On August 19, the federal government issued a final rule addressing certain aspects of the No Surprises Act (NSA). The NSA was enacted in December 2020 to protect commercially insured patients from receiving surprise medical...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
5/6/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Clinical Laboratories ,
Enforcement Actions ,
Fair Market Value ,
Fraud ,
Hospitals ,
Kickbacks ,
OIG ,
Pay-Per-Click ,
Payment Services Directive ,
Remuneration ,
Risk Factors
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
10/25/2021
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational Device Exemptions ,
Investigations ,
IRB ,
Life Sciences ,
Medical Devices ,
Research and Development ,
The Common Rule
On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more
8/9/2021
/ Comment Period ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Federal Employees ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Interim Final Rules (IFR) ,
Notice Requirements ,
Out of Network Provider ,
Patients ,
Proposed Regulation ,
Rulemaking Process ,
State and Local Government ,
Surprise Medical Bills ,
U.S. Treasury
The Centers for Medicare & Medicaid Services (CMS) recently issued Advisory Opinion No. CMS-AO-2021-01, clarifying that physician groups that furnish designated health services (e.g., laboratory, imaging) through wholly-owned...more
After months of quiet introspection, on June 11, 2021, the U.S. Department of Health and Human Services (HHS) released long-awaited updated Post-Payment Notice of Reporting Requirements, which outlines updated reporting...more
Private equity investors’ interest in gastroenterology (GI) practices continues to remain strong, despite some headwinds that GI practices have experienced as a result of the COVID-19 pandemic and further investment in this...more
On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more
Yesterday, President Biden signed into law the American Rescue Plan Act of 2021 (Act), which narrowly passed the U.S. Senate (50 – 49) and House of Representatives (220 – 211) earlier this week. The Act provides for $1.9...more
3/12/2021
/ Affordable Care Act ,
Ambulance Providers ,
American Rescue Plan Act of 2021 ,
Biden Administration ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Hospitals ,
Medicaid ,
Medical Centers ,
Mental Health ,
Regulatory Oversight ,
Relief Measures ,
Rural Health Care Providers ,
Skilled Nursing Facility ,
Substance Abuse ,
Vaccinations ,
Virus Testing
After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more
2/8/2021
/ Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Healthcare ,
Medical Billing Codes ,
Notice and Comment ,
Patients ,
Price Transparency ,
Proposed Rules ,
Reimbursements ,
Reporting Requirements ,
Stakeholder Engagement ,
Surprise Medical Bills ,
Telehealth
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
2/4/2021
/ Annual Reports ,
Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Long Term Care Facilities ,
Medical Devices ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
Nurses ,
Nursing Homes ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Pharmacist ,
Physicians ,
Qui Tam ,
Settlement Agreements ,
Stark Law ,
Telemedicine
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
12/22/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Final Rules ,
Health Care Providers ,
New Value Exception ,
OIG ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Rebates ,
Safe Harbors ,
Stark Law ,
Technology Sector
On December 4, the U.S. Department of Health and Human Services (HHS) revised its Public Health and Social Services Emergency Fund (Relief Fund) Frequently Asked Questions (FAQs), indicating that providers must return Relief...more
12/9/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Reporting ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Income Taxes ,
Provider Payments ,
Provider Relief Fund ,
Public Health Emergency ,
Relief Measures ,
Tax Revenues
The COVID-19 pandemic has stressed the M&A market at every stage of the deal-making process – from complicating on-site visits and intensifying the diligence process to introducing valuation gaps (relative to pre-COVID-19...more
12/7/2020
/ Accelerated Payments ,
Buyers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Employee Retention ,
False Claims Act (FCA) ,
Families First Coronavirus Response Act (FFCRA) ,
Government Investigations ,
Indemnification ,
Loan Forgiveness ,
Main Street Lending Programs ,
Material Adverse Effects ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Private Equity ,
Provider Relief Fund ,
Representations and Warranties ,
SBA ,
Securities and Exchange Commission (SEC) ,
Sellers ,
SIGPR ,
Tax Credits ,
Tax Deferral
The Health Resources and Services Administration (HRSA) quietly released a Post-Payment Notice of Reporting Requirements (Notice) over the weekend, which provides some initial details regarding the reporting requirements...more
9/23/2020
/ Borrowers ,
CARES Act ,
Coronavirus/COVID-19 ,
Deadlines ,
Guidance Update ,
Health Care Providers ,
HRSA ,
Provider Relief Fund ,
Reimbursements ,
Relief Measures ,
Reporting Requirements ,
Time Extensions
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more
9/3/2020
/ CARES Act ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Public Health Emergency ,
Uninsured Patients ,
Virus Testing
Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more
9/1/2020
/ CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Enforcement Actions ,
Health Care Providers ,
Interim Final Rules (IFR) ,
Long Term Care Facilities ,
Medicare ,
Physicians ,
Reporting Requirements ,
Urgent Care Facilities ,
Virus Testing
On Sunday, August 23, the Food & Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. This EUA...more
The U.S. Department of Health and Human Services (HHS) recently issued new guidance regarding reporting and auditing requirements that may impact providers and suppliers who retain payments received from the Public Health and...more
8/10/2020
/ Audit Policies ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Medicaid ,
New Guidance ,
Provider Relief Fund ,
Secretary of HHS ,
Skilled Nursing Facility ,
Suppliers
On Tuesday, June 9, the U.S. Department of Health and Human Services (HHS) announced in a press release that it expects to distribute approximately $15 billion from the Public Health and Social Services Emergency Fund (Relief...more
On Friday, May 22, the U.S. Department of Health and Human Services (HHS) issued a press release announcing that it has begun distributing nearly $4.9 billion to skilled nursing facilities (SNFs) to “support nursing homes...more
Following the announcement of additional allocations from the $100 billion Public Health and Social Services Emergency Fund (PHSSEF) under the CARES Act, on April 24, the U.S. Department of Health and Human Services (HHS)...more
On April 21, the U.S. Senate approved an additional $100 billion in funding for the Public Health and Social Services Emergency Fund established under the CARES Act, including $75 billion for eligible healthcare providers and...more
On Wednesday, April 22, the U.S. Department of Health and Human Services (HHS) issued a press release announcing additional allocations from the $100 billion Public Health and Social Services Emergency Fund (PHSSEF) for...more
In connection with its efforts to expand COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) announced last week that it will increase payment for high-throughput COVID-19 lab tests to $100. Before this...more