- FDA approves eight European regulators to inspect drug factories for U.S. (reuters.com)
The U.S. Food and Drug Administration said...it will allow regulators in eight European countries to determine whether drug manufacturing facilities there meet FDA requirements, freeing up American inspectors to spend more time in higher-risk countries like India and China...The FDA said it will begin relying on inspection data from the regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom as of Nov. 1...in some situations the United States could still do inspections in those countries...The move is the first step by the FDA to implement an agreement the United States and the EU finalized in March. The European Commission already determined in June that the FDA could carry out inspections for it in the United States...FDA Commissioner Scott Gottlieb said in a statement that partnering with European regulators would allow the agencies to get “the greatest bang for our collective inspectional buck.”
- Connecticut AG on generic drug price-fixing suit: ‘This is just the tip of the iceberg’ (cnbc.com)
Connecticut Attorney General George Jepsen, who is leading a coalition of states suing generic drugmakers, told CNBC..."We've uncovered through emails, text messages and telephone patterns, plus cooperating witnesses, a very compelling case of systematic and pervasive price fixing within the industry,"...45 states, including Connecticut, as well as the District of Columbia and Puerto Rico moved to expand their lawsuit to 18 companies and 15 medicines. The suit also names two individual executives, including Rajiv Malik, president (of)...Mylan...The original complaint, filed in December, had focused on six companies and two medicines...
- What’s Causing America’s Rural Health Insurance Crisis? (realclearhealth.com)
...numerous rural health insurance markets have teetered on the brink of collapse. Rural areas have long posed a special challenge to health care policymakers, but a poorly-designed system of subsidies for rural hospital care has turned this into a crisis. It has fostered a rural hospital market structure that has crippled the ability of private insurers to negotiate reasonable payment rates, without fully securing the provision of essential care. By refocusing federal assistance on emergency care, it should be possible to restore rural insurance markets to health, while improving the affordability and access to care available to residents...MedPAC (Medicare Payment Advisory Commission)...has argued that CAHs (Critical Access Hospitals) are “not the best solution”, as “many small towns do not have the population to support efficient, high-quality inpatient services.” MedPAC has proposed...lump-sum payments to cover the overheads needed to provide 24/7 emergency care at geographically isolated outpatient-only facilities and suggested that Medicare reimbursement be extended to care provided by standalone emergency departments...This would focus subsidies to secure emergency services, which must be delivered locally, while leaving elective care to be located efficiently according to market demand. Such a reform would give emergency rural hospital care a firmer financial foundation while restoring payment rules for elective care that would make it possible for insurers to re-enter the rural marketplace.
- The Unhealthy Politics of Pork: How It Increases Your Medical Costs (nytimes.com)
No industry in America spends more on lobbying than health care...In 2016, the health care industry spent half a billion dollars on lobbying, with pharmaceutical companies, hospitals and health professionals making the largest contributions...Closely related to industry lobbying is the political maneuvering that congressional leaders use in an effort to pass legislation — specifically, targeted provisions known as earmarks, “sweeteners” or pork barrel spending...In 2010, Democrats hoping to secure votes from reluctant rural state senators added the “Frontier States” provision to the A.C.A., which increased Medicare payments to five states with low population densities...We all know earmarks and lobbying influence policymakers and policy. In health care, this has critical implications: who gets care, how much they get, how we pay for it. But there’s little hard data on exactly who benefits and how large the effects can be. A new study illuminates the ways these political dynamics can change congressional and hospital behavior — and how they can increase health care costs for the rest of us...America’s increasingly burdensome health care spending has many roots: new technologies, high drug prices, fragmented care, administrative expenses and the like. But lobbying and political maneuvering can increase costs, too — without clear benefits for patients, communities or society at large...Often these costs are borne by all of us, while the benefits — if any — go to a favored few. Excess medical spending, then, is driven not only by inefficiencies in our health system, but also by those in our political system. Our solutions, it seems, must confront that uncomfortable reality.
- EMCDDA publishes its first European guide on responding to drug problems (emcdda.europa.eu)
How to respond to the problems of older heroin users? How to tackle deaths from highly potent fentanils? How to prevent harms from drug and alcohol use in festivals and clubs? These are among the questions explored by a new European guide released today by the EU drugs agency (European Monitoring Centre for Drugs and Drug Addiction). Drawing on insights from 30 countries, Health and social responses to drug problems: a European guide presents the agency’s first overview of actions and interventions currently available to address the consequences of illicit drug use. It is designed to benefit those approaching drug problems from a public health planning perspective as well as frontline workers and practitioners.
Health and social responses to drug problems - A EUROPEAN GUIDE
Introduction
- A framework for developing health and social responses to drug problems
- Problems arising from particular types or patterns of drug use
- Responding to the needs of particular groups
- Responding in particular settings
- Supporting successful implementation
- Moving on: responding effectively to drug problems in Europe - Why CVS Won’t Buy Aetna (forbes.com)
Even before reports surfaced...claiming that CVS Health was in talks to buy Aetna, the nation’s third-largest health insurer, the two were known to be discussing forming closer ties...But a full-blown merger of the healthcare giants would be complicated and unlikely given recent antitrust scrutiny in the sector and given that the drugstore chain is already going into business with an Aetna rival, Anthem...Anthem just last week said it was forming its own pharmacy benefit management company, IngenioRx, with CVS, which operates a PBM. That was seen as a way to compete with the nation's largest health insurer, UnitedHealth Group, which owns the PBM OptumRx...But for CVS to operate a PBM with Anthem, the No. 2 health insurer, while owning Aetna, the No. 3 insurer, would be highly unusual coming off a period of intense antitrust scrutiny of the health insurance industry.
- This Week in Managed Care: October 27, 2017 (ajmc.com)
Kelly Davio, welcome to This Week in Managed Care from the Managed Markets News Network
- Smartphone-compatible ultrasound device gets FDA nod (pharmaphorum.com)
An iPhone-compatible ultrasound device that can deliver scanning for a fraction of the price of leading technologies, has been approved by the FDA...Traditionally, ultrasound scanners consist of three transducers connecting to large, bulky units which, when combined, carry a hefty price tag...The Butterfly iQ – the world’s first ‘ultrasound-on-a-chip’ device – houses all three of these transducers and over 10,000 sensors in a single handheld scanner, allowing for faster, easier, and cheaper ultrasound scanning...Doctors perform an ultrasound scan as they usually would with imagery appearing on their smartphone. The images are then sent to cloud storage, allowing for connectivity to hospital medical record systems...Offering a unique blend of affordability, diagnostic versatility, and assistive intelligence, Butterfly has the potential to impact human health more profoundly than any diagnostic device since the stethoscope, invented over 200 years ago. At less than $2,000, healthcare providers can purchase an easy-to-use, powerful, whole-body medical imaging system that fits in their pocket...
- Walmart uses robots to keep store shelves full (drugstorenews.com)
The discount giant is using a shelf-scanning robot to detect out-of-stock items, incorrect prices and wrong or missing labels. The initiative is an effort to automate tasks that are repeatable, predictable and manual for its associates, Walmart spokesman Justin Rushing said in the retailer’s blog...Using data and vision technology, the wheeled robot roams store aisles ready to simplify routine, but time-consuming tasks. On-hand robots are making it easier for personal shoppers to fulfill online orders, as well as freeing up associates to serve in-store shoppers...Jeremy King, chief technology officer for Walmart U.S. and e-commerce, said, “The robots are 50% more productive than their human counterparts, and can scan shelves significantly more accurately and three times faster.”...This is not Walmart’s first try at adding automated, robotic solutions. The discounter continues to expand its fleet of “Pickup Towers,” massive orange vending machines where shoppers can retrieve their online orders in less than a minute...The discounter was also recently granted a patent that would allow the chain to use drones to shuttle merchandise between departments and dedicated delivery locations within its stores...
- Week in Review: October 27, 2017 (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.