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.

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 of medicare reimbursement for breast cancer and reconstructive surgery.

This study evaluated trends in Medicare reimbursement for commonly performed breast oncologic and reconstructive procedures. Average national relative value units (RVUs) for physician-based work, facilities, and malpractice were collected along with the corresponding conversion factors for each year. From 2010 to 2021, there was an overall average decrease of 15% in Medicare reimbursement for both breast oncology (-11%) and reconstructive procedures (-16%). Based on these findings, breast and reconstructive surgeons should advocate for reimbursement that better reflects the costs of their practice.

Medicare volume and reimbursement trends in lingual and hyoid procedures for obstructive sleep apnea.

OBJECTIVES: This study aims to analyze utilization and reimbursement trends in lingual and hyoid surgery for obstructive sleep apnea (OSA). METHODS: Annual retrospective data on lingual and hyoid OSA surgeries was obtained from the 2000-2021 Medicare Part B National Summary Datafiles. Current Procedural Terminology (CPT) codes utilized included 21,685 (hyoid myotomy and suspension [HMS]), 41,512 (tongue base suspension [TBS]), 41,530 (radiofrequency ablation of the tongue [RFT]) and 42,870 (lingual tonsillectomy [LT]). RESULTS: The number of lingual and hyoid OSA surgeries rose 2777 % from 121 in 2000 to 3481 in 2015, before falling 82.9 % to 594 in 2021. Accordingly, Medicare payments rose 17,899 % from an inflation-adjusted $46,958 in 2000 to $8.45 million in 2015, before falling drastically to $341,011 in 2021. As the number of HMSs (2000: 91; 2015: 84; 2021: 165), TBS (2009: 48; 2015: 31; 2021: 16), and LTs (2000: 121; 2015: 261; 2021: 234) only experienced modest changes in utilization, this change was largely driven by RFT (2009: 340; 2015: 3105; 2021: 179). Average Medicare payments for RFT rose from $1110 in 2009 to $2994 in 2015, before falling drastically to $737 in 2021. CONCLUSION: Lingual and hyoid surgery for OSA has overall fallen in utilization among the Medicare population from 2000 to 2021. However, there was a brief spike in usage, peaking in 2015, driven by the adoption (and then quick dismissal) of RFT. The rise and fall in RFT use coincide with the rise and fall in reimbursement.

Examining the Effect of Depicting a Patient Affected by a Negative Reimbursement Decision in Healthcare on Public Disagreement with the Decision.

BACKGROUND: The availability of increasingly advanced and expensive new health technologies puts considerable pressure on publicly financed healthcare systems. Decisions to not-or no longer-reimburse a health technology from public funding may become inevitable. Nonetheless, policymakers are often pressured to amend or revoke negative reimbursement decisions due to the public disagreement that typically follows such decisions. Public disagreement may be reinforced by the publication of pictures of individual patients in the media. Our aim was to assess the effect of depicting a patient affected by a negative reimbursement decision on public disagreement with the decision. METHODS: We conducted a discrete choice experiment in a representative sample of the public (n = 1008) in the Netherlands and assessed the likelihood of respondents' disagreement with policymakers' decision to not reimburse a new pharmaceutical for one of two patient groups. We presented a picture of one of the patients affected by the decision for one patient group and "no picture available" for the other group. The groups were described on the basis of patients' age, health-related quality of life (HRQOL) and life expectancy (LE) before treatment, and HRQOL and LE gains from treatment. We applied random-intercept logit regression models to analyze the data. RESULTS: Our results indicate that respondents were more likely to disagree with the negative reimbursement decision when a picture of an affected patient was presented. Consistent with findings from other empirical studies, respondents were also more likely to disagree with the decision when patients were relatively young, had high levels of HRQOL and LE before treatment, and large LE gains from treatment. CONCLUSIONS: This study provides evidence for the effect of depicting individual, affected patients on public disagreement with negative reimbursement decisions in healthcare. Policymakers would do well to be aware of this effect so that they can anticipate it and implement policies to mitigate associated risks.

Trends of Medicare Reimbursement Rates for Gender-Affirming Surgery Procedures.

BACKGROUND: Awareness of Medicare reimbursement is important for gender-affirming surgeons who treat transgender patients with Medicare. In 2014, Medicare began to provide coverage for medically necessary transition-related surgery. The purpose of this study was to analyze trends in Medicare reimbursement rates for gender-affirming surgery procedures from 2014 to 2022. METHODS: The Medicare Physician Fee Schedule Look-Up Tool provided by the Centers for Medicare and Medicaid Services was used, and the Current Procedural Terminology codes for 43 gender-affirming surgery services were obtained. Monetary units, conversion factors, relative value units (RVUs) for work, facility, and malpractice costs for 30 transmasculine and 13 transfeminine procedures were analyzed. Descriptive statistics were performed to account for inflation and to determine the relative differences between 2014 and 2022. RESULTS: For all gender-affirming surgery procedures covered by Medicare, the average relative difference of monetary units decreased by 2.99% between 2014 and 2022. On average, there was a 3.97% decrease of work-based RVU charges for transmasculine procedures and a 1.73% decrease of work-based RVU charges for transfeminine procedures. After adjusting for inflation, the average relative difference of monetary units for all gender-affirming surgery procedures decreased by 23.42% between 2014 and 2022. CONCLUSIONS: Reimbursement rates for gender-affirming surgery procedures covered under Medicare have decreased over the observed period, and trends in reimbursement rates have not kept up with consumer price index inflation. Gender-affirming surgeons should be conscious of these changes in reimbursement rates and advocate for fairer compensation to promote medical care among an underserved population.

Unveiling the Hidden Discrepancies Between Medicare Physician Reimbursement Rates and Inflation Across Different Surgical Specialties.

OBJECTIVE: This study aimed to analyze the trends of Medicare physician reimbursement from 2011 to 2021 and compare the rates across different surgical specialties. BACKGROUND: Knowledge of Medicare is essential because of its significant contribution in physician reimbursements. Previous studies across surgical specialties have demonstrated that Medicare, despite keeping up with inflation in some areas, has remained flat when accounting for physician reimbursement. STUDY DESIGN: The Physician/Supplier Procedure Summary data for the calendar year 2021 were queried to extract the top 50% of Current Procedural Terminology codes based on case volume. The Physician Fee Schedule look-up tool was accessed, and the physician reimbursement fee was abstracted. Weighted mean reimbursement was adjusted for inflation. Growth rate and compound annual growth rate were calculated. Projection of future inflation and reimbursement rates were also calculated using the US Bureau of Labor Statistics. RESULTS: After adjusting for inflation, the weighted mean reimbursement across surgical specialties decreased by -22.5%. The largest reimbursement decrease was within the field of general surgery (-33.3%), followed by otolaryngology (-31.5%), vascular surgery (-23.3%), and plastic surgery (-22.8%). There was a significant decrease in median case volume across all specialties between 2011 and 2021 (P < 0.001). CONCLUSIONS: This study demonstrated that, when adjusted for inflation, over the study period, there has been a consistent decrease in reimbursement for all specialties analyzed. Awareness of the current downward trends in Medicare physician reimbursement should be a priority for all surgeons, as means of advocating for compensation and to maintain surgical care feasible and accessible to all patients.

A retrospective study of orthognathic surgery reimbursement and volume changes at an American academic medical center over a 13-year period.

OBJECTIVE: This study aimed to measure the association between orthognathic surgeon reimbursement and surgical volume over time. STUDY DESIGN: A retrospective cohort study of patients who underwent orthognathic surgery from January 1, 2010, to December 23, 2022, at an academic medical center was performed. Five patients per year were randomly selected and evaluated for insurance type and associated costs to create representative averages. Pearson correlation analysis was performed to test associations over 13 years with 2-tailed significance reported and statistical significance set at P < .05. RESULTS: A total of 618 patients who underwent 942 procedures were included. The average procedure charge was $6,153.76, and the average total surgeon collection was $1,535.75 per procedure. When monetary values were adjusted to reflect 2010 purchasing power, there was a negative correlation between the average charge per procedure and the year (r[11] = -0.59, P = .04). The year was not significantly correlated with the average amount collected (r[11] = -0.09, P = .78) or average insurance reimbursement (r[11] = -0.52, P = .07). CONCLUSIONS: Collections by surgeons did not change significantly over 13 years and were not correlated with the volume of procedures performed. Increased collections were correlated with increased patient costs. The stagnation of surgeon collection is concerning in the face of increased monetary inflation during this period. Increased volume of surgeries per year was correlated with decreases in patient cost and total collections.

Association of Launch Price and Clinical Value With Reimbursement Decisions for Anticancer Drugs in China.

BACKGROUND: The potential role played by launch price and clinical value in reimbursement decisions has not been sufficiently established in China. This study aimed to investigate the association of launch price and clinical value with reimbursement decisions for anticancer drugs after the implementation of reimbursement-linked price negotiation in China. METHODS: Anticancer drugs approved by the National Medical Products Administration (NMPA) of China from January 2017 to June 2022 were eligible for inclusion. Approval and reimbursement dates of included drug indications were retrieved from publicly available resources. We collected measures of clinical value, including survival, quality of life (QoL), and overall response rate from pivotal clinical trials and calculated treatment price at launch. Univariate and multivariate Cox proportional hazards models were employed to estimate the association between launch price, clinical value, and reimbursement decisions of anticancer drugs in China. RESULTS: The median reimbursement lag was 579 days (interquartile range [IQR]: 402-936) for 93 indications supported by randomized controlled trials and 637 days (IQR: 373-858) for 42 indications supported by single-arm clinical trials. Reimbursement was granted to 60 (65%) and 23 (55%) indications supported by randomized controlled and single-arm clinical trials, respectively. The launch price of anticancer drugs was not associated with reimbursement decisions in multivariate regression analyses. Indications supported by randomized controlled trials with higher clinical value were more likely to be reimbursed (hazard ratio [HR] for survival=1.07, 95% CI: 1.00-1.15, P=.037), while the overall response rate of indications supported by single-arm clinical trials was not associated with the likelihood of being reimbursed (HR=2.09, 95% CI: 0.14-32.28, P=.595). CONCLUSION: The launch price of anticancer drugs may not have a significant impact on reimbursement decisions, while the implementation of reimbursement-linked price negotiation in China has prioritized anticancer drugs with higher clinical value, but only for indications supported by randomized controlled trials. Efforts are needed to prioritize indications supported by single-arm clinical trials that have higher value during the process of price negotiation.

Pulmonary Rehabilitation Reimbursement Challenges.

Pulmonary rehabilitation (PR) is a highly effective intervention for persons with chronic respiratory diseases, resulting in improvement in exercise capacity, dyspnea, health-related quality of life, mood, reduced hospitalization, and improved survival and cost savings post-COPD hospitalization. Despite demonstrated effectiveness, PR is underutilized in part due to lack of awareness, limited access, and inadequate PR reimbursement. Poor payment is a long-standing barrier to PR's financial stability and access. Addressing PR payment, access, and utilization is a complex challenge and requires strategic, collaborative long-term approaches to meaningful solutions. Strategies to overcome payment disparities begin with legislative approaches to address limitations of Centers for Medicare and Medicaid Services coverage. Additional priorities include permanent approval for remote physician and advanced practice provider (APP) PR supervision, PR referrals by APPs, telerehabilitation using two-way audio/video technology, and elimination of the PR lifetime maximum limit of 72 h or units/patient. Methods are needed to effectively link appropriate PR prescribing and encouragement with primary care providers, hospitalists, case managers, and hospital navigators to optimize PR referrals. There is an important need to address inadequate PR access in rural settings. Potential opportunities to improve PR referrals and access include exploration of PR synergies with value-based care models that emphasize high-quality care and cost savings. Development and use of effective PR provider tools and resources may help address the above challenges as well as financially benefit PR programs.

Quantified trends in provider reimbursement and utilization volume in colorectal cancer screenings: analysis of Medicare claims from 2000 to 2019.

AIM: Colorectal cancer (CRC) screening rates in the United States remain persistently below guideline targets, partly due to suboptimal patient utilization and provider reimbursement. To guide long-term national utilization estimates and set reasonable screening adherence targets, this study aimed to quantify trends in utilization of and reimbursement for CRC screenings using Medicare claims. METHOD: Inflation-adjusted reimbursements and utilization volume associated with each CRC screening code were abstracted from Medicare claims between 2000 and 2019. Screenings, screenings/100 000 enrolees and reimbursement/screening were analysed with linear regression and compared with the equality of slopes tests. Average reimbursement per screening was compared using analysis of variance with Dunnett's T3 multiple comparisons test. RESULTS: The growth rate of multitarget stool DNA tests (mt-sDNA)/100 000 was the highest at 170.4 screenings/year (R2 = 0.99, p ≤ 0.001), while that of faecal occult blood tests/100 000 was the lowest at -446.4 screenings/year (R2 = 0.90, p ≤ 0.001) (p ≤ 0.001). Provider reimbursements averaged $546.95 (95% CI $520.12-$573.78) per mt-sDNA screening, significantly higher than reimbursements for all invasive screenings. Only FOBTs significantly increased in reimbursement per screening at $0.62/year (R2 = 0.91, p ≤ 0.001). CONCLUSION: We derived forecastable trend numbers for utilization and provider reimbursement. Faecal immunochemical tests/100 000 and mt-sDNA screenings/100 000 increased most rapidly during the entire study period. The number of nearly all invasive screenings/100 000 decreased rapidly; the number of colonoscopies/100 000 increased slightly, probably due to superior diagnostic strength. These trends indicate the that replacement of other invasive modalities with accessible noninvasive screenings will account for much of future screening behaviour and thus reductions in CRC incidence and mortality, especially given providers' reimbursement incentive to screen average-risk patients with stool-based tests.

Association of Medicaid Reimbursement Policies with Provision of Long-Acting Reversible Contraception in the Postpartum Period, 2012-2018.

Background: To address reimbursement challenges associated with long-acting reversible contraception (LARC) in the postpartum period, state Medicaid programs have provided additional payments ("carve-outs"). Implementation has been heterogeneous, with states providing separate payments for the device only, procedure only, or both the device and procedure. Methods: Claims data were drawn from 210,994 deliveries in the United States between 2012 and 2018. Using generalized estimating equations, we assess the relationship between Medicaid carve-out policies and the likelihood of LARC placement at (1) 3 days postpartum, (2) 60 days postpartum, and (3) 1 year postpartum, in Medicaid and commercially insured populations. Results: Among Medicaid beneficiaries, the likelihood of receiving LARC was higher in states with any carve-out, compared with states without carve-outs, at 3 days (adjusted odds ratio [aOR] 1.49 [95% confidence interval: 1.33-1.67], p < 0.001), 60 days (aOR: 1.40 [95% CI: 1.35-1.46], p < 0.001), and 1 year postpartum (aOR: 1.15 [95% CI: 1.11-1.20], p < 0.001). Adjustments were made for geographic region, seasonality, and patient age. Heterogeneity was observed by carve-out type; device carve-outs were consistently associated with greater likelihood of postpartum LARC placement, compared with states with no carve-outs. Similar trends were observed among commercially insured patients. Conclusion: Findings support the effectiveness of Medicaid carve-outs on postpartum LARC provision, particularly for device carve-outs, which were associated with increased postpartum LARC placement at 3 days, 60 days, and 1 year postpartum. This outcome suggests that policies to address cost-related barriers associated with LARC devices may prove most useful in overcoming barriers to immediate postpartum LARC placement, with the overarching aim of promoting reproductive autonomy.

Geographical Differences in Surgeon Reimbursement, Volume, and Patient Characteristics in Primary Total Hip Arthroplasty.

BACKGROUND: The purpose of this study was to evaluate changes in regional and national variations in reimbursement to arthroplasty surgeons, procedural volumes, and patient populations for total hip arthroplasty (THA) from 2013 to 2021. METHODS: The Medicare Physician and Other Practitioners database was queried for all billing episodes of primary THA for each year between 2013 and 2021. Inflation-adjusted surgeon reimbursement, procedural volume, physician address, and patient characteristics were extracted for each year. Data were stratified geographically based on the United States Census regions and rural-urban commuting codes. Kruskal-Wallis and multivariable regressions were utilized. RESULTS: Between 2013 and 2021, the overall THA volume and THAs per surgeon increased at the highest rate in the West (+48.2%, +20.2%). A decline in surgeon reimbursement was seen in all regions, most notably in the Midwest (-20.3%). Between 2013 and 2021, the average number of Medicare beneficiaries per surgeon declined by 12.6%, while the average number of services performed per beneficiary increased by 18.2%. In 2021, average surgeon reimbursement was the highest in the Northeast ($1,081.15) and the lowest in the Midwest ($988.03) (P < .001). Metropolitan and rural areas had greater reimbursement than micropolitan and small towns (P < .001). Patient age, race, sex, Medicaid eligibility, and comorbidity profiles differ between regions. Increased patient comorbidities, when controlling for patient characteristics, were associated with lower reimbursement in the Northeast and West (P < .01). CONCLUSIONS: Total hip arthroplasty (THA) volume and reimbursement differ between US regions, with the Midwest exhibiting the lowest increase in volume and greatest decline in reimbursement throughout the study period. Alternatively, the West had the greatest increase in THAs per surgeon. Patient comorbidity profiles differ between regions, and increased patient comorbidity is associated with decreased reimbursement in the Northeast and the West. This information is important for surgeons and policymakers as payment models regarding reimbursement for arthroplasty continue to evolve.

State Coverage and Reimbursement of Antiobesity Medications in Medicaid.

This study examines state Medicaid coverage policies for antiobesity medications and their trends in Medicaid reimbursement from 2011 to 2022.

Examining the Impact of the Current Reimbursement Regulation on Patient Access to Innovative Medical Devices in Taiwan: Insights From 8 Years' Reimbursement Data.

OBJECTIVES: This study aimed to assess the impact of the reimbursement regulation of medical devices (Regulation), introduced by the National Health Insurance Administration (NHIA) in 2013, on patients' access to innovative medical devices in Taiwan. METHODS: Analysis of the amount of time needed from application for NHIA reimbursement for new medical devices to receiving the decision from NHIA was done using the nonreimbursement product list featured on the NHIA website. Additionally, Welch analysis of variance was used to compare the amount of time it took from application to NHIA with reimbursement decisions made by the NHIA for different nonreimbursement code categories. Further, related Pharmaceutical Benefit Reimbursement Scheme meeting minutes were analyzed to obtain more detailed information concerning medical devices' reimbursement or not. RESULTS: From December 2012 to June 2021, the overall reimbursement percentage was 56.7%, and the average amount of time between application and reimbursement was 856.7 ± 474.7 days. The mandatory reimbursement rate was about 45%. NHIA reimbursement decisions as special medical devices also take a longer amount of time, because the applicants need to agree to the decision (P < .05). The NHIA decision-making process for nonreimbursement medical devices requires a significantly longer amount of time than for general materials (eg, suture, etc) decisions. CONCLUSIONS: Although the Regulation resolves payment issues, it also increases the amount of time to reach reimbursement decisions, thus hindering patient access to innovative medical devices. The study suggests that the review process needs to be simplified concerning reimbursement notification, using local real-world data to support reimbursement decisions.

Did Medicaid Reimbursements Shape the Effects of Medicaid Expansion on Access to Health Care Among the Low-Income Population?

BACKGROUND: Whether variation in Medicaid reimbursement fees influenced the impacts of the Medicaid expansions is not well understood. OBJECTIVE: We examine whether changes in health care access associated with Medicaid expansion are different in states with comparatively high Medicaid reimbursement rates compared against expanding in states with lower Medicaid reimbursement rates. DESIGN: Using a difference-in-difference-in-difference (DDD or triple-difference) regression approach, we compare relative differences in Medicaid expansion effects between lower and higher reimbursement states. PARTICIPANTS: 512,744 low-income adults aged 20-64 in the 2011-2019 Behavioral Risk Factor Surveillance System. MAIN MEASURES: Health insurance coverage status, unmet medical needs due to cost, regular source for health care, and a regular/scheduled checkup within the past year. KEY RESULTS: Medicaid expansion has significant and positive impacts on health coverage and access in both high- and low-fee states. In states with fee levels above the median Medicare-to-Medicaid ratios, expanding Medicaid eligibility reduced uninsurance rate by 15.2 percentage point (ppt, p < 0.01), shrank the cost-associated unmet medical need by 10.3 ppt (p < 0.01), improved access to usual source of care by 1.9 ppt (p < 0.1), and increased regular checkup by 14.4 ppt (p < 0.01), while such effects in low-fee states were 11.7 ppt (p < 0.01), 8.3 ppt (p < 0.01), 3.1 ppt (p < 0.1), and 12.3 ppt (p < 0.01), respectively. Our results suggest that Medicaid expansion effect on unmet medical need due to cost in higher-reimbursing states was 2.98 ppt (p < 0.05) larger than in lower-reimbursing states. Evidence suggests modest increases in health care access were more strongly associated with expansions in higher-fee states. CONCLUSIONS: Medicaid's fee structure should be considered as a factor influencing large-scale coverage expansions.