NATIONAL QUALITY FORUM

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1 NATIONAL QUALITY FORUM NQF #1551 Measure Evaluaton 4.1 December 2009 Ths form contans the measure nformaton submtted by stewards. Blank felds ndcate no nformaton was provded. Attachments also may have been submtted and are provded to revewers. The subcrtera and most of the footnotes from the evaluaton crtera are provded n Word comments wthn the form and wll appear f your cursor s over the hghlghted area. Hyperlnks to the evaluaton crtera and ratngs are provded n each secton. TAP/Workgroup (f utlzed): Complete all yellow hghlghted areas of the form. Evaluate the extent to whch each subcrteron s met. Based on your evaluaton, summarze the strengths and weaknesses n each secton. Note: If there s no TAP or workgroup, the SC also evaluates the subcrtera (yellow hghlghted areas). Steerng Commttee: Complete all pnk hghlghted areas of the form. Revew the workgroup/tap assessment of the subcrtera, notng any areas of dsagreement; then evaluate the extent to whch each major crteron s met; and fnally, ndcate your recommendaton for the endorsement. Provde the ratonale for your ratngs. Evaluaton ratngs of the extent to whch the crtera are met C = Completely (unquestonably demonstrated to meet the crteron) P = Partally (demonstrated to partally meet the crteron) M = Mnmally (addressed BUT demonstrated to only mnmally meet the crteron) N = Not at all (NOT addressed; OR ncorrectly addressed; OR demonstrated to NOT meet the crteron) NA = Not applcable (only an opton for a few subcrtera as ndcated) (for NQF staff use) NQF Revew #: 1551 NQF Project: Surgery Endorsement Mantenance 2010 MEASURE DESCRIPTIVE INFORMATION De.1 Measure Ttle: Hosptal-level 30-day all-cause rsk-standardzed readmsson rate (RSRR) followng electve prmary total hp arthroplasty (THA) and total knee arthroplasty (TKA) De.2 Bref descrpton of measure: Ths measure estmates hosptal 30-day RSRRs followng electve prmary THA and TKA n patents 65 years and older. The measure uses Medcare clams data to develop a hosptal-level RSRR for THA and TKA and wll nclude patents readmtted for any reason wthn 30 days of dscharge date of the ndex admsson. Some patents are admtted wthn 30 days of the ndex hosptalzaton to undergo another electve THA/TKA procedure. These are consdered planned readmssons and are NOT counted n the measure as readmssons Type of Measure: Outcome De.3 If ncluded n a composte or pared wth another measure, please dentfy composte or pared measure Ths measure s pared wth a complcatons measure for THA and TKA. De.4 Natonal Prorty Partners Prorty Area: Care coordnaton, Safety De.5 IOM Qualty Doman: Effectveness, Patent-centered, Effcency, Safety De.6 Consumer Care Need: Gettng better, Lvng wth llness CONDITIONS FOR CONSIDERATION BY NQF Four condtons must be met before proposed measures may be consdered and evaluated for sutablty as voluntary consensus standards: A. The measure s n the publc doman or an ntellectual property (measure steward agreement) s sgned. Publc doman only apples to governmental organzatons. All non-government organzatons must sgn a measure steward agreement even f measures are made publcly and freely avalable. A.1 Do you attest that the measure steward holds ntellectual property rghts to the measure and the rght to use aspects of the measure owned by another entty (e.g., rsk model, code set)? Yes A.2 Indcate f Propretary Measure (as defned n measure steward agreement): NQF Staff A Y N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 1

2 A.3 Measure Steward Agreement: Government entty and n the publc doman - no agreement necessary A.4 Measure Steward Agreement attached: B. The measure owner/steward verfes there s an dentfed responsble entty and process to mantan and update the measure on a schedule that s commensurate wth the rate of clncal nnovaton, but at least every 3 years. Yes, nformaton provded n contact secton C. The ntended use of the measure ncludes both publc reportng and qualty mprovement. Purpose: Publc Reportng, Qualty Improvement wth Benchmarkng (external benchmarkng to multple organzatons) D. The requested measure submsson nformaton s complete. Generally, measures should be fully developed and tested so that all the evaluaton crtera have been addressed and nformaton needed to evaluate the measure s provded. Measures that have not been tested are only potentally elgble for a tme-lmted endorsement and n that case, measure owners must verfy that testng wll be completed wthn 12 months of endorsement. D.1Testng: Yes, fully developed and tested D.2 Have NQF-endorsed measures been revewed to dentfy f there are smlar or related measures? Yes (for NQF staff use) Have all condtons for consderaton been met? Staff Notes to Steward (f submsson returned): Staff Notes to Revewers (ssues or questons regardng any crtera): Staff Revewer Name(s): NQF #1551 B Y N C Y N D Y N Met Y N TAP/Workgroup Revewer Name: Steerng Commttee Revewer Name: 1. IMPORTANCE TO MEASURE AND REPORT Extent to whch the specfc measure focus s mportant to makng sgnfcant gans n health care qualty (safety, tmelness, effectveness, effcency, equty, patent-centeredness) and mprovng health outcomes for a specfc hgh mpact aspect of healthcare where there s varaton n or overall poor performance. Measures must be judged to be mportant to measure and report n order to be evaluated aganst the remanng crtera. (evaluaton crtera) 1a. Hgh Impact (for NQF staff use) Specfc NPP goal: 1a.1 Demonstrated Hgh Impact Aspect of Healthcare: Affects large numbers, Frequently performed procedure, Hgh resource use, Other 1a.2 Hgh cost Eval Ratn g 1a.3 Summary of Evdence of Hgh Impact: Prmary electve THA and TKA are benefcal procedures that greatly mprove the qualty of lfe for patents who choose to undergo these procedures (Hawker et al., 1998). However, these hgh volume procedures are expensve and are assocated wth sgnfcant readmsson rates. Hgh Readmsson Rate We conducted analyses usng 2008 Medcare Part A npatent clams data and found a medan 30-day rskstandardzed hosptal readmsson rate of 6.1%. Ths rate s hgh consderng these are electve procedures typcally performed on younger, healther patents, as compared to other Medcare patents. Hgh Volume THA and TKA are prorty areas for outcomes measure development, as they are commonly performed procedures n the US. In 2003 there were 202,500 prmary hp arthroplastes and 402,100 prmary total knee arthroplastes performed (Kurtz et al., 2007). The number of procedures performed has ncreased steadly 1a C P M N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 2

3 over the past decade (Kurtz et al., 2007; Ong et al., 2006). NQF #1551 Hgh Cost Although these procedures can dramatcally mprove patent health-related qualty-of-lfe, they are costly. In 2005 annual hosptal charges totaled $3.95 bllon and $7.42 bllon for prmary THA and TKA, respectvely (Kurtz et al., 2007). These costs are projected to ncrease by 340% to 17.4 bllon for THA and by 450% to 40.8 bllon for TKA by 2015 (Kurtz et al., 2007). Medcare s the sngle largest payer for these procedures, coverng approxmately two-thrds of all THAs and TKAs performed n the US (Ong et al., 2006). THA and TKA procedures combned account for the largest procedural cost n the Medcare budget (Bozc et al., 2008). 1a.4 Ctatons for Evdence of Hgh Impact: Bozc KJ, Rubash HE, Sculco TP, Berry DJ. An analyss of medcare payment polcy for total jont arthroplasty. Journal of Arthroplasty. 2008;23(6 Suppl 1): Hawker GJ, Wrght J, Coyte P, Paul J, Dttus R, Croxford B, et al. Health-related qualty of lfe after knee replacement. J Bone Jont Surg Am. 1998; 80: Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projectons of prmary and revson hp and knee arthroplasty n the Unted States from 2005 to J Bone Jont Surg Am. Apr 2007;89(4): Kurtz SM, Ong KL, Schmer J, et al. Future clncal and economc mpact of revson total hp and knee arthroplasty. J Bone Jont Surg Am. Oct 2007;89 Suppl 3: Ong KL, Mowat FS, Chan N, Lau E, Halpern MT, Kurtz SM. Economc burden of revson hp and knee arthroplasty n Medcare enrollees. Cln Orthop Relat Res. May 2006;446: b. Opportunty for Improvement 1b.1 Benefts (mprovements n qualty) envsoned by use of ths measure: THA and TKA are prorty areas for outcomes measure development, as they are costly and commonly performed procedures. Hosptal readmsson s an outcome that s lkely attrbutable to care processes and s an mportant outcome for patents. Measurng and reportng readmsson rates wll nform health care provders about opportuntes to mprove care, strengthen ncentves for qualty mprovement, and ultmately mprove the qualty of care receved by Medcare patents. The measure wll also provde patents wth nformaton that could gude ther choces. Furthermore, the measure wll ncrease transparency for consumers and has the potental to lower health care costs assocated wth readmssons. 1b.2 Summary of data demonstratng performance gap (varaton or overall poor performance) across provders: Readmsson rates are hgh, gven these are electve procedures and there s marked varaton n rates across hosptals. The unadjusted mean readmsson rate was 6.78% and ranged from 0% to 100% across 3,310 hosptals n Even after adjustment for patent and clncal characterstcs, the mean readmsson rate was 6.30%, rangng from 3.06% to 50.94%. Because these are electve procedures that are performed on relatvely healthy patents, readmsson rates are expected to be lower n these patents as compared to patents admtted for an emergent procedure. The lterature ndcates there s consderable varaton n practce patterns, patent outcomes, and adherence to payer-defned practce gudelnes for both THA and TKA (Bozc et al 2008; Ong et al 2008). Our analyses are consstent wth ths evdence. In 2008, 30-day adjusted readmsson rates ranged from 3.06% to 50.94%. Ths varaton lkely ndcates dfferences n the qualty of care receved across hosptals. These fndngs suggest that many readmssons could potentally be prevented. 1b.3 Ctatons for data on performance gap: Bozc KJ, Chu V. Qualty Measurement and Publc Reportng n Total Jont Replacement. The Journal of Replacement. 2008; 23: Ong K, Lau E, Manley M, Kurtz S. Effect of procedure duraton on total hp arthroplasty and total knee arthroplasty survvorshp n the Unted States Medcare populaton. J Arthroplasty. 2008; 23(6): b.4 Summary of Data on dspartes by populaton group: 1b C P M N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 3

4 We conducted analyses to explore dspartes by SES. We used Medcad elgblty status dentfed n the Medcare clams enrollment database (EDB) as a proxy for SES. Ths approach s consstent wth pror research as well as NQF recommendatons ( Patents were categorzed nto two groups, based on ther elgblty status for Medcad (yes/no). The Medcad elgble populaton represents lower SES status. Analyses demonstrated that although SES s a sgnfcant predctor of readmsson at the patent level, t does not affect overall hosptal performance n the rsk-adjusted readmsson model. Consstent wth NQF gudelnes, ths measure does not rsk-adjust for SES factors. 1b.5 Ctatons for data on Dspartes: N/A 1c. Outcome or Evdence to Support Measure Focus 1c.1 Relatonshp to Outcomes (For non-outcome measures, brefly descrbe the relatonshp to desred outcome. For outcomes, descrbe why t s relevant to the target populaton): Ths measure wll calculate 30-day all-cause hosptal-level readmsson rates after electve prmary THA and/or TKA. The goal s to reduce readmsson rates post hosptalzaton for electve THA/TKA. It addresses an outcome for a commonly performed, hgh cost procedure performed for a prorty condton (osteoarthrts) and may lead to reduced morbdty and mortalty. 1c.2-3. Type of Evdence: Expert opnon, Systematc synthess of research 1c.4 Summary of Evdence (as descrbed n the crtera; for outcomes, summarze any evdence that healthcare servces/care processes nfluence the outcome): Readmsson s an outcome that reflects the qualty of healthcare for patents undergong a prmary electve THA and/or TKA procedure. However, evdence regardng the relatonshp between healthcare processes (ncludng npatent and post-dscharge care) and readmssons for ths populaton s sparse. A systematc revew of the lterature dd not dentfy any exstng statstcal models to compare hosptal-level readmsson for patents admtted for an electve THA or TKA. However, a workng group and techncal expert panel (TEP) of orthopedsts, rheumatologsts, consumer and purchaser perspectve, dspartes experts, and qualty mprovement experts were consulted n confrmng that readmsson s an outcome lkely attrbutable to care processes see secton 2c for detals) and that hosptal-level readmsson rates could be mproved. Research has shown that readmsson rates are nfluenced by the qualty of npatent and outpatent care, as well as hosptal system characterstcs, such as the bed capacty of the local health care system (Fsher et al. 1994). In addton, specfc hosptal processes such as dscharge plannng, medcaton reconclaton, and coordnaton of outpatent care have been shown to affect readmsson rates (Nelson et al. 2000). 1c.5 Ratng of strength/qualty of evdence (also provde narratve descrpton of the ratng and by whom): N/A 1c.6 Method for ratng evdence: N/A 1c.7 Summary of Controversy/Contradctory Evdence: All-cause readmsson NQF #1551 Ths measure calculates 30-day all cause readmsson rate. An alternatve approach would be to calculate readmssons for procedure-specfc complcatons (e.g. mechancal complcatons, revson, wound nfecton, surgcal ste bleedng). In consultaton wth an expert panel, we decded on all-cause readmsson (except for planned readmssons), rather than procedure-specfc readmsson for several reasons. Frst, from the patent perspectve, readmsson for any reason s lkely to be an undesrable outcome of care. Second, readmssons not assocated wth a procedure-specfc dagnoss may stll be related to npatent care and patents transtons to non-acute settng. Examples nclude errors n medcaton reconclaton, nadequate follow-up, and falure to ensure that patents dscharged home have adequate support. Thrd, a readmsson measure wll complement the complcatons measure for patents undergong TKA/THA that s submtted to NQF. Usng all-cause readmsson wll, however, undoubtedly nclude a mx of unavodable and avodable readmssons. However, the goal of the measure s not to reduce readmssons to zero, but to decrease the readmsson rates across hosptals. Readmssons wthn 30 days after dscharge from an electve procedure are lkely attrbutable to the care receved durng the ndex admsson. 1c C P M N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 4

5 NQF #1551 Planned Readmssons Some patents are admtted wthn 30 days of the ndex hosptalzaton to undergo another THA/TKA procedure. Some of these are consdered planned readmssons and we do NOT count them as readmssons n the measure. If a patent undergoes a second prmary THA/TKA and s admtted to the hosptal wthn 30 days of the dscharge date for the ndex admsson, and the admsson s assocated wth a prmary dscharge dagnoss of osteoarthrts, rheumatod arthrts, osteonecross, and arthropathy (excludng septc arthropathy), the readmsson s lkely planned and s not counted as a readmsson n the measure. Use of Herarchcal Generalzed Lnear Modelng Herarchcal modelng for hosptal outcomes measurement s the approprate statstcal approach for hosptal outcomes measures gven the structure of the data and the underlyng assumpton of such measures, whch s that hosptal qualty of care nfluences 30-day readmsson rates. However, CMS frequently receves comments and questons about ths approach, so we are concsely reteratng the ratonale for and merts of usng herarchcal logstc regresson. Patents are clustered wthn hosptals and, as such, have a shared exposure to the hosptal qualty and processes. The use of herarchcal modelng accounts for the clusterng of patents wthn hosptals. Second, herarchcal models dstngush wthn-hosptal varaton and betweenhosptal varaton to estmate the hosptal s contrbuton to the rsk of readmsson. Ths allows for an estmaton of the hosptal s nfluence on patent outcomes. Fnally, wthn herarchcal models we can account for both dfferences n case mx and sample sze to farly profle hosptal performance. If we dd not use herarchcal modelng we could overestmate varaton and potentally msclassfy hosptals performance. Accurately estmatng varaton s an mportant objectve for models used n publc reportng and potentally used n value-based purchasng programs. 1c.8 Ctatons for Evdence (other than gudelnes): Fsher ES, Wennberg JE, Stukel TA, Sharp SM. Hosptal readmsson rates for cohorts of Medcare benefcares n Boston and New Haven. N Engl J Med. 1994;331(15): Nelson EA, Marush ME, Axler JL. Effects of dscharge plannng and complance wth outpatent appontments on readmsson rates. Psychatr Serv. 2000;51(7): c.9 Quote the Specfc gudelne recommendaton (ncludng gudelne number and/or page number): Not applcable-we ddn t cte any clncal practce gudelnes because ths s an outcomes measure, not a process of care measure. 1c.10 Clncal Practce Gudelne Ctaton: N/A 1c.11 Natonal Gudelne Clearnghouse or other URL: N/A 1c.12 Ratng of strength of recommendaton (also provde narratve descrpton of the ratng and by whom): N/A 1c.13 Method for ratng strength of recommendaton (If dfferent from USPSTF system, also descrbe ratng and how t relates to USPSTF): N/A 1c.14 Ratonale for usng ths gudelne over others: N/A TAP/Workgroup: What are the strengths and weaknesses n relaton to the subcrtera for Importance to Measure and Report? 1 Steerng Commttee: Was the threshold crteron, Importance to Measure and Report, met? Ratonale: 2. SCIENTIFIC ACCEPTABILITY OF MEASURE PROPERTIES 1 Y N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 5

6 NQF #1551 Extent to whch the measure, as specfed, produces consstent (relable) and credble (vald) results about the qualty of care when mplemented. (evaluaton crtera) Eval Ratn g 2a. MEASURE SPECIFICATIONS S.1 Do you have a web page where current detaled measure specfcatons can be obtaned? S.2 If yes, provde web page URL: 2a. Precsely Specfed 2a.1 Numerator Statement (Bref, text descrpton of the numerator - what s beng measured about the target populaton, e.g. target condton, event, or outcome): Ths outcome measure does not have a tradtonal numerator and denomnator lke a core process measure (e.g., percentage of adult patents wth dabetes aged years recevng one or more hemoglobn A1c tests per year); thus, we are usng ths feld to defne readmssons. The outcome for ths measure s a readmsson to any acute care hosptal, for any reason occurrng wthn 30 days of the dscharge date of the ndex hosptalzaton. We do not count planned readmssons n the outcome (see numerator detals). 2a.2 Numerator Tme Wndow (The tme perod n whch cases are elgble for ncluson n the numerator): 30 days from dscharge date of ndex hosptalzaton 2a.3 Numerator Detals (All nformaton requred to collect/calculate the numerator, ncludng all codes, logc, and defntons): A readmsson to any acute care hosptal for any reason wthn 30 days of the dscharge date of ndex hosptalzaton. Planned (electve) readmssons: We do not count readmssons n the measure that are assocated wth a subsequent planned THA/TKA procedure wthn 30-days of dscharge from ndex hosptalzaton. Some patents may elect to stage ther orthopedc replacement procedures across hosptalzatons (for example, a patent may have the left and rght knees replaced wthn one or two weeks of each other, potentally across multple hosptalzatons). In consultaton wth an expert panel we defne planned readmssons as a second admsson wth an ICD-9 procedure code for THA or TKA AND a prncpal dscharge dagnoss of osteoarthrts, rheumatod arthrts, osteonecross, or arthropathy (excludng septc arthropathy). The crtera for dentfyng a subsequent planned THA and/or TKA s as follows: 1. Admsson wth at least one of the followng ICD-9 procedure codes wthn 30 days of dscharge date of ndex hosptalzaton: Prmary total hp replacement Prmary total knee replacement, AND 2. A prncpal dagnoss code of one the followng ICD-9 codes for osteoarthrts, rheumatod arthrts, osteonecross, or arthropathy: 714, 714.0, 714.1, 714.2, 714.3, , , , , 714.4, 714.8, , 714.9, 715, 715.0, , , 715.1, , , , , 715.2, , , , , 715.3, , , , , 715.8, , , 715.9, , , , , 716.5, , , , , , 716.8, , , , , , 716.9, , , , , , , a.4 Denomnator Statement (Bref, text descrpton of the denomnator - target populaton beng measured): The target populaton for ths measure ncludes admssons for patents at least 65 years of age undergong prmary THA and/or TKA procedures. 2a.5 Target populaton gender: Female, Male 2a.6 Target populaton age range: 65 years of age and older 2a.7 Denomnator Tme Wndow (The tme perod n whch cases are elgble for ncluson n the 2aspec s C P M N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 6

7 denomnator): Ths measure was developed usng clams data from calendar year 2007 and The tme perod for publc reportng has not been determned. 2a.8 Denomnator Detals (All nformaton requred to collect/calculate the denomnator - the target populaton beng measured - ncludng all codes, logc, and defntons): The denomnator ncludes patents aged 65 and older admtted to non-federal acute care hosptals for an electve, prmary THA and/or TKA n 2007 and Patents are elgble for ncluson n the denomnator f they had a THA and/or a TKA AND had contnuous enrollment n Medcare FFS one year pror to the date of ndex admsson. Ths cohort s defned usng the followng ICD-9-CM procedure codes dentfed n Medcare Part A Inpatent clams data: Total Hp Arthroplasty Total Knee Arthroplasty 2a.9 Denomnator Exclusons (Bref text descrpton of exclusons from the target populaton): Patents wll be excluded from the cohort f they meet any of the followed crtera: 1. Patents wth hp fractures Presence of one of the followng dagnoss codes: 733.1, , , , , 733.8, , , , , , 808.0, 808.1, , , , , , , , , , , , , , , , , 820.8, 820.9, 821, 821.0, , , 821.1, , , 808.xx Ratonale: Patents wth hp fractures have hgher mortalty, complcaton and readmsson rates and the procedure (THA) s generally not electve. 2. Patents undergong revson procedures (wth or wthout a concurrent THA/TKA) Presence of one of the followng procedure codes: 81.53, 81.55, 81.59, 00.70, 00.71, 00.72, 00.73, 00.80, 00.81, 00.82, 00.83, Ratonale: Revson procedures may be performed at a dsproportonately small number of hosptals and are assocated wth hgher mortalty, complcaton, and readmsson rates. 3. Patents undergong partal hp arthroplasty procedures (wth or wthout a concurrent THA/TKA) Presence of the followng procedure code: Ratonale: Partal arthroplastes are prmarly done for hp fractures and are typcally performed on patents who are older, more fral, and wth more comorbd condtons. 4. Patents undergong resurfacng procedures (wth or wthout a concurrent THA/TKA) Presence of one of the followng procedure codes: 00.85, 00.86, Ratonale: Resurfacng procedures are a dfferent type of procedure whch are typcally performed on younger, healther patents. 5. Patents wth a mechancal complcaton coded n the prncpal dscharge dagnoss feld of the ndex admsson* Ratonale: A complcaton coded n the prncpal feld ndcates t was present on admsson, and these patents underwent an arthroplasty due to a complcaton related to a pror procedure. Furthermore, these patents may requre more techncally complex arthroplasty procedures, and may be at ncreased rsk for complcatons, partcularly mechancal complcatons. 6. Patents wthout at least 30-days post-dscharge enrolment n Medcare Ratonale: The 30-day readmsson outcome cannot be assessed for the standardzed tme perod. 7. Patents who are transferred n to the ndex hosptal Ratonale: If the patent s transferred from another acute care faclty to the hosptal where the ndex procedure occurs, t s lkely that the procedure s not electve. 8. Patents who were admtted for the ndex procedure and subsequently transferred to another acute care faclty NQF #1551 Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 7

8 Ratonale: Attrbuton of readmsson to the ndex hosptal would not be possble n these cases, snce the ndex hosptal performed the procedure but another hosptal dscharged the patent to the non-acute care settng. 9. Patents who leave aganst medcal advce (AMA) Ratonale: Hosptals and physcans do not have the opportunty to provde the hghest qualty care for these patents. 10. Patents wth more than two THA/TKA procedures codes durng the ndex hosptalzaton Ratonale: Patents wth more than two procedure codes for THA/TKA are excluded because t s rare that a patent would have 3 arthroplasty procedures done at one tme. Ths s lkely to be a codng error. 11. Patents who de durng the ndex admsson Ratonale: Patents who de durng the ntal hosptalzaton are not elgble for readmsson. Addtonal otherwse qualfyng THA and/or TKA admssons that occurred wthn 30 days of dscharge date of an earler ndex admsson are not consdered as ndex admsson. They are consdered as potental readmssons. Any THA and/or TKA admsson s ether an ndex admsson or a potental readmsson, but not both. *Based on a medcal record valdaton study of the pared hosptal rsk-standardzed complcatons measure, we also excluded patents wth a mechancal complcaton coded n the prncpal dscharge dagnoss feld of the ndex admsson because a complcaton coded n the prncpal feld ndcates t was present on admsson. Furthermore, these patents represent more techncally complex arthroplasty procedures, and may be at ncreased rsk for readmsson, partcularly for mechancal complcatons. Pror to ths cohort excluson, there were 295,224 patents n the readmsson measure cohort (2008). After excludng from the measure cohort, the patents who had a mechancal complcaton coded n the prncpal dscharge dagnoss feld on the ndex admsson, the number of patents n the cohort decreased by 930 patents to 294,292 (less than 0.5% decrease). The hosptal rsk-standardzed mean readmsson rate pror to ths cohort excluson was 6.25% (range 3.03 to 50.97%). The hosptal rsk-standardzed mean readmsson rate after ths cohort excluson ncreased slghtly to 6.27% (range 3.06 to 50.72%). Thus, the addtonal cohort excluson has a mnmal effect on the hosptal rsk-standardzed mean readmsson rate, but the range of the rate stll shows sgnfcant varaton n hosptal readmsson rates. Detals regardng the valdaton study are provded n the NQF applcaton for the pared hosptal rskstandardzed complcatons measure (secton 2c, Valdty Testng). 2a.10 Denomnator Excluson Detals (All nformaton requred to collect exclusons to the denomnator, ncludng all codes, logc, and defntons): See Denomnator Excluson secton 2a.11 Stratfcaton Detals/Varables (All nformaton requred to stratfy the measure ncludng the stratfcaton varables, all codes, logc, and defntons): Ths measure s not stratfed. 2a Rsk Adjustment Type: Rsk-adjustment devsed specfcally for ths measure/condton 2a.14 Rsk Adjustment Methodology/Varables (Lst rsk adjustment varables and descrbe conceptual models, statstcal models, or other aspects of model or method): The measure estmates hosptal-level 30-day all-cause RSRRs usng herarchcal logstc regresson models. In bref, the approach smultaneously models outcomes at two levels (patent and hosptal) to account for the varance n patent outcomes wthn and between hosptals (Normand et al., 2007). To model the log-odds of 30-day all-cause readmsson at the patent level, the model adjusts for age, sex, and selected clncal covarates. The second level models the hosptal-specfc ntercepts as arsng from a normal dstrbuton. The hosptal ntercept represents the underlyng rsk of readmsson at the hosptal, after accountng for case mx. If there were no dfferences among hosptals, then after adjustng for case mx, the hosptal ntercepts NQF #1551 Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 8

9 should be dentcal across all hosptals. NQF #1551 The measure adjusts for key varables that are clncally relevant and have strong relatonshps wth the outcome (e.g. demographc factors, dsease severty ndcators, and ndcators of fralty). For each patent, covarates are obtaned from Medcare clams extendng 12 months pror to and ncludng the ndex admsson. The model adjusts for case mx dfferences based on the clncal status of the patent at the tme of admsson. We use condton categores (CCs), whch are clncally meanngful groupngs of more than 15,000 ICD-9-CM dagnoss and procedure codes. We do not rsk-adjust for CCs that are possble adverse events of care and that are only recorded n the ndex admsson. In addton, only comorbdtes that convey nformaton about the patent at that tme or n the 12-months pror, and not complcatons that arse durng the course of the hosptalzaton are ncluded n the rsk-adjustment. The rsk adjustment model ncluded 33 varables whch are lsted below: Demographcs 1. Age-65 (years above 65, contnuous) 2. Sex TKA/THA Procedure 3. THA procedure 4. Number of procedures (2 vs.1) Clncal Rsk Factors 5. Hstory of Infecton (CC 1, 3-6) 6. Metastatc cancer and acute leukema (CC 7) 7. Cancer (CC 8-12) 8. Dabetes and DM complcatons (CC 15-20, 119, 120) 9. Proten-calore malnutrton (CC 21) 10. Dsorders of Flud/Electrolyte/Acd-Base (CC 22, 23) 11. Rheumatod Arthrts and Inflammatory Connectve Tssue Dsease (CC 38) 12. Severe Hematologcal Dsorders (CC 44) 13. Dementa and senlty (CC 49, 50) 14. Major psychatrc dsorders (CC 54-56) 15. Hemplega, paraplega, paralyss, functonal dsablty (CC 67-69, , ) 16. Polyneuropathy (CC 71) 17. Congestve Heart Falure (CC 80) 18. Chronc Atheroscleross (CC 83-84) 19. Hypertenson (CC 89, 91) 20. Arrhythmas (CC 92, 93) 21. Stroke (CC 95, 96) 22. Vascular or crculatory dsease (CC ) 23. COPD (CC 108) 24. Pneumona (CC ) 25. End-stage renal dsease or dalyss (CC 129, 130) 26. Renal Falure (CC 131) 27. Decubtus ulcer or chronc skn ulcer (CC 148, 149) 28. Cellults, Local Skn Infecton (CC 152) 29. Other Injures (CC162) 30. Major Symptoms, Abnormaltes (CC 166) 31. Skeletal Deformtes (ICD-9 code ) 32. Post Traumatc Osteoarthrts (ICD-9 codes , ) 33. Morbd Obesty (ICD-9 code ) Normand S-LT, Shahan DM Statstcal and Clncal Aspects of Hosptal Outcomes Proflng. Stat Sc 22 (2): a Detaled rsk model avalable Web page URL or attachment: Attachment THA-TKA Readmsson Techncal Report.pdf 2a Type of Score: Rate/proporton Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 9

10 2a.20 Interpretaton of Score: Better qualty = Lower score 2a.21 Calculaton Algorthm (Descrbe the calculaton of the measure as a flowchart or seres of steps): The RSRR s calculated as the rato of the number of predcted to the number of expected readmssons, multpled by the natonal unadjusted readmsson rate. For each hosptal, the numerator of the rato s the number of readmssons wthn 30 days predcted on the bass of the hosptal s performance wth ts observed case mx, and the denomnator s the number of readmssons expected on the bass of the naton s performance wth that hosptal s case mx. Ths approach s analogous to a rato of observed to expected used n other types of statstcal analyses. It conceptually allows for a comparson of a partcular hosptal s performance gven ts case-mx to an average hosptal s performance wth the same case-mx. Thus a lower rato ndcates lower-than-expected readmsson or better qualty and a hgher rato ndcates hgherthan-expected readmsson or worse qualty. The predcted hosptal outcome (the numerator) s calculated by regressng the rsk factors and the hosptalspecfc ntercept on the rsk of readmsson, multplyng the estmated regresson coeffcents by the patent characterstcs n the hosptal, transformng, and then summng over all patents attrbuted to the hosptal to get a value. The expected number of readmssons (the denomnator) s obtaned by regressng the rsk factors and a common ntercept on the readmsson outcome usng all hosptals n our sample, multplyng the subsequent estmated regresson coeffcents by the patent characterstcs observed n the hosptal, transformng, and then summng over all patents n the hosptal to get a value. Please see attachment for more detals on the calculaton algorthm. 2a.22 Descrbe the method for dscrmnatng performance (e.g., sgnfcance testng): The method for dscrmnatng hosptal performance has not been determned. For the sx publcly reported measures of hosptal outcomes developed wth smlar methodology and reported on the CMS webste CMS currently estmates an nterval estmate for each rsk-standardzed rate to characterze the amount of uncertanty assocated wth the rate, compares the nterval estmate to the natonal crude rate for the outcome, and categorzes hosptals as better than the US natonal rate, worse than the US natonal rate, or no dfferent than the US natonal rate. However, the decson to publcly report ths measure and the approach has not been determned. 2a.23 Samplng (Survey) Methodology If measure s based on a sample (or survey), provde nstructons for obtanng the sample, conductng the survey and gudance on mnmum sample sze (response rate): Ths measure s not based on a survey or sample. 2a.24 Data Source (Check the source(s) for whch the measure s specfed and tested) Admnstratve clams 2a.25 Data source/data collecton nstrument (Identfy the specfc data source/data collecton nstrument, e.g. name of database, clncal regstry, collecton nstrument, etc.): We obtaned ndex admsson, readmsson, and n-hosptal comorbdty data from Medcare s Standard Analytc Fle (SAF). Comorbdtes were also assessed usng Part A npatent, outpatent, and Part B offce vst Medcare clams n the 12 months pror to ndex admsson. Enrollment and post-dscharge mortalty status were obtaned from Medcare s enrollment database whch contans benefcary demographc, beneft/coverage, and vtal status nformaton Part A (npatent) data Part A npatent data ncludes clams for Medcare npatent hosptal care, sklled nursng faclty care, some home health agency servces, and hospce care. For purposes of ths project, Part A s used to refer to npatent servces only and ncludes data from 2 tme perods: a. Index admsson: Index admsson data are based on the ncluson/excluson crtera for THA/TKA, and comorbdtes (f any) are dentfed from the secondary dagnoses assocated wth the ndex admsson. b. Pre-ndex: 12 months pror to the ndex admsson ( pre-ndex ) Part A (outpatent) data 12 months pre-ndex Hosptal outpatent refers to Medcare clams pad for the faclty component of surgcal or dagnostc procedures, emergency room care, and other non-npatent servces performed n a hosptal outpatent department or ambulatory surgcal/dagnostc center. 3. Part B data 12 months pre-ndex NQF #1551 Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 10

11 Part B data refers to Medcare clams for the servces of physcans (regardless of settng) and other outpatent care, servces, and supples. For purposes of ths project, Part B servces ncluded only face-toface encounters between a care provder and patent. We thus do not nclude servces such as laboratory tests, medcal supples, or other ambulatory servces. 2a Data source/data collecton nstrument reference web page URL or attachment: 2a Data dctonary/code table web page URL or attachment: URL N/A a Level of Measurement/Analyss (Check the level(s) for whch the measure s specfed and tested) Faclty 2a Care Settngs (Check the settng(s) for whch the measure s specfed and tested) Hosptal/Acute Care Faclty 2a Clncal Servces (Healthcare servces beng measured, check all that apply) NQF #1551 2b. Relablty testng TESTING/ANALYSIS 2b.1 Data/sample (descrpton of data/sample and sze): Medcare Part A npatent clams data for calendar year 2007 and 2008 were used to test relablty. The 2008 cohort ncluded 296,224 admssons and the 2007 cohort ncluded 300,338 admssons. 2b.2 Analytc Method (type of relablty & ratonale, method for testng): The relablty of the model was tested usng dentcal cohort ncluson/excluson crtera for patents who underwent THA and/or TKA. We randomly selected 50% of the THA and/or TKA admssons that met all ncluson and excluson crtera n 2008 and created a development sample, whch we used to buld the model. We used the remanng 50% of THA/TKA admssons n 2008 as the valdaton sample. We also used all qualfyng THA and/or TKA admssons n 2007 data as an addtonal sample to valdate the model. Model performance was assessed n the development dataset and both valdaton datasets. In addton we wll run the model n addtonal datasets and compare the rsk-standardzed readmsson rates for each hosptal. 2b.3 Testng Results (relablty statstcs, assessment of adequacy n the context of norms for the test conducted): Prelmnary results ndcate smlar model performance n the three cohorts (e.g., ROC=0.64 n all models). See addtonal results for these cohorts n the testng results secton below. 2c. Valdty testng 2b C P M N 2c.1 Data/sample (descrpton of data/sample and sze): Face valdty: model performance. 2c.2 Analytc Method (type of valdty & ratonale, method for testng): Durng measure development, we consulted wth representatves from potental users of ths measure ncludng clncans, professonal socetes, payers, and consumers. We use ths feld to descrbe the role that these representatves played on the workng group and Techncal Expert Panel (TEP). We used a structured measure evaluaton tool to assess face valdty and other measure propertes. We developed ths measure n consultaton wth natonal gudelnes for publcly reported outcomes measures, wth outsde experts, and wth the publc. The measure s consstent wth the techncal approach to outcomes measurement set forth n Natonal Qualty Forum (NQF) gudance for outcomes measures (Natonal Qualty Forum, 2010), CMS Measure Management System gudance, and the gudance artculated n the Amercan Heart Assocaton scentfc statement, Standards for Statstcal Models Used for Publc Reportng of Health Outcomes (Krumholz et al., 2006). We obtaned expert and stakeholder nput on the measure through three mechansms: frst, through regular dscussons wth a workng group; second, through 2c C P M N Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 11

12 a seres of three conference calls wth a natonal Techncal Expert Panel (TEP); and thrd, through a publc comment perod. Early n the development phase, we assembled a workng group that ncluded ndvduals wth clncal and methodologcal expertse relevant to orthopedc qualty measurement. We held regular conference calls throughout the development process, and the Yale team solcted detaled feedback and gudance on key clncal and methodologcal decsons pertanng to measure development. The workng group provded a forum for focused expert revew and dscusson of techncal ssues durng measure development pror to consderaton by the broader TEP. In algnment wth CMS Measure Management System, YNHHSC/CORE also released a publc call for nomnatons and convened a TEP. Potental members were also solcted va e-mal n consultaton wth the workng group and CMS. The role of the TEP was to provde feedback on key methodologcal decsons made n consultaton wth the workng group. The TEP was comprsed of ndvduals wth dverse perspectves and backgrounds ncludng clncans, consumers, hosptals, purchasers, and experts n qualty mprovement. Fnally, we solcted publc comment on the proposed measure through CMS Measure Management System Publc Comment ste ( Publc comments were summarzed and publcly posted for 30 days. The resultng content was taken nto consderaton durng the fnal stages of measure development. Natonal Qualty Forum. Natonal voluntary consensus standards for patent outcomes, frst report for phases 1 and 2: A consensus report Accessed August 19, Krumholz HM,Brnds RG,Brush JE, et al. Standards for Statstcal Models Used for Publc Reportng of Health Outcomes: An Amercan Heart Assocaton Scentfc Statement From the Qualty of Care and Outcomes Research Interdscplnary Wrtng Group: Cosponsored by the Councl on Epdemology and Preventon and the Stroke Councl Endorsed by the Amercan College of Cardology Foundaton. Crculaton. January 24, ;113(3): c.3 Testng Results (statstcal results, assessment of adequacy n the context of norms for the test conducted): The experts agree the measure accurately reflects the qualty of care and dstngushes levels of qualty for patents undergong THA and/or TKA. 2d. Exclusons Justfed 2d.1 Summary of Evdence supportng excluson(s): Ratonale for excluson s descrbed n Denomnator Exclusons. 2d.2 Ctatons for Evdence: See Denomnator Exclusons NQF #1551 2d.3 Data/sample (descrpton of data/sample and sze): N/A 2d.4 Analytc Method (type analyss & ratonale): N/A 2d.5 Testng Results (e.g., frequency, varablty, senstvty analyses): N/A 2e. Rsk Adjustment for Outcomes/ Resource Use Measures 2e.1 Data/sample (descrpton of data/sample and sze): 2008 Medcare Part A npatent and outpatent data and Part B outpatent data are used to dentfy canddate varables for rsk adjustment. Specfcally, Medcare Part A npatent data s used to dentfy varables for rsk adjustment n the ndex admsson. Part A outpatent and Part B data are used to dentfy comorbd condtons to nclude n the rsk adjustment n the 12-month perod precedng the ndex date of admsson. As descrbed n secton 2b, we developed and valdated the model n three separate cohorts to assess and compare model performance: (1) development 2d C P M N NA 2e C P M N NA Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 12

13 sample of 148,132 admssons n 2008 data; (2) valdaton sample of 148,092 n 2008 data; and (3) valdaton sample of 300,338 admssons n 2007 data. 2e.2 Analytc Method (type of rsk adjustment, analyss, & ratonale): Ths measure s fully rsk-adjusted usng a herarchcal logstc regresson model to calculate hosptal RSRRs. (see rsk adjustment methodology for addtonal detals). Approach to assessng model performance: For the development and valdaton cohorts, we computed fve summary statstcs for assessng model performance (Harrell, 2001): (1) over-fttng ndces (over-fttng refers to the phenomenon n whch a model accurately descrbes the relatonshp between predctve varables and outcome n the development dataset but fals to provde vald predctons n new patents) (2) predctve ablty (3) area under the recever operatng characterstc (ROC) curve (4) dstrbuton of resduals (5) model ch-square (A test of statstcal sgnfcance usually employed for categorcal data to determne whether there s a good ft between the observed data and expected values;.e., whether the dfferences between observed and expected values are attrbutable to true dfferences n characterstcs or nstead the result of chance varaton. F.E. Harrell and Y.C.T. Shh, Usng full probablty models to compute probabltes of actual nterest to decson makers, Int. J. Technol. Assess. Health Care 17 (2001), pp e.3 Testng Results (rsk model performance metrcs): Performance Metrcs n Development Cohort: Development cohort conssted of 148,132 patent stays at 3,223 hosptals (half of 2008 cohort), wth a rsk-adjusted medan readmsson rate of 6.04%. The development model has strong dscrmnaton and ft. The rsk-standardzed readmsson rate ranges from 3.2% to 46.8%, a range of 43.6%. Results are summarzed below: Over-fttng ndces: (0,1) Resduals lack of ft: <-2 = 0.0%; [-2, 0) = 93.8%; [0, 2) = 0.1%; [2+ = 6.0% Model Ch-square [# of covarates]: 2492 [33] Predctve ablty (lowest decle %, hghest decle %): (2.4, 13.4) Area under the ROC curve = 0.65 (GLM) The dscrmnaton and the explaned varaton of the model are consstent wth those of models currently used to publcly report condton specfc rates of both mortalty and readmsson. Model Valdaton usng 2008 Valdaton Cohort: 2008 Valdaton cohort conssted of 148,092 admssons (other half of the 2008 cohort) randomly selected from 3,213 hosptals, wth a rsk-standardzed medan readmsson rate of 6.02%. The model performance was not substantvely dfferent n ths valdaton sample, as compared to the development sample. Results are summarzed below: Over-fttng ndces: (-0.06, 0.98) Resduals lack of ft: <-2 = 0.0%; [-2, 0) = 93.8%; [0, 2) = 0.1%; [2+ = 6.0% Model Ch-square[# of covarates]: 2406 [33] Predctve ablty (lowest decle %, hghest decle %):(2.6, 13.2) Area under the ROC curve = 0.64 Model Valdaton usng 2007 Valdaton Cohort: 2007 valdaton cohort conssted of 300,338 admssons from 3,295 hosptals. The model performance was not substantvely dfferent n ths valdaton sample, as compared to the development sample. Results are summarzed below: NQF #1551 Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 13

14 NQF #1551 Over-fttng ndces: (-0.11, 0.94) Resduals lack of ft: <-2 = 0.0%; [-2, 0) = 93.6%; [0, 2) = 0.1%; [2+ = 6.2% Model Ch-square[# of covarates]: 4596 [33] Predctve ablty (lowest decle %, hghest decle %):(2.8, 13.4) Area under the ROC curve = 0.64 We also examned the temporal varaton of the standardzed estmates and frequences of the varables n the models. The frequences and regresson coeffcents are farly consstent over the three cohorts. 2e.4 If outcome or resource use measure s not rsk adjusted, provde ratonale: N/A 2f. Identfcaton of Meanngful Dfferences n Performance 2f.1 Data/sample from Testng or Current Use (descrpton of data/sample and sze): 2008 Medcare Part A npatent clams data 2f.2 Methods to dentfy statstcally sgnfcant and practcally/meanngfully dfferences n performance (type of analyss & ratonale): Unadjusted medan hosptal-level readmsson rates followng THA and/or TKA were assessed across hosptals. 2f.3 Provde Measure Scores from Testng or Current Use (descrpton of scores, e.g., dstrbuton by quartle, mean, medan, SD, etc.; dentfcaton of statstcally sgnfcant and meanngfully dfferences n performance): Medan hosptal-level rsk-standardzed readmsson rate of 2008 was 6.06% and ranged from 3.06% to 50.94%. Ths s lkely a sgnal of dfferences n the qualty of care receved for patents undergong THA and/or TKA. Total hp replacement and TKA are electve procedures typcally performed on healthy patents. Therefore, readmsson rates are expected to be lower than that for an emergent procedures and condtons. The varaton observed for readmssons s lkely a sgnal that though rates may be relatvely low there are dfferences n the qualty of care delvered across hosptals that result n varaton n outcomes. 2g. Comparablty of Multple Data Sources/Methods 2g.1 Data/sample (descrpton of data/sample and sze): No comparable data source s avalable at ths tme. We wll perform valdty testng of the development model n data from a dfferent tme frame. 2g.2 Analytc Method (type of analyss & ratonale): N/A 2g.3 Testng Results (e.g., correlaton statstcs, comparson of rankngs): N/A 2h. Dspartes n Care 2f C P M N 2g C P M N NA 2h.1 If measure s stratfed, provde stratfed results (scores by stratfed categores/cohorts): Ths measure s not stratfed. 2h.2 If dspartes have been reported/dentfed, but measure s not specfed to detect dspartes, provde follow-up plans: There were no hosptal-level dspartes detected durng measure development. Please see Summary of Data on Dspartes by Populaton Group for addtonal nformaton. TAP/Workgroup: What are the strengths and weaknesses n relaton to the subcrtera for Scentfc Acceptablty of Measure Propertes? 2 Steerng Commttee: Overall, to what extent was the crteron, Scentfc Acceptablty of Measure 2 Propertes, met? C Ratonale: P M N 2h C P M N NA Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 14

15 3. USABILITY Extent to whch ntended audences (e.g., consumers, purchasers, provders, polcy makers) can understand the results of the measure and are lkely to fnd them useful for decson makng. (evaluaton crtera) 3a. Meanngful, Understandable, and Useful Informaton 3a.1 Current Use: Not n use but testng completed 3a.2 Use n a publc reportng ntatve (dsclosure of performance results to the publc at large) (If used n a publc reportng ntatve, provde name of ntatve(s), locatons, Web page URL(s). If not publcly reported, state the plans to acheve publc reportng wthn 3 years): CMS plans to use the measures for publc reportng and wll propose the measures through rulemakng process. 3a.3 If used n other programs/ntatves (If used n qualty mprovement or other programs/ntatves, name of ntatve(s), locatons, Web page URL(s). If not used for QI, state the plans to acheve use for QI wthn 3 years): The measure s not currently n use. Testng of Interpretablty (Testng that demonstrates the results are understood by the potental users for publc reportng and qualty mprovement) 3a.4 Data/sample (descrpton of data/sample and sze): N/A NQF #1551 Eval Ratn g 3a.5 Methods (e.g., focus group, survey, QI project): No consumer or other feld testng has been completed at ths tme. However, ths measure was systematcally evaluated by an expert group of orthopedsts and a TEP over a perod of eght months. Regular meetngs were held throughout the development of ths measure, durng whch we receved nput and feedback on key methodologcal and other measure decsons (see secton 2c-Valdty Testng for more detals on process of TEP nput). 3a.6 Results (qualtatve and/or quanttatve results and conclusons): The TEP agreed that the measure would be useful n nformng consumers and hosptals. 3b/3c. Relaton to other NQF-endorsed measures 3a C P M N 3b.1 NQF # and Ttle of smlar or related measures: (for NQF staff use) Notes on smlar/related endorsed or submtted measures: 3b. Harmonzaton If ths measure s related to measure(s) already endorsed by NQF (e.g., same topc, but dfferent target populaton/settng/data source or dfferent topc but same target populaton): 3b.2 Are the measure specfcatons harmonzed? If not, why? 3b C P M N NA 3c. Dstnctve or Addtve Value 3c.1 Descrbe the dstnctve, mproved, or addtve value ths measure provdes to exstng NQFendorsed measures: 5.1 If ths measure s smlar to measure(s) already endorsed by NQF (.e., on the same topc and the same target populaton), Descrbe why t s a more vald or effcent way to measure qualty: N/A TAP/Workgroup: What are the strengths and weaknesses n relaton to the subcrtera for Usablty? 3 Steerng Commttee: Overall, to what extent was the crteron, Usablty, met? 3 3c C P M N NA Ratng: C=Completely; P=Partally; M=Mnmally; N=Not at all; NA=Not applcable 15