Review of Q1 2014 Federal Health IT Activity

by Helen R. Pfister, Susan R. Ingargiola and Dori Glanz, Manatt Health Solutions, iHealthBeat, Monday, April 21, 2014

The federal government continued to implement the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act, during the first quarter of 2014.


The first quarter of 2014 saw a number of important developments:

  • Final Rule Gives Patients Right to Access Laboratory Test Results. On Feb. 6, CMS, CDC and the Office for Civil Rights jointly issued a final rule that gives patients direct access to their laboratory test results. The final rule amends both the HIPAA Privacy Rule and the Clinical Laboratory Improvement Amendments of 1988 regulations.
  • HHS Strategic Plan Highlights Meaningful Use. On March 14, HHS released its five-year strategic plan for 2014 through 2018. The plan includes performance goals related to meaningful use, including increasing the number of primary care physicians that use electronic health records. The plan also identifies strategies to advance EHRs, such as using incentives, certification and grants to help increase EHR adoption.
  • ONC Releases Proposed Rule on 2015 EHR Certification Criteria. On Feb. 26, the Office of the National Coordinator for Health Information Technology, released a proposed rule that would specify the voluntary certification criteria that EHR developers and providers qualifying for the Medicare and Medicaid EHR Incentive Programs may adopt starting in 2015. The 2015 criteria would clarify, update and add to the 2014 criteria and simplify the certification of certain EHR modules. The 2015 criteria proposed in the rule would be voluntary. No EHR technology developer that has certified its EHR technology to the 2014 Edition would need to recertify to the 2015 Edition in order for its customers to participate in the EHR Incentive Programs. Furthermore, eligible professionals, eligible hospitals and critical access hospitals would not need to upgrade to EHR technology certified to the 2015 Edition in order to have EHR technology that meets the Certified EHR Technology definition. The proposed rule introduces the beginning of ONC's more frequent approach to health IT certification regulations. Under this approach, ONC intends to update certification criteria editions every 12 to 18 months in order to provide smaller, more incremental regulatory changes and policy proposals.

ONC Health IT Advisory Committees

Health IT Policy Committee

During the first quarter of 2014, the Health IT Policy Committee on March 11 voted to approve the Meaningful Use Workgroup recommendations for measures to be included in Stage 3 of meaningful use under the EHR Incentive Programs. ONC and CMS will consider the recommendations before releasing a proposed rule on Stage 3 this fall.  The recommendations suggest adoption of several new menu measures, including a measure on providing electronic notifications of significant health care events to a patient's care team and a measure requiring hospitals and health systems to accept patient-generated data. 

The committee also held hearings on the Privacy and Security Tiger Team recommendations regarding patient rights to access EHR data and provider disclosure of patient data. The recommendations urge HHS to limit the scope of data that should be disclosed to patients in order to avoid overwhelming the patient and burdening providers.

Health IT Standards Committee

During the first quarter of 2014, the Health IT Standards Committee discussed and heard public comment on the Health IT Policy Committee's Meaningful Use Stage 3 recommendations. The committee also discussed Consumer Technology Workgroup recommendations regarding patient-generated health data and heard updates from ONC on the Standards and Interoperability framework.

EHR Certification

ONC Solicits Applications To Serve as ONC-Approved Accreditor

On Jan. 16, ONC issued a notice soliciting applications from organizations wishing to act as the ONC-Approved Accreditor. The ONC-Approved Accreditor, currently the American National Standards Institute, is responsible for oversight and monitoring of ONC-Authorized Certification Bodies under the ONC Health IT Certification Program. The application period closed on Feb. 18.

Certification Commission for Health IT Announces End to Meaningful Use Certification

On Jan. 29, the Certification Commission for Health IT announced it will no longer offer ONC testing and certification services. CCHIT was one of three Authorized Certification Bodies designated by ONC in January 2013.

Medicare and Medicaid EHR Incentive Programs

CMS Extends Deadline for Meaningful Use Attestation

On Feb. 7, CMS extended the meaningful use attestation deadline for the 2013 Medicare-eligible professional reporting year from Feb. 28 to March 31. The extension allowed additional time for Medicare-eligible professionals to attest to meaningful use and qualify for incentive payments. Medicare-eligible professionals must attest to meaningful use before the deadline to avoid the 2015 Medicare payment adjustment.

CMS Issues Guidance on Exemptions From Medicare Payment Adjustments

On March 12, CMS issued guidance on hardship exemptions from Medicare payment adjustments for eligible professionals and hospitals who are unable to implement certified EHRs in time to demonstrate meaningful use for the 2014 reporting year. Providers who receive a hardship exemption would not be subject to the Medicare payment adjustment.

CMS Issues Updated Data on EHR Incentive Program Participation

In March, CMS issued new data on the EHR Incentive Programs, covering a period through February 2014. More than 458,000 eligible hospitals and professionals had registered to participate in the programs, and CMS had made more than $21 billion in payments.

ONC Issues New Data Briefs on Privacy and Clinical Labs

ONC issued three new data briefs in February highlighting new findings on patient views on provider efforts to ensure EHR privacy, on the ability of clinical laboratories  to exchange test results and on the number of clinical laboratories that allow patients direct access to clinical lab results.

AHRQ Awards Grants to Support Stage 3 of Meaningful Use

The Agency for Healthcare Research and Quality announced grant awards on March 24. The awards will fund 12 projects evaluating innovative strategies to help providers meet meaningful use requirements, and to improve and inform Stage 3 of meaningful use.   

OIG Releases Plans for EHR Investigations

On January 31, the HHS Office of the Inspector General released its 2014 work plan, which includes plans to review adoption of EHRs under the EHR Incentive Programs, security of certified EHR technology, and OCR oversight of compliance with the HIPAA Privacy Rule and the HITECH Breach Notification Rule.

Health Information Exchange and Interoperability

United States and United Kingdom Agree To Increase Data Exchange

On Jan. 23, HHS announced a new agreement laying out shared principles, and beginning a dialogue between the U.S. and United Kingdom on EHRs and data exchange. The agreement specifically focuses on aligning quality indicators and measurement, supporting data transparency and encouraging EHR adoption.

ONC Holds Transitions of Care Connect-a-thon

On Feb. 4 and Feb. 5, ONC held a "Connect-a-thon" to bring together EHR vendors and Health Information Service Providers to test and troubleshoot platforms that use Consolidated-Clinical Document Architecture standards for exchanging transition of care summaries.

CMS Issues Notice on Meaningful Use Data Transmission Database

On Feb. 7, CMS issued a notice indicating it will build a database to serve as a centralized source of readiness information on public health agencies and registries. The database is meant to help providers meet meaningful use measures related to data transmission to public health agencies and registries.

ONC Releases Report on Patient Matching Initiative

On Feb.7, ONC released a report on its Patient Matching Initiative. The report includes recommendations for improvements to patient identification and matching methods in order to facilitate information exchange across organizations. 

CMS and ONC Announce Designated Test EHR Program

On Jan. 14, ONC and CMS announced a new program under which they have designated three "test EHRs" to allow eligible professionals and hospitals to meet the Stage 2 meaningful use transition of care objective. To meet the objective, providers will need to conduct one or more successful tests of information exchange with a designated test EHR.

Privacy and Security

ONC Releases SAFER Guides on EHR Safety

On Jan. 15, ONC released new Safety Assurance Factors for EHR Resilience Guides that are meant to help health care providers and organizations increase the safety of EHRs. There are nine guides, focusing on high-level safety best practices, infrastructure and clinical processes.

HHS and Health Information Trust Alliance Launch Cybersecurity Initiative

On Jan. 13, HHS and the Health Information Trust Alliance announced a new initiative, called CyberRX, to simulate cyber-attacks on health care organizations in order to evaluate their preparedness for such attacks. 

HHS Issues Guidance on HIPAA and Mental Health Records

On Feb. 21, OCR issued guidance reiterating how HIPAA rules apply to mental health information. The series of questions and answers addresses providers' ability to communicate with a patient's family, caregivers and law enforcement, and explains how HIPAA applies to psychotherapy notes.

ONC and OCR Announce Digital Privacy Challenge

On Feb. 10, ONC and OCR announced a new Digital Privacy Notice Challenge seeking submissions of online notices of privacy practices that are readable and understandable by patients. Ideas are sought from designers, developers, and patient privacy experts. The challenge closed on April 7, and $25,000 in prizes will be awarded.

HHS Announces New Security Risk Assessment Tool

On March 28, ONC and OCR announced a new Security Risk Assessment Tool that will help health care providers in small- to medium-sized offices conduct security risk assessments, in accordance with HIPAA rules. The tool also will produce a report that may be used for audits.

Other Health IT Developments

ONC and CMS Kick Off Clinical Quality Framework Initiative

On March 21, ONC and CMS held a kickoff meeting for a new Clinical Quality Framework Initiative under the Standards & Interoperability Framework that will work with clinical quality stakeholders to better align standards for clinical decision support and electronic clinical quality measurement.

CMS Released Quality Reporting Implementation Guide

On Jan. 15, CMS released an updated Implementation Guide for eligible professionals, which provides guidance on the use of the 2014 CMS Quality Reporting Document Architecture format for reporting clinical quality measures through EHRs.

Institute of Medicine Proposes Cost Benefit Framework for Health IT

In a paper released on Jan. 6, the Institute of Medicine proposed a standard framework for measuring the costs and benefits of EHRs. The framework is meant to help health care providers measure and compare the potential return on investment that could be realized from spending on different types of EHR technology and across different types of institutions.

HHS Inspector General Issues Report on Lack of EHR Safeguards

In a Jan. 11 report, the HHS OIG criticized CMS for failing to adopt sufficient program integrity practices that would address vulnerabilities in EHRs. For example, the report notes that CMS has not provided sufficient guidance to anti-fraud contractors, and has not updated its fraud prevention policies to ensure copy and paste or auto-populate functions in EHRs are not used to inflate claims.

Government Accountability Office Issues Reports on EHR Performance Measures

In March, the Government Accountability Office issued two reports criticizing HHS strategic planning on the EHR Incentive Programs and on Health Information Exchange. The reports noted that HHS strategic plans on EHRs lack specific outcome-based performance measures by which to track progress, especially in the areas of quality, patient safety, efficiency and health information exchange.

ONC Announces Patient Engagement Initiative

On Jan. 10, ONC announced a new initiative, called Person@Center, which aims to enable individuals to better manage their health care using health IT. ONC launched the initiative by publishing an issue brief on the topic, describing opportunities, challenges and next steps to improve patient engagement.

Preliminary Evaluation of the Regional Extension Center Program Released

In January, the American Institutes for Research released an independent evaluation of the Regional Extension Center Program, now posted on ONC's website. The evaluation describes nine REC grantees, highlighting the technical assistance services they offer to providers and the challenges they face in helping providers adopt and meaningfully use EHRs.

HHS Announces New Initiative To Advance EHRs in Emergency Medicine

The HHS Office of the Assistant Secretary of Preparedness and Response and ONC launched a new online forum to connect emergency care, EMS and health IT communities and allow the exchange of ideas, projects and best practices that could increase the use of EHRs in emergency medicine. 

ONC Requests Federal Trade Commission Investigation of EHR Vendor Practices

In a workshop on March 20, ONC requested that the Federal Trade Commission investigate whether EHR vendors are using anti-competitive pricing policies, such as restricting access to data and setting prohibitively high prices for data exchange across vendors.  

President's Budget Requests Increased Funding for ONC

The President's budget, released on March 4, requests an increased 2015 budget of $75 million for ONC. ONC had budget authority of $60 million in FY 2014. A new $5 million Health IT Safety Center would be established under the proposal. Congressional hearings on the President's 2015 budget request began in March.

Source: iHealthBeat, Monday, April 21, 2014

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