Jeffrey A. Kelman

Recommendations from the national vaccine advisory committee: Standards for adult immunization practice

National Vaccine Advisory Committee The Advisory Committee on Immunization Practices (ACIP) makes recommendations for routine vaccination of adults in the United States.1 Standards for implementing the ACIP recommendations for adults were published by the National Vaccine Advisory Committee (NVAC) in 20032 and by the Infectious Diseases Society of America in 2009.3 In addition, NVAC published a report in 2012 outlining a pathway for improving adult immunization rates.4 While most of these documents included guidelines for immunization practice, recent changes in the practice climate for adult immunization necessitated an update of existing adult immunization standards. Some of these changes include expansion of vaccination services offered by pharmacists and other community immunization providers both during and since the 2009 H1N1 influenza pandemic; vaccination at the workplace; increased vaccination by providers who care for pregnant women; and changes in the health-care system, including the Affordable Care Act (ACA), which requires first-dollar coverage of ACIP-recommended vaccines for people with certain private insurance plans, or those who are beneficiaries of expanded Medicaid plans.5 The ACA first-dollar provision is expected to increase the number of adults who will be insured for vaccines. Other changes include expanding the inclusion of adults in state immunization information systems (IISs) (i.e., registries) and the Centers for Medicare & Medicaid Services Meaningful Use Stage 2 requirements, which mandate provider reporting of immunizations to registries, including reporting of adult vaccination in states where such reporting is allowed.6 For the purposes of this report, provider refers to any individual who provides health-care services to adult patients, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, and other health-care professionals. While previous versions of the adult immunization standards have been published, recommendations for adult vaccination are published annually, and many health-care organizations have endorsed routine assessment and vaccination of adults, vaccination among adults continues to be low.7–15 Several barriers to adult vaccination include:

Financing vaccination of children and adolescents: National Vaccine Advisory Committee recommendations

Increases in the number and cost of vaccines routinely recommended for children and adolescents have raised concerns about the ability of the current systems for vaccine financing and delivery to ensure that all children and adolescents have access to all routinely recommended vaccinations without financial barriers. The National Vaccine Advisory Committee (NVAC) was chartered in 1988 to advise and to make recommendations to the director of the National Vaccine Program and the Assistant Secretary for Health at the US Department of Health and Human Services on matters related to the prevention of infectious diseases through vaccination. In October 2006, NVAC established a Vaccine Financing Working Group to explore approaches for child and adolescent vaccine financing. The Vaccine Financing Working Group was charged with establishing a process for obtaining stakeholder input regarding challenges to creating optimal approaches to vaccine financing in both the public and private sectors. The goal of this process was to develop recommendations to ensure that all children and adolescents have access to all routinely recommended vaccinations without financial barriers.

Off-Label Topical Calcineurin Inhibitor Use in Children

OBJECTIVE: To assess off-label use of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, in children during periods before and after regulatory action by the US Food and Drug Administration (FDA) in 2005. METHODS: We identified new pediatric (age <20 years) users of topical tacrolimus or pimecrolimus in US Medicaid from 2001 to 2009, and examined the annual rate of drug use (pre- and postregulatory action) by age. We assessed medical claims for diagnoses consistent with an indication for a TCI, and assessed prescriptions for evidence of first-line atopic dermatitis therapy use before TCI initiation. RESULTS: There were 57u2009664 eligible pediatric tacrolimus users and 425u2009242 eligible pediatric pimecrolimus users at baseline. The rate of TCI use decreased substantially after FDA regulatory action. The proportion of new users younger than 2 years of age significantly decreased for both tacrolimus (36.7% to 22.5%, P < .001) and pimecrolimus (47.0% to 33.7%, P < .001) after regulatory actions. Previous use of topical corticosteroids increased by ∼7% for both TCIs from the pre- to postregulatory period. However, after regulatory actions, there was only a small increase in the proportion of tacrolimus or pimecrolimus users with an atopic dermatitis or eczema diagnosis before drug initiation, and high strength use of tacrolimus was unchanged. CONCLUSIONS: The rate of TCI use in children younger than 2 years of age fell substantially after FDA regulatory action in 2005. Off-label use of TCI as first-line therapy changed little.

Use of an active surveillance system by the FDA to observe patterns of quinine sulfate use and adverse hematologic outcomes in CMS Medicare data.

In 2005, the Food and Drug Administration approved Qualaquin (quinine) for treatment of malaria and later ordered unapproved quinine formulations off the market. In 2009, labeling for Qualaquin added a warning for use for leg cramps, as serious hematologic reactions could occur. We examined quinine use trends among Medicare beneficiaries focusing on indications for use and associations with adverse hematologic outcomes.

Medicare Claims Versus Beneficiary Self-Report for Influenza Vaccination Surveillance

BACKGROUNDnAlthough self-reported influenza vaccination status is routinely used in surveillance to estimate influenza vaccine coverage, Medicare data are becoming a promising resource for influenza surveillance to inform vaccination program management and planning.nnnPURPOSEnTo evaluate the concordance between self-reported influenza vaccination and influenza vaccination claims among Medicare beneficiaries.nnnMETHODSnThis study compared influenza vaccination based upon Medicare claims and self-report among a sample of Medicare beneficiaries (N=9,378) from the 2011 Medicare Current Beneficiary Survey, which was the most recent year of data at the time of analysis (summer 2013). Sensitivity, specificity, positive predictive value, and negative predictive value were calculated using self-reported data as the referent standard. Logistic regression was used to compute the marginal mean proportions for whether a Medicare influenza vaccination claim was present among beneficiaries who reported receiving the vaccination.nnnRESULTSnInfluenza vaccination was higher for self-report (69.4%) than Medicare claims (48.3%). For Medicare claims, sensitivity=67.5%, specificity=96.3%, positive predictive value=97.6%, and negative predictive value=56.7%. Among beneficiaries reporting receiving an influenza vaccination, the percentage of beneficiaries with a vaccination claim was lower for beneficiaries who were aged <65 years, male, non-Hispanic black or Hispanic, and had less than a college education.nnnCONCLUSIONSnThe classification of influenza vaccination status for Medicare beneficiaries can differ based upon survey and claims. To improve Medicare claims-based surveillance studies, further research is needed to determine the sources of discordance in self-reported and Medicare claims data, specifically for sensitivity and negative predictive value.

Temporal variation in patterns of comorbidities in the medicare population.

It is widely accepted that Medicare beneficiaries with multiple comorbidities (ie, patients with combinations of more than 1 disease) account for a disproportionate amount of mortality and expenditures. The authors previously studied this phenomenon by analyzing Medicare claims data from 2008 to determine the pattern of disease combinations (DCs) for 32,220,634 beneficiaries. Their findings indicated that 22% of these individuals mapped to a long-tailed distribution of approximately 1 million DCs. The presence of so many DCs, each populated by a small number of individuals, raises the possibility that the DC distribution varies over time. Measuring this variability is important because it indicates the rate at which the health care system must adapt to the needs of new patients. This article analyzes Medicare claims data for 3 consecutive calendar years, using 2 algorithms based on the Centers for Medicare & Medicaid Services (CMS)-Hierarchical Conditions Categories (HCC) claims model. These algorithms make different assumptions regarding the degree to which the CMS-HCC model could be disaggregated into its underlying International Classification of Diseases, Ninth Revision, Clinical Modification codes. The authors find that, although a large number of beneficiaries belong to a set of DCs that are nationally stable across the 3 study years, the number of DCs in this set is large (in the range of several hundred thousand). Furthermore, the small number of beneficiaries associated with the larger number of variable DCs (ie, DCs that were not constantly populated in all 3 study years) represents a disproportionally high level of expenditures and death.

A Comparison of Disease Burden Between Twins and Control Pairs in Medicare: Quantification of Heredity's Role in Human Health

To quantify hereditys effects on the burden of illness in the Medicare population, this study linked information between participants in a research twin registry to a comprehensive set of Medicare claims. To calculate disease categories, the authors used the Centers for Medicare & Medicaid Services Hierarchical Conditions Categories (HCC) model that was developed to risk adjust Medicares capitation payments to private health care plans based on the health expenditure risk of their enrollees. Using the Medicare database, 2 sets of unrelated but demographically matched control pairs (MCPs) were generated, one specific for the monozygotic twin population and the second specific for the dizygotic twin population. The concordance and correlation rates of the 70 HCC categories for the 2 twin populations, in comparison to their corresponding MCP, was then calculated using Medicare claims data from 1991 through 2011. When indicated, HCCs for which there was a statistically significant difference between the twin and corresponding MCP control group were analyzed by calculating concordance and correlation rates of the International Classification of Diseases, Ninth Revision codes that compose the HCC. Findings reveal that monozygotic twins share 6.5% more HCC disease categories than their MCP while dizygotic twins share 3.8% more HCC disease categories than their MCP. Atrial fibrillation is a highly heritable disease category, a finding consistent with prior literature describing the heritability of the cardiac arrhythmias. These findings are consistent with qualitative assessments of hereditys role found in previous models of population health, and provide both novel methods and quantitative evidence to support future model development.