Final Rule with Comment Period on Medicare OPPS - Ropes & Gray

74486 Federal Register / Vol. 76, No. 230 / Wednesday, November 30, 2011 / <strong>Rule</strong>s and Regulationsjlentini on DSK4TPTVN1PROD <strong>with</strong> RULES2<strong>Comment</strong>: One commenter requestedthat CMS re-evaluate the samplingrequirements for the Hospital OQRProgram to better align them <strong>with</strong> theHospital IQR Program and requested areduction in sample size requirementsto reduce burden on hospitals.Response: We interpret thecommenter as referring to the HospitalIQR Program sampling requirements forvalidation which stratify by measureand/or topic. As we have stated, we areinterested in whether the data submittedby hospitals accurately reflects the caredelivered and documented in themedical record, not what the accuracy isby measure or whether there aredifferences by measure or topic. Inaddition, by not stratifying by measureand/or topic, it is possible to samplefewer cases and maintain precision forreliability estimates for validationpurposes.<strong>Comment</strong>: One commenter opposedthe proposal to continue the CY 2012policy of sampling up to 12 records perquarter from hospitals selected forvalidation, stating their belief that thisnumber should be reduced as burden tohospitals should be reduced, not just theburden to CMS. One commenterbelieved that validating a larger numberof cases from a sample of hospitals hasadvantages over sampling a smallernumber of cases from a pool of allhospitals.Response: We thank the commentersfor their views on the number of casesto be sampled from hospitals selectedfor validation. In setting a sample sizewe are attempting to balance burden tohospitals <strong>with</strong> data accuracy; sentimentsmirrored in the comments received. Wediscussed our basis for the selection ofup to 12 records per quarter or 48 peryear in the CY 2011 OPPS/ASC finalrule <strong>with</strong> comment period (75 FR72104), and the CY 2012 OPPS/ASCproposed rule (76 FR 42332 through42333).After consideration of the publiccomments we received, we arefinalizing our proposals <strong>with</strong>outmodification.d. Validation Score CalculationIn the CY 2012 OPPS/ASC proposedrule (76 FR 42333), for the CY 2013payment determination, we proposed touse the validation calculation approachfinalized for the CY 2012 paymentdetermination <strong>with</strong> validation beingdone for each selected hospital.Specifically, we proposed to conduct ameasures level validation by calculatingeach measure <strong>with</strong>in a submitted recordusing the independently abstracted dataand then comparing this to the measurereported by the hospital; a percentagreement would then be calculated. Wewould also compare the measurecategory for quality measures <strong>with</strong>continuous units of measurement, suchas time, so that for these measures, boththe category and the measure wouldneed to match.To receive the full OPPS OPD feeschedule increase factor for CY 2013, weproposed that hospitals must attain atleast a 75 percent reliability score, basedupon the proposed validation process.We proposed to use the upper bound ofa two-tailed 95 percent confidenceinterval to estimate the validation score.If the calculated upper limit is above therequired 75 percent reliabilitythreshold, we would consider ahospital’s data to be ‘‘validated’’ forpayment purposes. Because we are moreinterested in whether the measure hasbeen accurately reported, we wouldcontinue to focus on whether themeasure data reported by the hospitalmatches the data documented in themedical record as determined by ourreabstraction. We proposed to calculatethe validation score using the samemethodology we finalized for the CY2012 payment determination (75 FR72105). We also proposed to use thesame medical record documentationsubmission procedures that we alsofinalized for the CY 2012 paymentdetermination (75 FR 72104) <strong>with</strong> onemodification.We proposed to shorten the timeperiod given to hospitals to submitmedical record documentation to theCMS contractor from 45 calendar daysto 30 calendar days. This proposedchange in submission timeframe willalign the process <strong>with</strong> requirements in42 CFR 476.78(b)(2), which allow 30days for chart submission in the contextof QIO review. We proposed thisdeadline of 30 days also to reduce thetime for data validation completion toincrease timeliness of providinghospitals <strong>with</strong> feedback on theirabstraction accuracy.<strong>Comment</strong>: Many commenters opposedthe proposal to reduce the time forhospitals to submit medical recorddocumentation for validation. Some ofthese commenters cited burden as anissue. Some commenters expressedconcern that the shortened timeframewould not allow adequate time toreview records before submission forvalidation purposes. One commenterstated that hospitals also have recordsthey are required to prepare forRecovery Audit Contractor (RAC)purposes. One commenter believed thatthis proposal would be a burden onmedical and quality staff if a hospitalhad been selected for both outpatientand inpatient hospital quality reporting.VerDate Mar2010 17:08 Nov 29, 2011 Jkt 226001 PO 00000 Frm 00366 Fmt 4701 Sfmt 4700 E:\FR\FM\30NOR2.SGM 30NOR2Response: We thank thesecommenters for expressing theirconcerns regarding this proposal. Basedon these comments, we have decided tonot finalize our proposal to reduce thetime for hospitals to submit medicalrecord documentation and, instead, dueto issues of burden as well asconsistency <strong>with</strong> other CMS programs(for example, the RAC, PERM, andCERT programs), we will retain ourexisting policy. Under this existingpolicy, the CMS contractor must receivethe requested documentation by 45calendar days from the date of therequest as documented in the requestletter. Other details of this policy,including the issuance of a secondrequest letter if the hospital does notrespond to the initial request <strong>with</strong>in 30days are detailed in the CY 2011 OPPS/ASC final rule <strong>with</strong> comment period (75FR 72104).<strong>Comment</strong>: Some commenters agreed<strong>with</strong> reducing the time from 45 days to30 days if the timeliness of feedbackwas improved.Response: We thank thesecommenters for supporting our proposalto reduce the time to submit medicalrecords for validation from 45 days to 30days if timeliness of feedback could beimproved. We agree that improvedtimelines of feedback is important forquality improvement.After consideration of the publiccomments we received, we havedecided to not finalize our proposal toreduce the time for hospitals to submitmedical record documentation. Asstated above, we will retain the medicalrecord return policy that we finalized inthe CY 2011 OPPS/ASC final rule forthe Hospital OQR Program CY 2012payment determination. We did notreceive any comments on our proposalregarding validation score calculation.Therefore, we are finalizing thisproposal <strong>with</strong>out modification.4. Additional Data ValidationConditions Under Consideration for CY2014 and Subsequent YearsWe continue to consider buildingupon our validation approach oftargeting hospitals to address dataquality concerns and to ensure that ourpayment decisions are made usingaccurate data. Thus, in the CY 2012OPPS/ASC proposed rule (76 FR 42333),we requested public comment on thefollowing additional targeting criteria toselect hospitals for validation:• Whether a hospital that was openunder its current CCN and had not beenselected for validation in the previous 3years. This is consistent <strong>with</strong> validationtargeting criteria we recently proposedto implement for the CY 2015 Hospital