,i #aacth ,,congress #ast ,session ,h4 ,r4 #cfha ,,in ,,the ,,house ,,of ,,representatives ,december #i1 #bjac,mr4 ,paulsen 7for himself1 ,mr4 ,matheson1 ,mr4 ,shimkus1 and ,mr4 ,barrow of ,georgia7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to promote health care technology innovation and access to medical devices and services for which patients choose to self-pay under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,accelerating ,innovation in ,medicine ,act of #bjac or the ,,aim ,act of #bjac4 #b4 ,findings ,congress finds as follows3 7#a7 ,innovation in health care technology is necessary to improve health outcomes and depends in part on the ability of medical technology developers1 including scientists1 physicians1 engineers1 and patient advocates1 to introduce medical devices into the marketplace4 7#b7 ,even after meeting requirements for marketing set by the ,food and ,drug ,administration1 there may be uncertainties about patient access through government health care programs1 causing significant delays in bringing innovative medical devices to patients or causing medical technology developers to abandon potential health care solutions4 7#c7 ,patients covered by the ,medicare program are often willing to enter into self-pay arrangements with physicians and other providers to purchase items or services1 yet under current laws restricting such freedom of choice1 the self-pay arrangements may be associated with regulatory impediments or a risk of civil penalties4 7#d7 ,enabling health care technology manufacturers to designate products to be directly available to self-pay patients and excluded from government health program payments at an early stage of product development will promote innovation and result in increased patient access to desired products and services1 save taxpayer dollars1 and reduce administrative burdens on physicians and the government4 7#e7 ,enabling health care technology manufacturers to designate their devices as available to self-pay patients would permit a window of time during which additional data may be obtained on outcomes1 comparative clinical effectiveness or other data elements for possible future coverage by the ,medicare program4 #c4 ,establishment of manufacturer opt-out program for medical devices 7a7 ,in general ,section #ahfb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7 is amended adding at the end the following new subsection3 7p7 ,establishment of accelerating innovation in medicine 7,,aim7 list of medical devices voluntarily excluded from coverage 7#a7 ,in general ,not later than #ij days after the date of the enactment of this subsection1 the ,secretary shall develop and maintain a listing 7in this section referred to as the ,,aim list7 of medical devices for which1 because of their inclusion in such listing1 no insurance benefit and no payment may be made for such a 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 and an individual who consents to receive such a device is responsible for payment for the device and services related to furnishing the device4 7#b7 ,procedures for inclusion in ,,aim list 7,a7 ,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 device4 7,b7 ,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 list4 ,in the case of such a device for which-- 7i7 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 ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 including pursuant to section #eaj7k7 or #eae7;c7 of such ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;e7c771 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 beginning at least #cj days after the date of such approval or clearance2 or 7ii7 the device is exempt from such approval and clearance requirements1 the request may be submitted at a time that is not later than the first business day of the month beginning at least #cj days after the date of the first sale of the device by its manufacturer4 7#c7 ,listing periods2 removal from list 7,a7 #c-year listing periods ,a medical device included in the ,,aim list shall be initially listed for a period of #c years and shall remain so listed for subsequent #c-year periods subject to subparagraphs 7,b7 and 7,c74 7,b7 ,removal at request of manufacturer ,at any time a device of a manufacturer included in the ,,aim list shall be removed from the ,,aim list upon the written request of the manufacturer4 ,subject to subparagraph 7,c71 such a device of a manufacturer may not be removed from the ,,aim list except upon the written request of the manufacturer4 7,c7 ,provision of data on clinical studies as a condition for continued listing ,as a condition for the continued inclusion of the device of a manufacturer in the ,,aim list for a subsequent #c-year listing period under subparagraph 7,a71 the manufacturer shall provide the ,secretary with published or publicly available data on clinical studies completed for the device at the end of the previous #c-year listing period4 ,if the ,secretary determines that a manufacturer of a device has materially failed to provide such data for the device1 the ,secretary may remove the device from the ,,aim list or not renew the listing for the device or both4 7#d7 ,medical device defined ,in this subsection1 the term medical device has the meaning given the term device in section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h774 7#e7 ,posting of listed devices on website ,the ,secretary shall post on a public website of the ,department of ,health and ,human ,services or other publicly accessible manner a list of the medical devices included in the ,,aim list and shall provide for updating the website on a real-time basis 7but no less frequently than monthly7 to reflect changes in the medical devices in the ,,aim list4 7#f7 ,regulations not required ,nothing in this subsection shall be construed as requiring the ,secretary to promulgate regulations to carry out this subsection4 7#g7 ,requirement for informed consent in order for provider to charge for device ,if a physician or other entity furnishes a medical device included in the ,,aim list to an individual under this title and failed to obtain1 before furnishing the device1 an appropriate informed consent under which the individual is informed of and accepts liability under paragraph 7#a7 for payment for the device 7and related services71 the physician or other entity is deemed to have agreed not to impose any charge under this title for such device 7and for services related to furnishing the device74 4 7b7 ,conforming amendment ,section #ahfb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7a77 is amended-- 7#a7 in paragraph 7#bd71 by striking or at the end2 7#b7 in paragraph 7#be71 by striking the period at the end and inserting 2 or2 and 7#c7 by inserting after paragraph 7#be7 the following new paragraph3 7#bf7 where such expenses are for a medical device included in the ,,aim list under section #ahfb7p7 or for items and services related to furnishing such device4 4