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Testimony on Comparative Effectiveness Research

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Purchasers have led many of the healthcare quality improvement initiatives of the past thirty years:  standardized measurement of managed care plans and providers, public reporting and pay for performance.  Purchasers are now focused on understanding the relative value of various treatments, programs, and systems of care in improving health.  A sustainable health care system will require all Americans to make health care decisions that reflect the relative likelihood of favorable outcomes and the commitment of personal and societal resources.

PBGH and its members are unequivocally supportive of comparative effectiveness research and the use of that research to improve health care decision-making and planning, said CEO David Lansky to the Federal Coordinating Committee for Comparative Effectiveness Research.  Too many therapies have value for some but are applied to many, without regard to the relative value and risk associated with the broad use of these treatments.  The new federal commitment to comparative effectiveness research provides the opportunity for an honest, transparent, and evidence-informed discussion about the benefits and risks afforded by different treatment strategies coupled with information on resource use.

The ARRA mandates the Secretary to address our absent infrastructure by encouraging the “development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.”  The Federal Coordinating Council should act aggressively to outline a national information infrastructure approach that will allow us to compile and apply effectiveness information continually.  It will be important to think of the comparative effectiveness enterprise less as a library of research studies, and more as an information-rich decision-making environment, supported by continuous learning from the results of routine care.  Let’s not produce 1,000 more good research papers but fail to create a robust, durable, and modern information infrastructure for continuous learning.  Such an infrastructure should be:

  • Federated:  Providers who are participating in structured registries and other clinical systems should maintain control of their patient data, but have the ability to federate with others to answer questions of mutual interest.
  • Standardized:  Cooperating local data sources should agree to conform to content and messaging standards for a core subset of data, as determined by their professional society and other stakeholders.
  • Integrated:  The network of federated registries and data systems should also have a well-structured interface to large aggregate data sets, including health plan and CMS claims data, RxHub and Surescripts dispensing data, and major laboratory results reporting systems.
  • Rich in feedback:  This infrastructure should support a multi-user environment, in which any authorized user can query the network to answer an appropriate question, and in which structured feedback is frequently provided to health professionals and to the public.

Purchasers believe the following principles should guide CER:

  1. The criteria for defining CER subject areas and priorities should be clearly articulated and patient-centered with consideration of the current variation in care, the magnitude of potential differences in patient outcomes based on alternative treatments, the absence of an existing evidence base for treatment, the amount of expenditures for alternative interventions.  CER investments should be focused on topics with the highest potential to help assure that all patients receive the right care at the right time, every time.
  2. CER should support better care delivery, improved care decision-making by both patients and clinicians, as well as to inform public and private policy making.
  3. CER should support standardized measurement of clinical outcomes, functional status and quality of life, patient experience, impact on health system utilization, episode of care costs and disparities across all patient populations, providers, and practice settings.
  4. The Federal government should establish transparent and open processes that assure CER is answering important and appropriate questions, is doing so with the right methodologies and scope, leverages international and private sector experience, and coordinated among public and private entities.
  5. CER needs to be relevant to users: patients, clinicians, researchers and purchasers.  The design of CER must support and inform patient-clinician decision-making, inform clinical practice guidelines as well as coverage and reimbursement strategies, such as value-based insurance design and performance-based payment.
  6. CER must address the resources required to deliver various therapies so that consumers can evaluate quality and costs.

Purchasers like the members of PBGH are impatient to see the health care system create the information-rich environment that has long been expected in other industries like aviation, finance, and manufacturing.  An infrastructure for data aggregation and analysis must be created to allow the many millions of engaged patients, families, and health professionals to fully participate in the decisions that will affect their health and their finances.

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Jenny Hu
Policy Analyst
Consumer-Purchaser Alliance

Email: jhu@pbgh.org
Tel: 415-615-6358