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Frequently Asked Questions About Meaningful Use: Testing, Validation, and Implementation Guide (Questions 1–13)

  1. Since cancer reporting is optional for Meaningful Use (MU) Stage 2, what happens if a provider wants to select the cancer reporting menu objective, but uses an electronic health record (EHR) system that is not certified for cancer reporting?
  2. If a provider uses a third party to perform cancer reporting, does that third party need to be certified?
  3. Is a timing element described in the cancer reporting process as to when data exchange will occur?
  4. Will CDC develop a content validation tool?
  5. Can CDC provide a tool that allows EHR vendors to validate reports before they begin testing with the states?
  6. Are there examples of automated processes for quality assurance and validation protocols?
  7. Will registries need to develop a local specification for the Health Level Seven (HL7) Clinical Document Architecture (CDA) physician reporting document?
  8. Will CDC help providers determine if their cancer reporting systems are working correctly?
  9. Why are ICD-9-CM codes used to trigger a physician event report?
  10. Why do physicians send a report after every encounter that has a first-listed diagnosis of cancer?
  11. Can EHRs send multiple CDA documents in one file or batch?
  12. The Cancer Implementation Guide and NIST test data indicate that CDC standards shall be used for race and ethnicity. MU requires use of Office of Management and Budget (OMB) standards for race and ethnicity. Which coding system is appropriate?
  13. Six categories of NIST test data must be tested. Will the EHR need to change to trigger these reports to be sent?
  1. Since cancer reporting is optional for Meaningful Use (MU) Stage 2, what happens if a provider wants to select the cancer reporting menu objective, but uses an electronic health record (EHR) system that is not certified for cancer reporting?

The 2014 certification rule states that providers don’t need to use a single EHR that is certified for everything. A system may have only one component that is certified for a specific requirement, such as cancer reporting. If providers want to select cancer reporting as one of their menu options, they must acquire EHR technology that is certified for cancer reporting. This technology could be a module that provides only cancer reporting, with the rest of the EHR not certified.

  1. If a provider uses a third party to perform cancer reporting, does that third party need to be certified?

If the third party performs services such as compiling or transforming cancer data from a system that has not been certified for the cancer reporting objective, then the third party must be certified for cancer reporting.

If the third party performs other services for providers who are using EHR technology that has been certified for the cancer reporting objective, such as providing the means of transporting the formatted Health Level 7 (HL7) Clinical Document Architecture (CDA) document, then the third party does not have to be certified.

  1. Is a timing element described in the cancer reporting process as to when data exchange will occur?

The Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries [PDF-1.9MB] (commonly called the Cancer Implementation Guide) requires a report to be sent every time the EHR identifies an encounter with cancer as the first-listed diagnosis (see page 7 for details).

  1. Will CDC develop a content validation tool?

CDC is evaluating the possibility of developing a content validation tool for state cancer registries.

  1. Can CDC provide a tool that allows EHR vendors to validate reports before they begin testing with the states?

The National Institute of Standards and Technology’s (NIST’s) Meaningful Use Cancer Registry Report Validation tool is available for EHR vendors to perform structural validation on cancer reports. The development of a content validation tool for vendors to use to perform validation before sending data to states is being considered.

  1. Are there examples of automated processes for quality assurance and validation protocols?

The Data Quality Assessment process implemented by the Michigan Immunization Program is one example.

  1. Will registries need to develop a local specification for the Health Level Seven (HL7) Clinical Document Architecture (CDA) physician reporting document?

State cancer registries do not need to develop local specifications. They should use the standard adopted by the Office of the National Coordinator for Health Information Technology (ONC), the Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries [PDF-1.9MB], for eligible professionals (EPs) to report cancer data. If your state has requirements that are not included in this standard, please work with CDC to standardize these elements. Please be aware that EHR vendors will not be required to include these additional data elements. CDC will work with state cancer registries to identify any additional data elements that were not included for MU Stage 2. CDC plans to update the national specification to include consistent data elements in the MU Stage 3 standard.

  1. Will CDC help providers determine if their cancer reporting systems are working correctly?

CDC does not receive direct data submissions from providers for MU cancer reporting and will not confirm a system’s accuracy. Cancer reporting can be implemented only with the state cancer registry. CDC’s role is to provide technical assistance to providers, vendors, state public health agencies (PHAs), and others to support cancer reporting to state cancer registries. CDC will help state cancer registries validate providers’ cancer reports. For more information, please visit CDC MU FAQs.

  1. Why are ICD-9-CM codes used to trigger a physician event report?

Diagnosis codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) were selected as the trigger for producing cancer event reports because this classification system is used in most medical billing systems and its codes are usually incorporated into the EHR. This approach allows for real-time reporting to the central cancer registry based on each patient visit (encounter).

A Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) reportability list has not been made available because a single diagnosis can have multiple concept identifiers (codes). SNOMED CT terms can be precoordinated or postcoordinated or have different concept codes that are close to but not quite synonyms. For example, SNOMED CT codes for breast cancer include: 82711006-Ductal carcinoma, 448952004-Invasive ductal carcinoma of female breast, and 423114009-Infiltrating ductal carcinoma of breast, stage 3.

Developing a complete SNOMED CT reportability list was not possible within the deadline for MU Stage 2. CDC’s Public Health Information Network Vocabulary Access and Distribution (PHIN VADS) team is helping evaluate options for creating a SNOMED CT reportability list.

The Cancer Implementation Guide indicates that the cancer reportability list should be applied against the first-listed diagnosis. This data element was chosen because it is a required data element in physician practices and has a standard definition and instructions for coding. The guidelines for ICD-9-CM and ICD-10-CM can be found on the Web site for CDC’s National Center for Health Statistics (NCHS).

The ICD-9-CM reportability list for physician reporting is based on the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program and CDC’s National Program of Cancer Registries (NPCR) reportability and casefinding lists. You can download the list at PHIN VADS.

  1. Why do physicians send a report after every encounter that has a first-listed diagnosis of cancer?

Submitting a report after every encounter for a cancer patient is the simplest reporting trigger for EHR vendors to implement. Vendors prioritize their work according to federal and state regulations and client (physician) needs. Public health is a secondary user of the information in the EHR. Complex implementation criteria would greatly reduce the number of EHR vendors willing to participate.

CDC’s NPCR-Advancing E-cancer Reporting and Registry Operations (NPCR-AERRO) Clinic/Physician Office Workgroup developed complex trigger criteria that would have reduced the number of reports transmitted to the cancer registry. The NAACCR physician workgroup evaluated these criteria when the Cancer Implementation Guide was drafted and found that they were too complex for the initial implementation phase for MU Stage 2 cancer reporting.

Receiving a report for every cancer-related encounter allows each registry to choose the encounters of interest without requiring an EHR vendor to set up specific trigger criteria for their registry. Cancer registries may ignore reports that are not of interest.

Receiving all reports allows cancer registries to evaluate all of the available information.

  1. Can EHRs send multiple CDA documents in one file or batch?

EHRs can send batches of CDA documents by placing each CDA document inside an HL7 message and batching the HL7 messages in a file. To perform this function, use gzip to compress individual CDA documents, encode the compressed content in the base-64 format, and put the encoded content inside the OBX segment of a single HL7 version 2.3.1 or 2.5.1 MDM^T02 message.

The Kentucky Cancer Registry developed a program to “unwrap” CDA documents from the HL7 message. This program will be shared with anyone who needs it, and it has been incorporated into eMaRC Plus.

  1. The Cancer Implementation Guide and NIST test data indicate that CDC standards shall be used for race and ethnicity. MU requires use of Office of Management and Budget (OMB) standards for race and ethnicity. Which coding system is appropriate?

CDC’s race and ethnicity codes are consistent with OMB’s standards for race and ethnicity. The description of CDC’s race and ethnicity code system is in PHIN VADS. (Click on “code system details.”)

If a vendor chooses to implement only the minimum race and ethnicity categories defined by OMB, they can use only the subset of codes (value set) that represent these categories (race category value set and ethnic group value set) and remain compliant with both the OMB standard and the Cancer Implementation Guide.

  1. Six categories of NIST test data must be tested. Will the EHR need to change to trigger these reports to be sent?

The reporting trigger must be generated whenever a cancer is a first-listed diagnosis, so the EHR may send a report multiple times for the same patient. For example, when a patient has chemotherapy, cancer should be the first-listed diagnosis for that visit, so it should trigger a report. If a patient comes in for something unrelated to his or her cancer diagnosis, such as a broken leg, it should not trigger a report because cancer is not the first-listed diagnosis.

 
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