On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals. The data covers 11.4 million financial transactions attributed to over 600,000 physicians
June 2015
FDA issues 48 product-specific bioequivalence recommendations for generic drugs
On June 29, 2015, FDA released 44 new and 4 revised product-specific bioequivalence recommendations for the development of generic drugs. FDA has now published a total of 1321 bioequivalence recommendations, listed by the active ingredient, on its website.
Under…
Obamacare saved by Supreme Court
In a 6-3 decision credited with saving Obamacare, the Supreme Court ruled on Thursday that the premium subsidies offered to qualifying enrollees of insurance plans offered on federal exchanges, which help more than 6 million Americans pay for their health…
Two new OIG reports signal intensified scrutiny on Medicare Part D fraud
On the heels of the largest nationwide health care fraud takedown in history announced last week, the federal government on Tuesday issued two new reports detailing what it believes to be extensive evidence of suspicious billing under Medicare Part D.…
Eighth issue of Cultivate now available
* posted by Cori Goldberg on June 25, 2015
Cultivate – Food and agribusiness newsletter
Issue 8:
We invite you to read about these developments affecting the food and agribusiness industry and welcome your thoughts on areas to cover in…
Feds unveil sweeping Medicare fraud “takedown”
On June 18, Federal officials announced criminal enforcement actions against 243 individuals across the country. The nationwide arrests mark the largest criminal health care fraud takedown in history and came as a result of Medicare Fraud Strike Force investigations. The…
FDA bans trans fats: food manufacturers to stop using trans fats within three years
On Tuesday, June 16, 2015, the Food and Drug Administration (”FDA”) announced its Final Determination Regarding Partially Hydrogenated Oils. According to the determination, by June 18, 2018, food sold in the United States may not contain partially hydrogenated oils, which…
D.C. Circuit sends HHS back to the drawing board on Medicare equipment lease rule
The U.S. Department of Health and Human Services (“HHS”) will be heading back to District Court—and likely the drawing board altogether—to grapple with a recent federal court holding that the Medicare equipment lease rule is probably illegal.
The final rule…
Government gears up: Sunshine data informs investigations and inquiries
This week at an enforcement panel, government representatives discussed using the Sunshine Act data to delve into allegations of kickbacks to doctors and detect industry trends of improper behavior.
During the American Conference Institute’s 7th Annual Forum on Sunshine Act…
FDA attempts to derail First Amendment challenge
In May, Amarin Pharma Inc. filed a lawsuit over its First Amendment right to distribute information about unapproved uses of its fish oil prescription, Vascepa. On June 8, in response to Amarin’s free speech challenge, the U.S. Food and Drug…