Sources: 42 C.F.R. § 411.353(f)

14. Inadvertent and Temporary Noncompliance

Arrangements that have unavoidably and temporarily fallen out of compliance with other exceptions provided:
 

  1. The arrangement has fully satisfied another exception for at least 180 consecutive calendar days immediately preceding the date on which the financial relationship became noncompliant with the exception;

  2. The arrangement has fallen out of compliance with the exception for reasons beyond the parties’ control, and the parties promptly take steps to rectify the non-compliance; and

  3. The arrangement does not violate the anti-kickback statute or any laws or regulations governing billing or claims submission.


Note that this exception lasts only up to 90 days and applies to DHS furnished during the 90-day period. By the end of the 90-day period, parties must either comply with another exception or terminate the arrangement.

Note also that this exception may be used by a DHS entity only once every 3 years.

Note finally that this exception does not apply to arrangements that previously complied with the exceptions for non-monetary compensation up to $392 or incidental medical staff benefits.

Special rule for non-compliance with signature requirements:   the parties obtain the required signature(s) within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90–day period) and the compensation arrangement otherwise complies with all criteria of the applicable exception.

Stark General Exception