On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
1/14/2025
/ Draft Guidance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Requirements
As the new year begins, change is afoot inside the Beltway as the 119th Congress gets underway and Washington prepares for President Trump’s second administration. While change is bringing uncertainty on some fronts, health...more
1/6/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Consolidated Appropriations Act (CAA) ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Federal Funding ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicaid ,
Medicare ,
Over The Counter Drugs (OTC) ,
Pharmacy Benefit Manager (PBM) ,
Policies and Procedures ,
Trump Administration
AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more
With a historic election now behind us, the 118th Congress will return to work for a Lame Duck session to address must-pass items and for Senate Democrats to pass as many final judicial appointments as time and political will...more
Key Points - Congress is increasing oversight and legislative activity related to the role of private equity in health care. Sen. Markey and Rep. Jayapal jointly introduced the Health Over Wealth Act on July 25, which aims to...more
8/9/2024
/ Health Care Providers ,
Healthcare ,
Investment ,
Lease Back Transactions ,
No Surprises Act (NSA) ,
Private Equity ,
Proposed Legislation ,
Regulatory Oversight ,
REIT ,
Reporting Requirements ,
Transparency
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
The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more
3/12/2024
/ Antitrust Provisions ,
Carbon Capture and Sequestration ,
CFIUS ,
China ,
Corporate Transparency Act ,
Divestiture ,
Domestic Dealmaking ,
Drug Pricing ,
Energy Sector ,
Foreign Direct Investment ,
Foreign Investment ,
Greenhouse Gas Emissions ,
Healthcare ,
Investment ,
Life Sciences ,
Liquidity ,
Mergers ,
Non-Compete Agreements ,
Prescription Drugs ,
Private Equity ,
Private Equity Firms ,
Renewable Energy ,
Reporting Requirements ,
UK ,
Unions ,
Venture Capital
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more
1/2/2024
/ Appropriation ,
Artificial Intelligence ,
Clinical Laboratories ,
Congressional Oversight ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Drug Pricing ,
Fiscal Year ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Medicare ,
Mental Health ,
Pharmaceutical Industry ,
Price Transparency ,
Proposed Rules ,
Supply Shortages
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
Introduction -
Congress returns from the August recess with a robust agenda and limited time to pursue it. The calendar is further constrained by the September 30 deadline to pass appropriations packages or a continuing...more
9/5/2023
/ Agricultural Sector ,
Climate Change ,
Continuing Resolution ,
EBITDA ,
Energy Sector ,
Environmental Social & Governance (ESG) ,
Fair Credit Reporting Act (FCRA) ,
Federal Aviation Administration (FAA) ,
Financial Services Industry ,
Government Shutdown ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
NDAA ,
Pharmacy Benefit Manager (PBM) ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Tax Cuts and Jobs Act
Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more
9/1/2023
/ Animal Drugs ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Opioid ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Supply Shortages ,
Telehealth ,
Transparency
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