Stark General Exception
Remuneration provided under an arrangement for the use of premises, equipment, personnel, items, supplies, or services if the following conditions are met:
1. The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.
2. The arrangement is between a physician (or the physician organization in whose shoes the physician stands under §411.354(c) and:
(i) A hospital; or
(ii) Physician organization of which the physician is not an owner, employee, or contractor.
3. The premises, equipment, personnel, items, supplies, and services covered by the arrangement are used:
(i) Predominantly for the provision of evaluation and management services to patients; and
(ii) On the same schedule.
4. The equipment covered by the arrangement is:
(i) Located in the same building where the evaluation and management services are furnished;
(ii) Not used to furnish designated health services other than those incidental to the evaluation and management services furnished at the time of the patient's evaluation and management visit; and
(iii) Not advanced imaging equipment, radiation therapy equipment, or clinical or pathology laboratory equipment (other than equipment used to perform CLIA–waived laboratory tests).
5. The arrangement is not conditioned on the referral of patients by the physician who is a party to the arrangement to the hospital or physician organization of which the physician is not an owner, employee, or contractor.
6. The compensation over the term of the arrangement is set in advance, consistent with fair market value, and not determined:
(i) In a manner that takes into account (directly or indirectly) the volume or value of referrals or other business generated between the parties; or
(ii) Using a formula based on:
(A) A percentage of the revenue raised, earned, billed, collected, or otherwise attributable to the services provided while using the premises, equipment, personnel, items, supplies, or services covered by the arrangement; or
(B) Per-unit of service fees that are not time-based, to the extent that such fees reflect services provided to patients referred by the party granting permission to use the premises, equipment, personnel, items, supplies, or services covered by the arrangement to the party to which the permission is granted.
7. The arrangement would be commercially reasonable even if no referrals were made between the parties.
8. The arrangement does not violate the anti-kickback statute (section 1128B(b) of the Act) or any Federal or State law or regulation governing billing or claims submission.
9. The arrangement does not convey a possessory leasehold interest in the office space that is the subject of the arrangement.
17. Timeshare Arrangements
Sources: 42 C.F.R. § 411.357(y)