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Category: Daily News

FDA Approves Bunavail for Opioid Addiction

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Bunavail (buprenorphine and naloxone buccal film) for the maintenance therapy of opioid dependence.

Bunavail is based on BioDelivery Sciences’ patented BioErodible MucoAdhesive (BEMA) drug delivery technology, which facilitates improved absorption of buprenorphine and helps in overcoming some of the administration challenges involved in the sublingual (under the tongue) form of dosage currently available in the market. Bunavail’s bioavailability (drug absorbed into the body) of buprenorphine is twice compared to Suboxone, which is the market leader in this category.  With this approval, Bunavail has become the first and only buprenorphine and naloxone buccal film formulation (to be applied as a thin film on the inner lining of the cheek) to be approved by the FDA. Bunavail is to be used as part of a complete treatment package including counseling and psychosocial support.

BioDelivery Sciences intends to launch Bunavail towards the end of the third quarter of 2014. BioDelivery is focusing totally on the commercialization of the drug and will use a dedicated sales force for the launch. The company inked an agreement with Quintiles in Mar 2014 for supporting the launch of the drug. In addition, BioDelivery Sciences’ agreement with Ashfield Market Access will maximize patient access to Bunavail by providing managed markets and trade support. The company will announce additional information regarding the commercialization of Bunavail shortly. Deals in ex-U.S. markets should also be signed in the near future.

The opioid dependence market in the U.S., which is worth more than $1.7 billion, according to BioDelivery Sciences, represents significant commercial potential. The approval of Bunavail further strengthens the company’s pain portfolio. Bunavail will compete with Suboxone sublingual film in the market for opioid dependence. In 2013, U.S. sales of Suboxone sublingual film were more than $1.3 billion. The company expects Bunavail peak sales in the U.S. to be up to $250 million.

Comp Costs Limit NFL Expanded Playoffs

The NFL considered expanding the playoffs, one of a number of issues on the agenda for the Spring League Meeting. But even if, as expected, there’s enough support in the room to go forward with the idea, the owners are expected to move carefully. And it’s not simply the idea of more playoff games that could get in the way.

Chances are, the burgeoning issue of workers compensation benefits will set up as the primary roadblock in the owners adding two teams to the playoff field for 2015. The NFL Players Association has stood in staunch opposition of a bill introduced in the Louisiana state legislature, and supported by the Saints, that would limit workers comp benefits based on the week in which a player is injured. Because players are paid their base salary in 17 installments during the regular-season weeks, it would leave them vulnerable during the playoffs, the offseason program, training camp and the preseason. The union has opposed similar legislation in California, Arizona and North Carolina. The controversial workers’ compensation bill in Louisiana that sparked a battle between the New Orleans Saints and the NFL Players Association has been pulled from consideration for the current legislative session.

Union sources say the NFLPA isn’t necessarily opposed to expanded playoffs — which would bring explicit (financial) and implicit (added job security) benefits for players — but is prepared to use approving such a measure as a negotiating point. The NFL has not yet presented the NFLPA with any proposal for changes to the existing playoff structure.

Cowboys owner Jerry Jones said that he believes the league could move forward unilaterally, but the NFLPA vehemently disagrees. Union sources say it would constitute a change in work conditions, and those types of changes must be collectively bargained. Also, the NFLPA would cite Article (XX) of the NFL’s Constitution and Bylaws, which spells out the playoff structure. The front of the Constitution and Bylaws reads that “provisions of the constitution relating to the players remain subject to provisions of the collective bargaining agreement.” It then cites a number of Articles, but not Article XX explicitly, which leaves some gray area on whether or not the league could move forward without the NFLPA’s consent.

Two league sources said that the NFL doesn’t plan to force expanded playoffs through. The idea, rather, will be to come up with a plan, and then present it to the players and have extensive discussions before implementing it. That could be when the NFLPA looks to the NFL for workers comp reform.While there are five pages on workers comp in the CBA, the NFLPA’s proposal to have a comprehensive policy implemented during the 2011 negotiations didn’t result in an agreement. Since then, the union has been wary of the NFL taking players out state by state with the type of legislation that’s been presented in Louisiana.

So the NFLPA now views the owners’ desire to expand the playoffs as a chance to amend what it views as a growing problem.

Pacific Grove Architect Guilty of Comp Fraud

Architect Robert Gunn, 70, of Pacific Grove, pleaded guilty to one felony count of failure to register as an employer and one misdemeanor count of failing to secure workers’ compensation insurance. A Department of Insurance investigation found that Gunn had not purchased workers’ compensation insurance prior to an employee’s injury.

In May 2013, Department of Insurance officials received information that Gunn informed his employees that he did not have workers’ compensation insurance, but if he did, he would take the cost of the insurance out of their paychecks. The Department of Insurance began an investigation in collaboration with the Monterey County District Attorney’s Office and the Contractor’s State License Board.

The investigation led to Gunn being interviewed while employing contractors at a rental property. Investigators found that one of Gunn’s workers had been injured while on the job and that Gunn paid for him to obtain chiropractic treatments. Gunn told investigators he purchased workers’ compensation insurance recently, but did not have it at the time of the worker’s injury, and was in the process of registering as an employer with the Employment Development Department.

Gunn pleaded guilty to one felony count of failure to register as an employer and one misdemeanor count of failing to secure workers’ compensation insurance. He is scheduled to be sentenced on July 2, 2014.

Dancing Kia Hamster Headed to Jail

The Los Angeles Times reports that one of the actors who played a dancing hamster in those infectious Kia car commercials has been charged with fraud for allegedly working – including shooting at least one of the ads – while collecting state disability payments. Leroy Barnes, 27, of Los Angeles also worked as a backup dancer for pop stars Madonna, Kelly Rowland and Chris Brown while collecting state workers’ compensation benefits, said Nancy Kincaid, spokeswoman for the California Department of Insurance.

Barnes claimed he was struck and injured by a falling piece of ceiling in June 2010 while dancing for a theatrical production company, Kincaid said. He collected $51,000 in workers’ compensation benefits from September 2010 to September 2011, according to investigators for the department of insurance. He is accused of continuing to work while claiming to be disabled.

“Fraudulently collecting disability benefits is not only illegal, it disrespects legitimately injured Californians who are unable to work,” said Insurance Commissioner Dave Jones.

Barnes told his doctors he was not working during the year he collected the benefits, Kincaid said. In addition to the car commercial and the backup dancing, Barnes also performed in a rap group called the Rej3ctz while on disability, Kincaid said. Barnes could not be reached for comment Wednesday afternoon.

Barnes was arrested March 20, 2014, when LAPD officers were conducting a traffic stop. He was released the next day from the L.A. County Valley Jail on $50,000 bail.

Farm Worker Pleads Guilty in Fraud Case

A 64-year-old King City man pleaded guilty Tuesday to falsely obtaining workers’ compensation and disability benefits, according to the Monterey County District Attorney’s Office. Jorge Silva pleaded guilty specifically to two counts of making a false statement for the purpose of obtaining workers’ compensation benefits, one count of making a false statement for disability benefits and one count for the use of false documents. Silva entered his plea under the condition he would be placed on felony probation, prosecutors said. He is scheduled to be sentenced Aug. 12.

The 64-year-old was employed as an irrigation foreman for a local ranch until March 14, 2012, when he was unable to renew the driver’s license necessary for the job. A month after his termination, Silva alleged he sustained multiple injuries to his left ankle, left knee, left leg, neck, back and right wrist during the course of his employment. He claimed the injuries were cumulative between January 1992 and March 2012. On two occasions, Silva testified under oath he hadn’t worked since his termination.

The employer’s workers’ compensation insurance carrier discovered Silva was working at another local farm during the time he claimed to have been unemployed. Undercover surveillance confirmed the discovery. Silva also illegally collected state disability benefits from the Employment Development Department under a Social Security number that was not his and provided different Social Security numbers to each of his employers.

Restitution can be ordered in each case and can include attorney’s fees and the cost of investigation. in Silva’s case, the estimated restitution is $37,477.05. The EDD has indicated a loss of $26,208.

RAND Evaluates Impact of Expiration of Terrorism Risk Insurance Act

If Congress does not reauthorize the Terrorism Risk Insurance Act by the end of 2014, it could significantly affect the cost and availability of workers’ compensation coverage, according to new policy brief by RAND researchers. The report examines how insurers might respond if TRIA expires, especially in the workers’ compensation markets because states “rigidly define the terms of the coverage.” For example, insurers cannot exclude terrorism from such policies, impose policy limits or exclude losses from nuclear, biological, chemical or radiological attacks as a way to control their exposure.

Congress passed TRIA the year after the Sept. 11, 2011 terrorist attacks, which resulted in $40 billion of insured losses – considered “the most expensive man made catastrophe in insurance history,” the brief said. TRIA provides a high-level federal backstop in case of large catastrophic losses greater than $100 million. This helps mitigate the impact of terrorism on the insurance markets by spreading the losses across all property and casualty policyholders.

RAND researchers said if the TRIA expires and there is not a sufficient private reinsurance capacity covering terrorism losses then insurers could decline to provide workers’ compensation coverage to businesses considered high risk. Compared with other insurance lines covered by the Terrorism Risk Insurance Act (TRIA), workers’ compensation offers insurers less flexibility to control terrorism exposure through modifications in coverage: WC policies cannot exclude terrorism, impose policy limits, or exclude losses from nuclear, biological, chemical, or radiological (NBCR) attacks.

Terrorism does present the potential for extremely large WC losses. Attack simulations performed by Risk Management Solutions (RMS) for previous RAND work suggest that losses in WC could be more than $10 billion from a large conventional attack (10-ton truck bomb) and more than $300 billion from a nuclear attack. In comparison, the 9/11 attacks caused approximately $2.6 billion (in 2013 dollars) of WC losses. What is more, the probabilities of these catastrophic events are highly uncertain. As discussed in a previous RAND policy brief on TRIA, terrorism risk models are limited in their ability to predict the frequency of events.

As a result, some employers might have to get coverage in residual markets where higher premiums are charged. The higher cost of coverage could reduce incomes and economic growth although the brief said this effect would likely be small. And if TRIA expires and there is another terrorist attack, then businesses and taxpayers would likely finance workers’ compensation losses within the state where the attack occurred, adding to the challenge of rebuilding. “It is important that policy makers be aware of this plausible scenario when debating how to proceed with TRIA,” the brief said.

Coventry Reports Reduction in Narcotic Medication Usage

Coventry Workers’ Comp Services prepared a in a new 2013 First Script Drug Trends Analysis of workers’ compensation prescription drug utilization. While the cost and utilization per workers compensation claimant for narcotics have decreased 3.3%, the report concludes that the cost per prescription has increased by 5.3%. A few trend highlights from this year’s report include:

1) Claimants using narcotics across the First Script book of business have declined 9.1%
2) The top 10 drugs remained consistent; however, the top two most prescribed narcotics declined from 2012
3) Oxycontin®, Vicodin® and Opana® ER had decreases in utilization and spend from the prior year
4) The number of narcotic prescriptions remained relatively flat in newer claims (years 1-4), demonstrating the ongoing effectiveness of early intervention programs
5) The cost per narcotic script decreased year-over-year for all claim years (1-10), when normalized for inflation
6) Focused attention on decreasing narcotics resulted in utilization increases across adjuvant medications to support pain management
7) Average Wholesale Price (AWP) increased 12.5% in 2013, the greatest increase in the past four years
8) Generic utilization and efficiency continue to improve.

Anti-anxiety medications, antipsychotics and sedatives/hypnotics all followed a similar pattern, with decreases in cost and utilization per claimant and increases in cost per script, according to the report, which was compiled using prescriptions billed through Coventry’s pharmacy management program, First Script, in 2013.

The top 10 medications by volume have remained consistent, but the two most prescribed narcotics – Vicodin and Percocet – continue to decline, the report found. Meanwhile, utilization of other drugs in the top 10, including Neurontin, Ultram, Flexeril and Motrin, continue to increase.

According to the analysis, Oxycontin, which isn’t among the top 10 most popular medications, has decreased in utilization and spend since 2012 and makes up less than 2% of total utilization.

CWCI Computes 2015 Benefit Payment Increases

California’s State Average Weekly Wage (SAWW) climbed just under 2.666% from $1,067.25 to $1095.70 in the 12 months ending March 31, 2014, which the California Workers’ Compensation Institute (CWCI) notes will push the maximum temporary total disability (TTD) rate for 2015 job injuries to more than $1,100 a week and boost other workers’ comp benefits that are tied to changes in the SAWW as well.

California’s current maximum TTD rate is $1,074.64 per week for 2014 job injuries, but under state law the increase in the SAWW will boost the weekly maximum to $1,103.29 for claims with injury dates on or after January 1, 2015. The minimum weekly TTD rate is also tied to increases in the SAWW, so CWCI calculates that the minimum will rise from the current $161.19 to $165.49 for claims with 2015 injury dates. The Institute has confirmed both the minimum and maximum TTD rates for 2015 injury claims with the state Division of Workers’ Compensation.

Other benefits that will be bumped up by the SAWW increase include TTD paid 2 years or more after injury, life pension and Permanent Total Disability payments for injuries on or after January 1, 2003, and death claim installment payments. Underpayment of benefits results in penalties, so CWCI encourages claims administrators to review changes in benefit rates with legal counsel to assure that adjustments are appropriate and accurate. A CWCI Bulletin with more details is available to Institute members and subscribers who log in at www.cwci.org.

Nurse Faces Fraud Charges For Exaggerated Claim

A nurse who worked at Kern Medical Center faces three felony charges of workers’ compensation fraud. Nicole Nunez, 45, told a doctor she was still in pain, though investigators say surveillance video showed a different picture.

Reports reviewed by Eyewitness News say during doctor visits in September 2012, and Nunez “represented herself with significant pain and a worsening condition.” She reportedly went to a doctor at the memorial Occupational Medicine Clinic on Sept. 17 and Sept. 26. The investigation report says Nunez told the doctor she had “moderate back pain with pain running down her legs with numbness and tingling,” and the doctor continued her TTD benefits.

But, the doctor then reviewed surveillance video from dates before and after these appointments. On all of those days, the doctor said the surveillance showed her moving easily.”Nunez was noted to move much easier into the driver’s seat of her SUV vehicle than she had displayed during the office visit approximately 30 minutes earlier,'” the report reads. The doctor said that video didn’t match how Nunez had described her condition, and he modified her benefits.

Investigators say on Sept. 26 Nunez went back to the doctor and asked why her work status had changed. She also told the doctor her condition was getting worse and she had fallen since the last appointment and re-injured herself.

Eyewitness News tried to contact Nunez and left several messages, but those have not been returned. Kern County Deputy District Attorney Kate Zimmermann told Eyewitness News workers’ comp laws require recipients to report their conditions with “complete truthfulness” and provide all relevant information. She said doctors must rely on recipients’ reports when it comes to pain and function levels.

Zimmermann said Nunez is alleged to have misrepresented information twice, and withheld information once. Investigators say Nunez was fraudulently paid TTD benefits totaling $2,114.Nunez is set to be in court on the three felony charges on June 13.

DWC Sets Hearing on WCIS Regulations

The Division of Workers’ Compensation (DWC) has issued a notice of public hearing for proposed Workers’ Compensation Information system (WCIS) Electronic Data Interchange (EDI) reporting regulations. The public hearing has been scheduled for 10 a.m., Monday, July 14, 2014, in the auditorium of the Elihu Harris State Office Building, 1515 Clay Street, Oakland, CA 94612. Members of the public may also submit written comments on the regulations until 5 p.m. that day. Labor Code section 138.6 requires the Administrative Director of the DWC to develop a cost-efficient WCIS to accomplish four objectives:

1. Assist the Department of Industrial Relations to manage the workers’ compensation system in an efficient and effective manner.
2. Facilitate the evaluation of the efficiency and effectiveness of the benefit delivery system.
3. Assist in measuring how adequately the system indemnifies injured workers and their dependents.
4. Provide statistical data for research into specific aspects of the workers’ compensation system.

The statute requires that the data collected electronically by the WCIS be compatible with the EDI system of the International Association of Industrial Accident Boards and Commissions (IAIABC). The statute further directs the Administrative Director to adopt regulations specifying the data elements to be collected by EDI.

The initial regulations implementing Labor Code section 138.6 (California Code of Regulations, title 8, sections 9700 – 9704) became operative November 5, 1999. The regulations were amended in April 2006, primarily to require the electronic reporting of medical bill payment data. In 2010, the regulations were amended again to refine WCIS reporting by eliminating unnecessary data elements, adding relevant data elements, correcting errors in the text of the regulation, adding lien payment data elements for medical bill payment reporting, and updating the two California-specific implementation guides. The California EDI Implementation Guide for First and Subsequent Reports of Injury and the California EDI Implementation Guide for Medical Bill Payment Records, in conjunction with the more comprehensive guides issued by the IAIABC, explain how the data transmission is accomplished, explain how to edit data transactions, provide the required codes for transmitting data, and set forth the system specifications. Currently, workers’ compensation claims administrators adjusting approximately 95 percent of all workers’ compensation claims in the State are electronically reporting claim data information to WCIS.

The IABIABC is again updating its Medical Bill Data Reporting guidelines, moving from version 1.1 to Release 2.0. Correspondingly, the California EDI Implementation Guide for Medical Bill Payment Records is being updated to be consistent with IAIABIC’s Medical Bill Data Reporting Implementation Guide, Release 2.0. It is therefore necessary to also revise sections 9701 and 9702 of Title 8 of the California Code of Regulations, concerning transmittal of EDI to WCIS so that these regulations will not be inconsistent with the revised California EDI Implementation Guide for Medical Bill Payment Records and the IAIABC’s Medical Bill Data Reporting guidelines, Release 2.0.

These proposed regulations implement, interpret, and make specific Labor Code section 138.6, which mandates the development of the WCIS, requires data to be collected electronically to be compatible with the IAIABC EDI system, and requires data elements to be collected through EDI to be set forth in regulations. Changes in certain regulatory definitions and in the data elements to be reported have been proposed to bring WCIS into compliance with the new IAIABC requirements. The notice and text of the regulations can be found on the proposed regulations page.