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Fed Panels Agree on Drug Compounding Bill

House of Representatives and Senate committees have agreed on legislation that would give the Food and Drug Administration greater authority to regulate companies that compound sterile drugs and ship them across state lines. The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain to help thwart the introduction of fake medication into the drug supply.

Reuters Health reports that the bill, called the Drug Quality and Security Act, comes in response to a deadly outbreak last year of fungal meningitis that killed more than 50 people and was traced to a tainted steroid sold by the New England Compounding Center in Framingham, Massachusetts.

The legislation is expect to pass smoothly and quickly through the full House and Senate.

Traditionally, pharmacists who compound medication mix tailored doses for individual patients in response to specific prescriptions. Over the last decade the practice has mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use. The legislation would draw a distinction between traditional compounding pharmacies and those such as NECC which ship sterile products across state lines. These larger organizations, to be known as “outsourcing facilities,” would be regulated by the FDA but be exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies. Traditional compounding pharmacies would continue to be regulated by state boards of pharmacy.

Previous attempts to create national standards to track and trace drugs have foundered amid complaints from companies that they would be too costly to implement. But concerns over counterfeit drugs have been growing. Last year, fake vials of Roche Holding AG’s cancer drug Avastin appeared in the United States from Britain where it was purchased from a Turkish wholesaler.

The World Health Organization estimates that less than 1 percent of medicines available in the developed world are likely to be counterfeit. Globally, that number is around 10 percent.

In the United States, dozens of states have some type of regulation designed to track a drug’s pedigree, but the rules are inconsistent. The bill is designed to resolve the current patchwork of federal regulation by applying a uniform standard nationwide.

Sexual Conviction Restricts L.A. Orthopedic AME/QME Medical License

Fred F. Hafezi, M.D. is currently listed on the DWC QME database as a spine specialist with offices in Azusa and Ontario California. The Medical Board of California reflects that he holds Physicians and Surgeons certificate G19337 originally issued in October 1970. The Board records reflect that he is certified in Orthopedic Surgery.

Medical Board records also reflect that on June 25, 2013 the office of the Attorney General of California filed an Accusation against Dr. Hafezi asking that the Board revoke or suspend his Physician and Surgeon’s Certificate,

In support of this request, the Accusation alleged that “on April 25, 2013, in the case of The People of the State of California v. Farhad Fred Hafezi, Los Angeles County Superior Court case number KA090841, Respondent (Hafezi) was ordered, as part of his sentence, to register as a sex offender pursuant to the provisions of Penal Code section 290. As a result of his being ordered to register as a sex offender, Respondent’s Physician’s and Surgeons’ Certificate No. 019337 is subject to mandatory revocation pursuant to the provisions of Business and Professions Code Section 2232.”

The Accusation continues to allege the circumstances of the criminal prosecution. “Respondent was charged with several counts of oral copulation, contact with a minor with intent to commit a sexual offense, unlawful sexual intercourse with a person under the age of 18, all violations of the Penal Code. On April 1, 2011, Respondent did an “open plea” and pled nolo contendere to all 4 counts. Then on May 26, 2011, Respondent withdrew his plea of guilty. On April 5, 2013, the court denied Respondent’s motion to withdraw his guilty plea. As a result of his plea, he now stands convicted of several counts of oral copulation and a count of unlawful sexual intercourse with a person under 18. Respondent was sentenced on May 23, 2013. Imposition of sentence was suspended, and Respondent was placed on formal probation for 36 months, ordered to serve 180 days in the Los Angeles County Jail and required to register as a sex offender pursuant to Penal Code section 290. Respondent is currently out of jail as he was given credit for time served for his county jail sentence.”

On August 6, 2013, while being represented in the Matter of the Accusation by the Law Offices of Richard A. Moss, Hafezi and his attorney signed a Stipulation for Restricted Practice. The purpose of the Stipulation was to restrict his Physicians and Surgeons certificate pursuant to Government Code section 11529.

Pursuant to the Stipulation, on August 16, Hafezi was ordered to “cease performing any activity for which a license as a physician is required in the State o! California with the sole and singular exception he may complete reports on patients seen as workers compensation referrals who were referred to him prior to the date of endorsement of this Stipulation by the administrative law judge.”

It is further stipulated and agreed that the Stipulation would be posted on the Boards website as a public document. The Stipulation is to remain in effect until completion of the administrative proceedings against him, and the issuance of a final decision of the Medical Board thereon.

A Medical Board “Action Report” dated July 1997 reflects prior discipline for Dr. Hafezi based upon Business and Professions Code §2234(b)(c)(d) “Negligent and incompetent treatment of a patient with a back injury.”

FSK Employment Law Conference Set for November 7

Floyd, Skeren and Kelly LLP is pleased to announce its Northern California Annual Employment Law Conference, which will feature keynote speakers Christine Baker, Director of the Department of Industrial Relations and Phyllis W. Cheng, Director of the California Department of Fair Employment and Housing (DFEH).

The conference will be held on November 7, at the South San Francisco Conference Center.

This is an all-day event, designed for employers, managers, claims adjusters, risk managers, attorneys, and any other professionals associated with human resources and employment law. The conference will provide helpful guidance related to numerous workplace topics, including: the new California disability regulations (which impact an employer’s policies on reasonable accommodation, the interactive process and leaves of absence); the new comprehensive pregnancy disability regulations; a workers’ compensation update, focusing in on the latest developments related to SB 863; an overview of important OSHA workplace requirements and procedures; a review of 6 critical steps an employer can take to avoid costly employment related lawsuits; and, an update on the evolving role of social media in the workplace.

Ms. Cheng will discuss the important new disability and pregnancy regulations in effect as of January 2013. The new disability regulations significantly expand the protections for disabled workers and set forth new employer obligations and requirements related to disability discrimination, reasonable accommodation, the interactive process, job descriptions, and medical certifications. The new pregnancy disability regulations greatly expand the protections afforded to employees disabled by pregnancy including new notice requirements and an expanded list of conditions that constitute a pregnancy disability. Ms. Cheng will review key provisions of the new regulations, what is new for employers, the DFEH’s enforcement perspective, and employer best practices for ensuring compliance.

Ms. Baker will co-present with David W. O’Brien, Esq., Retired Workers’ Compensation Administrative Law Judge. They will provide a workers’ compensation update focusing in on the latest developments pertaining to SB 863 and new case law.

Visit www.fskhrtraining.com for more information and online registration.

LexisNexis Data Compromised by Identity Theft Hackers

An identity theft service that sells Social Security numbers, birth records, credit and background reports on millions of Americans has infiltrated computers at some of America’s largest consumer and business data aggregators, according to a seven-month investigation by KrebsOnSecurity.

Two of the hacked servers were inside the networks of Atlanta, Ga.-based LexisNexis Inc., a company that maintains the world’s largest electronic database for legal and public-records related information. LexisNexis is also widely used by members of the workers’ compensation community for legal research.

Contacted about the findings, LexisNexis confirmed that the two systems listed in the botnet interface were public-facing LexisNexis Web servers that had been compromised.

A tiny unauthorized program called “nbc.exe” was placed on the servers as far back as April 10, 2013, suggesting the intruders have had access to the company’s internal networks for at least the past five months. The program was designed to open an encrypted channel of communications from within LexisNexis’s internal systems to the botnet controller on the public Internet.

An initial analysis of the malicious bot program installed on the hacked servers reveals that it was carefully engineered to avoid detection by antivirus tools. A review of the bot malware in early September using Virustotal.com – which scrutinizes submitted files for signs of malicious behavior by scanning them with antivirus software from nearly four dozen security firms simultaneously – gave it a clean bill of health: none of the 46 top anti-malware tools on the market today detected it as malicious.

All three victim companies said they are working with federal authorities and third-party forensics firms in the early stages of determining how far the breaches extend, and whether indeed any sensitive information was accessed and exfiltrated from their networks.

For its part, LexisNexis confirmed that the compromises appear to have begun in April of this year, but said it found “no evidence that customer or consumer data were reached or retrieved,” via the hacked systems. The company indicated that it was still in the process of investigating whether other systems on its network may have been compromised by the intrusion.

“Immediately upon becoming aware of this matter, we contacted the FBI and initiated a comprehensive investigation working with a leading third party forensic investigation firm,” said Aurobindo Sundaram, vice president of information assurance and data protection at Reed Elsevier, the parent company of LexisNexis. “In that investigation, we have identified an intrusion targeting our data but to date have found no evidence that customer or consumer data were reached or retrieved. Because this matter is actively being investigated by law enforcement, I can’t provide further information at this time.”

NICB Reports That Reports of Questionable Comp Claims Are Increasing

The National Insurance Crime Bureau (NICB) just released an analysis of workers’ compensation questionable claims (QC) referrals submitted from Jan. 1, 2011, through June 30, 2013. The report finds that while the total number of WC claims has been decreasing, the percentage that is deemed “questionable” has been rising.

QCs are claims that NICB member insurance companies refer to NICB for closer review and investigation based on one or more indicators of possible fraud. A single claim may contain up to seven referral reasons.

California ranked first generating a total of 2,270 WC QCs. It was followed by Illinois with 689. New York was third with 688.

In 2011, 3,349,925 WC claims were found in the Insurance Services Office (ISO) ClaimSearch® database. That number decreased to 3,244,679 in 2012, and is on track to decrease again in 2013 based on the 1,498,725 claims received in the first half of 2013.

In 2011, 3,474 WC QCs were referred to NICB. That number increased to 4,460 in 2012 – a 28 percent rise. WC QCs accounted for 3.5 percent of the 100,201 QCs submitted in 2011, and increased to 3.8 percent of the 116,171 QCs in 2012.  Through the first half of 2013, 2,325 WC CQs have been referred to NICB (3.7 percent of 62,352 total QCs), compared with 1,681 through the first half of 2011 and 2,174 through the first half of 2013.

The distribution of WC QCs follows a standard Monday – Friday workweek with the QCs almost evenly divided during the week with steep drop-offs in the numbers for Saturday and Sunday.

There are several referral reasons from which NICB member companies can select to further describe a QC. The top three referral reasons were the same in each year. First was “claimant fraud” with 6,107. Second was “prior injury/not related to work” with 2,319, and third was “malingering” with 1,380.

An injury not related to work is typically a person who suffers an injury during a recreational or day off activity but fails to report it until at work, thus claiming the injury happened on the job. A malingerer is someone who has suffered a legitimate injury but continues to feign symptoms, thus collecting benefits long after he or she has fully recovered.

The full report is available online..

WCAB Does Not Have Exclusive Jurisdiction Over Attorney Fee Distribution

The Law Offices of Mark R. Leeds entered into a contract with the Law Offices of Donald J. Reino, whereby Leeds agreed to refer workers’ compensation cases to Reino in consideration for payment of 25 percent of the attorney fees earned on those cases, 100 percent of all deposition fees (Lab. Code, § 5710) if “handled” by Leeds, and 25 percent of the vocational rehabilitation attorney fees.

Three years later, in 1997, Reino and Iida, a Professional Corporation, and Law Offices of Myles Iida were formed as successors of Reino. By this time, plaintiff had referred over 1,000 cases to Reino pursuant to the agreement. Leeds entered into a new agreement to the successor firm that is substantially similar to the original agreement with Reino

Reino and the successor firms paid plaintiff in accordance with the terms of the agreements for about 16 years.

On October 1, 2010, Leeds separated from the successor firms and formed his own firm in Long Beach California. at separation, many of the referred clients manifested their intent to substitute Leeds as counsel of record while others elected to remain with Reino; and some of the previously referred clients had substituted other firms to handle their claims. Reino then refused to pay any attorney fees to Leeds, and Leeds filed a civil action in Superior Court to collect the fees he claims to have earned.

Reino demurred to the complaint on three grounds: (1) the trial court lacked subject matter jurisdiction over the subject of the cause of action, because WCAB has exclusive jurisdiction over disputes regarding attorney fees in workers’ compensation matters; (2) another action is pending before the WCAB entitled Lovato v. The Kroger Co. dba Ralph’s Grocery, case No. ADJ7354967 (Lovato) between the same parties on the same issues, i.e., “the alleged failure of Defendants to pay Plaintiff[’s] referral fees allegedly earned under the alleged contract . . . including California Labor Code section 5710 deposition fees;” and (3) no cause of action for declaratory relief is stated. The trial court sustained the demurrer without leave to amend on all grounds asserted in the demurrer and entered its order (judgment) dismissing the complaint with prejudice.

Leeds appealed the dismissal, and the Court of Appeal reversed in the unpublished case of Leeds v. Reino and Iida.

The Court of Appeal concluded that the distribution of attorney fees in a final award pursuant to a fee splitting agreement is not subject to the exclusive jurisdiction of the WCAB. “Once the WCAB has resolved the ‘reasonable amount’ of the attorney fees and makes a final award in this amount, the WCAB has no further interest in, or obligation to determine, how the fees are to be disbursed or otherwise disposed of by the lien claimant. We therefore conclude that a dispute between the lien claimant and a third party regarding allocation or division of the attorney fees in a final award issued by the WCAB is outside the jurisdiction of the WCAB. ”

FDA Issues Rules on Mobile Medical Apps

The U.S. Food and Drug Administration has issued final rules governing the development of mobile medical apps, saying it will focus its oversight on those products that have the potential to harm consumers if they do not function properly.

The rules, announced on Monday, come more than two years after the FDA released draft guidance in which it proposed regulating any mobile app deemed to be a medical device.

The FDA said it will only regulate products that transform smartphones into devices the agency currently regulates, such as electrocardiography (ECG) machines that can determine whether a patient is having a heart attack.

The agency will also regulate apps that would be used as an accessory to a regulated device, such as one that displays images used by physicians to diagnose patients.

The agency said it will not regulate the sale or general consumer use of smartphones or tablets or mobile app distributors such as the iTunes store or Google Play store. Nor will it regulate personal wellness apps such as pedometers or heart-rate monitors.

Dr. Jeffrey Shuren, director of the FDA’s medical device division, said on a conference call with reporters that whether the agency regulates a product will depend on its function and its risk. If a heart device used in a hospital is currently regulated, chances are a mobile app will be too.

“It’s not about the platform. It’s about the functionality,” Shuren said. “An ECG is an ECG.”

Such products will need to be cleared by the FDA before being allowed on the market. The agency has cleared about 100 mobile medical apps over the past decade, of which 40 were cleared in the last two years. Shuren said the average review time was 67 days.

The agency said it is not going to enforce its powers on mobile apps it considers relatively safe such as those that help patients organize and track their health information, or promote strategies for maintaining a healthy weight or adhering to medication dosing schedules.

According to a report published in March by research2guidance, a research firm, the market for mobile health apps will reach $26 billion by 2017. Currently, there are about 97,000 mobile health applications in major app stores, the report said.

Claimant Convicted of Comp Fraud for Owning San Francisco Bar

A 78-year-old Auburn man pleaded guilty in federal court in Sacramento to making false statements to obtain federal workers’ compensation benefits.

According to the plea agreement, Bruce Lee Cearlock has been receiving workers’ compensation benefits under the Federal Employees’ Compensation Act for an injury that he suffered as a civilian employee for the U.S. Navy on Aug. 26, 1987. When filing the periodic reports required by the Office of Workers’ Compensation Program to justify continued payments, between 2006 and 2008, Cearlock stated under penalty of perjury that he was neither self-employed nor involved in “any business enterprise.”

Court documents, however, state that from at least 1999 until 2011, Cearlock was involved in operating Fuse, a bar in San Francisco. Cearlock hired and fired employees, made decisions on capital expenditures and dealt with private citizens and public officials as the owner of Fuse.

During that time, Cearlock also was president and secretary of a privately held corporation, Alleycorp Inc., the sole purpose of which was to own the Fuse nightclub, authorities said. Shares in Alleycorp were equally split between Cearlock and his wife.

On the basis of his statements to the Office of Workers’ Compensation Program that he was not involved in any business enterprise, Cearlock continued to receive federal disability benefits.

Cearlock is to be sentenced Dec. 5 by U.S. District Judge Troy L. Nunley.

The case resulted from an investigation by the Department of Defense, Defense Criminal Investigation Service, Sacramento; the Naval Criminal Investigative Service; and the U.S. Department of Labor.

San Diego Woman Pleads Guilty to Aiding Psychologist in Fraud Scheme

A Spring Valley woman pleaded guilty to taking part in a multi-year scheme to falsify medical certifications while working as an advocate for immigrants seeking help in obtaining U.S. citizenship or government benefits.

Nawal Talia, 57, admitted during a hearing in federal court in San Diego that she recruited patients for National City psychologist Roberto Velasquez, who was sentenced earlier this year to 21 months in prison and ordered to repay more than $1.5 million to the Social Security Administration in the largest single restitution order in the agency’s history.

As part of her job, Talia for several years submitted documents to federal agencies on behalf of her clients, certifying that they were mentally disabled. Rather than obtain benefits legitimately, she and Velasquez worked together to falsify medical certifications and fabricate patient histories, according to prosecutors.

Talia admitted that she helped Velasquez falsify disability-exception certification forms used by the Department of Homeland Security during the naturalization process and medical letters used by the Social Security Administration to award Supplemental Security Income and disability payments. She conceded that she lied on both types of documents about the length of time her clients had been under the care of Velasquez. In one case, she certified that a patient had been treated by Velasquez for a year, when the person actually had met Velasquez only once, court papers show.

In another instance, she filed a Social Security appeal falsely certifying that a man had been treated by Velasquez for 11 months. Talia simply made up that number so he appeared to be eligible for disability benefits, when Talia knew he was not, according to court documents. Investigators established that Talia repeatedly lied about durations of treatment in order to create a “track record” that would satisfy reviewers at the Social Security Administration and immigration agencies.

The scheme came to light during an undercover operation conducted jointly by the Department of Homeland Security, Immigration and Customs Enforcement, and the Office of Inspector General, Social Security Administration..

Contractor Jailed For Premium Fraud

Douglas Lambert, 48, of West Hills and owner of Lambert Air Conditioning was convicted of committing workers’ compensation insurance premium fraud for failing to properly report employee payroll to the insurance carrier.

Lambert was ordered to pay more than $110,300 in restitution to Clarendon National and the State of California.

In response to a complaint in February 2010, the Department of Insurance in a joint effort with the Tulare County District Attorney’s Office began an investigation into Lambert. Lambert, a licensed air conditioning contractor operating in Tulare County, did not report any employee payroll to Clarendon National Insurance Company causing his business to pay at a lower premium. The investigation uncovered evidence Lambert failed to properly report employee payroll to the carrier from 2006 to 2009.

Lambert reported no employee payroll to Clarendon for the first three quarters of 2006 yet the business reported more than $8,800 in wages to the Employment Development Department during this same time period.

Further investigation revealed Lambert reported an employee injury to Clarendon National as a workers’ compensation claim although he was reporting no employee wages to them.

Douglas Lambert pled guilty to one count of insurance fraud.