Author: WorkCompAcademy

The case of Fernando Martinez v Santa Clarita Community College District involves a denied claim of continuous trauma injury to his back, circulatory system, psyche, nervous system, hypertension,diabetes, and upper and lower gastrointestinal system.

The applicant objected to the report from the treating orthopedist Dr. Robert Reisch dated October 3, 2012, based upon “The disability status of the applicant’s medical condition.” The applicant simultaneously filed three separate requests for QME panels in the specialties of orthopedic, psychiatric and internal medicine. All of the requests are dated January 9, 2014. In each of the Form I 06s, the applicant checked off the box indicating that the reason that the QME panel is being requested is “§4062 (nonmedical treatment dispute under 4062).”

An Orthopedic panel issued February 7, 2014. Panels were issued in the specialties of psychiatry and internal medicine on February 10, 2014. The Defendant objected to the internal and psychiatric panels. The parties proceed to trial regarding the limited issue of whether the applicant is entitled to undergo QME panels in orthopedics, psychiatry and internal medicine. The WCJ ordered the defendant to authorize the orthopedic PQME evaluation and found that the applicant was not entitled to undergo PQME evaluations in the specialties of psychiatry and internal medicine, at the time of trial and that issues regarding applicant’s entitlement to psychiatric and internal PQME(s) after completion of the orthopedic PQME evaluation were deferred, with jurisdiction reserved.

The applicant petitioned for removal which was denied in what Lexis is characterizing as a “noteworthy panel decision.” The denial incorporated the reasoning of the WCJ as follows.

The applicant must first complete an initial PQME examination prior to obtaining PQME evaluations in other specialties. The applicant has not met the criteria in rule §31.7 for obtaining different specialties at the time of trial. The applicant also failed to submit the appropriate form to request QME panels regarding other specialties. As per Title 8 California Code of Regulations §31 7 a party “shall” utilize Form 31.7 to request an additional QME panel in a different specialty. It is noted that Fonn 31.7 requires that the prior PQME panel number be identified when requesting other specialties, which could not have been done in this case, as all three QME panels were improperly requested at the same time.

The applicant also failed to comply with the requirements of Labor Code §4062 regarding psychiatric and internal PQMEs. The applicant stated in the three QME requests that the reason for the QME panel is “§4062 (nonmedical treatment dispute under 4062).” However, the letter attached to each PQME request objects solely to the opinions rendered by orthopedist Dr. Reisch in his report dated October 3, 2012. In said report Dr. Reisch stated that the applicant was given refills of Voltaren gel, and was given a Toradol injection. Further, Dr. Reisch stated that the applicant was to continue working modified duties as previously. There is no reference in said report with regard to any alleged internal or psychiatric injuries or complaints. Moreover, the applicant did not object to the findings of a psychiatrist or internal doctor prior to requesting PQME panels in the specialties of psychiatry and internal medicine. Accordingly, the applicant failed to comply with the requirements of Labor Code 4062 with regard to obtaining a PQME panel in specialties other than orthopedics, at the time of trial.

Every year, the FDA inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However according to an investigation published in the JAMA Internal Medicine, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.

Charles Seife, a New York University journalism professor conducted literature research “to identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature.” He reviewed 78 published papers on clinical trials with which the Food and Drug Administration (FDA) labeled “official action indicated” (OAI), meaning the agency found objectionable conditions or practices significant enough to warrant regulatory action, yet he found that only three of the papers mentioned the OAI status of the trials. The violations included researchers falsifying data and occurrences where clinical trial participants should have been ruled ineligible. His finding was published in the JAMA Internal Medicine “Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.”

“This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.” Seife concluded “When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.”

In one of the illustrative cases he reviewed, a case involving a trial of a chemotherapy regimen, the researcher eventually pleaded guilty to fraud and was sentenced to prison after poor results were hidden and a patient died from the treatment (United States of America v. Paul H. Kornak, 03-cr-00436 (Northern District of New York). “Although this episode is described in detail in FDA documents as well as court documents, none of the publications in the peer-reviewed literature associated with the chemotherapy study in which the patient died have any mention of the falsification, fraud, or homicide. The publications associated with two of the three other studies for which the researcher falsified documents also do not report on the violations,” according to the study.

“The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect. However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants.”

The article concludes by saying “To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents.”

“The FDA should be more transparent about its findings of research misconduct; however, most of the burden for ensuring the integrity of the research in the peer-reviewed literature falls to the authors of the articles submitted to peer-reviewed journals. Currently, there is no formal requirement for authors seeking to publish clinical trial data to disclose any adverse findings noted during FDA inspections. Journals should require that any such findings be disclosed. Voluntary disclosures are never foolproof, but, as with conflict-of-interest statements, requiring authors and journals to be forthcoming about significant departures from good clinical practice will help raise the standard for the reporting of research toward greater transparency.”

The unpublished Court of Appeal decision in Electronic Waveform Lab v. EK Health Services addresses whether UR is an “official proceeding” within the meaning of Code of Civil Procedure section 425.16, subdivision (e)(2) (the anti-SLAPP statute [SLAPP is the abbreviation for strategic lawsuit against public participation]) and whether the trial court correctly resolved the motion to dismiss under that statute filed by defendant State Compensation Insurance Fund.

Waveform manufactures and sells an electrotherapy device, commonly known as an H-Wave device, which physicians may prescribe to assist in treating various muscular injuries. State Fund contracts with EK Health and “independent contractor individual physician reviewers” to provide UR services to workers covered by their employers’ workers’ compensation policies issued by State Fund. Waveform filed suit against EK Health, alleging that EK Health was “situated as a monopolistic ‘gate keeper’ to a significant and substantial market share of patients who are injured on the job.” Waveform further alleged that EK Health and the Reviewers conspired to defame Waveform and consistently denied the H-Wave device for treatment of individual patients, with the result that treating physicians asked Waveform to remove H-Wave equipment from doctors’ offices and physical therapy clinics. Waveform alleged that the conduct of all of the defendants violated the Cartwright Act (Bus. & Prof. Code, §§ 16720 et seq.) and that the acts of EK Health and of a subset of the Reviewers constituted intentional interference with prospective economic advantage and trade libel.

EK Health and the Reviewers filed a special motion to strike the complaint under section 425.16 (anti-SLAPP motion) which was denied. The denial of the EK Health motion was not appealed.

Waveform then filed a first amended complaint adding State Fund as a defendant. Waveform alleged that State Fund had implemented through EK Health a “blanket policy” to deny and reject physicians’ prescriptions for utilization of the H-Wave device in treatment of patients’ injures and that “[w]hile creating the appearance of reviewer independence, EK Health and the reviewers in fact complied with State Fund’s policy that all H-Wave requests be denied.” Waveform alleged, the policy “violates the independent medical decision-making that reviewers are required to engage in. . . .”

State Fund filed its own anti-SLAPP motion seeking to dismiss both causes of action alleged against it. The trial court ruled that State Fund had established that its actions arose from “official proceedings” as its actions constituted “statements made in connection with an issue under consideration in a legally-authorized official proceeding.” The trial court also concluded that plaintiff had not shown a probability of prevailing against State Fund at trial and for these reasons granted the State Funds anti-SLAPP motion and it was dismissed. The Court of Appeal reversed.

The parties contest whether UR is an “official proceeding authorized by law” as that term is used in section 425.16, subdivision (e)(2). State Fund argues that “official proceedings” include administrative agency actions involving review and investigation of grievances, and that the workers’ compensation UR system, which involves resolution of claims for medical treatment, should be similarly viewed. Waveform argues that the UR process is not quasi-judicial or part of a comprehensive statutory licensing scheme which is subject to judicial review by administrative mandate. The Court of Appeal ruled that it was not an official proceeding and distinguished UR from case law on arbitration proceedings by saying “UR review is medical rather than legal and informal rather than formal.” “For this reason alone, the trial court erred in concluding that UR is an “official proceeding” within the meaning of that term in section 425.16, subdivision (e)(2).”

The judgment dismissing State Fund from Waveform’s first amended complaint was reversed.

Under SB 899, apportionment can now be based upon causation. Apportionment can be used to divide a specific injury case into two cases, the original specific injury, and then a continuous trauma case if continuous trauma played a causation role in the current medical problem. This strategy can take a life pension specific injury claim and reduce it to two smaller cases neither of which triggers a life pension. For this reason, it becomes significant to follow medical literature as elements of causation are developed in the medical literature. Here is a current example.

New research reveals the physical and psychosocial factors that significantly increase the risk of low back pain onset. In fact, according to the article in Science Daily, results published in Arthritis Care and Research, a journal of the American College of Rheumatology (ACR), show that being engaged in manual tasks involving awkward positions will increase the risk of low back pain by eight times. Those who are distracted during activities or fatigued also significantly increase their risk of acute low back pain.

At some point, nearly 10% of the world’s population experience back pain, which is the leading cause of disability according to the World Health Organization (WHO) Global Burden of Disease report (2010). WHO reports that low back pain has a greater impact on global health than malaria, diabetes, or lung cancer; yet little progress has been made to identify effective prevention strategies.

“Understanding which risk factors contribute to back pain and controlling exposure to these risks is an important first step in prevention,” explains Associate Professor Manuela Ferreira, Ph.D., with The George Institute for Global Health and Sydney Medical School at The University of Sydney in New South Wales, Australia. “Our study is the first to examine brief exposure to a range of modifiable triggers for an acute episode of low back pain.”

For this case-crossover study, researchers recruited 999 participants from 300 primary care clinics in Sydney, Australia, who had an acute low back pain episode between October 2011 and November 2012. Study subjects were asked to report exposure to 12 physical or psychosocial factors in the 96 hours prior to the onset of back pain.

The risk of a new episode of low back pain significantly increased due to a range of triggers, from an odds ratio of 2.7 for moderate to vigorous physical activity to 25.0 for distraction during an activity. Researchers found that age moderated the effect of exposure to heavy loads, with odds ratio for individuals 20, 40, or 60 years of age at 13.6, 6.0, and 2.7, respectively. A new finding not reported previously was that back pain risk was highest between 7:00 a.m. and noon.

“Understanding which modifiable risk factors lead to low back pain is an important step toward controlling a condition that affects so many worldwide,” concludes A/Prof Ferreira. “Our findings enhance knowledge of low back pain triggers and will assist the development of new prevention programs that can reduce suffering from this potentially disabling condition.”

The citation to this study is: Daniel Steffens, Manuela L Ferreira, Jane Latimer, Paulo H Ferreira, Bart W Koes, Fiona Blyth, Qiang Li, Christopher G Maher. What triggers an episode of acute low back pain? A case-crossover study. Arthritis Care Research, 2014; DOI: 10.1002/acr.22533

Security experts are warning healthcare and insurance companies that 2015 will be the “Year of the Healthcare Hack,” as cybercriminals are increasingly attracted to troves of personal information held by U.S. insurers and hospitals that command high prices on the underground market according to the story in Reuters Health.

Anthem Inc, the No. 2 U.S. health insurer, last week disclosed a massive breach of its database containing nearly 80 million records, prompting investigations by state and federal authorities. That hack followed a breach last year at hospital operator Community Health Systems, which compromised some 4.5 million records.

“People feel that this will be the year of medical industry breaches,” said Dave Kennedy, chief executive of TrustedSEC LLC. In the past decade, cybercriminals focused their efforts on attacking banks and retailers to steal financial data including online banking credentials and payment card numbers. But as those companies boost security, using stolen credit card numbers has become more difficult. Their prices on criminal exchanges have also dropped, prompting hackers to turn to the less-secure medical sector, just as the amount of digital healthcare data is growing dramatically, Kennedy said.

Stolen healthcare data can be used to fraudulently obtain medical services and prescriptions as well as to commit identity theft and other financial crimes, according to security experts. Criminals can also use stolen data to build more convincing profiles of users, boosting the success of scams. “All of these factors are making healthcare information more attractive to criminals,” said Rob Sadowski, marketing director at RSA, the security division of EMC Corp.

RSA Executive Chairman Art Coviello recently wrote in a letter to customers that he expected well-organized cybercriminals to turn their attention to stealing personal information from healthcare providers. “A name, address, social and a medical identity … That’s incredibly easy to monetize fairly quickly,” said Bob Gregg, CEO of ID Experts, which sells identity protection software and services. Identities can sell for $20 apiece, or more, he said. Insurers, medical equipment makers and other companies say they have been preparing for breaches after seeing the waves of attacks on other industries.

Cigna Corp has looked to financial and defense companies for best practices, including hiring hackers to break into its systems, said Chief Executive David Cordani. Attempts to break into corporate systems to probe for information are a constant, he said in an interview.

St Jude Medical Inc CEO Daniel Starks said the company increased investment in cybersecurity significantly over the last few years, to protect both patient data and the medical devices it manufactures. “You may see from time to time law enforcement briefings on nation-based (intellectual property) issues, espionage,” he said. “Those are things that we take very seriously and have been briefed on and that we work to guard against.”

The insurers UnitedHealth Group Inc and Aetna Inc have warned investors about the risks of cyber crime in their annual reports since 2011. UnitedHealth has said the costs to eliminate or address the threats could be significant and that remediation may not be successful, resulting in lost customers. In response to the Anthem attack, UnitedHealth spokesman Tyler Mason said in an emailed statement: “We are in close contact with our peers in … the industry cybersecurity organization, and are monitoring our systems and the situation closely.”

Aetna has cited the automated attempts to gain access to public-facing networks, denial of service attacks that seek to disrupt websites, attempted virus infections, phishing and efforts to infect websites with malicious content. Aetna spokeswoman Cynthia Michener said in a statement: “We closely follow the technical details of every breach that’s reported to look for opportunities to continually improve our own IT security program and the health sector’s information protection practices broadly.”