Reflecting on lessons learned and complaints received during the COVID-19 pandemic, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released detailed frequently asked questions (FAQs)...more
2/23/2024
/ Coronavirus/COVID-19 ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Discrimination ,
Healthcare ,
Hospitals ,
Long Term Care Facilities ,
OCR ,
Patients ,
Policies and Procedures ,
Regulatory Requirements
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more
2/8/2023
/ Anti-Kickback Statute ,
Audits ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Fraud ,
Health Care Violations ,
Medicaid ,
Medical Devices ,
OIG ,
Regulatory Agenda
Nursing homes and long-term care facilities were hit hard by COVID-19. However, as of September 11, 2022, 87.3% of residents and 86.9% of staff have completed primary vaccination. Such adherence may have been instrumental in...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
5/27/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Co-payments ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
False Claims Act (FCA) ,
Health Care Providers ,
Manufacturers ,
Medicaid Drug Rebate Program ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law
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
Stay current on the healthcare enforcement issues impacting your business’ compliance strategies. In this installment of the Healthcare Enforcement Roundup, we address:
• Key areas of enforcement scrutiny in 2021,...more
4/2/2021
/ 1135 Waivers ,
Biden Administration ,
Coronavirus/COVID-19 ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Enforcement Guidance ,
Executive Orders ,
False Claims Act (FCA) ,
Healthcare Fraud ,
OIG ,
Private Equity ,
Regulatory Oversight ,
Revocation ,
Telehealth ,
Telemedicine
The Centers for Medicare and Medicaid Services (CMS) notified state survey agency directors that it has lifted previously imposed hospital survey suspensions and resumed routine hospital reaccreditation and recertification...more
In this installment of the Healthcare Enforcement Roundup we cover new and longstanding issues impacting the healthcare enforcement landscape. First, we explore the impact of the Coronavirus (COVID-19) on the healthcare...more
7/27/2020
/ 1135 Waivers ,
Compliance ,
Continuing Legal Education ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
e ,
False Claims Act (FCA) ,
Guidance Update ,
Health Care Providers ,
Hospitals ,
Objective Falsity ,
Physicians ,
Split of Authority ,
Stark Law ,
Whistleblowers
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
As previously reported, President Trump’s Opening Up America plans introduce measures to slowly ease business and social restrictions and require enhanced testing and reporting of Coronavirus (COVID-19) incidences in long...more
Long-term care facilities, including nursing homes, (collectively, LTCF) have been a hot spot for the transmission of the novel coronavirus disease (COVID-19). In an effort to balance quality, transparency and infection...more
On April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Quality, Safety and Oversight Group (QSO) memorandum (QSO-20-26-NH) informing long term care facilities, including nursing homes, about certain...more
On March 30, 2020, CMS issued QSO-20-15-REVISED, which updated and expanded the guidance provided in its original QSO-20-15 memorandum issued March 9, 2020, as further described in the On the Subject appended below....more
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
Intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs) and psychiatric residential treatment facilities (PRTFs) face unique concerns when it comes to providing care and services—and when...more
4/1/2020
/ Business Continuity Plans ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Health and Safety ,
Healthcare Facilities ,
Infectious Diseases ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Workplace Safety
On March 30, 2020, CMS issued updates to its March 9, 2020, memo from the Quality Safety and Oversight (QSO) Group on controlling and preventing the spread of Coronavirus (COVID-19) in dialysis facilities and other...more
4/1/2020
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Dialysis Providers ,
Emergency Response ,
Health Care Providers ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Nursing Homes ,
Risk Management ,
State of Emergency
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
As the US federal government dedicates trillions of dollars toward containing and treating Coronavirus (COVID-19) and stimulating the national economy, it is also waiving many federal health program requirements to allow...more
The Centers for Medicare and Medicaid Services (CMS) recently released Quality, Safety & Oversight Group (QSO) standards for infection control and prevention of Coronavirus Disease 2019 (COVID-19) in nursing facilities,...more
3/16/2020
/ Best Practices ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Dialysis Providers ,
Emergency Response ,
Health Care Providers ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Nursing Homes ,
Risk Management ,
State of Emergency
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
As more cases emerge highlighting the transmission of COVID-19 from person-to-person contact in the general public rather than through contact with a known infected individual, hospitals and health systems must be ready to...more