This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
5/29/2024
/ Advisory Opinions ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Laboratory Developed Tests ,
Medical Devices ,
Medicare Advantage ,
Medicare Fraud ,
Medicare Part D ,
Non-Compete Agreements ,
Nursing Homes ,
OCR ,
OIG ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Sentencing ,
Settlement ,
Telemedicine
This report reviews notable areas for government enforcement actions during 2023 that were discussed in our monthly Healthcare Regulatory Check-Up reports. In the past year, we saw the relevant federal government enforcement...more
2/29/2024
/ Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Stark Law
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 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 this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and ambulatory surgery centers...more
5/26/2023
/ Ambulatory Surgery Centers ,
Centers for Medicare & Medicaid Services (CMS) ,
Compensation ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
OIG ,
Physicians ,
Professional Conferences ,
Self-Referral Disclosure Protocol ,
Stark Law
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 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
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
The COVID-19 global health crisis has accelerated the demand for improved, economically viable and more robust delivery of healthcare services around the world. In years past, healthcare systems and operators, as well as...more
The Centers for Medicare and Medicaid Services (CMS) has started phasing out certain program flexibilities granted during the COVID-19 public health emergency. Beginning in October 2021, CMS will resume several provider and...more
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/14/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/13/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
Maintain Connections with Healthcare Leaders. Stay Current on Market Trends. Look Ahead to 2021 and Beyond.
Join us virtually for McDermott's signature HPE New York conference. We'll bring together preeminent healthcare...more
10/7/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
HPE New York brings together preeminent healthcare private equity executives and investment bankers and unmatched keynote speakers to your remote workspace in a cutting-edge format – unlike any other conference this...more
10/6/2020
/ Ambulatory Surgery Centers ,
Banking Sector ,
Coronavirus/COVID-19 ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Home Health Care ,
Hospice ,
Infectious Diseases ,
Investment Banks ,
Investors ,
Legislative Agendas ,
Medical Reimbursement ,
Mental Health ,
Pharmaceutical Industry ,
Physical Therapists ,
Physicians ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Vaccinations ,
Webinars
The Centers for Medicare and Medicaid Services (CMS) issued blanket waivers under Section 1135 of the Social Security Act (Section 1135 waivers) on April 30, 2020. Fast on the heels of a more modest waiver announcement on...more
5/7/2020
/ 1135 Waivers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospice ,
Long Term Care Facilities ,
OCR ,
Public Health Emergency ,
Relief Measures ,
Telehealth ,
Telemedicine
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
On April 21, 2020, the Centers for Medicare and Medicaid Services (CMS) issued explanatory guidance on the scope and application of a series of nationwide Section 1135 waivers of the physician self-referral law (Stark Law)...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
The Centers for Medicare and Medicaid Services (CMS) recently provided Section 1135 waivers and guidance granting flexibilities to home health agencies (HHAs) and hospices during the Coronavirus (COVID-19) pandemic national...more
On April 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued Quality, Safety & Oversight memorandum QSO-20-24-ASC (the QSO Memo), addressed to state survey agencies to provide guidance on processing attestation...more
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
Accelerated or advance Medicare payments can provide some cash flow as providers and suppliers combat the effects of the Coronavirus (COVID-19) pandemic. This program requires a one-page application and funds may be available...more
The Centers for Medicare and Medicaid Services is expediting Medicare enrollment applications and allowing certain categories of practitioners to temporarily enroll in Medicare Part B to increase the number of healthcare...more
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