The American Recovery and Reinvestment Act (ARRA) included a major expansion of federal efforts to compare the effectiveness of different medical treatments, including more than $1 billion in funding for comparative effectiveness research (CER). Two federal panels recently released reports on CER priorities under the ARRA. First, the Federal Coordinating Council for Comparative Effectiveness Research issued its recommendations for a strategic framework for CER activity and investments. The Council recommended that the primary investment for CER funding should be data infrastructure (e.g., linking current data sources to enable answering CER questions, development of distributed electronic data networks and patient registries, and partnerships with the private sector). Other key areas for research identified by the Council are:

  • Medical and assistive devices (e.g., comparing rehabilitative devices).
  • Procedures and surgery (e.g., evaluating surgical options or surgery versus medical management).
  • Diagnostic Testing (e.g. comparing imaging modalities for evaluating certain types of cancer).
  • Behavioral change (e.g., developing and assessing smoking cessation programs).
  • Delivery system strategies (e.g., testing two different discharge process care models on readmission rates or testing two different medical home models on preventing hospital admissions and improving quality of life).
  • Prevention (e.g., comparing two interventions to prevent or decrease obesity, comparing strategies for reaching populations that do not access the health care system with prevention efforts).

Separately, on June 30, 2009, the Institute of Medicine (IOM) released its ARRA-mandated report on “Initial National Priorities for Comparative Effectiveness Research,” which identifies 100 heath topics that should get priority attention and funding under federal comparative effectiveness efforts. Priority topics include health delivery, health disparities, cardiovascular care, geriatrics, psychiatry, endocrinology, and oncology/hematology, among many others. The IOM cautions, however that comparative effectiveness research “will not yield real improvements unless the results are adopted by health care providers and organizations and integrated into clinical practice.”   A Washington Legal Foundation “Critical Legal Issues Working Paper Series” article by Reed Smith attorneys Areta Kupchyk and Kathleen McGuan entitled “Comparative Effectiveness: Refining the Standards for FDA Approval & CMS Coverage,” is available here.