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FDA Approves Abuse Resistant Opioid Patch

The FDA has approved BioDelivery Sciences International Inc abuse resistant opioid treatment for chronic pain.
The story in Reuters Health says that Belbuca is an opioid film patch and aims to treat patients with chronic pain who need round-the-clock treatment and for whom current alternatives do not suffice.The patch is expected to be commercially available in the United States by the first quarter ending March in seven dosages.

Belbuca is placed on the inner lining of the cheek, leading to faster delivery of analgesic drug buprenorphine directly into the blood stream. Buprenorphine has a lower abuse potential than most opioid medications. The Belbuca treatment can also prevent misuse through snorting or injecting as the film patch is difficult to crush or liquefy. Since most of the drug is absorbed through the cheek and with little going through the digestive tract, Belbuca could potentially lead to lower constipation, a common side effect that most oral drugs are known to cause.

Given the lower possibilities of misuse as seen with buprenorphine, physicians can write a six-month prescription as opposed to writing one on a strict monthly basis. The abuse of opioids, a class of drugs that include heroin and prescription painkillers, has long been a concern in the United States. An overdose of prescription painkillers can produce euphoric highs and even disrupt parts of the brain that control breathing.

The approval comes a little more than a month after the FDA staff flagged dosage concerns over Collegium Pharmaceutical Inc’s opioid drug, Xtampza, and Purdue Pharma’s fast-acting oxycodone painkiller.

Each Defendant May Seek PQME in Multi-Party Case

Estela Chanchavac filed a Continuous Trauma Claim against LB Industries Inc., and its two industrial carriers, Sentry Insurance and Twin City Fire Insurance Company. There was no election against either carrier, both remained active defendant participants in the case. Thus it was the view of the WCJ that “It should be noted at the outset that the employer is no longer a party to this action. Its carriers have entered their appearances in this case, so the employer is effectively dismissed as a party. cf. L.C. section 3757”.

One of the carriers, Twin City, had already obtained a chiropractic PQME with the applicant. Sentry sought to obtain its own PQME in orthopedics. Applicant objected contending that jointly, the two carriers can only obtain one PQME. The WCJ ruled that Sentry Select had been properly assigned a QME panel in orthopedics, and that applicant and Sentry should utilize the doctor remaining after the striking process to resolve any disputes between them. Applicant petitioned for Reconsideration and/or Removal which was denied by the WCAB in the case of Chanchavac v LB Industries.

The Petitions were dismissed without considering the merits. However, the WCJ noted that most of the exhibits introduced by applicant which relate to the selection procedure show that Sentry was entirely shut out from that process.

Applicant argued that permitting each defendant to obtain its own QME evaluations will result in “dueling reports” that will complicate the proceedings. In response the WCJ said “That is certainly true, which is why the legislature provided a simple expedient to avoid the problem. As noted in the Opinion, applicant could simply have elected against Twin City, thereby stopping Sentry from conducting any discovery at all. Cf. Kelm v Koret of California (1981) 46 CCC 113.”

As noted in that decision, the election process under L.C. section 5500.5 is specifically designed “for the purpose of ameliorating the procedural morass which has faced the board in multiple defendant cases”, and to “avoid the confusion and delay inevitable where multiple defendants are involved.”

The WCJ went on to note that “Although this option was presented to applicant on the morning of trial, she steadfastly refused to avail herself of it. She has instead insisted that Sentry remain an active party defendant in this case, while simultaneously attempting to prevent it from acting. The undersigned believes she cannot have it both ways. If she does not wish to designate one carrier with whom she wishes to litigate, she must litigate with all of them, all of whom must in turn be permitted to defend their own interests as they see fit. There is simply no basis or precedent for designating one carrier as some sort of “lead carrier” which other carriers must follow, or the carrier in which all other carriers are in “privity” and therefore bound by its decisions and actions.”

DIR Hosts Workplace Justice Summit

California Labor Commissioner Julie A. Su, the Department of Industrial Relations, the California Commission on the Status of Women and Girls and other community sponsors including Asian Americans Advancing Justice – Los Angeles hosted the Workplace Justice Summit to focus on enforcing workplace protections. The summit at Loyola Law School brought together government leaders, workers’ rights advocates, employer organizations, prosecutors and law enforcement to increase collaboration in efforts to fight wage theft and other workplace abuses.

“This year is the 20th anniversary of the freedom of the heroic Thai garment workers who were trafficked into the U.S. and forced to work behind barbed wire and under armed guard in El Monte,” said Labor Commissioner Su. “The purpose of the Summit is to honor our commitment to those workers and increase our effectiveness to ensure the horror of El Monte is never repeated.” Su honored the Thai garment workers at a special reception the preceding evening.

The Labor Commissioner has had a record-breaking four years in enforcing labor laws. Since 2012, hearing awards in Berman wage claims have been at a record high. Total wages and civil penalties assessed in citations have been more than $70 million a year each year from 2012 to 2014, compared to $25.4 million in 2010. Under Labor Commissioner Su, public works enforcement has also been at all-time highs of $25.2 million in 2012, $40.2 million in 2013 and $30.4 million in 2014, compared to less than $25 million every year in the decade prior.

The summit focused on strategies to fight workplace abuses, including wage theft, discrimination and the gender pay disparity, human trafficking, workplace violence and retaliation. District attorneys who have partnered with the Labor Commissioner’s Office provided training on how to prosecute wage theft cases.

“This summit will help make workplace justice a reality for even more California workers,” said Christine Baker, Director of the Department of Industrial Relations (DIR). The Labor Commissioner’s Office, officially known as the Division of Labor Standards Enforcement (DLSE), is a division of DIR.

“Fair pay, economic justice and a level playing field for businesses require creative solutions and collaboration with advocates, workers, prosecutors and employers,” said David M. Lanier, Secretary of the California Labor and Workforce Development Agency.

CWCI Readies New Benefit Notices For January

In August, California amended workers’ comp benefit notice regulations that govern the DWC-1 claim form/Notice of Potential Eligibility (NOPE), posting notices and other notices that employers and claims administrators use to inform employees of their rights and obligations under state law.

The regulations address statutory changes enacted in 2012, and require additions to notices including Medical Provider Network (MPN) information that replaces the requirement for a separate MPN poster, new language on electronic service of notices, advice that medical services are subject to approval, a revised permanent disability description and new language on timely reporting.

The state made the regulations effective January 1, 2016 to allow claims operations and employers time to obtain and distribute revised notices, so they may continue to use current versions until the end of 2015, after which they should begin using updated materials. With the January 1 effective date less than 3 months away, the community must gear up quickly.

Private entities may publish the required workers’ comp posting notices and new hire pamphlets if they are approved by the state, and many insurers and employers rely on the California Workers’ Compensation Institute (CWCI) to produce these materials and keep them up to date. After the state amended the regulations in August, CWCI updated its new hire pamphlet and posting notice, obtained state approvals, translated them into Spanish and printed them along with the new DWC-1/NOPE, which as of January will consist of a 3-page NOPE attached to four copies of the claim form, printed on NCR paper to eliminate the need to photocopy. In addition to the changes adopted in August, CWCI added information to its pamphlet and posting notice on the state’s $120 million Return to Work Supplement Program to reflect regulations adopted in April, and updated its “Facts For Injured Workers” pamphlet, which many claims administrators use to provide information to injured workers early in the life of a claim, and to meet the notice requirement about fraudulent receipt of temporary disability and the notice requirement for victims of workplace crime.

CWCI now has the revised materials in stock and ready to ship. Claims operations or employers that wish to obtain revised notices so they can update their claim kits before the January 1 deadline, or who need more details, can visit www.cwci.org/store.html or call (510) 251-9470.

Insurance Commissioner Rebuffs Carrier for High Prices

Insurance Commissioner Dave Jones announced that Department of Insurance actuaries found Aetna Life Insurance Company’s most recent small group health insurance rate increase excessive and unreasonable. Aetna is increasing rates for small businesses and their employees by an annual average of 27.4 percent. This increase will impact small businesses that renew their policies in the fourth quarter of 2015 -affecting over 40,000 employees.

“Small businesses are the lifeblood of California’s economy,” said Commissioner Jones. “Small businesses simply cannot afford unwarranted and unreasonable increases in health insurance costs nor can their employees.”

Department of Insurance actuaries reviewed Aetna’s rate filing and found that the average 27.4 percent increase was not based on Aetna’s most recent claims experience but was based on an unreasonable and excessive pricing trend and other unreasonable assumptions. Commissioner Jones advised Aetna of the department’s finding that the rate increase was unjustified. Aetna decided to impose the rate increase despite the finding that the rate increase is excessive and unreasonable, costing small businesses a projected $5.5 million in excessive rates.

Unlike 35 other states, California does not have the legal authority to reject excessive health insurance rate increases. A recent national study found that those states with the authority to regulate health insurance rates had lower rate increases as compared to states like California which do not have the authority to regulate health insurance rates.

DWC Announces Chief Judge and Medical Director Changes

Division of Workers’ Compensation Chief Judge Richard Newman and Executive Medical Director Rupali Das are leaving the division for new endeavors: Judge Newman will join the Workers’ Compensation Appeals Board (WCAB) and Dr. Das will retire from state service.

Chief Judge Newman will leave DWC at the end of November to assume the position of Secretary and Deputy Commissioner of the WCAB as of December 2. The current Secretary, Rick Dietrich, retires effective December 30. Judge Newman has had a long career in workers’ compensation. Prior to beginning his tenure as chief judge in September 2011, he worked for the Division as an attorney, judge and presiding judge. As chief judge, Newman had the responsibility of overseeing the Division’s 24 district offices, including the hiring and supervision of judges and judicial staff and involvement in facility and personnel issues.

During his tenure, Judge Newman re-instituted yearly statewide judge and I and A training and regular PJ training. He worked to promote uniform district office procedures and forms, participated in a major revision of the Policy and Procedure Manual, helped in the creation of the new online QME panel process. He assisted the Division in the implementation of SB 863, including development of the lien fee payment process and revision of the lien filing regulations. He also helped bring in Court Call to enable the option of telephonic conferencing by attorneys, and he worked to equalize the workload among district offices through the use of video lien trials and conferences. He is currently overseeing the creation of updated and simplified EAMS manuals for judges, secretaries and hearing officers. Judge Thomas Clarke will assume the position of acting chief judge.

After dedicating her career to improving the health of Californians, Dr. Rupali Das will be retiring from state service in January 2016. Since her appointment as DWC Executive Medical Director in 2012, Dr. Das has been an influential and innovative member of the DIR executive team and played a key role in implementing SB 863, Governor Brown’s groundbreaking workers’ compensation reform legislation, including Independent Medical Review, Independent Bill Review, and an updated physician fee schedule.

Dr. Das advocated for appropriate evidence-based practices, transparency, and metrics to guide and improve policy and prioritize quality of care. She was a strong proponent of the importance of prevention in all policies. Dr. Das worked closely with her team to strengthen the evidence-based framework of DWC’s Medical Treatment Utilization Schedule and introduce updated guidelines for the treatment of chronic pain in workers. She collaborated with other state agencies to address the nationwide epidemic of prescription drug overdose and death and propose guidelines for prescribing opioids for injured workers. She worked to educate medical audiences about workers’ compensation and enhance the quality of Qualified Medical Evaluators.

Dr. Das joined state service in 1993. Prior to joining DWC, she served at Cal/EPA and the California Department of Public Health. Following retirement, she will be joining Zenith Insurance Company as its Senior Vice President and California Medical Director.

Immediately following Dr. Das’ retirement, Associate Medical Director Dr. Raymond Meister will assume interim responsibilities while DWC conducts an active search for an Executive Medical Director.

Study Compares Total Knee Replacement Alternatives

Total knee replacement can usually relieve pain and improve function, but a nonsurgical regimen can also be effective in some people without posing the complication risks that can plague people who choose surgery, according to a new study reviewed in Reuters Health. The test found that while 85 percent of patients who underwent surgery showed clinically-significant improvement after one year, so did 67 percent assigned to a combination of supervised exercise, use of insoles, pain medication, education and dietary advice.

There’s little debate that knee replacement helps many people, and the new test of 100 patients – the first randomized controlled trial ever done on the technique – confirms it. Surgery patients didn’t show just some improvement. They registered far less pain and disability than those assigned to the non-surgery group.

Yet the study was needed because as many as 1 percent of surgery patients die within 90 days of their operation and about 1 in 5 have residual pain at least six months after the procedure, said Dr. Jeffrey Katz of Harvard Medical School in Cambridge, Massachusetts, in an accompanying editorial in the New England Journal of Medicine. “Until now, we have lacked rigorously controlled comparisons between total knee replacement and its alternatives.”

“People need to understand and respect that knee replacement is not without complication. Knee replacement is a big surgical procedure and there are risks associated with it,” Dr. Andrew Pollak, chairman of orthopedics at the University of Maryland School of Medicine in Baltimore, told Reuters Health. The study “really emphasizes what we suspected all along – total knee replacement works. It will be obvious to many of us who take care of patients. But for patients with significant symptoms and evidence of arthritis, total knee replacement is a very effective way of improving quality of life,” said Pollak, who was not associated with the research. “Therapy alone has a role. It does help certain patients. It can certainly prolong the time to when knee replacement is necessary.”

More than 670,000 total knee replacements are done in the U.S. each year at a cost of $36.1 billion.

Lawmakers Seek Workers’ Compensation Federal Oversight

A story published on NPR says that ten ranking Democrats on key Senate and House committees are urging the Labor Department to respond to a “pattern of detrimental changes in state workers’ compensation laws” that have reduced protections and benefits for injured workers over the past decade.

In a letter to Labor Secretary Thomas Perez, the lawmakers cited an investigation by NPR and ProPublica, which found that 33 states have cut workers’ comp benefits, made it more difficult to qualify or given employers more control over medical care decisions. The letter also referred to NPR/ProPublica stories last week that detailed an emerging trend that permits employers to dump out of state-regulated workers’ comp programs, write their own injury plans and limit benefits on their own. “State workers’ compensation laws are no longer providing adequate levels of support and compensation for workers injured on the job,” the lawmakers wrote. “The race to the bottom now appears to be nearly bottomless…”

The letter is signed by Bernie Sanders, the Democratic presidential hopeful and ranking minority member of the Senate Budget Committee, Patty Murray, D-Washington, the ranking member of the Senate Labor Committee, Bobby Scott, D-Virginia, the ranking member of the House Workforce Committee, and seven other senior Democrats on House and Senate Budget, Finance, Employment, Workforce, Ways and Means, and Social Security Committees.

The agency said it would review the letter and work “with stakeholders to find real solutions” but did not commit to any specific action. An NPR/ProPublica request to speak with Secretary Perez was declined.

Until budget cuts in 2004, the Labor Department tracked changes in state workers’ comp laws and failures to meet 19 minimum and essential standards for benefits established by a 1972 Commission convened by President Richard Nixon.

Rep. Scott says the benefits cutbacks make federal action necessary, even though workers’ comp is legislated and managed by states. “If these workers aren’t getting benefits under workers’ comp a lot of them end up getting benefits under Social Security Disability or Medicaid [and] food stamps because they’re not working,” said Rep Scott. “And so there is a strong federal interest in making sure that the workers’ comp programs pay appropriate benefits.”

A 2007 study by J. Paul Leigh, a health economist at the University of California, Davis, estimated that workplace injuries not covered by workers’ comp cost government programs about $30 billion a year.

Federal intervention may also come as the result of the “opt out” movement in Texas and Oklahoma, in which employers shun heavily-regulated workers’ comp and are permitted to write and administer their own largely-unregulated workplace injury plans. South Carolina and Tennessee are considering opt-out laws now and proponents are aiming for a dozen states by the end of the decade.

11 Percent of Americans Now on Antidepressant Meds

A recent study indicates that more than two-thirds of people who have been prescribed antidepressants are likely not suffering from depression at all. Sixty-nine percent of those taking SSRIs (selective serotonin reuptake inhibitors) such as Prozac, do not display the classic symptoms of major depressive disorder, which is commonly known as clinical depression, according to a report published in the Journal of Clinical Psychiatry.

SSRIs are also prescribed for other mental disorders, including generalized anxiety disorder, social phobia, obsessive compulsive disorder, and panic disorder, but the researchers found that 38 percent of those taking the drugs did not meet the criteria for these conditions either.

Commonly considered to have fewer side effects than other antidepressants, SSRIs are the most prescribed class of drugs for treating depression and other psychiatric disorders.

The authors of the study say that many individuals who are prescribed and use antidepressant medications may not have met criteria for mental disorders. Our data indicate that antidepressants are commonly used in the absence of clear evidence-based indications.

Between 1988 and 2008, the use of antidepressants increased almost 400 percent, with 11 percent of Americans now taking these drugs regularly. This statistic is certainly not reflected in this histories given to PTPs in typical workers’ compensation cases. One might question why workers’ compensation claimants differ, or why PTPs and QMEs do not challenge histories that routinely defy existing epidemiological data.

The official U.S. guidelines for diagnosing clinical depression are when a “person has five or more depressive symptoms over a two week period, most of the day, nearly every day.” Symptoms of clinical depression range from a depressed mood to thoughts of suicide. They might also include a lack of interest in normal activities, changes in weight or appetite, insomnia or too much sleep, restlessness, fatigue, guilty feelings and problems with concentration or decision-making.

Although SSRIs are considered to be safer than other antidepressants, they are not without potentially serious side effects. Studies have shown that the use of antidepressants involves an “increased risk of suicidal behaviour and thoughts in children and adolescents, particularly in the early stages of treatment.” The use of Prozac and Seroxat actually doubles the risk of suicidal behavior among young people. Studies have also indicated an increased risk of children being born with autism when their mothers take SSRIs during pregnancy.

Considering the risks, these drugs should never be casually prescribed. However, in this climate of increased reliance on pills to solve every problem, over-prescription of medications is rampant, particularly in the U.S.

FEHA Does Not Mandate Shift of Duties to Other Employees

Virglio Duarte worked for The Vons Companies, Inc. as a baker since 1990. He suffered a work-related injury in 2009 that restricted his ability to use his left arm. Vons rescheduled Duarte for 12 weeks to a shift at which he had access to a “baker’s helper,” who did the lifting, pushing and pulling that the baker usually does.

Vons generally offers up to 12 weeks of what it calls modified duty to employees who have a workers’ compensation injury. If the employee continues to have work restrictions after 12 weeks, he or she is taken off this modified duty and put on temporary disability – in this case involuntarily. Vons investigated another position for Duarte that turned out to be unavailable. After a lengthy leave of absence, Vons terminated Duarte.

Duarte contends in his civil suit against Vons that he was not accommodated properly, Vons failed to engage in a good faith interactive process, and he was harassed because of his disability. Duarte brought claims under FEHA, as well as other causes of action. Vons moved for summary judgment arguing there was no triable issue of fact. The trial court granted a summary judgment in favor of Vons, and the Court of Appeal affirmed in the unpublished case of Duarte v. The Vons Companies, Inc.

For a plaintiff to prevail on claims for disability discrimination and failure to provide a reasonable accommodation, he or she must show that he or she was able to perform the essential functions of the position from which he or she was terminated with or without a reasonable accommodation. The FEHA does not require an employer to shift a disabled employee’s essential duty to other employees. The statute does not require other employees to work harder or longer. Slowing production or assigning an injured worker lighter loads is not required by law.  Also, that another employee is required to do an employee’s duties suggests that the duties are essential.

Although an employee cannot be expected to identify and request all possible accommodations during the interactive process, “the employee should be able to identify specific, available reasonable accommodations through the litigation process, and particularly by the time the parties have conducted discovery and reached the summary stage.” .) If the employee cannot identify such a reasonable accommodation after discovery in litigation, he or she has suffered no remediable injury from any violation.

The only accommodations Duarte proposed was to have a helper do all the lifting, pulling, pushing, and reaching and pouring of heavy material and allowing Duarte to use a scooper instead of pouring. The proposed accommodation was not reasonable as a matter of law. With regard to Duarte’s claims that Vons did not fulfill its duty to engage in the interactive process, Duarte’s failure to identify a reasonable accommodation that was available at the time the interactive process should have occurred, dooms his claim.