The Centers for Medicare & Medicaid Services (CMS) has rescinded its 2022 guidance and accompanying letter that reinforced hospitals' obligations under the Emergency Medical Treatment and Labor Act (EMTALA) to provide...more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
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
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
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
The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services and Office of the Secretary (collectively, HHS) released on May 6, 2024, the agencies' Final Rule governing the implementation of...more
5/13/2024
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Non-Discrimination Rules ,
Notice Requirements ,
Policies and Procedures ,
Section 1557
The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services and the Office of the Secretary (collectively, HHS) released the agencies' Final Rule governing the implementation of Section 1557 of...more
5/13/2024
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disabilities ,
Health Care Providers ,
Health Insurance ,
Limited English Proficiency (LEP) ,
Medicaid ,
Medicare ,
Non-Discrimination Rules ,
Section 1557
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
On April 17, 2023, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a Proposed Rule to support reproductive health care privacy in the Federal Register. Through the...more
President Biden recently announced that his administration plans to end the COVID-19 PHE on May 11, 2023. This provides more clarity about the long-anticipated end date for certain telehealth waivers and enforcement...more
On September 14, 2022, the U.S. Department of Health and Human Services (HHS) published its Roadmap for Behavioral Health Integration outlining how HHS plans to advance President Biden’s national strategy to address mental...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued its 2023 Physician Fee Schedule Final Rule (Final Rule). The Final Rule made several noteworthy changes, including expanding access to covered...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Physician Fee Schedule (PFS) Final Rule. This article highlights noteworthy provisions of the Final Rule...more