Governance Framework for Trusted Electronic Health Information Exchange

The ONC has released the Governance Framework for Trusted Electronic Health Information Exchange. The Governance Framework reflects the principles in which ONC believes when it comes to the policy set for HIE governance. This framework is intended to provide a common foundation for all types of governance models. Entities that set HIE policy should look to the Governance Framework’s principles as a way to align their work with national priorities. The four key categories of principles discussed in the Governance Framework include:

1. Organizational Principles: Identify generally applicable approaches for good self-governance;
2. Trust Principles: Guide HIE governance entities on patient privacy, meaningful choice, and data management in HIE;
3. Business Principles: Focus on responsible financial and operational policies for governance entities, with emphasis on transparency and HIE with the patients best interests in mind;
4. Technical Principles: Express priorities for the use of standards in order to support the Trust and Business Principles as well as furthering the execution of interoperability.

The Governance Framework’s intended audience includes any entities that set HIE policy such as: State governments, public-private partnerships, health information exchange organizations (HIOs), and private companies, but is not meant to speak directly to “users” of the exchange services governed by such entities. As Steven Posnack, Director of the Federal Policy Division at ONC and health IT policy wonk extraordinaire  said at the NeHC HIE Governance Forum in announcing the framework, "These principles are the pillars of health information exchange governance." A very important part of the strategy, and one of these pillars, are the Trust Principles, which would require that an entity that sets HIE policy is responsible for creating an environment in which patients should:

1. Be able to publicly access, in lay person terms, a “Notice of Data Practices.” Such notice would explain the purpose(s) for which personally identifiable and de-identified data, consistent with applicable laws, would or could be electronically exchanged (e.g., treatment, payment, research, quality improvement, public health reporting, population health management).
2. Receive a simple explanation of the privacy and security policies and practices that are in place to protect their personally identifiable information when it is electronically exchanged and who is permitted to access and use electronic HIE services.
3. Consistent with applicable laws, be provided with meaningful choice as to whether their personally identifiable information can be electronically exchanged.
4. Consistent with applicable laws, be able to request data exchange limits based on data type or source (e.g., substance abuse treatment).
5. Consistent with applicable laws, be able to electronically access and request corrections to their personally identifiable information.
6. Be assured that their personally identifiable information is consistently and accurately matched when electronically exchanged.

National Coordinator Farzad Mostashari said in a blog post outlining the framework, "The Governance Framework reflects what matters most to ONC when it comes to national health information exchange governance and the principles in which ONC believes. We’ve published this framework to provide a common foundation for all types of governance models. Entities that set health information exchange policy should look to the Governance Framework’s principles as a way to align their work with national priorities." I encourage everyone interested in health data exchange to carefully read the Governance Framework: http://www.healthit.gov/sites/default/files/GovernanceFrameworkTrustedEHIE_Final.pdf

CMS and OIG Proposed Rules on EHR Software Exception and Safe Harbor Promote Interoperability

On April 10, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) published parallel proposed rules revising, respectively, the Stark exception and Anti-Kickback safe harbor concerning electronic health record (EHR) items and services. Highlights of the proposed rules include:

Sunset Provision. The EHR exception and safe harbor are scheduled to sunset on December 31, 2013. The proposed rules seek to extend the sunset provision to December 31, 2016.

Interoperability. Under the current EHR Regulations, a software is deemed interoperable “if a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it is provided to the physician.” CMS and the OIG propose two changes to the requirement of interoperability.

• First, CMS and the OIG propose to reflect that the Office of the National Coordinator for Health Information Technology (ONC) is responsible for recognizing certifying bodies and that entities must successfully complete an authorization process established by ONC.
• Second, CMS and the OIG seek to amend the 12-month time period in which a donor has to furnish the EHR software to the recipient. The purpose of the current timeframe is to ensure that products have an up-to-date certification. Consistent with the current ONC regulatory process for adopting certification criteria and standards for EHRs, CMS and the OIG propose to amend the 12-month time frame to allow software to be eligible for deeming interoperability “if, on the date it is provided to the recipient, it has been certified to any edition of the electronic health record certification criteria that is identified in the then applicable definition of Certified EHR Technology in 45 CFR part 170.” This proposal allows for greater flexibility in determining interoperability without the 12-month deadline.

Electronic Prescribing Provision. The current EHR rules require the donated software to contain e-prescribing capability. The proposed rules seek to eliminate this condition because sufficient alternative policy drivers exist to support the adoption of e-prescribing capabilities.

Additional Proposals and Considerations.

• Protected Donors. The EHR exception and safe harbor are currently available to a broad class of donors. The proposed rules seek to limit the availability of the EHR exception and safe harbor to cover only the original MMA-mandated donors: hospitals, group practices, Part D plan sponsors and Medicare Advantage organizations. In the alternative, the rules propose to exclude certain suppliers associated with a high risk of fraud and abuse in this context including laboratories, DME suppliers and independent home health agencies.
• Data Lock-In and Exchange. Due to the concern of using the EHR exception and safe harbor to lock-in referrals, the proposed rules request comments on new or modified conditions that could be added to the rules to achieve the goals of: (a) preventing data and referral lock-ins, and (b) encouraging interoperability and the free exchange of data.
• Covered Technology. The proposed rules seek comments on whether the regulatory text should be modified to explicitly reflect the items and services that fall within the scope of covered technology. The agencies consider the current regulatory text, when read in light of the preamble discussion, sufficiently clear but seek input from the public regarding this issue.

CMS and OIG are accepting comments on the proposed rules through June 10, 2013.

Big Data Challenge to Transform Healthcare Delivery

The Bipartisan Policy Center (BPC), Heritage Provider Network (HPN), and The Advisory Board Company have launched the Care Transformation Prize Series, a national contest to address the most daunting data problems US health care organizations face as they implement new delivery system and payment reforms. This challenge will will examine the most difficult questions facing health care organizations today, and will engage the nation’s best and brightest data scientists to develop solutions.

The Care Transformation Prize Series is the latest competition sponsored by Dr. Richard Merkin, President and CEO of HPN, in an ongoing effort to spur innovations that improve quality and reduce inefficiencies as organizations work to implement new delivery system and payment reforms. Prizes will be awarded to the teams that develop the best solutions and the winning algorithms will be made widely available to the public and health care organizations. A Prize Board made up of prominent leaders from many sectors of healthcare will determine which challenges will be addressed by competing teams of leading data scientists.

Heritage Provider Network and The Advisory Board Company will offer at least three quarterly prizes of $100,000 to the teams that develop the best solutions to the selected challenges. The winning algorithms will then be made available to health care organizations and the public. For more information about The Care Transformation Prize Series or to submit a question, please visit http://www.caretransformationprize.com

You can watch the video from the announcement below:

User Fees for Electronic Health Records

President Obama has released his 2014 budget proposal, which includes $80.1 billion in spending for the Department of Health and Human Services (HHS), an increase of  $3.9 billion. The proposed budget for The Office of the National Coordinator for Health IT (ONC) would increase its $61 million budget to $78 million, a 28% increase. The plan also includes a $1 million fee for electronic health record vendors that would almost certainly be passed along to users of the systems.

“In addition to the expanding marketplace and corresponding increase in workload for ONC, much of the work to date has been funded using Recovery Act funds scheduled to expire at the end of FY 2013. Consequently, a new revenue source is necessary to ensure that ONC can continue to fully administer the Certification Program as well as invest resources to improve its efficiency," the ONC explains in the budget proposal appendix.

In particular, the fee could be used to fund:

• Development of implementation guides and other forms of technical assistance for incorporating standards and specifications into products
• Development of health IT testing tools that are used by developers, testing laboratories and certification bodies
• Development of consensus standards, specifications and policy documents related to health IT certification criteria
• Administration of the ONC Health IT Certification Program and maintenance of the Certified Health IT Product List
• Post-market surveillance, field testing and monitoring of certified products to ensure they are meeting applicable performance metrics in the clinical environment

If approved the collections will likely begin late in fiscal year 2014 and would be gradually phased in. According to the proposal "user fees would be collected from Health IT vendors," and then "would be collected on ONC’s behalf by ONC-Authorized Certification Bodies (ONCACBs)" which already certify EHR systems as part of the meaningful use program. A fee structure would be established by the Secretary and published in the Federal Register, but a tiered system is being proposed where EHR modules would likely be assessed at a lower rate than a complete EHR system.

The HIMSS EHR Association opposes ONC's proposal. "EHR developers are already devoting extensive resources to successful implementation of the EHR Meaningful Use Incentive Program and other healthcare delivery reform efforts, including the significant fees associated with EHR product certification," the group said in a statement. I'm not automatically opposed to fees, however it is not the vendors that would ultimately bear the cost. My biggest issue with the EHR Incentive Program is that it should be more accurately called the EHR Vendor Incentive Program since these companies are making record profits and any payments to providers are simply a pass through to the vendors.

I would like to see steeper requirements for certification as future stages of meaningful use are developed. There are WAY too many products on the Certified Health IT Products List (CHPL) for small practices, community and critical access hospitals to make sense of and choose an appropriate vendor. When this program first launched a software developer friend reviewed the standards and certification criteria and claimed that she could design a product that would meet all of the certification requirements and yet be completely unusable in actual practice. I told her not to waste her time since it appeared that some companies had already done that...