In the CY 2026 Medicare Physician Fee Schedule proposed rule (PFS Proposed Rule), released on July 14, 2025, the Center for Medicare and Medicaid Innovation (CMMI) introduced the Ambulatory Specialty Model (ASM), a new...more
8/1/2025
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinically Integrated Networks (CINs) ,
CMMI ,
Health Information Technologies ,
Medicare ,
Medicare Part B ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Value-Based Payments
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services...more
On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement)...more
The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more
In 2024, the Department of Justice (DOJ) resolved several noteworthy False Claims Act (FCA) cases against hospitals and health systems. In particular, DOJ obtained a number of large recoveries in cases where Stark Law and...more
1/17/2025
/ Anti-Kickback Statute ,
Compliance ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Hospitals ,
Medicaid ,
Medical Bills ,
Medicare ,
Physicians ,
Stark Law
As part of its Modernization Initiative, the Department of Health and Human Services’ Office of Inspector General (OIG) recently published its first industry-segment specific Compliance Program Guidance, which focuses on...more
12/17/2024
/ Anti-Kickback Statute ,
Billing ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Healthcare ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
OIG ,
Patient-Driven Payment Model (PDPM) ,
Skilled Nursing Facility
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more
The Office of Inspector General (OIG) started 2024 with a flurry of activity by issuing four new Advisory Opinions on January 3, 2024. In one of these Advisory Opinions, the OIG approved a vendor’s referral program that...more
The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance...more
11/13/2023
/ Anti-Kickback Statute ,
Compliance ,
Conflicts of Interest ,
Department of Health and Human Services (HHS) ,
Federal Health Care Programs (FHCP) ,
Fraud and Abuse ,
Healthcare ,
Healthcare Fraud ,
Incentives ,
Information Blocking Rules ,
New Guidance ,
OIG ,
Request For Information ,
Risk Assessment
Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the...more
On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more
4/6/2023
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiary Inducement ,
Cancer ,
Clinical Laboratory Testing ,
CMP Law ,
Fraud and Abuse ,
Gift-Cards ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Incentives ,
Life Sciences ,
Medicaid ,
Medicare ,
OIG ,
Preventive Health Care
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more
10/11/2022
/ Anti-Kickback Statute ,
California ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Civil Monetary Penalty ,
Databases ,
Department of Health and Human Services (HHS) ,
Medicaid ,
Medical Devices ,
Medicare ,
New Legislation ,
Open Payments ,
Physicians ,
Prescription Drugs ,
Sunshine Act
In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth...more
On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health...more
5/9/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Coronavirus/COVID-19 ,
FCC ,
FQHC ,
Loans ,
Medicaid ,
Medicare ,
OIG ,
Public Health Emergency ,
Smartphones ,
Telehealth
On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more
4/28/2022
/ Advisory Opinions ,
Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Healthcare Facilities ,
Medical Devices ,
OIG ,
Physician-Owned Distributors ,
Sunshine Act
The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’...more
On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to...more
1/26/2022
/ Advisory Opinions ,
Anti-Kickback Statute ,
Discount Pricing ,
Medicaid ,
Medicare ,
OIG ,
Online Marketplace ,
Pharmacies ,
Reimbursements ,
Retailers ,
SNAP Program ,
Social Security Income
On September 15, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a hospital’s proposal to implement a program through which patients...more
On Friday, August 6, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA), the preeminent trade association representing pharmaceutical companies, announced revisions to its Code on Interactions with Health Care...more
For many health care systems, patient leakage – when patients leave a health care system’s network in favor of out-of-network providers – is a rampant problem that results in substantial lost revenue. While sometimes patient...more
Pharmaceutical and medical device manufacturers should be advised that the government is using its enforcement authority under the Open Payments Program (otherwise known as the Sunshine Act) in conjunction with the...more
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i)...more
On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more