million, The Vinings, Clarksville, Tenn.
“Access to safe and affordable housing is one of the
greatest obstacles to better health, making it a social determinant that
affects people’s well-being and quality of life. UnitedHealthcare partners with
other socially minded organizations in helping make a positive impact in our
communities,” said Steve Nelson,
UnitedHealthcare’s CEO, in the news
release.
According to the American Hospital Association (AHA) and the Health Research and Educational Trust (HRET), housing, or lack of it, impacts health. In “Housing and the Role of Hospitals,” the second guide in the organizations’ “Social Determinants of Health Series,” AHA and HRET state that 1.48 million people are homeless each year, and that unstable living conditions are associated with less preventative care, as well as the propensity to acquire diabetes, cardiovascular disease, chronic obstructive pulmonary disorder, and other healthcare conditions.
Social determinants of health programs are gaining in
popularity. And as they become more robust, proactive clinical laboratory
leaders may find opportunities to work with insurers and healthcare providers
toward SDH goals to help healthcare consumers stay healthy, as well as reducing
unnecessary hospital admissions and healthcare costs.
