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Contractor Faces 34 Charges

A landscaper operating in Contra Costa County is facing 34 felony and misdemeanor charges for allegedly taking exorbitant down payments from prospective clients and never completing the work. Adan “Adam” Rivas, 34, of Concord, is alleged to have defrauded 11 families in Danville, San Ramon, Alamo, Lafayette, Orinda and Walnut Creek, prosecutors said. He has a $139,000 warrant for his arrest. For each alleged victim, Rivas faces felony charges of diverting construction funds and misdemeanor charges of entering into unlawful home improvement contracts and failing to secure worker’s compensation insurance.

In May last year, one family was so perturbed by his actions, they created the website adamrivastreescam.com in the hopes of reaching other potential victims. Commenters complained of back yards torn up and left “a huge mess,” elderly neighbors who had driveways ripped up and never re-paved, and dozens of calls or text messages that went unanswered. Reviews on Yelp show a similar modus operandi. Deputy District Attorney William Murphy said the district attorney’s office believes there are additional unreported victims.

It’s a pattern that appears to repeat itself as more victims come forward, District Attorney Mark Peterson said. “These families are looking to hire someone to help them,” Peterson said in a statement. “Instead, they are getting nothing but messed up yards and depleted bank accounts.”

Deputy District Attorney William Murphy said the bids would often range from $8,000 to $12,000 and Rivas would ask for down payments of $3,000 to $5,000. Contractors are only legally able to take 10 percent of the estimated cost as a down payment, Murphy said. “Sometimes he would do additional negotiations for more work and take more down payment monies,” Murphy said.

The website lists several aliases for the landscaping service such as “New View Tree Care,” “New View Tree Service,” “One Way Tree Service,” “View Maintenance and Landscaping,” “View Landscaping and Tree Service,” and “High Tech Tree Care.”

Court of Appeal Affirms Fraud Conviction

Victor Santiesteban was employed by American City Pest and Termite as a service technician until American learned he was simultaneously working for his son at another pest-control company in violation of his agreement with American. While employed by American, Santiesteban worked a night route from 4:00 p.m. to about 10:00 p.m. in a company-assigned vehicle. Santiesteban’s last day of work for American was October 26, 2009. Santiesteban filed a claim for Unemployment Insurance, which was denied on December 8, 2009. His appeal of the denial of the insurance claim was denied on or about April 7, 2010.

On January 25, 2010, Santiesteban filed a workers’ compensation claim for an injury he allegedly suffered on October 1, 2009. In the workers’ compensation claim form, Santiesteban stated he had been rear-ended while in an American truck and had suffered injuries to his “trunk.” Santiesteban’s workers’ compensation claim ultimately went to the Workers’ Compensation Appeal Board where it was denied. Although no award was made to Santiesteban, investigation fees, copy service fees, and defense attorney fees were paid out.

Santiesteban was deposed in connection with his workers’ compensation claim. At the deposition, Santiesteban testified he had suffered injuries in an accident in October 2009 while driving his assigned American truck northbound on the 110 Freeway toward the 101 Freeway after fumigating a restaurant on Figueroa Street. Santiesteban did not remember the precise date of the accident. He remembered the accident occurred at night, but did not remember the exact time. When his truck was struck, he pulled to the side of the road. Five other vehicles were involved in the collision. Based on what other drivers told him, he believed the driver of a black Chevrolet Blazer caused the accident. He obtained insurance information from that driver, but he “hardly remembered anything” about the vehicle that struck him because he was too nervous.

Santiesteban attempted to contact his supervisor to report the accident but was unable to reach him. It was not until the following day that he was first advised there was an accident form in the glove compartment of his vehicle that needed to be completed. Santiesteban indicated he realized the night of the accident he had been injured. He felt pain that night and the pain worsened the following day. When he reported the accident to his employer the following day, he indicated he was experiencing pain from the accident. Santiesteban described going to Harbor UCLA Hospital a few days after the accident and receiving treatment for his injuries.

A jury convicted Santiesteban of the offense of making a fraudulent statement in his workers’ compensation claim in violation of Insurance Code section 1871.4, subdivision (a)(1) (count 1), and of the offense of attempted perjury under oath in violation of Penal Code sections 118, subdivision (a), 664, subdivision (a) (count 2). Santiesteban appealed the conviction, and the Court of Appeal affirmed the conviction in the case of People v Santiesteban.

In addition to other evidence presented in the criminal case, it was shown that Santiesteban’s vehicle was equipped with a “Teletrac” global positioning device at all times. Katie Witman, Teletrac’s Director of Customer Implementation, testified Telectrac tracks vehicles through cell towers. A report of Santiesteban’s vehicle’s movements and locations was generated for the period from September 30, 2009, through October 2, 2009. At 3:00 a.m. on October 2, 2009, Santiesteban’s vehicle was on the 101 Freeway traveling at 44 miles per hour. At 3:05 a.m., Santiesteban’s vehicle was traveling to 5851 Sunset Boulevard. The vehicle spent about 10 minutes on the 101 Freeway and was never at the 110/101 Freeway interchange. A vehicle stopped for 20 to 25 minutes would have been noted on the Teletrac report.

Edward Messinger, an insurance fraud investigator for the Orange County District Attorney’s office, was assigned to Santiesteban’s case. Messinger verified Santiesteban’s identity and matched it to the records involving his claim. Messinger also matched Santiesteban’s medical records from UCLA to his medical history. The records contained no mention of the October 1, 2009, accident or back pain. The records reflected no doctor visit during September and October 2009.

A review of the record including the possible issues raised by appellate counsel, has disclosed no reasonably arguable appellate issue. On its own motion, an appellate court with jurisdiction of a case may order correction of clerical errors contained in the abstract of judgment. The case is remanded to the trial court with directions to amend the sentencing minute order to reflect the jail sentence was imposed on both counts.

DWC Sets Claim Audit Compliance Standards for 2015

Labor Code §§ 129 and 129.5, require the Audit Unit of the Division of Workers’ Compensation to conduct a routine profile audit review (PAR audit) for all adjusting locations of California workers’ compensation claims at least once every five years. The performance of an audit subject is rated for provision of specific workers’ compensation benefits and measured against standards set by the results of prior audits within the industry. The Administrative Director annually establishes the profile audit review and full compliance audit standards. The 2015 standards are based on the audit results of calendar years 2011 through 2013.

The Profile Audit Review (PAR) Performance Standard for audits conducted in 2015 is 1.53446. Audit subjects with PAR performance ratings of 1.53446 or lower will be required to pay any unpaid compensation, but no penalties will be assessed. If a PAR audit subject’s PAR Performance rating is 1.53447 or higher, the audit will expand to a Full Compliance Audit, and an additional sample of indemnity claims will be audited.

It is estimated that approximately 80% of audit subjects meet or exceed the PAR Performance Standard and that approximately 20% of audit subjects will be subject to a Full Compliance Audit.

The Full Compliance Audit (FCA) Performance Standard for audits conducted in 2015 is 1.68525. FCA audit subjects with an FCA performance rating of 1.68525 or less will be required to pay any unpaid compensation and penalties will be assessed for all violations involving unpaid and late paid compensation. If an FCA subject’s full compliance audit performance rating is 1.83496 or higher, an additional sample of denied claims as well as the expanded samples of indemnity claims will be audited. Penalties will be assessed for all violations as appropriate pursuant to 8CCR§§10111 though 10111.2.

It is estimated that approximately 50% of FCA audit subjects (10% of the PAR audit subjects) will meet or exceed the FCA Performance Standard and that approximately 50% (the 10% poorest performing of all audit subjects) will fail the Full Compliance Audit.

Court of Appeal Reverses Psyche Award

The Second District Court of Appeal reversed the WCAB finding that the medical evidence on the cause of the psychiatric injury and sleep disorder was not substantial evidence because it is based on an inadequate medical history. Here is what happened in the unpublished case of Radiator USA v. WCAB.

Am Kang sustained an admitted injury to his back on December 24, 2010 while working as a driver for Radiator USA. Kang additionally claimed to have sustained injury to his psyche in the form of a sleep disorder. David B. Pechman, M.D. was the AME in orthopedics. He noted that compression fractures in Kang’s vertebrae appeared old and he thought that most of Kang’s pain related to the compression fractures. Dr. Pechman apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease.

Rodney Bluestone, MD, the qualified medical evaluator of rheumatology, confirmed Kang had metabolic bone disease (osteopenia and osteoporosis) but could not determine a cause. Although Dr. Bluestone requested additional testing to determine the cause of the metabolic bone disease, there was no supplemental report that addressed causation.

Ana L. Nogales, Ph.D., evaluated Kang as a secondary treating physician in psychology. Dr. Nogales obtained a history of the injury, history of the treatment, and physical and emotional complaints exclusively from Kang. Dr. Nogales explicitly noted that she did not receive medical or employment records for review.

On the issue of causation, Dr. Nogales found that, as a “consequence of his industrial accident, Mr. Kang developed anxiety that increased with the passage of time and deteriorated at the end of 2011 when he saw that his condition is not improving.” Dr. Nogales opined that the “percentage of total causation of Mr. Kang’s current mental disorder is estimated at a higher level than the legal threshold of industrial causation of 50 [percent].” She specifically noted a nonindustrial causal factor of a dog bite in 2005 requiring stitches. Dr. Nogales made no mention of Dr. Pechman’s orthopedic diagnosis or his apportionment to the preexisting bone disease.

The matter was heard on September 26, 2013. The sole medical evidence of psychiatric industrial causation came from psychologist Dr. Nogales. Based upon this evidence, the WCJ issued findings of fact concluding Kang sustained industrial injury to his back, to his psyche, and in the form of a sleep disorder. Reconsideration was sought based “upon a lack of medical evidence to support this finding.” Reconsideration was denied. The appeals board found the doctors “based their opinions on extensive discussions with [Kang] regarding how he sustained his injury and his condition thereafter.” The appeals board found that, based on these discussions, Dr. Nogales concluded the industrial cause of Kang’s psychiatric injury was higher than the legal threshold. However the Court of Appeal reversed and remanded in the unpublished case.

In reversing the Court of Appeal noted that Dr. Nogales was completely unaware of the fact that Dr. Pechman had apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease. The Court posed the question does “this mean that 50 percent of the psychiatric injury is attributable to nonindustrial causes?”

The Court acknowledge that “these determinations cannot be made with mathematical precision, it is at least a major issue what portion of the psychiatric injury is attributable to nonindustrial causes. Although 50 percent is a reasonable surmise, on this silent record it is equally plausible to suppose that, given that psychiatric evaluations are unavoidably case-specific, 60 percent of the psychiatric injury – or 40 percent thereof – is attributable to nonindustrial causes. In short, what is needed here is an expert opinion that is based on a complete medical history, which necessarily includes Dr. Pechman’s finding that 50 percent of the orthopedic injury is attributable to nonindustrial causes.”

“Given the lack of competent medical evidence on causation, the decision of the appeals board cannot stand. It is now well established that the appeals board has an affirmative duty to develop an adequate record. As an example, where the medical evidence was evenly balanced on the issue of industrial causation, our Supreme Court held that the appeals board was not free to simply rule that the employee had failed to sustain his burden of proof but was required to take additional evidence in order to resolve the doubts raised by the existing medical reports”.

The decision of the appeals board is annulled and the matter is remanded for further proceedings consistent with this opinion.

UCLA Patients Infected by Deadly CRE Bacteria

CRE or Carbapenem-Resistant Enterobacteriaceae is the new and frightening “superbug.” The bacteria can kill up to half of patients who get bloodstream infections, a rate much higher than other resistant infections such as MRSA or Clostridium difficile. The bacteria are also sometimes referred to as the “nightmare bacteria”

According to a report in USA Today, the deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh and Chicago. CRE is perhaps the most feared of superbugs, because it resists even “last defense” antibiotics. And in each hospital case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.

CRE has now infected patients closer to home. The Los Angeles Times reports that nearly 180 patients at UCLA’s Ronald Reagan Medical Center may have been exposed to potentially deadly bacteria from contaminated medical scopes, and two deaths have already been linked to the outbreak. The Times has learned that the two people who died are among seven patients that UCLA found were infected by CRE – a number that may grow as more patients get tested. UCLA said it discovered the outbreak late last month while running tests on a patient. This week, it began to notify 179 other patients who were treated from October to January and offer them medical tests. By some estimates, if the infection spreads to a person’s bloodstream..

UCLA said it immediately notified public health authorities after discovering the bacteria in one patient and tracing the problem to two of these endoscopes. The university said it had been cleaning the scopes “according to standards stipulated by the manufacturer,” and it changed how it disinfects the instruments after the infections occurred. Dale Tate, a university spokeswoman, said “the two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond the manufacturer and national standards.”

Yet neither the scopes’ manufacturers nor the Food and Drug Administration, which regulates them, have publicized or offered guidance on the problem. So, many doctors who use the scopes – and most of the patients they treat – don’t know the risks. Nor do they know that steps can be taken to cut those risks dramatically. “Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that’s got to change,” says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County Public Health Department.

The FDA says in a written statement to USA TODAY that it is “aware of and closely monitoring” the infection risks associated with the scopes. “Some parts of the scopes may be extremely difficult to access and clean thoroughly,” the agency adds, “and effective cleaning of all areas of the duodenoscope may not be possible.” The agency is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the scopes should be redesigned entirely. Meanwhile, the scopes’ “lifesaving” ability to detect and treat potentially fatal digestive disorders outweighs their infection risks, the statement adds. “It (is) important for these devices to remain available.” Few dispute the scopes’ importance.

But public health officials and endoscopy experts who have studied the problem believe the FDA and scope manufacturers have been slow to bring attention to the infection risks and publicize steps hospitals can take to reduce them dramatically. “It’s fair to ask whether the FDA could have been doing more to regulate these devices and significantly reduce the risk of patient harm,” says Lawrence Muscarella, a biomedical engineer and independent consultant who advises hospitals on endoscope safety. “Patients have died, and the agency seems to be moving slowly.” .

Salinas Pain Doctor Faces Discipline and Drug Investigation

As authorities conducted a drug raid on Salinas’ Chinatown last Thursday, a second set of federal officers searched a Salinas doctor’s office and home in connection with an alleged fraud case.

The Californian reports that Dr. Steven Mangar, who runs Pacific Pain Care Institute, was arrested on Valentine’s Day last year on suspicion of driving under the influence of methamphetamine. A California Highway Patrol officer stopped 44-year-old Mangar at Highway 101 and Sanborn Road. But, prosecutor Ed Hazel said the U.S. Department of Justice crime lab in Sacramento is so backed up, Mangar’s toxicology report was not available until last month. Mangar was charged Jan. 21. He was ultimately arraigned 364 days after his arrest. Mangar’s arraignment in Monterey County Superior Court followed a day after federal agents swooped down on his West Alisal Street office and his home on Madeira Avenue in Salinas. Authorities with the Monterey County District Attorney’s Office’s Health Care and Workers’ Compensation fraud units served the search warrant with help from the State Medical Board, the Department of Insurance, the Drug Enforcement Agency and the DOJ Office of the Inspector General. At the same time, another alphabet soup of agents searched Salinas’ Chinatown for methamphetamine, heroin, marijuana and cash. Twelve arrests stemmed from that raid.

Between 2005 and 2012, Mangar collected 10 traffic citations for minor incidents, Hazel said. In that time period, he was also sued four times in civil court. This was not the first time Mangar has come under scrutiny from the State Medical Board. On Oct. 5, 2012, Mangar was placed on three years’ probation following an investigation into his treatment between 2003 and 2010 of a 60-year-old man who had chronic neck pain. According to court documents, Mangar kept shoddy records that indicated he examined the patient at times when, in fact, he hadn’t. Mangar prescribed the man Percocet and Oxycontin, both powerful pain killers, according to the records. After the investigation, he was ordered to enroll in prescribing practices and record-keeping courses.

On May 15, 2013, Mangar was cited and fined $350 for failing to submit a quarterly declaration in conjunction with his probation.

On Nov. 6, 2014, Medical Board officials filed a petition to revoke Mangar’s probation. Doing so could result in the loss of Mangar’s physician’s and surgeon’s certificate. The petition revolved around Mangar’s treatment of a 40-year-old man with chronic back pain, according to court records. Although the patient’s quality of life didn’t improve, Mangar continued prescribing him Oxycontin. He later added in Ritalin when the man said he couldn’t stay awake. In doing so, Mangar acted unprofessionally and failed to develop an objective-oriented treatment plan, according to the allegation. A decision is still pending in that petition.

ProPublica analysis shows Mangar was the third-leading hydrocodone prescriber in California in 2012. Hydrocodone, also known as Vicodin, is another powerful pain killer. In 2012, 72 percent and 55 percent of Mangar’s 241 patients filled Schedule II and Schedule III drug prescriptions, respectively, according to ProPublica. Drugs are classified into five categories, per the DEA. Schedule II drugs are potentially highly addictive. Schedule III drugs carry a moderate to low risk of abuse. On average, specialists in Mangar’s area only prescribed Schedule II and Schedule III drugs 4 percent and 13 percent of the time, respectively. Only 23 percent of Mangar’s prescriptions were for brand names, compared with a 29 percent average at other specialists’ offices. But Mangar’s prescriptions also cost $170 on average compared with $99 from other prescribers.

Mangar, who is represented by defense attorney Susan Chapman, is expected to return to court March 5, Hazel said. Mangar and Chapman weren’t immediately available for comment.

DWC Adjusts OMFS Practitioner Services Section

The Division of Workers’ Compensation has posted an order adjusting the Physician Services/Non-Physician Practitioner Services section of the Official Medical Fee Schedule (OMFS) to conform to relevant 2015 changes in the Medicare payment system as required by Labor Code section 5307.1.

The Physician and Non-Physician Practitioner Fee Schedule based on the federal Resource Based Relative Value Scale (RBRVS) was adopted pursuant to the requirements of Senate Bill 863 (SB 863) and became effective for services rendered on or after January 1, 2014. As mandated by SB 863, the fee schedule starts with separate conversion factors for surgery, radiology, and “all other services” in 2014 and transitions to a single conversion factor (CF) beginning in 2017, for all services except anesthesia. The 2015 transition conversion factors reflect a blend of 50 percent pre-2014 OMFS CF and 50 percent 120% RBRVS Medicare CF.

The Physician and Non-Physician Practitioner Fee Schedule update order adopts revisions to several sections of Title 8 California Code of Regulations, including the following changes

1) Adopts the CMS Medicare National Physician Fee Schedule Relative Value File(RVU file) RVU15A and related files for services rendered on or after March 1,2015
2) Updates the Conversion Factors, applying the Medicare relative value scaleadjustments and the Medicare Economic Index (MEI) inflation increase to thetransitional conversion factors set forth in the regulation
3) Updates the Statewide Geographic Adjustment Factors
4) Adopts the 2015 National Correct Coding Initiative Edits/2015 NCCI PolicyManual
5) Updates the California specific codes with the MEI inflation increase

The administrative director update order adopting the OMFS adjustments effective for services rendered on or after March 1, 2015, can be found on the DWC website. An explanation of changes is attached to the order, identifying the basis for the changes included in the update.

WCAB Says Applicant Gets One QME Panel at a Time

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.

California Obamacare Botches 100,000 Tax Forms

The Los Angeles Times reports that California’s Obamacare exchange sent erroneous tax forms to about 100,000 households that received federal premium subsidies last year. At issue is Form 1095-A, which health-law exchanges must send to individuals and families showing how much money they received in 2014 from the federal government to subsidize their health insurance premiums. Covered California said it sent incorrect information on some forms because its customer data didn’t match what health plans had on file. For instance, there may have been a discrepancy for the person’s length of coverage in 2014 and amount of subsidy received.

Amy Palmer, an exchange spokeswoman, said the agency is reconciling that information and sending revised forms to the affected customers later this month. She said customers will also be notified by email when the updated forms are available in their online account. Overall, Covered California sent tax forms to more than 800,000 households statewide.

Obamacare customers who take taxpayer subsidies to cut down the price of health coverage must later fill out Form 1095-A, which documents how much money they received in subsidies in all of 2014. But the total amount of subsidies were incorrect for a large chunk of the exchange’s customers due to the disconnect between the exchange and health insurers. In some cases, the length of time a customer was insured was incorrect, changing the total amount of taxpayer assistance received.

The error affects 100,000 households in the state, out of 800,000 households that received Covered California forms in total. The accurate information is important for people when filing their 2014 taxes. Consumers may have to repay some portion of that government assistance as part of their tax return if their income was higher than what they estimated during enrollment. The blunder puts an extra burden on 100,000 households with Obamacare customers in California just ahead of tax season, who were already facing what experts warn will be the most complicated tax season ever. The 1095-A forms in question are new this year, the government’s answer to the complications Obamacare introduces into filing taxes. Each health-care exchange will issue the forms to customers who received subsidies in the form of tax subsidies. The federal government will issue about 4 million of the new 1095-A forms to Obamacare customers using the federal website this year.

Four in ten low-income Obamacare participants will face sticker shock this April 15 when they discover they owe a great deal of money to the IRS because of a little-known “clawback” provision in the health-care law. A family of four could owe the government as much as $11,200, according to a 2013 prediction by researchers at the University of California, Berkeley. Authors of the UC study, written by supporters of the health-care law, warned the repayment feature could kill future support for Obamacare. “Repayment requirements could lead to public dissatisfaction with the exchanges. And if there is much media attention to the need for repayments, some people could be dissuaded from participating in the exchanges,” they cautioned. The California researchers admitted even a $2,500 repayment could be devastating to a couple. “A repayment requirement of $2,500 could be a financial shock to a family of two earning $50,000 a year,” they stated.

FDA Identified Research Misconduct Hidden in Plain Sight

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.”