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The U.S. Food and Drug Administration (FDA) announced today the availability of a new draft guidance titled, “Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format.” This draft guidance provides insight into the FDA’s current thinking related to the INDICATIONS AND USAGE section […]
The Centers for Medicare & Medicaid Services (CMS) released today the 2017 data disclosed by 1,525 manufacturers and group purchasing organizations (GPOs) related to payments and transfers of value provided to physicians and teaching hospitals, as well as ownership or investment interests held by physicians and their immediate family members. […]
The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]