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
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
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
[co-authors: Mara McDermott and Katie Waldo, McDermott+Consultants]
This report from McDermott Will & Emery and McDermott+Consulting provides a detailed analysis of the latest Provider Relief Fund (PRF) distributions,...more
9/14/2020
/ Children's Health Insurance Program (CHIP) ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Fund Distribution ,
Health Care Providers ,
Hospitals ,
Indian Health Service (IHS) ,
Medicaid ,
Medicare ,
Nursing Homes ,
Provider Relief Fund ,
Rural Health Care Providers ,
Skilled Nursing Facility
This On the Subject was updated on April 7, 2020, to address the Department of Health and Human Services Office of Inspector General’s (OIG’s) April 3, 2020, Policy Statement and its potential impact as well.
The Centers...more
In the midst of the Coronavirus (COVID-19) pandemic, healthcare providers and suppliers will need to make decisions on how to ensure compliance with existing federal fraud and abuse laws while taking swift action to avoid...more
3/23/2020
/ Anti-Kickback Statute ,
Bureau of Industry and Security (BIS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
OIG ,
Public Health ,
Public Health Emergency ,
Remuneration ,
Waivers
Following our inaugural installment of the Health Care Enforcement Quarterly Roundup, we are pleased to be back this quarter with another overview of key enforcement trends in the health care industry. In this issue, we...more
On June 25, 2018, the Centers for Medicare and Medicaid Services (CMS) published a request for information, seeking input from the public on how to address any undue regulatory impact and burden of the physician self-referral...more
On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate...more
On July 8, 2015, the Centers for Medicare & Medicaid Services (CMS) published a notice of proposed rulemaking to amend its regulations implementing and interpreting the Stark Law (the Proposed Rule). 80 Fed. Reg. 41,686,...more
7/28/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
FQHC ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Nurse Practitioners ,
Patient Referrals ,
Physician Compensation Arrangements ,
Physician-Owned Hospitals ,
Physicians ,
Proposed Regulation ,
Rural Health Care Providers ,
Stark Law
On July 13, 2015, the Centers for Medicare & Medicaid (CMS) issued a long-awaited proposed rule (Proposed Rule) that would revise the requirements that long-term care (LTC) facilities must meet to participate in the Medicare...more
7/16/2015
/ Affordable Care Act ,
Binding Arbitration ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Elder Abuse ,
Employee Training ,
Federal Register ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Long Term Care Facilities ,
Long-Term Care ,
Medicaid ,
Medicare ,
Neglect ,
Nurse Practitioners ,
Nurses ,
Physicians ,
Prescription Drugs ,
Proposed Regulation ,
Quality Assurance Programs ,
Training Requirements