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The parties agreed to utilize Doctors Abeliuk, Johnson, and Lapins as AMEs in this case.

Applicant’s counsel provided defendants with draft copies of letters to the AME's asking if defendants had an objection to them. The defendants objected to all the letters and asked applicant’s counsel to redraft and send the letters back for review. But applicant’s counsel then sent these letters to the AMEs over their objections.

A hearing was set to resolve issues related to applicant’s submission of the advocacy letters.The parties specified the following issue to be decided: "Whether applicant counsel’s letter to Drs. Johnson, Abeliuk and Lapins constitutes ‘other information’ as contemplated by Labor Code § 4062.3 and 8 CCR § 35."

The WCJ found that the letters to Doctors Lapins, Abeliuk, and Johnson constituted "communications" under section 4062.3(f), rather than "information" under section 4062.3(c), and thus did not require defendants’ agreement before they were sent. Specifically, the WCJ found that section "4062.3(f) controls and when ‘communications,’ including advocacy letters, are sent to an AME, they need only be served on the opposing party."

The defendant filed a Petition for Removal. The WCJ recommended that the petition be granted "because applicant’s letter arguably constituted both a "communication" and "information" under the Labor Code, it likely should not have been served on the AMEs over defendants’ objection without an order from the WCJ." Thus the WCAB granted the Petition for Removal in the En Banc case of Maxham v California Department of Corrections and Rehabilitation Service, and return this matter the trial level for further development of the record after clarifying the law on this issue.

The Labor Code requires the parties’agreement before any "information" is provided to an AME. (Lab. Code, § 4062.3(c).) In contrast, when a party wishes to send a "communication" to an AME, it is necessary only to serve the opposing party with that communication. Obtaining the opposing party’s consent regarding a "communication" with an AME is not necessary. (Lab. Code, § 4062.3(f).)

Because of the tension between these provisions, it is important to delineate when documents and other materials provided to an AME constitute "information" rather than "communication." Section 4062.3(a) defines "information" as follows: "(1) Records prepared or maintained by the employee’s treating physician or physicians[,]" or "(2) Medical and nonmedical records relevant to determination of the medical issue."

At first blush, applicant’s advocacy letters to the AMEs should constitute "communication" because they do not fall into one of the two categories of records that characterize "information," as that term is defined in section 4062.3(a). however, that "[a] given piece of correspondence or a letter to a party, under certain circumstances, may be more than simply an act of ‘communication.’ It may also be ‘information.’ ... We have accordingly held that sub rosa video provided to a QME constituted "information" because, "Information, such as a film or video is separate from a communication and its enclosure with a communication will not transform it into a communication."

"We disagree with defendants, however, that applicant’s letters to the AMEs constitute "information" simply because the body of the letter itself included the applicant’s legal position." "...advocacy letters discussing legal positions or decisions would not constitute "information" as defined by section 4062.3(a).

Correspondence engaging in "advocacy" or asserting a "legal or factual position" can, however, cross the line into "information" if it has the effect of disclosing impermissible "information" to the AME without explicitly containing, referencing, or enclosing it. Misrepresentation of case law or legal holdings, engaging in sophistry regarding factual or legal issues, or misrepresentation of actual "information" in a case are three ways in which a party might attempt to convey purported "information" to a medical examiner to which the opposing party has not agreed. The WCJ retains wide discretion in assessing the contents of a parties’ advocacy letters to ensure parties do not serve correspondence which could confuse or misdirect the attention of a medical examiner, even if that "communication" does not expressly contain, reference, or enclose "information."

"We recognize that previous panel decisions on this issue may have created confusion regarding the precise delineation between "communication" and "information" and whether engaging in advocacy crosses that line. To the extent that those decisions do not comport with the above analysis of the dividing line between "information" and "communication," we disagree with them. Despite our previous indications to the contrary, engaging in legitimate "advocacy" does not transform correspondence with a medical examiner from "communication" into "information."" ...
/ 2017 News, Daily News
Nearly a third of middle-aged workers suffer from some level of frailty, including fatigue, issues with walking and other physical limitations that make them less able to hold a job, according to a UK study published by Occupational and Environmental Medicine.

Frailty is more often something considered when treating elderly patients, but middle-aged patients may face some of the same symptoms, the study team writes in the journal Occupational and Environmental Medicine. Physical frailty leaves many people out of work entirely, while others take a lot of days off or struggle with physical demands, especially in manual labor jobs, the research team writes.

To examine the link between frailty and employment, researchers recruited more than 8,000 people in their 50s and early 60s from 24 English general practices.

Overall, the researchers classified 4 percent of participants as frail, based on having three to five of the frailty symptoms, while nearly a third of participants were considered "pre-frail" because they reported one or two of the frailty symptoms.

Frailty was tied to a large impact on employment. Three-quarters of frail people were not working at all and 60 percent had left their last job on health grounds. Compared with non-frail people, frail people were 30 times more likely to lose their jobs. Frail people were nearly 11 times more likely to have been out of work on prolonged sick leave in the past year, compared with healthy workers. Frail workers were also over 17 times more likely to report needing to cut down a lot on work in the past year, compared with non-frail workers. Workers considered to be frail were nearly 15 times more likely to have difficulty coping with physical demands at work and to be unsure if they would be able to continue work in two years. The pre-frail workers were also at higher risk of bad outcomes compared to healthy counterparts, but their risk was not as extreme as that of frail people.

Frailty had the biggest impact on blue collar manual workers rather than office workers, although the office workers still saw a significant effect, researchers note.

"Older workers are more likely to be physically vulnerable than younger workers," said Lucie Kalousova, a researcher at the University of Michigan who studies frailty among workers.

Despite this, frailty is preventable and can be reversed, said Kalousova, who was not involved in the study. "Though medical science is not yet fully clear on the best ways to prevent frailty, it may be delayed or forestalled by regular exercise and a nutritious diet," Kalousova said by email. Although it is difficult to pinpoint the causes of frailty, research shows that for elderly people, exercise programs focused on balance and strength and attention to diet can improve health outcomes, Palmer noted ...
/ 2017 News, Daily News
A federal judge Monday temporarily blocked the proposed $37 billion mega-merger between health insurance industry giants Aetna and Humana, ruling that the transaction would reduce competition for consumers.

Although the antitrust decision can be appealed, the outcome could have significant ramifications on how older Americans purchase government Medicare and private Medicare Advantage coverage in the rapidly changing U.S. healthcare market, as well as on the options available to individuals who don't have employer coverage.

The ruling marks a significant setback for the companies, which in July announced the proposed deal to create the largest seller of Medicare Advantage plans, covering more than 4.1 million seniors. Humana could get a $1 billion breakup fee from Aetna if the deal ultimately falls through.

"In this case, the government alleged that the merger of Aetna and Humana would be likely to substantially lessen competition in markets for individual Medicare Advantage plans and health insurance sold on the public exchanges," U.S. District Court Judge John Bates wrote in his 156-page ruling. "After a 13-day trial, and based on careful consideration of the law, evidence, and arguments, the court mostly agrees."

The judge based his decision enjoining the merger on evidence of "overwhelming market concentration figures" the merger would generate, plus findings of head-to-head competition between Aetna and Humana that would be eliminated if the deal were finalized.

The decision represents legal vindication for the Justice Department, which was joined by eight states and the District of Columbia in opposing Hartford, Conn.-based Aetna's proposed takeover of Louisville, Ky.-based Humana during the Obama administration. Eight states and the District of Columbia joined the federal action.

The companies contended the deal would not lessen competition. They also said their complementary strengths in technology and relationships with health care providers would benefit consumers. But, calling those arguments "unpersuasive," Bates's ruling concluded that federal regulation would be insufficient to keep the merged firms from raising prices or cutting benefits. The judge also ruled that neither new health insurance competitors nor business divestitures the companies proposed to address antitrust concerns would replace competition eliminated by the merger.

"Today’s decision is a victory for American consumers - especially seniors and working families and individuals," Deputy Assistant Attorney General Brent Snyder, the current head of the Justice Department’s Antitrust Division said in an official statement. "Millions of consumers have benefited from competition between Aetna and Humana, and will continue to benefit, because of today’s decision to block this merger."

In response, Aetna spokesman T.J. Crawford said "we're reviewing the opinion now and giving serious consideration to an appeal, after putting forward a compelling case" in the non-jury antitrust trial heard by Bates in December ...
/ 2017 News, Daily News
The largest lobbying organization for pharmaceutical companies began running TV ads on Monday morning to improve the industry's image as criticism from U.S. President Donald Trump increases.

The industry is touting developments in science by pharmaceutical companies and will spend "tens of millions" on television commercials, according to an announcement on Monday by officials of lobbying group PhRMA. A spokesman did not provide a specific amount.

Pharmaceutical companies may be facing their most difficult time ahead as criticism about the price of drugs continues to increase. In a news conference this month, Trump said drug manufacturers were "getting away with murder" because of their pricing.

Additionally, drug manufacturers were considered winners when the Affordable Care Act became law because more people had increased access to prescriptions. A repeal of the law often known as Obamacare could mean many people losing insurance could not afford to purchase drugs.

PhRMA CEO Stephen Ubl cast the "Go Boldly" campaign as an effort to refocus the discussion about the strides in research. But he acknowledged the industry was at the center of criticism.

According to the PhRMA press release "The campaign will include national TV, print, digital, radio and out-of-home advertising. A new website, GoBoldly.com, will provide visitors with more information about the topics and themes featured in campaign advertisements, and a redesigned Innovation.org will provide in-depth information about exciting advances in biopharmaceutical innovation. #GoBoldly will be used across social media platforms to salute the sheer will and tenacity of patients and scientists fighting against disease every day."

"We take the concerns that have been raised by the president very seriously," Ubl said. "We think there are pragmatic policy solutions, and we look forward to working with the administration."

While outspoken while the Affordable Care Act was being drafted, PhRMA has largely remained quiet during the early discussions about whether the law should be repealed and replaced.

Planning for the group's campaign began six months ago, well before the November presidential election, according to spokesman Robert Zirkelbach. Like many organizations, the group signaled it expected Democrat Hillary Clinton was going to win and began planning to push back at her calls for capping drug prices. It continued with plans for the campaign, which Ubl said would have been the same had Clinton won, even after Trump was elected.

The group also released a four-part regulatory and legislative agenda that it said would be part of an extensive lobbying campaign, including advocating for changes to the Food and Drug Administration and the ability for drugmakers to coordinate with insurance companies when developing new treatments.

The campaign makes almost no mention of the repeal of Obamacare. "(This campaign) is not aimed at any one legislative issue," Ubl said ...
/ 2017 News, Daily News
NBC Bay Area has been highly critical of the California workers' compensation medical delivery system in a string of articles dating back to mid 2016.

Its thesis has been that "Many injured workers and their doctors say the California workers’ compensation system is dragging out their medical care, making it difficult to recover and get back on the job."

The Investigative Report essentially was based upon anecdotal accounts of perhaps a dozen cases that it says leads to its conclusion that "Injured workers across California say the workers’ compensation system is dragging out or denying the medical care needed to get them back to work. Those workers say they feel trapped in the sprawling labyrinth of a system, battling insurance companies and navigating through red tape instead of getting well."

But now the director tasked with administering California’s workers’ compensation system respondes to the criticism.

Christine Baker, the director of the Department of Industrial Relations, defended the system, saying reforms made four years ago improved access to medical treatment and helped contain costs. She also credits a new law enacted in January for further strengthening the system.

The major changes launched in 2013 under SB 863 emphasized evidence-based medicine and shifted treatment decisions from the courts to medical reviewers using state-approved guidelines to authorize or deny treatment requests. According to Baker, the changes are paying off.

"Benefits are going to workers, treatment has been sped up and appropriate treatment is being approved," she said. "It is overall an improvement to the workers’ comp system, which is very complex."

According to recent estimates, the reforms also cut costs to the nation’s most expensive workers’ comp system by more than a billion dollars per year.

NBC Bay Area responded to her assertion with more anecdotal accounts saying "many doctors and attorneys who represent injured workers told NBC Bay Area the savings have come at a price. They say denials have reached all-time highs. They believe the guidelines touted by state administrators are too rigid and don’t always keep up with modern treatment techniques".

Baker rejects those claims.

"Ninety-five percent of medical care decisions are approved," Baker said. "There are a few that don’t get approved and it could be that it’s inappropriate care or the doctor didn’t document the requirements for care."

NBC refutes Baker's claim. "But the data cited by Baker is impossible to verify. Until this year as a result of new reforms, the state has not collected data on the number of medical treatment requests that are approved or denied by insurers."

"Instead, state administrators point to studies published by the California Workers’ Compensation Institute. The research group relies on data voluntarily provided by its members - insurance companies - which is not made available for public inspection."

Baker said she’d have to look at these individual cases to understand why they faced denials, but reiterated the majority of the 250,000 workers who go through the system each year get satisfactory results.

"Most people are not stuck," Baker said. "Most get back to work. Most people are getting their treatment."

Baker said the state is also coordinating an outreach effort to help doctors understand how to properly document a request for a specific course of treatment, which she expects to further reduce denials.

"It’s an education piece and the Division of Workers’ Compensation is working hard at getting information and educational information about treatment guidelines on our website and how to use them," Baker said. "We’re hoping the holistic approach will overall really make improvements to workers’ comp in California."
...
/ 2017 News, Daily News
As deaths from powerful painkillers continue to rise, Canada is pursuing unprecedented measures to curb their use, including requiring cigarette-style warning stickers on every prescription, Health Minister Jane Philpott told Reuters.

Next month Health Canada plans to publish a detailed proposal for the stickers, which Philpott said would warn that opioid painkillers can cause addiction and overdose. In March, an advisory panel is set to consider a second measure, revising the official label definition of how opioids should - and should not - be used, officials said.

Any revision would affect marketing efforts by manufacturers, including privately held Purdue Pharma and Pharmascience, as well as publicly traded Teva Pharmaceuticals Industries, Mallinckrodt Plc, Novartis's Sandoz and Johnson & Johnson’s Janssen Pharma.

Warning stickers would be a first and could serve as an example. The measures would follow other strategies that failed to stem addiction and death involving prescription opioids, such as OxyContin and Hydromorph Contin, as well as illicit ones, including heroin and powerful fentanyl smuggled from China.

Fatal overdoses have increased across Canada, mirroring the much larger epidemic in the United States. Philpott has called the opioid epidemic the nation’s greatest public health crisis and pledged to use every tool at her disposal to fix it. "We’re concerned when opioid prescriptions are on the increase," she told Reuters. "We need to understand what’s behind that and make wise recommendations."

Drug companies have said they support measures to increase patient safety. Several companies and industry groups declined to comment until the government lays the new proposals.

Some doctors and public health experts who have long clamored for safeguards said the new measures may be too little, too late. "Stickers may have been helpful in 2006, 2007," said Edmonton, Alberta, addiction doctor Hakique Virani. "But when we’ve created this huge demand for opioids that is now being met by powder from China, and you can traffic a million doses of that stuff in a 10-gram greeting card envelope, I’m sorry, but stickers on pill bottles is not going to solve this problem."

In an effort to address Canada's drug problem, health officials made it more difficult to obtain OxyContin after Purdue introduced a tamper-resistant formulation of the drug in 2012. But physicians and addicts switched to different drugs. Illegal fentanyl flooded Canada’s streets, and doctors began prescribing more Hydromorph Contin, which has eclipsed oxycodone and fentanyl as the most commonly prescribed opioid in Ontario, B.C., Alberta, Saskatchewan and Quebec.

Canadian and U.S. public health advocates have campaigned unsuccessfully to restrict the long-term use of any opioid for non-cancer pain.

"The best available evidence does not support their use for treatment of chronic pain," said David Juurlink, an addiction specialist at Toronto’s Sunnybrook Health Sciences Center.

The U.S. Centers for Disease Control and Prevention released non-binding guidelines last year cautioning against the use of long-acting opioids as first-line treatment for chronic pain and urging low initial doses and discontinuation as soon as possible.
...
/ 2017 News, Daily News
The World Economic Forum (WEF) is a Swiss nonprofit foundation, based in Cologny, Geneva. The flagship event of the foundation is the invitation-only annual meeting held during the winter at the end of January in Davos, Switzerland, bringing together chief executive officers from its 1,000 member companies, as well as selected politicians, representatives from academia, NGOs, religious leaders, and the media in an alpine winter environment.

Among the many speakers at the 2017 Davos event was Vice President Joe Biden. Also at this years Davos event, leaders of the global pharmaceutical industry, blasted by incoming U.S. President Donald Trump for "getting away with murder" on drug prices, are putting a brave face on the challenges in their biggest market.

The following are comments from chief executives on U.S. pricing prospects, based on Reuters interviews at this week's Forum in Davos:

JOE JIMENEZ, NOVARTIS: "The new administration has been pretty vocal about supporting innovation. They understand that when you spend money on research and you develop intellectual property there needs to be some level of return for that investment. I believe, based on who the president-elect has put in place around him, that there is a clear understanding of investment and return on investment."

KEN FRAZIER, MERCK & CO: "Pricing will remain a challenging issue for those of us who are in the research-based pharmaceutical industry, as well as a challenge for the overall healthcare system in terms of what it can afford." "The tweets will be what they will be, but the subject matter of the tweets has been a challenge before the election and I think it will remain a challenge after the election."

ANDREW WITTY, GLAXOSMITHKLINE: "Clearly, the industry has an obligation to deliver value-creating innovation and it needs to price it at a level that is deemed to be acceptable." "Industry has to price in an empathetic way. Just because you can demonstrate value doesn't mean it is affordable."

SEVERIN SCHWAN, ROCHE: "If you provide true medical differentiation coupled with a strong intellectual property position, I think the U.S. will continue to reward this kind of innovation. If you don't offer that then, frankly, I think it is the right thing that prices should come down."

OLIVIER BRANDICOURT, SANOFI: "It's very difficult to understand what all those comments and tweets will end up being." "It's going to probably be very difficult to issue legislation on drug pricing."

FLEMMING ORNSKOV, SHIRE: "I think we are in good position to prove the value of our products but, of course, there will be challenges." ...
/ 2017 News, Daily News
Santa Barbara County District Attorney Joyce E. Dudley announced the release of a Public Service Announcement as part of the "District Attorney's Office Anti-Workers Compensation Fraud" program.

This Public Service Announcement comes at no cost to Santa Barbara County. It was created by the Santa Barbara County District Attorney's office with State funds in an effort to reduce pay outs for fraudulent Workers Compensation claims in Santa Barbara County.

The 30-second Public Service Announcement will be broadcast throughout Santa Barbara County. According to District Attorney Dudley, "The purpose of this Public Service Announcement is to raise awareness about Workers Compensation fraud, its impact on all of our Jives and how to report a potential violation.

Workers Compensation fraud is an escalating statewide problem which includes fraudulent claims by workers, medical providers and fraud committed by employers who fail to provide Workers Compensation Insurance. Further, Workers Compensation Fraud has had an impact on our local governmental, and non-profit agencies as well as small businesses and individuals."

District Attorney Dudley concluded by noting that, "All of the costs associated with the production and presentation of this Public Service Announcement came from grant funding from the State of California under the guidance of the California Department of Insurance and the Workers Compensation Fraud Assessment Commission." ...
/ 2017 News, 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) ...
/ 2017 News, Daily News
A new study published in the Journal of the American College of Surgeons and summarized by Reuters Heatlh claims that more aggressive malpractice climates do not necessarily protect patients from surgical complications.

Supporters of medical malpractice laws that make it easier for patients to sue doctors say these protections are necessary to improve care. But in the current study, the risk of litigation did not translate into better outcomes, said study leader Dr. Karl Bilimoria, director of the Surgical Outcomes and Quality Improvement Center at Northwestern University's Feinberg School of Medicine in Chicago.

"It doesn’t really work - malpractice environment doesn’t influence doctors to provide better care," Bilimoria said by email. "Rather, it may lead to defensive medicine practices where more tests and treatments are ordered unnecessarily just to try to minimize malpractice risk."

Bilimoria and colleagues examined state-specific data on medical malpractice insurance premiums, average award size and the number of claims for every 100 physicians in each state as of 2010.

During the study period, the average annual malpractice premium for general surgeons was roughly $47,000.

More aggressive malpractice laws and larger malpractice awards did not reduce patients’ risk for any of the postoperative complications studied. No individual state malpractice law was consistently associated with improved post-operative outcomes.

Instead, in states where doctors faced greater risk from malpractice claims, patients were 22 percent more likely to develop sepsis, a potentially life-threatening bloodstream infection, the study found. Patients in states where doctors had the most litigation risk were also 9 percent more likely to develop pneumonia, 15 percent more likely to suffer acute kidney failure and 18 percent more likely to have gastrointestinal bleeding.

The results add to a growing body of evidence suggesting that tort reforms aren't associated with better outcomes, said Michelle Mellow, a law professor at Stanford University in California who wasn't involved in the study. "This study contributes further evidence that liability pressure doesn't spur doctors to get better results for patients, but neither does adopting reforms to limit liability," Mellow said by email.

It's not surprising that the study didn't find a consistent link between malpractice environment and surgical complications because these associations can be specific to certain procedures or fields within medicine, said Dr. William Sage, a law and medicine professor at the University of Texas at Austin who wasn't involved in the study.

Some previous research suggests that one type of law, that compares doctors' results against national averages, can help improve outcomes in below-average states, said Dr. Anupam Jena, a researcher at Harvard University in Boston who wasn't involved in the study.

"Changing the standards against which physicians are judged, either by ensuring that all states adopt national standard laws, or using administrative courts that hold physicians to a pre-specified clinical standard, are ways that I think the malpractice system can be leveraged to improve quality," Jena said by email ...
/ 2017 News, Daily News
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 ...
/ 2017 News, Daily News
Division of Workers’ Compensation (DWC) Acting Administrative Director George Parisotto has appointed Deborah A. Whitcomb, workers’ compensation administrative law judge at the Stockton DWC district office, to serve as a member of the Workers’ Compensation Ethics Advisory Committee. The appointment is effective January 1, 2017.

Judge Whitcomb will fill the position designated for a workers’ compensation administrative law judge, replacing Tim Haxton.

The ethics advisory committee, established in 1995 by Title 8, California Code of Regulations, section 9722, reviews all ethics complaints from the public against workers' compensation administrative law judges.

The committee reviews all complaints without learning the names of complainants or judges, and then makes recommendations to the administrative director and the DWC court administrator. The committee meets quarterly and members serve without compensation.

The regulation provides that the committee must include three members of the public representing organized labor; insurers and self-insured employers, an attorney who formerly practiced before the Workers' Compensation Appeals Board and who usually represented insurers or employers, an attorney who formerly practiced before the Workers' Compensation Appeals Board and who usually represented applicants, a presiding judge, a workers’ compensation administrative law judge (WCALJ) or retired WCALJ, and two members of the public outside the workers' compensation community.

A judicial ethics complaint form and instructions can be found on the DWC website ...
/ 2017 News, Daily News
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." ...
/ 2017 News, Daily News
President-elect Donald Trump said last week that pharmaceutical companies are "getting away with murder" in what they charge the government for medicines, and promised that would change, sending drugs stock prices sharply lower.

The benchmark S&P 500 index .SPX slipped into negative territory after his remarks at a news conference spooked investors. The iShares Nasdaq Biotech ETF (IBB.O) dropped 4 percent at its session low and ended down 3 percent, its largest daily percentage drop in three months.

"When the president-elect says we're going to negotiate drug pricing, you have to take that seriously, but at the same this is a complicated issue because there's not going to be clarity on drug pricing reform anytime soon," said Brad Loncar, manager of the Loncar Cancer Immunotherapy ETF (CNCR.O). "When somebody that high profile says something that negative, people do not want to invest in it."

After his promise to bring down drug spending, the ARCA pharmaceutical index gave up as much as 2.6 percent and ended the day down 1.7 percent.

The drug industry has been on edge for two years about the potential for more government pressure on pricing after sharp increases in the costs of some life-saving drugs drew scrutiny in the press and among lawmakers. The government is investigating Medicaid and Medicare overspending on Mylan NV's (MYL.O) allergy treatment EpiPen, for instance.

David Katz, chief investment officer at Matrix Asset Advisors in New York, said negative comments on drug pricing trigger selling both from algorithms and investors who suffered from share drops when Democrat Hillary Clinton campaigned against healthcare cost increases.

Trump's campaign platform included allowing the Medicare healthcare program to negotiate with pharmaceutical companies, which the law currently prohibits. He has also discussed making it easier to import drugs at cheaper prices.

"We are going to start bidding. We are going to save billions of dollars over time," Trump said.

Medicare, which covers more than 55 million elderly or disabled Americans, spent $325 billion on medicines in 2015.

Industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA President Stephen Ubl said "Medicines are purchased in a competitive marketplace where large, sophisticated purchasers aggressively negotiate lower prices."

He said the industry is "committed to working with President-elect Trump and Congress to improve American competitiveness and protect American jobs."

But Speaker of the House, Paul Ryan did not quite seem to be on board with the Trump agenda. He said that he wants to "have more conversations about" Trump’s efforts to crack down on Big Pharma corruption before the president-elect - soon to be president- does so. "I believe that the current premium support system with Part D works extremely well," Ryan said. "I think there’s some real success stories - and I think we need to tell that story."

Yet Democrats seem to be urging Trump to move forward. Sens. Sherrod Brown and Al Franken are leading a letter to President-Elect Donald Trump last month, urging him to prioritize prescription drug price reform and saying that Senate Democrats are standing by to partner with his administration.

"During your campaign, you promised to address the high prescription drug prices that the vast majority of Republicans and Democrats expressed as a top concern in the election," Brown, Franken and 17 other Democrats write. "In this letter, we have listed tangible ways your Administration can lead bipartisan work on this issue."

...
/ 2017 News, Daily News
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 ...
/ 2017 News, Daily News
After survivors of the December 2, 2015 San Bernardino terrorist attack brought their problems with receiving timely medical treatment to the Board of Supervisors, county leaders pointed to workers' compensation. Now, the county has formed a task force, it says, set on mending issues with the statewide system beyond just those experienced by the attack survivors.

In conjunction with San Bernardino County's employee associations and unions, the county will "work with them to identify issues they're experiencing, their members are experiencing and see about suggestions for addressing those issues," county CEO Greg Devereaux said Tuesday.

The Victorville Daily Press reports that the task force is the latest effort by the county to deal with criticism levied by public health workers in November over delayed treatment received following the terrorist attack at the Inland Regional Center on Dec. 2, 2015, where 14 died and 22 more were injured.

As of late November, 18 employees in the county's Department of Public Health had filed for workers' compensation and officials had anticipated 36 more cases at that time. Public records showed the cases reflected physical, emotional and/or mental distress.

Last month, Supervisors hired a firm to provide enhanced nurse case management and system navigation services to county employees injured in the attack.

The county said it had found many of the issues raised by employees stemmed from the county not receiving supporting documentation from their treatment providers.

Supervisors Josie Gonzales and Janice Rutherford suggested that the task force, and the Dec. 2 attack generally, could springboard efforts to address the workers' compensation system as a whole. Gonzales added that "we have found that, in fact, the system works very much against the very solution and benefit that, again, originally was intended or that is needed."

"... I find this a great opportunity for us to take a leadership role to a great deal of frustrations that I'm sure other agencies, other boards, groups and employees have found challenging," she said, "but did not have the catalyst behind them to actually throw the doors open of this situation and say, 'hey, let's take a good and closer look.'"

Devereaux said the task force had already endorsed the wider review of the system.

"That's really the focus, it's the whole system for all employees," he said. "Dec. 2 and the impacts on those employees is what brought it to our attention, but it really is, we are looking at it more broadly."

He said the task force will regularly report back to the board. Supervisor Curt Hagman said he appreciated a turn toward proactiveness.
...
/ 2017 News, Daily News
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 ...
/ 2017 News, Daily News
Following four recent tree-trimming workplace fatalities, Cal/OSHA is reminding workers and employers in this high-risk industry to take precautions to avoid accidents.

Cal/OSHA is investigating the four deaths, which occurred over the last six weeks, and has launched a statewide safety awareness campaign for tree service companies, landscapers and other businesses.

The four tree-trimming deaths under investigation include:

1) a worker in Mariposa County who was struck by a branch on December 1
2) a worker in San Bernardino County who suffocated when dry palm fronds collapsed and trapped him on December 4
3) a worker in Los Angeles County who fell approximately 60 feet when the branch he was tethered to broke on January 6
4) a worker in Siskiyou County who was struck by the tree he was cutting to clear power lines on January 9

"Cal/OSHA’s safety awareness campaign aims to protect the lives of tree service workers," said Cal/OSHA Chief Juliann Sum. "Employers in this high-risk industry need to be aware of, and take steps to minimize, the hazards to their workers. We will cite employers that are not in compliance with safety requirements."

Cal/OSHA investigated nearly 70 accidents involving tree work, including trimming or removal services, in the two-year period between October 1, 2014 and September 30, 2016. Nearly three out of four of these accidents (74%) resulted in a worker hospitalization, and 12 of the accidents involved the death of a worker.

As part of the Tree Work Safety Emphasis Program, Cal/OSHA inspectors throughout the state who observe unsafe tree trimming or tree removal operations will investigate possible violations. Inspectors will also respond to reports of unsafe operations.

The major causes of tree trimming injuries and fatalities include falls, electrical shock, being struck by a tree branch, chainsaw lacerations, palm tree skirt collapses and ladder accidents. For example, on December 30, 2015, a Wright Tree Service worker in Humboldt County accidently cut the lanyard used to secure himself to a tree and fell 54 feet to his death. The investigation revealed the employer failed to ensure the worker was using a required second point of attachment in his security system while he was operating a chain saw in a tree.

Cal/OSHA has resources available to help employees and employers prevent accidents like these, including a Tree Work Safety Guide, fact sheet and checklist ...
/ 2017 News, Daily News
Simon Hong (who is also known as Seong Wook Hong), 55, a Brea man, who operated rehabilitation clinics in Walnut, Torrance and Los Angeles and defrauded Medicare out of approximately $3 million by billing for unneeded or unnecessary services has been sentenced to 121 months in federal prison.

Hong was found guilty in October of eight counts of healthcare fraud, nine counts of illegal kickbacks related to healthcare referrals and two counts of aggravated identity theft.

Hong owned physical therapy clinics operated by companies called Hong’s Medical Management, Inc., CMH Practice Solution, and HK Practice and Solution, Inc. As part of the scheme, Hong recruited Medicare beneficiaries and provided uncovered services like massage and acupuncture for them. Even though the beneficiaries did not receive actual physical therapy, Hong’s co-conspirators billed Medicare for physical therapy, and then funneled 56 percent of the reimbursement funds back to Hong.

Through this scheme Hong and his co-conspirators billed Medicare from the spring of 2009 until November 2013 and received approximately $2,929,775 in reimbursements, of which Hong received approximately $1,640,674. Hong was ordered to pay $2,929,775 in restitution.

Hong is one of 10 defendants who were charged in 2015 and early 2016 for healthcare fraud related to physical therapy. Eight others have pled guilty, and one, David Y. Kim, 54, of Los Angeles, remains a fugitive. Those previously convicted in the investigation are:

1) Joseff Sales, 39, of Buena Park, a co-owner and operator of Rehab Dynamics, who pleaded guilty to one count of healthcare fraud and one count of illegal kickbacks, and was sentenced last year to 51 months in prison;

2) Danniel Goyena, 39, of Buena Park, a co-owner and operator of Rehab Dynamics, who pleaded guilty to two counts of healthcare fraud and was sentenced last year to 51 months in prison;

3) Marlon Sonco, 39, of Sylmar, who pleaded guilty in June 2015 to conspiracy and is scheduled to be sentenced on January 23;

4) Eddieson Legaspi, 40, of Lomita, an employee of Rehab Dynamics, pleaded guilty to conspiracy to commit healthcare fraud and also was sentenced yesterday to 15 months;

5) Ohun Kwon, 50, of Fullerton, the owner/operator of E.K. Medical Management, which referred patients to Rehab Dynamics, pleaded guilty to conspiracy to commit healthcare fraud and was sentenced last year to 27 months in federal prison;

6) Leovigildo Sayat, 39, of Torrance, an employee of RSG Rehab, pleaded guilty to conspiracy to commit health care fraud and was sentenced last year to two years in prison;

7) Byong Chun "David" Min, 68, of Irvine, co-owner/operator of Glory Rehab Team, which operated as Dream Hospital in Orange County, who pleaded guilty to healthcare fraud and illegal kickbacks, also was sentenced yesterday to 45 months in prison; and

8) Jason S. Min, 35, of Irvine, David Min’s son, who was the other owner/operator of Glory Rehab, pleaded guilty last year to obstruction of justice and is scheduled to be sentenced on February 6.

These individuals should be precluded from recovery of any bills or liens that may be pending in California Workers' Compensation cases as a result of new law that took effect this year.

In a separate case, Hong pleaded guilty last month to conspiracy to commit health care fraud in another scheme involving occupational and physical therapy services that were never provided to Medicare beneficiaries. Medicare suffered losses of approximately $2.4 million in relation to this scheme. Hong is scheduled to be sentenced in this case in Los Angeles federal court by United States District Judge George Wu on March 6 ...
/ 2017 News, Daily News
The U.S. Department of Justice announced that 56 year old Randy Crowell plead guilty to fraudulently distributing more than $100 million worth of prescription drugs obtained on a nationwide black market. Crowell used a Utah-based wholesale distribution company to sell illicitly procured drugs to pharmacies, which in turn dispensed them to unsuspecting customers.

Crowell, purchased more than $100 million worth of prescription medications from a sinister black market chain at a fraction of the legitimate prices for these drugs, before selling the same as new, legitimate bottles of medication to legitimate licensed pharmacies all over the country. To maximize profits, Crowell and his co-conspirators focused on some of the most expensive medications on the market, including those used to treat HIV/AIDS.

Scheme participants targeted the cheapest possible source of supply for these drugs - Medicaid patients and other individuals who received these prescription drugs on a monthly basis for little or no cost, and who were then willing to sell their medicines rather than taking them as prescribed.

These Insurance Beneficiaries had prescriptions filled for medications each month at pharmacies across the country. And then sold their medications to low-level participants ("Collectors") in the scheme who worked on street corners and bodegas and would pay cash - typically as little as $40 or $50 per bottle.

Because the ultimate goal of the scheme was to resell these medications as new at full price, Collectors and other scheme participants used lighter fluid and other potentially hazardous chemicals to remove the patient labels affixed when the bottles were initially dispensed to the Insurance Beneficiaries. This process, referred to as "cleaning" the bottles, was dangerous, as these hazardous chemicals could infiltrate the bottles, rendering the medication unfit for human consumption.

Collectors then sold these second-hand drugs to higher-level scheme participants ("Aggregators") who bought dozens, and sometimes hundreds, of bottles at a time from multiple collectors before selling them to higher-level scheme participants with direct access to legitimate distribution channels, including corrupt wholesale companies like Crowell's accomplices.

The corrupt wholesale companies then resold the bottles as new, at full price, to pharmacies, including potentially the very same pharmacies that initially dispensed these medications.

Crowell and others acting at his direction created false and fraudulent documents known as "pedigrees" for these medications, which purported to document the legitimate movement of these medications bought and sold by them.

Crowell pled guilty to one count of conspiracy to commit health care fraud, which carries a maximum term of 10 years in prison. As a part of the plea, Crowell also consented to the forfeiture of more than $13 million in scheme proceeds, including the full contents of his primary operating account.

Crowell will be sentenced on May 11, 2017, at 12:30 ...
/ 2017 News, Daily News