health IT’s role in accelerating gains in health care quality, efficiency, and population health; the “triple-aim”. This $250 million program includes 17 diverse communities across the US where clinicians, hospitals, health plans and other partners are testing novel information
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technologies and clinical improvement strategies to measurably improve each component of the triple-aim in the delivery of care to patients. With a principle focus on primary care, each Beacon has chosen chronic disease conditions on which to target their efforts. These include diabetes, asthma, COPD, congestive heart failure, and cardio vascular disease.
In this case, we’re highlighting the patient empowerment benefit of the Meaningful Use Stage 2 View online, Download and Transmit (VDT) rule objective, and how the Beacon Communities could support this rule objective and measure its requirements.
3.1 Beacon Context
Integral to all Beacon programs is the meaningful use of electronic health records (EHRs). The effective coordination of care of patients across care settings is of primary concern to most Beacon programs. Meaningful Use Stage 2 has recognized this and has outlined a set of required and optional standardized transports to facilitate this workflow. While the previous workflow, ToC/Referral, targets transitioning between providers or care settings, this workflow focuses on making clinical information available to the patient:
Viewing data from a recent encounter
Downloading a personal copy to keep handy for any number of situations
Transmitting personal copies to a PHR or care team member, facilitating the patient’s ability to conduct their own transition of care (patient mediated exchange).
The actions and/or combinations of actions are entirely within the patient’s control.
In the CMS Meaningful use Stage 2 regulation, 170.314(e)(1) view, download and transmit to a 3rd party, there are 2 measures:
1. Measure 1:
More than 50% of all unique patients seen (or discharged from the hospital) by the Eligible Professional (EP) or Eligible Hospital/Critical Access Hospital (EH/CAH)during the EHR reporting period are provided timely online access to their health
information. For an EP that is within 4 days after the EP has all information, or 36 hours after an inpatient discharge
2. Measure 2:
More the 5% of all unique patients seen by the EP (or discharged from the hospital) during the EHR reporting period, view, download or transmit to a third party their health information.
This User Story describes the use of EHR technology and clinical information exchange standards to improve patient care through the electronic exchange of a standards-based clinical summary between provider and patient. This is exchanged within a Beacon community leveraging existing capabilities in use by the providers in those communities. The occasion for this exchange begins with the provider summarizing the patient’s most recent visit and then making the information electronically available to the patient within 4 business days.
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3.2 Actors
Originating Provider– In this case a Primary Care Provider (PCP)–The PCP provides both the first contact for a person with an undiagnosed health concern as well as continued care for varied medical conditions, not limited by cause, organ system, or diagnosis. The EP delivers care to the patient and documents the care in an Electronic Health Record (EHR) system (Using 2014 Edition Certified Electronic Health Record Technology (CEHRT)). The PCP will cause their EHR to create an electronic, standards- based, clinical summary in the form of a clinical care document (CDA-based clinical summary) and then make available and/or grant the patient the ability electronically view, download and transmit the contents of the CDA-based clinical summary.
Patient – In this case a university student –The student has an opportunity to travel abroad and may have undiagnosed medical condition in addition to the need to verify and/or receive vaccinations appropriate for the student’s geographic destination(s).
3.3 Pre Conditions
Use Case preconditions:
Patient presents for care and is seen by a PCP at a primary care setting. The patient’s demographic and clinical information is documented in the practice’s certified EHR. Data is structured and encoded where appropriate with codes drawn from standard medical terminologies. The PCP’s EHR has the appropriate technical capabilities to create a
structured/codified ambulatory summary data within 4 business days of the information being available to the PCP.
Meaningful Use preconditions:
Meaningful Use Certification
o Patient portal - the system that the patient uses to VDT must be certified. This portal can be supplied either by the provider’s environment (EHR) by the Beacon’s environment, or by a 3rd party modularly certified PHR. If the Beacon decides to provide this they will have to go through Meaningful Use modular certification.
Meaningful Use Attestation
o The provider that has seen the patient must be able to document how many of his or her patients have:
access to information in 4 days
view, download or transmitted to a third party the clinical summary document
o When going through attestation if the Beacon has provided the certified patient portal then it will have to be listed as a module that enabled the provider to fully meet the VDT requirements.
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3.4 Story Narrative
Patient/Bucknell University Student Sara Jones, 19 years of age, needs an appointment to be cleared to travel abroad. The patient starts the process by requesting an appointment at the Student Heath Center through her Patient Health Record (PHR). The Student Health Service receives the request and schedules the appointment. As the appointment is being made, the reason for the appointment is noted and the PCP follows-up with a query to the state’s immunization registry. The results are immediately returned and any immunizations not already recorded are added to the patient’s Electronic Health Record (EHR).
The patient arrives at the Student Health Center and is evaluated by the physician (Dr. White) on duty. During the assessment with Dr. White, Ms. Jones did report an increased thirst, with an onset of 3 months, and an unexplained ten pound weight loss. Dr. White’s clinical findings showed an elevated body mass index of 29. Patient had an in-office urinalysis and finger-stick blood glucose was performed. Her urinalysis showed 4+ glucose, and her finger stick glucose was 245. Stat labs were drawn, and tests performed at a local laboratory. The PCP and patient agreed not to address travel immunization requirements until the lab results have been reviewed.
Once the results were returned to the PCP and added to the EHR, Dr. White found that her HgA1C was 8%, which was within the normal range. After signing/closing the patient encounter, an ambulatory summary was automatically generated and transmitted to the Beacon HIE. The visit notes included:
The patient was stable and was cleared to travel.
The patient should monitor her daily glucose level.
The patient should review their immunization history in relation to the vaccination requirements for her specific geographic destination.
Later the next day, the patient accessed a Patient portal available through either a certified EHR or HIE to review the results of her last visit with her PCP. She learned that she had been cleared to travel. She then went to the CDC’s online Travelers Health guide and learned that the geographic destination required vaccination for Hepatitis A. The patient then made a follow-up visit with her PCP to administer the Hepatitis A vaccine. After her visit, the Beacon HIE was once again updated with the latest clinical data including the new immunization. Because the student is traveling abroad as part of a university-sponsored trip, she was asked to supply a complete list of medications, problems, allergies, and immunizations to university medical services in preparation of her International travel. Ms. Jones logged into the Beacon Portal where she was able to transmit via Direct her latest Ambulatory Summary which contained all the necessary data. She later downloaded the same summary from the Beacon Portal and stored it on a secure USB thumb-drive where it can be referenced should she have any related medical issues while abroad.
In this use case the patient performed all three actions of the measure (view, download and transmit) for matters of tabulating this for meaningful use this would count as one patient in the denominator and only one in the numerator (even though she performed more actions with her information)
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3.5 Post Conditions
The patient’s primary care provider has electronically shared important clinical patient information of a patient with the Beacon HIE. This documentation was provided in a
standardized, structured, and encoded form via a CDA-based clinical summary, enabling any authorized recipient to both render the document in an easily readable and organized form and to consume all or part of the document as structured data into the EHR database. Additionally, the Beacon offers features that allow the patient to personally view the data, download the data to the patient’s device of choice, and transmit the information using secure, standards-based transport(s) to their recipient of choice. The resulting portability of the patient’s clinical data empowered the patient to have more of a direct role in determining her healthcare needs and outcomes.
3.6 Definition of Terms
Access – When a patient possesses all of the necessary information needed to view, download, or transmit their information. This could include providing patients with
instructions on how to access their health information, the website address they must visit for online access, a unique and registered username or password, instructions on how to create a login, or any other instructions, tools, or materials that patients need in order to view,
download, or transmit their information.
Appropriate Technical Capabilities – A technical capability would be appropriate if it protected the electronic health information created or maintained by the certified EHR technology. All of these capabilities could be part of the certified EHR technology or outside systems and
programs that support the privacy and security of certified EHR technology.
Modular Certification – “EHR Module refers to any service, component, or combination thereof that meets at least one certification criterion adopted by the Secretary.” “An EHR Module could provide a single capability required by one certification criterion or it could provide all capabilities but one, required by the certification criteria for a Complete EHR.” Source: http://www.healthit.gov/policy-researchers-implementers/standards-certification- regulations-faqs
Transmission – Any means of electronic transmission according to any transport standard(s) (SMTP, FTP, REST, SOAP, etc.). However, the relocation of physical electronic media (for example, USB, CD) does not qualify as transmission although the movement of the information from online to the physical electronic media will be a download.
Personal Health Record (PHR) - a patient-maintained electronic health record where details concerning the patients individualized care is stored. This is in contrast to an Electronic Health/Medical Record (EMR/EHR) patient portal, which is owned and maintained by health
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care institutions such as physician practices, hospitals, clinics, etc. The primary intent of the patient maintaining the data is to empower the patient to make informed health care
decisions in addition to sharing the information with anyone that the patient seeks to inform. The data could consist of medications, lab results, vital signs, problems, etc. and is meant to be a dynamic record where data may be added, changed or removed by the patient based on the patient’s individual needs.
(Based on CMS.gov, “Regulations and Guidance”)
3.7 Data Sets/Data Elements
Data Specification –A Consolidated Clinical Document Architecture (CCDA) is specified for this exchange. The CDA shall conform to the HL7 Implementation Guide for CDA Release 2: IHE Health Story Consolidation specification for content, structure, and encoding. Content sections will include the Common MU Data Set plus additional sections:
Common MU Data Set Consolidated CDA Template
Patient Name General Header
Sex General Header
Date of Birth General Header
Race General Header
Ethnicity General Header
Preferred language General Header
Smoking Status Social History Section
Smoking Status Observation Entry
Problems Problem Section
Medication List Medications (entries required)
Section
Hospital Discharge Medications Section
Medication Allergies Allergies (entries required)
Section
Laboratory test(s) Plan of Care Section
Plan of Care Activity Observation Entry
Laboratory value(s)/result(s) Results (entries required)
Section
Vital signs – height, weight, blood pressure, BMI Vital Signs Section
Care plan field(s), including goals and instructions Plan of Care Section
Procedures Procedures (entries required)
Section
Care team member(s) General Header
Referenced from the S&I framework data requirements document: wiki.siframework.org/file/view/MU2+Data+Requirements.docx
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Since the V/D/T requirements are associated primarily with the Ambulatory Summary, only one additional section is required:
Data Requirements Consolidated CDA Template
Provider Name & Office Contact Information- Ambulatory
Only General Header
Referenced from the S&I framework data requirements document: wiki.siframework.org/file/view/MU2+Data+Requirements.docx
3.8 Vocabularies/Coding Systems
Data is encoded with standard medical terms and codes using ICD-9-CM, ICD-10-CM, LOINC, SNOMED-CT, RxNorm, HCPCS, and CPT.
3.9 Diagrams/Supporting Material
The User Story does not prescribe a particular means of exchange or usage. It does require however that the CDA-based clinical summary be a standards-based document, fully encoded and structured and that this document must be both human-readable and consumable as structured data by the provider’s EHR technology.
In the first scenario (shown in figure 5) the patient is accessing the patient portal associated with the provider’s EHR. From here the patient is given the ability to view, download and transmit this information. This information will be transmitted to a Beacon HIE that will make this information available in a variety of ways, depending on the individual Beacon
Community. That information may be available to the community of providers, incorporated into a PHR or transmitted to an external PHR.
The second scenario (shown in figure 6) is similar with the difference being that the certified patient portal is provided by the Beacon Community.
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VDT with an EHR based, certified patient portal
Figure 5
VDT with a modularly certified patient portal
Figure 6
3.10 Triggers
All V-D-T workflows are manually performed by the patient either proactively (e.g., transmitting to a PHR) or reactively (e.g., responding to a notification or managing their own ToC). In doing so, the patient could utilize a portal provided by either the provider’s EHR (see 2.2.8-1), or the Beacon HIE (see 2.2.8-2). However, the V-D-T workflows may be
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facilitated by the provider/EHR sending current clinical data to the Beacon HIE, either manually or via automated trigger(s). Additionally, a notification of data availability may be sent to the patient, which would help bolster the 5% objective [170.314(e)(1)].
3.11 Transports
Although the ONC certification criteria for VDT require CEHRTs to support Direct for the VDT objective, the CMS objective and Measure is transport neutral as long as the
transport used is secure. [Cite the CMS and ONC guidance]
The push of information lends itself to the use of Direct or a specific transaction of XDS.b, known as XDR. These support the ability to push data to a known recipient.
Additionally, secure variations of FTP or HTTP could be used to download CDA-based clinical summary via a Patient Portal available through either a certified EHR or HIE.
a. Direct
i. Can be achieved in 3 ways a.SMTP
b. SMTP with XDR/XDM
c.XDR/XDM - Transport infrastructure based on web-services following NwHIN standards
ii. Uses certificates as means of security b. XDS.b
i. The Provide and Register transaction
ii. Transport infrastructure based on web-services following eHealth Exchange standards
iii. Uses certificates as means of security c. Minimal Lower Level Protocol (MLLP)
iv. Pipe delimited messages based on HL7 v2 standards, including MDM and ORU messages
v. Connectivity achieved by allowing access to an IP Address and Port on the receiving system
vi. Uses VPN (virtual private network) as the means of securing the transport d. Secure FTP / HTTP
i. Relatively simple, widely available secure transports ii. Commonly used for downloading data
3.12 Achieving the VDT MU 2 Objective: Numerator/Denominator Calculations
As an outcome of Dr. White making an electronic patient summary available to his patient in the practice’s patient portal, and his patient’s subsequent viewing of the summary, he was also able to count the event toward achieving the MU Stage 2 View Online, Download and Transmit objective. His CEHRT will automatically count the electronic viewing in the numerator and the denominator. The specification for the VDT measure 2, is as follows: Objective: Provide patients the ability to view online, download and transmit their health information within four buisiness days of the infrmation being available to the EP.40
Measure 2: More than 5 percent of all unique patients seen by the EP during the EHR reporting period (or their authorized representative) view, download, or transmit to a thire party their health information.
• Denominator: Number of unique patients seen by the EP duirng the EHR reporting period
• Numerator: The number of unique patients or their authorized representatives) in the denominator who have viewed online, downloaded or transmitted to a third party the patient’s health information.
View – The patient (or authorized representative) access their health information online. Transmission – Any means of electronic transmission according to ANY transport
standard(s) (SMTP, FTP, REST, SOAP, etc.). However, the relocation of physical electronic media (for example, USB, CD) does not qualify as transmission although the movement of the informaiton from online to the physical electronicd media will be downloaded.