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The medical care of elderly Medicare beneficiaries who died between 1985 and 1995 is analyzed to assess the consequences of advance medical directives. The care of patients from states that adopted laws enhancing incentives for compliance with advance directives and laws requiring the appointment of health care surrogate in the absence of an advance directive to the care of patients from states that did not have been compared.

Direct reforms improve medical productivity by malpractice claims rates and also compensation conditions on a claim. The policies that reduce the time spent and amount of conflict involved in defending a claim can also reduce defensive practices.

RWE has potential to provide efficient and relevant information on the effectiveness of medical products, complementing the data generated in clinical trials; however, how RWE can support regulatory decision‐making is unclear, potentially limiting its use. The objective of this study was to identify and characterize instances where RWE was included in the evidence package to support the effectiveness of a medical product regulated by U.S. Food and Drug Administration. A retrospective landscape analysis was conducted to identify instances where RWE was submitted to support effectiveness through targeted review of white and gray literature and publicly available FDA reviews of medical products. Trained evaluators examined FDA reviews to determine if and how RWE contributed to regulatory decision‐making regarding effectiveness. Evaluators identified 34 instances of RWE submitted between 1954 and 2020, where 26% of instances were for oncology, 18% for hematology, and 12% for neurology. Over 50% of the products were indicated for use in rare disease or pediatric populations. 82% of products where RWE was submitted received an orphan designation. RWE was included in the product label in 59% of instances. Stated reasons indicating why submitted RWE did not significantly contribute to regulatory decision‐making included lack of pre‐specification of study design and analysis as well as data reliability and relevancy concerns. While there is historical use of RWE to support medical product effectiveness for oncology and rare diseases, potential exists to leverage the strengths of RWE to support other therapeutic areas and capture outcomes that are most relevant to patients. [ABSTRACT FROM AUTHOR]

Background: Quality measurement has become a priority for national healthcare reform, and valid measures are necessary to discriminate hospital performance and support value‐based healthcare delivery. The Commission on Cancer (CoC) is the largest cancer‐specific accreditor of hospital quality in the United States and has implemented Quality of Care Measures to evaluate cancer care delivery. However, none has been formally tested as a valid metric for assessing hospital performance based on actual patient outcomes. Methods: Eligibility and compliance with the Quality of Care Measures are reported within the National Cancer Database, which also captures data for robust patient‐level risk adjustment. Hospital‐level compliance was calculated for the core measures, and the association with patient survival was tested using Cox regression. Results: Seven hundred sixty‐eight thousand nine hundred sixty‐nine unique cancer cases were included from 1323 facilities. Increasing hospital‐level compliance was associated with improved survival for only two measures, including a 35% reduced risk of mortality for the gastric cancer measure G15RLN (HR 0.65, 95% CI 0.58–0.72) and a 19% reduced risk of mortality for the colon cancer measure 12RLN (HR 0.81, 95% CI 0.77–0.85). For the lung cancer measure LNoSurg, increasing compliance was paradoxically associated with an increased risk of mortality (HR 1.14, 95% CI 1.08–1.20). For the remaining measures, hospital‐level compliance demonstrated no consistent association with patient survival. Conclusion: Hospital‐level compliance with the CoC's Quality of Care Measures is not uniformly aligned with patient survival. In their current form, these measures do not reliably discriminate hospital performance and are limited as a tool for value‐based healthcare delivery. [ABSTRACT FROM AUTHOR]

New prescription-drug coverage under Medicare was launched in the US on January 1, 2006, whereby the benefit is provided by competing 'stand-alone' private drug plans that work with the traditional fee-for-service Medicare benefit and by plans that are part of private Medicare Advantage programs. The Centers for Medicare and Medicaid Services (CMS) claims Medicare Part D is being successfully implemented May 2006, despite the initial start-up challenges.

The Centers for Medicare and Medicaid Services have developed the blueprint for the drug benefit, which would help patients, and doctors work together to alleviate symptoms and reduce the rate of complications of serious illness. The blueprint aims to have access to high-quality, affordable drug coverage, continuous access to drugs needed by the chronically ill and wide array of benefits to consumers.