Changes in reimbursement models and federal compliance, as well as tougher payer audits, make it critical clinical laboratory managers are fully informed and prepared for what lies ahead in 2020
Not only does January 1st bring the new year of 2020, but it
also brings tough challenges for leaders of the nation’s clinical
laboratories and anatomic
pathology groups. Most of these challenges are triggered by the ongoing
transformation of the American healthcare system.
“Healthcare’s transformation in this country has two primary
elements,” said Robert L.
Michel, Editor-in-Chief of The Dark
Report, sister publication of Dark Daily. “One is the
integration of medical care to meet the related goals of keeping people out of
hospitals—the most expensive site of care—and to proactively manage patients to
keep them healthy.
“The second is reimbursement reform,” he continued.
“Healthcare policymakers want to eliminate fee-for-service
payments and move providers to different forms of value-based
reimbursement. The federal Medicare program seems to be taking the lead
over private payers as it introduces different pilot programs that reimburse
physicians and hospitals through such methods as bundled
payments, shared-savings arrangements, and per-member per-month (PMPM)
arrangements.”
Michel predicts that both the integration of care delivery
and the shift away from fee-for-service payment will become more urgent
challenges for clinical laboratory managers and pathologists during 2020.
“Take the integration of care, for example. Clinical laboratories,
since their inception, have been organized to serve the different provider
silos,” Michel stated. “Each client—whether it was a primary care physician, a
specialist doctor, a hospital, or a nursing home—could be served as a
stand-alone customer. That client ordered tests and the lab performed those
tests, submitted the results to that client, then billed insurance as
appropriate.
“Integration of clinical care changes that laboratory
service model in significant ways,” he continued. “Now, when a provider within
an integrated health system orders a medical laboratory test, the lab will want
those lab test results to be available, via the electronic
health record (EHR) system, to other providers within that health system.
“That is one example of how integrated care requires
clinical labs to realign their service model,” Michel added. “Combine that need
to change with the steady transition away from fee-for-service to reimbursement
based on value and you can see why all labs in the United States will be
uniquely challenged, not just in 2020, but in the succeeding years.”
Robert Michel (above) is Editor-in-Chief of The Dark Report and Dark Daily and founder of The Dark Intelligence Group. He will be hosting the 25th anniversary Executive War College on Lab and Pathology Management, which takes place April 28-29, 2020, in New Orleans. (Photo copyright: The Dark Report.)
Even Minor Changes in Care Require Major Responses by
Medical Laboratories
It is important for clinical laboratory managers, pathology
practice administrators, and the pathologists who are the business leaders of
their groups to understand the width and depth of the changes happening in
healthcare and laboratory medicine in the United States today. Even little
changes in how care is delivered can require a major response in how medical
laboratories are organized and how they deliver lab testing services.
For example, here are distinct trends associated with how
providers are responding to healthcare’s current transformation:
Meanwhile, the clinical laboratory industry is undergoing
its own transformation. Three major trends illustrate how labs are responding
to the new healthcare marketplace realities:
More use of Lean,
Six Sigma,
and process improvement techniques as labs strive to cut costs while protecting
quality and maintaining top-flight service levels.
More collaboration with providers, payers, and
even consumers, as innovative medical laboratory organizations move to deliver
more value, consistent with the Clinical Lab
2.0 business model.
Acquiring more robust information technologies
and analytics tools needed to leverage the lab’s clinical test data in ways to
provide increased value, not just to hospitals and physicians, but to payers,
patients, and a new class of care management companies that want to use big data and machine learning to
help payers and providers improve patient outcomes.
All of these trends will not only be high profile during
2020, but they will be driving forces throughout the decade of the 2020s.
This is why The Dark Report’s 25th anniversary Executive War College on Lab and
Pathology Management, which takes place April 28-29, 2020, in New Orleans,
will feature essential sessions and expert speakers who have the answers you need
to guide your lab through the challenging times yet to come.
Narrowing networks that exclude your lab from access to
patients? Executive War College has health plan lab network managers to share
insights with you, along with experienced lab managed care contracting
executives who can challenge these payers and teach you the secrets of winning
and keeping status as an in-network laboratory.
Concerned about new compliance issues—such as EKRA
(Eliminating Kickback in Recovery Act of 2018) and Medicare’s recent affiliation
disclosure rule for tougher government and private payer audits—that
challenge your lab’s financial integrity? Executive War College is bringing
together the nation’s smartest minds in compliance, billing/collections, and
lab accreditation to give you first-hand updates on the must-dos and the
must-avoids, so your lab is always inspection ready and compliant.
Because this is the 25th anniversary of the Executive War
College, we are pulling out all the stops to put on the biggest and best
conference on lab and pathology management that the nation has seen. There will
be more than 125 speakers and 90 sessions, along with our always-popular
two-roundtables for Lab CFOs, Academic Pathology, Lab CIOs, and Lab
Quality/Compliance Managers.
Most importantly for you, this year’s Executive War College
may be the most important lab management meeting you attend in 2020, because
there is no other place that puts you face-to-face with experts in every aspect
of clinical laboratories and anatomic pathology group management, while—at the
same time—giving you unparalleled networking with the lab profession’s
innovators.
This is the best investment you can make in both your professional management career and the successful operation of your laboratory.
Register today at https://dark.regfox.com/executive-war-college-2020 to reserve your seat and save $200 off regular registration rates, but act now while it’s fresh on your mind as these super-early-bird savings end January 31.
In response to Harvard’s conclusions, the Joint Commission claimed the study contained “factual errors” and “multiple methodological flaws” in strong rebuttals to findings
Today’s emphasis on value-based healthcare rewards hospitals, physicians, clinical laboratories, and other healthcare service providers for improved patient outcomes. But does hospital accreditation play a role in those improved outcomes? A study published in the British Medical Journal (BMJ) suggests that hospital accreditation may not directly correlate to improved patient care and that one accrediting organization may be just as good as another.
Researchers at Harvard T.H. Chan School of Public Health (Harvard) conducted the study. They looked at healthcare outcomes from 4,400 US hospitals between 2014 and 2017, of which 3,337 were accredited (2,847 by The Joint Commission) and 1,063 received state-based reviews.
The researchers’ objective was “To determine whether
patients admitted to US hospitals that are accredited have better outcomes than
those admitted to hospitals reviewed through state surveys, and whether
accreditation by The Joint Commission (the largest and most well-known
accrediting body with an international presence) confers any additional
benefits for patients compared with other independent accrediting
organizations.”
In their published results, the Harvard researchers concluded:
“Patients treated at accredited hospitals had
lower 30-day mortality rates (although not statistically significant lower
rates, based on the prespecified P value threshold) than those at hospitals
that were reviewed by a state survey agency … but nearly identical rates of
mortality for the six surgical conditions;
“Readmissions for the 15 medical conditions at
30 days were significantly lower at accredited hospitals than at state survey …
but did not differ for the surgical conditions;
No statistically significant differences were
seen in 30-day mortality or readmission rates (for both the medical or surgical
conditions) between hospitals accredited by The Joint Commission and those
accredited by other independent organizations.”
Why is this finding important? As the largest independent
accrediting organization, The Joint Commission holds enormous influence over
doctors and other healthcare service providers. The Joint Commission accredits more
than 21,000 US healthcare providers, as well as hospitals throughout the world.
Most states require Joint Commission accreditation for hospitals to receive
Medicare/Medicaid reimbursements.
However, Harvard’s study found hospitals accredited by the
Joint Commission had no better patient outcomes than hospitals reviewed by
state survey agencies. The conclusions published by this research team casts
doubt on the perceived higher value of the Joint Commission’s accreditation
over other accrediting bodies, and on the value of accreditation itself.
“There was no evidence in this study to indicate that
patients choosing a hospital accredited by the Joint Commission confer any
healthcare benefits over choosing a hospital accredited by another independent
accrediting organization,” the researchers concluded in their paper.
Ashish Jha, MD, MPH (above) K. T. Li Professor of Global Health and Health Policy at the Harvard T. H. Chan School of Public, co-authored the Harvard study. He maintains that for accreditation to ensure hospital quality, accreditation standards must be refocused. “First, there must be a clear delineation of high-quality care (good outcomes, good experience) and that must be the guiding principle behind accreditation,” he wrote in JAMA Forum. “Hospitals should be held accountable for those outcomes. Accrediting bodies should focus on those processes and structural factors that have been convincingly shown to be associated with good outcomes.” (Photo copyright: Harvard.)
Not So Fast!
The Joint Commission is an independent, not-for-profit organization
that has accredited hospitals for nearly 70 years. Approximately 81% of
hospitals accredited in the US are accredited by the Joint Commission. So, of
course, the Joint Commission took issue with the Harvard researchers’ findings.
In a formal statement and a response published in BMJ, the Joint Commission cited “factual errors” and “multiple methodological flaws that make the [study] results invalid.”
Nonetheless, the Joint Commission also pointed out that
Joint Commission-accredited hospitals were found by the researchers to demonstrate
lower mortality than state-surveyed hospitals and lower readmission rates for
the medical conditions cited.
“While study authors considered the differences ‘modest,’
applying them to the more than three million patients with medical conditions
addressed in this study indicates that patients treated in Joint
Commission-accredited hospitals experienced 12,000 fewer deaths and 24,000
fewer readmissions,” the formal statement said. “We believe that makes a
difference to patients as much as it does to us.”
Joint Commission Partners with Leapfrog Group
Scrutiny of hospital accrediting bodies is not new. A 2002 article by The Dark Report, Dark Daily’s sister publication, reported on the Joint Commission’s decision to become a “formal partner” in the Leapfrog Group, a non-profit organization founded in 2000 that advocates for improved hospital safety and quality. (See TDR, “Provider Performance Ranking Now Hitting Healthcare System,” January 28, 2002.)
The Joint Commission announced the partnership one day before the Leapfrog Group’s release of data in the journal Quality Management in Healthcare showing “that a hospital’s accreditation status did not correlate to better quality and safety of patient care. The study specifically noted that hospitals with higher-than-average rates of deaths and complications often received favorable scores from the [Joint Commission],” TDR reported.
However, as Robert Michel, TDR’s Editor-in-Chief and Publisher, noted in the article, “The [Joint Commission’s] willingness to partner with the Leapfrog Group is a significant event. The timing of the [Joint Commission’s] announcement, one day before Leapfrog made its hospital data available to the public, demonstrates that it will become more responsive to the quality concerns of employers.
“For laboratory executives and pathologists,” Michel
continued, “this is a signal event in determining how the healthcare system
will evolve in the next few years. I believe it is the first of what will become
a major effort to identify, measure, and report on the quality performance of
all categories of healthcare providers.”
Michel made his comments in 2002. Today, hospital and
individual health provider reimbursements are increasingly based on those very
performance and quality-of-outcome reports.
Healthcare systems now publish data on healthcare providers so
patients can make informed decisions. It is consistent with the trend to rank
providers by patient outcomes and similar metrics, which TDR predicted
nearly two decades ago.
Moreover, the growing availability of the outcomes data from
hospitals, physicians, and other types of providers is a signal to both
clinical laboratories and individual pathologists that public scorecards on the
quality, outcomes, and costs of their labs or their professional pathology
services are coming.
However, since major change in the healthcare system takes
years to achieve, public scorecards for labs and pathologists are probably
still years away as well.
Presenters at the 13th Annual Lab Quality Confab 2019 discussed the negative impact of disparities between medical laboratory processes and SOPs
ATLANTA, Oct. 18, 2019—Several weeks ago, the Centers for Medicare and Medicaid Services (CMS) quietly released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, which went to all State Survey Agency Directors, includes a “comprehensive revision to establish quality laboratory policies and procedures to ensure accurate and reliable test results to protect patients and improve the quality of healthcare,” CMS’ website states.
The revisions went into effect September 26, 2019.
For clinical laboratory administrators, managers, and
quality team members, reviewing the Special Procedures for Laboratories is
worth the effort as part of your 2020 lab quality program and continuous
improvement efforts. CMS made it easy to see what has changed by highlighting
the revisions in red.
One revision worth noting is 6006.4–Certificate of
Compliance, which has been revised to say, “A Certificate of Compliance is
issued to a laboratory after an inspection finds the laboratory to be in
compliance with all
applicable requirements.”
CMS Stepping Up Scrutiny, Particularly in Preanalytical Phase
Laboratories that deviate practices and processes from their
standard operating policies and procedures (SOPs) are going to get dinged,
Flynn explained during her session. Some examples recommended for review
included:
Validating specimen types, initially and as part
of a change in a major component;
Showing that temperature is properly controlled
during specimen transport; and
Mitigating risks as part of the shift to more
nurse-drawn specimens.
Additionally, Flynn noted that addressing deficiency citations, deficiency practice related survey data tags (D-Tags), and Form CMS-2567 (Statement of Deficiencies and Plan of Correction) are all daunting and complex. Many D-Tags have multiple regulatory requirements, according to CMS.
During her breakout session at The Dark Report’s 13th Annual Lab Quality Confab in Atlanta, Linda Flynn (above), Principal of LS Flynn and Associates, explained that the rigors of a CMS inspection far exceed those of other inspectors. “This is digging,” she stressed, adding that a CMS inspection comes with a big team of career inspectors. “It’s almost punitive … they know what they are looking for.” (Photo copyright: The Dark Report.)
Are Medical Laboratories at Risk for Factors They Cannot
Control?
Several attendees pointed out that in certain scenarios,
specimen jeopardy and patient risk are out of the medical laboratory’s control.
Nevertheless, Flynn says the laboratory is still responsible.
In addition to how a failure can adversely affect a patient,
the cost of failures can run into the millions of dollars which are attributed
to legal fees, consulting, staff overtime, and sanctions for the laboratory,
she said.
To reduce risk, Flynn recommends that medical laboratory
management address the complete lab continuum by getting out of the lab and
interfacing with people outside the lab who may adversely affect specimens.
Lessons Learned Through Health System’s Policy
Standardization Project
Intermountain generates approximately 10 million laboratory
tests per month, according to Zern. However, years ago, the health system’s
laboratories were not standardized at all. They were individually managed, they
had been writing unique SOPs, they were purchasing their own equipment, and
their vendor contracts were facility specific.
To standardize the labs, 11 discipline-specific practice
councils (work groups) were developed, each including representatives from
rural and core laboratory sites.
“What we found is that there is a lot of personal attachment
to SOPs,” Zern said. “As a team, we came up with better wording than we did as
individuals.” The end product was a single SOP, developed with the oversight of
medical directors and workable for everyone.
Clinical laboratory administrators, managers, and quality team members learned much at this year’s LQC. If you were unable to attend Lab Quality Confab this year, the digital audio recording series of 41 presentations is available for purchase. Go to https://www.labqualityconfab.com for more information.
At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs
This is an opportunity for clinical laboratory directors,
pathologists, and other lab professionals, to comment on the proposed revisions
to CLIA before or during the upcoming CLIAC meeting on Nov. 6.
The agenda for the meeting is posted on the CDC’s website.
Public to be Heard on CLIA Regulations
“For the first time in its 26-year history, the council has
called for three workgroups to address how to revise CLIA,” Salerno said. The
workgroups will address these topics:
“It’s a dramatic step for the government to ask the
laboratory community how to revise the CLIA regulations,” Salerno commented.
Chartered in 1992, the advisory council meets twice a year, once in April and
once in November.
In the coming weeks, Dark Daily will publish more
information on how clinical laboratory professionals can comment on the
important issue of CLIA revisions.
Digital slides from Salerno’s keynote address are posted on LQC’s presentations website.
Clinical Laboratory Testing is Increasing in Value,
Keynote Speaker Says
As a service to clinical laboratories, Salerno outlined many
of the services the CDC’s Division of Laboratory Systems provides for free to
clinical labs, including information on such topics as:
During his remarks at the 13th Annual Lab Quality Confab in Atlanta, Salerno had good news for the clinical laboratory professionals in attendance. He said that lab testing was becoming a more valued commodity in healthcare because physicians and other providers were growing increasingly confident in lab test results. [Photo copyright: The Dark Report.]
Healthcare System Disruption Impacts Providers, Including
Clinical Laboratories
Other keynote speakers addressed how disruption in the US
healthcare systems affects provider organizations in significant ways. For
clinical laboratories, such disruption has resulted in reduced payment and
demands for quality improvement and shorter turnaround times.
For all these reasons, quality
management systems may be every clinical laboratory’s best strategy to
survive and thrive, the keynote speakers said.
The first keynoter was Robert L. Michel, Editor-in-Chief and Publisher of The Dark Report. Michel’s remarks focused on how price cuts from Medicare, Medicaid, private payers, and the drive for value-based payment, are requiring labs to do more with less. For this reason, quality management systems are necessary for all labs seeking to improve results, eliminate errors, and cut costs, he said.
“The people closest to the work know how to fix these
problems,” he added. “That’s why labs know they must train their staff to
identify problems and then report them up the chain so they can be fixed,”
Michel commented. “Labs that are best at listening to their employees are
getting very good at identifying problems by measuring results and monitoring
and reporting on their own performance.”
Michel identified three principle factors that are
disrupting healthcare:
The shift from reactive care in which the health system cares for sick patients to proactive care in which the health system aims to keep patients healthy and out of the hospital and other costly sites of care.
The transition away from fee-for-service payment that encourages providers to do more for patients, whether more care is needed or not, to value-based payment that aims to reward providers for keeping patients healthy.
The consolidation among hospitals, health systems, physicians, and other providers. A trend that requires clinical laboratories to find new partners and new ways to improve lab services and reduce costs.
Informatics Performance Data Help Clinical Laboratories
Respond to Change
“The attributes of new and successful labs are that they will have faster workflow and shorter cycle times for clinical lab tests and anatomic pathology specimen results,” Michel explained. “That means that labs will attack non-value-added processes by implementing continuous improvement strategies [such as Lean and Six Sigma] and by the sophisticated use of informatics.”
Making use of performance data enables clinical laboratory
directors to make changes in response to disruptions that affect healthcare.
“If you have good informatics, then seven or eight of every 10 decisions you
make will be good decisions, and with the other two and three decisions, you’ll
have time to pull back and adjust,” Michel commented.
The second keynote speaker, Jeremy Schubert, MBA, MPH, Division Vice President of Abbott, reiterated what Michel said about how the health system is moving away from fee-for-service payment. Instead of focusing on caring for sick patients exclusively, he said, health insurers are paying all healthcare providers to keep patients healthy.
“Healthcare today is about the whole life course of the
individual,” Schubert explained. “Patients no longer want healthcare only when
they’re sick. Instead, they want to be healthy. And health creation is not just
about a person’s physical health. It’s about their mental health, their
emotional health, and their social wellbeing.
“In fact,” he continued, “you can learn more about a
person’s health from their Zip code than from their genetic code.”
That is essentially what TriCore Reference Laboratories (TriCore) has been doing in New Mexico, Schubert added. During his presentation, Michel mentioned TriCore as being one of four clinical laboratories participating in Project Santa Fe, a non-profit organization that promotes the movement from Clinical Lab 1.0 to Clinical Lab 2.0. (See “TriCore Forges Ahead to Help Payers Manage Population Health,” The Dark Report, May 20, 2019.)
“If you want to be a quality engine in healthcare you have
to be operating at Lab 2.0. Who is best qualified to interpret information?
It’s the lab,” Schubert said. Then he challenged labs to begin pursuing the
goal of achieving Lab 3.0, saying “Lab 3.0 is being able to interface with the
patient to address each patient’s problems.”
The 13th Annual Lab Quality Confab (LQC) in Atlanta continues through the 17th with post-event workshops in Six Sigma and mastering quality management systems. In attendance are 300 clinical laboratory administrators, managers, and quality team members who are learning a complete array of professional training methods.
To register to attend, click here or enter https://www.labqualityconfab.com/register into your browser, or call 707-829-9485, or e-mail lqcreg@amcnetwork.com.
How medical laboratories can show value through process improvement methods and analytics will be among many key topics presented at the upcoming Lab Quality Confab conference
Quality management is the clinical laboratory’s best strategy for surviving and thriving in this era of shrinking lab budgets, PAMA price cuts, and value-based payment. In fact, the actions laboratories take in the next few months will set the course for their path to clinical success and financial sustainability in 2020 and beyond.
But how do medical laboratory managers and pathologists address these challenges while demonstrating their lab’s value? One way is through process improvement methods and another is through the use of analytics.
Clinical pathologists, hospital lab leaders, and independent lab executives have told Dark Daily that the trends demanding their focus include:
Ensuring needed resources and appropriate tests,
while the lab is scrutinized by insurance companies and internally by hospital
administration;
“Our impact on patient care, in many cases, is very
indirect. So, it is difficult to point to outcomes that occur. We know things
we do matter and change patient care, but objectively showing that is a real
struggle. And we are being asked to do more than we ever had before, and those
are the two big things that keep me up at night these days,” he added.
This is where process improvement methods and analytics are
helping clinical laboratories understand critical issues and find opportunities
for positive change.
“You need to have a strategy that you can adapt to a changing landscape in healthcare. You have to use analytics to guide your progress and measure your success,” Patricia Nortmann, System Director of Laboratory Services at St. Elizabeth Healthcare, Erlanger, Ky., told Dark Daily.
Clinical Laboratories Can Collaborate Instead of Compete
Prior to a joint venture with TriHealth in Cincinnati, St. Elizabeth lab leaders used data to inform their decision-making. Over about 12 years preceding the consolidation of labs they:
Implemented front-end automation outside the core area and in the microbiology lab.
“We are now considered a regional reference lab in the state
of Kentucky for two healthcare organizations—St. Elizabeth and TriHealth,”
Nortmann said.
Thanks to these changes, the lab more than doubled its
workload, growing from 2.1 million to 4.3 million outreach tests in the core
laboratory, she added.
Christopher Doern, PhD (left), Director of Microbiology and Associate Professor of Pathology at Virginia Commonwealth University Health System; Patricia Nortmann (center), System Director of Laboratory Services at St. Elizabeth Healthcare; and Joseph Cugini (right), Manager Client Solutions at Health Network Laboratories, will present practical solutions and case studies in quality improvement and analytics for clinical laboratory professionals at the 13th Annual Lab Quality Confab, October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. (Photo copyright: The Dark Report.)
Using Analytics to Test the Tests
Clinical laboratories also are using analytics and information technology (IT) to improve test utilization.
At VCH Health, Doern said an analytics solution interfaces
with their LIS, providing insights into test orders and informing decisions
about workflow. “I use this analytics system in different ways to answer
different questions, such as:
How are clinicians using our tests?
When do things come to the lab?
When should we be working on them?
“This is important for microbiology, which is a very delayed
discipline because of the incubation and growth required for the tests we do,”
he said.
Using analytics, the lab solved an issue with Clostridium
difficile (C diff) testing turnaround-time (TAT) after associating it with
specimen transportation.
Inappropriate or duplicate testing also
can be revealed through analytics. A physician may reconsider a test after discovering
another doctor recently ordered the same test. And the technology can guide
doctors in choosing tests in areas where the related diseases are obscure, such
as serology.
Avoiding Duplicate Records While
Improving Payment
Another example of process
improvement is Health Network Laboratories (HNL) in Allentown, Pa. A team there established an enterprise master patient index (EMPI) and implemented digital tools to find and eliminate
duplicate patient information and improve lab financial indicators.
“The system uses trusted sources of data to make sure data is clean and the lab has what it needs to send out a proper bill. That is necessary on the reimbursement side—from private insurance companies especially—to prevent denials,” Joseph Cugini, HNL’s Manager Client Solutions, told Dark Daily.
HNL reduced duplicate records in its database from 23% to
under one percent. “When you are talking about several million records, that is
quite a significant improvement,” he said.
Processes have improved not only on the billing side, but in
HNL’s patient service centers as well, he added. Staff there easily find
patients’ electronic test orders, and the flow of consumers through their
visits is enhanced.
Learn More at Lab Quality Confab Conference
Cugini, Doern, and Nortmann will speak on these topics and more during the 13th Annual Lab Quality Confab (LQC), October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. They will offer insights, practical knowledge, and case studies involving Lean, Six Sigma, and other process improvement methods during this important 2-day conference, a Dark Dailynews release notes.
Register for LQC, which is produced by Dark Daily’s sister publication The Dark Report, online at https://www.labqualityconfab.com/register, or by calling 512-264-7103.
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.”
“We are confident that, if this case goes to a trial, there will be no evidence of wrongdoing—only proof that Wheeling Hospital offers the Northern Panhandle Community access to superior care, [and] world class physicians and services,” KHN reported Gregg Warren (above), Vice President of Marketing and Public Relations at Wheeling Hospital, saying in a statement. (Photo copyright: LinkedIn.)
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.
