News & Analysis as of

Patients Anti-Kickback Statute

Arnall Golden Gregory LLP

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

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

Mintz - Health Care Viewpoints

The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients

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

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

Holland & Hart LLP

Patient Inducements: Law and Limits

Holland & Hart LLP on

Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...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

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

McDermott Will & Emery

OIG Issues AO on Providing Gift Cards for Completed Colon Cancer Screening Tests

McDermott Will & Emery on

The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Laboratory Arrangement to Offer Discounts

King & Spalding on

On March 29, 2023, OIG posted Advisory Opinion No. 23-03 regarding a laboratory’s proposed arrangement to provide a prepaid card of up to $75 to encourage individuals to return the sample collection kit associated with the...more

Bass, Berry & Sims PLC

OIG Approves Gift Cards to Promote Patient Compliance with a Preventive Screening Measure

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more

Health Care Compliance Association (HCCA)

Patient Steering and Charting

It’s critical for patients leaving the hospital for a post acute care (PAC) provider that the handoff be conducted well. Some facilities will be better suited to the patients needs than others, which is why the process needs...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

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

OIG Allows Gift Card Incentives for Rescheduling and Attending Missed FQHC Appointments in Advisory Opinion 20-08

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A federally qualified health center (FQHC) received the go-ahead of the Office of Inspector General (OIG) to offer $20 gift cards as one-time incentives for pediatric patients who have previously missed at least two care...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

Butler Snow LLP on

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

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Manatt, Phelps & Phillips, LLP

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

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

Robinson+Cole Health Law Diagnosis

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...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

Thoughts on Recent Amendments to the Florida Patient Brokering Act - The Sky Is Not Falling

Holland & Knight LLP on

The Florida Legislature recently amended the Florida Patient Brokering Act (PBA), effective July 1, 2019. Since then, a raft of articles have argued that long-standing arrangements between healthcare providers and potential...more

Bradley Arant Boult Cummings LLP

Significant Changes to Florida’s Patient Brokering Act: Uncertainty Lies Ahead - Healthcare Alert

A pair of legislative and judicial developments in the last month has the potential to significantly impact healthcare providers doing business in Florida. Until some of the uncertainty is resolved, healthcare providers would...more

Holland & Knight LLP

Changes to Florida’s Patient Brokering Act

Holland & Knight LLP on

Florida Governor Ron DeSantis recently signed House Bill 369, Chapter No. 2019-159, Laws of Florida, which became effective on July 1, 2019. The primary focus of the bill relates to substance abuse services. For example, the...more

Akerman LLP - Health Law Rx

Florida Patient Brokering Act Amended – Does it Clarify or Create New Issues?

The Florida Legislature recently passed HB 369 (the Bill), which would tweak an important provision of the Florida Patient Brokering Act, Section 817.505 of the Florida Statutes (Patient Brokering Act)....more

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