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
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
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
On December 29, 2022, the President signed into law the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) as part of the Consolidated Appropriations Act, 2023 (P.L....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
Washington, D.C. is currently focused on a September continuing resolution (CR) to keep the federal government funded, but it is worth looking ahead to the broader health care horizon and the key Medicare issues that await...more
9/19/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Lame Duck Session ,
Legislative Agendas ,
Medicare ,
Mental Health ,
Substance Abuse ,
Telehealth ,
Telemedicine
Today, President Biden signed the Inflation Reduction Act of 2022 (IRA) into law. The final IRA bill came together after more than 18 months of intra-party negotiations among Democrats about what legislative priorities to...more
The following alert provides a high level update to the August 4 Akin Gump comprehensive section-by-section report, which was published before the Senate vote-a-rama and final Senate passage. This update is being published...more
Sens. Joe Manchin (D-WV) and Chuck Schumer (D-NY) shocked Washington, D.C. when they announced an agreement around a budget reconciliation package that includes clean energy and health care provisions and tax reform. The...more
In October of 2018, Congress passed the SUPPORT for Patients and Communities Act (P.L. 115-271). The comprehensive opioid treatment law passed both chambers of Congress with large bipartisan support and tackled many aspects...more
For the past two years, the United States government has had to deal with most major legislative and regulatory actions against the backdrop of the COVID-19 pandemic. In making policy, the federal government has been forced,...more
Background on Cures 2.0 -
The COVID-19 pandemic response demonstrated the tremendous impact innovation can have on a global scale. The unprecedented experiences of the past year and a half have spurred renewed interest in...more
In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more
On February 17, 2021, it was reported that President Biden would nominate Chiquita Brooks-LaSure as Administrator of the Centers for Medicare & Medicaid Services (CMS), the largest operating division of the U.S. Department of...more
The Biden administration announced on Tuesday, January 26 that it plans to purchase 200 million additional doses of vaccine against COVID-19. Additionally, the administration announced that it plans to increase shipments of...more
- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.”
- A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
- Legislation to bolster the U.S. supply chain for medical equipment becomes an issue of bipartisan focus in Congress.
- Differing proposals included in the House and Senate “Phase 4” COVID-relief proposals as well...more
8/5/2020
/ Acquisitions ,
Coronavirus/COVID-19 ,
Manufacturers ,
Medical Equipment ,
Medical Supplies ,
Onshoring ,
Personal Protective Equipment ,
Proposed Legislation ,
Relief Measures ,
Supply Chain ,
Tax Credits
The recently enacted “Coronavirus Preparedness and Response Emergency Supplemental Appropriations Act” provided $7.8 billion in federal funding to support the government’s response to the COVID-19 outbreak. The total funding...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
We are now one year away from the 2020 presidential election, with the Iowa caucuses (February 3, 2020) and the New Hampshire primary (February 11, 2020) fast approaching. While these two states’ contests are important, in...more
• On July 18, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare & Medicaid Innovation (CMMI) published a proposal to implement a new mandatory Medicare payment model in select geographic...more
8/12/2019
/ Alternative Payment Models (APM) ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Fee-for-Service ,
Health Care Providers ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
PAMA ,
Physician Fee Schedule ,
Quality Payment Program (QPP) ,
Secretary of HHS ,
Social Security Act
• In recent proposed rulemaking, the Centers for Medicare and Medicaid Services (CMS) make several significant recommendations that incentivize innovation and break down patient barriers to accessing cutting-edge medical...more
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted.
• Many of the more dramatic proposals would require federal rulemaking or...more
5/17/2018
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Medicare Part D ,
Out-of-Pocket Expenses ,
Patients ,
Pharmaceutical Industry ,
Prescription Drugs ,
Request For Information ,
Section 340B ,
Trade Agreements ,
Trump Administration ,
WTO