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Dozens Charged in $1.2 Billion Health Care Fraud Takedown

The Department of Justice announced criminal charges against 36 defendants in 13 federal districts across the United States for more than $1.2 billion in alleged fraudulent telemedicine, cardiovascular and cancer genetic testing, and durable medical equipment (DME) schemes.

The nationwide coordinated law enforcement action includes criminal charges against a telemedicine company executive, owners and executives of clinical laboratories, durable medical equipment companies, marketing organizations, and medical professionals.

Additionally, the Centers for Medicare & Medicaid Services (CMS), Center for Program Integrity (CPI) announced today that it took adverse administrative actions against 52 providers involved in similar schemes. In connection with the enforcement action, the department seized over $8 million in cash, luxury vehicles, and other fraud proceeds.

The coordinated federal investigations primarily targeted alleged schemes involving the payment of illegal kickbacks and bribes by laboratory owners and operators in exchange for the referral of patients by medical professionals working with fraudulent telemedicine and digital medical technology companies. Telemedicine schemes account for more than $1 billion of the total alleged intended losses associated with the enforcement action.

These charges include some of the first prosecutions in the nation related to fraudulent cardiovascular genetic testing, a burgeoning scheme. As alleged in court documents, medical professionals made referrals for expensive and medically unnecessary cardiovascular and cancer genetic tests, as well as durable medical equipment. For example, cardiovascular genetic testing was not a method of diagnosing whether an individual presently had a cardiac condition and was not approved by Medicare for use as a general screening test for indicating an increased risk of developing cardiovascular conditions in the future.

One particular case charged involved the operator of several clinical laboratories, who was charged in connection with a scheme to pay over $16 million in kickbacks to marketers who, in turn, paid kickbacks to telemedicine companies and call centers in exchange for doctors’ orders. As alleged in court documents, orders for cardiovascular and cancer genetic testing were used by the defendant and others to submit over $174 million in false and fraudulent claims to Medicare – but the results of the testing were not used in treatment of patients. The defendant allegedly laundered the proceeds of the fraudulent scheme through a complex network of bank accounts and entities, including to purchase luxury vehicles, a yacht, and real estate. The indictment seeks forfeiture of over $7 million in United States currency, three properties, the yacht, and a Tesla and other vehicles.  

Some of the defendants charged in this enforcement action allegedly controlled a telemarketing network, based both domestically and overseas, that lured thousands of elderly and/or disabled patients into a criminal scheme. The owners of marketing organizations allegedly had telemarketers use deceptive techniques to induce Medicare beneficiaries to agree to cardiovascular genetic testing, and other genetic testing and equipment.

The charges allege that the telemedicine companies arranged for medical professionals to order these expensive genetic tests and durable medical equipment regardless of whether the patients needed them, and that they were ordered without any patient interaction or with only a brief telephonic conversation. Often, these test results or durable medical equipment were not provided to the patients or were worthless to their primary care doctors.

This announcement builds on prior telemedicine enforcement actions involving over $8 billion in fraud, including 2019’s Operation Brace Yourself, 2019’s Operation Double Helix, 2020’s Operation Rubber Stamp, and the telemedicine component of the 2021 National Health Care Fraud Enforcement Action. Specifically, the Operation Brace Yourself Telemedicine and Durable Medical Equipment Takedown alone resulted in an estimated cost avoidance of more than $1.9 billion in the amount paid by Medicare for orthotic braces in the 20 months following that enforcement action.

Prior to the charges announced as part of today’s nationwide enforcement action and since its inception in March 2007, the Health Care Fraud Strike Force, which maintains 16 strike forces operating in 27 districts, has charged more than 5,000 defendants who collectively billed federal health care programs and private insurers approximately $24.7 billion.

400 Truckers at AB5 Protest Shut Down Port of Oakland

After a slow showing early Monday morning, an estimated 400 owner-operators managed to shut down truck traffic at all three terminals at the Port of Oakland to protest California’s controversial independent contractor law, AB5.

By Monday afternoon, the SSA, TraPac and Everport terminals announced there would be no night shift hours as the protesting owner-operators were only allowing around two company trucks per hour into the terminal gates throughout the day. On average, 250 trucks an hour would flow through the terminals on a typical work day.

Matt Schrap, CEO of the Harbor Trucking Association (HTA), who was in Oakland on Monday, lauded the demonstration.

“It was very impressive to see the power of social media on display at the Port of Oakland today,” Schrap told FreightWaves. “We watched the protests grow organically in a matter of a few days and brought together hundreds of individuals who feel they are being disproportionately impacted by this law.”

He said clarification is needed about how AB5 will be enforced and how to ensure owner-operators comply with the law. AB5 seeks to limit the use of independent contractors and largely classify them as employee drivers.

The HTA is a coalition of intermodal carriers serving the three major California ports, including Los Angeles/Long Beach and Oakland.

Oakland protestors, who own their own rigs and currently choose which loads they want to take, don’t want to work as company drivers as many would be forced to do under AB5.

By 8 a.m. PST Monday, the port drivers had successfully blocked the east and west gates at the SSA terminal in Oakland. While the terminal opened a back gate briefly to let company trucks in, owner-operators successfully blocked that access, too, forcing some company drivers to turn around and leave port property and try again Tuesday. Protestors gathered on foot to block company trucks from entering the terminals.

Kimberly Sulsar-Campos, vice president of Oakland-based Iraheta Bros. Trucking, said some owner-operators want to protest again on Tuesday. While the initial protest was planned for three days, nearly 200 port drivers decided on one day at a meeting near the port on Friday.

Iraheta Bros. was founded by a group of owner-operators who wanted to start their own trucking company, she said. The drayage company now has 20 owner-operators who oppose AB5 and want a choice about how to run their businesses.

“We have owner-operators who want to be able to choose when they want to work and don’t want to be company drivers and be told by a company when they will work and decide how much they will be paid,” Sulsar-Campos told FreightWaves.

Some California truckers who move containers in and out of the marine terminals at the ports of Los Angeles and Long Beach participated in a work stoppage Wednesday to protest AB5 and urged the Oakland drivers to stage their own protest as well.

Rafael Quintero, owner of one of the oldest drayage companies that serve the Port of Oakland, attended the protest to support his 10 owner-operators. He called AB5 “an American dream killer” for thousands of minority drivers who immigrated to the U.S. with the dream of owning their own businesses.

Some protesters in Oakland held signs that said, “The 70,000+ owner-operators choose freedom over fear” and “Don’t let AB5 take our freedom.”

Joe Rajkovacz, director of governmental affairs for the Western States Trucking Association, said his members are concerned about AB5’s impact. He said WSTA members seeking legal advice have received mixed messages from attorneys about how to comply with AB5 if the law stays on the books.

Trucks entering the Port of Oakland Monday were largely driven by company drivers from California’s Central Valley. Most owner-operators were in their rigs or personal vehicles, while others stayed home and didn’t pull containers from the port to show solidarity with those protesting AB5.

EEOC Updates Employer Mandatory COVID Testing Guidance

EEOC has updated a number of Q&As on July 12, 2022, including former answers A.6 and A.7 which pertain to testing employees for COVID.

EEOC’s assessment at the outset of the pandemic was that the ADA standard for conducting medical examinations was, at that time, always met for employers to conduct worksite COVID-19 viral screening testing.

With the revision of Q&A A.6, below, on July 12, 2022, EEOC makes clear that going forward employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify viral screening testing of employees to prevent workplace transmission of COVID-19.

A.6. offers employers possible factors to consider in making this assessment, including community transmission levels and types of contacts between employees and others in the workplace. This change is not meant to suggest that such testing is or is not warranted; rather, the revised Q&A acknowledges that evolving pandemic circumstances will require an individualized assessment by employers to determine whether such testing is warranted consistent with the requirements of the ADA.

Q&A A.6 provides an answer to the question “Under the ADA, may an employer, as a mandatory screening measure, administer a COVID-19 viral test (a test to detect the presence of the COVID-19 virus) when evaluating an employee’s initial or continued presence in the workplace? (Updated 7/12/22)”

Yes, if the employer can show it is job-related and consistent with business necessity the “business necessity” standard based on relevant facts.

The answer goes on to state that “Possible considerations in making the “business necessity” assessment may include the level of community transmission, the vaccination status of employees, the accuracy and speed of processing for different types of COVID-19 viral tests, the degree to which breakthrough infections are possible for employees who are “up to date” on vaccinations, the ease of transmissibility of the current variant(s), the possible severity of illness from the current variant, what types of contacts employees may have with others in the workplace or elsewhere that they are required to work (e.g., working with medically vulnerable individuals), and the potential impact on operations if an employee enters the workplace with COVID-19. “

“In making these assessments, employers should check the latest CDC guidance (and any other relevant sources) to determine whether screening testing is appropriate for these employees.”

And Q&A A.7 is also relevant to this topic. “Under the ADA, may an employer require antibody testing before permitting employees to re-enter the workplace? (Updated 7/12/22)”

“No. An antibody test, as a medical examination under the ADA, must be job-related and consistent with business necessity. As of July 2022, CDC guidance explains that antibody testing may not show whether an employee has a current infection, nor establish that an employee is immune to infection; as a result, it should not be used to determine whether an employee may enter the workplace”.

“Based on this CDC guidance, at this time such testing does not meet the ADA’s “business necessity” standard for medical examinations or inquiries for employees. Therefore, requiring antibody testing before allowing employees to re-enter the workplace is not allowed under the ADA. An antibody test is different from a test to determine if someone has evidence of infection with SARS-CoV-2 or has COVID-19 (i.e., a viral test).”

Uber Resolves Claims for Overcharging People With Disabilities

The Department of Justice filed a multi-million-dollar settlement agreement with Uber Technologies Inc. to resolve a lawsuit alleging that Uber violated the Americans with Disabilities Act. Under the agreement, Uber will offer several million dollars in compensation to more than 65,000 Uber users who were charged discriminatory fees due to disability.

In November 2021, the department filed a lawsuit alleging that Uber violated Title III of the ADA, which prohibits discrimination by private transportation companies like Uber.

According to the complaint, in April 2016, Uber began charging passengers wait time fees in a number of cities, eventually expanding the policy nationwide. The wait time fees started two minutes after the Uber car arrived at the pickup location and were charged until the car began its trip.

The department’s complaint alleged that Uber violated the ADA by failing to reasonably modify its wait time fee policy for passengers who, because of disability, needed more than two minutes to get in an Uber car. Passengers with disabilities may need additional time to enter a car for various reasons. A passenger may, for example, use a wheelchair or walker that needs to be broken down and stored in the car. Or a passenger who is blind may need additional time to safely walk from the pickup location to the car itself. The department’s lawsuit alleged that, even when Uber was aware that passengers’ need for additional time was clearly disability-based, Uber started charging a wait time fee at the two-minute mark.

Under the two-year agreement, Uber has committed to waive wait time fees for all Uber riders who certify that they (or someone they frequently travel with) need more time to get in an Uber car because of a disability. Uber also will ensure that refunds are easily available for anyone who does not have a waiver and is charged a wait time fee because of disability. Uber will advertise the wait time fee waiver program and train its customer service representatives on the waiver program and refund process to ensure that people with disabilities are not charged illegal fees.

Additionally, Uber will credit the accounts of more than 65,000 eligible riders who signed up for the waiver program for double the amount of wait time fees they were ever charged, which could amount to potentially hundreds of thousands or millions of dollars in compensation.

Uber will also pay $1,738,500 to more than one thousand riders who complained to Uber about being charged wait time fees because of disability, and $500,000 to other harmed individuals identified by the department.

This litigation was handled jointly by Assistant U.S. Attorney David DeVito for the Northern District of California and the Civil Rights Division’s Disability Rights Section.

CDI Adopts Advisory Rate Lower Than Requested by WCIRB

The California Insurance Commissioner adopted and issued a rate for workers’ compensation insurance that reflects California’s still-recovering economy.

The Commissioner’s action maintains the benchmark rate at $1.45 per $100 of payroll for workers’ compensation insurance unchanged from last year and within the reasonable actuarial range proposed by other experts, effective September 1, 2022.

Because of continued uncertainty regarding COVID-19 and its effects on the economy, this year’s pure premium rate remains the same as last year’s rate, and again does not include a COVID-19 factor.

The Commissioner will continue to review data in future pure premium rate filings to determine the long-term impact of COVID-19 claims as well as other experience data.

“We’re working hard to get California back to business as usual as people return to work,” said Commissioner Lara. “This year’s rate is on par with normal, pre-pandemic levels while still reflecting the long-term benefits of workers’ compensation reform passed by the State Legislature and signed by the Governor to reduce costs.”

Commissioner Lara’s decision results in an average advisory pure premium rate that is below the $1.56 average rate proposed by the Workers’ Compensation Insurance Rating Bureau of California (WCIRB) in its filing with the Department of Insurance. This advisory rate follows a virtual public hearing that was convened on June 14, 2022 and a careful review of the testimony and evidence submitted by stakeholders.

The pure premium rate is only advisory, as the State Legislature has not given the Commissioner rate setting authority over workers’ compensation rates. The average advisory pure premium rate level of $1.45 approved by the Commissioner is about 18 percent lower than the industry-filed average pure premium rate of $1.77 as of January 1, 2022.

The Commissioner issued emergency rules in June 2020 allowing businesses to reduce costs for workers whose duties changed to lower-risk classifications or were furloughed due to the pandemic.

Late last month, the Commissioner issued an Order directing the WCIRB to continue implementing the rule he adopted in 2020 which excludes COVID-19 claims from being used in calculating experience modification rates from December 1, 2019 forward.

S.F. Voters Pass New Paid Emergency Leave Effective October 1

The City of San Francisco generally requires employers to provide employees with paid sick leave based on hours worked in San Francisco. The City also provides its employees with paid sick leave. The City did not have a law addressing paid public health emergency leave. That will change on October 1, 2022.

On March 1, 2022, the Board of Supervisors voted 11 to 0 to place Proposition G on the ballot. And the Proposition has now been approved by 64.44% of City voters.

Starting on October 1, 2022, Proposition G would generally require private employers and the City to provide paid leave to employees for public health emergencies.

This requirement would apply to private employers with more than 100 employees worldwide and would cover only their employees working in San Francisco. The amount of leave provided each year would be equal to the number of hours that each employee regularly works over a two-week period, up to a maximum of 80 hours. This leave can be used only during a public health emergency. A public health emergency includes:

– – a local or state health emergency relating to any infectious disease, as declared by a local or state health official; or
– – when a Spare the Air Alert is in effect.

Employees may use public health emergency leave in several circumstances, including when:

– – the employee or their family member is unable to work due to the recommendations or requirements of a health order addressing the emergency;
– – the employee or their family member experiences symptoms of the disease causing the emergency or tests positive for the disease; or
– – the employee primarily works outdoors and has heart or lung disease, has respiratory problems, is pregnant, or is at least 60 years old when a Spare the Air Alert is in effect.

An employee may choose to use public health emergency leave or paid sick leave in circumstances where both could apply. Any unused public health emergency leave does not carry over to the next year.

CHHSA Meets AB 133 July Deadline For Health Data Exchange Network

It has been nearly one year since Governor Gavin Newsom signed into law health care trailer bill AB 133 which aims to transform healthcare for Californians by expanding Medi-Cal eligibility, investing in behavioral health initiatives, and requiring providers and health plans to share data with each other by 2024.

This law requires, on or before July 1, 2022, that California Health and Human Services Agency (CHHSA), in consultation with stakeholders and local partners, establish the California Health and Human Services Data Exchange Framework that includes a single data sharing agreement and common set of policies and procedures that will govern and require the exchange of health information among health care entities and government agencies in California.

AB 133 required the creation of a framework for the seamless and secure exchange of this data in real time between healthcare entities across the state, and the convening of a Stakeholder Advisory Group to advise on the development and implementation of the data exchange framework.

AB 133 requires all “specified entities” to “exchange health information or provide access to health information to and from” other specified entities in real-time, as defined in the bill, by January 31, 2024. Specified entities include general acute care hospitals, physician organizations and medical groups, skilled nursing facilities, health care service plans, disability insurers, Medi-Cal Managed Care Plans, clinical laboratories, and acute psychiatric hospitals.

Certain health care providers do not need to meet the data sharing mandate until January 31, 2026. This includes physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, and rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers.

But little attention went to Section 1862 of the bill, which required just one public hearing about the rules and operating principles for the largest-ever state compendium of private medical records. An there is now some consternation about privacy in the media.

An article this week in the Orange County Register says that the law will “end the concept of patients keeping any secrets from doctors, psychologists or other medical folk.”  Conversely, it would seem that the flow of electronic health information will assist with the data collection and distribution needed to manage the delivery of medical benefits in the workers’ compensation claims administration process.

It will also assist with the discovery of important medical histories during the discovery phase of workers’ compensation litigation.

It also remains to be seen if the information network materializes within the specified timeframe. There have been previous attempts and failures along the way in California.

A Timeline of Health Data Exchange in California, prepared by the California Health Care Foundation (CHCF), Governor Arnold Schwarzenegger issued an executive order calling for “100% electronic health data exchange” within 10 years.

The order identified key actions, including providing state leadership, taking advantage of the state’s purchasing power, developing a quality reporting mechanism through the Office of the Patient Advocate, and strengthening the ability of the Office of Statewide Health Planning and Development to collect, integrate, and distribute data.

The 100% goal within ten years specified by Governor Schwarzenegger has not materialized. However, this month, the first mandated deliverable under AB 133 seems to be on track as scheduled.

A July 2022  announcement by the California Health & Human Services Agency said the agency has finalized the state’s first-ever Health and Human Services Data Exchange Framework, a single data sharing agreement and common set of policies and procedures that will govern and require the exchange of health information among health care entities and government agencies in California beginning in 2024.

And Executive Summary prepared by the Agency sets for the timeline of the remaining steps anticipated to take place to meet the 2024 startup.  

Arguments Made in 14th Year of Jan-Pro California Wage Theft Case

With a federal judge in California is poised to rule that it misclassified janitors as contract workers and the D.C. attorney general suing them for wage theft, commercial cleaning company a report in Courthouse News says that Jan-Pro International is now arguing that it’s not in the janitorial business at all.

The Georgia-based company operates as a multilevel franchising scheme, selling cleaning businesses to “Regional Master Franchisees” throughout the nation who in turn sign “unit franchisee” agreements with individuals who perform the actual janitorial work.

Master franchisee middlemen pay janitors only after deducting 4% for Jan-Pro, and the janitors are also required to pay a “franchisee fee” to be allowed to work, from which the master franchisees pass on 10% to Jan-Pro.

“We are in the business of selling and supporting master franchises,” Jan-Pro attorney Jeffrey Rosin said. “There are a lot facts here, a lot of actual facts a jury could hold on to and find that Jan-Pro is not in the cleaning business.”

That argument didn’t appear to sway the federal judge who issued a tentative ruling ahead of Thursday’s hearing that mostly sides with the workers – granting them both class certification and summary judgment on a host of claims that include unlawfully deducting royalties and failing to pay minimum wages or reimburse for supplies, uniforms, and travel time.

In a lawsuit first filed in Massachusetts in 2008, low-wage cleaners accused Jan-Pro of preying on immigrant workers by inducing them to buy cleaning franchises while taking a hefty cut of their earnings as “royalties” and misclassifying them as independent contractors. Claims brought by janitors who live in California were eventually severed and transferred to the Northern District.

In finding for Jan-Pro in 2017, the federal judge applied the employment relationship defined by the California Supreme Court in Martinez v. Combs. Alsup also looked to the high court’s ruling in Patterson v. Domino’s Pizza, which determined that franchisors are not vicariously liable for franchisees’ workplace conduct.

The Ninth Circuit disregarded Patterson when it overturned Judge Alsup in 2019, since it was not a wage-and-hour case but focused instead on a franchisor’s vicarious liability for a worker’s sexual assault.

Then in 2018, the California Supreme Court ruled in Dynamex Operations West, Inc. v. Superior Court of Los Angeles that employers can only classify workers as independent contractors if they can show A) the hiring entity does not directly control the worker, B) the work falls outside the hiring entity’s usual course of business, and C) the worker is “customarily engaged in an independently established trade occupation, or business of the same nature as the work performed.”

The test was written into California Labor Code with the passage of Assembly Bill 5 in 2019.

Judge Alsup was asked to take another look at the case after the Supreme Court ruled that Dynamex applies retroactively. Having done so, Alsup found the janitors are necessary to Jan-Pro’s business under the “B” prong of the Dynamex test.

He also flatly rejected Jan-Pro’s argument that it’s not a cleaning business.

On Thursday, labor attorney Adelaide Pagano, a partner at Lichten & Liss-Riordan, urged Alsup to adopt his tentative decision. “It was exactly on point,” she said. “These cleaning workers are essential to its business and it is not correct for Jan-Pro to suggest it is in a different business than the cleaning franchisees.”

Rosin asked Alsup to reconsider, saying Jan-Pro should qualify for a Dynamex exemption under AB 5, which allows a more permissive standard for determining independent contractor status for a business that is contracted to provide services to another business.

Thursday’s hearing coincides with D.C. Attorney General Karl Racine suing the company over its labor practices, including misclassifying janitors and saddling them with unfair franchise fees.

Business Owners Allowed to Proceed Against Carrier for COVID Losses

Fireman’s Fund issued its commercial property insurance policy for the period July 1, 2019 to July 1, 2020 to provide coverage for Hotel Erwin and Larry’s (a restaurant adjacent to the hotel) in Venice Beach.

The policy’s general property coverage provision states, “[W]e will pay for direct physical loss or damage to [the insured property] caused by or resulting from a covered cause of loss during the Policy Period.”

A claim was filed under this policy for the COVID-19 related physical loss or damage to property which the insureds claimed required the closure or suspension of operations at Hotel Erwin and Larry’s. Fireman’s Fund refused to pay for any loss under the policy.

The owners sued Fireman’s Fund Insurance Company alleging the COVID-19 virus was present on, and had physically transformed, portions of the insured properties – “direct physical loss or damage” within the meaning of Fireman’s Fund’s first-party commercial property insurance policy.

The trial court sustained Fireman’s Fund’s demurrer to the insureds’ first amended complaint without leave to amend and dismissed the lawsuit, ruling the COVID-19 virus cannot cause direct physical loss or damage to property for purposes of insurance coverage. The Court of Appeal reversed the dismissal in the published case of Marina Pacific Hotel and Suites v Fireman’s Fund Insurance Company – B316501 (July 2022)

Fireman’s Fund argued that courts across the country had ruled the pandemic does not equate to physical loss or damage and argued loss of use alone does not constitute direct physical loss or damage required by the policy language.

Plaintiffs argued that cases from California (e.g., Armstrong World Industries, Inc. v. Aetna Casualty & Surety Co. (1996) 45 Cal.App.4th [involving asbestos fibers]) and across the country have refused to dismiss similar lawsuits at the pleading stage.

The Court of Appeal agreed with the plaintiffs. The insureds specifically alleged they were required to “dispose of property damaged by COVID-19 and limit operations at the Insured Properties.”

The court concluded that “the insureds have unquestionably pleaded direct physical loss or damage to covered property within the definition articulated in MRI Healthcare – a distinct, demonstrable, physical alteration of the property” (MRI Healthcare Center of Glendale, Inc. v. State Farm General Ins. Co. (2010) 187 Cal.App.4th 766)

They also “adequately alleged that physical loss or damage caused a slowdown in, or cessation of, the operation of the insureds’ business while the covered property was restored or remediated, thereby triggering their business interruption (“business income and extra expense”) coverage.”

The court went on to add that “We recognize this conclusion is at odds with almost all (but not all) decisions considering whether business losses from the pandemic are covered by the business owners’ first person commercial property insurance.

Orthopedists Increase Use of Orthobiologics Over Surgical Intervention

Regenerative medicine is a new field of medicine in which orthopedic surgeons aim to move away from replacement and toward joint preservation. Using orthobiologics, they plan provide the body with the cells, materials, and stimulation it needs to heal without you ever going under the knife.

According to the report on News-Medical.net, the promise of regenerative medicine in orthopedics is a future where a joint replacement can be delayed for as long as possible, perhaps offering a solution to long transplant waiting lists for other disciplines of medicine. The main debate in orthobiologics is whether the body of evidence currently supports incorporating regenerative medicine techniques into national guidelines and conventional treatment strategies.

Case studies and anecdotal evidence often support orthobiologics (biological substances orthopedics surgeons can use to help the body heal) as a treatment option. However, the size and consistency of available studies are still a problem. There is plenty of evidence to support regenerative medicine techniques in specific circumstances such as osteoarthritis and tendinopathy. Still, a broader evidence base will be required before these treatments are accepted as standard practice in wider orthopedic circles.

The idea behind regenerative medicine isn’t new. More recently, regenerative medicine has focused on the implantation of cells to initiate healing in musculoskeletal structures, with the introduction of modern interventions such as platelet-rich plasma, mesenchymal stem cells, and injections of biomaterials that can induce a healing response.

Modern orthopedic regenerative medicine treatments still struggle to find a place within standard practice and large healthcare organizations, owing to the debate over whether the evidence base currently supports its use. Therapies such as platelet-rich plasma and adipose (fat cell) derived stem cell injections often require patients to pay out of pocket as insurance companies refuse to cover these forms of treatment.

There is, however, a growing number of practitioners who use orthobiologics as part of their standard practice. With a growing evidence base, these practitioners have started to treat conditions such as osteoarthritis and tendinopathy in this way, offering treatments including injection of:

– – Platelet-rich plasma – blood plasma with a high concentration of platelets taken from the patient’s blood.
– – Mesenchymal stem cells – stem cells sourced from fat tissue, bone marrow, and pregnancy-related sources such as the umbilical cord, amniotic fluid, and the placenta.
– – Biomaterials – biological substances such as autologous chondrocytes (cells taken from the patient which produce cartilage), bovine collagen, bone matrix, and proteins.

These orthobiologics are generally considered conservative treatments, meaning they are used as a less invasive alternative to surgery or as an additional option when other treatments have failed.

The popularity of orthobiologics is increasing, in no small part due to media coverage of famous athletes undergoing these procedures – Tiger Woods, Steph Curry, and Raphael Nadal, to name just a few. This may have added to the controversy surrounding regenerative medicine. In these circumstances, therapies were used to treat injuries and aid post-surgical healing – an area with less research backing.

Regenerative medicine holds the promise of delaying and possibly reducing surgical intervention in patients with degenerative joint conditions and musculoskeletal injuries. In the near future, we may see orthobiologics used as a middle-ground for conditions like arthritis, sitting somewhere between conservative treatment (such as steroid injection) and surgery.

In the far future, we may even see a complete overhaul of how we replace joints – moving away from metal and ceramic joint replacements towards biological replacement and regeneration. We can also expect a move towards orthobiologic injection as a preventative measure for degenerative joint conditions.