Piper Report
Blog on Medicare, Medicaid, pharma, biotech, health reform, and more. Insights and resources on hot issues. Kip Piper, editor.
Health care strategist, speaker, and writer. Expert on Medicare, Medicaid, and pharma, biotech, and device industries. President, Health Results Group LLC. Senior Counselor, Fleishman-Hillard. Senior Consultant, Sellers Dorsey. Visit KipPiper.com. Or email Kip here.
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posted: May 27, 2009

Federal%20CER.jpgFederal agencies are busy implementing the new program for comparative effectiveness research. The Federal Coordinating Council for Comparative Effectiveness Research (CER) has released, for public comment, a draft definition of CER and draft prioritization criteria for making research selections. The definition and criteria are intended to help guide, albeit at a high level, federal use of the $1.1 billion appropriated for comparative effectiveness research in FY 2009 and FY 2010 in the American Recovery and Reinvestment Act (ARRA).


Draft Definition of Comparative Effectiveness Research for the Federal Coordinating Council:


Comparative effectiveness research is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions. The purpose of this research is to inform patients, providers, and decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies, and delivery system interventions. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness.


Draft Prioritization Criteria for Comparative Effectiveness Research:


Threshold Minimal Criteria (i.e. must meet these to be considered):


  • Included within statutory limits of Recovery Act and FCC definition of CER.

  • Responsiveness to expressed needs and preferences of patients, clinicians, and other stakeholders, including community engagement in research.

  • Feasibility of research topic (including time necessary for research).

  • Prioritization Criteria:


    The criteria for scientifically meritorious research and investments are:


  • Potential Impact (based on prevalence of condition, burden of disease, variability in outcomes, and costs of care).

  • Potential to evaluate comparative effectiveness in diverse populations and patient sub-populations.

  • Uncertainty within the clinical and public health communities regarding management decisions.

  • Addresses need or gap unlikely to be addressed through other funding mechanisms.

  • Potential for multiplicative effect (e.g. lays foundation for future CER or generates additional investment outside government).

  • To comment on the draft definition and criteria, click here.


    Plans for Implementing Comparative Effectiveness Research:


    Of the $1.1 billion Congress appropriated for comparative effectiveness research, the Agency for Healthcare Research and Quality (AHRQ) received $300 million, the National Institutes of Health (NIH) received $400 million, and the HHS Office of the Secretary (OS) received $400 million. They have each developed plans for implementing their parts of the federal CER initiative:


  • AHRQ Implementation Plan for Comparative Effectiveness Research.

  • NIH Implementation Plan for Comparative Effectiveness Research.

  • Office of the Secretary Implementation Plan for Comparative Effectiveness Research.

  • Lessons from Comparative Effectiveness Research in Other Countries:


    Meanwhile, an interesting new report from the Deloitte Center for Health Solutions profiles comparative effectiveness programs in the United Kingdom, Australia, Canada, and Germany. The report nicely lays out the complexity, challenges, and usefulness of comparative effectiveness. It also gives a helpful history of CER in the U.S. To read the report, click here (PDF).

    posted: May 18, 2009

    AHDB_0509.jpgHere are articles from the latest issue of American Health & Drug Benefits. AHDB is the peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries:


    May 2009 Issue:


    The Paradox of Public Policy Reform: Change or Continuum?
    By Robert E. Henry


    Are You Kidding Me? Clinical Comparative Effectiveness or Evidence-Based Medicine
    By Thomas Kaye RPh, MBA, FASHP


    MIPPA: First Broad Changes to Medicare Part D Plan Operations
    By Jean D. LeMasurier and Babette Edgar, PharmD, MBA
    Stakeholder Perspective by Mark Newsom, MSc


    ProvenCare: Geisinger's Model for Care Transformation through Innovative Clinical Initiatives and Value Creation
    Interview with Ronald A. Paulus, MD, MBA


    Perspective: The Integrated Patient-Centered Medical Home: Tools for Transforming Our Healthcare Delivery System
    By Matias A. Klein


    Increased Patient Cost-Sharing, Weak US Economy, and Poor Health Habits: Implications for Employers and Insurers
    By Melinda C. Haren, RN; Kirk McConnell; Arthur F. Shinn, PharmD, FASCP
    Stakeholder Perspective by Paul Anthony Polansky, BSPharm, MBA


    New Legislations on Generics and Biosimilars Brewing in Congress
    By Dalia Buffery, MA, ABD


    Paying for Cancer Care: Economic Models Start to Emerge, Dovetailing Healthcare Reform
    By Caroline Helwick


    Read Current and Past Issues:


    American Health & Drug Benefits (AHDB) is available in print and online at www.AHDBonline.com. To view the current or past issues, click here.


    AHDB also published web exclusives, available for reading here.


    Kip Piper is health policy editor of American Health & Drug Benefits.

    posted: April 1, 2009

    State%20Health%20Access%20Grants.jpgAs part of the FY 2009 Omnibus Appropriations Act, Congress created the State Health Access Grant Program. On a competitive basis, states may receive grants of $2 million to $10 million each year for five years to improve access to health insurance coverage. Grant funds will help cover the cost of staff, actuarial work, etc. to design and implement major state-based reforms.


    The grant funds should help a dozen or more states jump start reforms such as (1) subsidizing access for the uninsured, (2) modernize inefficient enrollment systems, and (3) facilitating choice of affordable insurance products in the market.


    The new program is a great opportunity for health care businesses, such as health plans, to partners with states. States must cover up with 20% match for the grants but some or all of the matching dollars may come from third parties, including health plans, provider groups, or drug manufacturers.


    My friends at Sellers Dorsey have developed an excellent summary of the State Health Access Grant Program.


    The State Health Access Grant Program is the brainchild of House Appropriations Committee Chairman Dave Obey (D, WI) and builds off the earlier State Health Planning Grant Program. The Health Resources and Services Administration (HRSA) will administer the grant program.

    Consider This
    In ancient China, physicians were paid only when their patients were kept well and often not paid if the patient got sick. If a patient died, a special lantern was hung outside the doctor's house. Upon each death, another lantern was added. This is the first known use of the two most powerful drivers for health care performance - incentives and transparency.
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