Author: WorkCompAcademy

Fifteen surgeons and 17 hospitals nationwide along with more than a dozen other people, are accused of participating in a counterfeit spinal-hardware ring that resulted in patients receiving non-FDA approved implants, according to a civil complaint and story reported by America Tonight. The document, which was filed in February in California on behalf of dozens of insurance companies, was unsealed Thursday and details a massive alleged health care fraud scheme and conspiracy involving the use and billing of fake surgical hardware to hospitals and doctors across the country.

According to the filing, owners and operators of California-based Spinal Solutions, LLC, manufactured faked spinal implants and “insidiously co-mingled fake implantable hardware with genuine” parts. The fake parts were then allegedly implanted in patients at hospitals in California, Texas, Maryland, Wisconsin and Nevada, according to the complaint. Production of the counterfeit rods and cages allegedly began in 2007 at a machine and tool shop in Temecula, California, according to the complaint. It’s alleged the defendants – doctors, hospitals and distributors – began a five-year relationship with Spinal Solutions to market the fake parts.

It’s alleged that kickbacks were paid to surgeons who would then use the fake products in surgeries. According to the complaint, Maryland surgeon Dr. Randy Davis entered into a “sham agreement” with Spinal Solutions and was paid $458,962 in kickbacks in exchange for getting the non-FDA approved products used in surgeries at the University of Maryland’s Baltimore Washington Medical Center. More than $1 million in sales were made to Baltimore Washington Medical Center, according to the filing, although it’s unclear over what period of time.

Calls to Davis were not returned. Kevin Cservek, a spokesperson for Baltimore Washington Medical Center said they have not heard about the complaint and couldn’t comment.

Nevada surgeons Jaswinder Grover and Patrick McNulty are accused of taking kickbacks in return for implanting the fake parts into unsuspecting patients at the Nevada Orthopedic and Spine Center. Calls to them were not returned.

Like several other doctors, Wisconsin-based surgeon Cully White is accused of entering into a “sham design and development agreement” with Spinal Solutions, which would then allegedly pay the surgeon a kickback in return of using the products. White, who has completed a prison sentence on an unrelated health care fraud conviction, allegedly implanted the hardware into unsuspecting patients at Milwaukee’s St. Francis Hospital and Aurora St. Luke’s Medical Center, before losing his medical license.

Several California surgeons are named in the complaint: Jack Akmakjian, Khalid Ahmed, Darren Bergey, Edward Kolpin, John Joseph Regan, Mitchell Cohen, Justin Paquette, Roger Shortz and Gurvinder Uppal. Dr. Paul McDonough of Texas is also a defendant. Calls to them have not been returned.

Surgeons named in the suit are also accused accepting cash, free airplane rides, meals, vacations and other forms of “entertainment” in exchange for referring patients to certain hospitals where they would get the fake parts implanted. Those hospitals are also defendants in the complaint.

Diagnostic facilities are accused of also taking kickbacks in return for false reports justifying the need for surgeries. The complaint does not name any facility.

Hospitals allegedly “turned a blind eye” to the surgeon, the vendor and products in order to submit false and misleading billings to insurance companies. Those named are located in Nevada, California, Texas, Wisconsin and Maryland.

The lawsuit was not a shock to California spinal surgeon Scott Lederhaus, who, as president of the Association for Medical Ethics, has been a watchdog regarding spinal surgeries. “It doesn’t surprise me. This has got to end,” Lederhaus said. “The spine industry is corrupt and it needs a washing from top to bottom.”

The industry has seen significant growth in sales, going from $250 million in 1994 to $7 billion in 2009, according to Orthopedic Network News, an industry newsletter. And there’s big money in the spinal hardware. In a separate whistleblower lawsuit filed against Spinal Solutions, documents show big markups in its spinal hardware. Six Spinal Solution screw caps cost $2,850 but sold to a hospital for $17,370, which then turned around and charged an insurance carrier $49,260. The chance to break the rules and tap into this lucrative industry can be tempting, Lederhaus said, adding that he thinks more than just a lawsuit is needed to fight that temptation. “I think they should all lose their licenses and go to jail and pay heavy fines,” Lederhaus said.

A story in the Washington Post says that Obama’s administration, with support from House Republicans, is pushing reductions to workers’ compensation for federal employees – to the consternation of fellow Democrats and his union allies. And Tim Walberg, the Republican chairman of a House Education and the Workforce subcommittee, cited “concerns” that workers’ comp benefits “are too generous and can discourage an employee’s return to work.”

But there is assuredly opposition. “I am disappointed that the Department of Labor would come forward for the third time in the past five years with a proposal to cut benefits for injured workers that is not evidence-based, and whose justification has been completely debunked by the Government Accountability Office,” said Rep. Robert “Bobby” Scott (Va.), the top Democrat on the full committee. He finds it “incomprehensible that we are now considering” hits to feds “who have suffered a disabling work-related injury while doing their jobs in service to the American people.”

Currently, the compensation level for injured workers with no dependents is two-thirds of their pre-injury wages. For employees with dependents, about 64 percent of the recipients, the compensation level is 75 percent. Among several proposals, including some Democrats like, the Labor Department is calling for one rate, 70 percent for all, which would mean reduced benefits for the majority of future recipients.

“The 75 percent compensation rate can result in benefits greater than the injured worker’s usual take-home pay,” Leonard J. Howie III, director of the Labor Department’s office of workers’ compensation programs, recently told the House workforce subcommittee. The administration says the current program, with its tax-free compensation, can encourage workers to stay off the job longer than necessary. Without a restructuring, which would apply to future recipients, “we cannot overcome the fundamental disincentives in the current law,” Howie said. Yet, his 10-page statement did not demonstrate that employees actually are discouraged from working. In fact, he said more than 90 percent return to work within two years. He estimated the savings of the labor Department’s proposals would be $360 million over a 10-year period.

Democrats and workers reject the notion that employees don’t return to work as quickly as they could because of disincentives in the current law. With better than 90 percent “going back within two years, you’ve got a system where fundamentally people are going back to work,” said Rep. Mark Pocan (D-Wis.).

Bearing silent witness at the hearing were several injured members of the National Association of Letter Carriers (NALC), who did not testify. Though they would not be directly hit by the Labor Department’s plan, they attended the session to represent those who whose injuries are yet to come. The injured employees at the hearing didn’t appreciate any suggestion that workers’-comp recipients are malingerers.

“It angers me that anyone would propose to reduce payments to injured workers who want nothing more than to recover and return to work ASAP,” said Joel X. Cabrera, 55, a San Gabriel, Calif., postal employee, told the Federal Diary. He just recently returned to work after being crushed by another vehicle two years ago as he loaded mail onto this work vehicle. He was in intensive care for three months and had four surgeries.”Since I was lucky enough not lose my legs and life, I was determined to return to the route I had been doing the past 30 years,” where, he said, the kids call him “Uncle Joey.”

Plaintiff HCF Insurance Agency provides brokerage and agency services for casualty, accident and health, property, life and surplus lines of insurance. Plaintiff is a California corporation with its principal place of business in Los Angeles. Plaintiff is authorized to conduct business in California. Shomer Insurance Agency, Incorporated and Intercare Specialty Risk Services are direct competitors with plaintiff in the insurance market in the greater Los Angeles area. They specialize in brokering workers’ compensation policies for extended care facilities.

Defendant Patriot Underwriters had a sub-producer agreement with Intercare Specialty Risk Services and Shomer Insurance Agency, Incorporated. Patriot is a Delaware corporation with its principal place of business in Fort Lauderdale, Florida. Patriot is a program administrator and managing general underwriter servicing regional and national workers’ compensation insurance carriers. Patriot provides products to insurance agencies and wholesalers with expertise in workers’ compensation. It also offers services such as claims and risk management. Patriot is in competition with other managing general underwriters in California such as Safety National Casualty Company.

Defendant Patriot specializes in the creation and management of new individual, agency, or group captive insurers for workers’ compensation. A captive insurer is a dedicated in-house subsidiary entity which provides insurance to its owner, a parent corporation. The parent corporation pays premiums to the captive insurer rather than an outside firm to insure some business risk. The captive insurer reinvests the premiums it receives and then pays claims by drawing on the principal and return on its investment. Captive insurers can lower costs and facilitate coverage for certain hard-to-insure risks that traditional carriers may not underwrite.

Around July 2012, Patriot considered entering into a business relationship with plaintiff HCF Insurance Agency. The enterprise was to involve plaintiff’s healthcare-based workers’ compensation business. Ultimately the effort resulted in litigation between the parties after a convoluted series of events. Plaintiff HCF Insurance Agency filed a first amended complaint containing multiple causes of action against defendant Patriot Underwriters and other parties. It alleges the following causes of action: contract breach (first); breach of the implied covenant of good faith and fair dealing (second); fraud (third); intentional interference with economic advantage (fourth); and unlawful group boycott in violation of Business and Professions Code section 16720 et seq., also known as the Cartwright Act (ninth).

Defendant Patriot moved to compel arbitration pursuant to an agreement signed by plaintiff. The trial court ordered arbitration as to the contract and implied covenant breach claims because those two causes of action were within the scope of the arbitration agreement. The trial court denied the arbitration petition as to the fraud and intentional interference with economic advantage causes of action. The trial court ruled those two claims did not fall within the scope of the arbitration agreement. The trial court also denied the arbitration petition as to the Cartwright Act cause of action. The trial court ruled application of the arbitration clause’s Florida choice-of-law provision prevented plaintiff from securing any relief. The trial court found the group boycott claim involved an important public policy because it is California’s antitrust statute.

Defendant, Patriot Underwriters appealed the order partially denying its motion to compel arbitration against plaintiff, HCF Insurance Agency. The trial court was affirmed by the court of appeal in the unpublished case of HCF Insurance Agency v Patriot Underwriters Inc.

The trial court denied the arbitration petition as to the fraud and intentional interference with economic advantage causes of action. The trial court ruled those two claims did not fall within the scope of the arbitration agreement. The trial court also denied the arbitration petition as to the Cartwright Act cause of action. The trial court ruled application of the arbitration clause’s Florida choice-of-law provision prevented plaintiff from securing any relief. The trial court found the group boycott claim involved an important public policy because it is California’s antitrust statute. After review of Florida, California and federal law, the Court of Appeal agreed and affirmed the order.

A registered nurse who owned a medical supply company was sentenced in Los Angeles to four years in federal prison for her role in an $8.3 million Medicare fraud scheme.

Olufunke Ibiyemi Fadojutimi, 43, of Carson, California, was convicted by a jury of conspiracy to commit health care fraud, seven counts of health care fraud and one count of money laundering. In addition to the prison term, U.S. District Judge Christina A. Snyder of the Central District of California ordered Fadojutimi was ordered to pay restitution in the amount of $4,372,466, jointly and severally with a co-defendant.

During trial, the evidence showed that Fadojutimi, a registered nurse and the former owner of Lutemi Medical Supply, fraudulently billed Medicare for more than $8 million of durable medical equipment that was not medically necessary. The evidence specifically showed that, between September 2003 and May 2010, Fadojutimi and others paid cash kickbacks to patient recruiters in exchange for patient referrals, and additional kickbacks to physicians for fraudulent prescriptions for medically unnecessary durable medical equipment, such as power wheelchairs. Fadojutimi and others then used these prescriptions to support fraudulent claims to Medicare.

As a result of this fraud scheme, Fadojutimi and others submitted approximately $8.3 million in false and fraudulent claims to Medicare, and received almost $4.3 million on those claims.

The case was investigated by the FBI, IRS, and HHS-OIG’s Los Angeles Regional Office, and was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Central District of California. The case was prosecuted by Trial Attorneys Fred Medick and Blanca Quintero of the Criminal Division’s Fraud Section. Assistant Attorney General Leslie R. Caldwell of the Criminal Division, Acting U.S. Attorney Stephanie Yonekura of the Central District of California, Special Agent in Charge Glenn R. Ferry of the U.S. Department of Health and Human Services, Office of Inspector General’s (HHS-OIG) Los Angeles Region, Assistant Director in Charge David L. Bowdich of the FBI’s Los Angeles Field Office and Special Agent in Charge Erick Martinez of the IRS-Criminal Investigation’s Los Angeles Field Office made the announcement.

Medical treatment in the California workers’ compensation now requires that the treatment pass the scrutiny of “evidence based medicine” which means that scientific studies support the safety and efficacy of the requested care. That might seem like a straight forward process.

But, an article in Scientific American claims that false positives and exaggerated results in peer-reviewed scientific studies have reached epidemic proportions in recent years. The problem is rampant in economics, the social sciences and even the natural sciences, but it is particularly egregious in biomedicine. Many studies that claim some drug or treatment is beneficial have turned out not to be true. We need only look to conflicting findings about beta-carotene, vitamin E, hormone treatments, Vioxx and Avandia. Even when effects are genuine, their true magnitude is often smaller than originally claimed.

The problem begins with the public’s rising expectations of science. Being human, scientists are tempted to show that they know more than they do. The number of investigators – and the number of experiments, observations and analyses they produce – has also increased exponentially in many fields, but adequate safeguards against bias are lacking. Research is fragmented, competition is fierce and emphasis is often given to single studies instead of the big picture.

Much research is conducted for reasons other than the pursuit of truth. Conflicts of interest abound, and they influence outcomes. In health care, research is often performed at the behest of companies that have a large financial stake in the results. Even for academics, success often hinges on publishing positive findings. The oligopoly of high-impact journals also has a distorting effect on funding, academic careers and market shares. Industry tailors research agendas to suit its needs, which also shapes academic priorities, journal revenue and even public funding.

The crisis should not shake confidence in the scientific method. The ability to prove something false continues to be a hallmark of science. But scientists need to improve the way they do their research and how they disseminate evidence.

First, we must routinely demand robust and extensive external validation – in the form of additional studies – for any report that claims to have found something new. Many fields pay little attention to the need for replication or do it sparingly and haphazardly. Second, scientific reports should take into account the number of analyses that have been conducted, which would tend to downplay false positives. Of course, that would mean some valid claims might get overlooked. Here is where large international collaborations may be indispensable. Human-genome epidemiology has recently had a good track record because several large-scale consortia rigorously validate genetic risk factors.

Many scientists engaged in high-stakes research will refuse to make thorough disclosures. More important, much essential research has already been abandoned to the pharmaceutical and biomedical device industries, which may sometimes design and report studies in ways most favorable to their products. This is an embarrassment. Increased investment in evidence-based clinical and population research, for instance, should be designed not by industry but by scientists free of material conflicts of interest.

Eventually findings that bear on treatment decisions and policies should come with a disclosure of any uncertainty that surrounds them. It is fully acceptable for patients and physicians to follow a treatment based on information that has, say, only a 1 percent chance of being correct. But we must be realistic about the odds.