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
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
A Virginia Federal Judge recently rejected a challenge to a negative Advisory Opinion issued by the Department of Health & Human Services’ Office of Inspector General (OIG) that disapproved of a proposal where certain...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
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
11/7/2023
/ 21st Century Cures Act ,
ACOs ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Information Blocking Rules ,
Investigations ,
Medicare Shared Savings Program ,
OIG ,
ONC ,
Reporting Requirements ,
Social Security Act
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 Department of Health and Human Services’ Office of Inspector General (OIG) announced on April 24, 2023 that it will soon issue long overdue updates to its compliance program guidance documents (CPGs). First introduced in...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
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 November 22, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) posted a negative Advisory Opinion regarding a proposed joint venture (JV) for the provision of therapy services...more
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other...more
11/11/2021
/ Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
False Claims Act (FCA) ,
Health Care Violations ,
Healthcare Fraud ,
OIG ,
Provider Self-Disclosure Protocol ,
Reporting Requirements ,
Settlement ,
Whistleblowers
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
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
As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more
As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more
12/7/2020
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Final Rules ,
Health Care Providers ,
OIG ,
Remuneration ,
Safe Harbors ,
Stark Law ,
Value-Based Care
While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more
11/24/2020
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
DMEPOS ,
Final Rules ,
OIG ,
Safe Harbors ,
Stark Law ,
Value-Based Care