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.  

Grantees of HIE Funds Get "PIN-ned" on Privacy, Security and Patient Consent

 Pushpin.jpgOn March 22, 2012 HHS/ONC released a new Program Information Notice (PIN) called the "Privacy and Security Framework Requirements and Guidance for State Health Information Exchange Cooperative Agreement Program" (P&S PIN).  The P&S PIN applies to all State Health Information Exchange Cooperative Agreement Program Recipients, including State Designated Entities (SDEs), SDE sub-grantees, and other direct grantees of the federal HIE Cooperative program. Here is a link to the HHS/ONC PIN website.

The P&S PIN requires all SDEs to submit as part of a 2012 annual SOP (Strategic and Operational Plan) an update of their privacy and security framework consisting of all relevant statewide policies and practices adopted by recipients, and operational policies and practices for HIE services being implemented by Grant recipients of funding in whole or in part with federal cooperative agreement funds (HIE Grant Recipients).

Among other things, each HIE Grant Recipient will need to submit how their existing privacy and security policies align with each domain of the Fair Information Practices (FIPs), which the ONC and the ONC's Privacy & Security Tiger Team have each previously pointed to as providing a privacy and security framework for networked HIE.  The FIPs are:

  1. Openness and Transparency
  2. Collection and Use and Disclosure Limitation
  3. Safeguards
  4. Accountability
  5. Individual Access
  6. Correction
  7. Individual Choice
  8. Data Quality and Integrity

Specifically, Point-to-Point Directed HIE Exchange Models will be required to demonstrate that their P&S policies address FIPs 1-4, and have the option of addressing FIPs 5-8. HIE models that aggregate data will be required to demonstrate that their P&S policies address FIPs 1-8. If any GAPs exist between a FIP and the HIE Grant Recipient's current policies (i.e. a domain is not addressed), this must be identified and a strategy timeline and action plan for addressing these gaps in the 2012 SOP update must be provided.

One of the most debated topics with networked HIE has been patient consent. Many HIEs and stakeholders have asked the federal government on guidance on when and what form of consent is required for networked HIE.  

The P&S PIN addresses patient consent with HIE, and requires that aggregated HIE models offer, at a minimum, individuals with a meaningful choice with regard to whether their individually identifiable health information (IIHI) may be exchanged through an HIO entity that aggregates data.

The P&S PIN then further goes on to define “meaningful choice” as including:

  • Made with advance knowledge
  • Not used for discriminatory purposes or as condition for receiving treatment
  • Made with full transparency and education
  • Commensurate with circumstances for why IIHI is exchanged
  • Consistent with patient expectations
  • Revocable at any time

Notably, the P&S PIN confirms that both opt-in and opt-out are acceptable means of satisfying patient choice. On Wednesday, March 27th,  I had the opportunity to speak at the HIPAA Summit in Washington D.C. where an audience member asked whether a “no choice” HIE model is now no longer a viable option for HIE.  Both Joy Pritts, ONC Privacy Officer, and Deven McGraw, Co-Chair of the ONC P&S Tiger Team, confirmed that at least with respect to HIE Grant Recipients who are operating an aggregated HIE model, the P&S PIN must be followed and each patient must be afforded with meaningful choice to participate in networked HIE. It's also important to note that while the P&S PIN requirement could potentially be satisfied through obtaining written consent from the patient, written consent is not required and, moreover, Ms Pritts specifically pointed out that obtaining a written blanket consent without any supporting meaningful processes would not meet the FIP standard. Thus, whether an opt-in or opt-out model is used, HIOs must focus on ensuring that educational information about HIE is being delivered to patients, and the patient's decision-making process is meaningful.

The FIPs are nothing new, and ONC actually issued its Nationwide Privacy and Security Framework for Electronic Exchange of Individually Identifiable Health information back in December of 2008!  Ever since then, I have been advising HIE initiatives to BUILD their HIE Policies around the FIPs and this ONC guidance document. Here is an example of how I crosswalk the FIPs with my template set of HIE Policies for HIOs that aggregate IIHI.

For a copy of a sample set of our HIE Policies, email me at helen@oscislaw.com, or visit www.ohcsolutions.com which going live soon as a source for legal forms and templates.

Uncertainty in Federal Budget Prompts Kansas to Return $31.5M Early Innovator Grant

On Tuesday, August 9th, Kansas Governor Sam Brownback announced that Kansas would be returning $31.5M in federal grant money awarded to it from the Department of Health and Human Services (HHS).

There is much uncertainty surrounding the ability of the federal government to meet its already budgeted future spending obligations....To deal with that reality, Kansas needs to maintain maximum flexibility.  That requires freeing Kansas from the strings attached to the Early Innovator Grant."  Kansas Governor Sam Brownback.

The HHS Early Innovator competitive funding program awarded two-year grants to a select number of States to develop innovative information technology (IT) infrastructures needed to operate the Health Insurance Exchanges established by the Patient Protection and Affordable Care Act. Systems developed through the program are intended to be used as models for all States in their development and implementation of Exchanges. 

The return of the grant money is the second largest award to be returned for implementing the federal health care reform.  Oklahoma Governor Mary Fallin announced this past April that Oklahoma would not be accepting its $54.6M Early Innovator grant.  Other states have returned or turned down smaller grants.

Kansas plans on working towards developing state-based innovative solutions.  Although the return of the grant money likely will make it harder for Kansas to develop its own exchange, it paves the way for more substantial involvement from the Legislature.

Dr. Robert Moser, Secretary for the Kansas Department of Health and Environment said that the grant did not address the most important issue in health care reform, that of slowing the rate of cost growth in health care.  He stated, "Through the statewide Medicaid reform meetings, Kansas is taking the opportunity to decide for ourselves how best to provide health care access, improve outcomes and reduce costs for our state." 

HHS expressed disappointment in Kansas's decision to return the grant money, noting that "Kansas has given up an opportunity to be a leader in the development of technology for state exchanges, which could have benefited the citizens of Kansas as well as those in other parts of the country."

Governor Brownback's statement can be found here

ONC Announces Launch of "Direct Project" Pilots

In a Press Release posted today, February 2nd, ONC announced that providers and public health agencies in Minnesota and Rhode Island began this month exchanging health information using specifications developed by the Direct Project, which is described as an "open government" initiative that calls on cooperative efforts by organizations in the health care and information technology sectors. The ONC Press Release notes that other Direct Project pilot programs will also be launched soon in New York, Connecticut, Tennessee, Texas, Oklahoma and California. The story is also covered today by the New York Times in Steve Lohr's article "U.S. Tries Open-Source Model for Health Data Systems".

The ONC Press Release notes that Direct Project is intended to give health care providers early access to an easy-to-use, internet-based tool that can replace mail and fax transmissions of patient data with secure and efficient electronic health information exchange.  It was designed as part of President Obama’s ‘open government’ initiative to drive rapid innovation, and last year is said to have brought together some 200 participants from more than 60 companies and other organizations. Volunteers worked together to assemble consensus standards that support secure exchange of basic clinical information and public health data. Now, pilot testing of information exchange based on Direct Project specifications is being carried out this year with the aim toward formal adoption of the standards by 2012.

ONC states that information exchange supported by Direct Project specifications address core needs, including standardized exchange of laboratory results; physician-to-physician transfers of summary patient records; transmission of data from physicians to hospitals for patient admission; transmission of hospital discharge data back to physicians; and transmission of information to public health agencies. The Press Release also notes

[t]hat in addition to representing most-needed information transfers for clinicians and hospitals, these information exchange capabilities will also support providers in meeting 'meaningful use' objectives established last year by HHS, and will thus support providers in qualifying for Medicare and Medicaid incentive payments in their use of electronic health records.

If you would like more information about Direct Project, or have questions such as:

  • How does direct exchange fit into the big picture?
  • How is direct exchange different than HIE initiatives?
  • Does direct exchange support or supplant State HIE initiatives?
  • What is the security model for Direct Project?
  • Who issues Digital Certificates for users?
  • What are the limitations of the Direct Project model?

Then, check out the following links for excellent information:



HHS Announces New Funding to Help States Implement Affordable Care Act

Posted today on HHS' Website:

Today, Health and Human Services (HHS) Secretary Kathleen Sebelius announced a new funding opportunity for grants to help states continue their work to implement a key provision of the Affordable Care Act – Health Insurance Exchanges.

When the Affordable Care Act is fully implemented in 2014, Health Insurance Exchanges will provide individuals and small businesses with a “one-stop shop” to find and compare affordable, high-quality health insurance options.

[']States are moving forward, implementing the Affordable Care Act and making reform a reality,['] said Sebelius. [']These grants will help ensure states have the resources they need to establish exchanges and ensure Americans are no longer on their own when shopping for insurance.[']

Health Insurance Exchanges will bring new transparency to the market so that consumers will be able to compare plans based on price and quality and will offer all Americans the same insurance choices members of Congress will have. By increasing competition among insurance companies and allowing individuals and small businesses to band together to purchase insurance, Exchanges will also lower costs.

The Exchange establishment grants announced today recognize that states are making progress toward establishing Exchanges but doing so at different paces. States that are moving ahead on a faster pace can apply for multi-year funding. States that are making progress in establishing their Exchange through a step-by-step approach can apply for funding for each project year. Moving forward, states will have multiple opportunities to apply for funding as they progress through Exchange establishment. This process gives states maximum flexibility and ensures that states can move forward on their own timetables as they work to build an Exchange.

States can use the Exchange establishment grants for a number of different activities including conducting background research, consulting with stakeholders, making legislative and regulatory changes, governing the exchange, establishing information technology systems, conducting financial management and performing oversight and ensuring program integrity.

States are already taking their first steps toward 2014 when Health Insurance Exchanges will be operational. For example, California signed first-in-the-nation legislation to implement a Health Insurance Exchange under the Affordable Care Act on September 30, 2010. Maryland’s Health Reform Coordinating Council has already carried out research to understand the state’s health insurance marketplace and health expenditures, as well as how to make health care costs and quality more transparent. Colorado is holding regular community forums on issues around developing an Exchange, as well as conducting extensive research and economic analyses on the state’s health insurance market.

Many of those activities have been funded by the $49 million in Exchange planning grants awarded by HHS in July of 2010. States applied to use those grants for a number of important planning activities including research to understand their insurance markets, efforts to obtain the legislative authority to create Exchanges, and steps to establishing the governing structures of Exchanges.

The Exchange establishment funding announcement can be found at www.Grants.gov by searching for CFDA number 93.525. More information can be found at http://www.healthcare.gov/news/factsheets/exchestannc.html