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Tag: 2018 News

14% of Pharmaceuticals May Be Fake

A recent study published in the JAMA Open claims that about one in eight essential medicines in low- and middle-income countries may be fake or contain dangerous mixes of ingredients that put patients’ lives at risk.

Researchers examined data from more 350 previous studies that tested more 400,000 drug samples in low- and middle-income countries. Overall, roughly 14 percent of medicines were counterfeit, expired or otherwise low quality and unlikely to be as safe or effective as patients might expect.

And the lead study author Sachiko Ozawa of the University of North Carolina at Chapel Hill said that while the study didn’t examine high-income countries, drug quality concerns are by no means limited to less affluent nations.

Much of the research to date on counterfeit or otherwise unsafe medicines has focused on Africa, and about half of the studies in the current analysis were done there. Almost one in five medications tested in Africa were fake or otherwise potentially unsafe, researchers report in JAMA Network Open.

Another third of the studies were done in Asia, where about 14 percent of medicines tested were found to be counterfeit or otherwise unsafe.

Antibiotics and antimalarials were the most tested drugs in the analysis. Overall, about 19 percent of antimalarials and 12 percent of antibiotics were falsified or otherwise unsafe.

While fake or improperly made medicines undoubtedly harm patients, the current analysis couldn’t tell how many people suffered serious side effects or died as a result of falsified drugs.

But researchers did try to assess the economic impact of counterfeit or improperly made medicines and found the annual cost might run anywhere from $10 billion to $200 billion.

“Even in high-income countries, purchasing cheaper medicines from illegitimate sources online could result in obtaining substandard or falsified medicines,” Ozawa said. “Verify the source before you buy medications, and make policymakers aware of the problem so they can work to improve the global supply chain of medicines.”‘’

The report “provides important validation of what is largely already known,” Tim Mackey of the Global Health Policy Institute in La Jolla, California, writes in an accompanying editorial. “It is important to note that although the study is comprehensive, its narrow scope means it only provides a snapshot of the entire problem, as it is limited to studies conducted in low- and middle-income countries and to those medicines classified as essential by the World Health Organization.”

Ethics Committee Publishes Report of WCJ Investigations

The Division of Workers’ Compensation has posted the 2017 ethics advisory committee’s annual report. The workers’ compensation ethics advisory committee is a state committee independent from the DWC, that is charged with reviewing and monitoring complaints of misconduct filed against workers’ compensation administrative law judges.

As civil servants, workers’ compensation administrative law judges (WCALJs or judges) are not subject to review by the California Commission on Judicial Performance, the agency responsible for investigating misconduct complaints against supreme, superior, and appellate court judges. Instead, it is the EAC that monitors and reviews complaints of judicial misconduct filed against WCALJs.

Of the 34 complaints reviewed by the EAC, misconduct was found in five of them. Many of the complaints involved allegations of rude, abrasive or other inappropriate conduct by judges in courtrooms, mostly toward attorneys, at at times toward claimants.

For example, in one case, an applicant claimed the WCJ showed racial prejudice because “as soon as the judge saw complainant’s spouse, before asking any other questions, the judge asked, ‘Do we need an interpreter?’ Complainant’s spouse felt insulted by being regarded as a non-English-speaking person based solely upon the spouse’s appearance and perceived race.”

The same claimant had further problems during trial. ” At several points during the trial, the judge stopped the proceedings and requested to go off the record. Complainant complained that, with arms flailing, the judge used a loud voice directed at complainant and complainant’s attorney.”

In this case, the EAC identified violations of Canons 2A, 3B(7) and 3B(8) of the Code of Judicial Ethics and recommended to the CJ that appropriate action be taken.

In another illustrative case an applicant’s attorney, complained that the judge was prejudiced against the attorney’s firm. The judge would scold the applicant’s attorney in front of the applicant and the defense. The judge’s diatribes concerned what the judge thought the applicant’s firm had done incorrectly in the past. Similar examples were given in other specific litigated cases before the same judge.

In this case, the committee also identified violations of the Code of Judicial Ethics and recommended to the CJ that appropriate action be taken.

Many of the complaints found no ethical violations. Typically, they were based upon complaints about the merits of the claim, asserting the WCJ made the wrong decision. 29 cases were reviewed where no violation was found.

California Hospital Chain Files for Bankruptcy

Verity Health System of California Inc, a non-profit operator of six California hospitals filed voluntary petitions for protection under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Central District of California – Los Angeles Division.

Verity has secured debtor-in-possession financing of up to $185 million. This additional liquidity will enable continued operations without interruption to high-quality patient care, employees and suppliers throughout the Chapter 11 process.. The health system employed more than 6,000 people as of 2017.

The health system’s bankruptcy filing follows a series of deals that left it saddled with more than $1 billion in pension liabilities and bond debt. Verity, which serves low-income communities in Los Angeles and San Jose, secured a $185 million loan to help it stay operational through the bankruptcy.

Verity Chief Executive Officer Richard Adcock told Reuters he expected the operator to remain in bankruptcy protection from creditors for a couple years as it restructures and works with potential buyers.

“We’ve had over 100 parties formally reach out to us,” he said of the sale process, which Verity started in July. He said potential suitors include large national operators, and could include deals for individual facilities.

He emphasized the bankruptcy would allow the operator to maintain patient care while restructuring.

Its hospitals are St. Francis Medical Center and St. Vincent Medical Center in southern California, and O’Connor Hospital, St. Louise Regional Hospital, Seton Medical Center and Seton Medical Center Coastside in northern California. The non-profit also runs a physician network and medical foundation that encompasses urgent care centers and doctors’ offices.

Verity has been losing close to $175 million per year on a cash flow basis, Adcock said.

U.S. hospitals are suffering from costs that are rising faster than revenue and the industry is on an unsustainable path, credit rating agency Moody’s said in a report this week.

Daughters of Charity of St. Vincent de Paul, Province of the West, a religious organization, originally owned Verity. In 2015, the Daughters selected hedge fund BlueMountain Capital Management LLC to recapitalize the system with an investment of about $250 million.

Atlas General Now Covers Calif.Cannabis Industry

This summer, Atlas General Insurance Services, LLC, added an exclusive new workers’ compensation insurance program with Accredited Surety & Casualty Company, Inc., a Florida-headquartered insurance company.

Accredited recently expanded its insurance offerings to include workers’ compensation and selected Atlas as its exclusive program administrator nationwide.

California is the first state where the program is available, and Atlas is actively working with Accredited to expand this program nationwide.

And now, Atlas announced its new workers’ compensation program for the cannabis industry in California.

This exclusive program with Accredited Surety and Casualty Co. can accommodate work comp risks involved in all aspects of the cannabis industry – including growers, extractors, analytical labs, medicine manufacturers, food & beverage products manufacturing, packaging, warehousing & distribution, transportation and dispensaries.

According to Bill Trzos, CEO of Atlas, “Atlas has been studying the cannabis industry well before it became legalized in California,” said Trzos “through our research we recognized the opportunity to be proactive in entering the cannabis market and are excited to be one of a few work comp platforms in the state.”

While the program is only available in California now, Atlas will be opening this program in other states that have legalized cannabis.

Atlas heard the call to action from Insurance Commissioner Dave Jones last year and responded by developing a comprehensive workers’ compensation program to serve the industry.

“Cannabis businesses should have insurance coverage available to them just like any other California business,” said Insurance Commissioner Dave Jones. “As Insurance Commissioner, my mission is insurance protection for all Californians, which includes insurance for California’s legalized cannabis businesses and its workers.

This new program from Atlas is a crucial step in the right direction for this evolving industry. I encourage more insurance companies to offer cannabis business insurance products with the department to meet the needs of this emerging market.”

Two Arrested in Decade-Long Underground Economy Fraud Scheme

Brian Scott Krasnoff, 64, of Castaic and Lori Michelle Russum, 52, of Valencia were arrested and charged with more than 30 felony counts which include conspiracy to commit grand theft, grand theft, forgery, and failure to secure payment of compensation.

Krasnoff worked as a subcontractor for maintenance companies throughout the country for over a decade. He was the owner and operator of Commercial Window Cleaning Co., and allegedly conspired with Russum who owned a typing company to create false certificates of insurance.

Krasnoff submitted the false certificates to these maintenance companies to secure jobs in Southern California where he performed maintenance services. These businesses believed Krasnoff was insured when in actuality he was not, and paid more than half a million dollars for his services.

The California Department of Insurance says that in the process of hiring a professional to work on your home or property it’s not enough to see an insurance certificate, you should always call the insurance company and confirm the policy is active,” Jones added. “Taking this extra step should ensure your assets are protected and you are not liable in the event of an accident or injury.”

Employer Fights Bizarre Fraud Conviction for 15 Years

In 2003, defendants Jose Luis Alvarez, and Kim Marugg, (at the time known as Kim Alvarez) pled guilty to charges they had defrauded the State Compensation Insurance Fund. At the time, Alvarez and Marugg were husband and wife and operated Alverez Construction Company. Some of the workers were paid in cash by an intermediary and as a result SCIF was not paid workers’ compensation premium.

Marugg later claimed that, although she “was not guilty of the charges and . . . insistent on moving forward to trial,” she nonetheless pled guilty in December 2003 because the plea agreement “sounded like a sound financial decision.”

Marugg and Alvarez separated in February 2003; and began dissolution of marriage proceedings in 2004. She then married the prosecutor in her criminal case after she and the prosecutor began a personal relationship on some undisclosed date. The prosecutor died in October 2013, while they were still married.

Marugg testified she had “since learned” that, at time she pled guilty in 2003, her criminal defense counsel was colluding with Jose Luis Alvarez’s family law attorney. and her criminal conviction had an adverse effect on her community property rights.

In January 2007, Marugg started her court battled and filed what she calls a “Petition for Expungement” of the conviction, seeking relief under Penal Code sections 1203.4 and 1203.4a which was taken off calendar and not resolved.

In November 2009, Marugg discovered another woman who previously had been prosecuted by the same deputy district attorney, and with whom the prosecutor later engaged in a romantic relationship. This other woman’s story was “almost identical” to Marugg’s.

This woman complained to the district attorney’s office, and at some point during the August – October 2010 time period, the office commenced an internal affairs investigation of the prosecutor. During the investigation, Marugg learned that the prosecutor had engaged in “personal” and “romantic” relationships with other defendants he had prosecuted, as well as one of the principal witnesses, the SCIF investigator, whom the prosecutor had presented to the grand jury in May 2002 in his effort to indict Defendants.

After the investigation, in May 2011, the superior court ruled in favor of this other woman, finding in her case “that there have been substantial irregularities in the prosecution of this case, of which the court was unaware until this petition, that undermine the lawfulness of defendant’s conviction.”

In September 2011, at Marugg’s request, the prosecuting deputy district attorney (who, by this time, was Marugg’s husband) provided Marugg with a declaration that she submitted to the State Bar of California as part of a complaint she filed against the defense attorney who represented her at the time she pled guilty and was sentenced in 2003. In part, the prosecutor testified that, as early as 2002, he knew that “[Marugg] was not the guilty party.”

A year later, in September 2012, Marugg wrote a letter to the district attorney, asking that the People stipulate to allow Marugg to withdraw her plea. The People declined Marugg’s request in an October 2012 letter.

After gaining information in 2015 regarding what Marugg considered to be criminal behavior of one of the SCIF investigators who testified before the grand jury in May 2002, Marugg requested and obtained copies of all of the state’s records from its investigation into the activities of Alvarez Construction that led to the grand jury evidence, the indictment, and the convictions. She received the initial documents in July 2015 and retained a forensic accounting firm in November 2015.

In 2016, Marugg filed petitions for writs of error coram nobis and section 1473.7 motions to vacate her convictions. Much of Marugg’s January 2017 testimony attempts to impeach evidence presented to the grand jury in May 2002. Marugg denied portions of witnesses’ grand jury testimony, presented evidence that she contended contradicted grand jury evidence, and identified facts that she believed discredited grand jury witnesses.

Based on what she found, Marugg testified that her criminal defense attorney “completely failed to identify and present evidence that exonerated [her] as well as failed to challenge by way of motions false evidence that was presented to the Grand Jury and challenge the prosecutor’s failure to present exonerating evidence to the Grand Jury.”

The trial court denied the requested relief. The Court of Appeal gave her a second chance in the unpublished case of People v Marugg.

The major problem for Marugg was her failure to raise her concerns earlier, and/or to exercise due diligence on time. Much of what she argues in 2017 was know much earlier, and should have been known with a due diligence investigation, both prerequisites to granting her relief.

Nonetheless, the trial court procedurally failed to hold a hearing as statutorily requiredand timely requested by Marugg before ruling on Marugg’s section 1473.7 motion. The case was remanded for that purpose.

Saratoga Physician Sentenced to 63 Months

Vilasini Ganesh M.D. a Saratoga family practitioner was just sentenced to 63 months in prison for health care fraud and making false statements related to a health care benefits program.

Ganesh, and her husband orthopedic surgeon Gregory Belcher M.D., were convicted of the charges on December 15, 2017, after an eight-week trial.

The evidence at trial demonstrated Ganesh submitted a series of false medical claims related to the family medical practice she owned, Campbell Medical Group in Saratoga.

For example, Ganesh submitted claims for days when a patient had not been seen by the provider and claims for patients who had been seen by a physician provider who no longer was affiliated with her practice.

Additionally, Ganesh billed insurers with claims that certain patients were seen twelve to fifteen times in a single month.

On July 13, 2017, a federal grand jury indicted Ganesh and Belcher, charging them with one count of conspiracy to commit health care fraud, one count of conspiracy to commit money laundering, multiple counts health care fraud, and making a false statement relating to health care matters.

The jury convicted Belcher of one count of health care fraud and convicted Ganesh of five counts of health care fraud and five counts of making false statements. The jury acquitted defendants of the remaining counts.

During Ganesh’s sentencing hearing, Judge Koh stated that Ganesh obstructed justice by misrepresenting her understanding of the legal system, the amount of money she was paid by insurers, and whether she understood that it was improper to “upcharge” when submitting claims to insurers.

In addition to the prison term, Ganesh was sentenced to a 3-year term of supervised release and ordered to pay restitution in the amount of $344,916.20. Ganesh will begin serving the prison sentence on November 1, 2018.

On April 4, 2018, Judge Koh sentenced Belcher to a year and a day in prison to be followed by three years of supervised release.

Compound Med Costs Continue to Decline

Compounded medications are custom-made medications that traditionally were formulated by pharmacies for specific patients. By 2012, the practice had mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures for physicians to keep for future use.

Now utilization and costs associated with compound medications fell significantly for both managed and unmanaged claims in 2017. This welcome news is attributable to payers continuing to leverage processes that identify whether a compound is necessary and only allowing those prescriptions that appear to provide medical benefit. In addition, most states have either been considering or have already implemented formularies in part to short-circuit exorbitant compound use.

Coventry reports that managed compound costs have steadily declined for three consecutive years and fell by more than half between 2016 and 2017.

The decreases were notable in California, New York, Pennsylvania, and Texas. Each of these states saw the percentage of all claims using compounds drop by more than half for the last two years.

Unmanaged compound costs have likewise posted sharp declines. Spending has now reached the lowest level in seven years.

The same large states that logged decreases in managed compound costs also registered sizable drops in unmanaged compound costs. Eight of the top 10 states experienced at least 40% reductions in the number of injured workers using compounds. These states were Arizona, California, Connecticut, Georgia, Illinois, New York, Pennsylvania, and Texas.

More payers, prescribers and injured workers have begun to question the need for a compound over a commercially available formulation. The workers’ compensation industry has for several years highlighted the limited clinical appropriateness of compounds, their high cost and the continued instances of civil and criminal investigations into compounding.

And the Food and Drug Administration is poised to limit large scale compounding.

In 2012 there was a fungal meningitis outbreak caused by tainted steroids made by a compounding pharmacy. That prompted Congress in 2013 to pass a law aimed at bringing more compounding pharmacies, traditionally overseen by states, under FDA oversight. The law, the Drug Quality and Security Act, created a category of “outsourcing facilities” that could register with the FDA and sell products in bulk while following federal manufacturing standards.

Under this new law, the FDA on Monday proposed excluding  three substances from a list of ingredients that could be used to manufacture compounded medications in bulk for use by hospitals and doctors’ offices. The action was the first time the regulator has moved to exclude any substance from a list of ingredients that may be used to produce in bulk compounded medications that do not need to go through the agency’s safety approval process.

Congress Again Attempts MSA Reform Bill

For numerous years, a slightly varied version of essentially the same proposed legislation regarding Workers’ Compensation Medicare Set-Asides continues to be re-introduced in Congress. This year the MSA Bill was again introduced in the Senate. It is titled “Medicare Secondary Payer and Workers’ Compensation Settlement Agreements Act of 2018.”  The Bill has generally failed to gain traction and support year after year.

The MSA Bill seeks to formally legislate guidelines around the WCMSA process. Currently, the MSA and CMS review process have never been formalized in statute or legislation. All CMS guidance around protection of Medicare’s interest has been issued via administrative guidance (i.e., the WCMSA Reference Guide, CMS memoranda, etc.).

While the Medicare Secondary Payer Act (MSP) does clearly indicate that Medicare should not pay where a beneficiary has received primary payment and MSAs in settlements with Medicare beneficiaries have become a de facto Best Practice in the industry, the MSP and its corresponding regulations have never explicitly addressed the MSA and CMS approval process.

Essentially, the MSA Bill would provide formal regulatory teeth to the WCMSA approval process that never previously existed. As such, the industry has been hesitant to provide CMS extra teeth into its currently voluntary MSA review program.

When the MSA Bill was initially formulated close to ten years ago, the industry was experiencing many difficulties with CMS’ current contractor regarding inconsistencies in approvals, high/unreasonable Part D allocations in the WCMSA, and long turnaround times.

However, the current and last contractor have become more consistent in their review policies, and turnaround times are reasonable. With all necessary documentation, CMS reviews WCMSAs within 3-4 weeks. As such, there is not currently a strong desire for WCMSA reform.

That’s not to say that the CMS review process is without flaw. Overallocation of prescription drugs, particularly opioids, continues to be an issue that such over-use potentially could cause long-term health issues for the beneficiary. Further, outside of a limited Re-Review/Amended Review process, no appeal process providing full due process in our court system exists; a CMS determination is final.

Changes from the last version of the MSA Bill include: Removal of the threshold for settlements under $25k where the plan wouldn’t be considered primary (the Bill now seems to indicate there is no threshold to make a plan primary) and removal of all the Qualified MSA language (this was proposed in the prior Bill to make an MSA considered final and adequate without CMS review).

The MSA Bill provides that the MSA shall include payment for “items and services” covered by the workers’ compensation law or plan. “Items and services” are technically not prescription drugs as defined under the MSP. Does this MSA Bill seek to exclude Part D prescription drugs from the MSA? That is not clear, and this point is ambiguous in the text proposed.

Overall, the MSA Bill is vague and missing out on a number of components more pressing and needed in WCMSA Reform.

Gabapentin (AKA “Gabbies”) Addiction Abuse Rising

Doctors who are cutting back on prescribing opioids increasingly are opting for gabapentin, believed to be a safer, non-narcotic drug. The anticonvulsant is available in generic form and sold under the brand names Neurotonin and Gralise, among others. However, recreational use and abuse of the prescription drug is on the rise, and the increase has raised concern among officials in several states.

The Food and Drug Administration has approved gabapentinoids for the treatment of postherpetic neuralgia (gabapentin and pregabalin), fibromyalgia (pregabalin), and neuropathic pain associated with diabetes or spinal cord injuries (pregabalin).

Past marketing practices also help explain the growing use of gabapentinoids for various types of pain. The manufacturer (Parke-Davis, a subsidiary of Warner-Lambert, which was later acquired by Pfizer) engaged in an extensive marketing campaign to increase off-label prescribing of Neurontin for pain.

On the street gabapentin pills, known as “johnnys” or “gabbies,” which often sell for less than a dollar each, enhance the euphoric effects of heroin and when taken alone in high doses can produce a marijuana-like high.

Gabapentin is currently not a controlled substance in the United States, so federal authorities do not consider it a drug with a high potential for abuse. But recent data indicate that the drug promoted as an alternative to opioids is one to watch as gabapentin-related complications and overdose deaths are increasing.

Gabapentin is now one of the most popular prescription drugs in the United States, according to the New England Journal of Medicine. It was the 10th-most-prescribed medication in 2016. Its more expensive cousin, pregabalin, sold as Lyrica and also made by Pfizer, was the eighth best-selling.

Some states have taken note of the increase in use and are pursuing stricter measures for access to the drug.

Gabapentin was the No. 1 drug dispensed in Ohio in December 2016, according to the Ohio Board of Pharmacy. In that same year, the medication was dispensed at a greater rate than any other controlled substance. This information promoted the Ohio Substance Abuse Monitoring Network to issue an alert about the illicit use of gabapentin across the state.

Kentucky designated gabapentin as a Schedule 5 controlled substance in July 2017. The regulation requires authorized practitioners to be properly licensed and registered with the DEA before they can dispense the medication.

West Virginia is also tracking gabapentin abuse and may introduce legislation in January 2018 that would aim to classify it as a controlled substance in the state. Gabapentin has market value on the streets and it is being abused according to the definition of a scheduled drug, Dr. Brad Henry, president of the West Virginia State Medical Association, told the newspaper.

According to the Charleston Gazette-Mail, “In a recent month, West Virginia pharmacies filled prescriptions for 5.8 million gabapentin tablets – more than the combined number of doses of two popular painkillers, hydrocodone, and oxycodone.”

Ohio also has been monitoring gabapentin prescriptions for more than a year.

People who have abused gabapentin and now find themselves addicted to the drug are advised to avoid going cold turkey. Instead, a professional addiction recovery treatment program is well advised..