This week marks the second anniversary of the enactment of the Inflation Reduction Act, a partisan law that ushered in sweeping Medicare price setting reforms. The Biden-Harris Administration is poised to announce the first...more
8/14/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Due Process ,
Fair Price ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part D ,
Negotiations ,
Pharmacy Benefit Manager (PBM) ,
PHRMA
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
Senators Ed Markey (D-MA.) and Elizabeth Warren (D-MA.) unveiled “The Corporate Crimes Against Health Care Act of 2024” on June 11, 2024, which seeks to create new civil and criminal penalties for health care investors who...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
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
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
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 April 4, the Centers for Medicare & Medicaid Services (CMS) released the Contract Year (CY) 2025 Medicare Advantage (MA) and Medicare Part D Policy and Technical Changes final rule (“Final Rule”), which included revisions...more
Despite strong private equity interest in drug and device targets, policy changes in the healthcare industry have made the M&A market tricky to navigate. Healthcare has been one of the most active policy focus areas in 2023...more
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
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
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
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
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
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
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...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
On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more
The Biden-Harris administration and Congress appear poised to continue focusing on drug pricing issues this year, most notably with the Centers for Medicare & Medicaid Services moving forward with implementation of the drug...more
The House and Senate convened this week to kick off the 118th Congress. Republicans control the House after four years of a Democratic majority. House Republicans have a very slim majority, with only 222 seats to the...more
1/12/2023
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Congressional Budget Resolution ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
Medicare Part B ,
Regulatory Agenda