On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
9/19/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Group Health Plans ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Shared Savings Program
On August 28, as part of its Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Final Rule, the Centers for Medicare & Medicaid Services (CMS) finalized the Transforming Episode Accountability Model (TEAM)...more
8/29/2024
/ Acute Facilities ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Mandatory Requirements ,
Medicare Part A ,
Medicare Part B ,
Value-Based Payments
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
The Centers for Medicare & Medicaid Services (CMS) recently proposed the Transforming Episode Accountability Model (TEAM) – a new, mandatory, episode-based alternative payment model in the Fiscal Year 2025 Hospital Inpatient...more
We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
2/27/2024
/ Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam ,
Settlement ,
Stark Law ,
Telemedicine
W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more
1/9/2024
/ Acquisitions ,
Artificial Intelligence ,
Corporate Transparency Act ,
Department of Justice (DOJ) ,
Diversity ,
Equity Markets ,
FinCEN ,
Funding ,
Healthcare ,
Investment ,
Investors ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Popular ,
Privacy Laws ,
Private Equity ,
Reporting Requirements ,
Restrictive Covenants ,
Risk Management ,
Safe Harbors ,
Section 340B ,
Self-Disclosure Requirements ,
Value-Based Care
On November 16, the Centers for Medicare & Medicaid Services (CMS) published its Medicare Physician Fee Schedule (PFS) final rule for calendar year 2024 (PFS Final Rule). According to the CMS press release, the PFS Final Rule...more
11/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Medical Reimbursement ,
Medicare ,
Mental Health ,
New Regulations ,
Outpatient Prospective Payment System (OPPS) ,
Outpatient Services ,
Physician Fee Schedule ,
Physicians ,
Psychological Counseling ,
Telehealth
On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
On October 6, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule providing for a second temporary extension of its COVID-19 telemedicine...more
On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more
The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more
On November 2, 2022, Centers for Medicare & Medicaid Services (CMS) filed its final rule implementing changes to the Medicare Physician Fee Schedule for CY 2023 (Final Rule). Embedded within this Final Rule are important...more
11/17/2022
/ ADLT ,
Bureau of Labor Statistics ,
Centers for Medicare & Medicaid Services (CMS) ,
CLFS ,
Clinical Laboratories ,
Data Collection ,
Fees ,
Final Rules ,
Home Health Agencies ,
Medicare ,
PAMA ,
Physician Fee Schedule
On November 2, 2022, the Centers for Medicare & Medicaid Services (CMS) filed its Medicare Physician Fee Schedule (PFS) final rule (Final Rule) for calendar year (CY) 2023. CMS finalized several noteworthy updates specific to...more
This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more
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