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Office of the Inspector General Advisory Opinions Pharmacies

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

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On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

Arnall Golden Gregory LLP

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...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

Baker Donelson

OIG Approves Loyalty Rewards Program in Supermarket Pharmacies

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In its last Advisory Opinion of 2019 (19-06), the OIG approved a proposed arrangement involving a retailer rewards program through which out-of-pocket costs on in-store pharmacy purchases would qualify customers for future...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

Ruder Ware

OIG Opinion on Donation of Telehealth Equipment

Ruder Ware on

A recent Advisory Opinion (Advisory Opinion 18-03) from the Office of Inspector General (OIG) of the Department of Health and Human Services addresses potential kickback issues involved in the donation of telehealth...more

Baker Donelson

Advisory Opinion 18-03 Confirms OIG's Focus on Telehealth

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In prior articles regarding the OIG's Work Plan (July 2017 and November 2017) and its recent telehealth claim audit, we have noted how telehealth is clearly on the OIG's radar. Now, the first advisory opinion addressing...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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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

Baker Donelson

OIG Advisory Opinion 18-01: Excluded Individual May Serve as Marketing Liaison to LTC Pharmacies

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In OIG Advisory Opinion 18-01, published February 27, 2018, the OIG concluded a proposed employment arrangement between an excluded individual and a for-profit company selling discounted emergency medications to long term...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

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A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management...

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more

Baker Donelson

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

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The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

Dorsey & Whitney LLP

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

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On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

Roetzel & Andress

New Anti-Kickback Safe Harbors

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On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more

King & Spalding

OIG Issues Two Favorable Advisory Opinions

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OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

Tucker Arensberg, P.C.

OIG Rejects Specialty Pharmacy Request to Pay “Per-Fill” Payents to Retail Pharmacies

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In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the...more

Faegre Drinker Biddle & Reath LLP

OIG Rejects Pharmacy’s Plan for Per-Fill Referral Fees, Or Be Careful What You Ask For

Advisory Opinion No. 14-06, issued August 15, addressed a plan by the chain to reimburse local pharmacies for referrals of patients in need of specialized drugs that the local pharmacies did not dispense. In the scenario...more

Mintz - Health Care Viewpoints

OIG Finds Risk of Abuse in Specialty Pharmacy’s Per-Fill Fee Proposal

In an Advisory Opinion posted August 15, 2014, the Office of Inspector General (“OIG”) concluded that a proposed arrangement by a specialty pharmacy (“Requestor”) might generate prohibited remuneration under the Federal...more

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