The State of State Biomarker Testing Insurance Coverage Laws.

This Viewpoint discusses laws mandating insurance coverage of biomarker testing to broaden access to care for patients with cancer.

Oral and monoclonal antibody treatments for relapsing forms of multiple sclerosis: Effectiveness and value.

DISCLOSURES: Ms McKenna, Dr Lin, Dr Whittington, Mr Nikitin, Ms Herron-Smith, Dr Campbell, and Dr Peterson report grants from Arnold Ventures, grants from Blue Cross Blue Shield of MA, grants from California Healthcare Foundation, grants from The Commonwealth Fund, and grants from The Peterson Center on Healthcare, during the conduct of the study; other from America's Health Insurance Plans, other from Anthem, other from AbbVie, other from Alnylam, other from AstraZeneca, other from Biogen, other from Blue Shield of CA, other from CVS, other from Editas, other from Express Scripts, other from Genentech/Roche, other from GlaxoSmithKline, other from Harvard Pilgrim, other from Health Care Service Corporation, other from Kaiser Permanente, other from LEO Pharma, other from Mallinckrodt, other from Merck, other from Novartis, other from National Pharmaceutical Council, other from Premera, other from Prime Therapeutics, other from Regeneron, other from Sanofi, other from United Healthcare, other from HealthFirst, other from Pfizer, other from Boehringer-Ingelheim, other from uniQure, other from Envolve Pharmacy Solutions, other from Humana, and other from Sun Life, outside the submitted work.

Association of Device Industry Payments, Physician Supply, and Regional Utilization of Orthopedic and Cardiac Procedures.

BACKGROUND: Geographic variation in high-cost medical procedure utilization in the USA is not fully explained by patient factors but may be influenced by the supply of procedural physicians and marketing payments. OBJECTIVE: To examine the association between physician supply, medical device-related marketing payments to physicians, and utilization of knee arthroplasty (KA) and percutaneous coronary interventions (PCI) within hospital referral regions (HRRs). DESIGN: Cross-sectional analysis of data from the 2018 CMS Open Payments database and procedural utilization data from the CMS Provider Utilization and Payment database. PARTICIPANTS: Medicare-participating procedural cardiologists and orthopedic surgeons. MAIN MEASURES: Regional rates of PCIs and KAs per 100,000 Medicare fee-for-service (FFS) beneficiaries were estimated after adjustment for beneficiary demographics. KEY RESULTS: Across 306 HRRs, there were 109,301 payments (value $17,554,728) to cardiologists for cardiac stents and 68,132 payments (value $40,492,126) to orthopedic surgeons for prosthetic knees. Among HRRs, one additional interventional cardiologist was associated with an increase of 12.9 (CI, 9.3-16.5) PCIs per 100,000 beneficiaries, and one additional orthopedic surgeon was associated with an increase of 20.6 (CI, 16.9-24.4) KAs per 100,000 beneficiaries. A $10,000 increase in gift payments from stent manufacturers was associated with an increase of 26.0 (CI, 5.1-46.9) PCIs per 100,000 beneficiaries, while total and service payments were not associated with greater regional PCI utilization. A $10,000 increase in total payments from knee prosthetic manufacturers was associated with an increase of 2.9 (CI, 1.4-4.5) KAs per 100,000 beneficiaries, while a similar increase in gift and service payments was associated with an increase of 14.5 (CI, 5.0-24.1) and 3.4 (CI, 1.6-5.2) KAs, respectively. CONCLUSIONS: Among Medicare FFS beneficiaries, regional supply of physicians and receipt of industry payments were associated with greater use of PCIs and KAs. Relationships between payments and procedural utilization were more consistent for KAs, a largely elective procedure, compared to PCIs, which may be elective or emergent.

Geriatricians' Perspectives on the Multiple Dimensions of Utility of Genetic Testing for Alzheimer's Disease: A Qualitative Study.

BACKGROUND: Research advancements in Alzheimer's disease (AD) raise opportunities for genetic testing to improve diagnostic and risk assessment. Despite emerging developments, it is unclear how geriatricians perceive the potential clinical and personal utility of genetic testing for their patients. Geriatricians' perspectives are essential to understanding potential ethical, policy, and clinical challenges. OBJECTIVE: In this paper, we report on geriatricians' perspectives on the utility of genetic testing for AD. METHODS: Semi-structured interviews with California geriatricians within different practices settings to collect and characterize their perspectives on genetic testing for AD. We used an adapted grounded theory approach to analyze recorded and transcribed interviews. RESULTS: We identified geriatricians' (n = 10) perspectives on the clinical and personal utility of testing, alongside their views on clinical care approaches for older adults. Geriatricians perceived minimal clinical utility of genetic testing for AD, though that may change with the availability of disease-modifying therapies. Yet, they recognized the potential personal utility of testing (e.g., assisting with future financial planning). Finally, geriatricians expressed concerns regarding patients' anxiety from learning about genetic status, particularly through direct-to-consumer (DTC) testing. CONCLUSION: Our data highlight that the decision to order genetic testing requires clinical and ethical considerations, including balancing limited clinical utility with the potential personal utility. Although DTC testing is available, geriatricians perceive that they have an important role in managing the decision to test and interpreting the results. Further research is needed to inform policy and ethical guidelines to support geriatricians' critical role to counsel patients considering clinical and DTC genetic testing.

Cost-Effectiveness and Value-Based Pricing of Aducanumab for Patients With Early Alzheimer Disease.

BACKGROUND AND OBJECTIVES: Aducanumab was granted accelerated approval with a conflicting evidence base, near-unanimous Food and Drug Administration Advisory Committee vote to reject approval, and a widely criticized launch price of $56,000 per year. The objective of this analysis was to estimate its cost-effectiveness. METHODS: We developed a Markov model to compare aducanumab in addition to supportive care to supportive care alone over a lifetime horizon. Results were presented from both the health system and modified societal perspective. The model tracked the severity of disease and the care setting. Incremental cost-effectiveness ratios were calculated and a threshold analysis was conducted to estimate at what price aducanumab would meet commonly used cost-effectiveness thresholds. RESULTS: Using estimates of effectiveness based on pooling of data from both pivotal trials, patients treated with aducanumab spent 4 more months in earlier stages of Alzheimer disease. Over the lifetime time horizon, treating a patient with aducanumab results in 0.154 more quality-adjusted life-years (QALYs) gained per patient and 0.201 equal value of life-years gained (evLYG) per patient from the health care system perspective, with additional costs of approximately $204,000 per patient. The incremental outcomes were similar for the modified societal perspective. At the launch price of $56,000 per year, the cost-effectiveness ranged from $1.02 million per evLYG to $1.33 million per QALY gained from the health care system perspective and from $938,000 per evLYG to $1.27 million per QALY gained in the modified societal perspective. The annual price to meet commonly used cost-effectiveness thresholds ranged from $2,950 to $8,360, which represents a discount of 85%-95% off from the annual launch price set by the manufacturer. Using estimates of effectiveness based only on the trial that suggested a benefit, the mean incremental cost was greater than $400,000 per QALY gained. CONCLUSION: Patients treated with aducanumab received minimal improvements in health outcomes at considerable cost. This resulted in incremental cost-effectiveness ratios that far exceeded commonly used value thresholds, even under optimistic treatment effectiveness assumptions. These findings are subject to the substantial uncertainty regarding whether aducanumab provides any true net health benefit, but evidence available currently suggests that an annual price of aducanumab of $56,000 is not in reasonable alignment with its clinical benefits.

Influence of payer coverage and out-of-pocket costs on ordering of NGS panel tests for hereditary cancer in diverse settings.

The landscape of payment for genetic testing has been changing, with an increase in the number of laboratories offering testing, larger panel offerings, and lower prices. To determine the influence of payer coverage and out-of-pocket costs on the ordering of NGS panel tests for hereditary cancer in diverse settings, we conducted semi-structured interviews with providers who conduct genetic counseling and order next-generation sequencing (NGS) panels purposefully recruited from 11 safety-net clinics and academic medical centers (AMCs) in California and North Carolina, states with diverse populations and divergent Medicaid expansion policies. Thematic analysis was done to identify themes related to the impact of reimbursement and out-of-pocket expenses on test ordering. Specific focus was put on differences between settings. Respondents from both safety-net clinics and AMCs reported that they are increasingly ordering panels instead of single-gene tests, and tests were ordered primarily from a few commercial laboratories. Surprisingly, safety-net clinics reported few barriers to testing related to cost, largely due to laboratory assistance with prior authorization requests and patient payment assistance programs that result in little to no patient out-of-pocket expenses. AMCs reported greater challenges navigating insurance issues, particularly prior authorization. Both groups cited non-coverage of genetic counseling as a major barrier to testing. Difficulty of access to cascade testing, particularly for family members that do not live in the United States, was also of concern. Long-term sustainability of laboratory payment assistance programs was a major concern; safety-net clinics were particularly concerned about access to testing without such programs. There were few differences between states. In conclusion, the use of laboratories with payment assistance programs reduces barriers to NGS panel testing among diverse populations. Such programs represent a major change to the financing and affordability of genetic testing. However, access to genetic counseling is a barrier and must be addressed to ensure equity in testing.

Hereditary cancer panel testing challenges and solutions for the latinx community: costs, access, and variants.

Hereditary breast and ovarian cancers (HBOCs) are common among the Latinx population, and risk testing is recommended using multi-gene hereditary cancer panels (HCPs). However, little is known about how payer reimbursement and out-of-pocket expenses impact provider ordering of HCP in the Latinx population. Our objective is to describe key challenges and possible solutions for HCP testing in the Latinx population. As part of a larger study, we conducted semi-structured interviews with key provider informants (genetic counselors, oncologist, nurse practitioner) from safety-net institutions in the San Francisco Bay Area. We used a deductive thematic analysis approach to summarize themes around challenges and possible solutions to facilitating HCP testing in Latinx patients. We found few financial barriers for HCP testing for the Latinx population due to laboratory patient assistance programs that cover testing at low or no cost to patients. However, we found potential challenges related to the sustainability of low-cost testing and out-of-pocket expenses for patients, access to cascade testing for family members, and pathogenic variants specific to Latinx. Providers questioned whether current laboratory payment programs that decrease barriers to testing are sustainable and suggested solutions for accessing cascade testing and ensuring variants specific to the Latinx population were included in testing. The use of laboratories with payment assistance programs reduces barriers to HCP testing among the US population; however, other barriers are present that may impact testing use in the Latinx population and must be addressed to ensure equitable access to HCP testing for this population.

The effectiveness and value of aducanumab for Alzheimer's disease.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Whittington, Rind, and Pearson are employed by ICER. Through their affiliated institutions, Synnott and Lin received funding from ICER for the work described in this summary. In addition, Synnott reports support from Biogen for the Tufts Medical Center Cost-Effectiveness Analysis Registry, which is maintained by the Center for the Evaluation of Value and Risk in Health.

The effectiveness and value of bempedoic acid and inclisiran for heterozygous familial hypercholesterolemia and secondary prevention of ASCVD.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Agboola, McKenna, and Pearson are employed by ICER. Lin and Kazi received funding from ICER for work on this report.

Is Better Patient Knowledge Associated with Different Treatment Preferences? A Survey of Patients with Stable Coronary Artery Disease.

BACKGROUND: In stable coronary artery disease (CAD), shared decision-making (SDM) is encouraged when deciding whether to pursue percutaneous coronary intervention (PCI) given similar cardiovascular outcomes between PCI and medical therapy. However, it remains unclear whether improving patient-provider communication and patient knowledge, the main tenets of SDM, changes patient preferences or the treatment chosen. We explored the relationships between patient-provider communication, patient knowledge, patient preferences, and the treatment received. METHODS: We surveyed stable CAD patients referred for elective cardiac catheterization at seven hospitals from 6/2016 to 9/2018. Surveys assessed patient-provider communication, medical knowledge, and preferences for treatment and decision-making. We verified treatments received by chart review. We used linear and logistic regression to examine relationships between patient-provider communication and knowledge, knowledge and preference, and preference and treatment received. RESULTS: Eighty-seven patients completed the survey. More discussion of the benefits and risks of both medical therapy and PCI associated with higher patient knowledge scores (ß=0.28, p<0.01). Patient knowledge level was not associated with preference for PCI (OR=0.78, 95% CI 0.57-1.03, p=0.09). Black patients had more than four times the odds of preferring medical therapy to PCI (OR=4.49, 1.22-18.45, p=0.03). Patients preferring medical therapy were not significantly less likely to receive PCI (OR=0.67, 0.16-2.52, p=0.57). CONCLUSIONS: While communicating the risks of PCI may improve patient knowledge, this knowledge may not affect patient treatment preferences. Rather, other factors such as race may be significantly more influential on a patient's treatment preferences. Furthermore, patient preferences are still not well reflected in the treatment received. Improving shared decision-making in stable CAD therefore may require not only increasing patient education but also better understanding and including a patient's background and pre-existing beliefs.

The Effectiveness and Value of Deflazacort and Exon-Skipping Therapies for the Management of Duchenne Muscular Dystrophy.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, Commonwealth Fund, California Health Care Foundation, National Institute for Health Care Management (NIHCM), New England States Consortium Systems Organization, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, Kaiser Foundation Health Plan, and Partners HealthCare to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fluetsch, Rind, and Pearson are employed by ICER. Lin reports support from ICER during work on this economic model and grants from Mount Zion Health Fund, National Institutes of Health (National Cancer Institute and National Heart, Lung, and Blood Institute), and the Tobacco-Related Diseases Research Program, unrelated to this work. Walton reports support from ICER for work on this economic model and unrelated consulting fees from Baxter.

Association of Primary Language and Hospitalization for Ambulatory Care Sensitive Conditions.

BACKGROUND: Limited English proficiency is associated with decreased access to ambulatory care, however, it is unclear if this disparity leads to increased use of emergency departments (EDs) for low severity ambulatory care sensitive conditions (ACSCs). OBJECTIVE: We sought to determine the association between the patient's preferred language and hospital utilization for ACSCs. RESEARCH DESIGN: We conducted a retrospective cohort study of all ED visits in New Jersey in 2013 and 2014. The primary outcome was hospital admission for acute ACSCs, chronic ACSCs, and fractures (a nonambulatory care sensitive control condition). Secondary outcomes included intensive care unit (ICU) utilization and length of stay. Mixed-effect regression models estimated the association between preferred language (English vs. non-English) and study outcomes, controlling for demographics, comorbidities, and hospital characteristics. RESULTS: We examined 201,351 ED visits for acute ACSCs, 251,193 visits for chronic ACSCs, and 148,428 visits for fractures, of which 13.5%, 11.1%, and 9.9%, respectively, were by non-English speakers. In adjusted analyses, non-English speakers were less likely to be admitted for acute ACSCs [-3.1%; 95% confidence interval (CI), -3.6% to -2.5%] and chronic ACSCs (-2.3%; 95% CI, -2.8% to -1.7%) but not fractures (0.4%; 95% CI, -0.2% to 1.0%). Among hospitalized patients, non-English speakers were less likely to receive ICU services but had no difference in length of stay. CONCLUSIONS: These findings suggest non-English-speaking patients may seek ED care for lower acuity ACSCs than English-speaking patients. Efforts to decrease preventable ED and increase access to ambulatory care use should consider the needs of non-English-speaking patients.

Electronic health records systems and hospital clinical performance: a study of nationwide hospital data.

OBJECTIVE: Electronic health records (EHRs) were expected to yield numerous benefits. However, early studies found mixed evidence of this. We sought to determine whether widespread adoption of modern EHRs in the US has improved clinical care. METHODS: We studied hospitals reporting performance measures from 2008-2015 in the Centers for Medicare and Medicaid Services Hospital Compare database that also reported having an EHR in the American Hospital Association 2015 IT supplement. Using interrupted time-series analysis, we examined the association of EHR implementation, EHR vendor, and Meaningful Use status with 11 process measures and 30-day hospital readmission and mortality rates for heart failure, pneumonia, and acute myocardial infarction. RESULTS: A total of 1246 hospitals contributed 8222 hospital-years. Compared to hospitals without EHRs, hospitals with EHRs had significant improvements over time on 5 of 11 process measures. There were no substantial differences in readmission or mortality rates. Hospitals with CPSI EHR systems performed worse on several process and outcome measures. Otherwise, we found no substantial improvements in process measures or condition-specific outcomes by duration of EHR use, EHR vendor, or a hospital's Meaningful Use Stage 1 or Stage 2 status. CONCLUSION: In this national study of hospitals with modern EHRs, EHR use was associated with better process of care measure performance but did not improve condition-specific readmission or mortality rates regardless of duration of EHR use, vendor choice, or Meaningful Use status. Further research is required to understand why EHRs have yet to improve standard outcome measures and how to better realize the potential benefits of EHR systems.