This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
9/6/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Information Blocking Rules ,
Medicare ,
OIG ,
Proposed Regulation ,
Regulatory Agenda ,
Telehealth
At the end of the 2024 term, the executive branch struck out when the US Supreme Court issued three separate decisions along ideological lines that have the potential to materially weaken the enforcement authority of federal...more
Starting in mid-2024, Illinois hospitals will be required to take a much more active role in limiting consumers’ medical debt by screening all consenting uninsured patients for both public health insurance program coverage...more
12/4/2023
/ Affordable Care Act ,
Debt ,
Debt Collection ,
Enforcement Actions ,
Financial Regulatory Reform ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Hospitals ,
Illinois ,
Medical Debt ,
New Legislation ,
New Regulations ,
No Surprises Act (NSA) ,
Patients ,
Uninsured Patients
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more
11/30/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Healthcare Reform ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Agenda
On September 20, 2023, the US Departments of Health and Human Services (HHS), Labor (DOL) and the Treasury (collectively, the departments) issued a proposed rule related to the No Surprises Act’s (NSA’s) federal independent...more
10/4/2023
/ Comment Period ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Dispute Resolution ,
Fees ,
No Surprises Act (NSA) ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Rulemaking Process ,
U.S. Treasury
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
On December 2, 2022, the US Department of Health and Human Services (HHS) issued an FAQ announcing that it will not enforce the requirement for convening providers and convening facilities to include expected charges for...more
12/22/2022
/ Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Good Faith ,
Health Care Providers ,
Healthcare Facilities ,
Information Technology ,
No Surprises Act (NSA) ,
Proposed Regulation ,
Rulemaking Process ,
Surprise Medical Bills
On August 19, 2022, the US Departments of Health and Human Services (HHS), Labor and Treasury posted a final rule revising portions of the federal No Surprises Act (NSA). Generally, the rule finalizes three aspects of the...more
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
By July 2022, the US Supreme Court is expected to release its opinion in American Hospital Association v. Becerra, a case that not only has significant ramifications for healthcare providers but may also impacts the deference...more
2/15/2022
/ American Hospital Association ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Medicaid Reimbursements ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
SCOTUS ,
Section 340B
In December 2021, the US Centers for Medicare and Medicaid Services (CMS) issued the second part of its FY 2022 Inpatient Prospective Payment System (IPPS) Final Rule with Comment Period. Among other policies, the Final Rule...more
1/10/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Consolidated Appropriations Act (CAA) ,
Deadlines ,
Final Rules ,
FTEs ,
Graduate Medical Education ,
Health Care Providers ,
Inpatient Prospective Payment System (IPPS) ,
Medical School ,
Residency Requirements ,
Rural Areas ,
Rural Health Care Providers
On December 27, 2020, the No Surprises Act was signed into law as part of the Consolidated Appropriations Act, 2021. In July and October 2021, respectively, the Department of Health and Human Services, the Department of...more
12/31/2021
/ Billing ,
Consent ,
Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Good Faith ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Out of Network Provider ,
Surprise Medical Bills ,
Telehealth ,
Telemedicine ,
U.S. Treasury
The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more
7/7/2021
/ Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
Medicare ,
Outpatient Prospective Payment System (OPPS) ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Section 340B
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
On January 1, 2021, Governor Charlie Baker signed an omnibus healthcare law entitled “An Act promoting a resilient health care system that puts patients first,” which is aimed at addressing pressing healthcare issues in...more
2/9/2021
/ Coronavirus/COVID-19 ,
Eligibility ,
Governor Baker ,
Health Care Providers ,
Hospitals ,
Medicaid ,
Patients ,
Proposed Legislation ,
Scope of Work ,
State and Local Government ,
State Legislatures ,
Surprise Medical Bills ,
Telehealth ,
Value-Based Care
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
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
The MassHealth funding announced on April 7, 2020, will be divided among hospitals, nursing facilities and other healthcare providers dealing with the effects of the Coronavirus (COVID-19) pandemic. The funds are expected to...more
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
Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more
1/14/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
GAO ,
Hospitals ,
HRSA ,
Medicaid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Section 340B
On May 13, the US Supreme Court (the Court) unanimously ruled in Cochise Consultancy, Inc., v. U.S. ex rel. Hunt that the “government knowledge” statute of limitations under the federal False Claims Act (FCA), §31 U.S.C....more
6/19/2019
/ Appeals ,
Cause of Action Accrual ,
Cochise Consultancy Inc v United States ex rel Hunt ,
Dismissals ,
False Claims Act (FCA) ,
Intervenors ,
Limitation Periods ,
Qui Tam ,
Reaffirmation ,
Relators ,
Reversal ,
SCOTUS ,
Statute of Limitations
On April 26, 2019, the US Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties (the Notice) to inform the public...more
5/10/2019
/ Civil Monetary Penalty ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Eighth Amendment ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
HITECH Act ,
OCR ,
Regulatory Agenda ,
Settlement Negotiations
Introduction -
In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in...more
4/26/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EHR ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
OIG ,
Opioid ,
Prescription Drugs ,
Qui Tam ,
Statute of Limitations ,
Telemedicine ,
The Granston Memo
In its first update in a decade and effective January 1, 2020, the revised Advanced Medical Technology Association (AdvaMed) Code of Ethics in Interactions with Health Care Professionals (Code) in the United States contains...more
The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the...more