On Monday, May 12, President Donald Trump signed an Executive Order (EO) titled, “Delivering Most-Favored-Nation Prescription Drug Pricing to Americans,” aimed at reducing prescription drug prices by implementing a...more
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more
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
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more
Are Accelerated Approval Drugs a New Target for Cost Reductions? As outlined in our prior analysis, the Inflation Reduction Act (IRA) included sweeping drug pricing reforms for the Medicare program and the Biden-Harris...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
Key Points -
U.S. hospitals, health systems, suppliers, pharmaceutical companies and other industry stakeholders are invited to submit voluntary pledges to reduce greenhouse gas emissions and increase their climate...more
[co-author: Christina Barone]
The Infrastructure Investment and Jobs Act (the “bill”) is historic bipartisan legislation that will make available $1.2 trillion in funding for infrastructure programs across the...more
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...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
On February 17, 2021, it was reported that President Biden would nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare & Medicaid Services (CMS), the largest operating division of the U.S. Department of...more
President-elect Biden’s agenda and approach for his first 100 days in office will depend to a large degree on which party controls the United States Senate. Many of the incoming President’s major campaign promises—such as...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
Cole Memorandum ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Opioid ,
Public Policy ,
Regulatory Agenda
Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants.
On the drug pricing front, the...more
11/23/2020
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
OIG ,
Pharmaceutical Industry ,
Stark Law ,
Trump Administration ,
Value-Based Care
- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule.
- HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more
9/15/2020
/ Administrative Review ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Guidance Documents ,
Judicial Review ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Public Comment ,
Regulatory Agencies ,
Request For Information ,
Rulemaking Process
- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more
5/4/2020
/ Blocking Statutes ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Coronavirus/COVID-19 ,
Data Blocking ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Health Information Technologies ,
Information Technology ,
OIG ,
ONC
On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more