The Daily Scan

July 20, 2018

Last Updated: 8:50 AM EST

Litigation

  • Latham, New York-based medical device manufacturer AngioDynamics, Inc. has agreed to pay the United States a total of $12.5 million to resolve allegations that the company caused healthcare providers to submit false claims to Medicare, Medicaid, and other federal healthcare programs relating to the use of two medical devices, LC Bead and the Perforator Vein Ablation Kit (PVAK), the Justice Department announced yesterday. (Justice.gov)

 

  • Following two weeks of trial, a federal jury in Brooklyn convicted Dr. Martin Tesher yesterday of 10 counts of unlawful distribution of oxycodone without legitimate medical purpose to five patients, one of whom died as a result two days after his last visit with the defendant. When sentenced by United States District Judge Raymond J. Dearie, Dr. Tesher faces a mandatory minimum sentence of 20 years’ imprisonment and a maximum of life in prison. (Justice.gov)

Medicare

  • On Thursday, progressive House Democrats announced the formation of a Medicare for All caucus of members who support moving to a single-payer health care system. “We are united today by a common conviction that healthcare is a human right,” Rep. Pramila Jayapal said during the caucus’s launch event. “That health care must be affordable and accessible to all residents of the United States, and that one of the best ways to ensure healthcare for all is to use the system that already exists for millions of seniors […] and that is Medicare.” So far, the caucus—which Jayapal co-chairs alongside Reps. Debbie Dingell and Keith Ellison, the Democratic National Committee’s deputy chair—has at least 70 members. (Slate.com, Facebook.com)

 

  • A new report from the Department of Health and Human Service Office of Inspector General revealed that during calendar years 2014-2016, Medicare made improper payments of $8.7 million to providers for nonemergency ambulance transports to destinations not covered by Medicare, including the identified ground mileage associated with the transports. The majority of the improperly billed claim lines (59%) were for transports to diagnostic or therapeutic sites, other than a physician's office or a hospital, that did not originate from SNFs. (OIG.HHS.gov)

Regulation

  • As part of the Trump administration’s efforts to lower drug prices and put American patients first, Health and Human Services Secretary Alex Azar requested yesterday that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities. “We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients,” said Secretary Azar. (HHS.gov)

 

  • During a speech given on Wednesday in Washington, DC, FDA Commissioner Scott Gottlieb, MD, announced the release of the long-awaited Biosimilar Action Plan. The plan is meant to spur biosimilar competition in the US marketplace by addressing 4 key areas: Improving the efficiency of the biosimilar and interchangeable product development and approval process; Maximizing scientific and regulatory clarity for the biosimilar product development community; Developing effective communications to improve understanding of biosimilars among patients, providers, and payers; Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products. “While less than 2% of Americans use biologics, they represent 40% of total spending on prescription drugs,” said Gottlieb. “So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and facilitating more innovation. (CenterForBiosimilars.com)

 

 

 

 

 

 

 

 

 

 

 

 

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