,,ii #aaith ,,congress #b;d ,session ,s4 #djcg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #aj1 #bjbf,mrs4 ,shaheen 7for herself and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to ensure continued access to diabetes technology upon ,medicare enrollment1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,diabetes ,interventions ,addressing ,barriers to ,enrollment1 ,technology1 and ,education ,services 7,,diabetes7 ,act or the ,diabetes ,act4 #b4 ,findings2 ,sense of ,congress 7a7 ,findings ,congress finds the following3 7#a7 ,according to the ,centers for ,disease ,control and ,prevention1 in #bjba1 an estimated #ch1djj1jjj ,americans1 or #aa4f percent of the entire ,united ,states population1 have diabetes4 7#b7 ,the total number of individuals with diabetes is projected to increase to an estimated #ed1ijj1jjj individuals by #bjcj4 7#c7 ,diabetes disproportionately impacts the ,medicare population1 as the ,centers for ,medicare ,medicaid ,services found in #bjbb1 and #bf percent of ,medicare beneficiaries have diabetes4 7#d7 ,both type #a and #b diabetes can significantly harm long-term health and is associated with numerous comorbidities such as cancer1 heart disease1 chronic kidney disease1 blindness1 and amputations4 7#e7 ,the direct and indirect cost of diabetes is significant as the ,american ,diabetes ,association found that the total annual cost of diabetes in #bjbb was #dab1ijj1jjj1jjj1 #cjf1fjj1jjj1jjj of which is attributable to direct medical costs4 7#f7 ,the ,american ,diabetes ,association and the ,american ,association of ,clinical ,endocrinology have set forth clinical guidelines that include the use of continuous glucose monitors1 insulin pumps1 automated insulin delivery systems1 and diabetes self-management training for individuals with diabetes4 7#g7 ,an automated insulin delivery system consists of a continuous glucose monitor1 an insulin pump1 and an algorithm or software4 7#h7 ,the algorithm or software is a critical component of an automated insulin delivery system as it continuously learns the user's behavior and physiological responses and automatically administers the appropriate amount of insulin4 7#i7 ,medicare currently fails to separately reimburse for the essential algorithms and software that drive automated insulin delivery 7,,aid7 systems1 which may stifle future innovation and maintenance1 and impede beneficiary access4 7#aj7 ,medicare has an existing pathway to separately reimburse for the algorithm or software in an automated insulin delivery system1 the ,medicare durable medical equipment benefit4 7#aa7 ,including continuous glucose monitors1 durable insulin pumps1 and related supplies into the competitive bidding program further limits innovation and access to diabetes technologies4 7#ab7 ,the ,centers for ,medicare ,medicaid ,services' final rule entitled ,medicare and ,medicaid ,programs2 ,calendar ,year #bjbf ,home ,health ,prospective ,payment ,system 7,,hh ,,pps7 ,rate ,update2 ,requirements for the ,,hh ,quality ,reporting ,program and the ,,hh ,value-,based ,purchasing ,expanded ,model2 ,durable ,medical ,equipment1 ,prosthetics1 ,orthotics1 and ,supplies 7,,dmepos7 ,competitive ,bidding ,program ,updates2 ,,dmepos ,accreditation ,requirements2 ,provider ,enrollment2 and ,other ,medicare and ,medicaid ,policies 7#ij ,fed4 ,reg4 #eecdb 7,december #b1 #bjbe771 which reclassifies continuous glucose monitors and durable insulin pumps as items requiring frequent and substantial servicing when they are phased into the competitive bidding program1 will have numerous unintended consequences that may prevent ,medicare beneficiaries from accessing the continuous glucose monitor or durable insulin pump they need to survive4 7b7 ,sense of ,congress regarding automated insulin delivery systems ,it is the sense of ,congress that the ,secretary of ,health and ,human ,services should commit to take administrative action to-- 7#a7 recognize that the algorithm or software in an automated insulin delivery system is a reasonable and necessary item for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member consistent with ,medicare coverage requirements under section #ahfb7;a77#a77;,a7 of the ,social ,security ,act2 7#b7 ensure the algorithm or software in an automated insulin delivery system is treated as a separately payable supply to durable medical equipment2 and 7#c7 when applicable1 recognize the algorithm or software in an automated insulin delivery system as medical supplies associated with the injection of insulin consistent with section #ahfj;,d-#b7;e77#a7 of the ,social ,security ,act4 #c4 ,continued access to diabetes related technologies 7a7 ,in general ,section #ahfa7ww7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking and after upon the agreement with the individual12 and 7,b7 by inserting and ensuring care continuity for individuals using diabetes technology covered under part ,b as described in paragraph 7#e71 after 7as defined in paragraph 7#d7712 and 7#b7 by adding at the end the following new paragraph3 7#e7 7,a7 ,subject to subparagraphs 7,b7 and 7,c7 of this paragraph1 during the first #ab months of an individual's enrollment for benefits under part ,b1 a provider 7as defined in subparagraph 7,e77 may certify to the ,secretary that an individual is using #a or multiple diabetes technologies covered under part ,b 7as defined in subparagraph 7,d774 7,b7 ,during the initial preventive physical examination or other covered service as determined appropriate by the ,secretary during the period described in subparagraph 7,a71 the provider may make a determination of the individual's use of diabetes technology covered under part ,b4 ,in the case where the provider makes such determination1 the provider shall submit a certification to the ,secretary as required under subparagraph 7,c74 7,c7 ,not later than ,january #a1 #bjbg1 the ,secretary shall-- 7i7 issue a finalized certification form1 developed pursuant to public notice and opportunity for comment1 for use under this paragraph2 7ii7 issue guidance and instructions to medicare administrative contractors 7as defined in section #ahgd;,a7a77#c771 that require the relevant medicare administrative contractors to only assess whether the certification form is included in the individual's medical records when making a determination of whether coverage of the diabetes technology covered under part ,b is reasonable and necessary as described in section #ahfb7;a77#a77;,a72 7iii7 develop a process through notice and comment rulemaking for considering whether an individual's diabetes technology that is not covered under part ,b at the time of the certification described in subparagraph 7,a7 should be a covered benefit under existing statutory authority2 and 7iv7 issue appropriate guidance to relevant audit and oversight entities to ensure those entities do not inappropriately cause disruptions in access to diabetes technology covered under part ,b4 7,d7 ,for purposes of this paragraph1 the term diabetes technology covered under part ,b means1 with respect to an individual1 any device1 related supplies1 and software or algorithm that1 at the time the certification described in subparagraph 7,c7 is made with respect to the individual1 is covered under part ,b for an individual that has diabetes under the applicable ,,icd-#aj code list1 as determined by the ,secretary4 7,e7 ,for purposes of this paragraph1 the term provider means a physician 7as defined in section #ahfa7r771 nurse practitioner1 clinical nurse specialist1 physician assistant1 7as those terms are defined in section #ahfa7;aa77#e771 or certified nurse-midwife 7as defined in section #ahfa7;gg77#b771 or other provider of services or supplier as determined appropriate by the ,secretary4 4 7b7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjbg4 #d4 ,improving access to diabetes outpatient self-management training services 7a7 ,in general ,section #ahfa7qq7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7qq77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 by striking the ,secretary determines appropriate and inserting specified in paragraph 7#c72 and 7,b7 by striking the physician who is managing the individual's diabetic condition and inserting a physician or qualified nonphysician practitioner2 7#b7 in paragraph 7#b77;,b71 by striking paragraph and inserting subparagraph2 and 7#c7 by adding at the end the following new paragraph3 7#c7 ,for purposes of paragraph 7#a7 and subject to subparagraph 7,b71 the times specified in this paragraph are the following3 7,a7 ,an initial #aj hours of individual or group educational and training services to remain available until used4 7,b7 ,an additional #b hours of individual or group educational and training services each year1 beginning with the year in which the initial #aj hours described in subparagraph 7,a7 are completed4 7#d7 ,the ,secretary shall not limit the quantity or duration of educational and training services furnished by a certified provider to an individual with diabetes if such services are deemed medically necessary by a physician or qualified non-physician practitioner4 4 7b7 ,medical nutrition therapy services ,section #ahfa7s77#b77,v7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77,v77 is amended-- 7#a7 by striking clause 7i72 7#b7 by redesignating clauses 7ii7 and 7iii7 as clauses 7i7 and 7ii71 respectively2 and 7#c7 in clause 7ii71 as so redesignated1 by striking after consideration of and inserting consistent with4 7c7 ,cost-,sharing ,section #ahcc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7 is amended-- 7#a7 in subsection 7a77#a7-- 7,a7 by striking and 7,,hh7 and inserting 7,,hh72 and 7,b7 by inserting the following before the semicolon at the end3 and 7,,ii7 with respect to diabetes outpatient self-management training services 7as defined in section #ahfa7qq771 the amount paid shall be #ajj percent of the lesser of the actual charge for the services or the amount determined under the fee schedule that applies to such services under this part22 and 7#b7 in subsection 7b71 in the first sentence-- 7,a7 by striking 1 and 7#ac7 and inserting 7#ac72 and 7,b7 by striking #ahfa7n744 and inserting #ahfa7n71 and 7#ad7 such deductible shall not apply with respect to diabetes outpatient self-management training services 7as defined in section #ahfa7qq774 7d7 ,application ,the amendments made by this section shall apply with respect to items and services furnished on or after ,january #a1 #bjbg4 #e4 ,,cmi testing of providing virtual diabetes outpatient self-management training services ,section #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7 is amended-- 7#a7 in subsection 7b77#b77;,a71 by adding at the end the following new sentence3 ,the models selected under this subparagraph shall include the testing of the model described in subsection 7h742 and 7#b7 by adding at the end the following new subsection3 7h7 ,testing of providing virtual diabetes outpatient self-,management training services 7#a7 ,establishment ,not later than ,january #a1 #bjbg1 the ,secretary shall implement a model to test the impact of providing coverage under title ,,xviii for virtual diabetes outpatient self-management training services furnished to applicable beneficiaries with respect to improved health outcomes for such applicable beneficiaries and reduced expenditures under such title ,,xviii4 7#b7 ,model design 7,a7 ,in general ,the ,secretary shall design the model under this subsection in such a manner to allow for the evaluation of demographic characteristics of applicable beneficiaries participating in such model and the extent to which such model accomplishes the following purposes3 7i7 ,improvement in health outcomes with respect to the diabetic conditions1 including by reducing ,a#a;c levels4 7ii7 ,reduced hospitalizations due to diabetic-related complications4 7iii7 ,increased utilization of diabetes outpatient self-management training services as evidenced by1 for example1 ,medicare beneficiary participation and utilization of covered hours during the first year and subsequent years or use of diabetes outpatient self-management training services in rural and underserved communities4 7iv7 ,improved medication adherence4 7v7 ,reduced expenditures under this title attributable to the model4 7,b7 ,consultation ,in designing the model under this subsection1 the ,secretary shall1 not later than #c months after the date of the enactment of this subsection1 consult with stakeholders in the field of diabetes care and education1 clinicians in the primary care community1 experts in digital health1 and beneficiary groups4 7#c7 ,definitions ,in this subsection3 7,a7 ,applicable beneficiary ,the term applicable beneficiary means an individual with diabetes as described in section #ahfa7qq74 7,b7 ,qualified web-based program ,the term qualified web-based program means a web-based program-- 7i7 designed to furnish educational and training services to an individual with diabetes to ensure therapy compliance with respect to the individual's diabetic condition or to provide the individual with necessary skills and knowledge 7including skills related to the self-administration of injectable drugs7 to participate in the individual's management of such condition2 and 7ii7 that meets the quality standards described in section #ahfa7qq77#b77;,b74 7,c7 ,virtual diabetes outpatient self-management training services ,the term virtual diabetes outpatient self-management training services means any diabetes outpatient self-management training services 7as defined in section #ahfa7qq77 furnished by a qualified web-based program for synchronous or asynchronous diabetes outpatient self-management training services4 4 #f4 ,providing insulin pump training and education 7a7 ,in general ,not later than ,january #a1 #bjbg1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish new ,healthcare ,common ,procedure ,coding ,system codes under the fee schedule established under section #ahdh7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7;b77 that describe hook-up1 calibration1 and patient training with respect to an insulin pump similar to ,current ,procedural ,terminology codes #iebdi and #iebej 7and any succeeding codes74 ,the ,secretary shall ensure the newly established codes sufficiently describe patient education and training as well as insulin pump placement services for technologies covered under section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 and part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 7b7 ,education and outreach ,the ,secretary shall use existing communications and mechanisms to provide education and outreach to stakeholders with respect to the ability of health professionals to bill the newly established codes described in subsection 7a74 #g4 ,national coverage determination on insulin pumps ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue a proposed national coverage determination 7as defined in section #ahfi7;f77#a77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ff7f77#a77;,b777 for infusion pumps1 continuous subcutaneous insulin infusion 7,,csii71 number #bhj4ad pursuant to section #ahfb7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l774 #h4 ,report on enrollee access to diabetes-related services and technologies in ,federal health care programs 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states1 in collaboration with the ,secretary of ,health and ,human ,services1 shall submit to the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives1 a report that assesses the barriers individuals face in accessing diabetes technologies and diabetes self-management education and support services across ,federal health care programs4 ,the report shall specifically review barriers1 which include prior authorization practices1 the use of preferred formularies1 coverage intensity limitations1 and other utilization management techniques1 to accessing diabetes technologies and diabetes self-management education and support services faced by individuals enrolled in a ,federal health care program1 and whether any ,federal law1 regulation1 or policy adversely affects access to those covered services or limits the ability of individuals with diabetes to receive services that align with standards of care4 7b7 ,definitions ,in this section3 7#a7 ,diabetes technologies ,the term diabetes technologies means items described in section #ahfa7ww77#e77;,d7 of the ,social ,security ,act1 as added by section #c1 and any device1 related supplies1 and software or algorithm that monitors or manages an individual's diabetes that is medically necessary for the individual's diagnosis of diabetes1 regardless of whether the device1 related supplies1 and software or algorithm is covered under part ,b of title ,,xviii of the ,social ,security ,act4 ,such term includes glucose monitors1 insulin delivery technologies1 related supplies1 and software or algorithms4 7#b7 ,diabetes self-management education and support services ,the term diabetes self-management education and support services means services described in section #ahfa7qq7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7qq774 7#c7 ,federal health care program ,the term ,federal health care program means any plan or program that provides health benefits1 whether through insurance or otherwise1 that is directly funded in whole or in part1 by the ,united ,states ,government1 including a ,federal health care program 7as defined in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f777 and a health benefits plan under chapter #hi of title #e1 ,united ,states ,code4 #i4 ,ensuring access to diabetes-related technologies ,section #ahdg7;a77#b7 of the ,social ,security ,act 7#db #aciew-#c7;a77#b77 is amended by adding at the end the following new subparagraph3 7,e7 ,certain diabetic-related items ,continuous glucose monitors and insulin pumps that are covered as durable medical equipment under section #ahfa7n7 furnished on or after ,january #a1 #bjca4 4