No abstract

There are multiple payers in the US health care system, each making its own coverage determinations for medical technologies. For each of the forty-seven medical devices considered in national coverage determinations (NCDs) of the Centers for Medicare and Medicaid Services (CMS) issued between February 1999 and August 2013, we compared CMS's coverage policy with the policies issued by the largest sixteen private payers that made their decisions publicly available. Overall, we found that NCDs were equivalent to the corresponding private payer policies roughly half of the time, more restrictive approximately a quarter of the time, and less restrictive about a quarter of the time. Our findings indicate that patients may have variable access to medical technology across Medicare and private plans. They also suggest that private plans do not necessarily follow CMS's lead in making coverage decisions.

We examined Medicare national coverage determinations for medical interventions to determine whether or not they have become more restrictive over time. National coverage determinations address whether particular big-ticket medical items, services, treatment procedures, and technologies can be paid for under Medicare. We found that after we adjusted for the strength of evidence and other factors known to influence the determinations of the Centers for Medicare and Medicaid Services (CMS), the evidentiary bar for coverage has risen. More recent coverage determinations (from mid-March 2008 through August 2012) were twenty times less likely to be positive than earlier coverage determinations (from February 1999 through January 2002). Furthermore, coverage during the study period was increasingly and positively associated both with the degree of consistency of favorable findings in the CMS reviewed clinical evidence and with recommendations made in clinical guidelines. Coverage policy is an important payer tool for promoting the appropriate use of medical interventions, but CMS's rising evidence standards also raise questions about patients' access to new technologies and about hurdles for the pharmaceutical and device industries as they attempt to bring innovations to the market.

Specialty drugs are often many times more expensive than traditional drugs, which raises questions of affordability and value. We compared the value of specialty and traditional drugs approved by the Food and Drug Administration (FDA) in the period 1999-2011. To do this, we identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) and increased costs of drug and health care resource use that were associated with fifty-eight specialty drugs and forty-four traditional drugs, compared to preexisting care. We found that specialty drugs offered greater QALY gains (0.183 versus 0.002 QALYs) but were associated with greater additional costs ($12,238 versus $784), compared to traditional drugs. The two types of drugs had comparable cost-effectiveness. However, the distributions across the two types differed, with 26 percent of specialty drugs--but only 9 percent of traditional drugs--associated with incremental cost-effectiveness ratios of greater than $150,000 per QALY. Our study suggests that although specialty drugs often have higher costs than traditional drugs, they also tend to confer greater benefits and hence may still offer reasonable value for money.

Funding for this study was provided by Genentech. Chambers has participated in a Sanofi advisory board, unrelated to this study. The authors report no other potential conflicts of interest. Study concept and design were contributed by Chambers. Anderson, Wilkinson, and Chenoweth collected the data, assisted by Chambers, and data interpretation was primarily performed by Chambers, along with Anderson and with assistance from Wilkinson and Chenoweth. The manuscript was written primarily by Chambers, along with Wilkinson and with assistance from Anderson and Chenoweth. Chambers, Chenoweth, Wilkinson, and Anderson revised the manuscript.

Identified trends reflect broader changes in Medicare as CMS shifts its focus from treatment to prevention of disease, addresses potentially overutilized technologies, and attempts to issue flexible coverage policies.

A419Objectives: Throughout Europe, economic conditions are forcing health care systems to reduce costs. One primary driver of health care costs is hospital length of stay (LOS). This study sought to determine which European countries have been most successful at reducing their average LOS for five inpatient admissions. This research also sought to quantify the potential savings for countries that have not been as successful in reducing their average LOS if they can align with their peers. MethOds: A review of hospital LOS and cost per day of hospital stay data was conducted in five European countries (France, Germany, Italy, Spain and the United Kingdom), utilizing data published by the World Health Organization (WHO). Additionally, hospital payment systems were assessed in each country through published research to understand systemic motivations of health care providers with regards to LOS. Results: Substantial variability exists in average LOS for the studied admissions. The greatest variability was in breast cancer, with average stays ranging from 4.36 days in the UK to 11.01 days in Germany. The average LOS for three admissions (single spontaneous delivery, cataracts, and pneumonia) are relatively similar across countries. However, the average LOS in Germany for malignant neoplasm of the breast and acute myocardial infarction are significantly higher than the other four countries. There is little variability, however, in average costs per bed-day in the target countries. A review of payment mechanisms for inpatient stays revealed that hospitals are financially incentivized to minimize LOS in all five countries. cOnclusiOns: Additional research is needed to understand the reason for the discrepancy between German stays and the other four countries. While there are many potential reasons for the differences, should Germany align their average LOS for malignant neoplasm of the breast and acute myocardial infarction with the other four countries, they could save € 744 million per year.

Background Hypertension is a major contributor to various adverse health outcomes. Although previous studies have shown the benefits of home blood pressure (BP) monitoring over office-based measurements, there is limited evidence comparing the effectiveness of whether a BP monitor integrated into the electronic health record is superior to a nonintegrated BP monitor. Objective In this paper, we describe the protocol for a pragmatic multisite implementation of a quality improvement initiative directly comparing integrated to nonintegrated BP monitors for hypertension improvement. Methods We will conduct a randomized, comparative effectiveness trial at 3 large academic health centers across California. The 3 sites will enroll a total of 660 participants (approximately n=220 per site), with 330 in the integrated BP monitor arm and 330 in the nonintegrated BP control arm. The primary outcome of this study will be the absolute difference in systolic BP in mm Hg from enrollment to 6 months. Secondary outcome measures include binary measures of hypertension (controlled vs uncontrolled), hypertension-related health complications, hospitalizations, and death. The list of possible participants will be generated from a central data warehouse. Randomization will occur after enrollment in the study. Participants will use their assigned BP monitor and join site-specific hypertension interventions. Cross-site learning will occur at regular all-site meetings facilitated by the University of California, Los Angeles Value-Based Care Research Consortium. A pre- and poststudy questionnaire will be conducted to further evaluate participants’ perspectives regarding their BP monitor. Linear mixed effects models will be used to compare the primary outcome measure between study arms. Mixed effects logistic regression models will be used to compare secondary outcome measures between study arms. Results The study will start enrolling participants in the second quarter of 2023 and will be completed by the first half of 2024. Results will be published by the end of 2024. Conclusions This pragmatic trial will contribute to the growing field of chronic care management using remote monitoring by answering whether a hypertension intervention coupled with an electronic health record integrated home BP monitor improves patients’ hypertension better than a hypertension intervention with a nonintegrated BP monitor. The outcomes of this study may help health system decision makers determine whether to invest in integrated BP monitors for vulnerable patient populations. Trial Registration ClinicalTrials.gov NCT05390502; clinicaltrials.gov/study/NCT05390502 International Registered Report Identifier (IRRID) PRR1-10.2196/45915