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• What is an ICD-10-CM code?
  International Classification of Diseases, Tenth Revision, Clinical Modification coding, known as ICD-10-CM coding, is a system used by clinicians to classify and record all diagnoses and symptoms for care within the United States. Codes are based on the International Classification of Diseases, which is published by the World Health Organization (WHO), using unique alphanumeric codes to identify known diseases and other health problems. ICD-10-CM codes provide a level of detail that is necessary for storing and retrieving diagnostic information, compiling national mortality and morbidity statistics, and processing health insurance claims.

   

• What is an ICD-10-CM Z code for Social Determinants of Health (SDOH)?
  ICD-10-CM codes include a category called Z codes, which are used to describe experiences, circumstances, or problems that affect patient health, but are not considered a specific disease or injury. Z codes identify patients facing socioeconomic and psychosocial circumstances that may influence their health status and contact with health services. Currently, codes included in categories Z55-Z65 document patients’ SDOH in a standardized manner.

   

• How does standardizing the capture of SDOH data codes benefit population health?
  Traditionally, data recorded during a patient visit directly relates to a patient’s health but does not incorporate outside factors that can impact well-being. SDOH data captures information at a level traditional health data sources cannot, and ICD-10-CM Z codes can record this information, giving deeper insights into factors impacting health, such as employment, food insecurity, and housing. Standardizing SDOH would assist in identifying, documenting, and tracking additional markers of health, beyond the physical, and would permit clinicians, hospitals, and health plans to share the information through medical records and insurance claims data.

   

• Are there guidelines for using ICD-10-CM codes for SDOH?
  ICD-10-CM diagnosis codes have been adopted under the Health Insurance Portability and Accountability Act (HIPAA) for all healthcare settings. Guidelines for Z codes are included in the Centers for Medicare & Medicaid Services (CMS) ICD-10-CM Official Guidelines for Coding and Reporting for FY 2020. https://www.cdc.gov/nchs/data/icd/10cmguidelines-FY2020_final.pdf

   

• Why should providers, non-physician healthcare providers, and coders use ICD-10-CM Z codes for SDOH?
  Utilizing Z codes for SDOH enables hospitals and health systems to better track patient needs and identify solutions to improve the health of their communities. The extraction of SDOH data from the Electronic Health Record (EHR) for clinical, operational, and research purposes can facilitate tracking, identification, and referrals to social and governmental services. Rather than a new system or new tool to capture SDOH, leveraging existing ICD-10-CM codes offers an opportunity to expand on the existing system. This practical application brings SDOH into a clinician’s workflow and becomes a part of the patient’s electronic medical record and claims history.

   

• What are the limitations of ICD-10-CM Z codes for SDOH?
  Currently, Z codes for SDOH capture some, but not all, domains of SDOH. Stakeholder groups have requested that the ICD-10 Coordination and Maintenance Committee expand the codes to represent more granular information that would inform more precise, effective, and efficient social interventions, such as “barrier situations” which prevent consumers from obtaining medications and routine and preventive care. Although coding for SDOH is not mandated, when there is documentation of SDOH in the patient’s notes, it is still possible to use Z codes in the same manner that medical coding is done. Coding professionals may not know to scan for SDOH or may be hesitant to use the codes. Additionally, if a code has not been developed for a specific SDOH issue, the issue will not be coded and will not be included in the patient’s overall plan of care, nor as part of the claim submission process, unless it is recorded as narrative text.

   

• Are coding professionals allowed to use non-physician documentation to support ICD-10-CM coding for societal and environmental conditions?
  Yes, coding professionals at hospitals and health systems can report these codes based on documentation by all clinicians involved in the care of patients, such as case managers, discharge planners, social workers and nurses. In early 2018, the American Hospital Association’s (AHA) Coding Clinic published guidance that allows the reporting of SDOH ICD-10 codes based on non-physician documentation. The ICD-10-CM Cooperating Parties approved the advice, with the change effective February 2018.

   

• Where can I find more resources and initiatives around SDOH data and ICD-10-CM Coding?
  • American Hospital Association (AHA) Information sheet on ICD-10 Coding for Social Determinants of Health
  • "Health Disparities: Social Determinants of Health)” (Free online education module by the American Medical Association (AMA)
  • AMA’s Integrated Health Model Initiative (IHMI), Resource Link & Link 2
  • AMA and UnitedHealthcare’s collaboration to support the creation of new ICD-10 codes related to SDOH
  • Centers for Disease Control (CDC) Social Determinants of Health Webpage
  • CMS 2020 ICD-10-CM Files
  • CMS ICD-10-CM Official Guidelines for Coding and Reporting for FY 2020
  • CMS’ Accountable Health Communities Health-Related Social Needs Screening Tool & FAQ
  • Healthy People 2020’s Social Determinants of Health Webpage
  • Humana Food Insecurity and Loneliness Toolkits
  • The National Association of Community Health Centers (NACHC) Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE)
  • American Academy of Family Physicians (AAFP)’s EveryONE Project Toolkit
  • SIREN’s (Social Interventions Research and Evaluation Network) Gravity Project Resource Link & Link 2
  • NCQA Population Health Management Resource Guide

In Summer of 2019, eHealth Initiative and UnitedHealthcare’s National Strategic Partnerships Division convened a collaborative meeting of leaders from payer organizations and other stakeholder groups to address the use of ICD-10-CM codes for capturing social determinants of health (SDOH) data. This meeting marked a significant milestone in the shift to value-based care. Despite the competitive nature of healthcare, the private sector is working together to address factors pertinent to patient care and well-being in a sustainable, scalable manner. The group discussed the need for better education of provider and billing coders on the value of collecting and using SDOH data and identified strategies to accomplish this task:

• Develop a consistent and unified approach to communicate and assist providers and coders in utilizing existing ICD-10-CM codes for SDOH.
• Formulate a strategy and unified approach for providers and coders to assist with adoption and utilization of the proposed SDOH codes once approved.

Attendees agreed that the best strategy to communicate and promote the adoption of ICD-10-CM codes for SDOH to various stakeholder audiences was to:

• Develop this document as well as two-page communication tools for various audiences, including providers and coders. The coder tool, Transforming health care: Why including SDOH codes on claims is critical and provider tool, Using SDOH coding to transform health outcomes are available for use.
• Promote the use of the communication tools at various payer organizations through a high-level communication plan that outlines dissemination to stakeholder groups.

For a brief overview on the topic, check out our eHI Explains ICD-10-CM Coding for SDOH. Links to the provider and coder documents are forthcoming.

Liberating Telemedicine: Options to Eliminate the State-Licensing Roadblock

Aside from the ideal of eliminating government licensing of clinicians, or the second-best option of relying on states to open their borders to physicians licensed in other states, the most feasible option for expanding telemedicine is for Congress to define the location of the practice of telemedicine as that of the physician, treating digital patients like patients who physically make a trip across state or national borders to secure medical care.

Under such a law, a physician would need only one license to engage in the practice of telemedicine, and would be responsible for only one set of licensing rules—those of the state in which the physician practices. Existing telemedicine providers would be able to recruit physicians in greater numbers and to provide higher-quality and lower-cost services to far more patients. The ability of patients in emergent situations or with rare illnesses to obtain care from top specialists would expand dramatically. New entrants into a national market for telemedicine would drive down prices for both telemedicine and in-person medical services.

The full article can be downloaded below.  

Traditional and Digital Biomarkers: Two Worlds Apart?

The identification and application of biomarkers in the clinical and medical fields has an enormous impact on society. The increase of digital devices and the rise in popularity of healthrelated mobile apps has produced a new trove of biomarkers in large, diverse, and complex data. However, the unclear definition of digital biomarkers, population groups, and their intersection with traditional biomarkers hinders their discovery and validation. We have identified current issues in the field of digital biomarkers and put forth suggestions to address them during the DayOne Workshop with participants from academia and industry. We have found similarities and differences between traditional and digital biomarkers in order to synchronize semantics, define unique features, review current regulatory procedures, and describe novel applications that enable precision medicine.

The full article can be downloaded below.  

ONC continues to re-draw the map of patient care with its Trusted Exchange Framework and Common Framework (TEFCA) Draft 2 that aims to:

• Provide a single “on-ramp” to nationwide electronic health connectivity;
• Ensure electronic information securely follows when/where needed; and
• Support nationwide scalability for network connectivity.

TEFCA Draft 2 is an alphabet soup of abbreviations.  Two of the most important concepts are the Qualified Health Information Network (QHIN) -- the hub and main actor in the TEFCA universe --  and the Recognized Coordinated Entity (RCE). The yet-to-be selected RCE  -- a non-profit, industry-based organization -- will deal with the Common Agreement that creates baseline technical and legal requirements for sharing electronic health information on a nationwide scale across disparate networks.

eHI recently submitted feedback to ONC on TEFCA Draft 2.  We congratulated ONC on:

• QTF - Adding a separate QHIN Technical Framework (QTF);
• More Reasonable Timelines - Extending the timeline for QHINs to update and comply with agreements and technical requirements from 12 to 18 months;
• Positive QHIN Refinements - Refining QHIN exchange modalities and pre-requisites, to better reflect today’s healthcare practice and market realities; and
• Flexibility and Phase-Ins - Incorporating more flexibility to build from existing exchange capability and standards, as well as a phasing-in of appropriate provisions and requirements.

eHI cautioned ONC on:

• Tread Carefully - eHealth Initiative cautions ONC to be very mindful the Congressional intent expressed in the 21^st Century Cures Act that the TEFCA avoid disruption and duplication of “existing exchanges between participants of health information networks.” And, where existing networks that meet needs are in place, ONC is encouraged to build upon them.
• Complex QHINs - ONC’s TEFCA Draft 2 document offers many additional details about the Qualified Health Information Networks (QHINs). eHealth Initiative expresses concern and caution about the complexity of the QHIN concept and its ecosystem. We urge ONC to pay close attention to public comments about whether the QHINs, as currently conceived, will work effectively and build enough value.
• Sustainability – The TEFCA processes, including the RCE and the QHIN, must be financially sustainable and not overly dependent on federal funding.
• RCE Independence – The RCE should have significant independence from ONC with transparent accountability (including to ONC) and governance that engages all stakeholders, and particularly end-users.
• Fees - eHealth Initiative requests additional information around QHIN to QHIN fee details, particularly what constitutes “reasonable and non-discriminatory criteria” that a QHIN is to use if it charges any fees to another QHIN. Effective ONC and RCE communication with relevant stakeholders on fee issues will be absolutely critical.
   

See our attached comments for more details. eHI is in a unique position to comment and offer insight on federal government as the only national organization that represents all stakeholders in the healthcare industry. Stay tuned for more!

eHI's Policy Guy Summarizes Comments on ONC & CMS Interoperability Proposals

June saw the end of exhaustive and exhausting comment periods on interoperability-focused proposed rules from the Office of the National Coordinator for Health IT (ONC) and the Centers from Medicare and Medicaid Services (CMS), discussed in my prior blog. The annual CMS Medicare hospital payment proposed rule also touched on interoperability issues and the physician-focused annual proposed rule is expected imminently.  In the U.S. Congress, there was also renewed activity to fill in the interoperability puzzle, including provisions in a Senate HELP Committee approved bill on cost reduction that would build on the Blue Button 2.0 expansion in the recent CMS interoperability proposed rule, as well as interest in expanding HIPAA to non-covered entities to address privacy and security concerns with application programming interfaces (APIs) and apps. There was also House action to remove statutory restrictions on federal consideration of a national patient identifier.

ONC and CMS Information Blocking and Interoperability Proposed Rule Comments

The ONC and CMS interoperability proposed rules stimulated many comments (including from the eHealth Initiative). The ONC proposed rule received over 2,000 comments, many if not most, on price transparency, the subject of a June 25 Executive Order. ONC has formally targeted November 2019 for a final rule, although a later release is likely given the number and tenor of comments, including calls for second round of proposed rulemaking.  

Common issues in comments on the ONC interoperability and information blocking proposed rule were:

• Broad support for increased patient access to information, standards-based open APIs, and reduction of information blocking;
• Likely significant burdens on information blocking-relevant “actors,” especially complexity and compliance costs;
• The Information Blocking definition is too broad and the need for specific guidance to develop compliance plans;
• Definitions of Health Information Network and Health Information Exchange are too broad and confusing;
• The focus on Electronic Health Information (EHI) should be scaled back to HIPAA Protected Health Information (PHI);
• The proposed information blocking exceptions cover the right categories, but requirements are too detailed and rigid, although some see exceptions as loopholes;
• Pricing and contracting limits are too restrictive, requiring extensive documentation, and could distort markets (the Federal Trade Commission agreed);
• The scope (which products and developers) of information blocking liability for health IT developers; and
• The effective dates and timelines for developers and implementers should be extended.

Trusted Exchange Framework and Common Agreement (TEFCA) Draft 2

The ONC Trusted Exchange Framework and Common Agreement (TEFCA) Draft 2 received far fewer comments (about 125) by the June 17 deadline, including from the eHealth Initiative. A common theme was for ONC to be more consistent with congressional intent to support and not disrupt or duplicate existing exchange networks and frameworks and their in-place trust agreements. There were also calls for ONC to reconcile the TEFCA with HIPAA privacy and security regulations and with forthcoming information blocking and open API regulations. There was particular attention to how Individual Access will be implemented, including the role of apps and APIs, as well as how to implement Meaningful Choice, which would enable individuals to opt out of the TEFCA.

Comments also emphasized that the Recognized Coordinating Entity (RCE) to be designated in August by ONC should have considerable leeway to work with stakeholders to refine and implement the policy and technical aspects of the TEFCA. The RCE will be a nonprofit organization assigned to develop, update, implement, and maintain the TEFCA Common Agreement. The RCE will also work with ONC to designate and monitor the Qualified Health Information Networks (QHINs) that will be the backbone of nationwide queries, modify and update the accompanying QHIN Technical Framework (QTF) that will govern QHIN-to-QHIN interactions, and engage with stakeholders through virtual listening sessions.

Following its review of these TEFCA Draft 2 comments, ONC intends to:

• Finalize and publish final principles for the Trusted Exchange Framework (TEF);
• Have the RCE issue for public comment, after ONC approval, Draft 1 of the Common Agreement, which will include Minimum Required Terms and Conditions (MRTCs) developed by ONC and Additional Required Terms and Conditions (ARTCs) developed by the RCE and approved by ONC;
• Have the RCE issue for public comment, after ONC approval, Draft 2 of the QTF;
• Have the RCE issue for production, after ONC approval, Final Version 1 of the Common Agreement (to be published in the Federal Register);
• Have the RCE issue for production, after ONC approval, Final Version 1 of the QTF;
• Have the RCE designate and monitor QHINs that sign and adopt the Common Agreement—QHINs would “flow-down” Common Agreement provisions to their Participants and Participant Members;
• Have the RCE implement an ONC-approved process to determine QHIN compliance with the Common Agreement;
• Have the RCE implement a process to update the Common Agreement, as needed, for ONC final approval and publication; and
• Have the RCE propose strategies to sustain the Common Agreement at a national level after expiration of the four-year term of the Cooperative Agreement.

Based on a review of the TEFCA Draft 2 and the companion ONC Notice of Funding Opportunity for the RCE, it is likely that the revised Common Agreement, the QTF, and initial QHINs will all roll-out during 2020.

Implications for eHealth Initiative Members

The flurry of federal activity in June sets the stage for expanded healthcare interoperability in the U.S. and for a more complex regulatory environment.  Key changes to prepare for include:

• Expanded nationwide query-based access to health information, initially at the “document” level (e.g., C-CDA) and later at the level of individual data elements, using standards like HL7® FHIR®. This access will accommodate queries by patients and their designees;
• Regulatory drivers to reinforce private sector growth in standards-based APIs for granular, patient-focused, health data access, again relying on HL7® FHIR®;
• Pressures for federal and state privacy and security protections to follow the shift to an API/app ecosystem;
• Increased recognition of the need to enhance patient matching, with a robust federal role;
• Continued tensions between federal government prescriptiveness and reliance on private sector dynamics, recognizing that the latter can be driven by high-level federal initiatives around areas like value-based payment and information blocking; and
• Implementation of federal laws and regulations on information blocking that will transform the digital health space, resulting in both increased data liquidity and a complex and costly compliance environment, potentially rivaling what we have seen with HIPAA.
   

Mark Segal, PhD, FHIMSS, Principal, Digital Health Policy Advisors, LLC. Member and Past Chair of the eHI Policy Steering Committee. July, 9 2019. Twitter @msegal111

eHI thinks Mark Segal is a super cool guy and is providing his opinions for informational purposes only. The opinions presented, do not represent those of eHealth Initiative, our members or the Foundation.

‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework

Engagement of patients and healthcare professionals is increasingly considered as fundamental to pharmacovigilance and risk minimisation activities. Few empirical studies of engagement exist and a lack of explicit conceptualisations impedes effective measurement, research and the development of evidence-based engagement interventions.

This article (1) develops a widely applicable conceptualisation, (2) considers various methodological challenges to researching engagement, proposing some solutions, and (3) outlines a basis for converting the conceptualisation into specific measures and indicators of engagement among stakeholders. 

We synthesise social science work on risk governance and public understandings of science with insights from studies in the pharmacovigilance field.

This leads us to define engagement as an ongoing process of knowledge exchange among stakeholders, with the adoption of this knowledge as the outcome which may feed back into engagement processes over time. We conceptualise this process via three dimensions; breadth, depth and texture. In addressing challenges to capturing each dimension, we emphasise the importance of combining survey approaches with qualitative studies and secondary data on medicines use, prescribing, adverse reaction reporting and health outcomes. A framework for evaluating engagement intervention processes and outcomes is proposed. Alongside measuring engagement via breadth and depth, we highlight the need to research the engagement process through attentiveness to texture— what engagement feels like, what it means to people, and how this shapes motivations based on values, emotions, trust and rationales.

 Capturing all three dimensions of engagement is vital to develop valid understandings of what works and why, thus informing engagement interventions of patients and healthcare professionals to given regulatory pharmacovigilance scenarios.

The full article can be downloaded below.  

Frequently Asked Questions on HIPAA and Health Plans Support Care Coordination and Continuity of Care

2019 is a year of unprecedented regulatory releases and activity by federal healthcare agencies. eHealth Initiative (eHI) responded to two of the year's most significant proposed rules related to interoperability and information blocking on Thursday, May 30. Key issues highlighted in eHI’s CMS and ONC responses include:

Overarching ONC and CMS Issues

• Agency Coordination – Practical, thoughtful agency coordination between ONC and CMS on implementing programs related to these proposed rules is needed.
   
• Promoting Patient Access to and Control over Health Information – eHI expresses support for the ONC and CMS strategy to anchor their proposed rule around fostering innovation that promotes patient access to and control over their health information. eHI emphasizes that patient self-efficacy is critical in value-based payment and patient engagement/education is fundamental to that success.
   
• Patient Matching RFI – eHI supports the intent expressed in the proposed rules to identify additional opportunities in the patient matching space and explore ways that ONC and CMS can lead and contribute to coordination efforts with respect to patient matching. eHI also offers its perspectives and support on patient matching issues such as:
  • Matching solutions involving patients;
  • Adoption of well-tested demographic data standards to improve patient matching; and
  • Working with industry and experts to identify other regularly collected demographic data elements that could be incorporated into the US Core Data for Interoperability (USCDI) to support patient matching.

ONC Specific Issues

• Scope of Electronic Health Information - Given that the electronic health information definitions will form the basis for both action and penalty in our healthcare system, eHI urges ONC to further define and appropriately focus and specify the electronic health information definition for the final rule.  
   
• Conditions and Maintenance of Certification (APIs) - eHI commends ONC for selecting an innovative and flexible suite of standards and associated resources, including HL7® Fast Healthcare Interoperability Resources (FHIR®).

As with the proposed information blocking provisions, eHI urges caution given our concerns about complex and costly compliance, documentation, patient education and healthcare stakeholder risk issues related to the proposed API provisions. All parties will need to undertake significant steps to implement APIs and all stakeholders will need to work together to ensure a measured, secure, informed and realistic approach to this transition.

eHI also registers concern regarding the proposed rules’ API provisions and the associated app and attestation process, which could present risk to both providers and patients. Specifically, according to the ONC proposed rule:

APIs should require a “yes” attestation by the app that patients are provided meaningful notice and control over how their protected health information (PHI) is used to connect to the API.

eHI believes that this traditional "click yes to continue" model likely isn't enough to communicate to the patient the risk managing that data might have or to give confidence to providers concerned that patients understand the risks and benefits of this data use. Healthcare providers and others should be assured that patients comprehend the risk prior to using their data in apps and in choosing using the API.

We urge ONC to evaluate for future certification criteria, ways in which certified health IT can gather and store information specific to a patients’ understanding of the use of the data, drawing as appropriate on elements of the Model Privacy Notice created by ONC.

• Information Blocking - eHI urges a review of the very broad definitions of health care actors related to information blocking, particularly health information networks and health information exchanges. We also register caution and concern about complex and costly compliance and documentation related to the proposed information blocking provisions.  eHI expresses its willingness as a leading, multi-stakeholder national HIE resource to work with ONC on HIE issues as they evolve and grow within ONC program purview.

CMS Specific Issues

• Patient Access Through APIs (Open API Proposal for MA, Medicaid, CHIP, and QHP Issuers in FFEs) - eHI registers caution and concern about complex and costly compliance, documentation, patient education and healthcare stakeholder risk and liability issues related to the proposed API provisions. Significant steps to implement APIs will be required and all parties will need to work together to ensure a measured, secure, informed and realistic approach to this transition.

Cited as particularly aggressive are the API implementation and data availability timeframes - January 1, 2020 for MA plans and QHP issuers in FFEs, July 1, 2020 for Medicaid FFS, Medicaid managed care plans and CHIP managed care entities.

For more information, please see eHI’s detailed ONC and CMS comments attached below.