DEPARTMENT OF HEALTH AND HUMAN SERVICES

DISCLAIMER: The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy. The information is being provided to TPSAC to aid the committee in its evaluation of the issues and questions referred to the committee. The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the advisory committee meeting.

This will enable us to--  New Website Address: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS023618 The MHCQ demonstration will test major changes to improve quality of care while increasing efficiency across an entire health care system. Broadly stated, the goals of the Medicare Health Care Quality demonstration are to--• Improve patient safety; • Enhance quality; • Increase efficiency; and • Reduce scientific uncertainty and the unwarranted variation in medical practice that results in both lower quality and higher costs.
The legislation anticipates that we can facilitate these overarching goals by providing incentives for system redesigns built on adoption and use of decision support tools by physicians and their patients, such as evidence-based medicine guidelines, best practice guidelines, and shared decision-making programs; reform of payment methodologies; measurement of outcomes; and enhanced cultural competence in the delivery of care.

II. Provisions of This Notice
The MHCQ demonstration will test the ability of health care groups to implement major system changes that reallocate resources to improve quality and reduce costs of Medicare Parts A, B, and C. Each proposal is expected to address all of the Institute of Medicine's "Six Aims for Improvement." New Website Address: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS023618 The proposed system redesign should: • include steps to improve patient safety in the delivery of care, • increase the effectiveness of the health care delivered, minimizing the over-and under-utilization of services through the use of best practice guidelines and other measures, • prioritize patient-centeredness in the delivery of care with primary focus on patients' needs and comfort, including increased emphasis on patient education and development of self-care skills, • improve the timeliness of care, significantly reducing delay in the delivery of needed health care services, • emphasize ways of improving efficiency in care delivery and thus improving quality, and • assure equity of care for all persons.
Further, we are persuaded that such system redesign should include the integration of health information technology consistent with the national health information infrastructure strategy and that--• Informs clinical practice; • Interconnects clinicians; • Personalizes health care; and New Website Address: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS023618 • Improves population health.
We intend to use this demonstration to identify, develop, test, and disseminate major and multi-faceted improvements to the entire health care system. The focus will be on redesign projects that "bundle" multiple delivery improvements so as to introduce "system-ness" across the spectrum of care delivery -changes across and even between organizations. The redesign must make the system patientfocused and must undo the effects of a payment methodology that systematically fragments care while encouraging both omissions and duplication of care. At its "grandest," particularly if a demonstration project is conducted by a regional coalition and entails the participation of other payers besides Medicare, this demonstration affords us and the awardees an opportunity to reinvent the health care delivery system.
In keeping with our view that this demonstration authority is intended to test models of basic health care system redesign, including payment reform, we note that the statute provides broad authority for us to waive both payment and non-payment provisions of the Medicare program. Therefore, we are not specifying particular models of health care systems that demonstration applicants must propose and test, but are looking to applicants to specify the models New Website Address: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS023618 they believe they can successfully put into practice for the patients they serve in their communities.
As provided by applicable Federal statute, physician groups, integrated delivery systems, and organizations representing regional coalitions of physician groups or integrated delivery systems are eligible to apply. Payments under the MHCQ demonstration will be made for services furnished to Medicare beneficiaries and will be tied to cost savings, as well as improvements in process and outcome measures, increases in efficiencies, and reductions in costs in the targeted population compared to a similar group or sample. Eligible organizations may propose a variety of payment methodologies as long as those New Website Address: http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.asp?itemID=CMS023618