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considerations of the models we laid out. Specifically, we explore the friction between competition and collaboration, and the balance of control and innovation.

Questions 14, 15, 16, 17, &

18

4.0 Standards and Policies to Achieve Interoperability – Identifies the critical standards that need to be adopted to ensure interoperability and explores the role of Federal Government in definition and adoption.

Questions 19, 20, 21, & 22

5.0 Financial and/or Regulatory Incentives and Legal Considerations – Provides our current thinking regarding industry incentives to build, and stakeholder incentives to use, the NHIN, and explores the legislative landscape surrounding these subjects.

Questions

23 & 24 6.0 Other – Contains a working draft of a conceptual technical architecture for the NHIN, and provides suggestions for measuring the successful performance and value of an NHIN.

1 . 0 G E N E R A L I N F O R M A T I O N

In Section 1.0, General Information, The Booz Allen Collaborators provide responses to the first three

questions contained in the request for information. We provide a working definition of the NHIN (Section 1.1), a general overview of the business and organization models that could be needed to implement the NHIN (Section 1.2), and our general thinking about the scope and reach of the NHIN (Section 1.3).

1.1 Answer 1: NHIN – A Working Definition

RFI 1. The primary impetus for considering a NHIN is to achieve interoperability of health information technologies used in the mainstream delivery of health care in America. Please provide your working definition of a NHIN as completely as possible, particularly as it pertains to the information contained in or used by electronic health records.

Please include key barriers to this interoperability that exist or are envisioned, and key enablers that exist or are envisioned. This description will allow reviewers of your submission to better interpret your responses to subsequent questions in this RFI regarding interoperability.

Our working definition of the NHIN provides the context within which the remainder of our responses can be understood. The working definition includes five related topics: 1) an articulation of the different aspects of an NHIN, 2) a discussion of the Electronic Health Record (EHR) and the role it plays in implementing the NHIN, 3) our perspective on an incremental approach to realizing interoperability, 4) the enablers of interoperability based on the healthcare value chain, and 5) a discussion of interoperability barriers.

The NHIN is the technology, governance and business framework, legislative actions, and change management that result in interoperability among geography-based and domain-based health

information networks.

The NHIN we define can be realized through multiple technical and business approaches without limiting the integrity of the definition. This flexibility in defining the NHIN is useful because the business and technology approaches ultimately taken may vary, depending on the priority of the different increments of interoperability that the NHIN seeks to address. For practical reasons, the NHIN cannot be realized all at once. The most compelling case for action – whether it concerns patient safety, reducing costs in all health delivery settings, compliance, or product safety – will determine the starting point(s) for interoperability and the sequence in which increments of interoperability can be realized.

Each aspect of our NHIN definition is described below:

• Technology – the hardware, software, telecommunications, data exchange standards and business rules that support secure, private and reliable movement of information across the Internet and among a defined community of health care stakeholders. We envision a network-centric model for interoperability.

• Governance Framework – the leadership, organization structure, and operational roles and

responsibilities needed to identify, build, and operate the technology, promulgate the business rules, enact legislative and policy changes, and manage stakeholder relationships, and to monitor the

performance outcomes. We envision an industry-led and government enabled framework – a joint public-private partnership.

• Business Framework – the funding models needed to build and sustain the technology and the governance structure. We envision a funding model that builds from government seed money and evolves quickly to private funding or self-funding (similar to the growth of the Internet).

• Legislative Actions and Policy Decision – the actions needed to remove obstacles to realizing the vision of an NHIN and to formalize incentives for health information technology adoption. We envision negotiation of trade spaces between sharing and privacy and between collaboration and competition.

• Change Management – the training, outreach and communication needed to generate public

understanding and demand needed to adopt this new way of providing healthcare and doing business.

The concept of an NHIN is based on the understanding that information needed by the healthcare community will be digitized for electronic transfer. Therefore, an electronic health record is the foundation of the NHIN.

Development of an NHIN must remain in synch with evolving EHR definitions and adoption.

An EHR is fundamental to enabling health information exchange at all levels within the national health care system – the challenge is to identify the minimal set of data needed to solve the national business problem.

Electronic Health Record is the term most often used to refer to electronic storage and availability of health information to authorized practitioners. The electronic health record concept is often combined with the advantages of a computerized healthcare information system, resulting in the creation of many different terms (see box at right).

Just recently, The HiMSS Electronic Health Record committee chartered an effort to publish an EHR Definitional Model to support measurement of the penetration of electronic health records in health systems and physician practices by 2010. This definitional model clearly and effectively articulates the broad and varying nature of the information that can be contained in an EHR. At its most robust, an EHR is a patient-centric information resource containing the patient health record for clinical care, and it contains

billing, quality management, outcomes reporting, resource planning, and public health disease surveillance and reporting information. But adoption of a standard definition and use of EHR is not fully matured.

Therefore, the NHIN implementation strategy must complement efforts to increase adoption and must remain

4 Adapted from Healthcare Informatics; May 2003; EHR vs. CPR vs. EMR; C. Peter Waegemann EHR – What’s In a Name?4

CPR Computer-Based Patient Record. Lifetime patient record that includes all information from all specialties (even dentist, psychiatrist) and requires full interoperability (potentially internationally); unlikely to be achieved in foreseeable future

PCR Patient-Carried Record. All information contained on a token or card that patient carries; most pilots and demonstration projects have been discontinued.

CMR Computerized Medical Record. Any document imaging-based system.

EPR Electronic Patient Record. Similar to CPR but not necessarily containing a lifetime record and not including dental, behavioral, or alternative care; focuses on relevant information.

EMR Electronic Medical Record. Electronic record with full interoperability within an enterprise (hospital, clinic, practice).

DMR Digital Medical Record. Web-based patient record using

"pull" technology (minimum of messages).

PMRI Patient Medical Record Information. Used in Dept. of Health and Human Services/ National Committee on Vital and Health Statistics language.

PHR Personal Health Record. Managed and controlled by patient; mostly Web-based

CCR Continuity of Care Record. Used to organize and make transportable a set of basic patient information consisting of the most relevant and timely facts about a patient’s condition (patient and provider information, insurance information, patient’s health status, recent care provided, care plan, and the reason for referral or transfer).

synchronized with EHR evolutionary activities. Otherwise, the result can be a system of silos without interoperability, even with 100% adoption.

The first step towards realizing the NHIN is identifying a high-impact and high-value increment of interoperability and proceeding one milestone at a time.

The aspiration may be a national network that supports real-time, point-of-care, secure access to all health information. However, the reality is that the first increment of interoperability must be designed and

implemented to maximize the use of existing constructs. And, of these constructs, we believe that the NHIN must identify the minimal set of information that is needed on a national level to meet a specific nationwide need.

Federal electronic government (e-Gov) initiatives, such as GovBenefits.gov, Consolidated Health Informatics (CHI) and Grants.gov, have demonstrated that efforts focused on the early delivery of value have gained the advocacy needed to continue. These same efforts then continued to demonstrate “chunks” of value in frequent intervals and have been able to maintain the momentum needed to make consistent forward progress. Like these e-Gov initiatives, the NHIN must be built in increments of high impact interoperability designed to maximize the use of what already exists, using the minimal set of information needed to meet a specific nationwide need.

A recent Markle Foundation study found that, although provider spend on technology is increasing and remains a strategic priority, only 14% of hospitals have implemented some form of EHR. How valuable could it be to ensure that this 14% could share patient episodes of care on a nationwide basis? To what extent are other areas of the health record automated at the local and regional levels? Would a focus on exchanging current epidemiological studies have a greater impact by helping researchers and physicians determine which treatments work for patients with similar characteristics, illnesses and gene markers? Before we can identify the high impact, early “wins” for NHIN, we will need to create a baseline understanding of what exists.

Once we understand what there is at the grassroots level that can be leveraged toward an early win, we need to understand how nationalizing it will add value to the different members of healthcare value chain. In other words, we must be prepared to answer the question “What’s in this for me?” for each stakeholder.

Understanding the value proposition of interoperability from the perspective of the different stakeholders in the healthcare value chain will provide a framework for identifying quick wins that will build advocacy for the next wave of investment and next increment of interoperability.

Exhibit 2 – Notional NHIN Impact Assessment5

A baseline understanding of what exists can inform decisions about where to start.

To enable interoperability we must create momentum and evolve the expectations of each stakeholder in the healthcare system.

From a practical perspective, a key enabler of interoperability is agreement on reference information and terminology, followed by widespread adoption of EHR tools with appropriate security and privacy controls to ensure patient trust. Once adoption occurs at the point of care, we can build agreements to enable sharing of information. Once the organization and business framework, legislative actions, and policy decisions that define a national network are in place, we can share information nationwide. The capability to develop technology tools exists, there is shared commitment to creating the language and exchange standards needed, and there is general agreement on the benefits to patients and the general public health. So why is this change moving so slowly?

5 Adapted from Gartner Group, Inc.

One reason may be that, even though most

stakeholders perceive interoperability as a beneficial goal, individuals will only embrace the idea if they believe others will also embrace it at the same time.

Because the healthcare system is so interrelated, changing the status quo in one area of the system can be perceived as too risky. In the current healthcare system, each player knows what to expect from the others. Each player makes choices based on their own context within this equilibrium, not from the perspective of the patient. Bhaskar Chakravorti of the Monitor Group provides a clear example of this type of

equilibrium in his book, The Slow Pace of Fast Change – Bringing Innovations to Market in a Connect World.

He explains that physicians have the incentive to change only if other participants in the system change.

At the same time, insurance companies have no reason to comply with a standard method of

exchanging information across the industry unless all the physicians they interact with change as well.

Finding a way to disrupt the status quo and create

momentum is key to enabling interoperability. Understanding how much value accrues to each stakeholder can identify the starting point for disrupting the status quo.

The NHIN is envisioned as improving the quality of healthcare delivered, the degree of patient/person safety, and enabling efficiencies in the healthcare system for Americans. Evidence indicates that the secure

exchange of medical information will improve healthcare quality and patient safety by reducing medical errors, reducing wasteful and dangerous inefficiencies in the delivery of care, improving administrative efficiencies by reducing paperwork and improving communications, and increasing access to affordable healthcare.6 While in theory these benefits abound, we do not know exactly how these benefits accrue to different stakeholders in the healthcare value chain. Further investigation of how and where these benefits might accrue in the value chain is an imperative to understanding how to deploy and manage and NHIN.

6 Creative Incentives for the Nationwide Adoption of Interoperable Health Information Technology, White Paper, July 2004, The Center for Health Transformation

Practical Steps toward Interoperability

y An indisputable value proposition that provides the incentive for complying with the business rules, acquiring technology needed, and publishing the information in way that can be shared.

y Consensus on information and terminology reference models y Information collected at the point of care or patient interaction

that can be digitized for sharing.

y Funding to standup and operate a nationwide governance structure.

y Dedicated and committed leadership – clear accountability for actions.

y A joint public-private governance structure that will establish and maintain a vision, set priorities, create a road map toward realizing the vision, and broker relationships among the stakeholders and primary actors.

y A support operation to act as the focal point for the actors engaged in realizing the NHIN.

y Working groups that identify, drive and oversee the tactical actions (standards, laws, policies, etc.) and initiatives that will support achieving the vision of the governing body.

y Business rules defining who can participate in the information exchange, and methods for certifying and accrediting participants in the health information exchange relationships.

y A data exchange specification (syntax) to publish information for the purpose of sharing it with communities, regions and other national networks in a secure way using the Internet.

The value realized through national interoperability will vary across the health care value chain.

Common sense holds that if a provider has all the relevant knowledge about the patient in front of her, then she can make

informed decisions about a course of treatment, avoid the cost (fiscal and emotional) of redundant tests, and prevent some forms of medical errors.

The clear beneficiary of interoperability is the patient. But patients are not likely or realistically capable of changing the status quo due to financial, insurance and geographic barriers impeding absolute free choice in care decisions. In fact, no one member in the value chain currently has the leverage needed to disrupt the inertia that exists among physician offices, labs, other clinical departments, consulting physicians, medical information sources, insurers, pharmacists, and others.

By examining the impact of information exchange from the different perspectives of the healthcare value chain, we may identify the starting points for interoperability that have both high impact and high value, giving these starting points a high likelihood of being early successes. For example, most patient healthcare is local with the majority of health information transferred within a patient’s own community – between primary care physician and pharmacy, among attending and admitting physicians, among imaging services and a specialist. National payers have the ability to aggregate claims data across plans and populations to study trends in utilization and the impact of particular disease management programs. This ability enables them to decrease costs by improving care (less medication errors etc), decrease redundancy, reduce fraud, and enables the ability to better measure population health and the effects of particular interventions on that health. Other initial thoughts on the accrual of value across the value chain are depicted below. This exhibit is intended to illustrate the point of value accrual and does not represent an exhaustive list.

7 Based on The Health Care Value Chain: Producers, Purchasers, and Providers, Lawton R. Burns (Wharton School, Univ. of Pennsylvania, Philadelphia, Pennsylvania); Wharton School Colleagues.

Exhibit 3 – Healthcare Value Chain7

Exhibit 4 – Notional Value Chain Assessment

Motivation to change the status quo will be greatest where the greatest value accrues.

Patients y Improved quality of care through ready access to complete and accurate health records.

y Potential to reduce healthcare costs through reduction in medical errors and redundancy.

Payers y Reduced entitlement payments due to lower critical care costs.

y Improved ability to customize insurance policies to meet regional and demographic needs.

Fiscal Intermediaries y Improved market analysis and business intelligence capabilities.

Providers y Improved access to research and best practices.

y Reduced administrative costs.

y Reduced preventable medical errors.

Purchasers y Improved market analysis and business intelligence capabilities.

y Improved ability to manage constituents’ health and associated costs through incentives for preventative treatment of chronic conditions.

Producers y Potential to generate targeted therapies with increased efficacy.

y Reduced cycle times due to increased access to targeted medically relevant data.

The greatest current barrier to national interoperability is not technological – it is the absence of incentives in the face of legal and economic risks.

Much has been written about the barriers to adoption of health information technology in general. Barriers range from the lack of financial incentives to privacy concerns, from increased risk of liability in a litigious society to compliance with anti trust laws. There is the barrier presented by competitive interests versus a need to collaborate toward technology standards. Surmounting these barriers will require significant

investments in time, advocacy and leadership, as well as the right political and financial environment in order to break increase incentives and opportunity to change. However, the full benefit of surmounting these barriers will not be realized if the provider community does not embrace interoperability as a business imperative.

Exhibit 5 – Key Barriers to Interoperability

Market Forces Competition Operating Models Costs

Given competitive pressures and need to increase stakeholder value, need a compelling business case of ROI

Interoperability of health systems requires the timely sharing of sensitive and potentially proprietary information, challenging industry to work in concert with competitors

Adhering to privacy and security measures and standards often introduces new operating inefficiencies, challenging industry to contend with added costs and administrative burdens

Significant perception of costs and risks associated with technology investments without a view to the future, leading to aversion around investing before the landscape is clear.

The notion that interoperability is the right thing to do will not be enough for a significant portion of the

healthcare community as they are faced with significant resource restrictions and business drivers mandating clear and quantifiable returns on all investments. Stakeholders will need evidence to drive their focus from what achieves business goals today to what will achieve goals of tomorrow.

The healthcare provider community will need to embrace automated means of recording care, and build trust in the quality of automated clinical information. For example, public and private organizations will need to

trust that others adhere to security and privacy principals (e.g., identify and access management) as they move toward networked medical devices and wireless technology.

trust that others adhere to security and privacy principals (e.g., identify and access management) as they move toward networked medical devices and wireless technology.

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