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
On September 19, 2019, House Speaker Nancy Pelosi (D-CA) released H.R. 3, the Lower Drug Costs Now Act, to make a series of changes to Medicare to lower the price of prescription drugs. The bill must move through three...more
On May 23, 2019, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) released the Lower Health Care Costs Act of 2019 – bipartisan draft legislation to reduce...more
5/30/2019
/ Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Healthcare Costs ,
Prescription Drugs ,
Proposed Legislation ,
Public Health ,
Surprise Medical Bills ,
Transparency
Last week, three House Committees held hearings about protecting the Affordable Care Act (ACA), receiving testimony from patient advocates, researchers, and ACA supporters. Members of both parties supported preserving...more
United States District Court Judge Reed O’Connor of the Northern District of Texas issued a ruling on Friday, December 14, 2018, declaring the Patient Protection and Affordable Care Act (ACA) unconstitutional in its entirety....more
In a November 9, 2018 comment submitted to the U.S. Department of Commerce’s National Telecommunications and Information Administration (“NTIA”), the staff of the Federal Trade Commission (“FTC”) called for a balanced...more
On October 29, Deputy Secretary of the Department of Health and Human Services (“HHS”) Eric Hargan announced the official opening of the Health Sector Cybersecurity Coordination Center (“HC3”). Deputy Secretary Hargan...more