House Questions ONC’s Regulatory Ambitions
Key Takeaway: Republican leaders on the House Energy & Commerce Committee sent a letter to the Office of the National Coordinator for Health IT (ONC), questioning its authority to regulate health IT apart from Meaningful Use certification.
Why it Matters: Congressional scrutiny of ONC’s authority may dampen the agency’s ambitions to regulate patient safety and develop certification programs apart from MU. However, ONC should be able to easily justify most – if not all – of its ongoing activities to critics through statutory language established by the HITECH Act.
Since early last summer, ONC has been actively pursuing a range of activities beyond the grant programs established by the HITECH Act. In July 2013, ONC published its Patient Safety Surveillance & Action Plan, positioning the agency as the overseer of HHS activities related to health IT and safety. In December, the agency published an NPRM creating a voluntary 2015 Edition certification option, divorcing previous efforts from Meaningful Use. And most recently, ONC joined the FDA and the FCC in releasing a risk-based regulatory framework for health IT. Last week, Republican leaders from the House Energy & Commerce Committee asked under what authority ONC felt compelled to regulate such activities. “[I]t is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities,” Reps. Upton, Pitts, Blackburn and Walden said in a letter date June 3. Specifically, the E&C leadership asked for clarification on:
- Certification authority, particularly in non-Meaningful Use areas
- Authority to work with the FDA and FCC on patient safety
- How the 2015 Edition NPRM represents a departure from previous Edition priorities, including interoperability, privacy and quality reporting criteria
- The role ONC intends to play in the future in areas such as health IT safety and EHR certification, and how ONC will use its Federal Advisory Committees to inform the office’s work
While the House letter represents a new chapter of interaction between ONC and Congress, it will have an impact only if ONC inadequately addresses the letter’s underlying concerns.
Creating a Learning Health System
Key Takeaway: Last week the ONC published a white paper, outlining their 3-, 6- and 10-year plan for interoperability. The near-term focus will be on send, receive and query capabilities for existing systems; the mid-term will focus on connecting disparate parties in the care continuum, including individual patients; and the long-term plan will take steps toward creating a “learning health system.”
Why It Matters: Amid the ongoing restructuring of ONC and its Federal Advisory Committees, this high-level white paper joins the ranks of similar papers produced by ONC and other health IT industry stakeholders. With the policy direction set, the real work starts in efforts to translate the policy into action by focusing on the details of the technology and standards work.
Released as part of an ONC blog, National Coordinator DeSalvo unveiled the office’s interoperability vision for the next decade. In looking at 3-, 6- and 10-year increments, ONC hopes to address near- and mid-term challenges associated with developing a nationwide, interoperable health IT infrastructure. To do this, ONC pledged to “develop an interoperability roadmap” that “involves improving the interoperability of existing health information networks, and scaling existing approaches for fluidly exchanging health information across vendor platforms to support a broad array of transitions of care and public health.” In the near-term, ONC hopes to develop an infrastructure that enables disparate systems to send, receive, query and integrate data from each other. Officials hope this can be accomplished before 2017, so that interoperable systems can connect patients, payer and public health data. The final chapter of this paper’s plan hopes to see health data from across all settings and stakeholders inform decisions made on individual patients, in a “learning health system.” To get there, ONC will develop a “shared agenda” to focus on five “building blocks,” which include:
- Core technical standards and functions
- Certification to support adoption and optimization of health IT products and services
- Privacy and security protections for health information
- Supportive business, clinical, cultural and regulatory environments
- Rules of engagement and governance
For more information on the white paper, click here.
Burwell Confirmed by Bipartisan Vote
Key Takeaway: HHS gets new blood with the confirmation of Sylvia Mathews Burwell in a 78-17 bipartisan Senate vote last Thursday.
Why it Matters: While Burwell had a fairly easy confirmation process, she still had some dissenting Republican Senators who opposed her because of her support of the Affordable Care Act. Burwell will have to navigate the politics of her new position carefully to ensure the success of many programs that intend to transform healthcare in the United States.
The stakes are high as Burwell takes her place at HHS. The rollout of the Affordable Care Act was bumpy, but resulted in more than 8 million enrollments in 2014; multiple incentive programs are evolving or winding down (eRX, Meaningful Use, IQR, PQRS, among others); and alternative payment models are becoming more prominent, among other initiatives such as telemedicine. While she has great credentials as the head of the Office of Management and Budget, she’s fairly new to healthcare, so she will have to work hard to prove she can manage the ever-changing healthcare environment as head of HHS.
The Administration and many in Congress will expect her to exhibit a rapid learning curve to increase the number of exchange enrollees, oversee repairs to the healthcare.gov website, and manage the agency’s other healthcare programs during the next two years before the next election.
Proposed Meaningful Use Changes in 2014 (Monday, June 9, 2014 / 2:00 PM - 3:00 PM ET)
Speaker: Jeff Smith, Sr. Director of Federal Affairs, CHIME
On May 23, CMS and ONC released a proposed rule to make modifications to Meaningful Use in 2014. The agencies acknowledged that delays in EHR certification have negatively impacted affected providers’ ability to meet MU in 2014 and have proposed new pathways to help EHs and EPs avoid penalties.
To understand what these pathways are, how they may help, and what pitfalls to avoid, please join CHIME for this online briefing, which will include:
- An overview of the proposed rule and context-setting from Washington, DC;
- A listing of areas for comment and preliminary CHIME responses; and
- Recommendations for CHIME members looking to take advantage of the new MU pathways in 2014.