Real-world evidence from electronic health records (EHRs) and claims data are being evaluated for use in regulatory decision-making.1,2 The objective of our study was to determine the concordance between EHR and Medicare Part D (MPD) claims data for the receipt of oral anticancer agents, a rapidly growing treatment option for cancer

Giordano, Sharon H.

Holmes, Holly M.

Johnson, Michael L.

Sharma, Manvi

Zhao, Hui

English

eGrove (Univ. of Mississippi)

University of Mississippi eGrove Faculty and Student Publications Pharmacy, School of 4-30-2020 Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use Manvi Sharma University of Mississippi, msharma1@olemiss.edu Michael L. Johnson University of Houston Hui Zhao The University of Texas MD Anderson Cancer Center Sharon H. Giordano The University of Texas MD Anderson Cancer Center Holly M. Holmes University of Texas Health Science Center at Houston Follow this and additional works at: https://egrove.olemiss.edu/pharmacy_facpubs  Part of the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Sharma M, Johnson ML, Zhao H, Giordano SH, Holmes HM. Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use. JAMA Netw Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 This Article is brought to you for free and open access by the Pharmacy, School of at eGrove. It has been accepted for inclusion in Faculty and Student Publications by an authorized administrator of eGrove. For more information, please contact egrove@olemiss.edu. Research Letter | Health PolicyConcordance Between Electronic Health Record DataandMedicare Part D Claims Data for Oral Anticancer Drug UseManvi Sharma, RPh, MBA, MS, PhD; Michael L. Johnson, PhD; Hui Zhao, PhD; Sharon H. Giordano, MD, MPH, FASCO; Holly M. Holmes, MD, MS, AGSFIntroductionReal-world evidence from electronic health records (EHRs) and claims data are being evaluated foruse in regulatory decision-making.1,2 The objective of our study was to determine the concordancebetween EHR and Medicare Part D (MPD) claims data for the receipt of oral anticancer agents, arapidly growing treatment option for cancer.MethodsIn this cross-sectional study, MPD claims were linked with EHRs for patients treated at The Universityof TexasMDAnderson Cancer Center (MDACC) via the Texas Cancer registry. The institutional reviewboards of The University of Texas MDACC, the Texas Cancer Registry, and the Centers for Medicare&Medicaid Services approved this study. Informed consent was waived because this study describedall data in aggregate form, without the identification of any individual participants, and involved nomore thanminimal risk to participants. Furthermore, the waiver would not adversely affect the rightsand welfare of the participants, and the research could not be carried out without the waiver. Thisstudy followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)reporting guideline for cross-sectional studies.Patients were aged 65 years and older; had breast, prostate, kidney, or colon cancer or chronicmyeloid leukemia; andwere enrolled inMPD during treatment atMDACC between January 2007 andDecember 2012. Use of any oral anticancer agent was extracted from theMDACC EHR throughretrospective medical record review of reconciled medication lists, pharmacy records, and clinicnotes (eFigure in the Supplement). The EHR did not have computerized order entry, and thus, thedata reflect medication reconciliation, indicating potential use of a medication. Event files in MPDclaims data were searched to identify claims for any oral anticancer drug for each patient and toreflect prescriptions that were actually dispensed to patients.Data analysis was conducted fromNovember 2017 to April 2019, in SAS Enterprise Guide 6.1(SAS Institute). We ascertained EHR andMPD concordance rates with κ statistics after matching drugname and requiring overlapping treatment dates. No prespecified level of significance was set.ResultsThe study sample consisted of 208 EHRmedication records and 250MPD claims for 170 patients.Patients had a median (interquartile range) age of 69 (65-73) years, and 106 (62.4%) were men.There were 22 different oral anticancer drugs evaluated (Box). Bicalutamide (74 records [29.6%] inMPD, 54 records [25.9%] in EHR), anastrozole (36 [14.4%] in MPD, 34 [16.3%] in EHR), andpazopanib (25 [10.0%] in MPD, 18 [8.6%] in EHR) were themost frequently used drugs. The overallpercentage agreement between the 2 data sets was 73.8%, inwhich 176 events were yes in both datasets and 123 eventswere no in both data sets. The percentage disagreementwas 26.2%, inwhich 74MPD claims (18.3%) were not found in the EHR, and 32 EHR drugs (7.9%) were not found in theMPD(κ = 0.47; 95% CI, 0.39-0.56) (Table).Box. List of Oral Anticancer DrugsAssessed for Use1. Abiraterone2. Anastrozole3. Axitinib4. Bicalutamide5. Dasatinib6. Diethyl Stilbestrol7. Enzalutamide8. Erlotinib9. Estramustine10. Everolimus11. Exemestane12. Flutamide13. Hydroxyurea14. Imatinib15. Letrozole16. Nilotinib17. Nilutamide18. Pazopanib19. Sorafenib20. Sunitinib21. Tamoxifen22. Thalidomide+ Supplemental contentAuthor affiliations and article information arelisted at the end of this article.Open Access. This is an open access article distributed under the terms of the CC-BY License.JAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 1/3Downloaded From: https://jamanetwork.com/ on 06/11/2020DiscussionThemoderate rate of agreement (ie, 73.8%) found in this studymay be because of various reasons.The EHR may be missing oral anticancer use for patients receiving only a consultation or because ofincompletemedication reconciliation ormedical record information. Claims inMPDmay bemissingbecause patients could obtain medications by other means that do not result in an MPD claim,including discount or other assistance programs. Du et al3 reported a 96% rate of agreement with aκ of 0.72 (95% CI, 0.64-0.79) between a tumor registry and medical records for tamoxifen oraromatase-inhibitors for breast cancer. Lund et al4 reported 55% sensitivity and 47% specificity ofMedicare claims to identify the use of capecitabine when compared with data from the NationalCancer Institute Patterns of Care study. However, to our knowledge, our study was the first tocompare MPD claims with EHR data for use of oral anticancer agents. A potential limitation of thisstudy is that it was a single site study, thus the results may not be generalizable to all MPD claims.This study provides an estimate of the potential information difference that may be presentwhen EHR or claims data alone are used, with important implications for studies of oral anticancerdrug use patterns, drug spending, outcomes, and quality measures. For the drugs that are in the EHRbut are missing fromMPD (8%), there is concern regarding how to fully evaluate the use of costlyanticancer drugs using MPD data.2,5 For the drugs that are in theMPD but are missing in EHR (18%),there is concern regarding the completeness of utilization patterns that are generated basedon EHR.6A data linkage between EHR and administrative claims would potentially improve the captureof exposures and outcomes and thus produce better quality data that could be used in regulatorydecision-making.ARTICLE INFORMATIONAccepted for Publication:March 2, 2020.Published: April 30, 2020. doi:10.1001/jamanetworkopen.2020.3821Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 SharmaMet al. JAMA Network Open.Corresponding Author:Manvi Sharma, RPh, MBA, MS, PhD, Department of Pharmacy Administration, School ofPharmacy, The University of Mississippi, PO Box 1848, Faser Hall 235, Oxford, MS 38677 (msharma1@olemiss.edu).Author Affiliations:Department of Pharmacy Administration, School of Pharmacy, The University of Mississippi,Oxford (Sharma); Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University ofHouston, Houston, Texas (Johnson); Department of Health Services Research, The University of Texas MDAnderson Cancer Center, Houston (Zhao, Giordano); Division of Geriatric and Palliative Medicine, McGovernMedical School, The University of Texas Health Science Center, Houston (Holmes).Author Contributions:Drs Sharma and Zhao had full access to all of the data in the study and take responsibilityfor the integrity of the data and the accuracy of the data analysis.Concept and design: Sharma, Johnson, Zhao, Holmes.Acquisition, analysis, or interpretation of data: All authors.Drafting of the manuscript: Sharma.Critical revision of the manuscript for important intellectual content: All authors.Table. Comparison of Oral Anticancer Drug Claims Between Electronic Health Records andMedicare Part DOral anticancer drugs in electronic health recordsOral anticancer drugs in Medicare Part D claimsYes No TotalYes 176 32 208No 74 123 197Total 250 155 405JAMANetworkOpen | Health Policy Electronic Health Record Data andMedicare Part D Claims Data for Oral Anticancer Drug UseJAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 2/3Downloaded From: https://jamanetwork.com/ on 06/11/2020Statistical analysis: Sharma, Johnson, Zhao.Administrative, technical, or material support: Zhao, Giordano.Supervision: Johnson, Holmes.Conflict of Interest Disclosures:Dr Holmes reported receiving grants fromHealth Care Services Corporationoutside the submitted work. No other disclosures were reported.Funding/Support: This study was supported by grant P30 CA016672 from the National Cancer Institute to MDAnderson Cancer Center support grant. Dr Giordano is supported by grant RP160674 from the Cancer Preventionand Research Institute of Texas and grant SAC150061 from Susan GKomen. Dr Holmeswas supported by internaldepartment funds fromMcGovernMedical School.Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection,management, analysis, and interpretation of the data; preparation, review, or approval of themanuscript; anddecision to submit themanuscript for publication.REFERENCES1. US Food and Drug Administration. Framework for FDA’s real-world evidence program. Published December2018. Accessed June 3, 2019. https://www.fda.gov/media/120060/download2. Dusetzina SB, Huskamp HA, Keating NL. Specialty drug pricing and out-of-pocket spending on orallyadministered anticancer drugs in Medicare Part D, 2010 to 2019. JAMA. 2019;321(20):2025-2027. doi:10.1001/jama.2019.44923. Du XL, Key CR, Dickie L, Darling R, Geraci JM, Zhang D. External validation of Medicare claims for breast cancerchemotherapy compared with medical chart reviews.Med Care. 2006;44(2):124-131. doi:10.1097/01.mlr.0000196978.34283.a64. Lund JL, Stürmer T, Harlan LC, et al. Identifying specific chemotherapeutic agents in Medicare data: a validationstudy.Med Care. 2013;51(5):e27-e34. doi:10.1097/MLR.0b013e31823ab60f5. Huntington SF, Davidoff AJ. High-cost, high-value oral specialty drugs: more evidence on the impact of costsharing in Medicare Part D. J Clin Oncol. 2016;34(36):4307-4309. doi:10.1200/JCO.2016.70.27386. Malangone-Monaco E, Foley K, Varker H, Wilson KL, McKenzie S, Ellis L. Prescribing patterns of oralantineoplastic therapies observed in the treatment of patients with advanced prostate cancer between 2012 and2014: results of an oncology EMR analysis. Clin Ther. 2016;38(8):1817-1824. doi:10.1016/j.clinthera.2016.07.004SUPPLEMENT.eFigure.Detailed Methods for the Study and the Process of Manual Chart ReviewJAMANetworkOpen | Health Policy Electronic Health Record Data andMedicare Part D Claims Data for Oral Anticancer Drug UseJAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 3/3Downloaded From: https://jamanetwork.com/ on 06/11/2020

Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use

University of Mississippi eGrove Faculty and Student Publications Pharmacy, School of 4-1-2020 Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use Manvi Sharma University of Mississippi Michael L. Johnson University of Houston Hui Zhao University of Texas MD Anderson Cancer Center Sharon H. Giordano University of Texas MD Anderson Cancer Center Holly M. Holmes University of Texas Health Science Center at Houston Follow this and additional works at: https://egrove.olemiss.edu/pharmacy_facpubs  Part of the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Sharma, M., Johnson, M. L., Zhao, H., Giordano, S. H., & Holmes, H. M. (2020). Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use. JAMA Network Open, 3(4), e203821. https://doi.org/10.1001/jamanetworkopen.2020.3821 This Article is brought to you for free and open access by the Pharmacy, School of at eGrove. It has been accepted for inclusion in Faculty and Student Publications by an authorized administrator of eGrove. For more information, please contact egrove@olemiss.edu. Research Letter | Health PolicyConcordance Between Electronic Health Record Dataand Medicare Part D Claims Data for Oral Anticancer Drug UseManvi Sharma, RPh, MBA, MS, PhD; Michael L. Johnson, PhD; Hui Zhao, PhD; Sharon H. Giordano, MD, MPH, FASCO; Holly M. Holmes, MD, MS, AGSFIntroductionReal-world evidence from electronic health records (EHRs) and claims data are being evaluated foruse in regulatory decision-making.1,2 The objective of our study was to determine the concordancebetween EHR and Medicare Part D (MPD) claims data for the receipt of oral anticancer agents, arapidly growing treatment option for cancer.MethodsIn this cross-sectional study, MPD claims were linked with EHRs for patients treated at The Universityof Texas MD Anderson Cancer Center (MDACC) via the Texas Cancer registry. The institutional reviewboards of The University of Texas MDACC, the Texas Cancer Registry, and the Centers for Medicare& Medicaid Services approved this study. Informed consent was waived because this study describedall data in aggregate form, without the identification of any individual participants, and involved nomore than minimal risk to participants. Furthermore, the waiver would not adversely affect the rightsand welfare of the participants, and the research could not be carried out without the waiver. Thisstudy followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)reporting guideline for cross-sectional studies.Patients were aged 65 years and older; had breast, prostate, kidney, or colon cancer or chronicmyeloid leukemia; and were enrolled in MPD during treatment at MDACC between January 2007 andDecember 2012. Use of any oral anticancer agent was extracted from the MDACC EHR throughretrospective medical record review of reconciled medication lists, pharmacy records, and clinicnotes (eFigure in the Supplement). The EHR did not have computerized order entry, and thus, thedata reflect medication reconciliation, indicating potential use of a medication. Event files in MPDclaims data were searched to identify claims for any oral anticancer drug for each patient and toreflect prescriptions that were actually dispensed to patients.Data analysis was conducted from November 2017 to April 2019, in SAS Enterprise Guide 6.1(SAS Institute). We ascertained EHR and MPD concordance rates with κ statistics after matching drugname and requiring overlapping treatment dates. No prespecified level of significance was set.ResultsThe study sample consisted of 208 EHR medication records and 250 MPD claims for 170 patients.Patients had a median (interquartile range) age of 69 (65-73) years, and 106 (62.4%) were men.There were 22 different oral anticancer drugs evaluated (Box). Bicalutamide (74 records [29.6%] inMPD, 54 records [25.9%] in EHR), anastrozole (36 [14.4%] in MPD, 34 [16.3%] in EHR), andpazopanib (25 [10.0%] in MPD, 18 [8.6%] in EHR) were the most frequently used drugs. The overallpercentage agreement between the 2 data sets was 73.8%, in which 176 events were yes in both datasets and 123 events were no in both data sets. The percentage disagreement was 26.2%, in which 74MPD claims (18.3%) were not found in the EHR, and 32 EHR drugs (7.9%) were not found in the MPD(κ = 0.47; 95% CI, 0.39-0.56) (Table).Box. List of Oral Anticancer DrugsAssessed for Use1. Abiraterone2. Anastrozole3. Axitinib4. Bicalutamide5. Dasatinib6. Diethyl Stilbestrol7. Enzalutamide8. Erlotinib9. Estramustine10. Everolimus11. Exemestane12. Flutamide13. Hydroxyurea14. Imatinib15. Letrozole16. Nilotinib17. Nilutamide18. Pazopanib19. Sorafenib20. Sunitinib21. Tamoxifen22. Thalidomide+ Supplemental contentAuthor affiliations and article information arelisted at the end of this article.Open Access. This is an open access article distributed under the terms of the CC-BY License.JAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 1/3Downloaded From: https://jamanetwork.com/ on 03/10/2021DiscussionThe moderate rate of agreement (ie, 73.8%) found in this study may be because of various reasons.The EHR may be missing oral anticancer use for patients receiving only a consultation or because ofincomplete medication reconciliation or medical record information. Claims in MPD may be missingbecause patients could obtain medications by other means that do not result in an MPD claim,including discount or other assistance programs. Du et al3 reported a 96% rate of agreement with aκ of 0.72 (95% CI, 0.64-0.79) between a tumor registry and medical records for tamoxifen oraromatase-inhibitors for breast cancer. Lund et al4 reported 55% sensitivity and 47% specificity ofMedicare claims to identify the use of capecitabine when compared with data from the NationalCancer Institute Patterns of Care study. However, to our knowledge, our study was the first tocompare MPD claims with EHR data for use of oral anticancer agents. A potential limitation of thisstudy is that it was a single site study, thus the results may not be generalizable to all MPD claims.This study provides an estimate of the potential information difference that may be presentwhen EHR or claims data alone are used, with important implications for studies of oral anticancerdrug use patterns, drug spending, outcomes, and quality measures. For the drugs that are in the EHRbut are missing from MPD (8%), there is concern regarding how to fully evaluate the use of costlyanticancer drugs using MPD data.2,5 For the drugs that are in the MPD but are missing in EHR (18%),there is concern regarding the completeness of utilization patterns that are generated basedon EHR.6A data linkage between EHR and administrative claims would potentially improve the captureof exposures and outcomes and thus produce better quality data that could be used in regulatorydecision-making.ARTICLE INFORMATIONAccepted for Publication: March 2, 2020.Published: April 30, 2020. doi:10.1001/jamanetworkopen.2020.3821Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Sharma Met al. JAMA Network Open.Corresponding Author: Manvi Sharma, RPh, MBA, MS, PhD, Department of Pharmacy Administration, School ofPharmacy, The University of Mississippi, PO Box 1848, Faser Hall 235, Oxford, MS 38677 (msharma1@olemiss.edu).Author Affiliations: Department of Pharmacy Administration, School of Pharmacy, The University of Mississippi,Oxford (Sharma); Department of Pharmaceutical Health Outcomes and Policy, College of Pharmacy, University ofHouston, Houston, Texas (Johnson); Department of Health Services Research, The University of Texas MDAnderson Cancer Center, Houston (Zhao, Giordano); Division of Geriatric and Palliative Medicine, McGovernMedical School, The University of Texas Health Science Center, Houston (Holmes).Author Contributions: Drs Sharma and Zhao had full access to all of the data in the study and take responsibilityfor the integrity of the data and the accuracy of the data analysis.Concept and design: Sharma, Johnson, Zhao, Holmes.Acquisition, analysis, or interpretation of data: All authors.Drafting of the manuscript: Sharma.Critical revision of the manuscript for important intellectual content: All authors.Table. Comparison of Oral Anticancer Drug Claims Between Electronic Health Records and Medicare Part DOral anticancer drugs in electronic health recordsOral anticancer drugs in Medicare Part D claimsYes No TotalYes 176 32 208No 74 123 197Total 250 155 405JAMA Network Open | Health Policy Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug UseJAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 2/3Downloaded From: https://jamanetwork.com/ on 03/10/2021Statistical analysis: Sharma, Johnson, Zhao.Administrative, technical, or material support: Zhao, Giordano.Supervision: Johnson, Holmes.Conflict of Interest Disclosures: Dr Holmes reported receiving grants from Health Care Services Corporationoutside the submitted work. No other disclosures were reported.Funding/Support: This study was supported by grant P30 CA016672 from the National Cancer Institute to MDAnderson Cancer Center support grant. Dr Giordano is supported by grant RP160674 from the Cancer Preventionand Research Institute of Texas and grant SAC150061 from Susan G Komen. Dr Holmes was supported by internaldepartment funds from McGovern Medical School.Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection,management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; anddecision to submit the manuscript for publication.REFERENCES1. US Food and Drug Administration. Framework for FDA’s real-world evidence program. Published December2018. Accessed June 3, 2019. https://www.fda.gov/media/120060/download2. Dusetzina SB, Huskamp HA, Keating NL. Specialty drug pricing and out-of-pocket spending on orallyadministered anticancer drugs in Medicare Part D, 2010 to 2019. JAMA. 2019;321(20):2025-2027. doi:10.1001/jama.2019.44923. Du XL, Key CR, Dickie L, Darling R, Geraci JM, Zhang D. External validation of Medicare claims for breast cancerchemotherapy compared with medical chart reviews. Med Care. 2006;44(2):124-131. doi:10.1097/01.mlr.0000196978.34283.a64. Lund JL, Stürmer T, Harlan LC, et al. Identifying specific chemotherapeutic agents in Medicare data: a validationstudy. Med Care. 2013;51(5):e27-e34. doi:10.1097/MLR.0b013e31823ab60f5. Huntington SF, Davidoff AJ. High-cost, high-value oral specialty drugs: more evidence on the impact of costsharing in Medicare Part D. J Clin Oncol. 2016;34(36):4307-4309. doi:10.1200/JCO.2016.70.27386. Malangone-Monaco E, Foley K, Varker H, Wilson KL, McKenzie S, Ellis L. Prescribing patterns of oralantineoplastic therapies observed in the treatment of patients with advanced prostate cancer between 2012 and2014: results of an oncology EMR analysis. Clin Ther. 2016;38(8):1817-1824. doi:10.1016/j.clinthera.2016.07.004SUPPLEMENT.eFigure. Detailed Methods for the Study and the Process of Manual Chart ReviewJAMA Network Open | Health Policy Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug UseJAMA Network Open. 2020;3(4):e203821. doi:10.1001/jamanetworkopen.2020.3821 (Reprinted) April 30, 2020 3/3Downloaded From: https://jamanetwork.com/ on 03/10/2021

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Concordance Between Electronic Health Record Data and Medicare Part D Claims Data for Oral Anticancer Drug Use

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