Many state legislatures have recently convened for 2025 legislative sessions, and members have already proposed a significant number of bills that, if passed, would materially impact transactions and/or corporate structures...more
2/3/2025
/ Acquisitions ,
Corporate Governance ,
Disclosure Requirements ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
New Legislation ,
Private Equity ,
Regulatory Requirements ,
State and Local Government ,
State Legislatures
On September 28, California Governor Newsom vetoed Assembly Bill 3129 (Bill), which would have created significant oversight of private investment in and management of certain healthcare transactions and arrangements in...more
9/30/2024
/ California ,
Filing Requirements ,
Governor Newsom ,
Governor Vetoes ,
Health Care Providers ,
Healthcare ,
Investment ,
Legislative Agendas ,
New Legislation ,
Private Equity ,
Regulatory Agenda ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance on June 26, 2024, entitled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical...more
On June 26, the California Senate Health Committee passed Assembly Bill 3129 (Bill), which was further amended on June 27 and re-referred to the Committee on Judiciary. The following is a summary of the material changes made...more
Effective January 1, 2025, if enacted, California Assembly Bill 3129 (Bill) would grant sweeping power to the Attorney General by authorizing the Attorney General to approve, conditionally approve, or disapprove of certain...more
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud...more
4/11/2023
/ Advisory Opinions ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
OIG ,
Physicians ,
Request For Information ,
Self-Disclosure Requirements ,
Telemedicine ,
Wellness Programs
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services recently posted Advisory Opinion 22-20, approving an acute care hospital’s arrangement under which its employed nurse practitioners...more
1/6/2023
/ Acute Facilities ,
Advisory Opinions ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Nurse Practitioners ,
OIG ,
Physicians ,
Remuneration ,
Stark Law
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
10/4/2022
/ 21st Century Cures Act ,
Clinical Trials ,
Consent ,
Department of Health and Human Services (HHS) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
New Guidance ,
Notice of Proposed Rulemaking (NOPR) ,
Office for Human Research Protections (OHRP) ,
Recordkeeping Requirements ,
The Common Rule ,
Waivers
Effective October 1, 2022, certain providers participating in the Florida Medicaid program will be required to pay direct care workers a minimum of $15 per hour. Below we’ve outlined which organizations are subject to this...more
The United States Food and Drug Administration (FDA) issued draft guidance on April 13, 2022, entitled, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical...more
On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more
interdisciplinary care focused on treating symptoms to improve quality of life rather than curing disease. Investment activity in the post-acute care sector continues to grow as the market remains largely fragmented and the...more
On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more
The Medicare Physician Fee Schedule Final Rule for Calendar Year 2021 (the Final Rule) issued by the Centers for Medicare & Medicaid Services (CMS) on December 1, 2020, and published in the Federal Register on December 28,...more
1/5/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Final Rules ,
Health Care Providers ,
Medical Coding ,
Medicare ,
Opioid ,
Physician Fee Schedule ,
Physicians ,
Public Health Emergency ,
Reporting Requirements ,
Scope of Treatment ,
Telehealth ,
Vaccinations ,
Verification Requirements
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
12/22/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Final Rules ,
Health Care Providers ,
New Value Exception ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Rebates ,
Safe Harbors ,
Stark Law ,
Technology Sector
On August 3, the Centers for Medicare & Medicaid Services (CMS) released its proposed Medicare Physician Fee Schedule (MPFS) updates for the 2021 calendar year, addressing among other policy changes how CMS will treat...more
Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more
9/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Long Term Care Facilities ,
Medicare ,
Physicians ,
Reporting Requirements ,
Urgent Care Facilities ,
Virus Testing
On May 29, President Trump issued a proclamation, effective on June 1, 2020, to suspend and limit certain nonimmigrant Chinese nationals who seek to enter the United States with an F or J visa. This latest action by the Trump...more
6/9/2020
/ Best Practices ,
China ,
Enforcement Actions ,
Federal Funded Research and Development Centers (FFRDCs) ,
Foreign Nationals ,
Fraud ,
Medical Research ,
Medical School ,
National Institute of Health (NIH) ,
Presidential Proclamations ,
STEM ,
Students ,
Travel Restrictions ,
Trump Administration ,
Universities ,
Visas