On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year 2025 final rule for services reimbursed under the Medicare physician fee schedule. Among other developments, the final rule...more
In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more
McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most.
Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more
10/10/2023
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Antitrust Provisions ,
Attorney-Client Privilege ,
Chief Compliance Officers ,
Compliance ,
Continuing Legal Education ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Investigations ,
Life Sciences ,
Physicians ,
Regulatory Requirements ,
Restrictive Covenants
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
9/1/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medicare ,
OIG ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Reimbursements ,
Settlement
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more
6/23/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Employer Mandates ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicare ,
Nursing Homes ,
OIG ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Public Health Emergency ,
Regulatory Agenda ,
Telehealth ,
Telemedicine ,
Vaccinations
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for March 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and...more
5/3/2023
/ Coronavirus/COVID-19 ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
False Statements ,
Florida ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Physicians ,
Remand ,
Settlement ,
Voluntary Disclosure ,
Whistleblowers
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
3/9/2023
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Health Care Providers ,
Hospitals ,
Manufacturers ,
Medical Devices ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Physicians ,
Proposed Regulation ,
Regulatory Agenda ,
Self-Referral ,
Stark Law
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
10/7/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Antitrust Violations ,
Biotechnology ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Medicare ,
Medicare Shared Savings Program ,
Nurses ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency ,
Technology ,
Telehealth ,
TRICARE
Beginning in 2023, Medicare will recognize a new provider type: the Rural Emergency Hospital (REH). The establishment of REHs is intended to preserve access to emergency departments and other outpatient services in rural...more
8/11/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Emergency Rooms ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Services ,
Physician Ownership ,
Physicians ,
Proposed Rules ,
Provider Payments ,
Rural Areas ,
Rural Health Care Providers ,
Stark Law ,
Statutory Requirements ,
Webinars
This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more
6/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Competition ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Hospitals ,
Information Technology ,
Inpatient Prospective Payment System (IPPS) ,
Medical Devices ,
Nursing Homes ,
OIG ,
Payment Systems ,
Physicians ,
Regulatory Agenda ,
Skilled Nursing Facility ,
Telehealth ,
Telemedicine
The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more
4/19/2022
/ Anti-Kickback Statute ,
Asset Purchase Agreements ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Professional Services Contract ,
Qui Tam ,
Reimbursements ,
Reversal ,
Section 340B
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more
On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) final rule which, among other policy and regulatory changes, finalized...more
On July 13, 2021, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2022 Medicare Physician Fee Schedule (MPFS) proposed rule (Proposed Rule). The Proposed Rule sets forth CMS’ plans to revise...more
7/16/2021
/ Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Medicare ,
Medicare Payment Reform ,
MPFS ,
New Regulations ,
Nurse Practitioners ,
Physician Assistants ,
Physicians ,
Proposed Rules
The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more
7/12/2021
/ Best Practices ,
Compliance ,
Continuing Legal Education ,
Covered Entities ,
DSH ,
Eligibility ,
Enforcement Actions ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Medical Billing Codes ,
Medicare ,
Overpayment ,
Payor Contracts ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Prescription Drugs ,
Refunds ,
Regulatory Oversight ,
Section 340B ,
Webinars
This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow.
Our...more
3/16/2021
/ Biden Administration ,
Billing ,
Covered Entities ,
Dispute Resolution ,
Drug Pricing ,
Health Care Providers ,
Legislative Agendas ,
Manufacturers ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Section 340B ,
Webinars
The Consolidated Appropriations Act, 2021, creates 1,000 new Medicare-funded graduate medical education (GME) residency positions, expands opportunities for rural residency training, and allows hospitals that have very low...more
1/18/2021
/ Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Hospitals ,
Medicare ,
Physicians ,
Public Health Emergency ,
Teaching Hospitals ,
Training
The updated waivers build upon the more limited set of Section 1135 waivers issued on March 13, 2020, and address common concerns among Medicare providers and suppliers as they deal with the Coronavirus (COVID-19) pandemic....more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
OCR ,
Physicians ,
Public Health ,
Relief Measures ,
Telehealth ,
Telemedicine ,
Waivers
The Centers for Medicare and Medicaid Services (CMS) released several fact sheets on COVID-19 coverage and benefits, and announced a second Healthcare Common Procedure Coding System (HCPCS) code, U0002, for billing COVID-19...more
3/11/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Part A ,
Medicare Part B ,
Medicare Part D ,
Physicians ,
Provider Payments
On September 10, 2019, the US Department of Health and Human Services Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) expanding Medicare, Medicaid and Children’s Health Insurance Program...more
10/1/2019
/ Affiliates ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Document Retention Policies ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Opt-Outs ,
Physicians ,
Public Comment ,
Reporting Requirements
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
On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more
10/30/2015
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Debt Ceiling ,
Federal Budget ,
Generic Drugs ,
Health Care Providers ,
Healthcare ,
Hospitals ,
HRSA ,
Medicaid ,
Medicare ,
Medicare Part B ,
OPPS ,
Pending Legislation ,
Physician Fee Schedule ,
Physicians ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Sequestration
Among the proposed changes to Medicare regulatory requirements related to billing and coverage of physician services set forth in the 2016 Medicare Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for...more
7/21/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Proposed Regulation ,
Stark Law ,
Supervision