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Pain Doctor Pays $200,000K to Resolve Opiate Overprescribing

San Diego area pain clinic doctor Brenton Wynn, M.D., has paid $200,000 to resolve allegations that he illegally prescribed opioids and other dangerous drugs to his patients. Wynn has an office at 502 Euclid Ave., Suite 200, in National City.  He was a graduate of Howard University College of Medicine in 1998.

The Controlled Substances Act provides that doctors may write prescriptions for opioids only for a legitimate medical purpose while acting in the usual course of their professional practice. The United States alleged that Dr. Wynn wrote opioid prescriptions to patients without a legitimate medical purpose and/or outside the usual course of his professional practice for more than five years.  Dr. Wynn wrote prescriptions for fentanyl, oxycodone, hydromorphone, methadone, oxymorphone, and morphine.

The United States further alleged that Dr. Wynn prescribed at the same time a dangerous combination of opioids and benzodiazepines such as Xanax and Valium.  Of even more concern, Dr. Wynn allegedly prescribed to some patients a combination of at least one opioid, one benzodiazepine and one muscle relaxant such as Soma.  Drug abusers colloquially refer to the opioid, benzodiazepine, and muscle relaxant combination as the “Trinity” or “Holy Trinity” because of its rapid euphoric effects.  These drug combinations are known to significantly increase the risk of addiction, abuse, and overdose.

Based on its investigation, the United States alleged that Dr. Wynn prescribed large quantities of opioids to his patients that reached high daily MME levels, often even exceeding 120 MME.  The United States further alleged that Dr. Wynn sometimes continued to prescribe dangerous opioids even when his patients’ urine drug test results showed that they were not taking the drugs Dr. Wynn prescribed.

The DEA has a pending administrative action against Dr. Wynn (Docket No. 20-10) to revoke his ability to prescribe opioids and other controlled substances.

“While the vast amount of medical professionals prescribe opioids legitimately and are meeting their patients’ standard of care, DEA will vigorously pursue information from the public about the doctors who are not,” said DEA Special Agent in Charge John W. Callery. “DEA will always protect the public from doctors who put their patients in harm’s way.”

Assistant U.S. Attorney Dylan M. Aste of the U.S. Attorney’s Office for the Southern District of California handled this matter along with DEA investigators.

Mu COVID Variant Spreads to 49 States

The Mu coronavirus variant has been recorded in 49 US states, with Florida and California reporting the highest numbers of Mu infections. California has recorded 384 Mu variant cases, with 167 cases contained in Los Angeles County area. Until recently, Alaska had the highest number of Mu cases, with 146 people testing positive for the variant. With its relatively small population, of 730,000 people, Mu made up four per cent of the state’s sample size.

Nebraska is the only state in the United States to have not detected a case of the Mu variant of COVID-19, which may render vaccines less effective.

Since being first identified in Colombia in January, the Mu variant has spread to 41 countries, including the United States. Mu is not an “immediate threat“, said Dr Anthony Fauci, in a news conference. But scientists will be “keeping a very close eye on it”.

“This variant has a constellation of mutations that suggests that it would evade certain antibodies, not only monoclonal antibodies, but vaccine- and convalescent serum-induced antibodies,” he said.

At least one case of the Mu variant has been detected in the District of Columbia and every state in the U.S. aside from Nebraska, according to Outbreak.info, a website that provides open source data on COVID-19 variants.

LA County Public Health issued a statement explaining more work is needed to tell what we are dealing with: “More studies are needed to determine whether Mu variant is more contagious, more deadly or more resistant to vaccine and treatments than other Covid-19 strains,” it said.

Maine, Connecticut and Florida round out the list of states with the highest prevalence of Mu cases. Florida’s had the second-highest number of samples, at 384 of the 60,475 samples that were sequenced being of the Mu variant.

The World Health Organization labeled Mu a variant of interest on August 30 because its characteristics could make it more transmissible or resistant to vaccines. However, the Centers for Disease Control and Prevention (CDC) has yet to make the same classification.

WCIRB Publishes Annual Medical Trends Report

The Workers’ Compensation Insurance Rating Bureau of California has released the 2020 California Workers’ Compensation Aggregate Medical Payment Trends report comparing medical payment information from 2018 to 2020.

This report analyzes medical payment and utilization trends by provider type, service locations and different service types. The report also includes an analysis on utilization and cost of opioid prescriptions and physical medicine services over time and by region.

General Trends in the Medical Payments and Transactions in CY2020

– – Overall medical payments declined significantly, largely driven by a sharp drop in the number of claims during the COVID-19 pandemic.
– – Average medical payment per claim and the number of transactions per claim started to increase despite the continuous declines in prior years, potentially due to a decrease in the number of smaller medical-only claims in 2020.
– – Utilization of telehealth services increased sharply, in particular, during the pandemic

Fastest Growing Physician Services Procedures and Therapeutic Group

– – Physical Medicine and Rehabilitation procedures continued to grow and are the fastest growing physician services.
– – Use of Analgesics Anti-Inflammatory increased more significantly than that of any other therapeutic groups.

Opioid and Physical Medicine Utilization and Costs

– – The share of claims that involve opioid prescriptions continued to decrease. Suburban and rural areas have seen higher shares of claims involving opioid prescriptions, while urban areas generally have lower shares.
– – On the contrary, the share of claims that involve physical medicine services increased steadily. Urban areas had a higher share of claims involving physical medicine services, while more suburban and rural areas had lower shares.

The report is available in the Research section of the WCIRB website.

19 Guilty Pleas in SoCal Substance Abuse Facility $18.5M Fraud Case

The former president and chief executive officer of a Long Beach substance abuse treatment provider was sentenced to 84 months in federal prison for participating in a scheme in which more than $18.5 million in fraudulent claims were submitted to California’s Drug Medi-Cal program for alcohol and drug treatment services for high school and middle school students.

Richard Mark Ciampa, 67, of Commerce, was sentenced and also ordered to pay $17,640,325 in restitution. Ciampa pleaded guilty on January 6 to one count of health care fraud.

Prosecutors have obtained a total of 19 guilty pleas in this case and related cases, including former ARS Program Manager Lori Renee Miller, 60, of Lakewood, multiple former ARS managers and counselors, and Dr. Leland Whitson, 81, of Redondo Beach, the former Medical/Clinical Director of ARS who previously pleaded guilty to making a false statement affecting a health care program.

Gregory Hearns, 65, of Long Beach, the billing supervisor for ARS who compiled the monthly billing and arranged for its submission to Medi-Cal, LaLonnie Egans, 63, of Long Beach, a former manager, and Tina Lynn St. Julian, 57, of Inglewood, a former counselor, are expected to go on trial on January 6. They are charged with multiple counts of health care fraud.

Ciampa founded the non-profit Atlantic Recovery Services (ARS), later called Atlantic Health Services, in 1996 and served as its president and CEO until its closure in April 2013 following a suspension in payments. ARS provided substance use disorder treatment services to students at local high schools and middle schools through Medi-Cal and its Drug Medi-Cal program.

From March 2009 to April 2013, Ciampa participated in a scheme to defraud Medi-Cal in which ARS billed the Drug Medi-Cal program for services to students who did not medically need alcohol or drug treatment. ARS also billed Drug Medi-Cal for group and individual counseling sessions that were not provided or did not meet the requirements for reimbursement as to size, length or setting. ARS employees falsified documents to support the false claims.

In March 2009, Drug Medi-Cal ordered ARS to repay an overpayment assessed to the organization, which caused a significant amount of financial pressure on Ciampa. Ciampa, in turn, passed along this financial pressure to his employees and threatened the employees that they would lose their jobs with ARS or have their hours reduced to part-time if they did not generate significant billings.

Ciampa was aware or willfully blind to the fact that, in response to his threats, ARS employees were generating false and fraudulent claims for submission to Drug Medi-Cal. He also encouraged ARS employees to engage in fraud, telling them they should “find a way” to enroll more students in ARS’ program despite Drug Medi-Cal’s medical necessity requirement.

The scheme was executed in several ways, including ARS counselors and managers maintaining student caseloads by enrolling students in the ARS substance abuse counseling program even if they had used drugs or alcohol only occasionally or even just once.

For example, in December 2011, ARS fraudulently submitted a claim for Medi-Cal reimbursement for an individual counseling session for a student on November 23, 2011 – a school holiday and the day before Thanksgiving – when the student was absent and the counselor listed on the claim did not provide any counseling.

In total, $18,530,927 in fraudulent claims were submitted because of the scheme, resulting in an actual loss to Medi-Cal of $17,640,325.

NCCI Finds No Pandemic Related Access Delays for Comp Care

The COVID-19 pandemic and resultant shelter-in-place orders disrupted nearly all business activity, especially access to medical care. While the specific timing of disruptions varied by state, April 2020 saw many healthcare facilities suspend all nonurgent medical procedures.

In a newly published study, the National Council on Compensation Insurance associated costs with the time to treatment for WC claims based on historical information to provide some insight into the impact of postponed medical care for specific WC injuries.

The pandemic’s impact on medical services includes:

– – A decline in active claim volume
– – An increased use of telemedicine
– – Minimal change in both the share and seriousness of injuries treated in an emergency room (ER)
– – An increase (after April 2020) in the use of ambulatory surgical centers (ASCs) above pre-pandemic levels

With respect to time to treatment, the pandemic:

– – Did not adversely impact access to care, as measured by the time from injury to initial treatment
– – Produced a backlog of surgeries in April and May 2020 that diminished throughout the summer
– – May have resulted in greater use of noninvasive treatments that, with comparable outcomes, are often preferred over invasive procedures

For four common WC injuries (one back, one shoulder, and two knee injuries), we studied historical experience of how the total incurred cost per case is associated with the time from injury to surgery and found:

– – Post-pandemic delays are typically too short to impact the average incurred cost per case
– – The largest cost increases occur for back and shoulder injuries – and only after exceptionally long delays to surgery
– – For these four WC injuries, the cost impact due to pandemic – based suspensions is minimal

While NCCI found clear evidence of small delays in access to care associated with the pandemic, it found no convincing evidence that either access to care or the quality of care was adversely impacted. The overall impact on claim costs directly associated with postponed medical care is uncertain. While still preliminary, it found no convincing evidence that access to quality care was adversely impacted.

DWC Announces Return of In-Person Hearings

The Division of Workers’ Compensation announced that as of October 1, 2021, in-person hearings will resume at all DWC district offices except Eureka, which is now a completely virtual office, and satellite locations Bishop, Marysville, Chico and Ukiah, which will also remain virtual. In-person hearings will consist of trials, lien trials, expedited hearings and special adjudication unit (SAU) trials only.

Until further notice, DWC will continue to telephonically hear all mandatory settlement conferences, priority conferences, status conferences, SAU conferences, and lien conferences via the individually assigned judges’ conference lines as announced in Newslines issued on April 3, April 28, May 28, August 12 and September 9, 2020.

DWC’s hearing notices will be updated as of September 17, 2021. Thus, there may be a period of time after that date during which notices will state that trials, lien trials, expedited hearings and SAU trials are being heard on the conference lines when they are actually being held in-person.

Parties should be aware that although a notice might state that the case is being heard telephonically, if it is one of the types of cases listed above and not at a satellite office, it will be held in the assigned district office.

DWC appreciates the community’s patience during this transition. If a party to a DWC hearing has a question on a specific case, they may contact the DWC call center at (909) 383-4522.

DWC requires all visitors to DWC offices to wear face coverings regardless of vaccination status or county mandates, following recommendation from the California Department of Public Health (CDPH).

Court of Appeal to Decide Landmark COVID Exclusive Remedy Issue

A lawsuit filed against See’s Candies, a century-old California institution, could make a fundamental change in the workers’ compensation system and its “exclusive remedy” provision.

Matilde Ek, a worker at a See’s distribution center in Southern California, contracted COVID-19 and apparently infected her 72-year-old husband, Arturo, who died. Ek said she worked on the See’s packing line without proper social distancing or other protections even though some workers were coughing, sneezing and showing other signs of COVID-19 infections.

She and her daughters sued See’s, alleging that since her workplace lacked sufficient safeguards against infection, the company is liable for his death.

See’s acknowledged that Ek’s illness was job-related but argued that since it was, the company was protected from liability for her husband’s death under the “exclusive remedy” doctrine.

Los Angeles Superior Court Judge Daniel M. Crowley refused, however, to throw out Ek’s lawsuit, agreeing with Ek’s attorney that her husband’s death was a separate event from her workplace infection.

Crowley’s ruling sent the issue into the appellate courts and it’s drawing attention from major California and national business groups, which see it as potentially undermining a bedrock principle of the workers’ compensation system.

The California Chamber of Commerce, California Workers’ Compensation Institute, Restaurant Law Center, California Restaurant Association, National Association of Manufacturers, and National Retail Federation have filed documents in the case as amicus.

They argue that the “issue presented in the petition is extremely important to employers and their employees in California. As explained in the petition, the Superior Court’s overruling of petitioners’ demurrer was contrary to the longstanding “derivative injury rule” that establishes workers’ compensation as the exclusive remedy for all claims that are derivative of an employee’s covered workplace injury – including claims for injuries sustained by members of the employee’s household. The Superior Court created a new exception to that bright-line rule for injuries from COVID-19 that allegedly derive from employees who contract the virus in the employer’s workplace and then infect their family members.”

The potential impact of this decision on the balance between the workers’ compensation system and the civil court system can hardly be overstated.

The Court of Appeal docket reflects that an Order was issued to the Superior Court on July 21, 2021, directing that it show cause why a peremptory writ should not issue, ordering it to vacate its April 13, 2021 order overruling petitioners’ demurrer to the complaint. The written return in opposition to the writ shall be served and filed on or before August 18, 2021. Any reply to the opposition shall be served and filed on or before September 16, 2021.

International Overdose Awareness Day Focused on Societal Approach

International Overdose Awareness Day is a global event held on 31 August each year. Its purpose is to raise awareness of overdoses, reduce the stigma of drug-related deaths and acknowledge the grief felt by families and friends.

On this day, acting U.S. Attorney Randy Grossman again warned the San Diego community about the serious fentanyl crisis and advocated an “all of society” approach to countering overdoses.

Grossman emphasized that federal prosecutors are leaving no stone unturned to hold peddlers of fentanyl accountable. “These overdose prosecutions seek to accomplish three goals: Deter the distribution of illegal drugs, send a clear message that traffickers of deadly poison will face serious repercussions, and provide a measure of closure and justice to those faced with devastating personal loss,” Grossman said.

Experts report that fentanyl is 50-100 times more powerful than morphine and so dangerous that in its purest form, even a very small amount can be deadly.” San Diego County officials report that fentanyl overdose deaths surged during the pandemic and are expected to reach as high as 700 this year, a staggering increase over 2019, when 152 individuals died from fentanyl overdoses; in 2020, the 2019 number more than tripled to 461.

Grossman emphasized that, in the face of this crisis, “law enforcement is just one part of the solution.  We need an all of society approach.  As a community, we must consider ways that we can all play a role in furthering the public understanding that substance abuse disorder is a disease that warrants treatment, resources, and positive collective action.”

In addition to prosecuting opioid dealers and smugglers, the U.S. Attorney’s Office raises awareness of harm reduction, prevention and education efforts, through Opioid Coordinators Larry Casper and Dylan Aste, and Outreach Director Cindy Cipriani, who Co-Chairs the San Diego Prescription Drug Abuse Task Force. The U.S. Attorney’s Office also coordinates a quarterly Fentanyl Working Group, which brings together more than 100 law enforcement officers to share trends and best practices to combat the fentanyl scourge in this district.

Finally, the U.S. Attorney’s Office co-sponsors a biannual summit that convenes hundreds of leaders to focus on sharing information, reducing stigma, facilitating treatment, and implementing innovative evidence-based harm reduction prevention strategies. This year’s virtual Western States Opioid/Stimulant Summit, scheduled for November 4-5, 2021, will bring multiple disciplines together to address every aspect of the opioid crisis. National Institute of Drug Abuse Executive Director Nora Vokow, M.D., and Acting ONDCP Director Regina LaBelle will be featured speakers, along with dozens of leaders from the prevention, public health, treatment and law enforcement communities.

Grossman urged those struggling with a substance use disorder and their family members to talk to a doctor or pharmacist about Naloxone, which can reverse an opioid overdose.

To learn how to assist a person who is overdosing, including how to administer Naloxone, please see: https://www.sandiegorxabusetaskforce.org/naloxone.

To obtain information about treatment, see the resources at the PDATF Treatment website: https://www.sandiegorxabusetaskforce.org/treatment.

Ninth Circuit Rejects Medical Marijuana Legalization Case

The Controlled Substances Act of 1970 places federally regulated substances into one of five schedules depending on the substance’s “potential for abuse, “medical use,” “safety,” and likelihood of physical or psychological “dependence.” See 21 U.S.C. § 812(b). Schedule I is the most restrictive schedule. Marijuana is currently a Schedule I substance. To merit scheduling in Schedule I, a substance must have “a high potential for abuse,” “no currently accepted medical use in treatment in the United States,” and “a lack of accepted safety for use . . . under medical supervision.”

Stephen Zyszkiewicz, joined by Jeramy Bowers, filed a one-page, handwritten petition to the United States Drug Enforcement Administration (“DEA”) seeking the rescheduling of marijuana in all of its forms under the Controlled Substances Act (“CSA”), 21 U.S.C. § 801 et seq. Zyszkiewicz stated in his petition that he was in prison after a conviction for selling cannabis. In his petition he claimed the current situation of cannabis in Schedule I completely untenable since half the states allow for medical use.

The DEA wrote a letter in response, stating that Zyszkiewicz’s letter was not in the proper format for a petition but that it welcomed the opportunity to respond to his concerns. The DEA’s letter gave reasons for having denied an earlier rescheduling petition filed by Governors Lincoln Chafee of Rhode Island and Christine Gregoire of Washington State. Zyszkiewicz treated the DEA’s answer as a denial of his petition and unsuccessfully sought judicial review.

Zyszkiewicz petitioned for mandamus in the District Court for the District of Columbia. The district court denied mandamus, and the D.C. Circuit affirmed.

Subsequently in May 2020, Dr. Suzanne Sisley an Arizona-based medical marijuana researcher, Scottsdale Research Institute, LLC (“SRI”), Battlefield Foundation (the non-profit research arm of SRI), and three veterans who claim to suffer ongoing harm from cannabis’ status as a Schedule I drug(collectively, “Petitioners”) asked for judicial review of the DEA’s response to Zyszkiewicz’s petition in the 9th Circuit which has jurisdiction over Arizona (and California). These new petitioners did not seek to intervene in Zyszkiewicz’s petition before the DEA, nor have they filed a petition of their own before the DEA.

The government challenges Petitioners’ standing and argues that Petitioners failed to exhaust their claims before the DEA.

The 9th Circuit held in the published opinion of Sisley v DEA that these petitioners satisfy Article III’s standing requirements, but that they have failed to exhaust their administrative remedies under the CSA. The Court therefore did not reach the merits of Petitioners’ arguments. It therefore dismissed their petition for review on this technical ground.

“We are well aware that reclassification of cannabis is a matter of ongoing active debate,” U.S. Circuit Judge William Fletcher, a Bill Clinton appointee, wrote for the panel. “However, this is not an appropriate case in which to consider that issue.”

In a concurring opinion, Judge Watford said “I write separately to note that, in an appropriate case, the Drug Enforcement Administration may well be obliged to initiate a reclassification proceeding for marijuana, given the strength of petitioners’ arguments that the agency has misinterpreted the controlling statute by concluding that marijuana ‘has no currently accepted medical use in treatment in the United States,”

Lawmakers Seek Proof of Vaccination Law to Enter Public Spaces

The Sacramento Bee reports that California lawmakers are considering legislation to require people to prove they’re fully vaccinated against COVID-19 before entering indoor public spaces like restaurants, bars, movie theaters, gyms, hotels and stadiums.

The proposal hasn’t been formally introduced in the Legislature, and the timeline for action is unclear.

Assemblywoman Buffy Wicks, D-Oakland, said the coalition of lawmakers supporting the concept has not decided whether to push the plan immediately before the legislative year’s Sept. 10 deadline or wait until January when lawmakers return to work. The Sacramento Bee obtained a copy of the draft legislation, which Wicks said is also subject to change.

Wicks said she is in conversations with business leaders, union representatives and others whose support is necessary for any legislation to be successful.

“I think everyone right now is honestly and earnestly at the table,” Wicks said.

As currently written, the proposal would take effect immediately upon the governor’s signature, and would direct the Department of Public Health to develop an enforcement mechanism by Nov. 1.

The proposal, first reported by Politico, would create one of the strictest statewide vaccination requirements in the nation.

The state Department of Public Health said last week that it was leading the nation with a requirement that everyone attending an indoor event with 1,000 people or more show proof of vaccination or a negative COVID-19 test. That requirement takes effect Sept. 20.

Wicks said the new verification requirement could help drive up vaccination rates in California and finally end a pandemic that has spread in the state for 18 months. The system could help schools and businesses keep their doors open, Wicks said, and ease overburdened hospitals clogged with COVID-19 patients amid the delta variant surge.