The start of Donald Trump’s second presidency and Republican control in the 119th Congress raises questions about the future of the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), which could be...more
Following a hotly contested election, Donald Trump is once again the president-elect and will return to the White House on January 20, 2025. He will do so with a dominant electoral college win, potentially a win of the...more
11/11/2024
/ Affordable Care Act ,
Artificial Intelligence ,
Blockchain ,
Canada ,
Chevron Deference ,
Consumer Product Safety Commission (CPSC) ,
Cryptocurrency ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Digital Assets ,
Dodd-Frank ,
Energy Sector ,
Environmental Social & Governance (ESG) ,
Estate Tax ,
Financial Services Industry ,
Food and Drug Administration (FDA) ,
Healthcare ,
Imports ,
Inflation Reduction Act (IRA) ,
Infrastructure ,
International Trade ,
Liquid Natural Gas ,
Medicaid ,
Medicare ,
NAFTA ,
Paris Agreement ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Presidential Elections ,
SALT ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Social Security ,
Supply Chain ,
Sustainability ,
Tariffs ,
Tax Cuts and Jobs Act ,
United States-Mexico-Canada Agreement (USMCA)
President Biden’s Executive Order on AI (AI EO), issued on October 30, 2023, directed various agencies to take certain actions within one year of the AI EO’s issuance. On October 24, 2024, the White House announced that...more
11/8/2024
/ Algorithms ,
Artificial Intelligence ,
Copyright Office ,
Data Storage ,
Department of Education ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Executive Orders ,
Government Agencies ,
Infrastructure ,
National Security ,
OMB ,
Research and Development
President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more
5/10/2024
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Automation Systems ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Employment Discrimination ,
Equal Employment Opportunity Commission (EEOC) ,
Executive Orders ,
General Services Administration (GSA) ,
Healthcare ,
HUD ,
National Security ,
NIST ,
OPM ,
Research and Development ,
Rulemaking Process ,
State Labor Laws ,
Transmission Grid ,
USDA
President Joe Biden’s fiscal year (FY) 2025 budget proposal includes hundreds of millions of dollars allocated towards executive branch AI efforts.
The budget proposal’s AI-related provisions can be sorted into three...more
3/29/2024
/ Artificial Intelligence ,
Automation Systems ,
Biden Administration ,
Department of Agriculture ,
Department of Education ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Executive Orders ,
Federal Budget ,
Fraud and Abuse ,
HUD ,
National Science Foundation ,
NHTSA ,
NIST ,
Research and Development ,
Risk Management ,
U.S. Commerce Department ,
U.S. Treasury
Congress — Big Agenda & Little Time -
With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
1/12/2024
/ Artificial Intelligence ,
China ,
DEA ,
Department of Energy (DOE) ,
Department of Health and Human Services (HHS) ,
Department of Transportation (DOT) ,
Environmental Protection Agency (EPA) ,
FCC ,
Federal Aviation Administration (FAA) ,
Federal Highway Administration ,
Federal Trade Commission (FTC) ,
FERC ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labor Shortage ,
Legislative Agendas ,
NHTSA ,
Notice of Proposed Rulemaking (NOPR) ,
Popular ,
Primary Elections ,
Proposed Legislation ,
Regulatory Agenda ,
Research and Development ,
Tariffs ,
Tax Incentives ,
U.S. Commerce Department ,
U.S. Treasury
Drug Pricing Issues Heat Up Following HHS Forum -
Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more
Senate Working Group Pressing Forward on Telehealth -
As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
10/29/2015
/ Affordable Care Act ,
Alternative Payment Models (APM) ,
Barack Obama ,
Cadillac Tax ,
Co-Op ,
Congressional Committees ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
E-Cigarettes ,
Elder Issues ,
Federal Trade Commission (FTC) ,
Fee-for-Service ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Mental Health ,
Orphan Drugs ,
PACE ,
Prescription Drugs ,
SAMHSA ,
Section 340B ,
Social Security ,
State Health Insurance Exchanges ,
Substance Abuse ,
Telehealth ,
Telemedicine
Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more
8/11/2015
/ Affordable Care Act ,
Amarin ,
Caronia ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
FCC ,
First Amendment ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Care Providers ,
ICD-10 ,
Medicaid ,
Off-Label Promotion ,
OIG ,
OMB ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Regulatory Agenda
ACA Repeal Votes Continue: As part of a rare Senate Sunday session to consider a bill to replenish the highway trust fund for six years, Majority Leader Mitch McConnell (R-KY) brought up an amendment to repeal the ACA—in...more
7/29/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
Obama Administration ,
Proposed Legislation ,
Regulatory Agenda ,
Substance Abuse
In This Issue:
- Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck
- Implementation of the Affordable Care Act
- Federal Regulatory Initiatives
- Congressional Initiatives
- Other...more
7/8/2015
/ Affordable Care Act ,
Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Ebola ,
ESRD ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Health Insurance Exchanges ,
Home Health Agencies ,
Hospitals ,
Medicaid ,
Medical Devices ,
Medicare ,
Medicare Payment Reform ,
OIG ,
OPPS ,
Physician Fee Schedule ,
Premiums ,
Regulatory Agenda ,
Reinsurance ,
SAMHSA ,
Unique Device Identifiers
In This Issue:
- CMS Finalizes ACO Program Rules; Scales Alternative Payment Model
- Implementation of the Affordable Care Act
- Federal Regulatory Initiatives
- Congressional Initiatives
- Other...more
In This Issue:
- Permanent Medicare Doc-Fix Entering Critical Week
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other...more
In This Issue:
- King v. Burwell before the Supreme Court and the Potential Congressional Response
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional...more
3/8/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Congressional Investigations & Hearings ,
Department of Health and Human Services (HHS) ,
Health Insurance ,
Health Insurance Exchanges ,
Healthcare ,
HELP ,
Infectious Diseases ,
IRS ,
King v Burwell ,
Medical Devices ,
Medicare ,
Public Health Insurance Marketplace ,
Section 340B ,
Subsidies ,
Ways and Means Committee
In This Issue:
- Open Enrollment Update
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other Health Care News
-...more
In This Issue:
- President Obama Releases FY2016 Budget Proposal
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other Health...more
In This Issue:
- Changes Ahead for Health Policy In 2015
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other Health Care...more
In This Issue:
- SGR Already Strong Focus of 114th Congress:
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Congressional Initiatives
- Other Health...more
In This Issue:
- FDA Releases Menu Labeling Rule
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Upcoming Congressional Hearings
- Excerpt from FDA...more
12/3/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Fast-Food Industry ,
Food and Drug Administration (FDA) ,
Food Safety ,
Health Insurance ,
Health Insurance Exchanges ,
Labeling ,
Legislative Agendas ,
Medicare Part D ,
Restaurant Industry
In This Issue:
- Policymakers Continue Bi-partisan Push to Accelerate ACO Evolution
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and...more
In This Issue:
- HealthCare.gov Hacking Breach
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and State Initiatives
- Other Health...more
In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more
9/5/2014
/ Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
FSMB ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
ICD Codes ,
ICD-10 ,
Legislative Agendas ,
Medicaid ,
Medical Devices ,
Medicare ,
PHSA ,
Physicians ,
Proposed Legislation ,
Telemedicine
In This Issue:
- Administration Releases Updated Contraception Coverage Rules
- Federal Regulatory Initiatives
- Other Congressional and State Initiatives
- Other Health Care News
- Upcoming...more
8/27/2014
/ Affordable Care Act ,
Burwell v Hobby Lobby ,
Closely Held Businesses ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Employer Liability Issues ,
Final Rules ,
Healthcare ,
Obama Administration ,
Religious Exemption
In This Issue:
- First Guidance following Hobby Lobby released
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Congressional and State...more
7/23/2014
/ Affordable Care Act ,
Burwell v Hobby Lobby ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Closely Held Businesses ,
Contraceptive Coverage Mandate ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
EHR ,
Employer Mandates ,
Food and Drug Administration (FDA) ,
Healthcare ,
National Institute of Health (NIH) ,
ONC ,
Opt-Outs ,
PHRMA ,
Religious Freedom Restoration Act (RFRA) ,
SCOTUS
In This Issue:
- E&C continues to push for bipartisan efforts to improve drug pipeline
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
- Other Health Care...more
7/8/2014
/ Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Legislative Agendas ,
Legislative Committees ,
National Institute of Health (NIH) ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Telemedicine