Considerations for US coverage and reimbursement: Which digital health products to evaluate? Findings from a modified Delphi study.

BACKGROUND: The rapid growth of digital health tools, including digital applications, wearables, sensors, diagnostics, digital therapeutics (DTx), and prescription DTx, offers new ways to treat patients and close gaps in care. Payers need transparent, credible, and efficient processes to differentiate products for potential reimbursement from the larger universe of digital health products. OBJECTIVE: To identify areas of agreement, disagreement, and rationale for payers to determine which digital health products should be evaluated for formulary consideration and to develop generalizable criteria for health care decision-makers developing policies and approaches for digital health products. METHODS: Experts from the Academy of Managed Care Pharmacy DTx Advisory Group Payer Evaluation subcommittee rated whether a pharmacy and therapeutics committee, health technology assessment group, or an innovation center within a health plan or pharmacy benefit manager should consider 14 hypothetical products for potential formulary coverage. Using a 4-step modified Delphi approach, experts rated whether it was appropriate for a payer to evaluate each product on a scale of 1 (strongly disagree) to 9 (strongly agree). Quantitative agreement was assessed using terciles of responses, medians, and the distribution of appropriateness scores. The corresponding discussions are summarized to identify generalizable criteria for payers to consider as they develop approaches to determine which digital health products to evaluate. RESULTS: Among the 14 hypothetical products, 4 achieved quantitative agreement that payers should evaluate the product. 5 products had quantitative disagreement, and the remaining were indeterminant. Payers were most likely to review a product if it (1) was reviewed by the US Food and Drug Administration, (2) required a prescription, (3) was intended to be paid for using premium dollars, (4) treated rather than diagnosed or monitored a clinical condition, (5) had a low clinical opportunity cost, and (6) could address population health metrics. CONCLUSIONS: The rapid availability of digital health and DTx options can be daunting for health care decision-makers when determining which products to evaluate. These generalizable criteria can help payers develop a more efficient process.

The Role of Individual Coverage Health Reimbursement Arrangements-The Liger of Health Insurance?

This JAMA Forum discusses aspects of individual coverage health reimbursement arrangements and their expanded use over the last few years.

Quantifying the insurance value for rare diseases: Duchenne muscular dystrophy.

OBJECTIVES: To quantify the magnitude of an ISPOR novel value element, insurance value, as applied to new treatments for a rare, severe disease with pediatric onset: Duchenne muscular dystrophy (DMD). STUDY DESIGN: Prospective survey of individuals planning to have children in the future. METHODS: A survey was administered to US adults (aged ≥ 21 years) planning to have a child in the future to elicit willingness to pay (WTP) for insurance coverage for a new hypothetical DMD treatment that improved mortality and morbidity relative to the current standard of care. To identify an indifference point between status quo insurance and insurance with additional cost that would cover the treatment if respondents had a child with DMD, a multiple random staircase design was used. Insurance value-the value individuals receive from a reduction in future health risks-was calculated as the difference between respondent's WTP and what a risk-neutral individual would pay. The risk-neutral value was the product of the (1) probability of having a child with DMD (decision weighted), (2) quality-adjusted life-years (QALYs) gained from the new treatment, and (3) WTP per QALY. RESULTS: Among 207 respondents, 80.2% (n = 166) were aged 25 to 44 years, and 59.9% (n = 124) were women. WTP for insurance coverage of the hypothetical treatment was $973 annually, whereas the decision-weighted risk-neutral value was $452 per year. Thus, insurance value constituted 53.5% ($520) of value for new DMD treatments. CONCLUSIONS: Individuals planning to have children in the future are willing to pay more for insurance coverage of novel DMD treatments than is assumed under risk-neutral, QALY-based frameworks.

The impact of the expanded health insurance coverage policy on healthcare spending: evidence from Korea.

BACKGROUND: South Korea's National Health Insurance (NHI) system pursues universal health coverage, but it has not been able to alleviate patients' financial burden owing to limited coverage and a high proportion of out-of-pocket expenses. In 2017, the government announced a plan to strengthen universality by providing coverage for all unincluded services, expanding coverage, and alleviating household financial burden. We aimed to evaluate the effect of "Moon Care" with a focus on changes in health expenditures following policy implementation, and to provide empirical evidence for future policies to strengthen the NHI system's universality. METHODS: Using data from the 2016 and 2018 Korea Health Panel (KHP), we established a treatment group affected by the policy and an unaffected control group; we ensured homogeneity between the groups using propensity score matching (PSM). Subsequently, we examined changes in NHI payments, non-payments, and out-of-pocket payments (OOP); we performed difference-in-differences (DID) analysis to evaluate the policy's effect. RESULTS: Following policy implementation, the control group had a higher increase than the treatment group in all categories of health expenditures, including NHI payments, non-payments, and OOP. We noted significant decreases in all three categories of health expenditures when comparing the differences before and after policy implementation, as well as between the treatment and control groups. However, we witnessed a significant decrease in the interaction term, which confirms the policy's effect, but only for non-payments. CONCLUSIONS: We observed the policy's intervention effect over time as a decrease in non-payments, on the effectivity of remunerating covered medical services. However, the policy did not work for NHI payments and OOP, suggesting that it failed to control the creation of new non-covered services as noncovered services were converted into covered ones. Thus, it is crucial to discuss the financial spending of health insurance regarding the inclusion of non-covered services in the NHI benefits package.

Formulary Coverage of Brand-Name Adalimumab and Biosimilars Across Medicare Part D Plans.

This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans.

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.

The impact of national health insurance on the cost of auricular reconstruction with skin expansion for microtia in China: A single-center retrospective study based on 1290 surgeries.

BACKGROUND: Congenital microtia presents challenges that encompass physical disabilities and psychosocial distress. It is reported that people with low income have a higher possibility of giving birth to babies with congenital malformations. At the end of June 2023, auricular reconstruction was partially incorporated into national health insurance in our hospital. METHODS: Briefly, 1290 surgeries, including stage-I and stage-II auricular reconstruction with tissue expansion were performed in 2023, involving 779 patients. Patient data, including age, sex, length of stay, residence, and costs, were retrieved from the electronic medical record system. The final cost before and after health insurance coverage, as well as the medical insurance reimbursement ratio in each province and municipality were statistically analyzed. RESULTS: Following insurance coverage, a significant increase in the number of surgeries was observed (514 [39.84%] vs. 776 [60.16%], χ2 = 45.99, p = 0.000), with notable reductions in out-of-pocket costs for unilateral and bilateral stage-I and -II auricular reconstructions ($3915.01 vs. $6645.28, p < 0.05; $11546.80 vs. $5198.08, p < 0.05). Disparities in reimbursement rates across regions were evident, but showed no correlation to the local GDP per capita. There was a positive correlation between the length of stay and inpatient cost. Patient's age was not related to the inpatient cost, but to the length of stay. CONCLUSION: The health insurance coverage for microtia treatment significantly alleviated financial burdens on the patients' family and increased the number of auricular reconstruction surgeries. These findings underscore the critical role of insurance coverage in enhancing healthcare accessibility and affordability for patients with congenital microtia.

Horizontal and vertical equity and public subsidies for private health insurance in the U.S.

The United States offers two markedly different subsidy structures for private health insurance. When covered through employer-based plans, employees and their dependents benefit from the exclusion from taxable income of the premiums. Individuals without access to employer coverage may obtain subsidies for Marketplace coverage. This paper seeks to understand how the public subsidies embedded in the privately financed portion of the U.S. healthcare system impact the payments families are required to make under both ESI and Marketplace coverage, and the implications for finance equity. Using the Household Component of the Medical Expenditure Panel Survey (MEPS-HC) and Marketplace premium data, we assess horizontal and vertical equity by calculating public subsidies for and expected family spending under each coverage source and using Lorenz curves and Gini and concentration coefficients. Our study pooled the 2018 and 2019 MEPS-HC to achieve a sample size of 10,593 observations. Our simulations showed a marked horizontal inequity for lower-income families with access to employer coverage who cannot obtain Marketplace subsidies. Relative to both the financing of employer coverage and earlier Marketplace tax credits, the more generous Marketplace premium subsidies, first made available in 2021 under the American Rescue Plan Act, substantially increased the vertical equity of Marketplace financing. While Marketplace subsidies have clearly improved equity within the United States, we conclude with a comparison to other OECD countries highlighting the persistence of inequities in the U.S. stemming from its noteworthy reliance on employer-based private health insurance.

Medicare Coverage and Patient Out-of-Pocket Costs for Cardiovascular-Kidney-Metabolic Medications.

This cross-sectional study evaluates the association between Medicare coverage and patient out-of-pocket costs for cardiovascular-kidney-metabolic medications.

The value of microvascular breast reconstruction: Cost equivalence of TRAM and DIEP flaps implications in the era of CMS reforms.

BACKGROUND: Recent CMS billing changes have raised concerns about insurance coverage for deep inferior epigastric perforator (DIEP) flap breast reconstruction. This study compared the costs and utilization of transverse rectus abdominis myocutaneous (TRAM), DIEP, and latissimus dorsi (LD) flaps in breast reconstruction. METHOD: The study utilized the National Inpatient Sample database to identify female patients who underwent DIEP, TRAM, and LD flap procedures from 2016 to 2019. Key data such as patient demographics, length of stay, complications, and costs (adjusted to 2021 USD) were analyzed, focusing on differences across the flap types. RESULTS: A total of 17,770 weighted patient encounters were identified, with the median age being 51. The majority underwent DIEP flaps (73.5%), followed by TRAM (14.2%) and LD (12.1%) flaps. The findings revealed that DIEP and TRAM flaps had a similar length of stay (LOS), while LD flaps typically had a shorter LOS. The total hospital charges to costs using cost-to-charge ratio were also comparable between DIEP and TRAM flaps, whereas LD flaps were significantly less expensive. Factors such as income quartile, primary payer of hospitalization, and geographic region significantly influenced flap choice. CONCLUSION: The study's results appear to contradict the prevailing notion that TRAM flaps are more cost-effective than DIEP flaps. The total hospital charges to costs using cost-to-charge ratio and hospital stays associated with TRAM and DIEP flaps were found to be similar. These findings suggest that changes in the insurance landscape, which may limit the use of DIEP flaps, could undermine patient autonomy while not necessarily reducing healthcare costs. Such policy shifts could favor less costly options like the LD flap, potentially altering the landscape of microvascular breast reconstruction.

Medicare Should Cover Weight Loss Drugs as Long as the Prices are Affordable.

Glucagon-like peptide-1 receptor agonists are effective for treating obesity, but the high cost of these medications endangers the financial viability of our health care system. To ensure that these drugs are available to Medicare beneficiaries, pharmaceutical manufacturers must lower their prices.

Physician-Based Approaches to Price Transparency: A Solution in Search of a Problem?

Physician-based transparency approaches have been advanced as a strategy for informing patients of the likely financial consequences of using services. The structure of health care pricing and insurance coverage, and the low uptake of existing tools, suggest these approaches are likely to be unwieldy and unsuccessful. They may also generate new ethical challenges.

Cancer diagnosis and treatment in working-age adults: Implications for employment, health insurance coverage, and financial hardship in the United States.

The rising costs of cancer care and subsequent medical financial hardship for cancer survivors and families are well documented in the United States. Less attention has been paid to employment disruptions and loss of household income after a cancer diagnosis and during treatment, potentially resulting in lasting financial hardship, particularly for working-age adults not yet age-eligible for Medicare coverage and their families. In this article, the authors use a composite patient case to illustrate the adverse consequences of cancer diagnosis and treatment for employment, health insurance coverage, household income, and other aspects of financial hardship. They summarize existing research and provide nationally representative estimates of multiple aspects of financial hardship and health insurance coverage, benefit design, and employee benefits, such as paid sick leave, among working-age adults with a history of cancer and compare them with estimates among working-age adults without a history of cancer from the most recently available years of the National Health Interview Survey (2019-2021). Then, the authors identify opportunities for addressing employment and health insurance coverage challenges at multiple levels, including federal, state, and local policies; employers; cancer care delivery organizations; and nonprofit organizations. These efforts, when informed by research to identify best practices, can potentially help mitigate the financial hardship associated with cancer.

The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

The anterior saphenous vein. Part 3. Systematic review of the literature and payor coverage policies. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

OBJECTIVE: The objective of this study is to systemically review the literature on Anterior Saphenous Vein (ASV) reflux treatment and insurance impediments to treatment coverage. METHODS: A literature search was performed using a PRISMA framework. In addition, a cross-sectional analysis of insurance policies for ASV treatment was evaluated. RESULTS: Published evidence and treatment considerations in the literature for ASV treatment are discussed. In 155 of 226 (68.6%) insurance policies reviewed coverage of ASV ablation was allowed while 62/226 (27.4%) did not specify coverage and 9/226 (4.0%) specified ASV treatment was not covered. Of the 155 that provide ASV coverage, 98 (62.2%) provide coverage with criteria such as requiring prior treatment of the great saphenous vein. CONCLUSIONS: Vein treatment experts should continue to advocate to insurance carriers to update their varicose vein treatment policies to reflect the substantial clinical evidence so that patients with ASV reflux can be appropriately treated.

Joint effects of Medicaid eligibility and fees on recession-linked declines in healthcare access and health status.

Whether Medicaid can function as a safety net to offset health risks created by health insurance coverage losses due to job loss is conditional on (1) the eligibility guidelines shaping the pathway for households to access the program for temporary relief, and (2) Medicaid reimbursement policies affecting the value of the program for both the newly and previously enrolled. We find states with more expansive eligibility guidelines lowered the healthcare access and health risk of coverage loss associated with rising unemployment during the 2007-2009 Great Recession. Rises in cost-related barriers to care associated with unemployment were smallest in states with expansive eligibility guidelines and higher Medicaid-to-Medicare fee ratios. Similarly, states whose Medicaid programs had expansive eligibility guidelines and higher fees saw the smallest recession-linked declines in self-reported good health. Medicaid can work to stabilize access to health care during periods of joblessness. Our findings yield important insights into the alignment of at least two Medicaid policies (i.e., eligibility and payment) shaping Medicaid's viability as a safety net.