Impacts of the American Recovery & Reinvestment Act of 2009 on ONC, NeHC, HITSP, and CCHIT

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1 Impacts of the American Recovery & Reinvestment Act of 2009 on ONC, NeHC, HITSP, and CCHIT David W. Roberts, MPA, FHIMSS, Vice President, Government Relations, HIMSS John Halamka, MD, CIO of Beth Israel Deaconess and Harvard Medical School Mark Leavitt, MD, PhD, FHIMSS Chairman of CCHIT March 11, 2009

2 Overview Update on ARRA of 2009 Office of National Coordinator (ONC) National ehealth Collaborative (NeHC) Health Information Technology Standards Panel (HITSP) Certification Commission on Health Information Technology (CCHIT) 2

3 Purpose of Legislation The legislation aims to stimulate the economy through investments in infrastructure, unemployment benefits, transportation, education, healthcare and includes over $20 billion to aid in the development of a robust IT infrastructure for healthcare and to assist providers and other entities in adopting and using health IT. 3

4 Economic Stimulus Key Components Leadership Standards Certification Funding and Incentives Research and Development Education and Outreach Privacy and Security Additional Items 4

5 Leadership Office of the National Coordinator ($2 billion) HIT Policy Committee HIT Standards Committee National ehealth Collaborative 5

6 Office of National Coordinator Office of the National Coordinator charged with developing a nationwide HIT infrastructure to improve quality, reduce costs, and protect privacy Chief Privacy Officer to be appointed by ONC within 12 months Federal Health IT Strategic Plan to be updated on published on a website. Must include a plan for implementation of EHRs for every patient in the US by

7 HIT Policy Committee Federal Advisory Committee to make recommendations to ONC regarding nationwide infrastructure and Federal Health IT strategic plan Includes policies that will address standards, implementation specifications, certification criteria, authentication, and privacy/security 7

8 HIT Standards Committee Federal Advisory Committee to recommend standards, implementation specifications and certification criteria needed to achieve interoperability Secretary of HHS has until December 31, 2009 to adopt the initial set of standards Secretary must submit a report within 2 years (and annually thereafter) describing actions taken to create a nationwide health IT network 8

9 HITSP 2009 and Beyond The Impact of ARRA Sponsored by the HITSP Education, Communications and Outreach Committee enabling healthcare interoperability 1

10 Existing Planned Work for 2009 Filling Gaps and Providing Extensions to existing HITSP Interoperability Specifications. Newborn Screening Use Case Clinical Research Value Case Usability improvements HITSP enabling healthcare interoperability Slide

11 Gaps and Extensions Order Sets Clinical Encounter Notes Medical Home: Co-Morbidity & Registries Maternal & Child Health Medication Management Long Term Care Advanced Device Interfacing Consumer Adverse Event Reporting Scheduling Prior-Authorization in Support of Treatment, Payment, & Operations Consumer Preferences HITSP enabling healthcare interoperability Slide

12 New Use Case: Newborn Screening Newborn screening for treatable genetic, endocrinologic, metabolic and hematologic diseases leads to early diagnoses and treatment of diseases. To support this use case, HITSP will select and integrate the standards required to exchange newborn screening information. HITSP enabling healthcare interoperability Slide

13 New Value Case: Clinical Research Initial priority will be identifying a common set of information that can readily be exchanged between electronic health records and clinical research systems; this will provide a foundation for future projects: Patient participation in clinical research Pharmacovigilence (studying an preventing adverse effects of medications) Pharmacogenomics and biomarkers (looking at how someone s genes and personal traits effect their response to medication) Ultimate vision is to create an infrastructure through which healthcare advances clinical research which in turn informs clinical care Collaboration with CDISC and other stakeholders. CDISC = Clinical Data Interchange Standards Consortium Recommends standards for interoperability to improve medical research and related areas of healthcare HITSP enabling healthcare interoperability Slide

14 Improving Usability of HITSP Specifications Aligning our specifications with SOA the business industry de facto standard for interoperability SOA = Service Oriented Architecture Automated Validation Against HITSP Specifications Allows for easy automatic determination of how an implementation conforms to a HITSP specification Uses XML Schematron Technology Improving documentation publishing Providing a variety of document formats for customer flexibility Improving addenda and errata process HITSP enabling healthcare interoperability Slide

15 My Hopes and Expectations Sponsored by the HITSP Education, Communications and Outreach Committee enabling healthcare interoperability 7

16 HIT Policy Committee Make recommendations on HIT infrastructure Identify and prioritize specific areas of standard development (including standards, implementation specifications and certification criteria), harmonization and recognition. Consider privacy technologies, NHIN infrastructure, use of certified EHR for each person, accounting for disclosures, improving quality and others Also consider collection of quality and public reporting, public health and biosurveillance, research and drug safety, self service, home care and telemedicine, et. al.

17 HIT Standards Committee Recommend to ONC standards, implementation specifications and certification criteria for the electronic exchange and use of HIT for purposes of adoption in Sec 3004, implementing strategic plan and in accordance with HIT Policy Committee Shall update recommendations and make new recommendations Recognize harmonized or updated standards from an entity or entities for the purpose of harmonizing or updating standards and implementation specifications in order to achieve uniform and consistent implementation of standards and implementation specifications. Shall provide for the testing of such standards by NIST Consistent with HIPAA Serve as forum for a broad range of stakeholders Not less than 90 days after the date of enactment, the HIT Standards Committee shall develop a schedule for assessment of policy recommendations from the HIT Policy Committee. Conduct open meeting and process comments

18 The Role of HITSP Continue 2009 work in progress especially the move to a Service Oriented Architecture Serve the Standards Committee Important work ahead Quality Data Set standards for NQF/HITEP and CMS which also support Comparative Effectiveness measurement Social Security Administration MEGAHIT (Medical Evidence Gathering and Analysis through Health IT) Transport/Routing Harmonization supporting HIT Extension Centers HITSP enabling healthcare interoperability Slide

19 HITSP Quality Measures Project Goal: Develop a model for measure specification addressing EHR available data Create, with measure developer, interoperable specification to clearly define: Patients included in measure population; expected interventions/outcomes Patients excluded from the population or expected interventions How to calculate measure based on these sets Identify standard electronically interoperable measure specification Identify a standard electronically interoperable performance report HITSP Quality Measures Project to produce three artifacts: Updated HITSP IS06 Quality to fill gaps and complete the roadmap Template (new HITSP construct) for interoperable description of a measure Definition of a measure including links to data elements, value/code sets Template (new HITSP construct) for interoperable performance reporting Demonstrate 3 inpatient measure sets Venous Thromboembolism (VTE) Stroke Emergency Department HITSP enabling healthcare interoperability Slide

20 Join HITSP in developing a safe and secure health information network for the United States Visit or contact: Michelle Deane, ANSI mmaasdeane@ansi.org Re: HITSP, its Board and Coordinating Committees HITSP enabling healthcare interoperability Slide

21 Certification Commission for Healthcare Information Technology Certification of Health IT under the American Recovery and Reinvestment Act (ARRA) Mark Leavitt, MD, PhD Chair, CCHIT HIMSS Economic Stimulus Webinar March 11, 2009 Slide 21

22 Topics Putting Health IT under ARRA in Context Certification Language in ARRA CCHIT under ARRA 2009 Slide 22

23 Putting Health IT under ARRA in Historical Context Apollo Program ARRA/Health IT National goal Manned spaceflight to the moon Electronic health records for every American Level of leadership Presidential: John F Kennedy Presidential: Barack Obama Timeframe (8 years) (5 years) Driver Scientific exploration + National security Enabler of health reform + Economic recovery Total government funding $22B (1969 dollars) $19B (2009 dollars) Management NASA (gov t agency) HHS/ONC (gov t agency) Execution Multiple contractors (private sector) Multiple contractors (private sector) [note: educated guess] Major challenges Developing multiple, completely new technologies Safety of astronaut lives Broad implementation of (partially) existing technology Changing the behavior and attitudes of professionals and organizations 2009 Slide 23

24 For Health IT Professionals: New and Unfamiliar Territory Health IT becomes a major Federal program overnight! Fastest funding growth of any program since WW2 (except Homeland Security post 9/11) Information available is limited Concurrent major political transition still not complete Many decisions must be made by HHS Secretary and National Coordinator; FACA Committees empaneled; Federal rule-making processes undertaken So we re experiencing: High levels of speculation Rumors and misinformation (as seen in political campaigns) Bottom line: beware of pundits bearing secrets (myself included) 2009 Slide 24

25 Certification Language in ARRA The National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, shall keep or recognize a program or programs for the voluntary certification of health information technology as being in compliance with applicable certification criteria adopted under this subtitle Slide 25

26 Certification in the Medicare and Medicaid Incentive Programs Incentives are for Adoption and Meaningful Use of Certified EHR Technology Incentives actually total ~$34B CBO calculation The $17B figure is the net expenditure after including expected savings in health care costs 2009 Slide 26

27 Additional Roles of NIST Pilot Testing of Standards and Implementation Specifications (in coordination with the HIT Standards Committee) Support the establishment of a conformance testing infrastructure, including the development of technical test beds. The development of this conformance testing infrastructure may include a program to accredit independent, non-federal laboratories to perform testing Slide 27

28 The Future of CCHIT under ARRA Why we are confident CCHIT will be a Federally recognized certification program under ARRA CCHIT has been Federally recognized since 2006 The organization met all contractual goals, on time/on budget Operationally successful and sustainable with high levels of market acceptance large number of EHR products currently certified and adoption-ready Why we do not believe a brand new EHR certification organization/program would be developed from scratch Adoption incentives start in 20 months; purchases and implementations need to begin right away It is not practical to design, bid, and develop a credible new certification body in that timeframe ONC has many other challenging new programs to develop 2009 Slide 28

29 Transitioning CCHIT Certification Programs to ARRA Certification Criteria as recognized by HITSC (late 2009?) Criteria that may be omitted from an ARRA certification program CCHIT 09 Criteria that are also recognized by HITSC Criteria that must be added for an ARRA certification program CCHIT 09 Criteria (planned launch July 2009) 2009 Slide 29

30 How CCHIT Must Evolve under ARRA Increased scope of responsibility Guardian of a major public investment Increased risk of fraud and abuse fake EHRs Privacy concerns heightened by speed and breadth of EHR adoption Expectations of certification no longer end with software testing must consider usability, safety, successful implementations, data exchange, and ultimate impacts on quality and cost Increased scale of programs Expand to new domains EHRs must be available for all providers and facilities eligible for incentives Volume of EHR suppliers will increase expect new capital investments, new entrants to the field Encourage continued innovation Avoid creating unnecessary barriers address concerns re: open source EHRs, self-developed EHRs, modular EHRs 2009 Slide 30

31 Thank you! Q & A For more information:

32 HIMSS09 Upcoming HIMSS Events April 4 8 in Chicago Economic Stimulus Track (11 Sessions) Government Health IT Conference & Exhibition June 4 5 in Washington, DC HIMSS Virtual Conference & Exhibition June 9 10 National Health IT Week and Advocacy Day September in Washington, DC 32

33 Resources One-stop shop on the ARRA: Summary & Analysis FAQs: Gen l, Privacy & Security, and Funding Incentive Worksheets & Updated News HIMSS09 Sessions on ARRA: CCHIT: HITSP: ONC: NeHC: 33

34 Resources (cont.) HIMSS Pulse on Public Policy e-newsletter Government Relations Team in HIMSS Washington, DC, office Congressional Affairs Federal Affairs State Government Relations Institute for e-health Policy Davies Program 34

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