Joanne Armstrong

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.

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

BackgroundAdministrative 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. ObjectivesTo describe agreement, sensitivity, and specificity of administrative claims compared with medical records for 2 pairs of targeted tests and treatments for breast cancer. Research DesignRetrospective 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). SubjectsWomen (35 to 65 y of age) with incident breast cancer diagnosed in 2006 to 2007 (n=775). MeasuresUse of human epidermal growth factor receptor 2 (HER2) and gene expression profiling (GEP) testing, trastuzumab, and adjuvant chemotherapy in claims and medical records. ResultsAgreement 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. ConclusionsHigher 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.

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 (<

Codevelopment of Genome-Based Therapeutics and Companion Diagnostics Insights From an Institute of Medicine Roundtable

40,000) were less likely than those with an income of

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

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.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 (<

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

40,000) were less likely than those with an income of

Early Diffusion Of Gene Expression Profiling In Breast Cancer Patients Associated With Areas Of High Income Inequality

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.

Antihyperglycemic Medications: A Claims-Based Estimate of First-Line Therapy Use Before Initialization of Second-Line Medications

More than 100 therapeutics, mostly for oncology, have biomarker tests recommended in their US Food and Drug Administration (FDA) labels.1 Moreover, a strategy to codevelop and cosubmit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond has had success recently with vemurafenib, targeting the BRAF V600 mutation in metastatic melanoma, and with crizotinib, targeting the EML4-ALK mutation in non–small cell lung cancer.2 Companion diagnostic tests define the subset of patients who are most likely to benefit from a therapy or who should not receive the therapy because of ineffectiveness or predicted adverse effects.3 Genome-based, targeted therapeutics and codeveloped CoDx tests are the foundation of personalized medicine and have potential for contributing to high-value health care.

Technology Assessment and the Road to Reimbursement of Genomic Based Diagnostics

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.

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

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 persons 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.