The CDC and Profit Driven Drug Testing

(Editor’s Note: As part of its draft opioid prescribing guidelines, the Centers for Disease Control and Prevention (CDC) recommends that physicians “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.”  Mark Collen is an expert in this field and has submitted the following to the CDC.)

By Mark Collen, Guest Columnist

There are a number of conflating factors which have led to the CDC‘s recommendation for urine drug testing (UDT) in pain management -- none of which have to do with quality patient care. These include the federal government‘s complicity in the overprescribing of drugs, the unethical marketing of OxyContin by Purdue Pharma, the profit motive which drove drug testing patients in pain, and physicians‘ fears and inability to effectively treat pain.

We live in a drug addled society with Americans consuming record amounts of prescription drugs, including opioids. In other words, American healthcare providers are exceptional at writing prescriptions. Someone needs to tell them to, “Just say no.”

The pharmaceutical industry‘s direct-to-consumer advertising (DTCA) has driven demand for drugs and has contributed to the escalating cost of prescription medications. Both Congress and the FDA are largely responsible for this overprescribing public health issue since they have allowed DTCA to exist and spread.

What has not been investigated is the influence the incessant drug ads have had on the American culture and more importantly, the American psyche in terms of one‘s views on drug use, prescription or otherwise. Almasi and colleagues write, “DTCA pushes a ‘Brave New World‘  where if anything unpleasant should somehow happen, why, there‘s always [the sedative] soma to give you a holiday from the facts.” DTCA may influence the abuse of opioids and other drugs.

The pharmaceutical company Purdue Pharma was responsible for one of the most deceptive marketing campaigns in history with their medication OxyContin, a timed-release oxycodone. Art Van Zee writes, “A consistent feature in the promotion and marketing of OxyContin was a systematic effort to minimize the risk of addiction in the use of opioids for the treatment of chronic non–cancer-related pain.” As a result, OxyContin became the poster boy for prescription drug abuse and Purdue was fined $600 million to settle criminal complaints. That has had little impact on the Sackler family, Purdue‘s owners, with Forbes estimating their worth at $14 billion.

Although Purdue is not completely responsible for the current opioid abuse epidemic, they certainly have played a meaningful role. In addition, a congressional investigation suggested that the pharmaceutical industry has promoted opioid sales through a number of organizations including the American Pain Society and the American Academy of Pain Medicine, both of which write treatment guidelines. 

As opioid abuse and overdose deaths began to rise, so did the drug testing industry within pain management. Drug testing labs used a similar strategy as the pharmaceutical industry in promoting their wares and money was used as an incentive to drug test. 

In my 2012 article entitled, “Profit-Driven Drug Testing,” I presented Medicare data which showed a meteoric rise in drug testing:

“A deeper examination finds that between 2000 and 2009, the total number of CLIA-waived drug tests paid for by Medicare and conducted at physicians‘ offices increased approximately 3,172,910%; with 101 tests conducted in 2000 and 3,204,740 in 2009. Furthermore, during that same time period and within the specialty of anesthesiology, CLIA-waived drug tests increased 63,687,900%.”

The annual cost of drug testing in pain management is estimated at $2 billion per year. Unfortunately, that may be a gross underestimate since no study has ever evaluated the indirect costs of patient harm or harming the therapeutic patient-provider relationship—likely the most important aspect of pain management. A November, 2014 article in the Wall Street Journal reported that some physicians are making more money from drug testing patients than treating them.

Not unlike big pharma, there appears to be a dearth of integrity in the drug testing industry. Millennium Health, the largest drug tester in pain management, was recently fined $256 million by the U.S. Department of Justice and then filed for bankruptcy. This led to the discovery that the founders took $1.3 billion out of the business in 2014.

Ameritox, the second largest drug tester, actually paid physicians to drug test their patients, and as a result was fined $16.3 million by the Justice Department. Calloway Laboratories is yet another drug testing lab that was prosecuted and it is going out of business.

This author asked Debra Maul, a whistleblower in the laboratory industry, for her comment on UDT in pain management for this paper. Debra wrote, “Personally, I believe it‘s all about the money. When I entered the laboratory business in 2003, it was very difficult to get physicians to test their patients. In 2007, when Millennium entered the industry with the POCT (point of care tests) business model, pain doctors significantly increased their patient testing, I believe, because they could make money on in-office testing. New labs were popping up everywhere promoting this business model.”

She continued, “If you look at the information the WSJ obtained from CMS regarding Medicare reimbursements for UDT, reimbursements for simple UDTs grew significantly from 2007 until reimbursements were cut in 2010. Then in 2011 and 2012, high tech drug testing took a big jump, I believe, due to laboratories promoting in-office analyzers and other high-tech testing equipment to doctors, so they could continue billing for UDTs. It will be interesting to see what happens with in-office testing and the entire UDT market, with the significantly reduced reimbursements this year.”

What follows is a list of drug testing labs and the amount they were reimbursed by Medicare for urine drug testing in 2012. These numbers come from Medicare‘s website and were provided by Debra Maul:

• Millennium: $109,031,768
• Ameritox: $99,553,258
• Aegis: $36,140,368
• Alere: $16,937,116
• AIT: $13,845,880
• Dominion: $12,551,313
• Calloway: $6,918,972

To complicate matters, healthcare providers do a poor job at treating chronic pain and opioids may not be the best choice for the long-term treatment of chronic, non-acute, non-malignant pain. Moreover, insurers have been known to reimburse for pain medication and not physical therapy. It is likely that a number of clinicians prescribe opioids because they don‘t know what else to do, and then perform random drug tests in hopes of mitigating any damage they may cause, but it does not work. There is a great need to develop and test cost effective, alternative interventions to pharmacotherapy for the treatment of chronic pain and illness in the primary care setting.

The overriding factor in this historical perspective is the consistent and negative impact industry has on medicine and in this case, pain medicine. A good example of how close the drug testing industry gets to individuals who write guidelines, please go to this link and note the presenter is the lead author of the CDC guideline (Dr. Deborah Dowell) and a conference sponsor is a drug testing lab (Ameritox). 

There is no question that industry has a negative influence on medicine. Stamatakis and colleagues write, “The industry has created means to intervene in all steps of the processes that influence healthcare research, strategy, expenditure and practice. These include evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluation, clinical guidelines formation, healthcare professional education and direct influences on healthcare professional decisions.”

Urine drug testing in pain management costs an estimated $2 billion per year and there is no proof of efficacy. Moreover, it may cause patient harm and harm to the patient-provider relationship and thus increase healthcare costs even further. 

The desire for profits likely started and maintains UDT in pain management along with fear. Fear of prosecution has been attributed to the proliferation of drug testing by doctors treating chronic pain. Goldberg and Rich write, “This singular focus strongly suggests purposes beyond ensuring quality patient care, such as fear of regulatory scrutiny and potential legal liability.”

The CDC has turned a blind eye to a number of important issues regarding UDT in pain management, including its constitutionality and the fact that it was likely driven by profits. Group think can negatively influence treatment guidelines and that is likely to blame for the CDC urine drug test recommendation. Giving a person with pain a “choice” to either submit to a drug test or not receive pain medication is really the option to either submit to a search or suffer, and that is coercion. It exemplifies patriarchal medicine at its worst and is the antithesis of patient-centered care. 

James L. Madara, MD, CEO of the American Medical Association, was quoted as saying about the CDC guideline, "The guidelines and supporting discussion are devoid of a patient-centered view and any real acknowledgment or empathy of the problems chronic pain patients may face."

The CDC should not recommend UDT as part of the current guideline since there is no proof of efficacy, it may be unconstitutional, and was likely driven by profits and nurtured through fear. Furthermore, it is very expensive and may cause harm to the patient and patient-provider.

Mark Collen is an independent scholar and patient advocate. He serves on the editorial board of the Journal of Pain & Palliative Care Pharmacotherapy, and has peer reviewed manuscripts for journals including The Patient: Patient-Centered Outcomes Research, The American Journal of Pharmacy Benefits, and The Clinical Journal of Pain. 

Mark is also the founder of PainExhibit.org, an online art exhibit from artists with chronic pain, which seeks to educate healthcare providers and the public about chronic pain through art, and to give a voice to the many who suffer in silence.

This column is an abbreviated version of the comment Mark has submitted to the CDC. The full version of Mark’s comment can be read here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Millennium Wins FDA Contract Despite Fraud Charges

By Pat Anson, Editor

Just days after agreeing to pay $256 million to the federal government to settle fraud and kickback charges, Millennium Health has been selected to provide urine drug tests to the Food and Drug Administration for a clinical trial.

The trial will assess the development of opioid tolerance in patients taking pain medication with an abuse deterrent formula. Millennium could potentially make $1.6 million under the FDA contract.

"Long term opioid treatment can produce positive outcomes when prescribed and used appropriately, but they also carry risks that must be managed. UDT (urine drug testing) plays a critical role in aiding the clinician in evaluating patient safety. Millennium's selection as a service partner in this important initiative reflects our advanced technical and analytic capabilities and commitment to excellence," said Millennium CEO Brock Hardaway.

Millennium -- the nation’s largest drug testing company -- won the contract soon after it agreed to settle fraud charges under the Federal False Claims Act. Millennium was accused of bilking Medicare, Medicaid and other federal health care programs for a large number of medically unnecessary urine drug and genetic tests. The San Diego based firm was also accused of violating federal kickback laws by providing physicians with free urine “point of care” (POC) test cups if they referred more expensive laboratory testing to Millennium.  

“Millennium allegedly promoted indiscriminate and unnecessary testing that increased medical costs without serving patients’ real medical needs,” said U.S. Attorney Carmen M. Ortiz of the District of Massachusetts.  “A laboratory that promotes and knowingly conducts medically unnecessary drug testing operates unlawfully and squanders our precious federal health care resources.”

Under terms of its settlement with the Department of Justice (DOJ), Millennium will pay $237 million to settle claims for unnecessary urine and genetic tests. Millennium also entered into a corporate integrity agreement with the Department of Health and Human Services, and will pay $19.2 million to the Centers for Medicare and Medicaid Services to resolve issues over its billing practices. The government, in turn, will pay whistleblowers over $30 million for their help in building the case against Millennium.

“Millennium used a variety of schemes to cause physicians, including many of its biggest referrers, to routinely order excessive amounts of UDT (urine drug tests) for all patients (including Medicare and Medicaid patients) regardless of individual patient assessment or need. Millennium’s abusive practices included the use of physician standing order forms to encourage routine, excessive UDT, and the dissemination of false and misleading statements about drug abuse rates and the value of its testing,” the original government complaint said.

"While Millennium may debate some of the merits of the DOJ's allegations, we respect the government's role in health care oversight and enforcement,” said Millennium's Hardaway. “At the end of the day, it was time to bring closure to an investigation that began nearly four years ago. Millennium Health is currently a very different organization than we were in the past. We fully embrace our obligation to both commercial and publicly funded health plans to provide value to the health care system overall and ensure that doctors who order our testing solutions adequately demonstrate that those solutions are clinically necessary.”

After the settlement was reached, Moody's Investors Service downgraded Millennium's Health's corporate debt rating and said its rating outlook was negative.

"The downgrade reflects Moody's expectation that Millennium will complete a distressed debt exchange or file for Chapter 11 bankruptcy in the near term. Moody's is estimating that lenders will suffer material losses in the event of a default," Moody's said in a statement.

Millennium is not the first drug testing company to face fraud and kickback charges. Competitors Amertiox, Calloway Labs, Quest Diagnostics, and LabCorp have all faced similar charges and paid millions of dollars in fines.As a result of these cases, Medicare has proposed lowering its billing rates for diagnostic testing as early as 2016, moving to a flat-rate fee structure to prevent drug-testing companies from charging more by testing for more substances.

As Pain News Network has reported, urine drug testing grew into a lucrative $4 billion industry – what some call “liquid gold” – largely because so many doctors who treat addicts and chronic pain patients require them to submit to urine drug screens. In many cases, point-of-care tests are used, even though many experts consider them unreliable.

Doctor Defends Use of Urine Drug Tests

By Pat Anson, Editor

A prominent pain doctor is disputing reports that a widely used urine drug test often gives faulty results.

“They are reasonably reliable and highly cost effective for use in a pain management practice. I would strongly recommend the practitioners use this,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Dr. LAXMAIAH MANCHIKANTI

Dr. Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, was the lead author of a study published in the journal Pain Physician in 2011, which looked at the reliability of immunoassay “point-of-care” (POC) tests. The urine tests are inexpensive and give immediate results, and doctors often use them to monitor their patients for opioid or illicit drug use.

“The UDT (urine drug test) with immunoassay in an office setting is appropriate, convenient and cost effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay office testing had high specificity and agreement,” Manchikanti's study found.

Pain News Network recently reported on the results of a second study conducted by Millennium Health, a San Diego-based drug testing laboratory, which found that POC tests were wrong about half the time – frequently giving false positive and false negatives results for drugs like marijuana and oxycodone. The Millennium study advocates the use of chromatography-mass-spectrometry – a more complex laboratory test that costs thousands of dollars – to confirm POC test results.

“Following the advice from companies in reference to numerous expensive tests and also income generating avenues will only lead to time in the slammer and will not improve patient care at all,” said Manchikanti.

“(The) Millennium study is performed by the company which makes a living by testing. The more samples that are sent to them, the better off they are. Further, they are not even a practical setting. From our practice we send approximately only 2% of the samples for confirmation testing. Even then, the patients can’t pay their bills.”

Manchikanti’s study found false negative and false positive rates for POC tests that were far below the rates reported by Millennium.

For example, Millennium’s false positive rate for oxycodone was 41.3 percent. For Manchikanti, it was only 7.7 percent.

Millennium’s false positive rate for marijuana was 21.3 percent. For Manchikanti, it was just 2 percent.

There were discrepancies between the two studies for several other drugs, including methadone, cocaine and methamphetamine.

Millennium Sponsored Both Studies

How could two studies come to such different conclusions?

There were some differences in their design. Urine samples in the Millennium study came from nearly 4,300 patients in addiction treatment clinics, while the urine samples in Manchikanti’s study came from 1,000 patients in pain management programs. Millennium maintains the patients in its study were younger and more likely to be drug users.

Ironically, the laboratory tests for both studies were conducted by Millennium – which collected samples and provided chromatography-mass-spectrometry testing at no cost to Manchikanti. Millennium is identified as the “sponsor” of Manchikanti’s study, but he says the company had “no influence or interference” in his and his three co-authors’ findings.

“We had our agreement in the beginning itself that they will not be involved in any way in writing the manuscript or publishing the results. Consequently, they really did not have much input into the publication. The publication was as it is and without any bias from the industry,” Manchikanti wrote in an email to Pain News Network.

Millennium’s study, which was published last year in the Journal of Opioid Management, had six co-authors. All but one were employees of the company. The lone exception is a pain management doctor who frequently testifies as a legal expert for Millennium in court cases.

A source with broad experience in the drug testing industry told Pain News Network the data in Millennium’s study was “skewed toward exaggeration.”

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test. Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company,” the source said.

Millennium bristles at the notion that its study was biased.

“Millennium Health strongly disagrees with the characterization… that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.

“Millennium is committed to providing data that helps clinicians evaluate the best course of treatment for patients with pain and addiction issues. Millennium Health performs only the tests ordered by clinicians.”

In recent years a growing number of doctors who treat addicts and pain patients have required them to submit to drug tests. The competition between Millennium and other laboratories for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry.

But Manchikanti maintains that a single inexpensive urine test that costs about $20 is often the only one that’s needed.

“If a proper (patient) history is provided which matches with the test, there is no need for further testing,” he said.

Urine Drug Test Often Gives False Results

By Pat Anson, Editor

A urine drug test widely used by pain management and addiction treatment doctors to screen patients for illicit drug use is wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The “point-of-care” or POC tests come with immunoassay testing strips that use antibodies to detect signs of recent drug use. Physicians like the urine tests because they can be performed in their offices, are inexpensive, and give immediate results. But experts say the tests are wrong so often that no doctor should base a treatment decision solely on the results of one test. 

“Immunoassay testing has an extraordinarily high rate of false positives and false negatives as compared to laboratory testing,” said Steve Passik, PhD, Vice President of Research and Advocacy for Millennium Health, which analyzed urine samples from nearly 4,300 POC tests obtained at addiction treatment clinics.The Millennium study was published in The Journal of Opioid Management.

A false positive reading means a drug was detected that isn’t actually there, while a false negative means the POC test missed finding a drug that was present in a urine sample.

The Millennium study found plenty of both.

False positive readings for marijuana, for example, were given over 21% of the time, while false negative results for marijuana also appeared about 21% of the time.

The POC tests had an even worse track record for oxycodone, a widely prescribed opioid pain reliever. False positive results were detected over 41% of the time and false negatives over 31% of the time for oxycodone.

“We always knew it wasn’t as sensitive and we always knew that it didn’t look for specific drugs within a class. But this was revealing in regard to how much it misses, with false negative and false positives rates in 40 to 50 percent in some instances,” said Passik.

“If we were in another area of medicine, let’s say oncology, and you had a tumor marker or a test that you were going to base important treatment decisions on, and it was as inaccurate as immunoassay is, the oncologists would never stand for it.”

Passik says “the word is starting to get out” how inaccurate the immunoassay tests are. But few patients are aware of it and some doctors are still dropping patients from pain management programs after POC tests found illicit or unprescribed drugs in their urine. 

Passik told Pain News Network that patients should insist on a second test if they feel the first one is wrong.

“If they think it’s a false positive, they need to ask the doctor to be re-tested. And particularly they should ask what method was used. And if they find out they were tested with immunoassay, they should say they want the same specimen either re-tested at the lab or they want to provide another specimen tested at the lab,” Passik said.

A laboratory test that uses chromatography-mass-spectrometry to break down and identify individual molecules is far more accurate than an immunoassay POC test, but it could cost thousands of dollars -- something many insurers and patients are unwilling to pay for.

And critics say Millennium – one of the largest drug screening companies in the nation – has produced a self-serving study designed to drum up more business for itself.

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test,” said a source with broad experience in the drug testing industry. “Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company.”

The source told Pain News Network the data in Millennium’s study was “skewed toward exaggeration” and questioned the need for further testing.

“In addiction centers, there is not really a large demand for confirmation testing. I understand Millennium wants to increase that business because that’s what they do.  However, medical necessity does play into all laboratory testing.  The great majority of the time, when a patient in a treatment center is confronted with the results of a POC test that shows a drug in their system that shouldn’t be there, they will confess to taking the drug.  So, what would be the medical necessity of confirming that test?

“I believe many of the urine drug testing labs are promoting confirmation testing when it is not medically necessary.”

Millennium took offense that the validity of its study was being questioned.

“Millennium Health strongly disagrees with the characterization in the story that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.”

"Liquid Gold"

A growing number of doctors who treat addicts and chronic pain patients require them to submit to random drug screens. And some companies and government agencies also require employees and job applicants to submit to POC tests as a condition of employment.

The competition between drug screening companies for this business is intense. 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.

But addiction experts say more reliable and expensive testing is needed, simply to be fair to patients.

“Heavy reliance on immunoassays in addiction treatment can be detrimental to the patient due to their higher risk for false positives and false negatives in comparison with more reliable technology, such as chromatography-mass-spectrometry,” said Michael Barnes, executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a non-profit that gets some of its funding from Millennium.

“A false positive can be detrimental to a patient by subjecting her to unjust suspicion or accusations, unnecessary adjustments to the treatment plan, or the deterioration of the practitioner-patient relationship. A false negative may result in delayed diagnosis or misdiagnosis, false confidence that a patient has not relapsed, and failure to catch behavior that could eventual result in a preventable overdose death. Therefore, chromatography-mass-spectrometry is often more appropriate.”

Millennium’s Passik says most doctors recognize that both tests may be needed.

“These two different methods yield very different kinds of results,” Passik said. “If I was still practicing, I wouldn’t feel that immunoassay is accurate enough to be the only test that you use.”

Ironically, a federal court last year found Millennium guilty of giving illegal kickbacks to doctors by providing them with free POC test cups – the very tests the company says have an “extraordinarily high rate” of false results.