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DWC Revises Proposed QME Regs

Following a public hearing on May 22, 2015 and a review of submitted comments, the Division of Workers’ Compensation (DWC) has made revisions to the Qualified Medical Evaluator (QME) regulations.

Members of the public are invited to present written comments regarding the proposed modifications to dwcrules@dir.ca.gov until 5 p.m. on Saturday, June 20, 2015.

Proposed revisions include the following requirements and clarifications:

1) Initial represented panel requests postmarked after September 3, 2015 will not be accepted or processed by the Medical Unit for initial represented panel requests only. The last day to mail in panel requests will be September 3, 2015.
2) Effective October 1, 2015, all initial panel requests must be submitted electronically.
3) Parties will have ten days from service of the panel list to strike a doctor.
4) Disputes regarding the validity of panel requests must be resolved by a workers’ compensation judge.
5) Disputes regarding the appropriateness of the specialty designated must be resolved by the Medical Director. Either party may appeal the decision with a workers’ compensation judge. • MAA Anesthesiology is added as a specialty listing.
6) QME Form 105 is amended to make a spelling correction and to indicate that the requesting party must select only one specialty.

The notice and text of the regulations can be found on the DWC proposed regulations page.

EDD Launches New $16 Million Website

EDD officials showed off the new website at their downtown Sacramento headquarters Thursday. The site, called UI Online, is being launched a year and a half late and has cost more than expected, but aims to greatly reduce the need to call the agency with questions about claims.

“It’s pretty good,” said Amandeep Kaur, one of a small number of Californians who have been given access to it so far. “It’s simple. It’s fast.”

Kaur told KCRA 3 she got laid off in April from a job at Apple in Elk Grove. She tried a few times to reach EDD by phone, waiting roughly 30 minutes for someone to answer, she said. Then, she was given access to the new website, which also comes in a mobile app. Connecting with EDD has been a breeze ever since, Kaur said.

This is the outcome EDD had hoped for in September 2013, when it launched a new software system its employees could use to process unemployment claims. But the version the public would use was delayed after that software launch failed and crippled much of EDD’s work.

“I think it was well worth the wait to finally roll out a system that all our customers can use,” said Sabrina Reed, EDD’s deputy director for unemployment insurance.

The new site, which cost $16 million, lets customers do most of the work of applying for benefits and makes it easier for the agency to contact people online. Of the 15,000 people given access to it so far, only two people have needed help using it, Reed said.

EDD plans to roll out the new site to 100,000 customers at a time, starting this weekend, until all 400,000 people currently receiving benefits have access.

That’s a fraction of the number of people who were collecting benefits during the height of the recession, roughly 1.5 million, according to EDD. That reduction has helped reduce a backlog of claims the agency processes and helped reduce the backlog of calls.

At one time, people may have called as many as 45 times before someone at EDD answered, said the agency’s spokesperson, Loree Levy. Now, that number is down to three times, Levy said.  

Court Sanctions Injured Worker and/or Lawyer for Frivolous Appeal

While in the course of his employment, plaintiff Marco Lopez was a passenger in a big rig truck driven by his co-worker. The truck was hit by another vehicle and Lopez was injured as a result.

After the accident Lopez, in propria persona, filed a form complaint for negligence against his employer who filed a demurrer to the complaint on the ground workers’ compensation barred a civil action. Lopez did not oppose the demurrer, and the court sustained it on the basis of the exclusive workers’ compensation remedy. (Lab. Code, § 3706.) The court took judicial notice of plaintiff’s workers’ compensation application in which he admitted the accident occurred during the course and scope of his employment. It granted Lopez “conditional leave to amend” if he could properly allege his employer had no workers’ compensation insurance, thereby excepting the case from the workers’ compensation statutory scheme.

Subsequently, an attorney filed an amended complaint on plaintiff’s behalf, alleging the employer negligently hired the driver and, on information and belief, that the employer was self-insured and had “used that position to deny [p]laintiff medical coverage and needed medical treatment.”

The employer again demurred, The court sustained the demurrer without leave to amend based on the exclusivity of workers’ compensation statutes. The dismissal was sustained by the Court of Appeal in the unpublished case of Lopez v The Fishel Co. The court concluded that there “is no question the court properly sustained the demurrer without leave to amend. Plaintiff alleged he was defendant’s employee and was injured while on the job.”

The court took judicial notice of plaintiff’s workers’ compensation claim form and the compromise and release form showing the claim was settled. With few exceptions, the workers’ compensation statutes provide an exclusive remedy for job-related injuries. Thus, absent an exception, a civil action may not be filed against an employer. In sustaining the demurrer to the original complaint, the court granted plaintiff leave to amend if he could plead such an exception, i.e., that defendant had no workers’ compensation insurance. Plaintiff made no such allegation in the amended complaint.

Plaintiff asserts defendant is self-insured, complaining it refused to authorize over $700,000 for his necessary medical treatment. But the compromise and release order shows the claim was fully settled. Any unhappiness with the result cannot be litigated in this forum. Plaintiff’s argument the settlement did not include this lawsuit has no merit. This action itself is improper and in any event could not be included in a settlement of the workers’ compensation claim.

On the issue of sanctions, the Court noted “there was no valid basis for filing the complaint to begin with, much less the appeal. The workers’ compensation body of law makes clear the statutory scheme is exclusive, absent a narrow set of exceptions.” We are aware sanctions should be awarded only in the most egregious cases. But all of the circumstances convince us this is such a case. In addition to the wholly improper form of the brief, the contents are equally deficient. The brief is confusing and unclear. The case contains no unique issues or complicated facts, nor was there an argument that existing law should be extended, modified, or reversed, as might justify filing this appeal. We do not believe a reasonable person would have thought it proper to file it.

“Sanctions are awarded against plaintiff or against his lawyer or against both. We remand to the trial court to determine against whom the sanctions are to be awarded and the amount of sanctions.” Lopez was represented by the Justice Law Center and Lee H. Durst when he filed the appeal.

In an unrelated case, Durst, a California lawyer for 30 years, was accused in a lawsuit of botching his client’s legal claim against the mortgage company, which foreclosed on her San Juan Capistrano home. In 2001 a jury returned a verdict that said the Santa Ana lawyer was to pay $21 million to the woman who claimed that his faulty advice in business dealings left her destitute. State Bar records show no public record of discipline or of administrative actions against Durst.

Two Comp Systems Under Constitutional Attack

Aggressive claimant attorneys have launched constitutional attacks on workers’ compensation reforms in a number of states including California and Florida. The California Court of Appeal has scheduled oral argument in the the case of Frances Stevens v WCAB that challenges the IMR process. Stevens is now set for oral argument on September 30. Another similar constitutional challenge is working its way through the Third District Court of Appeal that recently agreed to hear the case of Ramirez v The State of California Department of Health Care Services.

In Florida, two high-profile workers’ compensation cases still sit on the desk of the Florida Supreme Court – (1) Castellanos v. Next Door Company and (2) Westphal v. City of St. Petersburg – both of which could have a negative impact on the Florida workers’ compensation system. The workers’ compensation system in Florida has continuously come under scrutiny from opponents looking to overhaul the reforms that were put in place in 2003 by Gov. Jeb Bush and the Legislature.

In the Castellanos case the Florida Supreme Court will decide if the 2003 and 2009 Amendments to the Florida attorney fee law are unconstitutional. In 2003, the Legislature amended the law and limited the amount of attorney’s fees. This severely limited the types of cases or claims an attorney could file. The Court will now decide if the law prevents certain cases or claimants the access to courts as allowed under the Constitution. The National Employment Lawyers Association has given its support to a suit asking the Florida Supreme Court to overturn a statutory limitation on prevailing-party attorneys’ fees in workers’ compensation cases, which the group argues violates the separation of powers doctrine and courts’ authority. The formula for calculating attorneys’ fees in a Florida’s workers’ compensation statute awarded the attorney in the Castellanos case $164 in fees for 107 hours of legal work.

In Westphal the Court of Appeal found that the law stipulating a 104-week limit on temporary benefits was unjust since it puts injured workers like Westphal in a no-win situation of being unable to receive temporary benefits while also not being eligible for permanent benefits. The appeals court concluded that the Florida statue that limited an injured worker to no more than 104 weeks of temporary disability benefits even when he is totally disabled was unconstitutional. Striking down the 1994 amendment to Florida’s workers’ compensation law that established the 104-week limit for temporary disability, the court re-established the previously existing 260-week limit. After rehearing the court re-interpreted the law to mean workers could apply for and receive permanent benefits at the end of the 104-week period because they are “deemed to be at maximum medical improvement as a matter of law,” even if they could one day return to work. The Florida Supreme Court decided to hear the case,

According to the Florida Division of Workers’ Compensation, the running list of reforms in 2003 included making changes to “Permanent Total Disability, Permanent Total Supplement, Permanent Partial Benefits, Practice Parameters and Protocols mandatory in medical care, changes to Independent Medical Examinations, Attorney Fee Award structure, Compliance, Exemptions, elimination of Supplemental Benefits,” among others.The slew of changes to the system focused on one important goal: getting an injured worker back to work, and doing so by weeding out fraud in the no-fault system. The focus wasn’t on making the insurers, medical field or attorneys happy, it was on the employer and the employee.

Business groups credit the Florida reforms for helping drive down insurance rates (down more than 50 percent) and welcoming significant cost savings that allow for the purchase of better policies and coverage for employees. Insurers credit the Florida reforms for opening up the marketplace and creating a healthy and competitive environment. The medical community credits the Florida reforms for adequate medical reimbursement and access to care. But what you won’t hear is trial lawyers crediting this “no-fault” system for much of anything.

Stakeholders in both California and Florida are closely watching these cases which should be decided in the coming months.

Compared to Other Countries – Americans Have More Pain Despite More Pills

New research presented at this year’s Euroanaesthesia conference in Berlin shows that American patients undergoing orthopaedic surgery receive more treatments for pain and that their experience of pain differs in some aspects to orthopaedic patients internationally. The study is by Drs Winfried Meissner and Ruth Zaslansky, University Hospital Jena, Germany, and Dr C. Richard Chapman Utah, Pain Research Center, Salt Lake City, USA. All researchers are part of the international PAIN OUT research group.

Poorly controlled pain after surgery is a major problem internationally despite efforts to improve it. American hospitals regularly assess pain because it is a requirement for accreditation. Regular pain assessment is regarded as a cornerstone for good pain management as it allows gauging of a patient’s needs for treatment. Prior to this study, the research team believed that because pain assessment is an accreditation requirement in the USA, there would be meaningfully lower pain reports on the first day after surgery in USA patients compared with other countries, where pain measurement is not uniformly an accreditation requirement.

Using the PAIN-OUT international acute pain registry to examine perioperative pain control in a large group of patients undergoing different orthopaedic surgical procedures, the authors compared patient reported outcomes in a pooled patient sample from four American (n= 1011) (different regions of the US) versus 45 International hospitals (INT) hospitals (n = 28,510). The international hospitals involved in the study were based in Belgium, France, Germany, Italy, Spain, Sweden, Switzerland, Moldovia, Romania, Malaysia, Ukraine, Serbia, Israel and the UK.

The study found that American patients, contrary to prediction, had higher mean worst pain scores than INT patients (7.5 on a standard 11 point pain measurement scale versus 5.2). American patients also reported that they felt ‘greater participation in decisions about pain treatment’ and that the pain had a more severe effect on their level of anxiety and helplessness. Yet, there were no differences in other outcomes, such as the time patients reported spending in severe pain on the first day after surgery or in the extent of relief provided by pain treatments. Outcomes were measured using standard rating scales employed in clinical pain studies.

These findings were surprising and so the authors did further analyses to check pain management practices provided to American patients as compared with INT patients. They found that American patients were actually receiving more opioid medication in the different phases of surgery – before hospitalization, just before surgery and during the first day after surgery. They also received more regional analgesia after surgery. INT patients received more non-opioid medications in some phases of treatment.

Since high amounts of opioids can sensitize patients to nociception (meaning they experience worse pain), the authors then checked to see if American patients receiving the lowest opioid doses also experienced more pain. They found that the 25% of USA patients receiving the lowest doses of opioids had a higher worse pain score (6.62) than the 25% of INT patients receiving the lowest doses of opioids (4.93). This indicates that sensitization by opioids is not necessarily the reason for the observed differences.

The authors say: “The higher mean worst pain score in USA patients on the first day after orthopedic surgery does not have a simple explanation. USA patients receive more pain medication than international patients and yet report worse pain. This merits further investigation.”

The authors conclude: “The findings of this study are puzzling as American patients were treated according to current clinical practice guidelines to a greater extent compared to INT patients. Their pain is regularly assessed; they received more opioids and regional analgesia. Are the differences cultural? Perhaps pain is measured mechanistically and this in itself is insufficient in procuring good management of pain? Could frequent pain measurement draw patient’s attention to the pain and intensify the experience? Maybe opioids sensitize some aspects of the post-surgical experience of pain? Further research is needed to understand the findings.”

CDC Says Antibiotic Resistance Single Most Important Health Threat

The White House Forum on Antibiotic Stewardship brought together some 150 representatives from food companies, retailers, drugmakers, farmers, medical societies and others involved in human and animal health to discuss limiting the overuse of antibiotics in livestock, animal feed and humans.

The Forum builds on a number of steps the Administration has taken to combat antibiotic resistance. In September 2014, President Obama signed Executive Order 13676 prioritizing Federal efforts to combat the rise in antibiotic-resistant bacteria. The Administration also issued the National Strategy on Combating Antibiotic-Resistant Bacteria, and the President’s Council of Advisors on Science and Technology released a report with recommendations to address the crisis of the proliferation of antibiotic-resistant bacterial infections. In March 2015, the Administration released the National Action Plan for Combating Antibiotic-Resistant Bacteria, a comprehensive plan that identifies critical actions for key Federal departments and agencies to enhance diagnosis and treatment and limit the spread of antibiotic-resistant bacteria.

The Centers for Disease Control and Prevention estimates that drug-resistant bacteria, which stop responding to the medicines designed to kill them, cause 2 million illnesses and about 23,000 deaths each year in the United States alone. CDC Director Thomas Frieden said antibiotic resistance might be the single most important infectious disease threat today. “If we lose antibiotics, the medicine chest will be empty and it will not only undermine our ability to treat routine infections, but it will undermine much of modern medicine,” Frieden said on a conference call with reporters to announce the White House Forum. “We risk turning back the clock to a world where simple infections can be fatal just as they were a century ago.”

Among the topics under discussion will be developing guidelines and recommendations to control the overuse of antibiotics in hospitals and curtail their use in food animals.

Ahead of the meeting, President Barack Obama signed a memorandum directing Federal departments and agencies to create a preference for meat and poultry produced according to responsible antibiotic-use. The Presidential Food Service is also committing to serving meats and poultry that have not been treated with hormones or antibiotics. Separately, the Food and Drug Administration (FDA) will announce that it has finalized changes to the Veterinary Feed Directive (VFD) regulation, an important piece of FDA’s overall strategy to promote the judicious use of medically important antibiotics in food-producing animals as it facilitates bringing the feed-use of such antibiotics under the oversight of licensed veterinarians.

Oral Argument in IMR Constitutionality Case Set for September

The Court of Appeal has scheduled oral argument in the most closely watched case in California workers’ compensation. The case of Frances Stevens v WCAB is now set for oral argument on September 30, at 9:00 am at the First District Court of Appeal in San Francisco.

Stevens tripped on a rug and broke her foot as she carried boxes of magazines. The relatively simple break triggered serious nerve damage and she was eventually diagnosed with chronic or complex regional pain syndrome. She claims to be mostly confined to a wheelchair and she was awarded total permanent disability.

A dispute arose between Stevens and SCIF about two years ago over her medical care. For several years applicant had the assistance of a home health aide and used certain medications prescribed by Dr. Jamasbi to relieve her symptoms. In late 2012, the home health aide assisting applicant was injured and was unable to continue to provide those services. This led Dr. Jamasbi to submit a Request For Authorization (RFA) to defendant for a new home health aide along with a request to refill four prescriptions which were submitted to UR and denied. The request was also denied after the IMR process which took seven months to complete. In this case, the IMR determination states that that “Medical treatment does not include home maker services like shopping, cleaning, and laundry, and personal care given by home health aides like bathing, dressing, and using the bathroom when this is the only care needed.”

The applicant appealed and the WCJ found there was no provision for a reversal of the IMR finding since the labor code provides only limited circumstances upon which IMR can be reversed. The WCAB denied reconsideration in the panel decision of Stevens vs Outspoken Enterprises Inc. One of the key aspects of the Stevens argument was the constitutionality of the IMR process, an issue the California Applicants Attorney Association has been making since passage of SB 863. In response to this challenge, the WCJ found “While the Constitution confers on the Legislature the power to establish a system of workers’ compensation, section 3.5 of article III of the Constitution withholds from administrative agencies the power to determine the constitutional validity of any statute.” The WCAB agreed that it could not rule on the constitutional issue, and denied reconsideration saying “In sum, for purposes of appeal to the WCAB it does not matter whether the reasons given for an IMR determination support the determination unless the appealing party proves one or more of five grounds for appeal listed by the Legislature in section 4610(h) by clear and convincing evidence. Applicant did not do that in this case. The WCJ’s May 27, 2014 denial of applicant’s IMR appeal is affirmed.”

The First District Court of appeal has agreed to hear the case, and this will be the first appellate court to address the constitutional challenge to the IMR process. Briefs have been filed by a great number of Amicus parties including the California Workers’ Compensation Institute, the Property Casualty Insurers Association of America, the California Chamber of Commerce, Voters Injured at Work and the California Applicants’ Attorneys Association.

Another similar constitutional challenge to the IMR process is working its way through the Third District Court of Appeal that recently agreed to hear the case of Ramirez v The State of California Department of Health Care Services involves nearly identical issues. Stevens is more favorable to applicants since the 1st District Court of Appeal is the most liberal, and the Stevens case has the most passionate facts. The 3rd District is located in Sacramento and Its jurisdiction consists of twenty three counties many of which are conservative. Four of the sitting associate justices were appointed by Governor Schwartzenegger. Should the 3rd District in Ramirez rule differently than the 1st District in Stevens, a quagmire would be created that would trigger the intervention by the Supreme Court. Thus, for the defense, the Ramirez appeal is strategically a gift that gives it a foot in the door of a more conservative court.

Typically an opinion is published shortly after oral argument is concluded. It is likely that there will be a decision in Stevens by the end of the year. It is also likely that no matter what outcome, the case will be headed to the California Supreme Court.

Will “Inactivity” be the New Basis of CT Claims?

Last month the California Supreme Court once again reiterated the minimal standard of causation required for a workers compensation claim. The Court reversed the Court of Appeal’s judgment. in the case of South Coast Framing v WCAB and pointed out that unlike tort law, causation in workers’ compensation need only be a contributing cause. With that in mind, the industry is constantly aware that continuous trauma claims can be established for a number of physical stressor’s in the workplace that contribute to an injury. But now, a new report may suggest that being “inactive” and doing nothing physical at work may similarly “contribute” to a litany of physical problems.

People who work desk-based jobs should aim to stand and do light activity for a total of four hours throughout the day, according to an international panel of experts. People should first work toward standing or doing light activity – like walking – for two hours per day, the panel said in a consensus statement. The panel was commissioned by Public Health England and the company Active Working CIC, which owns the Get Britain Standing campaign.

According to the report in Reuters Health, too much sitting has been linked to poor health outcomes over the past several years. Still, no one had set a baseline for just how much time workers should spend on their feet each day, said Gavin Bradley of Active Working CIC in Teddington, U.K. “People weren’t prepared to say what we said, which is how many hours specifically,” Bradley told Reuters Health. The specific recommendation may change as more evidence emerges, but this two- to four-hours-per-day guidance is a good starting point, he said.

U.K. office workers spend as much as 75% of their time at work sitting down, the experts said June 1 in the British Journal of Sports Medicine.Similarly to prolonged periods of sitting, long periods of standing should be avoided, according to the panel, which included experts from several universities and research institutes in the U.K., U.S. and Australia.

Employers may help their employees achieve the two to four hours of standing or light activity by changing how and when people can take breaks that involve standing and movement, or by adopting desk designs and technologies that allow people to perform their work more easily in a standing position, the authors write.”There is good evidence now that too much sitting is associated with generally poorer health outcomes in the long run, including poor bone health, cardiovascular diseases, diabetes and certain cancers,” said Dr. Sebastien Chastin of Glasgow Caledonian University in the U.K.

Sitting seems to be one of the factors contributing to chronic disease, Chastin, who was not part of the new statement, told Reuters Health by email.

“For the last 20 to 30 years the emphasis has been to engage in more ‘purposeful’ exercise,” said Paddy Dempsey of the physical activity laboratory at the Baker IDI Heart and Diabetes Institute in Melbourne, Australia.”Exercise is great for health and we will all continue to advocate for it, but the sad reality is that it hasn’t gotten us all that far at the population level as many are still not engaging in purposeful exercise, and are now sitting increasingly more,” said Dempsey, who was not part of the new statement. Breaks in sedentary time should be an additional measure on top of purposeful exercise, he said by email.

“Research suggests that individuals who are not gaining the benefits of a physically active lifestyle may at least mitigate some of the health hazards associated with physical inactivity by standing more during the day,” said Dr. Lee Smith of the Health Behavior Research Center at University College London. He was also not part of the new statement. “Based on the evidence we have to date, the approximation of two hours increasing to at least four seems reasonable enough,” Dempsey told Reuters Health. We may not be able to pin down the optimal standing time for health effects yet, but these suggested figures seem to be about right, and achievable, Chastin said.

Some companies have already started to address the sitting problem, while others have yet to begin, and the situation can vary greatly by country, Bradley said. A similar Get America Standing campaign launches this week.

Education and public campaigns like these may lead to behavior change, but “it’s going to take us 20 years to get where we need to be,” he said. That’s going to require a cultural shift toward understanding and accepting standing phone calls, walking meetings and going over to a colleague’s desk to talk instead of emailing them, Bradley said.

ObamaCare Premiums May Increase 30% in 2016

Health care costs are the primary reasons for price increases in workers’ compensation premiums. But that is not the only market reeling from increased costs. Dozens of health insurers selling plans under ObamaCare have requested hefty premium increases for 2016, according to preliminary information published Monday by the White House and summarized in a story by Fox News. The insurers have cited higher-than-expected care costs from customers they gained under the ObamaCare’s coverage expansion and the rising cost of prescription drugs and other expenses as reasons for proposing the increases, many of which are in the double-digit percentages.

Among the market leaders, Blue Cross and Blue Shield of North Carolina is seeking a roughly 26 percent premium increase, while plans in Illinois and Florida, among other states, are asking for hikes of 20 percent or more. In Pennsylvania, Highmark Health Insurance Co. is asking for a 30 percent increase.

The preliminary requests were announced as the Supreme Court prepares to rule on the validity of ObamaCare’s tax credits to offset the cost of premiums for lower-income consumers in most states in the country.

Individual health insurance policies are a relatively small slice of the overall market. Many more people are insured through an employer. And it is not clear whether any of these preliminary rate hikes will stick.

Regulators in many states have the power to reject price increases, and many who don’t are expected to at least pressure insurers to soften their plans. Health insurance price hikes have been the subject of growing scrutiny for years. Health insurance experts say it’s tough to draw broad conclusions about prices from the requests released Monday. The health care law only requires insurers to report proposed hikes of 10 percent or more. That’s only a partial picture of the market that tilts toward a worst-case scenario.

“It’s hard to generalize, but that said, I think all signs are pointing to bigger premium increases than in 2015,” Larry Levitt of the nonpartisan Kaiser Family Foundation told the Associated Press. Levitt said part of the reason is that insurers will be basing their 2016 premiums on a full year’s worth of cost or claims data. That’s the first time that has happened for plans sold on the overhaul’s public insurance exchanges, which started enrolling customers in the fall of 2013.

Rates for 2015, for instance, were set based on only a few months of data collected last spring. Insurers normally want to see a couple years of claims from a patient population before they set rates. Higher-than-expected costs were the main reason behind the hike sought by Blue Cross and Blue Shield of North Carolina, which was allowed to impose a 13.5 percent increase for this year. The insurer cited the costs of emergency room use, heart and cancer treatments and the cost of specialty drugs treating hepatitis C in its rate justification filed with federal regulators.

Insurers will spend the next several weeks talking to regulators about their premiums before rates are finalized later this summer. The companies will have better data to back up their request for hikes, but that might mean little if they are negotiating with a regulator determined to hold down prices, said Dave Axene of the Society of Actuaries. “Even if you have all the evidence in the world, it’s not a friendly environment at times,” said Axene, an actuary who helped insurers in several states set prices for 2016.

Consumers should start learning how rates may change for their specific plan by early October. That will give them several weeks to shop for the best deal before Nov. 15, which is when people can start signing up for coverage.

Fake Spinal-Hardware Claims Spread to 17 Hospitals Nationwide

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.