Q4 2011 Saw Surge of Federal Health IT Activity

by Helen Pfister, Susan Ingargiola and Rachel Sam, Manatt Health Solutions

During the last quarter of 2011, the federal government continued to implement the HITECH Act, enacted as part of the American Recovery and Reinvestment Act. Below is a summary of key developments and milestones achieved between Oct. 1, 2011, and Dec. 31, 2011. 

Q4 2011 Health IT Highlights

The fourth quarter of 2011 saw a number of important developments, including the following.

  • IOM Publishes Report on Patient Safety and Health IT.
    On Nov. 8, 2011, the Institute of Medicine released a series of recommendations related to the effect of health IT on patient safety in a report titled, "Health IT and Patient Safety: Building Safer Systems for Better Care." The Office of the National Coordinator for Health IT commissioned the report and will use it to inform its development of health IT-related patient safety policies. 
  • HHS Revises Meaningful Use Timeline.
    On Nov. 30, 2011, HHS announced changes to the Medicare and Medicaid electronic health record incentive programs' meaningful use timeline. Under the changes, health care providers who meet Stage 1 meaningful use requirements in 2011 would not need to meet Stage 2 meaningful use requirements until 2014. 
  • ONC Announces Plans for Dashboard To Assess Progress of Health IT Grants.
    On Dec. 22, 2011, ONC published a notice in the Federal Register announcing plans to establish an "ONC Health IT Dashboard" to measure the effectiveness of grants awarded for a variety of health IT purposes. The Dashboard will include information from community college-based health IT training programs; individual physicians and hospitals; regional extension centers; state health information exchanges; and vendors that track health IT adoption and trends. ONC will use the Dashboard to compare the performance of grant recipients; develop a tool to evaluate the Medicare and Medicaid EHR incentive programs; and estimate state and national levels of health IT adoption. Researchers and the public will have access to the Dashboard. ONC will de-identify and aggregate any publicly accessible information.

Health IT Policy, Standards Committees

Policy Committee Endorses Privacy and Security Tiger Team Recommendations on Security Policy and QueryHealth

At its December 2011 meeting, the Health IT Policy Committee approved the Privacy and Security Tiger Team's recommendations for a security policy framework for EHRs. The recommendations were based on a gap analysis conducted by ONC and the National Institute of Standards and Technology that compared the HIPAA Security Rule to other commonly used security frameworks. While the Tiger Team indicated that a detailed analysis of specific gaps is beyond its expertise, it made a number of high-level security policy recommendations, including that security policies for entities collecting, storing and sharing electronic health information must be responsive to innovation and that such policies must also be flexible and scalable. The Policy Committee sent the recommendations to ONC on Dec. 14, 2011.

At its October 2011 meeting, the Policy Committee voted to amend and approve the Tiger Team's recommendations on ONC's QueryHealth pilot project, which is devoted to testing the utility of EHRs for query-based research purposes. According to the Tiger Team, data holders participating in QueryHealth should retain control over whether to respond to a query. Also, data exchanged through the pilot should be de-identified or aggregated. The Policy Committee sent these and other QueryHealth-related recommendations to ONC on Oct. 31, 2011.

Standards Committee Sets 2012 Agenda, Approves EHR Certification Recommendations

At its December 2011 meeting, the Health IT Standards Committee discussed its priorities and approved an agenda for 2012, which will include transitioning from a focus on standards for health IT implementation to standards for the interoperability of health data and new objectives for future stages of meaningful use. Specifically, the Standards Committee intends to review and comment on the forthcoming Stage 2 meaningful use proposed rule, address quality measures for future stages of meaningful use and assess the current status of the Nationwide Health Information Network.

At its November 2011 meeting, the Standards Committee approved the Implementation Workgroup's recommendations to revise the EHR certification process under Stage 2 of meaningful use. The recommendations would simplify and clarify the EHR certification process and, among other things, highlight the importance of realistic timelines for software developers and health care providers implementing EHRs. 

At its October 2011 meeting, the Standards Committee endorsed recommendations from its Privacy and Security Workgroup on security-related certification criteria, standards and implementation specifications for EHRs. The recommendations included that EHRs must be able to authenticate the identity of an authorized patient or personal representative using at least single-factor authentication and that EHRs must enable the patient to download a copy of his or her health information over a secure communication channel. The Standards Committee transmitted the recommendations to ONC on Oct. 21, 2011.

Standards Committee Gathers Public Feedback on NwHIN Implementation

On Nov. 9, 2011, the Standards Committee's NwHIN Power Team published a blog post requesting comments on data exchange through NwHIN Exchange. The Power Team solicited input from Exchange implementers regarding their experiences in implementing Exchange specifications; setting up the required operational and administrative infrastructure to deploy and operate Exchange; and using Exchange to meet their operational needs. Comments were due Dec. 15, 2011.

EHR Certification

ONC Issues Final Rule on ONC-Approved Accreditor Improper Conduct

On Nov. 25, 2011, ONC published a final rule to establish a process for addressing instances where the ONC-Approved Accreditor -- the accrediting organization that oversees ONC's permanent program for certifying EHRs -- engages in improper conduct or does not perform its responsibilities under the program. Under the final rule, ONC can issue a notice proposing to remove an ONC-AA from the permanent certification program if the entity fails to respond to a warning about a performance violation or if it commits a violation such as fraud or embezzlement.

ONC Extends Temporary EHR Certification Program

On Nov. 3, 2011, ONC published a notice in the Federal Register extending the temporary certification program for EHRs. The temporary certification program final rule, issued in June 2010, included a Dec. 31, 2011, sunset date but allowed ONC to determine a subsequent sunset date if the permanent certification program was not fully constituted at that time. According to the notice, ONC does not anticipate that there will be a sufficient number of accredited testing laboratories or ONC-Authorized Certification Bodies until summer 2012 and thus has determined it necessary to extend the temporary certification program until summer 2012.

Regional Extension Centers

More Than 100,000 Providers Registered for REC Services

On Nov. 17, 2011, ONC announced that more than 100,000 primary care providers signed up to adopt EHRs through their Regional Extension Center, representing more than one-third of all primary care providers nationwide.

Medicare and Medicaid EHR Incentive Programs

14 States Launch Medicaid EHR Incentive Programs in Q4 2011

On Oct. 3, 2011, California, Maine, Maryland, Massachusetts, Utah and Vermont launched their Medicaid EHR incentive programs, opening registration for eligible professionals and hospitals. Arkansas, Delaware, Montana, New Jersey, New York and North Dakota launched their programs on Nov. 7, 2011. South Dakota and Wyoming launched their programs on Dec. 5, 2011. As of the end of 2011, a total of 41 states had launched their Medicaid EHR incentive programs.

CMS Makes Incentive Program Payment and Registration Data Available Online

On Dec. 2, 2011, CMS launched a new website that provides Medicare and Medicaid EHR incentive program payment and registration data to the public. The website reports that more than $920 million in Medicare EHR incentive program payments were made between May 2011 and the end of November 2011, while more than $908 million in Medicaid EHR incentive program payments were made between January 2011 (when the first set of states launched their programs) and the end of November 2011. The website also includes the number of eligible professionals and hospitals that have registered to receive incentive payments under both programs.

CMS Final Physician Fee Schedule and OPPS Rules Include Detail on Quality Measure Reporting

On Nov. 28, 2011, CMS released the 2012 Medicare Physician Fee Schedule final rule. The final rule establishes a new Physician Quality Reporting System-Medicare EHR Incentive Pilot, which will allow eligible professionals participating in the Medicare EHR incentive program to report quality measures under the Physician Quality Reporting System and the Medicare EHR incentive program with a single submission.

On Nov. 30, 2011, CMS released the 2012 Medicare Outpatient Prospective Payment System final rule. The final rule allows eligible hospitals and critical access hospitals participating in the Medicare EHR Incentive program to continue reporting Medicare EHR incentive program quality measures through attestation or, as an alternative, to meet the program's clinical quality measure reporting requirements for payment year 2012 by participating in the new Medicare EHR incentive Program Electronic Reporting Pilot.

Health Information Exchange

ONC Announces Project To Promote Interoperability

In November 2011, ONC announced the launch of the Model-Driven Health Tools Project, a public-private open source collaboration formed between ONC, the Veterans Health Administration, IBM Research and Open Health Tools. The project is designed to lower the cost of participation in electronic HIE by simplifying HIE standards and producing accessible guides and software supporting the standards.

EHR/HIE Interoperability Workgroup Releases HIE Technical Specifications

On Nov. 8, 2011, the EHR/HIE Interoperability Workgroup released a set of technical specifications to standardize connections between health care providers, HIEs and other data-sharing partners. The specifications aim to remove impediments that make it difficult for EHRs to connect to HIEs, including technical specification differences, wait times for interface development and high costs. The workgroup was originally formed by the New York eHealth Collaborative and includes state-designated entities in seven states, eight EHR vendors and three HIE services vendors. The objective of the workgroup is to define a single set of standardized, easy-to-implement connections to increase adoption of EHRs and HIE services.

Vendors Test Transitions of Care Data Exchange Standard

In October 2011, ONC officials announced that 10 health IT and HIE vendors would participate in pilots to test the Consolidated Clinical Document Architecture, an interim single standard for providers to exchange core summary data as patients change care settings, as part of the Standards & Interoperability Framework Transitions of Care Initiative. Reports to ONC are expected in early 2012.

ONC Awards E-Consent Trial Project Contract

On Oct. 3, 2011, ONC's Office of the Chief Privacy Officer announced it awarded a contract to APP Design to "find an efficient, effective, and innovative way to help patients better understand their choices regarding whether and when their health care provider can share their health information electronically," including through a HIE organization. As described in the Statement of Work, APP Design will design, develop and pilot innovative ways to electronically implement existing patient choice policies, while improving business processes for health care providers. 

Privacy and Security

NIST Releases Toolkit To Facilitate HIPAA Security Rule Implementation

On Nov. 22, 2011, NIST announced the availability of a new HIPAA Security Rule Toolkit to help organizations understand and implement the requirements of the HIPAA Security Rule. According to NIST, target users include HIPAA covered entities, business associates and other organizations, including those providing HIPAA Security Rule implementation, assessment and compliance services.

HHS Releases Details of New HIPAA Audit Program

On Nov. 8, 2011, the HHS Office for Civil Rights posted on its website details about its new HIPAA Privacy and Security Audit Program. The program initially will consist of 150 audits of covered entities between November 2011 and December 2012 to assess privacy and security compliance. HHS retained the accounting firm KPMG LLP to conduct the audits.

ONC Announces Plan To Conduct Nationwide Survey of Consumer Privacy and Security Views

On Nov. 3, 2011, ONC published a notice in the Federal Register announcing plans to conduct a nationwide survey to assess the percentage of individuals who are concerned about the privacy and security of EHRs, who report having kept any part of their medical history from their doctor due to privacy concerns, and who are concerned that an unauthorized person would see their medical information if it is sent electronically, among other key measures. ONC will assess trends in consumer privacy and security views between 2012 and 2016. Survey results will be compiled into a final report. 

Other Health IT Developments

ONC Convened Grantee and Stakeholder Summit

ONC held its 2011 ONC Grantee and Stakeholder Summit on Nov. 17, 2011. The summit focused on health IT achievements and challenges, including electronic prescribing, EHR adoption, consumer e-health, privacy and security, and meaningful use. The summit also included updates from grantees in the State Health Information Exchange, REC, Workforce, Beacon Communities and SHARP programs.

USDA Awards $30 Million in Distance Learning and Telemedicine Grants

On Dec. 8, 2011, USDA awarded a total of $30 million to recipients in 34 states and one territory to improve access to health care and educational services in rural areas. The grants will fund distance learning and telemedicine projects under the USDA Distance Learning and Telemedicine Program.

Surgeon General and ONC Launch App Challenge

On Dec. 6, 2011, the Office of the Surgeon General and ONC launched the Surgeon General's Healthy Apps Challenge to encourage the development and submission of technology applications that will (1) provide health information tailored to the needs of the user; and (2) empower the public to regularly engage in health-promoting behaviors related to fitness and physical activity, nutrition and healthy eating, and/or physical, mental and emotional well-being. Contest entries were accepted between Dec. 6 and Dec. 31, 2011. Winners will be announced Jan. 31. 

National Research Council Issues Report on CMS IT Capabilities

On Nov. 14, 2011, the National Research Council released "Strategies and Priorities for Information Technology at the Centers for Medicare and Medicaid Services," a report calling for changes in the CMS IT infrastructure and capabilities to help drive the health IT and payment reform initiatives envisioned by the HITECH Act and the Patient Protection and Affordable Care Act.

VA Partners With Web-Based Care Vendor To Launch Telehealth Initiative

On Nov. 4, 2011, the Department of Veterans Affairs and American Well announced a new initiative to provide telehealth services to U.S. veterans in their homes, workplaces and other convenient locations, following an award from the VA Innovation Initiative's Industry Innovation Competition. Through this initiative, VA and American Well plan to establish three online medical practices for veterans remotely located from VA medical centers.

ONC Plans To Explore Consumer Views on Data Exchange Via Mobile Devices

On Nov. 1, 2011, ONC published a notice in the Federal Register proposing to collect data on consumer attitudes and preferences regarding the electronic communication of personal health information through mobile devices.

OIG 2012 Work Plan Includes Review of EHRs, Meaningful Use and Privacy

In October 2011, HHS' Office of Inspector General published its FY 2012 work plan. The work plan includes a review of fraud and abuse risks related to EHRs. OIG will also review Medicare and Medicaid EHR incentive payments to eligible providers, as well as OCR's implementation of the HIPAA Privacy Rule and the Breach Notification Rule. 

NIST Releases Draft Guidance on Testing EHR Usability

On Oct. 3, 2011, NIST released a draft report outlining protocols for evaluating, testing and validating the usability of EHRs. The report described a three-step process consisting of: (1) usability/human factors analysis during EHR user interface development; (2) expert review/analysis of the EHR user interface after it is designed/developed; and (3) testing of the EHR user interface with users. Comments on the draft guidance were due Nov. 10, 2011.

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