Tag: 2019 News

Jocelyn Bowen injured her neck and right shoulder while working for the County of San Bernardino. Since at least March 9, 2015, she was prescribed, and she used, Norco to control her symptoms of pain.

On November 23, 2015, IMR issued a final determination letter finding, that the prescribed Norco was medically necessary and appropriate. The rationale was that she “rates the pain 8-9 out of 10 on pain scale without medications and 4-5 out of 10 on the pain scale with medications . .. . The injured worker reports functional improvement and improvement in pain with medications. She notes improvement in activities of daily living (ADL) as well as increased ability to reach, lift, grab and hold as a result of her medication usage.”

The following month, the PTP again prescribed Norco based upon the same clinical observations. UR rejected the December RFA which was again appealed to IMR.The second IMR reviewer was a family practice physician, and upheld the UR denial.

The first November 23, 2015 IMR final determination letter was not included, in the information given to the second IMR reviewer, and there is no indication that the second IMR reviewer considered it. The second reviewer noted that “Although the physician noted an improvement in the level of function with medication use, there was no documentation of any specific objective functional improvements with the use of Norco.”

Applicant timely appealed the second IMR determination pursuant to L.C. section 4610.6(h). The WCJ granted the appeal, and found that the IMR determination contained plainly erroneous findings and was without or in excess of the powers of the AD, and rescinded the IMR determination, and ordered the dispute to a new IMR reviewer in the specialty of orthopedic surgery, pain management, and/or physical medicine and rehabilitation. The WCJ also indicated that the new IMR reviewer should review the previous IMR determination.

The former acting Administrative Director objected to the WCJ’s instruction that the new IMR reviewer should review a previous IMR determination approving the prescription for Norco, arguing that review of a prior IMR final determination may detract from the independence of the new review. The AD agreed that the IMR reviewer should be in a specialty more appropriately matched to applicant’s diagnosis, and submitted the matter for a new IMR determination.

The WCAB rejected the limits placed by the Administrative Director and affirmed the WCJ in the panel decision of Bowen v the County of San Bernardino.

The Court of Appeal held that IMR determinations are subject to meaningful review, even if the Appeals Board cannot change medical necessity determinations, noting that “[t]he Board’s authority to review an IMR determination includes the authority to determine whether it was adopted without authority or based on a plainly erroneous fact that is not a matter of expert opinion.” (Stevens v. Workers’ Comp. Appeals Bd. (2015) 241 Cal.App.4th 1074, 1100.)

The record reflects that the IMR reviewer did not review all the documents submitted. The record does not reflect the reason these documents were not included in the IMR review or what information was contained in them. It is unknown whether the IMR organization failed to provide these records to the reviewer, or whether the physician reviewer ignored or overlooked them.

As part of the new IMR, applicant may re-submit the November 23, 2015 IMR final determination and all of the PTP reports to the IMR reviewer.

Fresenius Medical Care operates more than 40 production sites on all continents. Its largest plants in terms of production output are in the U.S. (Ogden, Utah, and Concord, California), Germany (Schweinfurt and St. Wendel), and Japan (Buzen).

A division of Fresenius Medical Care North America (FMCNA), Fresenius Kidney Care is the worldwide leader in the treatment of renal disease and an innovative leader in kidney disease research. It claims to serve over 190,000 patients in over 2,400 facilities nationwide.

In 2012, Fresenius acquired Liberty Dialysis Holdings, in a deal which entailed the sale of its outpatient dialysis clinics in 43 local markets within the U.S.

In 2013, Fresenius Medical Care NA acquired Shiel Medical Laboratory Inc, expanding services to New York City metro area. In September 2017 the company announced the divestment of the business of Shiel Medical Laboratory, Inc. to Quest Diagnostics, Inc.

Fresenius Medical Care has just agreed to pay approximately $231 million to resolve investigations by the DOJ and the SEC into violations of the Foreign Corrupt Practices Act (FCPA) in connection with Fresenius’s participation in various corrupt schemes to obtain business in multiple foreign countries.

Fresenius admitted it paid bribes to publicly employed health and/or government officials to obtain or retain business in Angola and Saudi Arabia. as well as in Morocco, Spain, Turkey and countries in West Africa,

“Fresenius doled out millions of dollars in bribes across the globe to gain a competitive advantage in the medical services industry, profiting to the tune of over $140 million,” said Assistant Attorney General Benczkowski.

In total, Fresenius admitted to earning more than $140 million in profits from the corrupt schemes.

To resolve the case, Fresenius entered into a nonprosecution agreement (NPA) with the Department and agreed to pay a total criminal penalty of $84,715,273. As part of the NPA, Fresenius also agreed to continue to cooperate with the Department’s investigation, enhance its compliance program, implement rigorous internal controls and retain an independent corporate compliance monitor for at least two years.

Fresenius settled a related FCPA matter with the U.S. Securities and Exchange Commission (SEC), and will pay $147 million in disgorgement and prejudgment interest to the SEC, which the Department credited in its resolution, bringing the total amount paid by Fresenius to over $231 million.

This case is being investigated by the FBI’s International Corruption Squad in New York and the FBI’s Boston Field Office. Trial Attorneys Paul A. Hayden and Sonali D. Patel of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Jordi de Llano of the District of Massachusetts are prosecuting the case.

Cal/OSHA has issued serious health and safety citations to Underground Construction Co., Inc. of Benicia after two of its employees contracted Valley Fever. The workers were exposed to the fungal disease while using hand tools to dig trenches in Kings, Fresno and Merced counties—areas where the soil is known to contain harmful spores that cause the infection.

Cal/OSHA was notified in September 2018 that the employees were hospitalized after being diagnosed with Valley Fever, also known as Coccidioidomycosis. Symptoms of the disease are similar to the flu and include fatigue, shortness of breath and fever. Severe cases can cause serious lung problems.

The workers were tasked with digging trenches up to 5½ feet deep to allow access to gas pipelines for maintenance. Dust was not controlled, and the workers did not wear any respiratory protection. Exposure to the disease could have occurred in any one of the three counties where the fungal spores are known to be endemic.

Cal/OSHA’s investigation found that Underground Construction Co., Inc. did not evaluate the hazard of performing digging work in areas known to contain the coccidioides fungal spores. The employer did not suppress or control harmful dusts and failed to provide employees with respiratory protection. Cal/OSHA issued three citations to the employer with $27,000 in proposed penalties.

Since 2017, Cal/OSHA has cited 12 businesses for work-related Valley Fever.

Valley Fever is caused by a microscopic fungus known as Coccidioides immitis, which lives in the top two to 12 inches of soil in many parts of the state. When soil is disturbed by digging, driving or high winds, fungal spores can become airborne and may be inhaled by workers who are not protected. While the fungal spores are most likely to be present in the soils of the Central Valley, they may also be present in other areas of California. Cal/OSHA’s Valley Fever informational page provides detailed information including resources for workers and employers.

Tips for reducing the risk of Valley Fever exposure include:
— Determine if a worksite is in an area where fungal spores are likely to be present.
— Adopt site plans and work practices that minimize the disturbance of soil and maximize ground cover.
— Use water, appropriate soil stabilizers, and/or re-vegetation to reduce airborne dust.
— Limit workers’ exposure to outdoor dust in disease-endemic areas by (1) providing air-conditioned cabs for vehicles that generate dust and making sure workers keep windows and vents closed, (2) suspending work during heavy winds, and (3) providing sleeping quarters, if applicable, away from sources of dust.
— When exposure to dust is unavoidable, provide approved respiratory protection to filter particles.
– Train supervisors and workers in how to recognize symptoms of Valley Fever and minimize exposure. Cal/OSHA helps protect workers from health and safety hazards on the job in almost every workplace in

California. Cal/OSHA’s Consultation Services Branch provides free and voluntary assistance to employers to improve their health and safety programs. Employers should call (800) 963-9424 for assistance from Cal/OSHA Consultation Services

More than 1,000 lawsuits accusing Purdue Pharma and other opioid manufacturers of using deceptive practices to push addictive drugs that led to fatal overdoses are consolidated in an Ohio federal court.  One of them, a lesser-known opioid case: Oklahoma v. Purdue Pharma, was scheduled for trial in May in Norman, Oklahoma.

The Oklahoma trial was expected to presage many of the arguments the jury may be presented in the national case set in the fall on 2019, and others being scheduled for trial out of the 1000 or so that are in process.

Business Insurance reported a few weeks ago that Purdue Pharma was exploring filing for bankruptcy to address potentially significant liabilities from the lawsuits.

In an unexpected turn of events, the Oklahoma Attorney General just announced an historic settlement with Purdue Pharma that will establish a nearly $200 million endowment at the Oklahoma State University’s Center for Wellness and Recovery, which will go toward treating the ongoing addiction epidemic nationwide.

The trial against Johnson & Johnson, Teva and the other defendants named in the state’s lawsuit remains on track for May 28.

The endowment provides funding for an entity that will receive the initial $102.5 million that will go to the Oklahoma State University Center for Health Sciences Center for Wellness and Recovery, Oklahoma’s most comprehensive treatment and research center for treating pain and addiction.

Beginning Jan. 1, 2020, the entity will receive an annual $15 million payment over a five year period. During the same five year timeframe, it will receive ongoing contributions of addiction treatment medicine, valued at $20 million.

Oklahoma State University President Burns Hargis, who spoke at the news conference congratulated Attorney General Hunter and his team.

“We extend our congratulations to Oklahoma Attorney General Mike Hunter and the legal team for their foresight to skillfully craft a settlement that will position Oklahoma State University’s Center for Wellness and Recovery to serve as the premiere institution for research, education and treatment for addiction in the United States,” President Hargis said.

$12.5 million will go towards providing funds to directly abate and address the opioid epidemic’s effects in Oklahoma’s cities and counties. Purdue will also make a $60 million payment to offset all litigation costs up to this point.
Purdue will not promote opioids in Oklahoma, including employing or contracting with sales representatives to health care providers in Oklahoma.

“We appreciate that Purdue Pharma and its owners chose to work constructively with us to resolve this litigation in a way that will bring to life a new and unique national center with the goal of creating breakthrough innovations in the prevention and treatment of addiction,” Attorney General Hunter said.

South Bay QME, Venkat Aachi M.D. pleaded guilty to distributing hydrocodone outside the scope of his professional practice and without a legitimate medical need, and to health care fraud. The guilty plea was accepted by the Honorable Edward J. Davila, U.S. District Judge.

The DWC lists Vankat Aachi M.D. as a QME in Physical Medicine and Rehabilitation with offices at 221 E. Hacienda Avenue Suite D , Campbell, CA 95008-6625 and 2324 Montplelier Drive, Suite 2 , San Jose , Ca., 95116-1612

At the time of his arrest, federal prosecutors contended that Aachi submitted to an insurance company in July a false and fraudulent claim for payment for healthcare benefits, items and services.

According to the plea agreement, Aachi, 52, of Saratoga, was a licensed physician in the state of California who operated a pain clinic in San Jose. He maintained a DEA registration number authorizing him to prescribe controlled substances. Aachi admitted that from September 18, 2017, through July 2, 2018, he wrote hydrocodone-acetaminophen prescriptions that were outside the scope of his professional practice and not for a legitimate medical purpose.

The plea agreement describes transactions in which Aachi improperly distributed hydrocodone. For example, in November of 2017, he wrote a prescription enabling a patient to receive 90 hydrocodone-acetaminophen pills. Aachi did not conduct a physical examination of the patient nor discuss the patient’s pain or response to prior medication. Aachi acknowledged that he knew the prescriptions were not for a legitimate medical purpose and that he did not write the prescriptions in the usual course of his professional practice.

Further, Aachi admitted that on July 2, 2018, he falsely submitted to an insurance company a false and fraudulent claim for payment for healthcare benefits, items, and services. Aachi admitted he acted with the intend to defraud the insurance company.

On October 9, 2018, a federal grand jury indicted Aachi and charged him with six counts of distributing drugs outside the scope of professional practice, in violation of 21 U.S.C. § 841(a)(1) and (b)(1)(C), and one count of health care fraud, in violation of 18 U.S.C. § 1347. Aachi pleaded guilty to one count under each statute.

Aachi remains free on bail pending sentencing. Judge Davila scheduled Aachi’s sentencing hearing for July 1, 2019.

Aachi faces a maximum sentence of 20 years in prison and a fine of $1,000,000 for the illegal distribution of hydrocodone count and 10 years in prison and a $250,000 fine for the health care fraud count.

Additional fines, restitution, and additional periods of supervised release also could be ordered at sentencing. However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence, 18 U.S.C. § 3553.

This prosecution is the result of investigations by the DEA, FBI, HHS-OIG, and the BMFEA. Through the BMFEA, the California Department of Justice regularly works with other law enforcement agencies to investigate and prosecute fraud perpetrated on the Medi Cal program against a wide variety of healthcare providers, including doctors and pharmaceutical companies.

This case was investigated and prosecuted by member agencies of the Organized Crime Drug Enforcement Task Force, a focused multi-agency, multi-jurisdictional task force investigating and prosecuting the most significant drug trafficking organizations throughout the United States by leveraging the combined expertise of federal, state, and local law enforcement agencies.