,i #aafth ,,congress #ast ,session ,h4 ,r4 #bije ,,in ,,the ,,house ,,of ,,representatives ,may #bb1 #bjai,mr4 ,blumenauer 7for himself1 ,mr4 ,holding1 and ,mr4 ,butterfield7 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 ,a ,,bill ,to provide for a demonstration project to further examine the benefits of providing coverage and payment for items and services necessary to administer intravenous immune globulin 7,,ivig7 in the home1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicare ,,ivig ,access ,enhancement ,act4 #b4 ,medicare patient ,,ivig access demonstration project 7a7 ,establishment ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish and implement a demonstration project under part ,b of title ,,xviii of the ,social ,security ,act to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globulin for the treatment of chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy4 7b7 ,duration and scope 7#a7 ,duration ,beginning not later than #a year after the date of enactment of this ,act1 the ,secretary shall conduct the demonstration project for a period of #c years4 7#b7 ,scope ,the ,secretary shall1 subject to subsection 7d71 enroll not greater than #c1jjj ,medicare beneficiaries who have been diagnosed with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy for participation in the demonstration project4 ,subject to subsection 7d71 a ,medicare beneficiary may participate in the demonstration project on a voluntary basis and may terminate participation at any time4 7c7 ,coverage ,except as otherwise provided in this section1 items and services for which payment may be made under the demonstration program shall be treated and covered under part ,b of title ,,xviii of the ,social ,security ,act in the same manner as similar items and services covered under such part4 7d7 ,eligibility ,in order to participate in the demonstration project1 a ,medicare beneficiary must-- 7#a7 be covered under the original ,medicare fee-for-service program under parts ,a and ,b of title ,,xviii of the ,social ,security ,act and not enrolled in a ,medicare ,advantage plan under part ,c of such ,act2 7#b7 require intravenous immunoglobulin for the treatment of chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy2 and 7#c7 meet any other eligibility requirements specified by the ,secretary4 7e7 ,payment 7#a7 ,intravenous immune globulin ,for intravenous immune globulin furnished under this section1 the ,secretary shall make payment using the payment methodology under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 7#b7 ,other items and services 7,a7 ,in general ,the ,secretary shall establish1 subject to subparagraph 7,b71 a per-visit payment amount for items and services 7other than intravenous immune globulin7 needed for the in-home infusion of intravenous immune globulin for the treatment of chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy based on the national per visit low-utilization payment amount under the prospective payment system for home health services established under section #ahie of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;fff74 7,b7 ,limitation ,in establishing the per-visit payment amount established under subparagraph 7,a7 for items and services described in such subparagraph1 the ,secretary shall consider-- 7i7 including a component for requisite nursing care2 7ii7 establishing an appropriate furnishing fee for intravenous immune globulin similar to the separate payment for clotting factors under section #ahdb7o77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7o77#e772 7iii7 otherwise acknowledging the length of infusions for individuals needing in-home infusion of intravenous globulin for treatment described in subparagraph 7,a72 7iv7 that1 in total1 such amount potentially not being less than at least twice the payment amount applied under the demonstration project established under section #aja of the ,medicare ,,ivig ,access and ,strengthening ,medicare and ,repaying ,taxpayers ,act of #bjab 7,public ,law #aab-bdb7 for items and services needed for the in-home administration of intravenous immune globulin for the treatment of primary immune deficiency diseases in recognition of the fact that patients with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy tend to have longer infusion times1 require more product1 and have additional health care needs related to underlying neuromuscular challenges2 and 7v7 developing such amount in consultation with stakeholders4 7f7 ,waiver authority ,the ,secretary may waive such requirements of title ,,xviii of the ,social ,security ,act as may be necessary to carry out the demonstration project4 7g7 ,final evaluation and report ,not later than one year after the date of completion of the demonstration project1 the ,secretary shall submit to ,congress a report that contains-- 7#a7 a final evaluation of the impact of the demonstration project on access for ,medicare beneficiaries with chronic inflammatory demyelinating polyneuropathy and ,medicare beneficiaries with multifocal motor neuropathy to items and services needed for the in-home administration of intravenous immune globin2 and 7#b7 a final analysis of the appropriateness of expanding or extending the demonstration project or implementing a new methodology for payment for intravenous immune globulins in all care settings under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciek et seq47 and1 to the extent such analysis determines such an expansion1 extension1 or methodology appropriate1 recommendations for such expansion1 extension1 or methodology1 respectively4 7h7 ,definitions ,in this section3 7#a7 ,demonstration project ,the term demonstration project means the demonstration project conducted under this ,act4 7#b7 ,medicare beneficiary ,the term ,medicare beneficiary means an individual who is enrolled for benefits under part ,b of title ,,xviii of the ,social ,security ,act4