This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
2/26/2024
/ 1115 Waivers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medicaid ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Prior Authorization ,
Regulatory Agenda ,
Regulatory Reform ,
Self-Referral
On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more
Two separate lawsuits alleging False Claims Act (FCA) violations by retail drug pharmacies made their way to the Supreme Court of the United States this term. The lawsuits decided whether the pharmacies could defeat these...more
6/14/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for April 2023. We discuss several criminal and civil enforcement actions related to the Anti-Kickback Statute (AKS) and the...more
6/8/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Testing ,
False Claims Act (FCA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medical Debt ,
OIG ,
Self-Disclosure Requirements ,
Settlement ,
Stark Law ,
TRICARE
In the last few months, the US Centers for Medicare & Medicaid Services (CMS) has made several noteworthy changes and provided a material clarification for providers and suppliers who are subject to the federal physician...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
8/8/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Department of Health and Human Services (HHS) ,
Disproportionate Share Adjustments ,
Dobbs v. Jackson Women’s Health Organization ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Roe v Wade ,
Skilled Nursing Facility
On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more
11/25/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Electronic Medical Records ,
Final Rules ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Safe Harbors ,
Stark Law ,
Telehealth
On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more
The Centers for Medicare & Medicaid Services issued its long-awaited final rule on long-term care facility reform, which represents the first comprehensive change to long-term care conditions of participation since 1991. The...more
The US Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) released proposed updates to its Calendar Year (CY) 2017 Home Health Prospective Payment System (HH PPS) in the July 5, 2016,...more
On October 30, 2015, the Centers for Medicare & Medicaid Services (CMS) released its final rule updating the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for...more
The U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) published its proposed update to the home health prospective payment system (HHPPS) for calendar year (CY) 2016 in the July...more
7/20/2015
/ Affordable Care Act ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Home Health Agencies ,
Home Health Care ,
IMPACT Act ,
Medicaid ,
Medicare ,
OASIS ,
Proposed Regulation ,
Value-Based Purchasing
On July 1, 2015, the Centers for Medicare & Medicaid Services (CMS) released proposed updates to the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System for Calendar Year...more
7/8/2015
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Hospitals ,
Inpatient Billing ,
Medicaid ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Part A ,
OPPS ,
Physicians ,
Proposed Regulation ,
Recovery Audit Contractors (RACs) ,
Two-Midnight Rule