Category: Daily News

The U. S. Drug Enforcement Administration (DEA) published in the Federal Register the new Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data. The Federal Register has made the Final Rule available for preview on its website today at http://go.usa.gov/mc8d. This Final Rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle or propose to handle HCPs. It goes into effect in 45 days.

The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.) HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin.

“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart, “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II. The current analysis of HCPs by HHS and the DEA shows they have a high potential for abuse, and abuse may lead to severe psychological or physical dependence. Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential. The many findings by the DEA and HHS and the data that support these findings are presented in detail in the Final Rule on the website. Data and surveys from multiple federal and non-federal agencies show the extent of abuse of HCPs. For example, Monitoring the Future surveys of 8th, 10th, and 12th graders from 2002 to 2011 found that twice as many high school seniors used Vicodin®, an HCP, nonmedically as used OxyContin®, a Schedule II substance, which is more tightly controlled.

In general, substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations. Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party. (Detailed information on the scheduling and rescheduling process can be found beginning on page 8 of Drugs of Abuse on the DEA’s website at http://www.justice.gov/dea/pr/multimedia-library/publications/drug_of_abuse.pdf.)

The rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation. In 2013, the U. S. Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II by a vote of 19 to 10. Consistent with the outcome of that vote, in December of 2013 HHS sent such a recommendation to the DEA. Two months later, on February 27, the DEA informed Americans of its intent to move HCPs from Schedule III to Schedule II by publishing a Notice of Proposed Rulemaking in the Federal Register, outlining its rationale and the proposed changes in detail and soliciting public comments on the proposal, of which almost 600 were received. A small majority of the commenters supported the proposed change.

Jeff Sinclair worked for Praxair Inc. collecting and testing soil, water, and air samples from potentially contaminated sites. During his employment, he underwent annual physical examinations. Several of his annual physical examinations after 1993 showed he had high blood urea nitrogen and creatinine levels and the examiner noted he should follow up with his own physician. Although Sinclair received copies of all of his annual examination results, he never reviewed them and, therefore, never complied with the recommendation to follow up with his personal physician. Nonetheless, his personal physician diagnosed him with renal disease in 1994 and he admittedly knew of the diagnosis at least since 1996. At the time, his physician attributed his renal disease to gout.

In 2009, after another annual examination, he was diagnosed with stage IV renal failure and became disabled from work. A worker’s compensation qualified medical examiner determined 85 percent of the cause of his renal disease was from work-related chemical exposures.

The Sinclairs subsequently sued Praxair for intentional conduct violating public policy, intentional infliction of emotional distress, and loss of consortium. Their complaint principally alleged Praxair intentionally concealed that workplace chemical exposures both caused and aggravated Sinclair’s renal disease. Praxair moved for summary judgment, arguing the Sinclairs could not establish their claims fell within the fraudulent concealment exception to the workers’ compensation exclusivity doctrine because, among other reasons, Sinclair knew he had renal disease. The superior court agreed and granted summary judgment to Praxair.

The Court of Appeal affirmed in the unpublished case of Sinclair v Praxair Inc.

An employee injured during the course of employment is generally limited to remedies available under the Workers’ Compensation Act. Labor Code section 3602(b)(2) provides a narrow exception to this exclusivity rule and allows a civil suit ‘[w]here the employee’s injury is aggravated by the employer’s fraudulent concealment of the existence of the injury and its connection with the employment, in which case the employer’s liability shall be limited to those damages proximately caused by the aggravation . . . .’ This provision was enacted in 1982 and codifies the common law fraudulent concealment exception that was enunciated by the Supreme Court in Johns-Manville Products Corp. v. Superior Court (1980) 27 Cal.3d 465.

Three conditions are necessary for the fraudulent concealment exception to apply: (1) the employer must have concealed the existence of the injury; (2) the employer must have concealed the connection between the injury and the employment; and (3) the injury must have been aggravated following the concealment. If any one of these conditions is lacking, the exception does not apply and the employer is entitled to judgment in its favor.

Here, the undisputed evidence shows Sinclair was diagnosed with renal disease in 1994 and he knew of the diagnosis as early as 1996. Consequently, the Sinclairs cannot establish the first element of the fraudulent concealment exception, that Praxair concealed the existence of his injury from him.

The Commission on Health and Safety and Workers’ Compensation (CHSWC) has released on its website the 214 page study, “Examination of the California Public Sector Self-Insured Workers’ Compensation Program” for public comment. This study was part of Senate Bill (SB) 863 Reforms, required by Labor Code Section 3702.4, to examine the public sector self-insured workers’ compensation program and to make recommendations to improve the administration and performance of the program. CHSWC contracted with Bickmore to assist with this requirement.

Recent municipal bankruptcies have drawn attention to public entity employers and the adequacy of the resources they possess to meet their workers’ compensation obligations. It is unclear what the impact to employees and taxpayers would be in the event that large or multiple public entities become unable to provide for their workers’ compensation liabilities.The purpose of this study is to identify variances in the performance of public employers’ self insured workers’ compensation and to recommend areas for improvement. In addition, the study is to provide information that facilitates benchmarking public self-insured workers’ compensation programs.

The study found that a self-insurer’s region has a significant impact on the claims costs. Self-insurers in southern California have experienced higher claim frequency, higher average claim size, and higher overall cost per $100 of payroll. Over the past several years this disparity between southern California and the rest of the State has increased. In addition, claims of southern California self-insurers tend to stay open longer in comparison to those in the rest of the State. The analysis of insurance company data by the California Workers’ Compensation Insurance Rating Bureau (WCIRB) has also pointed to disparities between claim frequencies and costs between different regions of the State. The current analysis confirms that these disparities also exist for public self-insurers. Since one of the goals of the workers’ compensation system to have equal treatment of and benefits for injured workers, the authors believe it is worth exploring the root causes of this disparity.

The type of agency has a major impact on the loss rates, claims sizes, and claims frequencies. Municipalities tend to have the highest costs, whereas educational entities (schools, colleges, and universities) have the lowest. Over the past several years the cost of municipal claims has risen at a faster pace than that of counties or educational entities. This is primarily due to increases in the average claim size. Also, claims of education self-insurers tend to close faster in comparison to those of counties and cities.

In general, JPAs have experienced lower costs per $100 of payroll than individual self-insurers. However, JPA costs have been increasing at a faster rate than those of individual self-insurers over the past several years.

The study found almost no difference in loss rates between self-insurers that utilize a TPA versus those that self-administer. Those that self-administer tend to have a higher claim frequency, but this is offset by a lower average claim size. In addition, loss rates have been increasing at a slower pace for those that self-administer than for those that utilize a TPA.

Jacob Richard Bonzer, 27, formerly of Lake Forest, California was arrested this month in Chicago by the Chicago Police Department and a U.S. Marshals Task Force on 96 felony counts including grand theft, forgery and denial of benefits. If convicted, Bonzer faces a maximum sentence of more than 87 years in state prison. “Bonzer allegedly created more than a thousand insurance policies based on fraudulent information, which allowed him to collect $285,000 in unearned commission payments,” said Insurance Commissioner Dave Jones.

A joint investigation between the California Department of Insurance, the Orange County District Attorney’s Office and the Brea Police Department revealed Bonzer perpetrated several schemes for his personal financial gain.

Investigators discovered that in 2012 Bonzer created a fictitious insurance company called GW Mutual Risk Retention Group, LLC, which was registered in Florida. GW Mutual is not licensed to write insurance in California though Bonzer sold workers’ compensation and commercial insurance policies through his agency, Bonzer Insurance Brokerage, located in Orange County. Bonzer collected approximately $280,000 in premium from 58 California businesses that believed they were purchasing valid coverage. When questioned by a client about GW’s ability to offer insurance in California, Bonzer provided an altered CDI report of examination as proof. Department investigators also discovered premium payments entrusted to Bonzer were used on personal living expenses including the rental of luxury high-rise apartments, travel, wine clubs and fine dining.

“The fact Bonzer’s criminal activity left legitimate businesses without valid workers’ compensation insurance put business owners, their employees and the state at great financial risk. His multiple schemes to rip off insurers and businesses are egregious,” said Commissioner Jones.

Bonzer also submitted 128 fraudulent homeowners insurance applications containing bogus information using nonexistent policyholders for real properties, causing valid policies to be issued for phantom homeowners in escrow between April and July 2010. Bonzer received $46,000 in advanced commissions from the insurance company that expected to collect premiums when the properties closed escrow. Since the applicants were bogus, the insurer never received premium payments and Bonzer was eventually fired. Investigators allege Bonzer continued his scam through another agent after he was fired. It was determined Bonzer created a fictitious mortgage company that referred all residential short-sale business to Bonzer for homeowners insurance. Bonzer used the same scheme leading the insurer to believe they would receive premium payments at the close of escrow. Numerous policies were resubmitted multiple times with an explanation that escrow closing had been delayed. In some cases Bonzer received duplicate commission payments for the same property. Between August 2010 and November 2011, approximately 790 fraudulent homeowners insurance applications, containing bogus information, were submitted by Bonzer under another agent. As a result Bonzer received commission payments of $239,000.

Bonzer orchestrated these elaborate scams by using multiple post office boxes, virtual assistants, business entities, office spaces, email accounts, Website domains and bank accounts. The department has reason to believe that there are additional victims. Anyone who did business with Jacob Bonzer or believe they may be a victim, are encouraged to contact Department of Insurance supervising investigator Vera Grunke at (714) 712-7600.

The Division of Workers’ Compensation has posted a first 15-day notice of modification to the proposed Medical Treatment Utilization Schedule (MTUS) regulations to the DWC website. Members of the public are invited to present written comments regarding the proposed modifications to dwcrules@dir.ca.gov until 5 p.m. on August 30.

The MTUS is established as the standard for the provision of medical care in the workers’ compensation system in accordance with Labor Code section 4600. The proposed amendments to the MTUS clarify the scientific process by which evidence-based clinical decisions are to be made when the MTUS is silent on a particular issue and describe how the MTUS may be rebutted pursuant to Labor Code section 4604.5.

The proposed regulations detail the methods to evaluate medical evidence according to an explicit, systematic, strength-of-evidence methodology to determine recommendations that are supported with the best available evidence. The intent of these regulations is to enable workers to achieve appropriate care that is supported by the best available medical evidence. The proposed modifications include:

1) Revision of the definition of “ACOEM” by deleting the reference to the second edition 2004 version and adding a brief description of what the guidelines contain.
2) Revision of the definition of “chronic pain” by adding a three month timeline from the initial onset of pain for clarity.
3) Deletion of the definition of “MEDLINE” because this term is no longer used in the regulations.
4) Modification of the definition of “Appraisal of Guidelines for Research and Evaluation II (AGREE II) Instrument” by adding the May 2009 AGREE II version was adopted and incorporated by reference into the MTUS by the Administrative Director and a copy may be obtained from DWC’s website or by written request to DWC’s Medical Unit.
5) Re-organization and re-wording to express that medical care shall be in accordance with the best available medical evidence when the MTUS’s presumption of evidence is challenged pursuant to Labor Code section 4604.5 or when there is a topical gap and a medical treatment or diagnostic test is not addressed by the recommended guidelines set forth in the MTUS.
6) Clarification that treating physicians may apply the medical literature search sequence, and specifies when Utilization Review physicians and Independent Medical Review physicians shall apply the medical literature search sequence to find the best available medical evidence.
7) Specifies when and by whom the MTUS Hierarchy of Evidence for Different Clinical Questions shall be applied and how the levels of evidence shall be documented in a Utilization Review decision and in an Independent Medical Review decision.

There was a public hearing on this regulations in July. The transcript reflects the testimony of seven individuals who had comments about the MTUS regulatory proposals. Ken Eichler, an official with the Official Disability Guidelines (ODG) was in “full support” of these guidelines. He was however concerned about who was required to rank the evidence. Steve Cattolica, a spokesman for medical providers had similar concerns.

The notice and text of the regulations can be found on the proposed regulations page.