Standards Committee Gets Updates on FDASIA Workgroup, Interoperability Resources During the monthly meeting of the Health IT Standards Committee, officials from ONC said the first meeting of the FDA Safety and Innovation Act (FDASIA) workgroup would be April 9. Workgroup members have not yet been announced, but look for those next week. This workgroup will provide expert input on issues and concepts identified by FDA, ONC & FCC to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health IT.
Also during this week’s HITSC meeting, members were updated on work being done through the S&I Framework to define standards needed for Transitions of Care (ToC) and Exchange of Care Plan. Under the guidance of the Longitudinal Coordination of Care (LCC) Workgroup, a host of experts have been working to understand the needs practitioners and capabilities of technology across settings, including LTPAC. Findings of the workgroup include:
- Current standards for Transitions of Care and exchange of Care Plans do not meet policy expectations for MU2 and MU3 for Eligible Providers and Hospitals
- Extensive research and national participation has formed the foundation for evolving standards for ToC and Care Plans expected to complete HL7 balloting fall 2013
- Extending the C-CDA template set and availability of open source tools are facilitating multiple pilots of these new CDA documents this year
More information on this initiative can be found here.
Also discussed was a presentation made by the FDA, Center for Devices & Radiological Health on Unique Device Identification (UDI) and Health Information Standards.
ONC Launches ‘Planning Room’ to Update Strategic Health IT Plan, Unveils Resources for Interoperability In yet another move to expand opportunities for public input on strategic planning documents, the Office of the National Coordinator for Health IT has established a website – using a Cornell-developed platform – to enable citizen feedback on updates to the Federal Health IT Strategic Plan. According to the site, ONC’s Planning Room, the topic of conversation until May 9 will be Consumer eHealth. Inside of this broad topic are subtopics including:
- Enabling information access;
- Empowering consumer action;
- Shifting attitudes;
- Identifying useful health information;
- Patient generated health data;
- Shared decision-making;
- Personalized healthcare; and
- Supporting new healthcare delivery models.
The push for “interoperability” is on and ONC is leading the charge with an “Interoperability Basics Training Course” that consists of how interoperability is defined, the path to MU Stage 2, the building blocks of interop and the effect of interop on different categories of care. According to officials, four additional modules that cover the Meaningful Use Stage 2 interoperability data exchange criteria will be released:
1. Transitions of care between care providers and care venues
2. Lab interoperability between hospitals and ambulatory providers
3. View, download, and transmit of information between patients and providers
4. Transmission of information to public health agencies
Bill to Promote Cost Transparency Reappears Two Texas Congressmen want more transparency of healthcare cost data. Representatives Michael Burgess (R-Texas) and Gene Green (D-Texas) have re-released a bill, called the Health Care Price Transparency Promotion Act, which would establish a state-based system, mandating that hospitals publicly disclose information on the cost of various services. Additional provisions of the Health Care Price Transparency Act would require:
- Health insurers to provide consumers with information about estimated out-of-pocket costs for health care products and services and
- The Agency for Healthcare Research and Quality to identify the types of health care cost data that consumers find beneficial.
Although the AHA supports this approach because it would shine light on estimated out-of-pocket costs. Similar legislation introduced as far back as 2009 has stalled every year.
CHIME to HHS: Extend and Expand Safe Harbor Provisions for EHRs In a letter submitted to CMS Acting Administrator Marilyn Tavenner this week, CHIME outlined a rational for extending Stark and Anti-kickback exemption provisions due to sunset at the end of this year. Created in 2006, two new safe harbors to the Anti-Kickback Statute permitted the donation of health IT and related services for the purposes of improving electronic prescribing and electronic health record capabilities. Provisions also address the interoperability of donated software. CHIME believes these rules have encouraged the adoption of EHRs by addressing the upfront costs associated with the purchase of EHRs, particularly for small, independent, unaffiliated physician practices. Further, we believe they play an important role in new accountable care organizations being organized around the country. “CHIME recommends making Donation Rules permanent and aligning these rules with processes and timetables established under the EHR Incentive Payments program,” the letter said. But CHIME also said that there remains a need to further accelerate and encourage progress using the tools of health IT to improve the quality and effectiveness of patient care. “For example, as accountable care organizations (ACOs) and other value-based payment programs further drive physician integration, CHIME believes that hospitals need the ability to provide integrated portals, EHRs and health information exchanges, among other tools to facilitate exchange.” For this reason, CHIME further recommend that software “inherent to the certified EHR or specifically separate – yet interoperable – with the EHR should be covered by Donation Rules.”
CHIME Public Policy will continue to monitor progress on extending and expanding provisions of Stark and Anti-kickback exemptions.
Edited by Gabriel Perna