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CVS Drug Pricing Plan Gains Little Traction

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.

NCCI Reviews Air and Ground Ambulance Fees

The cost of ambulance services has risen in recent years – a single trip can exceed $45,000 for an air ambulance service and $1,400 for a ground ambulance service. Medical transportation in workers compensation (WC), however, can take many different forms. These include air ambulances, emergency and nonemergency ground ambulances, nonemergency transportation to and from medical appointments, mileage reimbursement for instances where the injured worker can drive themselves, and other ancillary transportation-related services.

Recently, air ambulance services and their associated costs have garnered attention. The US Congress, the National Association of Insurance Commissioners, and several state governments and related stakeholders have explored issues surrounding the cost of air ambulance services. In response, several states, as well as the US Congress, have introduced legislation aimed at addressing these concerns.

In the WC arena, much of the discussion has centered around a state’s ability to regulate air ambulance reimbursement rates. Some states have fee schedules that encompass air ambulance services, which are intended to regulate WC maximum allowable reimbursements (MARs). However, the federal Airline Deregulation Act of 1978 (ADA) expressly preempts state law “related to price, route, or service of an air carrier.” The question of which law governs fee schedule limitations on air ambulance reimbursement has led to legal challenges in several states. So far, state and federal courts have largely found that the ADA preempts state WC laws and regulations limiting air ambulance reimbursements.

Ambulance services include both ground ambulance and air ambulance. Before looking at the cost of these services, it is important to discuss how reimbursement for these services is determined. Typically, reimbursement consists of two components: a base payment and a mileage payment. The base payment rate reflects the level of service intensity and varies based on whether the transport:

— Is emergency or nonemergency
— Requires basic life-support staff (BLS) or advanced life-support (ALS) staff
— Is ground or air transport

The mileage payment rate reflects the cost of using the ambulance, including fuel and maintenance. While ground ambulance transports are utilized at a much higher rate than air ambulance transports, the cost per episode for ground transports is significantly lower. The frequency and cost per episode vary for each type of ground (emergency and nonemergency) and air ambulance (fixed- or rotary-wing) transport.

Air ambulances can be broken down into two categories: fixed wing (e.g., an airplane) and rotary wing (e.g., a helicopter). Rotary-wing ambulances can be used in place of ground ambulances in emergencies where the injured worker needs to be transported a short distance quickly. Another important characteristic of a rotary-wing ambulance is its ability to land in a variety of locations, including locations that could be difficult for a ground ambulance to reach. On the other hand, fixed-wing transports are typically utilized for longer distance travel.

Historically, rotary-wing episodes have been more prevalent than fixed-wing episodes; rotary-wing episodes accounted for approximately 85% of both payments and episodes for air ambulance services from 2013 to 2017. Chart 4 displays the average payment per episode for fixed-wing and rotary-wing episodes for the base and mileage components.

The average payment per episode increased for both fixed-wing and rotary-wing episodes since 2013. The average base payment is higher for rotary-wing episodes compared with fixed-wing episodes. In contrast, the average

The average payment per episode for an air ambulance is, however, costly, exceeding $20,000 in recent years. Payments for ambulance services, including ground and air, account for more than 75% of total medical transportation costs, and the average payment per episode for ambulances, both ground and air, has increased since 2013.

Filing Comp Claim Not Necessarily a FEHA “Protected Activity”

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.

Another Opioid Case Settles Before Trial

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.

Another Opiod Case Settles Before Trial

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.

Newsom Signs First Responder PTSD Presumption Law

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.

$2.1B Genetic Testing Fraud Takedown – Largest Ever Charged

A federal law enforcement action involving fraudulent genetic cancer testing has resulted in charges in five federal districts against 35 defendants associated with dozens of telemedicine companies and cancer genetic testing laboratories (CGx) for their alleged participation in one of the largest health care fraud schemes ever charged.

According to the charges, these defendants fraudulently billed Medicare more than $2.1 billion for these CGx tests. Among those charged are 10 medical professionals, including nine doctors.

No single organization was behind the fraud, and the operation dubbed “Double Helix” targeted defendants in Florida, Georgia, Louisiana, and Texas, the Justice Department said.

The alleged scheme was put into motion when a telemarketing or in-person “recruiter” would convince a Medicare enrollee to take a genetic test – assuring them that the full cost was covered by the program. Then, the patient would provide their Medicare information. Bills to Medicare connected with the scam mostly ranged from $7,000 to $12,000.

The coordinated federal investigation targeted an alleged scheme involving the payment of illegal kickbacks and bribes by CGx laboratories in exchange for the referral of Medicare beneficiaries by medical professionals working with fraudulent telemedicine companies for expensive cancer genetic tests that were medically unnecessary. Often, the test results were not provided to the beneficiaries or were worthless to their actual doctors.

Some of the defendants allegedly controlled a telemarketing network that lured hundreds of thousands of elderly and/or disabled patients into a criminal scheme that affected victims nationwide. The defendants allegedly paid doctors to prescribe CGx testing, either without any patient interaction or with only a brief telephonic conversation with patients they had never met or seen.

The U.S. Department of Health and Human Services Office of Inspector General has previously issued a fraud alert for consumers in an effort to educate the public about such schemes.

The enforcement actions were led and coordinated by the Health Care Fraud Unit of the Criminal Division’s Fraud Section in conjunction with its Medicare Fraud Strike Force (MFSF), as well as the U.S. Attorney’s Offices for the Southern District of Florida, Middle District of Florida, Southern District of Georgia, Eastern District of Louisiana, and Middle District of Louisiana.

The MFSF is a partnership among the Criminal Division, U.S. Attorney’s Offices, the FBI, DEA and HHS-OIG.

In addition, the operation included the participation of various other federal, state and local law enforcement agencies, including the Louisiana Medicaid Fraud Control Unit.

Requirements for SIBTF Benefits Unchanged After SB 899

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.

Heart Disease Linked to Pesticide Exposure at Work

According to a long-term study in Hawaii reviewed by Reuters Health, on-the-job exposure to high levels of pesticides might raise the risk of developing heart disease or having a stroke.

Farm and agricultural workers need to wear personal protective equipment and, even after they retire should continue to have their health monitored for cardiovascular complications, the authors conclude in the Journal of the American Heart Association.

Pesticides have a long half-life and exist in the body for a long time, so side effects may appear even 10-20 years later,” said lead author Zara Berg of Fort Peck Community College in Peck, Montana. “Many workers may not think that exposure during their younger or middle years is crucial, but it actually is,” said Berg.

For the analysis, Berg’s team used data from the Kuakini Honolulu Heart Program, established in 1965 to study heart disease in middle-aged Japanese-American men living on the island of Oahu. Participants were born between 1900 and 1919 in Japan or Hawaii and were between ages 45 and 68 at the beginning of the study. Data was updated through 1999, which allowed for up to 34 years of follow-up with surviving participants.

Berg and colleagues focused on 7,557 men who had provided information on their work history and had no heart disease at the beginning of the study period.

To gauge pesticide exposures, the research team used the Occupational Safety Health Administration exposure scale, which estimates typical pesticide amounts encountered during an eight-hour workday and 40-hour workweek based on a participant’s job, age and years worked in that industry, particularly for industrial, factory and agricultural workers.

Berg’s team then looked at medical records to assess who developed cardiovascular disease, which they defined as coronary heart disease or a cerebrovascular incident such as a stroke.

Overall, just 451 men had high exposure to pesticides and 410 men had low-moderate exposure, while the rest had none.

After adjusting for other cardiovascular risk factors like age, weight, physical activity, alcohol and smoking, researchers found that the men with high pesticide exposure were 42% more likely than those with none to develop cardiovascular disease during the first 10 years of follow-up.

“High exposure during middle age led to cardiovascular disease sooner,” Berg noted. “Pesticides can also affect cholesterol and the concentration of heavy metals in the body.”

Heart disease wasn’t associated with low or moderate levels of exposure to pesticides, and the link to high exposure was not seen in the longer term up to 34 years.

One limitation of the study is that only a small proportion of men had high or low-moderate pesticide exposure, the authors note. The fact that the men were all from a single ethnic group is a strength of the analysis because it removes some potential confounding differences, they add, but also means the results might not be generalizable to other populations.

Research studies are still trying to unpack how pesticides contribute to heart disease and death, whether through inflammation or oxidative stress, as well as how often or how much exposure is most harmful.

CWCI Reports Steady Decline in Spinal Fusions

New California Workers’ Compensation Institute research shows the number of California workers’ compensation inpatient hospital stays fell nearly 31 percent from 2010 through 2018, fueled in large part by a steady decline in spinal fusions.

The study, authored by CWCI Senior Research Associate Stacy Jones, uses hospital discharge data from nearly 32.3 million inpatient stays compiled by the state Office of Statewide Health Planning and Development (OSHPD) to measure and compare the volume and types of California inpatient hospitalizations paid under workers’ compensation to those paid by Medicare, Medi-Cal and private coverage.

Workers’ compensation is the smallest of the 4 medical delivery systems reviewed, accounting for just 0.4 percent of all inpatient stays in 2018, which is down from 0.6% in 2010, primarily due to a surge in Medi-Cal hospitalizations after 3.7 million adult Californians were added to the Medi-Cal rolls after Affordable Care Act plans became available in 2014.

At the same time, a number of factors spurred a decline in workers’ comp inpatient stays from 2010 to 2018, including:

— Fluctuations in the number and types of claims;
Increased use of ambulatory surgery centers;
The adoption of utilization review and independent medical review programs requiring that treatment meet evidence-based medicine standards;
Technological and procedural advances that allow more services to be provided in outpatient settings; and
A 45.9 percent reduction in the number of spinal fusions since 2010, though fusions are still the top inpatient service rendered in workers’ comp, representing more than 1 in 6 injured worker hospitalizations last year.

In addition to tracking inpatient trends for California workers’ compensation, Medicare, Medi-Cal and private plans over the 9-year span of the study, other analyses and exhibits in the report provide detailed data showing:

— The breakdown of workers’ comp inpatient stays among the top 5 Major Diagnostic Categories (MDCs);
— The proportion of surgical vs. “medical” (non-surgical) hospitalizations in each of the 4 payer groups;
— The top 5 workers’ comp surgical and medical inpatient discharges by diagnostic-related group (MS-DRG);
— The breakdown of the top 10 workers’ comp MS-DRGs across payer groups in 2018;
— The volume and prevalence of spinal fusion surgeries by payer group from 2010 through 2018;
— The top 10 hospitals based on the percentage of their inpatient discharges covered by workers’ comp, and the proportion of California workers’ comp medical and surgical hospitalizations rendered at those facilities.

CWCI has released its study as a Research Update report, “California Workers’ Compensation Inpatient Hospital Trends, 2010-2018.” Institute members and subscribers can access the report in the Research section at www.cwci.org and others can purchase it from the Institute’s online Store.