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Tag: 2021 News

Owner Pleads Guilty for $31M Home Health Care Kickback Scheme

Liana Karapetyan, 41, of El Dorado Hills, pleaded guilty to one count of conspiracy to commit health care fraud and one count of conspiracy to pay and receive health care kickbacks.

According to court documents, Karapetyan and another individual owned and controlled home health care and hospice agencies in the greater Sacramento area: ANG Health Care Inc., Excel Home Healthcare Inc., and Excel Hospice Inc.

Karapetyan and another individual paid and directed others to pay kickbacks to multiple individuals for beneficiary referrals, including employees of health care facilities, as well as employees’ spouses.

The kickback recipients included John Eby, a registered nurse who worked for a hospital in Sacramento; Anita Vijay, the director of social services at a skilled nursing and assisted living facility in Sacramento; Jai Vijay, Anita Vijay’s husband; and Mariela Panganiban, the director of social services at a skilled nursing facility in Roseville.

In total, Karapetyan and others caused the agencies to submit over 8,000 claims to Medicare for the cost of home health care and hospice services. Based on those claims, Medicare paid the agencies approximately $31 million. Of that amount, Medicare paid the agencies at least over $2 million for services purportedly provided to beneficiaries referred in exchange for kickbacks paid to, among others, Eby, Anita Vijay, Jai Vijay, and Panganiban.

Because the agencies obtained the beneficiary referrals by paying kickbacks, the agencies should not have received any Medicare reimbursement.

This case is a product of an investigation by the Federal Bureau of Investigation and the Department of Health and Human Services’ Office of Inspector General. Assistant U.S. Attorney Matthew Thuesen is prosecuting the case.

Karapetyan will be sentenced on on Aug. 26. She faces maximum statutory penalties of 10 years in prison for the health care fraud conspiracy charge and five years in prison for the kickback conspiracy charge. She also faces a maximum fine of $250,000 or twice the gross gain or loss for each charge.

In separate cases, Eby, Jai Vijay, Anita Vijay, and Panganiban pleaded guilty for their roles in the kickback scheme. They await sentencing.

NWCDC Panelists Discuss Inappropriate Use of Off-Label Drugs

myMatrixx Chief Clinical Officer, Phil Walls, was joined by Marcos Iglesias MD, Chief Medical Director of the Travelers and Constitution State Services to discuss the interaction between behavioral health and chronic pain management in workers’ compensation.

The presentation, Navigating the Intersection of Pain Management and Psychotropic Drugs, was held as part of the National Workers’ Compensation and Disability Conference’s (NWCDC) ongoing Digital Sessions Series.

During the panel, the two experts examined the types of psychotropic drugs that claims professionals most commonly encounter, including those used off-label, and effective strategies for managing safety and cost considerations.

Mental health is a growing concern that requires more attention – only 40% of the 39 million adults in the United States who experience a mental health event actually receive treatment.

In workers’ compensation, where so many injured workers deal with chronic pain, treated and untreated mental health conditions are associated with high claim costs over long periods of time.

According to Walls and Dr. Iglesias, certain drug combinations, such as opioids and benzodiazepines, require particular attention from both a patient safety and cost standpoint.

Another key topic in the presentation was off-label drug use. According to research, 73% of medications prescribed for an off-label use, such as using a drug for longer than indicated or to treat a different condition, had poor or no scientific support.

You can view the presentation in full and download slides on the NWCDC website.

DIR Launches New Supplemental Paid Sick Leave Navigation Tool

The Department of Industrial Relations and its California Labor Commissioner’s Office has launched a web-based tool in English and Spanish that offers key information on the new 2021 COVID-19 Supplemental Paid Sick Leave law, Senate Bill No. 95, signed by Governor Newsom on March 19.

The 2021 Supplemental Paid Sick Leave law provides workers up to 80 hours of paid sick leave if they or a family member are unable to work or telework due to COVID-19, including for vaccine-related reasons,” said Labor Commissioner Lilia García-Brower. “We designed this tool so workers and their employers can get information on workers’ paid sick leave options.”

The law, which went into effect on March 29 and is retroactive to January 1, 2021, requires that California workers are provided up to two weeks of supplemental paid sick leave if they are affected by COVID-19. Among the key updates in the new legislation, leave time now also applies to attending a COVID-19 vaccine appointment and recovering from symptoms related to the vaccine. The new law is in effect until September 30, 2021. Small businesses employing 25 or fewer workers are exempt from the law but may offer supplemental paid sick leave and receive a federal tax credit, if eligible.

The navigator tool, available in English and Spanish, helps workers and employers confirm if they are eligible for COVID-19 supplemental paid sick leave by answering short simple questions on the impact COVID-19 is having on an employee’s ability to work. Workers and employers need not provide a name or other personal details to determine eligibility. In addition, Supplemental Paid Sick Leave FAQs are posted online in English and Spanish.

In the FAQs, workers can find information on:

– – Required circumstances for taking COVID-19 leave
– – How to request paid sick leave from your employer
– – Where to file a claim if you were not paid for leave
– – What rights you have as a covered employee

Employers can find information on:

– – When must employers pay COVID-19 sick leave
– – Calculating leave time for full-time and part-time employees
– – Requirements for informing employees about the new law
– – How to calculate and list paid leave on pay stubs

The law also includes unique provisions for firefighters. The law defines what constitutes an “active” firefighter and it identifies the member firefighter agencies covered under SB 95.

Employees may also be eligible for workers’ compensation benefits if they believe their COVID-19 illness is work-related. In that instance, workers should tell their employers about their work-related illness as soon as possible and file a workers’ compensation claim, which pays for medical treatment and partial wages during recovery. For support, please contact the Division of Workers’ Compensation’s Information and Assistance Unit or call 1- 909-383-4341.

Workers whose employers refuse to provide paid sick leave or COVID-19 supplemental paid sick leave as required by law, or prevent workers from accessing paid sick hours, are encouraged to call the Labor Commissioner’s Office at 833-LCO-INFO (833-526-4636) to file a wage claim.

The Department of Industrial Relations’ Division of Labor Standards Enforcement, or the California Labor Commissioner’s Office, combats wage theft and unfair competition by investigating allegations of illegal and unfair business practices. Californians can follow the Labor Commissioner on Facebook and Twitter.

New COVID-19 Cases Fall 16% in U.S.

A Reuters analysis shows that new cases of COVID-19 in the United States fell 16% last week to about 409,000, the biggest percentage drop in weekly new cases since February, according to a Reuters analysis of state and county data.

Deaths from COVID-19 fell 4% to 4,972 in the week ended April 25, dropping below 5,000 for the first time since October.

Michigan still led the states in new cases per capita, though new infections fell 29% last week compared to the previous seven days. New cases also fell by over 20% in New Jersey and Pennsylvania, the states with the next highest rates of infection based on population. (Graphic with state-by-state details)

New infections are still rising on a weekly basis in 12 out of 50 states, down from 30 states last month. The states with the biggest percentage increases are Tennessee, Oregon and Arizona.

As of Sunday, 43% of the U.S. population has received at least one dose of a COVID-19 vaccine, and 29% was fully vaccinated, according to the Centers for Disease Control and Prevention.

Nationally, the pace of vaccinations fell 14% from the previous week to an average of 2.7 million shots per day.

The average number of COVID-19 patients in hospitals across the country held steady at about 41,000, according to the Reuters analysis.

FDA Approves New Spine Surgical Robotics

The FDA has cleared two Brainlab AG surgical robots: the Loop-X Mobile Imaging Robot and the Cirq Robotic Alignment Module, a robotic surgical system for spine procedures. The clearances follow CE mark approvals last summer.

Claiming the “first fully robotic intraoperative imaging device on the market,” the company said the Loop-X’s independently moving imaging source and detector panels, “enable flexible patient positioning and non-isocentric imaging which reduces the amount of radiation exposure and increases the variety of indications which can be treated.” The mobile imaging robot can be controlled wirelessly with a touchscreen tablet.

The Cirq Robotic Alignment Module, according to December 2020 FDA clearance documents, is intended to be an intraoperative image guided localization system “to support the surgeon to achieve pre-planned trajectories with surgical instruments.” The indications for use of the CIRQ module for spinal use “is the treatment of diseases where the placement of spinal screws is indicated.”

The company says the module is capable of “fine tuning the alignment to a pre-planned trajectory and freeing up surgeons’ hands, enabling them to focus on the patient’s anatomy.” The module has already been used by surgeons at Royal London Hospital for cases ranging from lumbar fusions to complex deformity and cervical fractures.

According to the FDA documents, the module is connected to the Surgical BaseSystem from Germany-based Medineering GmbH and aligns instruments to a pre-planned trajectory during surgical procedures using the Cirq Robotic Application Software together with the Brainlab IGS Spinal software applications.

Infrared passive marker-based tracking provided by the optical tracking camera unit of the navigation platform is used to determine the instrument’s and patient’s position. The relation between the patient and the reference attached to the patient is realized with a manual or automatic registration (manually or automatically).

The device is manually pre-aligned to the region of interest by opening the brakes of the Surgical Base System using its “7 degrees of freedom.” The tracking information is used to automatically fine align a tracked guide attached to the Cirq Robotic Alignment Module to “achieve a pre-planned trajectory” controlled by the application software. After finishing the alignment, the device remains in this position and the surgeon “can use surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory.”

Brainlab was founded in 1989, employs more than 1,500 people in 20 offices and is present in over 5,600 hospitals in 116 countries.

Precision Medicine Initiative Takes On Trauma Patients

Precision medicine aims to create specialized treatment regimens that are tailored to each individual’s unique genetics, environment, and lifestyle.

In his 2015 State of the Union address, President Obama announced that he was launching the Precision Medicine Initiative – a bold new research effort to revolutionize how we improve health and treat disease.

Most medical treatments have been designed for the “average patient.” As a result of this “one-size-fits-all” approach, treatments can be very successful for some patients but not for others.

Precision Medicine, on the other hand, is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles. It gives medical professionals the resources they need to target the specific treatments of the illnesses we encounter, further develops our scientific and medical research, and keeps our families healthier.

Today, there are numerous clinical applications of precision medicine that are expected to continue to shape how medicine and research are conducted for years to come. Precision medicine has been particularly successful in targeting various aspects of DNA in the treatment of various diseases, particularly cancer.

Patients with breast, lung, and colorectal cancers, as well as melanomas and leukemias, for instance, routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Precision methods are relatively unexplored in trauma patients. New research is being looked at for precision methods to treat patients with large extremity wounds, nonunions, and fractures associated with polytrauma.

Precision-based clinical decision tools are being validated to optimize timing for open wound definitive closure. Early patient-specific biomarkers to stratify nonunion risk within 1 week of fracture are being explored. Patient-specific data to stage timing of major fracture interventions in multiply injured patients are being interrogated.

CSU and UC Systems to Mandate COVID Vaccinations for RTW

Last month, the California Department of Fair Employment and Housing provided guidance that gave California employers the green light to make vaccinations a mandatory requirement for return to work, with some exceptions.

The next step is to see what employers will follow this guidance and require vaccinations for return to work.

For more than a year, state university campuses across California have been largely empty and students and professors have been forced to adapt to an online college experience. But the CSU and UC systems have their eyes set on reopening this fall, announcing Thursday they will require Covid-19 vaccines for students and faculty in order to return to campus.

The California State University and the University of California’s vaccination requirements affect more than a million students and faculty across the Golden State.

While ideally the requirement would begin with the fall 2021 term, students and faculty won’t be required to get the jab until the U.S. Food and Drug Administration formally approves one or more of the vaccines on the market for general use. The FDA issued emergency-use authorization for the Pfizer and Moderna Covid vaccines this past December, but the vaccines could receive full approval later this year. Use of the Johnson & Johnson vaccine has been paused pending investigation over reports of rare blood clots.

Immunization requirements are nothing new for California colleges, but students and faculty who return to school in the fall will be in classrooms, libraries, gyms and labs for the first time in a world with Covid-19.

CSU Chancellor Joseph Castro called the approach “the most comprehensive and consequential university plan for Covid-19 vaccines in the country.”

UC President Michael Drake, a medical doctor, said in a statement, “Receiving a vaccine for the virus that causes Covid-19 is a key step people can take to protect themselves, their friends and family, and our campus communities while helping bring the pandemic to an end.”

While terms of the university system vaccine plan have yet to be finalized, officials announced the plan now to give students, faculty and staff time to prepare. Students will need to update their vaccination records or provide an approved exception or medical exemption before they enroll for their fall semester. University officials say if students are unable to find a vaccination provider on their own, their student health centers might be able to help.

The CSU system boasts over 485,000 students across 20 campuses. The UC system has 10 campuses with over 280,000 students and roughly 227,000 faculty and staff.

News of the university vaccine plan comes as California has one of the lowest case rates in the country.

As of Thursday, roughly 43% of all Californians 16 years and older have received at least one vaccine dose.

Cal/OSHA Cites Employer $108K for Fatal Injury

Cal/OSHA has cited Sierra Pacific Industries $108,300 for workplace safety and health violations after one of its employees was fatally injured when a pipeline on an air compressor exploded.

On September 17, an employee working for Sierra Pacific Industries in Lincoln was setting up a Quincy 300 Compressor when a pipeline on the air compressor exploded. Pieces of the pipeline hit two employees nearby, injuring one and killing another
“Working on equipment attached to pressure vessels such as air compressors requires special precautions,” said Cal/OSHA Deputy Chief Debra Lee. “Employers must identify and evaluate potential hazards before assigning employees to perform work on this hazardous machinery and equipment.”

Cal/OSHA cited Sierra Pacific Industries $108,300 for nine violations, including three serious accident-related, three serious, and three general in nature. The serious accident-related violations were cited for the employer’s failure to:

– – Test the discharge piping prior to operating the Quincy 300 compressor and ensure proper connection
– – Ensure a pressure relieving safety device was installed in the line between the compressor and block valve
– – Ensure all pressure piping for the compressor was designed and fit in accordance with good engineering practice.

The serious violations were cited for the employer’s failure to ensure the energy within the pipeline system was controlled to prevent release during repair, and failure to ensure group lockout/tagout procedures were utilized and employees worked under supervision of a qualified person. The other citations were issued for violations related to uncertified employees welding, failure to establish hazardous energy control procedures and operating equipmentt under conditions of stress.

A serious violation is cited when there is a realistic possibility that death or serious harm could result from the actual hazard created by the violation. Violations are classified as accident-related when the injury, illness or fatality is caused by the violation. Cal/OSHA has extensive information on lock out / tag out requirements online.

Cal/OSHA’s Pressure Vessel Unit is responsible under Labor Code sections 7620-7771 for the permitting and inspection of boilers and tanks, including air compressors. All employers in California are required to have an effective written injury and illness prevention program, and a safety program to identify, assess and control hazards in the workplace. Cal/OSHA has online tools and publications to guide employers on how to establish an effective safety program.

New Mitchell Comp Survey Supports Telemedicine Adoption

Mitchell International, Inc., headquartered in San Diego, California, delivers smart technology solutions that simplify and accelerate claims handling and repair processes, driving more accurate, consistent and cost-effective resolutions.

The company announced the results of a survey of workers’ compensation professionals in the U.S., revealing how the COVID-19 pandemic has influenced technology usage in the industry.

The survey results show that the industry has rapidly increased its technology adoption in the last year, with more than 50% of respondents saying they adopted telemedicine during the pandemic. Forty percent of participants said changes and pressures related to the COVID-19 pandemic are the main driving factors for the increased pace of technology adoption in the industry today.

Looking ahead, the majority of respondents overwhelmingly believe that telemedicine (35%) and predictive analytics (35%) are the technologies that will have the biggest impact on the industry within the next 5-10 years, followed next by mobile coming in at a distant third place (8.5%). Respondents believe the most valuable applications of telemedicine – driven largely by a rising need for remote healthcare – will be for provider visits (54%). They also reported that they foresee predictive analytics being used best for claim triage, severity or reserving (35%).

In a similar survey conducted by Mitchell in 2020 before the COVID-19 pandemic began, respondents foresaw telemedicine as having the most significant influence on the industry (32%), but reported artificial intelligence (30%) as the second potential most impactful technology and ranked predictive analytics (20%) in third place.

The workers’ compensation industry has greatly benefitted from technology innovation in recent years, but the need to enable the continuity of care has brought explosive growth in new technology adoption as a result of COVID-19,” said Shahin Hatamian, senior vice president of product management at Mitchell. “The past year has only reinforced the trends our annual surveys have tracked in recent years, highlighting the rising importance of technologies that can automate manual processes and enable faster and smarter decision making.”

Mitchell’s survey also uncovered the biggest claims challenges experienced by workers’ compensation industry professionals. Almost one-quarter (22%) of participants ranked adapting to challenges from the COVID-19 pandemic as the top obstacle their organization is facing today, followed by workflow efficiency (19%) and cost pressures (18%). Other hurdles reported include return-to-work time, employee turnover, IT budget, keeping up with regulatory changes, and pharmaceutical management.

“As companies continue to focus on stabilizing and improving their businesses in the coming years, they will be seeking workflow efficiencies and determining ways to lower costs, to help injured employees return to the workforce even quicker,” said Hatamian. “We foresee a continued focus on automation, analytics and workflows to maximize care and improve outcomes.”

Mitchell surveyed nearly 100 workers’ compensation professionals at a range of companies, including insurance carriers, third-party administrators, public entities, brokers, and managed care and risk management organizations.

Merck Drug Shows “New Hope” for COVID Treatment

A new Covid-19 therapy has completed its phase two human trial and the results are promising.

Molnupiravir was developed at Emory University by the university’s drug innovation company, Drug Innovation Ventures at Emory (DRIVE). It was then acquired by Miami-based company Ridgeback Biotherapeutics, who later partnered with Merck & Co. to develop the drug further.

A review of the progress of further development of molnupiravir by Forbes concludes that the experimental phase of the development effort shows a “new hope for prevention and treatment of Covid-19 and other dangerous viruses.”

Merck and Ridgeback Biotherapeutics, LP announced preliminary results from Ridgeback’s Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir, an investigational oral antiviral agent.

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related.

In addition to the ongoing clinical studies, Merck has conducted a comprehensive nonclinical program to characterize the safety profile of molnupiravir.

“We are very pleased to share our initial Phase 2 infectivity data at this important conference, which remains at the forefront for critical clinical scientific information in infectious diseases,” shared Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.

“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising and if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally,” noted Dr. William Fischer, lead investigator of the study and Associate Professor of Medicine, Division of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina School of Medicine.

“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Molnupiravir is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19.

In addition to its reduction of Covid-19 transmission, Molnupiravir is likely to be useful against influenza, ebola, and a large swath of other viruses as well. Its development appears to be a major advancement in virus control and should be active against Covid-19 variants and variants of other viruses.

However, we caution Molnupiravir should be administered in conjunction with other therapies to avoid viruses rapidly developing resistance, which all these viruses are well-equipped to do.