,,ii #aafth ,,congress #b;d ,session ,s4 #dejc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #f1 #bjbj,mr4 ,warner 7for himself1 ,mr4 ,daines1 ,ms4 ,duckworth1 ,mr4 ,cassidy1 and ,mr4 ,cornyn7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to protect beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate1 safe1 effective1 patient-centered orthotic and prosthetic care1 to reduce fraud1 waste1 and abuse with respect to orthotics and prosthetics1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicare ,orthotics and ,prosthetics ,patient-,centered ,care ,act4 #b4 ,increasing protections for beneficiaries receiving orthotic and prosthetic care under the ,medicare program 7a7 ,distinguishing orthotists and prosthetists from suppliers of durable medical equipment and supplies ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended-- 7#a7 in subsection 7j77#e71 by striking subparagraph 7,c7 and redesignating the subsequent subparagraphs accordingly2 and 7#b7 by adding at the end the following new subsection3 7x7 ,requirements for orthotists and prosthetists 7#a7 ,issuance and renewal of supplier number 7,a7 ,payment 7i7 ,in general ,no payment may be made under this part to an orthotic or prosthetic supplier unless such orthotic or prosthetic supplier obtains 7and renews at such intervals as the ,secretary may require7 a supplier number4 7ii7 ,clarification regarding providers under part ,a ,nothing in clause 7i7 shall prohibit a provider otherwise permitted to receive payment for orthotics and prosthetics under part ,a from continuing to receive payment under such part without interruption4 7,b7 ,standards for possessing a supplier number ,an orthotic or prosthetic supplier may only obtain a supplier number if the supplier meets standards prescribed by the ,secretary that include requirements that the orthotic or prosthetic supplier 7and1 where applicable1 the orthotist or prosthetist7-- 7i7 licensure and accreditation-- 7,i7 complies with all applicable ,state and ,federal licensure and regulatory requirements2 and 7,,ii7 acquires accreditation from the ,american ,board for ,certification in ,orthotics1 ,prosthetics and ,pedorthics1 ,inc4 or the ,board of ,certification_/,accreditation1 ,international1 or other accreditation entity that the ,secretary determines has standards that are equivalent to the standards of such ,boards2 7ii7 maintains a physical facility on an appropriate site2 7iii7 has proof of appropriate liability insurance2 and 7iv7 meets such other requirements as the ,secretary shall specify4 7,c7 ,prohibition against multiple supplier numbers ,the ,secretary may not issue more than one supplier number to any orthotic or prosthetic supplier unless the ,secretary finds that the issuance of more than one number is appropriate to identify other entities under the ownership or control of the orthotic or prosthetic supplier4 7#b7 ,order for orthotics or prosthetics 7,a7 ,information provided by orthotists and prosthetists on detailed written orders for orthotics and prosthetics ,an orthotist or prosthetist may distribute to physicians1 physician assistants1 nurse practitioners1 clinical nurse specialists1 or individuals entitled to benefits under this part1 a detailed written order for orthotics or prosthetics 7as defined in paragraph 7#e77 for commercial purposes that contains the following information3 7i7 ,the identification of-- 7,i7 the orthotic or prosthetic supplier2 and 7,,ii7 the individual to whom the orthotics or prosthetics are furnished4 7ii7 ,the identification of the treating physician1 physician assistant1 nurse practitioner1 or clinical nurse specialist4 7iii7 ,a description of the orthotics or prosthetics ordered4 7iv7 ,the date of the order described in this subparagraph4 7,b7 ,information on coding and descriptors of components provided ,if an orthotist or prosthetist distributes a detailed written order for orthotics or prosthetics described in subparagraph 7,a71 the orthotist or prosthetist shall also list on the order the summary descriptors of the items and services being recommended prior to submission of the order to the treating physician for approval4 7,c7 ,signature by treating physician ,a detailed written order for orthotics or prosthetics described in subparagraph 7,a7 shall be signed by the treating physician4 7#c7 ,limitation on patient liability ,except as provided in paragraph 7#d71 if an orthotist or prosthetist-- 7,a7 furnishes an orthosis or prosthesis to a beneficiary for which no payment may be made under this part2 or 7,b7 subject to section #ahgi1 furnishes an orthosis or prosthesis to a beneficiary for which payment is denied under section #ahfb7;a77#a71 any expenses incurred for the orthosis or prosthesis furnished to an individual by the orthotist or prosthetist not on an assigned basis shall be the responsibility of such orthotist or prosthetist4 ,the individual shall have no financial responsibility for such expenses and the orthotist or prosthetist shall refund on a timely basis to the individual 7and shall be liable to the individual for7 any amounts collected from the individual for such items and services4 ,the provisions of subsection 7a77#ah7 shall apply to refunds required under the previous sentence in the same manner as such provisions apply to refunds under such subsection4 7#d7 ,patient liability ,if an orthotist or prosthetist furnishes an orthosis or prosthesis to a patient for which payment is denied in advance under subsection 7a77#ae71 expenses incurred for such orthosis or prosthesis furnished to the individual by the orthotist or prosthetist shall be the responsibility of the individual4 7#e7 ,definitions ,in this subsection3 7,a7 ,detailed written order for orthotics or prosthetics 7i7 ,in general ,the term detailed written order for orthotics or prosthetics means a form or other document prepared by an orthotist or prosthetist and signed by the physician 7as defined by section #ahfa7r77 that contains information required by the ,secretary to show that an orthosis or prosthesis is reasonable and necessary for the treatment of an illness or injury or to improve the functioning of a malformed body member4 7ii7 ,clarification ,the detailed written order for orthotics or prosthetics shall not be considered alone for purposes of determining the reasonableness1 medical necessity1 and functional level 7applicable to prosthetics7 of orthotics and prosthetics4 7,b7 ,orthotics and prosthetics ,the term orthotics and prosthetics has the meaning given that term in section #ahcd7;h77#d77;,c74 7,c7 ,orthotist or prosthetist ,the term orthotist or prosthetist means an individual who is specifically trained and educated in the provision of1 and patient care management related to1 prosthetics and custom-fabricated or custom-fit orthotics1 and-- 7i7 in the case of a ,state that provides for the licensing of orthotists and prosthetists1 is licensed by the ,state in which the orthotics or prosthetics were supplied2 or 7ii7 in the case of a ,state that does not provide for the licensing of orthotists and prosthetists1 is certified by the ,american ,board for ,certification in ,orthotics1 ,prosthetics and ,pedorthics1 ,inc4 or by the ,board of ,certification_/,accreditation1 ,international1 or is certified and approved by an entity that the ,secretary determines has certification and approval standards that are essentially equivalent to the certification and approval standards of such ,boards4 4 7b7 ,prohibiting payment for certain orthotics and prosthetics ,section #ahcd7;h77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77 is amended by adding at the end the following new subparagraph3 7,i7 ,special payment rules for orthotics or prosthetics 7i7 ,in general ,no payment shall be made under this subsection for-- 7,i7 a prosthesis 7excluding prosthetic supplies7 that is delivered by drop shipment2 7,,ii7 a custom-fabricated or custom-fitted orthosis 7excluding orthotic supplies7 described in subparagraph 7,f77ii7 that is delivered by drop shipment2 and 7,,iii7 an orthotic item that is not otherwise competitively bid that is delivered by drop shipment4 7ii7 ,drop shipment defined ,in this subparagraph1 the term drop shipment means the shipping of an orthosis or prosthesis to a beneficiary without receiving from a trained1 educated1 and certified or licensed health care practitioner1 orthotist1 or prosthetist direct patient care with respect to assessing1 adjusting1 and training in the care and use of the orthosis or prosthesis4 4 7c7 ,standardizing the definitions of orthotics and prosthetics ,section #ahcd7;h77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#d77 is amended-- 7#a7 in subparagraph 7,b71 by striking at the end and2 7#b7 in subparagraph 7,c7-- 7,a7 by striking the term orthotics and prosthetics has the meaning given such term and inserting the terms orthotics and prosthetics and orthoses and prostheses have the meaning given such terms2 and 7,b7 by striking the period at the end and inserting 2 and2 and 7#c7 by inserting after subparagraph 7,c71 as amended by paragraph 7#b71 the following new subparagraph3 7,d7 the terms prosthetics and prostheses refer to a device 7including the clinical services associated with such device7 that replaces all or part of a limb4 4 7d7 ,limitation of competitive acquisition for off-the-,shelf orthotics ,section #ahdg7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77 is amended-- 7#a7 in paragraph 7#b77;,c71 by inserting by the patient 7and not by another person7 after minimal self-adjustment2 and 7#b7 in paragraph 7#g77;,a77i7-- 7,a7 by inserting 1 orthotist or prosthetist 7as defined in section #ahcd7x77#e77;,c771 after by a physician2 7,b7 by inserting 1 orthotist's or prosthetist's1 after to the physician's2 and 7,c7 by inserting 1 orthotist's or prosthetist's1 after of the physician's4 7e7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate final regulations to implement the provisions of1 and amendments made by1 this ,act4