Introduction: Medicare Section 1013 and AHRQ's Effective Health Care Program.

OBJECTIVE: To introduce Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Agency for Healthcare Research and Quality's (AHRQ) Effective Health Care Program. BACKGROUND: AHRQ, under Section 1013 of the MMA of 2003, has been charged with conducting specific health care outcomes studies through the Effective Health Care Program. This research is aimed specifically at determining the safety and effectiveness of certain pharmaceuticals since comparative data is currently lacking. Highly utilized, high-cost (or both) treatments are the focus of the studies that will be conducted through AHRQ's Evidence-based Practice Centers (EPCs) and the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. Current and completed projects are noted, including more detailed information on the reviews pertaining to treatment of rheumatoid arthritis with nonbiologic disease-modifying antirheumatic drugs (DMARDs) and biologics (anti-tumor necrosis factor [TNF]-alpha therapies). SUMMARY: AHRQ's EPCs and the DEcIDE Network are studying safety and the comparative effectiveness of a number of different pharmaceutical-related topics, including the safety and effectiveness of biologic and nonbiologic DMARDS (e.g., TNF antagonists). The final reports, once complete, will be translated (explained in terms that can be more easily understood by all decision makers) and then disseminated to all stakeholders.

The comparative safety and effectiveness of TNF-alpha antagonists [corrected].

OBJECTIVE: To describe the current knowledge on safety and effectiveness of the tumor necrosis factor (TNF)-alpha antagonists and identify current knowledge/ evidence gaps for study by the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program. BACKGROUND: Evidence-based Practice Centers (EPCs) and the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network of AHRQ's Effective Health Care Program will study the safety and effectiveness of biologic and nonbiologic disease-modifying antirheumatic drugs (e.g., TNF-alpha antagonists). The current knowledge of safety and effectiveness of TNF-alpha antagonists is reviewed. SUMMARY: Treatment of adult rheumatoid arthritis (RA) involves determining which agents are safe, effective, and cost effective for an individual. Each individual patient's health system may also play a role in which agents are chosen. Many agents are available for the management of RA, some with high cost and unknown safety. Section 1013 of the Medicare Modernization Act of 2003 authorizes AHRQ to study comparative effectiveness and safety of RA treatments through both EPCs and DEcIDE centers to develop scientific knowledge for RA management as well as through epidemiologic studies. Results will be compiled through a Clinical Decisions and Communications Science Center, then disseminated to all appropriate stakeholders, including patients, payers, and health care professionals. The current knowledge of safety and effectiveness of TNF-alpha antagonists in the treatment of RA is reviewed. Increased rates of serious infections, including Mycobacterium tuberculosis (MTB), or tuberculosis reactivation, may occur with the use of TNF-a antagonists. It is still unclear if RA increases the risk of developing cancer, or if use of TNF-alpha antagonists increases cancer risk. CONCLUSIONS: TNF-alpha antagonists are costly, yet effective treatments for early and late RA. Use of these agents provides rapid relief of RA symptoms and provides positive outcomes, defined as improvements in American College of Rheumatology 20, 50, 70 scores; Health Assessment Questionnaire ratings; activities of daily living; joint space narrowing; erosions; and acute-phase reactants. Reactivation of latent MTB or onset of other infections or cancers may occur in RA patients with TNF-alpha antagonists.

AHRQ's Effective Health Care Program: its impact on managed care.

OBJECTIVE: To describe some of the managed care perspectives regarding the data development and coverage issues. BACKGROUND: Section 1013 of the Medicare Modernization Act of 2003 has initiated the formation of the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program, which is evaluating the treatments for rheumatoid arthritis (RA) in the Medicare population. The results of these studies have the potential to impact future drug utilization. It is not known whether this data could be applied to the commercial population. SUMMARY: Payers (e.g., managed care organizations, pharmacy benefit managers) make decisions about which drugs will be covered and to which formulary "tier" the drug will be assigned. These decisions are made by evaluating current evidence based on safety, effectiveness, outcomes, and cost. Patients believe in a "warranty" of care, meaning that there will always be a treatment option whether they are compliant with their treatment regimen or not. All treatments are measured by a "value," and each stakeholder may see this value differently. A return on medical investment is one way to assess this value. CONCLUSIONS: Different stakeholders view treatment value in different ways. The evidence that will be identified through AHRQ's Effective Health Care Program will partially define this value. If this model succeeds, it has the potential to significantly affect health care.

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.

Clifton Gaus, Administrator of the Agency for Health Care Policy and Research. Interview by Mark Hagland.

Clifton Gaus, Sc.D., joined the federal Agency for Health Care Policy and Research (AHCPR) last July, at a time when the agency's star had reached its zenith. With positive response from the field for its work in outcomes measurement research and the development of clinical guidelines, AHCPR was able to cite an array of accomplishments since its creation by Congress in 1989 (when the National Center for Health Services Research was subsumed into the new agency). But now AHCPR faces possibly severe budget cuts, or even elimination, by congressional leaders bent on balancing the budget. Gaus spoke last month with executive editor Mark Hagland on the agency's budget battles, its achievements to date, and its future.

Legal liability under managed care.

Market forces are driving the delivery of health care into managed care. New alignments among health care providers, payers, utilization reviewers and hospitals create new legal liability. Better-informed patients, concurrent credentialing by hospitals and payers, and new incentives to reduce hospital and physician-related costs have resulted in new federal legislation and agencies that reshape health care delivery and legal liability.

The legislative battle over health services research.

Budget reconciliation legislation in 1989 created the new Agency for Health Care Policy and Research (AHCPR), which folded in the National Center for Health Services Research and Health Care Technology Assessment, among the law's other provisions. The creation of the new agency represented a shift in priorities toward outcomes and effectiveness research in medical practice and made explicit the federal government's role in developing practice guidelines. The new agency was born in the midst of an extraordinary bipartisan budget negotiation process in late 1989; its becoming linked to the contentious issue of physician payment reform nearly killed the new agency before it appeared. The narrative of political wrangling that resulted in the creation of AHCPR spans Capitol Hill, the White House, the agencies of the Department of Health and Human Services, and renowed health services researchers on either coast and in Washington, D.C.