,i #aacth ,,congress #b;d ,session ,h4 ,r4 #edce ,,in ,,the ,,house ,,of ,,representatives ,september #aj1 #bjad ,mr4 ,engel 7for himself1 ,mr4 ,tiberi1 ,mr4 ,larson of ,connecticut1 ,mr4 ,harper1 ,mr4 ,meehan1 ,ms4 ,pingree of ,maine1 and ,mr4 ,peterson7 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 amend title ,,xviii of the ,social ,security ,act to provide for the coverage of home as a site of care for infusion therapy under the ,medicare ,program4 #a4 ,short title ,this ,act may be cited as the ,medicare ,home ,infusion ,site of ,care ,act of #bjad4 #b4 ,findings ,congress finds the following3 7#a7 ,the ,medicare fee-for-service program covers infusion therapy in the hospital1 skilled nursing facility1 physician office1 and hospital outpatient department1 but does not cover the full range of services for the provision of infusion therapies in a patient's home4 7#b7 ,the ,medicare program is presently the only major health care payer in the ,united ,states that does not provide comprehensive coverage of home infusion therapy4 7#c7 ,as a result of the ,medicare program not providing for comprehensive coverage of home infusion therapy1 many ,medicare beneficiaries are unable to obtain infusion therapy in the most cost-effective and convenient setting of their home1 and physicians are deprived of the ability to select the best site of care for their patients4 7#d7 ,the ,medicare program is paying for institutional care for the provision of infusion therapy in many instances when such institutional care could be avoided if the ,medicare program provided coverage for home infusion therapy4 7#e7 ,the ,government ,accountability ,office found in a #bjaj report that home infusion therapy is utilized widely by private payers providing health insurance coverage for individuals enrolled under such coverage and that such private payers generally are satisfied with the quality of care and the savings they achieve through avoided institutionalizations4 7#f7 ,a recent study has reported a potential savings for ,medicare if infusion therapies were covered in the home site of care4 #c4 ,medicare coverage of home infusion therapy 7a7 ,in general ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7s77#b7-- 7,a7 by striking and at the end of subparagraph 7,,ee72 7,b7 by inserting and at the end of subparagraph 7,,ff72 and 7,c7 by inserting at the end the following new subparagraph3 7,,gg7 home infusion therapy 7as defined in subsection 7iii77#a772 2 and 7#b7 by adding at the end the following new subsection3 7iii7 ,home ,infusion ,therapy 7#a7 ,the term home infusion therapy means the items and services described in paragraph 7#b7 furnished to an individual1 who is under the care of a physician1 which are provided by a qualified home infusion therapy supplier under a plan 7for furnishing such items and services to such individual7 established and periodically reviewed by a physician1 which items and services are provided in an integrated manner in the individual's home in conformance with uniform standards of care established by the ,secretary and in coordination with the provision of covered infusion drugs under part ,d4 ,the ,secretary shall establish such standards after taking into account the standards commonly used for home infusion therapy by ,medicare ,advantage plans and in the private sector and after consultation with all interested stakeholders4 7#b7 ,the items and services described in this paragraph are the following3 7,a7 ,professional services1 including nursing services 7other than nursing services covered as home health services71 provided in accordance with the plan 7including administrative1 compounding1 dispensing1 distribution1 clinical monitoring1 and care coordination services7 and all necessary supplies and equipment 7including medical supplies such as sterile tubing and infusion pumps74 7,b7 ,other items and services the ,secretary determines appropriate to administer infusion drug therapies to an individual safely and effectively in the home4 7#c7 ,for purposes of this subsection3 7,a7 ,the term home means a place of residence used as an individual's home and includes such other alternate settings as the ,secretary determines4 7,b7 ,the term qualified home infusion therapy supplier means any pharmacy1 physician1 or other provider licensed by the ,state in which the pharmacy1 physician1 or provider resides or provides services1 whose ,state authorized scope of practice includes dispensing authority and that-- 7i7 has expertise in the preparation of parenteral medications in compliance with enforceable standards of the ,united ,states ,pharmacopoeia and other nationally recognized standards that regulate preparation of parenteral medications as determined by the ,secretary and meets such standards2 7ii7 provides infusion therapy to patients with acute or chronic conditions requiring parenteral administration of drugs and biologicals administered through catheters or needles1 or both1 in a home2 and 7iii7 meets such other uniform requirements as the ,secretary determines are necessary to ensure the safe and effective provision and administration of home infusion therapy on a #g-;day-a-week1 #bd-;hour basis 7taking into account the standards of care for home infusion therapy established by ,medicare ,advantage plans and in the private sector71 and the efficient administration of the home infusion therapy benefit4 7#d7 ,a qualified home infusion therapy supplier may subcontract with a pharmacy1 physician1 provider1 or supplier to meet the requirements of paragraph 7#c77;,b74 4 7b7 ,payment for ,home ,infusion ,therapy ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7p7 ,payment for home infusion therapy 7#a7 ,in general ,the ,secretary shall determine a per diem schedule for payment for the professional services 7including nursing services71 supplies1 and equipment described in section #ahfa7;iii77#b77;,a7 for each infusion therapy type that reflects the reasonable costs which must be incurred by efficiently and economically operated qualified home infusion therapy suppliers to provide such services1 supplies1 and equipment in conformity with applicable ,state and ,federal laws1 regulations1 and the uniform quality and safety standards developed under section #ahfa7;iii77#a7 and to assure that ,medicare beneficiaries have reasonable access to such therapy4 7#b7 ,considerations ,in developing the per diem schedule under this subsection1 the ,secretary shall consider recent credible studies about the costs of providing infusion therapy in the home1 consult with home infusion therapy suppliers1 consider payment amounts established by ,medicare ,advantage plans and private payers for home infusion therapy1 and1 if necessary1 conduct a statistically valid national market analysis involving the costs of administering infusion drugs and of providing professional services necessary for the drugs' administration4 7#c7 ,annual updates ,the ,secretary shall update such schedule from year to year by the percentage increase in the ,consumer ,price ,index for all urban consumers 7,united ,states city average7 for the #ab-month period ending with ,june of the preceding year4 ,the ,secretary may modify the per diem schedule with respect to beneficiaries who qualify for home infusion therapy services under section #ahfa7;iii77#a7 but who receive nursing services as home health services4 4 7c7 ,conforming amendments 7#a7 ,payment reference ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciea7;a77#a77 is amended-- 7,a7 by striking and before 7,z72 and 7,b7 by inserting before the semicolon at the end the following3 1 and 7,,aa7 with respect to home infusion therapy1 the amounts paid shall be determined under section #ahcd7p74 7#b7 ,direct payment ,the first sentence of section #ahdb7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f77 is amended-- 7,a7 by striking and before 7,h72 and 7,b7 by inserting before the period at the end the following3 1 and 7,i7 in the case of home infusion therapy1 payment shall be made to the qualified home infusion therapy supplier4 7#c7 ,exclusion from durable medical equipment and home health services ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7,a7 in subsection 7m77#e7-- 7i7 by striking and before durable medical equipment and inserting a comma2 and 7ii7 by inserting before the semicolon at the end the following3 1 and supplies used in the provision of home infusion therapy after excluding other drugs and biologicals2 and 7,b7 in subsection 7n71 by adding at the end the following3 ,such term does not include home infusion therapy1 other than equipment and supplies used in the provision of insulin44 7#d7 ,application of accreditation provisions ,the provisions of section #ahfe7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;bb7a77 apply to the accreditation of qualified home infusion therapy suppliers in the same way as they apply to other suppliers4 #d4 ,medicare coverage of home infusion drugs ,section #ahfj;,d-#b7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking or at the end of subparagraph 7,a72 7,b7 by striking the comma at the end of subparagraph 7,b7 and inserting1 2 or2 and 7,c7 by inserting after subparagraph 7,b7 the following new subparagraph3 7,c7 an infusion drug 7as defined in paragraph 7#e771 2 and 7#b7 by adding at the end the following new paragraph3 7#e7 ,infusion drug defined ,for purposes of this part1 the term infusion drug means a parenteral drug or biological administered via an intravenous1 intraspinal1 intra-arterial1 intrathecal1 epidural1 subcutaneous1 or intramuscular access device or injection1 and may include a drug used for catheter maintenance and declotting1 a drug contained in a device1 additives including but not limited to vitamins1 minerals1 solutions1 and diluents1 and other components used in the provision of home infusion therapy4 4 #e4 ,ensuring beneficiary access to home infusion therapy 7a7 ,objectives in implementation ,the ,secretary of ,health and ,human ,services shall implement the ,medicare home infusion therapy benefit under the amendments made by this ,act in a manner that ensures that ,medicare beneficiaries have timely and appropriate access to infusion therapy in their homes and that there is rapid and seamless coordination between drug coverage under part ,d of title ,,xviii of the ,social ,security ,act and coverage for home infusion therapy services under part ,b of such title to avoid the filing of duplicative or otherwise improper claims4 ,specifically1 the ,secretary shall ensure that-- 7#a7 the benefit is practical and workable with minimal administrative burden for beneficiaries1 qualified home infusion therapy suppliers1 physicians1 prescription drug plans1 ,,ma-,,pd plans1 and ,medicare ,advantage plans1 and the ,secretary shall consider the use of consolidated claims encompassing covered part ,d drugs and part ,b services1 supplies1 and equipment under such part ,b to ensure the efficient operation of this benefit2 7#b7 any prior authorization or utilization review process is expeditious1 allowing ,medicare beneficiaries meaningful access to home infusion therapy2 7#c7 medical necessity determinations for home infusion therapy will be made-- 7,a7 except as provided in subparagraph 7,b71 by ,medicare administrative contractors under such part ,b and communicated to the appropriate prescription drug plans2 or 7,b7 in the case of an individual enrolled in a ,medicare ,advantage plan1 by the ,medicare ,advantage organization offering the plan2 and an individual may be initially qualified for coverage for such benefit for a #ij-;day period and subsequent #ij-;day periods thereafter2 7#d7 except as otherwise provided in this section1 the benefit is modeled on current private sector coverage and coding for home infusion therapy2 and 7#e7 prescription drug plans and ,,ma-,,pd plans structure their formularies1 utilization review protocols1 and policies in a manner that ensures that ,medicare beneficiaries have timely and appropriate access to infusion therapy in their homes4 7b7 ,report ,not later than ,january #a1 #bjah1 the ,comptroller ,general of the ,united ,states shall submit a report to ,congress on ,medicare beneficiary access to home infusion therapy4 ,such report shall specifically address whether the objectives specified in subsection 7a7 have been met and shall make recommendations to ,congress and the ,secretary of ,health and ,human ,services on how to improve the benefit and better ensure that ,medicare beneficiaries have timely and appropriate access to infusion therapy in their homes4 #f4 ,effective date ,the amendments made by this ,act shall apply to home infusion therapy furnished on or after ,january #a1 #bjae4