News & Analysis as of August 20, 2025

Proposed Rules

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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 -

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on 6/25/2025

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

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

McDermott Will & Schulte 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

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on 2/12/2019

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

Epstein Becker & Green on 2/6/2019

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

Bass, Berry & Sims PLC on 2/5/2019

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

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