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OxyContin – Good News and Bad News

A new OxyContin formulation is providing relief for workers compensation payers strapped with paying for the illegal diversion of the prescription pain reliever. But unfortunately for society overall, heroin and other narcotics are replacing OxyContin as a drug of choice among addicts because the new formulation contains polymers that make it harder to crush for snorting or melt for injecting.

According to the story in Business Insurance, the abuse-deterrent OxyContin formulation was introduced in 2010. Then in 2012, a study in the New England Journal of Medicine found that abusers preferred to shift from the reformulated OxyContin to heroin and other high-potency opioids. The study relied on surveys completed by 2,566 people entering treatment programs because of opioid dependency. It revealed that before the release of the abuse-deterrent formula, 35.6% favored OxyContin as their primary drug. That dropped to 12.8% just 21 months later, after introduction of the new OxyContin formulation.

The survey also found that of all opioids used to get high at least once during the past 30 days, OxyContin fell from 47% to 30%. Heroin use nearly doubled during that time and was the most-used alternative, according to the survey relying on data collected from July 2009 through March 2012.

Meanwhile, pharmacy benefit managers said in their workers compensation drug-trend reports released in April that opioid prescribing dropped during 2012.Westerville, Ohio-based Progressive Medical Inc., for instance, said a drop in opioid prescriptions resulted from changing government prescribing guidelines, urine drug testing and the introduction of abuse-deterrent formulations.

That means the new formulations affecting pharmaceutical payer efforts to eliminate the diversion of addictive narcotic opioids also are helping. Diversion refers to using drugs outside their intended purpose, such as helping people with legitimate pain-management needs, to selling them on the street illegally.Payers have stepped up efforts to discourage diversion with measures such as urine testing to assure claimants are consuming prescribed opioids rather than diverting them.

This is good news for the workers comp industry. But the authors of the New England Journal of Medicine study, titled “Effect of Abuse-Deterrent Formulation of OxyContin,” wrote, the new formula reduced the abuse of one drug, but replaced it with a “drug that may pose a much greater overall risk to public health.”

And Barry Lipton, practice leader and senior actuary for Boca Raton, Fla.-based NCCI Holdings Inc. said during the rating and research organization’s recent 2013 Annual Issues Symposium, “It’s not good news for society, but it is a big pressure release for workers comp.”

Common Firbromyaligia Medication Does As Much Harm as Good

Among fibromyalgia patients taking either of two commonly prescribed drugs to reduce pain, 22 percent report substantial improvement while 21 percent had to quit the regimen due to unpleasant side effects, according to a new review in The Cochrane Library summarized by Science Daily. People with fibromyalgia suffer from chronic widespread pain, sleep problems and fatigue. The illness affects more than 5 million Americans, 80 percent of whom are women. The cause of fibromyalgia is unknown and currently there is no cure. Using a Quality of Life (QOL) scale for fibromyalgia, the studies reviewed reported QOL ratings lower than 15 on a scale of 0 to 100 even among patients on medications. The two medications often prescribed to treat fibromalgia are duloxetine, known by the brand name Cymbalta or milnacipran, commonly known as Savella.

“A frank discussion between the physician and patient about the potential benefits and harms of both drugs should occur,” noted the reviewers, led by Winfried Häuser, M.D. of Technische Universität München.

The authors reviewed 10 high-quality studies comprising more than 6,000 adults who received either duloxetine, milnacipran, or a placebo for up to six months. A substantial majority of study participants were middle-aged, white women.

“This is a very important study,” says Fred Wolfe, M.D. of the National Data Bank for Rheumatic Diseases. “There’s an enormous amount of advertising suggesting that these drugs really help, whereas the research data show that the improvement is really minimal.”

Treatment with drugs alone “should be discouraged,” the reviewers added. Instead, the review authors recommend a multi-faceted treatment approach including medications for those who find them helpful, exercises to improve mobility and psychological counseling to improve coping skills. “The medical field does poorly with the treatment of fibromyalgia in general,” says Brian Walitt, M.D., M.P.H., a co-author of the review and an expert in pain syndromes at Washington Hospital Center in Washington, D.C. “Chasing [a cure] with medicine doesn’t seem to work.The people who seem to me to do best sort of figure it out on their own by thinking about things, getting to know themselves, and making changes in their lives to accommodate who they’ve become,” concludes Walitt.

The only other medication approved for fibromyalgia treatment in the U.S. is the anti-convulsant pregabalin, known by the brand name Lyrica. The Cochrane Library plans to publish a review of its effectiveness later this year.

Intensive neuroscientific research is needed to reveal the underlying causes of fibromyalgia and other pain syndromes, say the researchers. In the meantime, combinations of various medications as well as combinations of drug and non-drug treatments may offer better symptom control for sufferers.

DWC Posts Revised Proposed Interpreter Services Regulations

The Division of Workers’ Compensation has again modified the proposed Interpreter Services regulations. DWC posted the modified regulation text and forms on the DWC website and electronically distributed the second 15 – day notice of modification to interested parties. Members of the public may comment on the modifications until 5 p.m. on June 14.

The proposed modifications include:

  • A new subdivision to allow certification by passing the National Board of Certification for Medical Interpreters (National Board) exam.
  • Requiring recertification as set forth by Certification Commission for Healthcare Interpreters (CCHI) or the National Board.
  • Revising section 9795.5 to state that certified interpreters for the purposes of medical treatment appointments and medical legal exams are listed in the CCHI and National Board website directories.
  • A new subdivision that requires a certified interpreter for the purposes of medical treatment appointments and medical legal exams who is not listed on the CCHI or National Board registry to provide proof of certification to the claims administrator upon request.

The notice, text of the regulations, and forms can be found here .

San Diego Psychologist Sentenced to Prison

United States Attorney Laura E. Duffy announced that Roberto J. Velasquez, a San Diego area clinical psychologist, was sentenced for perpetrating a multi-year fraud scheme where he falsified medical certifications to the federal government. Chief District Judge Barry Ted Moskowitz sentenced Velasquez to serve 21 months in federal prison, followed by two years of supervised release and ordered Velasquez to pay more than $1.5 million in restitution to the Social Security Administration.

According to court documents, Velasquez masterminded a scheme whereby he falsely certified that dozens of patients were disabled, when in fact they were not. To further the fraud, Velasquez made up patient histories, fabricated test results, suggested symptoms and complaints that did not exist, intentionally underestimated patient scores on standardized tests, and lied about the length of time he had been seeing the patients. In exchange for each false report, Velasquez charged his patients a $200 kickback.

In his plea agreement, Velasquez admitted that he falsified two different types of disability reports. First, Velasquez falsified Medical Certification for Disability Exception Forms (Forms N-648), which are used by the Department of Homeland Security during the naturalization process. Velasquez’s false certifications allowed certain immigrants to avoid taking the English language and Civics portions of the U.S. citizenship exam. Based on the fraudulent N-648 forms, the Department of Homeland Security granted disability exemptions to approximately 50 immigrants who were not actually disabled.

Velasquez also admitted that he submitted fraudulent medical reports to the Social Security Administration, falsely certifying that certain patients were eligible for disability benefits when he knew they were not. Beginning in 2006, and continuing up to the date of Velasquez’s arrest in April 2012, the Social Security Administration paid out at least $1.5 million in unwarranted disability benefits based on Velasquez’s false certifications. Velasquez also admitted that approximately 33% of his patient files contained fabrications, false statements, and false certifications of disability.

The fraud was uncovered through an undercover operation conducted jointly by the Department of Homeland Security, Immigration and Customs Enforcement/Homeland Security Investigations, and the Office of Inspector General, Social Security Administration. The investigation revealed Velasquez’s disregard for federal disability requirements. He coached his patients who were attempting to skirt the citizenship requirements, instructing them to use poor English during their interviews and not mention that they had a college education. Velasquez also lied about the length of time he had been treating his patients, in order to create a “track record” that would satisfy reviewers at the Social Security Administration, where he had previously worked as a consultant.

Sunnyvale Chiropractors Charged With Insurance Fraud

Dr. Wendy Lanser, 47, of Los Altos, and Dr. Lisa Shaw-O’Conner, 33 of Fremont, have been charged with multiple felonies involving medical billing insurance fraud, according to Denise Raabe, deputy district attorney. The pair, who were arrested last week, are scheduled to be arraigned at 1:30 p.m. on June 11, 2013. If convicted of all counts, Lanser faces a maximum of 19 years and 8 months in prison and Shaw-O’Conner, a maximum of 13 years. Both would be ordered to pay full restitution.

According to the story in the Freemont Patch, Lanser owns Lanser Chiropractic Inc., located at 990 W. Fremont Ave. in Sunnyvale. Shaw-O’Conner is a part-time independent contractor working out of the office. It is alleged that over several years, Lanser provided weekly chiropractic treatments for her husband and two children. She then submitted insurance claim forms for payment for the treatments she provided to her family using the name and billing identification number in the ‘servicing physician’ section of the claim form of an unwitting employee chiropractor. This would constitute medical billing fraud because the name of the servicing physician on the form is not the physician that provided the treatment.

In addition, the insurance policy that covers Lanser and her family, specifically excludes from coverage any medical treatment provided by a family member. This is a common exclusion found in the majority of medical insurance policies and reflects the cost controlling and ethical understanding that an insurance company should not pay for services that are provided gratuitously between family members.

In more recent cases, Shaw-O’Conner allegedly knowingly signed insurance claim forms as the ‘servicing physician’ for Lanser’s family members, when she did not provide the chiropractic services to the family members.

The scheme was uncovered by a joint investigation by the California Department of Insurance, Silicon Valley Regional Office, and the Santa Clara County District Attorney’s Office, Bureau of Investigations.

Applicant Must “Intend” to be Personally Liable For Medical Care

A WCAB panel in the case of Crispin Mendez-Correa v Vevoda Dairy elaborated on the elements necessary to hold an applicant personally liable for payment of his own self procured medical expenses for treatment outside of an MPN. The panel concluded that although the employer is not responsible for payment of the treatment, similarly the applicant is not personally liable for the treatment either unless he “intended” at the time to treat at his own expense.

This was an admitted injury claim that occurred in Humbolt County. Applicant obtained treatment within the MPN until he was MMI. Applicant then moved to Southern California where he obtained an attorney who designated Khalid Ahmed, M.D., as primary treating physician notwithstanding defendant’s objection that the doctor was not in defendant’s MPN. Numerous other non-MPN providers subsequently filed treatment, medical legal and other liens in the case. There was no evidence at trial that applicant chose to go outside of the MPN “at his own expense” instead of using the employer provided care. Indeed, the record did not reflect why he went outside the MPN except that his attorney sent him to a non MPN physician. He was ultimately awarded 7% permanent disability and future medical care.

With respect to the treatment liens, the WCJ stated that “the applicant, in designating Dr. Khalid Ahmed as his non-MPN PTP, obtained self-procured medical treatment outside defendant’s MPN at his own expense under Labor Code section 4605.” The WCAB panel agreed that the employer was not responsible, but reversed indicating “that the WCJ incorrectly concluded that any and all medical treatment obtained outside of a properly noticed MPN is necessarily self-procured by the injured worker at his own expense pursuant to section 4605. The WCAB panel concluded “that is not the law.”

When a provider treats an industrially injured worker and takes certain actions such as submitting reports and billing statements to the employers’ insurance carrier, accepting payment from that carrier and/or seeking to obtain payment by filing a lien claim, the WCAB obtains exclusive jurisdiction over the payment dispute. Regardless of whether a lien claim is filed, the injured worker is only liable for medical treatment of an industrial injury that he or she intended to self-procure at his or her own expense pursuant to section 4605. The Appeals Board is authorized by section 4903 to “hear and determine any issue growing out of a controversy as to whether or not the physician was supplied by the employer or chosen by the employee at his own expense.” However, the authority to determine if a bill is the injured worker’s obligation under section 4605 is not the same as exercising jurisdiction under section 4903 to allow and determine a lien against compensation.

“If applicant intentionally self-procured medical treatment pursuant to section 4605 he would be personally liable under that section for the cost of the treatment, and the Appeals Board would have no jurisdiction to determine its reasonable value or to hold defendant liable for it as part of the applicant’s workers’ compensation.” .. “However, in this case there is no evidence that applicant intended to self-procure medical treatment from any lien claimants at his own expense pursuant to section 4605 following his move to Southern California.”

California Ballot Measure Seeks Physician Random Drug Testing

A new proposed state ballot measure is underway that would require doctors to be randomly subjected to drug and alcohol testing, the same way bus drivers are. According to the report in the San Francisco Chronicle, the measure is being pushed by a tech mogul who’s on a very personal crusade to clean up the state’s medical practices.

Bob Pack is a former AOL and NetZero exec whose 10-year-old son and 7-year-old daughter were struck and killed a decade ago near their Danville home by a driver under the influence of alcohol and prescription pills. After going public with a campaign to put his kids’ killer behind bars for second-degree murder, Pack turned his attention to helping the state track patient prescriptions and spot “doctor shoppers” like the driver in Danville. After state funding for the effort dried up, Pack tried and failed to qualify a ballot initiative that would have taxed drug companies to pay for the tracking.

Now he’s taking aim at doctors who abuse drugs themselves. He’s enlisted the help of consumer advocate Harvey Rosenfield – the guy behind the landmark 1988 measure regulating the insurance industry – and former Clinton White House adviser Chris Lehane, whose trial lawyer clients have already dropped $2 million into a campaign account. Pack and his pals are armed with a new poll showing 85 percent of California voters would be on board with random testing of physicians. They’re also touting an article in the prestigious Journal of American Medicine advocating confidential, mandatory testing.

They’re looking to hit the streets this summer with either a single-issue measure or a multi-prong initiative that would also lift the cap on damages in medical malpractice cases, change the makeup of the state Medical Board, which disciplines bad doctors, to require that a majority come from outside the medical profession, and ensure funding for a state database to track what drugs doctors are prescribing – and if they’re being recklessly prescribed.

The California Medical Association “isn’t in the business of speculating on every hypothetical, ridiculous ballot measure that is floated,” said spokeswoman Molly Weedn, but she calls the effort by Pack and his cohorts “nothing more than an ill-fated publicity stunt.” CMA claims the real goal to lift the decades-old cap on medical malpractice cases – a “money grab” by the trial lawyers that won’t fly with either the Legislature or voters.

Stem Cell Research Improves Spine Injury Outcomes

An international team led by researchers at the University of California, San Diego School of Medicine reports that a single injection of human neural stem cells produced neuronal regeneration and improvement of function and mobility in rats impaired by an acute spinal cord injury (SCI). The findings are published in the May 28, 2013 online issue of Stem Cell Research and Therapy.

According to the summary published in Science Daily, Martin Marsala, MD, professor in the Department of Anesthesiology, with colleagues at UC San Diego and in Slovakia, the Czech Republic and The Netherlands, said grafting neural stem cells derived from a human fetal spinal cord to the rats’ spinal injury site produced an array of therapeutic benefits — from less muscle spasticity to new connections between the injected stem cells and surviving host neurons. “The primary benefits were improvement in the positioning and control of paws during walking tests and suppression of muscle spasticity,” said Marsala, a specialist in spinal cord trauma and spinal injury-related disorders. Spasticity — exaggerated muscle tone or uncontrolled spasms — is a serious and common complication of traumatic injury to the spinal cord. The human stem cells, said the scientists, appeared to vigorously take root at the injury site. “In all cell-grafted animals, there was robust engraftment, and neuronal maturation of grafted human neurons was noted,” Marsala said. “Importantly, cysts or cavities that can form in or around spinal injuries were not present in any cell-treated animal. The injury-caused cavity was completely filled by grafted cells.”

The rats received the pure stem cell grafts three days after injury (no other supporting materials were used) and were given drugs to suppress an immune response to the foreign stem cells. Marsala said grafting at any time after the injury appears likely to work in terms of blocking the formation of spinal injury cavities, but that more work would be required to determine how timing affects functional neurological benefit. The grafted stem cells, according to Marsala, appear to be doing two things: stimulating host neuron regeneration and partially replacing the function of lost neurons.

“Grafted spinal stem cells are rich source of different growth factors which can have a neuroprotective effect and can promote sprouting of nerve fibers of the host neurons. We have also demonstrated that grafted neurons can develop contacts with the host neurons and, to some extent, restore the connectivity between centers, above and below the injury, which are involved in motor and sensory processing.”

The scientists used a line of human embryonic stem cells recently approved for Phase 1 human trials in patients with chronic traumatic spinal injuries. Marsala said the ultimate goal is to develop neural precursor cells (capable of becoming any of the three main cell types in the nervous system) from induced pluripotent stem cells derived from patients, which would likely eliminate the need for immunosuppression treatment.

Pending approval by UC San Diego’s Institutional Review Board, the next step is a small phase 1 trial to test safety and efficacy with patients who have suffered a thoracic spinal cord injury (between vertebrae T2-T12) one to two years earlier, and who have no motor or sensory function at or below the spinal injury site. “This is exciting, especially because, historically, there has been very little to offer patients with acute spinal cord injury,” said study co-author Joseph Ciacci, MD, professor of surgery and program director of the Neurosurgery Residency at the UC San Diego School of Medicine. Ciacci, who is also chief of neurosurgery for the Veterans Affairs San Diego Healthcare System, will oversee the clinical trial at UC San Diego and the VA. Ciacci said if the initial study confirms safety and efficacy, as well as the viability of the implanted cells, neural regeneration and decreased spasticity, the protocol can be expanded to other patients with other forms of severe spinal cord injury.

Cal/OSHA Fines Oakland Hospital For Health and Safety Issues

State regulators have fined Alta Bates Summit Medical Center in Oakland $142,970 for not properly isolating nearly two dozen patients suspected of having tuberculosis. The story in Mercury News says that the hospital failed to put the patients in appropriately ventilated rooms to prevent the disease from spreading to other patients and hospital employees, Cal-OSHA said.

As it turned out, none of these patients tested positive for tuberculosis during the period from Nov. 15 to Jan. 15, so no one was infected, said Mike Hill, a registered nurse at the hospital who was among a group of employees that Cal-OSHA briefed on its findings. But that did not appease Hill and other members of the California Nurses Association/National Nurses United, who are in the midst of a seven-day strike against Alta Bates Summit and other Sutter Health-affiliated hospitals in the East Bay.

“The hospital knew for over a year and a half that the one negative pressure room (in the intensive care unit) did not adequately protect us, patients or anyone walking by,” Hill said. A negative pressure room has a ventilation system that sucks air out of the room to prevent it from spilling into hallways and other areas of the hospital. Cal-OSHA said the system wasn’t working properly.

The hospital plans to appeal the citations, two of which were labeled willful and serious, spokeswoman Stacey Wells said. She noted that the hospital has a team of infection control and other experts who work to ensure a safe environment. “We are also reviewing our policies and procedures — as we regularly do — to ensure we always implement best practices and procedures that maintain and ensure the safety and health of our staff and patients,” Wells said.

Cal-OSHA also faulted the hospital for not ensuring that employees use a respirator when they perform certain procedures on patients suspected of having an infectious disease such as tuberculosis.

No Judicial Misconduct Reported in DWC Ethics Advisory Committee 2012 Annual Report

The Division of Workers’ Compensation (DWC) has posted the 2012 Ethics Advisory Committee’s annual report on its Web site. The Workers’ Compensation Ethics Advisory Committee is a state committee, independent from the DWC, charged with reviewing and monitoring complaints of misconduct filed against workers ’ compensation administrative law judges. The nine-member Ethics Advisory Committee is required to make a public report each year summarizing activities in the previous calendar year.

As civil servants, the WCALJs are not subject to review by the California Commission on Judicial Performance, the agency which is responsible for investigating misconduct complaints directed at judges serving on the Supreme, Superior and Appellate courts. The EAC’s authority and duties are set forth in the California Code of Regulations, title 8, sections 9722 through 9723.

The EAC meets at regular intervals to review complaints of judicial misconduct and to make recommendations to the Chief Judge and the Administrative Director of the DWC if a complaint warrants a formal investigation by the Administrative Director’s staff. Pursuant to California Code of Regulations, title 8, section 9722, the Ethics Advisory Committee is composed of nine members, each appointed by the Division of Workers’ Compensation’s Administrative Director for a term of four years. The EAC’s composition reflects the constituencies within the California workers’ compensation community, and is composed of a member of the public representing organized labor; A member of the public representing insurers; A member of the public representing self-insured employers; An attorney who formerly practiced before the Workers’ Compensation Appeals Board and who usually represented insurers or employers; An attorney who formerly practiced before the Workers’ Compensation Appeals Board and who usually represented applicants (injured workers); A presiding judge; A judge or retired judge, and, two members of the public outside the workers’ compensation community.

The EAC meets four times each year at the DWC Headquarters located at 1515 Clay Street, in Oakland, California. Although EAC meetings are open to the public, the Committee meets in executive session when it engages in the review and discussion of actual complaints, and that portion of the proceedings is closed to the public.

In 2012, the DWC had authority over 168 active judges. The EAC received 19 new complaints in the calendar year of 2012, 6 complaints resulted in investigations. The complaints set forth a wide variety of grievances. Three complaints were filed by employees represented by attorneys. Nine by non represented attorneys. One by a defense attorney. And one each by a hearing rep, lien claimant, and an attorney representing a lien claimant.

The Ethics Advisory Committee identified no judicial misconduct in 15 complaints, and did not recommended further action by the Chief Judge or the Administrative Director on any complaints. Three complaints presently remain pending and under investigation from complaints filed in 2012.