amia public policy briefing march 2011

8/7/2019 AMIA Public Policy Briefing March 2011

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www.amia.org

AMIA Public Policy BriefingMarch 2011

Meryl Bloomrosen

AMIA, Vice President Public Policy and Government Relations

andDoug Peddicord

President , Washington Health Strategies Group


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Todays Topics

Welcome and Introductions

Webinar Administrative Reminders

Overview of 2011-2012 Congressional,

Legislative, and Administrative Topics

Agency Highlights (CMS, FDA, and NIH)

AMIAs Policy Work (activities, priorities, events)

Questions and Discussion


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The Patient Protection andAffordable Care Act

B

Source: The PRM Report. Health Care Reform A Done Deal: Pharma Bets on the Right Horse. March 2010

32 million new customers forinsurers, health care organizations,pharmas

Intended to

operateindependently ofCongressionalmeddling; impacton physicians andhospitals?

Pharma andmedical deviceindustrydiscounts andfees

Patient-centeredOutcomes Research

Inst

CER will train aspotlight on valueand trigger acascade of real-world studies in the

private sector

Potential NewMarkets

IMAB

Closing the DonutHole

PCORI

CER

1

2

34

5


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Implications for AMIA: Health CareReform

New/revised corrections and implementing regulations

Ongoing workforce and education/training issues

Research implications

Migration of HIT emphasis to new sites of care (LTC)

Comparative effectiveness research (CER)

Patient safety

Consumer engagement

Quality initiatives: bundled payments, medical home,ACOs; expand PQRI

Implementation of ICD 10

Implementation of Meaningful Use (MU)


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The 112th Congress

Impact of 2010 Midterm election Republicans take majority in the House

Gain 63 seats for 242 193 majority

Democrats Senate majority narrows

Lose 6 seats for 53 47 majority (2 independentscaucus with Dems)

Turnover appears likely to continue in 2012

Democrats must defend 21 Senate seats (and the 2Independent seats) Republicans only 10

Already eight retirements (AZ, CT, HI,ND, NM, NV, TX,VA)


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In the House

New Leadership Speaker John Boehner (OH)

Majority Leader Eric Cantor (VA)

Majority Whip Kevin McCarthy (CA)

Chair, Appropriations Hal Rogers (KY)

Chair, Budget Paul Ryan (WI)

Chair, Education & the Workforce John Kline (MN)

Chair, Energy & Commerce Fred Upton (MI)

Chair, Ways & Means Dave Camp (MI)


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Legislative Agenda

Its About The Money: Reducing federalspending and the budget deficit

Fiscal Year 2011 budget (continuing resolution)

Fiscal Year 2012 budget

Creating jobs and strengthening the economy

Tax reform

Revisiting the health reform debate

Repealing the Affordable Care Act Blocking funds to prevent implementation


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Budget Debate

Fiscal Year 2011 budget

Six months into fiscal year

Spending at FY 2010 levels

Current funding expires April 8

Sides remain $50 billion apart

Health care and HIT are essentiallyunaffected at this point


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Presidents FY 2012 Budget ProposalHealth and Human Services Agency FY 2010 Funding

(in millions)

FY 2012 Proposed Funding

(in millions)

Food and Drug Administration (FDA) 2,597 2,744

(Program level- includes user fees) 3,284 4,360

Centers for Disease Control (CDC) 6,467 5,893

Health Resources and Services

Administration (HRSA)

8,057 9,034

Office of Civil Rights (OCR) 41 47

National Institutes of Health (NIH) 30,784 31,829

National Library of Medicine (NLM) 359 395

Agency for Healthcare Research and

Quality (AHRQ)

(Program level, non-add) 397 366Centers for Medicare and Medicaid

Services (CMS)

486,600 506,714

Office of the Coordinator for Health

Information Technology

45 57

(Program level) 61 78


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Fiscal Year 2012

Process:

Budget committees will develop resolutions to

set targets for FY 2012 appropriationsAppropriations committees/subcommittees

will draft funding bills

Will either budget resolution or spending bills

pass?


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AMIA Comments Submitted 2010

Medicare and Medicaid Programs; Electronic Health RecordIncentive (to CMS) Health Information Technology: Initial Set of Standards,

Implementation Specifications, and Certification Criteria forElectronic Health Record Technology (to ONC)

Proposed Establishment of Certification Programs for Health

Information Technology (to ONC) Electronic Prescriptions for Controlled Substances (to DEA) Modifications to the HIPAA Privacy, Security, and Enforcement Rules

Under the Health Information Technology for Economic and ClinicalHealth Act (to HHS)

Testimony to HIT Policy Committee, Adoption/Certification

Workgroup (Shortliffe) on Patient-safety Issues Related to the Useof Electronic Health Records ONC HIT Tiger Team on De-identification (also testimony) Joint AMIA /NIWG Comments on the Future of Nursing Initiative (to

Robert Wood Johnson Foundation/Institute of Medicine)


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AMIA 2011 Comments

National Institute for Nursing Research (NINR) StrategicPlan

Meaningful Use Stage 2 Federal Government Role in Standards(NIST)

Personal Health Records (ONC) NQF eMeasures NQF Common Reporting Format for Adverse Events

(AHRQ) Comments on Presidents Council of Advisors on

Science and Technology (PCAST) Report (Realizing theFull Potential of Health Information Technology toImprove Healthcare for Americans: The Path Forward)(ONC)


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Regs/Guidances Likely in 2011

Guidance on minimum necessary

Guidance regarding de-identification of PHI

Promulgation of regulations on what

information is to be included in theaccounting of disclosures by covered entitiesand business associates

Promulgation of regulations relating to thesale of EHRs and personal health information(PHI) obtained from EHRs without authorizedconsent

S f M i f l U


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Status of Meaningful UseStages 2 and 3

15

At a minimum, clinicians and hospitals will need

the following technologies, services, or

capabilities

EHR system capable of

basic electronic medical record creation and

maintenance

health information exchange

CPOE system with

electronic prescription capability (if applicable)

ability to maintain electronic formulary

Drug-drug, drug allergy checks

Active medication list

Active allergy list

Clinical decision support platform

Robust network connection/service

Quality measures

Security capabilities Secure platform

Review and analysis

Updates


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FDA Medical Device Data Systems

Medical device data systems" (MDDS) off-the-shelf or custom hardware or software products used

alone or in combination that display unaltered medical devicedata, or transfer, store or convert medical device data for futureuse, in accordance with a preset specification."

applies to health care providers that create their own softwareprotocols or interfaces to transfer data from a medical device, aswell as medical device manufacturers and third-party softwarevendors

custom solutions developed to feed data from a medical deviceto another data system, such as an electronic health record(EHR), could be considered MDDS and fall under FDA regulation

data systems that are sold as an integral part of a medical deviceare not considered MDDS, but are regulated as part of thedevice

FDA R i P h f M di l


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FDA Review Path for MedicalDevices

FDA Center for Devices and Radiological Health (CDRH)released 25 recommendations to better facilitate the process formarket approvals of 510 (k) medical devices.

In response to public concern regarding the need for improvedFDA methods to regulate and effectively monitor new andinnovative, low-risk medical devices in an era of rapidlyexpanding health information technology

The plan calls for the establishment of a new Center ScienceCouncil, composed of senior FDA experts, to assure consistent,evidence-based decision making, clarify submissionrequirements, and improve transparency throughout the approvalprocess.

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htmhttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htmhttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htmhttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm


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New NIH Institute

Plan to establish the National Center forAdvancing Translational Sciences (NCATS)

Assembled primarily from existing programs withinthe National Center for Research Resources(NCRR), the NIH Common Fund, and the NationalHuman Genome Research Institute (NHGRI).

Facilitator of translational research across the NIHand complementary to translational researchalready being conducted and supported on a largescale in the individual NIH Institutes and Centers


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Federal Open Government Activities Underway

The Community Health Data Initiative (CHDI) is a public-private collaborationthat is encouraging innovators to utilize data made publicly available by theDepartment of Health and Human Services (DHHS), to develop applications thatwill help raise awareness of community health performance, spark action toimprove performance, and empower individuals and communities to makeinformed choices about their health.

http://www.hhs.gov/open/datasets/initiative_launch.html

2011 Health 2.0 Developer Challenge. With support from the DHHS Health2.0has issued a challenge to developers to build innovative tools to improvepersonal and population health. http://health2challenge.org/

Secretary of Veterans Affairs announced the opening of the IndustryInnovation Competition by the Department of Veterans Affairs. VA seeks ideasfrom the private sector to address the departments most important challenges.

http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1907
http://www.hhs.gov/open/datasets/initiative_launch.htmlhttp://health2challenge.org/http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1907http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1907http://health2challenge.org/http://www.hhs.gov/open/datasets/initiative_launch.html


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AMIA 2011 Policy Priorities Informatics Research and Funding

AHRQ NIH NLM NINR

Impact of health IT on Patient Safety and Quality of Care

Meaningful Use (defending MU incentives) Ensuring safe, effective use of health IT and EHRs

Informatics and health IT Workforce (includes education andtraining) Informatics competencies Funding for training programs; pipeline of trainees

EHR Best Practices, Lessons Learned and Successes EHR Evaluation EHR Usability Evolution of Clinical Decision Support


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Ongoing AMIA Policy Focus Areas

Biomedical, clinical, translational, population/public health andapplied health informatics practice and research

Comparative effectiveness research Data stewardship Electronic health records Evidenced-based practice Health information exchange Health information technology HIPAA (privacy, confidentiality and security)

Interoperability National health information network Personal health records Standards

U S DHHS d E


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U.S. DHHS and EuropeanCommission MOU

To promote a common approach on the interoperability ofelectronic health records common standards and interoperability stand to create huge

growth opportunities for the eHealth industry as well as having apositive impact on the safety and quality of care

On education programs for information technology and healthprofessionals. Skilled health IT workforce is necessary to make the benefits of

eHealth services available to patients.

Aims to boost the potential of the eHealth market for EUcompanies wishing to do business in the U.S. and vice versa

Promoting the use of eHealth technologies, with a view toimproving the quality of health care, reducing medical costsand fostering independent living, including in remote places


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Upcoming AMIA Policy Meetings

AMIA Hill Day - April 14, 2011

https://www.amia.org/2011-capitol-hill-day

Sheldon Whitehouse Honorary Co-Host

AMIA Invitational Policy Meeting - December6-7, 2011

Informing the Form, Function and Use of the

Future EHR Challenges and Opportunities forClinical Data Capture, Content, andDocumentation
https://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-dayhttps://www.amia.org/2011-capitol-hill-day


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Other AMIA Policy Activities

Co-Convener(with AHRQ and Kaiser) of PolicyRoundtable: Can Health IT Promote Health Equity andPatient-Centered Care? www.amia.org/disparities-roundtable

Transatlantic Methods for Handling Global Challenges inthe European Union and United States (ARGOS)http://argos.eurorec.org/

ONC Project on Unintended Consequences of Health

Information Technology and Health InformationExchange

(Serving on) Advisory Council to ONC Project to DevelopCertification Examinations for HIT Roles
http://www.amia.org/disparities-roundtablehttp://www.amia.org/disparities-roundtablehttp://argos.eurorec.org/http://argos.eurorec.org/http://www.amia.org/disparities-roundtablehttp://www.amia.org/disparities-roundtablehttp://www.amia.org/disparities-roundtable


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Discussion, Questions, and

Comments

AMIA St ff P i t f


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AMIA Staff Points ofContact

Meryl BloomrosenVice President Public Policy and Government Relations

[email protected]

Yvette BollaPublic Policy Analyst

[email protected]

Jonathan GrauVice President Corporate Relations and Development

[email protected]

David PadghamPublic Policy Analyst

[email protected] Rader

Manager Member [email protected]
mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

amia public policy briefing march 2011

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