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O.C. Physician Faces Compound Med Fraud Charge

A doctor and patient were charged with insurance fraud for billing over $850,000 to an insurance provider for medically unnecessary prescriptions.

Between May 2014 and September 2014, Sabina Maciel Acevedo, 48, who lives in Anaheim, is accused of completing four compound cream prescription forms for herself and three immediate family members without receiving medical examinations.

Dr. David Todd Asher, 50, who lives in Fullerton, is accused of signing all of the forms without examining any of the family members or customizing each prescription. He was a graduate of the Dartmouth Medical School in 1997.

The completed prescription forms were sent to San Dimas Pharmacy in Bakersfield to be fulfilled, and the pharmacy billed $855,210 to Acevedo’s prescription insurance, Express Scripts, which is provided through the Santa Ana Unified School District.

Acevedo is accused of receiving $19,504.57 in kickbacks for fulfilling these prescriptions through San Dimas Pharmacy.

Express Scripts and SAUSD noticed the unusual charges and contacted the Orange County District Attorney’s Office, Bureau of Investigation, who investigated this case.

Dr. Asher has been charged with Insurance fraud with sentencing enhancement allegations for over $100,000 loss and an aggravated white collar crime over $500,000. He faces 13 years and eight months in state prison.

His patient, Sabina Aceedo has been charged with insurance fraud and grand theft with a sentencing enhancement allegations of a crime resulting in over$100,000 loss.

Asher was previously prosecuted in the United States District Court, Central District of California in February 2007. He was charged with conspiracy and illegal kickbacks for patient referrals. He plead guilty to the conspiracy charge in October, 2007 and placed on probation. He stipulated to discipline with the Medical Board for that offense.

Asher now faces new disciplinary charges by the California Medical Board for his conduct while a medical director of Reflections Recovery Center in Costa Mesa. The second charge appears to be related to his signing prescriptions for compounded medications for several patients who had filled out the prescription.

Bioengineered Discs to end Back Pain

A multidisciplinary research team from the University of Pennsylvania’s Perelman School of Medicine, School of Engineering and Applied Science, and School of Veterinary Medicine is aiming to solve back pain by developing bioengineered intervertebral discs made out of an individual’s own stem cells.

The researchers at the University of Pennsylvania have been working for the past 15 years on bioengineered disc models – first in laboratory studies, then in small animal studies, and most recently in large animal studies.

The current standard of care does not actually restore the disc, so the  hope with this engineered device is to replace it in a biological, functional way and regain full range of motion.

Previously, the researchers tested the new discs – called “disc-like angle ply structures” (DAPS) – in rat tails for 5 weeks. In the new study, whose results appear in the journal Science Translational Medicine, the team developed the engineered discs even further. They then tested the new model – called ” endplate-modified DAPS” (eDAPS) – in rats again, but this time for up to 20 weeks.

Following several tests – MRI scans and several in-depth tissue and mechanical analyses – the researchers found that, in the rat model, eDAPS effectively restored original disc structure and function.

This initial success motivated the research team to study eDAPS in goats, and they implanted the device into the cervical spines of some of the animals. The scientists chose to work with goats because, as they explain, the cervical spinal discs of goats have similar dimensions to those of humans. Moreover, goats have semi-upright stature, allowing the researchers to bring their study one step closer to human trials.

The researchers’ tests on goats were also successful. They noticed that the eDAPS integrated well with the surrounding tissue, and the mechanic function of the discs at least matched, if not surpassed, that of the original cervical discs of the goats.

The researchers say that the next step will include conducting further, more extensive trials in goats, which will allow the scientists to understand better how well eDAPS works.

Moreover, the research team plans to test out eDAPS in models of human intervertebral disc degeneration, thus hopefully getting one step closer to clinical trials.

The researchers say it would be a paradigm shift for how we really treat these spinal diseases and how to approach motion sparing reconstruction of joints.

December 3, 2018 Edition


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Calif Joins 32 States in Supreme Court Drug Pricing Case, Claimants Failure to Respond Dooms FEHA Case, Privette Doctrine Ends Civil Death Claim, Fake Drugmaker Gets 10 Year Sentence, Nurse Practitioner Convicted in $65M Compound Med Fraud, Drugmaker VP of Sales Pleads Guilty in Kickback Case, Psyche QME Disciplined For Gross Negligence, Insurers Concerned About New Privacy Laws, New Comp Carrier Approved in Calif, New Drug Costs $4 Million per Patient.

Uwaydah Connected Chiro Pleads Guilty

A 56-year-old chiropractor has pleaded guilty for his role in a massive workers’ compensation insurance fraud and conspiracy scheme.

Paul Turley (dob 11/12/62) of Granada Hills made a factual basis plea on Monday to one count each of conspiracy to commit insurance fraud, mayhem, insurance fraud and unlawful patient referral. As part of the written plea agreement filed with the court, Turley detailed his involvement in the scheme.

He faces up to eight years in state prison. Sentencing is set for June 14.

Turley is among a dozen defendants who were indicted by a grand jury in 2015 for fraudulently billing tens of millions of dollars to insurance companies for fraudulent surgeries, prescription medications, fake MRIs, falsifying medical reports and office visits.

Prosecutors later divided the larger case into three smaller ones in an effort to streamline the complex litigation and re-filed several counts that previously had been dismissed. However, indictments remain against orthopedic surgeon, Dr. Munir Uwaydah, and his office manager, Wendee Luke, both of whom are fugitives.

The conspiracy allegedly included paying lawyers and marketers as much as $10,000 a month for illegal patient referrals, known as “capping.”

Nearly two dozen patients allegedly were deceived into having surgeries they thought would be performed by Uwaydah. Instead, a physician’s assistant who never attended medical school, carried out invasive and sometimes unnecessary surgeries. Uwaydah was not present in the operating room for all surgeries, prosecutors said.

In addition, nearly two dozen patients have lasting physical scars and many needed additional surgeries to repair the original injury. Last year, co-defendant Marissa Nelson (dob 11/29/76) pleaded guilty to one felony count of conspiracy to commit insurance fraud and admitted a special allegation of taking property of a value exceeding $3.2 million. She faces up to nine years in state prison when she is scheduled to be sentenced on Jan. 25.

The other 10 defendants are awaiting trial. Among the charges they each face are conspiracy, money laundering and unlawful patient referral. Some of the defendants also face aggravated mayhem charges.

The cases were investigated by the Los Angeles County District Attorney’s Bureau of Investigation and the Organized Crime Division. Deputy District Attorneys Dayan Mathai, Catherine Chon, Karen Nishita and Kennes Ma are prosecuting the case.

Drugmaker Pays $360M to Resolve Kickback Case

Actelion Pharmaceuticals US, Inc., has agreed to pay $360 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients through a purportedly independent charitable foundation.

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a partial payment, which may take the form of a co-payment, co-insurance, or deductible. These co-pay obligations may be substantial for expensive medications.

Congress included co-pay requirements in these programs, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs.

The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directly or indirectly, any remuneration – which includes money or any other thing of value – to induce Medicare patients to purchase the companies’ drugs.

Prosecutors alleged that Actelion used a foundation as a conduit to pay the co-pay obligations of thousands of Medicare patients taking Actelion’s PAH drugs. By doing so, the government alleged, Actelion was able to induce patients to purchase its drugs when the prices Actelion had set for those drugs otherwise could have posed a barrier to purchases.

The government alleges that Actelion routinely obtained data from the foundation detailing how many patients on each Actelion drug the foundation had assisted, how much the foundation had spent on those patients, and how much the foundation expected to spend on those patients in the future.

Actelion used this information to budget for future payments to the foundation on a drug-specific basis and to confirm that its contribution amounts to the foundation were sufficient to cover the copays of patients taking Actelion’s drugs, but not of patients taking other manufacturers’ PAH drugs.

Actelion engaged in this practice even though the foundation warned the company against receiving data concerning the foundation’s expenditures on copays for Actelion’s drugs.

Meanwhile, the government also alleged that Actelion had a policy of not permitting Medicare patients to participate in its free drug program, which was open to other financially needy patients, even if those Medicare patients could not afford their copays for Actelion’s drugs. Instead, to generate revenue from Medicare and induce purchases of its drugs, the government alleged that Actelion referred such Medicare patients to the foundation, which allowed the patients’ copays to be paid and resulted in claims to Medicare for the remaining cost.  

On June 16, 2017, after the alleged conduct, Johnson & Johnson acquired Actelion. Johnson & Johnson was not involved, directly or indirectly, in the alleged conduct and the allegations above do not relate in any way to Johnson & Johnson.

Florida Urged to Adopt California IMR Process

In a research report published Tuesday, Florida TaxWatch analyzed California’s IMR process and determined that asking doctors, rather than attorneys and judges, to resolve disputed medical claims could save millions of dollars for Florida’s workers’ compensation system.

California lawmakers authorized IMR in 2012 with the expectation that IMR would reduce workers’ compensation disputes once doctors, attorneys, and other participants came to understand which services could be approved because they meet evidence-based medicine standards. In 2016, the IMRO processed nearly 250,000 applications, a slight decrease from 2015. Of those, 69 percent (172,452) were determined to be eligible for review. Concurrently, 176,002 cases were decided through the IMR process, involving 343,141 treatment request decisions.

In 2016, 167,563 (95.2 percent) of the 176,002 California cases decided using IMR were for applications that listed representation (attorney) for the injured worker. For those cases where the injured worker had representation, the results of the utilization review were upheld in 86.6 percent of the cases. This is similar for those cases where the injured worker did not have representation (84.1 percent).

The reports concludes by saying “California’s successful workers’ compensation reform suggests that replacing Florida’s dispute resolution process with the IMR process used in California might produce similar results in Florida.”

“Anytime you can replace a judicial review process that can take more than six months with a non-judicial review process that can take 30 days or less, it is something to, at least, take a look at,” TaxWatch Vice President for Research Robert G. Nave, one of the report’s authors, told Watchdog.org Wednesday.

An IMR process could reduce the average time to resolve workers’ comp disputes in Florida from 231 days to about 30, as it has in California, the nonpartisan, nonprofit government fiscal monitor claims in its analysis.

According to the report, adopting an IMR process could save Florida businesses $22.6 million annually and, more importantly, dramatically reduce, if not eliminate, attorney fees – which amounted to more than $400 million during the 2016-17 fiscal year.

Taxwatch’s analysis suggests the state could trim back or potentially even eliminate the 31 administrative judges in its Office of the Judges of Compensation Claims, which has annual $13.3 million budget.

More than 30 percent of reviewed California cases in 2016 involved opioid prescriptions with doctors approving access only 9.5 percent of the time. “Treatment providers who consistently prescribe opioids contrary to the established best practices governing the use of opioids run a greater risk of identification as a result of IMR,” the TaxWatch analysis says.

“If the state policymakers want to continue to grow Florida’s economy,” TaxWatch President and CEO Dominic M. Calabro said in the report’s introduction, “it is imperative that the Legislature take the IMR process into consideration.”

Such a proposal is certain to be resisted by the Florida Justice Association, which represents trial lawyers and has opposed attempts to cap attorney’s fees in the past.

Medical Device Makers Plead Guilty in KIckback case

Minnesota-based medical device manufacturer ev3 Inc. has agreed to plead guilty to charges related to its neurovascular medical device, Onyx Liquid Embolic System, and pay $17.9 million. Covidien LP, whose parent acquired ev3, separately paid $13 million to resolve False Claims Act allegations resulting from its alleged payment of kickbacks in connection with another medical device, the Solitaire mechanical thrombectomy device.

ev3 will plead guilty to a misdemeanor charge in connection with the company’s distribution of adulterated Onyx, in violation of the Food, Drug and Cosmetic Act. As part of the criminal resolution, ev3 will pay a criminal fine of $11.9 million and will forfeit $6 million.

According to the plea agreement, Onyx was approved by the U.S. Food and Drug Administration (FDA) as a liquid embolization device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. The FDA has approved Onyx only for use inside the brain.

Despite the FDA’s limited approval of Onyx, from 2005 to 2009, ev3 sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain. The company’s sales force continued to tout unapproved and potentially dangerous uses of Onyx even after FDA officials told ev3 executives that they had specific safety concerns regarding uses of Onyx outside the brain at a 2008 meeting. FDA officials told ev3 executives that a study would be required to gain approval for uses of Onyx outside the brain and to ensure that the benefits of the device outweighed the risks.

According to the criminal information, ev3’s management also set-up a system of sales quotas and bonuses that incentivized sales representatives to sell Onyx for unapproved uses and trained the sales force how to instruct physicians on unapproved uses of the device.

Covidien acquired ev3 in 2010, subsequent to the course of criminal conduct covered by the plea agreement. Covidien was acquired by Medtronic in 2015. Although Medtronic played no role in the criminal conduct, the company has agreed as part of the ev3 criminal resolution to implement new compensation structures to ensure the sales force responsible for marketing Onyx is not incentivized to sell the device for unapproved uses. Medtronic has also agreed to conduct compliance monitoring related to the Onyx sales and marketing components.

Covidien separately has agreed to pay $13 million to resolve its civil liability for allegedly paying kickbacks to induce the use of its Solitaire mechanical thrombectomy device. The Solitaire device is intended to restore blood flow and retrieve a blood clot in certain stroke patients.

The United States alleged that Covidien caused false claims to be submitted to Medicare and Medicaid by paying kickbacks to hospitals and institutions to induce them to use Covidien’s Solitaire device. Specifically, the United States alleged that after receiving FDA clearance for the Solitaire device, Covidien launched a registry to pay hospitals and institutions to collect data about user experiences with the device.

For about two years beginning in August 2014, Covidien paid a fee to hospitals and institutions that participated in a registry each time they used a new Solitaire device and reported certain clinical data about their practices for treating stroke patients to Covidien. Covidien solicited certain hospitals and institutions for the registry in order to convert their business from the competitor’s product and/or persuade them to continue using Covidien products, and knowingly and willfully used the registry as a means of increasing device sales.

The civil lawsuit was filed by Jeffrey Faatz, who worked for Covidien from 2012 to 2014, under the qui tam, or whistleblower, provisions of the False Claims Act. The Act allows private parties to sue on behalf of the government for false claims and to share in any recovery. As part of today’s resolution, Mr. Faatz will receive $2,015,000. The case is captioned United States ex rel. Doe v. Covidien PLC et al., Civil Action No. 8:15-cv-01796 AG (JCGx) (C.D. Cal.).

Vanguard Dismisses Lien Stay Law Challenge

The federal courtroom battle over the survival of the new automatic stay law governing liens filed by indicted medical providers, which has been mostly unsuccessful litigation, has now been dismissed.

Dr. Eduardo Anguizola, while facing multiple counts of insurance fraud filed by Orange County prosecutors, is one the plaintiffs who claims Labor Code 4615 – the automatic lien stay law – violates the procedural component of the due process clause because it immediately stays all liens without notice or a hearing.

Other plaintiffs were Vanguard Medical Management, One-Stop Multi-Specialty Medical Group and related entities.

Soon after this suit was filed, Governor Brown signed AB 1422 into law which was adverse to his federal claim. AB 1422 contains a new LC 4615 subsection (e) which reads “The automatic stay required by this section shall not preclude the appeals board from inquiring into and determining within a workers’ compensation proceeding whether a lien is stayed pursuant to subdivision (a) or whether a lien claimant is controlled by a physician, practitioner, or provider.”

In October, 2017 the federal court issued a restraining order against the DIR. It limited stays to instances where the lien claimant was given proper notice, and required a hearing before the WCAB should any of them claim they should not be subject to a stay. It was a partial victory for plaintiffs who sought more restraint.

In February 2018, the plaintiffs filed two new motions, one asking the court to hold the DWC in contempt, and the other, alternatively to reconsider its December 2017 ruling. The court denied both motions.

The defendants also filed a motion to dismiss certain claims in the First Amended Complaint. The court granted the motion, and last April, dismissed the first, second, third, fourth, and fifth claims (except for the facial due process component of the fourth claim for relief) without prejudice. As to the sixth and seventh claims for relief (the Supremacy Clause claim and the Takings Clause claim), the Court dismissed those claims with prejudice. The plaintiffs have until May 17 to file a Second Amended Complaint.

Things have not gotten any better for the lien claimants since then.

On November 28, the plaintiff lien claimants signed a Stipulation for Voluntary Dismissal of the Case. The parties agreed that “This stipulation and dismissal completely terminate the above-entitled action against all parties. Each party will bear its own attorneys’ fees and costs. The preliminary injunction currently in effect will be dissolved as of the filing of this stipulation of dismissal.”  Pursuant to the stipulation of the parties, Judge Wu signed an Order to Dismiss With Prejudice.

CVS/Aetna Proposed Merger Faces Court Scrutiny

A federal judge who has been asked to sign off on the U.S. government’s decision to approve CVS Health Corp’s acquisition of insurer Aetna Inc said Tuesday he was “less convinced” than the government that the companies had struck a deal that ensured the merger was legal under antitrust law.

According to the report by Reuters, Judge Richard Leon of the U.S. District Court for the District of Columbia had complained last week in a hearing that the two sides had treated him as a “rubber stamp” for the agreement. CVS closed the $69 billion transaction last week and began the integration process.

“At this stage, I am less convinced of the sufficiency of the government’s negotiated remedy than the government is,” he wrote in the order issued on Tuesday.

The Justice Department approved the merger of CVS, a pharmacy chain and benefits manager, and Aetna on condition that the health insurer sell its Medicare Part D drug plan business to WellCare Health Plans Inc (WCG.N). That sale was completed last month.

Also in the order, Leon asked the government and the companies to file a brief by Dec. 14 to show why their integration should not be halted while he considers whether or not to approve the consent decree reached in October.

Most consent agreements that the antitrust agencies strike with companies to resolve competitive concerns are approved by federal courts with little fuss under the 1974 Tunney Act, which requires courts to ensure the agreements are in the public interest.

Companies generally do not wait for final court approval before closing their transactions.

Jury Convicts Advanced Radiology Administrator

A jury has convicted Gonzalo Paredes, 62, of 51 felony counts of paying illegal kickbacks to a doctor for patient referrals and fraudulently billing workers’ compensation insurance companies in the California workers’ compensation system.

The jury reached their verdict on Thursday, November 29, after a nine-day trial.

This prosecution resulted from Operation Backlash, a large-scale, joint federal and state investigation into multi-million dollar fraud and illegal kickbacks in the state workers’ compensation system. Paredes was the office administrator for Advanced Radiology of Beverly Hills, owned by radiologist Dr. Ronald Grusd.

Earlier this year, the U.S. Attorney’s office convicted Grusd on 39 felony fraud counts for paying kickbacks for patient referrals from multiple clinics in San Diego and Imperial counties, resulting in fraudulent bills to insurance companies of over $22 million for medical services. Grusd was sentenced to 10 years in federal prison.

The scheme in San Diego involved Advanced Radiology paying a local chiropractor money in exchange for the referral of patients. This allowed Advanced Radiology to treat the patients and then bill several million dollars to insurance companies.

As the office administrator for Advanced Radiology, Paredes helped negotiate the kickback deals with the chiropractor and facilitated the kickback payments to the chiropractor and those working with him. “When law enforcement became aware of the scam, we began following the trail of dirty money and it took us in many different directions,” DA Summer Stephan said.

“This criminal network bought and sold patients like cattle and they cashed in on the backs of people who trusted them with their health. They conspired to illegally game the system on a level that we’ve not seen before, but the game is over.”

Paredes faces a maximum of 43 years and four months in state prison. His sentencing is set for February 1 in Department 1803 of the San Diego Superior Court downtown.

The District Attorney’s Office partnered with the FBI, California Department of Insurance, and U.S. Attorney’s Office in the investigation and prosecution of Paredes.

Insurance fraud in California is a $15 billion-a-year problem. It’s the second-largest economic crime in America, exceeded only by tax evasion.