Tag: faq

PhRMA Releases Updated Guiding Principles on DTC Advertising

The Pharmaceutical Research and Manufacturers of America (PhRMA) released today updated Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines (Guiding Principles), which will be effective April 15, 2019. These Guiding Principles replace the prior version. Revisions to the Guiding Principles include a new principle 19 that all product-related direct to […]

Nevada Issues Regulations and Guidance Related to Pharmaceutical Manufacturer Transparency Reporting Requirements

The Nevada Department of Health and Human Services (Department) recently released draft regulations implementing SB 539, which was signed into law in June 2017. The regulations require drug manufacturers and pharmacy benefits managers to submit a report in the format listed on the Department website by April 1st for the […]

New Sunshine Reporting FAQs Released by CMS

As announced last week, the Centers for Medicare & Medicaid Services (CMS) issued another round of FAQs related to the implementation of the Sunshine Act.  Below is a list of the 20 new CMS FAQs organized by category with a link to the answer from CMS for each.  Cooley’s CMS Sunshine FAQs trackers also have been […]

Launch of Cooley’s CMS Sunshine FAQ Tracking Chart

The Centers for Medicare and Medicaid Services (CMS) has issued several rounds of frequently asked questions (FAQs) related to Open Payments regarding the tracking and reporting of payments and other items of value provided by applicable manufacturers and group purchasing organizations (GPOs) to physicians and teaching hospitals.  In an effort to make the FAQs more accessible, we created […]

CMS Issues Another Round of Sunshine Reporting FAQs

The Centers for Medicare & Medicaid Services (CMS) issued today another round of FAQs related to the implementation of the Sunshine Act.  Pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) started tracking data on August 1, 2013.  Below is a list of the new 25 CMS FAQs organized […]