Menu Close

Author: WorkCompAcademy

Feds Join 4 Whistleblower Opiate Cases

The U.S. Justice Department has joined several whistleblower lawsuits against Indivior Plc and Reckitt Benckiser Group PLC, alleging that the drugmakers improperly marketed the opioid addiction treatment Suboxone.

The Justice Department in filings last week in federal court in Abingdon, Virginia, said it was intervening in four separate whistleblower lawsuits related to the Britain-based companies’ marketing of Suboxone and the related drug Subutex.

According to Reuters, the action came after Indivior, which was spun out of Reckitt in 2014, said last month it was in “advanced discussions” with the Justice Department to resolve an investigation dating back to 2013 related to its marketing practices.

Indivior said it has set aside $438 million to cover legal matters, most of which relates to the investigation. Reckitt has separately reserved 303 million pounds ($390 million) in connection with the investigation.

“We have been cooperating with the DOJ in its investigation for several years, and we remain in advanced discussions about a possible resolution that would render any suit by the department unnecessary,” Indivior said in a statement.

Reckitt spokeswoman Patty O’Hayer said on Wednesday that the company “will be presenting our case to the DOJ in the appropriate channels to defend the actions that we believe that we have taken.”

The Justice Department declined to comment.

The lawsuits were filed under the False Claims Act, which allows whistleblowers to sue companies on the government’s behalf. The government may intervene in the cases, which is typically a major boost for them.

Among the complaints unsealed on Aug. 2 was one filed by former Reckitt employee Ann Marie Williams.

Her 2013 lawsuit alleged the companies marketed unapproved dosages and uses of Suboxone and Subutex and claimed Reckitt made misleading claims to the U.S. Food and Drug Administration to obtain approval for a dissolvable film version of Suboxone.

The lawsuit claimed that as a period of marketing exclusivity granted by the FDA for the tablet form of Suboxone was coming to an end, Reckitt sought U.S. approval of a new patent-protected dissolvable strip version of the drug, which it claimed would be safer and less susceptible to abuse.

But the lawsuit alleges that the film version was inferior to the tablets as it could be more easily diverted for improper purposes and posed an increased risk to children who could accidentally put it in their mouths.

The companies marketed the Suboxone film as “safer” for patients and children than tablets, the lawsuit said.

The case is U.S. ex rel. Williams v. Reckitt Benckiser Inc, et al, U.S. District Court, Western District of Virginia, No. 13-cv-00036.

Another $2B Health Insurance/Pharmacy Merger

UnitedHealth Group is poised to grow its presence in the mental health sector if it closes a yet-to-be-confirmed deal for pharmacy operator Genoa Health.

This “convergence of retail, pharmacy and health insurance,” as former Blue Cross and Blue Shield of Minnesota CEO Michael Guyette put it to Twin City Business in an interview this April, has become an emerging trend in the marketplace.

While not formally announced, a source familiar with the deal told Axios that a tentative agreement had been reached.

Genoa, a Washington-state based company, operates 400 pharmacies across the country – all of which deal with patients with behavioral or other complex, chronic health issues.

Axios said that with Genoa under its belt, the Minnetonka-based Fortune 500 company UnitedHealth Group would control the specialty channel.

Axios didn’t offer a sale figure, but Bloomberg reported Tuesday that if Genoa sold, it could fetch a price of more than $2 billion. Bloomberg also noted Walgreens as a potential buyer.

The prospect of a UnitedHealth Group-Genoa deal follows an agreement reached late last year involving CVS buying Aetna for $69 billion, though the merger is still pending. Meanwhile, Amazon recently acquired prescription delivery startup PillPack Inc.

For localized healthcare entities, Guyette suggested this trend means a need to adjust to the changes to stay competitive, like by launching strategic partnerships.

Axios was told that after the sale to UnitedHealth Group, Genoa CEO John Figueroa would move on and Genoa chief commercial officer Mark Peterson would step in to run Genoa under UnitedHealth.

None of the parties involved in the potential deal, however, have yet commented.

Illegal Fentanyl Floods California Border

Illicit use of pharmaceutical fentanyl and its analogues first appeared in the mid-1970s in the medical community and continues in the present.

More than 12 different analogues of fentanyl, all unapproved and clandestinely-produced, have been identified in the U.S. drug traffic. The biological effects of the fentanyl analogues are similar to those of heroin, with the exception that many users report a noticeably less euphoric high associated with the drug and stronger sedative and analgesic effects.

Fentanyl analogues may be hundreds of times more potent than heroin.

Non-medical use of fentanyl by individuals without opiate tolerance can be very dangerous and has resulted in numerous deaths. Even those with opiate tolerances are at high risk for overdoses.

And fentanyl is regularly being smuggled into California.

This month 20 year old Flavio Diego Rivera Davalos, was sentenced to 87 months in custody based on his guilty plea admitting that he smuggled approximately 77 pounds of fentanyl into the United States.

Davalos, who was 19 at the time of the offense, was arrested at the San Ysidro Port of Entry on December 8, 2017 following one of the largest seizures of the deadly opioid along the Southwest border.

According to expert opinions included in court records, 77 pounds of fentanyl would yield 800,000 potentially fatal dosage units and a market value of more than $2 million.

And also this August, Fernando Jesus Peraza, a U.S. citizen living in Tijuana, was arraigned in federal court on charges of importing over 20,000 fentanyl pills in what is believed to be the largest seizure of fentanyl in pill form along the U.S.-Mexico border.

Peraza, who works in San Diego County, was arrested early August 9, at the San Ysidro Port of Entry

Peraza was the driver, registered owner and sole occupant of the vehicle. U.S. Custom Border & Protection officers initially contacted Peraza in preprimary inspection area but was then referred to secondary inspection, where officers found four packages concealed in the passenger side rear quarter panel. The pills tested positive for fentanyl but were designed to resemble M30s, or oxycodone.

Earlier this month, Cristian Araujo Aguirre, 19 of Tijuana, was charged with importing 11,490 fentanyl pills, 61 pounds of methamphetamine and 14 pounds of heroin.

Aguirre was arrested at the San Ysidro Port of Entry on August 1, 2018. Aguirre is currently detained. His next court appearance is on August 31, 2018.

“This is the biggest fentanyl pill seizure we’ve seen along the Southwest Border, and it’s likely a national record,” said U.S. Attorney Adam Braverman.

August is only 9 days old. The “national record” may be broken (again) before the end of the month.

WCIRB Proposes 4.5% Rate Reduction

The WCIRB Governing Committee voted to authorize the WCIRB to submit a January 1, 2019 Advisory Pure Premium Rate Filing to the California Insurance Commissioner.

The Filing will propose advisory pure premium rates that average $1.70 per $100 of payroll, which is 4.5% less than the average approved July 1, 2018 advisory pure premium rate of $1.78 and 20% less than the industry average filed pure premium rate of $2.13 as of July 1, 2018.

If adopted, this would be the eighth consecutive pure premium rate decrease since 2015 totaling approximately 40%.

In his presentation to the Governing Committee, WCIRB EVP and Chief Actuary Dave Bellusci noted that the indicated January 1, 2019 average advisory pure premium reflects continued downward loss development, acceleration in claim settlements, sharply declining pharmaceutical costs and decline in the number of liens being filed.

Despite these continued favorable trends, Mr. Bellusci cautioned that allocated loss adjustment expenses continue to increase and that the medical savings driving these advisory pure premium rate decreases could erode if medical inflation rates were to return to levels closer to historical norms.

The WCIRB will submit its January 1, 2019 Advisory Pure Premium Rate Filing to the California Department of Insurance (CDI) on or around August 21, 2018.

The CDI will schedule a public hearing to consider the Filing and once the Notice of Proposed Action and Notice of Public Hearing is issued, the WCIRB will post a copy in the Filings and Plans section of the WCIRB website.

Second WCAB Appointment Has No WC Experience

Katherine Williams Dodd, 29, of Napa, has just been appointed by Governor Brown to the California Workers’ Compensation Appeals Board.

Dodd has served as deputy legal affairs secretary in the Office of Governor Edmund G. Brown Jr. since 2017. She was assistant general manager and corporate secretary at Frog’s Leap Winery from 2016 to 2017.

Dodd was a legislative advocate at the American Civil Liberties Union of California Center for Advocacy and Policy from 2013 to 2016, where she was a legislative assistant from 2010 to 2013.

She earned a Juris Doctor degree from the University of the Pacific, McGeorge School of Law. She has been admitted to the California State Bar as an attorney since May 27, 2015, slightly more than three years ago.

Dodd is president of the Puertas Abiertas Community Resource Center Board of Directors.

She has no apparent experience in the practice of Workers’ Compensation law, or claims administration. This is the second WCAB appointment by Governor Brown this year of a candidate with virtually no experience in the field.

Earlier this month he appointed Juan Pedro Gaffney, 80, of Sebastopol to the California Workers’ Compensation Appeals Board.

Gaffney has been a member of the California Alcoholic Beverage Control Appeals Board since 2017 and director at Coro Hispano de San Francisco since 1975.

He was director of Hispanic liturgy at Mission Dolores from 1993 to 2008 and was the first artist-in-residence at the Yerba Buena Center for the Arts.

Gaffney was an associate professor of philosophy at St. Joseph’s College and a lecturer at Saint Mary’s College from 1972 to 1996.

Gaffney is a vice president of the Instituto Pro Música de California. He has been researching, editing, teaching and performing the choral music of Latin America, Spain and Portugal for the past 35 years.

In 1975 he founded the Coro Hispano de San Francisco and Conjunto Nuevo Mundo, and conjointly, the Instituto Pro Música’s Musicological Research Program, through which he has transcribed and/or edited more than 100 works by New World Renaissance and Baroque masters.

Maestro Gaffney also serves as Director of Hispanic Liturgy at the Basilica of Mission San Francisco de Asís.

He also does not have any background in workers’ compensation.

This position requires Senate confirmation and the compensation is $153,689. Dodd is a Democrat, and is Sen. Bill Dodd’s daughter in law. Gaffney is reportedly Brown’s high school classmate.

Indicted Owner of Sham Clinics Faces Immigration Charges

A Burbank man who operated a string of allegedly sham medical clinics – and who already faces federal charges of using the clinics to orchestrate a massive narcotics scheme – was arrested this week on new charges that he unlawfully procured United States citizenship.

Armen Simonyan, 44, who was free on bond in the narcotics-trafficking case, was arrested after being named in a two-count indictment returned this week by a federal grand jury. The new indictment charges Simonyan with unlawful procurement of United States citizenship and making a false statement on a passport application.

Simonyan was previously indicted in August 2017 on charges that he and other conspirators disseminated more than 2 million pills of controlled prescription drugs to the black market, mostly oxycodone and hydrocodone. Simonyan is currently scheduled to go on trial in that case on February 12, 2019.

The 2017 indictments charge 14 defendants who allegedly participated in an elaborate scheme they mistakenly hoped would conceal a high-volume drug trafficking operation. The alleged leader was Minas Matosyan, an Encino man also known as “Maserati Mike,” who is charged with leading the scheme and controlling six of the sham clinics.

Matosyan allegedly supplied corrupt doctors in exchange for kickbacks derived from proceeds generated when the other sham clinics created fraudulent prescriptions or submitted fraudulent bills to health care programs.

The new indictment outlines Simonyan’s 15-year history of securing United States immigration benefits via fraud and identity theft.

Simonyan allegedly entered the United States from Armenia under a stolen identity and a fraudulent passport. He then sought asylum in the United States, allegedly concocting a false narrative that he was born in Azerbaijan to parents of supposed mixed Armenian-Azerbaijani nationality; that his family suffered ethnic violence, including the murder of both his parents; and that he fled to the United States via Russia.

The new indictment alleges that, in fact, Simonyan was born in Armenia to Armenian parents, that he entered the United States from Armenia, and that both of his parents were alive.

Simonyan will lose his United States citizenship if convicted of the immigration fraud charge.

The indictment also charges Simonyan with lying on his application for a United States passport after he gained citizenship. The alleged false statements related to his place of birth, his date of birth, and his claim that his mother was deceased.

WCAB Adds Instead of Combining PD Ratings

Nohemi Taina suffered a significant injury to her neck and shoulders on 10/4/2011. As a compensable consequence of this injury, she developed psychiatric sequela.

The neck and shoulder injuries were assessed by an AME, David Pang, MD, who rated those disabilities at 48%. There is no dispute at present about the accuracy of this assessment.

The psychiatric consequences were evaluated by AME Joshua Kirz MD, who rated them at 39%, and this assessment is also agreed to have been accurate. Dr. Kirtz reported that applicant’s physical and psychiatric impairments do not overlap and that her “physical and psychiatric impairments appear additive” in their effect on permanent disability.

The sole disagreement was whether the overall level of permanent disability was best represented by combining the two values using the Combined Values Chart, which would produce 68% PD, or adding the two, which would produce 87% PD.

The WCJ found that adding the two disabilities was appropriate and awarded 87% Permanent Disability. The Defendant Petitioned for Reconsideration, which was denied in the panel decision of Taina v County of Santa Clara.

“To assure accuracy in the calculation of WPI, a physician may, with proper explanation, deviate from the percentages contained in the applicable chapter of the AMA Guides in order to better express the injured worker’s level of WPI in light of the physician’s skill, knowledge, and experience, as well as considerations unique to the injury and information derived from extrinsic resources. (Almaraz v.Environmental Recovery Service/Guzman v. Milpitas Unified School District (2009) 74 Cal.Comp.Cases 1084 (Appeals Board en banc).”

“Similarly, in finding permanent disability the WCAB applies its expertise to determine an accurate rating based upon the entirety of the record.”

In determining overall permanent disability, it has been recognized that the rating schedules provide only a “guide,” and that the final rating should reflect “the entire picture of disability and possibility of employability.”

“The disability values of multiple impairments may be added instead of combined using the CVC if that provides an accurate rating, particularly when there is no overlap, and when the synergistic effect of the multiple disabilities support that method of combination.”

The WCJ’ s decision to add the permanent disability values of applicant’s orthopedic and psychiatric conditions is based upon the reporting of the AMEs and is supported by the AMA Guides, as shown by the discussion of the role of the trier of fact that is provided in Chapters 14 and 1.5 on pages 9 and I0 of the AMA Guides, as follows:

“A scientific formula has not been established t o indicate the best way to combine multiple impairments. Given the diversity of impairments and great variability in herein in combining multiple impairments, it is difficult to establish a formula that accounts for all situations. A combination of some impairments could decrease overall functioning more than suggested by just adding the impairment ratings for the separate impairments (eg blindness and inability to use both hands). When other multiple impairments are combined, a less than additive approach may be more appropriate . . .”

FDA Rejects Another New Opioid

Remoxy ER (oxycodone) Extended-Release Capsules CII, based on Pain Therapeutics’ ORADUR technology, is a long-acting formulation of oxycodone designed to discourage most methods of tampering linked to opioid abuse.

However, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to the FDA voted 14 to 3 against approving the drug. And the FDA agreed and argued that the benefits of the drug did not outweigh the risks.

The company reacted badly.

“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said Remi Barbier, Pain Therapeutics’ president and chief executive officer, in a statement. “We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe Remoxy received an ideological judgment call that is vague in nature but conclusive in its damaging effects.”

This is the companies fourth rejection on Remoxy. Seemingly in response to the rejection, Pain Therapeutics has launched a strategic reorganization. It plans to shift its focus from tamper-resistant opioid formulations to Alzheimer’s disease. Details are expected to be released in the upcoming weeks.

The FDA has perhaps changed direction on approval of opioid pain management strategies. They have announced “we must also take steps to help those with acute and chronic pain who need access to medicines, including opioids, get improved treatment alternatives.”

“Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. While these innovative formulations are designed to make it harder for people to manipulate the opioid drug so they can’t be abused, it’s important that prescribers and patients understand that these drugs are not ‘abuse-proof,’ and they do not prevent addiction, overdose, or death.”

“In addition, part of our ongoing work is ensuring that drug approval and removal decisions are made within a benefit/risk framework that evaluates not only the outcomes of opioids when used a prescribed, but also the public health effects of inappropriate use of these drugs. We are continually re-evaluating the safety of approved opioid products based on both post-market data the FDA has required from sponsors and additional sources of information as part of our safety surveillance.”

Both the announced policy and the FDA current opioid rejection history seem to indicate a trend away from opioid drugs toward “alternatives,” whatever that might be.

August 6, 2018 Edition


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Parties Have no Unconditional Right to PQME, Safety Consultant Owes Duty of Care to Injured Workers, Jury Convicts San Leandro Physician’s Assistant, Nail Salon Cited for $1.2M Wage Theft, DWC Administrative Director Announces His Future Plans, DWC Corrects OMFS to Delete Zero Value MUE, Opioid Use Remains Tenaciously High in the U.S., FDA Rejects Opioid Drug From Controversial Company, Comp Industry Shows Strong Underwriting Performance, New WC Carrier Opens in San Diego.

14 California Hospitals Settle Fraud Claims for $65M

Prime Healthcare Services, Inc.; Prime Healthcare Foundation, Inc.; Prime Healthcare Management, Inc.; and Prime’s Founder and chief executive officer, Dr. Prem Reddy, have agreed to pay the United States $65 million to settle allegations that 14 Prime hospitals in California knowingly submitted false claims to Medicare by admitting patients who required only less costly, outpatient care and by billing for more expensive patient diagnoses than the patients had (a practice known as “up-coding”).

Under the settlement agreement, Reddy will pay $3.25 million and Prime will pay $61.75 million.

Headquartered in Ontario, California, Prime Healthcare Services and the not-for-profit Prime Healthcare Foundation constitute one of the largest hospital systems in the nation, with 45 acute-care hospitals located in 14 states.

The following 10 hospital defendants owned by Prime Healthcare Services are parties to the settlement agreement: Alvarado Hospital Medical Center, Garden Grove Medical Center, La Palma Intercommunity Hospital, Desert Valley Hospital, Chino Valley Medical Center, Paradise Valley Hospital, San Dimas Community Hospital, Shasta Regional Medical Center, West Anaheim Medical Center and Centinela Hospital Medical Center.

Four other hospital defendants owned by Prime Healthcare Foundation are also parties to the settlement agreement: Sherman Oaks Hospital, Montclair Hospital Medical Center, Huntington Beach Hospital and Encino Hospital Medical Center. Prime Healthcare Management, a subsidiary of Prime Healthcare Services, provides management, consulting and support services to hospitals owned and operated by Prime.

The settlement resolves allegations that, from 2006 through 2013, Prime engaged in a deliberate, corporate-driven scheme to increase inpatient admissions of Medicare beneficiaries who originally presented to the Emergency Departments at the 14 Prime hospitals in California.

The government claimed that the inpatient admission of these beneficiaries was not medically necessary because their symptoms and treatment needs should have been managed in a less-costly outpatient or observation setting. Hospitals generally receive significantly higher payments from Medicare for inpatient admissions as opposed to outpatient treatment; therefore, the admission of beneficiaries who do not need inpatient care, as alleged here, can result in substantial financial harm to the Medicare program.

The settlement also resolves allegations that, from 2006 through 2014, Prime engaged in up-coding by falsifying information concerning patient diagnoses, including complications and comorbidities, in order to increase Medicare reimbursement.

This settlement resolves a False Claims Act (FCA) lawsuit filed in federal court in Los Angeles by Karin Berntsen, the former director of performance improvement at Alvarado Hospital Medical Center in San Diego. Under the qui tam, or whistleblower, provisions of the FCA, private citizens are permitted to bring lawsuits on behalf of the United States and obtain a portion of the government’s recovery. The FCA also permits the government to intervene and take over the lawsuit, as it did in this case as to some of Ms. Berntsen’s allegations. Ms. Berntsen will receive $17,225,000 as her portion of the settlement amount.

The case is United States ex rel. Karin Berntsen v. Prime Healthcare Services, Inc., et al., CV11-08214-PJW (C.D. Cal.). The claims resolved by this settlement are allegations only and there has been no determination of liability.