AMCP NewsBreaks

AMCP Regulatory NewsBreaks

HHS and DEA Issue Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Controlled Medications

Due to the COVID-19 PHE, flexibilities were implemented to prevent lapses in patient care by allowing the prescribing of schedule II-V controlled medications via audio-video telemedicine encounters – including schedule III-V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management of opioid use disorder – even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient.
AMCP Regulatory NewsBreaks

August 30, 2023: FDA Issued Guidance on Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products

Due to the COVID-19 PHE, flexibilities were implemented to prevent lapses in patient care by allowing the prescribing of schedule II-V controlled medications via audio-video telemedicine encounters – including schedule III-V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management of opioid use disorder – even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient.
AMCP Regulatory NewsBreaks

August 29, 2023: CMS Announces First Selected Drugs for Medicare Price Negotiation

On August 29, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 Part D drugs selected for negotiation under the Medicare Drug Price Negotiation Program. The negotiation process for these drugs will take place during 2023 and 2024, and maximum fair prices will be applicable starting in 2026.
AMCP Regulatory NewsBreaks

June 30, 2023: CMS Issues Revised IRA Negotiation Guidance

On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) issued final guidance on the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program for the initial price applicability year 2026 (Revised Guidance).