Recommended Preliminary Questions and Supplementary Information for Addressing Requests for OIG Advisory Opinions In Accordance With Section 1128D of the Social Security Act and 42 CFR Part 1008

I. Introduction

In requesting an advisory opinion from the Office of Inspector General (OIG), you must fully and accurately provide the information required by regulations set forth at 42 CFR part 1008. In addition, you are encouraged, but not required, to respond to the suggested questions set forth below, as appropriate to the subject matter of your request. Providing the information that corresponds to the subject matter of your inquiry for an advisory opinion may expedite the processing of your request by the OIG. The Office of Inspector General reserves the right to modify or add suggested questions at any time.

For the purposes of the questions listed below, we will refer to the factual context of the question as the "arrangement" and use the following definitions. We ask that persons requesting an opinion use the same definitions in any submission.

• "Referral" means referral of a patient or the purchasing, leasing, ordering (or arranging for or recommending purchasing, leasing, or ordering) of any good, facility, service or item if any portion of that patient's care or the cost of the good, facility, service or item may be paid in whole or in part by Medicare, Medicaid, or any other Federal health care program.
• "Fair market value" means the value that would be assigned to the item or service in question by individuals or entities who have an arms-length relationship and who have no ability to influence referrals of any health care business to each other.
• "Federal Health Care Program" means any plan or program that provides health benefits, whether directly or indirectly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under 5 U.S.C. 89).
• "Party or Parties" are all individuals or entities that will or may participate in any way with the arrangement, including indirect ownership interests. This also includes any parties or third-party beneficiaries to contracts, as well as others affected by the arrangement. Generally, anyone who may pay or receive remuneration as a result of the arrangement is a party to the arrangement.
• "Remuneration" means anything of value, whether tangible or intangible. For example, a reduction or discount, like a direct payment, is remuneration.

II. Subject Areas

Set forth below are three specific subject areas for which we are providing suggested questions to be answered in advisory opinion requests.

Subject Areas

If the subject matter of your inquiry concerns:

1. What constitutes prohibited remuneration within the meaning of section 1128B(b) of the Social Security Act; or
2. Whether an activity, or proposed activity, constitutes grounds for the imposition of sanctions under section 1128B(b) of the Social Security Act.

Please refer to the suggested questions contained in Attachment A.

If the subject matter of your inquiry concerns:

1. Whether an arrangement, or proposed arrangement, satisfies the criteria set forth in section 1128B(b)(3) of the Social Security Act for activities which do not result in prohibited remuneration;
2. Whether an arrangement, or proposed arrangement, satisfies the criteria set forth in 42 CFR 1001.952 for activities which do not result in prohibited remuneration; or
3. Whether an arrangement, or proposed arrangement, although not satisfying the criteria of 1. or 2. above, is sufficiently similar to activities set forth in section 1128B(b)(3) or 42 CFR 1001.952 that it should not constitute grounds for the imposition of sanctions under section 1128B(b) of the Social Security Act.

Please refer to the suggested questions contained in Attachment B.

If the subject matter of your inquiry concerns:

1. 1. What constitutes an inducement to reduce or limit services to individuals entitled to benefits under title 18 or 19 of the Social Security Act within the meaning of section 1128A(b) of the Act ⁽¹⁾?

Please refer to the suggested questions contained in Attachment C.

Attachment A

1. What parties or potential parties to the arrangement have the ability to influence the referral of health care business to other parties?
2. or each party or potential party who has the ability to influence the referral of such business, describe the reasons for and extent of such ability.
3. What remuneration may or will be paid to or from parties to the arrangement?
   The answer to this question should identify each potential remuneration relationship and for each such relationship:
   1. Identify the payor and recipient of remuneration for that relationship;
   2. Explain the nature of the remuneration that will or may be paid through that relationship;
   3. Set forth the amount of remuneration and explain how the amount of remuneration will be calculated;
   4. Explain any variation in the amount of remuneration to be paid by or to various parties, the reasons for such variations and how are they calculated;
   5. For each party that is receiving remuneration, describe the services or other consideration is that party providing for the remuneration; and
   6. For each recipient of remuneration in the arrangement, does the remuneration received constitute the fair market value for the consideration that party is providing (as set forth in response to subpart (e) above))?
4. To the extent health care services or items are provided in accordance with the arrangement, are such items or services covered or reimbursed by any Federal health care program?
5. Please address whether the arrangement may result in any of the following:
   1. An increase or decrease in access to health care services;
   2. An increase or decrease in the quality of health care services;
   3. An increase or decrease in patient freedom of choice among health care providers;
   4. An increase or decrease in competition among health care providers;
   5. An increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations;
   6. (An increase or decrease in the cost to Federal health care programs; or
   7. The existence or nonexistence of any potential financial benefit to a health care professional or provider which may vary based on his or her decisions of-
      1. Whether to order a health care item or service; or
      2. Whether to arrange for a referral of health care items or services to a particular practitioner or provider.
6. Describe any other business arrangements or transactions among the parties, either in existence or planned.
7. Describe what factors or characteristics of the arrangement will prevent the kinds of abuse addressed by the anti-kickback statute.
8. Provide any other information that the requestor believes is relevant, e.g. a description of the requestor's compliance program, if any.

Attachment B

1. Describe the arrangement in detail.
2. To the extent health care services or items are provided pursuant to the arrangement, are such items or services covered or reimbursed by any Federal health care program.
3. Please address how the arrangement meets or fails to meet each of the elements of the relevant safe harbor at 42 CFR 1001.952 or the relevant subsection of section 1128B(b)(3) of the Social Security Act.
4. Please address whether the subject arrangement may result in any of the following:
   1. An increase or decrease in access to health care services;
   2. An increase or decrease in the quality of health care services;
   3. An increase or decrease in patient freedom if choice among health care providers;
   4. An increase or decrease in competition among health care providers;
   5. An increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations;
   6. An increase or decrease in the cost to Federal health care programs; or
   7. The existence or nonexistence of any potential financial benefit to a health care professional or provider which may vary based on his or her decisions of-
      1. Whether to order a health care item or service; or
      2. Whether to arrange for a referral of health care items or services to a particular practitioner or provider.
5. Describe what factors or characteristics of the arrangement will prevent the kinds of abuse addressed by the anti-kickback statute.
6. Describe any other business relationships or transactions among the parties, either in existence or planned.
7. Provide any other information that the requestor believes is relevant, e.g. a description of the requestor's compliance program, if any.

Attachment C

1. How does the hospital calculate the remuneration provided to physicians?
2. Does the hospital make any distinction between physicians in calculating the amounts of remuneration? If yes, describe and explain the distinctions.
3. Does the hospital make any distinctions between patients in determining the amounts of remuneration? If yes, describe and explain the distinctions.
4. What is the relationship, if any, between the amount and type of care provided to a Medicare or Medicaid beneficiary under the direct care of a physician and the amount of payments made to that physician?
5. Do the physicians receiving the payments have direct care responsibilities over Medicare or Medicaid beneficiaries?
6. How many patients are considered when determining the amount of the payment?
7. What is the physician's total income from the treatment of patients at the hospital?
8. What is the amount of payments made to the physician pursuant to the arrangement?
9. Are the payments calculated based on the practices of more than one physician? If so, how many physicians are in the pool used to calculate the incentive payments?
10. What is the period of time over which the amount of the payment is determined?
11. What safeguards does the hospital utilize to detect and deter poor care or underutilization by physicians?
12. Would the remuneration be allowable under the standards at 42 CFR 417.479 if made by an organization rather than a hospital? Explain why or why not.
13. Provide any other information that the requestor believes is relevant, e.g. a description of the requestor's utilization review and/or quality assurance program, patient grievance procedures, review of denials of care.

Footnote:

1. Although the statute refers to section 1128B(b), the reference is apparently intended to be section 1128A(b). ¶