News & Analysis as of

Anti-Kickback Statute › Department of Health and Human Services (HHS) › Patients

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... more +
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 -
Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

Arnall Golden Gregory LLP on

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

McDermott Will & Emery

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Sheppard Mullin Richter & Hampton LLP

New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

Sheppard Mullin Richter & Hampton LLP on

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more

Bass, Berry & Sims PLC

OIG Approves DME Manufacturer Loan Program in Latest Advisory Opinion

Bass, Berry & Sims PLC on

On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

Bass, Berry & Sims PLC on

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

Baker Donelson

Regulatory Sprint: Understanding the Impact on the Stark Law, Anti-kickback Statute, and Value-based Arrangements

Baker Donelson on

The Department of Health and Human Services has released extensive and significant revised final rules governing the Physician Self-Referral Law (the Stark law) and the Medicare Anti-Kickback Statute (AKS) in furtherance of...more

Steptoe & Johnson PLLC

What to Expect: HHS Issues Final Rules on Stark, AKS & CMP Laws

Steptoe & Johnson PLLC on

The U.S. Department of Health and Human Services (“HHS”) recently issued two corresponding final rules amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”),...more

Butler Snow LLP

CMS and OIG Release Stark and AKS Final Rules to Support Reforms for Coordinated, Value-Based Care

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On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

Manatt, Phelps & Phillips, LLP on

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

McDermott Will & Emery

[Webinar] Regulatory Sprint To Coordinate Care - November 19th, 21st, and December 5th, 12:30 pm ET

McDermott Will & Emery on

To help accelerate the transformation of the US healthcare system from a fee-for-service to a value-based system, the US Department of Health & Human Services (HHS) launched its “Regulatory Sprint to Coordinated Care”...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

K&L Gates LLP

K&L Gates Triage: Ride Sharing and Health Care Regulatory Considerations

K&L Gates LLP on

Transportation is often cited as one of the top barriers to health care for individuals in the United States. To reduce this burden and increase access to care, many health care providers are now partnering with ride-sharing...more

Baker Donelson

OIG Approves Limited, Free Drug Program

Baker Donelson on

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

King & Spalding

OIG Issues Favorable Opinion Regarding Post-Discharge Services Arrangement

King & Spalding on

The Department of Health & Human Services Office of Inspector General (OIG) recently issued a favorable advisory opinion regarding an electronic health record vendor’s plan to provide services to hospitals to help manage...more

McAfee & Taft

OIG rejects management arrangement that carves out federal healthcare program patients

McAfee & Taft on

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more

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