News & Analysis as of November 17, 2024

Anti-Kickback Statute › New Guidance

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Highlights from OIG’s New Compliance Program Guidance

Gardner Law on 3/5/2024

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

HHS-OIG Year in Review 2023

Bass, Berry & Sims PLC on 2/1/2024

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more

In Case You Missed It: New OIG General Compliance Program Guidance

Fox Rothschild LLP on 11/30/2023

On November 6, 2023, the HHS Office of Inspector General published a new compilation of compliance guidance under the title General Compliance Program Guidance (GCPG) for the healthcare compliance community and other health...more

Client Update – New OIG General Compliance Guidance Released

Chambliss, Bahner & Stophel, P.C. on 11/29/2023

November 28, 2023 | Legal Update On November 10, 2023, the Office of the Inspector General (OIG) released its widely anticipated General Compliance Program Guidance (GCPG). The OIG had previously announced that it would...more

A Practical Look at OIG’s New Compliance Guidance

Goodwin on 11/27/2023

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

OIG Publishes New Compliance Guidance for Health Care Entities, Along with Plan for Targeted “Industry Specific” Guidance Starting...

Lathrop GPM on 11/14/2023

On October 6, 2023, the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) released brand new “General Compliance Program Guidance” to assist health care providers, entities, and other...more

Key Takeaways from the OIG’s New Comprehensive General Compliance Program Guidance

Mintz - Health Care Viewpoints on 11/13/2023

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

OIG Issues Guidance for Ambulatory Surgery Center Safe Harbor’s “One-Third” Income Test

King & Spalding on 5/18/2023

In March, OIG published a new frequently asked questions (FAQ) page, General Questions Regarding Certain Fraud and Abuse Authorities. The FAQ page, located here, includes new guidance for ambulatory surgery center (ASC)...more

“Dear OIG”: The Newest Way to Attain Kickback Guidance

Bradley Arant Boult Cummings LLP on 5/11/2023

The Office of Inspector General (OIG) recently unveiled a quicker process to answer the healthcare industry’s most pressing questions on the Anti-Kickback Statute (AKS), allowing healthcare stakeholders to attain more timely...more

OIG Offers Guidance for ASCs When Physician-Investors Fail the One-Third Income Test

Bass, Berry & Sims PLC on 5/9/2023

Nearly 25 years ago, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) created a regulatory safe harbor to the federal Anti-Kickback Statute (AKS) for physician investment in...more

OIG Offers Stakeholders a New Avenue for Informal Fraud and Abuse Guidance

Bass, Berry & Sims PLC on 3/30/2023

On March 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) announced a new, expanded frequently asked questions (FAQs) process. Although OIG has long maintained FAQs on...more

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Health Care Compliance Association (HCCA) on 8/3/2022

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a research compliance work plan? - How to better shift your program’s research focus in...more

PhRMA Updates its Code on Interactions with Health Care Professionals in Response to the OIG's Special Fraud Alert on Speaker...

Mintz - Health Care Viewpoints on 8/18/2021

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

OIG Provides Additional Guidance Regarding Application of Administrative Enforcement Authorities to Arrangements Directly...

King & Spalding on 6/4/2021

On May 24, 2021, OIG provided additional guidance in the form of an FAQ as to whether an offer or provision of cash, cash-equivalent, or in-kind incentives or rewards to Federal health care program beneficiaries who receive...more

OIG Issues New Advisory Opinion Regarding Investment in Ambulatory Surgery Centers

King & Spalding on 5/12/2021

Last week, OIG considered a proposed investment by a health system, a management company, and certain surgeons in an ambulatory surgery center (ASC). OIG advised that the proposed arrangement would generate prohibited...more

New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and...

Hinshaw & Culbertson - Health Care on 2/23/2021

Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more

Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the...

Sheppard Mullin Richter & Hampton LLP on 11/30/2020

On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify”...more

HHS OIG Establishes Portal and Process to Provide Guidance on Anti-Kickback and Beneficiary Inducement Statutes During COVID-19...

McDermott Will & Emery on 3/27/2020

The US Department of Health and Human Services, Office of Inspector General has created an information portal and established a process to provide guidance on the application of the Anti-Kickback Statute and Beneficiary...more

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

Epstein Becker & Green on 1/30/2020

On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more

[Webinar] 2019 Q4 Healthcare Enforcement Roundup - February 5th, 2:30 pm ET

McDermott Will & Emery on 1/28/2020

The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more

The Role of Compliance in Government Enforcement

WilmerHale on 3/18/2019

As reflected in recent remarks by Deputy Attorney General Rod Rosenstein, the United States Department of Justice (DOJ) is “reinforcing its relationship with good corporate citizens” by coordinating with, and considering, the...more

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Mintz - Health Care Viewpoints on 2/7/2019

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

OIG Issues Advisory Opinion Giving the Green Light to a Pharmaceutical Manufacturer’s Plan to Provide Limited Functionality...

King & Spalding on 2/5/2019

On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more

OIG Approves Manufacturer Loaning Smartphones as Appropriate Patient Assistance to Support Digital Medicine

Akin Gump Strauss Hauer & Feld LLP on 1/30/2019

On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more

Buchalter Health Care Newsletter

Buchalter on 10/24/2018

Industry trends present a clear move from fee-for-service to value-based reimbursement models, particularly as patient engagement increases with the use of efficient technologies. As a response, new care delivery and payment...more

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Anti-Kickback Statute › New Guidance

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