The civil lawsuit names Comprehensive Pain Specialists, also known as Anesthesia Services Associates PLLC; four of its physician owners; and a former top executive. The doctors include Tennessee Republican State Sen. Steven Dickerson and Peter Kroll, both anesthesiologists.

At its peak, CPS ran 60 pain clinics in a dozen states and treated some 48,000 patients per month, according to the suit. It shut down abruptly last summer, leaving many chronic pain patients to find a new source of narcotic medicines.

The Justice Department fraud case centers largely on the company’s lucrative urine-testing lab in Brentwood, Tenn., which CPS financed with a $1.5 million loan. The suit also alleges overbilling from acupuncture and other services offered to patients.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized Medicare billings for urine drug tests.

Medicare and other federal programs paid over $70 million from 2011 to 2018 for CPS-ordered urine tests, an amount the lawsuit called “staggering.” TennCare, the state’s Medicaid program, paid more than $9 million more during that time.

“For this reason, CPS considered [urine tests] to be ‘liquid gold’ — with revenues of tens of millions of dollars for what was largely unnecessary medical testing,” according to the suit.

The chain’s owners and then-CEO John Davis “viewed every CPS patient as an opportunity to make money, without regard to the individualized need for treatment,” the suit alleges. Davis was convicted last year in Nashville on federal criminal health care fraud charges. He has since filed a motion for a new trial.

Dan Martin, an attorney representing Kroll, said in an emailed statement: “We are aware of the allegations and very familiar with the actual facts. Dr. Kroll did not engage in any wrongdoing whatsoever, and we look forward to correcting the government’s misunderstanding of the facts.”

Dickerson’s attorney, Ed Yarbrough, also issued a statement that read: “Dr. Dickerson is an honest man. We will prove that in court.”

In its investigation, KHN, with assistance from researchers at the Mayo Clinic, found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid medical providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

CPS was among the nation’s most aggressive testers. KHN found that in 2014 five of its medical professionals stood among the nation’s top billers. Anita Bayles, a nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

The Justice Department suit says that CPS believed Bayles ordered too many urine tests and overprescribed opioids and in September 2016 decided to fire her. But the decision was reversed by CEO Davis “because of her ability to generate revenues,” according to the suit. Bayles could not be reached for comment.

Though CPS ran six or more urine tests a year on many patients receiving narcotics, its doctors often did not review the results to make sure patients did not abuse them, according to the suit.

Kroll, who also served as CPS’ medical director, told KHN in 2017 that the high volume of tests was justified to keep patients safe and to reduce chances of black market sales of pills. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll said in a 2017 interview that he and Dickerson came up with the idea to open a high-quality pain practice over a cup of coffee at a Nashville Starbucks in 2005.

But the Justice Department alleges that CPS expanded rapidly through bilking the government, conduct that its top executives and founders “failed to take any action to stop,” according to the suit.

In what is called a “particularly egregious example of this fraudulent conduct,” the Justice Department alleged that Kroll caused over 2,500 claims to be submitted to Medicare, for which CPS was paid almost $350,000, during a 10-day period in May 2017 when Kroll was on vacation in Italy.

“Because of these fraudulent claims, Kroll’s billing privileges with Medicare have been revoked,” according to the suit.

The lawsuit states that Medicare officials began investigating overcharging for urine testing at CPS in 2014 and eventually directed the company to repay the government $27.4 million in an extrapolated penalty. But CPS aggressively appealed the decision and managed to get it overturned and stay in business.

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, as well as the criminal case against Davis. In a court filing in December, the company said that it had terminated all of its employees and that its debts “greatly exceed its assets.”

In total, Medicare paid CPS over $150 million from 2011 to 2018, a large part of which was related to urine testing, while TennCare paid CPS over $32.5 million, according to the suit.

The Justice Department complaint consolidates several whistleblower cases filed against the company by doctors and other former employees. Federal whistleblower cases seek recovery of money paid improperly and can include treble damages, or three times the amount of the original overpayment.

One of the whistleblowers said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the whistleblower’s suit.

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The federal suits target Tennessee-based Comprehensive Pain Specialists, also known as Anesthesia Services Associates, PLLC, and several of its physician owners. At its peak, CPS ran 60 pain clinics in 12 states, according to the suits, as well as a lucrative urine-testing lab in Brentwood, Tenn. CPS closed with no warning in July, leaving patients in several states distressed and to find a new source of narcotic pain medicines.

In federal court filings unsealed in Nashville this week, federal prosecutors said they would take over the urine-testing allegations and sue several CPS owners, including co-founding anesthesiologists Peter Kroll and Steven Dickerson. Dickerson is a Republican state senator representing Nashville.

Kroll could not be reached for comment Wednesday. Dickerson did not respond to an email or a phone message left at his legislative office.

It is not clear whether the whistleblowers, who include former CPS doctors and other employees, would pursue several allegations against the company that the federal government declined to join in. CPS, in an unrelated court filing in December, said the company had terminated all of its employees and that debts “greatly exceed its assets.”

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, and a criminal investigation that ensnared its former chief executive, John Davis. Davis, 41, was convicted this month in federal court in Nashville on health care fraud charges. He is to be sentenced later this year.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug tests. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

Kroll, who also served as CPS’ medical director, said at the time that the tests were justified for patient safety and to reduce chances the pills might be sold on the black market. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll in an interview with KHN at the time said that he and fellow anesthesiologist Dickerson came up with the idea for the pain clinics over a cup of coffee at a Nashville Starbucks in 2005.

One of the whistleblower suits alleging unnecessary urine tests was first filed under seal in 2016 by Suzanne Alt, a doctor who worked in the company’s pain clinics in Troy, Mo., and Keokuk, Iowa, from May 2014 to March 2015. She alleged CPS doctors were “strongly encouraged to order full-panel urine drug screens on each patient, every time, despite the patient’s history, compliance and risk.”

She also said that the company’s electronic medical records “made it extremely difficult to order anything less than the full panel.” Alt said she was told the Tennessee lab did about 600 of these screens daily. Another whistleblower said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the suit.

“They were making a killing,” said Birmingham, Ala., attorney Don McKenna, who represents Alt in the case.

Another of the whistleblowers, former CPS anesthesiologist Cynthia Niendorff, alleged that the company billed Medicare about $754 for each additional urine test, even though earlier results had come back negative. She said CPS grossed approximately $6 million per month from the urine-testing lab and said about 20% of this amount was suspect, according to the suit.

Mary Butner, a former insurance specialist for CPS in Gallatin, Tenn., alleged that CPS charged some patients $1,500 for a drug test to measure blood levels of medication and $400 for a drug test designed to detect illegal drugs — charges that the suit called “grossly inflated and disproportional to the actual costs.” She also alleged that CPS would fill prescriptions for patients whose drug tests detected the presence of illegal drugs, or showed that they were not taking their medication as directed.

Butner also accused medical director Kroll of approving prescriptions for back braces when it was “clearly medically unnecessary,” including some people who had injuries to a knee or elbow.

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This week, Tennessee-based Comprehensive Pain Specialists advised patients and employees about clinic closures, leaving patients scrambling to find new doctors willing to prescribe them opioids, according to a on WSMV television.

Based in the Nashville area, CPS opened in 2005 and quickly grew into a powerhouse, which has treated as many as 48,000 pain patients a month, at more than 50 clinics in Tennessee and other states.

CPS did not respond to numerous requests for comment.

The doctor-owned company has endured a series of recent setbacks, including earlier clinic closures, pending lawsuits over alleged debts and the criminal case against former CEO John Davis.

In April, a federal grand jury in Tennessee indicted Davis on criminal kickback charges. He has pleaded not guilty. CPS also has faced nearly a dozen civil lawsuits from contractors alleging unpaid debts, including suits brought by two of its former doctors. A Justice Department official said the closure was not related to the criminal case against Davis.

The shutdown of the clinics comes amid growing backlash against the use of opioids for treating chronic pain. The opioid crisis has cost the U.S. economy more than since 2001, estimates Altarum, an economic research firm. Since 1999, at least 200,000 people have died nationwide from overdoses, according to the Centers for Disease Control and Prevention.

According to the company’s website, CPS now operates 40 clinics in eight states: Arkansas, Illinois, Indiana, Kentucky, Mississippi, North Carolina, Ohio and Tennessee. Half are in Tennessee. The Tennessean Tuesday that all 21 clinics in the state would be closing by the end of the month.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug testing. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One nurse practitioner at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billing that year, according to Medicare records analyzed by KHN.

Peter Kroll, an anesthesiologist and one of CPS’ founders, said at the time that the tests were justified to monitor patients against risks of addiction or reduce chances the pills might be sold on the black market. Kroll, who is the company’s current CEO and medical director, billed Medicare $1.8 million for urine tests in 2015, agency records showed.

Kroll took charge of the business when Davis left the company abruptly last summer. He could not be reached for comment Tuesday.

Federal prosecutors charged Davis with accepting more than $750,000 in illegal bribes and kickbacks in a scheme that billed Medicare $4.6 million for durable medical equipment.

“As CEO, Davis oversaw the substantial expansion of CPS, recruiting new physicians and clinics to join CPS, as well as directing various aspects of the company’s overall treatment of patients,” prosecutors wrote in a May court filing.

Davis has pleaded not guilty. The U.S. attorney’s office has said in court filings that CPS and its employees are “victims” in the case.

The company also has been hit with civil suits. Anesthesiologist Donald E. Jones sued the company in May 2017, alleging that it failed to honor his employment contracts.

Jones said he joined the firm in 2012 to staff three Tennessee clinics at a salary of $30,000 a month plus a percentage of fees from laboratory and other services. Jones argued that he generated collections in excess of $9 million. In 2016, the clinics served 41,364 patients, the busiest of all the clinics, according to the suit.

But in April 2016, according to the suit, CPS quit paying him and in February 2017 the company began transferring his patients to other clinics and “making disparaging remarks” about him to patients.

CPS countered that Jones failed to deliver “safe and effective medical care, which CPS in court filings attributed to an “ongoing compensation dispute.” The suit is pending.

Pain specialist William Wagner also is suing the company. He said he relocated from New Mexico to open a CPS clinic in Anderson, S.C., lured by the promise of $30,000 a month in salary and a share of the profits from urine tests and other services.

Instead, according to Wagner, CPS failed to collect bills for services he rendered and then closed the clinic. CPS denies Wagner’s claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000. The case is pending.

Several contractors, including companies that leased office space and medical software, also have taken CPS to court alleging unpaid bills and leases, according to court filings. The cases are pending.

Kroll told KHN last year that he and fellow anesthesiologist  came up with the idea for CPS in August 2005, over a cup of coffee at a Nashville Starbucks. At the time, Tennessee was confronting an emerging opioid epidemic.

Kroll, raised in North Carolina, had moved to Nashville to launch a career in anesthesiology, a specialty he chose after watching his older brother die from an agonizing disease with little help from pain specialists.

Joined by two other doctors, Kroll and Dickerson opened with a single storefront in suburban Hendersonville. Dickerson, who was elected to the Tennessee Senate in 2012, remains at CPS, according to its website. Calls to Dickerson’s office were not returned.

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The Houston lab marketed a test to assess how a person’s genes affect tolerance for drugs such as opiates used to treat chronic pain. It also ran DNA tests to help treat cancer and urine screens to monitor drug abuse.

But the lab went bust last year after Medicare ordered it to repay more than $16 million for genetic tests health officials said were not needed.

Companion Dx is one of at least six clinical labs mired in bankruptcy court after Medicare alleged they improperly billed the government for unnecessary urine, genetic or heart disease tests expected to cause hundreds of millions dollars in losses to taxpayers, an investigation by Kaiser Health News found.

As the nation’s bill for drug and genetic tests has climbed to an estimated $8.5 billion a year, there’s mounting suspicion among health insurers that some testing may do more to boost profit margins than help treat patients.

Medicare has slashed fees for urine tests and tightened coverage of some genetic screens, which can cost Medicare $1,000 or more per person. Private insurers, who mostly have paid these bills without question, also are taking a more penetrating look at spending on the controversial lab work.

Yet, getting these firms to repay Medicare and private insurers remains a formidable challenge. While some doctor-owned labs have dodged collection efforts for years, several testing firms deeply in debt to Medicare appear to have few assets to repay overcharges dating back years, court records show.

“Medicare shouldn’t be paying for dubious tests, but the time to catch that is in the very beginning when [labs] are asking for payment,” said Steve Ellis, vice-president of Taxpayers for Common Sense, a budget watchdog group. “They need to increase oversight so the dollars don’t go out the door in the first place.”

A spokesman for the federal Centers for Medicare & Medicaid Services (CMS) had no comment. Neither did the Department of Justice, which represents the government’s interests in court.

Labs can run a range of genetic and drug tests using a saliva sample, blood or urine specimen. The price tag to Medicare can mount quickly, especially when doctors order highly specialized tests for large numbers of patients. Two bankrupt labs that federal officials say routinely overused tests to detect rare heart ailments in the elderly, for instance, could end up owing the government a total of more than $200 million, court records show.

Some labs have kept operating in bankruptcy while others liquidated equipment and sold off assets. Several bankruptcy trustees, whose duty is to ferret out assets, are suing suppliers, insurers and some doctors to recover funds.

Whether they can raise the pile of cash needed to repay Medicare is doubtful.

Companion Dx, according to bankruptcy records, had $117,497 cash on hand at the end of September. Medicare is seeking the return of $16.2 million paid to the company for services “not considered medically necessary,” according to a January court filing.

The Texas lab had no comment, but in court filings has blamed its collapse on disagreements with Medicare over the merits of its tests and government audits that retroactively disallowed claims. Medicare pays only for services it deems “medically necessary,” and audits typically take many years to complete.

Companion Dx opened in January 2012 expecting to “capture favorable profit margins that existed in connection with this cutting edge technology,” the company wrote in its bankruptcy filing.

However, starting in 2013, Medicare began having second thoughts about the validity of some tests and ultimately decided to cover them on just 1 percent of patients, according to the company. The lab declared bankruptcy in July 2016. The case is pending.

Iverson Genetic Diagnostics Inc. is another lab that turned to bankruptcy court as Medicare tried to reclaim $19.7 million, court records show. The case is pending.

Medicare took aim at the Seattle firm in November 2013 after reviewing “numerous” complaints of billings for genetic tests that patients “had not actually received,” federal officials wrote in a court filing.

A later federal audit concluded that Iverson had charged Medicare for tests that were “not reasonable and necessary.” In September 2015, about two months after Medicare called for the refund, the lab filed for bankruptcy.

Iverson denied overbilling Medicare and is appealing the Medicare decision, which it said in a court filing “was not based upon sufficient or proper evidence.” And Iverson denied wrongdoing in court filings.

Neither the lab, now located in Charleston, S.C., nor its lawyers would comment.

In another case, Pharmacogenetics Diagnostic Laboratory LLC in Louisville exited bankruptcy in late October without repaying Medicare $26.3 million for disallowed genetic tests. The lab, set up in 2004 by two University of Louisville professors, strongly disputed Medicare’s findings but said they were the “primary reason” for the bankruptcy, court records show.

Charity Neukomm, a lawyer for the lab, said another medical group agreed to purchase all its assets “free and clear of liens.” That left nothing for the government.

There’s also little chance that Natural Molecular Testing Corp., a defunct genetic testing lab, will repay the $71 million it owes Medicare, according to John Kaplan, an attorney for the bankruptcy trustee.

Kaplan said the lab near Seattle, which opened in 2010, was “printing money from billing Medicare” until the government suspended payments in April 2013. The company filed for bankruptcy in 2013 in the face of a Medicare audit of its billing and concern over its business practices, such as paying some doctors who ordered its tests as much as $10,000 a month in consulting fees, according to court records.

Five years in, the bankruptcy case is expected to settle next year, but there’s likely to be “no cash left” to repay Medicare, Kaplan said.

Critics argue that Medicare has been slow to assess the benefits of new and controversial tests and technologies — even when soaring costs signaled a warning of possible overuse.

Spending on genetic testing, for example, shot up from about $167 million in 2013 to more than $466 million a year later, according to Medicare billing data. In 2015, the program spent about $317 million on the tests and some $165 million last year. Government auditors credit tighter oversight for the sharp decline in billing.

Ellis, the budget watchdog, said the “huge jump” in these bills should have “sent out a red flag.”

Medicare officials don’t routinely verify that the sales claims labs make to doctors are rooted in scientific evidence. Some labs have hawked genetic tests as a tool for making pain management safer. The labs contend the tests can pinpoint the proper drugs and dosage for each patient based on their genetic makeup, thus reducing the threat of overdose or other injury.

However, many experts argue that the science hasn’t caught up to the sales pitch — and that some high-priced tests may do little to diagnose or treat illness.

Genetic tests “are not ready for prime time,” said Charles Argoff, professor of neurology at Albany Medical College in New York. He said their impact on medical care “hasn’t been measured.”

Court records show that the legal battles to recover assets from failed labs often plod on for years, especially when trustees believe labs paid illegal fees or other kickbacks to persuade doctors to order dubious tests.

“Some of these cases never go away,” said David Schumacher, a Boston health care lawyer who has defended doctors against these claims. Still, he said that even after years of legal wrangling Medicare often is unlikely to “be made whole and fully repaid.”

The trustee for Heart Diagnostic Laboratory, which marketed a panel of blood tests to detect heart disease and other illnesses before its June 2015 bankruptcy, has filed more than three dozen lawsuits to recover money paid to doctors and medical offices, including suspect consulting fees.

“Our analysis is that all of these payments were tainted and therefore we’re entitled to go after them,” said Richard Kanowitz. He added: “It’s an uphill battle.”

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Some of the seized records would show that Campbell endangered patients by prescribing opiates without any medical need, according to federal prosecutors. Campbell, who collected millions of dollars from Medicare for urine tests run at his office lab, also failed to act when test results revealed patients were abusing prescription and illegal drugs, according to a government medical expert’s report.

Four patients died from drug-related causes under his watch, the report said. Others flunked two dozen or more urine tests, but the clinic kept prescribing them pills. One patient with a history of overdoses failed 46 urine tests and was never confronted about it. Campbell denied wrongdoing.

The nation’s opioid crisis has prompted an explosion in urine testing. The scourge has driven huge profits for many pain clinics across the U.S., an ongoing Kaiser Health News investigation shows. Spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency, according to a KHN analysis of billing data from Medicare and private insurance billing from the Mayo Clinic.

Medicare and other insurers pay for urine tests with the expectation that clinics will use the results to detect and curb dangerous abuse. But some doctors have taken no action when patients are caught misusing pharmaceuticals, or taking street drugs such as cocaine or heroin. Federal pain guidelines say doctors should discuss test results with patients and taper medication if necessary.

Medicare and private insurers acknowledge that they lack the resources to routinely verify that doctors who order a high volume of drug-related tests do so to improve patient care, not fatten the bottom line.

“This is a big issue,” said Louis Saccoccio, who heads the National Health Care Anti-Fraud Association, a group formed by private insurers and government officials. “There are abusive practices out there.”

­In nearly a dozen recent criminal cases, prosecutors have cited evidence that doctors supplied opiates to patients with repeated abnormal urine test results.

One such doctor was Alabama pain specialist , who billed Medicare and private insurers over $9 million for urine tests solely “because he served to profit,” according to prosecutors in Alabama. He pleaded guilty to illegal prescribing and health care fraud. Earlier this year, a judge sentenced him to 15 years in prison.

Theodore Parran, who has served as an expert witness for the federal government, predicted more doctors could face fraud charges, or discipline by state medical licensing boards, over lab testing that appears to be profit-motivated.

“This is certainly on their radar,” Parran, a professor of medical education at Case Western Reserve University School of Medicine, said in an interview. Ignoring repeated abnormal urine tests “is bad medicine” that “endangers the safety of the patients and the community.”

°Õ³ó±ðÌýKHN investigation earlier this year found that dozens of pain doctors with their own labs took in $1 million or more in 2015 from Medicare for running urine and, in some cases, genetic drug tests. Some doctors derived at least 80 percent of their Medicare income this way.

Campbell’s office was among the clinics billing Medicare the most in the country, according to KHN’s data analysis of Medicare billing records.

Campbell and his staff at Physicians Primary Care PLLC billed the government agency a total of nearly $6 million for urine testing during 2014 and 2015, according to the KHN analysis.

In June, more than three years after the Indiana raid, a federal grand jury in Kentucky indicted Campbell and two associates. The charges — which were announced July 13 as part of a national health care fraud sweep — include multiple counts of illegally distributing prescription drugs and health care fraud; one fraud count accuses Campbell of ordering costly genetic tests through an outside lab that were “not medically necessary and never interpreted.” All of the defendants pleaded not guilty.

Neither Campbell nor his attorney, Page Pate, would comment for this story. However, in an interview with KHN several months before his indictment, Campbell said the government’s case was “without merit.” He denied he ran a “pill mill” and said he relied on his “state-of-the-art” lab, which serves the Jeffersonville clinic and a branch just across the Ohio River in Louisville, to help keep patients safe.

“We do a lot of drug testing for patients and we do it appropriately,” Campbell said.

Indeed, deciding how often to order these tests, and for which patients and drugs, can be a judgment call. Doctors also sometimes disagree over what action they should take against patients with “dirty” urine: Some doctors kick out drug abusers, while others argue that is unethical. Instead, doctors should counsel these patients and refer them for substance abuse treatment, they say.

Donald White, a spokesman for the U.S. Department of Health and Human Services’ Office of the Inspector General, said if test results are disregarded, “why is the test being ordered in the first place?”

“When abnormal urine drug test results are not acted upon by the physician who ordered the test, it raises concerns not only that the testing itself is not medically reasonable and necessary, but also that the doctor’s treatment of the patient may fall below the standard of care,” White said.

Prosecutors say Campbell kept them at bay for years by asserting that records seized in the raid, including computers and emails, contained privileged attorney communications. Clearing that hurdle delayed them from sending medical records to an outside expert for review, prosecutors said.

Indiana anesthesiologist Timothy King, who wrote the government medical expert’s report in the Campbell case, examined 19 patient files this year for his report. He concluded that Campbell “fails to practice medicine according to generally accepted medical principles and standards of care,” and “routinely” prescribed opiates “without a medical purpose.”

King said Campbell gave four patients a brew of pills known as the “Holy Trinity,” which King called “a street-popular combination of opiate, sedative and muscle relaxant that produces a heroin-like euphoria.”

These four patients were prescribed refills despite repeated abnormal urine tests. Two failed two dozen or more urine screens, according to King’s report.

All 19 patients repeatedly failed their tests, which King described as an obvious warning sign that they were ingesting prohibited drugs, or possibly peddling unused pills on the street.

“Urine drug screens are routinely inconsistent— [which can indicate] medication misuse, abuse and diversion,” the expert concluded.

The four people who died showed telltale signs of trouble such as admitting they had diverted some of their medicine, or had been visiting other doctors to feed pill habits according his report.

A 25-year-old woman identified only by the initials “CM” had “vague” complaints of lower-back pain and used drugs “for purposes of abuse and diversion,” according to King. She died three days after the clinic issued her a prescription for painkillers methadone and hydrocodone, King wrote. “EL,” who was homeless and disabled, died from a drug overdose in July 2014, also three days after her office visit, according to the report.

King also said Campbell appeared to order unnecessary tests, including X-rays, “to optimize billing.”

Less than a month after prosecutors received King’s report, a federal grand jury in Louisville indicted Campbell and nurse practitioners Dawn Antle and Mark Dyer.

All have pleaded not guilty. No trial date has been set.

Indiana officials quickly suspended their licenses to practice.

Prosecutors also are seeking forfeiture of Campbell’s Jeffersonville office building and other proceeds.

Attorneys for Antle and Dyer also had no comment. In the earlier interview with KHN, Campbell argued his practice attracts many difficult patients who have “no other option” to seek relief from pain. “Nobody else will see these people,” he said.

He ordered tests for a slew of substances because none of his drug-abusing patients “ever just uses one drug. They use everything they can get their hands on.”

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Gloved lab techs keep busy inside the cavernous facility, piping smaller urine samples into tubes. First there are tests to detect opiates that patients have been prescribed by CPS doctors. A second set identifies a wide range of drugs, both legal and illegal, in the urine. The doctors’ orders are displayed on computer screens and tracked by electronic medical records. Test results go back to the clinics in four to five days. The urine ends up stored for a month inside a massive walk-in refrigerator.

The high-tech testing lab’s raw material has become liquid gold for the doctors who own Comprehensive Pain Specialists. This testing process, driven by the nation’s epidemic of painkiller addiction, generates profits across the doctor-owned network of 54 clinics, the largest pain-treatment practice in the Southeast. Medicare paid the company at least $11 million for urine and related tests in 2014, when five of its professionals stood among the nation’s top billers. One nurse practitioner at the company’s clinic in Cleveland, Tenn., single-handedly generated $1.1 million in Medicare billings for urine tests that year, according to Medicare records.

Dr. Peter Kroll, one of the founders of CPS and its medical director, billed Medicare $1.8 million for these drug tests in 2015. He said the costly tests are medically justified to monitor patients on pain pills against risks of addiction or even selling of pills on the black market. “I have to know the medicine is safe and you’re taking it,” Kroll, 46, said in an interview. Kroll said that several states in which CPS is active have high rates of opioid use, which requires more urine testing.

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 — more than the entire budget of the Environmental Protection Agency. The federal government paid providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

Yet 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.

Tests to detect drugs in urine can be basic and cheap. Doctors have long used testing cups with strips that change color when drugs are present. The cups cost less than $10 each, and a strip can detect 10 types of drugs or more at once and display the results in minutes.

After noticing that some labs were levying huge charges for these simple urine screens, the Centers for Medicare & Medicaid Services moved in April 2010 to limit these billings. To circumvent the new rules, some doctors scrapped cup testing in favor of specialized — and much costlier — tests performed on machines they installed in their facilities. These machines had one major advantage over the cups: Each test for each drug could be billed individually under Medicare rules.

“It was almost a license to steal. You had such a lucrative possibility, it was very tempting to sell as many [tests] as you can,” said Charles Root, a longtime lab industry consultant whose company, CodeMap, has tracked the rise of testing labs in doctors’ offices.

Voluminous Drug Tests 

The CPS testing lab in Tennessee opened in 2013, not long before a pain specialist named William Wagner moved from New Mexico to open a CPS clinic in Anderson, S.C. He was lured by the promise of $30,000 a month in salary, which would grow as the clinic added patients and revenue, along with other benefits. His contract said he could be on-site for as little as 20 percent of the clinic’s operating hours.

When the company recruited him, Wagner said, he was told the job offered “potential to earn a great deal of money” from bonuses he would receive from services he generated, including a share of collections from lab services for urine tests done at the new Tennessee facility.

That did not happen, according to Wagner. He is suing CPS, saying that it failed to collect bills for services he rendered and then closed the clinic. CPS refutes Wagner’s claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000.

“All of their money was being made off of urine drug screens. They weren’t doing anything else properly,” Wagner said. The lawsuit is pending in federal court in Nashville.

Former CPS chief executive John Davis, in an interview, described the urine-testing lab as part of a “strategic expansion initiative” in which the company invested $6 million to $10 million in computerized equipment and swiftly acquired new clinics. Kroll, one of the owners of CPS, said the idea was to “take the company to the next level.”

Davis, who led the initiative before leaving the company in June, would not discuss the private company’s finances other than to say CPS is profitable and that lab profits “to a great degree” drove the expansion. “Urine screening isn’t the reason why we decided to grow our company. We wanted to help people in need,” Davis said.

Kroll acknowledged that urine tests are profit-makers, but stressed that verifying that patients aren’t abusing drugs gives him a “whole different level of confidence that I’m doing something right for the patients’ condition.”

He said his doctors try to be “judicious” in ordering urine tests. Kroll said some of his doctors and nurses treat “high-risk” patients who require more frequent testing. The company said that its Medicare billing practices, including urine screens, had withstood a “very in-depth” government audit.  The audit initially called for repayment of $25 million but was settled in 2016 for less than $7,000, according to the company. Medicare officials had no comment.

Kroll’s orthopedic career took a sharp turn more than a decade ago after watching his brother suffer through multiple surgeries for muscular dystrophy, along with bone fractures, stiffness and pain. His brother died at age 25, and Kroll decided to switch to anesthesiology and become a pain specialist.

“It sensitized me to the plight of people with chronic conditions that we have no medical answer for,” Kroll said. His brother “battled for his whole life.”

Kroll’s career change coincided with a national movement to establish pain management as a vital medical specialty, with its own accrediting societies and lobbying and political arm to advance its interests and those of patients.

Joined by three other doctors, he formed Comprehensive Pain Specialists at a storefront in suburban Hendersonville, Tenn. It quickly gained a foothold on referrals from local doctors unsure, or uneasy, about treating unyielding pain with heavy narcotics such as oxycodone, morphine and methadone.

In 2014, when CPS was among Medicare’s major urine-test billers, Tennessee led the nation in Medicare spending on urine drug tests run by doctors with in-house labs, according to federal billing records.

How Much Is Too Much?

There is wide disagreement among legislators, medical trade associations and the state boards that license doctors over the best approach to urine testing. One association of pain specialists argued in 2008 that urine testing could be done as often as weekly, while others have balked at that frequency.

Indiana’s medical board ordered mandatory urine tests for all pain patients in late 2013, only to face a lawsuit from the American Civil Liberties Union, which argued that the policy was unconstitutional and an unlawful search. Officials backed down the next year, and current policy states that testing can be done “at any time the physician determines that it is medically necessary.”

The federal Centers for Disease Control and Prevention, wary of both cost and privacy concerns, declined to set a definitive national standard despite years of debate. In long-awaited guidelines issued in March 2016, the CDC called for testing at the start of opioid therapy and once a year for long-term users. Beyond that, it said, testing should be “left up to the discretion” of the medical professional.

There is likewise little scientific justification for many of these new types of drug testing that have made their way onto doctors’ order sheets and laboratory menus.

Many pain patients on opioids are routinely tested for phencyclidine, an illegal, hallucinogenic drug also known as PCP, or angel dust, Medicare records show. Yet urine tests have rarely detected the drug. Millennium, the San Diego-based company that once topped Medicare billings for urine tests, found PCP in fewer than 1 percent of all patient samples, according to federal court filings.

In a tour of the CPS lab, Chief Operations Officer Jeff Hurst, who has more than two decades of experience working for commercial labs, rattled off a list of drugs ranging from cocaine to heroin and methamphetamine, which he said was “really big in East Tennessee.”

How often urine tests reveal serious drug abuse — or suggest patients might be selling some of their medications instead of taking them — is tough to pin down. Asked during a tour of the laboratory in Tennessee if CPS could provide such data, Hurst said he did not have it; Kroll said he didn’t either.

Hurst said the lab often ends up doing a “long list of tests” because CPS doctors are prescribing dangerous drugs that may be deadly if abused and “need to know what patients are taking.” Prescribed drugs, such as opiates and tranquilizers, are also measured at the CPS lab.

Government officials have criticized the explosive growth in testing for some prescription drugs, notably a class of tranquilizers known as tricyclic antidepressants. Medicare paid more than $45 million in 2014 for more than 200,000 people to be tested for tricyclic drugs, often multiple times. Medicare was billed for 644,495 tests for one tricyclic drug, amitriptyline, up from 6,173 tests five years earlier.

The Department of Justice argued in a 2012 whistleblower case that these tests often couldn’t be justified because of “low abuse potential” of the drugs and a “lack of abuse history for the vast majority of patients.”

Income Breakdown Raises ‘Red Flag’

When told that drug screens accounted for most of the Medicare income for dozens of pain doctors, federal officials said that was troubling.

“Doctors who receive the lion’s share of their Medicare funds from urine drug testing would certainly raise a red flag,” said Donald White, a spokesman for the Department of Health and Human Services’ Office of the Inspector General. “Confirmation of fraud would require federal investigation and a formal judicial proceeding.”

In a report released last fall, the watchdog office said some uptick in testing might be justified by the drug abuse epidemic, but noted that the situation also “could provide cover for labs that might seek to fraudulently bill Medicare for unnecessary drug testing.”

Medicare pays only for services it considers “medically necessary.” While that sometimes can be a judgment call, pain clinics that adopt a “one-size-fits-all” approach to urine testing may find themselves under suspicion, said Mehta, the assistant U.S. attorney in Florida.

Mehta’s office investigated a network of Florida clinics called Coastal Spine & Pain Center for alleged over-testing, including routinely billing for a second round of expensive tests simply to confirm earlier findings. In a press in August 2016, the government argued that these tests were “medically unnecessary.” The company paid $7.4 million last year to settle the False Claims Act case. Coastal Spine & Pain, which did not admit fault, had no comment.

Four Coastal Spine & Pain doctors were among the top 50 Medicare billers during 2014, when they charged nearly $6 million for drug tests, according to Medicare billing data analyzed by KHN.

Starting in 2016, Medicare began to crack down on urine billings as part of a federal law that is supposed to reset lab fees for the first time in three decades. Now tougher scrutiny of urine testing, and cuts in reimbursements, may be threatening CPS — or at least its profits.

CPS closed nine clinics last year and told its doctors that urine-testing revenue had dropped off 32 percent in the first quarter of the year, according to a letter then-CEO Davis sent its physician partners.

Davis said the company had to “make some changes” because of cuts in Medicare reimbursements for urine tests and other medical services. A company spokeswoman told KHN that the drop in urine revenue worsened through 2016 but has bounced back somewhat this year.

Despite the cuts, privately held CPS plans to open new clinics this year. Urine testing will remain a key service — for keeping patients safe, it said. CPS is just playing by the rules of the game. “Tell us how often to test,” said Hurst, the operations officer, “and we’ll be happy to follow it.”

KHN’s coverage related to aging & improving care of older adults is supported by .

‘Liquid Gold’ Investigation: Sifting Through The Data

Kaiser Health News relied on from Medicare’s fee-for-service program, available from the Centers for Medicare & Medicaid Services to analyze the prevalence and cost of urine drug testing and related genetic testing. Doctors and laboratories bill Medicare using standard codes. KHN consulted with several billing experts in the field and used government documents to identify relevant billing codes for this analysis.

Medicare reimburses providers for each code they bill based on a standard amount that allows for some geographic variation. Each code represents a type of test, and multiple tests can be done on a single urine sample; therefore, the amount that providers bill for a single sample of urine varies greatly.

Medicare’s Part B payment data is publicly available only for the years 2012 through 2015. KHN acquired historical data from the consulting firm going back to 2005 to analyze trends in billing.

KHN also teamed up with researchers at the Mayo Clinic to analyze claims data for private insurers and Medicare Advantage to estimate the total cost per year, which in 2014 was roughly $8.5 billion for private plus government payers. Mayo Clinic researchers accessed data from the Data Warehouse, which includes health insurance claims that cover about 20 million patients per year. The analysis included claims from physicians and independent labs, and excluded any facility (hospital or outpatient) fees. To estimate the yearly cost, KHN took the total cost per enrollee from the Mayo Clinic data analysis and applied it to the estimated populations for both private insurance (from the ) and Medicare Advantage (from CMS’ ). This is a rough estimate because the OptumLabs claims might not reflect some variations in medical care costs and health conditions across the country.

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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