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Tag: 2019 News

CHS – An Acute Illness From Cannabis Use

While state lawmakers are rushing to legalize cannabis for various reasons, including so called “medical reasons,” and courts are moving toward approving none FDA approved cannabis for treatment of workers’ compensation pain management, the medical research is trailing these decisions.

A good metaphor for this approach is “fire, ready, aim” since little is known about the relative harms of edible and inhalable cannabis products. And not all of the emerging medical research is good news for cannabis users

A new study funded by the Colorado Department of Public Health and Environment., and published in the Annals of Internal Medicine, documented a sharp rise in emergency-room visits linked with marijuana following legalization in Colorado. One of the key drivers of the ER visits was a mysterious syndrome characterized by severe nausea and repeated vomiting.

The researchers were tasked to describe and compare adult emergency department (ED) visits related to edible and inhaled cannabis exposure. The study focused on a chart review of emergency room visits between 1 January 2012 and 31 December 2016 at a large urban academic hospital in Colorado.

They found 9973 visits with an ICD-9-CM or ICD-10-CM code for cannabis use. Of these, 2567 (25.7%) visits were at least partially attributable to cannabis, and 238 of those (9.3%) were related to edible cannabis.

Very little is known about the condition, called cannabinoid hyperemesis syndrome, or CHS. Cannabinoid hyperemesis syndrome can occur with cannabis use and is characterized by recurrent nausea, vomiting, and crampy abdominal pain.

The pathogenesis of cannabinoid hyperemesis syndrome is unclear, but it may involve accumulation of exogenous cannabinoids or alterations in the brain’s regulation of body temperature.

The prodromal phase is characterized by subsyndromal symptoms of cannabinoid hyperemesis syndrome, including mild discomfort and nausea upon waking. Prior to the use of compensatory exposure to hot water to treat symptoms, people sometimes increase their intake of cannabinoids in an effort to treat the persistent nausea they experience. This phase can last for months or even years

The hyperemetic phase is characterized by the full syndromal symptoms of cannabinoid hyperemesis syndrome, including persistent nausea, vomiting, abdominal pain, and retching. Retching can occur up to 5 times per hour. It is very difficult to take food or medicine by mouth during this stage, and patients may develop a fear of eating. Weight loss and dehydration due to decreased oral intake and vomiting are possible.

Compensatory exposure to hot water, even for hours at a time, may be attempted for symptomatic relief, resulting in compulsive bathing/showering. People have described the hot water relief as “temperature-dependent,” meaning that hotter temperatures provide greater relief. It is during this phase that people with cannabinoid hyperemesis syndrome are likely to present to the emergency department of the hospital for treatment.

Individual attacks can lead to complications, such as acute kidney injury. In the setting of cannabinoid hyperemesis syndrome, this may be defined as cannabinoid hyperemesis acute renal failure (CHARF).

CHARF occurs through dehydration secondary due to persistent vomiting and hot showers, leading to prerenal azotemia. A case report of acute renal failure, albeit in the setting of rhabdomyolysis, has been reported with the use of synthetic cannabinoids.

While definitive treatment involves abstinence from cannabinoids, various drug therapies have been studied for symptomatic relief in the acute presentation of a patient suffering from cannabinoid hyperemesis syndrome, often in the setting of a hospital emergency department.

HHS Spends $1.4B for State Opioid Response Programs

The U.S. Department of Health and Human Services (HHS) released an additional $487 million to supplement first-year funding through its State Opioid Response (SOR) grant program. The awards to states and territories are part of HHS’s Five-Point Opioid Strategy to combat the opioid crisis.

Together with the $933 million in second-year, continuation awards to be provided under this program later this year, the total amount of SOR grants to states and territories this year will total more than $1.4 billion.

This funding will expand access to treatment that works, especially to medication-assisted treatment (MAT) with appropriate social supports.

The State Opioid Response grants administered by HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) aim to address the opioid crisis by increasing access to MAT using the three Food and Drug Administration (FDA) approved medications for the treatment of opioid use disorder, reducing unmet treatment need, and reducing opioid overdose-related deaths through the provision of prevention, treatment and recovery activities for opioid use disorder.

Strategies such as employing psychosocial supports, community recovery services and MAT using medicines approved by the FDA constitute the gold standard of treatment for opioid use disorders,” said Dr. Elinore F. McCance-Katz, Assistant Secretary for Mental Health and Substance Use.

Last summer, SAMHSA announced the first year of SOR funding. States and territories received funding based on a formula, with a 15 percent set-aside for the 10 states with the highest mortality rates related to drug overdose deaths.

Other funding, including $50 million for tribal communities under the Tribal Opioid Response (TOR) grant program, has been awarded separately. These programs are built from the foundations laid in the $1 billion provided to states and territories through SAMHSA’s Opioid State Targeted Response (STR) program. SAMHSA has complemented the work of the STR program with a national center of excellence that provides technical assistance and training to leverage local subject matter experts at the community level to sharpen treatment access and delivery.

SAMHSA also operates a 24/7, national Helpline that people can call to find treatment referral resources for mental health or substance use disorders: 800-662-HELP (4357). People can visit https://findtreatment.samhsa.gov/ to locate those resources, as well.

To learn more about SAMHSA-supported resources, please visit SAMHSA’s Prescription Drug Misuse and Abuse page.

Electronic Health Records – “Death By 1000 Clicks”

Food and Drug Administration Commissioner Scott Gottlieb called for tighter scrutiny of electronic health records systems, which have prompted thousands of reports of patient injuries and other safety problems over the past decade.

“What we really need is a much more tailored approach, so that we have appropriate oversight of EHRs when they’re doing things that could create risk for patients,” Gottlieb said in an interview with Kaiser Health News.

Gottlieb was responding to Botched Operation,” a report published this week by KHN and Fortune magazine.

The investigation found that the federal government has spent more than $36 billion over the past 10 years to switch doctors and hospitals from paper to digital records systems. In that time, electronic health records have created a host of risks to patient safety.

Patient harm: Electronic health records have created a host of risks to patient safety. Alarming reports of deaths, serious injuries and near misses – thousands of them – tied to software glitches, user errors or other system flaws have piled up for years in government and private repositories. Yet no central database exists to compile and study these incidents to improve safety.

One example, an electronic health records system, or EHR, made by eClinicalWorks (eCW), one of the leading sellers of record-keeping software for physicians in America, currently used by 850,000 health professionals in the U.S. It didn’t take long for Foster to assemble a dossier of troubling reports – Better Business Bureau complaints, issues flagged on an eCW user board, and legal cases filed around the country – suggesting the company’s technology didn’t work quite the way it said it did.

In May 2017, eCW paid a $155 million settlement to the government over alleged false claims and kickbacks – one physician made tens of thousands of dollars – to clients who promoted its product. Despite the record settlement, the company denied wrongdoing

Signs of fraud: Federal officials say the software can be misused to overcharge, a practice known as “upcoding.” Some doctors and health systems are alleged to have overstated their use of the new technology, a potentially enormous fraud against Medicare and Medicaid likely to take years to unravel. Two software makers have paid a total of more than $200 million to settle fraud allegations.

Gaps in interoperability: Proponents of electronic health records expected a seamless system so patients could share computerized medical histories in a flash with doctors and hospitals anywhere in the country. That has yet to materialize, largely because officials allowed hundreds of competing firms to sell medical records software unable to exchange information.

Doctor burnout: Many doctors say they spend half their day or more clicking pulldown menus and typing rather than interacting with patients. An emergency room doctor can be saddled with making up to 4,000 mouse clicks per shift. This has fueled concerns about doctor burnout, which in January the Harvard T.H. Chan School of Public Health and Massachusetts Medical Society called a “public health crisis.”

Web of secrets: Entrenched policies continue to keep software failures out of public view. Vendors of electronic health records have imposed contractual “gag clauses” that discourage buyers from speaking out about safety issues and disastrous software installations – and some hospitals fight to withhold records from injured patients or their families.

For an in-depth examination of electronic health records, read “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.

Second State AG Investigating PBMs

Kentucky Attorney General Andy Beshear has launched an investigation into allegations that state pharmacy benefit managers (PBMs) have overcharged the state health insurance programs for prescription drugs and discriminated against independent pharmacies.

Beshear is seeking details on how the PBMs, hired by state Medicaid managed-care organizations and the state employee health plan, have determined, billed and paid drug reimbursement rates over the past five years in Kentucky.

A report released last month by the state indicated two PBMs took in $123.5 million last year from the state Medicaid program by paying pharmacies a lower rate to fill prescriptions, while charging the state more for the same drugs.

Beshear said he is investigating PBMs because he wants to identify and recover any profits improperly retained at the expense of the Commonwealth and its taxpayers and ensure Kentucky families have affordable and accessible health care.

“I am demanding answers for Kentucky families and community pharmacies who want greater accountability and transparency surrounding the cost of prescription drugs,” said Beshear. “The current system is failing Kentuckians who just want a straightforward answer on whether they are receiving and paying a fair price.”

Beshear said PBMs were originally established to help companies and government programs better manage pharmacy costs, but have grown into powerful industry middlemen that go to great lengths to hide and complicate drug pricing information.

Last year, Sen. Max Wise, R-Campbellsville, introduced Senate Bill 5, because he said one of the state’s largest PBMs – CVS Caremark, which also owns its own chain of pharmacies – was not pay­ing independent pharmacists enough, putting many at risk of closing.

At the time, discussion centered around the significant decrease in the PBM’s professional dispensing fee of 85 cents per prescription, when the Centers for Medicare and Medicaid Services stated that the fee should be around $10.64, plus the cost of the drug being dispensed.

The provisions of that legislation lead to the recent report by the state and allow the Department for Medicaid Services to have greater oversight of pharmacy benefits once existing contracts expire.

The Ohio attorney general sued to recover nearly $16 million in prescription overcharges to the state for the cost of prescription drugs negotiated by PBMs.

U.C. Berkeley Claims Gig Economy Workers are “Exploited”

Many gig workers, whether in new occupations such as ride-hail driver, or traditional ones such as janitor or truck driver, could soon become employees in California after a ground breaking state Supreme Court ruling last year.

The Dynamex case implemented a simple criteria called the ABC test under which someone is an employee if a company controls what they do; if their work is linked to a company’s primary business; and if they do not have an independent business performing that work.

Assemblywoman Lorena Gonzalez, D-San Diego, is sponsoring a labor-backed bill that would codify that test. But numerous companies have lined up against it, saying it would undermine the flexibility that both they and gig workers value.

A separate case based on different criteria was decided in the U.S. Supreme Court this week. The high court declined to hear an appeal by the California Trucking Association, leaving intact a decision that could result in widespread reclassification of state truck drivers as employees.

Gig workers lack a whole list of protections afforded employees, including minimum wage, overtime, paid breaks, family and medical leave, paid sick leave, unemployment insurance and workers’ compensation. Those costs would add about 41 percent on top of the cost of wages, according to Bureau of Labor Statistics studies.

A new report from the UC Berkeley Labor Center examined demographics and wages, as well as employers’ classification practices, with an eye to the impact that changing workers’ status might have. Independent contractors – the status most gig workers have – don’t get benefits and must pay their own employment taxes, among other differences.

According to the summary prepared by the San Francisco ChronicleThese industries that are some of the worst offenders in California (for misclassification) have a disproportionate share of workers of color, immigrants and low-wage workers,” said Sarah Thomason, a research and policy associate at the Labor Center who co-authored the report. “These workers are in vulnerable positions and being exploited.

Contracted janitors, for instance, make a median hourly wage of $12.22, and are 80.9 percent Latino and 3.7 percent black. Almost half live in households defined as low income (below 200 percent of the federal poverty line).

The report estimated that 19 percent of California janitors are independent contractors, without suggesting how many are misclassified.

Among truck drivers, the median hourly wage was higher at $19.70 but drivers have high expenses, with many having to purchase a truck and pay for fuel, insurance, maintenance and repair. About 60 percent were Latino and 6 percent were black. About a fifth live in low-income households.

The report quoted a National Employment Law Project report that about four-fifths of drivers at ports are classified as independent contractors, with the majority misclassified.

For construction workers, median hourly pay is $14.98 with 73.2 percent being Latino and 2.3 percent black. About 40 percent live in low-income households.

If the ABC criteria becomes more widely applied, “definitely misclassification would not happen as frequently,” Thomason said.

Brown & Brown Acquires MEDVAL LLC

Brown & Brown, Inc. is a provider of insurance and reinsurance products and services to general business, corporate, governmental and quasi-governmental, institutional, professional, trade association and individual clients. Its headquarters are in Daytona Beach, Florida.

The company is currently ranked as the sixth largest independent insurance intermediary organization in the U.S. and eighth largest in the world based on the July 2018 ranking by Business Insurance magazine.

Brown & Brown is also one of the selected companies that comprise S&P 400 stock market index. In September 2007, Brown & Brown was ranked #10 on Forbes’s “The 100 Best Mid-Cap Stocks in America” list in 2007.

The company has reach from coast to coast, with several offices in California. And they are rapidly extending this reach with mergers and acquisitions this year.

J. Scott Penny, Chief Acquisitions Officer of Brown & Brown, Inc. announced that The Advocator Group, LLC, a wholly owned subsidiary of Brown & Brown, Inc., has acquired MEDVAL, LLC.

MEDVAL provides a suite of MSP-compliant services, which services incorporate front-line claims negotiation and comprehensive settlement solutions. MEDVAL has annual revenues of approximately $10,000,000.

The MEDVAL team will continue to operate from their offices in California, Pennsylvania and Maryland, as MEDVAL, LLC, under the leadership of Jon Gunter and the experienced MEDVAL team. MEDVAL leadership will report to Julie Turpin, Chief Executive Officer of The Advocator Group.

And it announced this month that Brown & Brown Insurance Services of California, Inc. has acquired substantially all of the assets of Austin & Austin Insurance Services, to serve the insurance needs of real estate professionals in the Bay Area of California. The firm specializes in providing errors and omissions insurance coverage to real estate brokers throughout California and has annual revenues of approximately $2 million.

Brown & Brown revenues for the fourth quarter of 2018 were $508.7 million, increasing $34.4 million, or 7.3%, compared to the fourth quarter of the prior year, with commissions and fees increasing by 7.2%.

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Legislative and Judicial Developments vs Fighting Fraud

More than 100 insurance-fraud bills are pending state action. Major state supreme court cases also could have a dramatic impact on fighting fraud. Privacy of consumer data – and how it affects fraud investigations – should be also be closely watched this year.

The California legislature rushed through AB 375, the nation’s most sweeping data privacy law last June. The California Consumer Privacy Act of 2018 (CCPA) takes effect Jan. 1, 2020.

The CCPA applies to insurers and all other businesses in the state and has very severe restrictions on the use of private data. It is not clear what impact it might or might not have on an insurer’s ability to even report fraud.

California legislators rushed a bill through to avoid a ballot initiative proposed by Alastair Mactaggart. Mactaggart agreed to withdraw the initiative if a law was signed by the Governor. Legislators in other states will watch closely for how California’s more-sweeping law moves forward.

The NAIC approved its model data security law. The model already was adopted last year by South Carolina, Ohio, and Michigan. Many other states will likely debate adopting versions of the NAIC model this year.

And there is relentless push back from the applicant/plaintiff attempting to impose personal bad-faith liability. Insurer employees can be sued personally for bad faith in Washington state, a lower court ruled.

Keodalah v. Allstate Insurance arose from a motorcycle collision with a pickup truck in Seattle, resulting in an uninsured motorist claim. The appeals court ruled that Tracey Smith, the Allstate adjuster, can be sued personally, including claims for treble damages and attorney fees. Liability also would extend to outside experts who assist insurers, such as IME physicians, third-party investigators and defense attorneys.

Keodalah addressed a split of authority in Washington. Several federal court judges issued rulings from 2005 through 2016 that non-insurer entities were exempt from bad faith claims and Consumer Protection Act claims.

In 2017, another Division of Washington’s Court of Appeals in Merriman v. American Guarantee & Liability Ins. Co., held that Washington’s generalized statute requiring good faith in the “business of insurance” applied to the insurer’s third-party administrator.

The Keodalah case has been appealed to the Washington state Supreme Court, and will be closely watched..

Courts in Montana, Texas, Mississippi and Kentucky, have long recognized claims against adjusters for bad faith and violations of statutes governing claim-handling practices. In contrast, numerous other courts – including in Oklahoma, Indiana, Hawaii, Alabama, Tennessee, New Mexico, West Virginia, California, New York and Pennsylvania – have held that adjusters generally cannot be liable for bad faith. Many other jurisdictions are undecided.

The plaintiffs bar has also sought to apply RICO laws as a penalty in workers’ compensation claims in a number of jurisdictions for at least a decade with poor results. The 9th Circuit Court of Appeals just affirmed the dismissal of a California effort in the unpublished case of Black v CorVel Enterprises Comp Inc.

CWCI Reports on Drug Formulary

New CWCI research shows that since California implemented its workers’ compensation formulary last year, an increasing share of drugs prescribed to injured workers are either “Exempt” from prospective utilization review (UR) or “Not Listed” in the formulary, while “Non-Exempt” drugs that require UR before they can be dispensed account for a declining share of the prescriptions.

In 2015, state lawmakers enacted legislation (AB 1124) requiring that the California Division of Workers’ Compensation (DWC) adopt a formulary that meets evidence-based medicine standards.

After two years of development, the Medical Treatment Utilization Schedule (MTUS) Prescription Drug Formulary took effect on January 1, 2018. The intent of the formulary was to improve quality of care by ensuring that drugs provided to injured workers meet evidence-based medicine standards in terms of frequency, duration, strength, and appropriateness; reduce the amount spent on drugs in the system; and reduce delays and frictional costs associated with prescription drug disputes.

The formulary adopted by the DWC includes Exempt and Non-Exempt Drug Lists, based on the need for prospective UR, while drugs that are not on either list (Not Listed) are allowed if the treating physician can show that their use for the specific injury is supported by the MTUS or other applicable guidelines.

To examine the formulary’s impact on the mix of drugs used in California workers’ compensation and the distribution of prescription drug payments, the authors compared pre-formulary data from prescriptions that were filled in the first half of 2016 and the first half of 2017 to post-formulary data from prescriptions dispensed to injured workers in the first half of 2018.

Among the findings, the study showed that after the formulary took effect:

Exempt drugs, which are available without prospective UR, increased to 38.5% of all prescriptions, up from 33.2% and 35.2% prior to the formulary.
Non-Exempt drugs, which require prospective UR, fell to 45.1% of the prescriptions, down from 54.3% and 52.9% in the pre-formulary periods.
Not Listed drugs rose to 16.4% of the prescriptions, up from 12.4% and 11.9% before the formulary took effect.
— The mix of prescription drug payments also changed, as Exempt drugs declined from about 22% of the payments to about 19%;
— Non-Exempt drugs fell from more than half of the payments to 42%; and Not Listed drugs increased from about a quarter of the total drug spend to nearly 39%.

CWCI has issued its study in a Spotlight Report, which includes additional analysis and tables showing the changing distributions of prescriptions for the top 20 drug ingredients overall and for the drugs on the Special Fill and Perioperative drug lists; as well as breakouts showing the changing percentages for the top 20 drugs in the Exempt, Non-Exempt and Not Listed categories.

Cannabis and Psychosis: Review of the Evidence

Many countries have legalized or decriminalized cannabis use, leading to concerns that this might result in an increase in cannabis use and associated harm.

Indeed, when it comes to “medical marijuana” the litigation and legislative trend seems to focus on the question of “cannabis – yes or no, – without contemplating the related questions of “how long” and “what kind.”

As the following study points out, there are highly potent forms of cannabis available in pot shops where an injured worker might fill a prescription. The legislators and litigation outcomes make no reference whatsoever to potent and dangerous types of cannabis which may sit side by side with other types in a pot shop.

Currently, cross-sectional and prospective epidemiological studies as well as biological evidence support a causal link between cannabis use and psychotic disorder. Meta-analysis shows a dose-response association with the highest odds of psychotic disorder in those with the heaviest cannabis use.

Nevertheless, it is not clear whether, at a population level, patterns of cannabis use influence rates of psychotic disorder.

For that reason, researchers aimed to identify patterns of cannabis use with the strongest effect on odds of psychotic disorder across Europe and explore whether differences in such patterns contribute to variations in the incidence rates of psychotic disorder.

To accomplish this mission, they targeted 901 patients aged 18 – 64 years who presented to psychiatric services in 11 sites across Europe and Brazil with first-episode psychosis and recruited controls representative of the local populations. The results of the study were published online this month in the Lancet Psychiatry.

Differences in frequency of daily cannabis use and in use of high-potency cannabis contributed to the striking variation in the incidence of psychotic disorder across the 11 studied sites. Given the increasing availability of high-potency cannabis, and the researchers say “this has important implications for public health.”

Daily cannabis use was associated with increased odds of psychotic disorder compared with never users increasing to nearly five-times increased odds for daily use of high-potency types of cannabis.

Use of high-potency cannabis was a strong predictor of psychotic disorder in Amsterdam, London, and Paris where high-potency cannabis was widely available, by contrast with sites such as Palermo where this type was not yet available. In the Netherlands, the THC content reaches up to 67% in Nederhasj and 22% in Nederwiet; in London, skunk-like cannabis (average THC of 14%) represents 94% of the street market whereas in countries like Italy, France, and Spain, herbal types of cannabis with THC content of less than 10% were still commonly used.

Researchers concluded that their findings are consistent with previous epidemiological and experimental evidence suggesting that the use of cannabis with a high concentration of THC has more harmful effects on mental health than does use of weaker forms.

If high-potency cannabis were no longer available, 12·2% of cases of first-episode psychosis could be prevented across the 11 sites, rising to 30·3% in London and 50·3% in Amsterdam.

DWC Updates MTUS

The Division of Workers’ Compensation has posted an order adopting regulations to update the evidence-based treatment guidelines of the Medical Treatment Utilization Schedule (MTUS).

The updates, effective for medical treatment services rendered on or after April 18, 2019, incorporate by reference the American College of Occupational and Environmental Medicine’s (ACOEM’s) most recent treatment guidelines to the Clinical Topics section of the MTUS.

“We are publishing this Administrative Order one month before its effective date to give the public, especially treating physicians and utilization review physicians, 30 days to prepare before these evidence-based updates become effective,” said DWC Administrative Director George Parisotto.

The ACOEM guidelines that are incorporated by reference into the MTUS are:

Ankle and Foot Disorders Guideline (ACOEM July 16, 2018)
Cervical and Thoracic Spine Disorders Guideline (ACOEM October 17, 2018)
Elbow Disorders Guideline (ACOEM August 23, 2018)
Hand, Wrist, and Forearm Disorders Guideline (ACOEM January 7, 2019)
— Workplace Mental Health: Posttraumatic Stress Disorder and Acute Stress Disorder Guideline (ACOEM December 18, 2018)

“DWC has incorporated the most recent guidelines to ensure the MTUS contain the most recent, state-of-the-art current evidence-based recommendations,” said DWC Executive Medical Director Dr. Raymond Meister. The administrative order consists of the order and two addendum:

— Addendum one shows the regulatory amendments directly related to the evidence-based updates to the MTUS.
— Addendum two contains hyperlinks to the updated ACOEM guidelines adopted and incorporated into the MTUS by reference.

Health care providers treating, evaluating (QME), or reviewing (UR or IMR) in the California workers’ compensation system may access the MTUS (ACOEM) Guidelines and MTUS Drug List at no cost by registering for an account.