BCBSA

Improving Health Care Value: Quality and Cost

Background: Researchers and policymakers agree there often is not enough information on what medical treatments work best.  Providers and patients must make important decisions without knowing how different treatments compare, and the health care system is unable to offer incentives to encourage use of more effective treatments.

Position: The Blue Cross and Blue Shield Association (BCBSA) is committed to ensuring that patients receive the right care at the right time, and providers have the information necessary to provide this optimal level of care.  BCBSA strongly recommends that Congress pass legislation creating a new Institute that would support research comparing the effectiveness of new and existing procedures, drugs, devices, and biologics based on four key principles:

  1. funding should be ensured by asking all payers – government and private – to contribute;
  2. the Institute should support a broad range of research, especially clinical trials;
  3. significant education programs and incentives are needed; and
  4. the new Institute should be governed by a board with both public and private representation.

BCBSA believes that federal legislation creating a new Institute to support comparative effectiveness research is essential to improving health care quality and improving the affordability of coverage.  Today, much of the health care delivered lacks a basis in evidence.  The end result:  patients pay more for sub-optimal care.  One study estimates up to 30% of health care spending pays for ineffective, inappropriate, or redundant care.1Another study estimated that only 54% of acute care and 56% of chronic care provided by physicians conforms to medical literature.2

 

The absence of good evidence can result in harmful care.  For example, in the mid to late 1980s, some studies provided limited evidence that autologous bone marrow transplant/high-dose chemotherapy (ABMT/HDC) was more effective than conventional chemotherapy for treating metastatic breast cancer.  However, after rigorous clinical trials were performed in the 1990s, it became apparent that conventional chemotherapy was superior to ABMT/HDC.  Thus, some 30,000 women were unnecessarily subjected to ABMT/HDC.  ABMT/HDC is estimated to have caused around 600 premature deaths.

The ABMT/HDC story – with the approximately 10-year delay in producing credible comparative information – shows the negative impacts that can occur due to insufficient research being done in critical areas.  In particular, expense is a major factor why not enough comparative clinical trials are being done – for example, the recent COURAGE study (comparing coronary stents versus drugs) cost approximately $33.5 million, and the ALLHAT study (comparing different antihypertensive and lipid-lowering drugs) cost more than $83 million.  While several federal agencies conduct some health services research, none has a strong focus on supporting comparative clinical trials.  For example, NIH does not have a significant focus on comparative trials, and AHRQ's modest budget is generally spent on literature reviews and other studies.  Furthermore, many of the clinical trials supported by the private sector focus on establishing product efficacy for purposes of FDA approval and typically do not involve comparisons to other treatment options.

BCBSA supports the following key principles for the development of a comparative effectiveness institute:

Funding Should Be Assured By Asking All Health Care Payers to Contribute

The most significant challenge in creating a new Institute is ensuring a stable and significant funding source.  BCBSA believes that the Institute should be funded by assessments on all private coverage (insured and self-funded) and public health care coverage such as Medicare, Medicaid, and other government programs.  BCBSA recommends a budget of no more than $375 million annually when the Institute is fully operational.  Broad-based funding ensures that all payers contribute to the development of new information that benefits the health care system as a whole.

The Institute Should Support a Broad Range of Research, Especially Clinical Trials

The Institute should prioritize and fund a variety of research – including clinical trials, cohort studies, literature reviews, and other studies – evaluating the comparative clinical and cost effectiveness of different procedures, drugs, devices, and biologics.  A broad research role is important because:

 

·        No government agency (e.g., NIH, AHRQ, etc.) currently has a significantly funded and dedicated focus on comparative clinical research; and

 

·        The great costs of comparative clinical trials make it unlikely that other entities will have the resources to sponsor them.

 

The Institute also should encourage improved efficiency by collaborating with the institutions that receive comparative research contracts to identify best practices and efficiencies to maximize research dollars.

Significant Education and Incentives Are Needed to Ensure New Research Improves Clinical Practice

The Institute should ensure that new comparative information is disseminated to providers, patients, and others.  Because experts estimate that medical research currently takes 17 years to be incorporated into practice, it is especially important that this information be provided in formats providers easily can use.  The Institute should work with medical societies to develop consensus practice guidelines drawing on the Institute's research, and electronic health records should be required to incorporate these guidelines into their clinical decision support systems.

In addition, the guidelines' evidence-based standards should create rebuttable presumptions concerning the standards of care that providers are expected to meet in medical malpractice cases.  Providers that reasonably rely on the guidelines should be given safe harbors for noneconomic (e.g., pain and suffering) and punitive damages, even if their use of the guidelines is later judged to be mistaken.  Similar protections should apply to insurers in adjudicating claims. 

Finally, Medicare and other public programs should be required to consider the Institute's research in developing pay-for-performance, coverage, reimbursement, and other policies.

The New Institute Should Be an Independent Entity

The Institute should be structured as an independent, not-for-profit entity.  The Institute should be governed by a board of experts who bring the perspectives of a wide range of stakeholders (e.g., providers, consumers, government, health insurers, employers, and, manufacturers).  This public-private structure is intended to achieve two related goals:

  • The Institute should be accountable to the public, given its mission and large budget; and

  • The Institute should be protected from political pressures so it can establish and maintain a reputation as a credible source for information on evidence-based medicine.

The Institute may contract with existing entities (e.g., AHRQ) to facilitate research.

1. Fisher, E., Wennberg, D., et al., The Implications of Regional Variations in Medicare Spending:  Part 2, Health Outcomes and Satisfaction with Care, Annals of Internal Medicine 2003; 138:288-98.

2. McGlynn E.A., et al., The Quality of Care Delivered to Adults in the United States, New England Journal of Medicine 2003; 348:2635-45.