The cups of urine journey by categorical mail to the Comprehensive Pain Specialists lab in an industrial park in Brentwood, Tennessee, not removed from Nashville. Most days deliver greater than 700 of the little sealed cups from clinics throughout 10 states, wrapped in red-tagged waste baggage. The community treats about 48,000 individuals every month, and lots of will likely be examined for medication.
Gloved lab techs maintain busy contained in the cavernous facility, piping smaller urine samples into tubes. First, there are checks to detect opiates sufferers have been prescribed by CPS docs. A second set identifies a variety of medicine, each authorized and unlawful, within the urine. The docs’ orders are displayed on pc screens and tracked by digital medical data. Test outcomes return to the clinics in 4 to 5 days. The urine finally ends up saved for a month inside an enormous walk-in fridge.
The high-tech testing lab’s uncooked materials has turn out to be liquid gold for the docs who personal Comprehensive Pain Specialists. This testing course of, pushed by the nation’s epidemic of painkiller dependancy, generates earnings throughout the doctor-owned community of 54 clinics, the biggest pain-treatment observe within the Southeast. Medicare paid the corporate no less than $11 million for urine and badociated checks in 2014, when 5 of its professionals stood among the many nation’s high billers. One nurse practitioner on the firm’s clinic in Cleveland, Tennessee, single-handedly generated $1.1 million in Medicare billings for urine checks that 12 months, in response to Medicare data.
Dr. Peter Kroll, one of many founders of CPS and its medical director, billed Medicare $1.eight million for these drug checks in 2015. He mentioned the expensive checks are medically justified to observe sufferers on ache drugs in opposition to dangers of dependancy and even of promoting drugs on the black market. “I have to know the medicine is safe and you’re taking it,” Kroll, 46, mentioned in an interview. Kroll mentioned that a number of states by which CPS is energetic have excessive charges of opioid use, which requires extra urine testing.
Kaiser Health News, with help from researchers on the Mayo Clinic, badyzed obtainable billing information from Medicare and personal insurance coverage billing nationwide and located that spending on urine screens and badociated genetic checks quadrupled from 2011 to 2014, to an estimated $eight.5 billion a 12 months—greater than the whole finances of the Environmental Protection Agency. The federal authorities paid suppliers extra to conduct urine drug checks in 2014 than it spent on the 4 most really useful most cancers screenings mixed.
Yet there are nearly no nationwide requirements concerning who will get examined, for which medication and the way typically. Medicare has spent tens of thousands and thousands of on checks to detect medication that offered minimal abuse hazard for many sufferers, in response to arguments made by authorities attorneys in court docket circumstances that problem the standing orders to check sufferers for medication. Payments have surged for urine checks for avenue medication equivalent to cocaine, PCP and ecstasy, which seldom have been detected in checks accomplished on ache sufferers. In reality, court docket data present a few of these checks hardly ever confirmed up optimistic—PCP, as an example, turned up simply 1 % of the time.
Urine testing has turn out to be significantly profitable for docs who function their very own labs. In 2014 and 2015, Medicare paid $1 million or extra for drug-related checks billed by well being professionals at greater than 50 ache administration practices throughout the U.S. At a dozen practices, Medicare billings have been twice that prime.
Thirty-one ache practitioners acquired 80 % or extra of their Medicare earnings simply from urine testing, which a federal official referred to as a “red flag” which will sign overuse and will result in a federal investigation.
“We’re focused on the fact that many physicians are making more money on testing than treating patients,” mentioned Jason Mehta, an badistant U.S. lawyer in Jacksonville, Florida. “It is troubling to see providers test everyone for every clbad of drugs every time they come in.”
As alarm unfold about opioid deaths and overdoses prior to now decade, docs who prescribed the drugs have been on the lookout for methods to forestall abuse and avert legal responsibility. Entrepreneurs noticed a profitable enterprise mannequin: persuade docs that testing would maintain them out of hbadle with licensing boards or legislation enforcement and defend their sufferers from hurt. Some firms supplied docs technical badist opening up their very own labs.
A 2011 whistleblower lawsuit in opposition to one of many nation’s high billers for urine checks, a San Diego-based laboratory owned by Millennium Health LLC, underscores the potential for revenue. “Doctor,” one lab consultant mentioned throughout gross sales calls, in response 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 data present, took in additional than $166 million from Medicare in 2014, regardless of being the goal of no less than eight whistleblower circumstances alleging fraud over the previous decade. A Millennium gross sales supervisor concerned in a 2012 case in Mbadachusetts reported incomes $700,000 in wage and gross sales commissions within the earlier 12 months.
Millennium inspired docs to order extra checks, each as a solution to decrease sufferers’ dangers and to defend the physicians in opposition to potential investigations by legislation enforcement or medical licensing boards, in response to court docket filings. Millennium denied the allegations within the whistleblower fits and settled all of them with the Justice Department in 2015 by agreeing to pay $256 million; its father or mother firm, Millennium Lab Holdings II, declared chapter.
Tests to detect medication in urine may be primary and low cost. Doctors have lengthy used testing cups with strips that change shade when medication are current. The cups price lower than $10 every, and a strip can detect 10 sorts of medication or extra without delay and show the ends in minutes.
After noticing that some labs have been levying enormous fees for these easy urine screens, the Centers for Medicare & Medicaid Services moved in April 2010 to restrict these billings. To circumvent the brand new guidelines, some docs scrapped cup testing in favor of specialised—and far costlier—checks carried out on machines they put in of their amenities. These machines had one main benefit over the cups: Each take a look at for every drug might be billed individually below Medicare guidelines.
“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,” mentioned Charles Root, a longtime lab business advisor whose firm, CodeMap, has tracked the rise of testing labs in docs’ places of work.
The CPS testing lab in Tennessee opened in 2013, not lengthy earlier than a ache specialist named William Wagner moved from New Mexico to open a CPS clinic in Anderson, South Carolina. He was lured by the promise of $30,000 a month in wage, which might develop because the clinic added sufferers and income, together with different advantages. His contract mentioned he might be on-site for as little as 20 % of the clinic’s working hours.
When the corporate recruited him, Wagner mentioned, he was instructed the job supplied “potential to earn a great deal of money” from bonuses he would obtain from providers he generated, together with a share of collections from lab providers for urine checks accomplished on the new Tennessee facility.
That didn’t occur, in response to Wagner. He is suing CPS, saying that it failed to gather payments for providers he rendered after which closed the clinic. CPS refutes Wagner’s claims and says it fulfilled its obligations below 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 mentioned. The lawsuit is pending in federal court docket in Nashville.
Former CPS Chief Executive Officer John Davis, in an interview, described the urine-testing lab as a part of a “strategic expansion initiative” by which the corporate invested $6 million to $10 million in computerized gear and swiftly acquired new clinics. Kroll, one of many house owners of CPS, mentioned the concept was to “take the company to the next level.”
Davis, who led the initiative earlier than leaving the corporate in June, wouldn’t talk about the personal firm’s funds aside from to say CPS is worthwhile and that lab earnings, “to a great degree,” drove the enlargement. “Urine screening isn’t the reason why we decided to grow our company. We wanted to help people in need,” Davis mentioned.
Kroll acknowledged that urine checks are profit-makers, however confused that verifying that sufferers aren’t abusing medication offers him a “whole different level of confidence that I’m doing something right for the patients’ condition.”
He mentioned his docs attempt to be “judicious” in ordering urine checks. Kroll mentioned a few of his docs and nurses deal with “high-risk” sufferers, who require extra frequent testing. The firm mentioned that its Medicare billing practices, together with urine screens, had withstood a “very in-depth” authorities audit. The audit initially referred to as for reimbursement of $25 million however was settled in 2016 for lower than $7,000, in response to the corporate. Medicare officers had no remark.
Kroll’s orthopedic profession took a pointy flip greater than a decade in the past after watching his brother undergo by means of a number of surgical procedures for muscular dystrophy, together with bone fractures, stiffness and ache. His brother died at age 25, and Kroll determined to change to anesthesiology and turn out to be a ache specialist.
“It sensitized me to the plight of people with chronic conditions that we have no medical answer for,” Kroll mentioned. His brother “battled for his whole life.”
Kroll’s profession change coincided with a nationwide motion to ascertain ache administration as an important medical specialty, with its personal accrediting societies and lobbying and political arm to advance its pursuits and people of sufferers.
Joined by three different docs, he shaped Comprehensive Pain Specialists at a storefront in suburban Hendersonville, Tennessee. It rapidly gained a foothold on referrals from native docs uncertain, or uneasy, about treating unyielding ache with heavy narcotics equivalent to oxycodone, morphine and methadone.
In 2014, when CPS was amongst Medicare’s main urine-test billers, Tennessee led the nation in Medicare spending on urine drug checks run by docs with in-house labs, in response to federal billing data.
There is large disagreement amongst legislators, medical commerce badociations and the state boards that license docs over the perfect strategy to urine testing. One affiliation of ache specialists argued in 2008 that urine testing might be accomplished as typically as weekly, whereas others have balked at that frequency.
Indiana’s medical board ordered obligatory urine checks for all ache sufferers in late 2013, solely to face a lawsuit from the American Civil Liberties Union, which argued that the coverage was unconstitutional and an illegal search. Officials backed down the following 12 months, and present coverage states that testing may be accomplished “at any time the physician determines that it is medically necessary.”
The federal Centers for Disease Control and Prevention, cautious of each the badociated fee and privateness issues, declined to set a definitive nationwide customary, regardless of years of debate. In long-awaited tips issued in March 2016, the CDC referred to as for testing at first of opioid remedy and every year for long-term customers. Beyond that, it mentioned, testing ought to be “left up to the discretion” of the medical skilled.
There is likewise little scientific justification for a lot of of those new sorts of drug testing which have made their approach onto docs’ order sheets and laboratory menus.
Many ache sufferers on opioids are routinely examined for phencyclidine, an unlawful, hallucinogenic drug also called PCP, or angel mud, Medicare data present. Yet urine checks have hardly ever detected the drug. Millennium, the San Diego-based firm that when topped Medicare billings for urine checks, discovered PCP in fewer than 1 % of all affected person samples, in response to federal court docket filings.
In a tour of the CPS lab, Chief Operations Officer Jeff Hurst, who has greater than twenty years of expertise working for business labs, rattled off a listing of medicine starting from cocaine to heroin and methamphetamine, which he mentioned was “really big in East Tennessee.”
How typically urine checks reveal critical drug abuse—or recommend sufferers may be promoting a few of their drugs as a substitute of taking them—is hard to pin down. Asked throughout a tour of the laboratory in Tennessee if CPS might present such information, Hurst mentioned he didn’t have it; Kroll mentioned he didn’t, both.
Hurst mentioned the lab typically finally ends up doing a “long list of tests” as a result of CPS docs are prescribing harmful medication which may be lethal if abused and “need to know what patients are taking.” Prescribed medication, equivalent to opiates and tranquilizers, are additionally measured on the CPS lab.
Government officers have criticized the explosive development in testing for some pharmaceuticals, notably a category of tranquilizers referred to as tricyclic antidepressants. Medicare paid greater than $45 million in 2014 for greater than 200,000 individuals to be examined for tricyclic medication, typically a number of instances. Medicare was billed for 644,495 checks for one tricyclic drug, amitriptyline, up from 6,173 checks 5 years earlier.
The Department of Justice argued in a 2012 whistleblower case that these checks typically couldn’t be justified due to “low abuse potential” of the medication and a “lack of abuse history for the vast majority of patients.”
When instructed that drug screens accounted for a lot of the Medicare earnings for dozens of ache docs, federal officers mentioned that was troubling.
“Doctors who receive the lion’s share of their Medicare funds from urine drug testing would certainly raise a red flag,” mentioned 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 launched final fall, the watchdog workplace mentioned some uptick in testing may be justified by the drug-abuse epidemic, however famous that the state of affairs additionally “could provide cover for labs that might seek to fraudulently bill Medicare for unnecessary drug testing.”
Medicare pays just for providers it considers “medically necessary.” While that generally could be a judgment name, ache clinics that undertake a “one-size-fits-all” strategy to urine testing could discover themselves below suspicion, mentioned Mehta, the badistant U.S. lawyer in Florida.
Mehta’s workplace investigated a community of Florida clinics referred to as Coastal Spine & Pain Center for alleged over-testing, together with routinely billing for a second spherical of pricy checks merely to verify earlier findings. In a press launch in August 2016, the federal government argued that these checks have been “medically unnecessary.” The firm paid $7.four million final 12 months to settle the False Claims Act case. Coastal Spine & Pain, which didn’t admit fault, had no remark.
Four Coastal Spine & Pain docs have been among the many high 50 Medicare billers throughout 2014, after they charged practically $6 million for drug checks, in response to Medicare billing information badyzed by KHN.
Starting in 2016, Medicare started to crack down on urine billings as a part of a federal legislation that’s speculated to reset lab charges for the primary time in three a long time. Now more durable scrutiny of urine testing, and cuts in reimbursements, could also be threatening CPS—or no less than its earnings.
CPS closed 9 clinics final 12 months and instructed its docs that urine-testing income had dropped off 32 % within the first quarter of the 12 months, in response to a letter then-CEO Davis despatched its doctor companions.
Davis mentioned the corporate needed to “make some changes” due to cuts in Medicare reimbursements for urine checks and different medical providers. An organization spokeswoman instructed KHN that the drop in urine income worsened by means of 2016 however has bounced again considerably this 12 months.
Despite the cuts, privately held CPS plans to open new clinics this 12 months. Urine testing will stay a key service—for conserving sufferers secure, it mentioned. CPS is simply enjoying by the principles of the sport. “Tell us how often to test,” mentioned Hurst, the operations officer, “and we’ll be happy to follow it.”
Schulte is a senior correspondent and Lucas is a correspondent specializing in information evaluation for Kaiser Health News, a nonprofit well being newsroom whose tales seem in information shops nationwide. Kaiser Health News is an editorially unbiased a part of the Kaiser Family Foundation.
Kaiser Health News relied on fee information from Medicare’s fee-for-service program, obtainable from the Centers for Medicare & Medicaid Services to research the prevalence and value of urine drug testing and badociated genetic testing. Doctors and laboratories invoice Medicare utilizing customary codes. KHN consulted with a number of billing specialists within the discipline and used authorities paperwork to determine related billing codes for this evaluation.
Medicare reimburses suppliers for every code they invoice based mostly on a normal quantity that permits for some geographic variation. Each code represents a kind of take a look at, and a number of checks may be accomplished on a single urine pattern; subsequently, the quantity that suppliers invoice for a single pattern of urine varies significantly.
Medicare’s Part B fee information is publicly obtainable just for the years 2012 by means of 2015. KHN acquired historic information from the consulting agency CodeMap going again to 2005 to research traits in billing.
KHN additionally teamed up with researchers on the Mayo Clinic to research claims information for personal insurers and Medicare Advantage to estimate the overall price per 12 months, which in 2014 was roughly $eight.5 billion for personal plus authorities payers. Mayo Clinic researchers accessed information from the OptumLabs Data Warehouse, which incorporates medical insurance claims that cowl about 20 million sufferers per 12 months. The evaluation included claims from physicians and unbiased labs, and excluded any facility (hospital or outpatient) charges. To estimate the yearly price, KHN took the overall price per enrollee from the Mayo Clinic information evaluation and utilized it to the estimated populations for each personal insurance coverage (from the Current Population Survey) and Medicare Advantage (from CMS’ Beneficiary Public Use File). This is a tough estimate as a result of the OptumLabs claims won’t mirror some variations in medical care prices and well being circumstances throughout the nation.