Tag: 2016 News

Artificial disk replacement is a newer surgical procedure for relieving spine pain. Similar to hip or knee joint replacements, a disk replacement substitutes a mechanical device for an intervertebral disk in the spine. The device is meant to restore motion to the spine by replacing the worn, degenerated disk. It is an alternative to the commonly performed anterior cervical discectomy and fusion (ACDF), a surgical procedure that is designed to address the pathology by eliminating motion at the diseased disc level. Artificial disk replacement initially gained FDA approval for use in the U.S. in 2004. Over the past several years, numerous other disk replacement designs have been developed and are currently being tested. Development of these procedures first appeared in the lumbar spine, and more recently cervical total disc replacements (cTDR) at one level, and now at two levels.

The natural cervical intervertebral disc is an amazing mechanical structure from an engineering perspective. It has the ability to absorb a large compressive load while still providing an impressive range of motion between the bones in the neck. Duplicating the natural disc’s form and function with a synthetic – or artificial – disc is challenging. However, several artificial cervical discs have been developed and are available as a surgical option for patients with symptomatic cervical disc problems.

One of the newer developments, Mobi-C is a cobalt chromium alloy and polyethylene mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. All other cervical disc prostheses are FDA approved for one-level use only. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique.

Although both ACDF and cTDR satisfactorily treat clinically symptomatic cervical pathology, fusion alters cervical mechanics by placing increased stresses on adjacent segments, which may contribute to the development of symptomatic degeneration at those adjacent levels. In comparison, at least in theory, by preserving the motion of the operated segment, cTDR places comparatively less stresses on adjacent levels, which may serve to protect those levels. Multilevel ACDF is biomechanically more demanding than single-level ACDF with concomitant greater stress distribution on adjacent levels. Additionally, reoperation rates are generally higher in multilevel versus single-level ACDF. Currently there is a paucity of medical evidence evaluating the outcome of multilevel cTDR procedures.

However this month there is a new published study. Five-year clinical results of cervical total disc replacement (cTDR) compared with anterior discectomy and fusion for treatment of two-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial has just been published by the Journal of Neurosurgery: Spine.

A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients.

In both groups, the overall rates of patient satisfaction were high. However, there was significantly higher reported patient satisfaction in the cTDR group versus the ACDF group. At 5 years, 96.4% of cTDR patients and 89.5% of ACDF patients reported being either very satisfied or somewhat satisfied with their treatment. At 5 years, 94.8% of patients in the cTDR group and 84.2% of patients in the ACDF group reported that they would definitely or probably recommend the surgery to a friend.

In 2015, the industry observed the emergence of “captive pharmacies,” or pharmacies that enter arrangements to be owned or operated by pharmaceutical manufacturers. Captive pharmacies typically promote the manufacturer’s products instead of other lower-cost, equally effective medications. The intent is to circumvent formulary management programs designed to protect the patient and the plan sponsor from unnecessarily filling high-cost medications. The most high-profile captive pharmacy arrangements were between Valeant Pharmaceuticals International and Philidor Rx Services, and Horizon Pharma PLC and Linden Care Pharmacy.

Express Scripts Holding Co, the largest U.S. pharmacy benefit manager, is “reviewing and evaluating all similar captive pharmacy arrangements that we know of and will work to identify others,” said Brian Henry, a spokesman for Express Scripts. He defined a captive pharmacy as one that derives the vast majority of prescription volume from one manufacturer or one product. CVS Health, the second-largest pharmacy benefit manager, also said it is continuing to investigate other pharmacies to uncover inappropriate billing and dispensing activities.

The New York Times reports that Valeant has encouraged doctors to submit prescriptions for its products to Philidor Rx Services, rather than send patients to the corner drugstore. That makes it more difficult for pharmacists and insurers to substitute a less expensive alternative. Co-payments are often subsidized, making it easier for the patients to agree to get the higher-priced Valeant drug. And Philidor handles the task of fighting for reimbursement from insurers, taking that off doctors’ hands. What has raised even more suspicion is that Valeant did not disclose its relationship with Philidor until recently, when word started to get around, even though it had paid $100 million for an option to acquire the pharmacy, for no additional payment. Valeant said the transaction was too small to be material.

Phildor Rx Services was denied a license to dispense drugs in California because, the state said, it had not been truthful identifying its owners and financial officers. When Philidor failed to get the license in California, entities affiliated with it bought stakes in at least two California pharmacies. One of those, R&O Pharmacy, has presented evidence in litigation that the entity that bought the stake tried to hide that it was a front for Philidor. It also claims that Philidor used R&O’s pharmacy identification numbers to help fill its own prescriptions.

R&O Pharmacy is a small storefront community pharmacy amid rows of low-slung office buildings in Camarillo, California. According to Bloomberg News, 64-year-old pharmacist Russell Reitz agreed to sell his business there to a Delaware-registered company for $350,000. Even before the sale agreement was executed, other pharmacies began using an R&O identification number to bill for prescriptions that R&O hadn’t filled, sometimes for drugs the store didn’t stock, according to the court documents. Reitz asked why R&O’s suitor had signed an insurance-company audit for the pharmacy that Reitz still controlled. The next day, he received surprise visitors from a firm called Philidor RX Services, whose links to the buyer Reitz struggled to understand. Increasingly alarmed as millions of dollars in payments flowed in, Reitz started stashing away the checks. Then he got sued. It wasn’t pocket change. Valeant’s general counsel, in a September 4 letter to Reitz, said R&O owed Valeant in connection with gross invoices of $69.9 million. He threatened to take “any and all actions” to ensure payment.

As a result of publicity following the R&O lawsuit Valeant finally revealed that it had a secret network of pharmacies pushing its products around the country. In March, 2016 Valeant announced the litigation between the parties has been resolved by a “confidential settlement agreement that resolves all claims between them.” Reuters reported that Philidor Rx Services also has had questionable transactions with West Wilshire Pharmacy in Los Angeles.

One of the products dispensed by Philidor is Solodyn, a Valeant acne drug that costs more than $1,000 a month and is a formulation of an old generic antibiotic, minocycline. Another product is Jublia, an ointment for toenail fungus that costs more than $500 a bottle and is one of Valeant’s fastest-growing treatments. Philidor handled 44 percent of Valeant’s Jublia business in the third quarter.

The California Supreme Court ruled that employers cannot deny a worker a place to sit just because they prefer the person stand, and they must consider the employee’s work station, not their overall duties, when determining whether to provide a seat. The court’s opinion stemmed from lawsuits brought by cashiers at the CVS drugstore chain and tellers at Chase Bank who said they were wrongly denied a place to sit while working. Experts called the opinion a victory for the cashiers and tellers.

Nykeya Kilby worked for eight months as a customer service representative for CVS Pharmacy, Inc. During both the interview and training process, CVS told Kilby it expected her to stand while performing her various duties. Although actual duties varied by both store and shift, Kilby’s duties included operating a cash register, straightening and stocking shelves, organizing products in front of and behind the sales counter, cleaning the register, vacuuming, gathering shopping baskets, and removing trash. CVS did not provide Kilby a seat for these tasks. Kilby filed a federal class action lawsuit alleging CVS violated Wage Order No. 7-2001, applicable to the mercantile industry. The district court ruled that an employee’s “entire range of assigned duties” must be considered to determine whether the work permits the use of a seat or requires standing. It noted “there is no dispute that many of the duties performed by Clerk/Cashiers at CVS require the employee to stand while performing them . . . .” Accordingly, it granted summary judgment in favor of CVS and Kilby appealed.

Kemah Henderson and three other bank tellers worked at JPMorgan Chase Bank branches. They filed a class action suit against Chase for violating the suitable seating provision of Wage Order No. 4-2001, section 14, subdivision (A) (section 14(A)), applicable to “professional, technical, clerical, mechanical, and similar occupations.” The district court noted that the job duties varied depending on the shift or branch location and whether the employee was a lead or regular teller. Based on these differences, the district court denied class certification and Henderson appealed.

The Ninth Circuit Court of Appeal certified three questions that needed clarification to the California Supreme Court involving California wage order requirements that an employer provide suitable seating for employees under certain circumstances which were answered in the case of Kilby v CVS Pharmacy.

Over a century ago, the Legislature responded to the problem of inadequate wages and poor working conditions by establishing the Industrial Welfare Commission (IWC), giving it authority to investigate various industries and promulgate wage orders establishing minimum wages, maximum work hours, and conditions of labor. Wage and hour claims are today governed by two complementary and occasionally overlapping sources of authority: the provisions of the Labor Code, enacted by the Legislature, and a series of 18 wage orders.The wage orders at issue here state that “[a]ll working employees shall be provided with suitable seats when the nature of the work reasonably permits the use of seats.” (Cal. Code Regs., tit. 8, §§ 11040, subd. 14(A) (Wage Order No. 4-2001), 11070, subd. 14(A) (Wage Order No. 7-2001).)

The California Supreme Court answered the Questions posed by the federal Ninth Circuit Court of Appeals as follows:

(1) The “nature of the work” refers to an employee’s tasks performed at a given location for which a right to a suitable seat is claimed, rather than a “holistic” consideration of the entire range of an employee’s duties anywhere on the jobsite during a complete shift. If the tasks being performed at a given location reasonably permit sitting, and provision of a seat would not interfere with performance of any other tasks that may require standing, a seat is called for.
(2) Whether the nature of the work reasonably permits sitting is a question to be determined objectively based on the totality of the circumstances. An employer’s business judgment and the physical layout of the workplace are relevant but not dispositive factors. The inquiry focuses on the nature of the work, not an individual employee’s characteristics.
(3) The nature of the work aside, if an employer argues there is no suitable seat available, the burden is on the employer to prove unavailability.

With the answers to this questions, the matter will now be decided by the Ninth Circuit in due course. But Michael Rubin, an attorney for the plaintiffs, said the decision was a victory for all workers who have been denied a place to sit while they perform repetitive tasks in fixed locations. “For the millions of California worker in the retail industry, this is going to mean that in the next few weeks, their employers will start giving them seats, which will promote health and comfort,” he said.

In Medicare, medical professionals may be banned from seeking money to see patients if they’ve been convicted of defrauding a health care program or fraud-related offenses. But according to a report by the Center for Investigative Reporting, those banned providers have no problem starting a second career in California’s workers’ compensation system.

Medicare banned Dr. Thomas Heric in 2006 after he pleaded guilty to charges related to writing reports based on diagnostic tests that turned out to be fraudulent. In his letter to the judge who sentenced him, Heric pledged that going forward, he would use “whatever talents I may have in service to the community.” Heric then found a new line of work in the workers’ compensation medical system. His job was to review data on injured workers’ sleep patterns and issue reports needed to bill insurers.

Five years later, prosecutors accused Heric of fraud again. They say he was writing virtually identical reports that gave rise to sham billing. One expert testified in court that Heric’s sleep-study reports were so bad that they failed to address one worker’s serious breathing problems for months, a lapse that he said could harm “the general public.”

That case is pending in Orange County Superior Court. Heric’s attorney, Robert Moest, said Heric stands by the reports and is fighting the charges. “There are different opinions in the scientific community,” Moest said. “It shouldn’t be the matter of a criminal charge.”

A Center for Investigative Reporting analysis of public records found that several other chiropractors and doctors banned by Medicare moved their career to workers’ compensation.

Among them: chiropractor David C. Nguyen. Medicare banned him in 2005 over an insurance fraud conviction. Earlier this year, San Diego prosecutors indicted him for insurance fraud again, this time for passing along bribes from a chiropractor to a therapy center – both workers’ compensation medical providers.

And Medicare doesn’t bar just doctors, pharmacists and chiropractors with histories of fraud. It also takes a look at who’s in charge. Officials with the Department of Health and Human Services’ inspector general’s office will investigate clinic operators’ ownership and ban those with a 5 percent or greater stake who have a history of certain fraud convictions, according to Jason Weinstock. The rule covers direct and indirect ownership.

No such rule exists in workers’ comp. State labor department officials said they do not have the authority to review the practices of medical professionals. Instead, they said in a statement, the boards that issue licenses to medical providers are the “appropriate authority for regulation and review.” Yet no board or commission checks who’s running workers’ compensation clinics.

The state’s chiropractic board stripped Fred Khalili of his license and denied his attempt to get it back in 2013. But he still signs physicians’ paychecks at two Los Angeles County workers’ compensation clinics. Khalili’s legal problems started in 1995, when an FBI agent informed him that he was under investigation for paying $135,000 in kickbacks to auto-injury lawyers. Khalili was seeing a steady flow of patients who’d been hurt in car crashes, court records say.

Facing an indictment, he began to work undercover for the FBI. He recorded phone conversations with lawyers who demanded a cut of his medical treatment income in exchange for a parade of patients. He even went to the office of one lawyer who was believed to be a member of a Russian gang and kept a gun in his desk drawer, according to court records.

Khalili ultimately pleaded guilty to wire fraud and tax evasion and lost his chiropractic license in 2000. Twelve years later, he returned to the chiropractic board, hoping to get his license reinstated. The board refused, citing subsequent arrests for vandalism, a hit-and-run collision, driving without a license and making harassing phone calls. He appealed the decision to a higher court but lost.

Khalili remains heavily involved in workers’ compensation clinics, something that would draw scrutiny under Medicare’s rules as a fraud prevention measure. In the vacuum of such oversight in workers’ compensation, prosecutors now are pursuing charges against Khalili.

He was accused in February of insurance fraud for accepting kickbacks on behalf of First Choice Healthcare Medical Group clinics in Los Angeles and Panorama City. In exchange for the kickbacks, he directed staff at the clinics to dispense expensive pain creams to injured workers, the case alleges.

The charges against Khalili say he directed an attorney in 2009 to put the clinic ownership in the name of a physician, but Khalili controls the bank accounts. Attorney Malcolm McNeil, who advises First Choice, said Khalili does not own the clinics.

Khalili has not entered a plea in the case, and his criminal attorney did not return calls for comment.

Carlos Ivan Rodas worked as a dishwasher at Guido’s Restaurant. In 2012, Rodas took the trash from the restaurant to the dumpster located approximately 300 feet away from the restaurant. A patron later found Rodas unresponsive and bloodied in Guido’s parking lot. Rodas was pronounced dead at the scene by emergency personnel. The autopsy report concluded that Rodas’s death was caused by a hemorrhage from an invasive pulmonary aspergillosis as sequelae of treated cavitary tuberculosis. In lay terms he died from a pulmonary hemorrhage while taking out the garbage at work. Rodas’s arteries were prone to bleed because of lesions caused by tuberculosis.

Internist Ronald Zlotolow, M.D. opined that either coughing, brought about by refuse odors, or lifting the garbage caused the bleeding.

The WCJ concluded that Rodas sustained injury arising out of and occurring in the course of his employment that resulted in death. However, a split panel decision reversed and concluded that Dr. Zlotolow’s opinion was based on surmise, speculation, conjecture, or guess and therefore was not substantial evidence that Rodas’s work contributed to the cause of his pulmonary injury and death.

The Court of Appeal reversed, and based on the expert medical testimony of Dr. Zlotolow found that the injury that led to Rodas’s death arose out of and in the course of employment in the unpublished case of Rodas v WCAB.

In the context of this case, the Court noted that the question of what caused the intrathoracic pressure can be answered only by circumstantial evidence since direct evidence is obviously unavailable. “Circumstantial evidence is sufficient to support an award of the commission, and it may be based upon the reasonable inferences that arise from the reasonable probabilities flowing from the evidence; neither absolute certainty nor demonstration is required.” (Pacific Employers Ins. Co. v. Industrial Acci. Com. (1942) 19 Cal.2d 622, 629.)

Thus the Court concluded that In the case of death occurring at work, the difficulty in proving industrial causation is “no reason to deny an award if the evidence warrants it.” (Clemmens v. Workers’ Comp. Appeals Bd. (1968) 261 Cal.App.2d 1, 7.) All reasonable doubts as to whether an injury is compensable are to be resolved in favor of the employee. (Id. at p. 8.) This is consistent with the mandate that the workers’ compensation laws “shall be liberally construed by the courts with the purpose of extending their benefits for the protection of persons injured in the course of their employment.” (Lab. Code, § 3202.)

The Court of Appeal did not discuss the application of labor code section 3202.5 which was added to the Labor Code in 1993 after Clemmens (and other early cases defining the application of “liberal construction”) were decided. In adoption section 3202.5 in 1993 the Legislature expressly provided that “[n]othing contained in Section 3202 shall be construed as relieving a party from meeting the evidentiary burden of proof by a preponderance of the evidence.” Section 3202.5 was at the time part of a legislative reform package resolving long standing concerns over various issues by all stakeholders. Employers had for decades voiced concern about courts using liberal construction to decide the outcome of litigation, and the legislature addressed this concern in 1993 by limiting the application of liberal construction to resolve evidentiary disputes by enacting 3202.5. An appellate decision after the adoption of 3202.5 that resolves an evidentiary dispute by citing 3202 alone, without at the same time citing 3202.5 and discussing and reconciling both statutes does not seem to afford employers the benefit of the legislative process that attempted to balance the rights of employers and employees in workers compensation litigation. When a court cites decisions applying liberal construction before 1993 without noting there was a change in the law makes it seem as though section 3202.5 was never adopted by the legislature and does not exist. Indeed the Court of Appeal cites here in Rodas the recent Supreme Court case of South Coast Framing, Inc. v. Workers’ Comp. Appeals Bd. (2015) 61 Cal.4th 291 as support for this decision. But even in South Coast Framing, the California Supreme Court in 2015 cites section 3202, but makes no mention of how that should be reconciled with section 3202.5.

The Rodas decision is just another of many examples of courts applying “liberal construction” to resolve a factual dispute without consideration of what happens after 1993 when section 3202.5 was adopted.