News & Analysis as of

Office of the Inspector General Patients

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

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Travel-Related Financial Assistance Offering

On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...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

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization...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

Health Care Compliance Association (HCCA)

News Briefs: September 11, 2023

The HHS Office for Civil Rights (OCR) on Sept. 7 announced a proposed rule to bar discrimination based on disability.[1] “The rule, Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal...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

Harris Beach PLLC

Safe Harbor Update: Increase in Annual Cap on Patient Engagement Tools and Supports

Harris Beach PLLC on

The safe harbor cap on remuneration for patient engagement and support is adjusted annually based on changes to the consumer price index (“CPI”). 42 C.F.R. §1001.952(hh) protects specified arrangements for patient engagement...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

Nelson Mullins Riley & Scarborough LLP

When A High Rating Is Not Good

In the aftermath of the COVID-19 pandemic, we now know that well over 1,000 nursing homes “experienced an average overall mortality rate approaching 20%”, according to a recent report from the Office of Inspector General...more

Sheppard Mullin Richter & Hampton LLP

Finding Our Way Out of the Pandemic Haze: What Telehealth Tools Are Medicare Providers Allowed to Keep, and Which Must They Leave...

During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth...more

Harris Beach PLLC

OIG Opinion on Gift Cards for Medicare Patients’ Education as Inducements

Harris Beach PLLC on

This opinion regards the provision of a gift card to certain Medicare Advantage (“MA”) plan enrollees who complete specific steps in an online patient education program....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

Sheppard Mullin Richter & Hampton LLP

Health Law Policy Heading Into 2022 At The ABA Health Law Summit

The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues. But, as always at this conference, there are...more

Bass, Berry & Sims PLC

OIG Approves a Free Drug Program Limited to Hospital Inpatients

Bass, Berry & Sims PLC on

On November 16, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published Advisory Opinion 21-16, approving an arrangement under which a pharmaceutical manufacturer provides free...more

Arnall Golden Gregory LLP

OIG Determines a Drug Manufacturer’s Initiative to Cover Certain Patients’ Transportation Costs Poses Low Risk of Fraud and Abuse

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued an Advisory Opinion analyzing an arrangement where a drug manufacturer (the “Requestor”) provides financial assistance to cover...more

Baker Donelson

OIG Allows Pharmaceutical Manufacturer to Provide Financial Assistance for Travel, Lodging and Other Expenses to Certain Patients...

Baker Donelson on

A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's...more

Baker Donelson

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

Baker Donelson on

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

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

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