Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
5/29/2024
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Modernization Act ,
Medicare Part D ,
National Institute of Health (NIH) ,
Orange Book ,
Patents ,
Pharmaceutical Industry
This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more
8/16/2023
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Generic Drugs ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda
Congress is taking a closer look at business practices in the health care sector and considering bipartisan reforms in light of increasing consolidation and its perceived affects on patient access and affordability. Various...more
The Inflation Reduction Act (IRA), P.L. 117-169, which became law on August 16th, included some of the most consequential prescription drug pricing reforms ever passed by Congress. This week marked a pivotal milestone in the...more
Key Points -
The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more
In this debut episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome partner Kelly Cleary to discuss health policy, medical science and Washington...more
4/14/2021
/ Affordable Care Act ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Medicaid ,
New Guidance ,
Physicians ,
Vaccinations
In this episode, Akin Gump health care partners Kelly Cleary and Robert Salcido discuss the health care industry and how COVID-19 has impacted the industry and affected or driven legislative and regulatory activity.
Among...more
9/22/2020
/ CARES Act ,
Conflicts of Interest ,
Coronavirus/COVID-19 ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Legislative Agendas ,
Physicians ,
Regulatory Oversight ,
Stark Law ,
Telehealth ,
Telemedicine