Generic dispensing rates for substitutable drugs prescribed by general practitioners compared with other private ambulatory specialists: A study based on a French national reimbursement database.

BACKGROUND: The use of generic drugs is a way for healthcare systems to reduce costs, particularly in ambulatory care. Several studies suggest that the prescriber's speciality is associated with the use of generic drugs, and that substitutable drugs prescribed by General Practitioners (GPs) are more often generic, but this association has never been studied in France. In the French legislative context, except in rare situations, all substitutable drugs prescribed should be dispensed in generic form. OBJECTIVES: Compare the generic drugs dispensing rate among substitutable drugs dispensed in community pharmacies prescribed by French private GPs with that of other private specialists, all other specialities combined (first objective) or each other speciality taken individually (second objective). METHODS: We used a sample of an open available semi-aggregated database from the 2019 French health insurance system database. We compared with logistic regression models GPs to all other specialities combined, then GPs to the 19 other specialties taken individually, only on the substitutable drugs they prescribe in common. RESULTS: In 2019, 53.4% of the drugs prescribed by French private ambulatory physicians were substitutable drugs, and 81.5% of them were dispensed in generic form. After adjustment, the generic dispensing rate for substitutable drugs was significantly higher for GPs than for other specialties (ORa 0.74 [IC95% 0.72-0.76]). Thirteen of the nineteen other specialities taken individually, such as endocrinologists (ORa 0.64 [IC95% 0.57-0.72]) and cardiologists (ORa 0.60 [0.56-0.63]) had significantly lower generic dispensing rates than GPs. No other speciality had a rate significantly higher than GPs. CONCLUSIONS: Substitutable drugs prescribed by French private GPs are more often dispensed in generic form than those from other private ambulatory specialties. To understand this result and optimise the use of generic drugs in outpatient settings, we need to study the different stages of drug use, from prescription by the physician to dispensing by the pharmacist and acceptance by the patient.

82% of substitutable drugs prescribed by French private general practitioners in 2019 were dispensed in generic form.No other ambulatory specialty rated significantly higher than general practitioners.Research is needed to study reasons for non-generic drug prescription in the context of legislative changes.

National and Geographic Trends in Medicare Reimbursement for Pain Management 2014-2023.

BACKGROUND: Increasing enrollment in Medicare has coincided with reductions in reimbursement for various procedures, including interventional pain procedures. No previous analysis of state-to-state differences in Medicare reimbursement rates for practicing pain management physicians has been performed. OBJECTIVE: To quantify recent national and geographical trends for interventional pain procedures. STUDY DESIGN: This study used datasets from the Centers for Medicare and Medicaid Services to identify the top 10 highest-grossing Current Procedure Terminology (CPT) codes for pain procedures and for evaluation and management (E/M) from 2014 to 2023. Data analysis took place during May 2023. METHODS: Primary outcomes were calculated inflation-adjusted rates of yearly percent change (YPC) for each CPT code, state, territory, and U.S. Census region. An independent samples t-test compared the national YPC rates of procedure to those of E/M reimbursement. Medicare reimbursements throughout the United States for interventional pain procedures and clinic evaluations were measured from 2014-2023. RESULTS: From 2014 to 2023, inflation-adjusted Medicare reimbursement for interventional pain procedures decreased yearly by an average of 3.63%. In comparison, clinic evaluation reimbursement decreased by only 0.87% yearly and was significantly different from procedure reimbursement (P < 0.001). Pain management procedure reimbursement decreased the most in Illinois (-4.26%), Wyoming (-3.88%), Wisconsin (-3.87%), Nevada (-3.83%) and Kansas (-3.82%). Meanwhile, rates for Puerto Rico (-1.94%), Massachusetts (-3.24%), Washington (-3.31%), New York (-3.39%), and West Virginia (-3.47%) decreased the least. When states were grouped into U.S. Census regions, no significant regional differences in pain management procedure reimbursement changes could be observed. LIMITATIONS: Only the facility prices of the top 10 highest-grossing procedure and E/M CPT codes that had available data for 2014 to 2023 could be included in our analysis; trends for private insurance reimbursement could not be analyzed. CONCLUSIONS: Medicare reimbursement rates for interventional pain procedures have decreased from 2014 to 2023, both nationally and in each region of the U.S. Our analysis suggests that certain states and territories have experienced less favorable reimbursement trends than others. This issue is worthy of attention as larger proportions of the U.S. population become eligible for Medicare coverage; should these trends continue, interventional pain physicians may consider moving their practices to areas that are less affected. Major efforts are required to preserve the quality of care that Medicare beneficiaries receive and to remedy the problem of depreciating reimbursement.

Budget impact analysis of high-priced orphan medicinal products intended for the treatment of rare diseases in China: evidence from a densely populated metropolis of Chengdu.

BACKGROUND: An increasing number of orphan medicinal products (OMPs) are being included in social health insurance schemes, significantly improving access to medicines for patients with rare diseases. However, high-priced OMPs are still not covered, primarily due to health equity controversies and inadequate data systems required for economic evaluation. The aim of this study was to estimate the burden of drug expenditures and the size of the reimbursement budget required for high-priced OMPs from the perspectives of society and healthcare payers. METHODS: The study performed a budget impact analysis using data from multiple sources to estimate the reimbursement budget for high-priced OMPs in Chengdu, a densely populated metropolis in China. The budget analysis consisted of three main elements: the number of patients, the price of drugs, and the simulated policy scenario. By adjusting the combinations of these elements, the budget fluctuations for payers were estimated. Furthermore, the study predicted the budget trend for the next three years to validate its sustainability. RESULTS: The analysis indicated that 98 rare disease patients in Chengdu required high-priced OMPs in 2019. This suggested a projected budget of CNY 179 million for these patients without reimbursement policies, from a societal perspective. Under six assumed policy scenarios, this budget ranged from CNY 32 million to CNY 156 million. Over the next three years, the annual budget was estimated to range from CNY 200 million to CNY 1.303 billion. CONCLUSION: Integration of multi-source data helps to obtain more scientifically reliable results on budget impacts. The study found that the budgetary impacts of high-priced OMPs on society and payers are relatively limited. Health policymakers can choose appropriate reimbursement strategies based on financial affordability among a diverse mix of elements. The results of related studies provided insights for optimizing the allocation of health resources and improving patient access to medications.

Dwindling dollars: The inflation-adjusted decline of Medicare reimbursement in endocrine surgery (2003-2023).

INTRODUCTION: Medicare determines reimbursement rates for medical services, often setting a benchmark that is followed by private insurers. Across various medical specialties, decreases in Medicare reimbursement have been observed. However, the extent of Medicare reimbursement for endocrine surgery remains unexplored. This study investigates the trajectory of reimbursement rates for endocrine surgical procedures. METHODS: Data spanning 2003 to 2023 were gathered from the Physician Fee Schedule Look-Up Tool for 16 endocrine operations and procedures. Each operation's or procedure's relative value units and conversion factor, which accounts for geographic variation in relative value units, are determined annually by the Centers for Medicare and Medicaid Services. The total annual Medicare reimbursement for each operation or procedure was determined by multiplying procedure-specific relative value units with the conversion factor. Raw yearly percentage changes in reimbursement were computed and compared to changes in the general consumer price index. All data were then corrected for inflation. The compound annual growth rate for each procedure was calculated using inflation-adjusted data. RESULTS: From 2003 to 2023, the mean unadjusted percentage change for all queried procedures was +14.14% (standard deviation 0.28). During this same time, the consumer price index increased by 69.15% (P < .001). After adjusting for inflation, the mean total adjusted percentage change for all queried procedures over the entire study period was -31% (standard deviation 0.17). The adjusted average yearly compound annual growth rate was -1.93% (standard deviation 0.92). Only 1 procedure showed an increase in reimbursement (image-guided fine-needle aspiration, +32%). CONCLUSION: Inflation-adjusted Medicare reimbursement rates for endocrine surgical procedures have consistently declined. Stakeholders must address these trends to ensure access to quality surgical endocrine care in an evolving health care landscape.

Interrupted time series analysis of chronic periodontitis-related procedures before and after the scaling reimbursement policy in Korea.

AIM: To study the use of a quasi-experimental design to assess the effects of scaling reimbursement policies on the incidence of chronic-periodontitis procedures. MATERIALS AND METHODS: Interrupted time series analysis was used to compare the effects before and after policy implementation using data on the number of periodontitis-related procedures from the Korean National Health Insurance Service-National Sample Cohort (n = 740,467) and the Health Screening Cohort (n = 337,904). Periodontitis-related procedures with diagnosis codes were categorized into basic (scaling or root planing), intermediate (subgingival curettage) and advanced (tooth extraction, periodontal flap surgery, bone grafting for alveolar bone defects or guided tissue regeneration). Subjects' demographics and comorbidities were considered. The incidence rate of immediate changes and gradual effects before and after policy implementation was assessed. RESULTS: Following the policy implementation from July 2013, an immediate increase was observed in total and basic procedures. No significant changes were noted in intermediate and advanced procedures initially. A decrease in the slope of intermediate procedures was observed in both databases. Advanced procedures showed varied trends, with no change in the National Sample Cohort but an increase in the Health Screening Cohort, particularly among subjects with comorbidities. CONCLUSIONS: Following the new policy implementation, the number of intermediate procedures decreased while the number of advanced procedures increased, especially among patients with comorbidities. These findings offer valuable insights on policy evaluation.

Utilising Health Technology Assessment to Develop Managed Access Protocols to Facilitate Drug Reimbursement in Ireland.

The Health Service Executive, responsible for operating the Irish health service, has introduced health technology management (HTM) initiatives to manage expenditure on medicines. One such approach is managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. Herein we describe the development and operation of MAPs, using case studies of liraglutide (Saxenda®), dupilumab (Dupixent®) and calcitonin gene-related peptide monoclonal antibodies. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system. The choice of criteria are specific to each medicine, dictated by the areas of uncertainty highlighted in the health technology assessment report, such as the place in treatment, population, duration of treatment, etc., the commercial arrangements reached with the marketing authorisation holder, and specific recommendations made by the decision maker. By December 2023, there were 28 medicines reimbursed subject to a MAP in Ireland. Across the three case studies outlined, over 3000 patients were accessing novel treatments for chronic illnesses in September 2023. Managed access protocols can provide some cost certainty for the payer by aligning utilisation and expenditure with committed funds, while enabling access where unmet need is highest. Managed access protocols are now established in the drug reimbursement process in Ireland, meeting the needs of both payers, patients and industry, and are likely to remain a feature of the reimbursement landscape.

Assessment of national reimbursement anticancer medications availability in China: based on a medical institution perspective.

BACKGROUND: High clinical value national reimbursement anticancer medications (NRAMs) are pivotal treatments for patients with cancer. However, the availability of NRAMs in medical institutions is unknown. This study aimed to assess the availability of NRAMs in national and provincial medical institutions. METHODS: This cross-sectional study utilized national health insurance data to access the availability of NRAMs in national and provincial medical institutions. Further statistical analyses and visualizations were conducted in terms of medical institution level and daily cost. Using the Spearman's rank correlation test (α = 0.05), we calculated the correlation between the availability rates of NRAMs and their negotiation access time, daily cost, per capita disposable income, provincial gross product, and number of policy releases. RESULTS: Overall, 81 NRAMs, with an average availability rate of approximately 1.01% nationwide, were included. There were significant differences between provinces for each drug, and the availability of NRAMs gradually decreased in tertiary (13.41%), secondary (1.58%), and primary medical institutions (< 0.05%). Differences were also observed in the availability rate of NRAMs in various daily drug cost ranges. Among the factors examined, negotiation access time (r1 = 0.425), daily cost (r2 = - 0.326), per capita disposable income (r3 = 0.645), provincial gross product (r4 = 0.433), and number of policy releases (r5 = 0.461) were all correlated with the availability of NRAMs. CONCLUSIONS: The low availability of NRAMs in national and provincial medical institutions indicates that their willingness to equip NRAMs needs to be improved. All factors examined in this study affected the availability of NRAMs. Our findings can guide policymakers in improving relevant policies.

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.

Medicaid Reimbursement for Common Orthopaedic Trauma Procedures Is 16.0% Less Compared With Medicare With Substantial Variability Between States.

OBJECTIVES: This study seeks to evaluate the variability of Medicaid reimbursement and compare it with Medicare reimbursement using the 20 most commonly billed orthopaedic trauma Current Procedural Terminology (CPT) codes nationwide. The authors anticipate significant variability between states and hypothesize that Medicaid payment will be significantly less than Medicare payment. METHODS: The top 20 most common orthopaedic trauma surgery procedural codes were identified from a previous analysis performed by Haglin et al. The Centers for Medicare and Medicaid Services Physician Fee Schedule was used to determine reimbursement rates from Medicare, and state Medicaid fee schedules were used to determine reimbursement rates for Medicaid. State Medicaid rates were compared with their corresponding Medicare rates to determine a dollar difference. In addition, the dollar difference for each CPT code was divided by its respective physician relative value unit. This was used to acknowledge the possible variability in the complexity of orthopaedic procedures and the related physician effort. The Medicare Wage Index was used to adjust Medicaid rates based on the cost of living for the state as well. Coefficients of variation were calculated to represent overall variability in Medicaid and Medicare reimbursement rates. RESULTS: The mean reimbursement rates for Medicaid were lower for all 20 procedures compared with Medicare. On average, Medicaid reimbursed 16.0% less than Medicare and 29.6% less when adjusting for cost of living. MCD reimbursed at a higher rate than MCR for all procedures in only 9 states (Alaska, Arizona, Arkansas, Montana, Nebraska, New Jersey, New Mexico, North Dakota, and South Dakota) while 38 states reimbursed at a lower rate than MCR, on average. The coefficient of variation ranged from 0.24 to 0.34 for the Medicaid unadjusted group and from 0.35 to 0.46 for the Medicare Wage Index-adjusted group. By contrast, the Medicare group was consistent at 0.06 for all 20 procedures. The average dollar difference across the 20 CPT codes for Medicaid reimbursement compared with Medicare reimbursement ranged from -$76.89 to -$225.17, and the dollar difference per relative value unit ranged from -$5.96 to -$15.16. CONCLUSIONS: This study found a high amount of variation between state Medicaid reimbursement rates and average rates that were significantly lower than Medicare reimbursement rates for the top 20 most used orthopaedic trauma CPT codes as identified by Haglin et al. The discrepancy in reimbursement was increased when Medicaid rates were adjusted for state cost of living. LEVEL OF EVIDENCE: Prognostic, Level III. See Instructions for Authors for a complete description of levels of evidence.

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.

Developing an OBL: Key Considerations Before Spending a Dime Or Too Much Time.

The office-based laboratory (OBL) industry has proliferated over the past decade as surgical cases have increasingly migrated from inpatient to outpatient surgical settings, including OBLs, ambulatory surgery centers and infusion centers. Although many physicians and patients prefer to provide and receive care in an OBL setting because it provides a high quality, lower cost and convenient alternative to receiving care in a hospital, the OBL industry is nonetheless under attack on a variety of fronts. Governmental and commercial payor reimbursement for OBL procedures has declined substantially over time, and there have been lawsuits, governmental investigations and news articles that have been critical of care provided in OBLs. These issues have generated headwinds for this young but growing industry. It is therefore important for physicians and investors alike interested in developing an OBL to be aware of the complex landscape of laws and regulations that apply to OBLs. This article provides an overview of key legal, corporate, tax, financial and structural considerations for operators to be aware of before opening an OBL.

Trends in Patient Complexity, Practice Setting, and Surgeon Reimbursement for Urolithiasis: Do Rural Urologists Pay the Price?

OBJECTIVE: To evaluate the relationship between patient complexity, practice setting, and surgeon reimbursement for ureteroscopy and percutaneous nephrolithotomy (PCNL). METHODS: The "2021 Medicare Physician and Other Provider" file was used to collect Rural-Urban Commuting Area (RUCA) codes and hierarchical condition category (HCC) scores of urologists. Higher HCC score corresponds to higher medical complexity and higher RUCA code corresponds to a more rural area. Medicare reimbursement for ureteroscopy and PCNL were collected. Linear regressions were performed to predict change in reimbursement based on RUCA and HCC scores. RESULTS: In 2021, 52,816 procedures under Current Procedural Terminology (CPT) code 52356 (ureteroscopy) and 1649 procedures under 50080 or 50081 (PCNL) were billed to Medicare. Mean reimbursement was $338.24 for ureteroscopy and $957.89 for PCNL. For ureteroscopy, higher HCC score predicted lower reimbursement (P <.001). Higher HCC score predicted higher reimbursement for PCNL (P <.01). Average RUCA for ureteroscopy was higher than for PCNL (P = .02). Rural location predicted lower reimbursement for ureteroscopy (P <.001), however, there was no association for PCNL. CONCLUSION: For ureteroscopy, higher-risk patients are associated with lower reimbursement while the opposite holds true for PCNL. Rural practices were associated with lower reimbursement for ureteroscopy, but there was no association between location and PCNL reimbursement. Together, these findings suggest practice pattern variation between ureteroscopy and PCNL and highlight gaps in reimbursement policy. Risk-adjusted reimbursement should be considered to incentivize urologists to treat complex patients within their practice scope.

Market Factors, Not Quality, Influence Reimbursement for Pancreaticoduodenectomy in an Era of Price Transparency.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) price transparency rule tries to facilitate cost-conscious decision-making. For surgical services, such as pancreaticoduodenectomy (PD), factors mediating transparency and real-world reimbursement are not well described. METHODS: The Leapfrog Survey was used to identify United States hospitals performing PD. Financial and operational data were obtained from Turquoise Health and CMS Cost Reports. Chi-square tests and modified Poisson regression evaluated associations with reimbursement disclosure. Two-part logistic and gamma regression models estimated effects of hospital factors on commercial, Medicare, and self-pay reimbursements for PD. RESULTS: Of 452 Leapfrog hospitals, 295 (65%) disclosed PD hospital or procedure reimbursements. Disclosing hospitals were larger (beds > 200: 81.0% vs. 71.3%, p = 0.04), reported higher net margins (0.7% vs. - 2.1%, p = 0.04), more likely for-profit (26.1% vs. 6.4%, p < 0.001), and teaching-affiliated (82.0% vs. 65.6%, p < 0.001). Nonprofit status conferred hospitalization reimbursement increases of $8683-$12,329, while moderate market concentration predicted savings up to $5066. Teaching affiliation conferred reimbursement increases of $4589-$16,393 for hospitalizations and $644 for procedures. Top Leapfrog volume ratings predicted an increase of up to $7795 for only Medicare hospitalization reimbursement. CONCLUSIONS: Nondisclosure of hospital and procedural reimbursements for PD remains a major issue. Transparency was noted in hospitals with higher margins, size, and academic affiliation. Factors associated with higher reimbursement were non-profit status, academic affiliation, and more equitable market share. Reimbursement inconsistently tracked with PD quality or volume measures. Policy changes may be required to incentivize reimbursement disclosure and translate transparency into increased value for patients.

Why Evidence Generation Should Matter to Payers and How They Can Help.

Importance: The US leads the world in bringing new medical products to market, but the ability to generate evidence to inform clinical practice in postmarket settings needs improvement. Although a diverse group of stakeholders is working to improve postmarket evidence generation, the role of private payers has been underappreciated. Observations: Payers are crucial allies in improving evidence generation because better data would better inform coverage decisions, their policies and practices influence the conduct of care and research, and their claims data are a source of real-world evidence used in medical product evaluation. In addition, payers have a stake in improving evidence generation because the kinds of evidence needed to inform health care and coverage decisions are often not available when a product enters the market and may not be generated without their involvement. Here, we describe several key steps payers could take to improve evidence generation, including participating in efforts to reduce administrative and financial barriers to the conduct of clinical trials, directly incentivizing evidence generation on high-priority questions by funding potential cost-saving trials, increasing engagement with the medical products industry on evidentiary needs for coverage decisions, and improving usability of claims data by reducing data lags and routinely recording unique device identifiers. Broad payer engagement with US Food and Drug Administration recommendations regarding evidence generation will ensure that the opportunities to participate in clinical research are extended to all communities and that evidence needed to inform care is generated in trials and surveillance systems that reflect the clinical reality across the US. Conclusions and Relevance: Increasing payer involvement in evidence generation can benefit all participants in the medical innovation ecosystem. The importance of payers in these efforts will continue to grow in response to imperatives to increase integration of care and research, engage a diverse set of communities in clinical research, and move toward alternative payment models.

Evolving Economics: The Erosion of Medicare Reimbursement in Breast Surgery (2003-2023).

INTRODUCTION: Medicare significantly influences reimbursement rates, setting a standard that impacts private insurance policies. Despite declining rates in various specialties, the magnitude of these trends has not been examined in breast surgery. This study examines Medicare reimbursement trends for breast surgery operations. METHODS: Data for 10 breast operations from 2003 to 2023 were collected from the Medicare Physician Fee Look-Up Tool and yearly reimbursement was computed using the conversion factor. The year-to-year percentage change in reimbursement was calculated, and the overall median change was compared with the consumer price index (CPI) for inflation evaluation. All data were adjusted to 2023 United States dollars. The compound annual growth rate (CAGR) was calculated using inflation-adjusted data. RESULTS: Over the study period, reimbursement for the 10 breast operations had a mean unadjusted percentage increase of + 25.17%, while the CPI increased by 69.15% (p < 0.001). However, after adjustment, overall reimbursement decreased by - 20.70%. Only two operations (lumpectomy and simple mastectomy) saw increased inflation-adjusted Medicare reimbursement (+ 0.37% and + 3.58%, respectively). The CAGR was - 1.54% overall but remained positive for the same two operations (+ 0.02% and + 0.18%, respectively). Based on these findings, breast surgeons were estimated to be reimbursed $107,605,444 less in 2023 than if rates had kept pace with inflation over the past decade. CONCLUSION: Inflation-adjusted Medicare reimbursement rates for breast surgeries have declined from 2003 to 2023. This downward trend may strain resources, potentially leading to compromises in care quality. Surgeons, administrators, and policymakers must take proactive measures to address these issues and ensure the ongoing accessibility and quality of breast surgery.