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Advisory Opinions

In accordance with section 1128D(b) of the Social Security Act (42 U.S.C. 1320a-7d(b)) and 42 CFR part 1008, OIG issues advisory opinions about the application of OIG's fraud and abuse authorities to the requesting party's existing or proposed business arrangement. As required by the statute, these advisory opinions are being made available to the public through this OIG Web site.

One purpose of the advisory opinion process is to provide meaningful advice on the application of the anti-kickback statute and other OIG sanction statutes in specific factual situations. Please note, however, that advisory opinions are binding and may legally be relied upon only by the requestor. Since each opinion will apply legal standards to a set of facts involving certain known persons who provide specific statements about key factual issues, no third parties are bound nor may they legally rely on these advisory opinions.

We have redacted specific information regarding the requestor and certain privileged, confidential, or financial information associated with the individual or entity, unless otherwise specified by the requestor.

Advisory Opinions for 2021

Advisory Opinion 21-02 (regarding an investment by a health system, certain surgeons, and a management company in an ambulatory surgery center.)
Advisory Opinion 21-01 (regarding a free drug provided by a pharmaceutical manufacturer to certain patients to whom the manufacturer's drug has been prescribed.)

Advisory Opinions for 2020

Advisory Opinion 20-09 (regarding a program where a pharmaceutical manufacturer provides financial assistance for travel, lodging, and other expenses to certain patients prescribed the manufacturer's drug)
Advisory Opinion 20-08 (regarding a federally qualified health centerís proposal to offer gift cards to incentivize certain pediatric patients to attend rescheduled preventive and early intervention care appointments)
Advisory Opinion 20-07 (regarding a web-based platform where health care facilities and clinicians would, in particular circumstances, remit to patients and the patients' payors a portion of the claims for certain services for which payment may be made by the Medicare program as a secondary payor)
Advisory Opinion 20-06 (regarding a management company's provision of below fair market value Medicaid enrollment application assistance services to certain individuals and affiliated skilled nursing facilities' payments for those services in particular circumstances)
Advisory Opinion 20-05 (regarding a pharmaceutical manufacturer's proposal to provide cost-sharing assistance directly to Medicare beneficiaries who are prescribed either of two formulations of its drug)
Advisory Opinion 20-04 (regarding a charitable organization's proposal to purchase or receive donations of unpaid medical debt owed by qualifying patients from certain types of health care providers and then forgive that debt)
Advisory Opinion 20-03 (regarding an arrangement under which a discount medical plan organization ("DMPO") pays chiropractors and chiropractic clinics a fee for each new DMPO member referred by the chiropractor or chiropractic clinic)
Advisory Opinion 20-02 (regarding financial assistance for travel, lodging, and other expenses provided by a pharmaceutical manufacturer to certain patients prescribed the manufacturer's drug)
Advisory Opinion 20-01 (regarding a hospital's provision of discounted training to a specified fire department's personnel at the hospital's facility)

Advisory Opinions for 2019

Advisory Opinion 19-06 (regarding a supermarket's proposal to expand its current loyalty program to allow customers to earn rewards points on out-of-pocket costs paid in connection with pharmacy purchases)
Advisory Opinion 19-05 (regarding a proposed purchase of real estate from a limited liability company owned, in part, by an excluded individual)
Advisory Opinion 19-04 (regarding a technology company's proposal to make visible to Federal health care program beneficiaries: (i) its online healthcare directory for searching and booking medical appointments, where healthcare professionals pay, or would pay, per-click or per-booking fees to be listed in the directory; and (ii) sponsored advertisements on its online healthcare directory and third-party websites, where healthcare professionals pay, or would pay, per-impression or per-click fees for such sponsored advertisements (the "Proposed Arrangement"))
Advisory Opinion 19-03 (regarding a program offered by a medical center that provides free, in-home follow-up care to eligible individuals with congestive heart failure (the "Current Arrangement") and the proposed expansion of this program to include certain individuals with chronic obstructive pulmonary disease)
Advisory Opinion 19-02 (regarding a pharmaceutical manufacturer's proposal to loan, on a temporary basis, a limited- functionality smartphone to financially needy patients who do not have the technology necessary to receive adherence data from a sensor embedded in prescribed antipsychotic medication)
Advisory Opinion 19-01 (regarding a charitable pediatric clinic's arrangement under which the clinic waives cost-sharing amounts in certain circumstances)