Author: WorkCompAcademy

Security researchers at Symantec say a group of hackers has been targeting firms related to health care. Symantec has identified a previously unknown group called Orangeworm that has been observed installing a custom backdoor called Trojan.Kwampirs within large international corporations that operate within the healthcare sector in the United States, Europe, and Asia.

First identified in January 2015, Orangeworm has also conducted targeted attacks against organizations in related industries as part of a larger supply-chain attack in order to reach their intended victims. Known victims include healthcare providers, pharmaceuticals, IT solution providers for healthcare and equipment manufacturers that serve the healthcare industry, likely for the purpose of corporate espionage.

Based on the list of known victims, Orangeworm does not select its targets randomly or conduct opportunistic hacking. Rather, the group appears to choose its targets carefully and deliberately, conducting a good amount of planning before launching an attack.

According to Symantec telemetry, almost 40 percent of Orangeworm’s confirmed victim organizations operate within the healthcare industry. The Kwampirs malware was found on machines which had software installed for the use and control of high-tech imaging devices such as X-Ray and MRI machines. Additionally, Orangeworm was observed to have an interest in machines used to assist patients in completing consent forms for required procedures. The exact motives of the group are unclear.

Once Orangeworm has infiltrated a victim’s network, they deploy Trojan.Kwampirs, a backdoor Trojan that provides the attackers with remote access to the compromised computer. The backdoor collects some rudimentary information about the compromised computer including some basic network adapter information, system version information, and language settings.

Orangeworm likely uses this information to determine whether the system is a high-value target. Once Orangeworm determines that a potential victim is of interest, it proceeds to aggressively copy the backdoor across open network shares to infect other computers.

At this point, the attackers proceed to gather as much additional information about the victim’s network as possible, including any information pertaining to recently accessed computers, network adapter information, available network shares, mapped drives, and files present on the compromised computer.

Tshombe Anderson, 55, of Grand Prairie, Texas, was sentenced to 120 months in federal prison and ordered to pay $26,572,458.93 in restitution for his role in a scheme he ran along with his family members to fraudulently obtain more than $26 million from the Department of Labor, Office of Worker’s Compensation Programs.

Anderson pleaded guilty in August 2017 to one count of conspiracy to commit health care fraud.  Anderson agreed to forfeit $375,000 seized from his residence, a 2015 Mercedes, and his share of the $8,383,075 that was seized from 25 bank accounts. Anderson has been in custody since the time of his arrest in August 2015.

In addition to Anderson, his sister Lydia Bankhead, 63, his wife Brenda Anderson, 47, and his niece Lydia Taylor, 30, were also charged in the indictment returned in September 2015 and pleaded guilty to their roles in the scheme.  

“Tshombe Anderson and others conspired to defraud the U.S. Department of Labor’s Office of Workers’ Compensation Programs of more than $26 million. Anderson stole patient information from over 200 injured federal workers and then used the information to fraudulently bill OWCP, enriching himself and others with taxpayer dollars intended for the treatment of injured federal workers. We will continue to work with our law enforcement partners to safeguard all Department of Labor programs,” said Steven Grell, Special Agent in-Charge of the Dallas Regional Office of the U.S. Department of Labor, Office of Inspector General.

According to plea documents in the case, Tshombe Anderson worked as an attorney for Union Treatment Centers (UTC).  Anderson and his wife, Brenda Anderson, opened a durable medical equipment company called Best First Administration (BFA).  BFA was formed, initially, to provide durable medical equipment to patients referred to BFA from UTC.  In July 2011, Tshombe Anderson and Brenda Anderson disassociated from UTC.

In April 2013, Tshombe Anderson agreed with Bankhead to open Union Medical Supplies and Equipment (UMSE).  In August 2013, Tshombe Anderson opened Skycare Medical Supplies and Equipment (SMSE).  Both companies were created in order to submit claims that were inappropriate to OWCP.  The same medical information that BFA had received from UTC was used and billed to the same universe of claimants for duplicate, unwanted durable medical equipment that was not medically necessary, using outdated medical information.  

Tshombe Anderson continued to do so despite knowing that they were billing OWCP for items that were not associated with the claimant’s injuries and that claimants were often refusing or rejecting the durable medical equipment for which their company had billed.  

Tshombe Anderson had access to the operating accounts for UMSE and routinely transferred large sums of cash from those accounts for his personal use or to launder through business accounts for a shell company called American Federal Union Claims Advocates, as well as accounts associated with his law office.

An advisory panel to the U.S. Food and Drug Administration unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma. According to the story in Reuters, the drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and an FDA decision is expected by June 27.

The syrup contains less than 0.1 percent of tetrahydrocannabinol (THC), the substance that makes people high.

The FDA panel found that the drug’s benefits outweighed the risks to treat patients aged 2 years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.

The agency does not have to act on the recommendations of its experts, but usually does.

“The overall tone of the meeting was positive, with the FDA having identified no obstacles to approval,” Cantor Fitzgerald analyst Elemer Piros said, adding that he expects the drug will be approved much before June 27.

The panel’s backing comes after the FDA staff on Tuesday gave a favorable review, citing three clinical studies that showed the drug reduced frequency of seizures in patients with the disease when added to a current therapy.

Analysts said an approval will also confirm the therapeutic benefits of CBD. “This should aid CBD in being efficiently rescheduled by the Drug Enforcement Administration.” Under the U.S. federal law, marijuana is considered to have no medicinal value.

However, the FDA panel highlighted the limited association between the use of CBD and elevated liver enzymes, which Cantor Fitzgerald’s Piros believe could lead to a boxed warning label, the severest form of FDA warning.

It is estimated there are about 14,000-18,500 patients with LGS, and 1 in 40,000 sufferers of Dravet Syndrome in the United states, for which there is no approved treatment. Some LGS patients have to wear helmets to avoid brain injuries from “drop seizures” that cause loss of muscle strength.

Amazon Business, which sells bulk items to business customers, has shelved its plan to sell and distribute pharmaceutical products after considering it last year, according to people familiar with the matter.

Instead, CNBC reports that the company has found that business to be more challenging than expected. The setback illustrates the challenges of getting into the medical supply and pharmaceutical space, even for a company as big as Amazon. .

The change in plan comes partly because Amazon has not been able to convince big hospitals to change their traditional purchasing process, which typically involves a number of middlemen and loyal relationships, and perhaps illegal incentives as have been demonstrated in national civil and criminal litigation.

Moreover, Amazon would also need to build a more sophisticated logistics network that can handle temperature-sensitive pharmaceutical products, according to these people.

Still, Amazon hasn’t completely ruled out getting into the pharma distribution space eventually. Multiple reports have speculated that the company will someday add a direct-to-consumer prescription drug business. Amazon Business could also reconsider getting into the pharma space once it gains more scale, multiple people said.

Meanwhile, the company continues to explore other health-care projects through different teams across the company, including Alexa and the secretive Grand Challenge team, sometimes referred to as “1492.”

Amazon has started a secret skunkworks lab dedicated to opportunities in health care, including new areas such as electronic medical records and telemedicine. Amazon has dubbed this stealth team 1492, which appears to be a reference to the year Columbus first landed in the Americas.The stealth team, which is headquartered in Seattle, is focused on both hardware and software projects.

Amazon has been selling medical products like glucometers, gloves and stethoscopes to medical clinics for several years. It now has the necessary licensing in 47 out of 50 states and the District of Columbia, according to its website.

But Amazon has struggled to land contracts with large hospital networks, despite convening an advisory board that includes major hospital executives, according to two people familiar. These groups of hospitals have long-standing contracts with distributors, like Cardinal Health and McKesson. Many hospitals also own a stake in entities called group purchasing organizations that negotiate on their behalf, leveraging their collective negotiating power.

The CNBC report points out that that the health-care supply chain is well-entrenched and will be hard to break into, according to one expert. “The hospital and health-care systems have entangling alliances with their existing purchasing and supply chain partners,” said Tom Cassels, head of strategy and business development at Leidos Health. “It’s very difficult to replicate the Amazon buying experience in health care,” he said.

But, in an industry that is now well known for marketing, by some, by way of illegal kickbacks and perks, one must be left to wonder if that is yet another discovered or undiscovered impediment for the Amazon platform.

Interest in medicines, which use engineered viruses to carry healthy genetic material into the cells of sick people, has exploded recently as the first wave of gene-fixing drugs reach the market. That has left some drug companies scrambling for sufficient capacity at a time when the industry is also grappling with shortages of DNA-carrying viral vectors.

And now General Electric, the powerhouse industrial company, is raising its bet on biotechnology with the launch of prefabricated manufacturing units for producing virus-based gene and cell therapies, novel anti-cancer treatments and vaccines.

GE, better known for making jet engines and turbines, sees an opportunity in the fast-growing field. It aims to build on its existing expertise in biotech manufacturing by delivering a “factory-in-a-box” service specifically for viral vector-based medicine.

The U.S. conglomerate already makes off-the-shelf modular factories for other complex biological medicines, such as monoclonal antibodies.

Its so-called KUBio factories are cheaper and faster to construct than traditional factories, offering GE a way to win business for its growing life sciences business. Depending on the factory design and the drug being made, an equivalent KUBio could reduce build costs by as much as 50 percent, according to the company.

Taiwanese manufacturer of biologics, JHL Biotech, recently upped the ante and ordered an entire high-tech pharmaceuticals factory. Made by GE in Germany, Sweden and the U.S., the components for the world’s largest single-use modular plant for making biopharmaceuticals, recently left Europe for JHL’s new site in Wuhan, the capital of China’s Hubei Province.

GE Healthcare’s KUBIo includes everything from bioprocessing equipment to the building and overall project coordination. The modules at the site arrive 80 to 90 percent pre-equipped with the heating, ventilating, and air conditioning (HVAC) system, the clean room, most of the utility equipment, and all of the piping necessary to run the plant.

When the sixty-two completed KUBio modules that make up the factory reach the destination at Wuhan’s Biolake Science Park , they will help JHL make affordable biologics for markets where they are otherwise prohibitively expensive.

Biologics, also called biopharmaceuticals, are a new class of medicines made from strings of complex proteins. They are now leading the charge against disease and represent the fastest growing class of drugs. They range from synthetic insulin to medicines that can be used to treat cancer, rheumatoid arthritis and other diseases.

GE is also stepping up operations within the wider supply chain that is needed to deliver cell therapies like Novartis’ Kymriah and Gilead Sciences’ Yescarta, both of which were approved in 2017 for treating certain blood cancers.

Last year, for example, GE Healthcare bought British-based Asymptote, a specialist in freezing, preserving and transporting large volumes of living cells. Overall, GE says it expects to have a $1 billion-a-year gene and cell therapy business by 2025.

The are now more than 700 viral vector-based therapies in clinical trials, spurring demand for biologically secure bioreactors to churn out products. Since most such treatments are targeted therapies designed for small patient populations, GE is betting that drug companies will prefer its flexible small-scale KUBio units to large traditional factories.