Category: Daily News

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.

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.

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.

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.”

California’s insurance commissioner has launched an investigation into Aetna after learning a former medical director for the insurer admitted under oath he never looked at patients’ records when deciding whether to approve or deny care.

California Insurance Commissioner Dave Jones expressed outrage after CNN showed him a transcript of the testimony and said his office is looking into how widespread the practice is within Aetna.

“If the health insurer is making decisions to deny coverage without a physician actually ever reviewing medical records, that’s of significant concern to me as insurance commissioner in California — and potentially a violation of law,” he said.

Aetna, the nation’s third-largest insurance provider with 23.1 million customers, told CNN it looked forward to “explaining our clinical review process” to the commissioner.

The California probe centers on a deposition by Dr. Jay Ken Iinuma, who served as medical director for Aetna for Southern California from March 2012 to February 2015, according to the insurer.

The deposition came as part of a lawsuit filed against Aetna filed by Gillen Washington, a college student who suffers from a rare immune disorder. Washington was diagnosed with common variable immunodeficiency, or CVID, in high school, The case is expected to go to trial later this week in California Superior Court.

During his videotaped deposition in October 2016, Iinuma — who signed the pre-authorization denial — said he never read Washington’s medical records and knew next to nothing about his disorder. The doctor said he was following Aetna’s training, in which nurses reviewed records and made recommendations to him.

Questioned about Washington’s condition, Iinuma said he wasn’t sure what the drug of choice would be for people who suffer from his condition. Iinuma further says he’s not sure what the symptoms are for the disorder or what might happen if treatment is suddenly stopped for a patient. “Do I know what happens?” the doctor said. “Again, I’m not sure. … I don’t treat it.”

Aetna defended Iinuma, who is no longer with the company, saying in its legal brief that he relied on his “years of experience” as a trained physician in making his decision about Washington’s treatment and that he was following Aetna’s Clinical Policy Bulletin appropriately.

Jones said his expectation would be “that physicians would be reviewing treatment authorization requests,” and that it’s troubling that “during the entire course of time he was employed at Aetna, he never once looked at patients’ medical records himself.”

“That’s why we’ve contacted Aetna and asked that they provide us information about how they are making these claims decisions and why we’ve opened this investigation.”

He said his investigation will review every individual denial of coverage or pre-authorization during the medical director’s tenure to determine “whether it was appropriate or not for that decision to be made by someone other than a physician.”

If the probe determines that violations occurred, he said, California insurance code sets monetary penalties for each individual violation.