Office of the National Coordinator for Health IT (ONC) Certification Program

June 19, 2013

Lauren Fifield, Policy Adviser, Practice Fusion

TODAY’S AGENDA

• Introduction

• ONC Overview

• EHR Certification

• Discussion Topics

In 2009, the HITECH Act provisioned $19.2 billion to promote the adoption of EHRs

As developed under the Department of Health and Human Services (HHS), the EHR Incentive Program framework has three stages:– Stage 1: data capture and sharing (2011-2013) – Stage 2: advanced clinical processes (2014-2015) – Stage 3: improved outcomes (2015-2016)

Eligible Professionals (EPs) and Eligible Hospitals (EHs) earn incentives for adopting certified EHRs and successfully achieving Meaningful Use (MU).

Two organizations within HHS jointly oversee and manage the EHR Incentive Programs

– The Centers for Medicare and Medicaid Services (CMS) oversees MU and provides incentive payments to EPs and EHs who meaningfully use Certified EHR Technology (CEHRT)

– The Office of the National Coordinator for health IT (ONC), per the HITECH Act, was charged with creating the ONC HIT Certification Program

Certification vs. MU

Certification establishes standard EHR Technology capabilities that enable providers to adopt and pursue Meaningful Use of the technology.

Solely adopting certified EHR does not qualify an EP or EH to receive incentive payments.

The HITECH Act introduced a definition for health IT

‘Health information technology’: Hardware, software, integrated technologies, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information

TODAY’S AGENDA

• Introduction

• ONC Overview

• ONC HIT Certification Program

• Discussion Topics

The HITECH Act also established the ONC

Towards the “development a nationwide HIT infrastructure that allows for the electronic use and exchange of health information”, ONC duties include:

– Standards– HIT Policy Coordination (FACAs, HIT

Strategic Plan)– Measurable Outcome Goals– Publication– Certification– Reports and Publications– Assistance– Governance for Nationwide Health

Information Network

The Office of the National Coordinator

Goal: “to pursue the modernization of the American health care system through the implementation and meaningful use of health information technology”.

OPP and OCERT

Office of Policy and Planning (OPP)

• Develops and coordinates policies that support market optimization and provides proactive and forward-thinking strategies that reflect open and transparent processes

Office of Certification (OCERT) • Accredits the testing and certification bodies

that ensure health IT is certified for use by federal agencies and partners and as required for attestation by providers participating in the Meaningful Use Programs

ONC HIT Certification

Program Overview

OST

Office of Science and Technology (OST)

• Promotes the adoption of interoperable, open, standards-based technologies and architectures that ensure information can flow seamlessly and securely between interoperable health IT.

• By engaging a range of stakeholders through a standardized framework, OST accelerates the development and harmonization of health IT standards.

Standards Development, Testing, Acceleration

Investing in Innovation (i2)

– Under ONC’s i2 Program, competitions focus on using the Challenge.gov criteria and providing incentives that will help in the development of innovations that support HITECH Act, HHS goals, RECs, and learning health system

TODAY’S AGENDA

• Introduction

• ONC Overview

• ONC HIT Certification Program

• Discussion Topics

The ONC HIT Certification Program

– General Characteristics– Scope– Requirements– Process

General Characteristics: Tied to Meaningful Use

2011 2012 2013 2014 2015…

MU for Providers

Stage 1 Stage 1 Stage 1 Stage 1 & 2 Stage 1 & 2

Certification Required

2011 Edition

2011 Edition

2011 & 2014 Edition

2014 Edition

2014 Edition

Stage 2 delayed

General Characteristics

General Characteristics: Modular

Scope– Currently, certification is limited to electronic

health records (EHRs) and module functionality

– HITECH Act grants ONC authority to broadly certify health IT

– Certification was established as a voluntary program

Overview Certification Requirements

Vocabulary & Code Sets– e.g. LOINC, RxNorm, SNOMED CT,

Common MU Data Set

Transport– e.g. Applicability Statement for Secure

Health Transport

Content Exchange/Utilization– HL7 Infobutton + Igs, Consolidated CDA,

QRDA Category I & III, HL7 2.5.1+ IG

Other– Automated numerator recording– Safety-enhanced design – Medication related certification criteria– Quality management system – Price Transparency – Test Result Transparency

Certification Standards and Criteria

Certification Process

Testing - ATLs– Certification and testing activities are performed by separate

entities– Testing is performed by Accredited Testing Laboratories (ATLs)– The

National Voluntary Laboratory Accreditation Program (NVLAP) has been acknowledged by ONC, by regulation, as the Accreditation Body for Testing Laboratories in the ONC HIT Certification Program

– Approved test tools and test procedures are used to test Complete EHRs and/or EHR Modules in order for them to be eligible for certification by an ONC-Authorized Certification Body (ONC-ACB).

Certification – ONC-ACBs

– ANSI accredits certification bodies, which then seek ONC authorization to certify EHR technologies in the HIT Certification Program

– ONC-ACBs renew status every three years– A single organization can be both an ONC-

ACB and an ATL (if they have a strong firewall between the two programs)

Example

– Will review a test procedure and test data example

Certified HIT Product List

– The Certified Health IT Product List (CHPL) lists Complete Electronic Health Records (EHRs) and EHR Module(s)

– The website is managed by the ONC and for use by EPs and EHs to identify certified technology

TODAY’S AGENDA

• Introduction

• ONC Overview

• ONC HIT Certification Program

• Discussion Topics

Reduce Risk of Harm

– Require standard drug-drug, drug allergy interaction warnings

– Adoption of standards for exchange, vocabulary, reporting

– Baseline privacy and security capabilities– Clinical reconciliation and exchange

standards

Market Assurances

– Standards assurances (CHPL, surveillance and revocation of certification)

– Transparency into quality management system and safety-enhanced-design processes

– Standard guidelines for listing of CDS intervention source

Promote Innovation

– Modular certification– Challenges– Convening stakeholders– Acceleration of standards development– Shifting initiatives to private sector• HealtheWay (formerly NwHIN Exchange)

Challenges/Risks to Innovation

– Fine line: technology prescription vs. technology as means to end

– High level of complexity– Regulatory scaling concerns– Regulatory uncertainty stage-to-stage– Universal applicability issues

Challenges/Risks to Innovation

– Measurement Risks• Emergency Access, E-Prescribing,

Immunizations, Formulary check• Automated measure calculation

– Flexibility• Allergy decision support• Time to certify