AMIA Public Policy Briefing

March 2011

Meryl Bloomrosen
AMIA, Vice President Public Policy and Government Relations
and
Doug Peddicord
President , Washington Health Strategies Group

www.amia.org
 Today’s Topics
• Welcome and Introductions
• Webinar Administrative Reminders
• Overview of 2011-2012 Congressional,
Legislative, and Administrative Topics
• Agency Highlights (CMS, FDA, and NIH)
• AMIA’s Policy Work (activities, priorities, events)
• Questions and Discussion

www.amia.org
 The Patient Protection and
Affordable Care Act
B
Source: The PRM Report. Health Care Reform A Done Deal: Pharma Bets on the Right Horse. March 2010

1
• CER will train a
spotlight on value • 32 million new customers for
Potential New
and trigger a insurers, health care organizations,
Markets
cascade of real- pharmas
world studies in the • Intended to
private sector operate
5 2
independently of
IMAB Congressional
CER meddling; impact
on physicians and
• Patient-centered hospitals?
Outcomes Research
Inst
• Pharma and
3
4 medical device
Closing the Donut industry
PCORI
Hole discounts and
fees

www.amia.org
 Implications for AMIA: Health Care
Reform
• 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)

www.amia.org
 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 independents
caucus with Dems)
• Turnover appears likely to continue in 2012
• Democrats must defend 21 Senate seats (and the 2
Independent seats) – Republicans only 10
• Already eight retirements (AZ, CT, HI,ND, NM, NV, TX,
VA)

www.amia.org
 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)

www.amia.org
 Legislative Agenda
It’s About The Money: Reducing federal
spending 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

www.amia.org
 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 essentially
unaffected at this point

www.amia.org
President’s FY 2012 Budget Proposal
Health and Human Services Agency FY 2010 Funding FY 2012 Proposed Funding
(in millions) (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 8,057 9,034

Administration (HRSA)
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) 397 366
Centers for Medicare and Medicaid 486,600 506,714
Services (CMS)
Office of the Coordinator for Health 45 57
Information Technology
(Program level) 61 78

www.amia.org
Fiscal Year 2012 Budget Timeline
• April 15- Statutory deadline for Congress to complete its annual
budget resolution.
• May 15- The date after which the House may consider fiscal 2012
appropriations bills even if a final budget resolution has not been
adopted.
• June 24- Last day before House begins Independence Day recess,
the informal deadline that House leaders traditionally have set for
passing all 12 regular appropriations bills.
• Mid-August- Congressional Budget Office (CBO) issues updated
budget and deficit projections.
• September 6- House and Senate return from their summer recess
with 25 days to negotiate their differences and pass all
appropriations bills before the end of the fiscal year.
• October 1- Fiscal year 2012 begins. A Continuing Resolution (CR)
would be required to finance any agency whose appropriations bill
has not been enacted.

www.amia.org
 Fiscal Year 2012

Process:
Budget committees will develop resolutions to
set targets for FY 2012 appropriations
Appropriations committees/subcommittees
will draft funding bills
Will either budget resolution or spending bills
pass?

www.amia.org
 AMIA Comments Submitted 2010
• Medicare and Medicaid Programs; Electronic Health Record
Incentive (to CMS)
• Health Information Technology: Initial Set of Standards,
Implementation Specifications, and Certification Criteria for
Electronic 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 Clinical
Health Act (to HHS)
• Testimony to HIT Policy Committee, Adoption/Certification
Workgroup (Shortliffe) on Patient-safety Issues Related to the Use
of 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)

www.amia.org
 AMIA 2011 Comments
• National Institute for Nursing Research (NINR) Strategic
Plan
• 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 President’s Council of Advisors on
Science and Technology (PCAST) Report (Realizing the
Full Potential of Health Information Technology to
Improve Healthcare for Americans: The Path Forward)
(ONC)

www.amia.org
 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 the
accounting of disclosures by covered entities
and business associates
• Promulgation of regulations relating to the
sale of EHRs and personal health information
(PHI) obtained from EHRs without authorized
consent
www.amia.org
Status of Meaningful Use
Stages 2 and 3
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

www.amia.org
15
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 device
data, or transfer, store or convert medical device data for future
use, in accordance with a preset specification."
– applies to health care providers that create their own software
protocols or interfaces to transfer data from a medical device, as
well as medical device manufacturers and third-party software
vendors
– custom solutions developed to feed data from a medical device
to 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 device
are not considered MDDS, but are regulated as part of the
device

www.amia.org
 FDA Review Path for Medical
Devices
• FDA Center for Devices and Radiological Health (CDRH)
released 25 recommendations to better facilitate the process for
market approvals of 510 (k) medical devices.
• In response to public concern regarding the need for improved
FDA methods to regulate and effectively monitor new and
innovative, low-risk medical devices in an era of rapidly
expanding health information technology
• The plan calls for the establishment of a new Center Science
Council, composed of senior FDA experts, to assure consistent,
evidence-based decision making, clarify submission
requirements, and improve transparency throughout the approval
process.

• http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHRepo
rts/ucm239448.htm

www.amia.org
 New NIH Institute
• Plan to establish the National Center for
Advancing Translational Sciences (NCATS)
• Assembled primarily from existing programs within
the National Center for Research Resources
(NCRR), the NIH Common Fund, and the National
Human Genome Research Institute (NHGRI).
• Facilitator of translational research across the NIH
and complementary to translational research
already being conducted and supported on a large
scale in the individual NIH Institutes and Centers

www.amia.org
Federal Open Government Activities Underway

The Community Health Data Initiative (CHDI) is a public-private collaboration

that is encouraging innovators to utilize data made publicly available by the
Department of Health and Human Services (DHHS), to develop applications that
will help raise awareness of community health performance, spark action to
improve performance, and empower individuals and communities to make
informed choices about their health.
http://www.hhs.gov/open/datasets/initiative_launch.html

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

Secretary of Veterans Affairs announced the opening of the Industry

Innovation Competition by the Department of Veterans Affairs. VA seeks ideas
from the private sector to address the department’s most important challenges.
http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1907

www.amia.org
 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 and
training)
– 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

www.amia.org
Ongoing AMIA Policy Focus Areas
• Biomedical, clinical, translational, population/public health and
applied 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

www.amia.org
 U.S. DHHS and European
Commission MOU
• To promote a common approach on the interoperability of
electronic health records
– common standards and interoperability stand to create huge
growth opportunities for the eHealth industry as well as having a
positive impact on the safety and quality of care
• On education programs for information technology and health
professionals.
– 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 EU
companies wishing to do business in the U.S. and vice versa
• Promoting the use of eHealth technologies, with a view to
improving the quality of health care, reducing medical costs
and fostering independent living, including in remote places

www.amia.org
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 - December
6-7, 2011
– Informing the Form, Function and Use of the
Future EHR Challenges and Opportunities for
Clinical Data Capture, Content, and
Documentation

www.amia.org
 Other AMIA Policy Activities
• Co-Convener(with AHRQ and Kaiser) of Policy
Roundtable: Can Health IT Promote Health Equity and
Patient-Centered Care? www.amia.org/disparities-
roundtable
• Transatlantic Methods for Handling Global Challenges in
the European Union and United States (ARGOS)
http://argos.eurorec.org/
• ONC Project on Unintended Consequences of Health
Information Technology and Health Information
Exchange
• (Serving on) Advisory Council to ONC Project to Develop
Certification Examinations for HIT Roles
www.amia.org
Discussion, Questions, and
Comments

www.amia.org
 AMIA Staff Points of
Contact
Meryl Bloomrosen
Vice President Public Policy and Government Relations
meryl@amia.org
Yvette Bolla
Public Policy Analyst
yvette@amia.org
Jonathan Grau
Vice President Corporate Relations and Development
jonathan@amia.org
David Padgham
Public Policy Analyst
david@amia.org
Rob Rader
Manager Member Services
rob@amia.org

www.amia.org