Former VP of Genetic Test Company Pleads Guilty to Paying Doctors Illegal Kickbacks

By Pat Anson, PNN Editor

The former vice-president of marketing for a controversial genetic testing company has pleaded guilty in federal court to paying physicians millions of dollars in illegal kickbacks to order genetic tests for Medicare patients.

Donald Matthews, who was Vice President of Market Development for Proove Biosciences, pleaded guilty this week in federal court. Matthews faces up to 5 years in prison and a $250,000 fine when he’s sentenced in October.

Proove filed for bankruptcy in 2017 after its headquarters in Irvine, California was raided by FBI agents. The company specialized in DNA testing that supposedly identified whether a patient is at risk of opioid addiction and what medications would best treat their pain. Proove said its tests, which cost thousands of dollars, were proven effective in peer-reviewed clinical studies, but a genetic expert told STAT News the studies were “hogwash.”

According to Matthews’ plea agreement, Proove paid doctors at least $3.5 million to induce them to order DNA tests for their patients.  The company then billed Medicare approximately $45 million to pay for the tests and received about $21 million in unlawful payments.

“Proove concealed the true nature of the kickbacks by falsely characterizing the payments as compensation for participating in a clinical research program sponsored by Proove,” the U.S. Attorney’s Office in San Diego said in a statement. “In furtherance of the scheme, Proove placed its own employees in doctors’ offices.  The Proove employees collected a cheek swab and completed most of the paperwork associated with the ‘clinical research’ program.”

Prosecutors say Proove paid kickbacks to an undisclosed number of doctors throughout the country, with the payments tied to how many DNA tests that a doctor ordered. When doctors complained about delayed or reduced payments, a Proove executive demanded that they increase their testing volume. 

“Kickbacks corrupt the medical judgment of physicians, generate unnecessary tests and treatments, increase health care costs, and create unfair competition,” said U.S. Attorney Robert Brewer.

‘A Waste of Time and Money’

As PNN has reported, a non-profit healthcare system in Great Falls, Montana had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who was on Proove’s Medical Advisory Board. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them. The clinic also said the DNA tests were voluntary and only done on patients if they were appropriate.

 A copy of the clinic’s opioid policy obtained by PNN indicates the tests were mandatory for some patients.

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states.  

Proove had two types of tests for patients in pain management, an “Opioid Risk Test” and an “Opioid Risk Profile.” According to Proove, the tests could determine a patient’s risk of abusing pain medication.

A Benefis patient who took the tests said they were “a waste of time and money.”

“The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on,” she told PNN.

Controversial Genetic Testing Company in Receivership

By Pat Anson, Editor

A controversial genetic testing firm under federal investigation for healthcare fraud has been placed into court-ordered receivership – a form of bankruptcy – that could lead to the restructuring and sale of the company. The CEO and founder of Proove Biosciences has also left the company.

In an interview with STAT, former CEO Brian Meshkin blamed the company's financial problems on “erroneous and damaging” reports that were based on “false allegations” by disgruntled former employees.

Proove Biosciences specializes in DNA testing that the company claims can improve the effectiveness of pain management treatment and determine whether a patient is at risk of opioid addiction.

In June, FBI agents raided the company’s headquarters in Irvine, California. Former and current employees who were interviewed by STAT said the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

In July, PNN reported that Proove was linked to a Medicare fraud case, in which three Indiana healthcare providers allegedly “caused Proove Bioscience… to falsely and fraudulently bill various health care programs for genetic tests... that were not medically necessary and never interpreted."

Proove was not named as a defendant in the Indiana case. In an email to PNN, Meshkin said Proove had cooperated with investigators.

“Proove has cooperated with both the FBI and US Attorney’s office on this case," said Meshkin. "With regards to tests being 'medically necessary', Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

Meshkin also defended Proove research, published in the Journal of Addiction Research & Therapy, which claimed to show the effectiveness of its genetic tests.The publisher of the journal, OMICS International, has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

"Proove can only speak to its experience with this particular journal,” Meshkin said in an email to PNN. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'."

According to the FTC complaint filed last August, OMICS  has created hundreds of "open access" online medical journals that publish articles with little or no peer review. Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

Proove has aggressively promoted its genetic tests with healthcare providers around the country. A pain clinic in Montana, for example, had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center in Great Falls.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis apparently plays a significant role at the clinic, even though she only works there part time. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them.

STAT reported that Proove’s restructuring was apparently ordered by Mike Leavitt, a Proove board member, who also served as Utah governor and secretary of the Department of Health and Human Services. Leavitt’s investment firm, Leavitt Equity Partners, provided about $7 million in funding to Proove, according to Meshkin.

A former Proove manager told STAT that she initially felt good about going to work for the company, but soon had misgivings about Proove's research and billing practices.

“It sucked the life out of me, on an integrity level,” said Rhonda Frantz-Smith. “It got more and more corrupt.”

Feds Say Bankrupt Drug Lab Paid Millions in Kickbacks

By Pat Anson, Editor

A bankrupt drug testing lab with a checkered history has been linked to a large money laundering and pill mill operation in Tennessee.

According to an updated indictment in U.S. District Court in Knoxville, Confirmatrix Laboratory in Georgia and Sterling Laboratories in Seattle paid nearly $3 million in illegal kickbacks to have thousands of urine drug test samples sent to them from patients at the Knoxville Hope Clinic (KHC). In return, the labs submitted false claims for "unnecessary" drug tests to Medicare and TennCare, Tennesee’s Medicaid program.

“Confirmatrix, by and through its principals and agents, paid bribes and kickbacks to defendants Clyde Christopher Tipton and Maynard Alvarez in return for causing Medicare and TennCare beneficiaries from KHC to be referred to Confirmatrix for medically unnecessary drug screenings,” the indictment alleges.

“Medical providers at KHC prescribed opioids and other controlled substances to thousands of purported pain patients in exchange for grossly excessive fees. The vast majority of the prescriptions were unreasonable and medically unnecessary. Patients were required to keep follow-up appointments every 28 days to continue receiving their prescriptions. Providers at KHC ordered medically unnecessary Drug Screenings for every patient every 28 days.”

Tipton, Alvarez and six other defendants are accused of drug trafficking and money laundering in the long-running investigation of Tennessee pill mills. The ringleader of the pill mill scheme, a 53-year old grandmother named Sylvia Hofstetter, allegedly made millions of dollars while running clinics that prescribed 12 million opioid prescriptions. Prosecutors have alleged that at least nine patients at the clinics died from drug overdoses.

No one affiliated with Confirmatrix or Sterling Laboratories has been indicted so far in the case. Prosecutors say the   alleged kickbacks were paid from August 2013 to July 2016.

As PNN has reported, Confirmatrix filed for Chapter 11 bankruptcy last November, just two days after its headquarters near Atlanta was raided by FBI agents.  The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices finally caused Medicare to lower its reimbursement rates for drug testing, which led to Confirmatrix’s financial problems.

Although it filed for Chapter 11 bankruptcy nine months ago, Confirmatrix remains in business and continues to bill patients and insurance companies for costly drug screens.

Some current and former patients at the Benefis Pain Management Center, a pain clinic in Great Falls, Montana, have received bills from a collection agency seeking well over $1,000 for drug screens that normally cost a few hundred dollars.

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” one patient told PNN. “I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?”

In a statement to PNN in May, a Benefis official defended the clinic’s continued use of Confirmatrix, saying the company performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

Confirmatrix’s laboratory, office and warehouse space were recently put up for auction by the bankruptcy court under sealed bid.

Genetic Testing Company Raided by FBI

By Pat Anson, Editor

FBI agents have raided the headquarters of Proove Biosciences, a controversial genetic testing company that claims its DNA tests can improve the effectiveness of pain management and determine whether a patient is at risk of opioid addiction.

Over two dozen FBI agents appeared at Proove offices in Irvine, California Wednesday as part of a healthcare fraud investigation. They were later seen carrying dozens of boxes out of two buildings

“It is an ongoing investigation out of our San Diego office. It involves healthcare fraud. And unfortunately we are unable to say anything more about it at this time. The affidavit supporting the search warrant is under seal,” Cathy Kramer, an FBI special agent, told KABC-TV.

STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove.

Former and current employees who were interviewed by the FBI told STAT the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

The HHS Inspector General issued a Special Fraud Alert in 2014 warning physicians that any payments, referrals, rent or reimbursements from lab testing companies could be seen as violations of anti-kickback laws.

Proove promotes itself as the “leader in personalized pain medicine” and claims its genetic tests can identify medications that would be most effective at treating pain. The company recently claimed that 94% of patients experienced significant pain relief within 60 days of treatment changes recommended by Proove. Critics say most Proove studies are not peer-reviewed and one genetic expert has called them “hogwash.”

According to STAT, doctors affiliated with Proove in California, Florida and Kentucky were also raided by the FBI. Proove said it was cooperating with the investigation, and that no arrests or charges have been made.

"Proove has been subject to a handful of inaccurate stories initiated by STAT News that we believe have contributed to this latest action," the company said in a statement. "While we originally chose not to dignify these outlandish accusations with a response, we now understand that we can no longer ignore these false stories based on unreliable sources, and filled with erroneous accusations... spread by a few disgruntled former employees and consultants.  Proove is confident that the facts supported by verifiable and reliable sources will clearly restore our reputation."

Proove Linked to Montana Pain Clinic

Proove is the second laboratory testing company raided by the FBI that has been linked to Benefis Pain Management Center, a pain clinic in Great Falls, Montana. 

As PNN has reported, FBI agents last November raided the offices of Confirmatrix Laboratories near Atlanta. Two days later, the company filed for Chapter 11 bankruptcy protection. Confirmatrix was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

In 2013, Medicare identified Confirmatrix as the most expensive urine drug testing lab in the country, charging an average of $2,406 for each Medicare patient.

Benefis has continued to send urine drug samples to Confirmatrix for testing even after the company filed for bankruptcy. Some Benefis patients have recently been contacted by collection agencies seeking payment for urine tests costing well over $1,000 that their insurance refused to pay for. Similar tests by other labs cost only a few hundred dollars.

According to its bankruptcy filing, Confirmatrix has 152 employees in 15 different states, including one employee in Montana who apparently works on site at the Benefis pain clinic. PNN has also learned that Proove Biosciences has had employees working at the clinic. A Proove “patient engagement representative” was employed there as early as May 2016.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” says Rodney Lutes, a physician assistant (PA) who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.  What they did is they had a technician there in the department and every day I would get a list from that technician of patients that they would like to try to include in the program.”

Lutes says he recommended the DNA test to many of his patients, but never received any money from Proove. He says some of his patients later complained that their insurance was billed for the DNA test.

“One of the things that bothered me was that I signed a lot of the papers, but they also had my supervising doc on all of those papers,” Lutes told PNN. “I also felt like she was the one that brought them (Proove) in there.”

Lutes is referring to Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis plays a significant role at the pain clinic even though she only works there part time. 

“Dr. Lewis works for Benefis one week a month and has been instrumental in the development of our multidisciplinary approach and current protocols,” said Keri Garman, Director of Corporate Communications at Benefis.

In a statement emailed to PNN last month, Lewis said regular urine drug testing was necessary to ensure that “appropriate levels” of medication are present. Current clinic policy is that “high risk” patients should have a urine test at least once every two months.

“Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary,” Lewis said.

Benefis: No Kickbacks from Testing Labs

PNN has made repeated requests to Benefis to clarify its relationship with Confirmatrix and Proove, and whether Lewis or any other Benefis employees were receiving compensation from the laboratories for referring business to them. 

“Benefis and its employees, including Dr. Katrina Lewis, do not receive kickbacks from Confirmatrix or Proove. As for any questions you have regarding the lab business practices of these facilities, these would be best answered by the companies directly,” Benefis spokesman Ben Buckridge said in a statement emailed to PNN last week. 

“We take these accusations and defamatory statements against our organization and staff seriously. We appreciate your diligence on this issue.” 

In an earlier statement, a Benefis official said the DNA tests are voluntary and only done on patients if they are appropriate.

“Patients have the option to decline this testing, however, it proves to be very helpful in determining treatment plans for our patients in many cases. This testing has not been readily available until recently,” said Kathy Hills, Chief Operating Officer of Benefis Medical Group.

“Genetic testing allows us to see if the patient is appropriately synthesizing specific medications and can drastically alter treatment plans, showing us that sometimes the medications are not effectively metabolizing and therefore not as effective, which is why some patients have needed high doses. Our partners in this have an extensive patient assistance program that waives many costs, and patients are not penalized or removed from opioids if they refuse to have a genetic test performed.”

But a recent copy of the clinic’s opioid policy obtained by PNN says the tests are not voluntary for everyone. 

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states. The word "must" is capitalized in the document. 

One Benefis patient who took the DNA test said Lutes recommended it.

“He said everyone was doing it and that the insurance would be billed, but if they did not pay for it then Benefis would. I think he said something about it being a $6,000 test,” she told PNN.  “To me it was a waste of time and money. The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on.”

It is not clear whether the pain clinic's association with Proove or Confirmatrix had anything to do with Lutes’ firing in March. The 68-year old Lutes treated several hundred pain patients and was popular with many of them. 

Lutes was discharged for violating Benefis policy about record keeping, opioid dosage and urine drug testing, but feels he was “written up for violations that do not exist.” His supervising physician – Katrina Lewis – also requested removal from that role, meaning Lutes could no longer practice at Benefis as a physician assistant.

Since his dismissal, many of Lutes former patients who were on relatively high doses of opioids say their medication has been reduced or stopped entirely. One patient, whose opioid dose was cut significantly, committed suicide. Still others complain they were labeled and treated as addicts by clinic doctors and staff, and now have trouble finding new physicians in the Great Falls area. The ones who remain at Benefis say they are being told to take new tests and exams. 

Benefis says it cannot comment on the accusations because of patient and employee privacy rights.

“Unless Rodney Lutes, PA, or the patients with whom you are speaking will sign written releases allowing us to comment fully on the facts of their employment or their care, respectively, we are simply unable to engage in any further back and forth discussions.  We have provided all the information we are able given the legal limitations governing our industry,” Buckridge said.

Patient Suicide Blamed on Montana Pain Clinic

By Pat Anson, Editor

A 54-year old Montana man who apparently committed suicide earlier this month was a patient at a Great Falls pain clinic accused of mistreating patients and poorly managing their chronic pain. Bryan Spece was found dead in his Lewistown home on May 3.

“From what we know, about two weeks before his death, they had cut his pain pills back significantly. We’re not sure the exact amount. We’re trying to get ahold of his medical records,” said a family member. “When they called and told us that he’d been found with a gunshot wound, we thought someone had attacked him. Suicide was not even on our charts anywhere.”

BRYAN SPECE

"He was the last person anyone would have thought to take his own life. He was just not that guy," another family member said. "I know he was in a lot of pain and in a very dark spot."

Until recently, Spece was one of several hundred patients being treated at the Benefis Pain Management Center by Rodney Lutes, a physician assistant. The 68-year old Lutes was discharged by Benefis in March for unexplained reasons and the care of his patients was transferred to other providers at the clinic.

Many of Lutes' former patients – including some who were on relatively high doses of opioid pain medication – say they are now being “bullied” and treated like drug addicts by Benefis doctors and clinic staff. Their prescriptions for pain medication have been drastically reduced or stopped entirely. 

The Centers for Disease Control and Prevention recommends a "go slow" approach when patients are weaned or tapered to minimize symptoms of opioid withdrawal. The CDC says a "reasonable starting point" would be 10% of the original dose per week. Patients who have been on opioids for a long time should have even slower tapers of 10% a month, according to the CDC.

The Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks, although in some extreme cases the VA says an initial rapid taper of 20% to 50% a day is needed

Bryan Spece's dose may have been reduced by 70 percent.

"I talked to him a few days before he died and he said they had cut him from 100 milligrams of oxycodone a day to 30. He was not doing well," a relative told PNN.

“He was one of my patients that I saw routinely. He was doing very well on the regimen I had him on,” said Lutes, who treated Spece for about three years and never saw signs of depression.

“My suspicion is that, like the rest of my patients, he got totally slammed at this pain clinic at Benefis and they probably took all his medicines away,” Lutes said. “Right now I am so angry about this happening. This was a good guy.”

According to his obituary, Spece was a gun collector, Marine Corps veteran, Oakland Raiders fan and belonged to a motorcycle club. Friends and family called him “Bonz.”

“He was a very loud fun loving kind of guy you always knew when Bonz walked into a room,” reads the obituary published in the Helena Independent Record.

But recently some noticed that Spece was depressed about his inability to work regularly because of chronic pain from carpal tunnel syndrome and an old back injury.

“He was having money issues with not being able to work as often because of the pain and with having his pain pills cut back. He was just very stressed, constantly, about it,” said a family member, who believes Benefis is "100%" responsible for Spece's death.

“The police found several text messages on his phone. He was talking to his friends there in Lewistown, stating ‘Come get my guns. I’m in so much pain, I might do something stupid.’ And then he’d laugh it off. So nobody thought he was really thinking about ending his life.”

"We extend our condolences to the family during this difficult time," Benefis spokesman Ben Buckridge said in a statement. Buckridge said Benefis could not comment any further because of patient and employee privacy rights.

“I lay awake wondering how many Bryans are also laying awake at the same time and I pray to God to please let them know that we are here for them,” says Re Ann Rothwell, a former patient of Lutes who claims Benefis dropped her “like a dirty diaper.”

Rothwell has organized a support group for Lutes’ patients and has reached about 100 of them so far. The group has formed an active online community and is trying to locate hundreds of other former Lutes' patients to offer them support. Rothwell worries there could be more suicides.

“I truly feel that we failed in the case of Bryan Spece and perhaps several others who have taken their lives because of Benefis' actions. They felt so alone and in despair that suicide was the only answer. We just do not know about them yet.  It truly breaks my heart,” she said in an email. “We just need to figure out how to reach those folks. Perhaps Bryan's death will help us find a few more folks on the brink, who we can pull back with love, support and hugs.”

In April, a disgruntled pain patient burned down a doctor's home near Great Falls, held the doctor's wife at gunpoint and killed himself during a standoff with police. David Herron was not a patient at the pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with the doctor, an orthopedic surgeon for Benefis.

The pain clinic is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides a wide variety of medical services in Great Falls, a city of over 58,000 people in north central Montana. With over 3,000 physicians and other employees, Benefis is the largest employer in the area outside of government.

In a statement emailed to PNN last week, a Benefis pain management specialist outlined the clinic’s policy about opioid medication.

“Our clinic does not suddenly discontinue opioid prescriptions for patients unless we feel it is unsafe to continue prescribing them,” said Katrina Lewis, MD. “We know so much more now about how these drugs work than we did 20 years ago. The practice of medicine, procedures, and guidelines change over time, and we’re certainly seeing an evolution in how we care for people with chronic pain.

“We are following evidenced-based practice and recommendations of reputable pain societies in approaching the care we provide. We recognize that opioids absolutely have a place in the management of chronic pain for some patients. Our focus is to treat each patient individually with use of risk stratification and evaluation of patient pathology and co-morbidities.”

‘Dear Valued Patient’

But the form letters sent by Benefis to hundreds of Rodney Lutes’ patients in March could hardly be described as treating “each patient individually.” Patients were notified that Lutes was no longer practicing at the pain clinic, that they were being reassigned to new providers, and that their prescriptions would probably be changed. They were also told not to complain.

“Your new provider will do a thorough evaluation of all your medications and will likely make changes that he or she feels are in your best interests,” a form letter with the salutation “Dear Valued Patient” states. “Please be aware that arguing or complaining about changes in your prescriptions will not alter your clinician’s care plan.” 

“The prescriptions you will be given may not be what you are used to. It will be what is appropriate for your care,” another form letter says. “Verbal or written complaints to staff and management will not result in a change to your prescription.”

As PNN has reported, some patients also received letters stating that “all care providers” in the Great Falls area had been made aware of the changes at Benefis and “with what is going on with PA Lutes’ patients.” Many of those patients are now having trouble finding new doctors and feel they’ve been branded as addicts and drug seekers.

“We do our best to care for our patients and regret that this transition has been difficult for some. We realize we have opportunities to improve our communication with patients and will be working on that as a team moving forward. We are always looking at new ways to improve the patient experience, and we value patient feedback,” Nikki Phillips, Office Manager at the Benefis Pain Clinic, said in last week’s emailed statement.

What’s happening at Benefis is a microcosm of what’s happening all over the country. Patients are being abruptly weaned off opioids or being abandoned by doctors and pain clinics that are fearful of running afoul of the CDC’s “voluntary” prescribing guidelines, the DEA, or their own medical liability insurers.  Some providers are steering patients toward surgeries or costly “interventional” procedures that they don’t want.

At PNN, we hear regularly from chronic pain patients who were able to lead stable and productive lives for years on relatively high doses of opioids – a medical treatment that many are now denied and are told doesn't work. Many pain sufferers are in despair, increasingly disabled and having suicidal thoughts.

Until the needs of those patients are taken into consideration and appropriately balanced with society's need to prevent addiction, there will be more Bryan Speces and more grieving families.

“This man was the most happy-go-lucky man. He adored his grandchildren. He was a good time, all of the time. If he hadn’t been in so much pain, I don’t think he would have had a negative thought,” a family member told us.

“He lost a sister 12 years ago to suicide and he was always so broken up about that. He’s always said he would never do that.”

Spece’s death is still classified as a homicide because his autopsy report is incomplete. The Fergus County coroner is still awaiting results from toxicology tests.

Montana Urine Tests Sent to Bankrupt Drug Lab

By Pat Anson, Editor

Imagine getting an unexpected medical bill for over $1,500 that your insurance won’t cover. You can’t afford to pay it, have already missed several weeks of work due to chronic back pain, and you’re worried about losing your job.

That’s the dilemma faced by a Montana woman, one of the patients at a Great Falls pain clinic who are getting unusually large bills for urine drug testing at a laboratory over 2,000 miles away in Georgia. 

“I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?” said the patient, who asked that we not reveal her identity.

The lab in question is Confirmatrix Laboratory, a financially troubled company near Atlanta that specializes in urine drug testing.

For the last two years, Confirmatrix has conducted drug screens for the Benefis Pain Management Center, which is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides other medical services in Great Falls.

As PNN has reported, some current and former patients at the Benefis pain clinic believe they are being unfairly labeled and treated as addicts. Many are having their opioid doses reduced or stopped completely. All are required to take regular drug tests to prove they’re not abusing their pain medication.

“For the safety of our patients, regular urine drug screens are conducted to ensure the appropriate levels of prescribed medications, and only those medications, are present,” says Katrina Lewis, MD, a pain management specialist at Benefis.  “Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary.”

Urine drug testing is not uncommon at pain clinics, but the selection of Confirmatrix is. The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

Satary was arrested in 2001 and served more than three years in federal prison after pleading guilty to running a counterfeit CD operation in the Atlanta area valued at $50 million. At the time, it was the largest counterfeit music case in U.S. history, according to the Atlanta Journal Constitution.

Khalid and jordan satary (instagram photo)

Shortly after his release from prison, Satary founded Confirmatrix, Nue Medical Consulting and GNOS Medical, a medical billing firm, and then transferred his interests in the companies over to his son Jordan, a recent high school graduate.

The Journal Constitution reported in 2014 that Satary was subject to a federal deportation order, but immigration officials were unable to find a country willing to accept him. He still apparently lives in the U.S.

On November 2nd of last year, the FBI and the Georgia Department of Health and Human Services served search warrants at Confirmatrix and GNOS Medical, and agents removed documents from both facilities.

The agencies have not said what prompted the raids and no charges have been filed against either company.

Just two days after the search warrants were served, Confirmatrix filed for Chapter 11 federal bankruptcy protection, with Satary’s son Jordan the largest shareholder to sign the petition in the Northern District Court of Georgia. GNOS Medical is listed as one of the creditors that Confirmatrix owes money to.

“Although historically very profitable,” Confirmatrix CEO Ann Durham told the court the company “began experiencing financial troubles when recent changes to Medicare’s reimbursement rates resulted in a decrease (in) revenue from its toxicology business.”

Drug testing has indeed been a very profitable business for Confirmatrix and other drug labs. A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices, not only by Confirmatrix but other drug labs such as Millennium Health, finally caused Medicare to lower its reimbursement rates for drug testing.

Millennium filed for Chapter 11 bankruptcy in 2015, soon after paying a $256 million dollar fine to settle fraud and kickback charges, and to reimburse the government for unnecessary urine and genetic tests.

Under its Chapter 11 filing, Confirmatrix is still able to conduct business and perform lab tests, but it is exploring options for a possible sale of the company or a restructuring “to focus its operations on the blood testing business.” 

The company said it has 152 employees in 15 different states, including one employee in Montana who apparently works at the Benefis pain clinic in Great Falls.

“They had a gal who was there every day, I assume working there full time, and she was responsible for collecting the samples, processing them, and shipping them off to the lab,” said Rodney Lutes, a physician assistant who was discharged by Benefis in March. 

Benefis did not respond to inquiries from PNN about whether a Confirmatrix employee works at the pain clinic or if Benefis receives a commission or compensation from Confirmatrix for doing business with the company. According to clinic policy, patients on high doses of opioids "should have a minimum of one urine drug test every two months."

In a statement, a Benefis official said Confirmatrix performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs. This company does not send its patients to collections for an inability to pay a bill,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

But some Benefis patients are getting letters from collection agencies demanding payment for Confirmatrix drug screens that cost well over $1,000, the same tests that Medicare is charged about $150 for under its new reimbursement rates. A call to Confirmatrix for comment was not returned.

Other patients say they are getting bills for drug tests they’ve already paid for, and that Benefis has lost some of their billing and medical records. Still other patients are surprised to learn they may be legally responsible for drug tests that their insurance company refused to pay for.  

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” said one woman, a chronic pain sufferer for over 30 years, whose opioid dose was recently reduced substantially. “In the last 6 weeks I have been dropped to one third of the dosage I was on with intentions that I will be dropped even more. I have no desire to live, because this is not living.”

In April, a suicidal patient at Benefis Health System burned down his doctor's home and killed himself during a standoff with police. David Herron was not a patient at the Benefis pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with his doctor, an orthopedic surgeon.

The incident prompted Benefis to upgrade security procedures at its facilities, including training employees to handle active shooter situations, according to the Great Falls Tribune, which reported that "danger presents itself in the form of patients who are drug addicted looking for an early prescription."

Patients Allege Mistreatment at Montana Pain Clinic

By Pat Anson, Editor

A Montana pain clinic is under fire from patients for abruptly stopping their opioid medication, forcing them to take expensive drug tests, and steering them towards invasive and potentially dangerous procedures.

Some former patients at the Benefis Pain Management Center in Great Falls also allege they have been unfairly labeled as addicts, which has made it difficult for them to find new doctors.

“I’ve never been treated so badly in my life as I have at Benefis, to the point that I terminated my care with them, because I couldn’t do it. I couldn’t be called an addict and a junkie anymore,” says Tami Duncan, a 50-year old woman who suffers from chronic back pain.

“I’m not going back. I am done with them,” says another former patient. “It’s like I was a junkie just looking for my next fix. And that’s not the case at all.”

“You become terrified of who you are going to see next and what they are going to say and do to you,” said a current patient. “The fear of losing my job and not to mention my sanity. The fear that I am going to be labeled an addict if I don’t do what they tell me to.”

“They do not care. They do not know their patients. They do not review the records,” another current patient said. “There is so much more. Billing errors, rarely treated like a person, the wait to see doctors, and then 15 minutes (with them) and you are gone.”

The Benefis pain clinic is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides a wide variety of medical services in Great Falls, a city of over 58,000 people in north central Montana. With over 250 physicians and about 3,000 other employees, Benefis is the largest employer in the area outside of government.

“We have some of the finest nurses and Physician Pain Management specialists, with experience second to none. This experience combined with their compassion, provide a tremendous supportive atmosphere. Our pain management team aims to help people reduce and cope with pain,” Benefis says on its website.

Some patients disagree, saying Benefis doctors are quick to label a patient as non-compliant, which has led to patients being discharged from the clinic. In a rural state such as Montana, where options for pain care are limited, that is not a threat to be taken lightly.

“Any questions or requests can be seen as combative. To try and protect ourselves we were recording our appointments. Somehow it was found out and there are now signs everywhere stating no recording or photos,” a patient told PNN.

“We are not allowed to have anyone come into the appointment with us. I am being bounced around to different providers. There is no stability. I am still receiving meds but at a fraction of what they were. To say that I am hurting would be an understatement.”

“Our clinic does not suddenly discontinue opioid prescriptions for patients unless we feel it is unsafe to continue prescribing them,” said Katrina Lewis, MD, a Benefis pain management specialist. “We have patients that have been on pretty high doses of opioids for many years but are not experiencing much relief from pain anymore and their quality of life is suffering significantly.  

A SIGN POSTED AT THE BENEFIS PAIN CLINIC

“We have to do what is medically responsible and safe for our patients. Opioids are incredibly powerful drugs. Given the choice between a patient potentially dying and a patient going into withdrawal, we have to pick withdrawal.”

In an age of opioid hysteria and misleading headlines about an overdose epidemic fueled by painkillers, pain patients around the country – including many who have been stable and compliant on opioid medication for years – are seeing their doses cutback or eliminated. Some have been discharged by doctors who are leery of scrutiny by the DEA and no longer want to treat chronic pain.

What sets the disgruntled patients at Benefis apart from everyone else is that they have formed a support group for each other. And some are speaking out publicly against a provider they feel has shamed and abandoned them. For this story, PNN interviewed over a dozen current and former patients, including some who asked to remain anonymous.

Physician Assistant Fired

Many of the problems at the Benefis pain clinic can be traced back to the firing of Rodney Lutes, a popular 68-year old physician assistant (PA) who – until he was let go -- was treating as many as 1,000 pain patients.  

RODNEY LUTES, PA

“I was thunderstruck. It totally blindsided me. I thought I was doing everything I could for the patients,” says Lutes about his firing in early March.

Lutes was told he was “no longer a good fit” at the clinic and that his position was being eliminated. He believes the real reason was that some of his patients were on high doses of opioids that exceeded clinic policy.

“They didn’t come to me and say, ‘Hey Rod, you need to fall in line here and start reducing these people.’ There was no warning whatsoever,” said Lutes. “The majority of the patients were doing very well. You always have some patients who aren’t doing well and you try to adjust their medications. I had a number of those. But otherwise I felt that the patients were doing very well on the doses they were on.”

“We respect our employees’ privacy rights and consequently cannot comment on the details of Rodney Lutes employment with Benefis,” says Keri Garman, Director of Corporate Communications at Benefis.

There is no record of any disciplinary action against Lutes by Montana’s Board of Medical Examiners. He has been licensed as a PA in the state since 1991.

“He’s compassionate and understanding. I’ve never met anybody else like him in my life,” says Tami Duncan, a patient of Lutes for 20 years. “And Benefis is crucifying that man, along with his patients.”

Duncan was on relatively high doses of oxycodone and MS-Contin for chronic back pain caused by herniated and bulging discs, arthritis and fibromyalgia. She’s also had as many as 60 epidural injections, nerve blocks and other "interventional" procedures, which not only failed to stop her back pain, but may have given her adhesive arachnoiditis, a progressive and chronic inflammation of spinal nerves that she was recently diagnosed with.

“Sometimes it feels like I’m standing in a pot of hot boiling water all day,” says Duncan. The first thing she was told by her new doctor at Benefis was that he was taking her off opioids.

“He comes in and didn’t even look at my files, didn’t even look at my record. And he told me, ‘Well Mrs. Duncan, the game plan is we’re taking you off all your medications and then we’ll terminate your care.’” she recalled. “He didn’t know anything about what was wrong with me. Didn’t know I had nerve conduction tests done to show all the nerve damage I have in both of my legs. He basically came out and said, ‘All you patients all need to go into treatment. You’re addicts.’"

“There are many scenarios that may warrant discontinuation of a particular regimen for the benefit of the patient.  Opioids can have many negative side effects for patients,” said Dr. Lewis in a lengthy statement for PNN prepared by Benefis. “We understand that this can be unsettling for patients who have been with a provider for a long period of time and who are accustomed to their care plan.”

Duncan started looking for a new pain doctor and immediately ran into problems. When she visited a pain clinic in her hometown of Havre, she was turned away without an exam or review of her medical records.

“The RN proceeded to tell me that I was a junkie, those are her words, that I was an addict and the only thing that was wrong with me is that I needed to go to treatment,” she said. “I’ve called all over the state trying to find a different pain doctor. Nobody will take me. Benefis has called every doctor in the state of Montana saying not to take any of Lutes’ patients.”

Duncan cites a letter she received from Benefis, which states: “All care providers in our community have been made aware of the changes in our clinic and with what is going on with PA Lutes’ patients.”

“It is our standard practice to send a note to referring physicians within our own health system and community to let them know of changes to the providers practicing in our clinic.  The letters never indicate the reason a person is no longer with our organization,” Kathy Hill, Benefis’ Chief Operating Officer said in the statement. “Community providers had many patients calling with concerns about whether they would be able to get in with a new provider soon enough to avoid a lapse in their medications.

“Whether or not to prescribe opioids to any patient is at the discretion of the provider. Providers were not urged either way.”

‘Nobody Will See Pain Patients’

Regardless of the reason, many former patients of Lutes are having trouble finding new doctors, a not uncommon experience in rural areas where healthcare choices are limited.

“Nobody in Great Falls will see any pain patients. I’m just sitting here in limbo doing nothing but being in pain,” said a former patient who decided to leave Benefis after her opioid medication was stopped. The doctor who replaced Lutes persuaded her to have an epidural, a decision she now regrets.  

“They’re forcing everybody to get injections,” says Adrienne Barnoski, another former patient. She and her husband Joseph, who has severe back pain, had been treated by Lutes for years.

“I’m not going to have any injections on my back after what my husband has gone through. It sometimes makes things worse,” she said.

Epidural injections have been used for decades to relieve pain during childbirth, but in recent years injections of a steroid into the epidural space around the spinal cord have increasingly been used to treat back pain.  The shots have become a common and sometimes lucrative procedure at pain clinics, where costs vary from as little as $445 to $2,000 per injection. Critics say the injections are risky, overused and often a waste of money.

“An epidural steroid injection is an invasive procedure. It has its risks. And I think a patient always has the right to decline an invasive procedure,” says Lutes. “I’ve had a couple of patients tell me (that they were told) to do epidural steroid injections and if they didn’t do the injections they were no longer going to be prescribed any medications. To me, that’s kind of like blackmail.  

“My patients are being treated very, very poorly. It’s horrible. I’ve had calls from patients or their spouses, very concerned the patient was going to commit suicide. It just scares me to death. And these were patients that were functionally doing great. And now they’re being told, sorry, we’re taking your medication away from you.”

Benefis says it does not pressure patients into having invasive procedures, but admits there could have been communication problems between doctors and their patients.

"This is not a policy or an expectation in any way. While we expect patients to be active participants in getting better, there is never a mandatory procedure,” said Nikki Phillips, BSN, Clinic Office Manager at Benefis Neurosciences. “We do our best to care for our patients and regret that this transition has been difficult for some. We realize we have opportunities to improve our communication with patients and will be working on that as a team moving forward.”

“The decision of whether or not to prescribe opioids to a patient is in no way related to their decision to have or not have other interventional procedures,” said Dr. Lewis. “Unfortunately there are some patients who come into the clinic with a preconceived notion that opioids are the answer for them, whether because of past practice within the medical community or other reasons, and overcoming that preconceived notion can be challenging.”

A major challenge for the patients who remain at Benefis is paying for their urine drug tests, which can cost as much as $1,500 and are not always covered by insurance.  For the past two years, Benefis has been working with a drug laboratory over 2,000 miles away in Georgia, one with a questionable past and a very uncertain future. For more on that part of the story, click here.