Prescription Opioids Play Only Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

The role of prescription opioids in the nation’s overdose crisis continues to shrink.

In a new study from the drug testing firm Millennium Health, researchers say multiple substances were found last year in nearly 93% of urine samples in which fentanyl was detected. That is not altogether surprising, as “polysubstance” use increased as fentanyl came to dominate the illicit drug supply, appearing in more and more street drugs such as heroin, cocaine and methamphetamine.

What is surprising is the minimal role that prescription opioids now play. In 2013, opioid pain medication was the most common substance found in fentanyl-positive drug tests in the United States, appearing in over 70% of urine samples.  A decade later, prescription opioids were detected in less than one in ten samples — ranking far behind methamphetamine, cannabis, cocaine and heroin.

In fact, you are about twice as likely to find two other medications -- benzodiazepines (15.8%) and gabapentin (13.3%) -- than you are prescription opioids (7.6%) in urine samples testing positive for fentanyl.

Substances Detected in Fentanyl-Positive Drug Tests (2023)

MILLEnNIUM HEALTH

Millennium based its findings on over 4.1 million urine drug tests (UDTs) collected from 2013 to 2023 and analyzed through mass spectrometry. Because many of those samples came from people being treated for a substance use disorder, they offer a clear insight into drug trends that are driving the overdose crisis.

Now in its “fourth wave,” Millennium says a tidal shift has occurred in the so-called opioid epidemic, with illicit drug users far more likely to use non-opioid substances like stimulants than prescription opioids.

“National, regional, and state-level UDT data all suggest that people who use fentanyl are now, intentionally or unintentionally, much more likely to also use methamphetamine and cocaine,” the report found. “The results of our analyses also reveal shifting patterns of opioid use among those who use fentanyl. More specifically, they showed progressive declines in prescription opioid use from 2015 to 2023.”

The declining role of prescription opioids can be traced back to the 2016 CDC opioid guideline and a multiyear campaign by the DEA to slash opioid production quotas, which has reduced the supply of oxycodone and hydrocodone by about two-thirds. There is little evidence either of those federal efforts reduced the number of overdoses. The CDC estimates there were over 111,000 drug deaths in the 12-month period ending in September 2023 — nearly double the number of fatal overdoses in 2016.

The growing use of stimulants such as methamphetamine makes it difficult for public health campaigns to address the problem. Unlike opioids, there are no FDA-approved medications for stimulant use disorder, leaving behavioral therapies and abstinence as the only “evidence-based” treatments for people with a stimulant problem.

“Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences,” Millennium said.

Drug Tests Show Pain Patients on Opioids Less Likely to Use Illicit Drugs

By Pat Anson, PNN Editor

In an effort to reduce soaring rates of drug abuse and overdoses, many physicians have taken their pain patients off opioids and switched them to “safer” non-opioid drugs like pregabalin, gabapentin and duloxetine. Others have encouraged their patients to try non-pharmacological treatments, such as acupuncture, massage and meditation.

That strategy may be backfiring, according to a large new study by Millennium Health, which found that pain patients prescribed opioids are significantly less likely to use illicit drugs than pain patients not getting opioids.

The drug testing firm analyzed urine drug samples from 2019 to 2021 for nearly 55,000 patients being treated by U.S. pain management specialists. About 80% of the patients were prescribed an opioid like oxycodone or hydrocodone, while the other 20% were not prescribed opioids.

Millennium researchers say detectable levels of illicit fentanyl, heroin, methamphetamine and cocaine were far more likely to be found in the urine of non-opioid patients than those who were prescribed opioids. For example, illicit fentanyl was detected in 2.21% of the patients not getting an opioid, compared to 1.169% of those who were. The findings were similar for heroin, methamphetamine and cocaine.

“In all cases, we found that the population that was not prescribed an opioid was significantly more likely to be positive for an illicit drug than those patients who were prescribed opioids,” said lead author Penn Whitley, Director of Bioinformatics at Millennium. “(There was) a 40 to 60 percent increase in the likelihood of being positive if you were not prescribed an opioid.”

Illicit Drug Use By Pain Patients

MILLENNIUM HEALTH

What do the findings mean? Are pain patients getting ineffective non-opioid therapies so desperate for relief that they’re turning to illicit drugs? That’s possible, but the study doesn’t address that specifically.

Another possibility is that patients on opioids are simply being more cautious and careful about their drug use. Opioid prescribing in the U.S. has fallen by 48% over the past five years, with many patients being forcibly tapered or abandoned by doctors who feel pressured to reduce their prescribing.  

“Unfortunately, a lot of people with chronic pain have learned that it’s a bit tenuous, that their doctors are feeling pressure, and if they want to maintain their access (to opioids), they need their PDMP (Prescription Drug Monitoring Program) and their drug tests to look the way they need to look, so their doctor can feel comfortable continuing to prescribe,” said co-author Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium. “I do think they realize that they’re on a treatment and that access to it is not guaranteed.”   

Preliminary findings from the study were released today at PainWeek, an annual conference for pain management providers. The findings mirror those from another Millennium study earlier this year, which found that pain patients have lower rates of illicit drug use than patients being treated by other providers.     

“If your main way of protecting people in pain from getting involved in substance abuse is to limit their access to opioids, there’s at least a hint here that’s not the right approach,” Passik told PNN. “It’s not a definitive statement by any stretch of the imagination, but it’s an approach to patient safety that leaves a bit to be desired.”  

Another recent study at the University of Texas also found that restricting access to opioids is “not a panacea” and may even lead to more overdoses.  Researchers found that in states that mandated PDMP use, opioid prescribing decreased as intended, but heroin overdose deaths rose 50 percent.

“Past research has shown that when facing restricted access to addictive substances, individuals simply seek out alternatives rather than limiting consumption,” said lead author Tongil Kim, PhD, an assistant professor of marketing at University of Texas at Dallas. “In our case, we measured overdose deaths as a proxy and found a substantial increase, suggesting that the policy unintentionally spurred greater substitution.”

Pain Patients Have Low Rates of Illicit Drug Use

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that opioid medication is a gateway drug to heroin and other street drugs. That myth is so ingrained in the medical community that many pain patients are discriminated against by doctors and pharmacists, who suspect they are abusing their medication or using illicit drugs.

But a large new study by Millennium Health pokes a hole in that myth, finding that patients being treated in pain management practices are far less likely to use heroin, fentanyl, cocaine and methamphetamine than other patients.

The drug testing firm analyzed the lab results of two million urine tests from 2015 to 2021 – nearly 600,000 coming from pain patients -- and found that patients seeing primary care physicians, behavioral health doctors (psychiatrists and psychologists), or getting substance use disorder (SUD) treatment were significantly more likely to test positive for street drugs than patients of pain management providers.

SOURCE: MILLENNIUM HEALTH

“That’s one of the reasons why we decided to put this out there in the public domain, because it’s important. Because clearly there are differences across these groups,” said Eric Dawson, PharmD, Vice President of Clinical Affairs at Millennium Health.

For example, the positivity rate for fentanyl in urine samples is about 2% for pain management patients – a level that remained stable throughout the 6-year study period.

But Millennium found that for primary care and behavioral health patients, the positivity rate for fentanyl has ticked up to about 5 percent.

In patients getting SUD treatment, the positivity rate has skyrocketed to about 17 percent, no doubt a reflection of the growing presence of illicit fentanyl in street drugs.

Positivity rates for methamphetamine are also rising for most patients – but not for pain patients – while cocaine use has remained relatively flat. Positivity rates for heroin have declined steadily for all patients since 2015, according to Millennium.

“Generally speaking, the pain population that’s treated with opioids is an older population and uses illicit drugs at a very low rate,” said Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium.

“Not only are they low, they remain low,” says Dawson. “So many of the other groups, over time their positivity rates are increasing. The pain population started low and remains low. And that says they are different than the other groups.”

What makes the findings even more striking is that they include the first two years of the covid pandemic, a time when stress, isolation and depression led many people to abuse drugs.

“But that did not happen in the pain patients. You can actually see that,” says Passik, who believes regular drug testing makes pain management patients less likely to take risks that might affect their healthcare. He thinks the Millennium study should be reviewed by both providers and policymakers to get a better understanding of people in pain.

“There isn’t that much data like this out there. I think it’s unique and very positive about this population. And I think that should be factored in when people are talking about access to opioids,” Passik told PNN.

In addition to fentanyl, heroin and other street drugs, the Millennium study also looked at positivity rates for marijuana, which have soared in recent years due to the legalization of medical and recreational cannabis in many states. By the end of 2021, the positivity rate for cannabis had reached nearly 32 percent for most patients. But, like the other drugs, cannabis use remained relatively low for pain patients.  

Abuse of Rx Opioid Painkillers Unchanged During Pandemic

By Pat Anson, PNN Editor

An alarming spike in U.S. overdose deaths during the COVID-19 pandemic does not appear to be fueled by increased abuse of opioid painkillers, according to a new nationwide analysis of urine drug tests.

The Drug Enforcement Administration approved an exemption last year allowing patients to connect with doctors via telehealth – without a physical examination -- to get prescriptions for opioids and other controlled substances. While the relaxed rules made it easier for patients to get pain medication during the pandemic, they have not resulted in more diversion or abuse of oxycodone and hydrocodone, according to the Millennium Health Signals Report. Urine positivity rates for the two opioids remained flat during 2020.

“Despite the hardships faced during the pandemic, it is encouraging to see that positivity rates for non-prescribed use of hydrocodone and oxycodone have not changed,” said Michael Parr, MD, an addiction treatment specialist and consultant to Millennium.

“Patients requiring opioids for the treatment of pain have faced difficulty obtaining medications, as well as stigma, before the pandemic. Perhaps this data will reassure clinicians who have taken additional steps to safely prescribe these medications during the pandemic.”

There was an uptick in positivity rates for non-prescribed tramadol, a weaker opioid, particularly in Ohio, Tennessee and Kentucky. Millennium said there were more cases of people with substance use disorders using tramadol as their “drug of preference.”

Millennium researchers also found that positivity rates for non-prescribed gabapentin (Neurontin) showed little change in 2020 – but they remain at levels nearly three times higher than positivity rates for oxycodone, hydrocodone and tramadol. The abuse of non-prescribed gabapentin did rise significantly in Ohio and Virginia.

POSITIVITY RATES FOR NON-PRESCRIBED PAIN MEDICATIONS

SOURCE: MILLENNIUM HEALTH

The abuse of gabapentin has been going on for years, but with little public attention. Gabapentin is a non-opioid nerve medication increasingly prescribed for pain, despite the fact many patients say it doesn’t help and has too many side effects. Drug abusers, however, have found that gabapentin can heighten the effect of heroin and other street drugs.

While positivity rates for non-prescribed pain medication were mostly unchanged during the pandemic, they soared for illicit fentanyl and methamphetamine, increasing 78% and 29%, respectively.

After initially increasing in the early stages of the COVID-19 crisis, Millennium found that positivity rates for cocaine and heroin soon returned to pre-pandemic levels.

Another encouraging sign is that positivity rates for carfentanil, a deadly fentanyl analogue, have flatlined to nearly zero. It is unclear why carfentanil abuse has fallen so sharply, but Millennium said it may be because the pandemic has disrupted manufacturing and supply routes from China.     

Drug Tests Show Kratom Use Doubled in U.S.

By Pat Anson, PNN Editor

Kratom use in the U.S. appears to have doubled in the last two years, according to a large analysis of urine drug tests by Millennium Health. The first of its kind study also found that nearly 1 out of 4 people who tested positive for kratom were abusing opioids, benzodiazepines or other substances.

Kratom is an herbal supplement that millions of Americans use to self-treat their chronic pain, anxiety, depression and addiction. It comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever.

Millennium Health analyzed over 400,000 urine samples collected from 2017 to 2019, using liquid chromatography mass spectrometry to test for mitragynine and 7-hydroxymitragynine, two alkaloids that are the active ingredients in kratom.

The drug tests were ordered for patients by doctors in primary care, pain management and addiction treatment. As a result, the findings may not represent the typical kratom user.

Positivity rates for kratom doubled over the study period, rising from 0.9% in January 2017 to 1.8% in November 2019. Use of kratom rose in every section of the country, with the highest positivity rates reported in Idaho (4.2%), Montana (2.9%), Colorado (2.3%), Utah (2.3%) and Florida (2.1%).

The American Kratom Association generously estimates that over 15 million Americans use kratom. As interest in the herbal supplement has grown, so have the number of doctors ordering drug tests to see if their patients are using it.

“There are clinicians out there, that are caring for these type patients, that are likely to have kratom users in their population. It’s a small number, about 2 percent or so, but it’s likely increasing,” says Eric Dawson, PharmD, Vice-President of Clinical Affairs for Millennium.

One of the more surprising aspects of the study was how many kratom users were abusing other substances. For urine samples testing positive for kratom, nearly 25% were also found to be positive for non-prescribed opioids and 22% tested positive for non-prescribed benzodiazepines, an anti-anxiety drug.

Methamphetamine, fentanyl, cocaine and heroin were also more likely to be detected in positive samples for kratom versus those that tested negative.

SOURCE: MILLENNIUM HEALTH

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Many also use kratom to self-treat alcoholism or opioid addiction.

“You have these two camps, very pro-kratom and very anti-kratom. We purposely tried not to fall into either one and simply answer the questions we were being asked and see what the data is,” Dawson told PNN. “I’m very interested to see what happens to kratom moving forward in the next few years because the benefits are very compelling, but conversely so are the negatives. It’s quite an interesting compound for sure.”  

Most federal agencies take a dim view of kratom. The FDA says kratom is addictive, has opioid-like qualities, and should not be used for any medical condition. The CDC has linked kratom to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

Although kratom remains legal at the federal level, several states have banned kratom and some counties and cities have enacted local ordinances prohibiting sales.

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Doctors Soak Up Profits With Urine Drug Tests

By Fred Schulte and Elizabeth Lucas, Kaiser Health News

The cups of urine travel by express mail to the Comprehensive Pain Specialists lab in an industrial park in Brentwood, Tenn., not far from Nashville. Most days bring more than 700 of the little sealed cups from clinics across 10 states, wrapped in red-tagged waste bags. The network treats about 48,000 people each month, and many will be tested for drugs.

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.

kaiser health news (Heidi de Marco)

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.

$8.5 Billion in Urine Tests

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.

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.

“We’re focused on the fact that many physicians are making more money on testing than treating patients,” said Jason Mehta, an assistant U.S. attorney in Jacksonville, Fla. “It is troubling to see providers test everyone for every class of drugs every time they come in.”

 ‘Almost a License to Steal’

As alarm spread about opioid deaths and overdoses in the past decade, doctors who prescribed the pills were looking for ways to prevent abuse and avert liability. Entrepreneurs saw a lucrative business model: persuade doctors that testing would keep them out of trouble with licensing boards or law enforcement and protect their patients from harm. Some companies offered doctors technical help opening up their own labs.

A 2011 whistleblower lawsuit against one of the nation’s top billers for urine tests, a San Diego-based laboratory owned by Millennium Health LLC, underscores the potential for profit.

“Doctor,” one lab representative said during sales calls, according to an affidavit, “drug testing is not about medicine but about making money, and I am going to show you how to make a lot of money.”

Millennium Health, billing records show, took in more than $166 million from Medicare in 2014 despite being the target of at least eight whistleblower cases alleging fraud over the past decade. A Millennium sales manager involved in a 2012 case in Massachusetts reported earning $700,000 in salary and sales commissions in the previous year.

Millennium encouraged doctors to order more tests both as a way to lower patients’ risks and to shield the physicians against possible investigations by law enforcement or medical licensing boards, according to court filings. Millennium denied the allegations in the whistleblower suits and settled all of them with the Justice Department in 2015 by agreeing to pay $256 million; its parent company, Millennium Lab Holdings II, declared bankruptcy.

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.

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.

pain exhibit (Mark collen)

“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 release 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.”

Kaiser Health News is national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Study Depicts Half of Americans as Rx Abusers

 By Pat Anson, Editor

Over half of Americans “misused” their prescription drugs last year, according to a new report by a drug testing company that appears to draw several broad and misleading conclusions about the use of opioid pain medication.

Quest Diagnostics analyzed drug testing data from over 3 million patients and found that 54% had some type of prescription drug misuse in 2015 – down from 63% in 2011.

"The key takeaway from this massive, nationally representative analysis is that despite some gains, a large number of patients use prescription drugs inappropriately and even dangerously," said co-researcher Harvey W. Kaufman, MD, senior medical director for Quest Diagnostics.

"The CDC's recent recommendations to physicians to carefully weigh the risks and benefits of opioid drug therapy are a step in the right direction, but clearly more needs to be done to address this public health crisis."

The term “misuse” should be taken with a grain of salt, because it does not mean patients were abusing or addicted to prescription drugs – only that they did not take them as directed.

In 2015, for example, the study found that over half (55%) of the patients who had “inconsistent” test results did not have a prescribed drug in their system – meaning they no longer felt a need to take a medication, didn’t like the drug’s side effects, forgot to take it, or simply couldn’t afford it. It could also mean the drug was ineffective. the wrong drug was prescribed or the doctor made an incorrect diagnosis. There are literally dozens of reasons someone could stop taking a drug.

But patients who had no drugs detected – legal or illegal – were still classified in the “misuse" category.

Nevertheless, while acknowledging there were “methodology limitations” to the study, Quest made some sweeping conclusions about it in a press release, claiming that “the majority of American adults taking opioids and other commonly prescribed medications use them in ways that put their health at risk.”

But according to the study, opioids were not the most commonly misused class of medication. Depending on the age of the patient, that distinction went to amphetamines, benzodiazepines and marijuana. Opiates were the second most likely class of drugs to be misused by adults – but again that includes many patients who did not take opioids that were prescribed or had no drugs at all in their system.

This way of slicing the data has long been used by drug testing companies to make the abuse of opioids appear worse than it is and to justify more testing.

A similar study by Ameritox in 2012 found that nearly a third of older patients did not have a prescribed opioid detected in their urine -- and that was also considered misuse.

“This population has a risk of medication misuse and illicit drug use that warrants attention,” said Harry Leider, MD, who was then Chief Medical Officer of Ameritox. “This data provides a compelling rationale for routinely monitoring medication use in older patients on chronic opioids.”

Ameritox sponsored a study that same year claiming that patients should be drug tested at least four times annually if a doctor believes they are at risk misusing opioids.  The study was approved even though “there currently is a limited evidence base to support the expert panel’s recommendations.”

Guidelines adopted by the CDC earlier this year were also based on weak evidence. They recommend that physicians should use urine drug testing before starting opioid therapy and should re-test patients at least once annually.

As Pain News Network has reported, “point-of-care” urine drug tests that are widely used in doctors’ offices are wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone.

According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019. The competition between drug screening labs is intense and several companies have been fined by the federal government for giving illegal kickbacks to physicians. Last year, Millennium Health agreed to pay $256 million to the federal government to settle fraud and kickback charges. The company later filed for chapter 11 bankruptcy protection.