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California Opioid Addiction Physicians Struggle with Sublocade Solution

In California, where overdose deaths have been rising for years, addiction experts say administering a month’s worth of anti-addiction medication in a single injection holds great potential, particularly for people without housing or who struggle with other forms of instability. Yet despite its promise, the use of injectable buprenorphine remains fairly limited, especially compared with other forms of addiction medication. Researchers have yet to publish studies comparing different ways to administer buprenorphine.

Buprenorphine, one of three medications approved in the U.S. to treat opioid use disorder, works by binding to opioid receptors in the brain and reducing cravings and withdrawal symptoms. And because it occupies those receptor sites, buprenorphine keeps other opioids from binding and ensures that if a patient takes a high dose of a drug like heroin or fentanyl, they are less likely to overdose. Patients often stay on buprenorphine for years.

If Dr. Andrew Herring, who practices at an addiction clinic at Highland Hospital in the heart of Oakland, prescribes a supply of buprenorphine as a tablet or film that is placed under the tongue, the patient must commit to taking the medication at least once a day, and many fall out of treatment. He said this is especially true for his patients experiencing homelessness and those who also use methamphetamine.

Oral forms of buprenorphine have been available to treat addiction since 2002 and can be purchased as a generic for less than $100 a month. Injectable buprenorphine, sold under the brand name Sublocade, received FDA approval in 2017. It has a hefty list price of $1,829.05 for a monthly injection.

Still, addiction experts say, Sublocade use remains limited because of the regulatory hurdles required to dispense it.

Providers must register with the U.S. Drug Enforcement Administration and obtain a waiver to prescribe buprenorphine because it’s considered a controlled substance. In addition, clinics must complete an FDA safety certification program to dispense the medication. And Sublocade can be ordered only by a specialty pharmacy, which must also pass the FDA program.

“At many hospitals, that will mean either a delay in getting this medication on our shelves or just opting out,” said Dr. Rais Vohra, regional director for the California Bridge Network, a state-funded program that supports hospitals in offering treatment for substance use disorders, including Herring’s clinic.

Vohra said Community Regional Medical Center in Fresno, where he works as an emergency physician, is still looking through the documentation requirements to see if the hospital’s pharmacy can distribute the medication — which would make it one of the few Central Valley providers to do so.

Oral buprenorphine, by contrast, is a simple prescription that most local drugstores keep in stock.

“All the hoops that clinicians and patients have to jump through to get this medication is crazy. We don’t do that for any other disease,” said Dr. Hannah Snyder, who runs the addiction clinic at Zuckerberg San Francisco General Hospital across the bay.

“The most important question isn’t whether long-acting injectable bupenorphine is a better solution than sublingual buprenorphine for opioid use disorder,” said Dr. Michael Ostacher, a professor at Stanford University School of Medicine, who is comparing injectable and oral versions of buprenorphine through Veterans Affairs. “The bigger question is how we increase access to treatment for all people who need [the medication].”

California’s Medicaid program does not require prior authorization but providing Sublocade is still a challenge. At the Placerville clinic supported by the California Bridge Network, Dr. Juliet La Mers, the director, said a quarter of her buprenorphine patients get injections. Still, they often wait two weeks before Sublocade arrives from the specialty pharmacy.

In states where Medicaid plans may still require prior authorization, waits for Sublocade can stretch into months. Across the border at the Northern Nevada Hopes clinic in Reno, Nevada, for example, Dr. Taylor Tomlinson said she tells patients that between battles for coverage and pharmacy delays, they might have to wait two months for an injection.

Workers Seek Order Prohibiting WCAB “Grant and Study” Recon Orders

On March 4, 2022, a 78 page Petition for Writ of Mandate was filed against the Workers’ Compensation Appeals Board by a representative group of five California injured workers, all of whom claim they have been denied their constitutionally guaranteed right to speedy and unencumbered resolution of their claims for workers’ compensation benefits, as a result of the WCAB’s issuance of what they call “grant and study” orders in response to petitions for reconsideration seeking review of the trial level decisions in their cases.

The petition requests that Court of Appeal find that the “grant and study” procedure is unconstitutional and unlawful, revoke all of the “grant and study” orders issued by the WCAB, and order the WCAB to provide a timetable within which it will render final decisions in all cases where such “grant and study” orders have been issued.

This lead case is entitled Michele Earley, et al. v. The Workers’ Compensation Appeals Board of the State of California, et al., Case No. B318842, and has been assigned to Division of 8 of the Second District Court of Appeal.

The Labor Code requires that petitions for reconsideration be decided by the WCAB within 60 days. However, they say that in many cases the Board, following an unwritten, self-adopted policy and procedure, issues so-called “grant and study” orders which extend that time period indefinitely.

To make matters worse,” they say, “Petitioners are precluded from seeking adjudication of any further disputes which may arise until the WCAB finally issues its final decision regarding the issues placed on indefinite hold by the ‘grant and study’ orders issued in their cases.”

In response to a recent public records act request, they claim the WCAB provided data demonstrating that it has issued such “grant and study” orders in over 500 cases within a 3-year period alone, many of which remain undecided for years at time.

In the Earley case for example, her trial took place on February 26, 2020, and an award issued in her favor on May 14. However the carrier petitioned for reconsideration of that award. Then on June 29, 2020, the WCAB issued its Opinion and Order Granting Reconsideration “to further study the factual and legal issues presented in this case.” And as of the date of filing the Petition for Writ of Mandate (March 4, 2022) no decision had been issued. (However, the WCAB panel did issue an opinion on March 15, 2022).

According to the docket entries in the case now pending in the Court of Appeal, a number of Amicus parties have been allowed to participate in the case, mostly insurance carriers, and one prominent lien claimant.

The other four petitioning workers allege similar timelines as illustration of long delays in adjudicating their cases on reconsideration.

And on May 4, 2022, the Court of Appeal issued an Order to Show Cause directing the WCAB to show good cause why the relief sought by these injured workers should not be granted. The WCAB is directed to file it’s response by June 3, 2022, and the Petitioners, real parties in interest, and amicus curiae have until June 20, 2022 to reply.

This will be a closely followed case, as the “grand and study” orders have issued in reconsideration cases filed by both applicants and defendants for decades.

Walmart Avoids $504K in Photo Shoot Model Late Pay Penalties

Bijon Hill appeared in ten photo shoots organized by Walmart in San Francisco between July 2016 and August 2017 for a total of fifteen days, in non-consecutive periods of one or two days. Hill claims that this amounted to ten separate instances of employment and that she was “discharged” at the end of each photo shoot.

During this time, Hill was represented by Scout Talent Management Agency. Walmart had a contract with Scout and agreed to pay Scout a daily flat rate for each day of modeling services, which was to be passed along to Hill plus a commission. Walmart and Scout’s contract specified that Scout and its “personnel” were independent contractors.

Hill sued Walmart for its failure to pay her immediately after each photo shoot ended and sought more than $540,000 in penalties pursuant to California Labor Code § 203. Walmart removed the case to federal court based on diversity of citizenship. It also filed a third-party complaint against Scout.

The district court denied summary judgment on Walmart’s defense that plaintiff was an independent contractor outside the protection of the relevant Labor Code provisions due to disputes of material fact. However, it granted summary judgment on Walmart’s good-faith defense. The district court concluded that there was a good-faith dispute about whether plaintiff was an independent contractor that made it objectively reasonable for Walmart to believe plaintiff was not an employee.

The Court of Appeals for the Ninth Circuit affirmed the summary judgment in the published case of Hill v Walmart – 21-15180 (April 26, 2022).

8 C.C.R. § 13520 provides that “A willful failure to pay wages within the meaning of Labor Code Section 203 occurs when an employer intentionally fails to pay wages to an employee when those wages are due. However, a good faith dispute that any wages are due will preclude imposition of waiting time penalties under Section 203.

Moreover, 8 C.C.R. § 13520 explains that “[a] ‘good faith dispute’ that any wages are due occurs when an employer presents a defense, based in law or fact which, if successful, would preclude any recovery on the part of the employee.

It is undisputed that if Hill were an independent contractor, then she would not be an “employee” entitled to an immediate payment of wages upon discharge pursuant to Labor Code § 201(a) or to recover penalties from Walmart pursuant to § 203.

Consequently, Walmart’s argument that Hill was an independent contractor is a “good faith dispute that any wages are due.” See also Amaral v. Cintas Corp. No. 2, 163 Cal. App. 4th 1157, 1202 (2008) (employer had good-faith defense because its “legal obligations” were “unclear,” and the arguments it made for its ultimately incorrect legal position were not “unreasonable or frivolous”); Barnhill v. Robert Saunders & Co., 125 Cal. App. 3d 1, 8 (1981) (legal ambiguity is a valid basis for a good-faith defense).

May 2, 2022 – News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Privileges Protect CIGA and TPA From PTP Defamation Action. WCAB Reverses AOE/COE Using Substantial Medical Evidence Rules. 9th Circuit Reverses Prison Guard Vaccination Order. Californians Involved in Nationwide Health Care Fraud Takedown. $3.8M in COVID-19 Supplemental Paid Sick Leave Violation Citations. Torrance Car Wash Cited for $800K Wage Theft. GAO Audit Finds “Political Interference” With CDC and FDA Findings. Med-Malpractice Payout Limits to Increase in Deal With Legislature. Cal/OSHA Board Approves New COVID Rules Starting in May. WCRI Publishes Workers’ Compensation Laws as of January 1, 2022.

Travelers Report Says 35% of Injuries Occur During First Year on Job

The Travelers Companies, the country’s largest workers compensation insurer, just released its 2022 Injury Impact Report. The study analyzed more than 1.5 million workers compensation claims over a five-year period (2015-2019) and revealed that 35% of injuries occur during employees’ first year on the job, regardless of age or industry experience.

Travelers analyzed more than 1.5 million workers compensation claims it received between 2015 and 2019 from a variety of industries and business sizes. Findings were based solely on indemnity claims, where the injured employees could not immediately return to work and incurred medical costs. This is the second analysis of its kind conducted by the company. The first was in 2016 and included data between 2010 and 2014.

The study provided insights in a number of areas related to first-year injury claims.

The most common causes of first-year injuries were overexertion (27% of claims); slips, trips and falls (22%); being struck by an object (14%); cuts and punctures (6%); being caught in or between objects (6%); and motor vehicle accidents (6%).

The most expensive claims, accounting for just 8% of total claims but 26% of total claim costs, were amputations, multiple traumas, electric shock and dislocations.

The restaurant industry experienced the most claims from first-year employees, with 53% of the claims involving the newest workers and representing 47% of total claim costs. The construction industry was a close second, with nearly half of all claims coming from those who were new to the job, driving 52% of the industry’s claim costs.

First-year injuries led to more than 6 million lost workdays over the five-year period studied, representing 37% of all lost days. Among all worker injuries over the same period, construction workers on average missed the most workdays (98) due to an injury, followed by employees in transportation (88) and those in services (69), which includes businesses such as legal, engineering and accounting firms.

Dislocation and inflammation injuries resulted in the most time away from work on average, at 132 and 82 workdays, respectively. Strains and falls both caused workers to miss an average of 69 workdays, followed by motor vehicle accidents (61) and being struck by an object (59).

“Our data underscores the importance of comprehensive onboarding and training programs for employees, particularly as we continue to navigate the challenges of COVID-19 and see many workers starting new jobs,” said Chris Hayes, Assistant Vice President, Travelers Risk Control – Workers Compensation and Transportation. “While new employees are among the most vulnerable, many injuries sustained by employees of any tenure can often be prevented if the proper safety measures are in place.”

UCSD Smartphone App Screens for Neurological Disease

Researchers at the University of California San Diego have developed a smartphone app that could allow people to screen for Alzheimer’s disease, ADHD and other neurological diseases and disorders – by recording closeups of their eye.

The app uses a near-infrared camera, which is built into newer smartphones for facial recognition, along with a regular selfie camera to track how a person’s pupil changes in size. These pupil measurements could be used to assess a person’s cognitive condition.

The technology is described in a paper that will be presented at the ACM Computer Human Interaction Conference on Human Factors in Computing Systems (CHI 2022), which will take place from April 30 to May 5 in New Orleans as a hybrid-onsite event.

“While there is still a lot of work to be done, I am excited about the potential for using this technology to bring neurological screening out of clinical lab settings and into homes,” said Colin Barry, an electrical and computer engineering Ph.D. student at UC San Diego and the first author of the paper, which received an Honorable Mention for Best Paper award. “We hope that this opens the door to novel explorations of using smartphones to detect and monitor potential health problems earlier on.”

Pupil size can provide information about a person’s neurological functions, recent research has shown. For example, pupil size increases when a person performs a difficult cognitive task or hears an unexpected sound.

Measuring the changes in pupil diameter is done by performing what’s called a pupil response test. The test could offer a simple and easy way to diagnose and monitor various neurological diseases and disorders. However, it currently requires specialized and costly equipment, making it impractical to perform outside the lab or clinic.

Engineers in the Digital Health Lab, led by UC San Diego electrical and computer engineering professor Edward Wang, collaborated with researchers at the UC San Diego Center for Mental Health Technology (MHTech Center) to develop a more affordable and accessible solution.

“A scalable smartphone assessment tool that can be used for large-scale community screenings could facilitate the development of pupil response tests as minimally-invasive and inexpensive tests to aid in the detection and understanding of diseases like Alzheimer’s disease. This could have a huge public health impact,” said Eric Granholm, a psychiatry professor at UC San Diego School of Medicine and director of the MHTech Center.

The app developed by the UC San Diego team uses a smartphone’s near-infrared camera to detect a person’s pupil. In the near-infrared spectrum, the pupil can be easily differentiated from the iris, even in eyes with darker iris colors. This enables the app to calculate pupil size with sub-millimeter accuracy across various eye colors. The app also uses a color picture taken by the smartphone’s selfie camera to capture the stereoscopic distance between the smartphone and the user. The app then uses this distance to convert the pupil size from the near-infrared image into millimeter units.

The app’s measurements were comparable to those taken by a device called a pupillometer, which is the gold standard for measuring pupil size.

The researchers also included various features in their app to make it more user friendly for older adults.  The researchers worked with older adult participants to design a simple app interface that allows users to self administer pupil response tests. This interface included voice commands, image-based instructions, and a cheap, plastic scope to direct the user to place their eye within the view of the smartphone camera.

The Digital Health Lab is continuing this work in a project to enable similar pupillometry function on any smartphone rather than just the newer smartphones. Future studies will also involve working with older adults to evaluate home use of the technology. The team will work with older individuals with mild cognitive impairment to test the app as a risk screening tool for early stage Alzheimer’s disease.

This work was funded by the National Institute of Aging. To learn more about this project and other works by the UCSD Digital Health Lab, see their webpage and also download the paper on this device, “At-Home Pupillometry using Smartphone Facial Identification Cameras.

Biden Signs Law Limiting Employer Arbitration Mandates

The Federal Arbitration Act or FAA, enacted February 12, 1925, is federal law that provides for private dispute resolution through arbitration. The FAA recognizes benefits to society as a result of resolution of disputes in expeditious systems. It is most often implemented by use of an arbitration clause in the contract between the parties.  

An arbitration clause is a clause in a contract that requires the parties to resolve their disputes through an arbitration process. Mandatory arbitration clauses are widespread in the United States. For example, 15 of the largest 20 U.S. credit card issuers, and 7 of the 8 largest cell phone companies have arbitration clauses for resolution of disputes with customers.

In employment law, many employers have mandatory arbitration clauses in contracts with their employees, for the purpose of limiting the possibility of extreme jury verdicts in favor of former employees, as well as the risk of costly class action litigation.

Section 2 of the FAA declares that arbitration provisions will be subject to invalidation only for the same grounds applicable to contractual provisions generally, such as unconscionability or duress. Consequently, most state law that attempts to disfavors or limit the enforcement of mandatory arbitration agreements are preempted by the FAA.

Substantial federal and state litigation has evolved over the years on the issue of federal preemption precluding the ability of any state’s attempt to restrict an employer’s rights to force mandatory arbitration of disputes with employees. Generally speaking, individual states have not been successful in litigation efforts to limit the preemption provisions of the FAA.

However, President Biden has just signed into law the Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. This Act was introduced in 2017.

The Act amends the Federal Arbitration Act to give employees who are parties to arbitration agreements with their employers the option of bringing claims of sexual assault or sexual harassment either in arbitration or in court.

The Act amends the FAA to include a new section, which states, in part: “[A]t the election of the person alleging conduct constituting a sexual harassment dispute or a sexual assault dispute, or the named representative of a class or in a collective action alleging such conduct, no predispute arbitration agreement or predispute joint-action waiver shall be valid or enforceable with respect to a case which is filed under Federal, Tribal, or State law and relates to the sexual assault dispute or the sexual harassment dispute.”

Thus this new Act is an employment law game changer. It gives employees the option to circumvent arbitration agreements and class or collective action waivers with respect to sexual assault and sexual harassment claims.

The Act applies to all claims that arise or accrue after March 3, 2022, regardless of the date of the agreement at issue. The Act, however, does not affect claims that arose or accrued before March 3, 2022.

The Act does not affect otherwise valid arbitration agreements for claims that are not related sexual assault and sexual harassment. What is unanswered in the new law, is how it will apply when sexual assault and sexual harassment claims are intermixed with other employment law claims in a single litigation filing.

New Safety Standards Helps Organizations Prevent Workplace Injuries

Organizations typically measure safety and health performance by tracking incidents after the fact with lagging metrics. To improve that method, the American Society of Safety Professionals (ASSP) has published a voluntary national consensus standard that outlines a balanced measurement approach, using leading, lagging and impact metrics. The new standard can help organizations prevent injuries, illnesses and many other incidents from occurring in the first place.

ANSI/ASSP Z16.1-2022, Safety and Health Metrics and Performance Measures,incorporates a balanced evaluation of risk management factors and safety management systems that empowers a business to take a more comprehensive and effective approach to safety and health.

“Relying solely on lagging metrics does not improve workplace safety,” said Alexi Carli, M.S., CSP, chair of the Z16 committee. “We need a complete, systematic method to influence what happens while understanding how and why it happens. This standard’s balanced approach measures actions that drive improvement. It’s a major development that can help businesses thrive, especially in today’s challenging environment.”

“Occupational safety and health professionals are strategic business partners,” Carli added, “and the new standard enables them to help corporate leaders achieve greater organizational efficiencies and improve resilience.”

In addition to introducing a new standard, ASSP revised two standards that will also help advance workplace safety and health. Z117.1-2022, Safety Requirements for Entering Confined Spaces, provides minimum safety requirements to be followed while entering, exiting and working in confined spaces.

Confined space safety standards are critical across all industries because first responders may not have the capability to perform a rescue in all circumstances. Proactively implementing a standard such as Z117.1-2022 reduces risks such as oxygen deficiency, which is a leading atmospheric hazard in confined space incidents.

ANSI/ASSP A1264.2-2022, Reducing Slip Missteps on Walking-Working Surfaces, provides guidance for adequate slip resistance. Falls are the leading cause of accidental deaths in the United States. While these hazards exist in many work environments, organizations can take simple steps to mitigate or eliminate them.

Voluntary national consensus standards provide the latest expert guidance and fill gaps where federal regulations don’t exist. Companies rely on them to drive improvement and injury prevention. With regulatory requirements being slow to change and often out of date, compliance is not sufficient to protect workers.

ASSP is global leader in the development of workplace safety and health standards, helping employers minimize on-the-job risks. The organization’s broad collection of new and revised standards focuses on psychological safety and health, fall protection, construction and demolition operations, and prevention through design.

In addition to implementing safety and health standards, all employers are encouraged to regularly conduct workplace risk assessments, which are effective in combating many safety and health issues across all industries.

American Society of Safety Professionals is a global association for occupational safety and health professionals dedicated to creating safe work environments across all industries. For more than 100 years, ASSP has been at the forefront of helping occupational safety and health professionals protect people and property through their efforts to prevent workplace injuries, illnesses and fatalities. Find more information on ANSI/ASSP Z16.1-2022 on the ASSP website.

Physicians Combine Virtual Reality and Robotics For Safer Surgeries

At the Interdisciplinary Conference on Orthopedic Value-Based Care, According to an article in Helio, Randy Fagin, MD, chief medical officer – national group of HCA Healthcare, said among the 183 hospitals in the HCA Healthcare system, about 88,000 hip and knee replacements are performed annually, not including those performed at the system’s 125 ASCs.

And according to Dr. Fagin, “Physicians who use robotics are growing faster, 36% year-over-year case growth vs. 7% for those who are not using robotics.”

However, a factor that may be disruptive to robotics is augmented reality (AR), Fagin said. “Augmented reality is, I believe, going to be disruptive to robotics, massively disruptive. It is going to come on slow.”

However, because AR is a disruptive innovation, “it’s going to hit a dynamic growth curve” followed by a logarithm rise in utilization, until such time that the utilization levels out and become commoditized, Fagin said.

“We’re going to hit a logarithmic rise in utilization of augmented reality in hip and knee replacement and it will disrupt the robotic marketplace,” he said.

An article published by Stanford University helps explain how this new technology might be used by surgeons.

Surgeons make their way down to the Neurosurgical Simulation Lab to practice an upcoming operation. Because they’re practicing on images from the actual patient, rather than a generic brain, they can map out the surgery ahead of time. “It’s a window into the brain – and a window into the brain of the particular patient we’re going to operate on,” said Anand Veeravagu, MD, an assistant professor of neurosurgery and the head of the Stanford Neurosurgical Simulation Lab.

The three-dimensional aspect of the imagery eases surgeons’ planning and improves the accuracy of the surgery, with the aim of producing safer procedures. “We can plan out how we can approach a tumor and avoid critical areas like the motor cortex or the sensory areas,” said Steinberg, professor and chair of neurosurgery. “Before, we didn’t have the ability to reconstruct it in three dimensions; we’d have to do it in our minds. This way it’s a three-dimensional rendering.”

Stanford Medicine doctors are using the VR technology for the brain and spinal cord because these organs are stable and lend themselves to imagery – unlike other body parts, which move with blood flow and breathing. But Malie Collins, MS, senior program lead for the VR program said the technology may soon be available for the rest of the body.

Surgeons typically use video feeds while they are operating, but the new VR technology adds a three-dimensional view which they can superimpose on the real-time video. “It has much, much more detail,” said Steinberg.

And Johns Hopkins neurosurgeons have performed the institution’s first augmented reality surgeries in living patients. During the first procedure on June 8, 2020, the physicians placed six screws in a patient’s spine for spinal fusion surgery to fuse three vertebrae in order to relieve the patient’s chronic, debilitating back pain. For the second surgery on June 10, surgeons removed a cancerous tumor known as a chordoma from the spine of a patient.

The technology used by the physicians for the augmented reality surgeries consisted of a headset with a see-through eye display that projects images of the patient’s internal anatomy such as bones and other tissue based on CT scans – essentially giving the surgeons X-ray vision.

“When using augmented reality in the operating room, it’s like having a GPS navigator in front of your eyes in a natural way so you don’t have to look at a separate screen to see your patient’s CT scan,” says Timothy Witham, M.D., director of the Johns Hopkins Neurosurgery Spinal Fusion Laboratory and professor of neurosurgery at the Johns Hopkins University School of Medicine.

Temecula Physician to Serve 8 Years for $12M Medicare Fraud

A California doctor was sentenced to 93 months in prison for defrauding Medicare, re-packaging single-use catheters for re-use on patients, and submitting false declarations in a bankruptcy proceeding.

On June 6, 2016, Donald Woo Lee, 55, of Temecula, California, was charged with seven counts of health care fraud in an indictment returned by a federal grand jury in the Central District of California. Lee was additionally charged with one count of adulteration of a medical device and one count of false statements in bankruptcy in a subsequent superseding indictment filed on June 7, 2018.

Lee was an internal medicine doctor who owned, operated, and oversaw several medical clinics in the greater Los Angeles and Riverside areas. He was a 1994 graduate of St. George’s University in Grenada, His medical license in California was surrendered on November 7, 2019 after disciplinary charges were filed against him.

According to court documents, Lee recruited Medicare beneficiaries to his clinics, falsely diagnosed the beneficiaries, and provided the beneficiaries with medically unnecessary procedures. Lee billed these unnecessary procedures to Medicare using an inappropriate code in order to obtain a higher reimbursement, a practice known as “upcoding.”

In addition, the evidence showed that Lee re-packaged used, contaminated catheters for re-use on patients. These catheters had been cleared by the Food and Drug Administration (FDA) for marketing as single-use only and the re-use of these devices put patients at risk of infection and other bodily injury. Lee submitted claims of approximately $12 million to Medicare for the vein ablation procedures he performed, and received $4.5 million as a result.

In October 2019, Lee was convicted after a five-day trial, when a jury found him guilty of seven counts of health care fraud and one count of adulteration of a medical device. Lee also pleaded guilty on March 2, 2020, to one count of submitting false declarations in a bankruptcy proceeding.

In addition to the term of imprisonment, Lee was sentenced to serve three years of supervised release and ordered to pay more than $4.5 million in restitution to Medicare.

Since its inception in March 2007, the Medicare Fraud Strike Force, which maintains 15 strike forces operating in 24 districts, has charged more than 4,200 defendants who have collectively billed the Medicare program for nearly $19 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.