Effect of the Accountable Care Act of 2010 on Clinical Trial Insurance Coverage

2012 ◽  
Vol 30 (5) ◽  
pp. 548-553 ◽  
Author(s):  
Sheetal M. Kircher ◽  
Al B. Benson ◽  
Matthew Farber ◽  
Halla S. Nimeiri

Purpose The Affordable Care Act (ACA) of 2010 implemented dramatic changes in our health care system. The new law requires that insurers and health plans provide coverage for individuals participating in clinical trials. Currently, there are states that already have laws or agreements requiring clinical trial coverage, but there remain deficiencies that will need to be addressed to achieve compliance with the new law. Methods State mandates were reviewed to determine current laws and agreements. The ACA was reviewed to outline its provisions, and these were compared with current mandates to identify deficiencies. Results Eighteen states meet the requirements set forth by the ACA either through a state law or agreement; 33 states do not meet the requirements. Of these 33 states, 15 do not have any existing laws or agreements in place regarding clinical trials. In states that have deficient policies in place, the most common deficiency is the lack of phase I coverage. The second most common deficiency in policy is coverage of only therapeutic studies. Conclusion Most states currently do not meet the requirements of the ACA and will be required to make changes by 2014. The implications of the ACA with regard to insurance coverage of clinical trials remain unclear as implementation of the legislation unfolds. State governments can take steps to ensure insurance coverage by creating and expanding agreements with insurance companies.

2021 ◽  
pp. 826-832
Author(s):  
Jay G. Ronquillo ◽  
William T. Lester

PURPOSE Cloud computing has led to dramatic growth in the volume, variety, and velocity of cancer data. However, cloud platforms and services present new challenges for cancer research, particularly in understanding the practical tradeoffs between cloud performance, cost, and complexity. The goal of this study was to describe the practical challenges when using a cloud-based service to improve the cancer clinical trial matching process. METHODS We collected information for all interventional cancer clinical trials from ClinicalTrials.gov and used the Google Cloud Healthcare Natural Language Application Programming Interface (API) to analyze clinical trial Title and Eligibility Criteria text. An informatics pipeline leveraging interoperability standards summarized the distribution of cancer clinical trials, genes, laboratory tests, and medications extracted from cloud-based entity analysis. RESULTS There were a total of 38,851 cancer-related clinical trials found in this study, with the distribution of cancer categories extracted from Title text significantly different than in ClinicalTrials.gov ( P < .001). Cloud-based entity analysis of clinical trial criteria identified a total of 949 genes, 1,782 laboratory tests, 2,086 medications, and 4,902 National Cancer Institute Thesaurus terms, with estimated detection accuracies ranging from 12.8% to 89.9%. A total of 77,702 API calls processed an estimated 167,179 text records, which took a total of 1,979 processing-minutes (33.0 processing-hours), or approximately 1.5 seconds per API call. CONCLUSION Current general-purpose cloud health care tools—like the Google service in this study—should not be used for automated clinical trial matching unless they can perform effective extraction and classification of the clinical, genetic, and medication concepts central to precision oncology research. A strong understanding of the practical aspects of cloud computing will help researchers effectively navigate the vast data ecosystems in cancer research.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18573-e18573
Author(s):  
Jessica Yasmine Islam ◽  
Denise Christina Vidot ◽  
Imran K Islam ◽  
Argelis Rivera ◽  
Marlene Camacho-Rivera

e18573 Background: Despite the use of clinical trials to provide gold-standard evidence of treatment and intervention effectiveness, racial/ethnic minorities are frequently underrepresented participants. Our objective was to evaluate racial/ethnic differences in knowledge and attitudes towards clinical trials among adults in the U.S. Methods: We leveraged Health Informational National Trends Survey (HINTS) data, which is a weighted, nationally representative survey of 3865 adults (≥18 years). Data were collected between February-June 2020, and included age, race/ethnicity, sex, cancer history, and comorbidities. Participants were asked questions focused on clinical trials, including their knowledge, influential factors to participate, trusted sources of information, and if they were ever invited or participated in a clinical trial. Among adults who self-reported to have heard of clinical trials (n = 2366), we used multivariable logistic regression to evaluate racial/ethnic differences in self-reported invitation and participation in clinical trials after adjustment for cancer history, age, sex, comorbidities, and insurance status. Results: Overall, the sample included 64% non-Hispanic (NH) White, 11% NH-Black, 17% Hispanic, and 5% NH-Asian respondents. Nine percent were cancer survivors. Almost 60% self-reported to at least have some knowledge about clinical trials. When asked about factors that would influence their decision to participate in clinical trials “A lot”, participants across racial groups most frequently chose “I would want to get better” and “If the standard care was not covered by my insurance.” Cancer survivors also frequently reported their decision would be influenced “A lot” or “Somewhat” if “My doctor encouraged me to participate.” NH-White (76%), NH-Black (78%), and Hispanic (77%) cancer survivors reported their trusted source of information about clinical trials was their health care provider; NH-Asian cancer survivors reported their health care provider (51%) as well as government health agencies (30%). Compared to NH-White adults, NH-Black adults were more likely to be invited to participate in a clinical trial (OR: 2.60, 95% CI: 1.53-4.43). However, compared to NH-White adults, our data suggest NH-Black adults were less likely to participate in the clinical trial (OR: 0.76, 95% CI: 0.39-1.49) although not statistically significant. Compared to NH-White adults, NH-Asian adults were less likely to participate in clinical trials (OR: 0.10, 95% CI: 0.06-0.18). Conclusions: Health care providers are a trusted source of clinical trial information. Although NH-Black adults are more likely to be invited, they are less likely to participate in a clinical trial; as well as Asian adults. Efforts to leverage insights gained on factors of influence and sources of trusted information on clinical trials should be prioritized.


2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S53-S53
Author(s):  
David Rubin ◽  
Laurent Peyrin-Biroulet ◽  
Walter Reinisch ◽  
Swati Tole ◽  
Laura Sullivan ◽  
...  

Abstract Background Despite recent progress in treatment for inflammatory bowel diseases (IBD), there is a need for therapies with long-term efficacy and improved safety. Clinical trials in IBD face challenges with patient recruitment because of study designs, competitive or overlapping trials, and a limited number of eligible patients. We sought to better understand patients’ motivations, awareness of, and experience with IBD clinical trials. Methods We conducted an international survey of adult patients with IBD consisting of 2 components. The quantitative component, a 15-minute online survey, was completed by all patients. A qualitative component, a 30-minute telephone interview, was completed by a subset of patients from the United States (US). All percentages indicate results from the online survey. Results 226 patients (mean age, 41.9 y) completed the online survey. Survey respondents included patients with ulcerative colitis (52%) and Crohn’s disease (48%) from the US (n=100, 21 of whom underwent a phone interview), Brazil (n=26), Canada (n=25), France (n=25), Germany (n=25), and Spain (n=25). Ninety-six percent of respondents reported at least a basic understanding of clinical trials, and 34 (15%) were current or past clinical trial participants. Patients reported learning about trials through 1 or more sources (could select as many as applied): health care providers (42%), pharmaceutical manufacturer websites (31%), social media (30%), online support groups (28%), and foundations (18%-23%). In the survey, patients rated conversations with health care providers most helpful, but patients who were interviewed revealed that most physicians often do not initiate conversations about clinical trials, and patients typically do not ask. Primary motivators for trial participation (rated from “does not encourage me at all” to “encourages me very much”) included altruistic goals of advancing medicine (67%), potentially mitigating risks of uncontrolled IBD such as colon cancer (59%), and access to treatment options that could improve quality of life (59%) or would otherwise be unaffordable (52%). Major barriers to participation (rated from “does not discourage me at all” to “discourages me very much”) included invasive screening and monitoring (35%), concern over receiving placebo (35%), or suboptimal treatment (33%), and concerns about posttrial access to study medication (27%). The majority (68%) reported that being in a clinical trial means being a “guinea pig” for an experimental treatment. Conclusion Opportunities to improve patients’ clinical trial experience in IBD include better communication with health care providers and improved patient education about clinical trial design and ethics. Ultimately, a better understanding of the patient perspective will be important for more informed patients and potentially higher recruitment and enrollment.


2020 ◽  
Vol 45 (4) ◽  
pp. 501-515
Author(s):  
Allison K. Hoffman

Abstract The Affordable Care Act (ACA) is in many ways a success. Millions more Americans now have access to health care, and the ACA catalyzed advances in health care delivery reform. Simultaneously, it has reinforced and bolstered a problem at the heart of American health policy and regulation: a love affair with choice. The ACA's insurance reforms doubled down on the particularly American obsession with choice. This article describes three ways in which that doubling down is problematic for the future of US health policy. First, pragmatically, health policy theory predicts that choice among health plans will produce tangible benefits that it does not actually produce. Most people do not like choosing among health plan options, and many people—even if well educated and knowledgeable—do not make good choices. Second, creating the regulatory structures to support these choices built and reinforced a massive market bureaucracy. Finally, and most important, philosophically and sociologically the ACA reinforces the idea that the goal of health regulation should be to preserve choice, even when that choice is empty. This vicious cycle seems likely to persist based on the lead up to the 2020 presidential election.


2020 ◽  
Author(s):  
Derek D. Satre ◽  
Sujaya Parthasarathy ◽  
Michael J. Silverberg ◽  
Michael Horberg ◽  
Kelly C. Young-Wolff ◽  
...  

Abstract Background: The Affordable Care Act (ACA) increased insurance coverage for people with HIV (PWH) in the United States, yet post-ACA health care utilization and HIV outcomes have rarely been examined. Methods: Among PWH newly enrolled in an integrated health care system (Kaiser Permanente Northern California) in 2014 (N=880), we examined use of health care and modeled associations between enrollment mechanisms (enrolled in a Qualified Health Plan through the California Exchange vs. other sources), deductibles (none, $1-$999 and >= $1000), receipt of benefits from the California AIDS Drug Assistance Program (ADAP), demographic factors, and three-year patterns of health service utilization (primary care, psychiatry, substance treatment, emergency, inpatient) and HIV outcomes (CD4 counts, viral suppression). Results: Health care use was greatest immediately after enrollment and decreased over three years. Those with high deductibles were less likely to use primary care (OR=0.64, 95% CI=0.49 - 0.83, p < 0.001) or psychiatry OR=0.58, 95% CI=0.36, 0.93, p=0.02) than those with low or no deductibles. Enrollment via the Exchange was associated with fewer psychiatry visits (rate ratio [RR]=0.38, 95% CI=0.17 - 0.83; p=0.02), but ADAP was positively associated with number of psychiatry visits (RR=2.22, 95% CI=1.22 – 4.05 p=0.01). There was no association between enrollment mechanism or deductibles and HIV outcomes, but ADAP enrollment was associated with viral suppression (OR=2.23, 95% CI=1.35 - 3.68, p<0.001). Non-white PWH were less likely to be virally suppressed, (OR=0.47, 95% CI= 0.31 - 0.71, p< 0.001). Conclusions: In this sample of PWH drawn from an integrated health care system in California, findings suggest that enrollment via the Exchange and higher deductibles were negatively associated with some aspects of service utilization but did not impact HIV outcomes; support from ADAP appeared to help patients achieve viral suppression; ethnic disparities remain important to address in post-ACA health services for PWH even among those with access to insurance coverage.


2016 ◽  
Vol 41 (1) ◽  
pp. 101-116 ◽  
Author(s):  
Tiffany D. Joseph

Abstract The 2010 Patient Protection and Affordable Care Act (ACA) was passed to provide more affordable health coverage to Americans beginning in 2014. Modeled after the 2006 Massachusetts health care reform, the ACA includes an individual mandate, Medicaid expansion, and health exchanges through which middle-income individuals can purchase coverage from private insurance companies. However, while the ACA provisions exclude all undocumented and some documented immigrants, Massachusetts uses state and hospital funds to extend coverage to these groups. This article examines the ACA reform using the Massachusetts reform as a comparative case study to outline how citizenship status influences individuals' coverage options under both policies. The article then briefly discusses other states that provide coverage to ACA-ineligible immigrants and the implications of uneven ACA implementation for immigrants and citizens nationwide.


2019 ◽  
Author(s):  
Huiyao Huang ◽  
Dawei Wu ◽  
Qi Fan ◽  
Jun Wang ◽  
Shuhang Wang ◽  
...  

Abstract Background: To analyze the time trend and regional difference of insurance coverage of cancer drug trials in mainland China for the past decade, thus to provide data support for the improvement and implementation of related policies, such as clinical trial insurance and ethical review in China. Methods: Based on the national authoritative database, “Drug Clinical Trial Registration and Information Disclosure Platform”, the time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, the group comparisons between seven regions, as well as different drug types and study phases, were also performed. Data processing and analysis were carried out using SAS 9.4. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons. Results: A total of 1433 clinical trials were finally included, with 1153 (80.5%) trials being international. In average, the insurance rate of trials was 75.9%, and it was steadily increased by 7.8% annually. While the insurance coverage of Chinese participants was 58.8%, and it showed a wavy upward trend. Compared with international trials (90.0%), insurance rate of domestic trials (72.4%)) was significantly lower ( P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate for clinical trials in Northeast China (83.3%) was the highest, followed by South area (80.7%), North area (78.1%), and that for Northwest China (37.5%) was lowest. Compared with chemicals (74.8%) and biological products (79.9%), trials on traditional Chinese medicine had significantly lower rate of insurance (30.4%). For different study phase, insurance coverage in BE studies was the lowest (57.1%), followed by phase II trials, while it achieved the highest in phase III trials (85.1%). Conclusions: The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis in the near future. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.


Author(s):  
John D Halamka ◽  
Gil Alterovitz ◽  
William J. Buchanan ◽  
Tory Cenaj ◽  
Kevin A. Clauson ◽  
...  

To review blockchain lessons learned in 2018 and near-future predictions for blockchain in healthcare, Blockchain in Healthcare Today (BHTY) asked the world's blockchain in healthcare experts to share their insights. Here, our internationally-renowned BHTY peer-review board discusses their major predictions.Based on their responses, presented in detail below, ten major themes (Table ) for the future of blockchain in healthcare will emerge over the 12 months. CORRIGENDUM: This following paragraph has been corrected (page 3, first paragraph) from: "Fourth, with over 1000 insurance companies in the country, filling out paperwork to documentprovider training and licensure is a nightmare. The Synaptic Health Alliance aims to simplifythis process by putting all credentialing information on a distributed public ledger for all stakeholders to access.1" To: "Fourth, keeping health care provider directories maintained by health plans up-to-date is a critical, complex issue facing organizations across the health care system. The first project of the Synaptic Health Alliance aims to simplify this process by putting provider demographic information on a permissioned blockchain for Alliance members to access and maintain.1"


Sign in / Sign up

Export Citation Format

Share Document