Tag: 2022 News

The Food and Drug Administration recently granted marketing authorization for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The FDA granted the marketing authorization to Miach Orthopaedics, Inc.

The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture.

And the San Diego Union Tribune reports that Jenna Richardson of Oceanside, was the first in the area to choose BEAR over reconstruction after tearing her ACL while mountain biking in July. After reading every study she could find, the medical sales representative said she liked the idea of avoiding the ligament harvesting process which requires an additional incision and increases the amount of rehabilitation necessary after surgery. She also shied away from replacement with tissue from a deceased organ donor after several friends who went that route experienced additional tears.

Dr. Tim Wang, an orthopedic surgeon and sports medicine specialist at Scripps Clinic, performed the procedure on Aug. 22, making Richardson the first patient in San Diego County to undergo BEAR repair. “The early data and research shows that it’s as good as our standard of care with a potential for faster muscle recovery,” Wang said.

The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair.

Professional athletes are likely to continue going the reconstruction route for some time to come, said Dr. Tal David, a San Diego orthopedic surgeon whose practice often includes pro athletes.

As the only other surgeon in the county approved to perform BEAR procedures, David said that it’s difficult to recommend something brand new when a person’s livelihood hangs in the balance and the existing standard yields very good results.

“We’ve done many, many thousands of reconstructions over many years, and the risk of retearing is around 5 percent,” David said. “For professional athletes, I would say it’s about a predictable outcome.”

On the other hand, there are clear advantages to repair. In addition to avoiding a harvesting procedure David said that healing in place may prove better for recovery of the nerves that allow the body to sense knee position.

The BEAR Implant is a resorbable implant – meaning it is absorbed by the body – made from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient’s ACL. The patient’s own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body’s healing process. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body’s own tissue.

The BEAR Implant is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.

Dr. Martha Murray’s research on the development of the company’s BEAR® Implant was selected for the 2022 Orthopaedic Research and Education Foundation (OREF) Clinical Research Award. The award for “Bridge-Enhanced ACL Restoration: Translation from Academic Lab to FDA Approval” was presented at the Orthopaedic Research Society Annual Meeting Feb. 6 in Tampa Bay, Florida.

A subsidiary of Dutch medical device maker Philips has agreed to pay over $24 million to resolve alleged false claims over respiratory-related medical equipment. Philips & Co was founded in 1891 in Eindhoven, the Netherlands, by Frederik Philips and his son, Gerard.

Philips RS North America LLC, formerly known as Respironics Inc., a manufacturer of durable medical equipment (DME) based in Pittsburgh, Pennsylvania, has agreed to pay over $24 million to resolve False Claims Act allegations that it misled federal health care programs by paying kickbacks to DME suppliers.The affected programs were Medicare, Medicaid and TRICARE, which is the health care program for active military and their families.

The settlement resolves allegations that Respironics caused DME suppliers to submit claims for ventilators, oxygen concentrators, CPAP and BiPAP machines, and other respiratory-related medical equipment that were false because Respironics provided illegal inducements to the DME suppliers. Respironics allegedly gave the DME suppliers physician prescribing data free of charge that could assist their marketing efforts to physicians.

The Anti-Kickback Statute prohibits the knowing and willful payment of any remuneration to induce the referral of services or items that are paid for by a federal health care program, such as Medicare, Medicaid or TRICARE. Claims submitted to these programs in violation of the Anti-Kickback Statute give rise to liability under the False Claims Act.

The settlement provides that Respironics will pay $22.62 million to the United States, and in addition, will pay $2.13 million to the various states as a result of the impact of Respironics’ conduct on their Medicaid programs, pursuant to the terms of separate settlement agreements that Respironics has, or will enter into, with those states.

The settlement resolves a lawsuit originally brought by Jeremy Orling, a Respironics’ employee, under the qui tam or whistleblower provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Orling will receive approximately $4.3 million of the federal settlement amount.

This settlement was the result of a coordinated effort by the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the District of South Carolina with assistance from the HHS-OIG and HHS Office of Investigations; DCIS; the Defense Health Agency Office of General Counsel; and the National Association of Medicaid Fraud Control Units.  

And Philips has had other problems with government DME sales during the pandemic.

In April 2020, the United States Department of Health & Human Services (HHS) entered into a contract with Philips Respironics for 43,000 bundled Trilogy Evo Universal ventilator hospital ventilators. This included the production and delivery of ventilators to the Strategic National Stockpile – about 156,000 by the end of August 2020 and 187,000 more by the end of 2020. During the COVID-19 pandemic, beginning in March 2020, in response to an international demand,

Philips increased production of the ventilators fourfold within five months. Production lines were added in the United States with employees working around the clock in factories producing ventilators, in Western Pennsylvania and California, for example.

In March 2020, ProPublica published a series of articles on the Philips ventilator contract as negotiated by trade adviser Peter Navarro.

In response to the ProPublica series, in August, the United States House of Representatives undertook a “congressional investigation” into the acquisition of the Philips ventilators. The lawmakers investigation found “evidence of fraud, waste and abuse.” The deal negotiated by Navarro reportedly had resulted in an over-payment to Philips by the US government of “hundreds of millions.”

Courthouse News reports that a well-publicized fraud lawsuit brought by the district attorneys of San Francisco and Los Angeles accusing California law firm Potter Handy of shaking down small businesses with phony disability rights complaints met its end this week with a San Francisco judge’s dismissal of the case on privilege grounds.

Then-San Francisco DA Chesa Boudin and his LA counterpart George Gascón filed the high-profile case seeking the return of millions of dollars the business owners paid to settle thousands of groundless disability-rights lawsuits.

The pair claimed lawyers for the San Diego-based firm file thousands of boilerplate Americans with Disabilities Act lawsuits on behalf of a handful of disabled clients against small businesses only to pressure the owners to quickly settle for an amount between $10,000 and $20,000.

One Potter Handy client, Orlando Garcia, has allegedly filed more than 800 lawsuits. Another client, Brian Whitaker, filed more than 1,700 federal cases. The complaint also lists serial filers Chris Langer, Rafael Arroyo, and Scott Johnson, who was indicted by a federal grand jury in 2019 for failing to report the income he received from the lawsuits on his taxes.

In a brief ruling Monday, San Francisco Superior Court Judge Curtis Karnow found the DAs’ case barred by rules governing “litigation privilege” that protect the filings and communications connected to Potter Handy’s ADA lawsuits from being used against them as they pursue their clients’ interests.

“The gist is that there is a recognition that bringing civil litigation is protected by the First Amendment right to petition the government. Prosecuting claims based on filing a lawsuit is a direct attack on this right, and inherently implicates numerous other rights,” Potter Handy partner Dennis Price said in an email Wednesday. “How do you engage in civil discovery when virtually every document is covered by attorney-client privilege? Further, if there is a threat of future litigation derived from bringing a lawsuit, it can have a chilling effect on future claims.”

Price said ADA filings from firms have dropped off since the district attorneys’ lawsuit, but Potter Handy is still filing cases.

Karnow did not give the attorneys an opportunity to amend the case, but said they can still bring criminal charges against Potter Handy, and that its lawyers could be disciplined by the State Bar for ethics violations “if the complaint’s allegations are true.”

Randy Quezada, a spokesperson for Boudin’s successor Brooke Jenkins said Wednesday that that are “considering all options before making any decisions.”

Price described the original civil suit as a “publicity stunt” meant to drum up support for Boudin and Gascón, who were both facing recall elections at the time. Only Gascón remains in the job.

“Gascón and Boudin wasted taxpayer money to shore up support from the small business communities that had lost faith in each of them by attacking a convenient scapegoat,” Price said. “People with disabilities are a small, politically forgotten, minority. This is the same cold calculation California businesses often make: disabled patrons represent a tiny fraction of their potential customer base, and people with disabilities face some of the highest rates of poverty of any minority group. Why invest in making physical changes to accommodate persons with disabilities? This is the reason the ADA was needed over 30 years ago and why it is still needed today.”

Rigoberto Jose Manuel was employed by BrightView Landscape Services, Inc.as an irrigation technician from 2007 to 2018. In January 2018 Manuel injured his back while on the job.

Manuel alleges that BrightView initially refused to take him to the company medical clinic and then had him sign a waiver for medical treatment. However, after several days of back pain Manuel went to an occupational medicine clinic accompanied by another BrightView employee. A physician examined Manuel, determined that he had sustained a back injury, and returned him to work with certain restrictions.

After Manuel returned to work and completed a full shift on January 22, 2018, Manuel’s immediate supervisor told him not to return to work and BrightView terminated his employment. Manuel filed a civil lawsuit against his employer for wrongful termination.

After Manuel objected to BrightView’s written discovery requests inquiring into his immigration status, BrightView brought a motion for an order compelling Manuel to provide further responses, which the trial court granted in its November 16, 2020 order.

Manuel challenged the order by filing a petition for writ of mandate. In the published case of Manuel v Superior Court H048665 (August 2022) the Court of Appeal issued a peremptory writ of mandate directing the trial court to vacate its order and to enter a new order denying BrightView’s motion for an order compelling Manuel to provide further responses to written discovery inquiring into his immigration status.

BrightView argued that its written discovery requests properly sought evidence from Manuel “establishing he was legally authorized to work in the United States.”

Manuel relied on the statutory provisions of Government Code section 7285, Labor Code section 1171.5, Civil Code section 3339, and Health and Safety Code section 2400, which he argued prohibited inquiry into a person’s immigration status unless the person seeking to make the inquiry has shown by clear and convincing evidence that the inquiry is necessary to comply with federal immigration law.

In 2002 Senate Bill 1818 added four nearly identical provisions to California’s statutory scheme, including Civil Code section 3339, Government Code section 7285, Health and Safety Code section 24000, and Labor Code section 1171.5. SB 1818 was in response to the United States Supreme Court’s decision earlier the same year in Hoffman Plastic Compounds, Inc. v. NLRB (2002) 535 U.S. 137, 122 S.Ct. 1275.

In Hoffman, the United States Supreme Court ruled that the NLRB could not “award backpay to an illegal alien for years of work not performed, for wages that could not lawfully have been earned, and for a job obtained in the first instance by a criminal fraud.”

Subsequently however, the California Supreme Court ruled in Salas v. Sierra Chemical Co. (2014) 59 Cal.4th 407 that Senate Bill 1818 was not preempted by federal law to the extent it makes the remedy of lost wages for unlawful termination available for the “prediscovery period,” when the “employer remains unaware of the employee’s unauthorized status.”

In Salas, the California Supreme Court reasoned that “not allowing unauthorized workers to obtain state remedies for unlawful discharge, including prediscovery period lost wages, would effectively immunize employers that, in violation of fundamental state policy, discriminate against their workers on grounds such as disability or race, retaliate against workers who seek compensation for disabling workplace injuries, or fail to pay the wages that state law requires.”

Thus in this case the Court of Appeal agreed with Mr. Manuel and concluded that “under Senate Bill 1818 and its statutory enactments the trial court acted outside the scope of the court’s discretion when the court granted BrightView’s motion to compel further responses to written discovery inquiring into Manuel’s immigration status.”

The workforce is transforming with millions leaving their jobs in the Great Resignation (also known as the Big Quit or the Great Reshuffle). And according to a report by Healthesystems.com, this has created a cascade of ripple effects, some of which bear considerations for the workers’ compensation industry.

The term “Great Resignation” was coined by Anthony Klotz, a professor of management at University College London’s School of Management, in May 2021, when he predicted a sustained mass exodus.

It is an ongoing economic trend in which employees have voluntarily resigned from their jobs en masse, beginning in early 2021. Possible causes include wage stagnation amid rising cost of living, long-lasting job dissatisfaction, safety concerns of the COVID-19 pandemic, and the desire to work for companies with better remote-working policies. Some economists have described the Great Resignation as akin to a general strike.

According to a PricewaterhouseCoopers survey conducted in early August 2021, 65% of employees said they were looking for a new job and 88% of executives said their company was experiencing higher turnover than normal. A Deloitte study published in Fortune magazine in October 2021 found that among Fortune 1000 companies, 73% of CEOs anticipated the work shortage would disrupt their businesses over the next 12 months, 57% believed attracting talent is among their company’s biggest challenges, and 35% already expanded benefits to bolster employee retention.

Even before the pandemic, the workers’ comp industry faced an impending talent shortage and now that problem has grown worse. Two of the hardest-hit roles happen to be two of the most crucial roles at claims organizations: claims adjusters and IT specialists.

Based on results from Healthesystems’ 2022 Workers’ Compensation Industry Insights Report, workers’ comp professionals now view the changing workforce/workplace as the number one factor impacting resiliency in workers’ comp, with 71% of workers’ comp professionals ranking the changing workforce as their top industry concern.

While there are some universal solutions a workplace can offer to attract and maintain employees – such as competitive compensation and benefits – there are industry-specific matters that workers’ comp must address.

According to the Report, many adjusters are reaching retirement age and there is a shortage of new talent entering the industry. The high level of stress associated with the role, outdated claims technology, and a lack of overall industry appeal to young professionals are all contributors.

Creating a clear career path and a picture of the unique expertise that can be gained from the workers’ comp industry – expertise that can be leveraged later in either a different industry or in a higher position – could be beneficial for attracting new talent to an industry that is not necessarily an obvious or sought-after career option for college graduates.

Additionally, younger workers have high expectations for the user experience of technology, and workers’ comp has historically lagged behind the consumer experience. Technology should be intuitive, easy to use, and should empower day-to-day decisions to reduce burden and the perceived complexity that comes with the insurance industry.

There is a larger lack of IT talent that is holding back overall technological growth across all industries – and workers’ comp is no exception. The current shortage of IT talent is the main factor holding back IT automation and half of digital workplace technologies in the works. With more and more companies offering remote work for technology positions, competition is fierce for these talented individuals.

Claims organizations can prioritize cloud and security technologies to allow for remote work when possible to entice IT workers. Claims organizations can also leverage partners and/or programs that already have the technological infrastructure in place to help them achieve connectivity goals within their workers’ comp medical management programs.