Category: Daily News

The Department of Industrial Relations filed a report this week on its anti-fraud efforts in the California workers’ compensation system, and announced it has stayed more than 200,000 liens worth a combined claim value of more than $1 billion. The liens are associated with 75 medical providers facing criminal fraud charges.

DIR’s efforts were bolstered by two new laws effective January . SB 1160 (Mendoza) requires DIR to automatically stay liens owned by providers who have been indicted or charged with crimes until the disposition of criminal proceedings. And AB 1244 requires the Division of Workers’ Compensation (DWC) Administrative Director to suspend any medical provider, physician or practitioner from participating in the workers’ compensation system when convicted of fraud. DWC has adopted provider suspension regulations and is now issuing notices of suspension to convicted providers.

DIR and the Department of Insurance convened working groups last June to gather stakeholder input and evidence of fraudulent activity. Participants offered a variety of observations on factors that facilitate fraud and strategies to combat it. DIR prepared a report on further recommendations to the Governor and the Legislature.

Proposed solutions included not only statutory and regulatory fixes, but also better enforcement of existing rules and procedural requirements, more information sharing and coordination among agencies, greater vigilance by insurers to identify and combat provider and premium fraud, more and better use of existing data, making examples of bad actors, greater education and transparency for the workers’ compensation system and system participants, and reviewing strategies used in other health-care systems.

The report notes that a “lien filer’s ability to get one foot inside the courthouse door creates tremendous pressure on the insurer to pay something in settlement, rather than taking on the expense of fighting or disproving a clearly invalid claim. A recent internal analysis showed that 10% of the state’s lien filers were responsible for 75% of the lien claims filed between 2013 and 2015. The top 1%, comprising 68 businesses, filed more than 273,000 liens, totaling $2.5 billion, and included five individuals who were being prosecuted or had already pled guilty to fraud. However, it remained possible to continue filing and settling liens notwithstanding fraud prosecutions and other lien-filing restrictions.”

“Over the past year, we have worked to prohibit criminal and indicted providers from lining their pockets through liens,” said DIR Director Christine Baker. “Removing fraudulent providers and their lien claims from the workers’ compensation system will further improve services to injured workers and ultimately reduce costs in the system.” DIR has posted information on its fraud prevention efforts online, including information on indicted medical providers.

DIR’s ongoing work to combat workers’ compensation fraud includes the creation of an Anti-Fraud Support Unit to share and track data from system participants. The department contracted with the RAND Corporation for an independent evaluation and recommendations, including a review of fraud detection in other federal and state health care programs. The study, currently in peer review, is slated for release this spring.

Physicians have been prohibited from referring workers for evaluation or treatment by another office or facility in which the physician has an ownership interest. And from having cross-referral or referral fee arrangements. DIR will be drafting financial interest disclosure rules to improve the transparency and tracking of ownership interests and referrals. DIR will then serve as a repository of information available for use by the workers’ compensation community, medical licensing boards, and other oversight agencies.

DIR is is also currently looking at filing data to identify physicians who consistently overbill for certain services, including through the use of incorrect billing codes, inflating the extent of time spent on an evaluation or treatment, and the “unbundling” of combined services (i.e., making separate claims for each element of service in order to increase the total amount charged).

The Department of Justice announced that McKesson Corporation, one of the nation’s largest distributors of pharmaceutical drugs, agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act (CSA).

The nationwide settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple years. The staged suspensions are among the most severe sanctions ever agreed to by a Drug Enforcement Administration (DEA) registered distributor. The settlement also imposes new and enhanced compliance obligations on McKesson’s distribution system.

In 2008, McKesson agreed to a $13.25 million civil penalty and administrative agreement for similar violations. In this case, the government alleged again that McKesson failed to design and implement an effective system to detect and report “suspicious orders” for controlled substances distributed to its independent and small chain pharmacy customers – i.e., orders that are unusual in their frequency, size, or other patterns. From 2008 until 2013, McKesson supplied various U.S. pharmacies an increasing amount of oxycodone and hydrocodone pills, frequently misused products that are part of the current opioid epidemic.

The government’s investigation developed evidence that even after designing a compliance program after the 2008 settlement, McKesson did not fully implement or adhere to its own program. In Colorado, for example, McKesson processed more than 1.6 million orders for controlled substances from June 2008 through May 2013, but reported just 16 orders as suspicious, all connected to one instance related to a recently terminated customer.  

In addition to the monetary penalties and suspensions, the government and McKesson agreed to enhanced compliance terms for the next five years. Among other things, McKesson has agreed to specific, rigorous staffing and organizational improvements; periodic auditing; and stipulated financial penalties for failing to adhere to the compliance terms. Critically, the settlement will require McKesson to engage an independent monitor to assess compliance – the first independent monitor of its kind in a CSA civil penalty settlement.

This was a multi-district investigation that involved several DEA Field Divisions including the San Francisco Field Division. Several U.S. Attorney’s Offices participated in the case including the Central and Eastern Districts of California,

This is the second reported recovery by federal authorities against a drug distributor for failing to report suspicious orders in less than a month.

Last December, a drug distributor owned by Cardinal Health Inc agreed to pay $10 million to resolve claims it failed to alert the U.S. Drug Enforcement Administration to suspiciously large orders of addictive painkillers by New York-area pharmacies.

The Kinray settlement came after a DEA investigation of pharmacies in New York and elsewhere that had ordered unusually large and frequent shipments of oxycodone or hydrocodone, according to court records.

From January 2011 and May 2012, Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor’s average sales of controlled substances to all of its customers, the lawsuit said. Kinray ignored numerous “red flags” and did not report any suspicious orders to the DEA despite requirements that it do so for such highly regulated drugs, the lawsuit said.

The latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years, according to Cardinal. The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere. The Dublin, Ohio-based company has set aside $44 million to cover those potential liabilities.

Cardinal Health, which announced its $1.3 billion acquisition of Kinray in 2010, said it continues to work with the U.S. Justice Department to resolve the matter.

The saga of Flint, Michigan, where residents suddenly found themselves drinking lead-poisoned tap water sets the stage for yet another pharmaceutical industry scandal. As the Flint water crisis unfolded one notorious pharmaceutical company saw a chance to cash in.

Valeant Pharmaceuticals raised the price of a drug used to treat lead poisoning by 2,700 percent after acquiring the drug in 2013. Before Valeant took control, the list price for a package of vials had been stable at $950. But in January 2014, Valeant boosted the price to $7,116. By December 2014, several more increases took the price to $26,927. Thus, by 2015 – as the issue of lead poisoning became prominent news – the price for a package of vials rose from $950 to $26,927.

This intravenous treatment, called Calcium EDTA, has been available for decades at a stable price, and is the most effective for severe and life-threatening cases of lead poisoning. The dramatic price increase has drawn the ire of poison control specialists and hospitals since it began.

The problem is, the drug does not have a long shelf life and is not needed in large quantities, since severe lead poisoning is relatively uncommon. This is precisely the excuse Valeant gives for its egregious price hikes, with a company spokesman saying, “The list price increases over the past several years have enabled us to provide to the market consistent availability of a product with high carrying costs and very limited purchase volume of 200 to 300 units per year.”

The greed of Valeant Pharmaceuticals – which does little more than buy up other pharma companies and raise drug prices – was celebrated by Wall St. for two years until an accounting scandal and congressional hearings began tarnishing its image.

By the end of 2015 Valeant raised prices on a number of critical brand-name drugs by an average of 66 percent – five times as much as its closest industry peers. These included Cuprimine, a decades-old drug that treats an inherited disorder called Wilson disease, and a diabetes drug called Glumetza.

Valeant relies on insurance companies and government programs to shield most patients from the skyrocketing costs, but this leads to higher premiums and co-payments, as well as an extra burden on taxpayers.

Doctors have complained to federal officials about the astronomical prices hikes for the lead-poisoning drug and others acquired by Valeant, but the problem is they are complaining to the very State that enables such exploitation through patent monopolies and barring drug imports from other countries.

“This is a drug that has long been a standard of care, and until recently it was widely accessible at an affordable price,” said Dr. Michael Kosnett, an associate clinical professor in the division of clinical pharmacology and toxicology at the University of Colorado’s School of Medicine and a consultant to the California Poison Control System, who has contacted Congress. “There’s no justification for the astronomical price increases by Valeant, which limit availability of the drug to children with life-threatening lead poisoning.”

Twenty-eight states and the District of Columbia have legalized marijuana for a variety of medical uses, and eight of those states plus the district have also legalized it for recreational use.

Now, a new report from the National Academies of Sciences, Engineering, and Medicine offers a rigorous review of scientific research published since 1999 about what is known about the health impacts of cannabis and cannabis-derived products – such as marijuana and active chemical compounds known as cannabinoids – ranging from their therapeutic effects to their risks for causing certain cancers, diseases, mental health disorders, and injuries.

The committee that carried out the study and wrote the report considered more than 10,000 scientific abstracts to reach its nearly 100 conclusions. The committee also proposed ways to expand and improve the quality of cannabis research efforts, enhance data collection efforts to support the advancement of research, and address the current barriers to cannabis research.

The committee found evidence to support that patients who were treated with cannabis or cannabinoids were more likely to experience a significant reduction in pain symptoms. For adults with multiple sclerosis-related muscle spasms, there was substantial evidence that short-term use of certain “oral cannabinoids” – man-made, cannabinoid-based medications that are orally ingested – improved their reported symptoms. Furthermore, in adults with chemotherapy-induced nausea and vomiting, there was conclusive evidence that certain oral cannabinoids were effective in preventing and treating those ailments.

But the report dismisses most of the drug’s other supposedly ‘medical benefits’ as unproven. Crucially, the researchers concluded there is not enough research to say whether marijuana effectively treats epilepsy – one of the most widely-recognized reasons for cannabis prescriptions.

The report also casts doubt on using cannabis to treat cancers, irritable bowel syndrome, or certain symptoms of Parkinson’s disease, or helping people beat addictions.

Turning to potential harms, the committee concluded:

1) Strong evidence links marijuana use to the risk of developing schizophrenia and other causes of psychosis, with the highest risk among the most frequent users.
2) Some evidence suggests a small increased risk for developing depressive disorders, but there’s no evidence either way on whether it affects the course or symptoms of such disorders, or the risk of developing post-traumatic stress disorder.
3) There’s strong evidence that using marijuana increases the risk of a traffic accident, but no clear indication that it promotes workplace accidents or injuries, or death from a marijuana overdose.
4) There’s only weak evidence for the idea that it hurts school achievement, raises unemployment rates or harms social functioning.
5) For pregnant women who smoke pot, there’s strong evidence of reduced birth weight but only weak evidence of any effect on pregnancy complications for the mother, or an infant’s need for admission to intensive care. There’s not enough evidence to show whether it affects the child later, like sudden infant death syndrome or substance use.
6) Some evidence suggests there’s no link to lung cancer in marijuana smokers. But there’s no evidence, or insufficient evidence, to support or rebut any link to developing cancers of the prostate, cervix, bladder, or esophagus.
7) Substantial evidence links pot smoking to worse respiratory symptoms and more frequent episodes of chronic bronchitis.
8) There’s weak evidence that suggests smoking marijuana can trigger a heart attack, especially for people at high risk of heart disease. But there’s no evidence either way on whether chronic use affects a person’s risk of a heart attack.
8) Some evidence suggests a link between using marijuana and developing a dependence on or abuse of other substances, including alcohol, tobacco and illicit drugs.

Currently, cannabis is the most popular illicit drug in the United States, in terms of past-month users. Based on a recent nationwide survey, 22.2 million Americans ages 12 and older reported using cannabis in the past 30 days. This survey also reports that 90 percent of adult cannabis users in the United States said their primary use was recreational, with about 10 percent reporting use solely for medical purposes. Around 36 percent reported mixed medical and recreational use. In addition, between 2002 and 2015, the percentage of past-month cannabis users in the U.S. population ages 12 and older has increased steadily from 6.2 percent to 8.3 percent.

A former Ventura County neurosurgeon has been sentenced to nearly twenty years in prison for his role in a $2.8 million health care fraud scheme in which he caused serious bodily harm to patients by performing unnecessary invasive spinal surgeries.

Aria O. Sabit M.D., 43, has a significant criminal history, dating back to 2010, while practicing at Ventura based Community Memorial Hospital. At the time Sabit was a licensed neurosurgeon in California.

Sabit admitted that, in approximately February 2010, while he was on the staff of a California Community Memorial Hospital, he became involved with Apex Medical Technologies LLC (Apex), which was owned by another neurosurgeon and three non-physicians. In exchange for the opportunity to invest in Apex and share in its profits, Sabit agreed to convince his hospital to buy spinal implant devices from Apex and to use a substantial number Apex spinal implant devices in his surgical procedures. Sabit further admitted that he and Apex’s co-owners concealed Sabit’s involvement in Apex from the hospitals and surgical centers.

As a result of these unnecessary surgeries, about 30 of Dr. Sabit’s patients sued him for malpractice. Community Memorial Hospital cut ties with Dr. Sabit in December 2010 to protect patients.

With his California career in the rearview mirror, Sabit took his practice to Detroit. His fraudulent ways were far from over, however. He convinced patients in Detroit to receive spinal fusions with metal instrumentation, but “subsequent diagnostic imaging revealed that he never installed the hardware, just bone dowels, and never achieved fusion,”.

On Nov. 24, 2014, authorities arrested Dr. Sabit. By May 2015, he pleaded guilty to four counts of health care fraud, one count of conspiracy to commit health care fraud and one count of unlawful distribution of a controlled substance, resulting in losses to Medicare, Medicaid and various private insurance companies.

In connection with his guilty plea, Sabit admitted that he derived significant profits by convincing patients to undergo spinal fusion surgeries with “instrumentation” (medical devices designed to stabilize and strengthen the spine) that he never performed and billed public and private healthcare benefit programs for those fraudulent services.

Sabit further admitted that, in some instances, he operated on patients and dictated in his operative reports – which he knew would later be used to support fraudulent insurance claims – that he had performed spinal fusion with instrumentation, when he had not. Specifically, Sabit fraudulently billed public and private health care programs for instrumentation when, in fact, he used cortical bone dowels made of tissue. Sabit failed to render services in relation to lumbar and thoracic fusion surgeries, including in certain instances, billing for implants that were not provided.

In connection with his guilty plea, Sabit admitted that the financial incentives provided to him by Apex and his co-conspirators caused him to use more spinal implant devices than were medically necessary to treat his patients in order to generate more sales revenue for Apex, which resulted in serious bodily injury to his patients. Sabit also admitted that, on a few occasions, the money he made from using Apex spinal implant devices motivated him either to refer patients for unnecessary spine surgeries or for more complex procedures that they did not need.

Sabit also is a defendant in two civil False Claims Act cases brought by the Justice Department in the Central District of California. These cases remain pending.