Tag: 2015 News

A new study published in the Annals of Internal Medicine and summarized by Reuters Health says that spinal epidural injections of steroids may relieve low back pain from a ruptured disc, but only briefly. And the injections offer no significant relief for pain related to narrowing of the spaces around the spinal cord, the researchers say. Some earlier studies have reached similar conclusions, but others have shown some benefit. Meanwhile, the use of epidural steroid injections has been increasing in the face of contradictory guidelines for physicians.

To clarify this confusing situation, Dr. Roger Chou from Oregon Health and Science University in Portland and colleagues sorted through the evidence from 63 published reports about the use of epidural steroid injections for treating low back pain from ruptured discs or spinal narrowing. “I think the important thing is for patients and clinicians to be able to make informed decisions,” Chou told Reuters Health by email. “Epidural corticosteroid injections are perceived as being more effective than they are.”

Spinal steroid injections brought immediate relief of pain and improvement in function in patients with ruptured discs, but not in patients with spinal narrowing, or stenosis, the researchers reported in Annals of Internal Medicine. Injections also seemed to reduce the need for disc surgery in the short term. But in the long term, the effects of injecting steroids epidurally were no better than the effects of a placebo, the researchers say, and there was no reduction in the need for surgery. It didn’t seem to matter what specific injection technique or which particular steroid was used.

The new analysis seems unlikely to settle any controversies, however. Dr. Zack McCormick, who specializes in physical medicine and rehabilitation at Northwestern University Feinberg School of Medicine in Chicago, told Reuters Health by email that because the studies available for analysis by Chou’s team were of low quality, the conclusions “cannot be applied to the realistic day-to-day practice of spine medicine. The goal of epidural steroid injection is not for long term ‘cure,’ but rather to (improve) symptoms in order to allow restoration of sleep, quality of life, and tolerance of physical therapy,” McCormick said.

Dr. Laxmaiah Manchikanti from the University of Louisville, Kentucky, who is CEO and Chairman of the Board of American Society of Interventional Pain Physicians, was also skeptical, and he told Reuters Health by email that patients with lower back pain from a ruptured disk or spinal stenosis should talk to their physician rather than trust the new conclusions. “Over a million people receive epidural injections either with steroids or with local anesthetic alone per year and at least 60% of them receive significant relief,” he said.

Dr. Steven P. Cohen, a pain specialist at Johns Hopkins School of Medicine in Baltimore, Maryland told Reuters Health by email, “I do not think we should categorically discontinue epidural steroid injections for either of these conditions, but we need to limit their use to those people who are most likely to benefit, and to only repeat them if patients obtain clearly defined improvements in function and quality of life. Otherwise, the costs and risks may outweigh the benefits.”

The allegations in the Pacific Hospital of Long Beach criminal and civil litigation claims that fake hardware has been implanted in the spines of hundreds of victims. These allegations raise questions about surgeries in general. For example, it is now common to have hip or knee implants, or stents placed in an artery. Yet does anyone know who manufactured the surgical part, why that part was selected over any other part, what was the manufacturers warranty or if that was the best choice at the time it was made? Or, was it chosen because of kickbacks or other reasons? Consumers spend hours choosing the latest flat panel TV, but essentially zero time learning about a costly surgical part before it is implanted. Yet recent news continues to provoke questions about how surgeons select surgical products.

For example, the United States Attorney announced that Dr. Paul S. Singh, 55, of Tehachapi, pleaded guilty to mail fraud for a scheme to defraud his patients and their insurers by implanting and billing for unapproved intrauterine devices (IUDs). Singh had an office in Tehachapi. He provided obstetric and gynecological services to women. One form of birth control he provided were IUDs, which the Food and Drug Administration (FDA) regulates. The FDA has approved only one IUD that uses copper as its active ingredient, the ParaGard T-380A, which was sold only by its manufacturer and not available on third-party websites. The insertion of a non-FDA-approved copper IUD risks a patient’s safety. It can result in an increased risk of pelvic inflammatory disease, ectopic pregnancy, hysterectomy, and other serious complications.

According to court documents, Singh bought unapproved IUDs on the Internet but fraudulently billed his patients and their insurers as if he had inserted FDA-approved IUDs, all without the permission or consent of his patients, Singh was sent multiple bulletins and newsletters warning against the use of unapproved IUDs. He was also warned that products sold by online pharmacies were not identical to the ParaGard T-380A and had not been approved as safe and effective by the FDA. In spite of the warnings, Singh purchased unapproved IUDs from online retailers and implanted them in numerous patients without their consent.

In August 2010, agents from the FDA confronted Singh about his history of implanting unapproved IUDs. During the meeting, Singh agreed to stop implanting them in his patients. Agents later conducted a search warrant of Singh’s office in 2012 and learned that he had continued to implant unapproved IUDs in his patients.

Singh failed to advise his patients of the risks of unapproved IUDs or of the fact that one had been implanted in them. According to the plea agreement, many of Singh’s patients later complained to him and other doctors about medical complications they associated with Singh’s insertion of the IUD. In multiple instances, Singh responded to such complaints by re-inserting the IUD rather than removing it. Some patients ultimately had to switch doctors in order to have the IUD removed. Singh profited from the implanting unapproved IUDs by billing his patients and their insurers for the higher cost of approved IUDs, which was false and fraudulent.

Singh is scheduled to be sentenced by United States District Judge Anthony W. Ishii on November 23, 2015. Singh faces a maximum statutory penalty of 20 years in prison and a $250,000 fine.

The owner and operator of three medical clinics located in Los Angeles pleaded guilty last week to submitting more than $4.5 million in fraudulent claims to Medicare.

Hovik Simitian, 48, of Los Angeles, pleaded guilty before U.S. District Court Judge Beverly Reid O’Connell of the Central District of California to one count of conspiracy to commit health care fraud. Sentencing has been scheduled for Nov. 16, 2015.

Simitian owned and operated three medical clinics that were located in the Los Angeles area: Columbia Medical Group Inc., Life Care Medical Clinic and Safe Health Medical Clinic, all in the same office buillding. In connection with his guilty plea, Simitian admitted that, from approximately February 2010 through June 2014, he and his co-conspirators paid cash kickbacks to patient recruiters who brought Medicare beneficiaries to the clinics. Simitian also admitted that he and his co-conspirators billed Medicare for lab tests and other services that either were not medically necessary or were not actually provided to the Medicare beneficiaries, and that, to support the bills to Medicare, he and others created false documentation reflecting that the services had been provided.

Simitian further admitted that, between February 2010 and June 2014, he and his co-conspirators submitted approximately $4,526,791 in false and fraudulent claims to Medicare.Medicare paid approximately $1,668,559 of those claims.

UR and IMR supports its decision on treatment guidelines derived from peer reviewed published medical journal articles. This sounds like a straight forward process. But, now there is a marked increase in the number of scientific and medical articles being retracted because of fraud, or suspected fraud. According to Retraction Watch, “[t]he number of papers retracted by all publishers for fake peer reviews since 2012 is now approximately 250, with another 32 flagged for peer review fraud . . . but not yet retracted.” Retraction Watch estimates that approximately 1,500 papers have been retracted overall since 2012.

This week a major publisher of scientific and medical articles has confirmed that it is retracting 64 articles from 10 of its subscription journals based on concerns that the peer review process was “compromised.” The publisher, Springer, issued this statement:

“Springer confirms that 64 articles are being retracted from 10 Springer subscription journals, after editorial checks spotted fake email addresses, and subsequent internal investigations uncovered fabricated peer review reports. After a thorough investigation we have strong reason to believe that the peer review process on these 64 articles was compromised. We reported this to the Committee on Publishing Ethics (COPE) immediately. Attempts to manipulate peer review have affected journals across a number of publishers as detailed by COPE in their December 2014 statement. Springer has made COPE aware of the findings of its own internal investigations and has followed COPE’s recommendations, as outlined in their statement, for dealing with this issue. Springer will continue to participate and do whatever we can to support COPE’s efforts in this matter.”

The Springer journal collection includes more than 2.500 English-language and close to 200 German-language journals. Springer is also home to the largest portfolio of open access journals, including the journals from BioMed Central and the SpringerOpen portfolio. The announcement from Springer about the 64 retracted articles is brief – it does not say which papers were withdrawn or where they were published. Nor does it identify the source of the fake reviews The announcement comes nine months after 43 studies were retracted by BioMed Central (one of Springer’s imprints) for the same reason.

An LA-based Uber driver who says he was beaten up by a customer filed a class action accusing the ride-hailing upstart of refusing to buy workers’ compensation insurance.

According to the report in Courthouse News Service, Uber driver and lead plaintiff Omar Zine on Friday sued Uber Technologies, Rasier LLC, Rasier-CA, Laju Choudhury, and a person identified only as Doe Assailant, in LA County Superior Court.

The California Labor Commission in June rejected Uber’s arguments that it is a “neutral technological platform,” finding that the company is “involved in every aspect of the operation.” Given that involvement, the commission determined that drivers are properly classified as employees and ordered Uber to pay driver Barbara Berwick $4,152 in reimbursable business expenses.

Nevertheless, the plaintiff alleges that Uber still classifies drivers as independent contractors so it can avoid covering them under workers’ compensation insurance. This lack of coverage meant he could not drive and earn income for weeks after a customer’s friend beat him up, according to the complaint.

The plaintiff says he was driving Choudhury and Doe in December 2014 when he and Doe got into an argument: “A verbal dispute occurred and Doe assailant escalated this situation by repeatedly, and viciously, punching and hitting plaintiff in the face and head. Attorneys say that the assailant used a metal pipe or similar object during the assault. “He is driving again, but is not able to go back to full-time work,” his attorney added. He is now allegedly permanently disabled and has struggled with depression, anxiety, sleeplessness, and humiliation after the “heinous beating” he suffered.

He also claims there are thousands of current and former drivers who are entitled to workers’ compensation benefits they never received because Uber misclassified them as independent contractors. Zine wants a declaration that Uber must classify all drivers as employees, restitution for himself and all class members for all the profits Uber made by failing to protect them with workers’ compensation coverage, and special, punitive and exemplary damages for unfair business practices, assault and battery.

Uber has been the target of several similar lawsuits since the 2013 suit brought by former drivers claiming they were misclassified as contractors. In June this year, Uber drivers Lori Kellett and David Cotoi of Los Angeles sued Uber for allegedly failing to pay overtime and regular wages and not providing them with meal and rest breaks. An administrative law judge in mid July recommended that Uber be fined $7.3 million for breaking several California laws, such as failing to report on disabled accessibility requirements and problems with drivers. Uber stated that it would appeal the ruling.