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
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
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 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
Key Points -
Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs.
Co-pay programs remain unavailable to participants in federal...more
Key Points -
U.S. hospitals, health systems, suppliers, pharmaceutical companies and other industry stakeholders are invited to submit voluntary pledges to reduce greenhouse gas emissions and increase their climate...more
Key Points:
The OASH under HHS is soliciting input from the public on its 2022 Environmental Justice Strategy and Implementation Plan Draft Outline. Comments are due to HHS by May 19, 2022.
The 2022 HHS Environmental...more
The Office of Climate Change and Health Equity -
The Department of Health and Human Services (HHS) recently established the Office of Climate Change and Health Equity (OCCHE), reinforcing the Biden-Harris administration’s...more
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
9/10/2021
/ Biden Administration ,
Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Competition ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Healthcare Reform ,
Hospitals ,
Life Sciences ,
Pharmaceutical Industry
President-elect Biden’s agenda and approach for his first 100 days in office will depend to a large degree on which party controls the United States Senate. Many of the incoming President’s major campaign promises—such as...more
11/24/2020
/ Affordable Care Act ,
Biden Administration ,
Cole Memorandum ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Healthcare Reform ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Opioid ,
Public Policy ,
Regulatory Agenda
Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants.
On the drug pricing front, the...more
11/23/2020
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Interim Final Rules (IFR) ,
Medicare Part B ,
Most-Favored Nations ,
OIG ,
Pharmaceutical Industry ,
Stark Law ,
Trump Administration ,
Value-Based Care
- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule.
- HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more
9/15/2020
/ Administrative Review ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Guidance Documents ,
Judicial Review ,
Notice of Proposed Rulemaking (NOPR) ,
Proposed Rules ,
Public Comment ,
Regulatory Agencies ,
Request For Information ,
Rulemaking Process
While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more
4/1/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Stimulus ,
Health Care Providers ,
Hospitals ,
Medical Devices ,
Medical Supplies ,
Medical Testing ,
Over The Counter Drugs (OTC) ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Relief Measures
As the number of COVID-19 cases in the U.S. continues to grow, the CARES Act makes a number of changes to support the ability of the health care system to respond to the crisis over the coming months. In addition, the package...more
3/30/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Financial Stimulus ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Medical Supplies ,
Medicare ,
Public Health Emergency ,
Telehealth