On the afternoon of July 4, President Trump signed into law H.R. 1, the One Big Beautiful Bill Act – comprehensive budget reconciliation legislation that represents the core of President’s second-term domestic agenda and...more
7/14/2025
/ Affordable Care Act ,
Cost-Sharing ,
Federal Budget ,
Gender Identity ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicaid Expansion ,
Medicaid Work Requirements ,
New Legislation ,
One Big Beautiful Bill Act ,
Rural Health Care Program ,
Trump Administration
On June 16, 2025, the U.S. Senate Finance Committee released draft legislative language for its version of the “One Big Beautiful Bill Act,” a comprehensive budget reconciliation proposal that includes significant changes to...more
On May 22, 2025, the House passed H.R. 1, the One Big Beautiful Bill Act (the Bill), its budget reconciliation legislation that upheld most of the Medicaid-related provisions originally approved by the House Energy and...more
6/6/2025
/ Budget Reconciliation ,
Centers for Medicare & Medicaid Services (CMS) ,
Federal Funding ,
Government Agencies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
New Legislation ,
Proposed Legislation ,
State and Local Government
The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more
Last week, the House Energy & Commerce Committee marked up legislation that would significantly affect the Medicaid program, including changes to state Medicaid financing mechanisms, state directed payment programs that...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
12/11/2024
/ Acquisitions ,
Affordable Care Act ,
Affordable Housing ,
Antitrust Provisions ,
Canada ,
Capital Formation ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clean Air Act ,
Colleges ,
Congressional Investigations & Hearings ,
Coronavirus/COVID-19 ,
Data Privacy ,
Department of Energy (DOE) ,
Department of Justice (DOJ) ,
Deregulation ,
Digital Assets ,
Drinking Water ,
Drug Pricing ,
Electric Vehicles ,
Energy Sector ,
Enforcement ,
Environmental Protection Agency (EPA) ,
Exports ,
Federal Trade Commission (FTC) ,
Final Rules ,
Financial Services Industry ,
Food and Drug Administration (FDA) ,
Fraud ,
Greenhouse Gas Emissions ,
Healthcare ,
Imports ,
Infrastructure ,
Lead ,
Medicaid ,
Medicare Advantage ,
Mergers ,
Mexico ,
Money Laundering ,
NAFTA ,
National Institute of Health (NIH) ,
Nuclear Power ,
Offshore Drilling ,
Offshore Wind ,
Oil & Gas ,
PFAS ,
Popular ,
Social Media ,
Tariffs ,
Tax Cuts ,
Technology ,
Transparency ,
Trump Administration ,
United States-Mexico-Canada Agreement (USMCA) ,
Universities ,
Waivers
Since the enactment of the Inflation Reduction Act of 2022 (the “IRA”) in the United States, the Department of the Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) have issued notices of proposed regulations...more
3/13/2024
/ Administrative Procedure Act ,
Congressional Review Act ,
Department of Energy (DOE) ,
Department of Labor (DOL) ,
GAO ,
Inflation Reduction Act (IRA) ,
Internal Revenue Code (IRC) ,
Investment Tax Credits ,
IRS ,
Members of Congress ,
Notice of Proposed Rulemaking (NOPR) ,
OIRA ,
OMB ,
Policies and Procedures ,
Production Tax Credit ,
Public Comment ,
Rulemaking Process ,
SCOTUS
On the afternoon of Saturday, September 30, 2023, Congress passed H.R. 5860, the Continuing Appropriations, 2024 and Other Extensions Act, averting a government shutdown and funding the federal government for forty-five days...more
The gas stove wars continue to heat up. On April 17, 2023, the United States Court of Appeals for the Ninth Circuit took a stand and ruled that the City of Berkeley does not have the authority to prohibit connecting natural...more
On February 16, 2023, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing concerning the current health care workforce shortage. On March 2, 2023, Chairman Sanders and Ranking Member Cassidy of...more
Not a day seems to go by in recent weeks without multiple articles and media hits on controversies over gas stoves. Across the U.S., opponents of gas stoves have implemented a coordinated effort by government regulators,...more
2/27/2023
/ Administrative Procedure Act ,
Apartments ,
Clean Air Act ,
Commercial Buildings ,
Consumer Product Safety Commission (CPSC) ,
Department of Energy (DOE) ,
Energy Sector ,
Environmental Protection Agency (EPA) ,
Fossil Fuel ,
Proposed Rules ,
Single Family Housing ,
State and Local Government
On February 1, 2023, the U.S. International Trade Commission (the “ITC”) initiated an investigation into the impact of intellectual property (“IP”) rights on the production, supply, and availability of diagnostics and...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
1/10/2023
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BsUFA ,
Clinical Trials ,
Cosmetics ,
Disclosure Requirements ,
Diversity and Inclusion Standards (D&I) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
Inspections ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Misbranding ,
Opioid ,
Orphan Drugs ,
Over The Counter Drugs (OTC) ,
PDUFA ,
Public Health ,
Real World Evidence ,
User Fees
House Passage and President Biden’s Signature Expected This Week -
On Sunday, August 7, following an all-night voting session, the Senate approved the Inflation Reduction Act (IRA) by a vote of 51-50. The IRA was...more
8/11/2022
/ Affordable Care Act ,
Biden Administration ,
Carbon Capture and Sequestration ,
Clean Air Act ,
Corporate Taxes ,
Drug Pricing ,
Environmental Justice ,
IRS ,
Local Taxes ,
Prevailing Wages ,
Price Inflation ,
Stock Repurchases ,
Tax Reform
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
6/2/2022
/ Animal Testing ,
BsUFA ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
HELP ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
PDUFA ,
PFAS ,
Prescription Drugs ,
Public Health ,
Public Health Service Act ,
Purple Book ,
REMS ,
Title III
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
5/11/2022
/ Biosimilars ,
BsUFA ,
CDRH ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Diversity ,
Drug Approvals ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
GDUFA ,
Generic Drugs ,
Inspections ,
Labeling ,
Medical Device User Fee Program (MDUFA IV) ,
Misbranding ,
PDUFA ,
Pharmaceutical Industry ,
Popular ,
Waivers
The House and Senate voted last week, and President Biden signed into law on December 10, 2021, a bill to delay looming reduction in Medicare rates set to take effect in 2022. The bill, the Protecting Medicare and American...more
Last week, President Biden presented an outline of a $1.75 trillion Build Back Better (BBB) social spending reconciliation framework resulting from months of negotiations with House and Senate Democrats. Congressional...more
11/3/2021
/ Affordable Care Act ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Veterans Affairs ,
Federal Poverty Line ,
FMAP ,
Healthcare ,
Healthcare Reform ,
Home and Community Based Services (HCBS) ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Mental Health ,
Nursing Homes
On Saturday, March 6, 2021, by a vote of 50-49, the Senate amended and approved the American Rescue Plan Act of 2021, which is reconciliation legislation to provide $1.9 trillion in COVID-19 relief. The House of...more
3/11/2021
/ Affordable Care Act ,
American Rescue Plan Act of 2021 ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
COBRA ,
Community Health Systems ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
FMAP ,
Medicaid ,
New Legislation ,
Provider Relief Fund ,
Relief Measures ,
Tax Credits ,
Unemployment Benefits ,
Vaccinations ,
Virus Testing
As members of Congress negotiate an end of year agreement on Fiscal Year 2021 federal spending and a potential COVID-19 relief package, there is a strong potential that surprise billing legislation may also be included. On...more
On June 9, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) released a 40-page white paper, Preparing for the Next Pandemic. Chairman Alexander is seeking stakeholder input to...more
On June 5, 2020, President Trump signed into law the Paycheck Protection Program Flexibility Act, H.R. 7010 (P.L. 116-142). While this law does not add any new funding to the Small Business Administration (SBA) Paycheck...more
On March 18, President Trump signed into law H.R. 6201, the Families First Coronavirus Response Act (Public Law 116-127), a second coronavirus, or COVID-19, response package. Funds in the Act are designated as emergency...more
3/23/2020
/ Coronavirus/COVID-19 ,
EFMLA ,
Families First Coronavirus Response Act (FFCRA) ,
Family and Medical Leave Act (FMLA) ,
FMAP ,
New Legislation ,
PREPA ,
Relief Measures ,
Sick Leave ,
Sick Pay ,
Tax Credits
On March 6, 2020, President Trump signed H.R. 6074, the Coronavirus Preparedness and Response Supplemental Appropriations Act (the Act) into law (Public Law 116-123). The legislation, which was introduced on March 4 and...more
On December 17, 2019, Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.) reintroduced legislation to address the backlog of Medicare appeals cases awaiting review before an...more
1/13/2020
/ Administrative Appeal Office ,
Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicare ,
Ombudsman ,
OMHA ,
Proposed Legislation ,
Recovery Audit Contractors (RACs) ,
Senate Finance Committee