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Development and Utility of the Observational Research in Oncology Toolbox: Cancer Medications Enquiry Database-Healthcare Common Procedure Coding System (HCPCS)

Development and Utility of the Observational Research in Oncology Toolbox: Cancer Medications... Purpose: Health-care claims are of increasing utility as a rich, real-world data resource for conducting treatment-related can- cer research. However, multiple dynamic coding nomenclatures exist, leading to study variability. To promote increased standardization and reproducibility, the National Cancer Institute (NCI) developed the Cancer Medications Enquiry Database (CanMED)-Healthcare Common Procedure Coding System (HCPCS) within the Observational Research in Oncology Toolbox. Methods: The CanMED-HCPCS includes codes for oncology medications that a) have a US Food and Drug Administration- approved indication for cancer treatment or treatment-related symptom management; b) are present in National Comprehensive Cancer Network guidelines; or c) carry an orphan drug designation for treatment or management of cancer. Included medications and their HCPCS codes were primarily identified based on Center for Medicare and Medicaid Services annual HCPCS Indices (2012–2018). To demonstrate the utility of the CanMED-HCPCS, use of systemic treatment for stage II– IV colorectal cancer patients included in the Surveillance, Epidemiology, and End Results-Medicare data (2007–2013) was assessed. Results: The CanMED-HCPCS (v2018) includes 332 HCPCS codes for cancer-related medications: chemotherapy (156), immu- notherapy (74), hormonal therapy (54), and ancillary therapy (48). Observed treatment trends within the NCI Surveillance, Epidemiology, and End Results-Medicare data were as expected; utilization of each treatment type increased with stage, and immunotherapy was largely confined to use among stage IV patients. Conclusion: The CanMED-HCPCS provides a comprehensive resource that can be used by the research community to facili- tate systematic identification of medications within claims or electronic health data using the HCPCS nomenclature and greater reproducibility of cancer surveillance and health services research. Healthcare claims are often queried to identify receipt of ther- Surveillance, Epidemiology, and End Results (SEER) Program- apy for observational cancer research. Such studies, including Medicare data, which is a linkage of the SEER Program those conducted using the National Cancer Institute (NCI) population-based cancer registry data with Medicare Received: September 23, 2019; Accepted: October 16, 2019 Published by Oxford University Press 2020. This work is written by US Government employees and is in the public domain in the US. 39 Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 40 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 enrollment and claims data (1), rely on the accurate identifica- addition, any oncology medications listed in the SEER*Rx data- tion of individual medications using codes listed on the health- base meeting the above criteria were included. The medications care claims. The Healthcare Common Procedure Coding System identified from either list were reviewed to remove duplicates, (HCPCS) is one of the primary nomenclatures used for coding misclassified medications (eg, those not actually used for medication dispensing and administrative billing (2). cancer-related treatment), and experimental drugs (eg, clinical Observational studies have identified trends in the utiliza- trial use exclusively). The combined list of medications was tion, cost, and effectiveness for cancer treatments by assessing then cross-referenced with two commercially available drug which HCPCS codes are included on administrative claims (3–5). databases, Micromedex and Lexicomp (8,9), to further ensure However, varying definitions of cancer therapies (eg, what con- completeness. Only FDA-approved medications were eligible for stitutes chemotherapy vs immunotherapy, modes of adminis- inclusion; thus, approval status was verified via Drugs@FDA tration considered, and relevant medications included), the (10). Medications that are no longer FDA approved are retained extensive number of HCPCS codes, and the frequent addition to allow for retrospective assessments. Each of the above steps and retirement of HCPCS codes have made comparisons and was validated independently by two pharmacists. evaluation of treatment across studies challenging. Varying therapy definitions, which have been especially common in Treatment Categories cancer care research because of the rapid approval of new ther- To ensure consistency with cancer surveillance efforts within the apies, can affect study design (eg, study population and data SEER cancer registries, oncologic medications were assigned to a sources), misclassification, and, thus, results. mutually exclusive treatment category: chemotherapy, immuno- Improved standardized capture of cancer treatments in ob- therapy, hormonal therapy, and ancillary therapy. Chemotherapy servational oncology research is essential for comparability of is defined as systemic treatment that targets various phases of results and reproducibility. In supporting this goal, the NCI is the cell cycle to destroy cancer cells or interrupt cellular signaling developing the Observational Research in Oncology Toolbox, through targeted inhibition of key pathways (11). Immunotherapy which was conceptualized to guide systematic, standardized, is defined as systemic treatment that primarily targets an im- and reproducible research for observational studies that require mune response and mediates tumor growth through immune the use of specialized ontologies or nomenclatures during study modification (eg, monoclonal antibodies, checkpoint inhibitors, design. The first publicly available resource within the toolbox and vaccines). Hormonal therapy, which is used to treat hormon- is the Cancer Medications Enquiry Database (CanMED), which ally linked cancers (eg, breast and prostate cancers), is defined as includes comprehensive, queryable, ontologic databases of US functional endocrine modifiers that affect hormone production Food and Drug Administration (FDA)-approved cancer medica- and reduce tumor effects. Ancillary medications are defined as tions and their associated codes. medications required for or directly associated with the adminis- The focus of this article is the CanMED-HCPCS, which is a tration of chemotherapy, immunotherapy, or hormonal therapy. database of oncology medications and associated HCPCS codes. Many drugs that are used for the management of disease onset, The aims of this article are to provide a methodological descrip- cancer progression, and treatment exacerbations could be tion of how this database was created and to demonstrate its included as ancillary medications; however, here, ancillary medi- utility by examining trends in colorectal cancer (CRC) systemic cations are restricted to chemotherapy administration-related treatment. medications or medications specially given for treatment-related symptom management. Methods HCPCS Nomenclature HCPCS codes can be divided into two components: Level I codes CanMED-HCPCS Development managed by the American Medical Association as Common Data Sources Procedure Terminology (CPT) and Level II codes managed by the Multiple data sources were reviewed to ensure a comprehensive CMS (2). CPT/Level I HCPCS, or CPT codes, were first developed list of oncology medications, and associated HCPCS codes were in 1966. Level II HCPCS are five-digit alphanumeric codes that included in CanMED-HCPCS. The two primary data sources uti- were introduced by CMS in 1978 for reimbursement of items lized were the Center for Medicare and Medicaid Services (CMS) and services not covered by the CPT/Level I codes, including the HCPCS Indices, which include all HCPCS drug codes approved administration of cancer-related medications and subsequently for Medicare billing purposes (6), and the SEER*Rx database, adopted by other health care insurers. With each Level II HCPCS which was created by the NCI to facilitate the coding of cancer code, the letter indicates the type of code (eg, J: permanent medications and for use in the development of regimen ontolo- codes for medications; C: temporary codes using the outpatient gies for cancer registry data (7). FDA and commercially available perspective payment system) (12). Level III HCPCS codes were drug databases were also cross-referenced and reviewed to en- discontinued in 2003 in response to legal requirements that sure completeness, as described in more detail below (8,9). CMS have a uniform coding system. In the CanMED-HCPCS, only Level II HCPCS codes are included. Discontinued HCPCS codes are retained with a discontinuation date to allow for his- Oncology Medication Inclusion Strategy toric analyses. Oncology medications were eligible for inclusion in the CanMED-HCPCS if they a) had an FDA-approved indication for cancer treatment or treatment-related symptom management, Special Methodological Considerations b) were present in the National Comprehensive Cancer Network Medications used to treat cancer can be used for other disease (NCCN) guidelines, or c) carried an orphan drug designation for indications. For example, erythropoietin has a different HCPCS the treatment or management of cancer. code when used to treat anemia secondary to cancer treatment The CMS HCPCS Indices were reviewed from 2012 to 2018 to effects than when used to treat anemia secondary to end-stage identify Medicare-reimbursable cancer-related medications. In renal disease. The CanMED-HCPCS is cancer focused and thus Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 D. R. Rivera et al. |41 Figure 1. Cancer Medication Enquiry Database-Healthcare Common Procedure Coding System (CanMED-HCPCS) Database Interface. only includes HCPCS codes for oncologic medications. search, for example, to medications that were approved during a Assessing utilization of erythropoietin for cancer treatment us- certain time period or to a specific treatment category (eg, chemo- ing all erythropoietin HCPCS codes could result in overestima- therapy, immunotherapy, hormone therapy, or ancillary ther- tion and misclassification, whereas limiting to cancer-related apy). The specific variables available in the CanMED-HCPCS HCPCS codes should result in more accurate cancer-related uti- include HCPCS code, Generic Name, Brand Name, Strength, lization, assuming the accurate code was listed on the health SEER*Rx Category, Major Drug Class, Minor Drug Class, Oral care claim. There are other ancillary medications, such as predni- Treatment Indicator, FDA Approval Year, FDA Discontinuation sone, that can be used broadly for noncancer indications and do Year, CMS Effective Date, CMS Discontinuation Date, and Status not have cancer-specific HCPCS codes. As a result, certain ancil- of Product in Use. Query results are exportable to Excel for use lary therapy HCPCS codes included in the CanMED-HCPCS are not with common programming languages such as SAS and R. indication specific. Additionally, sometimes there is lag-time between when a medication is approved for use and when a HCPCS code is Use-Case Example assigned. To make the CanMED-HCPCS as comprehensive as To demonstrate the utility of the CanMED-HCPCS for cancer re- possible, all identified cancer-related systemic medications are search, systemic treatment patterns for CRC patients in the included regardless of whether the medication has or will have SEER-Medicare database were assessed. Patients were included an associated HCPCS code. As such, if an identified medication if they were diagnosed with a first primary CRC between 2007 did not have a HCPCS code when the CanMED-HCPCS was last and 2013 at age 66 or older and survived for at least 6 months af- updated, the HCPCS code will be listed as not available (“NA”). ter diagnosis. Patients also had to have continuous fee-for-ser- Finally, HCPCS codes are primarily used for parenteral medi- vice Medicare Part A and B from diagnosis through 6 months cations; however, some oral medications are assigned HCPCS postdiagnosis. Systemic therapy is guideline recommended for codes such as alternatives to intravenously administered medi- patients diagnosed with stages II-IV CRC (Derived AJCC Stage, cations (eg, capecitabine) or medications with very specific ad- 6th ed.); therefore, patients with earlier or unknown stage dis- ministration guidelines that allow for initial dosing of certain ease were excluded. oral medications (eg, imatinib). Therefore, some oral medica- The assessment of medication use was based on Medicare tions are included in the CanMED-HCPCS; these medications Part B claims through 2014; Medicare Part A and Part D claims are easily identifiable via the oral treatment indicator variable. do not include HCPCS codes and, thus, were not considered. Medications assessed were identified using the NCCN guide- lines, which allowed for characterization of stage-specific CanMED-HCPCS Database Interface treatment. The corresponding HCPCS codes for the guideline- The CanMED-HCPCS interface includes features that can be used recommended medications were identified using the to search by specific drug name (brand or generic) to identify all CanMED-HCPCS and aggregated by treatment category. related HCPCS codes or, conversely, search by HCPCS code to Chemotherapies that are used to treat CRC but are only ad- identify a drug name (Figure 1). In addition, the user can limit the ministered orally (eg, regorafenib, trifluridine, and tipiracil) Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 42 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 are billed using National Drug Codes (NDCs) and were not assessed; these medications are not reported to CMS via HCPCS codes and were, thus, beyond the objective of this study. An exception is capecitabine; as an orally administered prodrug of the IV-administered 5-Flurouracil, it is covered un- der Medicare Part B and thus has been assigned HCPCS codes. Although capecitabine is known to be underascertained in Medicare Part B claims, it was included (13). Hormonal therapy was also not assessed because it is not a CRC guideline-recom- mended treatment. Descriptive statistics assessing the receipt of each treatment category within 6 months of diagnosis, overall and by stage and calendar year, were calculated to describe treatment trends. Results The CanMED-HCPCS (11_2018v1.2.4) includes 496 entries and 332 HCPCS codes for oncology medications: chemotherapy (156), immunotherapy (74), hormonal therapy (54), and ancillary therapy (48) (14). Output from the CanMED-HCPCS allows for the tracking of specific medications to different classification groups. Additional detail on how the medications were mapped to the categories, and major and minor drug classifications, is provided in Supplementary Table 1 (available online). For exam- ple, bevacizumab was classified as immunotherapy; major class: monoclonal antibody; minor class: VEGFR. Use-Case Example Medications included in the NCCN Guidelines for CRC treatment were identified using the CanMED-HCPCS as shown in Table 1. From 2007 to 2013, there were 34 114 patients in the SEER- Medicare data diagnosed with stage II-IV CRC: 44.2% with stage II, 37.5% with stage III, and 18.3% with stage IV (Table 2). During the study period, guideline-directed chemotherapy was admin- istered in 12.2% (annual range ¼ 14.2–9.7%) of stage II patients, 46.7% (annual range ¼ 48.6–44.4%) of stage III patients, and 60.5% (annual range ¼ 58.8–63.4%) of stage IV patients. Similar trends by stage and year were observed for ancillary therapy. Due to low utilization among stage II–III patients (and lack of guideline recommendations), trends in immunotherapy were only reported among stage IV patients. Overall, 41.0% of stage IV patients received immunotherapy (annual range ¼ 38.0–42.9%). Discussion The primary objective of the CanMED-HCPCS is to provide a cur- rent, comprehensive resource that provides a standardized method of identifying HCPCS codes for systemic oncology medi- cations or, conversely, the identification of medications associ- ated with HCPCS codes extracted from claims. Cancer registries can use the CanMED-HCPCS to appropriately identify medica- tions for registry operations, such as case finding or supple- menting registry treatment data using health-care claims. Additionally, the broader cancer research community can use the CanMED-HCPCS to more quickly identify necessary HCPCS codes (eg, for a specific treatment category, drug class, or agent) and increase comparability or reproducibility with other cancer- related studies. The SEER-Medicare use-case example served as a demon- stration of the utility of the CanMED-HCPCS to standardize the identification and categorization of cancer-related medications Table 1. NCCN Guideline-Recommended CRC treatment and associated CanMED-HCPCS*,† variables for assessing treatment trends in SEER-Medicare, 2007–2013 Administration FDA Stage Stage Stage FDA NCCN Generic Brand route approval Category II III IV indication guidelines HCPCS Bevacizumab Avastin IV 2004 Immunotherapy X Y Y Q2024 C9257 C9214 J9035 S0116 Cetuximab Erbitux IV 2004 Immunotherapy X Y Y C9215 J9055 Fluorouracil Adrucil IV 1962 Chemotherapy X X X Y (only stage IV) Y J9190 Irinotecan Camptosar IV 1996 Chemotherapy X Y (only stage IV) Y J9206 C9474 Leucovorin Calcium Wellcovorin IV only indicated 1952 Chemotherapy X X X Y Y J0640 Levoleucovorin Fusilev IV 2008 Chemotherapy X X Y (only stage IV) Y J0641 Oxaliplatin Eloxatin IV 2002 Chemotherapy X X X Y Y C9205 J9263 Panitumumab Vectibix IV 2006 Immunotherapy X Y Y C9235 J9303 Pembrolizumab Keytruda IV 2014 Immunotherapy X Y Y C9027 J9271 Ramucirumab Cyramza IV 2014 Immunotherapy X Y Y C9025 J9308 Ziv-aflibercept Zaltrap IV 2012 Chemotherapy X Y Y C9296 J9400 Capecitabine Xeloda Oral 1998 Chemotherapy X X X Y Y J8520 J8521 *CanMED-HCPCS (Version 2018) is available at: https://seer.cancer.gov/oncologytoolbox/canmed/hcpcs/. CRC ¼ colorectal cancer; CanMED-HCPCS ¼ Cancer Medications Enquiry Database-Healthcare Common Procedure Coding System; FDA ¼ US Food and Drug Administration; NCCN ¼ National Comprehensive Cancer Network; SEER ¼ National Cancer Institute Surveillance, Epidemiology, and End Results. †The following drugs were excluded because they are not captured by HCPCS claims: regorafenib (oral), trifluridine, and tipiracil (oral). For the purposes of this analysis, capecitabine was included; however, given it is an oral agent, it may be underascertained. Assessment of oral agents should include claims billed using National Drug Codes. Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 D. R. Rivera et al. |43 Table 2. Trends in the receipt of NCCN guideline-recommended treatment among colorectal cancer patients diagnosed between 2007–2013 in SEER-Medicare using medication codes identified via the CanMED-HCPCS v.2018. Stage II Stage III Stage IV Received Received any Received Received Received Received Received recommended* ancillary recommended* any ancillary recommended* any ancillary any chemotherapy therapy† chemotherapy therapy† chemotherapy therapy† immunotherapy‡ Year of Total Total Total diagnosis No. No. % No. % No. No. % No. % No. No. % No. % No. % 2007 2477 351 14.2 352 14.2 2170 1054 48.6 1014 46.7 938 552 58.8 538 57.4 392 41.8 2008 2400 319 13.3 300 12.5 2018 938 46.5 915 45.3 944 564 59.7 545 57.7 389 41.2 2009 2180 283 13.0 272 12.5 1883 904 48.0 862 45.8 926 550 59.4 538 58.1 379 40.9 2010 2147 273 12.7 240 11.2 1743 819 47.0 770 44.2 947 584 61.7 566 59.8 406 42.9 2011 2054 233 11.3 191 9.3 1758 791 45.0 708 40.3 856 516 60.3 487 56.9 325 38.0 2012 2034 204 10.0 178 8.8 1682 789 46.9 743 44.2 817 491 60.1 475 58.1 321 39.3 2013 1775 173 9.7 153 8.6 1542 685 44.4 653 42.3 823 522 63.4 513 62.3 348 42.3 Total 15 067 1836 12.2 1686 11.1 12 796 5980 46.7 5665 44.3 6251 3779 60.5 3662 58.6 2560 41.0 *Recommended chemotherapy by stage: stage II included capecitabine, fluorouracil, leucovorin calcium, or oxaliplatin; stage III included capecitabine, fluorouracil, leucovorin calcium, levoleucovorin, or oxaliplatin; and stage IV included capecitabine, fluorouracil, irinotecan, leucovorin calcium, levoleucovorin, oxaliplatin, or ziv-aflibercept. CanMED-HCPCS ¼ Cancer Medication Enquiry Database-Healthcare Common Procedure Coding System; NCCN ¼ National Comprehensive Cancer Network. †Any ancillary therapy: any therapy listed as Ancillary Therapy in CanMED v2018. Non-guideline use for other stages was minimal and is not reported. ‡Recommended immunotherapy in stage IV included bevacizumab, cetuximab, pembrolizumab, panitumumab, and ramucirumab. Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 44 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 for a research study. Through this example, we explored the use Classification of Diseases code), be a specific part of an adminis- of various therapeutic categories and illustrated trends by stage tered cancer regimen (eg, R-CHOP), or be used in a cancer-spe- and year. cific algorithm in order to be considered cancer-related Chemotherapy use increased with advanced stage as treatment (15–20). For increased confidence, this recommenda- expected, as earlier stage patients might be eligible for modali- tion may be extended to any medication assessed. ties such as surgery prior to use of chemotherapy. The notice- Researchers need to be cognizant that identification of able difference in use of ancillary therapy between stage II, III, cancer-related therapies solely using HCPCS codes will lead to and IV treatments is likely related to the increased use of che- underascertainment as more cancer-related medications are motherapy and immunotherapy in advanced disease along exclusively being administered orally and are billed used a dif- with the potential complications related to more complex regi- ferent coding nomenclature: NDCs (eg, Medicare Part D). As mens or adverse effects, which require additional treatment or such, these oral medications are not typically assigned HCPCS supportive care. The NCCN guidelines recommend immuno- codes, the exceptions being initial dosing of oral agents and oral therapy use only in stage IV CRC, and there was notable (40.9%) alternatives to IV agents. However, for completeness, all oncol- use among these patients (Table 2). Since newer immunothera- ogy medications will be included in CanMED-HCPCS; if the pies continue to have expanded labeling and new indication agent does not have an associated HCPCS code, it will be listed approvals, it is increasingly important to have a current refer- as “NA” in the database. All oral agents will also be included in ence for identifying the correct HCPCS codes associated with the companion CanMED-NDC (Rivera et al. NDC). Researchers these medications for observational studies. conducting administrative claims-based studies of cancer treat- This example confirmed that codes from CanMED-HCPCS ment are advised to use both the CanMED-HCPCS and CanMED- can support analyses that assess temporal trends in treatment NDC, when applicable, to identify a comprehensive list of rele- and concordance with guideline recommendations. Beyond this vant codes to understand exposure and longitudinal medication specific example, codes from CanMED-HCPCS can be used to utilization. standardize coding between studies, thus improving the consis- Reproducibility in cancer treatment research is important, tency across treatment-related cancer care research. CanMED is given the vast amount of available data resources and the need a valuable resource to use when creating a cohort to define the for real-world evidence, to allow patients and providers to make appropriate claims-based cancer treatment and to reduce the informed decisions. Standardizing treatment-related research potential for missed treated cases or misclassification biases is a pivotal step in the direction of better evidence generation. (treated vs untreated). Applications for use may include, but are There are currently no specific guidelines for identifying medi- not limited to utilization and dissemination of medications, cation codes; however, the NCI seeks to foster systematic, stan- treatment trends, adherence to guideline-recommended treat- dardized, and reproducible cancer research for observational ment or quality of care, health outcomes, exposure definition studies, and use of CanMED-HCPCS may facilitate standardiza- for adverse event studies, and general pharmacoepidemiology tion of future cancer treatment research. The CanMED-HCPCS or health services research. provides a consolidated, comprehensive resource that can be There are limitations to the development and use of the used to increase reproducibility of cancer surveillance and CanMED-HCPCS. The included HCPCS codes were identified us- health services research using claims or electronic health data ing publicly available coding information. Therefore, it is possi- that include the HCPCS nomenclature. ble that some historical codes were not included and some fields (eg, CMS starts date) may be left blank if unavailable in Notes the public data. However, we diligently attempted to identify all relevant HCPCS codes, and this is reflected in the most compre- Affiliations of authors: Surveillance Research Program, Division hensive, public resource for oncologic therapies to our knowl- of Cancer Control and Population Sciences, National Cancer edge. The constantly changing landscape of cancer treatment Institute, Rockville, MD (DRR, CJKL, VIP, QT, LD, AMN, ABM, LP); also makes the prospective development of the CanMED-HCPCS Information Management Services, Inc., Calverton, MD (SB, both challenging and necessary. There may be a lag time be- TSM, BO); Healthcare Delivery Research Program, Division of tween when a new therapy is FDA approved and when it is in- Cancer Control and Population, Sciences, National Cancer cluded in the CanMED-HCPCS, given possible delays at CMS in Institute, Rockville, MD (LE, DPW). assigning a unique HCPCS code to new medications. Newly ap- The authors have no conflicts of interest to declare. proved medications can be billed using a general chemotherapy HCPCS code (eg, J8999 or J9999) if a medication is References administered prior to being assigned a specific HCPCS code, though identification of an individual medication exposure in 1. Warren JL, Klabunde CN, Schrag D, Bach PB, Riley GF. Overview of the SEER- Medicare data: content, research applications, and generalizability to the claims data is not possible until they are assigned specific United States elderly population. Med Care. 2002;40(suppl 8):IV–3–18. HCPCS codes. However, to stay as relevant as possible, the 2. Center for Medicare and Medicaid Services (CMS). Medicare Claims CanMED-HCPCS will be maintained through a dual review pro- Processing Manual. https://www.cms.gov/Regulations-and-Guidance/ Guidance/Manuals/downloads/clm104c12.pdf. Accessed November 21, 2018. cess by NCI clinicians, and any changes will be updated on a 3. Gilden DM, Kubisiak JM, Pohl GM, et al. Treatment patterns and cost- yearly basis. effectiveness of first line treatment of advanced non-squamous non-small There are other limitations that researchers need to consider cell lung cancer in Medicare patients. J Med Econ. 2017;20(2):151–161. 4. Eaton AA, Sima CS, Panageas KS. Prevalence and safety of off-label use of when using CanMED-HCPCS. Certain medications, such as chemotherapeutic agents in older patients with breast cancer: estimates methotrexate, can be used for cancer and for multiple other from SEER-Medicare data. J Natl Compr Canc Netw. 2016;14(1):57–65. conditions (eg, treatment of rheumatoid and juvenile arthritis). 5. Behera M, Ragin C, Kim S, et al. Trends, predictors, and impact of systemic chemotherapy in small cell lung cancer patients between 1985 and 2005. Users should be cautious when including such medications in Cancer. 2016;122(1):50–60. their cancer-related treatment analyses. It is recommended 6. Center For Medicare and Medicaid Services (CMS). Alpha Numeric HCPCS that medications without indication-specific HCPCS codes File. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha- should accompany a cancer diagnosis (International Numeric-HCPCS.html. Accessed November 21, 2018. Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 D. R. Rivera et al. |45 7. National Cancer Institute. Division of Cancer Control and Population Sciences. 15. Modi PK, Kaufman SR, Qi J, et al. 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Payne S, Miles D. Mechanisms of anticancer drugs. In: Watkinson JC, Clarke 17(1):330. RW, eds. Scott-Brown’s Otorhinolaryngology: Head and Neck Surgery 7Ed: 3 Volume 18. Clarke CL, Feigelson HS. Developing an algorithm to identify history of cancer Set. 2008: 134. using electronic medical records. EGEMS. 2016;4(1):1209. 12. Center for Medicare and Medicaid Services (CMS). Healthcare Common 19. Nordstrom BL, Whyte JL, Stolar M, Mercaldi C, Kallich JD. Identification of Procedures Coding System (HCPCS) Level II Coding Procedures. 2015. https:// metastatic cancer in claims data. Pharmacoepidemiol Drug Saf. 2012;21(suppl www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/HCPCSCODINGPROCE 2):21–28. SS. Accessed November 21, 2018. 20. Goldsbury D, Weber M, Yap S, Banks E, O’Connell DL, Canfell K. Identifying in- 13. Lund JL, Sturmer T, Harlan LC, et al. 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Development and Utility of the Observational Research in Oncology Toolbox: Cancer Medications Enquiry Database-Healthcare Common Procedure Coding System (HCPCS)

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Publisher
Oxford University Press
Copyright
Copyright © 2022 Oxford University Press
ISSN
1052-6773
eISSN
1745-6614
DOI
10.1093/jncimonographs/lgz034
Publisher site
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Abstract

Purpose: Health-care claims are of increasing utility as a rich, real-world data resource for conducting treatment-related can- cer research. However, multiple dynamic coding nomenclatures exist, leading to study variability. To promote increased standardization and reproducibility, the National Cancer Institute (NCI) developed the Cancer Medications Enquiry Database (CanMED)-Healthcare Common Procedure Coding System (HCPCS) within the Observational Research in Oncology Toolbox. Methods: The CanMED-HCPCS includes codes for oncology medications that a) have a US Food and Drug Administration- approved indication for cancer treatment or treatment-related symptom management; b) are present in National Comprehensive Cancer Network guidelines; or c) carry an orphan drug designation for treatment or management of cancer. Included medications and their HCPCS codes were primarily identified based on Center for Medicare and Medicaid Services annual HCPCS Indices (2012–2018). To demonstrate the utility of the CanMED-HCPCS, use of systemic treatment for stage II– IV colorectal cancer patients included in the Surveillance, Epidemiology, and End Results-Medicare data (2007–2013) was assessed. Results: The CanMED-HCPCS (v2018) includes 332 HCPCS codes for cancer-related medications: chemotherapy (156), immu- notherapy (74), hormonal therapy (54), and ancillary therapy (48). Observed treatment trends within the NCI Surveillance, Epidemiology, and End Results-Medicare data were as expected; utilization of each treatment type increased with stage, and immunotherapy was largely confined to use among stage IV patients. Conclusion: The CanMED-HCPCS provides a comprehensive resource that can be used by the research community to facili- tate systematic identification of medications within claims or electronic health data using the HCPCS nomenclature and greater reproducibility of cancer surveillance and health services research. Healthcare claims are often queried to identify receipt of ther- Surveillance, Epidemiology, and End Results (SEER) Program- apy for observational cancer research. Such studies, including Medicare data, which is a linkage of the SEER Program those conducted using the National Cancer Institute (NCI) population-based cancer registry data with Medicare Received: September 23, 2019; Accepted: October 16, 2019 Published by Oxford University Press 2020. This work is written by US Government employees and is in the public domain in the US. 39 Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 40 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 enrollment and claims data (1), rely on the accurate identifica- addition, any oncology medications listed in the SEER*Rx data- tion of individual medications using codes listed on the health- base meeting the above criteria were included. The medications care claims. The Healthcare Common Procedure Coding System identified from either list were reviewed to remove duplicates, (HCPCS) is one of the primary nomenclatures used for coding misclassified medications (eg, those not actually used for medication dispensing and administrative billing (2). cancer-related treatment), and experimental drugs (eg, clinical Observational studies have identified trends in the utiliza- trial use exclusively). The combined list of medications was tion, cost, and effectiveness for cancer treatments by assessing then cross-referenced with two commercially available drug which HCPCS codes are included on administrative claims (3–5). databases, Micromedex and Lexicomp (8,9), to further ensure However, varying definitions of cancer therapies (eg, what con- completeness. Only FDA-approved medications were eligible for stitutes chemotherapy vs immunotherapy, modes of adminis- inclusion; thus, approval status was verified via Drugs@FDA tration considered, and relevant medications included), the (10). Medications that are no longer FDA approved are retained extensive number of HCPCS codes, and the frequent addition to allow for retrospective assessments. Each of the above steps and retirement of HCPCS codes have made comparisons and was validated independently by two pharmacists. evaluation of treatment across studies challenging. Varying therapy definitions, which have been especially common in Treatment Categories cancer care research because of the rapid approval of new ther- To ensure consistency with cancer surveillance efforts within the apies, can affect study design (eg, study population and data SEER cancer registries, oncologic medications were assigned to a sources), misclassification, and, thus, results. mutually exclusive treatment category: chemotherapy, immuno- Improved standardized capture of cancer treatments in ob- therapy, hormonal therapy, and ancillary therapy. Chemotherapy servational oncology research is essential for comparability of is defined as systemic treatment that targets various phases of results and reproducibility. In supporting this goal, the NCI is the cell cycle to destroy cancer cells or interrupt cellular signaling developing the Observational Research in Oncology Toolbox, through targeted inhibition of key pathways (11). Immunotherapy which was conceptualized to guide systematic, standardized, is defined as systemic treatment that primarily targets an im- and reproducible research for observational studies that require mune response and mediates tumor growth through immune the use of specialized ontologies or nomenclatures during study modification (eg, monoclonal antibodies, checkpoint inhibitors, design. The first publicly available resource within the toolbox and vaccines). Hormonal therapy, which is used to treat hormon- is the Cancer Medications Enquiry Database (CanMED), which ally linked cancers (eg, breast and prostate cancers), is defined as includes comprehensive, queryable, ontologic databases of US functional endocrine modifiers that affect hormone production Food and Drug Administration (FDA)-approved cancer medica- and reduce tumor effects. Ancillary medications are defined as tions and their associated codes. medications required for or directly associated with the adminis- The focus of this article is the CanMED-HCPCS, which is a tration of chemotherapy, immunotherapy, or hormonal therapy. database of oncology medications and associated HCPCS codes. Many drugs that are used for the management of disease onset, The aims of this article are to provide a methodological descrip- cancer progression, and treatment exacerbations could be tion of how this database was created and to demonstrate its included as ancillary medications; however, here, ancillary medi- utility by examining trends in colorectal cancer (CRC) systemic cations are restricted to chemotherapy administration-related treatment. medications or medications specially given for treatment-related symptom management. Methods HCPCS Nomenclature HCPCS codes can be divided into two components: Level I codes CanMED-HCPCS Development managed by the American Medical Association as Common Data Sources Procedure Terminology (CPT) and Level II codes managed by the Multiple data sources were reviewed to ensure a comprehensive CMS (2). CPT/Level I HCPCS, or CPT codes, were first developed list of oncology medications, and associated HCPCS codes were in 1966. Level II HCPCS are five-digit alphanumeric codes that included in CanMED-HCPCS. The two primary data sources uti- were introduced by CMS in 1978 for reimbursement of items lized were the Center for Medicare and Medicaid Services (CMS) and services not covered by the CPT/Level I codes, including the HCPCS Indices, which include all HCPCS drug codes approved administration of cancer-related medications and subsequently for Medicare billing purposes (6), and the SEER*Rx database, adopted by other health care insurers. With each Level II HCPCS which was created by the NCI to facilitate the coding of cancer code, the letter indicates the type of code (eg, J: permanent medications and for use in the development of regimen ontolo- codes for medications; C: temporary codes using the outpatient gies for cancer registry data (7). FDA and commercially available perspective payment system) (12). Level III HCPCS codes were drug databases were also cross-referenced and reviewed to en- discontinued in 2003 in response to legal requirements that sure completeness, as described in more detail below (8,9). CMS have a uniform coding system. In the CanMED-HCPCS, only Level II HCPCS codes are included. Discontinued HCPCS codes are retained with a discontinuation date to allow for his- Oncology Medication Inclusion Strategy toric analyses. Oncology medications were eligible for inclusion in the CanMED-HCPCS if they a) had an FDA-approved indication for cancer treatment or treatment-related symptom management, Special Methodological Considerations b) were present in the National Comprehensive Cancer Network Medications used to treat cancer can be used for other disease (NCCN) guidelines, or c) carried an orphan drug designation for indications. For example, erythropoietin has a different HCPCS the treatment or management of cancer. code when used to treat anemia secondary to cancer treatment The CMS HCPCS Indices were reviewed from 2012 to 2018 to effects than when used to treat anemia secondary to end-stage identify Medicare-reimbursable cancer-related medications. In renal disease. The CanMED-HCPCS is cancer focused and thus Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 D. R. Rivera et al. |41 Figure 1. Cancer Medication Enquiry Database-Healthcare Common Procedure Coding System (CanMED-HCPCS) Database Interface. only includes HCPCS codes for oncologic medications. search, for example, to medications that were approved during a Assessing utilization of erythropoietin for cancer treatment us- certain time period or to a specific treatment category (eg, chemo- ing all erythropoietin HCPCS codes could result in overestima- therapy, immunotherapy, hormone therapy, or ancillary ther- tion and misclassification, whereas limiting to cancer-related apy). The specific variables available in the CanMED-HCPCS HCPCS codes should result in more accurate cancer-related uti- include HCPCS code, Generic Name, Brand Name, Strength, lization, assuming the accurate code was listed on the health SEER*Rx Category, Major Drug Class, Minor Drug Class, Oral care claim. There are other ancillary medications, such as predni- Treatment Indicator, FDA Approval Year, FDA Discontinuation sone, that can be used broadly for noncancer indications and do Year, CMS Effective Date, CMS Discontinuation Date, and Status not have cancer-specific HCPCS codes. As a result, certain ancil- of Product in Use. Query results are exportable to Excel for use lary therapy HCPCS codes included in the CanMED-HCPCS are not with common programming languages such as SAS and R. indication specific. Additionally, sometimes there is lag-time between when a medication is approved for use and when a HCPCS code is Use-Case Example assigned. To make the CanMED-HCPCS as comprehensive as To demonstrate the utility of the CanMED-HCPCS for cancer re- possible, all identified cancer-related systemic medications are search, systemic treatment patterns for CRC patients in the included regardless of whether the medication has or will have SEER-Medicare database were assessed. Patients were included an associated HCPCS code. As such, if an identified medication if they were diagnosed with a first primary CRC between 2007 did not have a HCPCS code when the CanMED-HCPCS was last and 2013 at age 66 or older and survived for at least 6 months af- updated, the HCPCS code will be listed as not available (“NA”). ter diagnosis. Patients also had to have continuous fee-for-ser- Finally, HCPCS codes are primarily used for parenteral medi- vice Medicare Part A and B from diagnosis through 6 months cations; however, some oral medications are assigned HCPCS postdiagnosis. Systemic therapy is guideline recommended for codes such as alternatives to intravenously administered medi- patients diagnosed with stages II-IV CRC (Derived AJCC Stage, cations (eg, capecitabine) or medications with very specific ad- 6th ed.); therefore, patients with earlier or unknown stage dis- ministration guidelines that allow for initial dosing of certain ease were excluded. oral medications (eg, imatinib). Therefore, some oral medica- The assessment of medication use was based on Medicare tions are included in the CanMED-HCPCS; these medications Part B claims through 2014; Medicare Part A and Part D claims are easily identifiable via the oral treatment indicator variable. do not include HCPCS codes and, thus, were not considered. Medications assessed were identified using the NCCN guide- lines, which allowed for characterization of stage-specific CanMED-HCPCS Database Interface treatment. The corresponding HCPCS codes for the guideline- The CanMED-HCPCS interface includes features that can be used recommended medications were identified using the to search by specific drug name (brand or generic) to identify all CanMED-HCPCS and aggregated by treatment category. related HCPCS codes or, conversely, search by HCPCS code to Chemotherapies that are used to treat CRC but are only ad- identify a drug name (Figure 1). In addition, the user can limit the ministered orally (eg, regorafenib, trifluridine, and tipiracil) Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 42 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 are billed using National Drug Codes (NDCs) and were not assessed; these medications are not reported to CMS via HCPCS codes and were, thus, beyond the objective of this study. An exception is capecitabine; as an orally administered prodrug of the IV-administered 5-Flurouracil, it is covered un- der Medicare Part B and thus has been assigned HCPCS codes. Although capecitabine is known to be underascertained in Medicare Part B claims, it was included (13). Hormonal therapy was also not assessed because it is not a CRC guideline-recom- mended treatment. Descriptive statistics assessing the receipt of each treatment category within 6 months of diagnosis, overall and by stage and calendar year, were calculated to describe treatment trends. Results The CanMED-HCPCS (11_2018v1.2.4) includes 496 entries and 332 HCPCS codes for oncology medications: chemotherapy (156), immunotherapy (74), hormonal therapy (54), and ancillary therapy (48) (14). Output from the CanMED-HCPCS allows for the tracking of specific medications to different classification groups. Additional detail on how the medications were mapped to the categories, and major and minor drug classifications, is provided in Supplementary Table 1 (available online). For exam- ple, bevacizumab was classified as immunotherapy; major class: monoclonal antibody; minor class: VEGFR. Use-Case Example Medications included in the NCCN Guidelines for CRC treatment were identified using the CanMED-HCPCS as shown in Table 1. From 2007 to 2013, there were 34 114 patients in the SEER- Medicare data diagnosed with stage II-IV CRC: 44.2% with stage II, 37.5% with stage III, and 18.3% with stage IV (Table 2). During the study period, guideline-directed chemotherapy was admin- istered in 12.2% (annual range ¼ 14.2–9.7%) of stage II patients, 46.7% (annual range ¼ 48.6–44.4%) of stage III patients, and 60.5% (annual range ¼ 58.8–63.4%) of stage IV patients. Similar trends by stage and year were observed for ancillary therapy. Due to low utilization among stage II–III patients (and lack of guideline recommendations), trends in immunotherapy were only reported among stage IV patients. Overall, 41.0% of stage IV patients received immunotherapy (annual range ¼ 38.0–42.9%). Discussion The primary objective of the CanMED-HCPCS is to provide a cur- rent, comprehensive resource that provides a standardized method of identifying HCPCS codes for systemic oncology medi- cations or, conversely, the identification of medications associ- ated with HCPCS codes extracted from claims. Cancer registries can use the CanMED-HCPCS to appropriately identify medica- tions for registry operations, such as case finding or supple- menting registry treatment data using health-care claims. Additionally, the broader cancer research community can use the CanMED-HCPCS to more quickly identify necessary HCPCS codes (eg, for a specific treatment category, drug class, or agent) and increase comparability or reproducibility with other cancer- related studies. The SEER-Medicare use-case example served as a demon- stration of the utility of the CanMED-HCPCS to standardize the identification and categorization of cancer-related medications Table 1. NCCN Guideline-Recommended CRC treatment and associated CanMED-HCPCS*,† variables for assessing treatment trends in SEER-Medicare, 2007–2013 Administration FDA Stage Stage Stage FDA NCCN Generic Brand route approval Category II III IV indication guidelines HCPCS Bevacizumab Avastin IV 2004 Immunotherapy X Y Y Q2024 C9257 C9214 J9035 S0116 Cetuximab Erbitux IV 2004 Immunotherapy X Y Y C9215 J9055 Fluorouracil Adrucil IV 1962 Chemotherapy X X X Y (only stage IV) Y J9190 Irinotecan Camptosar IV 1996 Chemotherapy X Y (only stage IV) Y J9206 C9474 Leucovorin Calcium Wellcovorin IV only indicated 1952 Chemotherapy X X X Y Y J0640 Levoleucovorin Fusilev IV 2008 Chemotherapy X X Y (only stage IV) Y J0641 Oxaliplatin Eloxatin IV 2002 Chemotherapy X X X Y Y C9205 J9263 Panitumumab Vectibix IV 2006 Immunotherapy X Y Y C9235 J9303 Pembrolizumab Keytruda IV 2014 Immunotherapy X Y Y C9027 J9271 Ramucirumab Cyramza IV 2014 Immunotherapy X Y Y C9025 J9308 Ziv-aflibercept Zaltrap IV 2012 Chemotherapy X Y Y C9296 J9400 Capecitabine Xeloda Oral 1998 Chemotherapy X X X Y Y J8520 J8521 *CanMED-HCPCS (Version 2018) is available at: https://seer.cancer.gov/oncologytoolbox/canmed/hcpcs/. CRC ¼ colorectal cancer; CanMED-HCPCS ¼ Cancer Medications Enquiry Database-Healthcare Common Procedure Coding System; FDA ¼ US Food and Drug Administration; NCCN ¼ National Comprehensive Cancer Network; SEER ¼ National Cancer Institute Surveillance, Epidemiology, and End Results. †The following drugs were excluded because they are not captured by HCPCS claims: regorafenib (oral), trifluridine, and tipiracil (oral). For the purposes of this analysis, capecitabine was included; however, given it is an oral agent, it may be underascertained. Assessment of oral agents should include claims billed using National Drug Codes. Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 D. R. Rivera et al. |43 Table 2. Trends in the receipt of NCCN guideline-recommended treatment among colorectal cancer patients diagnosed between 2007–2013 in SEER-Medicare using medication codes identified via the CanMED-HCPCS v.2018. Stage II Stage III Stage IV Received Received any Received Received Received Received Received recommended* ancillary recommended* any ancillary recommended* any ancillary any chemotherapy therapy† chemotherapy therapy† chemotherapy therapy† immunotherapy‡ Year of Total Total Total diagnosis No. No. % No. % No. No. % No. % No. No. % No. % No. % 2007 2477 351 14.2 352 14.2 2170 1054 48.6 1014 46.7 938 552 58.8 538 57.4 392 41.8 2008 2400 319 13.3 300 12.5 2018 938 46.5 915 45.3 944 564 59.7 545 57.7 389 41.2 2009 2180 283 13.0 272 12.5 1883 904 48.0 862 45.8 926 550 59.4 538 58.1 379 40.9 2010 2147 273 12.7 240 11.2 1743 819 47.0 770 44.2 947 584 61.7 566 59.8 406 42.9 2011 2054 233 11.3 191 9.3 1758 791 45.0 708 40.3 856 516 60.3 487 56.9 325 38.0 2012 2034 204 10.0 178 8.8 1682 789 46.9 743 44.2 817 491 60.1 475 58.1 321 39.3 2013 1775 173 9.7 153 8.6 1542 685 44.4 653 42.3 823 522 63.4 513 62.3 348 42.3 Total 15 067 1836 12.2 1686 11.1 12 796 5980 46.7 5665 44.3 6251 3779 60.5 3662 58.6 2560 41.0 *Recommended chemotherapy by stage: stage II included capecitabine, fluorouracil, leucovorin calcium, or oxaliplatin; stage III included capecitabine, fluorouracil, leucovorin calcium, levoleucovorin, or oxaliplatin; and stage IV included capecitabine, fluorouracil, irinotecan, leucovorin calcium, levoleucovorin, oxaliplatin, or ziv-aflibercept. CanMED-HCPCS ¼ Cancer Medication Enquiry Database-Healthcare Common Procedure Coding System; NCCN ¼ National Comprehensive Cancer Network. †Any ancillary therapy: any therapy listed as Ancillary Therapy in CanMED v2018. Non-guideline use for other stages was minimal and is not reported. ‡Recommended immunotherapy in stage IV included bevacizumab, cetuximab, pembrolizumab, panitumumab, and ramucirumab. Downloaded from https://academic.oup.com/jncimono/article/2020/55/39/5837291 by DeepDyve user on 14 August 2022 44 | J Natl Cancer Inst Monogr, 2020, Vol. 2020, No. 55 for a research study. Through this example, we explored the use Classification of Diseases code), be a specific part of an adminis- of various therapeutic categories and illustrated trends by stage tered cancer regimen (eg, R-CHOP), or be used in a cancer-spe- and year. cific algorithm in order to be considered cancer-related Chemotherapy use increased with advanced stage as treatment (15–20). For increased confidence, this recommenda- expected, as earlier stage patients might be eligible for modali- tion may be extended to any medication assessed. ties such as surgery prior to use of chemotherapy. The notice- Researchers need to be cognizant that identification of able difference in use of ancillary therapy between stage II, III, cancer-related therapies solely using HCPCS codes will lead to and IV treatments is likely related to the increased use of che- underascertainment as more cancer-related medications are motherapy and immunotherapy in advanced disease along exclusively being administered orally and are billed used a dif- with the potential complications related to more complex regi- ferent coding nomenclature: NDCs (eg, Medicare Part D). As mens or adverse effects, which require additional treatment or such, these oral medications are not typically assigned HCPCS supportive care. The NCCN guidelines recommend immuno- codes, the exceptions being initial dosing of oral agents and oral therapy use only in stage IV CRC, and there was notable (40.9%) alternatives to IV agents. However, for completeness, all oncol- use among these patients (Table 2). Since newer immunothera- ogy medications will be included in CanMED-HCPCS; if the pies continue to have expanded labeling and new indication agent does not have an associated HCPCS code, it will be listed approvals, it is increasingly important to have a current refer- as “NA” in the database. All oral agents will also be included in ence for identifying the correct HCPCS codes associated with the companion CanMED-NDC (Rivera et al. NDC). Researchers these medications for observational studies. conducting administrative claims-based studies of cancer treat- This example confirmed that codes from CanMED-HCPCS ment are advised to use both the CanMED-HCPCS and CanMED- can support analyses that assess temporal trends in treatment NDC, when applicable, to identify a comprehensive list of rele- and concordance with guideline recommendations. Beyond this vant codes to understand exposure and longitudinal medication specific example, codes from CanMED-HCPCS can be used to utilization. standardize coding between studies, thus improving the consis- Reproducibility in cancer treatment research is important, tency across treatment-related cancer care research. CanMED is given the vast amount of available data resources and the need a valuable resource to use when creating a cohort to define the for real-world evidence, to allow patients and providers to make appropriate claims-based cancer treatment and to reduce the informed decisions. Standardizing treatment-related research potential for missed treated cases or misclassification biases is a pivotal step in the direction of better evidence generation. (treated vs untreated). Applications for use may include, but are There are currently no specific guidelines for identifying medi- not limited to utilization and dissemination of medications, cation codes; however, the NCI seeks to foster systematic, stan- treatment trends, adherence to guideline-recommended treat- dardized, and reproducible cancer research for observational ment or quality of care, health outcomes, exposure definition studies, and use of CanMED-HCPCS may facilitate standardiza- for adverse event studies, and general pharmacoepidemiology tion of future cancer treatment research. The CanMED-HCPCS or health services research. provides a consolidated, comprehensive resource that can be There are limitations to the development and use of the used to increase reproducibility of cancer surveillance and CanMED-HCPCS. The included HCPCS codes were identified us- health services research using claims or electronic health data ing publicly available coding information. Therefore, it is possi- that include the HCPCS nomenclature. ble that some historical codes were not included and some fields (eg, CMS starts date) may be left blank if unavailable in Notes the public data. However, we diligently attempted to identify all relevant HCPCS codes, and this is reflected in the most compre- Affiliations of authors: Surveillance Research Program, Division hensive, public resource for oncologic therapies to our knowl- of Cancer Control and Population Sciences, National Cancer edge. The constantly changing landscape of cancer treatment Institute, Rockville, MD (DRR, CJKL, VIP, QT, LD, AMN, ABM, LP); also makes the prospective development of the CanMED-HCPCS Information Management Services, Inc., Calverton, MD (SB, both challenging and necessary. There may be a lag time be- TSM, BO); Healthcare Delivery Research Program, Division of tween when a new therapy is FDA approved and when it is in- Cancer Control and Population, Sciences, National Cancer cluded in the CanMED-HCPCS, given possible delays at CMS in Institute, Rockville, MD (LE, DPW). assigning a unique HCPCS code to new medications. Newly ap- The authors have no conflicts of interest to declare. proved medications can be billed using a general chemotherapy HCPCS code (eg, J8999 or J9999) if a medication is References administered prior to being assigned a specific HCPCS code, though identification of an individual medication exposure in 1. Warren JL, Klabunde CN, Schrag D, Bach PB, Riley GF. Overview of the SEER- Medicare data: content, research applications, and generalizability to the claims data is not possible until they are assigned specific United States elderly population. Med Care. 2002;40(suppl 8):IV–3–18. HCPCS codes. 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Journal

JNCI MonographsOxford University Press

Published: May 1, 2020

Keywords: cancer; medical oncology; procedural coding; healthcare common procedure coding system; observational studies; chemotherapy regimen

There are no references for this article.