This rule proposes new, revised, and unchanged certification criteria that would establish the capabilities and related standards and implementation specifications for the certification of health IT, including EHR technology. We refer to these new, revised, and unchanged certification criteria as the “2015 Edition health IT certification criteria” and propose to add this term and its definition to § 170.102. As noted in the Executive Summary, we also refer to these criteria as the “2015 Edition” in this preamble. We propose to codify the 2015 Edition in § 170.315 to set them apart from other editions of certification criteria and make it easier for stakeholders to quickly determine the certification criteria the 2015 Edition includes. Health IT certified to these proposed certification criteria and associated standards and implementation specifications could be implemented as part of an EP’s, eligible hospital’s, or CAH’s CEHRT and used to demonstrate meaningful use (as identified in Table 2 below). We note that Table 2 does not identify certification criteria that are included in conditional certification requirements, such as privacy and security, safety-enhanced design, and quality management system certification criteria. We do, however, classify these types of certification criteria as “associated” with the EHR Incentives Programs Stage 3 for the purposes of the regulatory impact analysis we performed for this proposed rule (see section VIII.B.1). Health IT certified to the proposed certification criteria and associated standards and implementation specifications could also be used to meet other HHS program requirements (e.g., grant and contract requirements) or referenced by private sector associations and entities. Table 2. 2015 Edition Proposed Certification Criteria Associated with the EHR Incentive Programs Stage 3 Proposed CFR Citation Certification Criterion Proposed Inclusion in 2015 Edition Base EHR Definition Relationship to the Proposed CEHRT Definition and Proposed Stage 3 Objectives § 170.315 (a)(1) Computerized Provider Order Entry (CPOE) – medications Included Objective 4 § 170.315 CPOE – laboratory Included Objective 4
(a)(2) § 170.315 (a)(3) CPOE – diagnostic imaging Included Objective 4 § 170.315 (a)(4) Drug-drug, Drug-allergy Interaction Checks for CPOE Not included Objective 3 § 170.315 (a)(5) Demographics Included No additional relationship beyond the Base EHR definition § 170.315 (a)(7) Problem List Included No additional relationship beyond the Base EHR definition § 170.315 (a)(8) Medication List Included No additional relationship beyond the Base EHR definition § 170.315 (a)(9) Medication Allergy List Included No additional relationship beyond the Base EHR definition § 170.315 (a)(10) Clinical Decision Support Included Objective 3 § 170.315 (a)(11) Drug-formulary and Preferred Drug List Checks Not included Objective 2 § 170.315 (a)(12) Smoking Status Included No additional relationship beyond the Base EHR definition § 170.315 (a)(14) Family Health History Not included CEHRT § 170.315 (a)(15) Family Health History – pedigree Not included CEHRT § 170.315 (a)(17) Patient-specific Education Resources Not included Objective 5 § 170.315 (a)(19) Patient Health Information Capture Not included CEHRT Objective 6 § 170.315 (a)(20) Implantable Device List Included No additional relationship beyond the Base EHR definition § 170.315 (b)(1) Transitions of Care Included Objective 7 § 170.315 (b)(2) Clinical Information Reconciliation and Incorporation Not included Objective 7 § 170.315 (b)(3) Electronic Prescribing Not included Objective 2 § 170.315 (b)(6) Data Portability Included No additional relationship beyond the Base EHR definition § 170.315 (c)(1) Clinical Quality Measures – record and export Included CEHRT § 170.315 (e)(1) View, Download, and Transmit to Third Party Not included Objective 5 Objective 6 § 170.315 (e)(2) Secure Messaging Not included Objective 6 § 170.315 (f)(1) Transmission to Immunization Registries Not included Objective 8 § 170.315 (f)(2) Transmission to Public Health Agencies – syndromic surveillance Not included Objective 8 § 170.315 Transmission to Public Health Not included Objective 8
(f)(3) Agencies – reportable laboratory tests and values/results § 170.315 (f)(4) Transmission to Cancer Registries Not included Objective 8 § 170.315 (f)(5) Transmission to Public Health Agencies – case reporting Not included Objective 8 § 170.315 (f)(6) Transmission to Public Health Agencies – antimicrobial use and resistance reporting Not included Objective 8 § 170.315 (f)(7) Transmission to Public Health Agencies – health care surveys Not included Objective 8 § 170.315 (g)(1) Automated Numerator Recording Not included CEHRT § 170.315 (g)(2) Automated Measure Calculation Not included CEHRT § 170.315 (g)(7) Application Access to Common Clinical Data Set Included Objective 5 Objective 6 § 170.315 (h)(1) Direct Project Included No additional relationship beyond the Base EHR definition § 170.315 (h)(2) Direct Project, Edge Protocol, and XDR/XDM Included No additional relationship beyond the Base EHR definition 1. Applicability Section 170.300 establishes the applicability of subpart C – Certification Criteria for Health Information Technology. We propose to revise paragraph (d) of § 170.300 to add in a reference to § 170.315 and revise the parenthetical in the paragraph to say “i.e., apply to any health care setting” instead of “i.e., apply to both ambulatory and inpatient settings.” These proposed revisions would clarify which specific capabilities within a certification criterion included in § 170.315 have general applicability (i.e., apply to any health care setting) or apply only to an inpatient setting or an ambulatory setting. The proposed revision to change the language of the parenthetical aligns with our proposed approach to make the ONC Health IT Certification Program more agnostic to health care settings and accessible to health IT that supports care and practice settings beyond the ambulatory and inpatient settings. We refer readers to section IV.B of this preamble for a detailed discussion of our proposals to modify the ONC Health IT Certification Program.
and LOINC® codes. This would include the ability to record a patient’s decision not to provide the information. An individual’s health is shaped largely by life circumstances that fall outside the traditional health care system and include social, psychological, and behavioral factors. These factors include, but are not limited to, family support systems, stress, housing, nutrition, income, and education. This proposed certification criterion to further the collection and use of such patient data is not intended to be comprehensive; rather, it reflects efforts to further HHS priorities to transform health delivery, to reduce health disparities, and to achieve the overarching goals of the National Quality Strategy. In particular, the proposed certification criterion supports efforts to reduce disparities and efforts to collect patient social, psychological, and behavioral data for improved health care, such as by aligning with recommendations from HHS and the Institute of Medicine. We believe that offering certification that would require a Health IT Module to enable a user to record, change, and access a patient’s social, psychological, and behavioral data would assist a wide array of stakeholders (e.g., providers, consumers, payors, community-based organizations, and state and local governments) in better understanding how this data may adversely affect health. Ultimately, this can lead to better health outcomes for these populations through improved patient care, quality improvement, health equity, and clinical decision support based on individual factors. We also believe the self-reporting of information by individuals in response to the questions included in these social, psychological, and behavioral measures (i.e., the question and answer sets below) could be utilized for the EHR Incentive Programs Stage 3 which proposes an objective on patient engagement, including patient-generated health data. For more information,
pleasure in doing things in last 2 weeks [Reported.PHQ] Feeling down, depressed or hopeless in last 2 weeks [Reported.PHQ] [Patient Health Questionnaire 2 item (PHQ-2) total score [Reported]] the days, [3] Nearly every day [0] Not at all, [1] Several days, [2] More than half the days, [3] Nearly every day For example: 0-6 44255-8 55758-7 LL358-3 Answer is in UCUM units Physical Activity (Exercise Vital Signs) How many days of moderate to strenuous exercise, like a brisk walk, did you do in the last 7 days? [SAMHSA] On those days that you engage in moderate to strenuous exercise, how many minutes, on average, do you exercise? [SAMHSA] For example: 1,2,3,4,5,6,7, etc. For example: 10, 20, etc. 68515-6 68516-4 Answer is in UCUM units Answer is in UCUM units Alcohol Use (AUDIT-C) [Alcohol Use Disorder Identification Test – Consumption [AUDIT-C]] How often do you have a drink containing alcohol? [SAMHSA] How many N/A [a] Never [b] Monthly or less [c] 2–4 times a month [d] 2–3 times a week [e] 4 or more times a week [a] 1 or 2 72109-2 68518-0 68519-8 N/A LL2179-1 LL2180-9
standard drinks containing alcohol do you have on a typical day? [SAMHSA] How often do you have six or more drinks on one occasion? [SAMHSA] [Total score [AUDIT-C]] [b] 3 or 4 [c] 5 or 6 [d] 7 to 9 [e] 10 or more [a] Never [b] Less than monthly [c] Monthly [d] Weekly [e] Daily or almost daily N/A 68520-6 LL2181-7 N/A Social Connection and Isolation (NHANES III) Are you married or living together with someone in a partnership at the time of questioning? In a typical week, how many times do you talk on the telephone with family, friends, or neighbors? How often do you get together with friends or relatives? How often do you attend church or religious services? How often do you attend meetings of the clubs or organizations you belong to? For example, these categories form an ordinal scale assessing the number of types of social relationships on which a person is connected and not isolated, and has standard scoring. Individuals receive one point for each of the following: being married or living together with someone in a partnership at the time of questioning, averaging three or more social interactions per week (assessed with questions one and two, above), reporting attending church or other religious services more than four times per (assessed with question three, above), and reporting that they belong to a club or organization (assess with question four, above). A score of 0 represents the highest level of social isolation and a score of 4 represents the lowest level of social isolation. LOINC® code pending LOINC® code pending Exposure to violence: Intimate Within the last year, have you been humiliated Pending LOINC® code pending LOINC® code pending
Note that we have previously adopted a 2014 Edition “family health history” certification criterion that referenced the HL7 standard for representing genomic information and are proposing a 2015 Edition “family health history – pedigree” certification criterion that references that same standard as well as a related IG. In addition to their relevance for the tested patient, genomic test results are unique in that they have the potential to inform the health care of blood relatives of the tested individual, similar to a shared family history. We note that any application of genomic information across family members must be done in accordance with the HIPAA Privacy Rule and other privacy and patient rights laws regarding genetic information at the federal and state levels. We acknowledge that individually identifiable genetic information may be subject to federal and state privacy laws and regulations that are more privacy restrictive than the HIPAA Privacy Rule. As such, these privacy issues will impact any certification criteria or policy we might propose to adopt in future rulemaking. We therefore welcome input on factors to consider for health IT that allows the user to use or disclose genetic information in a manner compliant with federal and state privacy laws. Note that we are proposing two new 2015 Edition certification criteria for “data segmentation for privacy – send” and “data segmentation for privacy – receive” that would focus on the capability to separately track (“segment”) individually identifiable health information that is protected by rules that are more restrictive than the HIPAA Privacy Rule (please refer to Section III.A.3 for more information). We believe that the capabilities offered by the proposed “data segmentation for privacy” criteria could be leveraged for the segmentation of individually identifiable genetic information that are protected by federal and state privacy laws and regulations.
the “Common MU Data Set” as the assessment, plan of care (for treatment), goals, and health concerns for a single patient encounter or inpatient stay. These stakeholders have expressed safety concerns that the volume of data in a comprehensive care plan can be so extensive that it may be difficult for a provider to quickly determine the information of value for the patient for the given situation. In consideration of this feedback, we clarify that we intend “care plan field(s), including goals and instructions” to be a single provider’s documentation of their assessment, plan of treatment, goals, and health concerns for the patient (this clarification applies for 2014 Edition certification). We also make this clarification to better align with the terms used in the C-CDA Release 2.0, which includes the “Assessment and Plan Section (V2),” “Assessment Section (V2),” “Plan of Treatment Section (V2),” “Goals Section,” and “Health Concerns Section.” In previous iterations of the C-CDA, the “Plan of Treatment Section” was called the “Plan of Care Section,” which resulted in the same level of confusion on whether the information was intended to represent a single encounter or the synthesis of multiple encounters. For that reason, the “Plan of Care Section” is now called the “Plan of Treatment Section” to indicate that it is intended to represent a single encounter and not to be confused with the “Care Plan document template.” For certification to the 2015 Edition, we propose to include in the Common Clinical Data Set “assessment and plan of treatment,” “goals,” and “health concerns” data in accordance with the C-CDA Release 2.0 “Assessment and Plan Section (V2)” or both the “Assessment Section (V2)” and “Plan of Treatment Section (V2);” the “Goals Section;” and the “Health Concerns Section.” In practice, health care providers may document the assessment and plan of treatment together or separately, and the C-CDA Release 2.0 provides for both modes of practice. We understand that the C-CDA Release 2.0 permits both free-text and structured documentation of
Hospital Ambulatory Medical Care Surveys and the National Hospital Care Survey with data from hospital emergency and outpatient departments. NCPDP SCRIPT Implementation Recommendations Version 1.29. URL: . This is a direct link. The Implementation Recommendations Version 1.29 is available at no monetary cost, but references the NCPDP Structured and Codified Sig Implementation Guide Version 1.2. Access to NCPDP standards requires completion of a membership application and a paid membership. NCPDP has stated that membership allows NCPDP to provide a forum wherein a diverse membership can develop business solutions, standards, and guidance for promoting information exchanges related to medications, supplies, and services within the health care system through consensus building processes. Summary: This Implementation Recommendations document includes recommendations for implementation of the structured and codified sig format for a subset of component composites that represent the most common Sig segments using NCPDP Structured and Codified Sig Implementation Guide Version 1.2. The recommendations promote consistent and complete prescription transactions of the NCPDP SCRIPT Standard. Vocabulary standards for representing electronic health information – 45 CFR 170.207 IHTSDO SNOMED CT®, U.S. Edition, September 2014 Release. URL: . Access requires a user account and license agreement. There is no monetary cost for a user account and license agreement. Summary: Systemized Nomenclature of Medicine – Clinical Terms (SNOMED CT®) is a comprehensive clinical terminology, originally created by the College of American Pathologists and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation. SNOMED CT® improves the recording of
Bureau of Labor Statistics estimates that the median hourly wage for a software developer is $44.55. We have also calculated the costs of an employee’s benefits by assuming that an employer expends thirty-six percent (36%) of an employee’s hourly wage on benefits for the employee. We have concluded that a 36% expenditure on benefits is an appropriate estimate because it is the routine percentage used by HHS for contract cost estimates. We have rounded up the average software developer’s wage with benefits to $61 per hour. To calculate our cost estimates for each certification criterion in the tables below, we have multiplied both the average low and average high number of development and preparation hours by $61. For tables 8 and 9, dollar amounts are expressed in 2013 dollars. For unchanged certification criteria, we have estimated a range of 0-50 hours to account for new entrants in the Stage 3 Criteria table (Table 6) and used 60% less of that estimate in the “Independent Criteria” table (Table 7). To illustrate, that would produce a high development hours of 12,700 for the “medication list” criterion (item # 7). This likely still overestimates the burden hours of all potential new entrants. Estimated Health IT Developers and Development Hours Per Criterion Table 6. Estimated Health IT Developers and Development and Preparation Hours for Proposed Certification Criteria – Criteria Associated with the EHR Incentive Programs Stage 3 (“Stage 3 Criteria”) Item # CFR Text Certification Criterion Name Number of Health IT Developers who Develop Product(s) for Certification to Criterion Hourly Development Effort by Health IT Developer Low Avg High Avg 1 § 170.315(a)(1) CPOE – medications 83.3 0 50 2 § 170.315(a)(2) CPOE – laboratory 83.3 1000 2000 3 § 170.315(a)(3) CPOE – diagnostic imaging 83.3 0 50 4 § 170.315(a)(4) DD/DAI Checks for CPOE 242.2 400 800 5 § 170.315(a)(5) Demographics 268.8 500 1000 6 § 170.315(a)(7) Problem List 256.9 100 200 7 § 170.315(a)(8) Medication List 254.8 0 50 8 § 170.315(a)(9) Medication Allergy List 252.7 0 50 9 § 170.315(a)(10) Clinical Decision 235.2 600 1200
§ 170.315 (h)(2) Direct Project, Edge Protocol, and XDR/XDM 0/50 § 170.315(d)(1) through (d)(3) § 170.315(g)(4) § 170.315(g)(8) § 170.314 (b)(1)(i)(B), § 170.314 (b)(2)(ii)(B), and § 170.314(b)(8) Included No relationship beyond the Base EHR Definition 170.314(b)(8) and 170.314(h)(2) § 170.315 (h)(3) SOAP Transport and Security Specification and XDR/XDR for Direct Messaging 0/20 § 170.315(d)(1) through (d)(3) § 170.315(g)(4) § 170.315(g)(8) § 170.314 (b)(1)(i)(C) and § 170.314 (b)(2)(ii)(C) Not included No relationship § 170.314(h)(3) § 170.315 (h)(4) Healthcare Provider Directory – query request 120/240 § 170.315(d)(1) through (d)(3) § 170.315(g)(4) § 170.315(g)(8) Not eligible Not included No relationship § 170.315 (h)(5) Healthcare Provider Directory – query response 120/240 § 170.315(d)(1) through (d)(3) § 170.315(g)(4) § 170.315(g)(8) Not eligible Not included No relationship § 170.315 (j)(1) Electronic Submission of Medical Documentation 1000/200 § 170.315(d)(1) through (d)(3) and (d)(5) through (d)(8) § 170.315(g)(4) § 170.315(g)(6) § 170.315(g)(8) Not eligible Not included No relationship