Patient in Tulsa Hospital Shooting Was Angry About Pain Care

By Pat Anson, PNN Editor

The gunman who killed four people Wednesday at an Oklahoma hospital recently had back surgery and was angry about his post-operative pain not being treated, according to police and media reports.

Michael Louis shot and killed Dr. Preston Phillips, the surgeon who performed the operation, as well as another doctor, a medical receptionist and a bystander who took his wife to an appointment at Saint Francis Hospital in Tulsa. The 45-year-old Louis fatally shot himself as police closed in.

“What we currently know is that Louis was in pain, Louis expressed that he was in pain and was not getting relief and that was the circumstance surrounding this entire incident,” said Tulsa Police Chief Wendell Franklin. “He blamed Dr. Phillips for the ongoing pain that came from the surgery.”

Phillips was an orthopedic surgeon who specialized in spinal surgery and joint reconstruction. He graduated from Harvard Medical School in 1990.

No details have been released on what type of back surgery Louis had or what kind of pain medication he was given. According to a niece, he suffered from back pain for “a long time.”

“We are aware that he has been experiencing back pain for a long time but [there is] no reason for this senseless act,” the niece told The Daily Beast. “We are a Christian-based family. We have never experienced this before.”

Police say Phillips operated on Louis on May 19. Louis was released from the hospital on May 24, but called “several times over several days complaining of pain and wanted additional treatment,” according to Franklin. Louis had an appointment with Phillips on Tuesday, the day before the shooting, but it’s not clear if any further pain relief was offered to him.

In the days following his surgery, Louis was living in the home of his ex-wife, Dr. Edith Lubin, a family practice physician. Her lawyer released a statement saying Lubin had no knowledge of her former husband possessing a gun or having “any intent of harming anyone.”

“Dr. Lubin is praying for the families of all those affected. She acknowledges everyone’s concerns in understanding what happened, but she is at a loss for an explanation, other than the effect of continuing pain to Mr. Louis during his recovery,” the lawyer said in a statement to a KJRH-TV reporter.

Louis bought a handgun on Sunday and a semiautomatic rifle on Wednesday afternoon, just hours before the shooting. Both weapons were legally purchased, according to police.

Franklin said a letter found on Louis after the shooting “made it clear that he came in with the intent of killing Dr. Phillips and anyone who got in his way.”

Asked whether opioids were involved in Louis’ treatment, Franklin said investigators have only established that he was in pain and that other details about his care were still being investigated, according to The Washington Post.

‘Just a Matter of Time’

In recent years, many U.S. hospitals have stopped or reduced the use of opioids after surgery, fearing patients may become addicted. Non-opioid analgesics and over-the-counter pain relievers such as Tylenol are increasingly being used to treat post-operative pain.

"Out of all the hospital systems in Oklahoma, I have heard the most about the horrible pain treatment at St. Francis,” said Tamera Lynn Stewart, an Oklahoma patient advocate and Policy Director for the P3 Political Action Alliance. “I know so many who have had surgery there and received Tylenol only or who see doctors there that claim they aren’t allowed to prescribe." 

Opioid addiction is actually rare after surgery. Studies have found that less than 1% of patients are still taking opioids a year after major surgery or were later diagnosed with opioid dependence.  

With their pain poorly treated or left untreated, Stewart says some desperate patients in Oklahoma have threatened to kill themselves on the steps of the state capitol to make a statement. The mass shooting at the Tulsa hospital, while tragic, was not unexpected to her. 

“While our hearts are grieving with the families and victims, few in our grassroots communities built to advocate for appropriate treatment of pain without government or third-party interference can say this was completely unexpected. Veterans have committed suicide at VA’s across the country for the same reason,” Stewart told PNN. 

“Most of us knew it was just a matter of time before someone who could no longer bear the unrelenting pain did something more drastic in order to get the attention needed to end the restrictions (on opioids) and begin the much-needed process of swinging the pendulum back to a more neutral position.” 

Long before Tulsa, there were other cases where people in pain resorted to drastic action. In 2017, a man suffering from chronic back pain shot and wounded two people at a Las Vegas pain clinic before taking his own life.   

That same year, an Indiana doctor was fatally shot by a man who was upset because the physician refused to prescribe opioids to his wife, who suffered from chronic pain.

Virtual Reality Shows Long Term Benefits for Chronic Low Back Pain

By Pat Anson, PNN Editor

Critics of virtual reality therapy often say it’s a poor treatment for chronic pain because it only distracts patients from their pain and that the effects are temporary, at best.

But new research suggests that the benefits of virtual reality (VR) can last six months after treatment has stopped – at least for patients with chronic low back pain.

The study, published in the Journal of Medical Internet Research, followed 188 people with chronic low back pain who had an average pain intensity score of 5 on a zero to 10 point scale.

Half the participants were given an EaseVRx headset to watch 3-D programs daily for 8 weeks, immersing themselves in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is help patients learn how to manage pain through cognitive behavioral therapy.  

The other patients also used the EaseVRx headset, but only watched routine nature scenes as a placebo or sham VR treatment.  

JOURNAL OF MEDICAL INTERNET RESEARCH

Patients were followed for six months after treatment was stopped. Participants in both groups reported improvement in their pain and other symptoms six months after treatment, but the improvements were more significant in those who received VR therapy. Pain intensity was 31% lower for patients in the VR group, compared to 16% in the sham group. Physical function, mood, sleep and pain-related interference in activity were also better in those who received VR therapy. No adverse side effects were reported in either group.

“We have been pleasantly pleased and surprised that patients are maintaining clinically meaningful changes in pain intensity and interference 6 months after returning the device. It appears people are actually acquiring skills in a relatively short period that they continue to retain/apply months after treatment,” said Josh Sackman, co-founder and president of AppliedVR, which makes the EaseVRx headset.

AppliedVR is planning more research to see how patients respond long-term to VR treatment. A brain imaging study is being conducted to measure brain activity before, during and after treatment. Patients are also being recruited for a large clinical trial to see how VR therapy impacts pharmacy and medical claims.  

“In order to drive real acceptance, we are committed to extensive research to address any skepticism people may have,” Sackman told PNN.

The EaseVRx headset was given a Breakthrough Device Designation by the FDA in 2020 for fibromyalgia and low back pain. Last year the agency authorized the marketing of the headset for chronic low back pain in adults, the first medical device of its kind to receive that designation.

EaseVRx headsets are currently being used for pain management in over 200 hospitals and healthcare systems. A full commercial launch for home-based use is not expected until next year.

100,000 ‘Unnecessary’ Hospital Procedures Performed in First Year of Pandemic

By Pat Anson, PNN Editor

U.S. hospitals performed over 100,000 “low-value” procedures on Medicare patients in the first year of the Covid pandemic, including tens of thousands of spinal surgeries and knee arthroscopies, according to a recent study by the Lown Institute, a non-profit that seeks to reduce the use of unnecessary and ineffective medical treatments.

In 2020, no vaccines were available, the elderly were particularly vulnerable to the Covid-19 virus, and intensive care units were filled with infected patients. Yet many hospitals continued to perform questionable elective procedures at the same rate they did in 2019.

“You couldn’t go into your local coffee shop, but hospitals brought people in for all kinds of unnecessary procedures,” Vikas Saini, MD, president of the Lown Institute, said in a statement. “The fact that a pandemic barely slowed things down shows just how deeply entrenched overuse is in American healthcare.”

Lown researchers analyzed Medicare claims from U.S. hospitals for eight procedures that the non-profit considers to have “little to no clinical benefit” and are potentially harmful.  

Coronary stents were the most overused procedure, with over 45,000 balloon angioplasties performed to open up blocked arteries. The Lown Institute has long maintained that stents are unnecessary and risky in patients with stable heart disease.

Two spinal surgeries also made the list: 13,541 spinal fusions and 16,553 vertebroplasties were performed on older patients. In vertebroplasty, bone cement is injected into fractured vertebrae to stabilize the spine; while spinal fusions are used to join two or more vertebrae together to prevent them from moving and causing more pain. The Lown Institute considers fusions and vertebroplasties inappropriate for patients with low back pain and osteoporosis.

Nearly 1,600 knee arthroscopies were also performed in 2020, a type of “keyhole” surgery in which a small incision is made in the knee to diagnose and repair ligaments damaged by overuse or osteoarthritis. Recent independent studies have found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

“There are certain things, certain practices that are just insane. You shouldn’t be doing this. Nobody should pay for this,” said Saini.

Highland Hospital in Rochester, New York was rated as the top hospital in the country for avoiding overuse procedures. Richardson Medical Center in Rayville, Louisiana was ranked as the worst hospital.

The American Hospital Association disputed Lown's ranking system, calling it misleading.

"Throughout the pandemic, but especially in the early months, many nonessential services and procedures were put off due to government restrictions or voluntary actions from hospitals to make room for massive surges of COVID-19 patients," Aaron Wesolowski, AHA's VP of policy research, said in a statement to Becker’s Hospital Review.

"Studies have shown that these delays or sometimes even cancelations in nonemergent care have had some negative outcomes on the health and well-being of patients, who continue to show up at the hospital sicker and with more advanced illnesses. Many of these services may alleviate patients' pain or provide other help to patients. Lown may define these services as 'low value,' but they can be of tremendous value to the patients who receive them."

Emergency Treatment of Arachnoiditis After Spinal Injection

By Dr. Forest Tennant, PNN Columnist

In rare cases, symptoms suggesting adhesive arachnoiditis (AA) may occur after a spinal tap or epidural injection (therapeutic or obstetrical). These early symptoms may include localized lumbar pain, headaches, burning sensations, dizziness, leg weakness and bladder dysfunction. Spinal fluid leaks or blood in the spinal canal are often suspected in these cases.  

If symptoms indicate the possibility that AA may be developing, we recommend emergency treatment to hopefully prevent the spinal nerve inflammation from spreading and becoming chronic. 

A problem that we have routinely discovered is that medical practitioners commonly have the false belief that they can see signs of AA on an MRI when symptoms begin or within a few hours or days after a spinal tap or epidural injection. But AA typically does not show on an MRI for at least four to six weeks. Consequently, early emergency treatment must be based on patient history and symptoms, rather than on MRI findings. 

At the First International Congress on Arachnoiditis and Tarlov Cysts in 2010, physicians Donna Holder and Antonio Aldrete recommended that methylprednisolone 500 mg be given intravenously every day for five days as an emergency treatment for AA.  

Since that time, a variety of intravenous methylprednisolone attempts with different dosages and frequency have been used by physicians as emergency treatment to prevent AA. Dr. Aldrete opined that intravenous methylprednisolone is only effective in preventing AA if given within 60 days after the spinal tap or epidural. 

We have used the following alternative treatments to intravenous methylprednisolone: 

1. Medrol (methylprednisolone) six-day oral dose pack

2. Ketorolac 30 to 60 mg injection for three consecutive days

3. Medroxyprogesterone 10 mg given twice a day for six days

In some, but not all cases, AA symptoms will abate during the week that either intravenous methylprednisolone or the alternative treatments are administered. In most cases, however, symptoms reduce but don’t totally abate. The reason for this is unclear, but a reasonable assumption is that spinal canal inflammation may not be totally reversed once symptoms begin. 

If pain and other symptoms don’t totally abate, we recommend that the patient begin a three-component medical protocol for AA described in this bulletin, which includes nutritional, physiologic and pharmacologic elements. Patients should remain on these medical treatments until and if their pain and other symptoms resolve. 

It is unclear why only a small percentage of persons who have spinal taps or epidural injections develop AA. It is also unknown why symptoms that begin after these procedures usually don’t abate. 

A New Handbook for Practitioners

Our new book, "Clinical Diagnosis and Treatment of Adhesive Arachnoiditis” is now available on Amazon. 

This handbook for medical practitioners has been written for one simple reason.  AA is no longer a rare disease.  We conservatively estimate that there are at least 1.75 to 2.75 million adults in the U.S. who have AA.  

In the past, the cause of their back pain was often listed as unknown or inappropriately labeled as failed back syndrome, degenerative spine or simply low back pain. 

It is our fervent hope that this book will help medical practitioners and their patients diagnose and treat this most debilitating disease.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

High-Frequency Spinal Cord Stimulators Provide More Pain Relief

By Pat Anson, PNN Editor

Spinal cord stimulators are often considered the treatment of last resort for patients with intractable or severe chronic pain. The surgically implanted devices emit low levels of electricity that reduce pain signals, but have high failure rates and often have to be removed because they’re ineffective, cause infections or need new batteries.

Two new studies suggest there are ways to improve the success rate of spinal cord stimulators (SCS) through improved patient selection and the use of high-frequency devices.

Low-frequency SCS (50 Hz) was first approved by the Food and Drug Administration for intractable back and leg pain in 1989. Six years later, the FDA approved high-frequency devices (10,000 Hz), that deliver pulses of electrical stimulation that are shorter in duration, lower in amplitude and do not cause paresthesia, an irritating sensation of tingling or prickling.

In a retrospective study of 237 patients who received stimulators between 2004 and 2020, researchers at the University of California San Diego School of Medicine reported that high-frequency devices were more effective at reducing pain and opioid use than low-frequency ones.

The study findings, published in the journal Bioelectronic Medicine, also show that male patients benefit more than women from high-frequency neuromodulation.

"Our work was sparked by a growing literature that demonstrate sex specific immune pathways differentially contribute to chronic pain processes," said senior author Imanuel Lerman, MD, an associate professor of anesthesiology at UC San Diego Health. "The observed parameter-specific (high versus low frequency) sex-based differences in spinal cord stimulation efficacy and opiate use are definitely intriguing.”

It’s not clear why men benefit more than women, but researchers believe it may be due to the male hormone testosterone having a modulating effect on pain signals. The sex differences may also be due to males and females processing chronic pain differently.

"Clearly more work needs to be done to carefully characterize sex specific pain regulatory pathways that may prove responsive to specific types of neuromodulation and or pharmaceutical therapies," said Lerman.

Improved Patient Selection  

Although most patients are required to undergo psychological testing and a trial treatment before getting a SCS, failure rates for the devices remain high at around 25 to 30 percent. With about 50,000 stimulators implanted in the U.S. every year, that means thousands of patients are getting poor results.

To improve patient outcomes, researchers at Florida Atlantic University developed machine-learning algorithms to help predict which patients may benefit from SCS. Working with a cohort of 151 SCS patients, they evaluated 31 features or characteristics in each patient.  

Researchers found two distinct clusters of patients which differ significantly in age, duration of chronic pain, preoperative pain levels and pain catastrophizing scores. They used computers to fine-tune the results, identifying the 10 most influential features that contribute the most to a successful SCS implant.

Results of the study, published in the journal Neurosurgery, demonstrate for the first time the ability of machine-learning algorithms to predict long-term patient response to SCS placement. The next step is to validate the data in future patients to ensure that the algorithm is useful in real-world situations, not just computer models.

"Our study resulted in the development of a model to predict which patients would benefit from spinal cord stimulation," said lead author Julie Pilitsis, MD, dean and vice president of medical affairs at Florida Atlantic University's Schmidt College of Medicine.  "After we validate this work, our hope is that this machine-learning model can inform a clinical decision support tool to help physicians better choose which patients may be most appropriate."

SCS is no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of SCS to include lower limb pain from diabetic neuropathy.  Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A decision to get a SCS shouldn’t be taken lightly. A 2018 study by a team of investigative journalists found that stimulators have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving SCS found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

Sacroiliac Joints: An Overlooked Cause of Back Pain

By Victoria Reed, PNN Columnist

I’ve suffered from low back pain for a long time, beginning in my 20’s. I would have terrible spasms, pain, stiffness and leg numbness, which left me unable to walk or function at all.

I went through the usual testing to determine the cause and was asked if I had had some kind of accident or injury. The answer was always no. The only thing I could think of that may have contributed to the back pain was the fact that I ran track throughout my elementary and high school years. I figured all that running might have taken a toll on my spine.

An MRI revealed a bulging disk at the lumbar level. I was offered a nerve block, which helped relieve the pain for a while. But when I had children, the pain returned -- probably because the strain and added weight from pregnancy put extra pressure on my spine. 

A doctor offered a series of epidural spinal injections in which a steroid would be injected to try and shrink the bulging disk. The first shot didn’t work at all, but I was encouraged to try another one. The second didn’t work either. I was then put on pain and nerve medications, which did help somewhat.

Because I was using a prescription opioid, I had to go back periodically for regular exams to see if the meds were helping and still necessary. During one of those routine exams, the doctor asked me to point specifically to where the pain was coming from. I had been doing my own research online and thought the majority of the pain wasn’t coming from the bulging disk, but from my sacroiliac (SI) joints.

The SI joints are made up of the sacrum and the ilium of your pelvis, and are located on the right and left sides of your lower back. They are held in place by strong ligaments. Rheumatoid arthritis (RA) might increase the risk of having trouble with these joints. Though it’s commonly said that RA primarily affects the hands and feet, any joint can be affected.

I mentioned that to my doctor, but he wanted me to have more epidural steroid injections. I refused, partly because they didn’t help before and partly because I’m diabetic, and high-dose steroids cause the blood sugar to go up.

From there, I was sent to physical therapy. The therapy sessions were centered around strengthening my core abdominal muscles, and they did help reduce the number of times my back went out. However, the SI joint pain was still consistently there. During subsequent doctor appointments, and finally after some convincing, the doctor agreed that the SI joints were causing my pain.

SI joint pain is an often-overlooked cause of back pain, and can be confused with disk pain. It’s important to find any and all causes of persistent back pain because the treatments can be different.

Some years later, I agreed to try steroid injections into the SI joints, despite the effect I knew it would have on my blood sugar. Steroids can also make your body resistant to insulin.  I figured it was worth the risk if there was a chance at pain reduction. However, I knew that it would not be something that I could do regularly, and while not 100% helpful, there was some temporary modest relief. 

Since then, I’ve been able to identify what triggers the SI joint pain, and I use several different modalities for relief, including ice, low-dose oral steroids, stretches, and prescription pain medication.

How to Tell the Difference

Pain that is from a bulging or herniated disk can radiate down one leg and cause numbness or tingling. This pain is usually centered in the lower back, whereas pain from the SI joints can be pinpointed to one side or both. Pain from a bad disk can travel all the way down to the feet or toes, while SI joint pain usually stays above the knee.

Leg weakness can be very severe in a disk rupture, even to the point where you are dragging your foot. If you lose bowel or bladder control, that may be a sign of a serious condition called cauda equina syndrome and is considered a medical emergency!

Weakness in a leg from SI joint dysfunction usually isn’t prominent, but you can have numbness and tingling. SI joint pain can be triggered by going from a sitting to a standing position or by sleeping on one side. A trip or a stumble can also set off SI joint pain, and sitting for long periods of time can make either condition worse. Bending or twisting can aggravate a bulging or herniated disk.

While it’s always helpful to pay close attention to your symptoms, imaging is usually necessary. MRI is a valuable tool to get a good look at bulging or herniated disks. I would also keep a pain diary to make a note of what your pain triggers are and where the pain occurs. Make a note also of what relieves the pain (if anything).

All of these things can be helpful with assisting your doctor in making a proper diagnosis. Only until you get the correct diagnosis can you take steps to begin treatment and possibly achieve some lasting relief.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Chronic Pain Worsened for Many During Pandemic

By Pat Anson, PNN Editor

Nearly nine out of ten people with chronic pain say their symptoms have either not improved (51%) or gotten worse (36%) during the pandemic, according to a new Harris poll that found nearly half of respondents (44%) experienced delays in getting treatment due to Covid-19.

The online survey of 810 U.S. adults with chronic back or leg pain was conducted in October and November 2021. It was commissioned by Medtronic, which makes spinal cord stimulators and other neuromodulation devices that treat pain.

Nine in ten pain sufferers said pain impacts their lives on a daily basis, with poor sleep (63%) being the most common reported problem. Pain also negatively affects their mental health (60%), exercise habits (53%), mobility and function (51%), ability to enjoy hobbies (44%), social life (32%) and occupation (33%).

Over one in five (22%) said pain impacts their romantic relationships, including being intimate with a partner or spouse.

"This data bears out what we've heard from our clinician customers and patients for two years – the pandemic has been especially hard on those with chronic pain," Charlie Covert, Vice President & General Manager of Interventional Pain Therapies at Medtronic, said in a press release.

The survey found that nearly one in five pain sufferers (17%) said they have canceled a medical appointment or procedure without rescheduling, with the primary reason being fear of Covid-19 exposure. Only a third of surveyed patients (34%) feel comfortable going into a healthcare facility, and 5% say they will never feel comfortable returning to their provider.

The overwhelming majority of respondents (90%) wish there were more treatment options available to manage their pain. While most are aware of traditional treatments such as physical therapy and oral pain relievers, far fewer are familiar with options such as targeted drug delivery (38%) or spinal cord stimulation (34%).

"There is a tangible human cost to deferred procedures and delayed care. As COVID-19 hopefully begins its transition to a more endemic disease, we expect many of these patients to urgently seek relief through new or more effective treatment modalities,” said Covert. “Our survey demonstrated that an overwhelming majority want more treatment options, yet awareness of spinal cord stimulation and targeted drug delivery options remains relatively low."

The pandemic continues to affect the bottom line for Medtronic. Last month, the company said revenue losses were in the “low-double digits” for its neuromodulation and pain therapy devices.

In a conference call with analysts, Medtronic said the surge of omicron infections in January created “acute periods of worker absenteeism” with its customers, suppliers and staff. While conditions are improving, the company expects pandemic-related issues such as inflation, supply chain issues and healthcare worker shortages to linger.

How the Epstein Barr Virus Causes Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

The Epstein-Barr Virus (EBV) has long been known to cause autoimmune complications. For example, I described infectious mononucleosis in kidneys (glomerulonephritis) associated with EBV back in 1969, some 53 years ago.

Recently EBV has been shown to cause multiple sclerosis (MS), as well as certain cancers. Our studies have also revealed that many, if not the majority, of persons with adhesive arachnoiditis (AA) have extremely high EBV antibody levels. We now believe that EBV can cause AA as well as MS. 

Anything that boosts or helps a disorder to develop, is called a “co-factor.” In the case of EBV and AA, the “co-factors” or “co-partners” may include Ehlers-Danlos Syndromes, autoimmune diseases such as psoriasis, Lyme disease, and some other viruses like cytomegalus, coxsackie and covid.

‘Collagen Eaters’

Although almost everyone gets infected with EBV during their lifetime, some persons develop a large number of EBV antigens that literally attack and “eat away” or otherwise cause collagen to deteriorate and weaken. If the body creates large numbers of antigens, large numbers of antibodies are simultaneously made to hopefully counter them.

EBV collagen eating antigens like to attack tissues around the spine that have a lot of collagen. This includes intervertebral discs, cauda equina nerve roots, and the arachnoid-dural covering of the spinal canal. If collagen is weak or absent in spinal tissues, discs may slip, inflammation may form, and fluid leaks and cysts may develop.

Get Tested for EBV

All persons with confirmed or suspected AA should be tested for EBV antibodies.

Laboratories today do three types of tests for EBV. One is to tell if you currently have an active infection and the other two measure antibody levels to determine if you have had EBV in the past. If your antibodies are considerably above normal range, it suggests you have collagen eating antigens that put you at risk of developing AA.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Closed Pain Clinics Were ‘Always Pushing Injections’

By Anna Maria Barry-Jester and Jenny Gold, Kaiser Health News

On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: “Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021.”

In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state’s Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians.

Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.

The closures came on the same day that the California Department of Health Care Services suspended state Medi-Cal reimbursements to 17 of Lags Medical’s 28 locations, citing without detail “potential harm to patients” and an ongoing investigation by the state Department of Justice into “credible allegations of fraud.”

In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.

photo by Kathleen Hayden (KHN)

Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.

Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics’ patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California’s Medicaid program for low-income residents.

Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.

Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.

KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California’s extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.

Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state’s reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.

Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal’s average fee-for-service rates during that period.

In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.

‘Assembly Line’ Pain Care

Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.

Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. “If they saw over, like, 32 patients, they would get, like, $10 a patient,” Lagattuta testified.

The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient’s lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.

Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.

According to Sanchez’s testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. “We were incentivized initially to do these things with cash bonuses,” said one former employee, who asked not to be named for fear of retribution. “There was a lot of pressure to get those done, to talk patients into getting these done.”

In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.

‘Injections, Injections, Injections’

Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.

Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.

Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it’s known as the “suicide disease.” Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.

Ramirez said she often felt pressured to get procedures she didn’t want. “They were always just pushing injections, injections, injections,” she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.

She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. “If you refuse any treatment they say they’re going to give you, you’re considered noncompliant and they stop your medication,” Ramirez said.

She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. “It was horrible, horrible,” she said. Still, she said, she kept going to the office because there weren’t many other options in her town.

Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. “Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed,” attorney Matthew Brinegar wrote in an email. Lagattuta’s license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.

Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.

“What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well,” he said. For patients, he added, the consequences are not benign.

“I mean they are painful,” he said. “You’re putting needles into people.”

Cash Bonuses for Procedures

Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California’s Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.

The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.

On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise.

“In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain,” touted a biography once highlighted on the website.

Dr. Francis Lagattuta (Twitter)

Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.

Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women’s Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.

“The treatment is going to be the same whether you have a biopsy or not,” said Wang. “I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?”

Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. “I have scars down my leg,” she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.

Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. “It’s overwhelming to hear that they were doing it on a lot of people,” she said.

Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: “Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections” all qualified for $10 bonuses, he said in his testimony.

Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.

In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. “It was only for the patients,” he said. “We never did it based on procedures.”

Incentive systems for a specific procedure are “completely unethical,” said Dr. Michael Barnett, an assistant professor of health policy at Harvard. “It’s like giving police officers a quota for speeding tickets. What do you think they’re going to do? I can’t think of any justification.”

Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical’s Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients.

Johnson said he “never thought there was anything untoward going on” until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.

Nerve Ablations and Drug Tests

Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That’s more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.

An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.

Lags Medical also used the in-house lab to run drug tests on patients’ urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.

For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta’s provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.

Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn’t include less extensive drug screens or those billed under other providers’ numbers.

Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.

Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.

In December 2019, a patient who’d visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found “no deviations from the standard of care” and “did not find any over testing, or improperly performed biopsies.”

He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.

The medical board chalked it up to a record-keeping error and fined Lagattuta $350.

Opioids Needed for ‘Halfway-Normal Life’

On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California’s Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.

Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She’s been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.

Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. “There’s a difference between addiction and dependence. I need it to live a halfway-normal life,” Munoz said.

leah and ramon munoz

After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. “I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids’ birthday parties. You miss out on life,” she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.

Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. “If I didn’t get the procedures, I didn’t get the pain medication,” she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.

Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. “If you don’t cooperate with them, they would reduce your meds down,” he said.

At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn’t tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.

Soto’s biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn’t explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.

Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It’s well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by.

The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto. As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body.

GAIL SOTO

“My husband says sometimes when I sleep that my body will just jump up in the air,” she said. But now that Lags Medical is closed, she said, she can’t find a doctor willing to remove the device. “Most doctors are telling me right now, ‘We can’t, because we didn’t [put it in]. We don’t want nothing to do with that.’”

Waitlists and Withdrawal

Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.

“They left us all high and dry,” she said. “Everybody.”

In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn’t access their medical records, so other providers had no idea what their treatments had been.

“We had to create a crisis response to it because there was no organized response at that time,” said Dr. Rais Vohra, the interim health officer for Fresno County.

Fresno County’s health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: “You’d never do this with a cancer clinic,” he said. “You’d never abruptly stop chemo.”

The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.

“We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It’s really important to have a continuity, and that is not really possible in the current opioid-prescribing culture,” Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.

Gina, a retired nurse who asked to be identified by only her first name for fear she’d be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.

When she finally secured an appointment, she said, she was told by the doctor she was on “some very strong meds” and he would fill only one of her two prescriptions. “You’re like a criminal,” she said. “You’re branded as ‘we don’t trust you.’”

She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain “came back with a vengeance,” she said.

“I think about this, what I’d have been like if I’d never gone through pain management. I sometimes wonder if I’d be better off.”

As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn’t know whether she needs to worry about the care she received during more than four years at Lags Medical.

This story was produced by Kaiser Health News. Senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

Feds Use Mob Laws to Target Spine Surgery Fraud

By Fred Schulte, Kaiser Health News

A Texas consulting company that arranges spine surgery and other medical care for people injured in car crashes has come under scrutiny in a widening federal bribery investigation.

Meg Health Care, run by Dallas personal injury attorney Manuel Green and his wife, Melissa Green, is the focus of a search warrant recently unsealed by a Massachusetts federal court in an alleged health care fraud prosecution there. The probe is unusual because it uses a little-known law meant to crack down on organized crime racketeering across state lines.

Investigators alleged in the 2019 affidavit that the Texas company accepted thousands of dollars in bribes from SpineFrontier, a Massachusetts medical device company. SpineFrontier; its CEO, Dr. Kingsley Chin; and its chief financial officer, Aditya Humad, were indicted in September on charges of paying kickbacks to surgeons. All have pleaded not guilty.

No charges have been filed against the Greens or their company, and federal officials declined to discuss the investigation, which is detailed in the now-unsealed 2019 search warrant.

The Greens could not be reached for comment.

Meg Health Care sets up spine surgery and other medical treatment through “letters of protection,” or LOPs, legal contracts in which patients agree to pay medical bills using proceeds from a lawsuit or other claims against the party responsible for their injuries. These contracts are common in personal injury cases when people either lack health insurance or choose not to use it to pay for medical treatments after an accident. The downside is that patients can be left to foot the bill if their cases settle for less than they owe.

On its website, Meg Health Care says it “represents a group of doctors and hospitals who were tired of seeing injured people without access to medical care they needed after an accident. We hold firm to the belief that under the law, and as a matter of basic decency, the person or business that caused the injury should be held responsible.”

According to investigators, Manuel Green steered injured patients with LOPs to a local neurosurgeon who used SpineFrontier implants in surgeries at two Dallas-area hospitals.

“In exchange for attorney Green’s referral, SpineFrontier agreed to pay attorney Green forty percent (40%) of the revenue SpineFrontier received in connection with those surgical procedures as a bribe,” according to the search warrant affidavit.

Chin and SpineFrontier were the subjects of a KHN investigation published in June that found that manufacturers of hardware for spinal implants, artificial knees and hip joints paid more than $3.1 billion to orthopedic and neurological surgeons from 2013 through 2019.

Government officials have argued for years that payments from device makers to surgeons and other medical providers can corrupt medical decisions, endanger patients and inflate health care costs. The SpineFrontier indictment alleges that the company paid millions of dollars in bogus consulting fees to spine surgeons in exchange for their using its products, often in surgeries paid for by Medicare or other government-funded health insurance plans.

The Texas investigation adds a new dimension to the case by focusing on medical care that is paid for privately, which is not covered under federal anti-kickback statutes. Instead, the search warrant alleges violations of a law called the Travel Act. Enacted by Congress in the early 1960s to combat the mob, the Travel Act makes it a federal offense to commit crimes like bribery, prostitution, and extortion across state lines, including through the mail or by phone or email. Convictions can bring up to five years in prison, more if violence is involved.

Jonathan Halpern, a New York white-collar criminal defense attorney, said that such a use of the Travel Act reflects “an aggressive expansion” of the U.S. government’s power to prosecute health care fraud.

One of the first health care fraud prosecutions under the Travel Act took place in Texas and led to convictions on bribery and kickback charges of 14 people, including six doctors, associated with Forest Park Medical Center in Dallas. They drew a combined sentence of 74 years and were ordered to pay $82.9 million in restitution.

Chris Davis, a Dallas lawyer who specializes in government investigations, said the Travel Act grants federal prosecutors jurisdiction in cases “where you don’t have state or federal money involved.”

The Meg Health Care search warrant cites payments of more than $93,000 in 10 checks allegedly sent by SpineFrontier to the Texas company between April 2017 and October 2018. Investigators allege that the money was paid as a bribe for referring patients for surgeries using SpineFrontier products.

Investigators also cited a February 2016 email in which Melissa Green told the device company that a patient’s legal case had been settled and asked: “Please let me know when MEG can expect to receive payment per our agreement. Thank you!”

About two months later, the device maker cut the company a check for $3,953.60, according to the search warrant.

Nine of the 10 checks were signed either by Chin, a Fort Lauderdale spine surgeon and SpineFrontier’s founder, or Humad, according to the search warrant affidavit. Chin and Humad are the two executives indicted in September. Their lawyers had no comment.

‘Significant Medical Need’

Federal investigators sought the search warrant for Melissa Green’s email account at Meg Health Care in August 2019, arguing that they had “probable cause” to investigate the company for Travel Act violations, court records show. A federal judge in Massachusetts unsealed the warrant and related documents late last year.

Meg Health Care invites lawyers whose clients have a “significant medical need” to apply to the company, according to its website. If approved, Meg Health Care schedules an appointment with one of its doctors. “From there, our doctors will handle every aspect of the treatment sought, including surgery (if necessary),” the website says.

In a 2019 court filing in Dallas County, unrelated to the search warrant issued in the Massachusetts case, Manuel Green said he was the “founder and owner” of the company. He said it “assists physicians and medical facilities with reducing their exposure to risk when providing treatments to patients under [a] letter of protection.”

He went on to say the company’s “business model and the consulting services it provides are unique within the healthcare industry in the state of Texas.” The company’s website lists medical providers in 11 Texas cities.

According to investigators in the Massachusetts case, Green referred patients with LOPs to Dr. Jacob Rosenstein, an Arlington, Texas, neurosurgeon who used implants that SpineFrontier sold to two hospitals, Pine Creek Medical Center in Dallas and Saint Camillus Medical Center in Hurst, Texas. Pine Creek has since declared bankruptcy.

Neither Rosenstein nor representatives of the hospitals could be reached for comment.

Although proponents say that LOPs may be the only option for uninsured or underinsured crash victims to get medical care, a recent KHN investigation found that doctors and hospitals that accept them often charge much higher rates than Medicare or private insurance would pay for similar care and that the process can saddle patients with medical debt or expose them to safety risks.

Disputes over the size of medical bills and even whether the care was necessary are common in personal injury lawsuits in Texas. In one 2016 Dallas County case, for instance, a spine surgeon billed more than $100,000 for his services, while the hospital charged more than $435,000. By contrast, an expert hired by the defense set a reasonable fee at less than $4,000 for the surgeon and about $25,000 for the hospital, court records show. The case has since been settled.

Christine Dickison, a Texas nurse and medical coding consultant, said she routinely sees “hugely inflated” bills in car-crash lawsuits — and in some cases doubts whether the care was necessary.

“I see people who are undergoing surgery when there are literally no objective findings that support it,” Dickison said. “That is very disturbing to me.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.  

‘Letters of Protection’ Can Saddle Patients with Medical Debt

By Fred Schulte, Kaiser Health News

Jean Louis-Charles couldn’t afford spine surgery to ease nagging neck and back pain after a car crash. So he signed a document, promising to pay the bill with money he hoped to get from a lawsuit against the driver who caused the collision.

That never happened.

Louis-Charles, 68, died hours after the operation at a South Florida outpatient surgery center in March 2019. The surgery center had put him in an Uber with his wife, Marie Julien, according to depositions. After a 60-mile ride home, he collapsed, court records show.

Her husband’s death left Julien to deal with more than $100,000 in medical debt, as described in the “letter of protection,” or LOP, that Louis-Charles had signed.

In signing an LOP, people generally pledge to cover the costs of their care even if it exceeds what they win in a lawsuit or other settlement — and even if the prices are far higher than most doctors would charge.

The agreements are legal and binding in many states, though Florida appears to be the epicenter of their use in personal injury cases. Advocates say the letters throw a lifeline to low-income people who need vital medical care for injuries caused by the negligence of others and don’t have the money or insurance coverage to pay for it. Doctors and surgery centers that accept LOPs say they often wait years for a lawsuit to settle before being paid, if at all.

A KHN investigation found that letters of protection can saddle patients with medical debt — and drive a personal injury care system that operates with little oversight despite widespread complaints of grossly inflated billings and other problems that can place patients at risk.

Marie Julien blamed Dr. Kingsley R. Chin — a controversial Hollywood, Florida, surgeon who has accepted LOP payments for more than a decade — for her husband’s death after the spinal fusion procedure. Last year, she filed a malpractice suit against Chin alleging that Louis-Charles died after he “was discharged home while still in pain and with signs and symptoms of post-operative complications.” In court papers, Chin denied any negligence.

“We felt that the way the whole thing happened was very bizarre,” Julien, 71, a certified nursing assistant, recalled in a deposition taken in the case.

A ‘Terrible Situation’

Just before 8 a.m. on New Year’s Day 2018, Louis-Charles’ car was stopped at a red light near his home. Suddenly a white police vehicle, driven by a Palm Beach County Sheriff’s Office detective, backed into his Toyota Corolla, hitting the passenger side door, according to a police report.

In her deposition, Julien said Chin operated on her husband’s shoulder in 2018. But that didn’t help much, and Chin recommended more extensive surgery, she said. “I wasn’t happy at all with that idea,” she added.

Julien said she relented because Louis-Charles’ pain was getting worse “day by day” and he had confidence in the surgeon. The Aventura Surgery Center in Hallandale, Florida, where Chin had served as medical director, sent an Uber to collect the couple the morning of March 12, 2019, Julien said.

During the two-hour spinal fusion, Chin replaced three disks with an implant he invented, according to his deposition. The patient spent an hour or so in a recovery room before a nurse wheeled him out to a waiting Uber just after 3 p.m., according to Chin’s testimony.

Louis-Charles couldn’t speak, but signaled he was in pain and struggled to breathe during the hourlong ride home, according to Julien’s deposition. She helped him walk through the front door of their Riviera Beach home. Once inside he collapsed, she testified.

A fire rescue crew rushed him to a hospital in West Palm Beach, where he died just after 5:30 p.m., according to a Palm Beach County Medical Examiner’s autopsy report. The medical examiner ruled the death an accident caused by “post-surgical bleeding with airway compression.”

In his deposition, Chin said that Louis-Charles “looked great” heading out to the car and that traveling along the urban Interstate 95 corridor the driver was “at any given time probably within 10 minutes or so” from a “major hospital or emergency room.”

Chin called the outcome a “terrible situation” and told Julien’s lawyer during the deposition: “I just hope you can appreciate how much I regret what happened.”

Asked how her husband’s death has affected her life, Julien said: “How can you find words to explain such a thing?” The couple wed in 1987 in Miami after moving from their native Haiti, where he worked as a house carpenter.

“It’s been almost two years now. I have not been able to sleep on [the] bed” she shared with him, she said.

In late September, Julien and Chin settled the suit under confidential terms and the bills were “written off,” according to Kevin Smith, an attorney who represented Julien. Chin has denied any liability.

‘A Mixed Bag’

Though little-known to the public, letters of protection are commonly used to finance major medical care in personal injury cases, including costly orthopedic surgery.

Attorneys who refer injured clients to willing doctors say the liens are their best tool for ensuring clients not only gain access to care, but also are in a position to win fair settlements from insurance companies that fight to minimize their liability and costs.

An LOP form used by some Florida medical providers says they agree to wait for payment as a “courtesy” to the injured person, adding in boldface: “We understand insurance companies have unlimited resources, will hire defense lawyers and defense experts that will cause our payment to be delayed for months or years.”

The business community and insurers counter that LOP providers grossly inflate their medical fees to give juries a false picture of the costs of medical care.

“The sole purpose of the LOP, why it exists, is to drive up verdicts and settlements,” Lauren McBride, a lawyer for Publix Super Markets, a chain with more than 800 stores in Florida, testified in a state legislative hearing in February 2019.

McBride said that nearly two-thirds of “slip-and-fall” injury claims in Publix stores involve letters of protection. In more than half those cases, the injured person had some form of insurance but declined to use it, she said. In some cases, injured people traveled long distances for costly care they could have received closer to home at far less expense, she said. She also argued that LOPs give doctors an incentive to overtreat patients “to keep driving up medical bills” — and persuade juries to award big verdicts.

Kevin Leahy, an Austin, Texas, lawyer who has researched the practice there and represented clients on both sides of the debate, said LOPs deserve more scrutiny. “It’s a mixed bag,” he said. “There are definitely abuses going on. There are also hurt people getting care they need to get better.”

Leahy said LOPs have helped create a “liability-based” health care network with few checks on its financial dealings or other standards. He called it “unregulated, opaque and not fully accurate about charges.”

Across the country, LOPs have been tied to a range of alleged medical overcharges or other billing abuses, court records show.

Nearly 200 women from 42 states, for example, have joined a class-action suit that alleges doctors and lawyers talked them into signing LOPs promising to pay for surgical removal of pelvic mesh — whether they needed it removed or not.

The women allege that the doctors billed sky-high rates and told them their insurance would not cover the cost, so signing an LOP was the only way to safeguard their health. Private insurance would have paid about $8,000 for these services, far less than the $76,000-plus the women were charged under the LOP, according to the suit, filed in late August. The case is pending. Six doctors have filed motions to dismiss the case.

In a 2020 federal civil case, evidence emerged that a Texas spine surgeon charged nearly $400,000 under an LOP for procedures that Medicare would reimburse at less than $20,000, court records state.

Reviewing court cases in Florida, KHN found dozens of examples in which patients who signed LOPs alleged they were later sued for payment of excessive fees or received substandard medical care.

‘Unnecessary and Dangerous’

On the day of his spinal surgery, Louis-Charles signed a letter of protection that read in part: “While I am injured and need care, I cannot financially afford to pay your bill at the time services are rendered, I therefore, grant this provider a lien on my claim against any and all proceeds from any settlement, insurance benefits or judgment.”

The documents said he would be charged “what is usual and customary for our area.” But the fees were much higher than private health insurance would cover or what the Medicare fee schedule provides for.

HANNAH NORMAN FOR KHN

The Aventura Surgery Center, co-owned by Miami personal injury attorney Sagi Shaked, billed nearly $100,000 for the operation, court records show. Two other Shaked-affiliated companies billed more than $35,000 for surgical supplies and anesthesia, according to the court records. Shaked did not respond to numerous requests for comment. In his deposition, Chin said he no longer operates at the Aventura Surgery Center.

Mark Woodard, 54, who was rear-ended in an April 2017 car crash in Fort Lauderdale, had three spine operations at the Aventura Surgery Center performed by Chin under a letter of protection.

His bills topped $430,000, including $179,500 for the surgery center, $177,972 billed by Chin’s medical office and $39,327 for implants from SpineFrontier, a Massachusetts medical device company Chin owns, court records show.

“These charges are way out of line,” said Michael Arrigo, a medical billing expert in California asked by KHN to review Woodard’s bills. Arrigo said “usual and customary” charges would be less than one-fourth of what was billed.

Woodard, who has worked as a painter and maintenance technician at beachfront hotels in Fort Lauderdale, argues in his lawsuit that his injuries from the crash were “nothing more than cervical and lumbar sprains and strains … such that no reasonable physician would have performed surgery other than for monetary purposes.”

According to Woodard’s lawsuit, Chin persuaded him to have multiple operations and during one tore a 1-centimeter hole through a nerve root, leaving him in “extreme agony and excruciating pain.”

The suit, filed in March 2021, alleges the surgery center offered Chin a “safe haven to perform his unnecessary and dangerous surgeries.” It also alleges that Chin “was unable to perform surgery at any hospital in the state of Florida and most if not all surgery centers where he had applied had either denied him privileges or he had his privileges revoked at multiple hospitals.” In court filings, Shaked has denied the allegations and any liability.

Chin also has denied any negligence in court filings and in a deposition called the fees he charged “reasonable within the community.” Woodard’s lawsuit is pending in Broward County Circuit Court.

Chin has been sued repeatedly for medical negligence, including several cases involving LOPs. He has been sanctioned by physician-licensing boards in three states, unrelated to his use of LOPs.

In early December, the Florida Department of Health, which licenses doctors, issued Chin a “letter of concern” and fined him $8,000. The action settled a state administrative complaint alleging that in August 2019 Chin sent home a 73-year-old man who suffered from complications of spinal surgery who should have been transferred “to a higher level of care in an inpatient setting (such as a hospital).” Chin disputed the allegations.

Separately, federal agents arrested Chin in early September in Fort Lauderdale on kickback charges as CEO at SpineFrontier, which sells spinal implants he invented and used in operations on Louis-Charles and Woodard.

Chin has denied the civil allegations and has pleaded not guilty to the criminal charges. His attorney called Chin “a role model for aspiring Black professionals who have overcome great hardship and humble beginnings to achieve success through education, grit, and hard work,”

In October, a federal judge ordered Chin to post a $500,000 bond secured by his Florida home. He is free to travel within the country “for business purposes only” and may travel one time per month to Jamaica “only for the purpose of practicing medicine there,” the order states.

Chin has active medical licenses in Florida, Arizona, New Jersey, New York and in Jamaica, according to documents he filed with the court.

BROWARD COUNTY SHERIFF’S OFFICE

A ‘Complete Shock’

By its own account, the Broward Outpatient Surgical Center and its affiliates in Pompano Beach, Florida, have treated more than a thousand patients under letters of protection. But the billing practices — one lawsuit called its fees “astronomically unreasonable and inflated” — have been criticized in court filings for years. These cases often settle under confidential terms.

One patient argued in a lawsuit that injured patients were “bounced around” a web of affiliated clinics for services that included chiropractic care, pain injections, physical therapy and, finally, surgery, all done with no caps on the costs. The center denied the allegations, and the case has since been settled.

Albert Frevola, an attorney for the center, said that prior to treatment patients are given a price list and sign an agreement to pay the bills out of any settlement of their personal injury claims. He said the center serves many patients “who can’t afford to get medical care. It’s a service that is valuable and needed.”

Some three dozen former patients have filed a recent mass tort lawsuit alleging medical malpractice and billing fraud by the surgery center and its owners, chiropractors Brian and Craig Bauer, who are brothers. The suit also names spine surgeon Dr. Merrill Reuter, court records show. Neither Reuter nor his lawyer responded to requests for comment.

The patients allege they visited the center after a car crash or other accident and were persuaded to have spinal surgery. In some cases, the operations either were billed as more complex than they were, or not done at all, according to the suit. Patients often have run up bills of $100,000 or more under LOPs, court records show. “Due to the fact that personal injury patients rarely, if ever, use their private health insurance for such health care services, the Bauers and the Bauer entities were able to get away with charging inflated amounts,” according to the suit.

Frevola, who represents the brothers, said they “flatly deny” the allegations and “are sad and distressed that these accusations are being made by the same people they gave great care and medical treatment to.”

In a separate malpractice case, Terrell Harris, 37, alleged he was guided down a “treatment path” after a car crash in July 2017 that ended in surgery at prices “far beyond the scope of reason, let alone custom.” The center denied the allegations and filed a counterclaim accusing Harris of failing to pay for his care under the LOP.

The suit is one of eight pending in Broward County Circuit Court that make similar claims, including that of a woman who alleged she had the same pain after spinal surgery as she had beforehand. Nearly five years later, to her “complete shock,” an MRI found no evidence the operation she was billed for had been done, according to the suit.

In a February 2020 court filing in one of the cases, the center and Brian Bauer denied the allegations and called them “frivolous and scandalous.” They filed a counterclaim demanding to be paid for their services. The case is pending.

Warring Creditors

When fees are inflated under an LOP, patients can take home more money under an insurance settlement or jury verdict. But if a case settles for less than the sum of those bills, patients may be on the hook to pay the balance.

Lawyers who typically co-sign the LOPs try to persuade medical providers to reduce their fees, which often happens. When that fails, however, lawyers file a court action called an interpleader, which asks a judge to decide who gets what among warring creditors.

KHN reviewed dozens of Florida court cases in which medical creditors holding LOPs demanded payment in full. While many of these cases settled under confidential terms, court records show some accident victims ended up mired in debt or saw their damage awards drastically reduced by outsize medical billings and legal fees. In some cases, lawyers took home more than their injured clients.

That happened to Jose Merced, who fell and hurt himself after stepping into a hole outside his apartment in the Orlando area. He received a $75,000 settlement but incurred bills of more than $850,000 for operations and other medical costs, which he contested as “highly inflated,” court records show. The bills included more than $700,000 in orthopedic surgical and facility fees.

In August 2020, a judge allowed just over $35,000 to pay for the surgeries. Merced was awarded $10,000, while his lawyer got nearly $27,000, just over $18,000 of it for professional fees and the rest for expenses.

In some interpleader cases, lawyers asked judges for one-third of the total settlement for their fees, plus expenses, which can add hundreds, if not thousands, of dollars more to their share.

A law group founded by South Florida personal injury lawyer Robert Fenstersheib filed at least 50 interpleader cases in Broward County Circuit Court between January 2019 and October of this year. Fenstersheib, who was a fixture of local television ads as the “lawyer who listens,” was shot to death by his son in a murder-suicide in September 2020, though his Fenstersheib Law Group still operates under his relatives.

Many of the LOP patients now suing the Broward Outpatient Surgery Center and its owners were clients of the Fenstersheib firm, court records show. The center and the law firm did business for years, but the center sued the law firm in 2019 alleging the lawyers failed to pay it millions of dollars owed under LOPs. The law firm responded that it was a victim of a $6.5 million embezzlement by former employees who pocketed settlement money meant for the center. The suit was settled under confidential terms this year.

Federal prosecutors filed criminal charges against two former Fenstersheib employees in connection with the theft. In late November, one of the men, Michael Wihlborg, a 47-year-old high school dropout who had worked for the law firm for nearly two decades, admitted receiving more than $2.1 million in stolen funds from the scheme; he pleaded guilty to one count of conspiracy to commit wire fraud and three counts of filing a false income tax return, court records show. He faces up to 29 years in prison, according to court records. Co-defendant Matthew Matlock pleaded guilty to similar charges on Dec. 15, court records show. The law firm had no comment.

Ethics Question

Some lenders also accept LOPs as collateral for patients who borrow money to tide them over while their personal injury case winds through the courts, which typically takes years. Interest charges pile up fast.

A Miami man who was injured after a pile of wood fell on him at a home improvement store borrowed $51,400 from a finance company backed by an LOP in September 2014. He owed the company $140,322 three years later because of an interest rate of 18% charged every six months, court records show.

Doctors also can generate cash from letters of protection. While they argue they must wait years for payment, some spine surgeons sell the liens on a burgeoning medical debt market.

Court records in Florida show millions of dollars of these liens have changed hands when doctors sold them. Buyers paid 10% to 25% of the total amount of the bill and gambled they would be able to collect a tidy profit once a patient’s lawsuit was settled.

The ethics of doctors wheeling and dealing in patient bills and having a financial stake in the outcome of litigation has been questioned. An American Medical Association policy says such deals are unethical because “there is the ever-present danger that the physician may become less of a healer and more of an advocate or partisan in the proceedings.”

Dr. Scott Lederhaus, a retired California neurosurgeon who has reviewed personal injury cases for the defense, said some patients argue in depositions that under an LOP they never saw bills, so they had no idea of the extent of the medical costs they were incurring over time.

Lederhaus said there is little agreement on what is a reasonable medical fee and, as a result, doctors “are able to charge whatever they want” in personal injury cases.

And it remains unclear whether the No Surprises Act, which Congress passed last year amid a national outcry over huge and unexpected medical bills, offers patients who signed LOPs any protection.

“A lot of these doctors are under the impression they can do whatever they want and there’s not going to be any oversight by anyone,” Lederhaus said.

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues. 

A Promising Stem Cell Therapy for Back Pain

By Gabriella Kelly-Davies, PNN Columnist

Just before sunrise on Christmas Eve last year, a delivery van from our local fish market left a bulky box of fresh prawns, oysters and lobsters on our doorstep for Christmas Day celebrations.  

Sleepily bending over, I picked up the box, unaware it was packed to the brim with enormous blocks of ice to prevent the seafood from succumbing to Australia’s stifling summer heat. As I lifted the box from the doormat, I felt a sharp pain like an electric shock run down the back of my left leg and pins and needles explode in my left foot.  

Fast forward to now, and the pain and pins and needles sensation are constant, especially when I sit to write. Like millions of other people, I have chronic lower back pain, the leading cause of disability worldwide. And like them, I too want the pain to go away without surgery.  

Two weeks ago, my pain specialist injected cortisone into my spine, reducing the pain enough to allow me to sit for meals and do a little writing. But he warned I would most likely need surgery at some point. The neurosurgeon agreed, suggesting microdiscectomy was my only option.  

As a former physiotherapist, I know that a lumbar discectomy can relieve the symptoms of nerve compression, but it doesn’t reverse the underlying degeneration of the intervertebral disc. This is why up to one third of patients continue to experience back pain after surgery and some require further operations.

In my search for non-surgical treatments, I read an article about Australian research that has led to the development of a new stem cell therapy to treat back pain. Professor Tony Goldschlager, who leads the study, is a neurosurgeon who advocates for the use of minimally invasive spinal surgery. He heads up a research team at Monash University in Melbourne that is part of the Monash Health Translation Precinct (MHTP).  

Goldschlager started his stem cell research 15 years ago. He and his team developed the stem cell therapy in the laboratory, then spent years testing it in preclinical models. The results of several studies revealed that the therapy was safe and effective. After completing these studies, the researchers began human clinical trials, testing the ability of stem cells to regenerate the intervertebral disc and reduce back pain.  

“We’ve had success both in preclinical and clinical studies of being able to restore structure and function of the disc,” Goldschlager told me. “This reduces pain and improves quality of life for patients.” 

Phase Two clinical trials saw a significant number of patients report reduced back pain for up to two years after a single injection. Phase Three trials are almost complete and while Goldschlager hasn’t received all the results from overseas studies, the data he has seen so far is promising. He is hopeful the new treatment— a single injection — will be available in two years after the final round of clinical trials concludes. 

“What excites me is that we might be able to prevent surgery all together and regenerate the disc. Most of the current treatments don’t address the underlying problem. But the stem cell injection reduces the inflammation and stimulates a regenerative process in the disc, removing the source of back pain. The stem cells can become new disc-like cells and replenish the damaged disc cells,” explained Goldschlager. 

During the last 15 years, Goldschlager and his team have published the results of their studies in peer-reviewed journals such as Spine, Nature Outlook and the Journal of Neurosurgery. In 2015, they published an extensive review of the use of stem cell therapies in lumbar disc disease. 

New Era in Medicine

While the use of stem cells heralds the dawn of an exciting new era in modern medicine, it also raises several ethical and safety concerns. Critics say many stem cell therapies are unproven, and others believe it is unethical to destroy human embryos during research or create new embryos specifically for research. 

Goldschlager is acutely aware of these concerns and in 2010 as a neurosurgery registrar, worked in a research team that published an article on the ethics of using stem cell therapies in patients with spinal cord injuries. He says the therapy his team has developed doesn’t raise ethical concerns because it is based on a proprietary adult stem cell technology from Mesoblast, an Australian biotechnology company.

The cells are derived from the bone marrow of healthy young adults who have given informed consent. Young adults are selected because the number of stem cells in our bodies reduce as we age. The cells of older people are also less effective at repairing damaged tissues and organs.

Commercial stem cell clinics usually harvest the fat, muscle or cartilage cells of their patients, process the cells in a centrifuge, then inject them back into the same patient’s body. This yields a mixed population of cells with a small and inconsistent number of stem cells. Adults of all ages are offered this treatment, even though it might not work for older patients because their stem cells are not as plentiful or robust as those of younger ones. These treatments can cost thousands of dollars, are often ineffective, and come with a heightened risk compared to a pure, tested proprietary off-the-shelf product.  

Another reason for caution is that some of the clinicians who provide stem cell treatments lack sufficient training and accreditation, increasing the risk of safety and efficacy issues. It is critically important for patients to check the qualifications of clinicians who offer stem cell therapies and to understand how the cells used at these clinics are created. The therapy should have been through rigorous clinical trials to demonstrate safety and efficacy.  

While new stem cell treatments offer hope to millions of people who live with degenerative spinal conditions, they are not a “miracle cure.” Still, I hope I’ll have the option of trying Professor Goldschlager’s technique once it is available.

Gabriella Kelly-Davies lives with chronic migraine.  She recently authored “Breaking Through the Pain Barrier,” a biography of trailblazing Australian pain specialist Dr. Michael Cousins. Gabriella is President of Life Stories Australia Association and founder of Share your life story.

FDA Approves First Virtual Reality Device for Chronic Low Back Pain

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has authorized the marketing of the first home-based virtual reality (VR) device for the treatment of chronic lower back pain in adults.

The EaseVRx headset uses guided VR programs to help patients relax, meditate and distract themselves from their pain, using the principles of cognitive behavioral therapy (CBT). The device is made by AppliedVR, a Los Angeles-based company that is developing therapeutic VR programs to help treat pain and other conditions.

"Millions of adults in the United States are living with chronic lower back pain that can affect multiple aspects of their daily life," Christopher Loftus, MD, acting director of the FDA’s Office of Neurological and Physical Medicine Devices, said in a statement. “Today's authorization offers a treatment option for pain reduction that does not include opioid pain medications when used alongside other treatment methods for chronic lower back pain."

Chronic lower back pain is defined as moderate to severe pain in the lower back lasting longer than three months. It is one of the most common chronic pain conditions and a leading cause of disability.

The FDA’s marketing approval is based a clinical study of 179 participants with chronic lower back pain. Half were given an EaseVRx headset to watch immersive 3-D programs daily for 8 weeks. The other half also used the headset, but only watched routine nature scenes as a sham treatment.

APPLIEDVR IMAGE

At the end of treatment, 66% of those who watched VR programs reported at least a 30% reduction in pain, compared to 41% of participants in the sham control group.

Nearly half of those in the EaseVRx group reported at least a 50% reduction in lower back pain.

No serious adverse events were reported during the study. About 20% of participants reported discomfort with the headset and nearly 10% reported motion sickness and nausea.

EaseVRx was given a Breakthrough Device Designation by the FDA in 2020 for treating fibromyalgia and chronic lower back pain. The designation speeds up the development and review of new medical devices.

Marketing approval of EaseVRx – known as a "De Novo pre-market review" – creates a new regulatory classification for VR devices. It clears the way for similar devices with the same intended use to obtain marketing authorization – a significant development for the fledgling virtual reality industry.

"We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and couldn't be more thrilled to achieve this important milestone," said Josh Sackman, AppliedVR’s co-founder and president. "But, our mission does not stop with this one approval. We're committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications."

EaseVRx will only be available by prescription. Its software programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.  The content also incorporates biopsychosocial pain education, diaphragmatic breathing, mindfulness, and relaxation exercises.

AppliedVR headsets are already being used for pain management in over 200 hospitals and healthcare systems. A company spokesman told PNN that EaseVRx will be available on a limited basis through select providers toward the middle of 2022, with a full commercial launch expected in 2023. AppliedVR's is currently building a distribution network and working with insurers -- Medicare, Medicaid and commercial -- to establish reimbursement levels. No pricing plans have been announced for its VR headset or programs.

Experimental Injection Could Reverse Spinal Cord Injuries

By Pat Anson, PNN Editor

An experimental injection therapy that uses synthetic nanofibers to stimulate nerve cells could be used someday to reverse paralysis and repair damaged spinal cord tissues, according to a new study by researchers at Northwestern University.

In experiments on laboratory animals, the therapy successfully regenerated spinal cord nerves, reduced scar tissue and triggered the formation of new blood vessels. After a single injection, paralyzed mice regained the ability to walk within four weeks.

“Our research aims to find a therapy that can prevent individuals from becoming paralyzed after major trauma or disease,” said lead author Samuel Stupp, PhD, an expert in regenerative medicine and founding director of the Simpson Querrey Institute for BioNanotechnology (SQI) at Northwestern.

“For decades, this has remained a major challenge for scientists because our body’s central nervous system, which includes the brain and spinal cord, does not have any significant capacity to repair itself after injury or after the onset of a degenerative disease. We are going straight to the FDA to start the process of getting this new therapy approved for use in human patients, who currently have very few treatment options.”

Stupp and his colleagues used nanotechnology to develop synthetic nanofibers that mimic the natural environment around the spinal cord. Intensifying the motion of molecules within the nanofibers promotes the repair and regeneration of myelin, the insulating layer of axons that help nerve cells transmit electrical signals.

Researchers say the nanofibers biodegrade into nutrients for nerve cells within 12 weeks and completely disappear from the body without noticeable side effects. Their study, published in the journal Science, is the first in which researchers controlled the motion of molecules through changes in chemical structure to increase a therapy’s efficacy.

Nearly 300,000 people are currently living with a spinal cord injury in the United States. About 30% are hospitalized at least once a year after the initial injury and less than 3% of those with a severe injury ever recover basic physical functions. Life expectancy for patients with spinal cord injuries is significantly lower than healthy people and has not improved since the 1980s.

“Currently, there are no therapeutics that trigger spinal cord regeneration,” Stupp said in a news release. “I wanted to make a difference on the outcomes of spinal cord injury and to tackle this problem, given the tremendous impact it could have on the lives of patients.” 

The key behind Stupp’s breakthrough therapy is fine tuning the motion of molecules so that they can find and constantly engage with moving cellular receptors with bioactive signals. Injected as a liquid, the “dancing molecules” immediately form a gel in a complex network of nanofibers that mimic the extracellular matrix of the spinal cord.

“Receptors in neurons and other cells constantly move around,” Stupp said. “The key innovation in our research, which has never been done before, is to control the collective motion of more than 100,000 molecules within our nanofibers. By making the molecules move, ‘dance’ or even leap temporarily out of these structures, known as supramolecular polymers, they are able to connect more effectively with receptors.”

Stupp and his team found that fine-tuning the molecules’ motion within the nanofibers makes them more agile and results in greater therapeutic effect in paralyzed mice. They also confirmed that formulations of their therapy performed successfully in vitro tests with human cells, indicating increased bioactivity and cellular signaling.

Once connected to the nerve receptors, the dancing molecules trigger two cascading signals, both of which are critical to spinal cord repair. One signal induces myelin to rebuild around axons, which improves how nerve cells communicate with the brain. The second signal helps neurons survive after injury by promoting the regrowth of lost blood vessels that feed neurons and other cells for tissue repair. The therapy also reduces glial scarring, which acts as a physical barrier that prevents the spinal cord from healing. 

“The signals used in the study mimic the natural proteins that are needed to induce the desired biological responses. However, proteins have extremely short half-lives and are expensive to produce,” said first author Zaida Álvarez, a former research assistant in Stupp’s laboratory who is now a researcher scholar at SQI. “Our synthetic signals are short, modified peptides that — when bonded together by the thousands — will survive for weeks to deliver bioactivity. The end result is a therapy that is less expensive to produce and lasts much longer.”

While the new therapy could be used to treat paralysis after a major spinal cord injury, Stupp believes it could also be used to as a therapy for neurodegenerative diseases and strokes.

“The central nervous system tissues we have successfully regenerated in the injured spinal cord are similar to those in the brain affected by stroke and neurodegenerative diseases, such as ALS, Parkinson’s disease and Alzheimer’s disease,” Stupp said. “Beyond that, our fundamental discovery about controlling the motion of molecular assemblies to enhance cell signaling could be applied universally across biomedical targets.”

You can learn more about Stupp’s research in this podcast and by watching this video:

Recent research at Yale University and Sapporo Medical University in Japan found that injections of mesenchymal stem cells (MSCs) in patients paralyzed by spinal cord injuries led to significant improvement in their motor functions. In a small study, more than half of the paralyzed patients showed substantial improvements in function within weeks of being injected with autologous MSCs derived from their own bone marrow.

Guidelines Urge More Caution in Use of Invasive Neck Procedures

By Pat Anson, PNN Editor

Invasive procedures such as steroid injections, nerve blocks and radiofrequency ablation should be used more cautiously when treating chronic neck pain, according to new guidelines adopted by the American Academy of Pain Medicine and American Society of Regional Anesthesia and Pain Medicine.

The two medical societies formed a joint guidelines committee in 2020 to look into cervical spine joint procedures, which are increasingly used despite questions about their effectiveness and safety. The use of radiofrequency ablation -- heat from an electric current used to burn painful nerve endings — has increased by 112% in the U.S. over the past decade.

Spine pain in the neck or lower back is the leading cause of disability worldwide, with nearly half of adults likely to be affected at some point in their lives. The cervical facet joints, which allow the neck and back to tilt forwards, backwards and to rotate, are the primary source of pain in about 40% of patients with chronic neck pain and over half of those with neck pain after whiplash injury.

"It is precisely because neck pain and cervical spine procedures are so common, and there is so little high-quality evidence to guide care, that consensus guidelines are needed,” says lead author Steven Cohen, MD, a professor of anesthesiology at Johns Hopkins Hospital and co-chair of the guidelines committee.

The new guidelines, published online in the journal Regional Anesthesia & Pain Medicine, are based on over 400 publications and clinical studies of cervical spine procedures. Reviewers also looked at clinical signs and imaging used to select patients for particular procedures; the diagnostic and prognostic value of procedures; and several aspects of radiofrequency ablation (RFA), including how to reduce the risk of complications from the procedure and whether it should be repeated.

Because acute neck pain often resolves by itself, the guidelines recommend 6 weeks of conservative management, such as non-opioid painkillers and physical therapy, before opting for RFA or nerve blocks.

The reviewers found that RFA may be helpful for easing chronic neck pain, but only in patients whose pain corresponds to the joints being treated; those whose symptoms don’t emanate from a nerve root; and those who obtain meaningful pain relief from diagnostic nerve blocks, which are typically performed before RFA. 

Many insurance carriers require two nerve blocks, but the evidence indicates that doubling up will result in a significant number of unnecessary procedures and higher costs. Reviewers say the evidence for performing only a single block is much stronger for the neck than for the lower back.

The guidelines also recommend against stringent patient selection criteria, such as requiring nearly total pain relief from diagnostic blocks, because it might exclude patients who might benefit from radiofrequency ablation. None of the clinical studies that were reviewed support using pain relief thresholds above 50 percent.

Physicians should warn patients about the common side effects of RFA, such as tingling and burning sensations, numbness, dizziness, and loss of balance and coordination, which can last from a few days to a few weeks after the procedure. Patients also need to be told that RFA won’t cure them, and that pain relief typically lasts between 6 and 14 months. 

While most patients who have the procedure repeated will get pain relief, the benefits may wane over several years. RFA shouldn’t be repeated more than twice a year, the guidelines recommend.

Other key recommendations include:

• Use only soluble, short-acting steroids when injecting into the upper neck joints

• Use fluoroscopy imaging before spinal injections to avoid inadvertent needle placement

• Use smaller needles and electrodes than those used for the lower back

• Use nerve and muscle stimulation to improve effectiveness and reduce the risk of complications

• Take steps to minimize interference with implanted electrical devices such as pacemakers

“Clinical trials evaluating cervical facet blocks and RFA are characterized by widely disparate outcomes, and there is enormous variation in selecting patients and performing procedures. These multi-society guidelines have been developed to serve as a roadmap to improve outcomes, enhance safety, and minimize unnecessary tests and procedures,” the reviewers concluded.