Comparative changes in treatment practices and clinical outcomes following implementation of a prospective payment system: the STEPPS study.

Background: The aim of the US dialysis Prospective Payment System bundle, launched in January 2011, was reduction and more accurate prediction of costs of services, whilst maintaining or improving patient care. Dialysis facilities could either adopt the bundle completely (100%) in the first year of launch, or phase-in (25%) over four years. Differences in practice patterns and patient outcomes were hypothesized to occur in facilities that phased-in 25% compared to those that did not.

FDA actions against health economic promotions, 2002-2011.

Objective: To investigate Food and Drug Administration (FDA) regulatory actions against drug companies' health economic promotions from 2002 through 2011 to understand how frequently and in what circumstances the agency has considered such promotions false or misleading.

Methods: We reviewed all warning letters and notices of violation ("untitled letters") issued by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) to pharmaceutical companies from January 2002 through December 2011. We analyzed letters containing a violation related to "health economic promotion," defined according to one of several categories (e.

Therapies for advanced cancers pose a special challenge for health technology assessment organizations in many countries.

Health technology assessment organizations evaluate medical therapies and technologies to help inform coverage and reimbursement decisions for payers around the globe. Even as they establish strict review processes, these organizations--and the reimbursement authorities that use their assessments--have sometimes handled cancer interventions with special care. We found that some countries have created separate health technology assessment pathways for cancer treatment, while others have eased access to cancer treatments through end-of-life or disease-severity exceptions within health technology assessment policies.

Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents.

We assessed how much, if anything, people would pay for a laboratory test that predicted their future disease status. A questionnaire was administered via an internet-based survey to a random sample of adult US respondents. Each respondent answered questions about two different scenarios, each of which specified: one of four randomly selected diseases (Alzheimer's, arthritis, breast cancer, or prostate cancer); an ex ante risk of developing the disease (randomly designated 10 or 25%); and test accuracy (randomly designated perfect or 'not perfectly accurate').

Risk-sharing arrangements that link payment for drugs to health outcomes are proving hard to implement.

Risk-sharing agreements, under which payers and pharmaceutical manufacturers agree to link payment for drugs to health outcomes achieved, rather than the volume of products used, offer an appealing payment model for pharmaceuticals. Although such agreements have been widely touted, the experience to date mainly demonstrates how hard they are to implement. Barriers include high implementation costs, measurement challenges, and the absence of a suitable data infrastructure.

Low-value services in value-based insurance design.

Objectives: To identify potentially low-value services for inclusion in value-based insurance design (VBID) programs and to discuss challenges involved in incorporating such information.

Methods: We searched the Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.

Cancer therapy costs influence treatment: a national survey of oncologists.

A national survey of medical oncologists indicates that rising cancer treatment costs are influencing clinical practice, even as oncologists tend not to communicate with patients about costs. The survey shows that 84 percent of oncologists say that patients' out-of-pocket spending influences treatment recommendations. Only 43 percent always or frequently discuss costs with patients.

Is the United States ready for QALYs?

Quality-adjusted life-years (QALYs) are used in cost-effectiveness analyses to aid coverage and reimbursement decisions worldwide. QALYs provide a flexible and convenient metric for measuring and comparing health outcomes across diverse diseases and treatments. But their use has stirred controversy about how accurately they reflect preferences for health care and whether their use is fair.

Costing and perspective in published cost-effectiveness analysis.

Background: Methods for appropriate costing in Cost-effectiveness analyses (CEAs), seemingly straightforward, have always raised questions. Questions linger about what cost components to include under a "societal" perspective, as well as how to value resources.

Objectives: This article discusses issues surrounding costing and "perspective" in published CEA.

Medicare's national coverage decisions for technologies, 1999-2007.

An analysis of Medicare national coverage decisions (NCDs) from 1999 through 2007 reveals that the Centers for Medicare and Medicaid Services (CMS) considers the available evidence as no better than fair for most of the technologies considered. Still, the CMS issues favorable decisions in 60 percent of the cases it takes on, although almost always with conditions placed on coverage. Since enactment of the 2003 Medicare Modernization Act, which legislated maximum review times for NCDs, the CMS has eliminated "long duration" decisions (more than one year) and has issued several "coverage with evidence development" decisions, which promise flexibility but also carry implementation challenges.

Measuring the value of public health systems: the disconnect between health economists and public health practitioners.

We investigated ways of defining and measuring the value of services provided by governmental public health systems. Our data sources included literature syntheses and qualitative interviews of public health professionals. Our examination of the health economic literature revealed growing attempts to measure value of public health services explicitly, but few studies have addressed systems or infrastructure.

A strategic plan for integrating cost-effectiveness analysis into the US healthcare system.

The Panel on Integrating Cost-Effectiveness Considerations into Health Policy Decisions, composed of medical and pharmacy directors at public and private health plans, was convened to (1) explore the views of health plan purchasers about cost-effectiveness analysis (CEA) and (2) to develop a strategic plan for policymakers to address obstacles and to integrate CEA into health policy decisions, drawing on stakeholders as part of the solution. Panelists expressed strong support for a greater role for CEA in US health policy decisions, although they also highlighted barriers in the current system and challenges involved in moving forward. The strategic plan involves a series of activities to advance the use of CEA in the United States, including research and demonstration projects to illustrate potential gains from using the technique and ongoing consensus- building steps (eg, workshops, conferences, town meetings) involving a broad coalition of stakeholders.