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Advisory Opinions Medicare Medicaid

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

Foley & Lardner LLP

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

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In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

WilmerHale

OIG Issues New Advisory Opinion on Federal Anti-Kickback Statute

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The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion that explored the limits of a relatively new safe harbor to the federal Anti-Kickback Statute (AKS) that aims...more

Bass, Berry & Sims PLC

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

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On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

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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

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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

Harris Beach PLLC

OIG’s Favorable Opinion: Employed Physicians Paid Bonuses Based on ASCs’ Net Profits

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This opinion addresses a proposed arrangement (“Proposed Arrangement”) between a multi-specialty physician practice (“Requestor”) that employs approximately 11 physician employees (“Physician Employees”). In addition to base...more

Mintz - Health Care Viewpoints

OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more

Rivkin Radler LLP

OIG Advisory Opinion Warns on IONM Company “Surgeon Deals”

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On August 18, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published an Advisory Opinion warning that a common arrangement under which surgeons profit from referrals of their patients...more

ArentFox Schiff

OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws

ArentFox Schiff on

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...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

Mintz - Health Care Viewpoints

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

King & Spalding

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

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On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

King & Spalding

OIG Will Not Impose Sanctions on State’s EMS Division Lease Arrangement with Private Ambulance Company

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On December 20, 2022, OIG issued a favorable Advisory Opinion allowing for the political subdivision of a State and its Department of Health EMS division (Requestor) to accept the provision of emergency transportation...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 22-08 Permits Federally Qualified Health Center To Provide Smartphones to Patients to Promote Access to...

Telehealth—the provision and coordination of healthcare remotely by means of telecommunications technology—is now an essential tool in the delivery of health care services. The COVID-19 pandemic created an incentive for...more

Mintz - Health Care Viewpoints

OIG Issues Favorable Opinion on Federally Qualified Health Center’s Smartphone Loan Program

On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health...more

Mintz - Health Care Viewpoints

OIG Approves Online Retailer’s Discount Program

On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to...more

King & Spalding

OIG Determines That a Program to Provide Free Eye Drops to Eligible Patients Undergoing a Particular Treatment is Not Subject to...

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On December 6, 2021, OIG issued an advisory opinion (Advisory Opinion No. 21-19) to a pharmaceutical manufacturer regarding its arrangement to provide free eye drops to patients who are prescribed one of the manufacturer’s...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

King & Spalding

OIG Issues Advisory Opinion on Arrangement for Charitable Organization to Buy and Forgive Patient Debt from Providers

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On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more

King & Spalding

OIG Approves Customer Loyalty Program Involving Pharmacy Products

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On December 17, 2019, OIG published Advisory Opinion 19-06 approving a supermarket’s expansion of a loyalty program to allow customers to earn rewards points on out-of-pocket costs paid in connection with the purchase of...more

Troutman Pepper

OIG Advisory Opinion Has Key Takeaways for Programs Designed to Assist Needy Patients

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Can a pharmaceutical manufacturer provide free items or services to financially needy Medicare and Medicaid beneficiaries without running afoul of the Beneficiary Inducements Civil Monetary Penalty (CMP) or the Anti-Kickback...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

Baker Donelson

OIG Allows Cost-Sharing Waivers Among Fire Departments for Ambulance Services in Advisory Opinion 18-08

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A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more

Baker Donelson

OIG Allows Free and Reduced-Cost Services to Strained Caregivers in Advisory Opinion 18-05

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In what is becoming a steady trend, the Office of Inspector General (OIG) published another favorable opinion for an arrangement seeking to implement programs that support and engage family members who are increasingly...more

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