Category: Daily News

Two years ago the Court of Appeal opened the Pandora’s box of potential litigation against utilization review physicians in a published decision. The California Supreme Court agreed to review the case, and just reversed the Court of Appeal in Kirk King v Comppartners, Inc..

Kirk King suffered anxiety and depression due to chronic back pain resulting from the back injury at work in 2008. In 2011, he was prescribed an anti-anxiety medication known as Klonopin to be provided through Workers’ Compensation. The request for this medication was sent to Utilization Review.

Naresh Sharma, M.D, an anesthesiologist who conducted the utilization review determined the drug was unnecessary and decertified it. As a result, Kirk was required to immediately cease taking the Klonopin. Typically, a person withdraws from Klonopin gradually by slowly reducing the dosage. Due to the sudden cessation of Klonopin, King suffered four seizures, resulting in additional physical injuries.

In September 2013 another request for Klonopin was made by the PTP. Ali, a psychiatrist, conducted a second utilization review and also determined Klonopin was medically unnecessary. Neither Sharma nor Ali examined Kirk in-person, and neither warned Kirk of the dangers of an abrupt withdrawal from Klonopin. Sharma and Ali were employees of CompPartners a Workers’ Compensation utilization review company.

King then sued CompPartners, Inc. and Sharma for (1) professional negligence; (2) negligence; (3) intentional infliction of emotional distress; and (4) negligent infliction of emotional distress. Kirk’s wife, Sara King, sued for loss of consortium. The trial court sustained defendants’ demurrer without leave to amend. The Court of Appeal sustained the demurrer but reversed the denial of leave to amend.

The Court of Appeal decision concluded that the trial court “should have granted the Kings leave to amend because it is possible… that, when more details are provided they could support a conclusion that, under the circumstances, the scope of Sharma’s duty included some form of warning Kirk of or protecting Kirk from the risk of seizures.”

However, the California Supreme Court viewed the case differently. It concluded that the workers’ compensation law provides the exclusive remedy for the employee’s injuries and thus preempts the employee’s tort claims.

The Supreme Court said it is by now well established that the exclusivity provisions preempt not only those causes of action premised on a compensable workplace injury, but also those causes of action premised on injuries collateral to or derivative of’ such an injury. Such collateral or derivative injuries include injuries stemming from conduct occurring in the workers’ compensation claims process.

In performing their statutory functions, utilization reviewers, much like independent claims administrators, effectively stand in the shoes of employers. Thus, the Court concluded that “the exclusive remedy for the Kings’ injuries lies within the workers’ compensation system.”

The battle over high prescription drug prices, unsurprisingly, involves ample amounts of finger-pointing.

Drug manufacturers point to pharmacy benefit managers (PBMs), the powerful middlemen who administer drug coverage for insurers.

The drugmakers argue that the industry practice of providing rebates to large PBMs forces them to raise list prices, and provides PBMs with a perverse incentive to favor pricier drugs in their formularies.

They also charge that the PBMs pocket too much of the rebates to pad their profits, leaving consumers to pay higher prices.

Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market, which include CVS, Express Scripts and UnitedHealth’s Optum, and that those payers do not pass on enough of those savings to patients – a contention the PBMs dispute.

The drugmakers say the rebates force them to raise the price of their therapies over time to preserve their business.

PBMs counter that the drug makers are responsible for their high prices, and that there’s no correlation between rebates and rising prices. They say their purpose is to drive down prices for their clients, and they can point to research that shows that most of the money spent on pharmaceuticals in the U.S. goes to the drug makers.

The Trump administration has targeted PBMs and rebates as a key part of its blueprint to lower drug costs. “We’re very much eliminating the middlemen,” President Trump said in announcing the blueprint back in May.

And the Department of Health and Human Services last month proposed regulations to crack down on rebates.

While the PBM industry has challenged that regulatory move, arguing that eliminating rebates would have to be done via congressional legislation, in an interview with Reuters on Friday, Health and Human Services Secretary Alex Azar, a former executive at drugmaker Eli Lilly, said that eliminating rebates was within his agency’s power.

“The question of rebates may very well be fundamental to the issue of how you reverse these constant incentives to higher list prices (for medicines),” Azar told Reuters. But, Yasmeen Abutaleb writes, “He did not say when such new regulations, which are being reviewed by the Office of Management and Budget, might take effect.”

WCAB panel decisions are more frequently approving total disability awards based upon vocational rehabilitation experts. The trend seems to be an erosion of reliance upon the AMA Guides as was the intent of SB 899 when it passed in 2004.

In this new illustrative panel decision, Craig Hanus sustained injuries to his left shoulder, neck, low back and neurological system on November 15, 2014 while employed as a heavy equipment mechanic by URS / AECOM Corporation

Subsequently, in 2015, Hanus obtained a job at Northrup Grumman as a painter. He only lasted six hours before his “body shut down” as it had done when he tried to return to work for his prior employer.

Hanus testified at trial that when he stopped working for Northrup Grumman, he had pain in his hands, arms, shoulders, back, legs, headaches, and “shooting pain in his ears” that would sometimes go to his eyes and affect his eyesight. He currently has pain “everywhere,” has balance problems, and uses a cane to prevent falling. Following left shoulder surgery, he cannot raise his left arm above shoulder level (the court observed his left hand shaking when he lifted it that far) and cannot grip or grasp things in his left hand.

Applicant was seen by a vocational evaluator, Roderick Stoneburner, in October 2017. Mr. Stoneburner’s evaluation and found that he was untrainable and I 00% disabled

After trial WCJ found that Hanus sustained 100% permanent disability, without apportionment, as a result of his admitted November 15, 2014 industrial injury to his left shoulder, neck, low back and neurological system while employed as a heavy equipment mechanic by URS/ AECOM Corporation. The petition for reconsideration by the employer was denied in the panel decision of Hanus v URS/AECOM Corporation.

Defendant contested the WCJ’s finding that applicant is permanently totally disabled, an contended that applicant cannot rebut the 2013 permanent disability rating schedule using methods approved for rebutting the 2005 rating schedule. Defendant further argues that the vocational evidence does not rebut the rating schedule, since the vocational expert used impermissible factors, failed to consider the apportionment determination of the orthopedic Qualified Medical Evaluator and made unsubstantiated assertions that applicant was incapable of sedentary work.

In response the WCAB concluded that “To the extent the WCJ’s finding that applicant is permanently totally disabled is based upon applicant’s work restrictions, as the WCJ discusses in the last paragraph of page 5 of his Report, we note that the rating of permanent disability is not determined by measuring work restrictions, but rather, by reference to the rating of the whole person impairment under the appropriate sections of the AMA Guides.”

“Here, we find the descriptions of the extent of applicant’s impairments which are caused by his industrial injury in the medical reports of Dr. Doty, Dr. Patrick and Dr. Germanovich, as referenced and considered by the vocational expert, Mr. Stoneburner, support the WCJ’s finding that·applicant is permanently totally disabled.”

Elliott Galindo worked for the City of Los Angeles as cement finisher in the City’s Department of Public Works, Bureau of Street Services.

In 2004, Galindo suffered a work-related back injury and did not return to full duty as a cement finisher until 2006. In 2008 he suffered another back injury and was off work for almost a year while his worker’s compensation claim was pending.

In 2009 he was given permanent work restrictions including “Limited to light duty only. He cannot perform any type of strenuous work. He should avoid lifting greater than 10 lbs, avoid repetitive bending, . . . avoid repetitive twisting, and avoid unusual body positioning for his spinal condition.”

Galindo confirmed that the medical work restrictions were accurately stated. He believed he could nonetheless perform his job as a cement finisher if he was given a “lead man” role, “less hands on.” He declined to be considered for another job classification, declined transfer to a lower-wage position, and said he was not aware of any equipment or devices that could assist him in completing his regular job duties.

Numerous interactive process meetings were held by the City. At the first, he asked to be returned to his position as a cement finisher. The City asked him to complete a City employment application identifying all of his work qualifications so that he could be considered for other modified duties or classifications. Additional meetings took place with similar results.

By 2011 a disability retirement was approved by LACERS. Subsequently there were additional interactive process meetings after he was retired.  Essentially Mr. Galindo asked to return to work as a cement finisher and declined to consider other work. Ultimately he filed a claim of discrimination with the DFEH, obtained a right to sue letter and filed a civil complaint.

While his civil action was pending, in 2015 LACERS asked for three medical examinations to re-evaluate his disability retirement. All three doctors reported that he could return to work as a cement finisher without restrictions. By May, 2015 he returned to work as a cement finisher without restrictions.

The City moved for summary judgment in September 2015 which was granted and the case dismissed. The court of appeal affirmed the dismissal in the unpublished case of Galindo v City of Los Angeles.

The City presented undisputed evidence that it was at all times constrained by work restrictions issued by the Workers’ Compensation Division. In order to prevail on a claim of disability discrimination, an employee must show that the employer took the adverse employment action with a discriminatory animus. The employee cannot simply show that the employer’s decision was wrong or mistaken, since the factual dispute at issue is whether discriminatory animus motivated the employer, not whether the employer is wise, shrewd, prudent, or competent.

The Department of Justice and U.S. Drug Enforcement Administration have proposed a reduction for controlled substances that may be manufactured in the U.S. next year. President Trump’s “Safe Prescribing Plan” that seeks to “cut nationwide opioid prescription fills by one-third within three years.” The new proposal decreases manufacturing quotas for the six most frequently misused opioids for 2019 by an average ten percent as compared to the 2018 amount.

The Notice of Proposed Rulemaking marks the third straight year of proposed reductions, which help reduce the amount of drugs potentially diverted for trafficking and used to facilitate addiction.

On July 11, 2018, the Justice Department announced that DEA was issuing a final rule amending its regulations to improve the agency’s ability to consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits. The final rule also promotes greater involvement from state attorneys general, and today’s proposed reduction will be sent to those offices.

In setting the aggregate production quota, DEA considers data from many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.

The DEA has proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl.

Ultimately, revised limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potential addictive drugs while ensuring that the country has enough opioids for legitimate medical, scientific, research, and industrial needs.

Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased or decreased sales or exports, new manufacturers entering the market, new product development, or product recalls.

When Congress passed the Controlled Substances Act, the quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” by controlling the quantities of the basic ingredients needed for the manufacture of controlled substances.

The Proposed Aggregate Production Quotas for schedule I and II controlled substances published in the Federal Register reflects the total amount of controlled substances necessary to meet the country’s medical, scientific, research, industrial, and export needs for the year and for the establishment and maintenance of reserve stocks. DEA establishes an APQ for more than 250 schedule I and II controlled substances annually.

In 2016, the Centers for Disease Control and Prevention issued guidelines to practitioners recommending a reduction in the prescribing of opioid medications for chronic pain. DEA and its federal partners have increased efforts in the last several years to educate practitioners, pharmacists, manufacturers, distributors, and the public about the dangers associated with the misuse of opioid medications and the importance of proper prescribing.