Kaiser
Health News (KHN) recently
reported on investigations by the OIG into hospitals allegedly offering
unusually high salaries and other perks to specialists because they attract highly
profitable business.
Wheeling, KHN reported, paid one anesthesiologist $1.2
million per year, which, Rau notes, is higher than the salaries of 90% of the
pain management specialists around the country. Rau went on to describe how
Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a
cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.
In each of those cases, the whistleblower who prompted the qui tam investigation reported
that the specialists’ various departments were frequently in the red, reported KHN.
“The problem, according to the government, is that the
efforts run counter to federal self-referral bans and anti-kickback laws that
are designed to prevent financial considerations from warping physicians’
clinical decisions,” wrote Rau.
Wheeling not only contests the lawsuits brought against it,
but also has filed a countersuit against the whistleblower. KHN said the
hospital claims “its generous salaries were not kickbacks but the only way it
could provide specialized care to local residents who otherwise would have to
travel to other cities for services such as labor and delivery that are best
provided near home.”
OIG’s Fraud and Abuse Laws: A Roadmap for Physicians
The KHN article mentions
five laws the OIG lists on
its website that are particularly important for physicians to be aware of. They
include the:
False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.
“Together, these rules are intended to remove financial
incentives that can lead doctors to order up extraneous tests and treatments
that increase costs to Medicare and other insurers and expose patients to
unnecessary risks,” KHN said.
Other Hospitals Under Investigation
Wheeling Hospital is not the only healthcare institution
facing investigation. The Dallas
Morning News (DMN) reported on a case involving Forest
Park Medical Center (FPMC) in Dallas that resulted in the conviction of
seven defendants, including four doctors. Prosecutors outlined the scheme in
court, saying that FPMC illegally paid for surgeries.
“Prosecutors said the surgeons agreed to refer patients to
the Dallas hospital in exchange for money to market their practices,” DMN
reported, adding “Patients were a valuable commodity sold to the highest
bidder, according to the government.”
One of the convicted physicians, Michael Rimlawi, MD,
told DMN, “I’m in disbelief. I thought we had a good system, a fair
system.” His statement may indicate the level to which some healthcare
providers at FPMC did not clearly understand how anti-kickback laws work.
“The verdict in the Forest Park case is a reminder to
healthcare practitioners across the district that patients—not payments—should
guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.
Know What Is and Is Not a Kickback
Both the Wheeling Hospital investigation and the Forest Park
Medical Center case make it clear that kickbacks don’t always look like
kickbacks. Becker’s Hospital Review
published an article titled “Four
Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details
cases in which hospitals chose to settle.
These four incidents involved hospitals in Tennessee,
Montana, Pennsylvania, and New York. This demonstrates that kickback schemes
take place nationwide. And they show that violations of the Stark Law, the
False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.
Whether in a clinical laboratory or an enterprisewide health
network, violating laws written to prevent money—rather than appropriate
patient care—from being the primary motivator in hiring decisions, may result
in investigation, charges, fines, and even conviction.
“If we’re going to solve the healthcare pricing problem,
these kinds of practices are going to have to go away,” Vikas Saini, MD, President
of the Lown Institute, a Massachusetts
nonprofit that advocates for affordable care, told KHN.
Though these recent OIG investigations target hospitals,
clinical laboratory leaders know from past experience that they also must be
vigilant and ensure their hiring practices do not run afoul of anti-kickback
legislation.
Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder
Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures.
Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United
Kingdom (UK) announced it would be making the new test widely available.
The researchers published their findings in The
Lancet medical journal. Their paper explains that the clinical trial
took place in 11 maternity units in the UK from June 2016 through October 2017.
And that 1,023 women were divided into two groups:
576 (56%) were in the “intervention group,”
meaning they had PGF test results made available to their maternity teams;
447 (44%) did not have PGF test results made
available.
The researchers, the Independent
reported, wanted to determine the impact, if any, the new test’s results would
have on diagnoses.
Significantly Reduced Time to Diagnosis
Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated.
“Complications like stroke, seizures and maternal death fell
by 20% when doctors had access to PGF testing,” the Independent
reported.
The researchers stated in their study, “Our trial has shown
that, in women presenting with suspected pre-eclampsia, PGF measurement,
incorporated into a management algorithm based on national guidelines,
significantly reduces the time taken for treating clinicians to diagnose
pre-eclampsia. This improvement was associated with a significant reduction in
maternal adverse outcomes, with no detected difference in gestational age at
delivery or adverse perinatal outcomes.”
The King’s College press release states, “Pre-eclampsia is
suspected in around 10% of UK pregnancies, affecting approximately 80,000 women
annually. If untreated, it can progress to cause complications in the woman,
including damage to vital organs, fits, and can be fatal for the woman and
baby. Globally, 100 women die as a result of the condition every day.”
The release also noted that “doctors were able to diagnose
pre-eclampsia on average two days sooner. This was associated with significant
improvements in outcomes for women without causing health problems for babies.”
Measuring PGF in Clinical Laboratory Study
PGF is a molecular marker for inflammation associated mostly
with the mother’s placenta.
The King’s College researchers wanted to find out if a quicker diagnosis of
pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the
mother and baby?
“For the last hundred years, we have diagnosed pre-eclampsia
through measuring blood pressure and checking for protein in a woman’s urine.
These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD,
NIHR Research Professor in Obstetrics at King’s College, and lead author of the
study, in the news release.
“We knew that monitoring PGF was an accurate way to help
detect the condition, but [we] were unsure whether making this tool available
to clinicians would lead to better care for women. Now we know that it does,” she
concluded.
Pre-eclampsia can lead to stroke, seizures, and even death
of expectant mothers and unborn children. It is usually diagnosed after 20
weeks of gestation through blood pressure tests and urine tests that show
hypertension and elevated protein levels.
“We found that the availability of PGF test results
substantially reduced the time to clinical confirmation of pre-eclampsia. Where
PGF was implemented, we found a lower incidence of maternal adverse outcomes,”
the researchers wrote in their study.
Similar Study in the US
In the UK, pre-eclampsia affects about one in 20 pregnancies
or 80,000 women each year, New
Scientist explained. While in the US, data compiled from the Centers for Disease Control
and Prevention (CDC) indicate that pre-eclampsia affects one in 25
pregnancies or about 154,220 women annually.
Researchers in Ohio also recently reported on a test and a piloted
clinical study for rapid diagnosis of pre-eclampsia.
“This is the first clinical study using the point-of-care,
paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved
superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal
medicine physician at Wexner Medical Center and first author of the study said
in the Wexner press release. “Our findings will have a huge impact on the
health of women and children.”
The researchers published their findings in EClinicalMedicine,
a Lancet Journal.
“Pre-eclampsia is often described as ‘mysterious’ because
it’s difficult to diagnose. Our researchers show that there’s an easy,
non-invasive test that will help diagnose this condition and maintain the
health of pregnant women and their babies,” K. Craig
Kent, MD, OSU Dean of the College of Medicine, said in the press release.
Clinical laboratory tests such as these being developed in
the US and abroad could help pregnant women worldwide experience happy
pregnancies and give birth to healthy babies. Medical laboratory leaders in
this country may want to stay abreast of the development of these simple blood
and urine tests.
Following the raid, the company’s co-founders resigned
from the board of directors
Microbiome testing company, uBiome, a biotechnology developer that offers at-home direct-to-consumer (DTC) test kits to health-conscious individuals who wish to learn more about the bacteria in their gut, or who want to have their microbiome genetically sequenced, has recently come under investigation by insurance companies and state regulators that are looking into the company’s business practices.
CNBC
reported that the Federal Bureau of
Investigation (FBI) raided the company’s San Francisco headquarters in
April following allegations of insurance fraud and questionable billing
practices. The alleged offenses, according to CNBC, included claims that
uBiome routinely billed patients for tests multiple times without consent.
Becker’s
Hospital Review wrote that, “Billing documents obtained by The Wall Street
Journal and described in a June 24 report further illustrate uBiome’s
allegedly improper billing and prescribing practices. For example, the
documents reportedly show that the startup would bill insurers for a lab test
of 12 to 25 gastrointestinal pathogens, despite the fact that its tests only
included information for about five pathogens.”
Company Insider Allegations Trigger FBI Raid
In its article, CNBC stated that “company insiders”
alleged it was “common practice” for uBiome to bill patients’ insurance
companies multiple times for the same test.
“The company also pressured its doctors to approve tests
with minimal oversight, according to insiders and internal documents seen by CNBC.
The practices were in service of an aggressive growth plan that focused on
increasing the number of billable tests served,” CNBC wrote.
FierceBiotech reported that, “According to previous
reports, the large insurers Anthem, Aetna, and Regence BlueCross BlueShield
have been examining the company’s billing practices for its physician-ordered
tests—as has the California Department of Insurance—with probes focusing on
possible financial connections between uBiome and the doctors ordering the
tests, as well as rumors of double-billing for tests using the same sample.”
Becker’s Hospital Review revealed that when the FBI
raided uBiome they seized employee computers. And that, following the raid,
uBiome had announced it would temporarily suspend clinical operations and not
release reports, process samples, or bill health insurance for their services.
The company also announced layoffs and that it would stop
selling SmartJane and SmartGut test kits, Becker’s reported.
uBiome Assumes New Leadership
Following the FBI raid, uBiome placed its co-founders Jessica
Richman (CEO) and Zac
Apte (CTO) on administrative leave while conducting an internal
investigation (both have since resigned from the company’s board of directors).
The company’s board of directors then named general counsel, John Rakow, to be interim CEO,
FierceBiotech
reported.
After serving two months as the interim CEO, Rakow resigned
from the position. The interim leadership of uBiome was then handed over to
three directors from Goldin
Associates, a New York City-based consulting firm, FierceBiotech
reported. They include:
SmartFlu: a nasal microbiome swab that detects bacteria and viruses associated with the flu, the common cold, and bacterial infections.
What Went Wrong?
Richman and Apte founded uBiome in 2012 with the intent of
marketing a new test that would prove a link between peoples’ microbiome and their
overall health. The two founders initially raised more than $100 million from
venture capitalists, and, according to PitchBook,
uBiome was last valued at around $600 million, Forbes
reported.
Nevertheless, as a company, uBiome’s future is uncertain. Of
greater concern to clinical laboratory leaders is whether at-home microbiology
self-test kits will become a viable, safe alternative to tests traditionally performed
by qualified personnel in controlled laboratory environments.
The researchers unveiled a diagnostic device that uses microfluidic technology to identify cell types in blood by their size. The device also “can isolate individual cancer cells from patient blood samples,” according to a news release.
The ability to isolate circulating tumor cells could enable clinical laboratories to perform diagnostic cancer tests on liquid biopsies and blood samples. Dark Daily reported on various studies involving liquid biopsies—an alternative to invasive and costly cancer diagnostic procedures, such as surgery and tissue biopsies—in previous e-briefings.
The UIC and QUT researchers were motivated by the
information-rich nature of circulating tumor cells. They also saw opportunity
for escalated “purity” in results, as compared to past studies.
In the paper, they acknowledged the work of other scientists
who deployed microfluidic technology affinity-based methods to differentiate
tumor cells in blood. Past studies (including previous work by the authors)
also explored tumor cells based on size and difference from white blood cells.
“While many emerging systems have been tested using patient samples, they share a common shortcoming: their purity remains to be significantly improved. High purity is in strong demand for circulating tumor cell enumeration, molecular characterization, and functional assays with less background intervention from white blood cells,” the authors wrote in their paper.
How the Device Works
The scientists say their system leverages “size-dependent
inertial migration” of cells. According to the news release:
Blood passes through “microchannels” formed in
plastic in the device;
“Inertial migration and shear-induced diffusion”
separate cancer cells from blood;
Tiny differences in size determine a cell’s
attraction to a location; and
Cells separate to column locations as the liquid
moves.
In other words, the device works as a filter sorting out, in
blood samples, the circulating tumor cells based on their unique size, New
Atlas explained.
93% of Cancer Cells Recovered by Device
When the researchers tested their new device:
Researchers placed 10 small-cell-lung cancer cells into five-milliliter samples of healthy blood;
The blood was then flowed through the device; and
93% of the cancer cells were recovered.
“A 7.5 milliliter tube of blood, which is typical volume for
a blood draw, might have 10 cancer cells and 35- to 40-billion blood cells. So,
we are really looking for a needle in a haystack,” Papautsky stated in the news
release.
“We report on a novel multi-flow microfluidic system for the
separation of circulating tumor cells with high purity. The microchannel takes
advantage of inertial migration of cells. The lateral migration of cells
strongly depends on cell size in our microchannel, and label-free separation of
circulating tumor cells from white blood cells is thus achieved without
sophisticated sample predation steps and external controls required by
affinity-based and active approaches,” the researchers wrote in their paper.
The researchers plan wider trials and the addition of
biomarkers to enable cancer DNA detection, New Atlas reported, which described
the UIC/QUT study as part of a “new wave of diagnostics.”
With so much focus on liquid biopsy research, it may be
possible for medical laboratories to one day not only diagnose cancer through
blood tests, but also to find the disease earlier and in a more precise way
than with traditional tissue sample analysis.
This is important for clinical laboratory leaders to watch, because medical labs often interface with hospital EHRs to exchange vital patient data, a key component of complying with Medicare’s EHR incentive programs. If claims of interoperability are shown to be false, could labs engaged with those hospital systems under scrutiny be drawn into the DOJ’s investigations?
Violating the False Claims Act
In May, Coffey Health System (CHS), which includes Coffey County Hospital, a 25-bed critical access hospital located in Burlington, Kan., agreed to pay the US government a total of $250,000 to settle a claim that it violated the False Claims Act.
CHS’ former CIO filed the qui tam (aka, whistleblower) lawsuit, which allows individuals to sue on behalf of the government and share in monetary recovery. He alleged that CHS provided false information to the government about being in compliance with security standards to receive incentive payments under the EHR Incentive Program.
According to a DOJ press release, “the United States alleged that Coffey Health System falsely attested that it conducted and/or reviewed security risk analyses in accordance with requirements under a federal incentive program for the reporting periods of 2012 and 2013. The government contended that the hospital submitted false claims to the Medicare and Medicaid Programs pursuant the Electronic Health Records (EHR) Incentive Program.”
The Recovery Act allocated $25 billion to incentivize healthcare professionals and facilities to adopt and demonstrate meaningful use (MU) of electronic health records by January 1, 2014. The federal Centers for Medicare and Medicaid Services (CMS) released the incentive funds when providers attested to accomplishing specific goals set by the program.
The website of the Office of the National Coordinator for Health Information Technology (ONC), HealthIt.gov, defines “meaningful use” as the use of digital medical and health records to:
Improve quality, safety, efficiency, and reduce
health disparities;
Engage patients and their families;
Improve care coordination and population and
public health; and
Maintain privacy and security of patient health
information.
The purpose of the HITECH Act was to address privacy and security concerns linked to electronic storage and transference of protected health information (PHI). HITECH encourages healthcare organizations to update their health records and record systems, and it offers financial incentives to institutions that are in compliance with the requirements of the program.
When eligible professionals or eligible hospitals attest to being in compliance with Medicare’s EHR incentive program requirements, they can file claims for federal funds, which are paid and audited by the Department of Health and Human Services (HHS) through Medicare and Medicaid.
Institutions receiving funds must demonstrate meaningful use
of EHR records or risk potential penalties, including the delay or cancellation
of future payments and full reimbursement of payments already received. In
addition, false statements submitted in filed documents are subject to criminal
laws and civil penalties at both the state and federal levels.
EHR Developers Under Scrutiny by DOJ
EHR vendors also have been investigated and ordered to make
restitutions by the DOJ.
In February, Greenway Health, a Tampa-based EHR developer, agree to pay $57.25 million to resolve allegations related to the False Claims Act. In this case, the government contended that Greenway obtained certification for its “Prime Suite” EHR even though the technology did not meet the requirements for meaningful use.
And EHR vendor eClinicalWorks paid the government $155 million to settle allegations under the False Claims Act. The government maintained that eClinicalWorks misrepresented the capabilities of their software and provided $392,000 in kickbacks to customers who promoted its product.
Legal cases such as these demonstrate that the DOJ will
pursue both vendors and healthcare organizations that misrepresent their
products or falsely attest to interoperability under the terms laid out by
Medicare’s EHR Incentive Program.
Clinical laboratory leaders and pathology groups should carefully
study these cases. This knowledge may be helpful when they are asked to create
and maintain interfaces to exchange patient data with client EHRs.
“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.
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 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.