- Nevada drops plan for extra Medicaid paperwork for mental health care (reviewjournal.com)
Nevada Medicaid will reverse its decision to require prior authorization for mental health services after providers and patients raised concerns that the policy change could delay treatment...The Division of Health Care Financing and Policy will hold a public hearing in October to rescind prior authorization requirements for psychotherapy and neurotherapy services, including “talk therapy” and biofeedback. Medicaid behavioral health supervisor Alexis Tucey announced the change Tuesday at a public workshop in Las Vegas...The policy approved in August will still take effect Oct. 1, giving providers five sessions with a patient before they are required to submit additional documentation to the state Medicaid office...The change came as a relief to providers who were worried they would have to stop seeing patients while waiting for approval of additional sessions or risk denial of payment by continuing to see clients to avoid disruption in care...
- Why Big Pharma Cheers Rahm Emanuel’s Exit As Chicago’s Mayor (forbes.com)
Rahm Emanuel’s surprise decision to not run again for Mayor of Chicago next year for a third term may be good news for the pharmaceutical industry, which has become a high-profile target during his tenure...Emanuel was unafraid to put U.S. pharmaceutical companies and their marketing practices in his sights despite Chicago and its suburbs being home to major drug makers that are also big employers like Abbott Laboratories and its spin off Abbvie as well as Baxter International. Other drug makers and startups call Chicago home including Horizon Pharma...Emanuel led the charge for Chicago to introduce an ordinance requiring licenses for drug sales representatives . This summer, Chicago confirmed more than 1,500 licenses, which cost $750 annually, were issued after the first year of the ordinance. Marketing without a license could result in a $1,000 fine...
- How Scott Gottlieb is upending FDA communication, one tweet at a time (biopharmadive.com)
Just two weeks after the Senate confirmed Scott Gottlieb as the next Food and Drug Administration commissioner, he returned to face Congress...The event was slated to be a dry appropriations subcommittee hearing on the FDA budget — but Gottlieb had other things in mind...The former health official in George W. Bush's administration shifted topic to his plans to address abuse of the REMS system, in which pharmas are accused of slow-walking providing samples needed by generic companies to develop cheaper copies. He also previewed a proposal to list off-patent drugs with no generic competition...Now, more than a year into Gottlieb's tenure, the race to keep up with the FDA leader has only quickened...On his well-known Twitter account, he's averaged more than 14 tweets each day in 2018, or roughly 400 per month counting retweets and replies, one Twitter analysis service reported. He set a personal record in July with 554 total tweets...Stakeholders both inside and outside the agency have given Gottlieb credit for both transparency and effort...Among current FDA scientists, a recent survey found Gottlieb a positive force in an administration rated poorly by most federal scientists. His eagerness to publicly stand by his agency's work could be part of explaining the rank-and-file support he's received....
- This Week in Managed Care: September 7, 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
- This Week in Managed Care: September 14, 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
- EU officials clash with Chinese firm on drug factory inspection (reuters.com)
European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry to a factory run by Jiangsu Yew Pharmaceutical Co. Ltd...is the latest example of regulatory problems with bulk pharmaceutical substances manufactured in China...Jiangsu Yew refused to allow a site inspection by Hungarian officials, acting on behalf of Europe’s drug regulatory system. The rebuttal led the EU authorities to determine that its supplies of temozolomide, used to treat brain tumors, did not comply with good manufacturing standards...The company’s export director Henry Yang told Reuters via email that the inspection was refused because Jiangsu Yew only made an intermediate product, rather than an active pharmaceutical ingredient, so an audit was not required.
- Maryland charges Insys with engaging in deceptive opioid scheme (reuters.com)
Maryland...charged Insys Therapeutics Inc with deceptively marketing a powerful opioid pain killer so that it was prescribed inappropriately beyond its intended use with cancer patients...Maryland Attorney General Brian Frosh announced that he had filed administrative charges...which he said provided thousands of dollars in inducements to doctors to promote prescribing its medication Subsys to their patients...The state alleged that over 90 percent of the prescriptions for Subsys in Maryland ultimately were for patients who should never have received the product, an under-the-tongue spray that contains fentanyl, an opioid 100 times stronger than morphine...“The allegations against Insys describe a calculated scheme employing doctors, pharmacist, and sales reps to increase profits and market share at the expense of the health and well-being of vulnerable patients,” Frosh said in a statement.
- September 14 Pharmacy Week in Review: FDA Ensuring Compounding Quality, New Drug Therapy for Treating Asthma (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- The Latest: Nevada top doctor has no US medical license (ktvn.com)
The Latest on a court hearings on a pharmaceutical companies lawsuit to stop Nevada from using their drugs for a lethal injection...Nevada's top doctor isn't licensed to practice medicine in the United States...Ihsan Azzam testified in Las Vegas...that he has a master's degree and worked for several years in environmental public health and epidemiology before being named chief state medical officer last May...Azzam says he practiced for several years as an obstetrics and gynecology physician in Africa before moving to the United States in the 1990s...That qualifies Azzam for the job under Nevada state law...Azzam testified that while he has no background in anesthesia or pain management, he says the doses of three drugs proposed for an inmate's lethal injection would be enough to kill a mammoth.
- NHS announces new Genomic Medicine Service (healthcareitnews.com)
Agency said the goal is to provide access to genetic testing to drive personalized treatments and enable interventions for the whole country...National Health Service...announced a new national Genomic Medicine Service...The new service...will provide 'equitable access' to genetic and genomic testing, including whole genome sequencing, and drive personalized treatments and interventions for the country’s entire population, building on the 100,000 Genomes Project, delivered to ‘common national standards, specifications and protocols’...The U.S. also has a similar undertaking, the National Institutes of Health’s All of Us program, which aims to enroll 100,000 participants to share their data for research purposes. Both it and the NHS program comes as hospitals and technology vendors are increasingly building next-gen tools for precision medicine and genomics based on machine learning, SMART on FHIR and EHR integration to meet the demand for consumerism in healthcare...










