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Growing Acceptance of Acupuncture for Pain

Although long derided as pseudoscience and still questioned by many medical experts, acupuncture is increasingly being embraced by patients and doctors, sometimes as an alternative to the powerful painkillers behind the nation’s opioid crisis.

The military and Veterans Affairs medical system has been offering acupuncture for pain for several years, some insurance companies cover it and now a small but growing number of Medicaid programs in states hit hard by opioid overdoses have started providing it for low-income patients. Ohio’s Medicaid program recently expanded its coverage after an opioid task force urged state officials to explore alternative pain therapies.

While there’s now been a lot of research on acupuncture for different types of pain, the quality of the studies has been mixed, and so have the results. Federal research evaluators say there’s some good evidence acupuncture can help some patients manage some forms of pain. But they also have described the benefits of acupuncture as modest, and say more research is needed.

While research continues, insurance coverage of acupuncture keeps expanding. California, Massachusetts, Oregon and Rhode Island pay for acupuncture for pain through their Medicaid insurance programs. Massachusetts and Oregon also cover acupuncture as a treatment for substance abuse, though scientists question how well it reduces the cravings caused by chemical dependency.

The California Medical Treatment Utilization Schedule for workers’ compensation treatment contains an acupuncture section, and acupuncture is appropriate treatment in some circumstances.

The largest federal government insurance program, Medicare, does not pay for acupuncture. Tricare, the insurance program for active duty and retired military personnel and their families, does not pay for it either. But VA facilities offer it, charging no more than a copay.

Acupuncture has been practiced in China for thousands of years, and customarily involves inserting thin metal needles into specific points in the ears or other parts the body. Practitioners say needles applied at just the right spots can restore the flow of a mystical energy – called “qi” (pronounced CHEE) — through the body, and that can spur natural healing and pain relief.

In government surveys, 1 in 67 U.S. adults say they get acupuncture every year, up from 1 in 91 a decade earlier. That growth has taken place even though most patients pay for it themselves: 2012 figures show only a quarter of adults getting acupuncture had insurance covering the cost.

About a decade ago, the military and Veteran Affairs began promoting a range of alternative approaches to pain treatment, including acupuncture, yoga, and chiropractic care.

Now two-thirds of military hospitals and other treatment centers offer acupuncture, according to a recent study.

The military’s openness to alternatives is “because the need is so great there,” said Emmeline Edwards of the National Center for Complementary and Integrative Health, a federal scientific research agency. “Perhaps some of the approaches have been used without a strong evidence base. They’re more willing to try an approach and see if it works.”

Her agency is teaming up the Pentagon and the VA to spend $81 million on research projects to study the effectiveness of a variety of nondrug approaches to treating chronic pain.

New Employment Laws For 2018

The 2017 California legislative session ended with Governor Jerry Brown signing into law a number of bills affecting California employers:

The laws about what employers can ask job applicants continue to evolve. Here are two new areas of inquiry that are now not allowed:

AB 168 bars employers from asking job applicants about their previous salary. The legislation’s goal is to narrow the gender gap by preventing employers from basing offers on prior salary and thus, presumably, perpetuating historical discrimination. This will also remove the perceived gap in negotiating power between an employers and employees who must disclose their prior salary.

AB 1008 precludes employers from inquiring about an applicant’s conviction history until after a conditional offer of employment; and Imposes new limitations upon and disclosure requirements for considering conviction history information.

Employers who wish to rely on criminal conviction information to withdraw a conditional job offer must notify the applicant of their preliminary decision, give them a copy of the report (if any), explain the applicant’s right to respond, give them at least five business days to do so, and then wait five more business days to decide what to do when an applicant contests the decision. There are exceptions for employers who operate health facilities hiring employees who will have regular access to patients or drugs.

And there are new requirements for leave, pay and other protection for workers.

SB 3 increases California’s minimum wage to $11 in January 2018 and to $15 by 2022.

SB 63 requires employers with between 20 to 49 employees to provide up to 12 workweeks of “parental leave.”

AB 450 prohibits employers from allowing federal immigration agencies access to worksites unless certain conditions are met.

SB 396 requires that the currently mandated sexual harassment training for supervisors be expanded to include gender identity, gender expression, and sexual orientation.

AB 46 – Public Employers Subject to Equal Pay Act Violations.

AB 1710 – Hostile work Environment Protections for Military Service Members.

Fierce Competition Drives Novartis From Generic Drugs

Switzerland’s Novartis AG is preparing to auction its U.S. generic pill business, looking to shed a unit that has struggled amid fierce price competition, people familiar with the matter said on Friday.

The move illustrates how the unit has diverged from the fortunes of the rest of Novartis’ $10 billion Sandoz generics and biosimilars division. The company has fared better in manufacturing hard-to-make generic drugs, such as injectables and inhalables, than it has with easier to produce pills.

“It is a unique situation,” new Novartis Chief Executive Vasant Narasimhan told investors and analysts during the company’s fourth-quarter earnings call last month when asked about the future of the U.S. generic pills business.

“There are significant pricing declines. At least in the medium term, we don’t see a shift to that situation, and so we’re assessing how best to optimize that given that dynamic,” Narasimhan added, without saying what Novartis is looking to do with the business.

Novartis’ generic pills business could fetch as much as $1.6 billion based on estimated 12-month earnings before interest, taxes, depreciation and amortization of around $200 million, the sources said. A sale process for the unit will launch in the next few weeks and could attract other pharmaceutical companies or private equity firms, the sources added.

The sources asked not to be identified because the deliberations are confidential. Novartis declined to comment.

Sandoz was established in Basel in 1886 by Alfred Kern and Edouard Sandoz. By 1895 it had produced its first pharmaceutical substance, antipyrine, which was a fever-controlling agent.

In 1996, Sandoz was merged with rival Ciba-Geigy to form Novartis, one of the world’s biggest pharmaceutical companies which now has a market capitalization of 206 billion Swiss Francs ($223 billion).

Novartis has been looking for new blockbusters after its top seller, blood cancer drug Gleevec, lost its cancer protection. It is counting on approvals for new drugs against macular degeneration, a cause of blindness, and migraine, in partnership with U.S. drugmaker Amgen Inc (AMGN.O), as well as a pair of new multiple sclerosis drugs, to revitalize its growth.

Novartis also said last year it is considering a spin-off of its eyecare business Alcon.

Urine Drug Testing Becomes “Liquid Gold” for Fraudsters

Urine testing for patients with chronic pain has grown explosively over the past decade amid a rising death toll from opioid abuse. Pain doctors say drug testing helps them make sure patients are taking the drugs as prescribed and not mixing them with illegal substances.

Yet the testing boom costs billions of dollars annually and has raised concerns that some labs and doctors run urine tests needlessly – or charge exorbitant rates – to boost profits.

Some insurers have refused to pay, which can leave patients threatened with ruinously high bills they had no idea they had incurred.

“Surprise bills loaded with unexpected expenses and little explanation inflict sticker shock on vulnerable patients,” said James Quiggle, communications director of the Coalition Against Insurance Fraud, whose members include insurers, consumer groups and government agencies. Quiggle said many “puffed-up bills straddle a fine line between abuse and outright fraud.”

Prices for urine tests can vary widely depending upon complexity and the technology used. Some doctors’ offices use a simple cup test, which can detect several classes of drugs on the spot. These tests rarely cost more than $200, and typically much less.

Bills climb higher when labs check for levels of multiple drugs and bill for each one, a practice insurers argue is seldom medically justified. An egregious example is featured in an NPR story about Sunset Labs LLC in Houston. After a patient had back surgery in late 2015, her surgeon prescribed an opioid painkiller and a follow-up drug test that seemed routine – until the lab slapped her with a bill for $17,850.

It charged $4,675 to check her urine for a slew of different types of opioids: $2,975 for benzodiazepines, a class of drugs for treating anxiety, and $1,700 more for amphetamines. Tests to detect cocaine, marijuana and phencyclidine, an illegal hallucinogenic drug also known as PCP or angel dust, added $1,275 more.

Indeed, Kaiser Health News now refers to the urine drug testing business as “Liquid Gold.”

Kaiser Health News, with assistance from researchers at the Mayo Clinic, analyzed available billing data from Medicare and private insurance billing nationwide, and found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year.

There are virtually no national standards regarding who gets tested, for which drugs and how often. Medicare has spent tens of millions of dollars on tests to detect drugs that presented minimal abuse danger for most patients, according to arguments made by government lawyers in court cases that challenge the standing orders to test patients for drugs.

Payments have surged for urine tests for street drugs such as cocaine, PCP and ecstasy, which seldom have been detected in tests done on pain patients. In fact, court records show some of those tests showed up positive just 1 percent of the time.

Urine testing has become particularly lucrative for doctors who operate their own labs. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by health professionals at more than 50 pain management practices across the U.S. At a dozen practices, Medicare billings were twice that high.

Thirty-one pain practitioners received 80 percent or more of their Medicare income just from urine testing, which a federal official called a “red flag” that may signal overuse and could lead to a federal investigation.

Couple Sentenced for Making Fake Oxycodone from Fentanyl

42 year old Candelaria Vazquez, who lived in San Francisco, was sentenced to over 12 years in prison for her role in a conspiracy to manufacture, distribute, and possess with intent to distribute fentanyl. She pleaded guilty on November 8, 2016, to conspiracy to distribute fentanyl and conspiracy to launder drug proceeds.

According to the plea agreement, Vazquez admitted that she and her husband operated a pill press that generated thousands of fake oxycodone pills. Although stamped to appear like genuine oxycodone, the pills were in fact laced with fentanyl. Vazquez helped with the pill pressing operation and packaged, mailed, and delivered fentanyl pills for two years before the pair was arrested on June 10, 2016.

She also conspired to launder the drug proceeds, which were received in bitcoin and exchanged for cash using unlicensed bitcoin brokers.

Vazquez and her husband had distributed hundreds of thousands of fentanyl-laced pills via online marketplaces. Fentanyl is a dangerous and highly potent opiate about 100 times more powerful than morphine. Just two milligrams of fentanyl can constitute a lethal dose.

Fentanyl is particularly dangerous when it is used to create counterfeit pills. Illegal pill press operations will sometimes use fentanyl, which is cheaper than other opiates, to create fake pills that stamped to look like genuine oxycodone pills.

Because fentanyl is such a powerful opiate, a small difference in the amount of fentanyl in a homemade pill can make a huge difference in its potency. Counterfeit pills containing fentanyl have already been linked to numerous unintentional overdoses by users who believed they were ingesting a much less powerful opiate.

The prosecution is the result of an investigation by the Drug Enforcement Administration, United States Postal Inspector, Homeland Security Investigations, and the Internal Revenue Service.

This case is the product of the Organized Crime Drug Enforcement Task Force, a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state and local law enforcement agencies.

Central District of California Prosecutors Recovered $220M Last Year

The United States Attorney for the Central District of California announced that his office collected $219,179,887 in criminal and civil actions in Fiscal Year 2017. Of this amount, nearly $56 million was collected in criminal cases, and more than $163 million was collected in civil actions.

The United States Attorney’s Office for the Central District of California worked with other U.S. Attorney’s Offices and components of the Department of Justice to collect another $431,216,222 in cases that were pursued jointly with at least one other office. The vast majority of this money was collected in civil actions. Overall, the Justice Department collected just over $15 billion in civil and criminal actions in the 2017 fiscal year, which ended on September 30, 2017.

Additionally, the United States Attorney’s office, working with partner agencies and divisions, collected $34,749,352 in asset forfeiture actions in FY 2017. Forfeited assets deposited into the Department of Justice Assets Forfeiture Fund are used to restore funds to crime victims and for a variety of law enforcement purposes.

The United States Attorneys’ Offices, along with the Justice Department’s litigating divisions, are responsible for enforcing and collecting civil and criminal debts owed to the United States, as well as criminal debts owed to victims of federal crimes. Federal law requires defendants to pay restitution to victims of certain federal crimes who have suffered a physical injury or financial loss. While restitution is paid to victims, criminal fines and felony assessments are paid to the department’s Crime Victims’ Fund, which distributes the funds to state victim compensation and victim assistance programs.

Of the approximately $56 million collected in criminal cases this past year, approximately $44.6 million in restitution was collected and disbursed directly individuals and private entities, and $1.6 million was paid directly to the Crime Victims Fund. Most of the remaining $10 million was disbursed to federal agencies that suffered losses.

The largest civil collections last year were from affirmative civil enforcement cases in which the United States recovered government money lost to fraud or other misconduct, or collected fines imposed on individuals and/or corporations for violations of federal health, safety, civil rights and environmental laws. In addition, civil debts were collected on behalf of several federal agencies, including the U.S. Department of Housing and Urban Development, the U.S. Department of Health and Human Services, the Internal Revenue Service, the Small Business Administration and the Department of Education.

During fiscal year 2017, prosecutors in the Central District of California recovered $42 million from a settlement with Pacific Alliance Medical Center to resolve allegations that the medical center had improper financial relationships with referring physicians. Additionally, the Office recovered $26.5 million from a settlement with the City of Los Angeles Department of Water and Power for environmental and property damage sustained as a result of the 2013 Powerhouse Fire, which scorched more than 30,000 acres in northern Los Angeles County and destroyed 58 structures.

The United States Attorney’s Office for the Central District of California is based in Los Angeles and has branch offices in Santa Ana and Riverside. Currently, approximately 275 Assistant United States Attorneys serve nearly 20 million residents of the counties of Los Angeles, Orange, Riverside, San Bernardino, Ventura, Santa Barbara and San Luis Obispo.

One Shot Addiction Injection Arriving in February

Britain’s Indivior is launching a new weapon to fight the U.S. opioid crisis this month. The company believes its long-lasting Sublocade injection, which is being launched in the United States in the week of Feb. 26, will become a blockbuster medicine, despite the fact initial sales are likely to be slow.

The FDA approved Sublocade (buprenorphine extended- release) injection for subcutaneous use last year. It is the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product followed by dose adjustment for a minimum of seven days.

Sublocade is intended to be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support.

“The net revenue potential of this product is well above $1 billion but we don’t want people to be unrealistic about what we will achieve in the first year,” the Indivior Chief Executive Shaun Thaxter said in an interview.

Sublocade represents a new approach to treating addiction. Instead of going to the pharmacy to pick up tablets or Indivior’s existing under-the-tongue film, the new injections will be delivered direct to doctors’ offices for administration.

Thaxter said it would take time for the new distribution model to bed down, adding: “We would expect to see some very noticeable sales growth by the last quarter (of 2018).”

Indivior has been treating addiction for more than two decades, initially selling tablets to help wean addicts off opioids including heroin and prescription painkillers. Now its big seller is Suboxone Film, which patients place under their tongue or inside their cheek once a day to suppress cravings.

Sublocade, which could be launched in Canada, Australia and Europe from late 2019, is the latest iteration and is designed to eliminate any risk that treatment could be diverted and misused by putting the product exclusively in the doctor’s office.

Competition is growing but Indivior has had some lucky breaks against rivals in recent months, with regulatory delays to both a rival long-lasting injection from Camurus and a generic version of its film from Dr. Reddy.

Ultimately, Indivior’s opioid addiction business could be in jeopardy if the epidemic of drug misuse is brought under control, but Thaxter said his researchers were widening their focus to other addictions, such as cocaine and alcohol.

“As we continue to expand the scope of our business beyond the opioid crisis to other addictions, there will continue to be sustainable business growth for shareholders as well,” he said.

Attorneys Now Taking Opioid Cases on Contingency

Currently more than 70 states, cities and counties have filed lawsuits related to the costs of the opioid addiction crisis.

Discovery in litigation revealed that manufacturers cited biased medical studies to support claims that opioid addiction was rare. These companies allegedly hired pain management experts and doctors to promote use of opioids to other doctors and provided kickbacks and other incentives to doctors to promote use to other doctors.

Manufacturers also were accused of creating and funding a medical-front group to publish and promote false research and information about the drugs and published articles stating that opioid use was non-addicting, among other fraudulent acts.

An yet another city has joined in. According to the Sarasota Patch, the Sarasota City Commission has unanimously voted to retain Bill Robertson, personal injury attorney and CEO of Kirk Pinkerton P.A., and Steven W. Teppler with the Abbott Law Group to represent the City of Sarasota in a lawsuit to recover damages related to the opioid epidemic.

The attorney team will file a lawsuit in federal court with the Middle District in Tampa against as many as seven or more major pharmaceutical manufacturing companies and their distributors.

But there is a new twist. The two attorneys are taking the case on contingency, meaning the city will not incur any expenses unless recovered during the lawsuit.

“Our nation is in crisis and these pharmaceutical companies are putting profits above people by fueling the opioid epidemic with false claims and failure to disclose the long-term risks of these toxic drugs,” said Robertson. “Their conduct is fraudulent, unlawful and deceptive and municipalities have lost hundreds of thousands of dollars trying to keep up with expenses related to this malfeasance.”

“Damages to municipalities could add up to tens of millions of dollars,” said Teppler. “These firms grossly overstated the benefits of opioid therapy, leading to excessive collateral damage, including staggering costs for workers compensation, law enforcement and emergency services, relapse prevention and more.”

“We have lost so many to overdose and addiction, which is largely the reason I began a career in public service after law school — to provide a better path for people here,” said Sarasota City Commissioner Hagen Brody. “Our city has witnessed a pain pill epidemic that has led to dependence on street opiates like heroin when the supply of pills dried up. This lawsuit is an aggressive move to claw back some of the profit that pharmaceutical companies have made unscrupulously pedaling addiction in our community, and I fully support the effort.”

In 2016, Robertson and Teppler represented the City of Sarasota in the oil spill claim against BP, recovering $3 million for the city.

USI Publishes its 2018 Insurance Market Outlook

USI has served over 150,000 clients meeting their property & casualty, employee benefit, personal risk and retirement needs nationwide. It has more than 100 years of consulting and brokerage experience through acquired agencies. It has just published the 2018 Insurance Market Outlook – Insights from our national practice leaders

“In 2017, we saw a continued downward trend in workers’ compensation (WC), including a reduction in premium rates overall, particularly in the loss-sensitive marketplace.”

“Given the lack of deterioration in many larger carriers’ combined loss ratios, we expect similar aggressive targeting to grow market share in 2018. While returns for low-risk investment opportunities remain limited, the marketplace’s appetite for premium will drive aggressive – yet prudent- pricing. However, there is underwriting discipline for those clients with poor loss results, declining financials, residence in particular states (i.e. FL, CA, NY, and others) and those in more volatile industry classes.”

“Carriers will seek higher retentions as the result of client-specific loss severity or in circumstances when clients are pursuing greater premium savings.”

Other USI predictions for workers’ compensation:

– Loss-sensitive programs will either see flat rates or hikes as high as 5 percent, assuming clients have clean or improving loss experience. For those that are seeing worsening loss experience, rates in this category will increase more than 5 percent, and carriers will likely adjust their retention levels.
– For guaranteed-cost programs, USI sees rates ranging between 10 percent decreases to 10 percent jumps. Clients with very clean loss experience would escape changes, and pricing would also vary due to a client’s “specific state payroll distribution due to states’ legislative pressure on adequacy of rates,” according to the report.
– Medical cost inflation is expected to rise 6 percent year-over-year, and this upward trend will continue to affect workers’ compensation and loss liability totals.
– The industry can expect more increases in cost shifting from healthcare plans to workers’ compensation, due in part to problems with the Affordable Care Act.
– While self-insurance remains an alternative to insured workers’ compensation, USI says some states are becoming more conservative on their collateral position for many qualified self-insureds and more employers are “looking more closely at their existing self-insured status because of onerous associated administrative costs.”

The report also forecast trends in commercial market areas including property, general liability, umbrella liability, international, environmental, aviation, crime, cyber, medical malpractice; and kidnap, ransom and extortion.

Supreme Ct. Allows Big Fines for Workplace Safety Violations

The California Supreme Court reversed the Court of Appeal and held that an action by the Orange County District Attorney for civil penalties under the Unfair Competition Law was not preempted by Fed/OSHA . The ruling allows public prosecutors to invoke the UCL to pursue big civil penalties and injunctive relief against employers who fail to comply with workplace safety regulations.

Solus Industrial Innovations, LLC manufactures plastics at its Orange County facility. In 2007, it installed at the facility an electric water heater that was designed for residential use. In March 2009, the water heater exploded, killing two employees.

The Division of Occupational Safety and Health determined that the explosion had been caused by a failed safety valve and the lack of any other suitable safety features on the heater. In an administrative proceeding, the agency charged Solus with five violations of state occupational safety and health regulations, and also cited Solus with a willful violation for failing to maintain the water heater in a safe condition.

In addition, because two employees had died, the Division forwarded the investigation results to the District Attorney of Orange County. (See Lab. Code, § 6315, subd. (g).) In March 2012, the district attorney filed criminal charges against Solus’s plant manager and its maintenance supervisor for felony violations of Labor Code section 6425, subdivision (a).

The Orange County District Attorney also brought an action for civil penalties under this state’s unfair competition law (UCL; Bus. & Prof. Code, § 17200) and fair advertising law (FAL; id., § 17500) against an employer. The action alleged the employer violated workplace safety standards established by the state occupational safety and health law (Cal/OSHA; Lab. Code, § 6300 et seq.) and attendant regulations.

It alleged that Solus’s failure to comply with workplace safety standards amounted to an unlawful, unfair and fraudulent business practice under Business and Professions Code section 17200, and the district attorney requested imposition of civil penalties in the amount of up to $2,500 per day, per employee, for the period from November 29, 2007, through March 19, 2009.

The second was a claim that Solus “made numerous false and misleading representations concerning its commitment to workplace safety and its compliance with all applicable workplace safety standards, and as a result of those false and misleading statements, Solus was allegedly able to retain employees and customers in violation of Business and Professions Code section 17500.” The district attorney requested imposition of civil penalties in the same amount for the same period.

The employer contended, and the Trial Court and Court of Appeal ruled that the district attorney’s action was preempted by the federal Occupational Safety and Health Act of 1970. The California Supreme Court reversed in the case of Solus Industrial Innovations, LLC v The Superior Court of Orange County.

The Supreme Court concluded that “the federal OSH Act contemplates a cooperative system of workplace safety regulation, not an exclusively federal one. When federal schemes involve cooperation and concurrent jurisdiction, this circumstance also suggests that the scope of preemption was not intended to be broad.”

“Finally, we reiterate the strong presumption against preemption, arising both from the fact that the federal legislation addresses an area that has been the long-standing subject of state regulation and from the fact that California has assumed responsibility under the federal OSH Act to regulate worker safety and health, thereby preempting federal law.”