Diabetes affects 29 million Americans, imposing a substantial

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1 CLINICAL Comprtive Effectiveness nd Costs of Insulin Pump Therpy for Dibetes Ronld T. Ackermnn, MD, MPH; Amish Wlli, MD, MS; Rymond Kng, MA; Andrew Cooper, MPH; Theodore A. Prospect, FSA, MAAA; Lewis G. Sndy, MD, MBA; nd Deneen Vojt, MD Dibetes ffects 29 million Americns, imposing substntil helth nd economic burdens on the US popultion. 1 Intensive blood glucose mngement improves helth outcomes for most ptients, 2 but chieving this gol requires them to monitor blood glucose more often, use more medictions, including insulin; nd to follow up regulrly with helthcre providers. These ctivities increse helthcre expenditures nd re perceived by mny ptients to reduce their qulity of life (QOL). 3 This hs stimulted efforts to develop less demnding forms of insulin delivery to reduce ptient burden, while ttemping to limit dverse effects, such s hypoglycemi nd weight gin. Over the pst 2 decdes, there hs been n increse in the use of continuous subcutneous insulin infusion () therpy, or insulin pumps, for the tretment of dibetes. 4-6 An insulin pump is smll progrmmble device tht uses computer lgorithm to dminister insulin both continuously nd by ptient-initited bolus infusion through smll ctheter tht is left under the skin. The Americn Dibetes Assocition nd Americn Assocition of Clinicl Endocrinologists recommend intensive blood glucose mngement using either multiple dily insulin injections (MDII) or, but dvise primrily for well-educted nd motivted ptients who re unble to chieve optiml glycemic control with MDII. 6-8 Prior reserch hs suggested some potentil dvntges of over MDII therpy, such s reduced pin, less stigm, lower frequency nd severity of hypoglycemi, nd overcoming some brriers to dherence. 9,10 However, recent met-nlysis of trils directly compring MDII with found tht did not reduce hypoglycemi or weight gin nd hd inconsistent effects on QOL nd blood glucose control, with the results of only 1 tril showing greter improvement in glycted hemoglobin (A1C) mong dults with type 1 dibetes (T1D) who hd comprtively higher A1C levels t bseline. 11 Recent reports hve clled for clerer evidence-bsed guidelines for indictions nd more trnsprent reporting of sfety dt by pump mnufcturers. 8 Insulin infusion pumps hve been reported to cost bout $4500, with dditionl costs for supplies exceeding $1500 per ABSTRACT OBJECTIVES: Continuous subcutneous insulin infusion (), or insulin pump therpy, is n lterntive to multiple dily insulin injections (MDII) for mngement of dibetes. This study evlutes ptterns of helthcre utiliztion, costs, nd blood glucose control for ptients with dibetes who initite. STUDY DESIGN: Pre-post with propensity-mtched comprison design involving commercilly insured US dults (ged 18 to 64 yers) with insulin-requiring dibetes who trnsitioned from MDII to between July 1, 2009, nd June 30, 2012 ( inititors ; n = 2539), or who continued using MDI (n = 2539). METHODS: Medicl clims nd lbortory results files obtined from lrge US-wide helth pyer were used to construct direct medicl expenditures, hospitl use, helthcre encounters for hypoglycemi, nd men concentrtion of glycted hemoglobin (A1C). We fit difference-in-differences regression models to compre helthcre expenditures for 3 yers following the switch to. Strtified nlyses were performed for prespecified ptient subgroups. RESULTS: Over 3 yers, men per-person totl helthcre expenditures were $1714 (95% confidence intervl [CI], $1184-$2244) higher per qurter for inititors compred with mtched MDII ptients (totl men 3-yer difference of $20,565). Compred with mtched controls, men A1C concentrtions becme lower for inititors by 0.46% in yer 2 (P =.0003) nd by 0.32% in yer 3 (P =.047). inititors lso hd higher rte of hypoglycemi encounters in yer 1 (P =.002). CONCLUSIONS: For dults with insulin-requiring dibetes, trnsitioning from MDII to ws ssocited with modest improvements in A1C but more hypoglycemi encounters nd incresed helthcre expenditures, without significnt improvement in other potentilly offsetting res of helthcre consumption. Am J Mng Cre. 2017;23(6): THE AMERICAN JOURNAL OF MANAGED CARE VOL. 23, NO

2 CLINICAL TAKEAWAY POINTS Men totl helthcre expenditures were estimted to be $1714 higher per person per qurter for ptients who initite continuous subcutneous insulin infusion () compred with mtched multiple dily insulin injection (MDI) ptients, equting to totl 3-yer men difference of bout $20,565 per person. Subgroup nlyses showed modest differences in glycted hemoglobin fvoring recipients in yers 2 nd 3, but lso sttisticlly significnt differences in helthcre visits for hypoglycemi s ws being initited. It my remin chllenging for helth pyers or providers to develop policies regrding ccess or coverge for when, in ggregte, ppers to dd immedite costs with short-term benefits tht re uncertin nd/or re difficult to mesure. improvements in helth tht trnslte into higher QOL nd/or lower utiliztion of helthcre services. A relted importnt question is whether those outcomes might vry mong different subgroups of ptients. 9 To ddress these gps, we designed this study to evlute ptterns of helthcre utiliztion nd costs for dults who primrily hve T1D nd trnsition to in prctice, compring them with otherwise similr ptients who continued MDII therpy. person per yer. 10 Becuse helth insurnce typiclly pys for 80% to 90% of costs, ccess to insurnce nd coverge policies nturlly ply strong role in whether ptients choose to initite this pproch. Helth pyers generlly offer insurnce coverge for to ptients who meet specific clinicl criteri nd demonstrte good self-mngement prctices nd prticiption with helthcre visits. Medicre provides coverge for in ptients who hve evidence of either: ) prior use of with dherence to glucose self-testing prior to Medicre enrollment, or b) persistent hyperglycemi, recurring hypoglycemi, or other forms of poor blood glucose control despite completion of comprehensive dibetes eduction progrm nd dherence to glucose self-monitoring nd MDII for t lest 6 months. 12 Ptients must then complete regulr follow-up visits with supervising physicin t lest every 3 months to continue receiving helth pyer coverge for. Although prior reserch hs demonstrted the high cquisition costs for insulin infusion pumps nd supplies, it is not yet known if those higher upfront costs cn be recovered through FIGURE 1. Overview of Study Design Insulinrequiring dibetes MDII MDII Mtching period Index dte Pump "onbording" Pump strt switch (exposed) MDII (controls) Exposure period Costs nd outcomes Costs nd outcomes indictes continuous subcutneous insulin infusion; MDII, multiple dily insulin injections. The pump onbording period comprised medin of 145 dys during which dditionl pump-relted services could be utilized before the pump device dispensing dte. METHODS Overll Design nd Study Setting We used pre-post with propensity-mtched comprison group qusi-experimentl study design with difference-in-differences estimtion to evlute ptterns of helthcre costs, utiliztion, nd blood glucose control ssocited with the intition of by dults with insulin-requiring dibetes who received helth insurnce coverge from single, lrge, ntionwide commercil helth insurer. The study design is depicted in Figure 1 nd described further below. Study Smple nd Exposures The evlution smple included ptients with insulin-requiring dibetes who were ged 18 to 64 yers. Insulin-requiring dibetes ws defined s t lest 1 encounter with n Interntionl Clssifiction of Diseses, Ninth Revision, Clinicl Modifiction (ICD- 9-CM) code 250.XX nd t lest 1 dispensing event for MDII, but no previous use of n orl hypoglycemic clss mediction. This exclusion mde it more likely, but not certin, tht individuls included in the study hd T1D. inititors were defined by new dispensing event for n infusion pump (Helthcre Common Procedure Coding System billing code E0784 or A9274) ny time between July 1, 2009, nd June 30, Additionl -relted utiliztion nd supplies were identified using specific procedurl nd encounter codes (see eappendix Tble 1 for detils [eappendix vilble t jmc.com]). The dte of the first occurrence of one of these codes within 270 dys before the pump device dispensing dte ws defined s the index dte for our pre-post nlysis (Figure 1). This dte occurred medin of 145 dys before the pump dispensing dte, nd the time between these 2 dtes ws referred to s the pump onbording period. In follow-up nlyses, inititors were considered to hve stopped if they hd 120 dys of enrollment without ny clims for -relted supplies or services nd hd t lest 2 bsl insulin refills during tht sme period. To identify comprison group with similr bseline chrcteristics, we used nerest-neighbor propensity-mtching 354 JUNE

3 Insulin Pumps for Adults With Dibetes pproch. 13,14 The ptient-level propensity model used logistic regression to predict the odds of initition nd included bseline vribles relting to the outcomes of interest, for which prior reserch results hve demonstrted ssocitions with dibetes tretment choice or intensity. Propensity model predictive vribles included ptient sex, ge ctegory, Chrlson Comorbidity Index score, presence/bsence of prior obesity-relted ICD-9-CM code, most recent A1C test result or <8% (or vlue missing if not vilble), nd ech of the following utiliztion criteri within 180 dys before the index dte: totl encounters for hypoglycemi dignosis, totl encounters with n endocrinologist, nd the presence or bsence of t lest 1 billing code suggestive of poorly controlled dibetes (eappendix Tble 1). To enble direct comprisons between groups, mtched control clients were ssigned the sme index dte s the inititor to whom they were pired. To construct bseline vribles for the mtch, individuls in both groups were required to hve continuous helth pln enrollment for t lest 3 months before nd 3 months fter the index dte. Mesures nd Outcomes Study outcomes included direct medicl costs, ctegorized s inptient, outptient, phrmcy, nd totl helthcre costs; emergency deprtment (ED) visits; encounters for hypoglycemic events; nd, when vilble, A1C vlues. Totl helthcre costs, including both helth pln nd ptient cost shre components, were ssessed eqully cross ll ptient groups by pplying stndrdized price for ech clim. To minimize the effect of extreme outliers on men cost estimtes, we replced costs bove the 95th percentile with the 95th percentile vlue. 15 Dt Sources Dt sources included ntionl member enrollment files, medicl inptient nd mbultory clims, nd phrmcy clims mde vilble by lrge US-bsed commercil helth insurer. Although the completion of ll lbortory tests (including A1C tests) could be determined for ll ptients in both groups (ie, bsed on lbortory clims), subset of ntionl commercil lbortory vendors lso included the lbortory result with ech clim submitted to the pyer. A1C test results were vilble for bout 40% of submitted A1C lbortory clims for both - nd MDII-treted ptients. Becuse the vilbility of n A1C result ws determined by where the test ws perfomed rther thn by ptient s individul chrcteristics or form of dibetes tretment, this subsmple of individuls with A1C test results enbled unique opportunity for the nlysis of glycemic control within n unbised subset of ptients ntionlly. The Northwestern University Institutionl Review Bord reviewed the prent study nd determined tht this work involved the use of coded, nonidentifible dt nd ws not clssifible s humn subjects reserch. Sttisticl Anlysis Univrite nd bivrite descriptive sttistics for bseline chrcteristics were clculted for both inititors nd the mtched MDII comprison group. Student t tests were used to compre continuous vribles; χ 2 tests were used to compre ctegoricl vribles. Mens of continuous outcomes were plotted for ech 90-dy period before nd fter the index dte to observe comprbility of time trends between groups. To minimize the potentil for bis introduced by the nonrndomized study design, we used pre-post with propensity-mtched comprison group design. We estimted men between-group differences in qurterly outcomes over different time horizons (yer 1, yer 2, yer 3) using enrollee-level difference-in-differences rndom effects regression models tht included dummy vrible for group ( inititor versus MDII), clendr yer indictors (ie, clendr yer of the index dte), exposure yer (ie, yer 1, 2, or 3 reltive to the index dte), nd group-by-exposure-yer interction terms. Mens nd 95% confidence intervls (CIs) were estimted using generlized method of moments pproch. For estimting continuous outcomes, we used liner models becuse they provide estimtes in nturl units of the outcome vrible nd hve been shown to produce relible nd unbised estimtes of men cost differences nd CIs when smple sizes re lrge. 16 For count outcomes (eg, hypoglycemic encounters or ED visits), estimtions used negtive binomil distributionl ssumptions. Anlyses were conducted on the overll smple s well s cross prespecified ptient subgroups, including different pump-qulifying dignoses hypoglycemi encounters or evidence of poor glycemic control within 180 dys of the index dte nd whether or not the inititor lso used rel-time continuous glucose monitoring (rt-cgm) (see eappendix Tble 1). Becuse our nlysis ssumed helth pyer perspective, ech ptient who ws no longer enrolled with the helth pln ws censored from future mesurement periods, rther thn imputing missing dt or ssuming them to hve zero costs. To void potentil bis from differentil dropout rtes cross the 2 groups, we censored both the inititor nd mtched control ptient t ny point when either one ws no longer enrolled in the helth pln. This reduced smple sizes but ensured comprbility throughout the evlution period. RESULTS The bseline chrcteristics of 2539 inititors nd 2539 mtched controls re presented in Tble 1. There were no sttisticlly significnt differences in ny mjor chrcteristics between the 2 comprison groups, with good blnce on sex, ge, comorbidity index score, frequencies of encounters for hypoglycemi or hyperglycemi, nd visits to endocrinologists. About hlf of ptients in both groups were women nd lmost two-thirds were THE AMERICAN JOURNAL OF MANAGED CARE VOL. 23, NO

4 CLINICAL TABLE 1. Bseline Chrcteristics of Inititors nd Propensity-Mtched Controls pump-relted supplies by the end of yer 1; Chrcteristic Controls (n = 2539) Inititors (n = 2539) P 13.9% hd ssumed this pttern by the end of yer 2. There were no sttisticlly significnt differences in men ge, sex, or comorbidity Femle, n (%) 1238 (48.8) 1305 (51.4).06 scores between ptients who remined Age rnge ctegory, yers: n (%) (14.7) 391 (15.4).78 with their helth pln nd those who did not remin enrolled. Among those who remined (18.0) 468 (18.4) enrolled, the probbility of stopping use (29.2) 744 (29.3) ws higher mong ptients younger thn (38.1) 936 (36.9) yers compred with those ged 50 to 64 yers Chrlson Comorbidity Index score, b n (%) (42.9) 1067 (42.0).51 (15.3% vs 11.6%; P =.03). Overll Utiliztion nd Cost Ptterns (12.0) 320 (12.6) Figure 2 (pnels A-D) displys the men perperson-per-qurter helthcre expenditures of (21.8) 502 (19.8) (9.5) 241 (9.5) inititors nd mtched MDII users before (15.8) 409 (16.1) nd fter index dtes. Cost trends between Encounters for hypoglycemi in pst 3 months, n (%).10 groups were comprble before the index dte, (97.9) 2467 (97.2) but there ws smll uptick in totl expenditures 1 72 (2.1) 54 (2.8) for the pump users during the first 6 Encounter for uncontrolled hyperglycemi, n (%) 970 (38.2) 998 (39.3).42 months fter the index dte (ie, during the Any encounter with obesity dignosis, n (%) 305 (12.0) 300 (11.8).83 pump onbording period). This increse ws Endocrinologist visits in the pst 6 months, n (%).66 ssocited with clims for pump-relted services, (26.9) 720 (28.4) such s eduction nd lbortory testing required for pump uthoriztion, followed (19.4) 492 (19.4) by subsequent lrge spike in totl medicl expenditures during the first qurter (Q) (21.9) 552 (21.7) (31.8) 775 (30.5) fter receiving the pump ( for most clients), Lst A1C in 12 months before index dte, n (%).15 which relted to the pump device (men cost No test performed 609 (24.0) 564 (22.2) = $4786) plus supplies, dditionl eductionl Test performed but no result vilble 1148 (45.2) 1176 (46.3) encounters, nd follow-up visits. Modest differences Test performed nd result vilble 782 (30.8) 799 (31.5) in mbultory medicl nd phrmcy Result <8% 281 (11.1) 324 (12.8) expenditures lso persisted fter, reflecting Result 8% 501 (19.7) 475 (18.7) ongoing expenditures for pump supplies nd A1C indictes glycted hemoglobin concentrtion;, continuous subcutneous insulin infusion; MDII, multiple dily insulin injections. follow-up encounters. Predicted differences in men helthcre Student t tests for mens of continuous vribles; χ 2 tests for ctegoricl vribles b Lower numbers reflect fewer comorbid conditions nd better helth. expenditures per person per qurter re displyed in Tble 2. Men per-person totl 40 yers or older. Only 2.1% of controls nd 2.8% of inititors hd hypoglycemi billing code in the 90 dys prior to the index dte. More thn one-fourth of inititors did not hve n encounter with n endocrinologist in the 6 months before the index dte, suggesting mngement by nother type of provider. For the subgroup of ptients who used lbortory vendors tht provided test results to the pyer (bout 31% of ptients in ech tretment group t bseline), bout 60% hd bseline A1C concentrtions greter thn or equl to 8%. Among inititors, 25% were no longer enrolled fter 24 months. For those who remined enrolled, 8.5% hd resumed regulr refills of bsl insulin nd hd no further evidence of helthcre expenditures during yer 1 were estimted to be $2247 higher per qurter for inititors thn for mtched MDII ptients, mounting to totl difference of bout $9000 over the first yer. Over the entire 3-yer evlution period, the djusted men per-person totl helthcre expenditures were estimted to be $1714 (95% CI, $1184-$2244) higher per qurter for inititors compred with mtched MDII ptients, mounting to totl men difference of bout $20,565 over 3 yers. There were no sttisticlly significnt differences during ny follow-up yer in potentilly offsetting utiliztion, such s ED visit rtes, inptient utiliztion, or mbultory expenditures tht were not directly relted to therpy (dt not shown). 356 JUNE

5 Insulin Pumps for Adults With Dibetes Glycemic Control nd Hypoglycemi Encounters FIGURE 2. Qurterly Trends in Helthcre Expenditures For the subgroup nlysis of 31% of clients with vilble A1C results, trends in men A1C concentrtions prior to the index dte were well blnced, but then incresed slightly for inititors during the pump onbording period (-) (dt not shown) before dropping precipitously ner the time of pump initition. The men A1C ws estimted to be 0.46% lower for inititors thn MDII controls in yer 2 (P =.0003) nd 0.32% lower in yer 3 (P =.047). However, inititors lso hd higher rte of hypoglycemi encounters throughout yer 1 fter their index dte (P =.002). Comprtive Effectiveness Among Prespecified Ptient Subgroups Figure 3 displys qurterly trends in totl helthcre expenditures for the prespecified subgroups of inititors: presence/bsence of encounters for hypoglycemi (pnels A nd B), presence/bsence of encounters for uncontrolled or lbile blood glucose (pnels C nd D), nd concomitnt use/nonuse of rt-cgm in the first 2 yers of initition (pnels E nd F). These comprisons show tht inititors with either uncontrolled blood glucose or hypoglycemi encounters tended to hve higher men qurterly helthcre expenditures both before nd fter the index dte thn did inititors without those qulifying conditions. In ddition, the expenditure trends following initition did not seem to differ significntly between those qulifying conditions. Third, concomitnt use of rt-cgm (39.6% of users) ppered to hve no mesurble impct on expenditure trends. DISCUSSION This nturl experiment provides new informtion tht dults with insulin-requiring dibetes who trnsition from MDII to hve men totl helthcre expenditures over 3-yer period tht re bout $1700 higher ech qurter, equting to bout $20,500 more per person over 3 yers compred with otherwise similr ptients who continue to use MDII. Although we did observe fvorble men difference in A1C of 0.46% in yer 2 nd 0.32% in yer 3, we lso observed sttisticlly significnt differences in hypoglycemic encounters, which my indicte n dverse effect of A. Totl helthcre expenditures B. Ambultory medicl expenditures $14,000 $12,000 $8,000 $6,000 $4,000 $2,000 Q C. Inptient expenditures D. Phrmcy expenditures $14,000 $12,000 $8000 $6000 $4000 $2000 Q $14,000 $12,000 $8000 $6000 $4000 $2000 $14,000 $12,000 $8000 $6000 $4000 $2000 Q indictes continuous subcutneous insulin infusion; MDII, multiple dily insulin injections. In ll plots,, 2, 3, etc, represent the first, second, third, etc, qurter fter the index dte, nd,,, etc, represent qurters before the index dte. intensifiction in some ptients or need for dditionl eduction or trining. Although we explored if there might be different expenditure trends for prespecified ptient subgroups, we observed no differences between ptients with or without recent encounters for hypoglycemi, with or without evidence of poor glucose control, or those who used rt-cgm concomitntly with. Cost differences were driven primrily by 3 types of pump-relted expenditures: 1) the infusion pump, 2) pump insulin nd other supplies, nd 3) the incrementl use of helth services required for Q TABLE 2. Comprison of Men per-ptient Qurterly Helthcre Expenditures, by Yer Expenditure Ctegory Ambultory Inptient Phrmcy Totl Adjusted Between-Group Difference in Men per-person-per-qurter Helthcre Expenditures Men (95% CI) in US$ Yer 1 Yer 2 Yer 3 Sum Yers ( ) 866 ( 5377 to 3645) 202 ( ) 2247 ( ) 808 ( ) 2530 ( 7941 to 2881) 136 (68-205) 775 ( ) 1626 ( ) 9609 (625-18,592) 148 (12-284) 2449 ( ) 1445 ( ) 618 ( 4664 to 3429) 173 ( ) 1714 ( ) CI indictes confidence intervl. Estimted from difference-in-differences models. Positive numbers indicte tht men per-person expenditures re higher for the continuous subcutneous insulin infusion () inititors thn for the multiple dily insulin injections ptients; negtive numbers indicte expenditures re lower for the inititors. THE AMERICAN JOURNAL OF MANAGED CARE VOL. 23, NO

6 CLINICAL FIGURE 3. Qurterly Helthcre Expenditure Trends by User Subgroup A. Hypoglycemi encounters B. No hypoglycemi encounters C. Poor glucose control E. Use of rt-cgm, continuous subcutneous insulin infusion; hypo, hypoglycemi; MDII, multiple dily insulin injections; rt-cgm, rel-time continuous glucose monitor. In ll plots,, 2, 3, etc, represent the first, second, third, etc, qurter fter the index dte, nd,,, etc, represent qurters before the index dte. ongoing pump coverge. Those costs begn over medin of 145 dys prior to initition of the pump nd continued fter initition throughout the entire 3-yer nlytic time horizon. Becuse ptient-level costs nd utiliztion were mtched before the index dte, incrementl mbultory expenditures were unlikely to be cused by differences in dibetes severity between the 2 comprison groups. Conversely, these expenditures my hve resulted from coverge requirements tht ptients meet certin indictions (eg, hypoglycemi, poor glucose control) or complete certin services (dibetes self-mngement trining qurterly physicin visits) in order to retin pump coverge. To the extent tht ptients py cost shring mounts for those services, these incrementl costs re likely to impct not only the pyer but lso ptients nd helthcre providers. 17 Limittions with hypo event MDII mtched to with hypo event uncontrolled MDII mtched to uncontrolled with rt-cgm Mtched to with rt-cgm $20,000 D. Not poor glucose control F. No use of rt-cgm First, we only hd ccess to dministrtive dt sources, which do not cpture some meningful outcomes, such s reduced pin nd distress, improved QOL, or mild to moderte hypoglycemic events. with no hypo events MDII mtched to with no hypo events not uncontrolled MDII mtched to not uncontrolled without rt-cgm Mtched to without rt-cgm If these unmesured outcomes improve significntly for select ptients who re offered, it my lter conclusions bout the blnce of vlue nd costs. Second, dherence to pump therpy could not be verified. We censored individuls from the nlysis when they ppered to hve stopped refilling pump supplies nd insulin while resuming regulr refills of bsl insulin, but we hd no wy of verifying whether users continued to use the pump s prescribed. Third, we were only ble to nlyze direct medicl costs. Ptients my lso incur nonmedicl costs (eg, trnsporttion to doctor visits) or indirect costs (eg, missed workdys) fter receiving different therpies or services. Lst, lthough longer thn most rndomized controlled trils, the nlysis period in our study of 3 yers is still reltively short. In those for whom improves glycemic control, it my require longer period of time for this beneficil outcome to trnslte into lower overll helthcre utiliztion nd costs. CONCLUSIONS Considering the ongoing movement towrd vlue-bsed pyment nd delivery systems, there will be incresing incentives to offer mngement pproches tht hve higher upfront costs only when there is strong likelihood of benefit to the ptient. One importnt impliction of our findings is tht it my remin chllenging for helth pyers or providers to develop policies regrding ccess or coverge for when, in ggregte, ppers to dd very high immedite costs with uncertin nd/or difficult-to-mesure short-term benefits. Unfortuntely, our nlysis did not uncover cler ptient subgroup for which the comprtive effectiveness or costs of trnsitioning to were more fvorble in the short term. Pyers lredy require reltively strict set of criteri to be documented before pproving. These steps re intended to ensure is pproprite nd tht the ptient is fully informed nd motivted. However, these efforts lso hve n unintended effect of incresing helthcre utiliztion nd costs even before n insulin pump is dispensed, with some ptients never ctully inititing nd others reverting to MDII within only few months. For to be viewed s high vlue, dditionl reserch will be needed to inform more efficient strtegies tht identify ptients who re most likely to benefit, s well s to provide the right blnce of clinicl eduction nd support to prepre those ptients for nd mximize its potentil benefit. n 358 JUNE

7 Insulin Pumps for Adults With Dibetes Author Affilitions: Deprtment of Medicine, Northwestern University Feinberg School of Medicine (RTA, AW, RK, AC), Chicgo, IL; UnitedHelth Center for Helth Reform nd Moderniztion, UnitedHelth Group (TAP, LGS, DV), Minnetonk, MN. Source of Funding: Dr Ackermnn, Mr Kng, nd Mr Cooper were supported by grnt U58DP from the Centers for Disese Control nd Prevention nd Ntionl Institute for Dibetes nd Digestive nd Kidney Diseses s prt of the Nturl Experiments for Trnsltion in Dibetes (NEXT-D) Study. Author Disclosures: Drs Sndy nd Vojt nd Mr Prospect re employees nd stockholders of UnitedHelth Group. The remining uthors report no reltionship or finncil interest with ny entity tht would pose conflict of interest with the subject mtter of this rticle. Authorship Informtion: Concept nd design (RTA, AW, RK, TAP, LGS, DV); cquisition of dt (AC, TAP, DV); nlysis nd interprettion of dt (RTA, AW, RK, AC, TAP, LGS, DV); drfting of the mnuscript (RTA, RK); criticl revision of the mnuscript for importnt intellectul content (AW, AC, TAP, LGS, DV); sttisticl nlysis (RK, AC); provision of ptients or study mterils (TAP, DV); obtining funding (RTA); dministrtive, technicl, or logistic support (AC). Address Correspondence to: Ronld T. Ackermnn, MD, MPH, Northwestern University School of Medicine, 750 N Lke Shore Dr, Ste 680, Chicgo, IL E-mil: r.ckermnn@northwestern.edu. REFERENCES 1. Ntionl dibetes sttistics report: estimtes of dibetes nd its burden in the United Sttes, CDC website. Published October 24, Accessed Jnury 12, Nthn DM, Genuth S, Lchin J, et l; Dibetes Control nd Complictions Tril Reserch Group. The effect of intensive tretment of dibetes on the development nd progression of long-term complictions in insulindependent dibetes mellitus. N Engl J Med. 1993;329(14): Brown SE, Meltzer DO, Chin MH, Hung ES. Perceptions of qulity-of-life effects of tretments for dibetes mellitus in vulnerble nd nonvulnerble older ptients. J Am Geritr Soc. 2008;56(7): doi: /j x. 4. Bloomgrden ZT. Aspects of insulin tretment. Dibetes Cre. 2010;33(1):e1-e6. doi: /dc10-zb Reznik Y, Cohen O. Insulin pump for type 2 dibetes: use nd misuse of continuous subcutneous insulin infusion in type 2 dibetes. Dibetes Cre. 2013;36(suppl 2):S219-S225. doi: /dcS Stndrds of medicl cre in dibetes 2015: summry of revisions. Dibetes Cre. 2015;38(suppl):S4. doi: /dc15-S Grunberger G, Abelseth JM, Biley TS, et l. Consensus sttement by the Americn Assocition of Clinicl Endocrinologists/Americn College of Endocrinology insulin pump mngement tsk force. Endocr Prct. 2014;20(5): doi: /EP14145.PS. 8. Heinemnn L, Fleming GA, Petrie JR, Holl RW, Bergenstl RM, Peters AL. Insulin pump risks nd benefits: clinicl pprisl of pump sfety stndrds, dverse event reporting nd reserch needs. joint sttement of the Europen Assocition for the Study of Dibetes nd the Americn Dibetes Assocition Dibetes Technology Working Group. Dibetologi. 2015;58(5): doi: /s z. 9. Elsy T. Insulin pumps. Clin Dibetes. 2007;25(2): doi: /diclin Skylr JS, Ponder S, Kruger DF, Mtheson D, Prkin CG. Is there plce for insulin pump therpy in your prctice? Clin Dibetes. 2007;25(2): Yeh HC, Brown TT, Mruthur N, et l. Comprtive effectiveness nd sfety of methods of insulin delivery nd glucose monitoring for dibetes mellitus: systemtic review nd met-nlysis. Ann Intern Med. 2012;157(5): Ntionl coverge determintion (NCD) for infusion pumps (280.14). CMS website. medicre-coverge-dtbse/detils/ncd-detils.spx?ncdid=223. Published December 17, Accessed Mrch 18, D Agostino RB Jr. Propensity score methods for bis reduction in the comprison of tretment to nonrndomized control group. Stt Med. 1998;17(19): Rubin DB, Thoms N. Mtching using estimted propensity scores: relting theory to prctice. Biometrics. 1996;52(1): Thoms JW, Wrd K. Economic profiling of physicin specilists: use of outlier tretment nd episode ttribution rules. Inquiry. 2006;43(3): Lumley T, Diehr P, Emerson S, Chen L. The importnce of the normlity ssumption in lrge public helth dt sets. Annu Rev Public Helth. 2002;23: Xu S, Alexnder K, Brynt W, et l; The Austrlin Ntionl Adult Insulin Pump Therpy Working Group. Helthcre professionl requirements for the cre of dult dibetes ptients mnged with insulin pumps in Austrli. Internl Med J. 2015;45(1): doi: /imj Full text nd PDF t THE AMERICAN JOURNAL OF MANAGED CARE VOL. 23, NO

8 eappendix Tble 1. Definition of Ptient Chrcteristics or Exposures Using Administrtive Dt Sources Ptient Chrcteristic or Exposure Insulin-requiring dibetes mellitus Definition 1 encounter with 250.XX ICD-9-CM code; AND 0 dispensing events for n orl hypoglycemic-clss mediction; AND dispensing events for insulin within 90 dys of the index dte Dispensing of Insulin Pump 1 encounter with HCPCS billing code E0784 or A9274 -relted utiliztion & Any encounter including codes 86337; 86341; 84681; G0108; supplies G0109; 98960; 98961; 98962; A4221; A4222; A4231; A4232; A9274; G0454; J1817; K0552; S9140; S9141; S9150; S9160; S9165; V65.46; OR V53.91; Encounters for hypoglycemi Any occurrence of ICD-9-CM code: 250.3x; 251.0; OR Poorly controlled or lbile blood glucose control 1 encounter with ny of the following ICD-9-CM codes: ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; OR Use of rt-cgm Any occurrence in the follow-up period of codes 95250; 95251; A9276; A9277; OR A9278 ICD-9-CM, Interntionl Clssifiction of Diseses, Ninth Revision, Clinicl Modifiction; HCPCS, Helthcre Common Procedure Coding System;, continuous subcutneous insulin infusion; MDI, multiple dily insulin injections; rt-cgm, rel-time continuous glucose monitor