Prostate cancer is among the most common malignancies

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1 Implictions of Evolving Delivery System Reforms for Prostte Cncer Cre Brent K. Hollenbeck, MD, MS; Mggie J. Bierlein, MS; Smuel R. Kufmn, MS; Lindsey Herrel, MD; Ted A. Skolrus, MD, MPH; Dvid C. Miller, MD, MPH; nd Vhkn B. Shhinin, MD Prostte cncer is mong the most common mlignncies in men in the United Sttes. 1 Ongoing uncertinties bout how best to tret the disese, coupled with the vilbility of multiple options, hve led to wide vritions in both the quntity nd qulity of cre.,3 Prostte cncer spending hs incresed by 11% nnully over the lst decde, outpcing rtes for other common conditions (such s crdiovsculr nd pulmonry diseses) nd resulting in $1 billion in yerly expenditures.,5 Although the merits of screening re subject of ongoing debte in the field, consensus is growing tht some newly dignosed men with prostte cncer stnd to gin little from tretment. - Improving the efficiency of the delivery system nd eliminting wsteful spending hve long been priorities for pyers nd policy mkers, nd mny hope tht ccountble cre orgniztions (ACOs) nd relted components of helthcre reform will do just tht. By encourging closer lignment between hospitls nd cregivers, ACOs im to focus on improving qulity nd cutting costs both of which my ffect prostte cncer cre. To lrge extent, ACOs re extensions of integrted delivery systems tht, due to their emphsis on evidence-bsed medicine nd minimizing unnecessry helthcre, re ssocited with providing higher qulity. 9-1 Thus, understnding the implictions of integrted delivery systems for prostte cncer cre will help us to nticipte the likely effect of evolving reforms of the Affordble Cre Act. For this reson, we performed ntionl study to determine the impct of helthcre integrtion on the mngement of prostte cncer. We hypothesized tht the most integrted mrkets would be more selective in the use of curtive tretment for prostte cncer, prticulrly mong those unlikely to benefit from intervention. ABSTRACT OBJECTIVES: Prostte cncer tretment is significnt source of morbidity nd helthcre spending. Evolving clinicl dt hve supported expnding surveillnce s mens to right-size tretment. Integrted delivery systems fford the possibility of hstening this objective. STUDY DESIGN: Retrospective cohort study of Medicre beneficiries. METHODS: We used % smple of ntionl Medicre clims to ssess the impct of helthcre integrtion on rtes of tretment nd potentil overtretment in men newly dignosed with prostte cncer between 7 nd 11. Rtes were mesured ccording to the extent of integrtion within mrket (ie, none, low, intermedite, nd high). Generlized estimting equtions were used to ssess the reltionship between integrtion nd utiliztion, djusting for confounders. RESULTS: Rtes of tretment declined cross ll mrkets (P <.1 for overll time trend), but the rte of decline ws similr for the mrket types (P =.7). In the most integrted mrkets, the rte decresed by.%, or from 55.5 per 1, popultion in 7 to 39.5 per 1, in 11. After djusting for confounders, men residing in the most integrted mrkets were.1% less likely to be treted with curtive intent compred with those living in res without integrted delivery systems (P =.). However, rtes of potentil overtretment were similr cross ll mrkets regrdless of the level of integrtion (P =.1). CONCLUSIONS: Helthcre integrtion ws ssocited with smll declines in prostte cncer tretment in newly dignosed men, but not with potentil overtretment. Integrted cre lone my be insufficient to curtil potentil overtretment of prostte cncer. METHODS Using % smple of Medicre clims, we performed retrospective cohort study of fee-for-service beneficiries newly dignosed with prostte cncer between Jnury 1, 7, nd December 31, 11. We limited our study to men continuously Am J Mng Cre. 1;(9): THE AMERICAN JOURNAL OF MANAGED CARE VOL., NO. 9 59

2 TAKE-AWAY POINTS Integrtion ws ssocited with smll decrese in the tretment of prostte cncer. Integrtion ws not ssocited with tretment mong men lest likely to benefit (ie, those with high risk of noncncer mortlity). Integrtion lone my be insufficient to promote optiml cre for prostte cncer. Finncil risk, implied by evolving delivery system reforms, my help to promote better stewrdship of preference-sensitive diseses, such s prostte cncer. summed to yield n overll score for the delivery system, with higher scores reflecting greter degree of integrtion. All HRRs were chrcterized by the proportion of hospitl dischrges occurring from top-1 integrted delivery system. 1 Of these, 17 HRRs hd no dischrges from top integrted delivery system. The remining 179 HRRs were sorted into 3 equl groups (ie, terciles) rnging from lest integrted ( enrolled in Prts A nd B for t lest the 1-month periods prior men of 1% of dischrges from n integrted delivery system) to nd fter the prostte cncer dignosis. To ensure tht we hd to most ( men of 71% of dischrges from n integrted delivery complete clims on ll ptients, we excluded ptients in riskbering Medicre mnged cre plns. Ptients were followed tion exposure ws treted s ctegoricl vrible with levels: system). For the purpose of nlysis, our mrket level of integr- through December 31, 1. none, low, intermedite, nd high. To identify incident prostte cncer cses in ntionl Medicre Becuse our mesure of integrtion relies on public reports of clims, we developed n lgorithm nd vlidted it using Surveillnce Epidemiology nd End Results (SEER) cncer registry dt. between clinicl nd/or finncil integrtion, it is possible tht it integrted delivery systems nd does not necessrily distinguish Briefly, we used 5% smple of Medicre beneficiries residing my be insensitive to rel differences in qulity. For this reson, in ctchment re of SEER registry in the yers 3 to 5. we ssessed whether this mesure ws ble to identify differences in publicly vilble mesures 17 of qulity including ptients We selected men with t lest Evlution nd Mngement visit codes in which the line dignosis Interntionl Clssifiction with dibetes undergoing glycted hemoglobin (A1C) testing, of Diseses, Ninth Revision, Clinicl Modifiction (ICD-9-CM) code eye exmintions, nd blood lipid testing between nd ws 15 for prostte cncer. We further required tht ll incident 11. Generlly, we observed monotonic reltionship between cses underwent prostte biopsy within 1 dys of the first visit the level of integrtion nd dherence to ech mesure. In ll code ssocited with prostte cncer dignosis. Men with ny instnces, the most integrted mrkets performed better thn clim in the preceding 1-month period tht ws ssocited with those without integrtion. For instnce, beneficiries in highly n ICD-9-CM dignosis code of 15 (prostte cncer) or V1. integrted mrkets were 1% more likely to undergo A1C testing (personl history of mlignnt neoplsm of prostte) were excluded. Finlly, we vlidted this pproch ginst the Ptient delivery system. These dt support tht our exposure cn de- thn were those residing in mrkets without top-1 integrted Entitlement Denomintor Summry File, which identifies ll incident cses in SEER regions, nd found our lgorithm to hve clinicl integrtion is importnt. tect mesurble differences in qulity in circumstnces in which specificity nd positive predictive vlues of 99.% nd.7%, respectively. We then implemented this lgorithm in our % Outcomes ntionl smple of Medicre clims to identify incident cses, Our primry outcome ws the rte of curtive tretment (ie, surgery, externl bem rdition therpy, brchytherpy, nd cryo- which compose our study popultion. We used hospitl referrl regions (HRRs), s described by the therpy) within 1 months of dignosis, mesured t the HRR Drtmouth Atls, 13 to reflect distinct helthcre mrkets. There level. For this clcultion, the numertor ws determined by the re 3 HRRs in the United Sttes, ech of which represents collection of zip codes in which Medicre ptients receive the bulk forementioned tretments in given HRR; the denomintor ws nnul count of newly dignosed ptients undergoing ny of the of their helthcre. We determined ech mrket s level of integrtion by mesuring the proportion of hospitl dischrges occur- n HRR in given yer. determined by the eligible mle Medicre popultion residing in ring from n integrted delivery system, which were identified We lso mesured potentil overtretment. Becuse of their from public reports bsed on dt from IMS Helth 1 nd hve emphsis on qulity nd cost continment, integrted delivery been used in similr context. 15 These dt provide informtion systems nd, presumbly, the mrkets in which they dominte on delivery system reltionships, including ffilitions between my be more selective in the services they provide. In ccordnce hospitls nd physicin prctices. Ech helth system is rted for with clinicl guidelines, we would expect more-integrted mrkets to hve lower rtes of tretment mong those ptients with 33 ttributes in domins: overll integrtion, integrted technology, hospitl utiliztion, finncil stbility, services, ccess, high risk of noncncer mortlity within 1 yers of dignosis. contrct cpbilities, nd physicins. Domin-specific scores re These ptients typiclly hve low probbility of dying from the 57 SEPTEMBER 1

3 Integrted Delivery Systems nd Prostte Cncer TABLE. Differences in Ptient nd Regionl Chrcteristics According to Mrket-Level Degree of Helthcre Integrtion Chrcteristic Degree of Helthcre Integrtion P None (n = 17,95) Low (n = 19,15) Intermedite (n = 17,9) High (n = 1,797) Dischrges from IDN, % Ptient-level Age, yers: men (SD) 7.5 (5.1). (.) 9.3 (5.7) 9. (5.3).1 Rce: nonwhite, % <.1 Comorbidity: or more, % Socioeconomic clss: highest qurtile, % <.1 HRR-level Socil cpitl: femle hed-of-household, % (SD) 1.7 (3.) 1. (.) 11.9 (.) 11.7 (3.7).15 Eduction: high school degree, % (SD). (.).7 (.) 7.1 (3.7) 7.3 (.3) <.1 Supply: urologists per 1, popultion, n (SD).3 (.1).3 (.1).3 (.1).3 (.).33 Supply: hospitl beds per 1, popultion, n (SD) 3.1 (111.) 9. (7.7) 7. (.1).7 (1.1).11 HRR indictes hospitl referrl region; IDN, integrted delivery network; SD, stndrd devition. disese, even bsent tretment. 1,19 We ssessed tretment mong this popultion of ptients (ie, the qurtile of men with the highest risk of dying from noncncer cuses within 1 yers) by implementing methods developed by Gross nd collegues. Using 5% smple of Medicre beneficiries without cncer, we built robust ptient-level model to predict mortlity (C-index =.91). This enbled us to estimte the 1-yer mortlity risk of ptients in our prostte cncer cohort bsent their cncer dignosis. Those ptients in the top qurtile hd 7% risk of non prostte cncer mortlity within 1 yers of their dignosis. Potentil overtretment ws ssessed t the ptient level, nd popultion-bsed rtes were clculted s described bove (ie, the numertor ws the number of potentilly overtreted newly dignosed ptients with prostte cncer, nd the denomintor ws the number of eligible Medicre beneficiries). Anlysis We first contrsted ptient nd regionl chrcteristics ccording to the helthcre integrtion exposure (ie, none, low, intermedite, nd high). Sttisticl inference ws mde using the χ for ctegoricl dt nd t tests for continuous dt. We then fit Poisson model with n offset term for the popultion denomintor to ssess trend in popultion-bsed rtes of curtive tretment over time cross the integrtion groups. To test the independent effect of helthcre integrtion on rtes of prostte cncer tretment, we fit multivrible logistic regression model using ptient-level tretment s the outcome. Our helthcre integrtion exposure ws incorported into the model t the HRR level. To ccount for the nested nture of the dt (ie, ptients within HRRs), generlized estimting equtions were used. We djusted the model for ptient-level differences, including ge, rce, comorbidity, nd socioeconomic clss. Comorbidity ws clculted with ptient clims for the 1-month window prior to dignosis using estblished methods. 1 Socioeconomic clss ws estimted using composite mesure developed t the zip code level, s described by Diez-Roux nd collegues. We used the Are Resource File to derive severl mrket-level vribles to include in the model, including mesures of socil cpitl (% femle hed-of-household) nd eduction (% with high school degree or more), nd supply side vribles (urologists nd hospitl beds per cpit). We computed djusted percentges for the use of tretment for ech level of our mrket integrtion exposure by bck-trnsforming the predicted use from the model. Using similr methods, seprte model ws then fit to derive djusted percentges of tretment mong those lest likely to benefit. Further, we ssessed trends in rtes by both curtive (ie, surgery, externl bem rdition therpy, brchytherpy, cryotherpy) nd noncurtive (ie, hormone therpy, no tretment) modlities in the popultion lest likely to benefit from tretment. All nlyses were crried out using computerized softwre SAS version 9. (SAS Institute, Cry, North Crolin). All tests were -tiled nd the probbility of type 1 error ws set t.5. The study protocol ws judged to be exempt by the Institutionl Review Bord t the University of Michign. RESULTS Ptient nd regionl chrcteristics were contrsted ccording to the mrket level of integrtion (Tble). Although sttisticlly significnt differences mong mrket types were evident for some vribles (eg, ge), the mgnitudes of the bsolute differences were smll, with one exception. Among mrkets with t lest some dischrges from integrted delivery systems, ptients in mrkets with the lowest level of integrtion were more ffluent THE AMERICAN JOURNAL OF MANAGED CARE VOL., NO

4 thn those in more integrted ones. For instnce,.% of ptients in the lest integrted mrkets resided in the highest qurtile of socioeconomic clss compred with 1.9% of ptients in the most integrted ones (P <.1). Between 7 nd 11, popultion-bsed rtes of curtive tretment mong men newly dignosed with prostte cncer declined cross ll mrkets (Figure 1), regrdless of the level of integrtion (P <.1 for overll time trend). For exmple, in the most integrted mrkets, rtes of tretment decresed from 55.5 per 1, mle beneficiries in 7 to 39.5 per 1, in 11, reltive decrese of.%. In mrkets without integrted delivery systems (ie, no dischrges from these fcilities), rtes of tretment declined by 3.1%, or from 57. per 1, to. per 1, over the sme period. The rte of decline in tretment over time ws similr for the mrket types (P =.7). As illustrted in Figure, rtes of potentil overtretment tretment of those ptients with the highest probbility of deth from noncncer cuses lso decresed, lbeit to lesser extent (P <.1 for overll time trend). In the most integrted mrkets, curtive tretment in this popultion decresed by 19%, from 1. per 1, to.1 per 1,. Rtes of decline were similr for the less integrted mrkets (P =.9). We next explored chnges in tretment, by modlity, mong those lest likely to benefit from tretment (Figure 3). Rtes of rdicl prosttectomy in these ptients were low but remined stble over time (P =.99). Conversely, rtes of brchytherpy, cryotherpy, nd externl bem rdition therpy decresed during the course of the study (ech P <.1 for overll time trend), but these declines did not vry with respect to the mrket level of integrtion (ech P >.). Similr trends were observed for both noncurtive modlities. Finlly, we used multivrible modeling to ccount for the observed subtle differences between ptients nd helthcre mrkets (Figure ). Among beneficiries with newly dignosed prostte cncer, we found tht men residing in the most integrted mrkets were.1% less likely to be treted with curtive intent compred with those living in res without integrted delivery systems (P =.). However, rtes of potentil overtretment (ie, tretment of men with high probbility of deth from noncncer cuses) were similr cross ll mrkets regrdless of the level of integrtion (P =.1). DISCUSSION Rtes of tretment for prostte cncer mong Medicre beneficiries declined significntly between 7 nd 11. Similrly, tretment mong men with high risk of noncncer mortlity (ie, potentil overtretment) decresed over the sme period, lbeit to lesser extent. The use of nonsurgicl pproches decresed significntly in men with the highest probbility of noncncer deth within 1 yers, while rtes of surgery remined stble in this Rtes of Tretment (per 1, mle beneficiries) FIGURE 1. Rtes of Curtive Tretment for Prostte Cncer According to the Level of Integrtion in Helthcre Mrket Rtes of curtive tretment (prosttectomy, brchytherpy, cryotherpy, nd rdition) for prostte cncer, There ws significnt decline in rtes of tretment over time (P <.1 for overll trend); however, the rte of decline ws similr with respect to the level of mrket integrtion (P =.7) FIGURE. Rtes of Curtive Tretment Among Men Lest Likely to Benefit (ie, potentil overtretment) According to the Level of Integrtion in Helthcre Mrket Rtes of Potentil Overtretment (per 1, mle beneficiries) None Low Intermedite High None Low Intermedite High Rtes of curtive tretment (prosttectomy, brchytherpy, cryotherpy, nd rdition) for prostte cncer, 7-11, mong men with the highest risk of noncncer mortlity (ie, potentil overtretment). There ws significnt decline in the rtes of potentil overtretment over time (P <.1 for overll trend); however, the rte of decline ws similr with respect to the level of mrket integrtion (P =.9). popultion. Rtes of observtion (ie, no tretment) nd hormone therpy in this popultion declined similrly. This supports the theory tht seculr declines in screening nd dignosis, which re well estblished, 3 underlie the observed trends, s opposed 57 SEPTEMBER 1

5 Integrted Delivery Systems nd Prostte Cncer FIGURE 3. Rtes of Tretment Among Men Lest Likely to Benefit, by Modlity nd According to the Level of Integrtion in Helthcre Mrket,b per 1, Mle Beneficiries Prosttectomy per 1, Mle Beneficiries Brchytherpy per 1, Mle Beneficiries Cryotherpy per 1, Mle Beneficiries Rdition per 1, Mle Beneficiries Hormone Therpy per 1, Mle Beneficiries No Tretment Rtes of tretment, by modlity, mong those lest likely to benefit, Rtes of prosttectomy remined flt over time (P =.99 for overll trend) while rtes of brchytherpy, cryotherpy, nd rdition declined over time (ech P <.1 for overll trend). Similrly, rtes of both hormone therpy nd no tretment declined over time (both P <.1 for overll trend). b Trends over time, by modlity, were independent of the level of mrket integrtion (ech P >.). THE AMERICAN JOURNAL OF MANAGED CARE VOL., NO

6 Adjuster % of Newly Dignosed Medicre Beneficiries FIGURE. Adjusted Percentges of Curtive Tretment nd Potentil Overtretment According to the Level of Mrket Integrtion,b P =. Tretment P =.1 Potentil overtretment None Low Intermedite High Among ptients newly dignosed with prostte cncer, mrket-level integrtion ws ssocited with lower rtes of curtive tretment (P =.), but not with overtretment (P =.1) of prostte cncer. b Models were djusted for tretment yer, ptient chrcteristics (ge, rce, comorbidity, socioeconomic clss), nd mrket chrcteristics (% tht re femle hed-of-household, % with high school eduction or higher, urologists per 1, popultion, hospitl beds per 1, popultion). to more selective curtive tretment by physicins. Although ptients residing in mrkets with the highest level of integrtion were less likely to undergo curtive tretment for their cncer, the difference in mgnitude reltive to less integrted mrkets ws smll nd likely of limited clinicl significnce. Notwithstnding the dvntges of highly integrted mrkets to deliver better evidence-driven helthcre, we found tht the use of tretment mong those lest likely to benefit did not vry significntly ccording to the degree of integrtion in mrket. Although prostte cncer remins common cuse of cncerrelted deth in the United Sttes, consensus is growing bout the potentil pitflls of screening nd the indolent nture of some cncers. - Approches to mngement of prostte cncer hve evolved considerbly over the lst decde, nd surveillnce hs incresingly been recognized s strtegy in some men to prevent overtretment. Despite this recognition, there is little evidence tht the use of tretment in men unlikely to benefit is decresing; rther, popultion-bsed dt suggest tht it is incresing. In our study of ntionl Medicre beneficiries, we noted significnt decline in potentil overtretment cross ll mrkets regrdless of their level of integrtion. However, these declines were reltively modest given the nture of the popultion (ie, hving very high risk of noncncer mortlity within 1 yers of dignosis). Tht helthcre integrtion ws ssocited with smll declines in tretment, but not with potentil overtretment, is surprising. Indeed, integrted delivery systems re more pt to follow evidence-bsed prctice guidelines, dopt electronic helth informtion systems, nd implement strtegies for performnce improvement; ultimtely, they re ssocited with providing higher-qulity helthcre. 9-1 Becuse of these qulities, we would expect helthcre mrkets dominted by these systems to be more selective in whom they tret for prostte cncer, prticulrly mong those who re unlikely to benefit. With recent helth reforms towrd more ccountble cre, collections of providers nd, in some cses, hospitls, re evolving to become better stewrds of popultion helth. To some extent, ACOs re the result of the nturl evolution of highperforming integrted delivery systems. However, in ddition to shring focus on cre coordintion nd other spects of integrted cre, ACOs imply level of finncil risk likely surpssing tht which ws ssumed by integrted delivery systems in the er prior to helth reform. Perhps it is this risk, dded to the pressure to relize svings t the beneficiry level, tht will promote better stewrdship of preference-sensitive conditions in which there re cler trdeoffs with tretment, such s prostte cncer. Limittions One potentil limittion of our findings is the bsence of mesures of disese severity (ie, cncer grde, stge, nd prosttespecific ntigen levels) in ntionl Medicre clims. Although we clssify potentil overtretment using the probbility of noncncer deth, our findings my underestimte the scope of tretment in the popultion, s ptients with low-risk prostte cncer, regrdless of life expectncy, re well-ccepted cndidtes for surveillnce. Further, the bsence of disese severity mesures hs little impliction for our comprison of tretment rtes cross helthcre mrkets, s the distribution of cncer grde nd stge tends to be similr cross geogrphic regions. 5 CONCLUSIONS Our findings hve importnt implictions for evolving reforms imed t improving the efficiency of helthcre delivery. We observed smll, lbeit significnt, ssocition between higher levels of integrtion nd more constrined use of prostte cncer tretment. However, rtes of potentil overtretment of men with prostte cncer were similr, regrdless of the extent of mrket integrtion. Collectively, these findings suggest tht integrtion lone my be insufficient for optimizing the mngement of conditions such s prostte cncer, in which considerble uncertinty exists bout the trdeoffs between tretment nd observtion. Future reserch should explore how the dded finncil risk ssocited with ACOs is ble to modulte the mngement of preference-sensitive diseses such s prostte cncer. 57 SEPTEMBER 1

7 Integrted Delivery Systems nd Prostte Cncer Author Affilitions: Dow Division of Helth Services Reserch, Deprtment of Urology (BKH, MJB, SRK, LH, TAS, DCM) nd the Kidney Epidemiology Cost Center (VBS), University of Michign, Ann Arbor, MI. Source of Funding: This work ws supported by Reserch Scholr Grnt RSGI CPHPS to BKH from the Americn Cncer Society. VBS is supported by funding from the Ntionl Cncer Institute (R1 CA191). DCM is supported by funding from the Ntionl Cncer Institute (R1 CA177). Author Disclosures: Dr Hollenbeck received grnt from the Americn Cncer Society. Dr Miller received grnt from the Ntionl Cncer Institute. 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 (BKH, DCM, VBS); cquisition of dt (BKH); nlysis nd interprettion of dt (MJB, BKH, LH, SRK, TAS, VBS); drfting of the mnuscript (BKH, LH, DCM, TAS); criticl revision of the mnuscript for importnt intellectul content (MJB, BKH, LH, SRK, DCM, TAS, VBS); sttisticl nlysis (MJB, SRK); obtining funding (BKH, DCM, VBS); nd supervision (SRK). Address Correspondence to: Brent K. Hollenbeck, MD, MS, Dow Division of Helth Services Reserch, Deprtment of Urology, University of Michign, Plymouth Rd, NCRC Bldg 1, Ann Arbor, MI 19-. E-mil: REFERENCES 1. Siegel RL, Miller KD, Jeml A. Cncer sttistics, 15. CA Cncer J Clin. 15;5(1):5-9. doi: 1.33/ cc.15.. Cooperberg MR, Broering JM, Crroll PR. Time trends nd locl vrition in primry tretment of loclized prostte cncer. J Clin Oncol. 1;(7): doi: 1.1/JCO Spencer BA, Miller DC, Litwin MS, et l. Vritions in qulity of cre for men with erly-stge prostte cncer. 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