Federal 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):

Prioritization Criteria:

The criteria for scientifically meritorious research and investments are:

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:

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).

Here 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.

As 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.