New from the Institute of Medicine

September was an exciting month for those awaiting reports from the Institute of Medicine. Two significant reports have come forth that consolidate prevailing opinions, identify controversies, and set a possible course of action to improve the safety and delivery or health care in this country.

The September 21 release of "Rewarding Provider Performance: Aligning Incentives in Medicare" analyzes the promise and risks of instituting a pay-for-performance program within Medicare to encourage a more effective health care system.

The September 22 release of "The Future of Drug Safety: Promoting and Protecting the Health of the Public" raises concerns and controversies surrounding the safety of medications and the processes the FDA employs to achieve its mission.

Provider Performance
Concerning provider performance, the IOM report provides a long list of recommendations:

• The Secretary of the Department of Health and Human Services (DHHS) should implement pay for performance in Medicare using a phased approach as a stimulus to foster comprehensive and system-wide improvements in the quality of health care.
• Congress should derive initial funding (over the next 3-5 years) for a pay-for-performance program in Medicare largely from existing funds. Congress should give the Secretary of DHHS the authority to aggregate the pools for different care settings into one consolidated pool from which all providers would be rewarded when the development of new performance measures allows for shared accountability and more coordinated care across provider settings. In designing a pay-for-performance program, the Secretary of DHHS should initially reward health care that is of high clinical quality, patient-centered, and efficient.
• The Secretary of DHHS should design a pay-for performance program that initially rewards both providers who improve performance significantly and those who achieve high performance.
• Because public reporting of performance measures should be an integral component of a pay-for-performance program for Medicare, the Secretary of DHHS should offer incentives to providers for the submission of performance data, and ensure that information pertaining to provider performance is transparent and made public in ways that are both meaningful and understandable to consumers.
• The Secretary of DHHS should develop and implement a strategy for ensuring that virtually all Medicare providers submit performance measures for public reporting and participate in pay for performance as soon as possible. Initially, measure sets may need to be narrow, but they should evolve over time to provide more comprehensive and longitudinal assessments of provider and system performance. For many institutional providers, participation in public reporting and pay for performance can and should begin immediately. For physicians, a voluntary approach should be pursued initially, relying on financial incentives sufficient to ensure broad participation and recognizing that the initial set of measures and the pace of expansion of measure sets will need to be sensitive to the operational challenges faced by providers in small practice settings. Three years after the release of this report, the Secretary of DHHS should determine whether progress toward universal participation is sufficient and whether stronger actions- such as mandating provider participation are required.
• CMS should design the Medicare pay-for-performance program to include components that promote, recognize, and reward improved coordination of care across providers and through entire episodes of illness. Thus, CMS should (1) encourage beneficiaries and providers to identify providers who would be considered their principal responsible source of care, and (2) pay for and reward successful care coordination that meets specified standards for providers who take on that role.
• Because electronic health information technology will increase the probability of a successful pay-for-performance program, the Secretary of DHHS should explore a variety of approaches for assisting providers in the implementation of electronic data collection and reporting systems to strengthen the use of consistent performance measures.
• The Secretary of DHHS should implement a monitoring and evaluation system for the Medicare pay-for-performance program in order to:
  - Assess early experiences with implementation so timely corrective action can be taken.
  - Evaluate the overall impact of pay for performance on clinical quality, patient-centeredness and efficiency.
  - Identify the best practices of high-performing delivery settings that should be shared with others to improve care throughout the nation.

Complementary recent publications in this area include:

• Medicare's Quality Improvement Organization: Maximizing Potential (March 2006)
• Performance Measurement: Accelerating Improvement (December 2006)

Drug Safety

In the drug safety publication, the committee found that:

• There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry. Most stakeholders--the agency, the industry, consumer organizations, Congress, professional societies, health care entities--appear to agree on the need for certain improvements in the system.
• The drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement.
• FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.
• Noting that resources and therefore efforts to monitor medications' risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

Recommendations of the committee include:

• Labeling requirements and advertising limits for new medications
• Clarified authority and additional enforcement tools for the agency
• Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits
• Mandatory registration of clinical trial results to facilitate public access to drug safety information
• An increased role for FDA's drug safety staff A large boost in funding and staffing for the agency