Stark General Exception

Similar to the seven standards for Anti-Kickback, and more flexible beginning Jan. 1, 2016:

 

  1. Each arrangement is set out in writing (does not have to be a formal agreement), is signed by the parties, and specifies the services covered by the arrangement.

  2. The arrangement(s) covers all of the services to be furnished by the physician (or an immediate family member of the physician) to the entity (O.K. to incorporate each other by reference or cross-reference a master list of contracts).

  3. The aggregate services covered by the arrangement do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement(s).

  4. The duration of each arrangement is at least 1 year (arrangement that in fact lasts for 1 year satisfies this requirement).

  5. The compensation to be paid over the term of each arrangement is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties.

  6. The services to be furnished under each arrangement do not involve the counseling or promotion of a business arrangement or other activity that violates any Federal or State law.

  7. If the arrangement expires after a term of at least 1 year, a holdover arrangement immediately following the expiration of the arrangement satisfies this exception if the following conditions are met:

(i) The arrangement met the six conditions above when the arrangement

expired;

(ii) The holdover arrangement is on the same terms and conditions as the immediately preceding arrangement; and

(iii) The holdover arrangement continues to satisfy the six conditions above.

4. Personal Services and Management Contracts

Sources: 42 C.F.R. ยง 411.357(d)