,,ii #aahth ,,congress #b;d ,session ,s4 #eejb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ab1 #bjbd,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 7b7 ,sense of ,congress ,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 #bjbf1 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;,a7#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 list 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 #bjbf4 #d4 ,expanding 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 inserting and consistent with paragraph 7#b77;,c7 after as the ,secretary determines appropriate2 7,b7 by inserting or qualified non-physician practitioner after only if the physician2 and 7,c7 by inserting 7or other physician or qualified non-physician practitioner furnishing items or services to such individual1 in coordination with the physician or qualified non-physician practitioner managing such individual's diabetic condition7 after managing the individual's diabetic condition2 and 7#b7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 7,b7 in subparagraph 7,b7-- 7i7 by striking paragraph and inserting subparagraph2 and 7ii7 by striking the period at the end and inserting 2 and2 and 7,c7 by adding the following new subparagraph3 7,c7 the times determined appropriate by the ,secretary shall in no way limit the quantity or duration of educational and training services furnished by a certified provider to an individual with diabetes if such service is deemed medically necessary by a physician or qualified non-physician practitioner4 4 7b7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjbf4 #e4 ,providing insulin pump training and education 7a7 ,in general ,not later than ,january #a1 #bjbf1 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 #f4 ,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;,b77 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 #g4 ,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