01.02.2018 Views

NASL IT Committee

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong><br />

<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Meeting<br />

Tuesday, February 6, 2018 1:15-3:15pm<br />

Dolley Madison Ballroom<br />

Agenda<br />

I. Welcome & Call to Order<br />

Donna Doneski, <strong>NASL</strong> Director of Policy & Membership<br />

Introduce guests from federal agencies to include:<br />

• Zoe Barber, MPH<br />

Special Assistant, Principal Deputy National Coordinator<br />

Office of the National Coordinator for Health <strong>IT</strong> (ONC)<br />

U.S. Department of Health & Human Services (HHS)<br />

• Liz Palena Hall, RN, MIS, MBA<br />

LTPAC Coordinator, Office of Policy, ONC<br />

• Beth Connor, MS, RN<br />

Nurse Consultant, Center for Clinical Standards & Quality (CCSQ)<br />

Quality Measurement & Value-Based Incentives Group (QMVIG)<br />

Division of Chronic & Post-Acute Care (DCPAC)<br />

Centers for Medicare & Medicaid Services (CMS)<br />

II.<br />

Health <strong>IT</strong> Legislative & Regulatory Update<br />

Donna Doneski<br />

Review of current health <strong>IT</strong> legislation on Net Neutrality & Telehealth, plus implementation of the<br />

IMPACT Act and 21 st Century Cures Act’s health <strong>IT</strong> provisions.<br />

• See chart – Tab A in resource section.<br />

III.<br />

<strong>Committee</strong> Discussion of ONC’s Proposed Trusted Exchange Framework & Common Agreement<br />

(TEFCA), plus Draft US Core Data for Interoperability (USCDI)<br />

Ted Prettyman, Director, Sims Strategies<br />

• <strong>Committee</strong> discussion of proposed TEFCA and USCDI. Refer to Tabs B & C in resource section.


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong><br />

Tuesday, February 6, 2018 1:15-3:15pm<br />

Dolley Madison Ballroom<br />

Agenda – continued<br />

IV.<br />

Status of the Data Element Library<br />

Beth Connor, MS, RN<br />

CMS Nurse Consultant<br />

V. New Business<br />

• <strong>NASL</strong> TEFCA Webinar with ONC Principal Deputy National Coordinator Genevieve Morris<br />

Tuesday, February 13 at 2PM EST<br />

• <strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Schedule for 2018<br />

Calls are currently scheduled for the third Thursday of the month at 2PM Eastern<br />

• <strong>NASL</strong> & LTPAC at HIMSS18 – March 5 – 9, 2018 in Las Vegas, Nevada<br />

<strong>NASL</strong> is a collaborator of HIMSS18. <strong>NASL</strong> members may attend HIMSS18 in Las Vegas,<br />

March 5– 9 at discounted rate by using <strong>NASL</strong>’s collaborator code.<br />

• 14 th Annual LTPAC Health <strong>IT</strong> Summit<br />

June 25 – 27, 2018 at the Washington Hilton in Washington, DC<br />

<strong>NASL</strong> is helping to plan the Summit with our colleagues from the LTPAC Health <strong>IT</strong> Collaborative.<br />

Please let us know if you are interested in participating as a sponsor, presenter or attendee.<br />

Additional Resources:<br />

• Tab A – Health <strong>IT</strong> Legislative & Regulatory Chart – An overview of health <strong>IT</strong> legislation and<br />

regulation <strong>NASL</strong> is tracking for 2018<br />

• Tab B – <strong>NASL</strong> Summary of TEFCA<br />

• Tab C – Outline of Key Areas of Focus for <strong>NASL</strong> TEFCA & USCDI Discussion


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab A<br />

<strong>NASL</strong> Health <strong>IT</strong> Legislative & Regulatory Chart – February 1, 2018<br />

An overview of health <strong>IT</strong> legislation and regulation <strong>NASL</strong> is tracking for 2018<br />

Centers for Medicare & Medicaid Services (CMS)<br />

Policy/ Initiative Description Timeline<br />

IMPACT Act Quality<br />

Measures<br />

Transfer of Health Data & Care<br />

Preferences<br />

October 1, 2018<br />

Medicare Part D<br />

Proposed Rule,<br />

including an update<br />

to the electronic<br />

transaction standard<br />

used by Part D Plans<br />

<strong>NASL</strong> commented on CMS’ Medicare<br />

Part D Proposed Rule, which<br />

includes a provision proposing the<br />

adoption of the NDPDP SCRIPT<br />

Standard Version 2017071, and<br />

retirement of the current NCPDP<br />

SCRIPT Version 10.6, as the official<br />

electronic prescribing standard for<br />

transmitting prescriptions and<br />

prescription-related information using<br />

electronic media for covered Part D<br />

drugs for Part D eligible individuals.<br />

2018<br />

New Medicare<br />

Beneficiary Identifier<br />

(MBI)<br />

The Medicare Access & CHIP<br />

Reauthorization Act (MACRA) of<br />

2015 requires CMS to remove Social<br />

Security Numbers (SSNs) from all<br />

Medicare cards by April 2019. The<br />

new Medicare Beneficiary Identifier<br />

(MBI) will replace the SSN-based<br />

Health Insurance Claim Number<br />

(HICN) used for Medicare<br />

transactions such as billing, eligibility<br />

status, and claim status.<br />

April 2018<br />

CMS will begin sending new<br />

Medicare cards to all<br />

beneficiaries<br />

October 2018<br />

Transition period begins<br />

April 2019<br />

New MBI replaces HICN<br />

Resource: CMS’ New<br />

Medicare Card webpage<br />

Data Element Library<br />

(DEL)<br />

See <strong>NASL</strong> Winter Conference<br />

presentation<br />

May 2018<br />

Expected release of DEL<br />

IQIES & QTSO<br />

See <strong>NASL</strong> Winter Conference<br />

presentation<br />

May 2018<br />

QTSO deadline<br />

IQIES is a 3-year project<br />

<strong>NASL</strong> Health <strong>IT</strong> Legislative & Regulatory Chart<br />

As of February 1, 2018<br />

Page 1 of 3


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab A<br />

Office of the National Coordinator for Health Information Technology (ONC)<br />

Policy/ Initiative Description Timeline<br />

TEFCA & USCDI<br />

On January 5, 2018, the ONC<br />

released its proposed Trusted<br />

Exchange Framework & Common<br />

Agreement (TEFCA) and Draft US<br />

Core Data for Interoperability<br />

(USCDI) as required under the 21 st<br />

Century Cures Act.<br />

February 20, 2018<br />

Comments are due<br />

May-June 2018<br />

ONC is expected to issue a<br />

Funding Opportunity<br />

Announcement (FOA) for the<br />

Recognized Coordinating<br />

Entity (RCE)<br />

Late 2018<br />

Final TEFCA to be published<br />

Draft USCDI Version 1 Data Classes<br />

Patient name<br />

Sex (birth sex)<br />

Patient Date of Birth<br />

Preferred Language<br />

Race<br />

Ethnicity<br />

Smoking Status<br />

Laboratory tests<br />

Laboratory values/results<br />

Vital signs<br />

Problems<br />

Medications<br />

Medication Allergies<br />

Health concerns<br />

Care Team members<br />

Assessment and plan of treatment<br />

Immunizations<br />

Procedures<br />

Unique device identifier(s)<br />

Goals<br />

for a patient’s implantable device(s)<br />

Provenance<br />

Clinical Notes<br />

2018 Reference<br />

Edition<br />

Interoperability<br />

Standards Advisory<br />

(ISA)<br />

ONC has posted the latest,<br />

interactive Interoperability Standards<br />

Advisory.<br />

<strong>NASL</strong> Health <strong>IT</strong> Legislative & Regulatory Chart<br />

As of February 1, 2018<br />

Page 2 of 3


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab A<br />

Other Federal Agencies<br />

Policy/<br />

Description<br />

Initiative<br />

CDC’s Infectious CDC is engaged in a collaborative<br />

Diseases C-CDA effort to supplement three Health<br />

Project<br />

Level Seven (HL7) Consolidated-<br />

Clinical Document Architecture (C-<br />

CDA) documents:<br />

(1) Discharge Summary<br />

(2) Continuity of Care<br />

(3) Transitions of Care<br />

*As cited in materials for <strong>NASL</strong>’s <strong>IT</strong><br />

<strong>Committee</strong> briefing on November 16,<br />

2017 by Surveillance Branch Chief,<br />

Division of Healthcare Quality<br />

Promotion, Centers for Disease<br />

Control & Prevention (CDC) Daniel<br />

Pollock<br />

Timeline<br />

HL7 Implementation Guide (IG)<br />

Timeline:<br />

• May 28 – Scope Definition<br />

• June 11 – Scope Material<br />

• July 15 – Notice of Intent to<br />

Ballot Deadline, Fall 2018<br />

• July 23 – Design Freeze<br />

• August 19 – Fall 2018 Ballot<br />

Submission Deadline<br />

• September 29 – October 5<br />

Fall 2018 HL7 Working Group<br />

Meeting (WGM)<br />

• December 2018 – Estimated<br />

IG Publication<br />

FCC Repeal of Net<br />

Neutrality Rules<br />

carries implications<br />

for Telehealth<br />

Open Internet<br />

Preservation Act<br />

(H.R.4682)<br />

On December 14, 2017, the Federal<br />

Communications Commission (FCC)<br />

voted to repeal Net Neutrality rules.<br />

FCC’s repeal of the rules means<br />

Internet Service Providers (ISPs)<br />

could speed up or slow down, or<br />

potentially charge more for certain<br />

Internet content. The concern is that<br />

allowing ISPs to control internet<br />

speed based on users, services, sites<br />

visited or content, may negatively<br />

affect seniors or LTPAC providers.<br />

On December 19, 2017,<br />

Congressman Marsha Blackburn (R-<br />

TN) introduced legislation that could<br />

reinstitute some, but not all of the Net<br />

Neutrality rules. The Open Internet<br />

Preservation Act (H.R.4682) has25<br />

cosponsors as of as of January 31,<br />

2018).<br />

On January 16, 2018, New York<br />

Attorney General Eric Schneiderman,<br />

and a coalition of 22 Attorneys<br />

General, filed a multistate lawsuit to<br />

block FCC’s illegal rollback of net<br />

neutrality.<br />

Open Internet Preservation Act<br />

• Amends the Communications<br />

Act of 1934 by prohibiting<br />

broadband internet access<br />

service providers from: (1)<br />

blocking lawful content,<br />

applications, services or nonharmful<br />

devices; and (2)<br />

impairing or degrading lawful<br />

internet traffic on the basis of<br />

internet content, application<br />

or service, or use of a nonharmful<br />

device.<br />

• Such prohibitions do not<br />

prevent providers from<br />

offering specialized services<br />

that are offered over the<br />

same network and may share<br />

network capacity with the<br />

broadband internet access<br />

service.<br />

• Allows broadband internet<br />

access services to be eligible<br />

for federal universal service<br />

support funding.<br />

<strong>NASL</strong> Health <strong>IT</strong> Legislative & Regulatory Chart<br />

As of February 1, 2018<br />

Page 3 of 3


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

<strong>NASL</strong><br />

Summary & Analysis<br />

DRAFT Trusted Exchange Framework & Common Agreement (TEFCA)<br />

January 20, 2018<br />

Overview<br />

On January 5, 2018, the Office of the National Coordination for Health Information Technology<br />

(ONC) released the Draft Trusted Exchange Framework, which focuses on policies, procedures<br />

and technical standards intended to simplify the exchange of health information and limit costs<br />

associated with the creation of multiple point-to-point interfaces between organizations.<br />

ONC is required under the 21 st Century Cures Act to develop a final Trusted Exchange<br />

Framework & Common Agreement (TEFCA), which will establish a technical and governance<br />

infrastructure to connect disparate health information networks – and by extension to individuals<br />

and providers who use these networks to exchange health information. TEFCA is divided into<br />

two parts. The first part is the Trusted Exchange Framework, which outlines a set of six principles or<br />

“guard rails” for promoting trust across health information networks. These six principles –<br />

standardization, transparency, cooperation & non-discrimination, security & patient safety, access and<br />

data-driven accountability – are described in greater detail below. The second part is the Common<br />

Agreement, which is comprised of a set of minimum terms and conditions that will to help to ensure<br />

that common practices are in place and required of all participating in exchanging electronic health<br />

information. ONC expects to publish the final TEFCA in the Federal Register in late 2018.<br />

TEFCA’s technical infrastructure will support a series of primary networks called Qualified<br />

Health Information Networks (QHINs) that will serve as the main connections for transferring<br />

data across a variety of Health Information Networks (HINs), which facilitate “access, exchange<br />

or the use of electronic health information between or among two or more unaffiliated individuals<br />

or entities.” In addition to the QHINs and HINs, ONC delineates the stakeholders who can use<br />

the Trusted Exchange Framework as federal agencies; public health organizations and<br />

agencies; health information networks; individuals (e.g., patients, caregivers, authorized<br />

representatives and family members); payers; providers (i.e., to include ambulatory, inpatient,<br />

long-term and post-acute care (LTPAC), emergency medical services (EMS), behavioral health<br />

and home and community based services providers); and technology developers (e.g., EHR,<br />

HIE, analytics, laboratory information systems, PHRs, Qualified Clinical Data Registries<br />

(QCDRs), registries, pharmacy systems, mobile technology and other technology).<br />

As part of finalizing the Draft Trusted Exchange Framework, ONC will use an open, competitive<br />

process to select a Recognized Coordinating Entity (RCE). The RCE will work with ONC<br />

through a Cooperative Agreement using the Draft Framework to develop a Common Agreement.<br />

Given ONC’s solicitation for specific feedback regarding the RCE, we believe that ONC may<br />

have an existing entity (or entities) in mind that could be considered for such a Cooperative<br />

Agreement and serve in this oversight role.<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 1 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

Stakeholder feedback from the Draft Framework will inform the RCE and ONC’s development of<br />

a Common Agreement, which will serve as the fleshed out “terms and conditions” that entities<br />

must agree to in order to become QHINs. Entities can then agree to a single terms and<br />

conditions of the TEFCA to exchange information through the QHINs. A blogpost from ONC<br />

points out that much of the Trusted Exchange Framework is based on existing capabilities in the<br />

health <strong>IT</strong> landscape; however, “some modifications to existing HINs and Qualified HINs may be<br />

needed to meet the objectives identified by Congress in the Cures Act.”<br />

Functionally, the RCE will provide oversight and governance of the Common Agreement and for<br />

Qualified HINs (QHINs), which is defined as a network of organizations working together to<br />

share data and serving a wide range of participants. A Qualified HIN must meet all of the<br />

requirements of a HIN, as well as:<br />

<br />

<br />

<br />

<br />

Be able to locate and transmit ePHI between multiple persons and/or entities<br />

electronically;<br />

Have mechanisms in place to impose Minimum Core Obligations and to audit<br />

Participants’ compliance;<br />

Have controls and utilize a Connectivity Broker service;<br />

Be participant neutral; and<br />

<br />

Have Participants that are actively exchanging the data included in the USCDI in a live<br />

clinical environment.<br />

The QHINs will connect directly to each other, forming the core for nationwide interoperability.<br />

HINs can connect to the QHINs via a “connectivity broker,” which is a service provided by the<br />

QHIN and that delivers all functions for the “permitted purposes” (such as treatment or public<br />

health) to include: master patient index; Record Locator Service; Broadcast and Directed<br />

Queries, and EHI return to an authorized requesting Qualified HIN.<br />

In addition to the Draft Trusted Exchange Framework and TEFCA process and supporting<br />

materials, ONC released the Draft U.S. Core Data for Interoperability (Draft USCDI). The Draft<br />

USCDI is a set of standardized data elements that represent the minimum level of information to<br />

be shared through the TEFCA, with an annual process for proposing, reviewing and adding to<br />

these data elements. The Draft USCDI includes all of the elements of the Common Clinical Data<br />

Set (CCDS) with the addition of clinical notes and provenance.<br />

Comments on the Draft Trusted Exchange Framework and Draft USCDI are due to ONC<br />

by February 20, 2018.<br />

A more in-depth look at various aspects of the Draft Trusted Exchange Framework<br />

follows, along with additional resources and <strong>NASL</strong>’s schedule for review and comment of<br />

this proposed regulation.<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 2 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

Background & Implementation Timeline<br />

Section 4003 of the 21 st Century Cures Act (Public Law 114-255), which was signed into law on<br />

December 13, 2016, requires ONC to take steps to promote interoperability. Section 4003(b)<br />

directs ONC to, “for the purpose of ensuring full network-to-network exchange of health<br />

information, convene public-private and public-public partnerships to build consensus and<br />

develop or support a trusted exchange framework, including a common agreement among<br />

health information networks nationally. Such convention may occur at a frequency determined<br />

appropriate by the Secretary.” This section also lays out that a Common Agreement may<br />

include:<br />

(I)<br />

(II)<br />

(III)<br />

(IV)<br />

a common method for authenticating trusted health information network participants;<br />

a common set of rules for trusted exchange;<br />

organizational and operational policies to enable the exchange of health information<br />

among networks, including minimum conditions for such exchange to occur; and,<br />

a process for filing and adjudicating noncompliance with the terms of the common<br />

agreement.<br />

Section 4003 also lays out a timeline for implementation. The law directs ONC to<br />

<br />

<br />

<br />

convene stakeholders within six months of enactment;<br />

publish TEFCA one year after convening stakeholders;<br />

develop a directory of participating QHINs within two years of convening stakeholders.<br />

ONC is well on its way to achieving this implementation timeline. On July 24, 2017, ONC held its<br />

first Listening Session with Comment Period. <strong>NASL</strong> submitted comments in response to ONC's<br />

request for comment on August 25, 2017. A second and third listening sessions were held on<br />

September 29 and November 30, 2017, respectively. Moving forward, ONC’s implementation<br />

guideline is as follows:<br />

<br />

<br />

<br />

<br />

<br />

<br />

<br />

January 5, 2018 – Draft Trusted Exchange Framework Released for Public Comment<br />

January 5 – February 20, 2018 – 45-Day Public Comment Period<br />

March 19, 2018 – ONC’s H<strong>IT</strong>AC Trusted Exchange Framework Task Force Presentation<br />

April 18, 2018 – ONC’s H<strong>IT</strong>AC USCDI Task Force Presentation<br />

Mid-2018 – Selection of a Recognized Coordinating Entity (RCE)<br />

December 2018 – H<strong>IT</strong>AC Final Report<br />

Late 2018 – Release of Final TEFCA<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 3 of 10


Review & Analysis of ONC’s Draft Trusted Exchange Framework<br />

<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

The ONC’s Draft Trusted Exchange Framework lays out the framework for creating a network<br />

for nationwide interoperability of electronic health information. ONC is focused on ensuring “data<br />

liquidity,” meaning that data can flow freely between entities. Additionally, the openness of the<br />

network is intended to give new technologies (and app developers) access to the data in order<br />

to unlock the potential of health information technology. ONC envisions the products of the Draft<br />

Trusted Exchange Framework will support a “single on-ramp” through which an entity can agree<br />

to work with a single entity of their choice and have access to all electronic health information.<br />

This is done by end users connecting to participants (including Health Information Networks<br />

(HINs), EHR vendors and other organizations) that connect to Qualified Health Information<br />

Networks (QHINs), which in turn handle data requests through Connectivity Brokers,<br />

responsible for responding to queries and returning the requested electronic health information.<br />

Data requests must be for one of six “Permitted Purposes,” including: 1) Public Health; 2)<br />

Individual Access; 3) Benefits Determination; 4) Treatment; 5) Payment and 6) Healthcare<br />

Operations.<br />

NOTE – Participation is voluntary; however, we anticipate that it is possible future<br />

Medicare payment policies could require participating in interoperable exchange.<br />

Also, it is interesting to note that ONC’s supplemental materials for providers<br />

suggest that one way providers can be involved in the Trusted Exchange<br />

Framework is to “require the technology vendors or HINs they contract with be<br />

connected to the network created by the Trusted Exchange Framework.”<br />

TEFCA Goals<br />

ONC lays out five goals for the TEFCA in A User’s Guide to Understanding the Draft Trusted<br />

Exchange Framework. These goals are:<br />

1. Build on and extend existing work done by the industry;<br />

2. Provide a single “on-ramp” to interoperability for all;<br />

3. Be scalable to support the entire nation;<br />

4. Build a competitive market allowing all to compete on data services;<br />

5. Achieve long-term sustainability.<br />

Principles, Process & Operation<br />

The Draft Trusted Exchange Framework itself is divided into two parts. The first part is “Part A –<br />

Principles for Trusted Exchange,” providing an overview of the six key principles guiding the<br />

TEFCA process. The second part is “Part B – Minimum Required Terms and Conditions for<br />

Trusted Exchange,” which provides a framework “terms and conditions” based on these six<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 4 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

principles that will be used as the basis for developing a more comprehensive Common<br />

Agreement. The agreement will provide for:<br />

<br />

<br />

a common authentication processes of trusted health information network participants;<br />

a common set of rules for trusted exchange; and<br />

<br />

a minimum core set of organizational and operational policies to enable the exchange of<br />

electronic health information among networks.<br />

Through the terms and conditions of the Common Agreement entities accepting those terms<br />

can become Qualified Health Information Networks (QHINs), which will serve as the backbone<br />

of the exchange network.<br />

NOTE – TEFCA is designed to align with requirements under the Health Insurance<br />

Portability & Accountability Act of 1996 (HIPAA). Still, ONC recognizes that not all<br />

users of the TEFCA will be “Covered Entities” or “Business Associates” under<br />

HIPAA, which is the reason TEFCA includes specific terms and conditions to<br />

enable the broader exchange of health information.<br />

Principles<br />

The six principles outlined in the proposed Trusted Exchange Framework are:<br />

1. Standardization – Adhere to industry and federally recognized standards, policies, best<br />

practices and procedures.<br />

2. Transparency – Conduct all exchange openly and transparently.<br />

3. Cooperation & Non-Discrimination – Collaborate with stakeholders across the continuum<br />

of care to exchange electronic health information (EHI), even when a stakeholder may<br />

be a business competitor.<br />

4. Privacy, Security & Patient Safety – Exchange electronic health information (EHI)<br />

securely and in a manner that promotes patient safety and ensures data integrity.<br />

5. Access – Ensure that individuals and their authorized caregivers have easy access to<br />

their electronic health information (EHI).<br />

6. Data-driven Accountability – Exchange multiple records for a cohort of patients at one<br />

time in accordance with applicable law to enable identification and trending of data to<br />

lower the cost of care and improve the health of the population.<br />

Additional information on how these should be implemented appears in the second part of the<br />

TEFCA. The section begins with a lengthy outline of definitions used, followed by sections on<br />

each of the principles, plus sections on Requirements of Qualified HINs, Participant Obligations,<br />

End-User Obligations.<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 5 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

Process<br />

ONC intends to partner with a private sector entity for implementing the Draft Trusted Exchange<br />

Framework. ONC will select this entity – called a Recognized Coordinating Entity (RCE) – that<br />

will develop the final Common Agreement used in creating the full Trusted Exchange<br />

Framework & Common Agreement (TEFCA). ONC will begin the RCE selection process with a<br />

Funding Opportunity Announcement (FOA), which will award a single, multi-year Cooperative<br />

Agreement to a single RCE sometime in the Spring of 2018. The RCE will serve as the umbrella<br />

organization for governing the TEFCA, including developing the final Common Agreement and<br />

TEFCA products, onboarding QHINs and then governing implementation and ongoing<br />

enactment of the TEFCA. This also includes producing a directory of QHINs.<br />

With the RCE serving as a governance organization, the backbone of the interoperable<br />

exchange network is the QHINs, which are entities that have accepted the Common Agreement<br />

and meet other criteria.<br />

Operation<br />

Once the TEFCA and QHINs are established, QHINs will connect to each other and respond to<br />

inquiries for electronic health information (EHI). Using a Connectivity Broker service, QHINs<br />

respond to supported use cases for the permitted purposes of treatment, payment, healthcare<br />

operations, individual access, benefits determination and public health. The use cases currently<br />

include Broadcast Query (requesting all entities in the QHIN to search for and return<br />

information), Directed Query (seeking information from a single entity where you know<br />

information resides) and Population Level Data (for quality measurement, risk analysis or other<br />

analytics).<br />

In the event of a data breach, for example, the Draft Trusted Exchange Framework proposes<br />

requiring QHINs to notify the RCE within 15 days. Additionally, for security and identity proofing,<br />

the Draft Trusted Exchange Framework requires a minimum of IAL2 and AAL2 Authentication,<br />

with support for FAL2 or FAL3. For patients, providers and other entities can act as a “Trusted<br />

Referee” to confirm a patient’s identity if documents from an Authoritative Source are not<br />

available.<br />

Draft USCDI<br />

Finally, as part of the Draft Trusted Exchange Framework, ONC released the Draft U.S. Core<br />

Data for Interoperability (USCDI), which is designed to establish a minimum set of data classes<br />

that are required to be interoperable nationwide with the ability to expand in an iterative and<br />

predictable way. QHINs will be required to support the latest version of the USCDI, and a new<br />

version will be produced annually (with the first being USCDI v1). The initial USCDI data set<br />

includes the Common Clinical Data Set (CCDS) with the addition of clinical notes and<br />

provenance.<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 6 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

Draft USCDI Version 1 Data Classes<br />

Patient name<br />

Sex (birth sex)<br />

Patient Date of Birth<br />

Preferred Language<br />

Race<br />

Ethnicity<br />

Smoking Status<br />

Laboratory tests<br />

Laboratory values/results<br />

Vital signs<br />

Problems<br />

Medications<br />

Medication Allergies<br />

Health concerns<br />

Care Team members<br />

Assessment and plan of treatment<br />

Immunizations<br />

Procedures<br />

Unique device identifier(s)<br />

Goals<br />

for a patient’s implantable device(s)<br />

Provenance<br />

Clinical Notes<br />

Beyond USCDI v1, two other categories of data classes will be Candidate Data Classes, which<br />

are being considered for inclusion in future USCDI versions, and Emerging Data Classes, where<br />

stakeholders are working toward developing standardized data classes and setting technical<br />

specifications. Data elements can remain in these classes over multiple years before being<br />

accepted into the USCDI.<br />

ONC – Key Areas of Focus<br />

Here are a few of the specific areas of focus for which ONC is soliciting comment:<br />

Confidential Unclassified Information<br />

Entities interacting with federal agencies will have a responsibility for protecting<br />

Confidential Unclassified Information, but the agencies cannot enter into contracts with<br />

private entities requiring this protection. ONC is soliciting feedback on how protecting<br />

this information can be required.<br />

RCE Criteria<br />

ONC is seeking feedback on the criteria for selecting the RCE. ONC is seeking H<strong>IT</strong>AC<br />

feedback on whether particular eligibility requirements should be considered in<br />

developing the Cooperative Agreement for the RCE. Other criteria to consider include<br />

things such as whether the entity should be a non-profit, have experience convening<br />

stakeholders, be a health <strong>IT</strong> vendor or exchange and what level of neutrality the RCE’s<br />

subsidiaries or business partners should have to the RCE’s work.<br />

Authentication<br />

Trust is key to this framework, and ONC is seeking feedback on how to authenticate<br />

users across the system to ensure data is protected for providers and patients.<br />

Prescription Drug Monitoring Programs<br />

ONC is seeking comment on how the exchange of health information data in the Draft<br />

Trusted Exchange Framework could support Prescription Drug Monitoring Programs<br />

(PDMPs).<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 7 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

<strong>NASL</strong> – Key Areas of Focus<br />

In addition to ONC’s areas of focus, <strong>NASL</strong> flags the following topics for your consideration:<br />

<br />

<br />

<br />

<br />

<br />

<br />

Fees – The description of Principle 3 – Cooperation & Non-Discrimination – underscores<br />

ONC’s interest in ensuring the free flow of health information, “even when a stakeholder<br />

may be a business competitor.” In webinars and ONC’s presentation to the H<strong>IT</strong> Advisory<br />

<strong>Committee</strong> (H<strong>IT</strong>AC) on January 19, ONC leadership repeatedly point to Congress’ focus<br />

to prevent information blocking. In that same discussion, ONC acknowledged there may<br />

be some new market opportunities around the TEFCA, which is why ONC is seeking<br />

specific feedback on this topic. The Draft Trusted Exchange Framework would allow, but<br />

not require, QHINs to charge fees for “Reasonable Attributable Costs” related to its<br />

services, including developing APIs and the Connectivity Broker, and employing legal<br />

services for agreements. The Draft Trusted Exchange Framework does not specify what<br />

the fees could be, or set a maximum, so long as the fees are uniformly charged to<br />

entities accessing the QHIN. Are there existing norms with respect to fees for accessing<br />

existing health information networks? Are fees absorbed as part of the software<br />

development process or passed onto clients? Are there fee limits that should pertain<br />

specifically to LTPAC, behavioral health or other non-incentivized providers?<br />

RCE (Oversight Entity) Criteria – Also see ONC’s request for comment listed above.<br />

How should the RCE be selected? Should the RCE be a non-profit, a health <strong>IT</strong> vendor or<br />

some other type of organization? Are there concerns regarding existing business<br />

partnerships for an entity seeking to be the RCE?<br />

Data Set – How does the proposed USCDI process for adding new categories of data<br />

interact with industry? Will this process work like the NQF Measures Under<br />

Consideration (MUC) list? How will information be solicited?<br />

How Existing Entities Will Interact – How will the TEFCA relate to, replace or<br />

supplement existing exchange networks (HIEs, CommonWell, Carequality, etc.)? How<br />

will state-specific requirements be addressed?<br />

Business Considerations – During ONC’s presentations to date, several questions<br />

have been raised regarding what services an HIN or QHIN may be able to offer such as<br />

data aggregation. Others have questioned whether implementation of TEFCA will mean<br />

existing business/software contracts will have to be reviewed and/or renegotiated.<br />

Clearly, implementation of a new federal floor for health information exchange will create<br />

both new opportunities and costs. Are there any particular provisions or definitions that<br />

<strong>NASL</strong> should consider in our review and comment on the Draft Trusted Exchange<br />

Framework & Common Agreement?<br />

Certification – ONC has noted that TEFCA is voluntary at this point. How will TEFCA<br />

relate to ONC’s Certification Program moving forward?<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 8 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

<strong>NASL</strong> TEFCA Review Schedule<br />

As you consider what questions or concerns you have in response to the Draft Trusted<br />

Exchange Framework, including both ONC’s and <strong>NASL</strong>’s areas for focus, consider the following<br />

recommendations to best support <strong>NASL</strong>’s commenting process:<br />

• Please be specific with the section of the Draft Trusted Exchange Framework with which<br />

you have concerns, citing the specific page number, paragraph or section;<br />

• Please share any broad questions or themes where you have concerns, or any places<br />

where clarification is needed;<br />

• Specific recommendations for how concerns could be addressed, or text of the Draft<br />

Trusted Exchange Framework changed, are very helpful.<br />

Here is the schedule for <strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> review/comment:<br />

• Thursday, January 25 at 2PM EST – Initial discussion of key points by <strong>IT</strong> <strong>Committee</strong><br />

• Tuesday afternoon, February 6 – Presentation on TEFCA and review of <strong>NASL</strong>’s<br />

DRAFT comments during the face-to-face meeting of the <strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> during<br />

<strong>NASL</strong>’s Winter Conference in Washington, DC<br />

• February 12 or 13 – Possible webinar with ONC staff<br />

• Thursday, February 15 at 2PM EST – <strong>NASL</strong> will send out revised comments after the<br />

Winter Conference for review during our regular <strong>IT</strong> <strong>Committee</strong> meeting time slot on<br />

Thursday, February 15.<br />

• Tuesday, February 20 – Final comments are due to ONC.<br />

Resources<br />

• Draft Trusted Exchange Framework<br />

• Draft U.S. Core Data for Interoperability (USCDI) & Proposed Expansion Process<br />

• A User’s Guide to Understanding the Draft Trusted Exchange Framework<br />

• HHS Press Release on Draft Trusted Exchange Framework<br />

• Health <strong>IT</strong> Buzz Blog Post<br />

• Draft Trusted Exchange Framework Highlights for:<br />

<br />

<br />

<br />

Consumers<br />

Providers<br />

Payers<br />

• H<strong>IT</strong>AC TEFCA Task Forces<br />

ONC’s new Health Information Technology Advisory <strong>Committee</strong> (H<strong>IT</strong>AC) has set up two<br />

task forces, which will make recommendations relevant to TEFCA.<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 9 of 10


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab B<br />

H<strong>IT</strong>AC’s Trusted Exchange Framework Task Force will develop and advance<br />

recommendations regarding the Minimum Required Terms and Conditions, selection of the<br />

RCE, clarifying eligibility requirements for the Qualified HINs (QHINs), clarifications around<br />

the six permitted purposes and privacy and security standards regarding identity proofing<br />

and authentication.<br />

H<strong>IT</strong>AC’s S. Core Data for Interoperability Task Force will review and provide feedback on<br />

U.S. Core Data for Interoperability (USCDI) structure and process, including data class<br />

priorities, how USCDI would be expanded and any factors regarding the frequency with<br />

which USCDI would be published.<br />

View ONC’s presentation for H<strong>IT</strong>AC on TEFCA from January 19, 2018.<br />

###<br />

<strong>NASL</strong> Summary & Analysis<br />

ONC’s Draft TEFCA<br />

Page 10 of 10


Key Areas of Focus for <strong>NASL</strong> Discussion<br />

<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab C<br />

ONC’s Proposed Trusted Exchange Framework & Common Agreement (TEFCA)<br />

and Draft US Core Data for Interoperability (USCDI)<br />

ONC – Key Areas of Focus for which ONC is soliciting comment<br />

• Confidential Unclassified Information<br />

Entities interacting with federal agencies will have a responsibility for protecting<br />

Confidential Unclassified Information, but the agencies cannot enter into contracts<br />

with private entities requiring this protection. ONC is soliciting feedback on how<br />

protecting this information can be required.<br />

• RCE Criteria<br />

ONC is seeking feedback on the criteria for selecting the RCE. ONC is seeking<br />

H<strong>IT</strong>AC feedback on whether particular eligibility requirements should be considered<br />

in developing the Cooperative Agreement for the RCE. Other criteria to consider<br />

include things such as whether the entity should be a non-profit, have experience<br />

convening stakeholders, be a health <strong>IT</strong> vendor or exchange and what level of<br />

neutrality the RCE’s subsidiaries or business partners should have to the RCE’s<br />

work.<br />

• Authentication<br />

Trust is key to this framework, and ONC is seeking feedback on how to authenticate<br />

users across the system to ensure data is protected for providers and patients.<br />

• Prescription Drug Monitoring Programs<br />

ONC is seeking comment on how the exchange of health information data in the<br />

Draft Trusted Exchange Framework could support Prescription Drug Monitoring<br />

Programs (PDMPs).<br />

Additional Areas of Focus Identified by <strong>NASL</strong><br />

• Fees – The description of Principle 3 – Cooperation & Non-Discrimination –<br />

underscores ONC’s interest in ensuring the free flow of health information, “even<br />

when a stakeholder may be a business competitor.” In webinars and ONC’s<br />

presentation to the H<strong>IT</strong> Advisory <strong>Committee</strong> (H<strong>IT</strong>AC) on January 19, ONC<br />

leadership repeatedly point to Congress’ focus to prevent information blocking. In<br />

that same discussion, ONC acknowledged there may be some new market<br />

opportunities around the TEFCA, which is why ONC is seeking specific feedback on<br />

this topic. The Draft Trusted Exchange Framework would allow, but not require,<br />

QHINs to charge fees for “Reasonable Attributable Costs” related to its services,<br />

including developing APIs and the Connectivity Broker, and employing legal services<br />

for agreements. The Draft Trusted Exchange Framework does not specify what the


<strong>NASL</strong> <strong>IT</strong> <strong>Committee</strong> Agenda<br />

Tab C<br />

fees could be, or set a maximum, so long as the fees are uniformly charged to<br />

entities accessing the QHIN. Are there existing norms with respect to fees for<br />

accessing existing health information networks? Are fees absorbed as part of the<br />

software development process or passed onto clients? Are there fee limits that<br />

should pertain specifically to LTPAC, behavioral health or other non-incentivized<br />

providers?<br />

• RCE (Oversight Entity) Criteria – Also see ONC’s request for comment listed<br />

above. How should the RCE be selected? Should the RCE be a non-profit, a health<br />

<strong>IT</strong> vendor or some other type of organization? Are there concerns regarding existing<br />

business partnerships for an entity seeking to be the RCE?<br />

• Data Set – How does the proposed USCDI process for adding new categories of<br />

data interact with industry? Will this process work like the NQF Measures Under<br />

Consideration (MUC) list? How will information be solicited?<br />

• How Existing Entities Will Interact – How will the TEFCA relate to, replace or<br />

supplement existing exchange networks (HIEs, CommonWell, Carequality, etc.)?<br />

How will state-specific requirements be addressed?<br />

• Business Considerations – During ONC’s presentations to date, several questions<br />

have been raised regarding what services an HIN or QHIN may be able to offer such<br />

as data aggregation. Others have questioned whether implementation of TEFCA will<br />

mean existing business/software contracts will have to be reviewed and/or<br />

renegotiated. Clearly, implementation of a new federal floor for health information<br />

exchange will create both new opportunities and costs. Are there any particular<br />

provisions or definitions that <strong>NASL</strong> should consider in our review and comment on<br />

the Draft Trusted Exchange Framework & Common Agreement?<br />

• Certification – ONC has noted that TEFCA is voluntary at this point. How will<br />

TEFCA relate to ONC’s Certification Program moving forward?<br />

Draft USCDI Version 1 Data Classes<br />

Patient name<br />

Sex (birth sex)<br />

Patient Date of Birth<br />

Preferred Language<br />

Race<br />

Ethnicity<br />

Smoking Status<br />

Laboratory tests<br />

Laboratory values/results Vital signs<br />

Problems<br />

Medications<br />

Medication Allergies<br />

Health concerns<br />

Care Team members<br />

Assessment and plan of<br />

treatment<br />

Immunizations<br />

Procedures<br />

Unique device identifier(s) Goals<br />

for a patient’s implantable<br />

device(s)<br />

Provenance<br />

Clinical Notes

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!