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.
Quick Links/Resources
- 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.
- 12-07-2015
- Modification of OIG Advisory Opinion 07-11
(modifies Advisory Opinion 07-11, which concerned a nonprofit, tax-exempt, charitable organization's practice of providing financially needy cancer patients with grants to defray their out-of-pocket treatment costs, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.) - 11-20-2015
- Advisory Opinion 15-14 (regarding a non-profit, tax-exempt, charitable organization's program to help financially needy patients, including Medicare and Medicaid beneficiaries, obtain magnetic resonance imaging for the diagnosis or ongoing evaluation of [disease state redacted] (the "Arrangement").)
- 11-02-2015
- Modification of OIG Advisory Opinion 06-10
(modifies Advisory Opinion 06-10 which concerned a nonprofit, tax-exempt, charitable organization's practice of providing certain therapy management services and assistance with Medicare cost-sharing obligations to financially needy Medicare beneficiaries undergoing medical treatment for certain diseases, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.) - Modification of OIG Advisory Opinion 07-18
(modifies Advisory Opinion 07-18 concerning the management by a health care industry consultancy of a charitable organization's arrangements to subsidize patient cost-sharing and premium obligations, and its first modification at Modification of Advisory Opinion 07-18, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.) - 10-21-2015
- Advisory Opinion 15-13 (regarding a plan to offer free van shuttle service to certain medical facilities in an integrated health system)
- 08-13-2015
- Advisory Opinion 15-12 (regarding a home health provider's policy to offer free introductory visits to patients who have chosen it as their home health provider)
- 08-12-2015
- Advisory Opinion 15-11 (regarding a program to provide a drug for free for a limited time to patients who experience a delay in the insurance approval process)
- 07-28-2015
- Advisory Opinion 15-10 (regarding a hospital system's proposal to lease non-clinician employees and to provide operational and management services to a related psychiatric hospital for an amount equal to the hospital system's fully loaded costs)
- 07-23-2015
- Advisory Opinion 15-09 (regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies)
- 06-19-2015
- Advisory Opinion 15-08 (regarding the proposed use of a "preferred hospital" network in connection with a Medigap plan, whereby an insurer would indirectly contract with hospitals for discounts on the otherwise applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a renewal premium credit of $100 to policyholders who use a network hospital for an inpatient stay)
- 06-04-2015
- Advisory Opinion 15-07 (regarding subsidies a medical device manufacturer provides to certain patients participating in a clinical research study)
- Advisory Opinion 15-06 (regarding a nonprofit, tax-exempt, charitable organization's proposal to provide financial assistance to individuals with chronic diseases, including cancer, to assist with the costs of health insurance and drug and device therapies)
- 04-29-2015
- Advisory Opinion 15-05 (regarding the use of a “preferred hospital” network as part of Medicare Supplemental Health Insurance (“Medigap”) policies)
- 03-25-2015
- Advisory Opinion 15-04 (regarding a laboratory's proposal to enter into agreements with physician practices to provide all laboratory services for the practices' patients and waive all fees for those practices' patients who are enrollees of certain insurance plans that require the patients to use a different laboratory)
- 03-02-2015
- Advisory Opinion 15-03 (regarding the proposed use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies)
- 02-13-2015
- Advisory Opinion 15-02 (regarding the effect of exclusion from Medicare, Medicaid, and all other Federal health care programs)
- 02-02-2015
- Advisory Opinion 15-01 (regarding an entity's practice of advertising and providing free diapers and play yards in connection with the services it provides under a state's home visiting program for at-risk mothers and infants)
- 01-05-2015
- Advisory Opinion 14-11 (concerning a nonprofit, tax-exempt, charitable organization's proposal to provide assistance with copayment obligations to financially needy patients, including Medicare and Medicaid beneficiaries, diagnosed with Crohn's disease or ulcerative colitis)
- 10-21-2014
- Advisory Opinion 14-10
(concerning the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies) - 10-14-2014
- Advisory Opinion 14-09
(concerning an existing arrangement under which a township uses tax revenues to cover out-of-pocket amounts owed for basic life support emergency ambulance services received by local residents) - 09-24-2014
- Advisory Opinion 14-08
(concerning the proposed use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies) - 08-25-2014
- Advisory Opinion 14-07
(concerning the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies.) - 08-15-2014
- Advisory Opinion 14-06
(concerning a specialty pharmacy's proposal to pay local retail pharmacies a fee for support services they provide in connection with patient referrals to the specialty pharmacy.) - 07-28-2014
- Advisory Opinion 14-05
(concerning a pharmaceutical manufacturer's direct-to-patient product sales program that allows eligible patients to purchase one of the manufacturer's brand-name products for a fixed cash price from an online retail pharmacy vendor outside of any applicable prescription drug insurance benefit.) - 04-16-2014
- Advisory Opinion 14-04
(concerning the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies.) - 04-08-2014
- Advisory Opinion 14-03
(concerning a laboratory's arrangement with an electronic health record services vendor under which the laboratory pays a per-order fee for each test order the vendor transmits to the laboratory.) - Notice of Termination for Advisory Opinion 11-18
- Terminated Advisory Opinion 11-18
(concerning an online service that would facilitate the exchange of information between health care practitioners, providers, and suppliers.)
- Terminated Advisory Opinion 11-18
- 02-20-2014
- Advisory Opinion 14-02
(concerning the use of "preferred hospital" networks as part of certain Medicare Supplemental Health Insurance ("Medigap") policies.) - 01-22-2014
- Advisory Opinion 14-01
(concerning contracts under which a placement agency is compensated for referring new residents to senior communities where they may eventually receive services paid for by Federal health care programs.)
Advisory Opinions for 2015
Advisory Opinions for 2014
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