Author: WorkCompAcademy

A CVS Health Corp health plan that uses an outside drug pricing group to help it decide whether to cover certain new medicines has gained little traction with customers, according to its top medical executive, and has drawn fierce criticism from patient advocacy groups.

The company has held back on marketing the pharmacy benefit plan while it talks to these groups, CVS said. The plan, launched a year ago, is based on analyses by the Institute for Clinical and Economic Review (ICER), a Boston-based group that assesses effectiveness of drugs to determine appropriate prices.

Using ICER’s cost effectiveness assessment, CVS decides whether to include second or third medicines entering the market if there are already similar ones in the plan.

Opposition to the CVS plan is part of much broader concerns cited by drug companies and advocacy groups, many of which receive funding from the pharmaceutical industry. Some say that ICER’s analysis based on additional years of “quality life” gained from a given treatment is arbitrary and disregards the costs of drug development and patient needs.

More than 50 groups, including drugmakers, PhRMA, the industry’s main lobby group, and other advocacy groups, have provided comment during a public input period included in a review by ICER of its assessment methods. Many asked ICER to eliminate price recommendations from its efficacy analyses.

ICER has defended its methods, which are based on a widely-used cost effectiveness analysis.

The soft rollout of CVS’ ICER-related product comes as employer health plan sponsors – its biggest clients – are showing increased concern over their cost for new high-priced drugs, and are considering refusing to pay for them at all, CVS Chief Medical Officer Troy Brennan said in a recent interview.

If corporate customers follow through on that threat, CVS said it could change tactics with the plan.

Earlier this year, Novartis AG launched Zolgensma, a more than $2 million gene therapy for a rare but deadly disease called spinal muscular atrophy.

The new CVS program, cited as an example of ICER’s growing influence on U.S. drug pricing, would not apply to such a breakthrough treatment. It is a tiny plan by CVS standards as the company manages pharmaceutical benefits for more than 102 million people and also owns Aetna insurance and a national pharmacy chain.

The plan’s scope is limited to so-called me too drugs, those where similar effective treatments already exist, and aims to pressure drugmakers to set lower prices. For example, two of three very similar drugs for migraine approved in 2018 could have been excluded, but drugmakers set prices ICER deemed cost effective.

Large healthcare consultant and brokerage Mercer said it has begun to field similar concerns.

Nicole Riley worked in the El Dorado County Psychiatric Health Facility (PHF) where she expressed concerns about safety. These concerns related to changes to work schedules that resulted in fewer staff at times and construction modifications to the layout of the PHF that eliminated a hallway providing visual access to the community room before entering it..

After she was injured by a patient and filed a workers’ compensation claim, she took a higher paying job with the Office of the Public Guardian because she felt unsafe at the PHF.

Less than two months into the one-year probationary period for her new job, she was terminated for failure to complete probation satisfactorily. Riley sued the County for wrongful termination on a number of theories, including retaliation under the Fair Employment and Housing Act She alleged the proffered reason for her dismissal was pretextual.

She alleged “the real reason she was fired from the Public Guardian’s Office was to retaliate against her for her complaints about safety concerns” and the firing “constituted unlawful discrimination for her association with and advocacy for mental health and disabled patients and was retaliation for filing her worker’s compensation claim.“

The trial court granted the County’s motion for summary judgment. On appeal from the judgment in favor of the County, Riley contends the trial court erred in finding her claims were not covered by FEHA. She asserts that her advocating for mentally disabled patients and her filing of a workers’ compensation claim were protected activities and she had associational status due to her advocacy for a protected class.

The court of appeal affirmed the dismissal in the unpublished case of Riley v County of El Dorado.

In order to establish a prima facie case of retaliation under the FEHA, a plaintiff must show (1) he or she engaged in a ‘protected activity,’ (2) the employer subjected the employee to an adverse employment action, and (3) a causal link existed between the protected activity and the employer’s action.

Once an employee establishes a prima facie case, the employer is required to offer a legitimate, nonretaliatory reason for the adverse employment action. If the employer produces a legitimate reason for the adverse employment action, the presumption of retaliation “drops out of the picture,” and the burden shifts back to the employee to prove intentional retaliation.

In finding Riley’s complaints regarding safety were not a protected activity, the trial court relied in part on Dinslage v. City and County of San Francisco (2016) 5 Cal.App.5th 368. Complaints about workplace safety are not a protected activity that will support a FEHA retaliation claim.

With respect to the workers’ compensation claim, the determination as to what constitutes a protected activity is inherently fact driven.

Here, the filing of the workers’ compensation claim was completely unrelated to any discriminatory employment practice. Riley did not file for stress injuries caused by discriminatory harassment. Rather, she sought–and received–treatment in the form of physical therapy, chiropractic, and acupuncture services, for her physical injuries of bumps, bruises, and neck and shoulder injuries caused by an assault in the workplace. In this circumstance, the filing of a workers’ compensation claim is not a protected activity.

Reuters reports that Johnson & Johnson will pay $20.4 million to settle claims by two Ohio counties, allowing the U.S. healthcare giant to avoid an upcoming federal trial seeking to hold the industry responsible for the nation’s opioid epidemic.

J&J became the fourth drugmaker to settle claims ahead of the Federal Court trial against multiple manufacturers and distributors in Cleveland scheduled for later this month. The case is considered a bellwether for more than 2,600 lawsuits by state and local governments that are pending nationally.

“The settlement allows the company to avoid the resource demands and uncertainty of a trial as it continues to seek meaningful progress in addressing the nation’s opioid crisis,” J&J said in a statement.  “The company recognizes the opioid crisis is a complex public health challenge and is working collaboratively to help communities and people in need,” it added.

J&J which formerly marketed the painkillers Duragesic and Nucynta, said the settlement includes no admission of liability.

The company will pay $10 million to Cuyahoga and Summit counties, reimburse $5 million of their legal and other expenses and provide $5.4 million to non-profit organizations that run opioid-related programs in the counties.

Mallinckrodt Plc finalized a $24 million settlement with the same two counties on Monday. Endo International Plc and Allergan Plc also settled with the two counties in August to avoid going to trial.

The remaining defendants in the Oct. 21 federal trial include McKesson Corp, AmerisourceBergen, Cardinal Health, Teva Pharmaceutical Industries Ltd, Walgreens Boots Alliance Inc and Henry Schein Inc.

OxyContin maker Purdue Pharma LP succumbed to pressure from the lawsuits and filed for bankruptcy protection in September.

Earlier in the year, an Oklahoma judge ordered Johnson & Johnson to pay $572.1 million to the state for its part in fueling an opioid epidemic by deceptively marketing addictive painkillers.

Purdue Pharma and Teva had settled claims by Oklahoma’s attorney general for $270 million and $85 million, respectively.

Gov. Gavin Newsom signed Senate Bill 542. The new law creates a rebuttable presumption that a first responders PTSD struggles are an occupational injury, The new law would apply to injuries occurring on or after January 1, 2020.

The rebuttable presumptions for first responder work-related injuries already included physical ailments such as heart disease, cancer and hernias.

Before Newsom signed SB 542, California’s law limited psychiatric injury compensation to those that could prove the injury was at least 50 percent related to their job.

Section 3212.15 is added to the Labor Code. Under these new provisions, in the case of certain state and local firefighting personnel and peace officers, the term “injury” also includes post-traumatic stress that develops or manifests itself during a period in which the injured person is in the service of the department or unit.  And the law would prohibit compensation from being paid for a claim of injury unless the member has performed services for the department or unit for at least 6 months, unless the injury is caused by a sudden and extraordinary employment condition. The six months of employment need not be continuous.

The injury so developing or manifesting itself in these cases shall be presumed to arise out of and in the course of the employment. This presumption is disputable and may be controverted by other evidence.

This presumption shall be extended to a member following termination of service for a period of 3 calendar months for each full year of the requisite service, but not to exceed 60 months in any circumstance, commencing with the last date actually worked in the specified capacity.

Newsom signed the law alongside two other bills that will provide mental health support to firefighters and peace officers. The second new law establishes standards for peer support programs. The third signing prohibits the outsourcing of local emergency dispatch services to for-profit agencies.

AB 1116, the California Firefighter Peer Support and Crisis Referral Services Act by Assemblymember Tim Grayson (D-Concord), establishes statewide standards for first responder peer support programs to provide an agency-wide network of peer representatives available to aid fellow employees on emotional or professional issues.

SB 438 by Senator Robert Hertzberg (D-Van Nuys) will prohibit a public agency from outsourcing its local emergency dispatch services to a private, for-profit entity – except when pursuant to a joint powers or cooperative agreement. It also clarifies that a public safety agency maintains the authority to determine the appropriate deployment of emergency resources within the agency’s jurisdiction in order to provide the highest and best level of emergency response for the community it serves.

Victoria Enriquez sustained industrial injury to her psyche while employed during a cumulative period ending November 30, 2004 by County of Santa Barbara.

A 2014 Opinion and Decision After Reconsideration found permanent disability of 60 percent, based on an AME who reported that applicant was unable to compete in the open labor market.. However, the AME apportioned 40 percent of applicant’s permanent disability to other factors reducing her disability to 60 percent.

After the issuance of the Decision After Reconsideration of July 18, 2014, Enriquez sought SIBTF benefits.

After submission of the SIBTF case in 2016, the WCJ issued an Order Vacating Submission and Ordering Further Discovery. “Specifically/’ wrote the WCJ in his Order, “the parties are to elicit an opinion from the AME, Dr. Plesons, whether Applicant had a preexisting labor disabling permanent disability, prior to the industrial injury.” At an August 2016 hearing, it was noted that “SIBTF will write letter to doctor.”

Nevertheless, despite the fact that the WCJ found that further development of the record was necessary, the fact that defendant was designated to contact Dr. Plesons, and the fact that applicant carries the burden of proof on the issue, no further evidence was procured or admitted into the record.

Ultimately the WCJ rendered a decision on an evidentiary record he had previously found to be inadequate. The SIBTF Petition for Reconsideration was granted, and the Findings of Fact and Order was rescinded in the panel decision of Enriquez v County of Santa Barbara.

On April 19, 2004, SB 899 went into effect. SB 899 contained far-reaching amendments to the California workers’ compensation system. Among these changes, former Labor Code sections 4663 and 4750 were repealed, and a new Labor Code section 4663 was enacted to now provide that “Apportionment of permanent disability shall be based on causation.”

Although SB 899 repealed the old apportionment statutes, Labor Code section 4751 governing SIBTF liability remained unaltered. Thus, even after SB 899, in order to qualify for SIBTF benefits, the employee must show that his or her disability was labor disabling prior to the subsequent industrial injury. (Escobedo v. Marshalls (2005) 70 Cal.Comp.Cases 604, 619 (Appeals Board en banc).) “Accordingly, if an applicant’s non-industrial pathology causes apportionable permanent disability . . . then [SIBTF] benefits will not be payable under section 4751 unless the applicant demonstrates that the pathology was causing permanent disability prior to the subsequent industrial injury.”

The requirement for the existence of a prior “labor disabling” permanent disability under section 4751 is the same requirement that existed for apportionment of permanent disability under Labor Code section 4750 prior to the enactment of Senate Bill 899 (SB 899), effective April 19, 2004.

The finding that applicant had 40 percent disability apportionable to other factors pursuant to current Labor Code section 4663 “is in no way tantamount to a finding that applicant had 40 percent (or any) labor disabling permanent disability at the time of her industrial injury.” The WCJ must make a finding supported by substantial medical evidence that, at the time of the industrial injury, applicant had a labor disabling permanent disability.