Medicare program. 3. Establishment of manufacturer opt-out program for medical devices (a) In general Section 1862 of the Social Security Act ( 42 U.S.C. 1395y ) is amended adding at the end the following new subsection: (p) Establishment of accelerating innovation in medicine (AIM) list of medical devices voluntarily excluded from coverage (1) In general Not later than 90 days after the date of the enactment of this subsection, the Secretary shall develop and maintain a listing (in this section referred to as the AIM list ) of medical devices for which, because of their inclusion in such listing, no insurance benefit and no payment may be made for such a device (or for any items or services related to furnishing such device) under this title either directly or on a capitated basis such that no claim for payment may be submitted under this title for such a device (or for any items or services related to furnishing such device) and an individual who consents to receive such a device is responsible for payment for the device (and for any items and services related to furnishing such device). (2) Procedures for inclusion in AIM list (A) Requirement for written consent of manufacturer No medical device may be included in the AIM list without the written consent of the manufacturer of the device. (B) Submission process A manufacturer seeking to have a medical device included in the AIM list shall submit to the Secretary a request for inclusion of the device in the AIM list. In the case of such a device for which— (i) there is a request for approval or clearance for marketing and sale of the device by the Food and Drug Administration pursuant to authority granted by the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), including pursuant to section 510(k) or 515(c) of such Act ( 21 U.S.C. 360(k) , 360e(c)), the request for inclusion of the device in the AIM list may not be submitted earlier than the date of the request for such approval or clearance and no later than the first business day of the month