Exemption Requests Research Articles

Physicians and Medicaid Work Requirements: Variability in Primary Care Physician Response to Patient Exemption Requests

Physicians and Medicaid Work Requirements: Variability in Primary Care Physician Response to Patient Exemption Requests

Use of a comprehensive program to review religious and personal seasonal influenza vaccination exemption requests by healthcare personnel.

Vanderbilt University Medical Center (VUMC) requires that all faculty and staff receive the seasonal influenza vaccine annually or receive an approved vaccine exemption, either for a medical or deeply held religious or personal belief. We sought to understand the underlying principles behind these exemption requests and their interaction with a multidisciplinary exemption review process. All of the personal and religious exemption requests at VUMC for 3 consecutive influenza seasons from 2015 to 2018 were analyzed, categorizing these requests by 1 of 12 standardized employee categories and 1 of 18 unique reasons for vaccine exemption. Tertiary-care academic medical center. Healthcare personnel (HCP). Among the 3 influenza seasons, 1.1%-2.1% of all VUMC HCP requested religious or personal exemption from vaccination. The frequency of religious and personal exemption approval increased annually from 296 of 452 (65.5%) to 196 of 248 (80.2%) to 283 of 323 (87.6%) over the 3 seasons, representing a statistically significant increase each year. Of the 5 most common reasons against vaccination, 4 were explicitly religious in nature; the most common reason was that the "body is a temple or sacred." Nonclinical staff submitted the most religious and personal exemption requests of any job category, submitting approximately one-third of all requests every year. These results demonstrate how detailed the personal or religious convictions behind vaccine avoidance can be among HCP and how vaccine avoidance stems from much more than simple misinformation regarding vaccination. The intersection between misinformation and personal or religious beliefs provides a unique opportunity to address HCP opinions toward vaccination in an exemption and appeals process like the one described here.

Trump tariffs and firm relief: winners and losers from the steel tariff exclusion request

ABSTRACT The Trump administration introduced 25% tariffs on steel imports in March 2018. To minimize the adverse effects of these tariffs on downstream US producers who import steel products, the administration simultaneously introduced exclusion requests for tariff exemptions. In this paper, we investigate whether companies from states where Trump won the 2016 presidential election were more likely to receive tariff exemptions than were firms that applied for exemptions in non-Trump states. Our estimation result suggests that firms located in Trump states were more likely to be granted exemptions. In addition, firms with lower sales-to-employment ratios, a signal of lower efficiency, were more likely to have exclusion requests approved if they were from states where Trump won the election.

Implementation of a Mandatory Influenza Vaccine Policy: A 10-Year Experience.

Influenza vaccination of healthcare workers (HCWs) has been recommended for more than 30 years. In 2009, HCWs were designated as a priority group by the Centers for Disease Control and Prevention. Current HCW vaccination rates are 78% across all settings and reach approximately 92% among those employed in hospital settings. Over the last decade, it has become clear that mandatory vaccine policies result in maximal rates of HCW immunization. In this observational 10-year study, we describe the implementation of a mandatory influenza vaccination policy in a dedicated quaternary pediatric hospital setting by a multidisciplinary team. We analyzed 10 years of available data from deidentified occupational health records from 2009-2010 through the 2018-2019 influenza seasons. Descriptive statistics were performed using Stata v15 and Excel. Sustained increases in HCW immunization rates above 99% were observed in the 10 years postimplementation, in addition to a reduction in exemption requests and healthcare-associated influenza. In the year of implementation, 145 (1.6%) HCWs were placed on temporary suspension for failure to receive the vaccine without documentation of an exemption, with 9 (0.06%) subsequently being terminated. Since then, between 0 and 3 HCWs are terminated yearly for failure to receive the vaccine. Implementation of our mandatory influenza vaccination program succeeded in successfully increasing the proportion of immunized HCWs at a quaternary care children's hospital, reducing annual exemption requests with a small number of terminations secondary to vaccine refusal. Temporal trends suggest a positive impact on the safety of our patients.

Hospital exemption: a challenging milestone for the Andalusian Public Healthcare System

Background & Aim Advanced therapy medicinal products (ATMPs) are a particularly novel class of medicines, which include gene and cell therapies, and tissue engineered products. Patients can access to ATMPs through clinical trials (research phase), authorized market drugs, hospital exemption or exceptionally under compassionate use. To reach the marketing authorization for ATMPs it is needed to follow the centralised procedure stablished by the Regulation (EC) No 1394/2007. In addition, the article 28 of this Regulation concerning to “hospital exemption” was included to recognize the small scale and developmental nature of the activities carried out in some hospitals, which calls for a degree of flexibility in the nature of regulatory requirements. This article establishes the exemption as follow “ATMPs prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient”. In agreement with this article, the hospital exemption ensure the accessibility and sustainability of the Public Health Care System without the use of non-commercialize products. Methods, Results & Conclusion In Spain, according to Royal Degree 477/2014, Hospital exemption request must be submitted using the Common Technical Document (CTD) structure, consists of five modules where set of specifications for an application dossier for the registration of Medicines. In this sense, The Andalusian Network for the Design and Translation of Advanced Therapies (AND&TAT) which belongs to the Andalusian Health Care System and coordinate a network of 10 GMP facilities, has leading the Hospital exemptions submissions in several Andalusian Hospitals a challenging activity for an Academic Institution with limited resources. To date, three requests from three different Hospitals have been presented to Spanish medicine agency and are pending on some clarifications to be approved. In parallel, efforts are ongoing to submit another three dossiers which pretend to be presented in near future.

Mandatory employee vaccination as a strategy for early and comprehensive health care personnel immunization coverage: Experience from 10 influenza seasons

Influenza is responsible for thousands of deaths in the United States and presents particular challenges in health care facilities with a greater prevalence of people at increased risk for adverse outcomes. Annual influenza vaccination has long been recommended, and employer policies influence the likelihood health care personnel are immunized. This is a review of vaccination data maintained by a large health care organization to assess the effects of a mandatory health care personnel vaccination policy implemented during 2008-2009. Vaccination rates, timing of immunizations, and requests for medical or religious exemptions were assessed from 2006-2007 to 2017-2018. The health care personnel vaccination rate was 70% during the influenza season before the mandatory policy was implemented and increased to 98.4% immediately afterward. Vaccination rates exceeded 97% during the subsequent 9 years. Religious and medical exemptions decreased at academic medical centers and remained consistent at community hospitals. Among immunized employees, the peak date for vaccination shifted to late September or early October compared to late October or early November before the mandatory policy. Requiring vaccination led to sustained increases in staff vaccination coverage at academic medical centers and community hospitals. The mandatory policy also appeared to encourage earlier vaccination.

Factors Associated With Childhood Vaccination Adherence in Kindergartens of the Houston Independent School District.

Adequate childhood vaccination rates are crucial for successful control of infectious diseases. Nevertheless, exemption requests, lack of health care access and information and other barriers can reduce vaccination adherence rates, and increase the risk of epidemics. This study aimed to identify factors associated with kindergarten vaccination adherence in the Houston Independent School District (HISD). This study was a retrospective observational data analysis. The study used data from 155 elementary schools of the HISD. The data sets included were (1) Elementary School Profile Reports (2015-2016) and (2) Annual Report of Immunization Status (2016-2017). Logistic regression was used to examine the association between vaccination adherence in schools and the school's student demographic and economic profile, student behavior indicators, teacher profile, and school rank. A binary variable measuring adequate vaccination adherence rates in schools is the main outcome variable. Lower vaccination adherence among the kindergarten students was associated with higher enrollment, a higher percentage of African American students and students with English as second language, and a lower percentage of gifted/talented students in the schools. The school characteristics that were found to be significantly associated with kindergarten student vaccination adherence in this study are the ones that have historically been associated with socioeconomic determinants of health and socioeconomic privilege. Hence, the findings of this study suggest the need for development of policies and interventions that can help overcome the barriers associated with low socioeconomic status, language, and marginalization in order to improve vaccination rates in school districts. These include culturally appropriate polices and health promotion, patient navigation, and educational interventions that can overcome the challenges faced by socially and economically vulnerable minorities and immigrant communities in order to improve vaccination rates.

Stability Program for Hematopoietic Progenitor Products from Apheresis (HPC-A) at an Academic Institution

We perform stability testing on HPC-A products stored in vapor phase nitrogen from 1 week to 5 years. Stability is defined as CD34 viability of 70% or higher (±40% from baseline), and negative sterility results at 14 days. Potency is defined as 21 days or less to ANC engraftment if infused. We performed a comparison on frozen products from deceased patients or soon to be transplanted products stored for more than 10 years (group 3, n=7) or less than 10 years (group 2, n=10). The objective of our analysis was to establish a method to predict stability and potency, with clinical and economic implications. Thirteen patients were consented on an IRB approved protocol, and request for exemption was presented to the IRB for the remaining. Freshly isolated samples (group 1, n=3) provided control data. The demographic characteristics of the cellular products were matched between groups, except that older samples were volume reduced using the COBE-2991 device, (p=0.007). Samples in group 2 were stored for a median time of 3.6 years (range 0.42, 7.1), and samples in group 3 for 12.31 years (range10.12-14.34), respectively. We observed a post-thaw TNC decrease of 30% in group 2 and 36% in group 3 (p=0.9). CD34 counts decreased by 6.5% in group 2, and 11.37% in group 3 (p=0.7). We observed a 26% reduction of viable CD34 cells in group 2 vs. 34% in group 3 (p=0.1). All but two patients in group 3 received the first transplant, with products stored for a median of 2 days in group 1, 9 days in group two, and 137 days in group 3 (p=0.03). Cellular composition was consistent among products. All products engrafted ANCs within 12 days (p=0.5) and PLT within 17 days (p=0.4). Four patients in group 2 and 1 patient in group 3 received a second transplant. Median storage for group 2 was 3.6 years (0.42-7.09), compared with 12.3 years (10.12-14.34) in group 3 (p=1). All second transplants achieved prompt engraftment of both ANCs and PLT (≤12 d, p=0.2; 0.046, resp.). Regarding the ability of lineage depleted CD34 stem cells to form colonies in vitro, we collected data from 13 independent hematopoietic colony-forming unit assays. A statistically significant reduction in colony formation for both groups 2 and 3 was observed when compared with group 1. Other authors have reported successful engraftment in the absence of colony formation in vitro. Therefore, we decided to perform a functional evaluation of the aldehyde dehydrogenase (ALDH) enzyme activity using a commercially available flow cytometry kit in alternative. As expected, ALDH functionality correlated with CD34 viability (Pearson's coefficient: 0.4). (Figure 1). HPC-A products stored longer than 10 years resulted in efficient engraftment after the infusion of standard doses of viable CD34 cells. Viability assessed with 7-AAD is a simple and essential measure to assess the stability of frozen products, and the ALDH assay is an efficient adjunct to assess the functionality of CD34 stem cells.

Perspectives on state vaccine education mandate policy and implementation among public health department officials: a qualitative study

ABSTRACT In response to the increase in non-medical vaccine exemptions (NME), many states have adopted education mandates (EM), required vaccine education for parents requesting NMEs for their school-age children, but these EMs vary greatly in implementation. In order to learn about the administrative aspects of each state’s EM, we interviewed fourteen health department officials from nine states with EMs. Interviews were conducted over the phone, transcribed by a professional transcription service, and double-coded using NVivo 12 by two members of the study staff. The coding resulted in 3698 comments overall, 98.5% inter-coder reliability, and a κ statistic of 0.691. We found no consistent format for content delivery, and methods used included in-person dialogs, web-based education, and video modules. Content of the education is not standardized, and education length ranges from 15 to 60 minutes. Four major themes about the EM policies emerged: (1) the use of EMs to eliminate “convenience exemptions;” (2) the importance of health department communication with health-care providers; (3) facilitators and barriers to implementation; and (4) the positive recommendation for other states to adopt EM policies. We concluded that current EM implementation varies greatly, but officials in states which have adopted EMs for parents requesting NMEs for school-entry vaccinations overwhelmingly recommend other states to adopt them as well. Key features of successful programs may include conversations with parents requesting NMEs and strong communication channels with health-care providers. Systematic tracking of vaccine status after exemption requests and education is necessary to quantitatively determine the effectiveness of EM programs.

Sharʿī norms and German Schools: Court Challenges to Participation in Swimming Lessons, School Trips and Sex Education

ABSTRACTThis article examines the treatment by German courts, from the early 1970s to 2016, of requests made by Muslims to be exempted from school activities for religious reasons. Based on a qualitative reading of 72 court rulings, the article demonstrates a shift in the courts’ decision-making, from initially tolerating Muslim requests for exemption to firmly denying them. Arguments from the court rulings are substantiated by an analysis of the public discourse on Muslims in German schools. The results suggest that the transformation of court attitudes corresponded with the rise of broader concerns about multiculturalism and manifestations of Islam in the public sphere, the liberalization of gender norms, and increasing secularism within German society. The article further demonstrates that, contrary to public perception, requests for exemptions from school activities were not a distinctly Muslim phenomenon. Christian families have challenged school activities in a similar way.

Perspectives of public health nurses on the ethics of mandated vaccine education

BackgroundSince 2015, Michigan has required parents who request nonmedical exemptions (NMEs) from school or daycare immunization mandates to receive education from local public health staff (usually nurses). This is unlike most other US states that have implemented mandatory immunization counseling, which require physicians to document immunization education, or which provide online instruction. PurposeTo attend to the activity and dispositions of the public health staff who provide “waiver education”. MethodThis study reports results of focus group interviews with 39 of Michigan's vaccine waiver educators (37 nurses), conducted during 2016 and 2017, and analyzed in 2018. FindingsFour themes emerged from analysis of the transcripts of these interviews: Participants had (1) complex and nuanced observations and evaluations of parents' judgments and feelings about vaccines and vaccine education; (2) sympathetic attitudes about alternative vaccine schedules; (3) critical and supportive evaluations of institutional policies and the background political context of immunization education; and (4) consistent commitments to respect parents, affirm their values, and protect their rights. DiscussionThese results show that public health nurses are sensitive to the burdens mandatory immunization education places on families, the motivations for parents' requests for nonmedical exemptions, and the values implicated by personal immunization decisions and government immunization policies. In light of the unique training, experiences, and public reputation of nurses, there is good reason for additional investigation into the roles that nurses can play in immunization education and in vaccine mandate policies, more generally.

Protecting Moral Integrity Through Justified Exemption.

Medical professionals have a duty to prioritize patient needs and well-being, even when doing so is deemed distasteful or unpleasant. This does not mean, however, that such professionals are obliged to provide medical interventions when participation threatens their core moral integrity. Myriad state and federal "conscience clause" statutes and regulations have codified such protections, but in a way that makes it too easy to claim exemption. This essay argues that, given professional obligations and systemic power asymmetries, the burden of proof falls upon professionals to show that participation in the requested service represents a genuine threat to their integrity, as opposed to being merely offensive or economically disadvantageous. It concludes with a suggested mechanism for determining whether the exemption request is justified.

California's Senate Bill 277: Local Health Jurisdictions' Experiences With the Elimination of Nonmedical Vaccine Exemptions.

Objectives. To understand the experiences of local health jurisdictions with Senate Bill 277 (SB277), the California law that eliminated nonmedical vaccine exemptions for public- and private-school entry.Methods. We conducted semistructured telephone interviews with health officers and local health department (LHD) staff in California between August and September 2017.Results. Two overall themes emerged: (1) vague legislative and regulatory language led to variation in the interpretation and implementation of SB277, and (2) lack of centralized review of medical exemptions allowed medical exemptions that are not consistent with valid contraindications for immunizations to be accepted. Variation in the interpretation and implementation was commonly reported with provisions related to individualized education programs and special education, and independent study programs and homeschooling. Without a centralized review of medical exemption requests, respondents reported variation in the interpretation of which specialties of physicians can write medical exemptions, which conditions constitute a valid contraindication for immunization, and the process for reporting a questionable or suspicious medical exemption.Conclusions. The regulatory language within SB277 led to variation in how the law was interpreted and implemented within and across LHD jurisdictions and school districts.

Experiences With Medical Exemptions After a Change in Vaccine Exemption Policy in California.

We conducted semistructured telephone interviews between August 2017 and September 2017 with health officers and immunization staff from local health jurisdictions in California. Interviews were recorded, transcribed, and analyzed for key themes. We conducted 34 interviews with 40 health officers and immunization staff representing 35 of the 61 local health jurisdictions in California. Four main themes emerged related to experiences with medical exemptions: (1) the role of stakeholders, (2) reviewing medical exemptions received by schools, (3) medical exemptions that were perceived as problematic, and (4) frustration and concern over medical exemptions. Generally, local health jurisdictions described a narrow role in providing support and technical assistance to schools. Only 5 jurisdictions actively tracked medical exemptions received by schools, with 1 jurisdiction facing a lawsuit as a result. Examples were provided of medical exemptions that listed family history of allergies and autoimmune diseases as contraindications for immunization and of physicians charging steep fees for medical exemptions. Participants also reported concerns about the increase in medical exemptions after the implementation of SB277. Participants reported many challenges and concerns with medical exemptions under SB277. Without additional legal changes, including a standardized review of medical exemptions, some physicians may continue to write medical exemptions for vaccine-hesitant parents, potentially limiting the long-term impact of SB277.

Content analysis of requests for religious exemptions from a mandatory influenza vaccination program for healthcare personnel

ObjectiveHaving failed to achieve adequate influenza vaccination rates among employees through voluntary programmes, healthcare organisations have adopted mandatory ones. Some programmes permit religious exemptions, but little is known about who...

Constitutional Anomalies or As-Applied Challenges? A Defense of Religious Exemptions

In the wake of Burwell v. Hobby Lobby and now in anticipation of Craig v. Masterpiece Cakeshop, Inc., the notion that religious exemptions are dangerously out of step with norms of Constitutional jurisprudence has taken on a renewed popularity. Critics increasingly claim that religious exemptions, such as those available prior to Employment Division v. Smith and now available under the federal Religious Freedom Restoration Act (RFRA), are a threat to basic fairness, equality, and the rule of law. Under this view, exemptions create an anomalous private right to ignore laws that everyone else must obey, and such a scheme will result in a tidal wave of religious claimants striking down government action. Our Article presents an observation that undermines these central criticisms. Far from being “anomalous” or “out of step” with our constitutional traditions, religious exemptions are just a form of “as-applied” challenges offered as a default remedy elsewhere in constitutional adjudication. Courts regularly provide exemptions from generally applicable laws for other First Amendment protected activity like expressive conduct that mirror the exemptions critics fear in the context of religious exercise. The Article also presents original empirical analysis, including a national survey of all federal RFRA cases since Hobby Lobby, indicating that concerns of critics about religious exemptions have not been borne out as an empirical matter. Our findings suggest that even after Hobby Lobby, cases dealing with religious exemption requests remain much less common than cases dealing with other expressive claims, and are less likely to result in invalidation of government actions. Thus, far from creating anomalous preferential treatment that threatens the rule of law, a religious exemption framework simply offers a similar level of protection courts have long provided for dissenting minority rights housed elsewhere in the First Amendment.

Do votes matter? Voting weights and the success probability of member state requests in the Council of the European Union

The impact of votes on Council decision-making is a widely studied subject. A large body of theory supports the contention that more votes, ceteris paribus, translate into more influence. Empirical studies have, however, shown a negative relationship between the voting power of a member state and its bargaining success. Based on a new data set, this study shows empirically that there is a robust positive relationship between the number of votes backing a member state request to change European legislation and its success probability. The analysis is based on all unique member state requests for exemptions, lower standards or longer transitional time periods in the field of environmental policy between the first wave of Eastern Enlargement in 2004 and the entry into force of the Lisbon treaty in 2009 (N = 216). It also shows that member state requests are often successful, contrary to the image of an unresponsive Brussels.

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Individual Exemption Applications and Their Assessment: Lessons from the Competition Law Change in the Netherlands during the 1990s

One of the most distinctive features of the European competition law was the availability of individual exemptions to agreements or concerted practices which restricted competition, but nevertheless served the generals interests of the European Community. However, established by Regulation 17/62, the individual exemption regime was dismantled by Regulation 1/2003 in an attempt to modernize the European Union (EU) competition law. Prior to the annulment, one country in Europe -the Netherlands, which was famous for its “cartels”- used individual exemptions to provide legal certainty during a period when national competition policy was radically changed. Following the introduction of the Competition Act of 1998, undertakings were allowed to apply for exemption for agreements that were already in existence and that had begun under the superseded Economic Competition Act of 1956. Accordingly, the Netherlands Competition Authority (NMa) received and assessed hundreds of exemption requests, and gave verdicts on the pro-competitiveness of the agreements contained in these applications. This study uses information from 346 decisions of the NMa on exemption applications. It first reports insightful summary statistics concerning the nature of the agreements in the applications, number of parties involved, and duration and scale of the agreements. Then an ordered choice model is estimated to examine how the pro-competitiveness perception of the NMa changes with the nature of agreements and over time conditional on exemption application. The econometric findings are linked to legislative background and administrative implementation, thereby providing an historical overview that summarizes the NMa’s work in exemption applications.

DEVELOPMENT OF THE ALTERNATE PRESSURIZED THERMAL SHOCK RULE (10 CFR 50.61a) IN THE UNITED STATES

In the early 1980s, attention focused on the possibility that pressurized thermal shock (PTS) events could challenge the integrity of a nuclear reactor pressure vessel (RPV) because operational experience suggested that overcooling events, while not common, did occur, and because the results of in-reactor materials surveillance programs showed that RPV steels and welds, particularly those having high copper content, experience a loss of toughness with time due to neutron irradiation embrittlement. These recognitions motivated analysis of PTS and the development of toughness limits for safe operation. It is now widely recognized that state of knowledge and data limitations from this time necessitated conservative treatment of several key parameters and models used in the probabilistic calculations that provided the technical of the PTS Rule, 10 CFR 50.61. To remove the unnecessary burden imposed by these conservatisms, and to improve the NRC's efficiency in processing exemption and license exemption requests, the NRC undertook the PTS re-evaluation project. This paper provides a synopsis of the results of that project, and the resulting Alternate PTS rule, 10 CFR 50.61a.