News & Analysis as of

Medicare Safe Harbors Office of the Inspector General

Dickinson Wright

Telehealth Summer 2025: Collaboration Models, Enforcement Trends, and Reimbursement Guidance

Dickinson Wright on

It has been a busy summer for telehealth updates. Following is a high-level summary of the latest developments. On June 6, 2025, the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG”)...more

McGuireWoods LLP

OIG Approves Multi-MSO Telehealth Arrangement That Meets AKS Safe Harbor

McGuireWoods LLP on

On June 6, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion concerning a proposed telehealth staffing and services arrangement involving a management...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-03: Navigating Anti-Kickback Rules and Safe Harbors in Telehealth Contractual Arrangements

On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

Holland & Knight LLP

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

King & Spalding

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

King & Spalding on

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

ArentFox Schiff

OIG Declines To Challenge Debt Cancellation and Restructured Financial Arrangements Between Health System and FQHC “Look-Alike”...

ArentFox Schiff on

In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...more

King & Spalding

OIG Issues Favorable Advisory Opinions Regarding Medigap Plan and Preferred Hospital Organization Arrangements

King & Spalding on

Last week, OIG posted Advisory Opinions Nos. 21-03, 21-04, and 21-05 relating to three near-identical arrangements between Medigap plans and Preferred Hospital Organizations (PHOs). The arrangements involve (i) a discount on...more

King & Spalding

OIG Issues New Advisory Opinion Regarding Investment in Ambulatory Surgery Centers

King & Spalding on

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

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

McGuireWoods Consulting

Washington Healthcare Update - November 2019 #2

McGuireWoods Consulting on

This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr....more

Foley & Lardner LLP

Telemedicine and Digital Health Companies Will Benefit from Newly-Proposed Fraud and Abuse Waivers

Foley & Lardner LLP on

The OIG recently released proposed revisions to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP) Law. Several of these changes, if finalized, will directly benefit companies offering telemedicine and digital...more

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: CMS/AKS and OIG Stark Proposed Amendments

Tucker Arensberg, P.C. on

HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care. In June of 2018, HHS issued an RFI seeking additional information and HHS...more

Ballard Spahr LLP

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

Ballard Spahr LLP on

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more

Dorsey & Whitney LLP

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Dorsey & Whitney LLP on

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

Holland & Knight LLP

New Medicare Part D Demonstration to Address Proposed Changes to Anti-Kickback Safe Harbors

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more

Foley & Lardner LLP

ASCs Make Comeback with Multispecialty Ownership Groups

Foley & Lardner LLP on

Ambulatory surgery center (ASC) development and ownership has made a comeback after a number of years of stagnation due to an oversupply of centers and poor income growth. However, with significant changes in payment...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

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

Latham & Watkins LLP

Drug Pricing and Payment Policy: Sweeping HHS Rebate Reform Proposal and First 2019 Congressional Hearings

Latham & Watkins LLP on

HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts. On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more

Epstein Becker & Green

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

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

Dorsey & Whitney LLP

Drug Rebates Threatened Under Proposed Anti-kickback Rule

Dorsey & Whitney LLP on

The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

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

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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