Interoperability Roadmap Public Comments

Dear Office of the National Coordinator for Health IT:

On behalf of the Joint Public Health Informatics Taskforce (JPHIT), we are pleased to submit comments on the Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0 (henceforth “the Roadmap”). As a taskforce of nine national public health associations, JPHIT’s comments are informed by a broad perspective on federal actions that impact public health informatics capacity and practice in the United States of America. Relative to the Roadmap, JPHIT’s view encompasses stakeholders who:

• Support the public good;
• Generate new public health knowledge;
• Operate and connect health and public health IT capabilities;
• Govern, certify and/or have oversight; and
• Develop and maintain standards.

JPHIT is committed to supporting ONC’s efforts to protect and improve our nation’s health with interoperable electronic health information.

JPHIT supports the draft Roadmap’s overall goal, objectives, and approach. Public and private efforts to build an information ecosystem must advance toward the Learning Health System (LHS) to maximize public health benefits. Data flow among healthcare and health-related service settings to generate population-level insights is fundamental for a LHS. JPHIT, therefore, strongly supports actions that prioritize the development of interoperability building blocks for public health purposes.

JPHIT finds, however, significant gaps in the Roadmap to health information system interoperability for population and public health. The gaps are at both strategic and tactical levels. Strategically, JPHIT believes that clinical and public health information interoperability must be advanced concurrently, allowing for optimal coordination in development, implementation, and interactions. When actions are prioritized to benefit direct patient care first and then only later benefit community health, the overall benefit to the public and the patient is unnecessarily diminished and delayed. We recommend that the ONC adopt a strategy that prioritizes actions that have mutual, immediate benefit to the quality of clinical and public health services. At a tactical level, adoption of this recommendation would, at a minimum, entail the following:

1. Stakeholders: Recognize and address the interoperability needs of public health agencies, other essential public health service providers (e.g., NGOs), and other population health actors as data providers, as well as data consumers.

2. Governance: In any governance body and its component working groups, industry-led or otherwise, ensure balanced representation for the public good’s interest in setting policy and standards for interoperability. The governance body should include representation from local, state, and federal public health as these three entities have unique and vital roles in the exchange of health-related data.

3. Priority use cases: Public health use cases, mutually beneficial to patients and their communities, should be prioritized in the first three years of the Interoperability roadmap implementation plan. Doing so will promote near-term returns on federal Health IT investments that are population-wide, solutions to core legal barriers that constrain interstate public health data exchange, and information technologies with baseline functionalities for the public good. JPHIT recommends use case #2, "Clinical settings and public health are connected through bi-directional interfaces that enable seamless reporting to public health departments and seamless feedback and decision support from public health to clinical providers.”

4. Core technical standards and functions: The common “clinical” and patient-matching datasets must be further standardized and grown for public health purposes. JPHIT supports and refers ONC to the individual comments of our member organizations for further technical details on these matters.

JPHIT values the inclusive leadership and bold vision ONC exhibited in drafting the Roadmap. Public health agencies at local, state, and federal levels are partners in the process and essential components of the vision. Moving forward, JPHIT will continue to support all stakeholders in advancing health IT interoperability for more healthy and resilient individuals, families and communities.

Sincerely,

Marcus Cheatham, PhD
JPHIT Co-Chair, NACCHO representative

Stephanie Mayfield Gibson, MD, FCAP
JPHIT Co-Chair, ASTHO Representative

Please accept the attached as updated version dated 4-3. Thank you.

Attached is a comment submitted on behalf of the staff of the Federal Trade Commission’s Office of Policy Planning, Bureau of Competition, Bureau of Consumer Protection, and Bureau of Economics. We appreciate this opportunity to provide our views on ONC’s draft Interoperability Roadmap. We would be happy to address any questions you may have regarding competition and consumer protection policy in the health IT marketplace.

John Dubiansky
Attorney Advisor – Intellectual Property
Office of Policy Planning
Federal Trade Commission
202.326.2182
jdubiansky@ftc.gov

Attached are McKesson Corporation's comments on the Nationwide Interoperability Roadmap.

I have provided detailed comments which are attached on the following topics

A. ONC should proceed with the focus on addressing interoperability in significant use cases without further delay or distraction
B. Common technical standards or formats should be a desired capability for certain health information system software under some use cases but there should not reflect efforts to restrict additional, alternative formats when coupled with common format capability
C. Modularity, like exchange and common format capability, is important, but stakeholders must also assess the value and approaches to modularity under competing objectives and practical considerations
D. The Roadmap should try to articulate where there are separate transitional burdens from generally competing policy factors which include the value of innovation, competition, and tailoring products
E. Some type of National survey or other approach to measuring the current and future level and means of interoperability would be useful
F. Federal Agencies should commit to follow interoperability guidelines
G. ONC has not yet demonstrated a feasible model for requiring or managing the use of interoperable IT tools through Medicare payment programs or Conditions of Participation
H. The draft discussion on consent issues, including those on basic and granular choice, poses many problems and should be withdrawn except that consideration of developing comment consent mechanisms to facilitate consent where required under existing laws or other arrangement would be useful
I.I. Harmonization of privacy and security law is important and cannot per se preserve the most stringent aspects of existing laws

April 3, 2015

Dr. Karen DeSalvo
National Coordinator for Health Information Technologyp
Office of the National Coordinator for Health Information Technology
Hubert H. Humphrey Building
200 Independence Avenue SW
Washington, DC 20201

RE: ONC Shared Nationwide Interoperability Roadmap Draft 1.0

Dear Dr. DeSalvo:

I am writing on behalf of the Alliance for Home Health Quality and Innovation (the “Alliance”) with regard to the request for public comment on the Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0. The Alliance appreciates the opportunity to provide comments on the proposed interoperability roadmap.

About the Alliance for Home Health Quality and Innovation
The Alliance is a non-profit 501(c)(3) organization with the mission to lead and support research and education on the value of home health care to patients and the U.S. health care system. Working with researchers, key experts and thought leaders, and providers across the spectrum of care, we strive to foster solutions that will improve health care in America. We are also a membership based organization comprised of not-for-profit and proprietary home health care providers and other organizations dedicated to improving patient care and the nation’s healthcare system. For more information about our organization, please visit: http://ahhqi.org/.

The Alliance supports the direction of, and sentiment behind, the roadmap, and commends the Office of the National Coordinator for Health IT’s (ONC’s) efforts in focusing attention on the need for national interoperability in health information technology. With the roadmap, ONC is demonstrating an interest in moving forward the discussion of interoperability as a central component of a more efficient and cost-effective health care delivery system. As noted previously, the idea of a shared Nationwide Interoperability Roadmap is critical to providing high quality care to patients regardless of where they are treated in the continuum.
Additionally, the Alliance appreciates the mention of home health care and long-term and post-acute care (LTPAC) in the specific discussion of future care delivery and the move to community-based models of care delivery. The Alliance supports the work being done in the context of the S&I Framework’s electronic Long-Term Services and Support (eLTSS) initiative, and looks forward to engaging with the initiative. The eLTSS initiative will be useful in developing significant use cases for community-based care and possible standardized data elements.
Finally, the Alliance supports the expanded discussion of the Health Insurance Portability and Accountability Act (HIPAA) as it relates to what data can be exchanged, how, and by whom. Such clarification, as referenced within the Executive Summary of the proposed roadmap, will allow for more efficient and safe transfer of health information.
Although the Alliance supports the overall direction of the roadmap, the following are key considerations for ONC moving forward: (I) need for greater clarity on the roles of stakeholders; (II) expanded discussion of standards; (III) consideration of further incentives for adoption of interoperable systems; and (IV) inclusion of priority use cases that involve LTPAC.

I. In order to better achieve interoperability across all care settings, further clarity is needed on the roles of various stakeholders

Setting a national roadmap is a crucial first step in creating a truly interoperable learning health care system. As such, the Alliance applauds ONC’s efforts to set the course for the future. However, further clarity is still needed on the roles of individual stakeholders in advancing interoperability. Within the currently proposed roadmap, the roles of stakeholders are not clearly defined in the evolving learning health care system. Given that ONC refers to stakeholders as the true owners of the roadmap, it is crucial to flesh out their roles in seeing the ten-year timeline through.

II. Additionally, while the Alliance appreciates this first step, expanded discussion of standards is still needed to facilitate interoperability across stakeholder groups.

The inclusion of LTPAC, and discussion of the eLTSS initiative, within the roadmap are promising signs of the importance of community-based care and long-term supports and services in the health care system. Further discussion of standards is required to enable implementation of the roadmap across the continuum.

While the findings from the eLTSS initiative will be critical in the further development of standards, the Alliance recommends ONC consider further exploration of standards, consistent with the Alliance’s comments submitted last year on voluntary electronic health record (EHR) certification. Within these comments, the Alliance noted that interoperability should be the key behind the development of software certification standards as it is the best way to promote care integration across settings. This is further supported by the S&I Framework’s own Transitions of Care Initiative from 2011, which asserts standards are a critical enabler of care transitions.

Therefore, to fully reach a nationwide interoperable health system, standards must remain a critical focus across all care settings, including LTPAC, community services, and behavioral health.

III. Despite a shared interest in achieving interoperability, further consideration should be given to incentives for creation and adoption of interoperable health information technology systems

While the Alliance understands the need for individual providers to play a critical role in the development of interoperable systems and networks, the Alliance urges ONC to consider additional policy levers and supports for the success of interoperability long-term. One possible means of incentivizing interoperability is through new models of care delivery. For example, the incorporation of health IT requirements in to the Medicare Shared Savings Program (“ACO proposed rule”) would be one way of promoting interoperability. Such incentives are appropriate as long as they do not pose an undue burden.
Additionally, within the context of the meaningful use program, the Alliance recommends that meaningful use providers increasingly be required to exchange health information with LTPAC providers. By utilizing the existing meaningful use program to further health information exchange across settings, the goal of interoperability is furthered without great financial strain on the system.
Without greater incentives for creation of these systems, there is no assurance that even those interested will invest in interoperability. This is referenced on page 37 of the proposed roadmap, “Despite strong agreement on the need for interoperability to enable higher quality, more efficient, person-centered care, the demand among providers, consumers and purchasers of health care has not yet translated into seamless interoperability across the health care system.” Thus, the Alliance urges ONC and HHS to consider further appropriate policy levers to advance the health care system towards interoperability.

IV. The Priority Use Cases listed in Appendix H should include those related to LTPAC and care transitions.

The Alliance urges ONC to look to the use cases developed by the S&I Framework’s Longitudinal Coordination of Care (LCC) Workgroup for additional use cases that include LTPAC. As discussed in both the draft roadmap and above, the shift to community-based services will put a greater emphasis on long-term services and supports. As such, identifying use cases that include LTPAC services is critical to creating an interoperable health care system.
Therefore, the Alliance recommends the inclusion of the following use cases developed by the LCC WG, (1) a home health plan of care, (2) transitional care between home health and skilled nursing facilities (SNF), and (3) care transitions between SNFs and emergency departments.
Building upon these use cases will support the growth of interoperability as care shifts into the community, with a home as a critical locus of care.
* * *
The Alliance is appreciative of the efforts made by ONC to focus on goals for health IT in the midst of a changing health care landscape. By focusing on the expansion of HIT adoption and interoperability, patient well-being and safety will be furthered, and health care delivery will be improved overall.

In conclusion, the focus on the achievement of a nationwide interoperable learning health care system is one that the Alliance supports strongly. In order to maximize efficiency and achieve interoperability in the timelines discussed, greater discussion and clarification is needed on the role of individual stakeholders, appropriate standards, and incentives for adoption. Additionally, LTPAC and community-based services should remain a focus of discussion, with greater inclusion of the existing use cases.

Thank you again for the opportunity to comment. Should you have any questions about the Alliance’s comments, please contact me at (202) 239-3671 or tlee@ahhqi.org or Jennifer Schiller at (202) 239-3206 or jschiller@ahhqi.org.

Sincerely,
Teresa L. Lee, JD, MPH
Executive Director

Please accept the attached comments on the "Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0" on behalf of the American Academy of Pediatrics. If you have any questions or need additional information, please do not hesitate to contact me.

Thank you.

Sincerely,

Pat Johnson
Assistant Director, Dept. of Federal Affairs
American Academy of Pediatrics
(202) 347-8600
pjohnson@aap.org

The Roadmap approach to Governance, Architecture and Infrastructure and security & privacy are very good and shall require work, collaboration, and testing and validation before deployment to be useful. SEMHIE agrees that solutions should be vendor neutral and the architecture should allow for the process of multiple solutions as healthcare is a rather diverse and fragmented industry.

See Attachment

pg 12 - No. 1 - Governance link doesn't work

pg 14 - A high level overview of HIPAA in relation to interoperability might be beneficial to enhance understanding and stakeholder engagement
The link to the document 'Privacy and Security Protections for Health Information' doesn't work

pg 22 - fig 5 - Educational Institutions and Medical/Healthcare Professional Associations should also be engaged as Stakeholders to ensure that newly qualified professionals are coming into the healthcare system with an understanding that this is the normal way of working & the Professional Associations to champion it

pg 24- I - I believe currently that vendors are still developing non certified EHR technology, is the assumption that CEHRT systems are the current baseline for interoperability? If so, communication to providers is required to ensure they are aware of this to prevent/reduce barriers to the realization of nationwide interoperability.

General - there is mention of Shared profits for payers and providers and at the same time, lower healthcare costs as a benefit to patients. This means there is a reduction in profits which may be viewed negatively. I suggest that it should be made clear that the benefits, be it intangible would outweigh the costs.

General - I would suggest outlining the benefits of this for each stakeholder as a supporting document to the incentives

General - Comprehensive and interesting document which takes into account a lot of the issues, provides majority of the answers and identifies the challenges and gaps to achieving this huge but required interoperability especially in the face of ever changing and cutting edge technology. This means that the ONC and partners need to be agile to achieve this but also sensitive in approach to the cultural barriers of professionals who may never adopt such technology.