This week a California judge dismissed a lawsuit filed in December 2017 by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CA S.B. 17. PhRMA had sought a declaration that Section 4 of S.B. 17 was unconstitutional and a permanent injunction preventing the state’s Governor and Director of the Office […]
OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’
The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]
“Cooley is proud to partner with NY Health Business Leaders on their Q2 2018 NYC Healthcare Investment Update. In the second quarter of 2018, both deal volumes and aggregate dollars raised remained at historically high levels. In Q2 2018, Cooley handled 224 disclosable deals, representing more than $7.5 billion of […]
Revisions to the Limitations on and Obligations Associated with Prescriber Acceptance of Compensation from Pharmaceutical Manufacturers law, N.J.A.C. 13:45J-1.1 et seq. (NJ Gift Ban Law), have been proposed by the New Jersey Attorney General. The NJ Gift Ban Law, originally adopted effective January 16, 2018 and previously discussed on this blog, drew […]
The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.” The OIG reviewed data from calendar year 2015 available as of June 2016. The OIG’s key takeaway […]
Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing “step therapy” for Medicare Part B drugs. Recall, the concept of changing the way Medicare pays for Part B drugs was first discussed in the Administration’s May 2018 Blueprint.
The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]