Commentary: Evaluating oversight of human drugs and medical devices.

This article seeks to provide insights into appropriate FDA oversight of nanotechnology. This commentary identifies limitations in the methodology employed and concludes that the analysis would be stronger with a more in-depth institutional dimension based on administrative law and political science research.

The impact of Medicare coverage policies on health care utilization.

Objective: To determine whether Medicare coverage policies affect utilization of services in Medicare.

Data Sources: We constructed an analysis data set for eight different procedures using secondary data obtained from Medicare claims (1999-2002) and Medicare coverage policies posted on Center for Medicare and Medicaid Services website.

Study Design: We analyzed the impact of coverage policies using difference-in-difference approach in a regression framework.

Implementing evidence-based medicine through medicare coverage decisions.

Management of technology diffusion to improve quality and constrain spending in health care remains an elusive goal. Along with efforts to improve the quality of evidence, providers and payers must ensure that evidence actually effects changes in practice. Medicare coverage policies grant, limit, and condition payment based on evidentiary standards.

External review of health plan denials of mental health services: lessons from Minnesota.

There has been concern that health plans unfairly deny claims for mental health services. This study examines a unique Minnesota program that resulted from a legal settlement. An independent panel reviews all mental health service denials in the state's three largest health plans.

Rules for medical markets: the impact of medicare contractors on coverage policies.

Objective: Examine Medicare's local contractors' claim payment rules, focusing on how technology affects the balancing of competing demands to respond to local medical markets (rule heterogeneity) with concerns about national consistency in payment rules (rule homogeneity).

Data Sources: Local medical review policies (LMRPs) posted in policy sets by contractor organizations on the Centers for Medicare and Medicaid Services (CMS) website and a survey of Contractor Medical Directors.

Study Design: We classified LMRPs based on type (NT=new technology; TE=technology extensions, and UM=utilization management), and examined the effect of technology type on LMRP focus, evidence use, policy revisions, implementation speed, and reference material citation characteristics of LMRPs using multivariate analysis.

Defining a future for fee-for-service Medicare.

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) provides economic incentives that favor health plans over traditional fee-for-service (FFS) Medicare. This reflects an ideological preference for private plans rather than government-administered pricing and recognition that private plans can use tools effectively to improve quality. However, enrollment projections indicate that FFS will continue to attract the majority of beneficiaries for years to come.

Variation in Medicare's local coverage policies: content analysis of local medical review policies.

Objective: To assess variation in the content of Medicare's local medical review policies.

Study Design: Six case studies to compare differences in coverage policies by diagnosis codes, procedure codes, and indications for use.

Methods: All carrier policies from 48 carrier contracts (n = 5213) posted to the Centers for Medicare & Medicaid Services Web site were downloaded on May 31, 2001.

Resolving the tug-of-war between Medicare's national and local coverage.

Medicare's decentralized local coverage policy process leads to policy variation, raising serious equity and quality issues. The policy debate resembles a tug-of-war, with advocates favoring nationalization of all local policies or arguing for the status quo. We extensively analyzed thousands of local policies and surveyed Medicare's contractors.

Focus on locus: evolution of Medicare's local coverage policy.

Medicare relies on a highly decentralized local-contractor structure that emerged as a political compromise in 1965. Decisions regarding Medicare's coverage of new procedures and technologies are an important part of the program. A national coverage process exists, but Medicare's local contractors develop most coverage policies.

Politics of prevention: expanding prevention benefits in the Medicare program.

It is critical that public health advocates understand the structure of the Medicare program and the impact of the political process on Medicare's benefit set. This article provides an overview of the design of Medicare and its explicit exclusion of prevention benefits in the original legislation. We then provide a history of subsequent legislation authorizing coverage of specific prevention benefits over the last twenty years.

Why Medicare cannot promulgate a national coverage rule: a case of regula mortis.

For over twenty-five years, Medicare has tried to promulgate a rule to implement the broad congressional directive to pay only for items and services that are "reasonable and necessary." A rule would clarify legal authority and describe specific criteria for evaluation of new technology in Medicare. This case study is an intractable example of a larger issue of regula mortis or dead rule.