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O.C. Physician Assistant Indicted in Opioid Case

A physician assistant who practiced at a Fountain Valley clinic was arrested on an 11-count federal grand jury indictment charging him with conspiring to issue prescriptions for the highly addictive opioid painkiller oxycodone, without a medical purpose, to drug dealers in exchange for cash, knowing the drugs would be sold on the street.

Raif Wadie Iskander, 53, of Ladera Ranch, was arrested at his residence. He pleaded not guilty, and is free from jail on $100,000 bail.

Although Iskander most recently worked for Coast Pulmonary & Internal Medicine Associates in Fountain Valley, there is no evidence he was selling prescriptions out of that office, according to Ciaran McEvoy, a spokesman for the U.S. Attorney’s Office.

Officials with the clinic did not return a phone call from the Orange County Register seeking comment.

In May 2018, the Medical Board of California placed Iskander on five years probation for unprofessional conduct, negligence and inadequate record-keeping involving three patients. Specifically, the board found he failed to document examinations and diagnostic studies and did not offer any treatment alternatives other than narcotics.

According to the indictment, from October 2018 until April 2019, Iskander wrote prescriptions for “patients” he had never met or examined, including an undercover law enforcement officer. Iskander allegedly provided to drug brokers multiple paper prescriptions that he had signed, but with the patient names left blank, to be filled in by the drug brokers later.

In exchange for cash, Iskander wrote fraudulent oxycodone prescriptions to co-defendants Johnny Gilbert Alvarez, 39, a.k.a. “M.J.,” of Santa Ana, and Adam Anton Roggero, 36, of Costa Mesa, who sold the prescribed drugs on the street as well as to an undercover officer, the indictment alleges.

All three defendants have been charged with one count of conspiracy. Iskander also has been charged with two counts of intentionally distributing oxycodone without a medical purpose. In addition to the conspiracy charge, Alvarez faces felony counts of illegally distributing methamphetamine, fentanyl, and oxycodone. Roggero also has been charged with two felony drug distribution counts.

If convicted of all charges, Iskander would face a statutory maximum sentence of 60 years in federal prison. Alvarez would face a statutory maximum sentence of life in prison and a mandatory minimum sentence of 10 years’ imprisonment. Roggero would face a statutory maximum sentence of 60 years in prison.

This matter was investigated by the Drug Enforcement Administration, the Costa Mesa Police Department, and the California Department of Health Care Services.

This case is being prosecuted by Assistant United States Attorney Rosalind Wang of the Santa Ana Branch Office.

Opioid Drugmaker Loses First Opiate Trial

An Oklahoma judge found Johnson & Johnson and Janssen Pharmaceutical Companies liable for stoking the opioid crisis in the state and said the company must pay $572 million, far less the $17 billion that the state was seeking.

Judge Thad Balkman, of Cleveland County District Court in Norman, Oklahoma, is the first judge to rule in the opioid cases brought to trial by thousands of state and local governments against opioid manufacturers and distributors.

His precedent-setting ruling was being closely watched as 2,000 other pending suits await to be heard before a federal judge in Ohio in October.

J&J said it plans to appeal Balkman’s ruling and that the decision was “flawed.”

“Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome,” said Michael Ullmann, Executive Vice President, General Counsel, Johnson & Johnson. “We recognize the opioid crisis is a tremendously complex public health issue and we have deep sympathy for everyone affected. We are working with partners to find ways to help those in need” according to a company statement.

Oklahoma Attorney General Mike Hunter brought the case to trial for seven weeks, arguing the pharmaceutical company executed an intensive marketing campaign that overwhelmed the market and mislead consumers about the addictive risks of the drug.

Oklahoma lawyers dubbed J&J an opioid “kingpin” and alluded to its marketing tactics as a public health nuisance, under law. However, J&J absolves itself of any misconduct and presented research that said its painkillers, Duragesic and Nucynta, comprised a fraction of opioids prescribed in the state.

Oklahoma escalated the trial after resolving claims against OxyContin maker Purdue Pharma LP in March for $270 million and against Teva Pharmaceutical Industries Ltd in May for $85 million, with only J&J remaining as a defendant.

Plaintiffs’ lawyers have compared the opioid cases to litigation against the tobacco industry that led to the landmark $246 billion settlement in 1998. The city and county lawyers hope this decision could provide a model for future resolutions in public health issues Opens a New Window. like firearms and climate change and pollution.

“Oxygod” Sentenced to 17.5 Years for Fake Pills

A Santa Ana man who admitted his role in a scheme that used fentanyl and other synthetic opioids to manufacture and sell counterfeit pharmaceutical pills designed to look like brand-name oxycodone pills was sentenced to 210 months in federal prison.

Wyatt Pasek, 22, who lived in the penthouse of a luxury high-rise in Santa Ana until his arrest last year, was sentenced by United States District Judge James V. Selna.

Pasek – who used in the moniker “oxygod” when soliciting customers in online marketplaces, and posted images and videos of himself to social media platforms under the moniker Yung10x – pleaded guilty last November to participating in a narcotics-trafficking conspiracy, being a convicted felon in possession of a firearm, and money laundering.

Pasek “caused highly toxic drugs to be mixed into counterfeit pharmaceuticals at a clandestine laboratory in a highly populated residential and commercial area, the Newport Beach Peninsula, and sold the drugs in massive quantities for approximately one year,” prosecutors wrote in a sentencing memorandum filed with the court.

According to court documents, Pasek and two co-defendants obtained fentanyl and a similar drug called cyclopropyl fentanyl through internet from Chinese suppliers, used a pill press to make counterfeit pills, and distributed the narcotics through the mails, often arranging sales through a darknet marketplace. Pasek also sold the counterfeit pills in hand-to-hand transactions.

The other two defendants in this case – Duc Cao, 22, of Orange, and Isaiah Suarez, 23, of Newport Beach – also pleaded guilty and were sentenced earlier this year by Judge Selna to 87 months and 37 months in federal prison, respectively.

When the three defendants were arrested in April 2018, authorities seized a pill press lab in Suarez’s apartment, along with bags that contained nearly 100,000 counterfeit oxycodone pills, hundreds of bogus Xanax pills, nearly six kilograms of fentanyl and fentanyl analogues, and bundles of cash.

During a six-month investigation led by the Drug Enforcement Administration, Internal Revenue Service – Criminal Investigation, and the Costa Mesa Police Department, authorities recovered blue pills stamped “A 215” that resemble 30 mg. oxycodone pills. In the weeks leading up the arrests in this case, investigators intercepted 20 packages that were being sent to Pasek’s customers.

“Had federal agents not intercepted these packages, they would have resulted in substantial counterfeit opioids containing fentanyl and fentanyl analogues to be distributed to New York, California, Massachusetts, Illinois, Texas, Florida, Nevada, Georgia, Utah, Virginia, Tennessee, North Carolina, Colorado, Alabama, and Nebraska,” according to the sentencing memo.

Pasek, who has three prior drug-related convictions, apologized during his sentencing hearing. “I know I have affected countless [people],” he said. “I can’t even imagine how much damage I have done.”

As part of his plea agreement, Pasek agreed to forfeit to the government a number of items seized in relation to his arrest in April 2018: more than $21,000 in cash; jewelry, including a Silver Royal Offshore watch with diamonds, and a gold and diamond Bitcoin necklace; two gold bars seized from his mother’s residence; and thousands of dollars in cryptocurrency/Bitcoin he possessed in his Blockchain wallet.

UR Process “Ripe” for Automation

A report in Property Casualty 360 makes the case that the utilization review process for workers’ compensation claims is ripe for automation. The practice of determining whether healthcare is medically necessary for an injured worker has remained relatively unchanged for decades.  Requests for authorization are submitted, a nurse compares the requested care against evidence-based medical guidelines, and a determination is issued.

The determination is a tool for the treating provider, the claims examiner, and the claimant. Applying the determination during the actual delivery of care is traditionally accomplished by a person, typically a claim examiner or adjuster, or by a medical bill reviewer or auditor, but rarely is it done through technology-enabled automation.

Automation can have many touchpoints in the utilization review workstream. One of the first is the request intake process. Unlike bill review, the Request for Authorization (RFA) form is not standardized across the United States. Some states have very specific requirements for submitting the RFA, whereas other states offer little or no guidance on form submittal, which leads to a very manual process for data entry into a utilization review system.

This is changing with new UR platforms that combine optical character recognition tools and automated intelligence or AI. The faster and more effectively that requests can be submitted for review, the sooner claimants can receive appropriate care.

The next step that is ideal for automation is the application of the appropriate evidence-based medical guideline. This includes identifying the correct criteria set, as well as the correct guideline itself. The hallmark of a good utilization review program is consistency. This includes consistency in meeting turnaround times, consistency in applying guidelines, and consistency in outcomes. Rules-based technology increases guideline accuracy. In situations where an exact match cannot be found, algorithms can serve up best matches.

Automation can also relieve delays when a treatment request is denied. Instead of waiting for the provider to submit an appeal, the noncertified case can be instantly routed to a peer reviewer for assessment. Using a peer reviewer can improve clients’ outcomes when the peer reviewer is in the same specialty, has state licensure in the state where the claimant resides and has a clear understanding of the process’ goals. Automating the referral process to peer review gets the case into the right hands quickly, allowing time for an effective peer-to-peer discussion.

The dissemination of the determination is critical to communication and essential for timely management of the referral. Automating distribution is a time saver for all levels of the case. However, the biggest jump in value is achieved by tightly integrating utilization review with medical bill review.

Today, the workers’ compensation industry relies on claims examiners or bill review auditors to make a visual comparison of the approved or denied treatment to actual care rendered. The flaws in this approach are obvious, and mistakes are unavoidable.

A more intelligent approach is through automation. To accomplish this, the bill review and utilization review platforms need to speak the same language. Utilization review is regularly completed as a narrative and bill review reads in code. The solution is to create the request and the outcome using a medical code set that the bill review system can understand, such as CPT®, a medical code set maintained by the American Medical Association.

SCIF Declares $105 Million Dividend

State Compensation Insurance Fund’s Board of Directors announced plans to distribute an approximate $105 million dividend to its qualifying policyholders with policies that took effect between Jan. 1 and Aug. 19, 2019.

This dividend equals approximately 15% of the estimated annual premium reported in State Fund’s mid-year 2019 financial statement.

State Fund’s Board will consider dividends again for the remainder of the 2019 policy year at its February meeting in 2020. While the board cannot guarantee future dividends, this mid-year declaration does not affect the possibility of a future payout for the remainder of the 2019 policy year.

Through July of this year, State Fund is reporting over $662.5 million in premium and over $78.6 million in realized capital gains.

Additionally, State Fund has implemented several initiatives over the past few years that have led to improved claims outcomes for injured workers and employers. These efforts, combined with the general improvement in the California workers’ compensation insurance environment, have led to a significant decrease in the cost of its claims. This early dividend declaration reflects these positive developments.

“Declaring a dividend at this time helps tens of thousands of California businesses better understand their workers’ compensation insurance costs for the year and plan accordingly,” said Vern Steiner, State Fund’s President and CEO. “Thanks to effective investment management and improved claims outcomes, we are in a strong, stable financial position and want to return money to our policyholders as quickly as possible.”

Since its creation in 1914, State Fund has paid out more than $5 billion in dividends to policyholders – significantly more than any oter California workers’ compensation carrier over that time.

State Fund policyholders will begin to receive dividend payments during the second half of next year.

Oxnard Field Worker Convicted in Fraud Case

The Ventura County District Attorney announced that Oxnard resident Ernestina Rodriguez, was placed on formal probation for a period of 36 months after having pled guilty to a felony violation of lnsurance Code section 1871.4(a)(l), making a false or fraudulent statement of a material fact for the purpose of obtaining workers’ compensation benefits.

She had previously made restitution in full to the victim, Zenith Insurance Company, in the amount of $9,333.50 and will serve 150 days in the Ventura County jail as a condition of probation.

Rodriguez was employed as a field worker in Oxnard and filed a workers’ compensation claim for injuries to her back, neck, and knees on February 14, 2015.

She was placed off work and began receiving medical treatment and temporary total disability benefits provided by Zenith Insurance.

During the time she received treatment, she denied to her treating physicians, a Qualified Medical Examiner, and at a deposition that she had ever filed any prior workers’ compensation claims involving the same body parts as she was claiming in February 2015.

In fact, the defendant had filed and settled two prior workers’ compensation claims for the same body parts in 2002 and 2010.

Her material misrepresentations affected the way her claim was apportioned and caused Zenith Insurance to pay her $9,333.50 in benefits that she was not entitled to receive.

Owners of Sushi Restaurants Guilty in Premium Fraud Case

In June 2018, the married owners of sushi and barbecue restaurants in Pleasant Hill, Manteca, and Tracy were charged with 30 felony counts, including conspiracy, related to alleged payroll tax evasion and fraud. They have have now taken a plea deal in a conspiracy case that alleged workers compensation fraud and tax evasion.

The Mercury News reported that Lafayette residents 63 year old Kyung Yeon, and 65 year old Richard Howard, were both sentenced at a hearing Wednesday afternoon, according to court records. Yeon, the lead defendant, pleaded no contest to single charges of tax evasion and workers compensation fraud, both felonies.

Yeon’s husband, Howard, pleaded no contest to a misdemeanor insurance evasion charge. The couple had originally been charged with 30 counts, including conspiracy.

Yeon will serve 90 days on house arrest and five years of probation, and pay a $20,000 fine, prosecutors said. Howard was given 100 hours of community service, two years of probation and a $1,000 fine. Both defendants must also pay around $80,000 in restitution.

Yeon and Howard own Matsu Sushi and Chop Chop Korean BBQ – both in Pleasant Hill – as well as Bluefin Sushi in Tracy and Matsu Sushi in Manteca. At the time of the alleged offenses, the restaurants had a total of 28 full- and part-time employees, according to court records.

In July 2016 a federal wage investigator with the U.S. Department of Labor alerted the Contra Costa County District Attorney’s office that Yeon and Howard owed around $270,000 in employee back wages over a three-year period, from December 2012 to December 2015, according to court records.

In response to the tip, a D.A. inspector filed a search warrant and obtained payroll tax records from the restaurant. Roughly a year later, prosecutors filed the fraud and tax evasion charges.

They were charged in June 2018, through a criminal complaint that alleged they evaded $1.1 million in payroll taxes by using “under the table” cash payment systems for employees at all four restaurants.

Patients Over Paperwork Initiative Targets $39B in Costs

The Centers for Medicare & Medicaid Services (CMS) launched the Patients Over Paperwork Initiative in 2017, which seeks feedback from industry stakeholders on ways to reduce administrative burdens in health care and improving the patient experience.

The Initiative was in accord with President Trump’s Executive Order that directs federal agencies to “cut the red tape” to reduce burdensome regulations.

This year, CMS received over 560 comments in response to its request for information.

The American Hospital Association (AHA) asserted that providers spend nearly $39 billion each year on administrative activities related to regulatory compliance.

Other stakeholders pointed to prior authorization as a problematic practice, with the American Academy of Ophthalmology calling it the “most burdensome requirement in Medicare.”

The American Association of Neurological Surgeons argues that patients are experiencing significant barriers to medically necessary care because of prior authorization requirements.

Numerous stakeholders called for prior authorization reform in Medicare Advantage plans, but America’s Health Insurance Plans (AHIP) has pushed back, saying that less than 15 percent of covered treatments and services require prior authorization.

However, stakeholders agreed that greater automation would reduce the burdens of prior authorization. Greater standardization of prior authorizations would increase the speed at which they are approved and reduce care delays.

CMS has enacted several regulatory reforms as a result of information gathered through the Patients Over Paperwork Initiative, including reforming evaluation and management (E/M) coding, simplifying office visit documentation, and reducing the complexity of the Quality Payment Program.

Will prior authorization reform be the agency’s next target?

Conviction Illustrates Dark Web and Drugs

Sky Justin Gornik, age 39, of San Diego was sentenced to 70 months in prison for  participating in a conspiracy to deliver, distribute and dispense controlled substances through the internet. Gornik previously pled guilty to that charge and also admitted that he engaged in a conspiracy to launder drug proceeds using digital currencies.

As part of his guilty plea, Gornik admitted that he bought and sold controlled substances on the Dark Web.  Employing anonymous screen names, Gornik used multiple Dark Web marketplaces (including Alpha Bay, Trade Route, Abraxas, Evolution, Outlaw Market, and Dream Market) to buy and sell controlled substances.  

Specifically, Gornik admitted that he purchased and sold fentanyl and purchased the especially deadly opiate carfentanil using a variety of digital currencies. Gornik also purchased and sold multiple other controlled substances, including thousands of vials of ketamine, oxycodone pills, Dimethyltryptamine (DMT), Psilocybin and Psilocin, Amphetamine, Buprenorphine, Methamphetamine, and Naloxone.

Agents seized 1.7 grams of carfentanil inside Gornik’s residence on June 7, 2017. Carfentanil is a synthetic opioid approximately 10,000 more potent than morphine and 100 times more potent than fentanyl. The 1.722 grams of carfentanil seized in Gornik’s residence could equate to over 86,000 fatal dosages.  

Gornik also possessed sheets of fentanyl gelatin tablets (approximately 100 tabs per sheet), which agents seized during the search.  The public record reflects that Gornik obtained 600-1200 fentanyl gel tablets each week for approximately two years from a Dark Web vendor, identified as Steven Wallace George, who resides in Oklahoma.  George, who manufactured pure fentanyl obtained from China into gelatin tablets, was prosecuted by federal authorities in Oklahoma.

As part of his guilty plea, Gornik agreed to forfeit millions of dollars in digital or crypto currency including Bitcoins, Stratis, Ethereum, 2350 Monero, digital currency contained in Gornik’s Bittrex accounts, and digital currency contained in Gornik’s Poloniex accounts.  Gornik admitted that these digital or crypto currency represented drug trafficking proceeds of the offense and were involved in the offense of money laundering over the Dark Web.

This case is the result of the ongoing efforts by the Organized Crime Drug Enforcement Task Force (OCDETF), a partnership that brings together the combined expertise and unique abilities of federal, state and local law enforcement agencies. The principal mission of the OCDETF program is to identify, disrupt, dismantle and prosecute high-level members of drug trafficking, weapons trafficking and money laundering organizations and enterprises.

More Opioid Drugmakers Settle Claims

Reuters reports that Endo International Plc and Allergan Plc have agreed to pay $15 million to avoid going to trial in October in a landmark case by two Ohio counties accusing various drug manufacturers and distributors of fueling the U.S. opioid epidemic.

The tentative deals disclosed on Tuesday came ahead of the first trial to result from 2,000 lawsuits pending in federal court in Cleveland largely by local governments seeking to hold drug companies responsible for the deadly epidemic.

Endo announced said it had reached an agreement-in-principle to pay Cuyahoga and Summit counties $10 million to and provide them up to $1 million worth of two of its of its drug products free of charge.

Allergan has tentatively agreed to pay $5 million to resolve claims involving its branded opioids, though the deal does not resolve claims involving generic painkillers, said Frank Gallucci, a lawyer for Cuyahoga County.

The accords are the first to result from the counties’ cases, which were selected for the first bellwether, or test, trial in the litigation to allow parties to gauge the value of the remaining claims and inform potential settlement talks.

Other companies still set to face trial on Oct. 21 include drugmakers Purdue Pharma LP, Teva Pharmaceutical Industries Ltd and Johnson & Johnson and drug distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp.

Endo, which in 2017 withdrew its painkiller Opana ER from the market, said the settlement includes no admission of wrongdoing.

More than 2,300 lawsuits by state and local governments are pending nationally, accusing drug manufacturers of deceptively marketing opioids in ways that downplayed their risks and drug distributors of failing to detect and halt suspicious orders.

Most of the lawsuits are before U.S. District Judge Dan Polster in Cleveland, who has pushed for a settlement and will preside over the bellwether trial.

Purdue and Teva this year settled claims by Oklahoma’s attorney general for $270 million and $85 million, respectively, ahead of a trial before a state-court judge.

The state subsequently took Johnson & Johnson to trial. An Oklahoma judge will rule on Monday on whether the company should be held liable in a lawsuit by the state’s attorney general who argues the drugmaker should be forced to pay $17 billion for fueling the opioid epidemic.