,,ib ,union ,calendar ,no4 #ced #aaeth ,,congress #ast ,session ,h4 ,r4 #cgbf ,report ,no4 #aae-dgi1 ,part ,i ,,in ,,the ,,house ,,of ,,representatives ,september #aa1 #bjag ,mr4 ,marchant 7for himself1 ,mr4 ,kind1 and ,mr4 ,meehan7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 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 ,december #ba1 #bjag;,additional sponsor3 ,mr4 ,curbelo of ,florida ,december #ba1 #bjag ,reported from the ,committee on ,ways and ,means with an amendment ,strike out all after the enacting clause and insert the part printed in italic ,december #ba1 #bjag,the ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed,for text of introduced bill1 see copy of bill as introduced on ,september #aa1 #bjag ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to create alternative sanctions for technical noncompliance with the ,stark rule under ,medicare1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,stark ,administrative ,simplification ,act of #bjag4 #b4 ,alternative sanctions for technical noncompliance with ,stark rule under ,medicare ,section #ahgg of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7 is amended by adding at the end the following new subsection3 7j7 ,self-disclosure protocols 7#a7 ,in general ,beginning one year after the date of the enactment of this subsection-- 7,a7 an entity or individual may voluntarily disclose a compensation arrangement with actual or potential inadvertent technical noncompliance with subsection 7a77#a7 7as defined in paragraph 7#c77;,h77 pursuant to either the self-referral disclosure protocol 7defined in paragraph 7#b77 or the alternative protocol for technical noncompliance under paragraph 7#c72 7,b7 disclosures voluntarily withdrawn from the alternative protocol for technical noncompliance may be submitted to the self-referral disclosure protocol2 and 7,c7 an entity that1 prior to the establishment of the alternative protocol for technical noncompliance1 disclosed to the self-referral disclosure protocol a compensation arrangement that was in inadvertent technical noncompliance with subsection 7a77#a71 may elect1 not later than one year after such alternative protocol is established1 to withdraw such disclosure from the self-referral disclosure protocol and instead submit the disclosure to such alternative protocol4 7#b7 ,self-referral disclosure protocol ,the term self-referral disclosure protocol or ,,srdp means the protocol specified in section #fdji of ,public ,law #aaa-adh4 7#c7 ,alternative protocol for inadvertant technical noncompliance 7,a7 ,in general ,the ,secretary shall establish1 not later than one year after the date of the enactment of this subsection1 an alternative protocol for technical noncompliance 7in this subsection referred to as the ,,aptn7 to enable entities to disclose arrangements that were previously in inadvertent technical noncompliance with subsection 7a77#a7 and1 upon the ,secretary's acceptance of the disclosure1 make payment of a civil monetary penalty4 ,payment of such civil monetary penalty for an arrangement shall resolve only overpayments due and owing as a result of such arrangement's inadvertent technical noncompliance with subsection 7a77#a74 ,the provisions of section #fdji of ,public ,law #aaa-adh shall not apply to this subsection4 7,b7 ,disclosure requirements ,arrangements disclosed to the ,,aptn must-- 7i7 involve only inadvertent technical noncompliance with subsection 7a77#a7 that was ended by termination or expiration of the arrangement1 or by action of the parties to the arrangement to resolve the technical noncompliance1 prior to the date of submission of the disclosure to the ,,aptn2 7ii7 be made in the form and manner specified by the ,secretary on the public ,internet website of the ,centers for ,medicare ,medicaid ,services and include descriptions of-- 7,i7 the compensation arrangement that was in technical noncompliance with subsection 7a77#a72 7,,ii7 how and when the technical noncompliance with subsection 7a77#a7 was ended or the arrangement was otherwise terminated2 and 7,,iii7 how the remuneration paid under the compensation arrangement being disclosed was-- 7aa7 consistent with the fair market value of the items and services that were provided under the compensation arrangement2 and 7bb7 not determined in a manner that directly or indirectly takes into account the volume or value of referrals or other business generated between the parties2 7iii7 include a form settlement agreement provided by the ,secretary signed by the entity2 and 7iv7 include a certification from the entity that1 to the best of the entity's knowledge1 the information provided is truthful information and is based on a good faith effort to bring the matter to the ,secretary's attention4 7,c7 ,acceptance or rejection of disclosure by the secretary ,the following rules shall apply to the acceptance or rejection of a disclosure under the ,,aptn3 7i7 ,the ,secretary shall accept or reject a complete1 accurate1 and timely disclosure4 7ii7 ,upon receipt of a disclosure1 the ,secretary shall notify the disclosing party of such receipt4 7iii7 ,the ,secretary may request additional information from the disclosing party4 7iv7 ,upon acceptance by the ,secretary1 the ,secretary shall notify the disclosing party in writing of such acceptance4 7v7 ,the disclosure shall be rejected if-- 7,i7 the disclosing party fails to furnish the additional information requested by the ,secretary in such form and manner as the ,secretary may specify2 or 7,,ii7 in the ,secretary's sole determination1 the noncompliance disclosed did not meet the disclosure requirements specified in subparagraph 7,b74 7vi7 ,the disclosure shall be accepted if-- 7,i7 the ,secretary has issued a written notice to the disclosing party that the disclosure is determined to satisfy the requirements for disclosures under this section2 or 7,,ii7 the disclosure is complete1 accurate1 and timely and satisfies each of the requirements for disclosures under this section1 #ahj calendar days have passed since notification of receipt by the ,secretary of the disclosure1 and the ,secretary has not rejected the disclosure during that period4 7vii7 ,in determining whether to accept a disclosure1 the ,secretary may reasonably rely on the information and certifications included in the disclosure4 7,d7 ,rule for withdrawal of disclosure ,prior to acceptance or rejection of a disclosure by the ,secretary1 an entity may voluntarily withdraw such disclosure from the ,,aptn4 7,e7 ,civil monetary penalties pursuant to the alternative protocol for technical noncompliance 7i7 ,in general ,subject to clause 7ii71 for each arrangement disclosed under this subsection and accepted under subparagraph 7,c71 the ,secretary shall impose a single civil monetary penalty of-- 7,i7 #e1jjj1 in the case in which disclosure of the inadvertant technical noncompliance with subsection 7a77#a7 was submitted to the ,secretary not later than the date that is one year after the initial date of inadvertent technical noncompliance with subsection 7a77#a72 or 7,,ii7 #aj1jjj1 in the case in which the disclosure of the inadvertant technically noncompliance with subsection 7a77#a7 was submitted to the ,secretary-- 7aa7 after the date that is more than one year after the initial date of the entity's inadvertent technical noncompliance with subsection 7a77#a72 and 7bb7 not after the date that is #c years 7or1 in the case of a disclosure submitted after the #eth year for which this subsection applies1 the date that is #b years7 from the initial date of the entity's inadvertent technical noncompliance with subsection 7a77#a74 7ii7 ,special rule for entities that disclosed to the aptn after withdrawing a disclosure from the srdp ,in the case of an entity that elects under paragraph 7#a77;,c7 to withdraw a disclosure from the self-referral disclosure protocol 7as defined in paragraph 7#b77 and instead submit the disclosure to the ,,aptn under this subsection1 in determining the applicable civil monetary penalty under clause 7i71 the date of disclosure to the self-referral disclosure protocol shall be substituted for the date of disclosure to the ,,aptn4 7,f7 ,relation to advisory opinions ,the ,,aptn shall be separate from the advisory opinion process set forth in regulations implementing subsection 7g7 of this section4 7,g7 ,publication on internet website of aptn information ,not later than one year after the date of the enactment of this subsection1 the ,secretary shall post information on the public ,internet website of the ,centers for ,medicare ,medicaid ,services to inform relevant stakeholders of how to disclose and make payment of a civil monetary penalty for inadvertent technical noncompliance with subsection 7a77#a74 7,h7 ,definitions ,in this subsection3 7i7 ,technical noncompliance ,the term technical noncompliance with subsection 7a77#a7 means1 with respect to a compensation arrangement1 that-- 7,i7 the arrangement is not signed by one or more parties to the arrangement2 7,,ii7 following the expiration of the arrangement1 the arrangement was a holdover arrangement for a period longer than permitted in regulations issued by the ,secretary2 or 7,,iii7 the contemporaneous written documentation evidencing the terms of the arrangement identifies the parties to the arrangement and the items1 services1 space1 or equipment1 as applicable1 but is not sufficient to satisfy the writing requirement of an applicable exception4 7ii7 ,inadvertent ,the term inadvertent means1 with respect to a compensation arrangement that is in technical noncompliance with subsection 7a77#a71 that an entity that is a party to the compensation arrangement did not know or should not have known of the noncompliance4 7,i7 ,administration ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to this subsection4 7,j7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement the provisions of this paragraph by program instruction or otherwise4 4 ,december #ba1 #bjag ,reported from the ,committee on ,ways and ,means with an amendment,december #ba1 #bjag,the ,committee on ,energy and ,commerce discharged2 committed to the ,committee of the ,whole ,house on the ,state of the ,union and ordered to be printed