Author: Peter

Elizabeth Holmes was an even smoother scamster than anyone thought -- and she's apparently getting to keep her job...The SEC just charged the 34-year-old onetime billionaire with fraud related to claims she made about her blood-testing company, Theranos. To settle the charges, Holmes is giving up 18.9 million Theranos shares, losing voting control of the company, paying a $500,000 fine and will be barred from running a public company for ten years. She will, however, continue as the chief executive of Theranos, which under the fraudulent scheme described by the SEC raised $700 million...What emerges from the SEC's complaint is this: ...that Theranos’ sales were much lower than the company had led outsiders to believe. But the SEC puts a fine point on it: At a time when Theranos claimed it had annual sales of $100 million, sales were just $100,000...SEC says Holmes showed...(Walgreens) executives written evidence that Theranos would be able to run just about any blood test on its machines by the end of that year, using drops of blood taken from finger pricks instead of using needles. The next year, the pharmacy executives raised concerns with Holmes that this device might need to be approved by the FDA. But they missed the scale of her deception...Theranos miniLab was supposed to have been rolled out...the machine wasn't ready at all. That's when, (Sunny Balwani) Balwani and Holmes told their engineers to start using other companies' machines in unapproved ways to analyze finger-prick samples, the complaint says. Theranos allegedly never told the pharmacy executives...

Nevada Attorney General Adam Paul Laxalt has announced the formation of a Statewide Partnership on the Opioid Crisis. The Working Group’s first meeting will take place Thursday, and will include members from local and federal law enforcement, prosecutors, experts in the medical field, elected officials, and judicial and educational representatives...The primary function of the statewide partnership is to make recommendations to the Attorney General’s Office and Nevada’s Statewide Opioid Coordinator on best practices for data sharing to combat the opioid crisis. The AG says this remains a critical gap in Nevada’s response to the crisis...

Insurance is designed, theoretically, to protect against the catastrophic: tornadoes, floods, hurricanes — or, where our health is concerned, cancer or another devastating disease...To make that financial protection affordable, many pay into the system: the healthy are supposed to subsidize the sick...But at a conference...organized by the health insurance industry, FDA Commissioner Scott Gottlieb delivered a startling message: You're doing it wrong..."Sick people aren't supposed to be subsidizing the healthy," Gottlieb told an audience at the National Health Policy Conference of AHIP, the health insurer industry group. "That's exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance."...Gottlieb's remarks were focused on the health of the market for biosimilars — copycats of complex, biologic medicines — and his concerns that industry consolidation and what he called rigged payment schemes may be stifling their development.

A Rhode Island doctor was sentenced...to more than four years in prison after admitting he took kickbacks from Insys Therapeutics Inc to prescribe its fentanyl-based cancer pain drug to people who did not suffer from the condition...Jerrold Rosenberg...was sentenced by U.S. District Judge John McConnell...who said the doctor effectively sold his medical license to a pharmaceutical company seeking to boost its profits...McConnell said patients were put at risk by Rosenberg, who has admitted the $188,000 Insys paid him in the form of speaker fees were a factor in his decision to write prescriptions for the medication, Subsys...Federal prosecutors...have accused seven former executives and managers at Insys, including billionaire founder John Kapoor, of participating in a scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it...

Kelly Davio,  This Week in Managed Care from the Managed Markets News Network

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments...SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine...in 2016 and 2013 without safety oversight that is routinely performed by the FDA or an institutional review board...The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments…Rational Vaccines has said it considers the 2016 trial a success—though it is unclear what data it used to support that claim...SIU has...acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university.

UNLV is notifying 184 patients that they may have had dental implant work done with an instrument that had been used on other patients...A recent review of the dental implant process at the university’s Faculty Dental Practice Clinic found that healing abutments, which are manufactured to be a single-use item, were reused. The reuse of a healing abutment might increase the failure of a dental implant because of healing complications...“I am deeply disturbed by the allegations against the dentist in our dental school,” Regent Trevor Hayes said. “However, I am proud of the swift response of Chancellor Reilly and the system (Nevada System of Higher Education) staff in addressing these allegations and getting to the bottom of it. I have many concerns and questions regarding UNLV’s timeliness of response and depth of response, and I want to know why the system had to take over this matter.”...The dentist who reused the abutments, Dr. Phillip Devore, resigned as UNLV’s director of the faculty group practice in December and now works in private practice at Image Dental. He said there was never a public health risk because he sterilized the abutments. He said he would sometimes use a healing abutment up to five times.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Insurance companies may be asking people to shell out more money for drug co-payments than the drugs actually cost, a new study suggests...Generic drug co-payments in the U.S. exceeded the cost of medicines about 28 percent of the time – or for more than one in four prescriptions, researchers found...Co-payments for branded drugs were higher than the medication cost about 6 percent of the time, they report in JAMA...“This is money that patients could be saving if they knew about and could avoid the practice,” said lead study author Karen Van Nuys of the Schaeffer Center for Health Policy and Economics at the University of Southern California...To avoid overpayments, patients should always ask the pharmacist if their costs would be lower if they paid cash instead of using their insurance...“Pharmacists might not be allowed to offer this information to patients due to `gag clauses’ but if patients ask, pharmacists can tell them,”...“Several states have banned these practices and allow pharmacists to offer this information but even if you live in one of those states, you should ask,”...“Patients can also use pricing tools on the internet like GoodRx.com to see what prices they could expect across a variety of pharmacies if they paid cash.”

U.S. health insurer Cigna said...it would buy pharmacy benefits manager Express Scripts for about $54 billion, the latest deal in the sector aimed at tackling soaring healthcare costs...The move follows the $69 billion merger of insurer Aetna and drugstore chain CVS Health announced last December, and highlights a sector-wide trend toward deals between companies that do not have directly overlapping operations...The deals seek to lower healthcare costs by bringing under one roof pharmacy and medical claims, and give the combined entities greater leverage in price negotiations with drugmakers...Cigna's offer consists of $48.75 in cash and 0.2434 shares of stock of the combined company for each Express Scripts share...