Tuesday, March 30, 2010

Summary Of Employer Provisions In Health Reform

This summary identifies the main provisions of the Patient Protection and Affordable Care Act (Act), as amended by the Health Care and Education Affordability Reconciliation Act, that directly affect employers. The "Ice Miller Comments" column provides Ice Miller's analysis of specific provisions, which is intended to help employers understand and plan for changes required or desired as a result of the Act. Several terms in the summary are capitalized and link directly to the term's definition on the first reference for each topic. The link references the glossary at the end of the summary. The brief introduction explains how employer sponsored coverage is affected by the Act's requirement on individuals to have health coverage, the creation of health insurance exchanges, and the concept of "grandfathered" health plans.




via icemiller.com

Monday, March 29, 2010

Certification/Adoption Workgroup 3-29

The Certification/Adoption Workgroup met on March 29, 2010. Following up on the previousMarch 12, 2010 meeting and the February 25, 2010 meeting, the committee reviewed the revised set of recommendations to the ONC, and discussed concerns expressed about the potential for increased FDA regulation of EHR systems and possible ways that the ONC and FDA could possibly collaborate.

They considered a draft proposal today that outlined best practices for electronic reporting of patient safety hazards. The practices are expected to be included in the second phase of meaningful use starting in 2013. “Most unsafe conditions are not the result of a single software error. Instead, multiple factors are involved, including challenges with usability, processes, and interoperability,” says the draft proposal.

One of the concerns of increased FDA regulation expressed is that the FDA focuses on vendors who market their products. As a result, the FDA’s efforts do not cover open-source software and might not cover some self developed EHR modules. This “uneven playing field” is a significant concern because a patient centered approach to safety should not depend on the source of the software involved.

They identified a couple ways that the ONC and the FDA might collaborate. They recommended that the two agencies collaborate on certification criteria that improve patient safety and also that they focus on health IT areas that are creating safety risks for EHR implementations. One example of such a safety risk is retail pharmacies which do not process electronic order cancellations, which can result in over-medication of patients.

They also recommended that ONC commission a formal study to thoroughly evaluate health IT patient safety concerns and audit trails for health information exchange activities.

The audio from the meeting is posted with the agenda and meeting materials below:

Download




  • Agenda


  • Patient Safety Working Document


  • FDA Recommendation Working Document
  • Sunday, March 28, 2010

    Donald Berwick to be named as CMS Administrator

    After rumors surfaced over a year ago, the Obama administration has finally named Donald Berwick, MD to be CMS administrator. Dr. Berwick is a pediatrician and President/CEO of the not-for-profit Institute for Healthcare Improvement (IHI) in Cambridge, Mass.

    Since Medicare and Medicaid will be experiencing many significant changes as a result of the new health reform legislation, this appointment is timely. It may be that Berwick wanted health reform to be a done deal before he would accept the appointment. He will certainly have his work cut out for him, but I believe he is uniquely qualified for the job.

    Dr. Berwick is a summa cum laude graduate of Harvard College and a cum laude graduate of Harvard Medical School who also holds a master's degree in public policy from Harvard's Kennedy School of Government. In 1989, he authored "Continuous improvement as an ideal in healthcare" published in the New England Journal of Medicine, which has become a seminal article in the quality improvement movement, advocating the application to healthcare of quality improvement techniques used in other industries.

    Since 1991, Berwick has served as co-founder, president and CEO of the IHI, a not-for-profit that has campaigned for quality improvement efforts in healthcare in the U.S., Canada, Europe and the Middle East. The IHI's 100,000 Lives Campaign reported 3,100 participating hospitals had actually saved an estimated 122,300 lives.

    Despite the extreme partisan divide in the Senate right now, I expect that Berwick will be easily confirmed. "This is always a big job,” said Iowa Sen. Chuck Grassley, the senior Republican on the Senate Finance Committee, in a written statement, “but the administration of healthcare reform, which includes implementing the hundreds of billions of dollars in Medicare cuts and the biggest expansion of Medicaid in its history, will make it more challenging than ever. The Finance Committee vetting will need to explore the nominee's preparedness for the enormous challenges that face the agency.”

    At the IHI’s annual conference last December, Dr. Berwick issued this challenge to health care providers: “Over the next three years, reduce the total resource consumption of your health care system, no matter where you start, by 10 percent. Do that without a single instance of harm, without rationing effective care, without excluding needed services for any population you serve.”

    Check out this interview with Dr. Donald Berwick from Kaiser Health News. He says he hopes the public "gets a bit outraged and mobilized as voters ask why we pay health care systems the amount of money" we do and not have them adopt the best practices in treatment and efficiencies.



    This interview with Dr. Donald Berwick was originally published on Kaiser Health News on Nov. 12, 2009.

    Friday, March 26, 2010

    Discussion with Dr. David Blumenthal

    I was honored to have a wide ranging conversation with Dr. David Blumenthal today. The primary topics centered around transparency at the ONC, HITREC and communities of shared learning, Personal Health Records and how they fit within the strategic vision of the ONC, and finally overcoming challenges to adoption of electronic health records for rural providers, critical access hospitals and small practices.

    Some of the material that is helpful as you listen along:

    ONC Blog - http://healthit.hhs.gov/blog/onc/

    Institute for Health Improvement - http://www.ihi.org/ihi

    Electronic Health Records in Ambulatory Care — A National Survey of Physicians
    by Catherine M. DesRoches, Dr.P.H., Eric G. Campbell, Ph.D., Sowmya R. Rao, Ph.D., Karen Donelan, Sc.D., Timothy G. Ferris, M.D., M.P.H., Ashish Jha, M.D., M.P.H., Rainu Kaushal, M.D., M.P.H., Douglas E. Levy, Ph.D., Sara Rosenbaum, J.D., Alexandra E. Shields, Ph.D., and David Blumenthal, M.D., M.P.P. - http://content.nejm.org/cgi/content/full/359/1/50

    "Information Technology Comes to Medicine" by David Blumenthal, M.D., M.P.P., and John P. Glaser, Ph.D. - http://www.ipalc.org/EMR/Information%20Technology%20Comes%20to%20Medicine%20(NEJM%206-14-2007).pdf

    Download



    Thursday, March 25, 2010

    Consumer Consent Options for Electronic Health Information Exchange

    It is extremely important that appropriate guidance in the form of higher-level principles or recommendations are used in selecting and applying a particular consent model for electronic health information exchange, according to a whitepaper developed by George Washington University under contract with the Office of the National Coordinator for Health IT.

    The report describes in great detail the options regarding patient consent for exchanging data among healthcare organizations. The options include:
    • No consent: Automatically allowing the exchange of records without patient consent and without an opt-out clause;
    • Opt-out: Offering patients only an all-inclusive opt-out option;
    • Opt-out, with exceptions: Offering varying levels of opt-outs, such as allowing only selected data to be exchanged;
    • Opt-in: Requiring that patients explicitly grant permission for the exchange of all of their information; and
    • Opt-in, with restrictions: Enabling patients to grant permission for the exchange of specific subsets of their records.
    "While this document represents a starting point for discussion related to consent, it is imperative that future deliberations are informed by further research regarding the effectiveness and impact of various consent options, consideration of the broader policy landscape and assessment of the needs of those most affected by the consent decision," the report states.

    "Until the time when we are confident that we can protect health information in a systematic and thorough way, prudent use of the mechanism of consent appears to be one of the most reliable ways to pursue that goal."

    Here are links to the ONC documents:

    Executive Summary

    Whitepaper

    CONNECT Release 2.4

    Thursday, March 25 there was a webinar on the newest version of CONNECT, an open source software and community that promotes IT interoperability in the healthcare system. CONNECT uses Nationwide Health Information Network (NHIN) standards and governance to make sure that health information exchanges are compatible with other exchanges being set up throughout the country. The webinar reviewed changes made to CONNECT as part of the 2.4 release. Presentation topics included:
    • XDR Push Spec: The purpose of this specification is to provide the ability to "push" data for a given patient from one NHIE to another via configuration on the submission side. This is a different model of exchange than subscription because the sender decides who the data should go to and the receiver receives data on an appropriate available endpoint from the sources it authorizes.
    • Support for UDDI (Service Registry) spec enhancements
    • Subscriptions/Notifications; Secure Communications; Query by State; x.509 Certs
    • Support for CRL (Certificate Revocation Lists) CA (Certificate Authority)
    • Integrated Dynamic Document Assembly Components
    • Universal Client support for Patient Discovery
    • Authorization Framework enhancements: Support for two new SAML assertion fields
    • Address Memory Consumption and Long Build Times
    • Progress towards IDE Neutral Build Scripts

    CONNECT Release 2.4 includes the initial trial implementation of a new NHIN service, Document Submission, which implements a push exchange pattern. Changes to the CONNECT architecture reflected in this Software Architecture Documentation are limited to minor revisions to include new Document Submission service. There are no other architectural changes.

    The slides from the webinar are below and the audio will be posted:


    HIT Standards 3-24

    The HIT Standards Committee met on March 24, 2010. Much of the meeting focused on the new NHIN Direct project which John Halamka described as a “learning lab” to test out the transport of patient information. Dr. Blumenthal stated that NHIN direct is a "project" not a "product" and is designed to be nimble and responsive to customer requests, especially from small practices.

    The committee also heard from Doug Fridsma about plans for a framework for interoperability. The proposed framework is designed to engage a wide community of users and will use a process developed by National Information Exchange Model (NIEM). NIEM was originally developed by the Department of Justice and the Department of Homeland Security, but has been used by HHS and state and local governments. Dr. Blumenthal debunked a rumor that NIEM was a “Trojan Horse” for government control over health information. “The question has come up about whether NIEM will make it possible for health information to be transmitted to DOJ, the CIA, Homeland Security or other government agencies. The answer is ‘No.’ The ONC would not participate in a process that would lead to that.”

    Of course, the best summary of the meeting is found on John Halamka's blog:

    http://geekdoctor.blogspot.com/2010/03/march-hit-standards-committee-meeting.html


    The audio from the meeting is posted with the agenda and meeting materials below:

    Download




    Agenda

    Privacy and Security Workgroup Update

    Report on Certification NPRM

    Dr. David Blumenthal at HIMSS

    National Coordinator for Health Information Technology David Blumenthal, MD, MPP, presented the keynote address, "Becoming a Meaningful User of Health IT: Moving Toward a New Level of Professionalism in Healthcare," on Wednesday, March 3 during the 2010 Annual HIMSS Conference & Exhibition in Atlanta, Georgia. As a practicing primary care physician and leading national healthcare policy expert, Dr. Blumenthal shared his thoughts about ONC’s strategic efforts to advance rapid adoption and the meaningful use of health IT. Blumenthal said “about 10 years ago an electronic health record landed on my desk courtesy of my employer. I was trained with paper, I was comfortable with paper, I liked my prescription pad … I didn’t really see the need to change." But, “gradually, slowly, I learned that the EHR was making me a better doctor … I came to understand that information is the lifeblood of healthcare, and Health IT is destined to be the circulatory system.”

    Some of the top themes of Dr. Blumenthal’s Keynote Address were:

    • Professionalism – Science and experience support the notion that the ability to use and move information will become a core professional attribute for clinical professionals
    • Innovation – Human ingenuity will support advancements needed to keep pace with changes on healthcare landscape
    • Future of Health IT – EHRs will becomes as much a part of the fabric of medicine as stethescopes, EKGs, and MRIs.
    • Regulation – Four regulations released since January 2010 are forming the foundation of the Nationwide Health Information Network (fNHIN): the Meaningful Use NPRM, Standards and Certification Criteria IFR, HHS Certification Process NPRM, and Clinical Laboratory Improvement Amendments (CLIA)

    He was enthusiastically received by the crowd at HIMSS and he told us, "You have been leaders and we want you to continue to be leaders and we will follow your lead."

    Dr. Blumenthal noted that the ONC's focus soon will shift from policy to implementation. He recognized implementing the HITECH provisions of ARRA "is a huge job" and said that his office will "have to grow considerably to do it effectively." He said, "As I look back and look ahead at this Olympic time, I sometimes see us as either speed skating or downhill slalom. We have to move fast, but we can't miss a turn."



    *Dr. Blumenthal is announced about 19 minutes into the video

    Vocabulary Task Force

    The HIT Standards Committee’s Clinical Operations Workgroup set up a Vocabulary Task Force to address vocabulary subsets and value sets as facilitators and enablers of “meaningful use.” The Vocabulary Task Force met on March 23, 2010 after seeking input.

    As John Halamka, MD said in his blog:
    "To ensure the right subsets are available and maintained, we need governance - who decides what goes into the vocabularies, what mappings are created, and how disputes/redundancies are resolved? We need a place to store vocabularies that makes them easily accessible to all. We need a roadmap for future work."
    The audio is posted with the agenda and meeting materials below:

    Download






  • Agenda




  • Summary and Key Points from February Hearing




  • Panel 1: Office of the National Coordinator, Interoperability Framework

    • Douglas Fridsma, MD


  • Panel 2: Federal Provider Organizations



  • Panel 3:  Best Practices and Lessons Learned: Vocabulary Infrastructure



  • Panel 4:  Best Practices & Lessons Learned, con’t



  • Panel 5: Level 1 Governance Value Set

    • Sharon Sprenger, The Joint Commission
    • Karen Kmetik, American Medical Association
    • Greg Pawlson, National Committee for Quality Assurance (NCQA) [invited]
    • Janet Corrigan, National Quality Forum (NQF)
  • Certification Programs NPRM: Webinar




    IMPORTANT WEBINAR ~
    LIMITED SPACE SO DIAL IN EARLY!





    On March 25, 2010 from 4:00 – 5:00 p.m. EDT, The Office of the National Coordinator for Health Information Technology (ONC), with the National Institute of Standards and Technology (NIST), will present a webinar on the recently released Certification Programs for HIT Notice of Proposed Rulemaking (NPRM).  Public comments on the NPRM are now being accepted.  The temporary certification program’s comment period ends April 9 and the permanent certification program’s comment period ends May 10.  Because this NPRM is currently in the comment period phase, this webinar will be solely informational and seeks to help listeners better understand the proposals included in the NPRM.

    Background

    Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology.  This webinar will discuss the proposals included in the NPRM that would enable eligible professionals and eligible hospitals to adopt health IT that meets the definition of Certified EHR Technology. 
    Learn more about the NPRM at http://healthit.hhs.gov/CertificationNPRM
    To Participate

    There is limited space on this webinar. For those unable to join, there will be a transcript posted to the ONC website, http://healthit.hhs.gov, by March 29, 2010.
    Join the meeting
    Audio Information

    Dial-In: 1-888-673-9805

    Participant Passcode: 9033671
    First Time Users:

    To save time before the meeting, check your system to make sure it is ready to use Microsoft Office Live Meeting.
    Troubleshooting

    Unable to join the meeting? Follow these steps:
    1. Copy this address and paste it into your web browser:

    2. Copy and paste the required information:

      • Meeting ID: 9CS6RH
      • Entry Code: 5z}BQR5

    via hhs.gov

    Wednesday, March 24, 2010

    Leveraging Health Information Technology for Patient Empowerment


    National Web-Based Teleconference on Patient Empowerment

    Leveraging Health Information Technology for Patient Empowerment

    This free 90-minute teleconference will explore the latest research on how patients can utilize health IT to increase participation in their healthcare.
     
    Date: April 8, 2010
    Time: 3:00 – 4:30 p.m., EST
    Sponsored by the Agency for Healthcare Research and Quality’s (AHRQ) National Resource Center for Health IT
    Presenters:
    • Alexander Krist, M.D., M.P.H., serves as an Assistant Professor in the Virginia Commonwealth University (VCU) School of Medicine's Department of Family Medicine. The majority of his research is conducted through the VCU Department of Family Medicine’s multidisciplinary research team and its practice-based research network (the Virginia Ambulatory Care outcomes Research Network) of more than sixty primary care practices, spanning six health systems assembled to coordinate on research projects. In 2004 he helped direct his practice to implement a paperless electronic health record including e-prescribing, laboratory and radiology interfaces, electronic billing, performance monitoring, and a registry for population management.
    • Christine Ritchie, M.D., M.S.P.H., is an Associate Professor at the University of Alabama Birmingham (UAB) School of Medicine’s Center for Palliative Care. She holds the title of Director of the UAB Center for Palliative Care and Director of the Palliative Care Section within the Division of Gerontology and Geriatric Medicine. She served as the VA Network 9 Palliative Care Consult Team mentor, a member of the VA Network 9 Health Systems Council, and co-chair of the Network 9 Geriatrics and Extended Care Committee.
    • Christine Sinsky, M.D., B.S., is a General Internist at Medical Associates Clinic and Health Plans, in Dubuque, Iowa. She is a frequently invited lecturer on practice innovation, redesign, and the patient centered medical home (PCMH) and has been a presenter at the Patient Centered Primary Care Collaborative Stakeholder meeting. She serves on the physician advisory panel for the National Committee for Quality Assurance (NCQA) physician recognition programs and is a Director on the American Board of Internal Medicine.
    Dr. Sinsky will introduce the topic by providing an overview of challenges and innovations facing patient empowerment and health IT systems. Building on this foundation, Dr. Krist will discuss findings from a randomized controlled trial to evaluate the impact of a personal health record (PHR).  In his presentation he will explain how this PHR links patients to their health information in their physician’s electronic medical record (EMR) and provides personally tailored prevention recommendations to patients. Dr. Ritchie will discuss ongoing research in developing evidence-based tools to support patient-centered care. She will explain the findings from a randomized controlled trial investigating how to utilize IT systems to support patients with complex medical conditions as they transition from hospital to home-based care.  To conclude our presentation, Dr. Sinsky will discuss her on-the-ground experience with empowering patients via IT systems in clinical settings and the key barriers and enablers to success.


    To register for the teleconference, please visit: https://ahrq.peachnewmedia.com/store/seminar/seminar.php?seminar=4324 and select "Register."

    Today's Ada Lovelace

    For Ada Lovelace Day I wanted to promote the amazing work of Jennifer Pahlka and Code for America. I first met Jennifer at the Gov 2.0 Summit last year after following her for a while on Twitter and reading her blog PahlkaDot. Jennifer has always impressed me with her passion for making the world a better place and her brilliant mind. I can't think of anyone better for drawing attention to the achievements of women in technology and science.

    Jennifer transitioned from her role as co-chair and general manager of the Web 2.0 Expos for TechWeb, working with O'Reilly Media, to become Executive Director of Code for America. Previously she chaired Enterprise 2.0, and before that was the director of the Game Group at CMP. During her tenure in the games business, she oversaw the dramatic growth of the Game Developers Conference (GDC) from 1995 to 2003 and launched a number of notable programs, including the Independent Games Festival, known as the Sundance of the game industry, and the Game Developers Choice Awards. Her roles included publisher of Game Developer magazine and Gamasutra.com, the premiere web site for game developers, and executive director of the International Game Developers Association (IGDA), an independent non-profit association serving game developers around the world. She has served on the advisory boards of the Electronic Entertainment Expo (E3) and the GDC and held a board of directors position on the IGDA for three years. She graduated cum laude from Yale University. Besides this quite impressive history, Jennifer is a mother and truly wants to have an impact and leave this world in better shape for her daughter's generation.

    Being a mom seems to have had a profound impact on Jennifer. She said, "Being a parent makes me realize that time on this planet is precious and should be well spent." As any parent knows balancing the responsibilities of family, work and social activities can be a challenge. But Jennifer believes, "Being a mom actually helps me focus my work efforts. If I'm going to spend time away from my daughter every second is precious. You can't do everything so you make choices on what's important."

    Code for America began as an idea inspired in part by Teach for America. CFA wants to connect Web developers with city officials who want to improve connectivity and transparency then be shared and rolled out more broadly to cities across America. At the Gov 2.0 Summit Tim O'Reilly had mentioned to Jennifer that it would be great for an action oriented program to spring from from the event. Then Jennifer and her friend Andrew Greenhill, a CFA Board Member and the Mayor’s Chief of Staff for the City of Tucson, were chatting and she said "There should be a kind of Teach for America for the web industry." And thus was born Code for America...

    Eleven cities and agencies have applied for web-project help from CFA. The applicants each proposed up to three projects that the Code for America fellows would build for them if their city is chosen. "After we choose which cities and projects, then we can begin effective fellow recruitment," Jennifer said. Over the next six weeks is going to be a busy time at CFA as they choose cities and projects and then there will be a time of intensive fellow recruitment. If you have a desire and interest in helping, email Jennifer at jen@codeforamerica.org.

    Here is a great interview from GovFresh.tv which will help you get to know Jennifer better:

    Fixing NHS

    Health 2020 released a report "Fixing NHS IT: How to save £1bn and get IT working for patients"

    It makes for interesting reading and could help inform our own efforts on this side of the pond.


    Tuesday, March 23, 2010

    CMS Reorganization

    BILLING CODE: 4120-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Statement of Organization, Functions, and Delegations of Authority

    Part F of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), (Federal Register, Vol. 72, No. 248, pp. 73847 - 73850, dated Friday, December 28, 2007) is amended to reflect changes to the current structure of CMS.

    In an effort to improve the value and service that CMS provides to the Nation, the CMS has modified its structure to align similar functions under common executive leadership and allow CMS to establish a Center for Program Integrity and to strengthen its focus on beneficiary services and strategic planning.

    The structure includes the following, which all report to the Administrator, CMS: 1) Center for Medicare, 2) Center for Medicaid, CHIP and Survey & Certification, 3) Center for Strategic Planning, 4) Center for Program Integrity, and 5) Office of External Affairs and Beneficiary Services. In addition, the current role of the Chief Operating Officer (COO) has been formalized and remains responsible for operations, information systems, contracts, finance, E-health standards and services, and the Consortia. The COO continues to report to the Administrator, CMS. The following organizations remain substantively unchanged and continue to report to the Administrator, CMS: Office of Equal Opportunity and Civil Rights, Office of Legislation, Office of the Actuary, Office of Clinical Standards and Quality, and the Office of Strategic

    Operations and Regulatory Affairs (will be renamed the Office of Executive Operations and Regulatory Affairs to more accurately reflect the work of the organization). New administrative codes were assigned to all organizations, including the immediate office of the Administrator.

    Given the complexity and importance of CMS’ programs, this realignment of existing functions positions CMS to consistently excel in serving our beneficiaries and strategically positions CMS for the future. Additionally, this effort ensures common core functions are under common executive leadership and share a consistent vision.

    The specific amendments to Part F are described below:

    I. Under Part F, CMS, Office of the Administrator, FA.10 Organization is deleted in its entirety and replaced with the following:

    FC.10 Organization. CMS is headed by the Administrator, CMS, and includes the following organizational components:

    Office of the Administrator (FC) Office of Equal Opportunity and Civil Rights (FCA) Office of External Affairs and Beneficiary Services (FCB) Office of Legislation (FCC) Office of the Actuary (FCE)

    Office of Executive Operations and Regulatory Affairs (FCF)

    Office of Clinical Standards and Quality (FCG) Center for Medicare (FCH) Center for Medicaid, CHIP and Survey & Certification (FCJ) Center for Strategic Planning (FCK) Center for Program Integrity (FCL) Chief Operating Officer (FCM)

    II. Under Part F, CMS, Office of the Administrator, FA.20 Functions is replaced with FC.20 Functions. The functions of the new organizations read as follows:

    Office of External Affairs and Beneficiary Services (FCB)
    • Serves as CMS’ focal point for beneficiary communications and services, provides leadership for CMS in the areas of intergovernmental affairs, and media relations. Advises the Administrator and other CMS components in all activities related to these functions and on matters that affect other units and levels of government.
    • Contributes to the formulation of policies, programs, and systems as well as oversees beneficiary services, intergovernmental affairs, media relations, and tribal affairs, including CMS’ Ombudsman program, call center operations, web sites, and Medicare contractor communications. Coordinates with the Office of Legislation on the development and advancement of new legislative initiatives and improvements.
    • Oversees the analysis and evaluation of customer data for the purpose of improving beneficiary communication tools (including but not limited to brochures, program/media campaigns, handbooks, websites, reports, presentations/briefings) and identifying best practices for the benefit of beneficiaries and other CMS customers. Coordinates this data with other CMS components to resolve customer and beneficiary issues through continuous quality improvement.
    • Oversees all CMS interactions and collaboration with key stakeholders relating to beneficiary communications and services, media relations, and intergovernmental affairs (e.g., external advocacy groups, Medicare beneficiary customer service, the media, contractors, Native American and Alaskan Native tribes, HHS, the White House, other CMS components, and other Federal government entities).
    • Formulates and implements a customer service plan that serves as a roadmap for the effective treatment and advocacy of customers and the quality of information provided to them.
    • Coordinates communications, messaging, media relations, partner relations and Tribal Affairs outreach with the CMS Regional Offices.
    • Serves as senior advisor to the Administrator in all activities related to the media. Provides consultation, advice, and training to CMS' senior staff with respect to relations with the news media.
    • Serves as liaison between CMS and State and local officials, and individuals representing State and local officials and advocacy groups.
    • Serves as coordinator of tribal affairs issues and liaison between CMS and State and local officials representing tribal affairs groups.

    Center for Medicare (FCH)
    • Serves as CMS’ focal point for the formulation, coordination, integration, implementation, and evaluation of national Medicare program policies and operations.
    • Identifies and proposes modifications to Medicare programs and policies to reflect changes or trends in the health care industry, program objectives, and the needs of Medicare beneficiaries. Coordinates with the Office of Legislation on the development and advancement of new legislative initiatives and improvements.
    • Serves as CMS’ lead for management, oversight, budget and performance issues relating to Medicare Advantage and prescription drug plans, Medicare fee-for-service providers and contractors.
    • Oversees all CMS interactions and collaboration with key stakeholders relating to Medicare (e.g., plans, providers, other government entities, advocacy groups, Consortia) and communication and dissemination of policies, guidance and materials to same to understand their perspectives and to drive best practices in the health care industry.
    • Develops and implements a comprehensive strategic plan, objectives and measures to carry out CMS’ Medicare program mission and goals and position the organization to meet future challenges with the Medicare program and its beneficiaries.
    • Coordinates with the Center for Program Integrity on the identification of program vulnerabilities and implementation of strategies to eliminate fraud, waste, and abuse.

    Center for Medicaid, CHIP and Survey & Certification (FCJ)
    • Serves as CMS’ focal point for the formulation, coordination, integration, implementation, and evaluation of all national program policies and operations relating to Medicaid, CHIP, Survey & Certification, and the Clinical Laboratory Improvement Act (CLIA).
    • In partnership with States, evaluates the success of State agencies in carrying out their responsibilities for effective State program administration and beneficiary protection, and, as necessary, assists States in correcting problems and improving the quality of their operations.
    • Identifies and proposes modifications to Medicaid and CHIP program measures, regulations, laws and policies to reflect changes or trends in the health care industry, program objectives, and the needs of Medicaid and CHIP beneficiaries. Collaborates with the Office of Legislation on the development and advancement of new legislative initiatives and improvements.
    • Oversees the planning, coordination and implementation of the survey, certification and enforcement programs for all Medicare and Medicaid providers and suppliers, and for laboratories under the auspices of CLIA.
    • Serves as CMS’ lead for management, oversight, budget and performance issues relating to Medicaid, CHIP and Survey and Certification, and the related interactions with the States.
    • Coordinates with the Center for Program Integrity on the identification of program vulnerabilities and implementation of strategies to eliminate fraud, waste, and abuse.
    • In conjunction with the Office of External Affairs, oversees all CMS interactions and collaboration relating to Medicaid and CHIP with beneficiaries, States and territories and key stakeholders (i.e., health facilities and other health care providers, other Federal government entities, local governments) and communication and dissemination of policies, guidance and materials to same to understand their perspectives, support their efforts, and to drive best practices for beneficiaries, in States and throughout the health care industry.
    • Develops and implements a comprehensive strategic plan, objectives and measures to carry out CMS’ Medicaid and CHIP mission and goals and position the organization to meet future challenges with the Medicaid, CHIP and Survey & Certification, and CLIA programs.
    Center for Strategic Planning (FCK)
    • Serves as CMS’ focal point for the planning, formulation and coordination of long-term strategic plans, and future program policy and proposals for CMS.
    • Collaborates with the Office of Legislation on the development and advancement of new legislative initiatives and improvements.
    • Conducts environmental scanning, identifying, evaluating and reporting emerging trends in health care delivery and financing and their interactions with CMS programs and implications for future policy development and planning.
    • Oversees strategic, cross-cutting initiatives in coordination with other CMS components and external stakeholders.
    • In collaboration with other CMS components, designs, coordinates, conducts research, demonstrations, analyses and special studies, and evaluates the results for impacts on beneficiaries, providers, plans, health care programs and financing, States and other partners, designing and assessing potential improvements, and developing new measurement tools.
    • Oversees the development and dissemination of publications, data analyses, graphics, and briefing materials related to health care issues.

    Center for Program Integrity (FCL)
    • Serves as CMS’ focal point for all national and State-wide Medicare and Medicaid programs and CHIP integrity fraud and abuse issues.
    • Promotes the integrity of the Medicare and Medicaid programs and CHIP through provider/contractor audits and policy reviews, identification and monitoring of program vulnerabilities, and providing support and assistance to States. Recommends modifications to programs and operations as necessary and works with CMS Centers and Offices to affect changes as appropriate. Collaborates with the Office of Legislation on the development and advancement of new legislative initiatives and improvements to deter, reduce, and eliminate fraud, waste and abuse.
    • Oversees all CMS interactions and collaboration with key stakeholders relating to program integrity (i.e., U.S. Department of Justice, HHS Office of Inspector General, State law enforcement agencies, other Federal entities, CMS components) for the purposes of detecting, deterring, monitoring and combating fraud and abuse, as well as taking action against those that commit or participate in fraudulent or other unlawful activities.
    • In collaboration with other CMS Centers and Offices, develops and implements a comprehensive strategic plan, objectives and measures to carry out CMS’ Medicare, Medicaid and CHIP program integrity mission and goals, and ensure program vulnerabilities are identified and resolved.

    Chief Operating Officer (FCM)
    • Overall responsibility for facilitating the coordination, integration and execution of CMS policies and activities across CMS components, including new program initiatives.
    • Promotes accountability, communication, coordination, and facilitation of cooperative corporate decision-making among CMS senior leadership on management, operational and programmatic cross-cutting issues.
    • Tracks and monitors CMS performance and intervenes, as appropriate, to ensure key milestones/deliverables are successfully achieved. Keeps the Administrator and Principal Deputy Administrator advised of the status of significant national initiatives and programs that affect beneficiaries and/or the health care industry and makes recommendations regarding necessary corrective actions.
    • Provides executive leadership to CMS’ Consortia operations, including facilitating all required interaction and coordination between Consortia and other CMS components.
    • Oversees all planning, implementation and evaluation of administrative and operational activities for CMS, including enterprise-wide information systems and services, acquisition and grants, financial management, electronic health standards, facilities, and human resources.

    DELEGATIONS OF AUTHORITY

    All delegations and re-delegations of authority made to officials and employees of affected organizational components will continue in them or their successor organization pending further re-delegation, provided they are consistent with this realignment. (Authority: 44 U.S.C §3101) Dated: March 18, 2010

    Kathleen Sebelius Secretary

    [FR Doc. 2010-6429 Filed 03/23/2010 at 8:45 am; Publication Date: 03/24/2010]

    Monday, March 22, 2010

    Aligning Health IT and Health Reform

    Below is a video and information from a July 15, 2009 event by The Markle Foundation, the Center for American Progress and the Engelberg Center for Health Care Reform. They had been working with a wide array of collaborators to develop criteria for the "meaningful use" of the ARRA's health IT investments to increase their sustainability and foster and support health system transformation.

    Achieving an Information-Driven Health Care System


    "There's an incredible amount of energy in the private sector that wants to make health care better. But the private sector needs guidance in order to ascertain what exactly we're trying to do, what is policy trying to accomplish, where should innovation head, what are we trying to do as a country," said CAP Senior Fellow Todd Park at the event jointly hosted by the Center for American Progress, the Markle Foundation, and the Engelberg Center for Health Care Reform at the Brookings Institution.
    In addition to Park, speakers included David Blumenthal, national coordinator for health IT at the U.S. Department of Health and Human Services, Zoë Baird and Carol Diamond from the Markle Foundation, and Mark McClellan, director of the Engelberg Center for Health Care Reform at the Brookings Institution.
    The speakers were also joined by a number of panelists: Christine Bechtel from the National Partnership for Women & Families; Hunt Blair from Vermont Health Access; Steven Findlay from the Consumers Union; David Lansky from the Pacific Business Group on Health; and Steven Waldren from the American Academy of Family Physicians.
    Baird, Diamond, Park, and McClellan argued that committing to specific health targets will guide health IT investment and health care reform toward improving health outcomes, expanding coverage, and reducing cost growth. By digitizing and networking health information, health IT gives physicians access to a patient's comprehensive medical record (including medical history, medications, and test results) and allows them make more informed decisions and to coordinate care with other providers. What's more, health IT can increase safety by alerting physicians about potential drug allergies and interactions and by transmitting their orders with fewer errors. Health IT can also help reduce costs and cut down on administrative hassles.
    The American Recovery and Reinvestment Act, or ARRA, authorized over $30 billion in potential incentive payments to health care providers for achieving “meaningful use” of health IT, and directed HHS to craft the standard for “meaningful use.” To ensure that ARRA's health IT investments actually foster innovation in technology and care delivery, speakers argued, the standard should be guided by five criteria:
    • Set clear and achievable health improvement targets for 2015.
    • Focus on information use over technology features.
    • Tie payment to results.
    • Engage patients.
    • Craft a smart standards and certification regime that encourages innovation.
    Baird, Diamond, Park, and McClellan strongly endorsed the ambitious targets proposed by an HHS advisory committee working with Blumenthal. The goals include: preventing one million heart attacks and strokes; cutting rates of medication errors, preventable hospitalizations, and racial/ethnic disparities in diabetes control in half; and providing patients with easy access to their own health information. CAP, Markle, and Brookings also proposed adding two 2015 goals to specifically address growth in health care costs: identifying duplicative health care services and reducing them by 50 percent, and halving the time spent by physicians on administrative tasks.
    Park praised the targets as clear, bold, and achievable. "Why specifically do we love these goals? They're not platitudinous wonkery, they're concrete, everyone knows what they mean," he said, suggesting they can orient both ARRA's health IT investments and the broader health reform effort.
    Standards and certifications, such as the standard for “certified electronic health records,” are still evolving. "Certification needs to be as simple and as focused as we can get it. The technology that we want and need for 2015 is not the technology of today. We still need a lot of innovation," said Waldren.
    Speakers also argued that the stimulus package's health IT investments must be aligned with broader payment, benefit, and regulatory reforms of the American health care system. According to McClellan, quality measures are a "necessary prerequisite to implementing payment reform, where providers are paid not just for specific services but for actually improving outcomes and lowering costs."
    Patients must also be involved in shaping the evolution of "meaningful use" of technology. "Patient experience surveys can tell us a lot, not just about what my experience of care was like in the physician practice or in the hospital, but also about whether I understood the [health] information that was given to me," said Bechtel.
    As complex as health IT policy is, McClellan stressed that it is only one piece of the health reform puzzle. "Let's face it. Health IT can help achieve these [2015] goals, but it sure can't do it alone. We will also need better health care organizations, new kinds of staffing and delivery, better decisions by providers and patients," he said.

    Sunday, March 21, 2010

    Healthcare Reform Passes

    The votes have been cast and the House of Representatives have passed health reform. With the 219-to-212 vote the House gave approval to legislation passed by the Senate on Christmas Eve. The House also passed a package of fixes which would strip some of the more controversial provisions. It passed by a vote of 220 to 211.

    The fix package must be passed by the Senate, which is expected to take it up this coming Tuesday. It is being moved forward under a parliamentary procedure known as reconciliation that circumvents the filibuster and so requires only 51 votes to pass. If the Senate makes any changes then it would go back to the House for final approval.

    The geographic breakdown and remarks from the President are below:


    • Result: Passed by 7 votes
    • Date of Vote: March 21, 2010
    • Roll Call Number: 165


    Interactive graphic via politics.nytimes.com


    President Obama speaks after the historic passage by the House of Representatives of the Senate's health reform legislation.

    Friday, March 19, 2010

    Religion and Maps

    Matthew Zook, associate professor in the Geography department at the University of Kentucky and from Floating Sheep and Brian Grim, Senior Researcher with Pew Research Center’s Forum on Religion & Public Life both presented at Harvard's "New Technologies and Interdisciplinary Research on Religion"


    Impacting the World with Data: From a million data points to maps that tell the story
    OR Translating academic rigor into public information



    By Brian Grim
    Technologies make possible so many different ways of collecting and displaying data that often the real challenge is knowing which data to collect and the best way to present them. This presentation briefly shows how the Pew Forum on Religion & Public Life (Washington, DC) and the international Religious Demography Project at Boston University's nstitute on Culture, Religion and World Affairs (CURA) have organized millions of data points on world religion into relational databases that allow interactive online comparisons. The presentation then describes ways that these data have been reported and mapped, showing how they contribute to scholarly understanding as well as how they impact public discourse in the media and among policy makers. Examples include how a single published number became part of the public discourse DNA (i.e., the Forum's fnding that 1.57 billion people, or nearly oneinfour in the world today, are Muslim) as well as how data on religious demography and religionrelated violence can be turned into maps that consolidate knowledge. The presentation concludes with an illustration of how data on religion are combined with other global geospatial datasets in ways that provide critical cultural information to aid workers and others before they arrive in a new location; this developing database also is designed to incorporate realtime input from data contributors worldwide using a webbased application.

    Mapping Religious Cyberscapes: Google and User Generated Religion


    By Matthew Zook
    User generated information is more and more prevalent on the Internet and increasingly much of this content is spatially referenced. While there is a wide range of place related information available online, this paper introduces the metric of the number of user generated Google Maps placemarks containing specifc keywords (e.g., slam, Hinduism, Buddhism, church, etc.) to plot the contours of religious practice worldwide. These cyberscapes convey aspects of the material world undetectable by other methods and provide a fne grain mapping of religion as represented by online user activity. Although representations within Google Maps can often accurately mirror trends in the physical world, it is important to be aware of how the many powerrelationships and divides in the offine world can exclude certain places and certain types of knowledge in online representations. We are thus left to ask, to what extent can virtual representations reveal useful information about material trends and places, or to what degree are those representations reinforcing the power of the most networked elements of society and the ways in which they choose to represent place?

    The Future of News: Digital Democracy

    "The Future of News" is a 10-part series for public television where the best minds in traditional and new media meet to discuss the role of a free press in an ever-changing digital democracy. It attempts to highlight the emerging forms of news presentations and to emphasize the role of technological diversity in the modern media landscape. A common theme which runs through each show is the need for credible and verifiable news and information in a robust democracy.

    On October 31, 2009 Aneesh Chopra, US chief technology officer, and Ellen Miller, co-founder of the Sunlight Foundation, discussed privacy, net neutrality and the digital divide.

    The question which was a recurring theme was, "Who will control the channels of news and information on the Internet?"

    • Aneesh Chopra on the Federal Register being online.


    • Ellen Miller on technology allowing greater government transparency.



    "The more we make available online, the more we hope third parties and others will help inform their constituencies."
    — Aneesh Chopra

    "Transparency through the technology... enables citizens and their government to actually have a conversation."
    — Ellen S. Miller

    About Aneesh Chopra

    Aneesh Chopra is the chief technology officer and associate director for technology in the White House Office of Science & Technology Policy. He is the former secretary of technology for the Commonwealth of Virginia, and was managing director with the Advisory Board Company, a publicly-traded health-care think tank.

    About Ellen S. Miller

    Ellen S. Miller is co-founder of the Sunlight Foundation, a nonpartisan, nonprofit organization which advocates openness in government through the Internet. She is a former deputy director of campaign at America's Future, publisher of TomPaine.com, was a senior fellow at The American Prospect magazine.

    Webinar on Certification Programs for HIT NPRM

    March 25, 2010 from 4:00 – 5:00 p.m. EDT, The Office of the National Coordinator for Health Information Technology (ONC), with the National Institute of Standards and Technology (NIST), will present a webinar on the recently released Certification Programs for HIT Notice of Proposed Rulemaking (NPRM).  Public comments on the NPRM are now being accepted.  The temporary certification program’s comment period ends April 9 and the permanent certification program’s comment period ends May 10.  Because this NPRM is currently in the comment period phase, this webinar will be solely informational and seeks to help listeners better understand the proposals included in the NPRM.
    Background
    Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology.  This webinar will discuss the proposals included in the NPRM that would enable eligible professionals and eligible hospitals to adopt health IT that meets the definition of Certified EHR Technology. 
    Learn more about the NPRM at http://healthit.hhs.gov/CertificationNPRM
    To Participate
    There is limited space on this webinar. For those unable to join, there will be a transcript posted to the ONC website, http://healthit.hhs.gov, by March 29, 2010.
    Join the meeting

    Audio Information
    Dial-In: 1-888-673-9805
    Participant Passcode: 9033671
    First Time Users: 
    To save time before the meeting, check your system to make sure it is ready to use Microsoft Office Live Meeting.
    Troubleshooting
    Unable to join the meeting? Follow these steps:
    1. Copy this address and paste it into your web browser:


    2. Copy and paste the required information:


      • Meeting ID: 9CS6RH
      • Entry Code: 5z}BQR5
    If you still cannot enter the meeting, contact support


    via hhs.gov

    Thursday, March 18, 2010

    Health Reform Documents

    These are most of the documents pertaining to the health reform legislation:





  • 2-Page Summary of the Bill





  • 3-Page Summary of the Bill





  • Text of House Reconciliation Bill  (Amendment in the Nature of a Substitute)





  • Text of House Reconciliation Bill    (As Reported by the House Budget Committee)





  • Section-by-Section Analysis of Bill





  • CBO Scoring of Bill





  • CBO Director's Blog Post





  • Revenue Estimate of Joint Committee on Taxation





  • House Budget Committee Report  (Volume I)





  • House Budget Committee Report(Volume II)





  • Statement of Chairmen of 3 House Committees





  • Transcript of News Conference of Speaker and Democratic Leaders
  • How laws are made

    I thought it would be helpful to remind everyone how exactly the sausage making process works...







    Schoolhouse Rock style!!!










    Boy: Woof! You sure gotta climb a lot of steps to get to this Capitol Building here in Washington. But I wonder who that sad little scrap of paper is?

    ♪♫
    I'm just a bill.
    Yes, I'm only a bill.
    And I'm sitting here on Capitol Hill.
    Well, it's a long, long journey
    To the capital city.
    It's a long, long wait
    While I'm sitting in committee,
    But I know I'll be a law someday
    At least I hope and pray that I will,
    But today I am still just a bill.

    Boy: Gee, Bill, you certainly have a lot of patience and courage.


    Bill: Well I got this far. When I started, I wasn't even a bill, I was just an idea. Some folks back home decided they wanted a law passed, so they called their local Congressman and he said, "You're right, there oughta be a law." Then he sat down and wrote me out and introduced me to Congress. And I became a bill, and I'll remain a bill until they decide to make me a law.

    ♪♫
    I'm just a bill
    Yes I'm only a bill,
    And I got as far as Capitol Hill.
    Well, now I'm stuck in committee
    And I'll sit here and wait
    While a few key Congressmen discuss and debate
    Whether they should let me be a law.
    How I hope and pray that they will,
    But today I am still just a bill.

    Boy: Listen to those congressmen arguing! Is all that discussion and debate about you?


    Bill: Yeah, I'm one of the lucky ones. Most bills never even get this far. I hope they decide to report on me favourably, otherwise I may die.


    Boy: Die?


    Bill: Yeah, die in committee. Oooh, but it looks like I'm gonna live! Now I go to the House of Representatives, and they vote on me.


    Boy: If they vote yes, what happens?


    Bill: Then I go to the Senate and the whole thing starts all over again.


    Boy: Oh no!


    Bill: Oh yes!

    ♪♫
    I'm just a bill
    Yes, I'm only a bill
    And if they vote for me on Capitol Hill
    Well, then I'm off to the White House
    Where I'll wait in a line
    With a lot of other bills
    For the president to sign
    And if he signs me, then I'll be a law.
    How I hope and pray that he will,
    But today I am still just a bill.

    Boy: You mean even if the whole Congress says you should be a law, the president can still say no?


    Bill: Yes, that's called a veto. If the President vetoes me, I have to go back to Congress and they vote on me again, and by that time you're so old...


    Boy: By that time it's very unlikely that you'll become a law. It's not easy to become a law, is it?


    Bill: No!

    ♪♫
    But how I hope and I pray that I will,
    But today I am still just a bill.

    Congressman: He signed you, Bill! Now you're a law!


    Bill: Oh yes!!!

    Clinical Groupware Collaborative

    These are the slides from the Clinical Groupware Collaborative call today.

    Watch this group carefully. This is something on the edge of the future that will have a transformative effect on healthcare.

    Hubble 3D

    I am going to see the IMAX movie Hubble 3D this weekend. This should be pretty fascinating, both from a technology standpoint and an artistic perspective. I'm kind of a space geek any way, and add IMAX 3D to the mix and this looks to be a visual extravaganza.

    The review in the New York Times says:
    “Hubble 3D,” which records a trip made in 2009 by the space shuttle Atlantis to repair and modify the telescope, is dazzling to look at of course. But such ponderous, cliché-heavy narration. Leonardo DiCaprio delivers it, which might lead you to expect something moderately hip; instead it’s that same old leaden drone, which back when space flight was new perhaps conveyed suitable awe but these days just makes you feel as if you’re in a junior-high civics class.
    The Imax format, thankfully, makes it easy to block out all those “billions” — number of stars, number of light years — that Mr. DiCaprio is dutifully intoning and instead turn things over to your eyes, just letting them feast. An interesting fly-through effect gives the illusion of traveling across the universe, going deeper and deeper into space just as Hubble’s gaze has done. And the concluding image of a giant web of light, a sort of compilation of all that Hubble’s eye registers, is something to see.
    I will bring ear plugs ;-)
    So if DiCaprio starts to get on my nerves, I can just enjoy the feast for my eyes...

    3-17 HIT Policy Meeting

    On March 17, 2010 the HIT Policy Committee met. There were reports from the Strategic Plan Workgroup, which outlined its vision of a “learning health system,” where patients, providers, government and technology will work together to generate knowledge to improve quality and clinical outcomes. The Certification/Adoption Workgroup reported on its patient safety focused meeting. And the NHIN Workgroup reported on its work and gave an update on the NHIN Direct project. There was also an update from the HIT Standards Committee and a report on the Certification NPRM. Tony Trenkle from CMS gave remarks on the over 200 NPRM comments received (of which 1/2 have been already read) and the process going forward (see analysis on Health System CIO Blog), while Jessica Kahn, also from CMS, discussed the Clinical Laboratory Improvement Amendments(CLIA).

    Certification was a very important topic of the meeting. The NPRM proposing the establishment of certification programs for purposes of testing and certifying health information technology was issued earlier this month with a request for comments. The NPRM proposes a temporary certification program to assure the availability of Certified EHR Technology prior to the date on which health care providers seeking the incentive payments would begin to report demonstrable meaningful use of Certified EHR Technology. A permanent certification program will ultimately replace the temporary certification program.

    My favorite slide is this one during the presentation on the Certification NPRM which Carol Bean, a Standards Harmonization Analyst at the Office of the National Coordinator, did a fine job of explaining:


















    Another great slide was the animated version of Steven Posnak's explanation of how it works:



    The audio is posted with the meeting materials below:

    Download




    Wednesday, March 17, 2010

    Personal Health Record Act

    I wrote last September about the "Personal Health Record Act of 2009." It took a few months for the legislation to actually be introduced and it is now in the Ways and Means Committee.

    Representatives Patrick Kennedy (D-RI), Dave Reichert (R-WA) and Charles W. Boustany, Jr., (R-LA) actually introduced the legislation December 7, 2009 to amend the HITECH Act in order to enhance the interoperability and the meaningful use of electronic medical records with personal health records (PHR)s. Required components of a PHR under this act could include monitoring who accesses the record, automated reminders and education tools, ability for a patient to annotate the record and leave feedback for the health care provider, and emergency access procedures for medical personnel in cases where a patient or authorized representative is unable to give consent. The Office of the National Coordinator would also report to Congress on the technological, medicolegal, medical safety and other pertinent issues related to an individual's control of their PHR.

    Here is the full Act as introduced:


    111th CONGRESS
    1st Session

    H. R. 4216


      To amend the Public Health Service Act and titles XVIII and XIX of the Social Security Act to establish guidelines to enhance the meaningful use and interoperability of electronic medical records with personal health records, including for purposes of Medicare and Medicaid payment incentives.


    IN THE HOUSE OF REPRESENTATIVES

    December 7, 2009
      Mr. Kennedy (for himself and Mr. Reichert) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned




    A BILL

      To amend the Public Health Service Act and titles XVIII and XIX of the Social Security Act to establish guidelines to enhance the meaningful use and interoperability of electronic medical records with personal health records, including for purposes of Medicare and Medicaid payment incentives.

    Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
    SECTION 1. SHORT TITLE.

    This Act may be cited as the “Personal Health Record Act of 2009”.

    SEC. 2. ENHANCING MEANINGFUL USE OF ELECTRONIC HEALTH RECORDS THROUGH INTEROPERABILITY.

    (a) Definitions.—
    (1) IN GENERAL.—Section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended by adding at the end the following:
    “(15) ELECTRONIC EXCHANGE.—The term ‘electronic exchange’ shall include the automated transfer of individual health information between electronic medical records and personal health records, and between electronic medical records, personal health records, and other electronic systems.
    “(16) PERSONAL HEALTH RECORD.—The term ‘personal health record’ means an electronic record of PHR identifiable health information (as defined in section 13407(f)(2) of the HITECH Act) of an individual that—
    “(A) complies with appropriate data content standards;
    “(B) enables the individual, an authorized representative, vendor of personal health records (as defined in section 318.2(j) of title 16, Code of Federal Regulations, as in effect as of November 1, 2009), any covered entity (as defined for purposes of HIPAA privacy and security law, as defined in section 3009(a)(2)), or an entity to the extent that it engages in activities as a business associate (as defined for such purposes) of such a covered entity, to retrieve data from or input data into the electronic record; and
    “(C) is portable and capable of electronic communication between such individual and the relevant covered entity, business associate described in subparagraph (B), or vendor of personal health records of such individual that is managed, shared, and controlled by or primarily for the individual.”.



    (2) CONFORMING AMENDMENT.—Section 13400(11) of the HITECH Act (42 U.S.C. 17921(11)) is amended to read as follows:
    “(11) PERSONAL HEALTH RECORD.—The term ‘personal health record’ has the meaning given such term in section 3000(16) of the Public Health Service Act.”.



    (b) Access To Individually Identifiable Health Information.—Section 3001(b) of the Public Health Service Act (42 U.S.C. 300jj–11(b)) is amended—
    (1) in the matter preceding paragraph (1), by inserting “electronic” before “exchange”;
    (2) in paragraph (6)—
    (A) by inserting “individuals,” after “physician offices,”; and
    (B) by inserting “electronic” before “exchange of health care information”;

    (3) in paragraph (10), by striking at the end “and”;
    (4) in paragraph (11), by striking the period and inserting “; and”; and
    (5) by adding at the end the following new paragraph:
    “(12) allows for an individual to have access to their individually identifiable health information.”.



    (c) Strategic Plan Relating To Personal Health Records.—Section 3001(c)(3)(A) of the Public Health Service Act (42 U.S.C. 300jj–11(c)(3)(A)) is amended by adding at the end the following new clause:
    “(ix) The interoperability of a personal health record with an electronic health record.”.


    (d) Guidelines Relating To Personal Health Records.—Section 3001(c) of the Public Health Service Act (42 U.S.C. 300jj–11(c)) is amended by adding at the end the following new paragraph:
    “(9) GUIDELINES FOR PERSONAL HEALTH RECORDS.—Not later than the date that is 12 months after the date of the enactment of the Personal Health Record Act of 2009, the National Coordinator shall develop guidelines for making electronic health records interoperable with personal health records for the purpose of improving health care quality, reducing medical errors, and advancing the delivery of patient-centered medical care and health management. Such guidelines shall include—
    “(A) standards based on the recommendations provided in section 3002(b)(2)(B)(ix), including for purposes of requiring electronic health records to be made available through electronic exchange and interoperable with personal health records for purposes of demonstrating meaningful use of an electronic health record under sections 1848(o)(2)(A)(i), 1886(n)(3)(A)(i), and 1903(t)(6)(C)(i)(II) of the Social Security Act;
    “(B) recommendations for applying such a requirement of making electronic health records available, with respect to community and behavioral health programs, in the form of personal health records to improve the effective and efficient electronic exchange and management of information between the individual (or authorized representative of the individual), including those in medically underserved communities (as defined in section 799B(6)), and community health centers and behavioral health service providers;
    “(C) required components of a personal health record, which shall include—
    “(i) information on medical history, including diagnoses and procedures, including updates if diagnosis or procedures change after each provider encounter;
    “(ii) information on recent laboratory results, diagnostic examinations, and radiologic procedures, if available in electronic format;
    “(iii) information on medications and prescriptions, both current and historical, including updates if medications change after each provider encounter;
    “(iv) information on allergies, both medication and environmental, including the specific reaction;
    “(v) privacy, security, and electronic informed consents for disclosing individually identifiable health information;
    “(vi) computer programming standards determined by the National Coordinator that allow interoperability of individually identifiable health information and communications between covered entities (as defined for purposes of HIPAA privacy and security law, as defined in section 3009(a)(2)), entities to the extent that they engage in activities as business associates of such covered entities, individuals, and vendors of personal health records;
    “(vii) portability of the personal health record by the individual between covered entities, business associates described in clause (vi), or vendors of personal health records;
    “(viii) ability to use such record as part of the patient intake process;
    “(ix) accurate attribution of the source of all data in the personal health record, including the source of the information, the date that such information was entered into the personal health record, and standards-based protection of data provided by the health care provider (such as health care provider clinic notes, laboratory results, diagnostic examinations, and radiologic procedures) from changes;
    “(x) notification of the individual involved or the authorized representative of such individual of the risks of withholding medical information from a medical provider; and
    “(xi) health services communication tools, including those which offer online secure communication with covered entities (as defined for purposes of HIPAA privacy and security law, as defined in section 3009(a)(2)) and entities to the extent that they engage in activities as business associates (as defined for such purposes) of such a covered entity;

    “(D) other possible components for consideration of a personal health record, including—
    “(i) an audit trail to monitor who has accessed the personal health record of the individual;
    “(ii) automated appointment, care reminders, and health self-management tools;
    “(iii) the ability to provide education tools;
    “(iv) the ability of the individual or authorized representative involved to annotate (without changing) health care provider records, such as to provide feedback to health care providers of the individual;
    “(v) protection of clinical records in the personal health record which are imported from or exported to a covered entity, business associate described in clause (i), or vendor of personal health records from being changed by the individual, authorized representative of the individual, vendor of personal health records, the covered entity, or business associate;
    “(vi) the ability to allow comments by the individual, authorized representative, and covered entity within an area of the personal health record that is separate from the clinical record imported from or exported to a covered entity; and
    “(vii) emergency access procedures for medical personnel, with respect to the record, for clinical care in cases that the individual or authorized representative is not able to give consent; and

    “(E) security, privacy, and electronic informed consents for disclosing individually identifiable health information for personal health records, including the recommendations described in paragraph (6)(F).
    In the case that the Secretary determines that any standard or component for personal health records included under the guidance under this paragraph is not adequate pursuant to the report submitted under paragraph (6)(F), the Secretary shall notify the National Coordinator and the HIT Standards Committee in accordance with section 3004(a)(2)(B) and the National Coordinator may revise such standard or component, respectively.”.



    (e) Reports.—Section 3001(c)(6) of such Act (42 U.S.C. 300jj–11(c)(6)) is amended by adding at the end the following new subparagraphs:
    “(F) MONITORING PERSONAL HEALTH RECORDS.—Not later than the date that is 24 months after the date of the enactment of the Personal Health Record Act of 2009 and annually thereafter, the National Coordinator, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall submit to the appropriate committees of jurisdiction of Congress an annual report on—
    “(i) the extent to which personal health records have been integrated into the meaningful use of electronic health records for purposes of sections 1848(o)(2), 1886(n)(3), and 1903(t)(6) of the Social Security Act;
    “(ii) the extent to which the use of personal health records improve communication between individuals and covered entities (as defined for purposes of HIPAA privacy and security law, as defined in section 3009(a)(2)) and improve patient health management, including documentation of the extent to which there are cost savings;
    “(iii) the extent to which the use of personal health records, with respect to community health centers and behavioral health services, improve the effective and efficient exchange and management of information between the individual involved (or authorized representative of the individual), including those in medically underserved communities, and community health centers and behavioral health service providers;
    “(iv) status of the standards implemented in paragraph (9)(A) and the need to revise or include new standards;
    “(v) the adequacy of the components of a personal health record described in paragraph (9)(C); and
    “(vi) the affect of having an individual with full access to the medical records of such individual through use of a personal health record, including—
    “(I) a prospective study analyzing health care utilization (including the impact of personal health records on health care provider efficiency, health care provider reimbursement for time spent interacting with individuals as a result of personal health records, and defensive medicine practices);
    “(II) the extent that such access affects communications by means of such records between various health care providers of the individual (including the use of provider notations);
    “(III) a prospective study analyzing the affect of such access on the patient-health care provider relationship; and
    “(IV) the risks and benefits of an individual having full access to medical records of the individual through the use of personal health records.


    “(G) RECOMMENDATION RELATING TO SECURITY AND PRIVACY OF PERSONAL HEALTH RECORDS.—Not later than 6 months after the date of the enactment of the Personal Health Record Act of 2009, the National Coordinator shall submit to the appropriate committees of jurisdiction of Congress a report, including recommendations, on the technological, medicolegal, medical safety, and other pertinent issues related to an individual’s control of the personal health record of such individual and shall establish guidelines for such control. The National Coordinator shall ensure the participation in such a report of health care consumers, vendors of personal health records, and covered entities (as defined for purposes of HIPAA privacy and security law, as defined in section 3009(a)(2)), along with other health care stakeholders. The report shall encompass at least the following issues:
    “(i) the rights of an individual utilizing a personal health record with respect to the individual’s own individually identifiable health information contained in such; and
    “(ii) the security and privacy of an individual utilizing a personal health record, including—
    “(I) defining who has right of access to an individual’s personal health record in the case of a personal health record provided by a covered entity;
    “(II) security and privacy issues following medical emergency access of information in a personal health record by health care providers;
    “(III) the impact of an individual restricting medical information access in a personal health record of such individual to health care providers on patient care and safety;
    “(IV) the risks and benefits of health care provider notification if the personal health record of an individual is restricted by the individual;
    “(V) the uses and disclosures of the information of an individual contained in a personal health record that should be authorized or required by a vendor of personal health records providing and maintaining such record;
    “(VI) electronic informed consents for disclosing individually identifiable health information;
    “(VII) the use of an audit trail of who has entered, removed, and changed data within a personal health record; and
    “(VIII) the dissemination of abnormal laboratory results, diagnostic examinations, and radiological procedures into personal health records prior to notification of the abnormality by the health care provider.”.




    (f) Personal Health Record Standards Included In HIT Policy Committee Recommendations.—
    (1) IN GENERAL.—Section 3002(b)(2)(B) of the Public Health Service Act (42 U.S.C. 300jj–12(b)(2)(B)) is amended by adding at the end the following new clause:
    “(ix) Standards and implementation specifications for the interoperability of personal health records and electronic health records.”.


    (2) CONFORMING CHANGES RELATING TO HIT STANDARDS COMMITTEE RECOMMENDATIONS.—
    (A) DEADLINE FOR SUBMISSION OF RECOMMENDATIONS TO NATIONAL COORDINATOR.—Section 3003(b)(1)(A) of such Act (42 U.S.C. 300jj–13(b)(1)(A)) is amended by adding at the end the following: “Not later than the date that is 6 months after the date of the enactment of the Personal Health Record Act of 2009, the HIT Standards Committee shall recommend to the National Coordinator standards and implementation specifications described in section 3002(b)(2)(B)(ix). The HIT Standards Committee shall update such recommendations and make new recommendations as appropriate, including in response to notification sent under section 3004(a)(2)(B).”.
    (B) FORUM.—Section 3003(b)(2) of such Act (42 U.S.C. 300jj–13(b)(2)) is amended by inserting before the period the following: “, including for the adoption of interoperability of personal health records and electronic health records”.

    (3) CONFORMING CHANGES RELATING TO ADOPTION OF INITIAL SET OF STANDARDS.—Section 3004(b)(1) of such Act (42 U.S.C. 300jj–14(b)(1)) is amended by inserting “(other than clause (ix))” after “section 3002(b)(2)(B)”.

    (g) Application Of Guidelines To Meaningful Use Requirements Of Electronic Medical Records Under Medicare.—
    (1) ELIGIBLE PROFESSIONAL PAYMENT INCENTIVES.—Section 1848(o)(2)(A)(i) of the Social Security Act (42 U.S.C. 1395w–4(o)(2)(A)(i)) is amended by inserting before the period at the end the following: “and shall include demonstrating the availability of such technology to and use of such technology by individuals furnished items and services by such professional in the form of electronic and personal health records consistent with guidelines established by the National Coordinator under section 3001(c)(9)(A) of the Public Health Service Act”.
    (2) ELIGIBLE HOSPITAL PAYMENT INCENTIVES.—Section 1886(n)(3)(A)(i) of such Act (42 U.S.C. 1395ww(n)(3)(A)(i)) is amended by inserting before the period at the end the following: “, which shall include demonstrating the availability of such technology to and use of such technology by individuals furnished items and services by such hospital in the form of electronic and personal health records consistent with guidelines established by the National Coordinator under section 3001(c)(9)(A) of the Public Health Service Act”.

    (h) Application Of Guidelines To Meaningful EHR Use Requirements Under Medicaid.—Section 1903(t)(6)(C)(i)(II) of the Social Security Act (42 U.S.C. 1396b(t)(6)(C)(i)(II)) is amended—
    (1) by striking “and” before “that may be based”; and
    (2) by inserting before the period at the end the following: “, and which shall include demonstrating the availability of such technology to and use of such technology by individuals furnished items and services by such Medicaid provider in the form of electronic and personal health records consistent with guidelines established by the National Coordinator under section 3001(c)(9)(A) of the Public Health Service Act”.

    (i) Relationship To Other Laws.—Section 13421 of the HITECH Act (42 U.S.C. 17951) is amended by adding at the end the following new subsection:
    “(c) Health Information Portability And Accountability Act, Health Care Providers, And Personal Health Records.—Nothing in this subtitle or the provisions of or amendments made by the Personal Health Record Act of 2009 shall affect the ability of a health care provider involved in the direct care of an individual to obtain pertinent information on the medical history of such individual from another health care provider involved in the medical care of the individual, in accordance with HIPAA privacy and security law (as defined in section 3009(a)(2) of the Public Health Service Act) as in effect before the date of the enactment of the Personal Health Record Act of 2009.”.