HISTORY

The 1999 Institute of Medicine (IOM) report, To Err is Human: Building A Safer Health System, set a national agenda for reducing medical errors and improving health care quality. As a result, Congress, the administration, and industry have responded by proposing legislation, regulations, and other initiatives to improve safety and quality.

Comparative Effectiveness

The 110th Congress has shown strong interest in and support for research on the comparative effectiveness of medical interventions for medical conditions.
 
In June 2007, the Health Subcommittee of the House Committee on Ways and Means held a hearing to examine a comparative effectiveness bill sponsored by Rep. Tom Allen (D-ME).  The bill (H.R. 2184) would establish a comparative effectiveness advisory board and related clinical advisory panels to determine priorities in comparative effectiveness research, which would then be conducted by the Agency for Healthcare Research and Quality. The hearing solicited testimony from a variety of stakeholders significantly involved in the comparative effectiveness debate, including Gail Wilensky (Project HOPE), the Medicare Payment Advisory Commission (MedPAC), and Carolyn Clancy (AHRQ). 

The House-passed “Children’s Health and Medicare Protection Act” contained provisions based on H.R. 2184 that would have created a new comparative effectiveness research center, funded by Medicare and other payers, and a politically independent commission to set research priorities. The bill also would have expanded a Medicare demonstration program for medical homes and enabled proactive chronic care management and prevention, better use of information technology, and other reforms of primary care. In addition, HHS was required under the bill to coordinate development of quality measures to avoid a proliferation of competing measures and to promulgate a plan for systemwide health IT use in Medicare.  The Congressional Budget Office's review of the comparative effectiveness provisions said that they would result in a net increase of $1.1 billion in direct federal spending through 2017. The comparative effectiveness provisions were removed from the conference version of the legislation, which the president subsequently vetoed.  The Senate has not yet produced a proposal.

The IOM continues to hold a series of meetings and workshops related to its Roundtable on Evidence-Based Medicine, which is co-chaired by HLC Chairman Denis Cortese, Mayo Clinic. Its latest workshop focused on innovative and practice-based approaches to clinical effectiveness research, which compares the effectiveness of medical interventions.

In late December, CBO released a report entitled “Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role,” prepared at the request of Senate Finance Committee Chairman Max Baucus (D-MT) and Budget Committee Chairman Kent Conrad (D-ND). The report examines the current state of comparative effectiveness research, as well as several options for organizing and funding additional federal efforts. The report emphasizes that curbing rising health spending in both the public and private sector will be necessary for the nation’s long-term economic security. Following release of the report, Senator Baucus released a press release indicating that he and Senator Conrad would hold hearings and introduce legislation that would make comparative effectiveness “central” to his plans for health reform.

In late November, AHRQ gave notice that it will consider applications for FY 2008 research career development grant requests to focus on developing and improving research and methodologies for conducting comparative effectiveness research and integrate evidence into health care decision making. The details of the notice indicate that AHRQ continues to recognize a need to develop methods by which observational studies may be used in comparative effectiveness analysis.  Clinical researchers may also apply for grants to develop new evidence that fills knowledge gaps related to the comparative effectiveness of interventions related to a list of 10 diseases and conditions identified in the notice as of particular relevance to Medicare beneficiaries. 

MedPAC’s “Report to the Congress:  Promoting Greater Efficiency in Medicare” included a chapter devoted to recommendations on collecting comparative effectiveness information.  Among its recommendations, MedPAC urged Congress to form an independent entity to sponsor such research and disseminate findings to patients, providers, and payers. The report examined various options for placement and design of the entity, as well as different funding models, recommending that safeguards be installed to prevent private funds from improperly affecting research results.

Value-based Purchasing and Reporting of Quality Measures

Legislation passed in June 2007 by the Senate Health, Education, Labor and Pensions Committee, the “Wired for Health Care Quality Act,” directs the secretary of HHS to develop or adopt a quality measurement system that includes measures to determine the quality and efficiency of care patients received.  Under the legislation, the secretary is required to designate an organization to provide advice and recommendations on the key elements and priorities of a national system for health care performance measurement. Though broad support exists for the Senate legislation, progress has been held up due to concerns over a proposed amendment related to privacy offered by Judiciary Committee Chairman Patrick Leahy (D-VT).  House action on related legislation has not yet commenced but is expected in 2008.

Congress and the administration have already taken action to begin a value-based purchasing program in the federal Medicare Program. In January 2006, the Congress passed S. 1932, the “Deficit Reduction Act of 2005” (DRA), which the president signed into law (P.L. 109-171) in early February.  The law requires HHS to develop a plan to implement a value-based purchasing program for hospitals under Medicare beginning in 2009. In November 2007, CMS presented a “Plan to Implement a Medicare Hospital Value-Based Purchasing Program” to Congress.  The plan proposes tying anywhere from 2 to 5 percent of the current base diagnosis-related group (DRG) payment to both relative attainment and improvement on reportable quality measures. The VBP model would be phased in over a 3-year transition period and would build on the current Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program.  CMS had previously held several public listening sessions, and in March released an options paper outlining a proposed Medicare hospital VBP program.  Senate Finance Committee ranking member Charles Grassley (R-IA) was quick to endorse the plan and has urged Congress to quickly consider legislation that would grant the necessary approval and framework.  

Beginning July 1, 2007, physicians and other clinicians became eligible for bonus payments for reporting quality information in certain areas.  The bonus payment, subject to a cap, is the equivalent of 1.5 percent of total allowed charges for covered physician fee schedule services provided from July 1 through December 31, 2007. The “Medicare, Medicaid, and SCHIP Extension Act of 2007” (P.L. 110-173), enacted in December 2007, provides additional funds to the Physician Assistance and Quality Initiative Fund for the purposes of continuing PQRI through FY 2009.

With work on these priorities ongoing, the administration and others are hard at work on other efforts to advance reporting of quality measures and value-based purchasing.

CMS continues to make progress on several demonstration projects to facilitate the development and implementation of a set of Pay for Performance (P4P) initiatives to support quality improvement in Medicare. Two HLC members — Premier, Inc., and Marshfield Clinic — are participating. CMS recently announced that all of the physician groups participating in the Medicare Physician Group Practice (PGP) Demonstration have shown improvements in quality and generated cost savings in the management of diabetes during the first year of the project. The three-year demonstration, which began on April 1, 2005, is designed to reward providers for coordinating and managing the overall health care needs of Medicare patients with chronic conditions. Furthermore, the Premier Hospital Quality Incentive demonstration has proven effective, with decreases in both mortality and cost over a three-year period.

The 2008 Medicare Physician Fee Schedule (MPFS) Final Rule identifies 119 measures that CMS has selected for eligible professionals to report under the 2008 physician quality reporting initiative (PQRI). The rule also describes CMS' plans in 2008 to test quality measures data submission mechanisms based on clinical data registries and electronic health records. In December, CMS held a national provider call to discuss its decision to continue the Physician Quality Reporting Initiative (PQRI) in 2008 and how physicians may voluntarily participate.

The president also took a significant action in August 2006, signing an executive order requiring federal health agencies to provide information about the pricing and quality of health services to beneficiaries and enrollees. In developing quality measures for reporting, the executive order specified a multistakeholder process.  Private and government sources will develop provider and health plan-level quality measures which will involve aggregate, rather than individually identifiable, patient data.  Agencies were required to be in compliance with the executive order by January 1, 2007.

On October 2, 2007, the Robert Wood Johnson Foundation (RWJF) announced that it will fund the Engelberg Center for Health Care Reform at the Brookings Institution, directed by Mark McClellan, America’s Health Insurance Plans (AHIP) Foundation, and others to support the vision of the Quality Alliance Steering Committee (QASC).  The QASC project will combine data from many different national health plans to provide a broader picture of physicians’ care across their entire practices. It will work with Medicare to aggregate data across the public sector and the private sector. The project will use quality measures endorsed by the National Quality Forum (NQF), and it will collaborate to develop and implement new measures for comparing the cost of care. 

Efforts in previous Congresses have also supported patient safety initiatives. In 2000, Congress approved the creation of a center for patient safety within the Agency for Healthcare Research and Quality (AHRQ), under the jurisdiction of HHS. In 2002, the Department of Health and Human Services launched national quality initiatives for both the nursing home and hospital industries.  The Hospital Quality Information Initiative, a joint effort by HHS and a coalition of hospital industry organizations, will create a national strategy to make hospital performance information available to the public. The effort will use a common set of measures and priorities that relate to conditions or aspects of care, beginning with three specific conditions. The Nursing Home Quality Information Initiative will provide similar information on the quality of care provided in nursing homes. 

Private organizations also have contributed to the dialogue on improving patient safety and measuring quality of care. The National Quality Forum (NQF), a membership organization that endorses consensus standards for quality measurement and public reporting, announced the endorsement of five clinician-level national voluntary consensus standards for peri-operative care in July of 2007.  These new standards for gauging and publicly reporting the quality of care bring to 126 the total number of NQF-endorsed voluntary consensus standards for clinician-level performance.


THE FUTURE

The authors of the IOM report stated that "large, complex problems require thoughtful, multifaceted responses." A zero-error medical environment requires the devoted, thoughtful collaboration of everyone, including lawmakers, providers, health systems, and patients. Patient safety legislation enacted in the beginning of 2005 laid the groundwork for such an environment. P4P legislation enacted in early 2006 continued the drive toward improvements to the health care delivery system. 

Continued congressional and administration interest in efforts to develop greater quality transparency for reporting and performance initiatives suggests that the 110th Congress will continue to move forward on improving quality for patients and consumers. Potentially, an entity may be created to conduct comparative effectiveness research. In the development of such proposals Congress must make every effort to ensure that such entities and measures are collaborative, and clinicians and hospitals continue to be rewarded for quality improvement and not penalized for falling short of their colleagues’ and competitors’ best efforts.