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Tag: 2018 News

Psyche QME Disciplined For Gross Negligence

Janak K.. Mehtani, M.D. was issued a physician and surgeons certificate by the California Medical Board in 1978. He specialized in psychiatry with an office located at 2951 Fulton avenue in Sacramento. He practiced in an office clinic under the business name of Fair Oaks Psychiatric Associates. He is also listed by the DWC as a QME in psychiatry at that same address.

The current QME Disciplined Physicians List shows that his QME certification has been evoked with revocation stayed, and he was placed on probation through October 11, 2019 concurrent with Medical Board probation.

The Medical Board filed an Accusation against Mehtani accusing him of “grossly negligent acts in his care and treatment of Patients” three of whom were identified only by their initials. All three were being treated for the effects of workers’ compensation injuries.

One of them identified by the initials GC was a 47 year old female who was employed at a warehouse where she was injured on a number of different occasions and has had cumulative injuries since then. The first injury was in 2003 and she was first seen by Mehtani in 2008.

The Medical Board reviewed his clinical notes, and noted many medical errors and historical inconsistencies in his treatment of this patient. For example, with respect to patient GC, the Board alleged that he “prescribed atypical antipsychotics without clear indication for their necessity.” and he “inappropriately prescribed antipsychotics to Patient GC who has diabetes, to treat problems for sleep, depression and anxiety.”

GC was not proficient in English. The Board noted that Mehtani used his medical assistant to act as translator, and as a result he “failed to provide an interpreter in order for Patient GC to freely share her feelings and be open to psychotherapeutic interventions.”

The Board noted that he “also documented a global statement without providing any clinical justification or explanation. Respondent noted that ‘She remains disabled from gainful employment’ without explaining and documenting exactly what was Patient GC’s disability, how the disability affects her life and what are the barriers for progress.”

The Board also listed allegation against Mehtani for his treatment of Patient JC is a 59-year-old male who experienced a work related injury in 1989. And a third persons, Patient RW, a 48-year-old, male who was seriously injured during the course of his employment while on his way to a service call, He sustained a serious head injury and has been totally and permanently disabled ever since.

Mehtani signed a Stipulated Settlement and Disciplinary Order with the consent of his attorney. The Stipulation was the basis of the Medical Board and subsequent DWC probation orders.

Nurse Practitioner Convicted in $65M Compound Med Fraud

Candace Michelle Craven, a Tennessee-based nurse practitioner pleaded guilty in federal court this week, admitting that she participated in a health care fraud scheme that bilked TRICARE – the health care program that covers United States service members – out of more than $65 million. As part of her guilty plea, Craven admitted to conducting sham “telemedicine” evaluations that resulted in the prescription of exorbitantly expensive compounded medications to patients that she never saw or examined in person.

Craven will be sentenced at a hearing scheduled for February 8, 2019.

Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient requires a particular dosage or application or is allergic to a dye or other ingredient.

According to the guilty plea, a team of individuals worked to recruit and pay Marines, primarily from the San Diego area, and their dependents – all TRICARE beneficiaries – to obtain compounded medications that would be paid for by TRICARE.

This information was sent to Choice MD, the Tennessee medical clinic that employed Craven. Craven then conducted phone calls with the TRICARE beneficiaries, and recommended that they be prescribed compounded medications despite never examining the patients in person.

These prescriptions were then signed by doctors employed by Choice MD, were not given to the beneficiaries, but sent directly to particular pharmacies controlled by co-conspirators, which filled the prescriptions and billed TRICARE at exorbitant prices.

Josh Morgan, a former Marine from San Diego, pleaded guilty in April to Conspiracy to Commit Health Care Fraud for his role in recruiting TRICARE beneficiaries to fraudulently receive these prescriptions.

The doctors who signed the prescriptions, Carl Lindblad and Suzy Vergot, pleaded guilty to the same charges in September.

Between December 2014 and May 9, 2015 – the day that TRICARE stopped reimbursing for compounded medications – doctors working at Choice MD signed 4,442 total prescriptions. Over this time, their co-conspirators billed TRICARE $65,679,512 for these prescriptions.

Craven represents the seventh defendant charged in relation to this fraud scheme. In addition to Morgan, Lindblad, and Vergot, Jimmy and Ashley Collins, the owners of Choice MD, and CFK, Inc., the owner of a co-conspirator pharmacy, were indicted in March 2018 on charges of Conspiracy to Commit Health Care Fraud and Illegal Payments of Remunerations. That case remains pending.

This case is being prosecuted by Assistant United States Attorneys Benjamin J. Katz and Mark W. Pletcher.

Drugmaker VP of Sales Pleads Guilty in Kickback Case

A former opioid sales executive has admitted to participating in a conspiracy to bribe doctors to prescribe a highly addictive fentanyl spray.

Alec Burlakoff changed his plea to guilty on November 28, 2018 in a Boston federal courtroom. Prosecutors say the former vice president of sales for Insys Therapeutics has agreed to cooperate with them in the closely-watched case targeting executives at the Chandler, Arizona company, including billionaire founder John Kapoor. His sentencing will occur at a later date.

On December 6, 2016, the defendants, former executives and managers of Insys Therapeutics Inc., were charged by indictment by the United States Attorney’s Office for the District of Massachusetts with conspiracy to commit racketeering, mail and wire fraud, and conspiracy to violate the anti-kickback law in relation to a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud payers of the medication, including insurers.

The Insys executives are accused of paying kickbacks to doctors willing to write large numbers of prescriptions for the powerful medication Subsys, which is meant for cancer patients with severe pain. Prosecutors say the kickbacks were disguised as speaking fees for events billed as opportunities for other doctors to learn about the drug.

The indictment alleges that Michael L. Babich, 40, of Scottsdale, Ariz., the former CEO and President of the company; Alec Burlakoff, 42, of Charlotte, N.C., former Vice President of Sales; Richard M. Simon, 46, of Seal Beach, Calif., former National Director of Sales; former Regional Sales Directors, Sunrise Lee, 36, of Bryant City, Mich. and Joseph A. Rowan, 43, of Panama City, Fla.; and former Vice President of Managed Markets, Michael J. Gurry, 53, of Scottsdale, Ariz., conspired to bribe practitioners in various states, many of whom operated pain clinics, in order to get them to prescribe a fentanyl-based pain medication, called Subsys.

Subsys is a powerful narcotic intended to treat cancer patients suffering intense episodes of breakthrough pain. In exchange for bribes and kickbacks, the practitioners wrote large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer.

A status hearing has been scheduled for December 6, 2018, 03:30 PM for the remaining defendants. A pretrial motion hearing has been scheduled for defendant John Kapoor December 6, 2018, 03:30 PM at Courtroom 14, John Joseph Moakley Courthouse, 1 Courthouse Way, Boston, MA for defendant(s) John N. Kapoor before Judge Jennifer Boal.

Trial is scheduled to begin January 28, 2019 09:00 AM in Courtroom 17 before Judge Allison D. Burroughs

Privette Doctrine Ends Civil Death Claim

CalTrans contracted with Viking Construction Company for a construction project, known as the Chico 99 Project, to widen roadways and bridges on a state highway in Butte County. The Chico 99 Project included work on a bridge 21 feet above the ground in the Bidwell Park area.

In 2012, Deborah Davis, the CalTrans assistant resident engineer, told Viking’s foreman, Robert Burns, that the openings in a temporary traffic screen, known as a gawk screen or a glare screen were to be filled in by the end of the shift, 5:00 a.m. The purpose of the screen is to prevent motorists from being distracted by the construction work and to protect workers from the glare of headlights. The screen had been installed in accordance with the standard plans.

Burns and Bradley Capps, an employee of Viking, finished their scheduled work and began to install additional screens where necessary. On the final installation, while it was still dark, as Burns was adjusting the light and Capps unstrapped the screen from the truck, Burns heard a sound like a boot scuffing on concrete. When he turned, Capps had fallen from the bridge. Burns had fall protection for both men in the truck with him, but had not used it. Capps fell to his death from the bridge.

Capps’s surviving wife and children, brought suit against CalTrans, alleging the accident occurred while Capps was performing work at the specific direction of CalTrans. Plaintiffs had received workers’ compensation benefits for the accident.

CalTrans successfully moved for summary judgment on the basis that it was not liable per Privette v. Superior Court (1993) 5 Cal.4th 689 (Privette), which generally prohibits an independent contractor or his employees from suing the hirer of the contractor for workplace injuries, and the exception for negligent exercise of retained control did not apply. The court of appeal affirmed in the unpublished case of Capps v Dept. of Transportation.

On appeal, plaintiffs contend it was error to grant summary judgment because triable issues of fact remain as to whether CalTrans (the hirer) affirmatively contributed to Capps’s death by interfering with Viking’s (the contractor’s) work.

Specifically, they contend CalTrans interfered with Viking’s work by going outside the established chain of command to order unscheduled work. They further contend the trial court erred in requiring them to prove that CalTrans retained control while the law requires only that they raise a triable issue as to that fact. Finally, they contend all of their evidentiary objections are preserved for appeal because the trial court did not rule on them.

CalTrans provided evidence that under the contract, responsibility for worker safety was delegated to Viking. CalTrans did not give Viking any instructions as to how to fill the gaps in the screen, did not provide any equipment, and did not give any advice as to safety measures.

CalTrans provided excerpts of the deposition of Burns in which he testified he had fall protection with him but did not use it; he had removed or installed these screens at night “many, many times” and knew how to do it safely. Viking’s project manager Quiggle drove by and saw Burns and Capps doing the work and did not give them any safety instructions.

Privette held peculiar risk liability did not extend to employees of an independent contractor when “the injuries resulting from an independent contractor’s performance of inherently dangerous work are to an employee of the contractor, and thus subject to workers’ compensation coverage, the doctrine of peculiar risk affords no basis for the employee to seek recovery of tort damages from the person who hired the contractor but did not cause the injuries.”

The court of appeal found no triable issue as to whether CalTrans retained and negligently exercised control over Capps’s work at the time of his fall.

The manner in which CalTrans directed work to be done did not cause it to retain control over the manner in which Viking performed the work.

Calif Joins 32 States in Supreme Court Drug Pricing Case

The California Attorney General along with a bipartisan coalition of 32 Attorneys General, filed an amicus brief in the United States Supreme Court supporting states’ rights to regulate and address the rising cost of prescription drugs.

In Rutledge v. Pharmaceutical Care Management Association, the Attorneys General argue that in order to protect the well-being of consumers, States must regulate pharmacy benefit managers, also known as PBMs. PBMs act as gatekeepers between pharmacies, drug manufacturers, health insurance plans, and consumers for access to prescription drugs. The brief argues that regulation of the prescription drug market, including PBMs, is a critical tool for States to address access and affordability of prescription drugs and protect residents.

In 2015, the state of Arkansas implemented a law that regulated PBMs by setting standards for generic drug prices. Under the law, PBMs must raise their reimbursement rate for a drug if that rate falls below the pharmacy’s wholesale costs. The law also created an appeals process for pharmacies to challenge these reimbursement rates.

The law was challenged by the Pharmaceutical Care Management Association, who argued that the Employment Retirement Income Security Act (ERISA) prevents the State of Arkansas from implementing the law.

The Eighth Circuit Court of Appeals, in a unanimous three judge decision, last June, ruled in favor of the Pharmaceutical Care Management Association’s (PCMA) challenge (PCMA vs. Rutledge) to Arkansas law, Act 900, which restricted pharmacy benefit management (PBM) tools, and required employers and consumers to pay higher rates to independent drugstores for prescription drugs.

The federal Court of Appeals’ decision strikes down Act 900 for Medicare Part D drug plans by reversing a lower court’s decision that the law was not preempted by Medicare Part D. The appeals court also upheld the lower court’s earlier decision, in favor of PCMA, which held that the law was preempted by the Employee Retirement Income Security Act (ERISA).

This is a landmark ruling on behalf of the PBM industry. PBMs are part of the solution to high drug prices and use many tools to reduce prescription drug costs,” said PCMA President and CEO Mark Merritt. “This federal appeals court decision sends an important signal that states can’t impose costly mandates that raise costs on employers, unions, public programs as well as consumers.”

Arkansas has asked the U.S. Supreme Court to hear the case.

The Attorneys General argue that state laws regulating pharmacy benefit managers are not restricted by federal law. Regulation is critical to the states’ ability to improve the transparency of prescription drug marketplaces and to protect consumers’ access to affordable prescription drugs, especially those in underserved, rural and isolated communities.

In addition, the Attorneys General assert that the regulation of pharmacy benefit managers promotes healthcare access and affordability for residents – taking away a State’s ability to regulate would create confusion and uncertainty in the market and harm patients.

Joining the California Attorney General are the attorneys general from Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Texas, Utah, Vermont, Virginia, Washington, Wyoming, and the District of Columbia.

Insurers Concerned About New Privacy Laws

The California Consumer Privacy Act (CCPA) is a major new state law poised to affect the privacy landscape not just in California, but in the U.S. as a whole. It was signed into law by California Governor Jerry Brown on June 28, 2018, after being hastily introduced in the California Legislature just a few days prior.

z The Act gives “consumers” (defined as natural persons who are California residents) four basic rights in relation to their personal information:

1) The right to know, through a general privacy policy and with more specifics available upon request, what personal information a business has collected about them, where it was sourced from, what it is being used for, whether it is being disclosed or sold, and to whom it is being disclosed or sold;
2) The right to “opt out” of allowing a business to sell their personal information to third parties (or, for consumers who are under 16 years old, the right not to have their personal information sold absent their, or their parent’s, opt-in);
3) The right to have a business delete their personal information, with some exceptions; and
4) The right to receive equal service and pricing from a business, even if they exercise their privacy rights under the Act.

The Act will apply to for-profit businesses that collect and control California residents’ personal information, do business in the State of California, and: (a) have annual gross revenues in excess of $25 million; or (b) receive or disclose the personal information of 50,000 or more California residents, households or devices on an annual basis; or (c) derive 50 percent or more of their annual revenues from selling California residents’ personal information.

The law does not apply to information already regulated under the Health Insurance Portability and Accountability Act, the Graham-Leach Bliley Act, the Fair Credit Reporting Act, or the Drivers’ Privacy Protection Act; it still applies to entities covered by these laws to the extent they collect and process other personal information about California consumers.

Matthew Smith, director of Government Affairs and general counsel for the Coalition Against Insurance Fraud.commented on new laws governing cyber, data privacy in an article that appeared in the Claims Journal. Two of the most significant laws, he said, came out of South Carolina and California.

The California Privacy Law applies to insurers and all other businesses in the state and has very severe restrictions on the use of private data,” Smith explained.

“We’re looking at it from the standpoint of what impact it might or might not have on an insurer’s ability to even report fraud. We think we’re all right there, but we’re partnering with others to look to make certain that it does not infringe on the ability to report insurance fraud under the Privacy Act.”

Businesses will incur significant compliance costs in order to update procedures, policies and Web sites in accordance with the new law. Additionally, the Act’s grant of a private right of action means that companies will have to anticipate a possible flood of consumer-driven litigation.

It is expected that the state legislature will continue to refine and amend the Act’s privacy-related requirements before the final version of the law goes into effect on January 1, 2020.

Legal experts in the field of data privacy claim in an article published in a legal newsletter that “data privacy remains one of the most significant concerns facing the insurance industry. A flurry of new and evolving data security and privacy laws and regulations are re-shaping the regulatory landscape, making it more difficult for companies to avoid exposing themselves to regulatory and other legal risk:.

Companies should start formulating compliance strategies well before the law goes into effect January 1, 2020.

New Comp Carrier Approved in Calif.

Last August, another Massachusetts-based insurtech, Oyster Insurance, began offering Workers’ Comp. insurance in both New York and New Jersey. The company now insures over 70 classes of business in those states.

The company is now licensed in 26 states, Oyster Insurance just announced that they have begun providing workers’ compensation insurance to small businesses in California.

And, Oyster plans to launch their workers’ compensation coverage in an additional six states throughout 2019.

Coverage initially began with professional classes such as software consulting firms, lawyers and medical and dental offices. The company has expanded into covering variety stores, groceries/delis, bakeries, eating places, drug stores, jewelry stores and florists.

“Obtaining regulatory approval in California is very important to Oyster and to our partner network,” said Curt Stevenson, Managing Director at Oyster Insurance.

“The majority of our larger digital distribution partners are not only based in the Bay Area, but have a significant amount of their small business customers throughout the state. In aggregate, 40 percent of our potential customers are based in California and we are committed to their success.”

Oyster is enabling entrepreneurs and small business owners the ability to bind coverage online 24×7. Providing real-time quoting and binding capabilities to partners has been a significant factor in Oyster’s growth.

Oyster says they fuse technology, empathy and expertise to make insurance what it should be: simple and stress-free.

Backed by A.M. Best A rated underwriting, and fortified by decades of tech and insurance experience, Oyster was designed from scratch to be user-friendly and customer-focused, providing the utmost in security and value for its small business customers.

New Drug Costs $4 Mill per Patient

Just weeks after Novartis floated the idea that $4-5 million was fair value for its new gene therapy against a deadly neuromuscular disease, a major benefits manager is pushing back. The Swiss drugmaker’s assessment of AVXS-101’s value for treating spinal muscular atrophy (SMA) has put the company front-and-center in the debate over what “super drugs”, for rare diseases afflicting relatively few patients, are really worth.

Among the first to react was pharmacy benefits manager Express Scripts, which helps U.S. employers manage workers’ prescription costs.

Its chief medical officer, Steve Miller, told Reuters he “loves the science” behind Novartis’s therapy, a potential cure for newborns who are diagnosed early.

But $4 million or more per patient?  “You just can’t keep pushing these price points up,” Miller said. “I just don’t think we can allow it. It is not sustainable over time.”

Novartis, which bought U.S.-based AveXis for $8.7 billion in April to add the SMA therapy to its portfolio, is still mulling its asking price as it awaits U.S. Food and Drug Administration approval, likely in early 2019.

But the company has begun its campaign to convince insurance groups and governments to cover AVXS-101, contending the one-and-done infusion will save society money over the long haul, even with a cost near the highest ever for a one-time therapy.

There’s now only one approved drug for SMA, Biogen’s two-year-old Spinraza, and it is listed at $750,000 for the first year and $350,000 thereafter. Spinraza is not a cure and must be taken indefinitely.

“When we look at 10-year costs, you see somewhere between $2.5 million to $5 million being spent by societies to care for these types of patients,” Dave Lennon, AveXis’s president, said.  “Four million dollars is a significant amount of money, but we believe this is a cost-effective point.

A diagnosis of SMA, which affects one in 10,000 live births, is devastating. Forty percent of victims have the severest form and historically die within months. Children with less severe SMA can live to adulthood, although with profound physical disabilities. Though cognitively normal, many cannot feed themselves and require 24-hour care, wheelchairs and machines to help them breathe and cough.

As Novartis prepares to launch AVXS-101, it also hopes for tacit endorsement of its pricing strategy from the non-profit Institute for Clinical and Economic Review (ICER), which is currently reviewing the cost-effectiveness of SMA therapies.

The Boston-based non-profit, established in 2006, carries out cost-benefit analyses on drugs that it calls independent of “Big Pharma”, insurers and government.

Unlike European price regulators, ICER cannot dictate costs. But it has steadily gained influence in the U.S. pricing debate, as companies like Express Scripts and CVS Caremark and governments rely on its analyses.

ICER has conducted 11 assessments in 2018, some covering multiple drugs. In seven of the reviews, it concluded drugs’ prices aligned with their benefits, like when it said Roche’s $482,000 hemophilia medicine Hemlibra could save the U.S. system up to $1.9 million for the hardest-to-treat patients.

Four times, however, ICER concluded drugmakers were asking too much, giving payers ammunition to bargain them down. For instance, the New York Department of Health told Reuters that ICER’s finding that a $270,000-per-year cystic fibrosis drug from Vertex Pharmaceuticals represented “low long-term value” helped underpin the state’s demand for a steep discount.

Novartis and Biogen, as well as Switzerland’s Roche, which also has an SMA drug in development, are all lobbying ICER to broaden what it considers a meaningful benefit, potentially helping their therapies fare well in the group’s review.

Treatments for rare diseases like SMA are increasingly popular among drugmakers, because they command high prices while insurers are hard pressed to reject claims, especially for sick children. Sales of rare disease therapies will rise 11 percent annually, nearly twice the overall market rate, through 2024, when they’ll hit $262 billion, consultancy Evaluate Pharma has forecast.

Novartis Chief Executive Vas Narasimhan, with ambitions of treating hundreds of SMA patients annually, highlights 90 kids in AVXS-101 trials over four years, including some who would otherwise have been incapacitated and fed through tubes.

Applicant Hires Hit Man to Kill Attorney

The Bee reports that a Fresno man is in the Fresno County Jail, accused of trying to hire a hit man to kill a lawyer from the McCormick Barstow law firm.

Antoian Griffin, 57, pleaded not guilty this month in Superior Court to a felony charge of solicitation of murder. Police contend Griffin offered to pay someone $200,000 to kill the lawyer in September this year.

According to an affidavit by Fresno police detective Christopher Franks, Griffin targeted the lawyer because the lawyer had represented another lawyer who once represented Griffin in a workers’ compensation lawsuit. After Griffin lost the lawsuit, he sued both lawyers, court records show.

Court records show that an June 21st, Judge Mark Snauffer dismissed the suit against the two lawyers, Gary A. Hunt, and Alex Berlin Esq ruling that Griffin had no evidence to support his claim of civil conspiracy.

The target in the alleged murder plot works for McCormick, Barstow, Sheppard, Wayte & Carruth and specializes in personal injury, product liability, medical malpractice and other areas of civil litigation. On Monday, he declined to comment other than to ask The Bee to keep his name confidential for the safety of his family. Gar A. Hunt however is listed as a member of the firm.

Franks’ affidavit gives this account: Around 10:40 a.m. Sept. 27, a man called McCormick Barstow and told a receptionist that someone had “put a contract out” for the lawyer and was offering $200,000 to kill him. The receptionist put the caller in contact with the lawyer.

The caller told the lawyer that Griffin was looking for someone to kill the lawyer. The caller asked the lawyer not to call police because he feared Griffin would find out. The caller then hung up.

After the phone call, the lawyer contacted the Fresno Police Department. He told police that he knew Griffin from the prior court case.

The man called McCormick Barstow again on Nov. 2. “The caller specifically mentioned that (the lawyer’s ) family was in danger and then hung up,” the affidavit says.

After the lawyer notified police of the Nov. 2 call, detectives found the caller through the telephone number he had used to call McCormick Barstow. The man told police that he has known Griffin for about three years and that on Sept. 27, he went to Griffin’s home, where Griffin allegedly offered him $200,000 to kill the lawyer.

Griffin showed the man several guns that he kept in his home and offered to give him one to use in the killing, the affidavit says.

Griffin was upset about how (his) case was handled,” the affidavit says.

Worried about the lawyer’s safety, the man left Griffin’s home and called the lawyer to warn him about “the contract” on his life.

Using information provided by the caller, police were able to arrest Griffin on Nov. 9 and get a warrant to search his home near Fruit and Olive avenues. Inside the home, police found three shotguns, two rifles, three revolvers, a pistol and several rounds of ammunition.

Before his arrest, Griffin had only a misdemeanor conviction in 1983 for carrying a concealed weapon in public, the affidavit says.

SEAL Procedure Helps Failed Back Surgery

Failed back surgery (continued low back and leg pain after surgery) is relatively common. With each reoperation, success, as defined by pain reduction, becomes less likely and most patients do not improve.

However, preliminary studies using a simple procedure to remove scar tissue or adhesions suggests a new treatment could help those with post-surgical, chronic low back pain.

The study was approved by the Boston University Medical Center Institutional Review Board. This was a retrospective cohort, in which all patients had decompressive spine surgery that involved L4-5 or L5-S1 more than six months earlier. Current continuous symptoms included severe intractable radicular low back pain that failed conservative management including medications, physical therapy, and conventional epidural steroid procedures.

The Simplified Epiduralysis After Laminectomy/fusion (or SEAL) was performed on 30 patients who continued to experience low back and leg pain after back surgery.

Short-to moderate-term pain relief was reported in 74 percent of these patients. Nearly 40 percent reported greater than 50 percent pain relief. After three years of follow-up, only one patient went on to repeat lumbar spine surgery.

The SEAL procedure uses a low-cost standard obstetric epidural kit to place the epidural (via catheter) near the post-surgical site. The goal is to break up scar tissue or adhesions that are pushing up against the nerves.

There are more complex procedures and implantable devices that help failed back surgery, but SEAL is less invasive and done in one outpatient visit.

SEAL could be an efficacious intervention for failed back surgery with a simplified procedure, lower costs, shorter procedure times and minimal adverse events,” explained author Michael Perloff, MD, assistant professor of neurology at Boston University School of Medicine.

One of the study authors cautions that these findings could have bias yet given their promising results a clinical trial is planned for next year.

Details of the study, The Simplified Epiduralysis After Laminectomy/Fusion (SEAL) Procedure for Postsurgical Radicular Low Back Pain can be found in the journal Pain Medicine, 2018; DOI: 10.1093