Advisory Opinions
In accordance with section 1128(D)(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.
-
- Preliminary Checklist for Advisory Opinion Requests
- Recommended Preliminary Questions and Supplementary Information
- The full and current regulatory text of regulations governing requests for advisory opinions is available on the Code of Federal Regulations Web site. 42 CFR part 1008.
- The OIG Final Rule (73 Fed. Reg. 40982) revising the procedural aspects for submitting payments for advisory opinion costs.
- The OIG Interim Final Rule (73 Fed. Reg. 15937) revising the procedural aspects for submitting payments for advisory opinion costs.
- The OIG Interim Final Rule (62 Fed. Reg. 7350) and Revised Final Rule (63 Fed. Reg. 38311) addressing the procedural aspects for submitting a request and obtaining a formal advisory opinion from OIG.
Advisory Opinions for 2019
- 09-11-2019
- Advisory Opinion 19-05 (regarding a proposed purchase of real estate from a limited liability company owned, in part, by an excluded individual)
- 09-10-2019
- 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"))
- 03-07-2019
- 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)
- 01-29-2019
- 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)
- 01-14-2019
- Advisory Opinion 19-01 (regarding a charitable pediatric clinic's arrangement under which the clinic waives cost-sharing amounts in certain circumstances)
-
- 11-16-2018
- Advisory Opinion 18-14 (regarding a drug company's proposal to provide free product to hospitals for the hospitals to use exclusively to treat inpatients who have been diagnosed with one particular condition)
- 11-06-2018
- Advisory Opinion 18-13 (regarding proposed donations from a charitable trust and an individual donor to a medical research institute)
- 10-29-2018
- Advisory Opinion 18-12 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract indirectly with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay (the "Proposed Arrangement"))
- 10-18-2018
- Advisory Opinion 18-11 (regarding a health plan's proposal to pay its contracted providers and clinics to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment services that they provide to the health plan's enrolled Medicaid beneficiaries)
- 09-17-2018
- Advisory Opinion 18-10 (regarding a surgical device and wound care product manufacturer's proposal to offer hospital customers a warranty program covering a suite of three products)
- 08-21-2018
- Advisory Opinion 18-09 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract indirectly with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay)
- 08-14-2018
- Advisory Opinion 18-08 (regarding a proposal by certain government-operated fire departments and fire protection districts to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for such services according to the billing practices in the jurisdiction where such services are rendered)
- 08-06-2018
- Advisory Opinion 18-07 (regarding a proposal from a group purchasing organization ("GPO") to serve as a purchasing agent on behalf of certain GPO-affiliated health care facilities on the same terms and conditions that apply to its unaffiliated members)
- 07-18-2018
- Advisory Opinion 18-06 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract indirectly with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay)
- 06-25-2018
- Advisory Opinion 18-05 (regarding an arrangement under which a hospital has established a caregiver center that provides or arranges for free or reduced-cost support services to caregivers in the local community)
- 06-14-2018
- Advisory Opinion 18-04 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby insurance companies would contract indirectly with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 05-31-2018
- Advisory Opinion 18-03 (regarding a federally qualified health center look-alike's proposal to provide information technology items and services, without charge, to a county Department of Health's clinic to facilitate telemedicine encounters)
- 05-07-2018
- Advisory Opinion 18-02 (regarding an arrangement where a company that manufactures, distributes, and sells medical device and pharmaceutical products provides a limited number of free sample ostomy products to patients and contracts with a third party to conduct follow-up customer satisfaction surveys)
- 02-27-2018
- Advisory Opinion 18-01 (regarding the effect of your exclusion from Medicare, Medicaid, and all other Federal health care programs)
-
- 01-05-2018
- Advisory Opinion 17-09 (regarding an arrangement in which certain neurosurgeons have agreed to implement cost-reduction measures in designated surgical procedures performed at a medical center, and the medical center will share with such neurosurgeons a percentage of its cost savings resulting from these measures)
- 12-15-2017
- Advisory Opinion 17-08 (regarding your proposal to develop a state-wide network of nursing facilities that would provide discounts on the daily rates they charge to private long-term care insurers and the insurers' policyholders)
- 12-11-2017
- Advisory Opinion 17-07 (regarding a pharmaceutical manufacturer's proposal to collaborate with a trade association, a Medicare Advantage plan, and a hospital system to implement, fund, and evaluate a pilot program to provide the Medicare Advantage plan pharmacists who conduct medication therapy management services with new technology that would permit real-time electronic access to patient discharge information)
- 11-28-2017
- Final Notice of Rescission of Advisory Opinion 06-04 (rescinds Advisory Opinion 06-04, which concerned a nonprofit, tax-exempt, charitable corporation's proposal to provide financially needy Medicare beneficiaries with assistance with premiums and cost-sharing obligations)
- 11-16-2017
- Advisory Opinion 17-06 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would indirectly contract with hospitals for discounts on the otherwise applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 09-07-2017
- Advisory Opinion 17-05 (regarding a retail pharmacy chain's proposal to allow Federal health care program beneficiaries to participate in a paid membership program that includes discounts on certain prescriptions and clinic services)
- 08-31-2017
- Advisory Opinion 17-04 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby insurance companies indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 08-25-2017
- Advisory Opinion 17-03 (regarding a pharmaceutical manufacturer's proposal to replace products that require specialized handling that could not be administered to patients for certain reasons, at no additional charge to the purchaser)
- 07-07-2017
- Advisory Opinion 17-02 (regarding a hospital outpatient facility's proposal to reduce or waive, on a non-routine, unadvertised basis, cost-sharing amounts owed by financially needy Medicare beneficiaries for items and services furnished in connection with a clinical research study)
- 03-10-2017
- Advisory Opinion 17-01 (regarding a hospital system's proposal to provide free or reduced-cost lodging and meals to certain financially needy patients)
- Modification of Advisory Opinion 02-1 (modifies Advisory Opinion 02-1, which concerned a non-profit, tax-exempt, charitable organization's providing cost-sharing and premium assistance to financially needy patients diagnosed with specific chronic illnesses and rare disorders, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.)
-
- 12-20-2016
- Advisory Opinion 16-13 (regarding: (i) a proposal to waive cost-sharing obligations incurred by individuals for health care services required for participation in a government-funded clinical research study (the "Proposed Arrangement"); and (ii) the payment of a stipend to study participants for the time and effort required to participate in study visits)
- 12-05-2016
- Advisory Opinion 16-12 (regarding a laboratory's proposal to provide services consisting of the labeling of test tubes and specimen collection containers at no cost to dialysis facilities)
- 11-03-2016
- Advisory Opinion 16-11 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 10-11-2016
- Advisory Opinion 16-10 (regarding a local health care district's proposal to cooperate with another district to jointly fund the cost of a transportation coordinator to educate patients about local transportation options and subsidize certain forms of transportation for patients with financial need)
- 09-23-2016
- Advisory Opinion 16-09 (regarding a proposal to install a computerized point-of-care vaccine storage and dispensing system in physicians' offices for the physicians' use)
- 07-27-2016
- Advisory Opinion 16-08 (regarding an arrangement in which a hospice would make a supplemental payment to the nursing facilities in which the hospice's dually eligible patients reside when the nursing facilities-instead of the hospice-receive payment for their patients' room and board expenses)
- 07-22-2016
- Modification of Advisory Opinion 10-12 (modifies Advisory Opinion 10-12, which concerned a nonprofit, tax-exempt, charitable corporation's proposal to provide financially needy patients with grants to defray their cost-sharing obligations, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs)
- 06-27-2016
- Advisory Opinion 16-07 (regarding a savings card program under which individuals who have prescription drug coverage under Medicare Part D receive discounts on a drug that is statutorily excluded from coverage)
- 05-12-2016
- Modification of OIG Advisory Opinion 10-07 (modifies OIG Advisory Opinion 10-07 which concerned a nonprofit, tax-exempt, charitable organization's proposal to provide assistance with cost-sharing obligations to financially needy individuals, including Medicare and Medicaid beneficiaries, diagnosed with certain specified diseases, and its first modification at Modification of OIG Advisory Opinion 10-07 to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.)
- 05-09-2016
- Advisory Opinion 16-06 (regarding your proposal for an entity to purchase the remaining five percent ownership interest in a group purchasing organization)
- 05-03-2016
- Advisory Opinion 16-05 (regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies, whereby [name redacted] would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 04-19-2016
- Advisory Opinion 16-04 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby three insurance companies would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 04-06-2016
- Termination of OIG Advisory Opinion No. 06-09 (terminates OIG Advisory Opinion No. 06-09, which concerned a nonprofit, tax-exempt, charitable organization's proposals to subsidize Medicare Part D premium and cost-sharing obligations owed by financially needy patients with end-stage renal disease and chronic kidney disease.)
- 03-18-2016
- Advisory Opinion 16-03 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies)
- 03-01-2016
- Advisory Opinion 16-02 regarding a state academic medical center that in certain circumstances offers pregnant women: (1) transportation aid to and from the campus hospital for delivery; and (2) short-term lodging near the campus hospital)
- 01-25-2016
- Advisory Opinion 16-01 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby [names redacted] (the "Requestors") would indirectly contract with hospitals for discounts on the otherwise-applicable Medicare inpatient deductibles for their policyholders and, in turn, would provide a premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 01-20-2016
- Terminated Advisory Opinion No. 10-06 (concerning a patient assistance program that assists underinsured patients with their prescription drug co-payment obligations)
- Terminated Advisory Opinion No. 08-17 (concerning a nonprofit, tax-exempt, charitable organization's arrangement to provide financial assistance to cover cost-sharing obligations associated with outpatient drug treatment owed by financially needy Medicare or Medicaid patients with a certain disease)
- 01-06-2016
- Modification of Advisory Opinion 04-15 (modifies Advisory Opinion 04-15 grants provided by a nonprofit, charitable organization to financially-needy patients suffering from specific chronic or life-threatening diseases to defray the costs of prescription drug therapies, and its first modification at Modification of Advisory Opinion 04-15, to reflect guidance issued on May 21 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.)