A multi-state pain management company – once among America’s most prolific users of what it referred to as “tendon origin injections” – administered thousands of unnecessary and useless injections to patients, claiming they could ease pain and potentially lessen reliance on painkillers, while raking in millions of dollars.
One of them was Michelle Shaw, who each month went to a pain clinic to get the shots that made her back feel worse – so she could get the pills that made her back feel better.
Shaw (56), who has been dependent on opioid painkillers since she injured her back in a fall a decade ago, said in court testimony that the Tennessee clinic would write the prescriptions only if she first agreed to receive three or four “very painful” injections of another medicine along her spine.
The clinic claimed the injections were steroids that would relieve her pain, Shaw said, but with each shot her agony increased. She told KFF Health News she eventually tried to decline the shots, but the clinic issued an ultimatum: take the injections or get her painkillers elsewhere.
“I had nowhere else to go at the time,” Shaw testified. “I was stuck.”
CBS News reports that Shaw was among thousands of patients of Pain MD, which was famous for its “tendon origin injections”, and which would normally inject a single dose of steroids to relieve stiff or painful joints.
As many doctors were scaling back their use of prescription painkillers due to the opioid crisis, Pain MD paired opioids with monthly injections into patients’ backs, claiming the shots could ease pain and potentially lessen reliance on painkillers.
Now, years later, Pain MD’s injections have been proved in court to be part of a decade-long fraud scheme that made millions by capitalising on patients’ dependence on opioids.
Cadavers
The Department of Justice has successfully argued at trial that Pain MD’s “unnecessary and expensive injections” were largely ineffective because they targeted the wrong body part, contained short-lived numbing medications but no steroids, and appeared to be based on test shots given to cadavers – people who felt neither pain nor relief because they were dead.
Four Pain MD employees have pleaded guilty or been convicted of healthcare fraud, including company president Michael Kestner, who was found guilty of 13 counts at an October trial in Nashville, Tennessee.
According to a transcript from Kestner’s trial that became public in December, witnesses testified that the company documented giving patients about 700 000 total injections over about eight years, and said some patients got as many as 24 shots at once.
“Michael Kestner found out about an injection that could be billed a lot and paid well,” said federal prosecutor James Hayes. “And they turned some patients into human pin cushions.”
At trial, Kestner’s attorneys argued that he was a well-intentioned businessman who wanted to run pain clinics offering more than just pills.
He is due to be sentenced on 21 April.
Court documents show Shaw and three other former patients testifying that Pain MD’s injections did not ease their pain and sometimes made it worse. The patients tolerated the shots only so Pain MD wouldn’t cut off their prescriptions, without which they might have spiralled into withdrawal, they said.
“They told me that if I didn’t take the shots – because I said they didn’t help – I would not get my medication,” testified Patricia McNeil, a former patient.
Pain MD, which sometimes operated under the name Mid-South Pain Management, ran as many as 20 clinics in Tennessee, Virginia and North Carolina throughout much of the 2010s. Some clinics averaged more than 12 injections per patient each month, and at least two patients each received more than 500 shots in total, show court documents.
According to Medicare data filed in court, Pain MD and Mid-South Pain Management billed Medicare for more than 290 000 “tendon origin injections” from January 2010 to May 2018, which is about seven times that of any other Medicare biller in the US over the same period.
Tens of thousands of additional injections were billed to Medicaid and Tricare during those same years. Pain MD billed these government programmes for about $111 per injection and collected more than $5m from the government for the shots, according to the court documents.
More injections were billed to private insurance too, with BlueCross BlueShield testifying that Pain MD billed them about $40m for more than 380 000 injections from January 2010 to March 2013. The company paid out about $7m before it cut off Pain MD.
These kinds of enormous billing allegations are not uncommon in healthcare fraud cases, said Don Cochran, a former US attorney for the Middle District of Tennessee.
Tennessee alone has seen fraud allegations for unnecessary billing of urine testing, skin creams and other injections in just the past decade.
Authorities have also investigated an alleged fraud scheme involving a Tennessee company and hundreds of thousands of catheters billed to Medicare, according to The Washington Post, citing anonymous sources.
Cochran said the Pain MD case was especially “nefarious” because it used opioids to make patients play along.
Not injections into tendons
The allegations against Pain MD became public in 2018 when Cochran and the Department of Justice filed a civil lawsuit against the company, Kestner, and several associated clinics, alleging that Pain MD defrauded taxpayers and government insurance programmes by billing for “tendon origin injections” that were “not actually injections into tendons at all”.
Kestner, Pain MD and several associated clinics have each denied all allegations in that lawsuit, which is ongoing.
Scott Kreiner, an expert on spine care and pain medicine who testified at Kestner’s criminal trial, said that true tendon origin injections (or TOIs) typically are used to treat inflamed joints, like the condition known as “tennis elbow”, by injecting steroids or platelet-rich plasma into a tendon. Kreiner said most patients need only one shot at a time.
But Pain MD made repeated injections into patients’ backs that contained only lidocaine or Marcaine, which are anaesthetic medications that cause numbness for mere hours.
Pain MD also used needles that were often too short to reach back tendons, Kreiner said, and there was no imaging technology used to aim the needle anyway. He said he didn’t find any injections in Pain MD’s records that appeared medically necessary, and even if they had been, no one could need so many.
“I simply cannot fathom a scenario where the sheer quantity of TOIs I observed in the patient records would ever be medically necessary,” Kreiner said.
Jonathan White, a physician assistant who administered injections at Pain MD and trained other employees to do so, then later testified against Kestner as part of a plea deal, said at trial that he believed Pain MD’s injection technique was based on a “cadaveric investigation”.
According to the trial transcript, White said that while working at Pain MD he realised he could find no medical research that supported performing tendon origin injections on patients’ backs instead of their joints.
When he asked if Pain MD had any such research, White said, an employee responded with a two-paragraph letter from a Tennessee anatomy professor, not a medical doctor, that said it was possible to reach the region of back tendons in a cadaver by injecting “within two fingerbreadths” of the spine.
This process was “exactly the procedure” that was taught at Pain MD, White said.
During his own testimony, Kreiner said it was “potentially dangerous” to inject a patient as described in the letter, which should not have been used to justify medical care.
“This was done on a dead person,” Kreiner said, according to the trial transcript. “So the letter says nothing about how effective the treatment is.”
Over-injecting ‘killed my hand’
Pain MD collapsed into bankruptcy in 2019, leaving some patients unable to get new prescriptions because their medical records were stuck in locked storage units.
At the time, the company defended the injections and its practice of discharging patients who declined the shots. When a former patient publicly accused the company of treating his back “like a dartboard”, Pain MD filed a defamation lawsuit, then dropped it a month later.
According to court documents, eight former Pain MD medical providers testified that the driving force behind the injections was Kestner himself, who is not a medical professional and yet, regularly pressured employees to give more shots.
One nurse testified that she received emails “every single workday” pushing for more injections. Others said Kestner openly ranked employees by their injection rates, and implied that those who ranked low might be fired.
Brian Richey, a former Pain MD nurse practitioner who at times led the company’s injection rankings, and has since taken a plea deal that required him to testify in court, said at the trial that he “performed so many injections” that his hand became chronically inflamed and required surgery.
Throughout the trial, defence attorney Peter Strianse argued that Pain MD’s focus on injections was a result of Kestner’s “obsession” with ensuring the company “would never be called a pill mill”.
Strianse said Kestner “stayed up at night worrying about patients coming to clinics only to get opioid prescriptions”, so he pushed his employees to administer injections, too.
“Employers motivating employees is not a crime,” Strianse said at closing arguments. “We get pushed every day to perform. It’s not fraud; it’s a fact of life.”
Prosecutors insisted that this defence rang hollow. During the trial, former employees had testified that most patients’ opioid dosages remained steady or increased while at Pain MD, and that the clinics did not taper off the painkillers, no matter how many injections were given.
“Giving them injections does not fix the pill mill problem,” federal prosecutor Katherine Payerle said during closing arguments.
“The way to fix being a pill mill is to stop giving the drugs or taper them off.”
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