November Issue of Policy and Medicine Compliance Update — Features…
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November 2021
FDA Revises COVID-19 ANDA Guidance
In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug…
AdvaMed Releases Code of Ethics on Interactions with Health Care…
On October 1, 2021, the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with health care…
Federal Judge Rules in Favor of Eli Lilly, Vacates HHS and HRSA 340B…
On October 29, 2021, United States District Court Judge Sarah Evans Barker granted Eli Lilly’s request to vacate two…
Pharmaceutical Sales Rep Sentenced for Defrauding Insurance Companies
Mark Moffett, a former pharmaceutical sales representative for Aegerion Pharmaceuticals Inc., was recently sentenced to 54 months…
Senate Holds Hearing to Discuss the Future of Telehealth
On October 7, the Senate Commerce Subcommittee on Communications, Media, and Broadband held a hearing to discuss the future of…
CME-CE Programs to Assist Oncologists Diagnose, Treat Advanced Nonmelanoma…
Nonmelanoma skin cancers (NMSC), which account for at least 30% of all cancer diagnoses, are an increasing health burden.…
CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA…
Leading continuing medical education provider, Rockpointe, in conjunction with Boston University and Potomac Center for Medical…
GAO Report Indicates Providers Question MIPS Outcomes
Some providers question whether the Merit-based Incentive Payment System (MIPS) program is improving the quality of patient care…
CMS Issues Interim Final Rule on Surprise Billing
On September 30, the Centers for Medicare & Medicaid Services (CMS) issued its second interim final rule (IFR) to address…