Amazon employs thousands of people globally to help improve the Alexa digital assistant powering the company’s line of Echo devices, and this team listens to voice recordings captured in Echo owners’ homes and offices, Matt Day, Giles Turner, and Natalia Drozdiak of Bloomberg report. The team transcribes the recordings, annotates them, and then feeds them back into the software in an effort to cut down on gaps in the assistant’s understanding of human speech and help it respond better to commands, the authors say. The team of people listening and processing the recordings includes a mix of contractors and full-time Amazon employees who operate in outposts from Boston to Costa Rica, India, and Romania, according to Bloomberg, citing the people, who signed nondisclosure pacts prohibiting them from speaking publicly about the program. Members of the team each parse as many as 1,000 audio clips per daily nine-hour shift, the report’s authors say, citing two workers based at Amazon’s Bucharest office.
Wednesday, April 10, 2019
Federal agencies charge 24 in $1.2B Medicare telemedicine fraud scheme
The U.S. Department of Justice has announced the culmination of a massive investigation into an international network of telemedicine companies, device makers and healthcare providers, claiming they sold medically unnecessary orthotic braces to patients and sent the bills on to Medicare, totaling over $1.2 billion in fraudulent claims.
The scheme of illegal kickbacks and bribes could amount to one of the largest healthcare fraud cases ever seen by the FBI and the Department of Health and Human Services’ inspector general’s office, according to the agencies.
Arrests were made Tuesday, and two dozen people have been charged—including the CEOs and executives of five telemedicine companies, the owners of dozens of durable medical equipment manufacturers and three licensed physicians—alongside the execution of over 80 search warrants spanning 17 federal districts, in what was dubbed “Operation Brace Yourself.”
“These defendants—who range from corporate executives to medical professionals—allegedly participated in an expansive and sophisticated fraud to exploit telemedicine technology meant for patients otherwise unable to access health care,” Brian Benczkowski, assistant attorney general for the DOJ’s criminal division, said in a statement.
“This Department of Justice will not tolerate medical professionals and executives who look to line their pockets by cheating our health care programs,” Benczkowski added.
According to the HHS inspector general, the scheme worked like this: The owners of a call center would air commercials or make telemarketing calls up-selling “free or low-cost” back, shoulder, wrist or knee braces for beneficiaries, paid for by Medicare, to lure in hundreds of thousands of elderly or disabled patients.
The centers, based in the Philippines and Latin America, would then transfer the Medicare beneficiaries to a telemedicine firm for a doctor’s consultation, while paying the firm and doctors to prescribe medically unnecessary braces.
Next, those prescriptions would be collected and sold directly by the call centers to a range of medical equipment companies—who would then bill Medicare between $500 and $900 for the braces, and kick back almost $300 for each brace sold back up the chain to the other conspirators.
One of the five telemedicine companies involved, AffordADoc—named alongside Video Doctor USA, Web Doctors Plus, Integrated Support Plus and First Care MD—produced a YouTube videoexplaining how doctors in its network could supplement their income by $15,000 a month while performing consultations from home or over the phone and internet.
According to the DOJ, doctors prescribed medical devices without any patient interaction, or with only brief telephone conversations—while the proceeds were laundered through an elaborate network of international shell corporations to purchase “exotic automobiles, yachts and luxury real estate” in the U.S. and abroad.
“The breadth of this nationwide conspiracy should be frightening to all who rely on some form of healthcare,” said Don Fort, chief of the IRS’ criminal investigation unit.
“The conspiracy described in this indictment was not perpetrated by one individual. Rather, it details broad corruption, massive amounts of greed, and systemic flaws in our healthcare system that were exploited by the defendants,” Fort said. “We all suffer when schemes like this go undiscovered and I’m proud of the work our agents did in working with our partners to uncover this complex scheme.”
In addition, the Centers for Medicare & Medicaid Services suspended payments to another 130 equipment providers the agency says could prevent billions in additional losses. Those companies had submitted more than $1.7 billion in claims, and were already paid over $900 million.
“The mammoth coordination and cooperation demonstrated among the various offices, districts, and agencies involved in this case leaves no doubt. We will leverage the full weight of our resources to combat fraud and abuse, wherever it is found,” said Chapa Lopez, U.S. attorney for the Middle District of Florida.
Killing Dangerous Super Viruses With Cold Plasma
There are a lot of ways to kill viruses, but it’s not that easy to kill them in the air. For the most part, if you want to prevent viruses from infecting someone, or from entering a room, for example, you use a face mask or air filters. In some cases, such as in laboratory spaces, ultraviolet light is used to kill off pathogens. Of course, in some cases of specific disease-causing viruses, vaccines can be used in people, which safely trains your immune system to recognize and kill the viruses.
Now, researchers at the University of Michigan have shown that dangerous airborne viruses can be killed “on-the-fly” when exposed to so-called “cold plasma,” or energetic, charged air molecule fragments. They published their work in the Journal of Physics D: Applied Physics.
“The most difficult disease transmission route to guard against is airborne because we have relatively little to protect us when we breathe,” stated Herek Clack, UM research associate professor of civil and environmental engineering.
The researchers evaluated the virus-killing speed and effectiveness of nonthermal plasma, that ionized particles created around electrical discharges, such as sparks. They found the reactor inactivated or removed 99.9% of a test virus, mostly because of inactivation. The reactor had borosilicate glass beads packed into a cylinder. They initiated sparks between the void spaces and passed a model virus via flowing air into the reactor.
“In those void spaces, you’re initiating sparks,” Clack stated. “By passing through the packed bed, pathogens in the air stream are oxidized by unstable atoms called radicals. What’s left is a virus that has diminished ability to infect cells.”
The authors noted in their paper, “Outbreaks of airborne infectious diseases such as measles or severe acute respiratory syndrome (SARS) can cause significant public alarm. Where ventilation systems facilitate disease transmission to humans or animals, there exists a need for control measures that provide effective protection while imposing minimal pressure differential.”
The researchers also evaluated the amount of viral genome in the air samples. They determined that more than 99% of the air sterilizing effect of the reactor was caused by inactivating the virus, while the rest was the result of filtering the virus.
“The results tell us that nonthermal plasma treatment is very effective at inactivating airborne viruses,” stated Krista Wigginton, assistant professor of civil and environmental engineering. “There are limited technologies for air disinfection, so this is an important finding.”
The research team believes that a parallel approach of filtration and inactivation of airborne pathogens would be a more efficient way of sterilizing air than current technologies, such as infiltration and ultraviolet light. Face masks usually only filter out viral particles and ultraviolet irradiation is a slower process and not as thorough as the nonthermal plasma appears to be.
The group has begun testing their reactor on a livestock farm near Ann Arbor, Michigan, using it to sterilize ventilation air streams. Animal agriculture is often vulnerable to contagious livestock diseases such as avian influenza or porcine reproductive and respiratory syndrome (PRRS) virus.
For example, in hog farms, air filtration is very important but is considered to be very expensive. Typically those systems use filtration, while others use a partial filtration or “bailout” system, in which air is 100% filtered at lower temperatures. But when the ventilation needs to move warmer air from outside, say from 70 to 80 degrees Fahrenheit, the air enters unfiltered.
Potential Cancer ‘Vaccine’ Shows Promise in Early Non-Hodgkins Trial
Researchers with the Icahn School of Medicine at Mount Sinai in New York have had promising results with a cancer vaccine in an early-stage clinical trial. They published their work in the journal Nature Medicine.
Indolent non-Hodgkin’s lymphomas (iNHLs) do not respond to standard cancer therapy and respond poorly to checkpoint inhibitors. The research group, led by Joshua Brody, Director of the Lymphoma Immunotherapy Program at Icahn, showed that lymphoma cells could directly prime T-cells, but that actual immunity required multiple exposures, or cross-presentation.
Brody and his team developed a therapy that combined Flt3L, radiotherapy, and a TLR3 agonist, “which recruited, antigen-loaded and activated intratumoral, cross-presenting dendritic cells (DCs),” the authors wrote.
Brody told Live Science, “We’re seeing tumors all throughout the body melting away,” after injecting a single tumor.
The vaccine was tested in 11 patients with NHL. Not all patients responded to the therapy. But some of the patients, three, went into remission for relatively long periods. Because of its promise, the vaccine is now being tested in breast and head-and-neck cancers. The vaccine also appears to increase the effectiveness of checkpoint inhibitors in the disease, what Brody told Live Science “are remarkably synergistic.”
The treatment isn’t exactly a vaccine. That’s a word used for anything that provides long-lasting immunity against disease. But this new treatment, which is a type of immunotherapy, does involve injecting patients with two types of products that stimulate the immune system.
The therapy is a three-step process. First, patients receive an injection into the tumor of a compound that recruits dendritic cells, a type of immune cells. Dendritic cells send messages to T-cells, another type of immune cells, to attack the tumor. Then the patients receive a low dose of radiotherapy, which kills some of the cancer cells so they release antigens that the immune system can recognize. The dendritic cells identify those antigens and alert the T-cells.
Patients are then given a second injection of a compound that activates the dendritic cells. “The dendritic cells are learning the lesson … and telling it to the T-cells,” Brody told Live Science.
In mice, the researchers found that using a checkpoint inhibitor with their “vaccine,” about 75% went into long-term remission.
Brody told CNBC, the treatment “has broad implications for multiple types of cancer. This method could also increase the success of other immunotherapies such as checkpoint blockade.”
Silvia Formenti, Chairwoman of Radiation Oncology at Weill Cornell Medicine and New York-Presbyterian, who was not involved in the study, told CNBC, “It’s really promising, and the fact you get not only responses in treated areas, but areas outside the field [of treatment with radiation] is really significant.”
But the research is very early and conducted in a small group of patients. Eric Jacobsen, Clinical Director of the Dana-Farber Cancer Institute’s lymphoma program, told CNBC, “It’s definitely proof of concept, but larger studies are definitely needed and additional strategies to try to get more than three out of 11 patients to respond.”
The research was funded by The Damon Runyon Cancer Research Foundation, the Cancer Research Institute and Merck. Celldex and Oncovir provided the laboratory work and materials for the trial.
Sanofi Cuts the Costs of Some Insulin Products to $99 per Month
Days after Express Scripts and Cigna announced a cap on out-of-pocket expenses for insulin covered under plans the companies’ offer, one of the biggest insulin drugmakers announced it was cutting the price of its insulin medications.
On Tuesday, Sanofi announced an expansion to its one-year-old Insulins Valyou Savings Program that will lower the price of some of its insulin products to $99 per month. Beginning in June, Sanofi said people in the United States can pay $99 for up to 10 boxes of pens and/or 10 mL vials per month. The Insulins Valyou Savings Program does not include Sanofi’s combination insulin product, the company noted.
The move comes hours ahead of another appearance before Congress over the costs of insulin.
Michelle Carnahan, head of North America Primary Care at Sanofi, said the new plan will help address the challenge that too many patients face regarding unpredictable and unaffordable pricing for their insulin. Carnahan said concerns over diabetes patients having to choose between paying for their medicines or other basic needs is unacceptable to the company. This new plan will help address “affordability and access needs,” Carnahan added.
“By giving those who require both long-acting and/or mealtime insulins or use more than one box of pens or one vial per month access to their insulins for one flat price, we aim to help limit the burden on the individuals who have high out-of-pocket costs at the pharmacy counter,” Carnahan said in a statement.
The Valyou program is currently not available to patients on Medicare or Medicaid due to current government regulations, Sanofi said. People who are exposed to high out-of-pocket prices for their medications from private insurance plans or who do not qualify for other patient assistance programs can look to join the Valyou Savings plan.
Sanofi launched the Insulins Valyou Savings Program last year. Initially, the plan allowed patients to pay $99 for one 10mL vial or $149 for a box of pens. Now, it has been dramatically expanded to cover up to 10 boxes of vials and/ or pens. Since it was launched last April, the program, which is available at U.S. pharmacies, has resulted in approximately $10 million in patient savings, Sanofi said.
Congress continues to mount pressure on insulin makers over concerns that the costs of the life-saving medication are too high for many patients. Congress has called executives from some of the biggest pharma companies to testify before various committees and the price of insulin has been at the top of the list of concerns. Last year, Minnesota Attorney General Lori Swanson filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. In the lawsuit, Swanson said Eli Lilly, Sanofi and Novo Nordisk “deceptively raise the list price of insulin” and that the hikes have made the life-saving medication “less affordable.”
Last week, Express Scripts and Cigna launched the Patient Assurance Program, which will ensure eligible people with diabetes in participating plans pay no more than $25 for a 30-day supply of insulin. The new Patient Assurance Program is available to members who participate in non-government funded healthcare plans that are managed by Express Scripts, which includes Cigna and others. The companies said that in the majority of cases, people who use insulin will see lower out-of-pocket costs without any increased cost to the plan.
Sanofi isn’t the only company to respond to concerns and criticism over the costs of insulin. In March, Eli Lilly announced it will start selling an “authorized generic” version of its popular Humalog 100 at about 50 percent off the list prices. The price will be $137.35 per vial. Diabetes patients typically use two vials per month. The new product will be branded Insulin Lispro and sold through ImClone Systems, a Lilly subsidiary. Also in March, Eli Lilly disclosed data over the weekend that indicates the price for its lead insulin product Humalog dropped by 8 percentover the past five years.
Herbalife Nutrition downgraded to Hold from Buy at Argus
Argus analyst John Staszak downgraded Herbalife Nutrition to Hold from Buy
Wave Life Sciences expects to report PRECISION-HD program data by yearend
Wave Life Sciences provided an update on the timing of the topline data readout from its ongoing PRECISION-HD program, which consists of two global Phase 1b/2a clinical trials evaluating investigational therapies WVE-120101 and WVE-120102 for patients with Huntington’s disease, or HD. The company now expects to report topline clinical data from the PRECISION-HD program by the end of the year. The reason for the revised timeline is operational, resulting from slower than anticipated patient enrollment because of the logistics of screening and scheduling across global sites. This update is not due to a preclinical or clinical safety finding and the PRECISION-HD clinical program remains blinded. The company expects the topline clinical data will include a summary of clinical safety results, the degree of mutant huntingtin protein lowering in cerebrospinal fluid and the ratio of total huntingtin versus mutant huntingtin protein in CSF to assess wild-type huntingtin protein.
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