Recap of Q3 2014 Federal Health IT Activity
The federal government continued to implement the HITECH Act, enacted as part of the American Recovery and Reinvestment Act, during the third quarter of 2014. As implementation of HITECH's programs begin to wind down, more than $25 billion in incentive payments have been made to providers to spur electronic health record adoption, and more than 90% of eligible hospitals and 75% eligible professionals have adopted and are using EHRs as a result.
At the same time, interoperability and electronic health information exchange between EHRs remains a major challenge, and privacy issues continue to be a central focus for policymakers and regulators. With the amount of HITECH funding available to drive change diminishing, the federal government will be turning to new levers to continue driving adoption of health IT tools to enable real-time coordination and management of care for patients and consumers. Below is a summary of key developments and milestones achieved between July 1 and Sept. 30.
The third quarter of 2014 saw a number of important developments:
- HHS Releases Final Rules Providing Flexibility Under Meaningful Use Program. In two final rules, released by CMS on Sept. 4 and the Office of the National Coordinator for Health IT on Sept. 11, the agencies granted flexibility to providers struggling to implement the 2014 Edition Certified Electronic Health Record Technology by allowing them to instead use EHRs that have been previously certified under the 2011 criteria. The rules also updated the 2014 criteria, finalized the previously proposed extension of meaningful use Stage 2 through 2016 and eliminated ONC's proposed 2015 voluntary EHR certification criteria.
- ONC Releases More Information on 10-Year Interoperability Vision. In August, ONC launched a website seeking input from stakeholders on the interoperability roadmap it released in June. The website provides additional details on each of the roadmap's five "building blocks" for interoperability: technical standards and functions; certification; privacy and security; business, clinical, cultural and regulatory environment; and rules of engagement and governance of information exchange.
- OIG Releases Report Criticizing ONC Oversight of EHR-Certifying Bodies. In a report released Aug. 4, the HHS Office of the Inspector General said that ONC had not assured adequate security controls for EHRs certified under the meaningful use program and that ONC failed to evaluate EHRs to ensure they continued to meet federal standards. The report recommended that ONC develop new procedures and a training program to ensure sufficient oversight of the certification program.
- White House Chief Technology Officer Todd Park Steps Down. In August, President Obama announced that Todd Park would step down from his position as the White House Chief Technology Officer but would continue to serve as a presidential adviser on technology issues. On Sept. 4, Obama announced that former Google Executive Megan Smith would serve as the next CTO.
- ONC Consolidates Federal Advisory Committee Work Groups. In July, ONC announced that the work groups under both the Health IT Policy Committee and the Health IT Standards Committee would be consolidated. The 15 Policy Committee work groups will be restructured into seven subcommittees: (i) Advanced Health Models and Meaningful Use; (ii) Consumer; (iii) Health IT Implementation, Usability and Safety; (iv) Health IT Strategy and Innovation; (v) Interoperability and Health Information Exchange; (vi) JASON Task Force; and (vii)Privacy and Security. The nine Standards Committee workgroups will be restructured into six subcommittees: (i) Architecture, Services and Application Program Interfaces; (ii) Content Standards; (iii) Implementation, Certification and Testing; (iv) Semantic Standards; (v) Steering Committee; and (vi) Transport and Security Standards.
ONC Health IT Advisory Committees
Health IT Policy Committee
On July 8, the Policy Committee approved recommendations from the Quality Measure work group on the next generation of e-measures and sent the recommendations to ONC on July 21. Also on July 8, the Policy Committee approved recommendations from the Safety task force related to the Food and Drug Administration Safety and Innovation Act (FDASIA) report. The recommendations were sent to ONC on Aug. 6. In addition, the committee on Aug. 6 sent previously-approved recommendations from the Certification and Adoption work group on long-term post-acute care and behavioral health certification.
On Sept. 3, the Policy Committee's JASON task force presented its recommendations on the JASON report, which was released by the Agency for Healthcare Research and Quality in April. The task force recommended that ONC adopt a subset of the report's recommendations, but focus on incremental improvements to existing standards and infrastructure rather than creating a new software architecture to facilitate information exchange, as advised in the report. The recommendations have not yet been finalized.
Health IT Standards Committee
On July 16, the Standards Committee met to review the recommendations from the Policy Committee's Certification and Adoption work group on long-term, post-acute care and behavioral health certification, and to review recommendations from the Policy Committee's Privacy and Security Tiger Team on data segmentation, which focuses on ways to tag and separate different types of health data, so that policies governing disclosure can be appropriately applied to the data.
On July 28, IT vendors and other health care industry representatives told the Standards Committee's Implementation work group that EHRs certified for meaningful use Stage 2 often are incapable of exchanging health information needed to meet Stage 2 requirements. At their Aug. 11 meeting, Implementation work group members noted these concerns and recommended that ONC revise the standards it uses to facilitate electronic exchange of data for meaningful use. On Aug. 20, the Standards Committee met to review these recommendations from the Implementation work group and to receive updates from ONC on health information exchange and interoperability.
In addition, on Aug. 18, ONC released a notice updating the process by which the Standards Committee will review policy recommendations developed by the Policy Committee.
On Aug. 28, the Standards Committee's Nationwide Health Information Network Power Team work group also discussed its recommendations related to EHR interoperability. The work group noted that aligning technical standards for EHRs may not be sufficient to achieve interoperability and recommended that ONC organize a group of stakeholders to identify and resolve other interoperability challenges such as trust, patient identification and record location services. The work group presented its recommendations to the Standards Committee on Sept. 10.
Medicare and Medicaid EHR Incentive Programs
CMS Medicare Hospital Payment Rule Aligns Reporting With Meaningful Use Program
In a final rule released on Aug. 22, CMS aligned the 2015 Medicare acute care and long-term care hospital reporting requirements and schedule with the requirements for reporting on clinical quality measures in the meaningful use program.
CMS Releases Updated Data on Meaningful Use Participation
On Sept. 3, CMS released new data on meaningful use participation. As of July, more than 410,000 eligible hospitals and professionals had attested to meaningful use criteria and received incentive payments through the program, totaling nearly $25 billion.
AHRQ-Funded Study Examines Meaningful Use Effect on Adverse Drug Events
An AHRQ-funded study, released Aug. 8, found that adopting meaningful use objectives related to medication management was associated with reduced adverse drug events in hospitals. Among the studied hospitals in Florida, those adopting these objectives had the lowest rates of adverse drug events among all hospitals statewide.
Regional Extension Centers Assist More Than 100,000 Providers With Meaningful Use
On Sept. 17, ONC announced that its regional extension centers had assisted more than 100,000 providers to attest to Stage 1 of the meaningful use program, surpassing the program's performance goal. The announcement also noted that RECs are partnered with over 150,000 providers across the country, including 44% of all primary care providers and had helped 90% of these providers adopt an EHR system.
CMS Receives 44,000 Requests for Meaningful Use Hardship Exceptions
According to news reports, CMS confirmed in September that it had received 44,000 applications for hardship exceptions from providers seeking to avoid the meaningful use program's Medicare penalty in 2015.
Health Information Exchange and Interoperability
ONC Releases Data Brief on E-Prescribing Trends
In July, ONC released a new data brief examining the rate of electronic prescribing nationwide. The report found that 70% of physicians were e-prescribing through an EHR as of April, and the rate of e-prescribing has grown rapidly from only 24% since the meaningful use programs began in 2011. The brief also noted that 96% of community pharmacies accept e-prescriptions.
ONC Releases Final Workgroup Report on Interoperability
On Aug. 17, ONC posted the final report from its EHR/HIE Interoperability Workgroup (IWG), produced through ONC's Exemplar Health Information Exchange Governance Entities Program. The IWG, a collaborative of 19 states and 47 EHR and health information exchange developers and organizations, convened four pilot programs to test interoperability standards for provider directories under this project. The report highlights the pilot lessons learned and accomplishments and recommends improvements to interoperability specifications, tools and services.
AHRQ Solicits Scientific Information on Health Information Exchange
In a notice published Aug. 29, AHRQ requested public submissions of data and other scientific information that will contribute to the agency's review of the use of health information exchange and of the effect it has on clinical, economic and population outcomes.
Privacy and Security
HHS Names New Office for Civil Rights Director
In July, HHS announced that Jocelyn Samuels will be the next director of the Office for Civil Rights. Samuels will be responsible for HHS's oversight of HIPAA privacy, security and breach notification. Samuels was previously the acting assistant attorney general for civil rights at the Department of Justice.
Lawmakers Send Letter to HHS on HIPAA Rules for App Developers
In a letter sent Sept. 18, Reps. Tom Marino (R-Pa.) and Peter DeFazio (D-Ore.) requested that HHS update and clarify HIPAA regulations for developers of mobile applications, specifically noting that changes in mobile health applications are not addressed under existing guidance.
Other Health IT Developments
ONC Responds to House Letter on Health IT Safety Center
On July 8, ONC responded to a letter from the House Energy and Commerce Committee questioning the ONC's authority to create a Health IT Safety Center and to regulate health IT activities when the meaningful use program expires. In the response, ONC noted that the proposed Safety Center would not have the authority to regulate health IT and pointed to the HITECH statute, which allows ONC to perform a broad range of duties in order to develop a "nationwide health information technology infrastructure."
FDA To Expand EHR Surveillance Pilot Program
According to news reports, FDA will expand its Mini-Sentinel EHR Surveillance Pilot Program to a permanent system when pilot funding runs out at the end of this fiscal year. The program, which uses data from EHRs to monitor the safety of medical products regulated by FDA, is an important part of the agency's safety surveillance capability, according to the FDA spokeswoman.
CMS Proposes Health IT Changes in 2014 Physician Fee Schedule Rule
In a proposed rule issued July 11, CMS proposed adding new telehealth services, including annual wellness visits and psychotherapy, for Medicare beneficiaries. The proposed rule also would require Medicare physicians who provide chronic care management services to use a certified EHR or other health information exchange platform to share patient care plans with other providers caring for the patient.
ONC Launches Hypertension Challenge
On July 9, ONC published a notice launching a challenge for EHR innovations that can help improve the treatment of hypertension. Specifically, the challenge asks providers to submit successful examples of their efforts to use clinical decision support to implement evidence-based blood pressure treatment protocols.
CMS Announces Innovation Award Winners With Focus on HIT
On July 9, CMS announced a new round of 39 Health Care Innovation Awards through the Centers for Medicare and Medicaid Innovation. Several awardees will focus on using health IT to improve care (e.g., by linking primary care physicians to other types of providers to better manage patient care across settings).
FDA Releases Draft Guidance on Certain Medical Devices
FDA released draft guidance on Aug. 1 indicating that it would exempt certain medical devices, including some smartphone-enabled devices, from FDA pre-market authorization. The pre-market authorization process is typically used by FDA to review the safety and effectiveness of medical devices, but FDA indicated that these health devices are well understood and do not pose a safety risk to consumers.
ONC Announces New Leader of Consumer e-Health Initiative and Departure of Chief Science Officer
On Sept. 11, ONC named Lana Moriarty as the new head of the Consumer e-Health Program, where she will help lead ONC efforts on patient engagement. Meanwhile, ONC Chief Science Officer Doug Fridsma announced his departure on Sept. 22. Fridsma will serve as the president and CEO of the American Medical Informatics Association.
ONC and CMS Hold National Health IT Week
From Sept. 15 to Sept. 19, ONC and CMS convened the annual National Health IT Week to raise awareness of health IT efforts to transform health care. The event included several sessions focused on patient engagement, interoperability, and clinical quality and safety. During the event, CMS highlighted its eHealth initiative to identify efficiencies and improvements in health care delivery, and ONC unveiled a new Blue Button campaign and toolkit to boost consumer access to health information.
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