I. Introduction - The Centers for Medicare & Medicaid Services (CMS) issued the proposed rule on April 11, 2025, for the skilled nursing facility (SNF) prospective payment system (PPS) fiscal year (FY) 2026 update (the...more
In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more
President Trump issued an Executive Order on April 15, 2025, titled "Lowering Drug Prices by Once Again Putting Americans First," with the express goal of providing Americans and taxpayers access to prescription drugs. One...more
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
4/15/2025
/ Administrative Procedure Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Vacated
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
4/2/2025
/ Administrative Procedure Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Statutory Interpretation
The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more
3/25/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Foreign Workers ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
New Legislation ,
OIG ,
Overpayment ,
Physicians ,
Regulatory Reform ,
Regulatory Requirements ,
Settlement ,
Skilled Nursing Facility
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more
On December 9, 2024, the Centers for Medicare & Medicaid Services' (CMS's) Calendar Year 2025 Physician Fee Schedule Final Rule (the Final Rule) was published in the Federal Register. The Final Rule includes noteworthy...more
12/13/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medical Reimbursement ,
Medicare ,
Mental Health ,
Overpayment ,
Physician Fee Schedule ,
Physicians ,
Reimbursements ,
Telehealth ,
Telemedicine
South Carolina Governor Henry McMaster declared a State of Emergency on September 25, 2024, to prepare for Hurricane Helene. On September 29, 2024, the Federal Emergency Management Agency (FEMA) issued a Federal Major...more
10/7/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Disaster Aid ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Home Health Agencies ,
Hurricane Season ,
Natural Disasters ,
Public Health Emergency ,
Severe Weather ,
Skilled Nursing Facility ,
Waivers
CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more
9/6/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Payment Systems ,
Safety Standards ,
Social Security Act
Under the CY 2025 Medicare Physician Fee Schedule (PFS) proposed rule, CMS proposes several modifications to the Medicare Shared Savings Program (MSSP) that would become effective in performance year 2025. CMS also proposed...more
The Centers for Medicare & Medicaid Services (CMS) proposed to extend a number of COVID-era regulatory flexibilities related to telehealth, remote services, and supervision in the CY 2025 Medicare Physician Fee Schedule (PFS)...more
7/30/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare ,
Medicare ,
Mental Health ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Substance Abuse ,
Telehealth ,
Telemedicine
Skilled nursing facilities (SNFs) owned or operated by hospitals (hospital-owned SNFs) have a demonstrated track record of delivering positive outcomes for post-acute care patients. Such success, however, has not been without...more
In a settlement larger than Halifax and Tuomey combined, an Indianapolis-based health system recently settled with the Department of Justice for $345 million to resolve Stark Law and False Claims Act allegations relating to...more
The CY 2024 Medicare Physician Fee Schedule Final Rule (Final Rule) implemented several statutory extensions to COVID-19 telehealth waivers and flexibilities, finalized proposed policies, and extended an important telehealth...more
In this article, we highlight a number of policy proposals in the current year (CY) 2024 Medicare Physician Fee Schedule (MPFS) Proposed Rule that have significant health care delivery and operational implications. These...more
CMS recently released the CY 2024 Medicare Physician Fee Schedule (MPFS) Proposed Rule (Proposed Rule), which included many noteworthy proposals and clarifications related to Medicare telehealth services and other remote...more
On April 4, 2023, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule for FY 2024 addressing the Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice...more
Quality of care allegations against long term care providers are a focus for the Biden administration, the Department of Justice (DOJ), and the HHS-OIG – all of whom are targeting providers whom they deem to be providing...more
On December 27, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would, among other things, amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for an...more
Falls and other incidents are often the source of liability for assisted living communities and are the basis for litigation and other enforcement action. Not all falls and other incidents are preventable despite a...more