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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.

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Advisory Opinions for 2016

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.)

Advisory Opinions for 2015

01-02-2016
Advisory Opinion 15-17 (regarding a non-profit, tax-exempt, charitable organization's proposal to provide financial assistance with copayment obligations, health insurance premiums, and insurance deductibles to patients, including Medicare and Medicaid beneficiaries, receiving treatment for [disease state redacted])
Advisory Opinion 15-16 (regarding a nonprofit, tax-exempt, charitable organization's proposal to provide assistance with out-of-pocket expenses for outpatient prescription drugs to financially needy insured patients, including, but not limited to, Medicare and Medicaid beneficiaries)
12-30-2015
Modification of Advisory Opinion 06-04 (modifies 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, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.)
12-29-2015
Advisory Opinion 15-15 (regarding a proposal for a hospital to bill a radiology group for transcription of the radiology group's reports for individuals who are not hospital patients, but rather patients of a third-party clinic that provides the technical component of the radiology exams)
Modification of Advisory Opinion 07-06 (modifies Advisory Opinion 07-06 which concerned the management by a health care industry consultancy of a charitable organization's arrangements to assist patients with specified chronic diseases with cost-sharing and premium obligations, and its first modification at Modification of Advisory Opinion 07-06, to reflect guidance issued on May 21 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.)
Modification of Advisory Opinion 11-05 (modifies Advisory Opinion 11-05 which concerns a nonprofit, tax-exempt, charitable organization's practices of providing vouchers for genetic tests and assistance with cost-sharing obligations for certain genetic tests and prescription drugs for cancer treatment and its first modification at Modification of Advisory Opinion 11-05, to permit earmarking of donations to specific disease states and to reflect guidance issued on May 21 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.
12-16-2015
Modification of OIG Advisory Opinion 06-13 (modifies Advisory Opinion 06-13 concerning a nonprofit, tax-exempt, charitable organization's proposal to provide financially needy persons who have [diseases redacted] with grants to defray the costs of premiums and cost-sharing obligations under Medicare Part B, Medicare Part D, Medicare Supplementary Health Insurance, and Medicare Advantage, and its first modification, to reflect guidance issued on May 21, 2014 in the Supplemental Special Advisory Bulletin regarding Independent Charity Patient Assistance Programs.
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)

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