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.

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.

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.

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.

Preoperative medical testing in Medicare patients undergoing cataract surgery.

BACKGROUND: Routine preoperative testing is not recommended for patients undergoing cataract surgery, because testing neither decreases adverse events nor improves outcomes. We sought to assess adherence to this guideline, estimate expenditures from potentially unnecessary testing, and identify patient and health care system characteristics associated with potentially unnecessary testing. METHODS: Using an observational cohort of Medicare beneficiaries undergoing cataract surgery in 2011, we determined the prevalence and cost of preoperative testing in the month before surgery. We compared the prevalence of preoperative testing and office visits with the mean percentage of beneficiaries who underwent tests and had office visits during the preceding 11 months. Using multivariate hierarchical analyses, we examined the relationship between preoperative testing and characteristics of patients, health system characteristics, surgical setting, care team, and occurrence of a preoperative office visit. RESULTS: Of 440,857 patients, 53% had at least one preoperative test in the month before surgery. Expenditures on testing during that month were $4.8 million higher and expenditures on office visits $12.4 million higher (42% and 78% higher, respectively) than the mean monthly expenditures during the preceding 11 months. Testing varied widely among ophthalmologists; 36% of ophthalmologists ordered preoperative tests for more than 75% of their patients. A patient's probability of undergoing testing was associated mainly with the ophthalmologist who managed the preoperative evaluation. CONCLUSIONS: Preoperative testing before cataract surgery occurred frequently and was more strongly associated with provider practice patterns than with patient characteristics. (Funded by the Foundation for Anesthesia Education and Research and the Grove Foundation.).

An effort to spread decision aids in five California primary care practices yielded low distribution, highlighting hurdles.

Despite the proven efficacy of decision aids as interventions for increasing patient engagement and facilitating shared decision making, they are not used routinely in clinical care. Findings from a project designed to achieve such integration, conducted at five primary care practices in 2010-12, document low rates of distribution of decision aids to eligible patients due for colorectal cancer screening (9.3 percent) and experiencing back pain (10.7 percent). There were also no lasting increases in distribution rates in response to training sessions and other promotional activities for physicians and clinic staff. The results of focus groups, ethnographic field notes, and surveys suggest that major structural and cultural changes in health care practice and policy are necessary to achieve the levels of use of decision aids and shared decision making in routine practice envisioned in current policy. Among these changes are ongoing incentives for use, physician training, and a team-based practice model in which all care team members bear formal responsibility for the use of decision aids in routine primary care.

Patient decision aids for prostate cancer treatment: a systematic review of the literature.

Treatment decision-making can be difficult and complex for patients with low-risk prostate cancer. To the authors' knowledge, there is no consensus regarding an optimal treatment strategy and the choice of therapy involves tradeoffs between differing harms and benefits that are sensitive to patient values. In such situations, patients are often asked to participate actively in the decision-making process, and high-quality decisions require a well-informed patient whose values and preferences have been taken into consideration. Prior studies have indicated that patients have poor knowledge and unrealistic expectations regarding treatment, and physician judgments concerning patient preferences are often inaccurate. Decision aids (DAs) have been developed to help inform patients with low-risk prostate cancer about treatment options and assist in the decision-making process; however, little is currently known regarding the effects of such programs in this population. Thirteen studies of DAs for patients with prostate cancer were reviewed and it was found that the use of DAs can improve knowledge, encourage more active patient involvement in decision-making, and decrease levels of anxiety and distress. The effect of DAs on treatment choice was less clear, although fewer patients chose surgery compared with historical controls, particularly in Europe. Further studies are needed to determine how best to implement DAs into practice, and whether they improve the consistency between patient preferences and treatment choice.