2018 CMS Web Interface

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1 CMS Web Interface PREV-13: Statin Therapy fr the Preventin and Treatment f Cardivascular Disease Measure Steward: CMS CMS Web Interface V2.1 Page 1 f 27 06/25/

2 Cntents INTRODUCTION... 4 CMS WEB INTERFACE SAMPLING INFMATION... 5 BENEFICIARY SAMPLING... 5 NARRATIVE MEASURE SPECIFICATION... 6 DESCRIPTION:... 6 IMPROVEMENT NOTATION:... 6 INITIAL POPULATION:... 6 DENOMINAT:... 6 DENOMINAT EXCLUSIONS:... 6 DENOMINAT EXCEPTIONS:... 6 NUMERAT:... 6 NUMERAT NOTE... 6 NUMERAT EXCLUSIONS:... 7 DEFINITIONS:... 7 GUIDANCE:... 7 Denminatr Guidance fr Encunter:... 8 Intensity f statin therapy in primary and secndary preventin:... 8 Lifestyle mdificatin caching:... 8 SUBMISSION GUIDANCE... 9 PATIENT CONFIRMATION... 9 SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY SUBMISSION GUIDANCE NUMERAT REPTING DOCUMENTATION REQUIREMENTS APPENDIX I: PERFMANCE CALCULATION FLOW APPENDIX II: DOWNLOADABLE RESOURCE MAPPING TABLE CMS Web Interface V2.1 Page 2 f 27 06/25/

3 APPENDIX III: MEASURE RATIONALE AND CLINICAL RECOMMENDATION STATEMENTS RATIONALE: CLINICAL RECOMMENDATION STATEMENTS: APPENDIX IV: USE NOTICES, COPYRIGHTS, AND DISCLAIMERS COPYRIGHT CMS Web Interface V2.1 Page 3 f 27 06/25/

4 INTRODUCTION There are a ttal f 15 individual measures (including ne cmpsite cnsisting f tw measures) included in the CMS Web Interface targeting high-cst chrnic cnditins, preventive care, and patient safety. The measures dcuments are represented individually and cntain measure specific infrmatin. The crrespnding cding dcuments are psted separately in an Excel frmat. The measure dcuments are being prvided t allw grup practices and Accuntable Care Organizatins (ACOs) an pprtunity t better understand each f the 15 individual measures included in the CMS Web Interface data submissin methd. Each measure dcument cntains infrmatin necessary t submit data thrugh the CMS Web Interface. Narrative specificatins, supprting submissin dcumentatin, and calculatin flws are prvided within each dcument. Please review all f the measure dcumentatin in its entirety t ensure cmplete understanding f these measures. CMS Web Interface V2.1 Page 4 f 27 06/25/

5 CMS WEB INTERFACE SAMPLING INFMATION BENEFICIARY SAMPLING Fr mre infrmatin n the sampling prcess and methdlgy please refer t the CMS Web Interface Sampling Dcument, which will be made available during the perfrmance year at CMS.gv. CMS Web Interface V2.1 Page 5 f 27 06/25/

6 NARRATIVE MEASURE SPECIFICATION DESCRIPTION: Percentage f the fllwing patients - all cnsidered at high risk f cardivascular events - wh were prescribed r were n statin therapy during the measurement perid: Adults aged 21 years wh were previusly diagnsed with r currently have an active diagnsis f clinical athersclertic cardivascular disease (ASCVD); Adults aged 21 years wh have ever had a fasting r direct lw-density lipprtein chlesterl (LDL-C) level 190 mg/dl r were previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia; Adults aged years with a diagnsis f diabetes with a fasting r direct LDL-C level f mg/dl IMPROVEMENT NOTATION: Higher scre indicates better quality. INITIAL POPULATION: All patients aged 21 years and lder at the beginning f the measurement perid with a patient encunter during the measurement perid. DENOMINAT: All patients wh meet ne r mre f the fllwing criteria (cnsidered at "high risk" fr cardivascular events, under ACC/AHA guidelines): 1) Patients aged 21 years at the beginning f the measurement perid with clinical ASCVD diagnsis 2) Patients aged 21 years at the beginning f the measurement perid wh have ever had a fasting r direct labratry result f LDL-C 190 mg/dl r were previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia 3) Patients aged 40 t 75 years at the beginning f the measurement perid with Type 1 r Type 2 diabetes and with an LDL-C result f mg/dl recrded as the highest fasting r direct labratry test result in the measurement year r during the tw years prir t the beginning f the measurement perid DENOMINAT EXCLUSIONS: Patients wh have a diagnsis f pregnancy Patients wh are breastfeeding Patients wh have a diagnsis f rhabdmylysis DENOMINAT EXCEPTIONS: Patients with adverse effect, allergy, r intlerance t statin medicatin Patients with active liver disease r hepatic disease r insufficiency Patients with end-stage renal disease (ESRD) Patients with diabetes wh have the mst recent fasting r direct LDL-C labratry test result < 70 mg/dl and are nt taking statin therapy NUMERAT: Patients wh are actively using r wh receive an rder (prescriptin) fr statin therapy at any pint during the measurement perid NUMERAT NOTE: In rder t meet the measure, current statin therapy use must be dcumented in the patient s current medicatin list r rdered during the measurement perid. ONLY statin therapy meets the measure Numeratr criteria (NOT ther chlesterl lwering medicatins). Prescriptin r rder des NOT need t be linked t an encunter r visit; it may be called t the pharmacy. Statin medicatin samples prvided t patients can be dcumented as current statin therapy if dcumented in the medicatin list in health/medical recrd. Patients wh meet the denminatr criteria fr inclusin, but are nt prescribed r CMS Web Interface V2.1 Page 6 f 27 06/25/

7 using statin therapy, will NOT meet perfrmance fr this measure. Adherence t statin therapy is nt calculated in this measure. NUMERAT EXCLUSIONS: Nne DEFINITIONS: Clinical athersclertic cardivascular disease (ASCVD) includes: Acute crnary syndrmes Histry f mycardial infarctin Stable r unstable angina Crnary r ther arterial revascularizatin Strke r transient ischemic attack (TIA) Peripheral arterial disease f athersclertic rigin Lipprtein Density Chlesterl (LDL-C) result - A fasting r direct LDL-C labratry test perfrmed and test result dcumented in the medical recrd. Statin therapy - Administratin f ne r mre f a grup f medicatins that are used t lwer plasma lipprtein levels in the treatment f hyperlipprteinemia. Statin Medicatin Therapy List (NOTE: List des NOT include dsage) is included in the clinical recmmendatins. Sme patients may nt be apprpriate t prescribe r use statin therapy (see exceptins and exclusins fr a cmplete list). "Statin intlerance is the inability t tlerate a dse f statin required t reduce a persn's CV risk sufficiently frm their baseline risk and culd result frm different statin related side effects including: muscle symptms, headache, sleep disrders, dyspepsia, nausea, rash, alpecia, erectile dysfunctin, gynecmastia, and/r arthritis" (Banach, et al., 2015). Patients that experience symptms such as these may prefer nt t take r cntinue statin therapy and therefre may be exempt frm the denminatr. GUIDANCE: Denminatr Guidance: The denminatr cvers three distinct ppulatins. Use the fllwing prcess t prevent cunting patients mre than nce. Denminatr Ppulatin 1: Patients aged 21 years at the beginning f the measurement perid with clinical ASCVD If YES, patient meets Denminatr Ppulatin 1 risk categry If NO, screen fr next risk categry Denminatr Ppulatin 2: Patients aged 21 years at the beginning f the measurement perid wh have ever had a fasting r direct labratry test result f LDL-C 190 mg/dl r were previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia If YES, patient meets Denminatr Ppulatin 2 risk categry If NO, screen fr next risk categry Denminatr Ppulatin 3: Patients aged 40 thrugh 75 years at the beginning f the measurement perid with Type 1 r Type 2 diabetes and with an LDL-C result f mg/dl recrded as the highest fasting r CMS Web Interface V2.1 Page 7 f 27 06/25/

8 direct labratry test result in the measurement year r during the tw years prir t the beginning f the measurement perid If YES, patient meets Denminatr Ppulatin 3 risk categry If NO, patient des NOT meet denminatr criteria and is NOT eligible fr measure inclusin Denminatr Guidance fr Encunter: In rder fr the patient t be included in the denminatr, the patient must have ONE denminatr-eligible visit, defined as fllws: Outpatient encunter visit type Encunter perfrmed: initial r established ffice visit, face-t-face interactin, preventive care services, r annual wellness visit LDL-C Labratry test result ptins: The measure can be reprted fr all patients with a dcumented fasting r direct LDL-C level recrded as fllws: T meet Denminatr Ppulatin 1: There is n LDL-C result required T meet Denminatr Ppulatin 2: If a patient has ANY previus fasting r direct labratry result f LDL-C 190 mg/dl, reprt the highest value 190 mg/dl T meet Denminatr Ppulatin 3: If a patient has mre than ne LDL-C result during the measurement perid r during the tw years befre the start f the measurement perid, reprt the highest level recrded during either time. The Denminatr Exceptin, Patients with diabetes wh have the mst recent fasting r direct LDL-C labratry test result < 70 mg/dl and are nt taking statin therapy applies nly t Denminatr Ppulatin 3. Intensity f statin therapy in primary and secndary preventin: The expert panel f the 2013 ACC/AHA Guidelines (Stne et al. 2013) defines recmmended intensity f statin therapy n the basis f the average expected LDL-C respnse t specific statin and dse. Althugh intensity f statin therapy is imprtant in managing chlesterl, this measure assesses prescriptin f ANY statin therapy, irrespective f intensity. Assessment f apprpriate intensity and dsage dcumentatin added t much cmplexity t allw inclusin f statin therapy intensity in the measure at this time. Lifestyle mdificatin caching: A healthy lifestyle is imprtant fr the preventin f cardivascular disease. Hwever, lifestyle mdificatin mnitring and dcumentatin added t much cmplexity t allw its inclusin in the measure at this time. CMS Web Interface V2.1 Page 8 f 27 06/25/

9 PATIENT CONFIRMATION SUBMISSION GUIDANCE Establishing patient eligibility fr reprting requires the fllwing: Determine if the patient s medical recrd can be fund If yu can lcate the medical recrd select Yes If yu cannt lcate the medical recrd select N - Medical Recrd Nt Fund Determine if the patient is qualified fr the sample Guidance Patient Cnfirmatin If the patient is deceased, in hspice, mved ut f the cuntry r did nt have Feefr-Service (FFS) Medicare as their primary payer select Nt Qualified fr Sample, select the applicable reasn frm the prvided drp-dwn menu, and enter the date the patient became ineligible If N Medical Recrd Nt Fund r Nt Qualified fr Sample is selected, the patient is cmpleted but nt cnfirmed. The patient will be skipped and anther patient must be reprted in their place, if available. The CMS Web Interface will autmatically skip any patient fr whm N Medical Recrd Nt Fund r Nt Qualified fr Sample is selected in all ther measures int which they have been sampled. If Nt Qualified fr Sample is selected and the date is unknwn, yu may enter the last date f the measurement perid (i.e., 12/31/). The Measurement Perid is defined as January 1 December 31,. NOTE: - In Hspice: Select this ptin if the patient is nt qualified fr sample due t being in hspice care at any time during the measurement perid (this includes nn-hspice patients receiving palliative gals r cmfrt care) - Mved ut f Cuntry: Select this ptin if the patient is nt qualified fr sample because they mved ut f the cuntry any time during the measurement perid - Deceased: Select this ptin if the patient died during the measurement perid - Nn-FFS Medicare: Select this ptin if the patient was enrlled in Nn-FFS Medicare at any time during the measurement perid (i.e., cmmercial payers, Medicare Advantage, Nn-FFS Medicare, HMOs, etc.) This exclusin is intended t remve beneficiaries fr whm Fee-fr-Service Medicare is nt the primary payer. CMS Web Interface V2.1 Page 9 f 27 06/25/

10 SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY 1 Determine if the patient has a diagnsis f ASCVD (active r histry f) at any time up thrugh the last day f the measurement perid If the patient has a diagnsis f ASCVD (active r histry f) dcumented in the patient's medical recrd select Yes If yu are unable t cnfirm the diagnsis f ASCVD (active r histry f) dcumented in the patient's medical recrd select N - Diagnsis If there is a denminatr exclusin fr patient disqualificatin frm the measure select Denminatr Exclusin If there is an "ther" CMS apprved reasn fr patient disqualificatin frm the measure select N- Other CMS Apprved Reasn Denminatr and Denminatr Exclusin cdes can be fund in the CMS Web Interface PREV Cding Dcument. The Dwnladable Resurce Mapping Table can be lcated in Appendix II f this dcument. Guidance Denminatr If Yes is selected, skip t Statin Use Assessment. If N - Diagnsis is selected, cntinue t Risk Categry 2. If Denminatr Exclusin r N Other CMS Apprved Reasn is selected, the patient will be skipped and anther patient must be reprted in their place, if available. The patient will nly be remved frm the measure fr which ne f these ptins was selected, nt all CMS Web Interface measures. CMS Apprved Reasn may nly be selected when apprved by CMS. T request a CMS Apprved Reasn, yu wuld need t prvide the patient rank, measure, and reasn fr request in a Quality Payment Prgram Service Desk inquiry. A CMS decisin will be prvided in the reslutin f the inquiry. Patients fr whm a CMS Apprved Reasn is selected will be skipped and anther patient must be reprted in their place, if available. NOTE: - Denminatr Exclusin shuld be active during the measurement perid - Active Diagnsis is defined as a diagnsis that is either n the patient s prblem list, a diagnsis cde listed n the encunter, r is dcumented in a prgress nte indicating that the patient is being treated r managed fr the disease r cnditin during the measurement perid CMS Web Interface V2.1 Page 10 f 27 06/25/

11 SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY 2 Determine if the patient has ever had a fasting r direct labratry test result f LDL-C 190 mg/dl were previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia If the patient has ever had a fasting r direct labratry test result f LDL-C 190 mg/dl dcumented were previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia select Yes If the patient has never had a fasting r direct labratry test result f LDL-C 190 mg/dl r has never been previusly diagnsed with r currently have an active diagnsis f familial r pure hyperchlesterlemia dcumented select N - Diagnsis If there is a denminatr exclusin fr patient disqualificatin frm the measure select Denminatr Exclusin If there is an "ther" CMS apprved reasn fr patient disqualificatin frm the measure select N- Other CMS Apprved Reasn Denminatr and Denminatr Exclusin cdes can be fund in the CMS Web Interface PREV Cding Dcument. The Dwnladable Resurce Mapping Table can be lcated in Appendix II f this dcument. Guidance Denminatr If Yes is selected, skip t Statin Use Assessment. If N - Diagnsis is selected, cntinue t Risk Categry 3. If Denminatr Exclusin r N Other CMS Apprved Reasn is selected, the patient will be skipped and anther patient must be reprted in their place, if available. The patient will nly be remved frm the measure fr which ne f these ptins was selected, nt all CMS Web Interface measures. CMS Apprved Reasn may nly be selected when apprved by CMS. T request a CMS Apprved Reasn, yu wuld need t prvide the patient rank, measure, and reasn fr request in a Quality Payment Prgram Service Desk inquiry. A CMS decisin will be prvided in the reslutin f the inquiry. Patients fr whm a CMS Apprved Reasn is selected will be skipped and anther patient must be reprted in their place, if available. NOTES: - Denminatr Exclusin shuld be active during the measurement perid - If labratry unable t calculate LDL-C value due t high triglycerides, select "N". If the test result is labeled "unreliable" and a result is prvided, als select "N" - Active Diagnsis is defined as a diagnsis that is either n the patient s prblem list, a diagnsis cde listed n the encunter, r is dcumented in a prgress nte indicating that the patient is being treated r managed fr the disease r cnditin during the measurement perid CMS Web Interface V2.1 Page 11 f 27 06/25/

12 SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY 3 Determine if the patient is aged years with Type I r Type 2 Diabetes If the patient is aged years with Type 1 r Type 2 Diabetes select Yes If the patient is nt aged years r des nt have a diagnsis f Type 1 r Type 2 Diabetes select N - Diagnsis Denminatr cdes can be fund in the CMS Web Interface PREV Cding Dcument. The Dwnladable Resurce Mapping Table can be lcated in Appendix II f this dcument. Guidance Denminatr If Yes is selected, cntinue t LDL-C. If N Diagnsis r Nt Aged years is selected, mark apprpriately fr cmpletin and stp abstractin. Patient is remved frm the perfrmance calculatins fr this measure. The patient will be skipped and anther patient must be reprted in their place, if available. The patient will nly be remved frm the measure fr which ne f these ptins was selected, nt all CMS Web Interface measures. NOTE: - Diabetes diagnsis is defined as any histry f diabetes, prir t r during the measurement perid CMS Web Interface V2.1 Page 12 f 27 06/25/

13 SUBMISSION GUIDANCE DENOMINAT CONFIRMATION, RISK CATEGY 3 Determine if the patient has an LDL-C f mg/dl during the measurement perid r tw years prir t the beginning f the measurement perid If the patient has an LDL-C mg/dl dcumented select Yes If the patient des nt have an LDL-C mg/dl dcumented select N If there is a denminatr exclusin fr patient disqualificatin frm the measure select Denminatr Exclusin If there is an "ther" CMS apprved reasn fr patient disqualificatin frm the measure select N- Other CMS Apprved Reasn Denminatr and Denminatr Exclusin cdes can be fund in the CMS Web Interface PREV Cding Dcument. The Dwnladable Resurce Mapping Table can be lcated in Appendix II f this dcument. Guidance Denminatr If Yes is selected, cntinue t Statin Use Assessment. If N r Denminatr Exclusin r N Other CMS Apprved Reasn is selected, the patient will be skipped and anther patient must be reprted in their place, if available. The patient will nly be remved frm the measure fr which ne f these ptins was selected, nt all CMS Web Interface measures. CMS Apprved Reasn may nly be selected when apprved by CMS. T request a CMS Apprved Reasn, yu wuld need t prvide the patient rank, measure, and reasn fr request in a Quality Payment Prgram Service Desk inquiry. A CMS decisin will be prvided in the reslutin f the inquiry. Patients fr whm a CMS Apprved Reasn is selected will be skipped and anther patient must be reprted in their place, if available. NOTE: - Denminatr Exclusin shuld be active during the measurement perid - Active Diagnsis is defined as a diagnsis that is either n the patient s prblem list, a diagnsis cde listed n the encunter, r is dcumented in a prgress nte indicating that the patient is being treated r managed fr the disease r cnditin during the measurement perid CMS Web Interface V2.1 Page 13 f 27 06/25/

14 NUMERAT SUBMISSION SUBMISSION GUIDANCE Determine if the patient was taking r prescribed statin therapy during the measurement perid If the patient was nt taking r prescribed statin therapy select N If the patient was taking r prescribed statin therapy select Yes If the patient was nt prescribed statin therapy fr medical reasns select N - Denminatr Exceptin - Medical Reasns Numeratr Drug, Denminatr Exceptin and Denminatr Exceptin Drug cdes can be fund in the CMS Web Interface PREV Cding Dcument. The Dwnladable Resurce Mapping Table can be lcated in Appendix II f this dcument. Guidance Numeratr NOTE: - Fr mapping frm the EHR when an accepted drug allergy is fund, lk fr drug classificatin with a "Yc" (Yes-cnditinal) in the Drug EX clumn f the Denminatr Exceptin Drug Cdes tab. These drugs may be used as a Denminatr Exceptin if present in the patient's recrd accmpanied by an apprpriate cnditinal reasn why the patient isn't taking the drug (e.g. adverse effect, allergy, r intlerance t statin medicatin) - Dcumentatin f nt prescribed a statin fr Denminatr Exceptin - Medical Reasn(s) relevant t Risk Categry 3 ONLY: Patients with diabetes wh have the mst recent fasting r direct LDL-C labratry test result < 70 mg/dl and nt taking statin therapy. Other Denminatr Exceptin Medical Reasn(s) are relevant t all Risk Categries - Denminatr Exceptin shuld be active during the measurement perid - Dcumentatin f statin therapy prescribed r being taken during the measurement perid cannt be cmpleted during a telehealth encunter CMS Web Interface V2.1 Page 14 f 27 06/25/

15 DOCUMENTATION REQUIREMENTS When submitting data thrugh the CMS Web Interface, the expectatin is that medical recrd dcumentatin is available that supprts the actin reprted in the CMS Web Interface i.e., medical recrd dcumentatin is necessary t supprt the infrmatin that has been submitted. Claims data cannt be used t cnfirm a diagnsis (DM, IVD, HTN, etc.,) used fr sampling purpses as claims are the riginal surce f the diagnsis sampling. Claims data can be used t prepare the CMS Web Interface Excel but supprting medical recrd dcumentatin will be required t substantiate what is reprted in the event f an audit. CMS Web Interface V2.1 Page 15 f 27 06/25/

16 Appendix I: Perfrmance Calculatin Flw CMS Web Interface V2.1 Page 16 f 27 06/25/

17 CMS Web Interface V2.1 Page 17 f 27 06/25/

18 CMS Web Interface V2.1 Page 18 f 27 06/25/

19 Patient Cnfirmatin Flw Fr, cnfirmatin f the Medical Recrd Fund, r indicating the patient is Nt Qualified fr Sample with a reasn f In Hspice, Mved ut f Cuntry, Deceased, r Nn-FFS Medicare, will nly need t be dne nce per patient. Refer t the Measure Submissin Dcument fr further instructins. 1. Start Patient Cnfirmatin Flw. 2. Check t determine if Medical Recrd can be fund. a. If n, Medical Recrd nt fund, mark apprpriately fr cmpletin and stp abstractin. This remves the patient frm the beneficiary sample fr all measures. The patient will be skipped and replaced. Stp prcessing. b. If yes, Medical Recrd fund, cntinue prcessing. 3. Check t determine if Patient Qualified fr the sample. a. If n, the patient des nt qualify fr the sample, select the reasn why and enter the date (if date is unknwn, enter 12/31/) the patient became ineligible fr sample. Fr example; In Hspice, Mved ut f Cuntry, Deceased, Nn-FFS Medicare. Mark apprpriately fr cmpletin and stp abstractin. This remves the patient frm the beneficiary sample fr all measures. The patient will be skipped and replaced. Stp prcessing. b. If yes, the patient des qualify fr the sample; cntinue t the Measure Cnfirmatin Flw fr PREV-13. CMS Web Interface V2.1 Page 19 f 27 06/25/

20 Measure Cnfirmatin Flw fr PREV-13 Fr, measure specific reasns a patient is Nt Cnfirmed r excluded fr Denminatr Exclusin r Other CMS Apprved Reasn will need t be dne fr each measure where the patient appears. Refer t the Measure Submissin Dcument fr further instructins. 1. Start Measure Cnfirmatin Flw fr PREV-13. Cmplete fr cnsecutively ranked patients aged 21 years and lder at the beginning f the measurement perid. Further infrmatin regarding patient selectin fr specific disease and patient care measures can be fund in the CMS Web Interface Sampling Methdlgy Dcument. Fr patients wh have the incrrect date f birth listed, a change f the patient date f birth by the abstractr may result in the patient n lnger qualifying fr the PREV-13 measure. If this is the case, the system will autmatically remve the patient frm the measure requirements. 2. Check t determine if the patient has a diagnsis f ASCVD (active r histry f) at any time up thrugh the last day f the measurement perid. a. If n, the patient des nt have a diagnsis f ASCVD (active r histry f) at any time up thrugh the last day f the measurement perid, cntinue prcessing. b. If yes, the patient des have a diagnsis f ASCVD (active r histry f) at any time up thrugh the last day f the measurement perid, cntinue prcessing and prceed t step Check t determine if the patient has ever had a fasting r direct LDL-C greater than r equal t 190 mg/dl has ever had a diagnsis f familial r pure hyperchlesterlemia (active r histry f) at any time up thrugh the last day f the measurement perid. a. If n, the patient has nt ever had a fasting r direct LDL-C greater than r equal t 190 mg/dl has ever had a diagnsis f familial r pure hyperchlesterlemia (active r histry f) at any time up thrugh the last day f the measurement perid, cntinue prcessing. b. If yes, the patient has ever had a fasting r direct LDL-C greater than r equal t 190 mg/dl has ever had a diagnsis f familial r pure hyperchlesterlemia (active r histry f) at any time up thrugh the last day f the measurement perid, cntinue prcessing and prceed t step Check t determine if the patient is aged years with a diagnsis f Type 1 r Type 2 diabetes. a. If n, the patient is nt aged years r des nt have a diagnsis f Type 1 r Type 2 diabetes, mark apprpriately fr cmpletin and stp abstractin. Patient is remved frm the perfrmance calculatins fr this measure. The patient will be skipped and replaced. Stp prcessing. b. If yes, the patient is aged years with a diagnsis f Type 1 r Type 2 diabetes, cntinue prcessing. 5. Check t determine if highest fasting r direct LDL-C is mg/dl in the measurement perid r tw years prir t the beginning f the measurement perid. a. If n, the highest fasting r direct LDL-C is nt mg/dl in the measurement perid r tw years prir t the beginning f the measurement perid, mark apprpriately fr cmpletin and stp abstractin. Patient is remved frm the perfrmance calculatins fr this measure. The patient will be skipped and replaced. Stp prcessing. b. If yes, the highest fasting r direct LDL-C is mg/dl in the measurement perid r tw years prir t the beginning f the measurement perid, cntinue prcessing. 6. Check t determine if the patient qualifies fr the measure (Denminatr Exclusin). a. If n, the patient des nt qualify fr the measure select: Denminatr Exclusin fr patient disqualificatin. Mark apprpriately fr cmpletin and stp abstractin. Patient is remved frm CMS Web Interface V2.1 Page 20 f 27 06/25/

21 the perfrmance calculatins fr this measure. The patient will be skipped and replaced. Stp prcessing. b. If yes, the patient des qualify fr the measure, cntinue prcessing. 7. Check t determine if the patient qualifies fr the measure (Other CMS Apprved Reasn). a. If n, the patient des nt qualify fr the measure select: N Other CMS Apprved Reasn fr patient disqualificatin. Mark apprpriately fr cmpletin and stp abstractin. Patient is remved frm the perfrmance calculatins fr this measure. The patient will be skipped and replaced. Other CMS Apprved Reasn may nly be selected if yu have received an apprval frm CMS in the reslutin f a requested Quality Payment Prgram Service Desk Inquiry at QPP@cms.hhs.gv. Stp prcessing. b. If yes, the patient des qualify fr the measure, cntinue t the PREV-13 measure flw. CMS Web Interface V2.1 Page 21 f 27 06/25/

22 Measure Flw fr PREV-13 The measure diagrams were develped by CMS as a supplemental resurce t be used in cnjunctin with the measure specificatins. They shuld nt be used as a substitutin fr the measure specificatins. Fr Dwnladable Resurce Mapping Table, g t Appendix II and use the Variable Names lcated in the appendix alng with the applicable tabs within the PREV Cding Dcument. 1. Start prcessing PREV-13 Flw fr the patients that qualified fr the sample in the Patient Cnfirmatin Flw and the Measure Cnfirmatin Flw fr PREV-13. Nte: Include remainder f patients listed in the CMS Web Interface that were cnsecutively cnfirmed and cmpleted fr this measure in the denminatr. Fr the sample calculatin in the flw these patients wuld fall int the d categry (eligible denminatr, i.e. 227 patients). 2. Check t determine if the patient is actively using received an rder fr statin therapy during the measurement perid. a. If n, the patient is nt actively using did nt receive an rder fr statin therapy during the measurement perid, cntinue prcessing. b. If yes, the patient is actively using received an rder fr statin therapy during the measurement perid, perfrmance is met and the patient will be included in the numeratr. Fr the sample calculatin in the flw these patients wuld fall int the a categry (numeratr, i.e. 150 patients). Stp prcessing. 3. Check t determine if the patient is Nt actively using did Nt receive an rder fr statin therapy during the measurement perid fr a denminatr exceptin, medical reasn(s). a. If n, the patient is Nt actively using did Nt receive an rder fr statin therapy during the measurement perid fr a denminatr exceptin, medical reasn(s), perfrmance is nt met and the patient shuld nt be included in the numeratr. Stp prcessing. b. If yes, the patient is Nt actively using did Nt receive an rder fr statin therapy during the measurement perid fr a denminatr exceptin, medical reasn(s), this is a denminatr exceptin and the case shuld be subtracted frm the denminatr. Fr the sample calculatin in the flw these patients wuld fall int the b categry (denminatr exceptin, i.e. 40 patients). Stp prcessing. Sample Calculatin Perfrmance Rate Equals Perfrmance Met is categry a in the measure flw (150 patients) Denminatr is categry d in the measure flw (227 patients) Denminatr Exceptin is categry b in the measure flw (40 patients) 150 (Perfrmance Met) divided by 187 (Denminatr minus Denminatr Exceptin) equals a perfrmance rate f percent Calculatin May Change Pending Perfrmance Met CMS Web Interface V2.1 Page 22 f 27 06/25/

23 Appendix II: Dwnladable Resurce Mapping Table Each data element within this measure s denminatr r numeratr is defined as a pre-determined set f clinical cdes. These cdes can be fund in the CMS Web Interface PREV Cding Dcument. *PREV-13: Statin Therapy fr the Preventin and Treatment f Cardivascular Disease Measure Cmpnent/Excel Data Element Variable Name Cding System(s) Tab Denminatr/Denminatr Cdes ASCVD Diagnsis ANGINA_CODE I9 ATHERO_PAD_CODE I9 CABG_CODE I9 CAROTID_CODE I9 IHD-CODE I9 MI_CODE I9 PCI_CODE STROKE_TIA_CODE I9 LDL-C 190 Hyperchlesterlemia Diabetes AND aged AND LDL-C LDL_CODE HYPERCHOL_CODE DIABETES_DX_CODE LN WITH value 190 I9 I9 AND Aged LDL_CODE LN WITH value Denminatr Exclusin/ Denminatr Exclusin Cdes Exclusin BREASTFEEDING_CODE PREGNANCY_CODE RHABDOMYOLYSIS_CODE Numeratr/Numeratr Drug Statin Therapy STATIN_DRUG_CODE RxNrm (Drug CMS Web Interface V2.1 Page 23 f 27 06/25/

24 Measure Cmpnent/Excel Data Element Variable Name Cding System(s) Tab Cdes EX=N) Denminatr Exceptin/ Denminatr Exceptin Cdes/Denminatr Exceptin Medical Reasn ESRD_CODE I9 Drug Cdes HEPATITIS_A_CODE HEPATITIS_B_CODE LIVER_DISEASE_CODE I9 STATIN_ALLERGEN_CODE RxNrm (Drug EX=Yc) AND dcumented reasn fr nt receiving statin therapy Exclude patients frm Risk Categry 3 with: Diabetes AND Mst recent LDL-C < 70 mg/dl AND Nt taking statin therapy N cding prvided *Fr EHR mapping, PREV-13 cding is cnsidered all-inclusive. CMS Web Interface V2.1 Page 24 f 27 06/25/

25 Appendix III: Measure Ratinale and Clinical Recmmendatin Statements RATIONALE: Cardivascular disease (CVD) is the leading cause f death in the United States, causing apprximately 1 f every 7 deaths in the United States in In 2011, strke caused apprximately 1 f every 20 deaths in the United States.and, the estimated annual csts fr CVD and strke were $320.1 billin, including $195.6 billin in direct csts (hspital services, physicians and ther prfessinals, prescribed medicatins, hme health care, and ther medical durables) and $124.5 billin in indirect csts frm lst future prductivity (cardivascular and strke premature deaths). CVD csts mre than any ther diagnstic grup (Mzaffarian et al., 2015). Data cllected between 2009 and 2012 indicates that mre than 100 millin U.S. adults, 20 years r lder, had ttal chlesterl levels equal t 200 mg/dl r mre, while almst 31 millin had levels 240 mg/dl r mre (Mzaffarian et al., 2015). Elevated bld chlesterl is a majr risk factr fr CVD and statin therapy has been assciated with a reduced risk f CVD. Numerus randmized trials have demnstrated that treatment with a statin reduces LDL-C, and reduces the risk f majr cardivascular events by apprximately 20 percent (Ference, 2015). In 2013, guidelines n the treatment f bld chlesterl t reduce athersclertic cardivascular risk in adults were published (see Stne et al., 2013 ACC/AHA Guideline n the Treatment f Bld Chlesterl t Reduce Athersclertic Cardivascular Risk in Adults: a Reprt f the American Cllege f Cardilgy [ACC]/American Heart Assciatin [AHA] Task Frce n Practice Guidelines). This guideline was published by an Expert Panel, which synthesized evidence frm randmized cntrlled trials t identify peple mst likely t benefit frm chlesterllwering therapy. The ACC/AHA Guideline recmmendatins are intended t prvide a strng evidence-based fundatin fr the treatment f bld chlesterl fr the primary and secndary preventin and treatment f Athersclertic Cardivascular Disease (ASCVD) in adult men and wmen (21 years f age r lder). The dcument cncludes the additin f statin therapy reduces the risk f ASCVD amng high-risk individuals, defined as fllws: individuals with clinical ASCVD, with LDL-C 190 mg/dl, r with diabetes and LDL-C mg/dl (Stne et al., 2013). Hwever, ne study that surveyed U.S. cardivascular practices participating in the PINNACLE registry, fund that 32.4 percent f patients with an indicatin fr statins under the 2013 ACC/AHA chlesterl guidelines were nt currently receiving them (Maddx et al., 2014). Althugh systematic evidence review fund that statins are safe drugs with lw incidence f cnditins r diseases attributable t statin use (Law et al., 2006). Overall, the Statin Safety Expert Panel that participated in an NLA Statin Safety Task Frce meeting in Octber 2013 reaffirms the general safety f statin therapy. The panel members cncluded that fr mst patients requiring statin therapy, the ptential benefits f statin therapy utweigh the ptential risks. In general terms, the benefits f statins t prevent nn-fatal mycardial infarctin, revascularizatin, strke, and CVD mrtality, far utweighs any ptential harm related t the drug (Jacbsn, 2014). CLINICAL RECOMMENDATION STATEMENTS: This electrnic clinical quality measure is intended t align with the 2013 ACC/AHA Guideline n the Treatment f Bld Chlesterl (Stne et al. 2013), which indicates the use f statins as the first line f chlesterl-lwering medicatin therapy t lwer the risk f ASCVD amng at-risk ppulatins. Recmmendatins fr Treatment f Bld Chlesterl t Reduce Athersclertic Cardivascular Risk in Adults Statin Treatment: Secndary Preventin: 1. High-intensity statin therapy shuld be initiated r cntinued as first-line therapy in wmen and men < 75 years f age wh have clinical ASCVD, unless cntraindicated. (Level f Evidence A), (ACC/AHA, 2013) CMS Web Interface V2.1 Page 25 f 27 06/25/

26 2. In individuals with clinical ASCVD in whm high-intensity statin therapy wuld therwise be used, when high-intensity statin therapy is cntraindicated r when characteristics predispsing t statin-assciated adverse effects are present, mderate-intensity statin shuld be used as the secnd ptin, if tlerated. (Level f Evidence A), (ACC/AHA, 2013) Primary Preventin in Individuals 21 Years f Age With LDL-C 190 mg/dl: 2. Adults 21 years f age with primary LDL C 190 mg/dl shuld be treated with statin therapy. (10-year ASCVD risk estimatin is nt required.) (Level f Evidence B), (ACC/AHA, 2013) Primary Preventin in Individuals With Diabetes and LDL-C mg/dl: 1. Mderate-intensity statin therapy shuld be initiated r cntinued fr adults years f age with diabetes. (Level f Evidence A),(ACC/AHA, 2013) Intensity f statin therapy in primary and secndary preventin: The expert panel f the 2013 ACC/AHA Guidelines (Stne et al. 2013) defines recmmended intensity f statin therapy n the basis f the average expected LDL-C respnse t specific statin and dse. Althugh intensity f statin therapy is imprtant in managing chlesterl, this measure assesses prescriptin f ANY statin therapy, irrespective f intensity. Assessment f apprpriate intensity and dsage dcumentatin added t much cmplexity t allw inclusin f statin therapy intensity in the measure at this time. Statin Medicatin Therapy List Generic Name Brand r Trade Name Medicatin Type, If Applicable Atrvastatin Lipitr Statin Fluvastatin Lescl XL r Lescl Statin Lvastatin (Mevinlin) Mevacr r Altprev Statin Pitavastatin Lival Statin Pravastatin Sdium Pravachl Statin Rsuvastatin Calcium Crestr Statin Simvastatin Zcr Statin Amldipine Besylate/Atrvastatin Calcium Caduet Cmbinatin Ezetimibe/Simvastatin Vytrin Cmbinatin NOTE: List des NOT include dsage CMS Web Interface V2.1 Page 26 f 27 06/25/

27 Appendix IV: Use Ntices, Cpyrights, and Disclaimers COPYRIGHT Limited prprietary cding is cntained in the measure specificatins fr cnvenience. Users f the prprietary cde sets shuld btain all necessary licenses frm the wners f these cde sets. Quality Insights, Inc. disclaims all liability fr use r accuracy f any Current Prcedural Terminlgy (CPT ) r ther cding cntained in the specificatins. (CPT ) cntained in the Measure specificatins is cpyright American Medical Assciatin. LOINC cpyright [2.58] Regenstrief Institute, Inc. This material cntains SNOMED Clinical Terms (SNOMED CT ) cpyright [ ] Internatinal Health Terminlgy Standards Develpment Organizatin. All Rights Reserved. THE MEASURES AND SPECIFICATIONS ARE PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND CMS Web Interface V2.1 Page 27 f 27 06/25/

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