Extract to table

" This cleared indication for use defines the permissible scope of promotional claims by Solstice, ADS, and any sub-distributors, and serves as the baseline against which any promotional activity must be measured for FDA compliance purposes

To qualify, the following requirements must all be met: (1) The arrangement must be set out in writing and signed by the parties; (2) The writing must cover all of the services to be provided by the contractor; (3) If the arrangement is intended to provide for services on a periodic, sporadic, or part-time basis, rather than on a full-time basis for the term of the agreement, the agreement must specify exactly the schedule of such intervals, their precise length, and the exact charge for such intervals; (4) The term of the agreement must be for not less than one year; (5) The aggregate compensation paid to the contractor over the term of the agreement must be set in advance, must be consistent with fair market value in arm's-length transactions, and must not be determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under a federal healthcare program; and (6) The services performed under the agreement must not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law

Any transfer of value to a covered recipient that meets or exceeds these thresholds must be reported, unless an applicable exclusion applies

Data regarding transfers of value made during calendar year 2024 must be submitted to CMS by March 31, 2025

The absence of contractual data-collection provisions in the current ADS Distribution Agreement represents a significant compliance gap that must be remedied before the October 1, 2024 launch

ADS is required to maintain specified minimum inventory levels (Section 4