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Tag: 2016 News

Researchers Use fMRI to Diagnose Fibromyalgia

University of Colorado Boulder researchers have discovered a brain signature that identifies fibromyalgia sufferers with 93 percent accuracy, a potential breakthrough for future clinical diagnosis and treatment of the highly prevalent condition.

Traumatic injuries are alleged to be the causative element in many fibromyalgia workers’ compensation claims. It is commonly defined as chronic widespread musculoskeletal pain accompanied by symptoms such as fatigue, anxiety and mood disorders. The Centers for Disease Control and Prevention (CDC) estimates that fibromyalgia affects more than five million adults annually in the U.S., with significantly higher occurrence rates in women than in men.

Historically, fibromyalgia has been difficult to diagnose and treat due to a lack of a well-categorized tissue pathology and symptoms that overlap with other common chronic illnesses. Now there may be a new tool to help claim administrators evaluate fibromyalgia cases.

CU Boulder researchers used functional MRI scans (fMRI) to study brain activity in a group of 37 fibromyalgia patients and 35 control patients as they were exposed to a variety of non-painful visual, auditory and tactile cues as well as painful pressure.

The multisensory testing allowed the researchers to identify a series of three sub-markers, or neurological patterns, that correlated with the hypersensitivity to pain that characterizes fibromyalgia.

“The novelty of this study is that it provides potential neuroimaging-based tools that can be used with new patients to inform about the degree of certain neural pathology underlying their pain symptoms,” said Marina López-Solà, a post-doctoral researcher in CU Boulder’s Cognitive and Affective Control Laboratory and lead author of the new study. “The set of tools may be helpful to identify patient subtypes, which may be important for adjusting treatment selection on an individualized basis.”

The findings were recently published in the journal PAIN, published by the International Association for the Study of Pain.

“Though many pain specialists have established clinical procedures for diagnosing fibromyalgia, the clinical label does not explain what is happening neurologically and it does not reflect the full individuality of patients’ suffering,” said Tor Wager, director of the Cognitive and Affective Control Laboratory. “The potential for brain measures like the ones we developed here is that they can tell us something about the particular brain abnormalities that drive an individual’s suffering. That can help us both recognize fibromyalgia for what it is — a disorder of the central nervous system — and treat it more effectively.”

If replicated and expanded upon in future studies, the results could eventually provide a neurological road map to brain activity that would inform diagnosis and therapeutic interventions for fibromyalgia.

“This is a helpful first step that builds off of other important previous work and is a natural step in the evolution of our understanding of fibromyalgia as a brain disorder” said López-Solà.

DOJ Launches Corporate Health Care Fraud Unit (“CHCFU”)

Historically, the federal government has fought corporate health care fraud in two ways. First, the U.S. Department of Justice routinely intervenes in civil False Claims Act cases filed by qui tam relators. Second, the federal government typically has relied on individual U.S. Attorney’s Offices to initiate and prosecute criminal health care fraud cases.

Although the DOJ relied on tools such as the Medicare Fraud Strike Force to prosecute health care crimes in geographic areas that exhibited greater systemic abuse of the health care system, the focus of these efforts lay largely in individual prosecutions of Medicare fraud and abuse rather than corporate prosecutions.

According to the report by Law360, this approach changed late last year when DOJ formed a separate Corporate Health Care Fraud Unit (“CHCFU”) within the Criminal Division’s Fraud Section. Staffed by experienced health care fraud prosecutors, the unit brings increased resources and a new, nationwide focus on the investigation and prosecution of health care fraud against corporations.

The unit’s prosecutors review all FCA cases filed across the country and evaluate whether the allegations support the initiation of criminal investigation and prosecution. Indeed, earlier this year, Assistant Attorney General Leslie R. Caldwell indicated in a speech that, as a result of the unit’s efforts, there were over a dozen active corporate investigations. AAG Caldwell also stated that the DOJ was steering additional prosecutorial resources to this area to support fighting health care fraud through parallel civil and criminal investigations in order to “maximize the department’s ability to secure the appropriate outcome in each matter – whether it be financial penalties, restitution, federal program exclusion or criminal prosecution of both corporations and individuals.”

The DOJ’s efforts are already bearing fruit. Last month, the DOJ announced a settlement with Tenet Healthcare Corporation that signaled a shift in policy for health care fraud enforcement. The settlement represents one of the first returns on the DOJ’s investment of prosecutorial resources to combat health care fraud against corporations on a national level.

No longer satisfied to focus on fraud, even large-scale fraud, perpetuated by individual physicians, home health care providers, pharmacy owners, and medical supply company executives that were the traditional targets of the DOJ’s criminal task force efforts, the Tenet settlement makes clear that the DOJ is now bringing nationwide resources and expertise to the kind of corporate investigations and prosecutions historically left to regional U.S. Attorney’s Offices.

The Tenet settlement is an important development for health care companies because it demonstrates the impact of the DOJ’s expanded resources and nationwide focus on combating corporate health care fraud. In particular, the Tenet settlement offers four key takeaways:

1. The DOJ is no longer satisfied to prosecute individuals alone and is now, more than ever before, actively scrutinizing corporations for both civil and criminal health care fraud.
2. Health care companies operating in multiple jurisdictions are especially susceptible to the coordinated focus that comes with the DOJ’s involvement in the prosecution of corporate health care fraud.
3. The DOJ’s involvement opens the door to prosecutions in jurisdictions that do not have health care fraud expertise.
4. Corporations and individual executives alike should beware.

Well before Tenet resolved the corporate allegations, the DOJ secured pleas from two executives – Tracey Cota and Gary Lang – for their involvement in the kickback scheme. Cota and Lang each pled guilty to conspiracy to violate the Anti-Kickback Act by paying and receiving bribes in exchange for Medicaid patient referrals.

S.F. Based Zenefits to Pay $7 Million for Insurance License Violations

The California Department of Insurance announced that the enforcement action taken against Zenefits for multiple insurance broker license violations has resulted in a $7 million penalty.

Zenefits was charged with allowing unlicensed employees to transact insurance and circumventing insurance agent education requirements. This is the largest penalty assessed by any commissioner against Zenefits and one of the largest penalties for licensing violations ever assessed in the department’s history.

A 2013 start-up, Zenefits is a San Francisco based company whose business model was to provide online HR services to businesses and then encourage those same businesses to use Zenefits as an insurance broker.

The California Department of Insurance launched an investigation in 2015, after receiving complaints that Zenefits employees were transacting insurance without a license. Shortly after the investigation into Zenefits’ business practices and compliance began, the company announced publicly that they were not complying with insurance laws and regulations, which was followed by the resignation of Zenefits’ CEO, Parker Conrad.

The California Department of Insurance ultimately claimed in its Order to Show Cause that “From January 2014, through November 2015, Respondent employed individuals within and outside of California who solicited, negotiated and sold insurance policies to customers located in California. According to Respondent’s June 1, 2016 report, its employees sold 8,118 insurance policies to California consumers during the aforementioned time period. Of this total, at least 1,994 insurance policies were sold by employees who lacked the proper license required to transact insurance pursuant to CIC section 1631.”

The settlement agreement obtained by the insurance commissioner includes a $3 million penalty for licensing violations, including allowing unlicensed employees to transact insurance, a $4 million penalty for subverting the pre-licensing education and study-hour requirements for agent and broker licensing, and a $160,000 payment to reimburse the Department of Insurance for investigation and examination expenses.

In recognition of the self-reporting and remedial actions already implemented by the company, including the replacement of the former CEO, retraining of all licensed producers, and implementation of an automated process to verify that only licensed individuals solicit and sell insurance products, the settlement provides that half of the total $7 million in monetary penalties are suspended.

The suspended portion of the monetary penalty will be reinstated if Zenefits fails to confirm continued compliance with licensing and regulatory mandates based on an examination of the company’s business practices to be conducted in 2018.

Zenefits has been investigated and fined in other states for similar compliance issues, including Texas, Massachusetts, Tennessee and Washington. In July Zenefits reached a settlement with the Tennessee Department of Insurance and Commerce, agreeing to pay a fine of $62,500. And the Texas insurance regulators have fined Zenefits, $550,000 for its past use of unlicensed health insurance brokers.

Will Throwing Rogue Doctors Under the Bus Work?

Several new bills will become law on January 1, 2017 that will influence the management of workers’ compensation medical claims. The most important is SB 1160 which precludes the payment of medical bills when vendors have been accused or convicted of certain crimes such as workers’ compensation fraud, Medi-Cal fraud, or Medicare fraud.

AB 1244 provides that If a vendor is convicted of fraud, then they are automatically suspended from treating in the worker’s compensation system. The Administrative Director will create a list of all names on its website.

And other health care systems seem to be headed in the same direction.

It’s no secret that Medicare and Medicaid patients are crucial to the bottom line for many physicians. So being excluded from participating in the programs is a big deal and can sometimes mean the end of a medical practice.

Under the Social Security Act, the Office of the Inspector General is authorized to exclude individuals or entities that cause the submission of false or fraudulent claims to Federal health care programs. The exclusion law is applicable in nearly all conduct that forms the basis for a False Claims Act (FCA) action involving the Federal health care programs and serves to protect the integrity of these programs.

A recent 20-year exclusion issued by the HHS Office of Inspector General should serve as a cautionary tale for physicians and proof that the federal government is also keeping a close eye on physician conduct.

Labib Riachi, a New Jersey-based OB/GYN, was excluded for allegedly submitting thousands of fraudulent claims for pelvic floor therapy.

David Blank, a senior counsel with the OIG who represented the agency in the Riachi investigation, said the exclusion was one of the longest reached under the OIG’s permissive exclusion authority and the longest issued after an agency-initiated legal action.

Riachi reached a $5.25 million False Claims Act settlement in February over the false claims, but the OIG thought the settlement didn’t go far enough based on Riachi’s alleged actions.

The OIG set out to determine if Riachi required a corporate integrity agreement or exclusion, and Blank said it became readily apparent that exclusion was necessary.

In addition to the monetary loss Riachi caused to Medicare and Medicaid, the OIG determined his alleged actions carried a significant risk of patient harm. For example, Riachi allegedly provided electrical stimulus to patients with pacemakers and allowed unlicensed and unqualified staff to perform procedures.

An initial notice of proposed exclusion called for a 30-year exclusion for Riachi, but he ended up settling on a 20-year period rather than going before an administrative law judge, Blank said. While he agreed to the exclusion, Riachi denied any liability.

“Twenty years is a substantial period of exclusion and is a clear signal to physicians that they face significant consequences, beyond monetary penalties, for taking advantage of Federal health care programs and their beneficiaries,” said Gregory E. Demske, Chief Counsel to the HHS Inspector General. “In cases such as this, collecting money from a wrongdoer is not sufficient and OIG will pursue exclusion to protect our patients and programs.”

Judge Blocks DOL December 1 New Overtime Rule

A coalition of 21 state attorneys general and governors successfully sued to block the Obama administration’s overtime rule which was set to go into effect December 1.

Nevada attorney general Adam Laxalt, in partnership with 20 other state attorneys general and governors, had sued to stop it, and the group was granted a preliminary injunction; now, the rule will not be implemented as litigation continues. Unless the Department of Labor engages in an unusually aggressive effort to expedite the response to Mazzant’s ruling, the litigation is likely to outlast the Obama administration – and, under a Trump administration, one can assume that Department of Labor officials will drop the litigation or roll back the rule.

The rule would have forced both public- and private-sector employers to pay time-and-a-half overtime to any hourly employees earning less than $47,476 per year, nearly double the old threshold of $23,660. Employees earning less than the threshold but performing “executive, administrative, or professional” duties were previously exempt from the DOL’s overtime requirements, but the new rule mandates that they receive time-and-half pay for extra work, too.

In so doing, it directly overrides the exemptions outlined by Congress in the Fair Labor Standards Act. In addition to modifying the threshold and eliminating the white-collar exemption, the Obama administration created an algorithmic method to automatically update the salary threshold every three years based on wage growth and other factors. Laxalt calls this algorithm “ratcheting,” and it is a significant component of his lawsuit.

Laxalt and his coalition sued the Department of Labor on the grounds that the overtime rule overrode congressional authority by omitting white-collar exemptions; it violated the Tenth Amendment by forcing states to pay employees a specific salary, indirectly controlling state budgets; and it violated the Administrative Procedure Act by ratcheting up the salary threshold every three years.

The Judge, Amos L. Mazzant III of the Eastern District of Texas, ruled that the Obama administration had exceeded its authority by raising the overtime salary limit so significantly. The ruling was hailed by business groups who argued the new rules would be costly and result in fewer hours for workers.

The Labor Department said it “strongly disagreed” with the decision and was “considering all of our legal options,” raising the possibility of an appeal. Ross Eisenbrey of the Economic Policy Institute, whose writings on the subject helped shape the administration’s regulation, called the ruling “a disappointment to millions of workers who are forced to work long hours with no extra compensation.”

While the injunction is only a temporary measure that suspends the regulation until the judge can issue a ruling on the merits, many said the judge’s language indicated he was likely to strike down the regulation.

“We are, assuming that this preliminary injunction holds and there isn’t an appeal or some other thing that disrupts it, done with this regulation,” said Marc Freedman, executive director of labor law policy at the U.S. Chamber of Commerce, which had challenged the rule.

Medical Marijuana – Without Any Marijuana!

The workers’ compensation community is bracing for the potential, and some say eventual, tidal wave of claims for medical marijuana as a form of treatment for pain related industrial injuries. But soon it may be possible to provide the claimed benefits of “medical” marijuana – without any marijuana at all!

Science Daily reports that Indiana University neuroscientist Andrea Hohmann took the stage at a press conference Nov. 14 in San Diego to discuss research conducted at IU that has found evidence that the brain’s cannabis receptors may be used to treat chronic pain without the side effects associated with opioid-based pain relievers or medical marijuana.

The study was discussed during the annual meeting of the Society for Neuroscience, the world’s largest source of emerging news about brain science and health. Hohmann was joined by three other international researchers whose work focuses on similar topics.

“The most exciting aspect of this research is the potential to produce the same therapeutic benefits as opioid-based pain relievers without side effects like addiction risk or increased tolerance over time,” said Hohmann, a Linda and Jack Gill Chair of Neuroscience and professor in the IU Bloomington College of Arts and Sciences’ Department of Psychological and Brain Sciences.

Chronic pain is estimated to affect nearly 50 million adults in the United States. The rise in opioid-based pain relievers to treat chronic pain has also contributed to an opioid addiction epidemic in the United States, with 19,000 deaths linked to prescription opioid abuse in 2014. In Indiana, the use of needles associated with prescription opioid abuse led to a major HIV outbreak in the state’s southeastern region, prompting the governor to declare a public health emergency in 2015.

“The fact that deaths associated with prescription opioid abuse have surpassed cocaine and heroin overdose deaths combined is a significant factor in exploring cannabinoids as an alternative treatment for pain,” said Richard Slivicki, a graduate student in Hohmann’s lab who led the study. “It’s a major epidemiological crisis, and one that helps motivate our work.”

The IU study found that a compound that modulates the activity of the brain’s receptors for THC and endocannabinoids reduced chronic pain in mice. THC, or tetrahydrocannabinol, is the main psychoactive ingredient in marijuana; endocannabinoids are natural pain-relieving compounds released by the brain.

These modulating compounds, called positive allosteric modulators, or PAMs, work by binding to a recently discovered site on a cannabinoid receptor in the brain called CB1, which is different from the site that binds THC. The PAMs were synthesized by Ganesh A. Thakur at Northeastern University, who is a collaborator on the study.

The IU scientists specifically tested the effects of CB1 PAM on neuropathic pain, a type of chronic pain caused by nerve damage, which is estimated to affect as many as 40 percent of cancer patients as a side effect of chemotherapy. The scientists gave mice paclitaxel, a chemotherapy drug known to damage nerves and cause pain, and then treated them with CB1 PAM.

After receiving paclitaxel, mice became hypersensitive to both mechanical and cold stimulations to the paw, indicating increased pain. After treatment with the CB1 PAM, the mice behaved like normal mice that did not experience pain.

The study also found evidence that the use of CB1 PAM amplified the therapeutic effect of endocannabinoids without the negative side effects of a “marijuana high,” such as impaired motor function. The PAMs were administered in combination with a compound to increase endocannabinoid levels in the brain by preventing their breakdown in the body.

Moreover, the team found that the use of the CB1 PAM remained effective over time to prevent pain in mice, as opposed to THC and endocannabinoid breakdown inhibitors, both of which stopped working with repeated dosing.

“We found that the compound did not produce reward on its own, so it’s unlikely that a CB1 PAM would be abused as a recreational drug,” Hohmann added. “Our studies show that we can maintain or preserve therapeutic efficacy in ways that we haven’t seen with some of the other classes of analgesics that are used in the clinic.”

The event was titled “Targeting the Brain’s Cannabinoid System.”

5814 Penalties Apply to Peace Officer Disability Retirement Advances

Rebecca Gage applied for service-connected disability retirement with the Sacramento County Employees’ Retirement System (SCERS) on March 6, 2015. She requested section 4850.4 advance disability pension payments until her pension application was processed.

On June 29, the County informed Gage that her request for advance disability pension payments had been approved and the benefits were to commence effective May 8. The next day, Gage filed a petition for penalties for an unreasonable delay, noting the County had indicated the benefit check would not be sent until July 2 and Gage would not receive it until July 3 or 4.

The matter proceeded to trial. The issue was limited to whether section 5814 penalties were an appropriate remedy if the County failed to comply with the requirements of section 4850.4.

The WCJ found section 4850.4 advanced disability pension payments were “compensation” under section 3207 and therefore section 5814 penalties applied in the case of an unreasonable delay.

The WCAB granted reconsideration and reversed the order. It found that because advance disability retirement payments were not equivalent to regular workers’ compensation benefits, but are instead obligations of the applicable retirement system, a denial or delay in the payment of these benefits was not subject to a section 5814 penalty. One board member dissented, opining that section 4850.4 benefits fell within the clear statutory definition of compensation in section 3207. The County had the obligation to pay that compensation and the WCAB had jurisdiction to enforce that payment through the penalty provision of section 5814.

The Court of Appeal annulled the Order after Reconsideration and found jurisdiction to award the requested penalties in the unpublished case of Gage v WCAB and County of Sacramento.

The Court of Appeal concluded that “the Workers’ Compensation Appeals Board (WCAB) does indeed have jurisdiction to impose penalties under Labor Code section 5814 for the unreasonable delay or denial of advance disability pension payments, available under section 4850.4 to local peace officers who are disabled on the job” because: (1) such payments qualify as compensation under section 3207; (2) section 5814 penalties are available for unreasonable delay or denial of the payment of compensation; and (3) no other provision of the Labor Code evinces a legislative intent to exclude such payments from the penalty provisions of section 5814.

In 2002, the Legislature made these advance disability retirement payments mandatory. (Stats. 2002, ch. 189, § 1.) The county “shall make advanced disability pension payments in accordance with Section 4850.3 unless” a “physician determines that there no discernible injury to, or illness of, the employee,” the “employee was incontrovertibly outside the course of his or her employment duties when the injury occurred,” or there is proof of fraud. (§ 4850.4, subd. (a)).

The employer is required to make advanced disability payments if the employee files a timely application for disability retirement and fully cooperates in providing information and with the medical examination and evaluation process. The payments shall commence no later than 30 days after the latest of the employee’s last payment of wages or salary, benefits under section 4850, or sick leave.

“Compensation” under division 4 “includes every benefit or payment conferred by this division upon an injured employee, or in the event of his or her death, upon his or her dependents, without regard to negligence.” (§ 3207.) ‘The term “compensation” is a technical one and includes all payments conferred by the act upon an injured employee.

The WCAB may impose penalties where payment of compensation is denied or unreasonably delayed.

Jury Acquits Police Officer in “Ice Bucket Challenge” Fraud Case

Prosecutors said Pasadena police Officer Jaime Robison, 39, was supposed to be on disability for a lower back injury when she participated in the Ice Bucket Challenge.

In a video posted online in July 2014, Robison was shown picking up a five-gallon bucket containing ice water and pouring it over a fellow police officer, according to the Los Angeles County district attorney’s office.

Many people drenched themselves in freezing water in the viral campaign known as the Ice Bucket Challenge, which raised money for ALS research.

The campaign swept the country with celebrities, children and law enforcement officials filming each other as buckets of ice were poured over their heads, later posting the videos on YouTube.

Prosecutors alleged Robison’s actions resulted in losses of up to $117,000.

The prosecution originally charged Robison with four counts of insurance fraud.

The prosecution also accused Robison of insurance fraud in 2012 when she received disability pay for more than a year. But the two counts stemming from that allegation were dismissed earlier this year.

However jurors acquitted Robison after a November Los Angeles courtroom trial.

Post AB 1309 NFL Players Now Filing Comp Claims in Florida

Back in early 2014 California passed AB 1309 limiting most professional athletes from filing workers’ comp claims within the state.

The fallout was immediate: players from all over the US filed more than 1,000 injury claims, hoping to get treatment and compensation before the September, 2015 deadline. In the first two weeks of September, current and retired players filed 569 claims against NFL franchises, 283 claims against Major League Baseball clubs, 113 against National Hockey League teams and 79 against NBA squads, a Los Angeles Times analysis of state workers’ compensation data found.

And after the September 2015 California deadline, the NFL players needed to find a new venue for their litigation. It may be the state of Florida.

The Miami Harold reports that this month Tony Gaiter along with 141 other former NFL players filed a federal lawsuit in Fort Lauderdale against the league, seeking workers’ compensation benefits for CTE (traumatic brain injury) symptoms. The players contend CTE is an occupational hazard of playing football and should be covered under workers’ compensation.

“Right now, these players are not getting any compensation for their injuries,” said Tim Howard, the attorney representing the group. “There is no reason CTE shouldn’t fall under workers’ compensation.”

The lawsuit names nearly 40 former NFL players, including many who have ties to South Florida. Among the group of plaintiffs listed in the suit: Former Detroit Lions player Sedrick Irvin; former Dallas Cowboys player Kevin Harris; former Washington Redskins player Lawrence Jones; former Tampa Bay Buccaneers player Shevin Smith; and former New England Patriots player Santonio Thomas.

The suit could affect the more than 19,000 retired NFL players who don’t qualify for benefits under the existing settlement.

CTE, or Chronic Traumatic Encephalopathy, is allegedly caused by repeated brain trauma and can lead to memory loss, depression and dementia. The disease can only be diagnosed after someone has died. Autopsies have linked CTE and former NFL players.

Howard maintains that scientific developments have demonstrated that CTE can be diagnosed when someone is alive and begins to show symptoms.

In April 2015, a federal court approved a $1 billion settlement between the NFL and the players, who accused the league of not warning players and hiding the damage of brain injury. Earlier this year, a handful of players rejected the settlement and filed an appeal with the U.S. Supreme Court, contending that some future cases would not be compensated.

The NFL could not be reached for comment.

Howard said the settlement does not compensate players living with CTE or the families of players who died from CTE after July 2014. “This is a way for the players to get justice,” Howard said.

And these claims could not come at a worse time for Florida. On Sept. 27, the Florida Office of Insurance Regulation issued an order that will raise workers compensation rates by 14.5 percent. The hike applies to new and renewing policies, effective Dec. 1.

This change came in response to a recent judgment regarding personal injury trial lawyers and the fees they charge. Under current state law, attorneys are paid 20 percent for the first $5,000 and 15 percent of the next $5,000 of any benefits they help secure. But in April, the state Supreme Court ruled it unconstitutional to cap attorney fees.

DIR Calculates Administrative Cost Assessments for 2016/2017

Labor Code Sections 62.5 and 62.6 authorize the Department of Industrial Relations to assess employers for the costs of the administration of the workers’ compensation, health and safety and labor standards enforcement programs.

Christine Baker, Director, Department of Industrial Relations, has circulated a worksheet detailing the methodology used to compute the Workers’ Compensation Administration Revolving Fund, Uninsured Employers Benefits Trust Fund, Subsequent Injuries Trust Fund, Occupational Safety and Health Fund, Labor Enforcement and Compliance Fund allocation and Workers’ Compensation Fraud Account Assessment and to allocate the assessment between insured and self-insured employers.

The total assessment for all payers for fiscal year 2016/2017 is as follows:

1) Workers’ Compensation Administration Revolving Fund (WCARF) – $452,328,500

2) Uninsured Employers Benefits Trust Fund (UEBTF) – $56,914,500

3) Subsequent Injuries Benefits Trust Fund (SIBTF) – $54,565,550

4) Occupational Safety and Health Fund (OSHF) – $106,128,662

5) Labor Enforcement and Compliance Fund (LECF) – $85,588,500

6) Workers’ Compensation Fraud Account (FRAUD) – $58,862,000

The Labor Code requires allocation of the total assessment between insured and self-insured employers in proportion to payroll for the most recent year available.

Each self insured and carrier for an insured employer will be receiving an invoice for their share of these assessments.