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Geographic Dimensions of California Opioid Abuse

Trinity County is the state’s fourth-smallest, and ended last year with an estimated population of 13,628 people.

Its residents also filled prescriptions for oxycodone, hydrocodone and other opioids 18,439 times, the highest per capita rate in California.

Places like West Virginia, Ohio and rural New England have become synonymous with prescription painkiller abuse, a scourge blamed for more than 183,000 deaths from 1999 through 2015.

California, though, is far from a bystander to the crisis. There were 1,925 opioid-linked overdose deaths in California last year, according to recently updated state data, and thousands of emergency room visits.

The story in the Sacramento Bee reports that problem also has a decidedly geographic dimension in California. In rural and semi-rural parts of the state, where the demographics resemble Appalachia more than Anaheim, prescription drug use and death rates vastly exceed the state average, state data show.

Besides Trinity, other counties with more prescriptions than people include Lake, Shasta, Tuolumne and Del Norte counties. In the Sacramento region, El Dorado, Placer and Sacramento counties had prescription rates above the statewide average, with Yolo County slightly below the state average.

A county’s prescription total represents all opioids dispensed via prescriptions filled at a pharmacy and tracked by the state. Statewide, 15 percent of Californians were prescribed opioids in 2016, ranging from 7.3 percent of residents in tiny Alpine County to almost 27 percent in Lake County.

“The following characteristics were associated with higher amounts of opioids prescribed: a larger percentage of non-Hispanic whites; higher rates of uninsured and Medicaid enrollment; lower educational attainment; higher rates of unemployment; (small-town) status; more dentists and physicians per capita; a higher prevalence of diagnosed diabetes, arthritis, and disability; and higher suicide rates,” concluded the authors of a Centers for Disease Control and Prevention study released in July.

The National Institute on Drug Abuse last month awarded nine grants to address the opioid crisis in rural places. Oregon doctor Todd Korthuis, an expert on opioid abuse in the state, is the only grant recipient west of the Mississippi River. “What you’re seeing in California is what you’re seeing in many parts of the country, including Oregon,” Korthuis said. “There are still a lot of rural counties around the U.S. that are awash in prescription opioids.”

The state data also compiles prescriptions by ZIP code. In Sacramento County, for example, ZIP codes with the highest rates of prescription opioids include Galt’s 95632, Del Paso Heights’ 95838, and Rio Linda’s 95673.

The country’s opioid abuse epidemic tracks a quadrupling of prescription drug sales from 1999 to 2014. Once prescribed mainly for short-term pain relief, prescription painkillers increasingly are taken for chronic pain.

Young people are among the biggest abusers. Although overall teen drug use has declined nationally, prescription drugs are second only to marijuana in teen drug abuse. One in five teens has abused a prescription pain medication, according to the Partnership for Drug-Free Kids.

In California, residents aged 15 to 29 got 1.7 million prescriptions in 2016, representing 7.2 percent of the state total. That’s down from the 1.9 million prescriptions in 2015, which represented about 7.8 percent of the state total. The age range that featured the largest prescription rate increase were 70- to74-year-olds, whose prescriptions grew from almost 1,354 per 1,000 people in 2015 to 1,394 per 1,000 people in 2016.

The worsening crisis has prompted state legislation, although few bills on the subject seem likely to pass this year. A measure by Assemblywoman Marie Waldron, R-Escondido, to require California to create a public-awareness campaign about opioid abuse passed the Assembly without a dissenting vote. It was held last week in the Senate Appropriations Committee because of the cost. And a bill by Assemblyman Kevin McCarty, D-Sacramento, to levy a new fee on opioid manufacturers would have generated an estimated $88.1 million to pay for treatment and prevention efforts. It did not advance.

One of the few prescription painkiller bills still moving would require the state Department of Public Health to convene a working group to craft guidelines for the prescribing of opioid pain relievers. It has had no opposition.

Another State Sues Opioid Drugmakers

“Pile on” is a phrase used in football which describes the action of one or more players jumping on top of a player or group of players after a tackle has been made. The phrase may now be an accurate description of what states are doing to opioid drugmakers.

New Mexico seems to have joined a drugmaker pile on as it sued eight opioid manufacturers and wholesale distributors this month, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic.

Reuters Health reports that New Mexico Attorney General Hector Balderas accused Purdue Pharma LP, Johnson & Johnson, Allergan Plc, Endo International Plc and Teva Pharmaceuticals Industries Ltd of pushing addictive painkillers through deceptive marketing. The lawsuit also accused wholesale distributors McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp of breaching their legal duties to monitor, detect and report suspicious orders of prescription opioids.

“New Mexico continues to endure the most catastrophic effects of the opioid crisis, all while major out of state corporations make billions in profits at the expense of our families and communities,” Balderas said in a statement.

The lawsuit followed a wave of cases against drugmakers by Oklahoma, Mississippi, Ohio, Missouri, New Hampshire and South Carolina, as well as several cities and counties in states including California, Illinois and New York. The drug wholesalers have likewise faced litigation, particularly in West Virginia, where several county commissions and cities have the three main ones, following lawsuits filed by the state’s attorney general.

New Mexico’s lawsuit, filed in the First Judicial District Court in Santa Fe County, contended that the drugmakers downplayed the risks of addiction to prescription opioids and falsely touted the benefits of their long-term use. It also accused the wholesale distributors of violating their duties by selling large amounts of painkillers that were then diverted for illicit uses, helping to contribute to the opioid epidemic. The lawsuit seeks damages, including for the costs New Mexico has incurred responding to the epidemic.

The companies have in similar cases denied wrongdoing. The drugmakers have said they acted responsibly in connection with marketing the drugs, which carry U.S. Food and Drug Administration-approved labels warning about their risks.

“While we vigorously deny the allegations, we share public officials’ concerns about the opioid crisis and we are committed to working collaboratively to find solutions,” Purdue, the maker of OxyContin, said in a statement.

Cardinal Health in a statement called the lawsuit “misguided,” saying it was “launched in haste and without any factual investigation to support it.”

DWC Adds Modifications to Drug Formulary

The Department of Industrial Relations’ Division of Workers’ Compensation has issued modified proposed regulations to adopt the Medical Treatment Utilization Schedule (MTUS) Drug Formulary. The proposed rulemaking implements Assembly Bill 1124 (Statutes 2015, Chapter 525), which mandates adoption of an evidence-based drug formulary.

DWC has reviewed comments received during the first 15-day comment period and has modified the proposed regulations to provide additional detail and clarity. The second 15-day public comment period will end September 22, 2017. Members of the public may submit written comments on the proposed regulations until 5 p.m. that day.

Some of the changes proposed in the revised regulations include:

– Added language clarifying that a compounded drug is subject to the compounded drug regulation even if it includes an active ingredient listed as “Exempt” on the MTUS Drug List. This modification improves the clarity; it is expected to avert the possibility that someone could argue that a compounded drug using one of the listed drugs is “Exempt.”

– Removed a provision relating to repackaged drugs. The current structure of the MTUS Drug List does not require identification of a drug’s status as repackaged. In the future, after further evaluation, the Division may address repackaged drugs, and may determine whether particular provisions of the Formulary and MTUS Drug List are needed to address issues raised by use of repackaged drugs.

– Updated MTUS Drug List header text to match the regulatory language on the Perioperative period definition. It now states that the perioperative fill period begins 4 days, rather than 2 days, before surgery. This conforms the perioperative period to a modification in the text of section 9792.27.13, subdivision (b), that was made in the 1st 15-day comment period, but mistakenly overlooked on the drug list introductory language. This change appears to be the result of public comments made by Denise Algire with Albertson’s companies according to the transcript of her comments on page 6.

The notice of modification of text of proposed regulation and related rulemaking documents are posted on the DWC rulemaking web page. More information about the rulemaking process is posted on the Office of Administrative Law’s website.

New, Deadly, and Untreatable Hospital Acquired Infections

In the United States, the Centers for Disease Control and Prevention estimated roughly 1.7 million hospital-associated infections, from all types of microorganisms, including bacteria and fungi combined, cause or contribute to 99,000 deaths each year. And a hospital-associated infection of an injured worker being treated for an industrial injury may give rise to an additional claim for benefits as a compensable consequence injury.

And now a new medical study says that the risk now includes untreatable hospital-associated infections that are deadly.

Chinese researchers say an outbreak of severe pneumonia at a Chinese hospital was caused by hypervirulent, highly drug-resistant, and highly transmissible strains of Klebsiella pneumoniae. Their findings were reported recently in the Lancet Infectious Diseases.

The ST11 carbapenem-resistant hypervirulent K pneumoniae strains were identified in five patients in the intensive care unit (ICU) of a hospital in Hangzhou, China. All five patients – who were admitted to the ICU between late February and April of 2016 – had undergone surgery for multiple trauma followed by ventilation and subsequently developed carbapenem-resistant K pneumoniae infections and severe pneumonia that responded poorly to all available antibiotics.

All five patients died of severe lung infection, multi-organ failure, or septic shock.

Analysis of the 21 carbapenem-resistant K pneumoniae strains recovered from the patients indicated that the strains had almost identical antibacterial susceptibility profiles and shared highly similar DNA fingerprints. Further genetic and phenotypic characterization of one representative carbapenem-resistant K pneumoniae isolate from each patient showed that all five belonged to the ST11 lineage, contained several resistance genes, and originated from a single clone.

“Due to acquisition of a virulence plasmid by classic ST11 carbapenem-resistant K pneumoniae strains, these new strains are simultaneously hypervirulent, multidrug resistant, and transmissible, and should therefore be regarded as a real superbug that could pose a serious threat to public health,” the authors write.

In a commentary in the same journal issue, two experts from Rutgers University wrote that the study describes an alarming evolutionary event: plasmid-mediated convergence of multidrug-resistance and hypervirulence in an epidemic cabapenem-resistant K pneumoniae clone.

Though a similar event had been reported before, the new report on five fatal cases characterizes the virulence and resistance plasmids. The two wrote that the transfer of the virulence plasmids raises worries that the organisms might not only cause untreatable hospital infections, but also serious life-threatening ones in the community.

The new findings underscore the need for new effective antibiotics, and new strategies such as vaccines, phage therapy, and gene therapy for battling drug-resistant organisms offer optimism. “However, the reality is that we are now in a crisis,” they wrote, adding the keys to curbing the new hypervirulent strains are early detection and containment with comprehensive infection control measures.

From a claims administration standpoint, one might question the track record of facilities that are used to treat injured workers, and steer clear of facilities with tenacious infection histories. Some of this information is publicly available, but not widely know.

The Healthcare-Associated Infections (HAI) Program is one of two programs in the Center for Health Care Quality of the California Department of Public Health. The Program was created by mandate to oversee the prevention, surveillance, and reporting of HAI in California’s general acute care hospitals. Since 2010, the HAI Program has produced annual public reports of hospital HAI data to inform choices of healthcare consumers and prompt providers to take actions to prevent infections.

The latest 2015 report identifies 2894 infections and predicted an overall infection rate of 4744 which was then allocated to each of the medical facilities by name on the seven page table.  Surprisingly, the Ronald Regan UCLA Medical Center had 149 observed infections, the highest of any facility on the list.  It is likely that claims administrators can manage the risk of a compensable consequence injury caused by hospital-associated infections by periodic scrutiny of these reports and lists and strategies for the management of claims.

WCIRB Now Recommends 2% Rate Reduction for 2018

The WCIRB Governing Committee at it’s September meeting voted to amend the WCIRB’s January 1, 2018 Pure Premium Rate Filing that was submitted to the Insurance Commissioner on August 18, 2017.

The vote to amend the filing was based on the Actuarial Committee’s review of recently available June 30, 2017 loss experience, which showed lower than anticipated loss development in the second quarter.

The WCIRB anticipates amending its filing to propose advisory pure premium rates that average $1.96 per $100 of payroll in lieu of pure premium rates which averaged $2.01 per $100 of payroll that were proposed in the August 18, 2017 filing.

These amended proposed pure premium rates are on average 2% less than the average approved July 1, 2017 advisory pure premium rate of $2.00 and 16.1% less than the industry average filed pure premium rate of $2.34 as of July 1, 2017.

The amended filing will be submitted to the Insurance Commissioner within the next week and will be posted on its website once it is available.

The California Department of Insurance has scheduled a public hearing on October 5, 2017 in San Francisco to consider the WCIRB’s filing.

Charles Taylor Acquires Metro Risk Management

Charles Taylor has agreed to acquire Metro Risk Management LLC (MRM) from Nautilus International Holding Corporation for an undisclosed amount.

MRM was founded in 1996 as a subsidiary of Metropolitan Stevedore Company (the original parent corporation), which was one of the earliest self-insured, self-administered companies in the State of California.

Nautilus and its subsidiaries – Metro Ports, Metro Cruise Services, Metro Shore Services and Metro Risk Management – are a suite of companies known internationally as leaders in stevedoring, terminal operations, logistics, risk management and more.

Charles Taylor is a leading international provider of professional services to clients in the global insurance market. It has been providing services to insurance clients since 1884 and today has over 1,800 staff in 71 offices, spread across 28 countries in the UK, the Americas, Asia Pacific, Europe,the Middle East and Africa.

The deal is part of Charles Taylor’s plans to extend its US workers’ compensation claims capabilities. Based in Southern California, MRM provides state and federal workers’ compensation claims administration services to self-insured clients and insurers.

Acquiring the third-party claims administrator will see the addition of 13 highly experienced workers’ compensation claims specialists to the Charles Taylor team – expanding the buyer’s presence in Long Beach in support of its TPA growth in the US.

James Callahan, Nautilus chairman, president, and chief executive, said the transaction will provide its staff with greater opportunities for career development and advancement.

“We have worked closely with Charles Taylor for many years, and know first-hand the insurance expertise and professionalism of the team. Charles Taylor provides MRM with the resources and expertise to expand its services to a wider range of clients,” he noted.

Christopher Schaffer, USA CEO, Charles Taylor Insurance Support Services, commented: “We are excited to join forces with MRM, given the company’s history of providing quality services and proven expertise to long-term, deeply satisfied clients.”

He said MRM broadens Charles Taylor’s claim services on the West Coast – adding to the core federal workers’ compensation, ports and terminals, marine, casualty, and cyber TPA business.

For Charles Taylor group chief executive David Marock, the acquisition reflects the firm’s continued commitment to growing its TPA business in the US and globally.

Former CHP Officer Pleads No Contest to Comp Fraud

A former California Highway Patrol officer who injured his back while on duty has pleaded no contest to felony workers’ compensation insurance fraud as a result of the Sacramento County District Attorney felony workers’ compensation insurance fraud and attempted perjury charges in June 2012.

Former officer Brian Christopher Hansen was a California Highway Patrol officer who sustained a back injury while on duty in November 2008.

The criminal complaint alleged that between Nov. 14, 2008 and Oct. 1, 2011, Hansen made numerous false statements to various doctors, investigators and in a sworn deposition regarding the extent of his physical disabilities caused by an on-duty injury to his back.

Hansen stated that because of pain from his back injury, he could only drive for short periods of time, could not sit for more than 30 minutes, could not pick up items weighing more than 10 pounds, and was so restricted in his physical abilities that he could not even perform limited office duties.

After being medically treated, he was placed on limited duty status in April 2009. Hansen worked one day watching training videos for four hours, but never returned stating it was too painful to sit for extended periods of time.

In July 2009, the CHP began an investigation. Hansen was observed performing tasks that were in conflict with what he reported his functional limitations were at the time, including driving non-stop for hours and participating in outdoor activities. Videotaped surveillance showed him driving for hours at a time, moving furniture when he changed residences, bending over and picking up items weighing more than 30 pounds, and engaging in everyday activities with no signs of any physical limitations, the DA’s office said.

Physicians who reviewed his medical reports and surveillance videos agreed Hansen did suffer an injury, but that he overstated his symptoms and understated his capabilities regarding his workers’ compensation claim.

Hansen entered the plea Aug. 29 and was sentenced by Sacramento Superior Court Judge Jaime Román to 180 days in Sacramento County Jail and five years formal probation, according to a Sacramento County District Attorney’s Office news release. He also is prohibited from ever seeking or accepting employment as a law enforcement officer.

Hansen graduated from the CHP Academy in 2007 and left the department in January 2012. The Redding native worked for the Shasta County Sheriff’s Office before joining the CHP.

This case was investigated by the California Highway Patrol Internal Affairs Division Workers Compensation Insurance Fraud Unit.

No Ruling Yet on Lien Stay Challenge

Federal Judge George H. Wu was again scheduled to hear more arguments in his downtown Los Angeles Courtroom for and against imposing a preliminary injunction halting the implementation of newly adopted SB 1160. This new law provides for a stay on lien claims filed by indicted medical providers until after their case has been resolved.

Dr. Eduardo Anguizola is facing multiple counts of insurance fraud filed by Orange County prosecutors. His federal lawsuit claims that SB 1160 and Labor Code 4615, the anti-fraud law that took effect January 1, violates the 5th, 6th, and 14th amendments of the United States Constitution. His request for a preliminary injunction was originally scheduled for hearing on July 13, 2017 and the motion was continued to August 24 to allow additional briefing.

Plaintiffs argued that Labor Code 4615 violates the procedural component of the due process clause because it immediately stays all liens without notice or a hearing. The defendants responded that Section 4615 affords sufficient process because Plaintiffs still have the same rights afforded to them by the workers’ compensation scheme generally. However in the Tentative Ruling Judge Wu pointed out that “Defendants do not explain how these pre-existing procedures would actually be used to challenge a stay imposed by Section 4615.” He thus provided the parties additional time before the August 24 hearing to provide information about how due process might be afforded lien claimants under 4615.

The 18 page Tentative Ruling by Judge Wu in July focused the case on the narrow issue of a “facial” challenge to newly adopted Labor Code Section 4615 which implements SB 1160. He ruled that to succeed in a facial challenge to a statute a plaintiff must establish that a law is unconstitutional in all of its applications. Because facial constitutional challenges often rest on speculation, they are disfavored. Thus, the fact that a statute “might operate unconstitutionally under some circumstances is not enough to render it invalid against a facial challenge.”

Between July 13 and August 24 many additional arguments and declarations were filed by both parties. The Defense filed a 117 page Declaration of Workers’ Compensation Chief Judge Paige Levy that clearly articulated how lien claimants subject to 4615 have rights to due process under the new law, and indeed attached several illustrative cases on the stay law that have been decided by either Removal or Reconsideration by the WCAB. Essentially several panel decisions have held that any lien claimant who asserts they do not fall subject to the stay have the right to have their argument heard and decided upon filing a DOR on the issue. Any WCJ that had refused to do so was overturned. Judge Levy pointed out the statutory and regulatory provisions that allowed lien claimants to challenge the application of the “automatic stay” to their individual cases.

Plaintiffs responded to the Levy declaration by claiming “The State knows that the statute is unconstitutional on its face and that the statute provides no mechanism for due process to those affected by the statute. … Because of the clear lack of due process – on its face – the State had no choice but to throw a ‘Hail Mary.’ Behold the declaration of Paige Levy.” They asked for expedited discovery to depose Judge Levy.

The outcome of the August 24 hearing according to the minute order was “Court and counsel confer re scheduling. For reasons stated on the record, Plaintiffs’ motion is continued to September 25, 2017 at 8:30 a.m., with Plaintiffs’ supplemental declaration due by September 12, 2017. Defendants will respond by September 20, 2017.”  Thus the outcome of this case will not be known at least until the end of September.

Synthetic Painkiller not Heroin is Deadliest Drug In America

The drug epidemic in America is increasingly fueled by synthetic opioids like fentanyl, which overtook heroin as the deadliest substance in the U.S. in 2016.

The National Center for Health Statistics, part of the Centers for Disease Control and Prevention, released the first preliminary federal report, giving an accounting of drug overdose deaths in 2016. The CDC estimates that drug deaths rose by more than 22 percent in 2016, killing 64,070 Americans. Opioid deaths rose from 33,000 in 2015 to nearly 50,000 in 2016, driven primarily by fentanyl, a painkiller roughly 50 to 100 times more powerful than morphine, reports The New York Times.

Synthetic opioids, including fentanyl and its analogs, claimed roughly 20,100 lives in 2016, up from 9,945. Heroin continues to be a major problem, killing an estimated 15,400 Americans. Fentanyl is also fueling an increase in cocaine deaths, as dealers are increasingly cutting the fatal painkiller into their cocaine supplies.

The Drug Enforcement Agency issued new guidance to police departments across the country in June on how to handle heroin and other narcotics due to the increasing prevalence of fentanyl. Deputy Attorney General Rod Rosenstein warned it only takes two milligrams of fentanyl, “the equivalent of a few grains of table salt,” to cause a fatal overdose.

Dealers in the U.S. and Mexican cartels are turning to China in greater numbers for shipments of fentanyl at a fraction of the price of heroin. It is then used to create roughly 20 times more doses out of a heroin batch, providing dealers with huge profits. Officials estimate that more than 90 percent of heroin in the U.S. is flowing in from Mexico.

A bipartisan proposal in the Senate would give border agents the technology to screen for chemicals at U.S. entry points in an effort to target fentanyl shipments.

Democratic Sen. Ed Markey of Massachusetts and Republican Sen. Marco Rubio of Florida proposed the INTERDICT Act earlier this year and are renewing their call for support after recent data showed fentanyl deaths are rising.

Republican Sen. Rob Portman of Ohio is also leading a bipartisan effort to crack down on illegal shipments of synthetic opioids like fentanyl through the U.S. mail.

The STOP Act, co-sponsored by Rubio and Democratic Sen. Elizabeth Warren, aims to put packages shipped through the U.S. Postal Service under more intense security screenings to cut down on international trafficking.

Drug overdoses are now the leading cause of accidental death for Americans under 50.

A STAT analysis predicts the annual death toll from opioids will rise by roughly 35 percent between 2015 and 2027. Their research predicts that up to 500,000 people could die from opioids over the next decade. The experts agree, even in a best-case scenario, the crisis will not visibly start to subside until after 2020.

Irvine DNA Lab Enters Receivership Following FBI Probe

A controversial genetic testing firm under federal investigation for healthcare fraud has been placed into court-ordered receivership – a form of bankruptcy – that could lead to the restructuring and sale of the company. The CEO and founder of Proove Biosciences has also left the company.

Proove Biosciences specializes in DNA testing that the company claims can improve the effectiveness of pain management treatment and determine whether a patient is at risk of opioid addiction.

In June, FBI agents raided the company’s headquarters in Irvine, California. Former and current employees who were interviewed said the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

In July, Pain News Network reported that Proove was linked to a Medicare fraud case in which three Indiana healthcare providers allegedly “caused Proove Bioscience” to falsely and fraudulently bill various health care programs for genetic tests administered to Physicians Primary Care patients that were not medically necessary and never interpreted.”

Proove was not named as a defendant in the Indiana case. In an email to PNN, the company CEO said Proove had cooperated with investigators.

The CEO claimed “Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices.”

The CEO also defended Proove research, published in the Journal of Addiction Research & Therapy, which claimed to show the effectiveness of its genetic tests.The publisher of the journal, OMICS International, has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

“Proove can only speak to its experience with this particular journal,” the CEO said in an email to PNN. “Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be ‘peer-reviewed’.”

According to the FTC complaint filed last August, OMICS  has created hundreds of “open access” online medical journals that publish articles with little or no peer review. Researchers are also charged significant fees to get their articles published by OMICS, a “pay to play” policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

Proove has aggressively promoted its genetic tests with healthcare providers around the country. A pain clinic in Montana, for example, had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center.