On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more
6/2/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Gender Identity ,
Government Agencies ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
Reporting Requirements ,
Trump Administration
On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more
5/30/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Gender Identity ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Regulatory Requirements ,
Reporting Requirements ,
Trump Administration
The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more
3/12/2025
/ Anti-Kickback Statute ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Medicaid ,
Medical Billing Codes ,
Medicare ,
Nursing Homes ,
OIG ,
Popular ,
Regulatory Requirements ,
Skilled Nursing Facility
Nursing facilities and skilled nursing facilities that participate in the Medicare and Medicaid programs must comply with certain mandatory compliance program requirements of participation (ROPs). Under the Biden...more
1/29/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Priorities ,
Medicaid ,
Medicare ,
Patient Safety ,
Prescription Drugs ,
Quality Assurance Programs ,
Regulatory Agenda ,
Skilled Nursing Facility ,
Trump Administration
The Centers for Medicare and Medicaid Services (CMS) recently announced the release of updated model signage for use by Medicare-participating hospitals to inform patients of their rights under the Emergency Medical Treatment...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
8/1/2024
/ AIDS ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
HIV ,
Hospitals ,
Medicare ,
Medicare Part B ,
MIPS ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda ,
Stark Law
As we previously advised, the Centers for Medicare & Medicaid Services (CMS) is preparing to issue a national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV under...more
In February 2022, US President Joseph Biden announced an overhaul of regulations affecting nursing homes. These reforms, aimed at enhancing the safety and quality of care for nursing-home residents, focus on improving...more
On April 20, 2023, the US Department of Health and Human Services (HHS) made ownership data of all Medicare-certified hospices and home health agencies publicly available for the first time. This move is consistent with the...more
Following the Biden administration’s efforts to promote nursing home safety, transparency, accountability and quality, the US Centers for Medicare & Medicaid Services (CMS) announced a proposed rule governing nursing home...more
3/31/2023
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Data Reporting ,
Disclosure Requirements ,
Medicare ,
New Rules ,
Nursing Homes ,
REIT ,
Reporting Requirements ,
Skilled Nursing Facility ,
Transparency
On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s...more
3/14/2022
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health and Safety ,
Health Care Providers ,
Healthcare Reform ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
Regulatory Oversight ,
Skilled Nursing Facility
The Centers for Medicare and Medicaid Services (CMS) published an interim final rule with comment period (IFR) on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for...more
Since the early stages of the Coronavirus (COVID-19) pandemic, long term care facilities (LTCFs) have been an epicenter of transmission. Medicare Requirements for Participation for LTCFs include an obligation to establish and...more
6/9/2020
/ CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Long Term Care Facilities ,
Medicare ,
Nursing Homes ,
Quality Control Plan ,
Re-Opening Guidelines ,
Safety and Oversight Group (QSO) ,
Surveys
On March 30, 2020, CMS issued updates to its prior QSO memorandum, expanding its infection control and prevention guidance to include hospitals, critical access hospitals and psychiatric hospitals. The updated QSO memorandum...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Medicare ,
Mental Health ,
OCR ,
Psychiatric Hospitals ,
Public Access Laws ,
Public Health ,
Quarantine ,
Relief Measures ,
Telemedicine ,
Waivers
On March 30, 2020, the Centers for Medicare and Medicaid Services (CMS) released a Quality, Safety & Oversight Group (QSO) memorandum (QSO-20-22-ASC, CORF, CMHC, OPT, RHC/FQHCs) addressing standards for infection control and...more
4/1/2020
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Community Care Program ,
Community Health Systems ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Clinics ,
Healthcare Facilities ,
Hospitals ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Outpatient Services ,
Quality Assurance Programs
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
In this installment of the Healthcare Enforcement Quarterly Roundup we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts in 2020. In this...more
2/7/2020
/ Administrative Procedure Act ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Compounding ,
Drug Distribution ,
Enforcement Actions ,
Enforcement Guidance ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance ,
Healthcare Fraud ,
Healthcare Reform ,
Kickbacks ,
Medicare ,
Opioid ,
Overpayment ,
Pain Management ,
Pharmacies ,
Prescription Drugs ,
Private Equity ,
Regulatory Violations ,
Rulemaking Process ,
Settlement Negotiations ,
Stark Law