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Ethics, Informatics and Obamacare

Barry SmithUB Clinical/Research Ethics Seminar

November 20, 2012

http://ontology.buffalo.edu/12/ethics-informatics-obamacare.pptx

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David Brailer (first National Coordinator for Health Information Technology)

On saving money through Health IT

if patients’ information were shared across health care settings so that personal health information seamlessly followed any patient through various settings of care—$77 billion would be saved annually

“Economic Perspectives on Health Information Technology”, 2005

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Obamacare: “The ‘no-brainer’ of health IT”

• A central pillar of [ARRA’s] mammoth, $800 billion dollar legislation … is devoted to digitizing the nation's medical records and rewiring healthcare for the 21st century, via the $27 billion Health Information Technology for Economic and Clinical Health (HITECH) Act.

• health IT … has set the stage for broader healthcare reform, … may just be the most lasting, bipartisan and transformative piece of the stimulus bill.

Health IT News, TIME magazine correspondent Michael Grunwald, October 1, 2012

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Electronic Health Records

• gaps and duplication in patient care delivery can be reduced or eliminated through proven technologies such as electronic health records, e-prescribing, and telemedicine

• health information technology improves quality by making needed clinical information accessible to all appropriate providers and in a more complete and timely fashion than paper records

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through interoperability, EHRs will save money

David Brailer, again (from 2005):• Currently, as soon as a patient arrives at a hospital, a

battery of tests is performed … because clinicians have no way of knowing what has already been done.

• Eliminating this inefficiency and frustration through interoperability represents a significant challenge. It does not, however, require magical changes in the business processes or culture of health care to be realized. It is really about obtaining data by calling it up on a computer system rather than waiting for medical records to be delivered.

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Brailer: what can go wrong?

“the policy challenge is to get a critical mass of health IT adoption so that this nation can move forward. The reasoning is that once health IT adoption reaches the 40 to 50 percent range, market forces will take over, because health care IT will become a requirement for doing business.”

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Brailer: there are disincentives to early adopters

• They “are like the first owners of fax machines. … there is no infrastructure to which an EHR can connect. …

• there are 300 electronic health record products on the market that I know of, and that does not include all the home-grown products.

• Health care providers buy the wrong product virtually all the time. There is no price transparency around products, … .

• Physicians do not know how to contract for these technologies, so they almost always take unnecessary risks in their contracts. And they do not know how to implement them. …

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Why interoperability (combinability) is so hard

• Different EHR vendors have financial incentives to thwart interoperability

• Patients move between physicians and hospitals, who use EHR systems deriving from different vendors

• Even where hospitals or wards use the same EHR vendor, their EHR data may not be interoperable

• Even where coders in the same hospital or ward use the same EHR system, they may code in non-interoperable ways

• Interoperability standards are still slapdash

9http://hl7-watch.blogspot.com/

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HITECH Act: let’s bribe physicians to adopt these EHRs quickly, and then penalize them if they fail to do so

Eligible health care professionals and hospitals can qualify for more than $27 billion in Medicare and Medicaid incentive payments available to eligible providers and hospitals

https://www.cms.gov/ehrincentiveprograms/.

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  2011 2012 2013 2014 2015 2016 2017 TOTAL

Adopt 2011 $18,000 $12,000 $8,000 $4,000 $2,000 $0 $0 $44,000

Adopt 2012 ---------- $18,000 $12,000 $8,000 $4,000 $2,000 $0 $44,000

Adopt 2013 ---------- ----------- $15,000 $12,000 $8,000 $4,000 $0 $39,000

Adopt 2014 ---------- ----------- ----------- $12,000 $8,000 $4,000 $0 $24,000

Adopt 2015 + ---------- ----------- ----------- ---------- $0 $0 $0 $0

After ~2018 penalties, in the form of reduced Medicare reimbursements

EHR incentive payments to Medicare providers

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• Question: Why do it so quickly, when there are so few trained personnel, and when EHR systems are so bad, and when there are so many systems, and when the systems are not interoperable?

Answer: Magical thinking*

*What, after all, can go wrong?

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Question: In the age of Wikileaks, how do we ensure that success in achieving health IT interoperability will not be accompanied by massive threats to data security?

Answer: HIPAA*

*Big locks on all the doors (which will also make it hard to open the doors from the inside)

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through interoperability, EHRs will save money

David Brailer, again (from 2005):• Currently, as soon as a patient arrives at a hospital, a

battery of tests is performed … because clinicians have no way of knowing what has already been done.

• Eliminating this inefficiency and frustration through interoperability represents a significant challenge. It does not, however, require magical changes in the business processes or culture of health care to be realized. It is really about obtaining data by calling it up on a computer system rather than waiting for medical records to be delivered.

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Question: In the age of Wikileaks, how do we ensure that success in achieving health IT interoperability will not be accompanied by massive threats to data security?

Answer: HIPAA

*Big locks on all the doors

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Question: How do we ensure that physicians and software companies do not game the system by creating cheap Potemkin EHR systems and sharing the subsidy dollars?

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Question: How do we ensure that physicians and software companies do not game the system by creating cheap Potemkin EHR systems and sharing the subsidy dollars?

Answer: “Meaningful use”

Stage 1: ~2011 Stage 2: ~2013 Stage 3: TBD

1. Capturing health information in a coded format

2. Using the information to track key clinical conditions

3. Communicating captured information for care coordination purposes

4. Reporting of clinical quality measures and public health information

1. Disease management, clinical decision support

2. Medication management3. Support for patient access to

their health information4. Transitions in care 5. Quality measurement 6. Research7. Bi-directional communication

with public health agencies

1. Achieving improvements in quality, safety and efficiency

2. Focusing on decision support for national high priority conditions

3. Patient access to self-management tools

4. Access to comprehensive patient data

5. Improving population health outcomes

Capture information Report information Leverage information to

improve outcomes

CMS (Centers for Medicare & Medicaid Services) Staged Approach to Meaningful Use

Stage 1: ~2011 Stage 2: ~2013 Stage 3: TBD

1. Capturing health information in a coded format

2. Using the information to track key clinical conditions

3. Communicating captured information for care coordination purposes

4. Reporting of clinical quality measures and public health information

1. Disease management, clinical decision support

2. Medication management3. Support for patient access

to their health information4. Transitions in care 5. Quality measurement 6. Research7. Bi-directional

communication with public health agencies

1. Achieving improvements in quality, safety and efficiency

2. Focusing on decision support for national high priority conditions

3. Patient access to self-management tools

4. Access to comprehensive patient data

5. Improving population health outcomes

Capture information Report information Leverage information to

improve outcomes

CMS (Centers for Medicare & Medicaid Services) Staged Approach to Meaningful Use

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Examples of Stage 1 Objectives Measure

Maintain active medication allergy list 80%+ of patients

Record and chart changes in selected vital signs (height, weight, BP, BMI, growth charts (2-20 yrs.)

50%+ of patients

Record smoking status for patients 13 years old or older

50%+ of patients

Implement one clinical decision support rule along with the ability to track compliance to that rule

1 rule

Report ambulatory quality measures to CMS or the States

Aggregate numerator/

denominator

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J. Borman, Ethical Dimensions of Meaningful Use

• “Projected quality and safety benefits from MU could be so substantial that non-attainment may be egregious. … failure to meet MU staged thresholds in a timely manner might signify not only second-rate status, but confer an air of third-world competency.”

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Stephen T. Miller and Alastair MacGregor: Ethical Dimensions of Meaningful Use

Requirements for Electronic Health Records

“The need to bring clinical charting traditions into the electronic format is obvious. Anyone who works in a clinical setting knows that retrieving information from an outdated or otherwise separate chart is burdensome and inefficient. Having that information in a structured, easily retrievable format is a great boon to both health care professionals and patients.”

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from last week’s Congressional Hearing on Interoperability

Subcommittee on Technology and Innovation, Nov 14, 2012

• Is "Meaningful Use" Delivering Meaningful Results? An Examination of Health Information Technology Standards and Interoperability

US House of Representatives, 2318 Rayburn House Office Building Washington, DC 20515

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Willa Fields, Healthcare Information and Management Systems Society and Professor, School of Nursing, San Diego State University

Statement before the Technology and Innovation Subcommittee of US House of Representatives

Interoperability StatusThe impactfulness of electronic health record systems adoption is highly dependent upon health information exchange (HIE), since EHR data can most effectively be useful if it can be exchanged across healthcare delivery systems, EHR vendors, and health information exchanges. HITECH includes elements of information exchange in the Meaningful Use criteria and provides for state investment in health information exchange infrastructure (referred to as HIEs) through the State Health Information Exchange Cooperative Agreement Program.

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Currently only for VA? Also for military?

Stage 1: ~2011 Stage 2: ~2013 Stage 3: TBD

1. Capturing health information in a coded format

2. Using the information to track key clinical conditions

3. Communicating captured information for care coordination purposes

4. Reporting of clinical quality measures and public health information

1. Disease management, clinical decision support

2. Medication management3. Support for patient access to

their health information4. Transitions in care 5. Quality measurement 6. Research7. Bi-directional communication

with public health agencies

1. Achieving improvements in quality, safety and efficiency

2. Focusing on decision support for national high priority conditions

3. Patient access to self-management tools

4. Access to comprehensive patient data

5. Improving population health outcomes

Capture information

Report information Leverage information to

improve outcomes

Staged Approach to Meaningful Use

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Stage 2 standards (130 pages)https://

www.federalregister.gov/articles/2012/09/04/2012-20982/health-information-technology-standards-implementation-specifications-and-certification-criteria-for

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3. Scope of a Certification Criterion for CertificationIn the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§ 170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security (§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§ 170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting (ambulatory or inpatient).

Example paragraph from the Stage 2 Final Rule

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3. Scope of a Certification Criterion for CertificationIn the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§ 170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security (§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§ 170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting (ambulatory or inpatient).

Example paragraph from Final Rule

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3. Scope of a Certification Criterion for CertificationIn the Proposed Rule, based on our proposal to codify all the 2014 Edition EHR certification criteria in § 170.314, we clarified that certification to the certification criteria at § 170.314 would occur at the second paragraph level of the regulatory section. We noted that the first paragraph level in § 170.314 organizes the certification criteria into categories. These categories include: clinical (§ 170.314(a)); care coordination (§ 170.314(b)); clinical quality measures (§ 170.314(c)); privacy and security (§ 170.314(d)); patient engagement (§ 170.314(e)); public health (§ 170.314(f)); and utilization (§ 170.314(g)). Thus, we stated that a certification criterion in § 170.314 is at the second paragraph level and would encompass all of the specific capabilities in the paragraph levels below with, as noted in our discussion of “applicability,” an indication if the certification criterion or the specific capabilities within the criterion only apply to one setting (ambulatory or inpatient).

Example paragraph from Final Rule

What can go wrong?

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Pressure on hospitals to receive meaningful use payments will cost lives

Sam Bierstock, MD: There is “enormous pressure by the hospitals to force the physicians to use EHRs that are not necessarily very user-friendly and therefore disruptive to their work and to their efficiency,” • hospital EHRs “are simply not yet adequately intuitive to meet the

needs of clinicians.”• “Most EHRs result in a 20-30 percent decrease in efficiency of

emergency room doctors and an increase in the people who leave without being seen due to extended wait times.

• “Providers also face mounting expenses as a result of HITECH regulations, which … also strengthened security and privacy requirements, “which are complex, costly to implement and poorly understood by the majority of providers”

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Health IT and Patient Safety: Building Safer Systems for Better Care

Institute of Medicine, November 10, 2011

RecommendationsCurrent market forces are not adequately addressing the potential risks associated with use of health IT. All stakeholders must coordinate efforts to identify and understand patient safety risks associated with health IT by … creating a reporting and investigating system for health IT-related deaths, serious injuries, or unsafe conditions

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Disasters: AustraliaThe Age (Victoria, Australia), January 24, 2011:

• THE state government is considering abandoning Victoria's trouble-plagued $360 million health technology program,

• … The HealthSMART program - five years late and $35 million over budget - is supposed to link computer systems in hospitals and introduce processes such as electronic prescribing.

• But clinical applications are only partially running in just four hospitals, and doctors say patient safety is compromised by inadequate procedures that causes them to duplicate paperwork, chase test results and compete for access to computer terminals.

For more details see: http://www.systemswiki.org/index.php?title=An_Overview_-of_Health_Information_Technology_and_Health_Informatics

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Disasters: United KingdomThe UK National Program for Health IT (NPfIT)Conceived in 1998 to bring:• Lifelong electronic health records for every person in the country.• Round-the-clock on-line access to patient records and information

about best clinical practice, for all NHS clinicians.• Genuinely seamless care for patients through GPs, hospitals and

community services sharing information across the NHS information highway.

• Fast and convenient public access to information and care through on-line information services and telemedicine

• The effective use of NHS resources by providing health planners and managers with the information they need.

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Disasters: United Kingdom (some headlines)

• U.K. Scrapping National Health IT Network after $18.7 billion in wasted expenditure

• NPfIT stunted NHS IT market• Rotherham: NPfIT has put us back 10 yrs• NPfIT failures have left NHS IT “stuck”• NPfIT ‘pushed the NHS into disarray’• So good, they abolished it twice

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first reason for the NPfIT disaster: lack of patient privacy safeguards

Two Big Brother Awards– 2000 The NHS Executive—award for Most

Heinous Government Organisation– 2004 NFPIT - award for Most Appalling

Project because of its plans to computerise patient records without putting in place adequate privacy safeguards.

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second reason for disaster: lack of working standards

over-optimism on the part of Tony Blair and others as concerns the quality of available standards. “If we use international standards, sanctioned by ISO, what, after all, can go wrong?”

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Evidence to UK House of Commons Select Committee on Health in 2007:

from Richard Granger (Head of NPfIT program): • “there was some mythology in the Health Informatics

Community that the standards existed, HL7 was mature, and so forth. That was completely untrue.”

from UK Computing Research Committee: • “many of the technologies are new and have not been

tested. • Of the two standards at the heart of the EPR – HL7 v3 and

SNOMED-CT – “neither has ever been implemented anywhere on a large scale on their own, let alone together. Both have been criticized as seriously flawed.”

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Why national eHealth programs need dead philosophers: Wittgensteinian reflections on policymakers' reluctance to learn from history.

The Milbank Quarterly: Multidisciplinary Journal of Population Health and Health Policy, 2011, 89(4), 533-63

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Why national eHealth programs need dead philosophers

Findings National eHealth programs unfold as they do partly because no one fully understands what is going on. They fail when this lack of understanding becomes critical to the programs’ mission. View NPfiT as an “n of 1” case studyBut those in charge of national eHealth programs appear reluctant to learn from such studies.

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Enterprise

Comprehensive Basic

Components

EHR

Multimediagenetics

workflow

identity

Clinicalref data Clinical

models

terms

Security / access control

realtimegateway

telemedicine

HILS

otherprovider

UPDATEQUERY

demographics

guidelinesprotocolsInteractions

DSLocal

modelling

notifications

DSS

PAS

billing

portal

Alliedhealthpatient

PAYER

Msg gateway

Imaging lab

ECG etc

Path lab

LAB

Secondaryusers

Online drug,Interactions DB Online

archetypes

Online terminology

Online Demographic

registries

PatientRecord

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The problem

The content of EHR systems (and of terminology standards such as SNOMED) develops too slowly to meet the needs of clinical researchers1. They are functionally outdated 2. They do not allow vital distinctions to be made

(for example between disease and diagnosis)3. They are run by large committees / business

managers

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The Buffalo solution

• To find out what it takes to capture the reality on the side of the patient in a rigorous and effective way

• We will try to work out what is needed to bring about a radical overhaul of these systems, including creation of rigorous and up-to-date ontologies for specific disease domains

• which we will violently test in real-world scenarios until we know they work

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Ethical conclusion

Meaningful use regulations will certainly push things forward; they will give rise, in the short term, to much that is good.The question is, whether they will create a path for the longer term future that will bring lasting value for the wider public.

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END