,,ii #aadth ,,congress #ast ,session ,s4 #hbi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #bc1 #bjae ,mr4 ,grassley 7for himself and ,mr4 ,warner7 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 refine how ,medicare pays for orthotics and prosthetics and to improve beneficiary experience and outcomes with orthotic and prosthetic care1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,medicare ,orthotics and ,prosthetics ,improvement ,act of #bjae4 7b7 ,table of contents ,the ,table of ,contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,modification of requirements applicable under ,medicare to the designation of accreditation organizations for suppliers of orthotics and prosthetics4 ,sec4 #c4 ,application of existing accreditation and licensure requirements to certain prosthetics and custom-fabricated or custom-fitted orthotics4 ,sec4 #d4 ,eligibility for ,medicare payment for orthotics and prosthetics based on supplier qualifications and complexity of care4 ,sec4 #e4 ,orthotist's and prosthetist's clinical notes as part of the patient's medical record4 ,sec4 #f4 ,distinguishing orthotists and prosthetists from suppliers of durable medical equipment and supplies4 ,sec4 #g4 ,clarification about minimal self-adjustment for off-the-shelf orthotics4 ,sec4 #h4 ,regulations4 #b4 ,modification of requirements applicable under ,medicare to the designation of accreditation organizations for suppliers of orthotics and prosthetics 7a7 ,in general ,section #ahcd7;a77#bj77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77#bj77;,b77 is amended-- 7#a7 by striking organizations4--,not later than and inserting3 8organizations4-- 7i7 ,in general ,subject to clause 7ii71 not later than 2 and 7#b7 by adding after clause 7i71 as added by paragraph 7#a71 the following new clauses3 7ii7 ,special requirements for accreditation of suppliers of orthotics and prosthetics ,for purposes of applying quality standards under subparagraph 7,a7 for suppliers 7other than suppliers described in clause 7iii77 of items and services described in subparagraph 7,d77ii71 the ,secretary shall designate and approve independent accreditation organizations under clause 7i7 only if such organizations are ,boards or programs described in subsection 7h77#a77;,f77iv74 ,not later than ,january #a1 #bjaf1 the ,secretary shall ensure that at least one1 and ideally multiple1 independent accreditation organizations are designated and approved in accordance with this clause4 7iii7 ,exception ,suppliers described in this clause are physicians1 occupational therapists1 or physical therapists who are licensed or otherwise regulated by the ,state in which they are practicing and who receive payment under this title1 including regulations promulgated pursuant to this subsection4 4 7b7 ,effective date ,each organization must satisfy the requirement of section #ahcd7;a77#bj77;,b77ii71 as added by subsection 7a77#b71 not later than ,january #a1 #bjaf1 regardless of whether the organization is designated or approved as an independent accreditation organization before1 on1 or after the date of the enactment of this ,act4 #c4 ,application of existing accreditation and licensure requirements to certain prosthetics and custom-fabricated or custom-fitted orthotics 7a7 ,in general ,section #ahcd7;h77#a77;,f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#a77;,f77 is amended-- 7#a7 in the heading1 by inserting or custom-fitted after custom-fabricated2 7#b7 in clause 7i71 by striking an item of custom-fabricated orthotics described in clause 7ii7 or for an item of prosthetics unless such item is and inserting an item of orthotics or prosthetics1 including an item of custom-fabricated orthotics described in clause 7ii71 unless such item is2 7#c7 in clause 7ii77,,ii71 by striking a list of items to which this subparagraph applies and inserting a list of items for purposes of clause 7i72 7#d7 in clause 7iii77,,iii71 by striking to provide or manage the provision of prosthetics and custom-designed or -fabricated orthotics and inserting to provide or manage the provision of orthotics and prosthetics 7and custom-designed or -fabricated orthotics1 in the case of an item described in clause 7ii772 and 7#e7 by adding at the end the following new clause3 7v7 ,exemption of off-the-shelf orthotics included in a competitive acquisition program ,this subparagraph shall not apply to an item of orthotics described in paragraph 7#b77;,c7 of section #ahdg7;a7 furnished on or after ,january #a1 #bjaf1 that is included in a competitive acquisition area under such section4 4 7b7 ,effective date ,the amendments made by subsection 7a7 shall apply to orthotics and prosthetics furnished on or after ,january #a1 #bjaf4 #d4 ,eligibility for ,medicare payment for orthotics and prosthetics based on supplier qualifications and complexity of care ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is amended-- 7#a7 in paragraph 7#a77;,f77iii71 in the matter preceding subclause 7,i71 by striking other individual who and inserting other individual who1 with respect to the provision of orthotics and prosthetics furnished on or after ,january #a1 #bjaf1 and subject to paragraph 7#e77;,a71 satisfies all applicable criteria of the provider qualification designation for such orthotic or prosthetic1 and who2 7#b7 in paragraph 7#a77;,f77iv71 by inserting before the period the following3 and1 with respect to the provision of orthotics and prosthetics furnished on or after ,january #a1 #bjaf1 and subject to paragraph 7#e77;,a71 satisfies all applicable criteria of the provider qualification designation for such orthotic or prosthetic2 and 7#c7 by adding at the end the following new paragraph3 7#e7 ,eligibility for payment based on supplier qualifications and complexity of care 7,a7 ,considerations for eligibility for payments 7i7 ,in general ,in applying clauses 7iii7 and 7iv7 of paragraph 7#a77;,f7 for purposes of determining whether payment may be made under this subsection for orthotics and prosthetics furnished on or after ,january #a1 #bjaf1 the ,secretary shall take into account the complexity of the respective item and1 subject to clauses 7ii71 7iii71 and 7iv71 the qualifications of the individual or entity furnishing and fabricating such respective item in accordance with this paragraph4 7ii7 ,individuals and entities exempted from supplier qualification criteria ,with respect to the provision of orthotics or prosthetics1 any criteria for supplier qualifications shall not apply to physicians1 occupational therapists1 or physical therapists who are licensed or otherwise regulated by the ,state in which they are practicing and who receive payment under this title1 including regulations promulgated pursuant to this subsection1 for the provision of orthotics and prosthetics4 7iii7 ,suppliers ,medicare-eligible prior to ,january #a1 #bjaf1 exempted ,in the case of a qualified supplier who is eligible to receive payment under this title before ,january #a1 #bjaf1 with respect to the provision of orthotics and prosthetics1 any new criteria for provider qualifications established after such date shall not apply to such supplier1 for the furnishing or fabrication of such an item4 7iv7 ,modifications ,the ,secretary shall1 in consultation with the ,boards and programs described in paragraph 7#a77;,f77iv71 periodically review the criteria for supplier qualifications and may implement by regulation any modifications to such criteria1 as determined appropriate in accordance with such consultation4 ,any such modifications shall take effect no earlier than ,january #a1 #bjaf4 7,b7 ,assignment of billing codes ,for purposes of subparagraph 7,a71 the ,secretary1 in consultation with representatives of the fields of occupational therapy1 physical therapy1 orthotics1 and prosthetics1 shall utilize and incorporate the set of ,l-codes listed1 as of the date of enactment of this paragraph1 in the ,centers for ,medicare ,medicaid ,services document entitled ,transmittal #fef 7,,cms ,pub4 #ajj-jd1 ,change ,request #ciei1 ,august #ai1 #bjje74 ,transmittal #fef shall be the controlling source of category1 product1 and code assignments for the orthotics and prosthetics care1 using the supplier qualification designation for each ,,hcpcs code as stated in such document4 ,in the case that ,transmittal #fef is updated1 reissued1 or replaced by a subsequent document1 the preceding sentence shall be applied with respect to the most recent update1 reissuance1 or replacement of such document4 4 #e4 ,orthotist's and prosthetist's clinical notes as part of the patient's medical record ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h771 as amended by section #d1 is amended by adding at the end the following new paragraph3 7#f7 ,documentation created by orthotists and prosthetists ,with respect to claims filed after ,august #aa1 #bjaa1 for purposes of determining the reasonableness1 medical necessity1 and functional level 7applicable to prosthetics7 of prosthetic devices and orthotics and prosthetics1 documentation created by an orthotist or prosthetist shall be considered part of the patient's medical record and1 consistent with the treatment of orthotic and prosthetic patient care delivery stated in the health care professional exception provided in clause 7ii7 of subsection 7a77#bj77;,f71 shall be given the same consideration as documentation created by other health professionals1 including physicians1 nurse practitioners1 occupational therapists1 and physical therapists4 4 #f4 ,distinguishing orthotists and prosthetists from suppliers of durable medical equipment and supplies 7a7 ,requirements for suppliers of medical equipment and supplies ,section #ahcd7;j77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7j77#e77 is amended by striking subparagraph 7,c74 7b7 ,requirements for orthotists and prosthetists ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7r7 ,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 complies with all applicable ,state and ,federal licensure and regulatory requirements2 7ii7 acquires accreditation from the ,american ,board for ,certification in ,orthotics1 ,prosthetics and ,pedorthics1 ,inc4 7,,abc7 or the ,board of ,certification_/,accreditation1 ,international 7,,boc71 or other accreditation entity that the ,secretary determines has standards that are essentially equivalent to the standards of such ,boards2 7iii7 maintains a physical facility on an appropriate site2 7iv7 has proof of appropriate liability insurance2 and 7v7 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 or to an individual enrolled 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 including the name1 address1 and telephone number of the physician4 7iii7 ,a description of the orthotics or prosthetics ordered4 7iv7 ,any billing code identifying the orthotics or prosthetics4 7v7 ,diagnosis codes1 a description of the individual's medical and functional condition1 and information about the need for the orthotics or prosthetics4 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 ,,hcpcs codes and 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 individual liability ,except as provided in paragraph 7#d71 if an orthotist or prosthetist-- 7,a7 furnishes an orthosis or prosthesis to an individual for which no payment may be made under this part2 or 7,b7 subject to section #ahgi1 furnishes an orthosis or prosthesis to an individual 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 ,individual liability ,if an orthotist or prosthetist furnishes an orthosis or prosthesis to an individual 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 ,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 be submitted 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 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 of ,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 7c7 ,definition of orthotics and prosthetics synonymous with orthoses and prostheses ,section #ahcd7;h77#d77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77#d77;,c77 is amended by inserting 7which may also be referred to without distinction as orthoses and prostheses7 after the term orthotics and prosthetics4 7d7 ,limitation of competitive acquisition for off-the-,shelf orthotics ,section #ahdg7;a77#g77;,a77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77;,a77i77 is amended-- 7#a7 by inserting 1 orthotist or prosthetist 7as defined in section #ahcd7r77#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 ,effective date ,the amendments made by this section shall take effect on the date of enactment of this ,act1 and apply to items and services furnished on or after such date4 #g4 ,clarification about minimal self-adjustment for off-the-shelf orthotics 7a7 ,in general ,section #ahdg7;a77#b77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#b77;,c77 is amended-- 7#a7 by inserting furnished to a patient after section #ahfa7s77#i7 of this title2 7#b7 by inserting by that patient 7and not by any other person7 after minimal self-adjustment2 and 7#c7 by striking to fit to the individual and inserting to fit to that patient4 7b7 ,inclusion in medical and other health services ,section #ahfa7s77#i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#i77 is amended-- 7#a7 by striking leg1 arm and inserting 7,a7 leg1 arm2 7#b7 in subparagraph 7,a71 as added by paragraph 7#a71 by striking the semicolon and inserting 2 and2 and 7#c7 by adding the following new subparagraph3 7,b7 off-the-shelf orthotics 7as defined in section #ahdg7;a77#b77;,c774 4 7c7 ,effective date ,the amendments made by this section shall take effect on ,april #a1 #bjjg1 and apply to items and services furnished on or after such date4 #h4 ,regulations ,not later than #abj days after the date of enactment of this ,act1 the ,secretary shall promulgate regulations to implement-- 7#a7 the provisions of1 and amendments made by1 this ,act2 and 7#b7 the provisions of1 and amendments made by1 section #dbg of the ,medicare1 ,medicaid1 and ,,schip ,benefits ,improvement and ,protections ,act of #bjjj1 as enacted into law by section #a7;a77#f7 of ,public ,law #ajf-eed4