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RAND Says 1/3 of Opioid Prescriptions Unjustified

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Over the past decade, American doctors failed to provide a written medical justification for nearly one-third of opioid prescriptions.

Researchers from RAND Corporation and Harvard Medical School published a study Tuesday in the journal Annals of Internal Medicine showing 28.5 percent of the roughly 809 million doctor visits that resulted in a prescription for opioid painkillers between 2006 and 2015 lacked medical records showing a chronic pain condition or any symptoms of pain related to the patient, reports CNN.

Roughly 5.1 percent of opioid prescriptions were written for cancer patients suffering from breakthrough pain, while 66.4 percent were for patients with non-cancer related pain. Researchers note that while a lack of documented justification does not necessarily reveal “a nefarious purpose on the part of the doctor,” it might explain in part how Americans became so dependent on opioids.

“For these visits, it is unclear why a physician chose to prescribe an opioid or whether opioid therapy is justified,” said Dr. Tisamarie B. Sherry, a researcher for RAND Corporation and lead author of the study, according to CNN. “The reasons for this could be truly inappropriate prescribing of opioids or merely lax documentation. – If a doctor does not document a medical reason for prescribing an opioid, it could mean that the prescription is not clinically appropriate.”

A study published Aug. 1 in medical journal The BMJ reveals that between 2007 and 2016, the percentage of commercially insured patients prescribed opioids held steady at 14 percent.

The study, lead by Molly Moore Jeffery of the Mayo Clinic in Rochester, Minnesota, investigated the individual patient data of 48 million people with health insurance, both commercial and through Medicare. The prescription data was then converted into milligram morphine equivalents (MME). They found the average MME dosage across all patients reviewed in the study was higher in 2016 than in 2007, a level Jeffery said is a “point where you see a greater risk of overdose.”

The researchers advocate for a general shift within the medical community away from opioids, however, Jeffery does not advocate legislative solutions that end up impacting patient access to crucial medication.

Data released by officials with the CDC on July 11 shows the majority of opioid-linked deaths are the result of synthetic opioids like fentanyl. The report shows synthetic opioids killed roughly 27,000 people across the U.S. over the 12-month period ending November 2017, up from roughly 19,413 lives in 2016 and 9,580 lives in 2015.

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Man Sentenced for Pharmaceutical Trafficking

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Lahkwinder Singh and his corporation, Lovely Singh Inc., have been convicted for the illegal trafficking of pharmaceuticals.

While doing business as a franchise of shipping company Postal Annex, Lovely Singh Inc. facilitated the shipment of controlled pharmaceutical drugs such as hydrocodone, Xanax and oxycodone through the mail.

Lahkwinder Singh, the CEO of the company was sentenced i to 36 months in federal prison. The 36-month sentence is one of the longest imposed in the Southern District of California for a structuring conviction.

Singh’s closely held corporation, Lovely Singh, Inc., was ordered to forfeit $1,000,000, and serve a 5-year term of probation.

Singh owned and operated Postal Annex franchises in Lemon Grove, California, under the name Lovely Singh. According to the complaint, Singh engaged in a multi-year pattern of cash transactions below the $10,000 threshold to avoid detection by banks and law enforcement, with the intent to deposit Lovely Singh’s cash proceeds free from scrutiny.

The plea agreement admits that Singh and his co-defendant Lovely Singh Inc. distributed Schedule II controlled substances to persons throughout the United States.

Couriers imported pre-packaged quantities of controlled substances into the United States from Mexico and delivered them to the Postal Annexes. The substances were then illegally sold for prices ranging between $1 and $100.

The plea agreement also states that Singh attempted to set up $2,955,521 of currency transactions through 469 cash deposits at several domestic financial institutions. Singh conducted multiple deposits of less than $10,000 in cash on the same day. He also made deposits into at least 19 different bank accounts over the course of several business days.

These deposits were conducted with the purpose of avoiding a Currency Transaction Report, which is the report a financial institution must file for cash deposits exceeding $10,000 during any banking day. These cash deposits included money received in return for shipping controlled substances from the Postal Annex stores.

Singh was ultimately charged with and found guilty of Structuring Currency Transactions with One or More Financial Institutions.

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Scientists Re-generate Wound Tissue

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Scientists at the Salk Institute have developed a technique to directly convert the cells in an open wound into new skin cells. The approach relies on reprogramming the cells to a stem-cell-like state and could be useful for healing skin damage, countering the effects of aging and helping us to better understand skin cancer.

“Our observations constitute an initial proof of principle for in vivo regeneration of an entire three-dimensional tissue like the skin, not just individual cell types as previously shown,” says Salk Professor Juan Carlos Izpisua Belmonte, holder of the Roger Guillemin Chair and senior author of the new paper, published in the journal Nature on September 5, 2018. “This knowledge might not only be useful for enhancing skin repair but could also serve to guide in vivo regenerative strategies in other human pathological situations, as well as during aging, in which tissue repair is impaired.”

Cutaneous ulcers — wounds that can extend through multiple layers of the skin — are typically treated surgically, by transplanting existing skin to cover the wound. However, when the ulcer is especially large, it can be difficult for surgeons to graft enough skin. In these cases, researchers are able to isolate skin stem cells from a patient, grow them in the lab and transplant them back into the patient. However, such a procedure requires an extensive amount of time, which may put the patient’s life at risk and is sometimes not effective.

Izpisua Belmonte and Salk Research Associate Masakazu Kurita, who has a background in plastic surgery, knew that a critical step in wound recovery was the migration — or transplantation — of basal keratinocytes into wounds. These stem-cell-like cells act as precursors to the different types of skin cells. But large, severe wounds that have lost multiple layers of skin no longer have any basal keratinocytes. And even as these wounds heal, the cells multiplying in the area are mainly involved in wound closure and inflammation, rather than rebuilding healthy skin.

Izpisua Belmonte and Kurita wanted to directly convert these other cells into basal keratinocytes — without ever taking them out of the body. “We set out to make skin where there was no skin to start with,” says Kurita.

The researchers first compared the levels of different proteins of the two cell types (inflammation and keratinocytes) to get a sense of what they’d need to change to reprogram the cells’ identities. They pinpointed 55 “reprogramming factors” (proteins and RNA molecules) that were potentially involved in defining the distinct identity of the basal keratinocytes. Then, through trial and error and further experiments on each potential reprogramming factor, they narrowed the list down to four factors that could mediate the conversion to basal keratinocytes.

When the team topically treated skin ulcers on mice with the four factors, the ulcers grew healthy skin (known as epithelia) within 18 days. Over time, the epithelia expanded and connected to the surrounding skin, even in large ulcers. At three and six months later, the generated cells behaved like healthy skin cells in a number of molecular, genetic and cellular tests.

The researchers are planning more studies to optimize the technique and begin testing it in additional ulcer models. “Before going to the clinic, we have to do more studies on the long-term safety of our approach and enhance the efficiency as much as possible,” says Kurita.

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Surveillance Convicts Nursing Assistant

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Holly Merrill-Miller pled no contest to misdemeanor workers’ compensation fraud. The Honorable Lawrence Brown sentenced Miller to 3 years probation and ordered her to pay $8,382.31 in restitution.

Holly Miller was a 33-year-old nursing assistant with Sutter Health when she allegedly suffered an injury to her wrist.

On September 22, 2015, she claimed a patient grabbed her hand, twisted it and repeatedly jerked it, causing pain and swelling.

Miller was placed on restricted duty by the treating physician, but she complained her pain was getting worse.

Images were taken, which didn’t show an obvious injury. However, Miller continued to complain of increased pain and stress. After canceling several medical appointments, she was returned to work.

In November 2015, surveillance was conducted on Miller which showed her using her right hand without any apparent limitations or pain.

When the treating physician saw the video surveillance, he stated it was at odds with what Miller stated she could and could not do. Miller reiterated her complaints. The physician explained he had seen surveillance videos of her activity levels and was returning her to work with no restrictions.

This case was investigated and prosecuted by the District Attorney’s Insurance Fraud Unit

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September 10, 2018 Edition

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Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Cal Chiropractic Association Sues One Call Medical, Popular Ortho AME to Serve 7 Years for Child Pornography, Six L.A. Garment Contractors Fined $5 Million, DIR Reports IMR Efficiently Resolves Disputes, WCIRB Quarterly Update – Mostly Good News, Anti-Anxiety Drug Abuse Overtaking Opioids, 2018 Drug Prices Fell 5.8% in Second Quarter, 14% of Pharmaceuticals May Be Fake.

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Person Behind Opioid Epidemic Patents Addiction Treatment

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A former president of Purdue Pharma, the controversial drug manufacturer widely considered to have ignited the opioid epidemic through its aggressive marketing of OxyContin, has been awarded a patent for a new opioid addiction treatment. Dr. Richard Sackler is one of the six individuals on the patent issued in January, the Financial Times first reported Friday.

Critics expressed concern that Sackler, whose family is worth an estimated $13 billion largely from Purdue’s sale of opioid painkillers, now stands to profit further from medication that treats addiction to the very drugs peddled by his family.

The patent covers a new formulation of buprenorphine in a wafer form. The medication is shown to help people struggling with opioid addiction, and the Food and Drug Administration has already approved the drug in tablet and film form.

Sackler, who served as Purdue’s president from 1999 to 2003, was instrumental in pushing OxyContin’s sales through one of the largest pharmaceutical marketing campaigns in history. The campaign worked: Doctors previously averse to prescribing opioids for pain management due to their addictiveness were convinced by Purdue’s aggressive tactics that OxyContin was safe to prescribe.

Purdue later admitted that its marketing campaign was a sham.

The company was ordered to pay $635 million after it and three top executives pleaded guilty to misleading doctors about the addictiveness of OxyContin and its potential for abuse between 1996 and 2001. Put into perspective, the fine represents less than one-quarter of the sales revenue OxyContin generated for the Sacklers during that six-year period.

Purdue’s legal woes are far from over. The company is currently facing over 400 lawsuits from cities across the country in addition to 26 lawsuits by state attorneys general for downplaying the risks of OxyContin as part of an allegedly fraudulent marketing scheme to boost sales of OxyContin

Purdue has denied the allegations in the lawsuits and has recently taken steps to address the opioid crisis it helped create. The company has backed safer prescribing practices and announced Wednesday it’s contributing $3.4 million to a company developing a low-cost emergency medication for suspected opioid overdoses.

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New Study – Why Do Some Feel More Pain?

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Ever wonder why some people seem to feel less pain than others? A study conducted at Wake Forest School of Medicine may have found one of the answers-mindfulness.

“Mindfulness is related to being aware of the present moment without too much emotional reaction or judgment,” said the study’s lead author, Fadel Zeidan, Ph.D., assistant professor of neurobiology and anatomy at the medical school, part of Wake Forest Baptist Medical Center. “We now know that some people are more mindful than others, and those people seemingly feel less pain.”

The study is an article in press, published ahead-of-print in the journal Pain.

The researchers analyzed data obtained from a study published in 2015 that compared mindfulness meditation to placebo analgesia. In this follow-up study, Zeidan sought to determine if dispositional mindfulness, an individual’s innate or natural level of mindfulness, was associated with lower pain sensitivity, and to identify what brain mechanisms were involved.

In the study, 76 healthy volunteers who had never meditated first completed the Freiburg Mindfulness Inventory, a reliable clinical measurement of mindfulness, to determine their baseline levels. Then, while undergoing functional magnetic resonance imaging, they were administered painful heat stimulation (120°F).

Whole brain analyses revealed that higher dispositional mindfulness during painful heat was associated with greater deactivation of a brain region called the posterior cingulate cortex, a central neural node of the default mode network. Further, in those that reported higher pain, there was greater activation of this critically important brain region.

The default mode network extends from the posterior cingulate cortex to the medial prefrontal cortex of the brain. These two brain regions continuously feed information back and forth. This network is associated with processing feelings of self and mind wandering, Zeidan said.

“As soon as you start performing a task, the connection between these two brain regions in the default mode network disengages and the brain allocates information and processes to other neural areas,” he said.

“Default mode deactivates whenever you are performing any kind of task, such as reading or writing. Default mode network is reactivated whenever the individual stops performing a task and reverts to self-related thoughts, feelings and emotions. The results from our study showed that mindful individuals are seemingly less caught up in the experience of pain, which was associated with lower pain reports.”

The study provided novel neurobiological information that showed people with higher mindfulness ratings had less activation in the central nodes (posterior cingulate cortex) of the default network and experienced less pain. Those with lower mindfulness ratings had greater activation of this part of the brain and also felt more pain, Zeidan said.

“Now we have some new ammunition to target this brain region in the development of effective pain therapies. Importantly this work shows that we should consider one’s level of mindfulness when calculating why and how one feels less or more pain,” Zeidan said. “Based on our earlier research, we know we can increase mindfulness through relatively short periods of mindfulness meditation training, so this may prove to be an effective way to provide pain relief for the millions of people suffering from chronic pain.”

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Ortho AME to Serve 7 Years for Child Pornography

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A former Oakland orthopedic surgeon, and once popular AME, John D. Warbritton, III, was sentenced to 7 years in prison for transportation of child pornography.

Warbritton was a graduate of Harvard Medical School in 1980, and had an office at Frank Ogawa Plaza in Oakland. He surrendered his medical license on April 7, 2017, after the California Medical Board accused him of sexually harassing two of his workers’ compensation patients.

The DWC said Warbritton was one of 20 medical providers it recently suspended from participating in the workers’ compensation system.

The criminal indictment, which was filed on Oct. 13, 2016, alleges that Warbritton violated federal law by knowingly transporting child pornography. He was initially released on an unsecured bond.

But, after the United States Pretrial Services officer reported a violation of his conditions of release (possessing child pornography images on a mobile phone), the Honorable Magistrate Judge Elizabeth D. Laporte held a bail review hearing on January 17, 2017, and detained Dr. Warbritton. He was placed in the Santa Rita Jail.

Last May, he filed a Motion to Reopen his Detention Hearing. His lawyers claimed that “At the time of the alleged offense conduct and the subsequent pretrial release violation in this matter, Dr. Warbritton was suffering from both opioid use disorder and sexual impulsivity disorder.” They claim he subsequently began treatment with Carolyn Ann Schuman, M.D. for his opioid addiction, and that “his incarceration ultimately allowed him to “dry out” from the use of opioids and allowed the Suboxone treatment employed by Dr. Schuman to take effect.”

Prosecutors opposed the Motion claiming “defendant has been a hands-on offender because the defendant was arrested after returning to the United States from Thailand, where he admitted to agents he has spent long periods of time for the last several years” And among the child pornography taken from him by authorities, “one photo collage depicted the defendant along with an Asian female aged 8-10 years old. ….This photograph collage also raises concerns about whether the defendant may be a hands-on offender or someone who was preparing to do so.”

Prosecutors concluding by saying there are no conditions of release that could reasonably assure the safety of the community. Warbritton remains in custody awaiting trial.

Warbritton ultimately pleaded guilty to the child pornography charge on May 16, 2018. According to his plea agreement, in 2016, Warbritton traveled from Bangkok, Thailand, to San Francisco International Airport with electronic devices containing child pornography. Specifically, Warbritton was traveling with a laptop and a cellular telephone, both of which contained images depicting children under the age of 12 engaged in sexually explicit conduct.

The plea agreement describes some of the images that were on the devices, including depictions of grown men engaged in sexual acts with girls under the age of 12. Warbritton stipulated that between 150 and 300 images of child pornography were on his electronic devices as he traveled to SFO.

In addition to the prison term, Judge Breyer also ordered Warbritton to serve a seven-year term of supervised release to begin after the prison term ends.

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DIR Reports IMR Efficiently Resolves Disputes

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The Department of Industrial Relations and its Division of Workers’ Compensation posted a progress report on the department’s Independent Medical Review (IMR) program.

IMR is the medical dispute resolution process that uses medical expertise to obtain consistent, evidence-based decisions and is one of the most important components of Senate Bill 863, Governor Edmund G. Brown Jr.’s landmark 2012 workers’ compensation reform.

“This shows that Independent Medical Review – which replaced a system where injured workers had to wait for medical treatment while disputes were litigated – continues to provide a timely, efficient process for resolving treatment disputes and supporting appropriate care,” said George Parisotto, DWC Administrative Director.

Maximus Federal Services has been the Independent Medical Review Organization (IMRO) since the program’s inception in 2013 and is under contract to provide IMR through 2019.

In 2017, the IMRO processed 248,251 applications, a slight decrease from 2016. Concurrently, the IMRO issued 172,194 IMR determinations.

At the end of 2016, the average length of time the IMRO took to issue a determination, after the receipt of all necessary medical records, was 15 days. By mid-2017, this decreased to a monthly average of 11 days.

Overall, the IMRO overturned 8.3% of the utilization review decisions that denied treatment requests made by physicians treating injured workers.

Analysis of several variables, including the geographic region of the injured worker, the time elapsed since the worker’s work-related injury occurred, and representation by an attorney or other entity acting on behalf of the injured worker, shows similar rates of overturned case decisions.

As in the previous three calendar years, requests for pharmaceuticals in 2017 comprised nearly half (42.6%) the issues in dispute, with opioids the most common drug class (29.3%). Diagnostic tests, including radiology, imaging, and pathology, were the second-most-requested treatment category (16.2%).

Rehabilitation services – such as physical therapy, chiropractic, and acupuncture – were the third-most-requested category (14.1%).

The treatment category most often overturned was evaluation and management (with a 16.3% overturn rate), which includes specialist consultations and dental services, followed by behavioral and mental health services, which had an overturn rate of 16.3%.

Enhancements that may aid the IMR program continued in 2017. Updates to the Medical Treatment Utilization Schedule (MTUS) included several updated and new chapters as well as the adoption of a formulary. The Division of Workers’ Compensation (DWC) introduced its second online Physician Education Module.

Today’s report, as well as previous reports on IMR data, are posted on DWC’s IMR webpage under IMR program updates

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WCIRB Quarterly Update – Mostly Good News

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The WCIRB has released its quarterly update on California statewide insurer experience valued as of March 31, 2018. Highlights of the report include:

California written premium for the first calendar quarter of 2018 is $5.0 billion, which is consistent with the written premium reported for the first calendar quarter of 2017. The decrease in 2017 following 7 consecutive years of increases is primarily driven by decreases in insurer charged rates.

The projected industry average charged rate per $100 of payroll for policies incepting between January 1, 2018 and March 31, 2018 is $2.38, which is 6% below the average rate charged for policies incepting in 2017. The July 1, 2018 approved advisory pure premium rates are on average 37% below those for January 1, 2015.

The projected combined ratio for 2017 is 5 points higher than 2016 as premium levels have lowered while average claim severities increased moderately. Despite the recent increase, combined ratios for 2014 to 2017 remain the lowest since the 2004 through 2006 period.The WCIRB projects the ultimate accident year combined loss and expense ratio for 2017 to be four points above that for accident year 2016, driven by higher medical severities for 2017 and lower premium rates.

Indemnity claim frequency increased by 11% from accident year 2009 to accident year 2014, but has decreased by 5% from accident year 2014 through the first three months of accident year 2018. Indemnity claims continue to settle quicker, steadily improving over the last 5 years. Frequency increases since 2011 have largely been attributed to increases in cumulative injury claims and claims from the Los Angeles Basin area.

Cumulative trauma (CT) claim rates continue to be at high levels in 2016 and the ratio of CT claims to all indemnity claims has increased by over 65% since 2005. The sharp increase in CT claims since 2012 is in the Los Angeles and San Diego areas, as CT claims in other regions of CA have decreased. The WCIRB will be publishing a study of CT claim patterns later this year.

Projected claim severity for 2017 is 2.5% higher than that for 2016, following several years of relatively flat severities. Severity growth over the last several years has been relatively modest as increases in average indemnity and ALAE costs have been in part offset by declines in average medical costs.

Indemnity severity increases in 2014 are largely attributable to SB 863 increases to PD benefits. Indemnity severity growth since 2014 has been relatively modest and generally consistent with wage inflation.

Decreases in medical severities from 2011 to 2015 were driven by the medical cost savings arising from SB 863. It is unclear whether the projected 2017 medical severity increase of 3% will develop downward like other recent years or if it represents a return the more typical rates of post-reform medical inflation.

Pharmaceutical costs per claim decreased 70% from 2012 to 2017. These reductions have been driven by SB 863’s IMR & IBR, reduced utilization of opioids, and changes to Medi- Cal reimbursement rates. The new drug formulary effective in 2018 is expected to further reduce pharmaceutical cost levels.

SB 1160 and AB 1244 made changes to lien filings effective 1/1/2017. Some of the lien activity in the fourth quarter of 2016 through the first quarter of 2017 may be impacted by the transition to the reforms. The number of liens filed since the first quarter of 2017 are 40% below pre-SB 1160 and AB 1244 levels.

The full report is available in the Research section of the WCIRB website (wcirb.com) and linked below:

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