Ouch! Pain Clinic Chain Loses Whistleblower Case

$700 Ultrasound Machines

According to the complaint, the pain center managers instructed physicians to use ultrasonic guidance for injections. There is data which shows that the accuracy of joint injections can improve when a care provider uses fluoroscopic or ultrasonic guidance.

Specifically, said the government lawyers, “In or around 2012, Medicare stopped reimbursing for fluoroscopic guidance performed in conjunction with sacroiliac (SI) joint injections because the guidance was not medically necessary. To avoid the resultant dropoff in revenue caused by this change, National Spine instructed physicians to perform ultrasonic guidance for SI injections.”

“…and to increase its profitability on other injections, National Spine instituted a policy requiring that physicians and mid-level providers bill for ultrasound guidance on every joint injection where the government healthcare programs will not cover fluoroscopy.”

“Wisor (who was president of NSPC at the time) directed National Spine’s Facilities Manager, Kevin Gartland, to purchase the cheapest ultrasound machine available because he was concerned that the government healthcare programs and other insurers may soon stop reimbursing for ultrasound needle guidance, in which case National Spine would have no use for the equipment,” the complaint said.

The scanners purchased were $700 each, from Wuhan Tianyi Electronic, a Chinese company; the units plugged into a laptop. In contrast, a website, Costowl.com, says, “Most new ultrasound machines fall in the $20,000 to $75,000 range. Used or refurbished machines—which offer a great opportunity for saving money—usually run $5,000 to $40,000 for average models.”

“The image quality of the Wuhan Tianyi Electronic laptop ultrasound scanner is of such poor quality that physicians and mid-level providers could not even see the needle on the screen.”

“Accordingly, National Spine’s providers did not use the ultrasound for needle guidance. In accordance with National Spine’s directives, however, the providers reported utilizing ultrasonic guidance and billed for it. And, National Spine instructed the providers to take a picture of the ultrasound probe next to the joint and create a false patient note so that, in the event that the government audits the false bills, it will appear as though National Spine really utilized ultrasonic guidance for the injections,” the complaint says.

The reimbursement rate for ultrasound guidance for injections was $207 per use, the complaint said.

Milking the Opioid Testing Rules

According to an October 2009 Medicare directive, qualitative opioid drug screening is medically necessary when “illicit drug use is suspected”. That directive was reiterated on July 1, 2011.

According to the complaint, “qualitative drug screening is considered medically reasonable and necessary in patients receiving opioid therapy where (i) “illicit drug use, non-compliance or a significant pre-test probability of non-adherence to the prescribed drug regimen is suspected and documented in the medical record,” or (ii) the patients are “at high risk for medication abuse due to psychiatric issues…[patients] have engaged in aberrant drug-related behaviors, or who have a history of substance abuse.”

Medicare’s directive also said drug screening should be only for those drugs or classes likely to be present, and that confirmation (lab testing) is allowed only when the result of the drug screening is at odds with the patient’s medical history, clinical presentation, or the patient’s own statements.

National Spine, alleged the complaint, milked those directives by issuing “a blanket order requiring that each opioid therapy patient receive a qualitative drug test for numerous drug classes during each office visit and also that every patient’s urine sample be sent to an outside lab for confirmatory quantitative testing.”

“Relator witnessed the office manager and medical assistants at Fredericksburg train medical assistants from several other offices to collect a urine sample from every opioid therapy patient during each visit and then perform a qualitative twelve panel test on each sample and send each sample to an outside lab for quantitative testing,” the complaint alleged.

How many such tests were done? “Relator estimates that the Fredericksburg office alone administered approximately 400 in-house twelve panel qualitative drug screenings and ordered 400 duplicative quantitative drug tests per month.”

The complaint also alleges that NSPC put boilerplate language in each opioid patient’s chart falsely claiming that it did only random testing.

“Wisor characterized the mandatory, repeated drug screenings as “low hanging fruit” because they are a guaranteed way to generate revenue for National Spine and cash bonuses for employees,” the complaint alleged.

The False Claims Act “provides that a person is liable to the United States Government for three times the amount of damages that the Government sustains because of the act of that person, plus a civil penalty of $5,000 to $10,000 per violation,” according to the complaint. At those values, if the allegations are true, then the federally-insured half of the 400 qualitative test strip plus 400 quantitative lab monthly drug tests in the Fredericksburg office alone would result in damages and penalties far greater than the $3.29 million settlement over the period in question.