- FDA commissioner to health insurers: You’re doing it wrong (cnbc.com)
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.
- Doctor in Insys opioid kickback scheme gets four years in prison (reuters.com)
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...
- This Week in Managed Care: March 9, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- CMS Unveils Patient Data Access Initiatives (healthleadersmedia.com)
The Federal government...unveiled two initiatives designed to improve patients' access and control over their personal electronic medical records, and also pledged to overhaul Meaningful Use and refocus on data interoperability and ease of use among providers...Under the MyHealthEData initiative, patients will have access to their complete electronic health record, which they can take from doctor to doctor, choose the provider they want, and give that provider secure access to their data, leading to greater competition and reducing costs, the Centers for Medicare & Medicaid Services said...Under a second initiative, Medicare has launched Blue Button 2.0, which allows traditional Medicare beneficiaries to access and share personal health data in a universal digital format, and connect claims data to the secure applications, providers, and services they trust...CMS Administrator Seema Verma unveiled the initiatives...at the annual conference of the Healthcare Information and Management Systems Society...CMS is also taking an aggressive stance against data blocking...it is the priority of this administration to ensure that every patient and their doctor can receive free and timely access to their electronic data,"...
- UNLV dentist used single-use implant piece on multiple patients (reviewjournal.com)
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.
- “Pharma Bro” Martin Shkreli sentenced to 7 years in prison for fraud (cbsnews.com)You Hate Martin Shkreli. That's Sort Of The Problem (forbes.com)
Former pharmaceutical executive Martin Shkreli wept and apologized before being sentenced to seven years in prison...for securities fraud. A U.S. District Court judge in Brooklyn handed down the sentence after a jury in August found him guilty of defrauding investors in his hedge funds...Judge Kiyo Matsumoto said she believed Shkreli to be genuinely remorseful for his crimes, but she expressed concern that a minimal sentence might not deter him in future...The judge...also imposed a $75,000 fine apart from the $7.4 million forfeiture that she...ruled Shkreli must pay.
- Numbers show drugmakers are keeping RTFs under wraps (biopharmadive.com)
When Celgene Corp. revealed receipt of a Refusal-to-File letter for its blockbuster hopeful multiple sclerosis drug ozanimod, shares in the big biotech dropped as much as 10%...The decline is no surprise — such a major disclosure was bound to hit Celgene's stock price because the Food and Drug Administration's decision not to accept the New Drug Application will significantly impact the time when (and if) ozanimod ever gets to market, potentially costing Celgene hundreds of millions in future sales...But not all pharmas seem to be so upfront with shareholders about the letters from the FDA, according to a BioPharma Dive analysis...Public disclosure therefore falls to the company when it receives one of these rejections. Company executives can disclose as much or as little information about the letters as they deem appropriate...There has been controversy over the issue for years related to CRLs (Complete Response Letters) — and public and investor outcry for the FDA to publish the letters...it comes down to what is "material" to investors, something defined by the Securities and Exchange Commission but which also gives companies some latitude...
- Health insurer Cigna to buy Express Scripts in $67 billion deal (cnbc.com)
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...
- Pharmacy Week in Review: March 9, 2018 (pharmacytimes.com)
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.
- Virginia lawmakers aim to stop people from abusing their pets’ prescriptions (richmond.com)
Virginia’s fight against rising rates of opioid addiction has an unlikely new front: the vet’s office...the General Assembly is poised to begin tracking prescriptions issued to animals through the state’s prescription monitoring program...The system was put in place more than a decade ago to help identify human patients who visit multiple doctors to obtain painkiller prescriptions. The new law would expand it to make it easier to identify people who frequently seek out drugs with high potential for abuse for their pets, said the measure’s sponsor, state Sen. William Stanley, R-Franklin...“You’re talking about not just opioids,” Stanley said. “If your dog is afraid of thunder, they’re giving a sedative. There’s a lot of drugs that, when they’re administered to a person, it goes through the (monitoring) system, but it’s not happening for pet owners.”...The measure passed the Senate unanimously and the House of Delegates 97-1. It now goes to Gov. Ralph Northam’s desk.