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“Daubert” Evidence Standard Ends 300 Zoloft Lawsuits

The “Daubert” standard is a rule of evidence regarding the admissibility of expert witnesses’ testimony during United States federal legal proceedings, and litigation in many states. Pursuant to this standard, a party may raise a Daubert motion, which is a special case of motion in limine raised before or during trial to exclude the presentation of unqualified evidence to the jury.

The Daubert trilogy refers to the three United States Supreme Court cases that articulated the Daubert standard. Daubert v. Merrell Dow Pharmaceuticals, held in 1993 that Rule 702 of the Federal Rules of Evidence did not incorporate the Frye “general acceptance” test as a basis for assessing the admissibility of scientific expert testimony, but that the rule incorporated a flexible reliability standard instead. General Electric Co. v. Joiner held that a district court judge may exclude expert testimony when there are gaps between the evidence relied on by an expert and his conclusion, and that an abuse-of-discretion standard of review is the proper standard for appellate courts to use in reviewing a trial court’s decision of whether it should admit expert testimony and Kumho Tire Co. v. Carmichael held in 1999 that the judge’s gatekeeping function identified in Daubert applies to all expert testimony, including that which is non-scientific.

And here is how the Daubert standard works in litigation. Reuters Health reports that federal judge in Philadelphia dismissed more than 300 lawsuits against Pfizer Inc alleging that its antidepressant Zoloft caused birth defects in children born to women who took the drug while pregnant.

The decision from U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania said that plaintiffs had not produced enough evidence to show a plausible scientific link between the drug and birth defects, following several previous decisions that excluded testimony from key expert witnesses for plaintiffs.

“The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years,” Rufe wrote. “Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

The ruling affects more than 300 lawsuits against Pfizer consolidated before Rufe in federal court.

A Pfizer spokeswoman, Neha Wadhwa, said the decision “affirms that plaintiffs have failed to produce any reliable scientific evidence demonstrating that Zoloft causes the injuries they alleged.” Dianne Nast, a lead lawyer for the plaintiffs, did not immediately return a call for comment. Pfizer had previously prevailed in two trials involving Zoloft birth-defect claims in state courts in Philadelphia and Missouri.

California does not use the Daubert standard, It adheres to the more liberal “Frye” general acceptance test. Indeed, the court of appeal in the unpublished case of Star Insurance Company v WCAB and Maria Rosa Tavares specifically rejected the Daubert standard this January in workers’ compensation cases. This explains why it is easier to win cases on weak science in California that would not likely succeed in federal courts or states that have adopted the Daubert rule.

You May Want to Sit Down After You Read This New Case!

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.

Split Panel Decision Gives 24 Hours to Communicate UR Decision

Michael Green injured his spine, neck, right shoulder and hips at work in 2012. Dr. Jones, an authorized second opinion physician, sent a Request for Authorization (‘RFA’) dated April 17, 2015, which recommended artificial disc replacement arthroplasty at L4-L5 with a one to two day inpatient stay. The RF A was received by the insurance carrier via facsimile at 6: I 8 p.m. on Friday, April I 7, 2015. The procedure was denied by Howard Sturtz, M.D. in his UR letter of April 27, 2015 which was was served by facsimile only on April 27, 2015 just after 6:00 p.m. in the evening.

It is undisputed that the last business day for UR in this case was April 27, 2015.

The WCJ found that defendant’s “Utilization Review [UR] denial of April 27, 15 2015 was untimely,” and that the “(d]isc replacement/total disc arthroplasty procedure at L4-L5 16 requested by Dr. Jones under a Request for Authorization [RFA] of April 17, 2015 is reasonable and necessary” medical treatment and it was awarded.

The defendant’s petition for reconsideration was granted, and the decision reversed in the split panel decision of Green v Elle Placement dba Golden Gate Staffing. It was held that Defendant timely made a UR determination and served it within the allowed time. Any further dispute of a valid UR denial is subject to the Independent Medical Review (IMR) process.

AD Rule 9792.9.l(a)(l) provides that when an RFA is submitted after 5:30 p.m., it is considered to be received on the next business day. (Cal. Code Regs., tit. 8, § 9792.l.9(a)(l).) In that the RFA in this case was submitted after 5:30 p.m. on Friday, April 17, 2015, as shown by the fax received date stamped on its face, it is properly deemed under AD Rule 9792.9.I(a)(I) to have been received the next business day on Monday April 20, 2015.

AD Rule 9792.9.l(c){l) states that “the first day in counting any timeframe requirement is the day after the receipt of the DWC form RFA … ” (Cal. Code Regs., tit. 8, § 9792.I.9(c)(l). The day after the date the RFA was received was Tuesday, April 21, 2015. The WCJ was correct in concluding that the Monday, April, 27, 2015 UR decision timely issued within five working days of that date because Saturday, April 25, 2015 and Sunday, April 26, 2015 are not “working days” as described in section 4610(g)(l).

Section 9792.1.9(3)(A) provides in pertinent part that a prospective UR decision like the one in this case “shall be communicated to the requesting physician within 24 hours of the decision … initially by telephone or facsimile, and … in writing … within two business days of the decision … as prescribed by the administrative director.” AD Rule 9792.9.l(e) in tum provides that a prospective UR decision “shall be communicated to the requesting physician within 24 hours of the decision .. .initially by telephone, facsimile, or electronic mail … followed by written notice … “

Both of these regulations “plainly allow for communication of a UR decision ‘within 24 hours of the decision,’ and they do not include that time period within the time for making the decision. In this case, the decision was made on April 27, 2015, and it was communicated by facsimile to the treating physician on the same date, which was within 24 hours of the decision. The record shows that the UR decision was both timely made and timely communicated. As such, the UR is valid and there was no basis for the WCJ to award the disputed medical treatment.”

Commissioner Caplan wrote a dissenting opinion. “Accepting defendant’s contention that the time for sending a UR decision does not begin to run until the UR decision is made would expand the time within which UR is to be completed from five working/business days to five working/business days plus 24 hours. Such an expansion of the time for completion of UR is contrary to the Legislature’s intention in establishing a fixed time frame for completion of UR, and it is contrary to the AD regulations that require completion of UR within five business days of the defendant’s receipt of the RFA.

Workers’ Compensation Offers “Second Career” For Fraudulent Doctors

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.

Insurance Company Litigates to Be Declared “Unimportant”

LIfe Insurance companies usually go to inordinate lengths to demonstrate their dullness. That makes MetLife’s chief executive, Steven Kandarian, extraordinary. He did what the head of no other big American financial firm has dared to: challenge head-on the legitimacy of the business-shaping decisions made with increasing frequency by regulators in the wake of the financial crisis. More remarkable still, he won. On March 30th a federal court in Washington DC (Case 1:15-cv-00045) ordered the Financial Stability Oversight Council (FSOC), a new regulatory committee, to rescind its designation of MetLife as a “strategically important financial institution” or SIFI – a label that required it to have a bigger, and thus more expensive, cushion of capital.

According to the story in the Economist, MetLife is one of only four non-banks to have been declared a SIFI. Prudential Insurance, one of the other three, acceded after grumbling a bit. General Electric said little but has since dispensed with much of its financial operations. AIG, another insurer, seemed to accept the new status, perhaps because being a SIFI is seen as being synonymous with being too big to fail, and thus implies a government backstop. AIG’s implosion had been at the centre of the financial crisis: any inkling that the government stood behind it would do much to reassure customers debating whether to pay upfront for a product that will not be delivered for many years.

MetLife, however, had come through the financial crisis in good shape, earning the confidence of its customers. It judged that whatever additional reassurance they might glean from implicit government backing was outweighed by the costs, in terms both of using extra capital and of additional scrutiny from regulators. Moreover, it maintained that it was not sufficiently intertwined with other institutions to be considered systemic. Insurers, after all, make long-term investments, and are not normally subject to the sorts of panics and runs that afflict banks. The criteria for FSOC’s decision, MetLife argued, had been vague and arbitrary.

Initially, like other financial firms, it voiced these objections only privately. When that did not work, it complained publicly, again to no avail. The only member of FSOC with experience in the insurance business appeared sympathetic, but did not sway his colleagues. In frustration, MetLife turned to the courts.

“From the beginning, MetLife has said that its business model does not pose a threat to the financial stability of the United States,” Mr Kandarian said in a statement. “This decision is a win for MetLife’s customers, employees and shareholders.” Jack Lew, the treasury secretary, who chairs FSOC, released a statement saying it strongly disagreed and would defend its “designation process”, without specifying whether it would appeal. The court has not yet released its reasoning, which will presumably only add to the pressure on FSOC to clarify its procedures.

The ruling only applies to MetLife; no similar cases are pending. Yet the ramifications are enormous. The following day GE asked FSOC to rescind its SIFI label, given its recent restructuring. Until now, other financial firms felt they had little recourse against regulatory decisions, regardless of how much they disagreed. Rather than resort to the courts, they hired lobbyists in the hope of persuading the government to go easy. This may now change. Ironically, the decision comes a little too late for MetLife itself, which is spinning off its American life-insurance business, in part to ward off FSOC. Mr Kandarian says this divestment will still go ahead. But MetLife’s victory may give other financial firms the luxury of a little more breathing-room before making such decisions.

DCA Reverses Denial of Death Benefits Citing “Liberal Construction” While Ignoring LC 3202.5

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.

San Gabriel Valley Physician Pleads Guilty to Illegal Distribution of OxyContin

A San Gabriel Valley doctor has agreed to plead guilty to a federal drug trafficking charge for illegally distributing the powerful painkiller best known by the brand name OxyContin.

Dr. Daniel Cham, 48, of Covina, has agreed to plead guilty to one count of distribution of oxycodone and one count of money laundering.

In the plea agreement, Cham admits to unlawfully prescribing oxycodone to an undercover agent posing as a patient in March 2014 in exchange for $300 in money orders, which Cham then deposited into a bank account held in the name of another business. Cham made the deposit “knowing that the transaction was designed to conceal and disguise the nature and source of the money orders,” according to the plea agreement.

Cham was initially charged in this case in October 2014 when a federal grand jury returned an indictment alleging narcotics trafficking, money laundering, fraud and making false statement to authorities. The indictment focused on prescriptions Cham wrote at various locations, including his medical offices in La Puente and Artesia.

As part of the investigation investigators in May 2014 executed federal search warrants at 13 locations, including Cham’s residence and medical offices. According to the affidavit in support of the search warrants, the doctor often saw patients between 8 p.m. and 2 a.m. on Fridays, Saturdays and Sundays, and he post-dated prescriptions to make them appear to have been written on weekdays. Over the course of a year that ended in March 2014, Cham issued more than 5,500 prescriptions for controlled substances – primarily for oxycodone, hydrocodone, alprazolam and carisoprodol – and he issued more than 42,000 such prescriptions since July 2010, according to the affidavit.

The affidavit also discussed how an undercover officer made three visits to Cham’s La Puente office in 2014, and how Cham wrote prescriptions for controlled substances in exchange for $200 or $300 in cash or money orders. As discussed in the affidavit, Cham issued a prescription for oxycodone even though the undercover operative said he “had been high and drunk while receiving controlled substance prescriptions” previously from Cham. On another occasion, Cham prescribed oxycodone even though the undercover law enforcement officer presented, in lieu of photo identification, a written notice that his license had been suspended for driving under the influence.

The drug trafficking and money laundering charges that Cham has agreed to plead guilty to each count carry a statutory maximum penalty of 20 years in federal prison. In his plea agreement, Cham also agrees to forfeit to the government more than $60,000 in cash that he admits are “proceeds of [his] illegal activity.”

The investigation into Cham was conducted by the Drug Enforcement Administration, IRS Criminal Investigation, the Los Angeles County Sheriff’s Department’s Health Authority Law Enforcement Task Force, the Federal Bureau of Investigation, the California Medical Board, and the Los Angeles Police Department.

The California Medical Board shows three disciplinary actions taken against Cham starting in 2010. His license status is shown as “Delinquent – License renewal fee has not been paid. No practice is permitted.”

DWC Finally Updates 15 Year Old “Physicians Guide” for PTPs and QMEs

The Division of Workers’ Compensation finally announce the release of the 137 Page fourth edition of the Physician’s Guide to Medical Practice in the California Workers’ Compensation System. This comprehensive guide helps physicians and other health care providers dispense care to injured workers while complying with the statutes and regulations that are applicable to medical providers.

This edition of the Physician’s Guide to Medical Practice in the California Workers’ Compensation System has been developed by the Division of Workers’ Compensation to continue the mission set forth in the first three editions of the Physician’s Guide, namely, to assist physicians in understanding the many complexities in the California workers’ compensation system in order to provide optimal care to ill and injured workers.

“The physician’s guide was last revised in 2001, and much has happened in the last 15 years,” said DWC Acting Administrative Director George Parisotto. “The guide provides up-to-date information that will help practitioners apply the reforms set forth in SB 863.”

“Physician understanding of the workers’ compensation system is critical to helping deliver appropriate care to injured workers,” said DWC Acting Executive Medical Director Dr. Raymond Meister.

The manual contains 16 chapters, revising material from the third edition and providing new chapters on the following subjects:

1) Parties to the System
2) Benefits and Payments to Employees
3) Reports and Timelines in the System
4) Evidence-Based Medicine and the MTUS
5) Utilization Review and IMR
6) Physician Payment and the OMFS

The Physician’s Guide is intended as an educational and reference tool to supplement the reader’s professional experience. While intended primarily for treating providers, others in the workers’ compensation community may also find the information helpful, particularly Qualified Medical Evaluators (QMEs) and those preparing for the QME certification exam which is set for April 16th.

Claims administrators who encounter physicians who are having difficulty navigating and complying with the workers’ compensation system may find it expeditious to send a PDF copy of this Guide to the physician, pointing out the chapter that is most applicable for the physician to read in order to learn about how the system works. Physicians would be well served to look over this Guide in its entirety and have it handy as a reference source when questions arise.

DWC Posts Adjustments to the DMEPOS Section of the OMFS

The Division of Workers’ Compensation has posted an order adjusting the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) section of the Official Medical Fee Schedule to conform to the second quarter 2016 changes in the Medicare payment system as required by Labor Code section 5307.1.

The update includes all changes identified in Center for Medicare and Medicaid Services Change Request (CR) number 9554. The April 2016 DMEPOS Rural ZIP code file containing Quarter 2, 2016 rural ZIP Code changes, will replace the January 2016 DMEPOS Rural ZIP code file, for services rendered on or after April 1, 2016. There are no other changes to the DMEPOS fee schedule for the second quarter of 2016.

The order adopting the adjustment can be found on the DWC website. The fee schedule classifies most DMEPOS into one of the six categories:

1) Inexpensive or other routinely purchased DME (IRP)
2) Items requiring frequent and substantial servicing
3) Customized items
4) Other prosthetic and orthotic devices
5) Capped rental items
6) Oxygen and oxygen equipment

The DMEPOS Competitive Bidding Program (CBP) implemented by CMS was mandated by Congress through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The statute requires that Medicare replace the older fee schedule payment methodology for DMEPOS items with a competitive bid process. The intent was to improve the effectiveness of the Medicare methodology for setting DMEPOS payment amounts.CMS is required by law to recompete contracts under the DMEPOS Competitive Bidding Program at least once every three years. The Round 2 and national mail-order program contract periods expire on June 30, 2016. Round 2 Recompete and the national mail-order recompete contracts are scheduled to become effective on July 1, 2016, and will expire on December 31, 2018.

But some are very critical of this CMS Compteitive Bid Program. A recent article in Forbes characterizes the CMS competitive bidding process as a “fiasco.” It reasons “The CMS award model allows it to re-set pricing based on a formula that is tied to the standard deviations observed across the most competitive bids. In other words, the bidders are not bound by their own bids.  The CMS award calculus is based on a “musical chairs” philosophy. Low bidders don’t win based on price or by providing evidence that supports their price, they win based on where their price happens to fall “relative to peers” when the auction ends. A supplier could bid $30 for a product or service and “win” at a price set by the CMS at $42.”

This outcome is the result of the language of the CBP which states “Contracts are awarded to the Medicare suppliers who offer the best price and meet applicable quality and financial standards. Contracted suppliers will be paid the bid price amount. The bid price amount is derived from the median of all winning bids for an item.”

“Biosimilar” Drugs May Save $110 Billion in Drug Costs

A biosimilar drug (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original “innovator” products, and can be manufactured when the original product’s patent expires. Reference to the innovator product is an integral component of the approval.

And lower-cost copies of these complex biotech drugs could save the United States and Europe’s five top markets as much as 98 billion euros ($110 bln) by 2020, a new analysis showed on Tuesday as reported in an article by Reuters Health. Realizing those savings, however, depends on effective doctor education and healthcare providers adopting smart market access strategies, the report by IMS Institute for Healthcare Informatics said.

The potential for copycats to take business from original biotech brands is increasingly grabbing the attention of investors, with many worried about the impact on profits at companies like Roche and AbbVie. It also presents an opportunity for an emerging group of biosimilar specialists, such as South Korea’s Celltrion and large generic drugmakers with biotech know-how, like Novartis’ unit Sandoz.

A saving of 98 billion euros is based on eight major branded biotech drugs, including AbbVie’s Humira and Roche’s Herceptin, that are set to lose patent protection over the next five years. It also assumes an average biosimilar price discount of 40 percent, and savings would fall to 74 billion euros at a 30 percent discount and 49 billion at 20 percent. The IMS forecast covers Germany, France, Italy, Britain, Spain and the United States.

The European regulatory authorities led with a specially adapted approval procedure to authorize subsequent versions of previously approved biologics, termed “similar biological medicinal products”, or biosimilars. This procedure is based on a thorough demonstration of “comparability” of the “similar” product to an existing approved product. In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway. The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010; on March 6, 2015, Zarxio obtained the first approval of FDA.

Interest in biosimilars has grown significantly in the past two years thanks to the arrival of copies of sophisticated antibody drugs that are among the world’s biggest-selling prescription medicines. Europe has lengthy experience with biosimilars, having approved the first such products 10 years ago, but uptake still varies widely from country to country, depending on local market conditions.