This story additionally ran on Bloomberg. This story will be republished without cost (details).
In April 2014, state and federal drug brokers raided Jeffrey Campbell’s medical clinic in Jeffersonville, Ind. Police vehicles blocked the car parking zone as bewildered sufferers scattered and the brokers carted off packing containers of data from the physician’s workplace.
Some of the seized data would present that Campbell endangered sufferers by prescribing opiates with none medical want, in accordance with federal prosecutors. Campbell, who collected thousands and thousands of dollars from Medicare for urine exams run at his workplace lab, additionally didn’t act when check outcomes revealed sufferers had been abusing prescription and unlawful medicine, in accordance with a authorities medical knowledgeable’s report.
Four sufferers died from drug-related causes below his watch, the report mentioned. Others flunked two dozen or extra urine exams, however the clinic saved prescribing them drugs. One affected person with a historical past of overdoses failed 46 urine exams and was by no means confronted about it. Campbell denied wrongdoing.
The nation’s opioid disaster has prompted an explosion in urine testing. The scourge has pushed big earnings for a lot of ache clinics throughout the U.S., an ongoing Kaiser Health News investigation reveals. Spending on urine screens and associated genetic exams quadrupled from 2011 to 2014 to an estimated $Eight.5 billion a 12 months — greater than your complete price range of the Environmental Protection Agency, in accordance with a KHN evaluation of billing information from Medicare and personal insurance coverage billing from the Mayo Clinic.
Medicare and different insurers pay for urine exams with the expectation that clinics will use the outcomes to detect and curb harmful abuse. But some medical doctors have taken no motion when sufferers are caught misusing prescribed drugs, or taking avenue medicine equivalent to cocaine or heroin. Federal ache pointers say medical doctors ought to talk about check outcomes with sufferers and taper treatment if essential.
A lab technician inspects a urine pattern on the Comprehensive Pain Specialists lab in Brentwood, Tenn., in February. (Heidi de Marco/KHN)
Medicare and personal insurers acknowledge that they lack the assets to routinely confirm that medical doctors who order a excessive quantity of drug-related exams achieve this to enhance affected person care, not fatten the underside line.
“This is a big issue,” mentioned Louis Saccoccio, who heads the National Health Care Anti-Fraud Association, a gaggle fashioned by non-public insurers and authorities officers. “There are abusive practices out there.”
In almost a dozen current legal instances, prosecutors have cited proof that medical doctors provided opiates to sufferers with repeated irregular urine check outcomes.
One such physician was Alabama ache specialist Shelinder Aggarwal, who billed Medicare and personal insurers over $9 million for urine exams solely “because he served to profit,” in accordance with prosecutors in Alabama. He pleaded responsible to unlawful prescribing and well being care fraud. Earlier this 12 months, a choose sentenced him to 15 years in jail.
Theodore Parran, who has served as an knowledgeable witness for the federal authorities, predicted extra medical doctors might face fraud costs, or self-discipline by state medical licensing boards, over lab testing that seems to be profit-motivated.
“This is certainly on their radar,” Parran, a professor of medical training at Case Western Reserve University School of Medicine, mentioned in an interview. Ignoring repeated irregular urine exams “is bad medicine” that “endangers the safety of the patients and the community.”
The KHN investigation earlier this year discovered that dozens of ache medical doctors with their very own labs took in $1 million or extra in 2015 from Medicare for operating urine and, in some instances, genetic drug exams. Some medical doctors derived not less than 80 p.c of their Medicare earnings this manner.
Campbell’s workplace was among the many clinics billing Medicare essentially the most within the nation, in accordance with KHN’s information evaluation of Medicare billing data.
Campbell and his employees at Physicians Primary Care PLLC billed the federal government company a complete of almost $6 million for urine testing throughout 2014 and 2015, in accordance with the KHN evaluation.
John Kuhn Jr., U.S. lawyer for the Western District of Kentucky, in July introduced a variety of well being care fraud indictments, a part of a nationwide sweep that charged a whole lot of defendants. (Courtesy of the U.S. Department of Justice)
In June, greater than three years after the Indiana raid, a federal grand jury in Kentucky indicted Campbell and two associates. The costs — which had been introduced July 13 as a part of a nationwide well being care fraud sweep — embrace a number of counts of illegally distributing pharmaceuticals and well being care fraud; one fraud depend accuses Campbell of ordering expensive genetic exams by an outdoor lab that had been “not medically necessary and never interpreted.” All of the defendants pleaded not responsible.
Neither Campbell nor his lawyer, Page Pate, would remark for this story. However, in an interview with KHN a number of months earlier than his indictment, Campbell mentioned the federal government’s case was “without merit.” He denied he ran a “pill mill” and mentioned he relied on his “state-of-the-art” lab, which serves the Jeffersonville clinic and a department simply throughout the Ohio River in Louisville, to assist hold sufferers secure.
“We do a lot of drug testing for patients and we do it appropriately,” Campbell mentioned.
Indeed, deciding how typically to order these exams, and for which sufferers and medicines, could be a judgment name. Doctors additionally generally disagree over what motion they need to take in opposition to sufferers with “dirty” urine: Some medical doctors kick out drug abusers, whereas others argue that’s unethical. Instead, medical doctors ought to counsel these sufferers and refer them for substance abuse therapy, they are saying.
(Garth Superville for KHN)
Donald White, a spokesman for the U.S. Department of Health and Human Services’ Office of the Inspector General, mentioned if check outcomes 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 mentioned.
Prosecutors say Campbell saved them at bay for years by asserting that data seized within the raid, together with computer systems and emails, contained privileged lawyer communications. Clearing that hurdle delayed them from sending medical data to an outdoor knowledgeable for assessment, prosecutors mentioned.
KHN Investigation
Indiana anesthesiologist Timothy King, who wrote the federal government medical knowledgeable’s report within the Campbell case, examined 19 affected person information this 12 months 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 mentioned Campbell gave 4 sufferers a brew of drugs often called the “Holy Trinity,” which King known as “a street-popular combination of opiate, sedative and muscle relaxant that produces a heroin-like euphoria.”
These 4 sufferers had been prescribed refills regardless of repeated irregular urine exams. Two failed two dozen or extra urine screens, in accordance with King’s report.
All 19 sufferers repeatedly failed their exams, which King described as an apparent warning signal that they had been ingesting prohibited medicine, or presumably peddling unused drugs on the road.
“Urine drug screens are routinely inconsistent— [which can indicate] medication misuse, abuse and diversion,” the knowledgeable concluded.
The 4 individuals who died confirmed telltale indicators of bother equivalent to admitting they’d diverted a few of their medication, or had been visiting different medical doctors to feed capsule habits in accordance his report.
A 25-year-old girl recognized solely by the initials “CM” had “vague” complaints of lower-back ache and used medicine “for purposes of abuse and diversion,” in accordance with 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, additionally three days after her workplace go to, in accordance with the report.
King additionally mentioned Campbell appeared to order pointless exams, together with X-rays, “to optimize billing.”
Less than a month after prosecutors obtained King’s report, a federal grand jury in Louisville indicted Campbell and nurse practitioners Dawn Antle and Mark Dyer.
All have pleaded not responsible. No trial date has been set.
Indiana officers rapidly suspended their licenses to apply.
Prosecutors are also looking for forfeiture of Campbell’s Jeffersonville workplace constructing and different proceeds.
Attorneys for Antle and Dyer additionally had no remark. In the sooner interview with KHN, Campbell argued his apply attracts many tough sufferers who’ve “no other option” to hunt reduction from ache. “Nobody else will see these people,” he mentioned.
He ordered exams for a slew of drugs as a result of none of his drug-abusing sufferers “ever just uses one drug. They use everything they can get their hands on.”
KHN’s protection associated to growing older and bettering care of older adults is supported partially by The John A. Hartford Foundation.
Fred Schulte: fschulte@kff.org”>fschulte@kff.org, @fredschulte
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