Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Exclusions to Comp Policy Requires an Explicit Endorsement. NY Resolves Opiod Litigation With J&J for $230M. Second-Largest CA Nursing Facility Pays $450K in Fraud Claim. L.A. Jury Convicts Four Defendants For COVID Loan Fraud. WCIRB Reviews Medical Cost Trends at Actuarial Meeting. NCCI Reports $6000 Average COVID Claim Costs in 38 States. DWC Updates MTUS Drug List. 3M Healthcare Information Systems Improves Patient Care. Delta COVID Variant Spreading in California’s Unvaccinated. Drugmakers Target Parkinson’s and Alzheimers in $2.2B Deal.
Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: U.S. Supreme Court Rules Against California Union Organizers. Injury While on Personal Errand in “Mobile Office” is AOE-COE. Riverside County DA to Lead EDD Fraud Task Force. Convictions Show EDD Fraud a Decade Before Pandemic Began. Owner-Builder Requires Contractor License and WC Insurance. San Francisco First City to Mandate Employee Vaccinations. Employers Face “Hairball” of Post Pandemic Safety Rules. California Approves 100M Bailout for Failing Cannabis Industry. Research Shows New COVID Variant Spreading in US. Poorly Organized Ortho Surgical Trays Drive up Costs.
GlaxoSmithKline Plc agreed to pay San Francisco based biotech Alector Inc. as much as $2.2 billion to develop therapies targeting diseases such as Parkinson’s and Alzheimer’s.
Neurodegenerative disease has been the subject of costly workers’ compensation claims in past years. The most notable of them was the NFL and contact sport related claims for concussion caused dementia.
The agreement comes weeks after the FDA approved the first new Alzheimer’s drug in almost two decades, Biogen Inc’s Aduhelm, reinvigorating the industry’s efforts to develop more treatments in a challenging therapy category.
The trategic global collaboration was formed for the development of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101), which are targeting neurodegenerative disease.
AL001 is currently in a Phase 2 study in symptomatic frontotemporal dementia patients with a mutation in the C9orf72 gene and is planned to enter Phase 2 development for amyotrophic lateral sclerosis (ALS) in the second half of 2021.
Enrolment is currently underway for a pivotal Phase 3 trial for AL001 in people at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN).
AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.
Frontotemporal dementia is a rapidly progressing and severe form of dementia found most frequently in people less than 65 years old at the time of diagnosis. It affects 50,000 to 60,000 people in the United States and roughly 110,000 in the European Union, with potentially higher prevalence in Asia and Latin America.
There are currently no FDA-approved treatment options for frontotemporal dementia.
The therapies are part of an emerging field of research that tries to use the body’s own immune system to fight neurodegenerative diseases. In this case, scientists are seeking to increase levels of a protein in the brain called progranulin, which helps regulate the immune response and affects the survival of neurons.
Under the terms of the collaboration agreement, Alector will receive $700 million in upfront payments. In addition, Alector will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory and commercial launch-related milestone payments.
Alector will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. Thereafter, Alector and GSK will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and all costs for global development will be divided between the two companies.
Sacramento skilled nursing facility operator Plum Healthcare Group LLC and its entity Azalea Holdings LLC, dba McKinley Park Care Center have agreed to pay more than $451,439 to resolve allegations that they violated the False Claims Act.
Plum Healthcare Group agreed to resolve allegations that an employee at its McKinley Park Care Center knowingly created billing records for services that were not actually provided. According to the settlement agreement, Plum Healthcare Group then used these false records to bill Medicare, leading it to obtain Medicare reimbursements that were higher than warranted.
The government also alleges that the management of Plum Healthcare Group learned of the extent of these false billings to Medicare, did not conduct an adequate investigation into this conduct, and then failed to submit a refund to Medicare for the full amount management knew had been overbilled or otherwise disclose its false billings to the government.
The settlement with Plum Healthcare Group resolves allegations originally brought in a lawsuit filed by a former employee under the whistleblower provisions of the False Claims Act.
The act permits private parties to sue on behalf of the government for false claims for government funds and to receive a share of any recovery. The whistleblower will receive over $90,000 as her share of the recovery from Plum Healthcare Group. The whistleblower’s claims for retaliation and attorneys’ fees are not resolved by this settlement.
This case was the result of an investigation by the HHS Office of the Inspector General, the Federal Bureau of Investigation, along with the U.S. Attorney’s Office for the Eastern District of California. Assistant U.S. Attorney Steven Tennyson handled the matter for the United States. The claims settled by this agreement are allegations only, and there has been no determination of liability.
A federal jury has found four Los Angeles-area residents guilty of criminal charges for scheming to submit fraudulent loan applications seeking millions of dollars in Paycheck Protection Program (PPP) and Economic Injury Disaster Loan (EIDL) COVID-19 relief funds.
At the conclusion of an eight-day trial, the following defendants were found guilty on June 25:
– – Richard Ayvazyan, 42, of Encino;
– – Richard Ayvazyan’s wife, Marietta Terabelian, 37, of Encino;
– – Richard Ayvazyan’s brother, Artur Ayvazyan, 41, of Encino;
– – Vahe Dadyan, 41, of Glendale.
All four defendants were found guilty of one count of conspiracy to commit bank fraud and wire fraud, 11 counts of wire fraud, eight counts of bank fraud and one count of conspiracy to commit money laundering. Richard Ayvazyan also was found guilty of two counts of aggravated identity theft. Artur Ayvazyan also was found guilty of one count of aggravated identity theft. Vahe Dadyan also was found guilty of one count of money laundering.
The jury also found the defendants must forfeit bank accounts, jewelry, watches, gold coins, three residential properties and approximately $450,000 in cash.
The defendants used fake, stolen and synthetic identities to submit fraudulent applications for PPP and EIDL loans guaranteed by the Small Business Administration (SBA) under federal law. In support of the fraudulent applications, the defendants often submitted false and fictitious documents to lenders and the SBA, including fake identity documents, tax documents and payroll records.
A September 13 sentencing hearing has been scheduled, and each defendant will face decades in federal prison.
Prior to the verdict, the following defendants pleaded guilty to criminal charges in this case:
– – Manuk Grigoryan, 46, of Sun Valley, pleaded guilty on June 7 to one count of bank fraud and one count of aggravated identity theft. Judge Wilson has scheduled a September 13 sentencing hearing, at which time Grigoryan will face a statutory maximum sentence of 32 years in federal prison.
– – Edvard Paronyan, 40, of Granada Hills, pleaded guilty on June 11 to one count of wire fraud. He will face a statutory maximum sentence of 20 years in federal prison at his August 30 sentencing hearing.
– – Tamara Dadyan, 39, of Encino, Artur Ayvazyan’s wife and Vahe Dadyan’s cousin, pleaded guilty on June 14 to one count of conspiracy to commit bank fraud and wire fraud, one count of aggravated identity theft and one count of conspiracy to commit money laundering. She will face up to 52 years in federal prison at her September 27 sentencing hearing.
– – Arman Hayrapetyan, 41, of Glendale, pleaded guilty on June 21, to one count of conspiracy to commit money laundering. He will face up to 20 years in federal prison at his sentencing hearing, which is scheduled for September 20.
On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud.
Efrain Nevarez filed an Application for Adjudication of Claim alleging that he sustained an industrial injury as a result of a cumulative trauma through August 30, 2015, while employed by American Choice Van Lines and/or Go East Movers.
Coverage was denied by American Casualty Insurance Company based on “limited endorsements” contained in the policies. Coverage disputes are subject to mandatory arbitration under Labor Code section 5275(a), thus the issue was submitted for arbitration.
The arbitrator found that Go East Movers was insured by American Casualty Insurance during the alleged cumulative trauma period.
The arbitrator found that “[n]one of the limiting endorsements” complied with the statutory and regulatory requirements. The arbitrator also found that there was insufficient evidence that the employer engaged in fraudulent misrepresentation during the application process and there is evidence that American and its agents did not do their due diligence regarding the nature of the business of the insured prior to issuing the policy.
The arbitrator issued orders that the insurers shall be liable for the workers’ compensation benefits that may be awarded to the applicant and that the order does not limit defendant’s right to dispute the date of injury or the period of coverage for the injury. The arbitrator also dismissed the Uninsured Employers Benefit Trust Fund as a party defendant.
American Casualty Insurance Company petitioned for reconsideration of the Findings and Order. A WCAB panel essentially affirmed the arbitrator in the case of Efrain Nevarez v American Choice Van Lines et. al. (AD10407856 – March 2021)
American contends, in essence, that it was not required to exclude non-clerical employees because the policy only covered clerical employees.
Workers’ compensation policies provide coverage to all employees of an employer unless employees are explicitly excluded in the insurance contract with a limiting and restricting endorsement in accordance with regulations adopted by the Insurance Commissioner. (citations omitted)
American could not enter into a workers’ compensation insurance contract covering only some of an insured’s employees without complying with the Insurance Commissioner’s regulations. If an insurer contends that it has issued a limited policy, the insurer must provide evidence in the form of policy documents.
Therefore, American is incorrect that the policy could be construed to only cover clerical employees without an endorsement explicitly limiting the policy to those employees.
With respect to American’s contention that the arbitrator erred in failing to admit and consider evidence of employer misrepresentation and insurer due diligence, the evidence would only be relevant if rescission of the insurance contract was at issue and it was not at issue.
A workers’ compensation policy may be rescinded based on a material misrepresentation by the insured. (Southern Ins. Co. v. Workers’ Comp. Appeals Bd. (Berrios) (2017) 11 Cal.App.5th 961.) Rescission is a contract remedy that requires the rescinding party to give notice and restore or offer to restore everything of value obtained under the contract in accordance with a statutory procedure set forth in Civil Code section 1691.
However, in this case, American did not raise rescission as an issue and does not allege that it rescinded the insurance policy.
The focus of the WCIRB Actuarial Committee meeting held on June 22, was a review of recent system medical costs, along with a comparison of the effects of the COVID 19 pandemic.
Summary of the Medical Severity Trends through 2020
Pre-COVID-19 (before 3/15)
– Overall medical severity per claim increased slightly (+4%)
– Physician services, inpatient and medical-legal costs per claim increased despite a downward trend in prior years
– Pharmaceutical costs per claim continued to drop (-14%) mostly driven by continuously steep declines in opioid costs (-42%)
– Telemedicine services per claim increased at typical pre-COVID-19 rate (approximately 100%)
COVID-19 pandemic period (3/15 – 12/31)
– Overall medical severity per claim increased (+10%)
– – Increases in both service utilization and paid per transaction likely when shelter-in-place orders were lifted
– Increases in inpatient and outpatient costs per claim were driven mostly by higher paid per transaction
– Pharmaceutical costs per claim increased (+14%) mostly driven by increased use of non-opioids
– Telemedicine services per claim increased by more than 50-fold
Legislative Cost Monitoring Update – SB 1160 UR Provisions
– During the two years after the SB 1160 UR provisions became effective:
– – Number of physical therapy visits per claim increased in the first 30 days, while utilization of other types of medical services decreased during the same period.
– – Physical therapy services were provided earlier. The median time from injury to first physical therapy in the first 30 days decreased by 17%, from 12 days for AY2017 claims to 10 days for AY2019 claims.
– – There was less utilization of physical therapy services 5 months after the first 30 days.
– There is no indication of the SB 1160 UR provisions significantly impacting the cost of medical services through 6 months from the date of injury, and the increased medical severity is driven mostly by fee schedule updates.
– There is no indication of the UR provisions significantly impacting utilization review costs within two years of the reform implementation.
Summary of 3/31/2021 Experience (Excluding COVID-19)
– Almost 100% of market included – Main insights:
– – Loss development generally flat
– – Claim settlement rates continuing to decline
– – 1Q 2021 non-COVID-19 claim frequency up over 1Q 2020
– – Significant number of COVID-19 claims reported in first three months of 2021
– Projection methodologies are consistent with 9/1/21 Filing
– Projected loss ratio for September 1, 2021 to August 31, 2022 policies is 0.596 (same as 9/1/21 Filing)
– – Small increase (<0.005) from updated wage forecast
– – Small decrease (<0.005) from updated 2020 frequency trend
The New York Attorney General announced an agreement with Johnson & Johnson – the parent company of Janssen Pharmaceuticals, Inc. – that will deliver up to $230 million to New York state.
In March 2019, the New York Attorney General filed the nation’s most extensive lawsuit to hold accountable the various manufacturers and distributors responsible for the opioid epidemic. In addition to J&J, the manufacturers named in the complaint included Purdue Pharma and its affiliates, as well as members of the Sackler Family (owners of Purdue) and trusts they control; Mallinckrodt LLC and its affiliates; Endo Health Solutions and its affiliates; Teva Pharmaceuticals USA, Inc. and its affiliates; and Allergan Finance, LLC and its affiliates.
The distributors named in the complaint were McKesson Corporation, Cardinal Health Inc., Amerisource Bergen Drug Corporation, and Rochester Drug Cooperative Inc.
The agreement resolves claims made by for the company’s role in helping to fuel the opioid epidemic and would allocate payments over nine years, with substantial payments made upfront.
The agreement also makes enforceable a bar stopping J&J and all of its subsidiaries, predecessors, and successors from manufacturing or selling opioids anywhere in New York, and acknowledges Johnson & Johnson’s exit from the opioid business nationally.
The cases against Purdue Pharma (and subsequently the Sackler family), Mallinckrodt, and Rochester Drug Cooperative are all now moving separately through U.S. Bankruptcy Court. The trial against all other defendants is currently slated to begin this coming week.
The Attorney General negotiated substantial injunctive relief securing the end of J&J’s manufacturing of opioids and their distribution across New York and the rest of the nation.
The company will also provide the Office of the Attorney General with details of when the last of the inventory of opioids it has already shipped expires.
Additionally, J&J will be prohibited from promoting opioids or opioid products through sales representatives, sponsorships, financial support, or any other means; will not be allowed to provide financial incentives to its sales and marketing employees for the sale of these products; and will not, directly or indirectly, provide financial support or in-kind support to any third party that primarily engages in conduct that promotes opioids, opioid products, or products for the treatment of opioid-induced side effects.
J&J will additionally be forbidden from disciplining its sales and marketing employees for not hitting opioids sales quotas – one of the key motivators J&J and other companies had in marketing opioids so heavily to the American public – and will not be allowed to use, assist, or employ any third party to engage in any activity that J&J itself would be prohibited from engaging in pursuant to today’s agreement.
J&J will also be prohibited from lobbying federal, state, or local legislative or regulatory authorities about opioids or opioid products.
Finally, J&J will have to make additional information about opioids and opioid products more accessible to the public, including to patients, health care providers, and others. Part of how J&J will fulfill this provision is by sharing clinical trial data under the Yale University Open Data Access (YODA) Project to allow researchers qualified under the program to access the company’s propriety data under the terms of the project.
As part of the Becker’s Hospital Review 11th Annual Meeting, Travis Bias, DO, Medical Director of Clinician Solutions for event sponsor 3M Healthcare Information Systems (3M HIS), shared industry insights and expertise with hospital leaders during a May 17 roundtable.
Physicians spend significant time performing nonpatient-facing tasks like documentation, that are necessary but ultimately take time away from one-to-one patient care.
Technology solutions powered by artificial intelligence can reduce the amount of time spent away from the patient, vastly improving both their experience, and the physician’s.
Five key takeaways:
1. The multiple demands on physicians can fracture their time and attention. Physicians are asked to do more than just provide patient care; they are tasked with capturing the clinical complexity of their patient population. Although the time spent on additional tasks can improve the overall efficiency and efficacy of the health system, it adds to the workload and stress of the physician. “We know the demands pulling the physicians in different directions are great,” Dr. Bias said. “Because of that, we have to be really clear about how their time is prioritized.”
2. Reducing unnecessary technology interruptions improves the patient and physician experience. Interruptions, especially those requiring task switching, can be extremely disruptive. Digital tools like the solutions offered by 3M HIS significantly decrease those interruptions by unifying and/or automating workflows. This frees up time for the physicians to focus on patient care.
3. Physician buy-in is critical for successful healthcare technology solutions. In order for a technology solution to make a meaningful difference, physicians need to be willing to use the solution. While executive leadership is a key factor in encouraging use, clinicians are most likely to use tools if they understand how they will benefit their jobs, and if the solutions are easy and efficient to use.
4. The pandemic may have removed the technology trust barrier. Healthcare providers and patients alike were forced to make a quick shift from in-person visits to telehealth visits. The successful and speedy adoption of telemedicine could prove beneficial for other technologies, removing any reservations or barriers commonly seen as healthcare systems roll out new solutions.
5. Digital transformation enables healthcare providers to improve delivery of care. Whether it’s tracking the patient journey throughout the health system, visiting patients through telemedicine or remote patient monitoring through wearable technology, digital solutions can improve the patient and physician experience. Digital transformation can meet patients where they are, identify gaps in care and improve the overall quality of care, benefiting the patient, the physician and the bottom line.
In early 2020, COVID-19 seemed like a potentially significant and disruptive event for the workers compensation industry. NCCI responded by authoring its white paper, COVID-19 and Workers Compensation: Modeling Potential Impacts (PDF) and creating the COVID-19 Hypothetical Scenarios Tool to help the industry evaluate potential direct cost impacts the pandemic may have on WC losses.
Leveraging the COVID-19 claims data that has been reported to NCCI so far, can bring the ultimate impact that the pandemic may have on WC costs more into focus.
Key Takeaways:
– – NCCI has observed $260 million of case-incurred COVID-19 WC losses, excluding self-insureds, for Accident Year 2020 in jurisdictions where NCCI provides ratemaking services.
– – NCCI estimates that COVID-19 claims, excluding self-insureds, have the potential to ultimately result in WC losses exceeding $500 million over the entire duration of the pandemic across jurisdictions where NCCI provides ratemaking services. (NCCI provides ratemaking services in 38 jurisdictions.)
As of year-end 2020, private carriers and state funds reported 45,000 pandemic-related claims to NCCI associated with $260 million in case-incurred losses – an average COVID-19 cost per claim of approximately $6,000. Note: This claim count total reflects those claims with a reported payment or reserve (i.e., a loss or expense reserve).
Most of the reported COVID-19 claims to date have associated costs less than $1,500 and almost 95% have costs less than $10,000.
Further, while larger claims – those with losses greater than $100,000 – represent about 1% of all COVID-19 claims, they account for approximately 60% of reported COVID-19 losses to date. Claims in this category are generally more likely to remain open for extended periods of time, involve older workers, require inpatient hospitalization, and involve more complications due to the existence of comorbidities.
To date, nursing/convalescent home employees, other healthcare workers, and first responders have collectively accounted for more than 75% of all COVID-19 claims reported to NCCI. Other workers in the restaurant, building operations, distribution systems, and retail industries have collectively accounted for an additional 14% of reported COVID-19 claims.
Historically, medical-only claims (i.e., claims without an indemnity, lost-wage component) have accounted for almost 75% of all WC claims. Interestingly, this claim-type distribution reversed when we examined reported COVID-19 claims.
Of all the reported pandemic-related claims with a payment or loss reserve, almost 75% have an indemnity component, while only 25% are medical-only.