Medicare and private insurance claims for urine screenings for drugs, such as opioids, and related genetic tests increased fourfold from 2011 to 2014, which some legal experts and federal officials say raises red flags about possibly unnecessary drug testing, according to a Kaiser Health News analysis published Monday by Bloomberg.
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For the analysis, KHN collaborated with Mayo Clinic researchers and consulted with billing experts to analyze available claims data for Medicare and private insurers to examine the prevalence and cost of urine drug testing and related genetic testing. KHN also calculated what it called a "rough" estimate of the total annual cost of urine screenings for drugs and related genetic tests.
Urine, genetic test billing on the rise
According to the analysis, Medicare and private insurance billing data showed spending on urine screenings and related genetic tests quadrupled from 2011 to 2014, when it reached an estimated $8.5 billion.
The analysis found physicians who operate their own labs have experienced a financial boon from urine screenings and related genetic testing. According to the analysis, Medicare in 2014 and 2015 paid $1 million or more to health care professionals at more than 50 U.S. pain management practices for drug-related urine tests. Further, the analysis found that 12 pain management practices billed Medicare for twice that amount. According to the analysis, 31 pain management practitioners received at least 80% of their total Medicare payments from urine testing. According to the analysis, data suggests not all tests are necessary because they come back negative. For example, according to KHN, spending on urine testing for drugs such as cocaine, ecstasy, and phencyclidine—all of which are rarely detected in beneficiaries' urine samples—has increased.
The analysis determined that urine tests have become more prevalent in recent years in part because of the opioid misuse epidemic—which spurred physicians who prescribe opioids to seek ways to prevent misuse and avoid liability. The epidemic, according to KHN, spurred new pain management clinics—such as the Comprehensive Pain Specialists (CPS), a provider-owned network of 54 clinics in the Southeast—that "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."
However, KHN noted that until recently there were few national standards that establish urine testing protocols, such as who should be tested, for which drugs the tests should screen, and how frequently tests should be conducted. CDC in March 2016 issued guidelines that called for testing at the start of opioid therapy and once per year for long-term users. CDC said it should be "left up to the discretion" of the medical professional to determine whether testing should be done more frequently.
Providers could face scrutiny
HHS' Office of Inspector General (OIG) in a report released last fall acknowledged that the rise in testing might be warranted because of efforts to stem the opioid misuse epidemic, but noted that the epidemic "could provide cover for labs that might seek to fraudulently bill Medicare for unnecessary drug testing."
Donald White, a spokesperson for HHS' OIG, said, "Doctors who receive the lion's share of their Medicare funds from urine drug testing would certainly raise a red flag." But he added, "Confirmation of fraud would require federal investigation and a formal judicial proceeding."
Some providers have seen cases brought against them. For instance, a 2011 whistleblower lawsuit against a San Diego-based laboratory owned by Millennium Health—which in 2014 received more than $166 million from Medicare for urine testing, making it one of the United States' top billers for urine screenings—revealed that a lab representative during a sales call once told a physician that "drug testing is not about medicine but about making money," according to an affidavit.
According to KHN, Millennium in 2015 reached a $256 million settlement with the Department of Justice denying allegations that the company engaged in such sales practices.
Providers say they testing serves vital rule
Former CPS CEO John Davis, who left the company in June, acknowledged that lab profits, "to a great degree," drove the company's expansion. But he said, "Urine screening isn't the reason why we decided to grow our company. We wanted to help people in need."
Peter Kroll, one of the founders of CPS and its medical director, said that testing to ensure patients are not misusing drugs provides a "whole different level of confidence that I'm doing something right for the patients' condition."
Kroll—who transitioned from anesthesiology to a pain management after the death of his brother, who suffered from chronic pain—said his doctors try to be "judicious" when ordering urine tests. But that some treat "high-risk patients" who may require frequent testing (Schulte/Lucas, Kaiser Health News/Bloomberg, 11/6; Finnegan, FierceHealthcare, 11/6; Diamond, "Pulse," Politico, 11/7).
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