ONC Sells Successes of Health IT Adoption to Congress in Annual Report

The ONC released its second annual report on the adoption of health IT this past June.  The report provides a snapshot of the nation's efforts and continuing barriers to health IT adoption.  Although EHRs have been lambasted lately by Congress, the report primarily covers the ongoing big "wins" for health IT adoption: increased participation in the Medicare and Medicaid EHR Incentive Programs ("Meaningful Use") in 2012, increased adoption of EHR technology among physicians and hospitals and increased rRx, and various federal and state HIE and HIT efforts. 

For example, CMS is more than happy to report that over half of the nation's eligible professionals have received payments through Meaningful Use as of April 2013, with about 80% of eligible hospitals receiving incentive payments as well. Among the 50 States, only 8 do not have mechanisms broadly available statewide for directed exchange, whether fully implemented or in pilot phases, of which New Jersey is one of. And 36 states have query-based exchange available either statewide or through at least certain regions.   

The report also highlights the variety of programs, pilots and regulatory efforts undertaken by CMS and ONC, among others, and the success these have had since the passage of the HITECH Act. However, ONC acknowledges the barriers that remain for health IT, particularly interoperability, and remains committed to developing flexible, modular standards and policies for the interaction and exchange of information among various types of systems. 

To help support interoperability, the State HIE Program recently released a set of online training modules for providers, supporting the roll-out of Meaningful Use Stage 2 set to kickoff this October for eligible hospitals, and January 2014 for eligible providers. The Standards and Interoperability ("S&I") Framework continues to work with stakeholders in the vendor and provider communities to identify barriers and their solutions to achieving national interoperability.  And the public/private partnership through the national eHealth Exchange (formerly the Nationwide Health Information Network or NwHIN) continues as ONC's "incubator of innovation" in HIE. 

Additional efforts highlighted by ONC include:

  • improving consumer and provider confidence and trust in health IT and HIE;
  • engaging consumers in their ehealth and identifying solutions for consumers to better control and direct the flow of their information through HIE;
  • gathering data through various public forums and surveys on privacy and security concerns for safeguarding health information in health IT;
  • development of interactive tools for providers to assess mobile device security as well as general security tools for safeguarding electronic PHI and EHRs, and minimizing breaches;
  • identifying strategies for improving coordination and integration of behavioral health providers into broader health IT efforts, including launching an interstate Direct behavioral health pilot; and
  • identifying stragegies for improving coordination and integration of long-term and post-acute care providers into broader health IT efforts.

For the entire snapshot of the nation's health IT status, read the full report with its easy-to-read charts and graphs.  You may be surprised at how much ONC has been involved with and that has happened in the evolution of health IT and HIE.  

HHS Releases RFI on Interoperability and HIE

HHS, CMS and ONC have released a Request for Information (RFI) seeking input on policies and programs to encourage health information exchange (HIE) through interoperable systems.  Although the Medicare and Medicaid EHR Incentive Programs and other federal efforts are rapidly increasing the adoption of standards based HIE and EHR technology,

This alone will not be enough to achieve the widespread interoperability and electronic exchange of information necessary for delivery reform where information will routinely follow the patient regardless of wheter they receive care....

The overarching goal is to develop and implement a set of policies that would encourage providers to routinely exchange health information through interoperable systems in support of care coordination across health care settings.  

HHS therefore seeks comment on several options for encouraging HIE among providers and settings of care through a hodge-podge of existing statutory vehicles (primarily CMS and ONC programs and projects). In addition to requesting comment on these existing vehicles, CMS and ONC seek to identify what is currently working to encourage HIE, and which changes would have the biggest impact on HIE adoption, including regulatory requirements.

Furthermore, although long neglected under the EHR Incentive Programs, CMS and ONC specifically seek comment on what policies and programs would have the most impact on post-acute and LTC care providers as well as behavioral health.  They ask for insight into how these programs and policies should be implemented and developed to maximize care coordination and quality improvement for these populations. In addition, CMS and ONC specifically seek comment on policies and programs which would most impact patient access and use of their electronic health information for management of their care.   

Post-Acute and Long-Term Care Providers.  HHS acknowledges the low rates of EHRs and HIE among LTC and post-acute care providers and identifies existing authority which could be leveraged to expand HIE.  These include incorporating HIE as key components of:

  1. Medicaid health homes;
  2. Demonstration and pilot projects under Medicaid and the Childrens Health Insurance Program (CHIP);
  3. Home and community based services (HCBS), which would include LTC;
  4. State expansions of HIE infrastructure as part of the Medicaid EHR Incentive Program, and
  5. CMS Conditions of Participation or Coverage

Settings of Care.  HHS additionally acknowledges the need to accelerate HIE across providers, including ambulatory care, behavioral health, laboratory, and post-acute and LTC. For example, HHS seeks comment on:

  1. New e-specified measures for exchanging summary records following transitions of care aligned with CMS quality reporting programs, including the EHR Incentive Programs;
  2. Medicare Shared Savings Program, requiring or encouraging Accountable Care Organization (ACO) to engage in HIE as part of coordination of care;
  3. Payment and service delivery model testing under the Affordable Care Act, such as demonstration of use of interoperable technology for HIE to facilitate model participation decisions and requirements;
  4. Model testing to align Medicare and Medicaid financing and care integration under the Capitated Financial Alignment model.

Consumer and Patient Engagement.  HHS and CMS seek to encourage engagement of patients in their care by improving their access to health information and electronic communication between their health care providers.  Options to encourage consumer and patient engagement include:

  1. Incorporating new measures into Medicare Advantage Program consumer assessment serveys (CAHPS);
  2. Blue Button availability to all CMS beneficiaries;
  3. Payment and service delivery model testing under the Affordable Care Act, such as demonstration of incentives for consumers to more actively participate in their health; and
  4. Direct access to lab results from laboratories (CLIA and HIPAA Amendments).

The RFI will be published today in the Federal Register.  Comments may be submitted up to 5pm on April 22, 2013. 

ONC Setting Stage for NHIN Governance Guidance

Last year, ONC announced that it would not be moving forward on establishing governance regulations for the Nationwide Health Information Network (now called the "eHealth Exchange") as a result of the comments and feedback it received.  Instead, it proposed to move forward with developing best practices guidance and support activities for existing governance initiatives and goals in nationwide health information exchange (HIE).

This year, ONC is kicking off several activities to support HIE governance. First, a federal funding opportunity is available for existing governance entities to further develop and adopt policies, interoperability requirements, and business practice criteria relating to HIE. Applications may be submitted until February 4 on Grants.gov

Secondly, Dr. Mostashari and ONC have scheduled an open Town Hall listening session for this coming Thursday, January 17, as well as February 14 in order for stakeholders to express their priorities, concerns or issues.  Based on stakeholder input, the HIT Policy Committee and HIT Standards Committee are expected to hold a public hearing then on January 29 to discuss current HIE policies, practices and impediments, as well as opportunities to strengthen and improve governance. 

Finally, ONC will develop and publish a series of governance "guidelines" based on the feedback it has received for effective and trustworthy HIE.  Stay tuned for more information on ONC's new site for HIE Governance

FDA Moving Forward with Regulating Mobile Health Apps

This post is prepared by Christopher Dodson.

Mobile medical apps designed for use on phones and tablets are generally unregulated. In July 2011, the FDA published guidance indicating its intention to use the existing regulatorymobile app.png framework for a small subset of apps. It planned to scrutinize apps used as accessories to already-regulated medical devices and apps that use attachments to turn mobile devices into regulated medical devices.

Even as the FDA finalizes its guidelines, President Obama has signed the “Food and Drug Administration Safety and Innovation Act” which includes a provision laying the groundwork for broader regulation of mobile medical apps. Section 618 gives the HHS Secretary until January 2014 to issue a report with a proposed strategy for a risk-based regulatory framework for HIT, including mobile medical apps. The new law requires that the framework promote innovation, protect patient safety and avoid regulatory duplication.

In developing the framework, the Secretary has the option of assembling a working group of stakeholders to provide guidance. If the Secretary does form the group, it is required to have representatives from a variety of groups including patients, providers, health plans, startup companies, venture capitalists, technology vendors and small businesses.

This puts mobile medical app developers in a difficult position.

The FDA is still finalizing a narrow set of guidelines. But in 18 months the Secretary’s report will likely open the door to broader regulations sometime in the future. For now app developers are stuck with the reality that at an unknown point in the future there will probably be more regulations of an unpredictable nature.

Christopher is a former software developer and current J.D. candidate at the Earle Mack School of Law of Drexel University.  He is working with the Attorneys at Oscislawski LLC as a summer intern.

NeHC Releases Roadmap for Growth and Evolution of HIE, and Legal HIE Listed as a Helpful Resource!

Following ONC's release of its Program Information Notice "Privacy and Security Framework Requirements and Guidance for State Health Information Exchange Cooperative Agreement Program," (the P&S PIN discussed in a previous blog post) the National eHealth Collaborative (NeHC) has released a roadmap for successful and widespread growth of HIE to improve health and healthcare after extensive collaboration with private and public stakeholders (the HIE Roadmap). NeHC is a pubic-private partnership established through a grant from the ONC and is led by some of the nation's most respected thought leaders, and so we were thrilled to discover that our blog, Legal Health Information Exchange, was identified by NeHC as one of only a selected group of "Helpful Resources" found at Exhibit B of its HIE Roadmap. You can register with NeHC to download a copy of the HIE Roadmap here

Entitled "The Landscape and a Path Forward," the HIE Roadmap sets forth current HIE connectivity and exchange approaches across the nation, as well as federal efforts towards developing the foundation for interoperability and trusted HIE through common standards, services and policies.  It highlights those strategies for integrating these federal and private sector efforts, emphasizing the current progress that has been made and those challenges and barriers remaining to be overcome. 

Most importantly, it hopes to provide a roadmap of the major steps communities can follow to achieve progress towards HIE.  The HIE Roadmap states,

...Given the rapid market and policy changes and technology innovations occurring right now, there is confusion among healthcare stakeholders about how best to proceed with implementing HIE.  Leading HIE organizations are indeed charting new ground.  Emerging HIE efforts can and should learn from those who are further along in order to...leapfrog toward success."

It notes that in 2010, the number of public HIEs increased 81% from 37 to 67 with a whopping 210% increase in operating private HIEs, from 52 to 160.  Providing clear examples of leading HIE efforts, their leverage of national standards for exchange, and other factors contributing success, the HIE Roadmap seeks to capture the vision for why HIE is important to improving patient care and to the performance of our healthcare system, as well as provide a framework and a path forward for those working towards achieving HIE in their communities. 

The HIE Roadmap highlights several of the most notable challenges and barriers to HIE, including:

  • Funding and sustainability;
  • Variations in implementation of interoperability standards;
  • Provider adoption;
  • Disparate EMRs; and
  • Privacy and security concerns.

However, it recognizes that these challenges and barriers are being "tackled and overcome."  The HIE Roadmap highlights ONC efforts towards building a foundation of interoperability and trusted exchange, in particular, recommendations of the HIT Policy and Standards Committees and their workgroups, such as the Meaningful Use, Information Exchange, and Privacy and Security Policy Workgroups.  It highlights the importance the Direct Project and the Nationwide Health Information Network (NHIN) continues to play in developing a strong interoperable foundation and the potential the Direct Project and NHIN have to promote best practices, compliance with existing national standards and implementation recommendations, and following through responsibility to protect health information.

The HIE Roadmap describes the approaches taken by several HIE initiatives across the nation, including:

  • Care Connectivity Consortium, comprised of five leading health systems, Kaiser Permanent, Mayo Clinic, Geisinger Health, Intermountain Healthcare and Group Health;
  • HealthBridge, with 50 participating hospitals, 800 physician practices, and 7,500 physicians;
  • Indiana HIE (IHIE), with 90 hospitals and 19,000 participating physicians;
  • Inland Northwest Health Services (INHS), with an air ambulance collaborative, rehabilitation hospital, and IT management for 38 hospitals and EMR services for 750 physicians, and which also partners with the Departments of Defense and Veterans Affairs; and
  • Kaiser Permanente, which includes the Kaiser Foundation Health Plan and subsidiaries, 37 hospitals and over 450 clinical facilities, and the Permanente Medical Group Practices.

While highlighting the various strategies implemented by these initiative, the HIE Roadmap also recognizes that,

Indeed, interoperable HIE is a journey without a definite endpoint.  Many different approaches are being used, stakeholders are at different stages along this journey, and there is by no means a "one size fits all" model. 

It notes, however, that a key priority of many of these initiatives is to provide standards-based services to small physician practices, recognizing that most healthcare is delivered in these physician practices and the challenges they face.  Finally, the HIE Roadmap sets forth four major "steps" or phases for implementing successful and sustainable HIE, which starts wtih developing the HIE's objectives and vision.

In conclusion, the HIE Roadmap states,

The ultimate goal of HIE is to ensure that the right information is available at the right time and place every time to support the delivery of high quality, well coordinated, and cost effective patient-centered healthcare.  Keeping a consistent and clear focus on what is best for the patient is above all else the smartest way to stay on course in the ever-changing environment of HIE.

"Tapping" Apps for Physician Advice: No Waiting Room Necessary

This past week, I stumbled across a fascinating article by Michael Millenson on the Health Care Blog (originally on Forbes.com) that I almost bypassed entirely.  Described as a “social media darling”, the article focused on a relatively new health care service called “HealthTap.”  

To me, the name “HealthTap” immediately implied an iPhone or other smart phone appplication or “app” like TapFish, a virtual aquarium, or TapFarm – a likely deliberate marketing scheme to tap into (pun intended) the success that apps have had.  With apps to calculate the amount of calories you burn, fitness workouts, curing acne, and instant access to WebMD and WebMD Baby, consumers are turning to app downloads for solutions to their health problems.  As we all know too well, there’s an app for pretty much everything (and indeed, there is, in fact, a HealthTap app). 

I freely admit that I, like many others, don’t think twice about consulting WebMD and the like before my physician for any health questions I may have.  The availability and wealth of information and the ease which consumers can obtain it is a powerful attraction and a driving force behind over 9,000 health apps being available in the iTunes store.  Like many others, I generally only consult sources that to me appear reputable and from a trustworthy individual or organization. 

At first glance then, HealthTap appears to be an applaudable solution to help individuals become more involved in their health care and seek answers to general health questions.  HealthTap states that,

We help you better understand your health, make better health decisions, and find the best doctors...We believe that everyone has the right to free, reliable, and independent health information. We also believe that the most trustworthy health information comes from medical experts. Finally, we believe that the best health decisions take into account unbiased expert knowledge, community insights, and relevant data.

Individuals can log on and create an account, either as a physician or as a member.  A member can pose a question which any physician that signs up for HealthTap can answer.  For each question answered by a physician, he or she is granted points and levels, building his or her “reputation” in HealthTap.  Answers can be categorized as “Yes”, “No”, “Maybe”, “Complicated Question”, “Evaluation” and the like.

Because answers are only coming from a physician with supposed knowledge and expertise, not a random individual like with Yahoo Answers, it appears to be more credible and trustworthy.  In addition, HealthTap gives you information on physicians active on HealthTap who are in your area and their field or speciality.  It may give you their practice location and affiliations as well so you can choose to “follow-up” with a particular physician who answered your question if you so choose, establishing a bona fide physician-patient relationship. 

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SAMHSA Awards IT Grants for Behavioral Health

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced last week that it will award up to $13.2 million in health information technology (HIT) grants for mental and behavioral health care settings.  These grants will further SAMHSA's strategic initiatives for HIT over the next years and contribute to the national goals set forth in the Federal Health IT Strategic Plan released by the Office of the National Coordinator (ONC) this September. 

SAMHSA Administrator Pamela S. Hyde stated,

Electronic health records improve quality, accountability, and cost effectiveness of health care services.  Persons with behavioral health problems often have significant physical health issues as well.  These grants are a critical down payment on the health information technology investment needed to ensure behavioral health service providers are fully interoperable with the general health system.

Among the awards are one-year $200,000 grants to 47 community health centers working to integrate primary care with behavioral health services.  A $3.8M grant award to the National Council on Community Behavioral Health Care was also announced to assist state and community health centers with implementing EHRs. 

Integrating behavioral health data with primary care data is critical to coordination of care.  The new grants will be instrumental in developing the much-needed HIT infrastructure necessary for the exchange of behavioral health information among providers and health care facilities.  SAMHSA is actively working with ONC to address policies and standards concerning the unique needs of behavioral HIT adoption and information exchange. 

For more information and the list of grant recipients, visit SAMHSA's official news release here.  

ONC Releases Ambitious Health IT Strategic Plan

The Office of the National Coordinator (ONC) released its Federal Health Information Technology (IT) Strategic Plan this September, detailing its goals and strategies for transforming health care through health IT over the next five years.  An "ambitious" and "living document", the plan envisions a health care system that captures and uses information to empower individuals and improve health across the nation through health information and IT. 

The plan sets forth five key goals for the federal health IT agenda towards better technology, better information and the transformation of health care across the nation:

  • Adoption and Information Exchange through Meaningful Use of Health IT
  • Improve Care, Improve Population Health, and Reduce Health Care Costs through Use of Health IT
  • Inspire Confidence and Trust in Health IT
  • Empower Individuals with Health IT to Improve their Health and the Health Care System
  • Achieve Rapid Learning and Technological Advancement

The plan highlights current and future strategies and objectives undertaken by ONC and HHS to broaden privacy and security policies, achieve widespread transparency in how patient information is used and disclosed, increase patient access to information and education, and establish additional standards to support more advanced use of health IT.  In addition, it focuses on the key role of meaningful use of health IT through the Medicare/Medicaid EHR Incentive Programs. 

It also sets forth key policy areas to be addressed by HHS, including but not limited to: individual choice to participate in health information exchange, access limitations and transparency for electronic health information exchange, and secondary uses of health information for quality improvement, public health and research purposes. In addition, the plan highlights the need to improve technological solutions to allow for granularity of patient consent and data segmentation and current ONC efforts through its SHARP program to develop innovative means for doing so.  

Overall, the ONC's strategic plan is aggressive but by no means the end to planning.  As progress continues to be made, ONC will openly revisit, assess and update the plan as needed in coordination with federal, state and private and public stakeholders. To read the full plan, visit ONC's website.    


ONC Open Casting Calls

Prepared by Krystyna Nowik, Esq.

Last week, ONC opened a thirty-day window for organizations to apply to become the sole accrediting entity to oversee certifying organizations under the Permanent Certification Program for Health Information Technology (“Certification Program”). The Certification Program ensures certain electronic health record ("EHR") technology includes required capabilities for participation in the Medicare and Medicaid EHR Incentive Programs, which provide incentive payments to certain eligible health care professionals, hospitals and critical access hospitals that demonstrate meaningful use of certified EHR technology to adopt and utilize EHRs (“Meaningful Use”).

Currently, EHR vendors must be tested and certified by one of six ONC-approved entities (ONC-Authorized Testing and Certification Body or ONC-ATCB) under a temporary certification program implemented to ensure certified EHR technology was available for incentive payments beginning this year. Vendors who seek ONC-ATCB certification of their EHR technology as either a “Complete EHR" or an “EHR Module” must demonstrate compliance with certain capabilities, standards, implementation specifications and certification criteria. Once EHR technology has been ONC-ATCB certified, it can be used by health providers and hospitals to meet applicable meaningful use requirements. Complete EHRs provide all applicable certification criteria and the minimum capabilities a participant needs to comply with Meaningful Use. They may also include additional functions. EHR Modules, on the other hand, meet at least one, but not all, of the required certification criteria, and a combination of EHR Modules may be used to comply with Meaningful Use.

With the Final Rule for the Certification Program issued this January, accreditation and oversight is placed in the hands of the ONC Approved Accreditor or ONC-AA, which will be selected competitively every three years. The ONC-AA will be responsible for overseeing the ONC-ATCB entities and accrediting the Authorized Certified Bodies (ONC-ACB) under the Certification Program. Competing organizations for the ONC-AA will have to show what their proposed requirements would be for accrediting the ONC-ACBs, how surveillance of certified EHR technology would be conducted, their requirements for key personnel conducting the accreditation, and investigation and responding to complaints about ONC-ACBs. They also must show how they would adhere to ISO/IEC17011:2004 and experience with ISO/IEC Guide 65:1996, standards developed by the International Standardization Organization that specify general requirements for approving conformity assessment organizations and for product certifying organizations.

The ONC-ACBs replace the ONC-ATCBs created by the temporary certification program. Although ONC-ATCB status ends upon the sunset of the temporary certification program, certifications issued by ONC-ATCBs through the 2011/2012 payment years do not need to be re-certified for those years until ONC-ACB certification processes are in place.

The Notice for submission of requests for ONC-AA status may be found here.