Women Accessing Care at a National Network of Retail Health Clinics.

Background: Retail health clinics offer easy access and lower costs in seeking nonemergent and usually focused care. The objective of this observational study was to describe the use of retail clinic services by women at MinuteClinic at CVS, the largest network of retail clinics in the United States. Methods: The retail clinic's large database included complete national data for every in-person encounter as recorded on the same electronic health record. Virtual care and pharmacist-delivered services like COVID-19 testing were excluded from the analysis. The primary reason for the visit and the patient's age group (<15, 15-44, 45-64, ≥65 years) and self-reported sex were recorded at each encounter from the most recent 5 years (January 1, 2018, to December 31, 2022). Results: There were 17,969,483 encounters by women seeking care, and women ≥15 years old were more likely than men to attend the clinics. Half of all encounters (50.6%) were for non-gynecologic acute care, whereas one-third (33.6%) dealt with either an infection or the need for a vaccination. Gynecologic reasons involved 5.6% of all encounters in women ≥15 years of age. No obstetrical care was provided except for pregnancy testing with referral, acute non-obstetric needs, or guideline-recommended vaccinations. Conclusion: Women, especially of reproductive age, are more inclined than men to seek care at retail clinics. Acute care is the most common need, although requests for immunizations, infection screening and treatment, and reproductive health issues occurred often.

Utilization, Timing, and Outcomes of BRCA Genetic Testing Among Women With Newly Diagnosed Breast Cancer From a National Commercially Insured Population: The ABOARD Study.

PURPOSE: To evaluate timing and outcomes of BRCA testing and definitive surgical treatment among patients with newly diagnosed breast cancer. METHODS: Patient-reported (n = 1,381) and deidentified health-plan (n = 2,369) data were analyzed from a consecutive national series of 3,750 women whose healthcare providers ordered BRCA testing between March 2014 and June 2015, within 1 year following breast cancer diagnosis. RESULTS: Among 1,209 respondents, 54.4% received the genetic test results presurgery, 23.2% tested presurgery but received the results postsurgery, and 22.3% tested postsurgery. Patients aware of mutation-positive results presurgery were more likely to choose bilateral mastectomy (BLM) (n = 32/37) compared with patients who learned of positive results postsurgery (n = 14/32), (odds ratio [OR] = 8.23, 95% CI = 2.55 to 26.59, P < .001). When compared with women tested postsurgery, only women unaware of negative results presurgery had higher BLM rates (adjusted OR = 1.70, 95% CI = 1.07 to 2.69, P = .02). Among women > 50 tested presurgery, those unaware of negative results presurgery were more likely to choose BLM (n = 28/81) compared with those aware of negative results (n = 32/168) (OR = 2.25, 95% CI = 1.23 to 4.08, negative results awareness × age interaction, and P = .007). CONCLUSION: Nearly half of participants did not receive BRCA results presurgery, which limited their ability to make fully informed surgical treatment decisions. This may represent suboptimal care for unaware mutation-positive patients compared with those who were aware presurgery. Women > 50 who test negative are significantly less likely to choose BLM, a costly surgery that does not confer survival advantage, if they are aware of negative results presurgery. These results have important implications for quality of care and costs in the US health system.

Estimates of healthcare spending for preterm and low-birthweight infants in a commercially insured population: 2008-2016.

The growth in healthcare spending is an important topic in the United States, and preterm and low-birthweight infants have some of the highest healthcare expenditures of any patient population. We performed a retrospective cohort study of spending in this population using a large, national claims database of commercially insured individuals. A total of 763,566 infants with insurance coverage through Aetna, Inc. for the first 6 months of post-natal life were included, and received approximately $8.4 billion (2016 USD) in healthcare services. Infants with billing codes indicating preterm status (<37 weeks, n = 50,511) incurred medical expenditures of $76,153 on average, while low-birthweight status (<2500 g) was associated with average spending of $114,437. Infants born at 24 weeks gestation (n = 418) had the highest per infant average expenditures of $603,778. Understanding the drivers of variation in costs within gestational age and birthweight bands is an important target for future studies.

Antihyperglycemic Medications: A Claims-Based Estimate of First-line Therapy Use Prior to Initialization of Second-line Medications.

OBJECTIVE: The American Diabetes Association recommends metformin as first-line therapy for type 2 diabetes. However, nonadherence to antihyperglycemic medication is common, and a clinician could confuse nonadherence with pharmacologic failure, potentially leading to premature prescribing of second-line therapies. We measured metformin use prior to second-line therapy initialization. RESEARCH DESIGN AND METHODS: This retrospective cross-sectional study used unidentifiable member claims data from individuals covered from 2010 to 2015 by Aetna, a U.S. health benefits company. Beneficiaries with two physician claims or one hospitalization with a type 2 diabetes diagnosis were included. Recommended use of metformin was measured by the proportion of days covered over 60 days. Through sensitivity analysis, we varied estimates of the percentage of beneficiaries who used low-cost generic prescription medication programs. RESULTS: A total of 52,544 individuals with type 2 diabetes were eligible. Of 22,956 patients given second-line treatment, only 1,875 (8.2%) had evidence of recommended use of metformin in the prior 60 days, and 6,441 (28.0%) had no prior claims evidence of having taken metformin. At the top range of sensitivity, only 49.5% patients could have had recommended use. Patients were more likely to be given an additional second-line antihyperglycemic medication or insulin if they were given their initial second-line medication without evidence of recommended use of metformin (P < 0.001). CONCLUSIONS: Despite published guidelines, second-line therapy often is initiated without evidence of recommended use of first-line therapy. Apparent treatment failures, which may in fact be attributable to nonadherence to guidelines, are common. Point-of-care and population-level processes are needed to monitor and improve guideline adherence.

Coding update of the SMFM definition of low risk for cesarean delivery from ICD-9-CM to ICD-10-CM.

In 2015, the Society for Maternal-Fetal Medicine developed a low risk for cesarean delivery definition based on administrative claims-based diagnosis codes described by the International Classification of Diseases, Ninth Revision, Clinical Modification. The Society for Maternal-Fetal Medicine definition is a clinical enrichment of 2 available measures from the Joint Commission and the Agency for Healthcare Research and Quality measures. The Society for Maternal-Fetal Medicine measure excludes diagnosis codes that represent clinically relevant risk factors that are absolute or relative contraindications to vaginal birth while retaining diagnosis codes such as labor disorders that are discretionary risk factors for cesarean delivery. The introduction of the International Statistical Classification of Diseases, 10th Revision, Clinical Modification in October 2015 expanded the number of available diagnosis codes and enabled a greater depth and breadth of clinical description. These coding improvements further enhance the clinical validity of the Society for Maternal-Fetal Medicine definition and its potential utility in tracking progress toward the goal of safely lowering the US cesarean delivery rate. This report updates the Society for Maternal-Fetal Medicine definition of low risk for cesarean delivery using International Statistical Classification of Diseases, 10th Revision, Clinical Modification coding.

Predicting Falls in People Aged 65 Years and Older from Insurance Claims.

BACKGROUND: Accidental falls among people aged 65 years and older caused approximately 2,700,000 injuries, 27,000 deaths, and cost more than 34 billion dollars in the US annually in recent years. Here, we derive and validate a predictive model for falls based on a retrospective cohort of those 65 years and older. METHODS: Insurance claims from a 1-year observational period were used to predict a fall-related claim in the following 2 years. The predictive model takes into account a person's age, sex, prescriptions, and diagnoses. Through random assignment, half of the people had their claims used to derive the model, while the remaining people had their claims used to validate the model. RESULTS: Of 120,881 individuals with Aetna health insurance coverage, 12,431 (10.3%) members fell. During validation, people were risk stratified across 20 levels, where those in the highest risk stratum had 10.5 times the risk as those in the lowest stratum (33.1% vs 3.1%). CONCLUSIONS: Using only insurance claims, individuals in this large cohort at high risk of falls could be readily identified up to 2 years in advance. Although external validation is needed, the findings support the use of the model to better target interventions.

Comparing variation in hospital rates of cesarean delivery among low-risk women using 3 different measures.

This report describes the development of a measure of low-risk cesarean delivery by the Society for Maternal-Fetal Medicine (SMFM). Safely lowering the cesarean delivery rate is a priority for maternity care clinicians and health care delivery systems. Therefore, hospital quality assurance programs are increasingly tracking cesarean delivery rates among low-risk pregnancies. Two commonly used definitions of "low risk" are available, the Joint Commission (JC) and the Agency for Healthcare Research and Quality (AHRQ) measures, but these measures are not clinically comprehensive. We sought to refine the definition of the low-risk cesarean delivery rate to enhance the validity of the metric for quality measurement. We created this refined definition-called the SMFM definition-and compared it to the JC and AHRQ measures using claims-based data from the 2011 Nationwide Inpatient Sample of >863,000 births in 612 hospitals. Using these definitions, we calculated means and interquartile ranges (25th-75th percentile range) for hospital low-risk cesarean delivery rates, stratified by hospital size, teaching status, urban/rural location, and payer mix. Across all hospitals, the mean low-risk cesarean delivery rate was lowest for the SMFM definition (12.65%), but not substantially different from the JC and AHRQ measures (13.12% and 13.29%, respectively). We empirically examined the SMFM definition to ensure its validity and utility. This refined definition performs similarly to existing measures and has the added advantage of clinical perspective, enhanced face validity, and ease of use.

Utilization and Outcomes of BRCA Genetic Testing and Counseling in a National Commercially Insured Population: The ABOUT Study.

IMPORTANCE: BRCA genetic testing has substantial public health impact, yet little is known of the real-world experiences of the more than 100 000 Americans undergoing testing annually. OBJECTIVE: To identify factors associated with use of BRCA testing, assess whether delivery of genetic counseling and testing services adheres to professional guidelines, and measure the impact on patient-reported outcomes. DESIGN, SETTING, AND PARTICIPANTS: The American BRCA Outcomes and Utilization of Testing (ABOUT) Study analyzed data from a consecutive national series of 11 159 women whose clinicians ordered BRCA testing between December 2011 and December 2012. Aetna mailed recruitment information across the United States to commercial health plan members whose clinicians had ordered BRCA testing. A total of 3874 women (34.7%) completed questionnaires. Deidentified clinician-reported data from all respondents and a random sample of 2613 nonrespondents were also analyzed. MAIN OUTCOMES AND MEASURES: The proportion of eligible participants who met testing criteria and respondents' report of receiving genetic counseling by a genetics clinician and its association with BRCA knowledge, understanding, and satisfaction were assessed. RESULTS: Among 3628 women respondents whose clinicians ordered comprehensive BRCA testing, most were white non-Hispanic (2502 [69.0%]), college educated (2953 [81.4%]), married (2751 [75.8%]), and had higher incomes (2011 [55.4%]). Approximately 16.4% (596) did not meet testing criteria. Mutations were identified in 161 (5.3%) of these women who received comprehensive testing. Only 1334 (36.8%) reported receiving genetic counseling from a genetics clinician prior to testing; the lowest rates (130 [12.3%]) were among patients of obstetrician/gynecologists. The most commonly reported reason for not receiving this clinical service was lack of clinician recommendation. Those who received it demonstrated greater knowledge about BRCA (mean score difference adjusted for demographics and clinician specialty, ß = 0.99 [95% CI, 0.83-1.14]; P < .001) and expressed greater understanding (ß = 0.47 [95% CI, 0.41-0.54]; P < .001) and satisfaction (ß = 2.21 [95% CI, 1.60-2.81]; P < .001). CONCLUSIONS AND RELEVANCE: Despite improved patient knowledge, understanding, and satisfaction among patients who receive genetic counseling provided by a genetics clinician, as well as multiple guidelines emphasizing the importance of genetic counseling, most US women undergoing BRCA genetic testing do not receive this clinical service. Lack of physician recommendation is the most commonly reported reason. These findings demonstrate important gaps in clinical genetics services. Recently mandated coverage of genetic counseling services as a preventive service without patient cost sharing should contribute to improving clinical genetics services and associated outcomes in the future.

Early diffusion of gene expression profiling in breast cancer patients associated with areas of high income inequality.

With the Affordable Care Act reducing coverage disparities, social factors could prominently determine where and for whom innovations first diffuse in health care markets. Gene expression profiling is a potentially cost-effective innovation that guides chemotherapy decisions in early-stage breast cancer, but adoption has been uneven across the United States. Using a sample of commercially insured women, we evaluated whether income inequality in metropolitan areas was associated with receipt of gene expression profiling during its initial diffusion in 2006-07. In areas with high income inequality, gene expression profiling receipt was higher than elsewhere, but it was associated with a 10.6-percentage-point gap between high- and low-income women. In areas with low rates of income inequality, gene expression profiling receipt was lower, with no significant differences by income. Even among insured women, income inequality may indirectly shape diffusion of gene expression profiling, with benefits accruing to the highest-income patients in the most unequal places. Policies reducing gene expression profiling disparities should address low-inequality areas and, in unequal places, practice settings serving low-income patients.

Women's Health in the Age of Patient Protection and the Affordable Care Act.

The Patient Protection and Affordable Care Act of 2010 is the most sweeping health care legislation in a generation. The goal of the legislation is to increase access to both public and private insurance, and to improve the affordability and quality of care. Many provisions of the bill have a direct impact on the women's health care services. This paper provides an overview of the bill's provisions that have the largest impact on women's health care and provides data on the impact of the bill to date.

American BRCA Outcomes and Utilization of Testing (ABOUT) study: a pragmatic research model that incorporates personalized medicine/patient-centered outcomes in a real world setting.

Research to date regarding identification and management of hereditary breast and ovarian cancer syndrome (HBOC) in the U.S. has been confined primarily to academic center-based studies with limited patient engagement. To begin to understand and address the current gaps and disparities in delivery of services for the appropriate identification and optimal risk management of individuals with HBOC, we designed and have initiated the American BRCA Outcomes and Utilization of Testing (ABOUT) Study. ABOUT relies on a collaborative patient advocacy, academic and industry partnership to recruit and engage U.S. individuals who are at increased risk for HBOC and investigate their experiences, decisions and outcomes. It utilizes an extensive research infrastructure, including an interactive web-based data system and electronic interfaces for secure online participation and automated data exchange. We describe the novel recruitment approach that was designed for collaboration with a national commercial health plan partner to identify all individuals for whom a healthcare provider orders a BRCA test and mail to each individual an invitation to participate and study packet. The study packet contains detailed information about the study, a baseline questionnaire and informed consent for participation in the study, for release of relevant medical and health plan records and for ongoing research engagement. This approach employs patient-reported, laboratory-reported and health plan-reported outcomes and facilitates longitudinal engagement. We believe that the type of innovative methodology and collaborative framework we have developed for ABOUT is an ideal foundation for a patient-powered research network. This approach can make substantial contributions to identifying current and best practices in HBOC, leading to improved strategies for clinical care and optimal health outcomes among individuals with high inherited risk for cancer.

Facilitating comparative effectiveness research in cancer genomics: evaluating stakeholder perceptions of the engagement process.

AIMS: The Center for Comparative Effectiveness Research in Cancer Genomics completed a 2-year stakeholder-guided process for the prioritization of genomic tests for comparative effectiveness research studies. We sought to evaluate the effectiveness of engagement procedures in achieving project goals and to identify opportunities for future improvements. MATERIALS & METHODS: The evaluation included an online questionnaire, one-on-one telephone interviews and facilitated discussion. Responses to the online questionnaire were tabulated for descriptive purposes, while transcripts from key informant interviews were analyzed using a directed content analysis approach. RESULTS: A total of 11 out of 13 stakeholders completed both the online questionnaire and interview process, while nine participated in the facilitated discussion. Eighty-nine percent of questionnaire items received overall ratings of agree or strongly agree; 11% of responses were rated as neutral with the exception of a single rating of disagreement with an item regarding the clarity of how stakeholder input was incorporated into project decisions. Recommendations for future improvement included developing standard recruitment practices, role descriptions and processes for improved communication with clinical and comparative effectiveness research investigators. CONCLUSIONS: Evaluation of the stakeholder engagement process provided constructive feedback for future improvements and should be routinely conducted to ensure maximal effectiveness of stakeholder involvement.

Genomic testing and therapies for breast cancer in clinical practice.

PURPOSE: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. STUDY DESIGN: Cross-sectional. METHODS: We performed a medical record review of women age 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). RESULTS: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (< $40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% CI, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. CONCLUSION: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.

Genomic testing and therapies for breast cancer in clinical practice.

OBJECTIVE: Given the likely proliferation of targeted testing and treatment strategies for cancer, a better understanding of the utilization patterns of human epidermal growth factor receptor 2 (HER2) testing and trastuzumab and newer gene expression profiling (GEP) for risk stratification and chemotherapy decision making are important. STUDY DESIGN: Cross-sectional. METHODS: We performed a medical record review of women aged 35 to 65 years diagnosed between 2006 and 2007 with invasive localized breast cancer, identified using claims from a large national health plan (N = 775). RESULTS: Almost all women received HER2 testing (96.9%), and 24.9% of women with an accepted indication received GEP. Unexplained socioeconomic differences in GEP use were apparent after adjusting for age and clinical characteristics; specifically, GEP use increased with income. For example, those in the lowest income category (<$40,000) were less likely than those with an income of $125,000 or more to receive GEP (odds ratio, 0.34; 95% confidence interval, 0.16 to 0.73). A majority of women (57.7%) with HER2-positive disease received trastuzumab; among these women, differences in age and clinical characteristics were not apparent, although surprisingly, those in the lowest income category were more likely than those in the high-income category to receive trastuzumab (P = .02). Among women who did not have a positive HER2 test, 3.9% still received trastuzumab. Receipt of adjuvant chemotherapy increased as GEP score indicated greater risk of recurrence. CONCLUSION: Identifying and eliminating unnecessary variation in the use of these expensive tests and treatments should be part of quality improvement and efficiency programs.

Tradeoffs of using administrative claims and medical records to identify the use of personalized medicine for patients with breast cancer.

BACKGROUND: Administrative claims and medical records are important data sources to examine healthcare utilization and outcomes. Little is known about identifying personalized medicine technologies in these sources. OBJECTIVES: To describe agreement, sensitivity, and specificity of administrative claims compared with medical records for 2 pairs of targeted tests and treatments for breast cancer. RESEARCH DESIGN: Retrospective analysis of medical records linked to administrative claims from a large health plan. We examined whether agreement varied by factors that facilitate tracking in claims (coding and cost) and that enhance medical record completeness (records from multiple providers). SUBJECTS: Women (35 to 65 y of age) with incident breast cancer diagnosed in 2006 to 2007 (n=775). MEASURES: Use of human epidermal growth factor receptor 2 (HER2) and gene expression profiling (GEP) testing, trastuzumab, and adjuvant chemotherapy in claims and medical records. RESULTS: Agreement between claims and records was substantial for GEP, trastuzumab, and chemotherapy, and lowest for HER2 tests. GEP, an expensive test with unique billing codes, had higher agreement (91.6% vs. 75.2%), sensitivity (94.9% vs. 76.7%), and specificity (90.1% vs. 29.2%) than HER2, a test without unique billing codes. Trastuzumab, a treatment with unique billing codes, had slightly higher agreement (95.1% vs. 90%) and sensitivity (98.1% vs. 87.9%) than adjuvant chemotherapy. CONCLUSIONS: Higher agreement and specificity were associated with services that had unique billing codes and high cost. Administrative claims may be sufficient for examining services with unique billing codes. Medical records provide better data for identifying tests lacking specific codes and for research requiring detailed clinical information.

Real world experience with cancer genetic counseling via telephone.

One barrier to genetic testing is the lack of access to genetic counselors. We provided cancer genetic counseling via telephone, through a pilot project for employees of a national health insurer, Aetna, Inc. Knowledge transfer, behavioral intentions, and patient satisfaction were assessed by survey after genetic counseling. Aetna sent an individual email to its employees nationwide notifying them of the availability of a new telephone genetic counseling and testing program and providing a link to take a brief screening questionnaire to determine whether they may be at risk of hereditary cancer. Employees completing the questionnaire received immediate feedback regarding whether there appeared to be a risk of hereditary cancer. If so, they were invited to schedule a telephonic genetic counseling session. After the session, respondents completed an online survey. 397 individuals completed the questionnaire. 39 proceeded with telephone genetic counseling, and 22 completed the follow-up survey, including all 11 women with family history warranting genetic testing. One third reported prior discussion about inherited cancer risk with their primary care provider (PCP); 12% were referred to a geneticist; 20% had an accurate perception of their own cancer risk. After counseling, 94% reported understanding their risk for cancer and 87% were aware of available risk-reduction strategies. 87% of high-risk respondents intended to engage in risk-management interventions. 93% reported high satisfaction. 66% indicated they would not have pursued genetic counseling if it had not been available by phone. Results suggest telephone counseling is a viable option for increasing access to genetic experts. In this sample, telephone counseling increases knowledge of cancer risk, motivates intention to change health-related behaviors, and elicits a high satisfaction level. Consequently, Aetna now offers telephone cancer genetic counseling nationwide as a covered benefit.