News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Are Recent Predictions Regarding the Future of Healthcare Positive or Negative for Clinical Laboratories?

Medical laboratories that develop appropriate clinical strategies may find opportunities to leverage several new technologies expected to have a big impact on providers

Industry experts often speculate how developing technologies will impact healthcare. However, clinical laboratory leaders may be surprised by how much blockchain, medical malls, and Uber Health are expected to alter healthcare delivery in the next decade.

An article in FierceHealthcare states that “Healthcare is on the cusp of a technology revolution. Technology is primed to disrupt healthcare more explosively than it has any other industry.”

Medical advancements certainly impact clinical laboratories and anatomic pathology groups, and any acceleration in these developing technologies applied to healthcare will certainly be of interest to lab leaders who want to ensure their labs are ready.

Blockchain Provides Healthcare Security, Privacy, and Interoperability

Authored by Sloan Gaon, CEO, PulsePoint, the FierceHealthcare article predicts that blockchain will be an important feature in the future of healthcare. It will allow patients to have an online, accurate health record that is accessible only to necessary parties in real time. Consumers will be able to maintain, control, and share their data as they wish while increasing the security, privacy, and interoperability of their health information.

“A primary care physician could access a complete medical history of the member, while the radiologist could be limited to only the specifics he or she needs to perform the task at hand. For each, it’s about accessing the right data at the right time, and the blockchain technology could enable this type of specific ‘need-to-know’ medical history access,” wrote Bruce Broussard, President and CEO of Humana in a LinkedIn article.

The blockchain records can be shared among a network of computers and kept secure via cryptography. And the technology allows for easy transferability among different networks, improving performance and outcomes for patients. Broussard also stated that blockchain technology will provide more efficient payment for insurance claims.

“With transparency and automation, greater efficiencies will lead to lower administration costs, faster claims, and less money wasted. Blockchain enables claims to be paid without an intermediary, since health plan members are connecting directly with their providers. These consumers can also access their permanent electronic health records in a secure fashion, enabling them to have a real-time understanding of their health,” he wrote.

Should blockchain achieve widespread adoption as a platform for patient health information, the clinical laboratory industry will need to address the problem of different test methodologies and different reference ranges for test results. If blockchain makes it feasible to bring all pieces of a single patient’s cumulative health data into a single record, then clinical labs will need to address that problem in an effective way.

In his FierceHealthcare article, Sloan Gaon, CEO of PulsePoint, said “Technology will drive innovation, automation, transparency and efficiency, rendering the current healthcare landscape unrecognizable. As technology garners healthcare’s gold seal of approval, its effects will upend the industry, shrinking costs and improving outcomes.”

Medical Malls a Win-Win for Healthcare Providers and Retail Locations

With big shopping malls dying due to economic recessions and the emergence of online retail destinations, property owners are seeking new tenants. In the summer of 2017, there were still about 1,100 malls remaining in the US, however, a quarter of them were at a risk of closing within five years, Time noted that year.

As healthcare organizations expand, there is an overwhelming need for suitable space that is accessible for consumers at a reasonable price. Fading shopping malls with their convenient locations, sturdy foundations, and large parking lots could fill that gap.

In February of 2017, Avita Health System opened a boutique hospital in a space once occupied by an anchor store in a mall located in Ontario, Ohio. The healthcare provider purchased a 185,000 square-foot space that was formerly a Lazarus department store.

Mansfield News Journal reported that when the hospital opened, it included a walk-in clinic, an emergency room, surgical suites, pre-operative and post-operative areas, an onsite pharmacy, imaging services, a clinical laboratory, and 30 acute care beds.

Other services, including a Level II Cath lab, a maternity center, and the installation of a 3T Magnetic Resonance Imaging (3T MRI) machine, have been added since the facility opened. And there’s room for more expansion at the site.

Vanderbilt Medical Group (VMG) now occupies the entire second level of One Hundred Oaks Mall, in Nashville, Tenn. Their services at the once-struggling retail shopping center include 22 specialty clinics in 450,000 square feet of space designed by architecture firm Gresham Smith.

Patients can pick up a pager at the VMG facility and then shop on the lower level while waiting to be paged to see a healthcare professional or receive test results.

“More important than the significant increase in our available clinical space is the overall concept and design which is focused on providing our patients, faculty, and staff with a new paradigm for health and wellness. The convenience, accessibility, and innovative ways of providing care for our patients are a true transformation of both the architecture and the way our patients experience healthcare,” said Cyril Stewart, former Director of Facility Planning for Vanderbilt University Medical Center (VUMC) in a testimonial on the Gresham Smith website.

Non-Emergency Medical Transportation and Uber Health

Kaiser Family Foundation (KFF) reported in 2016 that “Medicaid’s non-emergency medical transportation (NEMT) benefit facilitates access to care for low income beneficiaries who otherwise may not have a reliable affordable means of getting to healthcare appointments. NEMT also assists people with disabilities who have frequent appointments and people who have limited public transit options and long travel times to healthcare providers, such as those in rural areas.”

The Hospital and Healthsystem Association of Pennsylvania (HAP) reported that an average of 3.6 million Americans miss their healthcare appointments annually due to lack of or unreliable transportation. These missed appointments can cause an avalanche of future problems, including increased visits to emergency rooms, extended hospital stays, and higher costs for providers.

Uber Health is positioned to become a major player in the field of non-emergency medical transportation (NEMT). The Verge reported in 2018 that independent research organization Transit Cooperative Research Program (TCRP) estimated that the NEMT market was worth more than $3 billion.

“If there are people who are missing their appointments because they’re using an unreliable bus service to get to and from their healthcare provider, this is a great solution for them,” Christopher Weber, General Manager and Senior Project Manager at Uber Health, told The Verge. “The types of individuals this is valuable for really is limitless.”

Uber health’s mobile device application (app) enables patients and healthcare providers to schedule non-emergency medical transportation for medical appointments within a few hours or up to a 30-day notice. It is also available both as an online dashboard and as an application-programming interface (API) for software developers to integrate the service into their proprietary healthcare tools.

An Uber (NYSE:UBER) account is not required, as notifications about rides can be sent to patients via text messages.

Clinical laboratory leaders may want to develop strategies around these three predictions to increase business and maximize profits. Since more healthcare organizations will soon be linked via blockchain, and an increased number of consumers could start using non-emergency medical transportation, such as Uber Health, to get to medical appointments, becoming familiar with these technologies could prove to be beneficial to labs.

In addition, medical facilities cropping up in former mall spaces will require medical laboratories to be onsite to support care and provide lab test results within an acceptable turnaround time.

—JP Schlingman

Related Information:

Industry Voices—How the Future of Healthcare Will be Shaped by the Likes of Uber, CVS

Blockchain: Transformational Technology for Health Care

Why the Death of Malls is about More than Shopping

Avita Ontario Hospital Poised to Open

Mall Landlords Welcome Medical Clinics as Retail Ails

Fighting the Blight: Reinventing Retail space for Vanderbilt Health

Uber is Driving Patients to Their Doctors in a Big Grab for Medical Transit Market

Association of Rideshare-Based Transportation Services and Missed Primary Care Appointments: A Clinical Trial

Study Finds Missed Medical Appointments Not Affected by Free Ride Services

Medicaid Non-Emergency Medical Transportation: Overview and Key Issues in Medicaid Expansion Waivers

Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

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:

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.

In fact, the US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) in September announced charges against 35 people including nine physicians for allegedly participating in healthcare fraud schemes involving genetic cancer testing of seniors nationwide, states a DOJ news release.

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.

The rule (CMS-6058-FC), called “Program Integrity Enhancements to the Provider Enrollment Process,” has new revocation and denial authorities to stop waste, fraud, and abuse, the news release points out.

Reasons CMS can revoke or deny enrollment to providers, according to another McDonald Hopkins Alert, include:

  • Outstanding debt to CMS following overpayment to the provider;
  • Coming back into CMS programs with a new identity;
  • Billing for services from non-compliant locations;
  • Abusive ordering or certifying under Medicare Part A or Medicare Part B.

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.

Register for “Bracing for Aggressive Payer Audits, Rigid Enforcement of Fraud and Abuse Laws, and More” at https://www.darkdaily.com/product/payor-audits-webinar/ or by calling 512-264-7103.

—Donna Marie Pocius

Related Information:

Dark Daily Webinar: What Lab Leaders Need to Know About How to Prepare for 2020: Bracing for Aggressive Payer Audits, Rigid Enforcement of Fraud and Abuse Laws, and More

Federal Law Enforcement Action Involving Fraudulent Genetic Testing Results in Charges Against 35 Individuals Responsible for Over $2.1 Billion in Losses is One of the Largest Healthcare Fraud Schemes Ever Charged

OIG Focusing on Laboratories Involved in Genetic Testing Scams

CMS Announces New Enforcement Authorities Reduce Criminal Behavior in Medicare, Medicaid, and CHIP

CMS Aims to Combat Criminal Behavior Through Enrollment Process

Does New Opioid Law Require Clinical Laboratories to Change How They Pay Sales Employees?

17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results

This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices

It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).

In September, Bloomberg reported that 17 former Orig3n employees said the company’s Deoxyribonucleic acid (DNA) tests sometimes failed to deliver the intended results or were often contaminated or inaccurate. The individuals had been employed by the company as managers, lab technicians, software engineers, marketers, and salespeople between 2015 and 2018.

The former employees claimed that Orig3n “habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards,” Bloomberg reported. The individuals also stated that advice intended to be personalized to individual consumers’ genetic profiles was often just generic information or advice that had no scientific basis.

According to Bloomberg, the individuals also alleged that Orig3n’s lab was careless in its handling of genetic samples in several ways, including:

  • Multiple samples being labeled with the same barcode;
  • DNA and blood samples for stem cell bank misplaced or mixed up;
  • No controls to ensure accuracy;
  • Handling methods that could lead to contamination; and
  • Fabricating results when a test outcome was unclear.

The former employees also stated that “Orig3n ran tests without proper authorization in its lab at the 49ers’ stadium, and that managers regularly compelled them to write positive reviews of Orig3n’s tests on Amazon.com and Google to offset waves of negative feedback,” Bloomberg reported.

“Accurate science didn’t seem to be a priority. Marketing was the priority,” said a former lab technician who spoke with Bloomberg on the condition of anonymity. Orig3n denied the accusations in a statement, describing them as “grossly inaccurate,” and claimed the former employees were simply disgruntled.

“In some cases, former employees are former employees for a reason,” Orig3n Chief Executive Officer Robin Smith told Bloomberg. “We’ve found after employees are gone that they have not done things appropriately.”

Jessica Stoll, MS, CGC (above), a certified genetic counselor and Associate Director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago Medicine, told NBC, “The majority of genetic testing is still a gray area and there’s always the possibility of uncertain results. I don’t find them particularly useful, and in some cases I can actually find them harmful.” (Photo copyright: Cancer Wellness Center.)

Is it Dog or Human DNA?

In 2018, NBC Chicago (NBC) conducted an investigation into various consumer DNA testing kits. NBC sent DNA samples to several different testing companies. This included non-human samples, which NBC’s investigators had obtained from a female Labrador Retriever.

With the exception of Orig3n, all of companies identified the DNA as non-human and did not process the kits. Orig3n did, however, process the canine DNA. It then returned a seven-page analysis that suggested the subject of the sample “would probably be great for quick movements like boxing and basketball, and that she has the cardiac output for long endurance bike rides or runs,” NBC reported.

This would be funny if it weren’t so concerning.

Following reports that it had processed dog DNA, Orig3n stated it had made changes and improvements to the company’s testing methodologies. Smith also stated Orig3n’s lab protocols had been improved as well.

“Sometimes we look at the accuracy of things and go, ‘Man, that’s not working,’” Smith told Bloomberg. “Our approach and our philosophy is [sic] to constantly improve the products.” 

Serious Accusations of Clinical Laboratory Malfeasance

Founded in 2014 with the intent of creating the world’s largest stem cell bank, by 2016, Boston-based Orig3n had refocused its attention on the burgeoning field of direct-to-consumer DNA testing. On its website, Orig3n sells several DNA-testing kits with varying costs.

Orig3n’s attempt to offer free genetic tests to large numbers of people at a professional sporting event in the fall of 2017 may be what caught the attention of federal investigators and led to a deeper investigation. Dark Daily previously covered this controversy, which centered around Orig3n’s plan to distribute free genetic testing kits to fans at a Baltimore Ravens football game.

In that situation, state and federal healthcare regulators blocked the giveaway over concerns about protected health information (PHI). Now, Orig3n is being accused of questionable business practices by 17 of its former employees. 

The former employees’ statements that the company’s genetic testing lab did not follow appropriate test protocols—and that it allegedly mishandled specimens and even reported false test results—are serious allegation of malfeasance and warrants an investigation.

Pathologists and clinical laboratory managers know that patient harm can potentially result from inaccurate genetic test results if used for clinical purposes. Dark Daily will continue to follow the investigation into Orig3n.

—JP Schlingman

Related Information:

DNA Company Tampered with Results, Former Employees Say

Home DNA Kits: What Do They Tell You?

Orig3n Holds Inaugural Ravens DNA Day on September 17 at M and T Bank Stadium to Kick Off the Season

Orig3n Partners with San Francisco 49ers to Reward Fans for Contributions to Advancing the Future of Medicine through Genetics and Regenerative Medicine Research

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Medical Tourism Lowers Healthcare Costs for Companies and Their Employees, But Is It Good Medicine for Patients and Can Clinical Laboratories Participate?

Some companies save so much in healthcare cost they pay their employees to participate in medical tourism programs

Medical tourism is not new, but it’s changing, and clinical laboratories have a role to play in the models employers use to save money on their employees’ health coverage costs.

Employers that manage the entire process—from securing passports for their employees, to ensuring they have access to high-quality care outside the country’s borders—report saving money as well as simplifying the process for their employees. An apparent win-win.

However, questions linger about:

  • Availability of diagnostic testing and clinical laboratories;
  • If patients treated outside the US receive adequate protections; and
  • Whether the quality of care is equal to that in the US.

One recent example of a company helping employers and employees receive high quality care outside of the US is NASH—the North American Specialty Hospital. NASH was featured in a Kaiser Health News (KHN) article that described one patient’s experience traveling to Cancún for a surgical procedure.

Location, Pre-Existing Conditions, Length of Stay, Etc., Affect Final Bill in US

One of NASH’s corporate clients is Ashley Furniture Industries. Headquartered in Arcadia, Wis., the American home furnishings manufacturer and retailer employs approximately 17,000 people, including Terry Ferguson. Terry’s wife, Donna, is the patient highlighted in the KHN story.

One of the healthcare providers NASH partners with is Galenia Hospital, a 55-bed general services hospital in Cancún, Mexico. NASH leases the entire third floor of the hospital. Galenia is next door to a Four Points Sheraton Hotel, making lodging a simple matter for medical tourists.

Currently, NASH focuses on orthopedic surgeries such as total knee replacements, the medical procedure Donna Ferguson underwent.

A 2015 BlueCross BlueShield study showed that costs for total-knee-replacement surgery in the US averaged about $31,000. However, depending on where the surgery takes place, it can cost as low as $11,317 (Alabama) and as high as $69,654 (New York City). Pre-existing conditions, length of time in the operating room, number of days in the hospital, and numerous other factors contribute to the final bill.

NASH, however, sets the final price is up front.

Some Companies Pay Their Employees to Use Medical Tourism

With the average cost for the surgery coming in at around $12,000, the cost savings to employers is so great some companies actually pay employees who are willing to travel for procedures, KHN reported. Donna Ferguson paid no co-pays for her surgery, paid nothing out of pocket for travel or lodging while in Cancún, and the Ferguson’s received a $5,000 check from Ashley Furniture.

Ferguson told KHN, “It’s been a great experience. Even if I had to pay, I would come back here because it’s just a different level of care—they treat you like family.”

That’s important for hospitals, clinical laboratories, and all healthcare providers in America to consider. In the minds of patients, quality of care starts with their experience at the hands of the provider.

Donna Ferguson (center) is shown above meeting Thomas Parisi, MD, JD (left), a surgeon with the Orthopedic Institute of Wisconsin, for the first time in Cancún the day before he performed her knee replacement surgery. Clinical laboratory tests, X-rays, and other diagnostics took place in the US prior to Ferguson’s authorization to undergo surgery in Mexico. (Photo copyright: Rocco Saint-Mleux/KHN.)

Clinical Laboratory Tests in US, Surgery in Mexico

Prior to traveling outside the US for surgery, Ferguson underwent a physical exam, X-rays, and other diagnostic testing to ensure the treatment approach was the best for her. Once that was confirmed, IndusHealth, Ashely’s medical travel plan administrator, “coordinated [Donna’s] medical care and made travel arrangements, including obtaining passports, airline tickets, hotel and meals,” for both Donna and Terry Ferguson, KHN reported.

It seems reasonable to assume that NASH has agreements with multiple clinical pathology laboratories and healthcare facilities throughout the US for patients to get the tests they need prior to surgery. Partnerships with medical tourism companies may well represent an avenue for pathology laboratories to pursue.

Protections for Patients

So, why hasn’t medical tourism become the healthcare juggernaut some experts predicted? Managed Care suggests one reason is that Americans tend to be skeptical of the quality of care they will receive in a foreign facility.

“Building a familiar culture in a foreign destination may be appealing to some American consumers, but I do not see it as a sustainable business,” Health consultant Irving Stackpole, PhD, MEd, Psychology, told KHN. “It’s not unusual for people thinking about this to have doctors, family, and friends who will see this as a high-risk undertaking.”

Several factors helped Ferguson feel better about her decision to travel to Mexico for surgery. One is that Galenia is credentialed.

Managed Care notes, “A number of organizations credential international facilities. The American Medical Association guidelines for medical tourism recommend that foreign medical providers have accreditation from the Joint Commission International or a similar organization.”

Galenia Hospital has accreditation from the Joint Commission International, the General Health Council of Mexico, as well as diamond-level accreditation from Canada’s Qmentum International Accreditation Program.

In addition to a credentialed facility and a highly trained surgeon, NASH also provides US malpractice insurance coverage, giving patients recourse in the event something goes wrong. Ferguson and American patients like her would be able to sue in the US if care under this arrangement was not successful.

Medical Tourism Pays Surgeon’s Full Fee

One fascinating twist in this story is that an American physician was flown to Cancun to perform this operation and was paid his full fee. The surgeon scheduled to perform Ferguson’s operation, Thomas Parisi, MD, JD, trained at the Mayo Clinic. He traveled from Wisconsin to Cancún to perform the procedure. “Dr. Parisi trained at Mayo, and you can’t do any better than that,” Ferguson told KHN.

KHN reported that Parisi spent less than 24 hours in Cancun and was paid $2,700 for this surgery. That fee is three times of the amount Medicare pays for this procedure. Further, Parisi’s fee was significantly above what many managed care plans would negotiate for this type of surgery.

American-trained physicians are common at many of the facilities credentialed by the Joint Commission International. “Many overseas hospitals are staffed in part by physicians and other health professionals who were trained in US hospitals. One hospital in India has 200 US-trained board-certified surgeons,” wrote James E. Dalen, MD, MPH, ScD, and Joseph S. Alpert, MD, in “Medical Tourists: Incoming and Outgoing,” published in The American Journal of Medicine (AMJMED).

“In the past, medical tourism has been mostly a blind leap to a country far away, to unknown hospitals and unknown doctors with unknown supplies, to a place without US medical malpractice insurance. We are making the experience completely different and removing as much uncertainty as we can,” James Polsfut, CEO and Chairman, North American Specialty Hospital (NASH), told KHN.

Clinical laboratories in America may find opportunities providing testing services to medical tourism organizations like NASH. It’s worth investigating.

 —Dava Stewart

Related Information:

To Save Money, American Patients and Surgeons Meet in Cancun

Blue Cross Blue Shield Association Study Reveals Extreme Cost Variations for Knee and Hip Replacement Surgeries

Understanding Knee Replacement Costs: What’s on the Bill?  

NASH Self-Pay Medical Tourism

Medical Tourism: Once Ready for Takeoff, Now Stuck at the Gate

Medical Tourists: Incoming and Outgoing

Medical Tourism Continues to Flourish as U.S. Patients Seek Lower Cost Healthcare in Overseas Countries

Healthcare Reform in the United States May Actually Increase Medical Tourism

Utah Public Employees Receive Transportation and a $500 Cash Bonus to Purchase Prescriptions in Mexico

Walmart Flies Employees to Top Hospitals for Surgeries in a Bid to Cut Healthcare Costs

Two New Definitive Healthcare Surveys Show Use of Inpatient Telehealth is Outpacing Outpatient Telehealth Services

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.

—Donna Marie Pocius

Related Information:

Definitive Healthcare Survey: Inpatient Telehealth Adoption on the Rise

Definitive Healthcare Survey: 2019 Outpatient Telehealth Adoption Remains Flat

Telehealth Use Jumps at Inpatient Settings

Telehealth Use Jumps at Inpatient Facilities While Outpatient Adoption Remains Flat: Survey

Inpatient Telehealth Adoption Surges

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Pathologist, Neurosurgeon, and Critical Care Specialist Face Criminal Charges in the Deaths of Dozens of Patients

Could local and federal prosecutors ask clinical laboratories to disclose information on their client physicians’ test-ordering activities when investigating medical errors?

Are physicians facing greater risk of criminal indictments when one of their patients dies, and investigators find that physician impairment or inappropriate medical treatments contributed to the patient’s death? Could clinical laboratories be drawn into federal investigations of their client physicians?

The healthcare industry is responding to often highly-publicized accusations of alleged wrongful care with extensive investigations of the doctors involved. And following suit, local and federal prosecutors increasingly seem willing to bring criminal charges against those physicians.

Thus, it behooves clinical laboratories to be aware of client physicians who may be over-ordering lab tests or regularly ordering inappropriate tests for their patients. At what point might criminal investigators hold medical laboratories accountable for not notifying authorities about lab test utilization patterns by physicians who could be reasonably understood to be putting their patients at risk of harm?

Doctors Charged in Three Cases Involving Deaths of Patients

In two separate reports, Fierce Healthcare covered three pending cases in which doctors are being charged in the deaths of their patients: article one covers a case is in Ohio; and article two covers cases in Arkansas and California. Charges were filed against:

  • William Husel, DO, an Ohio critical care specialist who was indicted for 25 counts of murder for allegedly intentionally ordering fatal drug overdoses, according to a statement by the Franklin County Prosecuting Attorney. He pleaded not guilty, the Associated Press reported.
  • Robert Levy, MD, an Arkansas pathologist who was indicted by a federal grand jury on “three counts of involuntary manslaughter” in the deaths of three patients, according to a statement by the US Attorney’s Office for the Western District of Arkansas. Levy pleaded not guilty at an arraignment in August, the Washington Post reported.  
  • Thomas Keller, MD, a California neurosurgeon who was indicted in the deaths of five patients, which allegedly resulted from his overprescribing opioids and narcotics, according to a statement from the State of California Department of Justice. Keller pleaded not guilty to second-degree murder charges in Sonoma County Court, according to the Press Democrat.
US Representative Bruce Westerman, R-Ark. (above) told the Washington Post, “Of all the medical professionals, the person you really don’t want messing up is a pathologist. If you have cancer, you want to know about it. If you don’t have it, you don’t want to be treated for it.” (Photo copyright: United States Congress.)

Dark Daily’s sister publication The Dark Report (TDR) covered the year-long investigation of Arkansas Pathologist Robert Levy, MD, by the US Attorney’s Office for the Western District of Arkansas. (See TDR, “Arkansas Pathologist Faces Three Manslaughter Charges,” September 30, 2019.)

Levy served as the Chief of Pathology and Laboratory Medical Services for the Veterans Health Care System of the Ozarks in Fayetteville, Ark., from 2005 through 2018.

In a statement, the US Attorney’s Office Western District of Arkansas said, “A federal grand jury … indicted Levy on twelve counts of wire fraud, twelve counts of mail fraud, four counts of making false statements in certain matters, and three counts of involuntary manslaughter.”  

A fact-finding panel interviewed Levy in 2015 after reports that he was under the influence of alcohol while on duty, stated the US Attorney Arkansas, adding that Levy denied the allegations.

In addition to other charges, the US Attorney Arkansas statement said, “The indictment charges Levy with three counts of involuntary manslaughter for causing the death of three patients through entering incorrect and misleading diagnoses and, on two occasions, by falsifying entries in the patients’ medical records to state that a second pathologist concurred with the diagnosis Levy had made. The indictment alleges that the incorrect and misleading diagnoses rendered by Levy caused the deaths of three veterans.”

In a news conference covered by the Washington Post, Duane Kees, US Attorney for the Western District of Arkansas, Department of Justice (DOJ), said, “I don’t think anyone would ever have imagined that a pathologist would use his knowledge and expertise to do something like this.”

Clinical laboratory leaders know how important it is to have quality processes to prevent misdiagnosis, mistakes, and inappropriate test utilization. Now, lab leaders may want to be aware of the activities of their client physicians as well.

During investigations involving harm to patients allegedly at the hands of healthcare providers, information kept by medical laboratories about the lab test ordering practices of their client physicians may become an important resource to officials conducting inquiries.

—Donna Marie Pocius

Related Information:

In California and Arkansas, Two Doctors Charged in Patient Deaths Over Opioid Prescriptions, Misdiagnosis

Ohio Doctor Charged with Murder in Deaths of 25 Hospitalized Patients

Attorney General Becerra Announces Arrest and Charges Against Santa Rosa Doctor

Santa Rosa Doctor Pleads Not Guilty to Murder Charges Connected to Four Patient Deaths

Dr. William S. Husel Indicted for 25 Counts of Murder in Mount Carmel Hospital Patient Deaths

Doctor Accused of Murder in 25 Patient Overdose Deaths

Fayetteville Doctor Arrested on Charges of Wire Fraud, Mail Fraud, Making False Statements, and Involuntary Manslaughter

Former VA Physician Charged with the Deaths of Three Veterans

Pathologist’s Errors Associated with Deaths at Arkansas VA

Pathologists Faces Three Manslaughter Charges

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