Congress may be in recess, but that has not slowed down drug pricing policy developments. In recent days, the Centers for Medicare & Medicaid Services (CMS) and the Congressional Budget Office (CBO) have rolled out a series...more
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 - 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
The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more
5/23/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Clean Energy ,
Climate Change ,
CMMI ,
Corporate Taxes ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Life Sciences ,
MedPAC ,
NIST
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
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 February 13, 2023, U.S. Senate Majority Whip Dick Durbin (D-IL), Chair of the Senate Judiciary Committee, sent a letter to the Antitrust Division of the Department of Justice (DOJ) and the Federal Trade Commission (FTC)...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
Key Points -
The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data.
New price setting provisions built into the IRA...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