Objective: To review the emerging evidence supporting the use of nerandomilast (Jascayd), a selective phosphodiesterase-4B (PDE4B) inhibitor, for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The review aims to summarize its mechanism of action, efficacy, safety, and potential role as monotherapy or in combination with existing antifibrotic therapies. Data Sources: A literature search was conducted using PubMed, Embase, ClinicalTrials.gov, and relevant conference proceedings from January 2018 through December 2025. Search terms included nerandomilast, BI 1015550, Jascayd, phosphodiesterase-4B inhibitor, idiopathic pulmonary fibrosis, progressive pulmonary fibrosis, interstitial lung disease, FIBRONEER-IPF, and FIBRONEER-ILD. Human studies published in English were included. Study Selection and Data Extraction: Original clinical studies, phase II and phase III trials, subgroup analyses, and regulatory publications evaluating nerandomilast in patients with IPF or PPF were reviewed. Studies were selected based on relevance to efficacy, safety, mechanism of action, and clinical outcomes. Data regarding study design, patient population, forced vital capacity (FVC) outcomes, adverse events, and concomitant antifibrotic use were extracted and qualitatively synthesized. Data Synthesis: Nerandomilast was approved in October 2025 for the treatment of IPF and PPF, representing the first PDE4B inhibitor approved for fibrotic lung disease. By inhibiting PDE4B, nerandomilast increases intracellular cyclic adenosine monophosphate (cAMP) levels, resulting in reduced inflammatory cytokine production and decreased fibroblast activation. Clinical trials, including the phase III FIBRONEER-IPF study, demonstrated a significant reduction in the rate of FVC decline compared with placebo, indicating attenuation of disease progression. Benefits were observed both in patients receiving nerandomilast alone and in those receiving background antifibrotic therapy with pirfenidone or nintedanib. Overall, nerandomilast demonstrated a favorable benefit-risk profile and offers a mechanistically distinct approach compared with currently available antifibrotic agents. Conclusions: Nerandomilast provides a novel anti-inflammatory and antifibrotic treatment option for patients with IPF and PPF. Available evidence suggests meaningful reductions in lung function decline with acceptable tolerability, including use alongside established antifibrotic therapies. As longer-term and real-world data emerge, nerandomilast may become an important component of the therapeutic strategy for progressive fibrotic lung diseases.

Background Anticoagulation for stroke prevention is often recommended for patients with non-valvular atrial fibrillation (AF), yet many eligible patients do not receive guideline-concordant anticoagulation. Prior quality improvement (QI) initiatives to improve anticoagulation in AF have had mixed results.Methods Preventing Preventable Strokes: Scalability used a triad of interventions to increase the number of eligible patients with AF receiving guideline-concordant anticoagulation, including (1) a best practice alert integrated with the electronic health record, (2) clinician education and (3) patient communication about the anticoagulation therapy that encouraged shared decision-making with clinicians. These interventions were conducted in primary care and cardiology outpatient clinics at (University of Florida Health). Patient-level data were collected during a 6-month intervention period and compared with a 6-month historical control period. Generalised estimating equations with a logistic link were used to estimate the odds of anticoagulant use, adjusting for demographic and clinical characteristics.Results A total of 3274 individuals were included during the intervention period and 3200 during the preintervention period. The average anticoagulation rate increased from 75.7% to 79.2% across the two periods. In the fully adjusted model, patients in the intervention period had significantly higher odds of anticoagulant use compared with the preintervention period (adjusted OR (aOR) 1.13, 95% CI 1.05 to 1.21, p=0.0007). MyChart activation (aOR 1.38, 95% CI 1.19 to 1.61, p<0.0001) was also associated with increased anticoagulant use. Older age and higher CHA2DS2-VASc scores were associated with greater odds of anticoagulant use, while higher HAS-BLED scores and care in primary care (rather than cardiology) were associated with lower odds.Conclusions A triad of QI interventions at the practice, clinician and patient levels increased guideline-concordant anticoagulation use among patients with AF in half of the primary care and cardiology clinics in the University of Florida Health system.

Pharmacists deliver high-value cognitive services in the ambulatory care setting; however, lack of provider recognition under the Social Security Act restricts their ability to independently deliver billable clinical services and access reimbursement through national payers such as Medicare Part B. This often raises the question of whether the collaborative efforts of a pharmacist and a billing provider (eg, physician) during a patient encounter can be combined as a "shared visit" to bill for a higher level of service (LOS). However, a distinction must be made between shared visits and "incident-to" billing. In an incident-to model, in which a pharmacist sees the patient alone under billing provider supervision, the service can only be billed at the lowest level, 99211, according to Medicare as of 2026. Even when both a pharmacist and billing provider see the patient and contribute to the visit, the pharmacist's documentation cannot be used to determine the LOS because they are not a recognized billing provider; only the billing provider's documented work counts for billing purposes. However, this should not deter collaboration between pharmacists and other health care providers given the clinical benefits of team-based care. With evolving billing requirements tied to documentation of the billing provider, opportunities remain to establish sustainable collaborative care models despite limitations in leveraging combined pharmacist-billing provider documentation to increase LOS through a shared visit model.

The American Heart Association recommended sodium-glucose cotransporter-2 inhibitors (SGLT2i) for the management of heart failure with preserved ejection fraction (HFpEF). However, little is known about their real-world in-class comparative safety in patients with HFpEF. We aimed to assess the comparative safety of SGLT2i in the risk of urinary tract infection (UTI) or genital infection separately or as a composite outcome among patients with HFpEF. This cohort study using MarketScan® Commercial and Medicare supplemental databases (2012–2020) included patients aged ≥ 18 years with a diagnosis of HFpEF who initiated SGLT2i therapy. Three pairwise comparison groups were established: cohort 1, dapagliflozin versus canagliflozin; cohort 2, empagliflozin versus canagliflozin; and cohort 3, dapagliflozin versus empagliflozin. After stabilized inverse probability treatment weighting, Cox proportional hazards regression was used to compare the risk of UTI or genital infection separately or as a composite outcome in each cohort. The risk of the composite outcome did not significantly differ between canagliflozin and dapagliflozin (adjusted hazard ratio [aHR] 0.64; 95

Purpose Sacubitril/valsartan (SAC/VAL) or angiotensin receptor blockers (ARBs) are recommended therapy for heart failure with preserved ejection fraction (HFpEF), but little is known about their real-world comparative effectiveness among patients with HFpEF. The objective of this study was to determine the comparative effectiveness of SAC/VAL vs ARBs in preventing HF-related hospitalization or all-cause hospitalization among patients with HFpEF.Methods We conducted a cohort study using IBM MarketScan commercial and Medicare supplemental databases to identify patients aged 18 years or older with a diagnosis of HFpEF and initiation of SAC/VAL (2015-2020) or ARB (2009-2014) therapy. The index date was the date of the first SAC/VAL or ARB prescription fill. After propensity score (PS) matching with a ratio of 1 up to 3, Cox proportional hazards regression was used with robust variance estimators to compare the risks of HF-related hospitalization and all-cause hospitalization between the 2 therapies. Several subgroup and sensitivity analyses were conducted to check the robustness of the main analysis.Results After PS matching, 2,520 patients (846 receiving SAC/VAL and 1,674 receiving an ARB) were included in the final analyses. After controlling for covariates, there was no difference in the risk of HF-related hospitalization between SAC/VAL and ARB recipients (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 0.99-1.77). There was also no difference in the risk of all-cause hospitalization between SAC/VAL and ARB recipients (aHR, 1.06; 95% CI, 0.91-1.24).Conclusion Among individuals with private or Medicare Advantage insurance plans, there was no significant difference in the risk of HF-related hospitalization or all-cause hospitalization between adults with HFpEF who received SAC/VAL and those who received ARB therapy.

The comparative effectiveness and safety of oral anticoagulant therapies to prevent a second recurrent venous thromboembolism (VTE) remains undetermined. We aimed to compare the benefits and harms of direct oral anticoagulant (DOAC) and warfarin therapies in preventing second recurrent VTE and major bleeding events among patients with a recurrent VTE episode following anticoagulation therapy for incident VTE. A retrospective cohort analysis of two large national insurance claims databases was conducted for patients with two episodes of VTE. Cox proportional hazards models were used after inverse probability treatment weighting to compare risks of second recurrent VTE and major bleeding events. Compared with warfarin, DOAC therapy was associated with significantly decreased risk of second recurrent VTE with no significant difference in risk of major bleeding events. Our findings suggest that, compared with warfarin, DOACs may reduce risk of second VTE recurrence among patients who have experienced one recurrence.

BACKGROUND: Little is known about medication adherence patterns and their association with effectiveness and safety among patients with venous thromboembolism (VTE) receiving direct oral anticoagulant (DOAC) therapy beyond 3-6 months of initial treatment. OBJECTIVE: To examine the associations between adherence trajectories of extended treatment with DOAC and the risks of recurrent VTE and major bleeding among patients with VTE. METHODS: We conducted a retrospective cohort study of patients with incident VTE who completed 6 months of initial anticoagulant treatment and received either DOAC extended therapy or no extended therapy using MarketScan Commercial and Medicare Supplemental databases (2013-2019). We used group-based trajectory models to identify distinct adherence patterns during extended treatment. Using inverse probability treatment weighted Cox proportional hazards models, we examined the association between the adherence trajectories and the risks of recurrent VTE and major bleeding. RESULTS: Among 10,960 patients with extended treatment with DOACs (rivaroxaban, apixaban, dabigatran, edoxaban) and 5,133 patients with no extended treatment, we identified 4 distinct trajectories (consistently high, gradually declining, rapidly declining, and no extended treatment). Compared with the no extended treatment group, the groups with consistently high adherence (hazard ratio = 0.09, 95% CI = 0.05-0.17) and with gradually declining adherence (0.13, 0.03-0.53) showed decreased recurrent VTE risk without increased major bleeding risk (consistently high adherence 1.19, 0.71-1.99; gradually declining adherence 1.96, 0.81-4.70). There was no difference in the risk of recurrent VTE (0.34, 0.10-1.16) for the group with rapidly declining adherence, but this group was associated with increased major bleeding risk (2.65, 1.01-6.92). CONCLUSIONS: Our findings underscore the clinical importance of continuing and remaining adherent to extended DOAC treatment without increased major bleeding risk for patients with VTE.

Background: The implementation of chronic care management (CCM) services has often been hindered by issues with reimbursement, raising concerns about sus-tainability. To date, little if any literature has examined the financial feasibility and sustainability of CCM services in rural practice settings.Objective: Assess financial reimbursement and productivity metrics for pharmacist-led CCM services at a rural, medically underserved family medicine clinic.Methods: This study retrospectively examined data from the clinic's CCM program from October 2020 through May 2021 and included total clinical encounters, minutes of pharmacist time spent on calls, CCM claims, work relative value units (wRVU), financial reimbursement, and overall personnel costs.Results: Over an 8-month period, 46 patients were enrolled in CCM services. Of the 49 CCM calls placed during this time, 31 (63.3%) were billable, though only 20 (64.5% of billable calls) were ultimately reimbursed. Approximately 37% of pharmacist "time-on-task" was not billable. Compared to the $643 required to cover pharmacist time on CCM calls, $822 of reimbursement was collected. This $179 profit, or 27.8% return-on-investment, is similar to results from more urbanized practices. Furthermore, services were "net productive" in wRVU generation, which may appeal to physician stakeholders interested in such targets.Conclusions: Concerns about profitability and sustainability have prevented more widespread CCM implementation. In the present study, pharmacist-led CCM services achieved a 27.8% return-on-investment. Though rural-based CCM services may never attain significant profit margins, this data suggests they can still be financially self-sustaining and "net productive," all while providing high-quality patient care.

Background: Little is known about anticoagulation medication nonadherence patterns impacting effectiveness and safety outcomes in clinical practice. Objective: We identified adherence trajectories of extended therapy with direct-acting oral anticoagulants (DOACs) and warfarin after 6 months initial anticoagulant therapy among Medicare beneficiaries with venous thromboembolism (VTE). We further assessed the associated recurrent VTE and major bleeding risks. Methods: Using group-based trajectory models, this retrospective cohort study identified distinct beneficiary subgroups with similar adherence patterns of extended-phase anticoagulant treatment (DOACs or warfarin) for patients with VTE who completed 6 months of initial anticoagulant treatment. We examined associations between adherence trajectories and risks of recurrent VTE and major bleeding using inverse probability treatment weighted Cox proportional hazards models. Results: Compared with no extended treatment, consistently high DOAC adherence was associated with decreased recurrent VTE risk (hazard ratio [HR] = 0.33, 95% confidence interval [CI] = 0.21-0.51) without increased major bleeding risk, and consistently high warfarin adherence was associated with decreased recurrent VTE risk (HR = 0.62, 95% CI = 0.40-0.95) and increased major bleeding risk (HR = 1.64, 95% CI = 1.12-2.41). Gradually declining adherence to DOACs (HR = 1.80, 95% CI = 1.07-3.03) or warfarin (HR = 2.34, 95% CI = 1.57-3.47) was associated with increased bleeding risk with no change in recurrent VTE risk. Conclusion and relevance: This real-world evidence suggests persistently adhering to extended DOAC therapy is associated with lower recurrent VTE risk without increasing major bleeding among Medicare beneficiaries with VTE. Persistently adhering to extended warfarin therapy was associated with lower recurrent VTE risk but higher major bleeding risk.

Billing issues are more commonplace than most healthcare professionals, including pharmacists, even realize. Undercoding-or billing outpatient visits for a lower level of service than may be justified-leads to decreased reimbursement, but almost no data captures what is being sacrificed, especially at the state level. Using publicly available data from the National Ambulatory Medical Care Survey and Centers for Medicare and Medicaid Services, we attempt to approximate just how much Medicare reimbursement is lost annually to undercoding in Florida. We also discuss the hidden dangers of undercoding, including how it could hinder the ability of clinical pharmacists to build sustainable clinical services and contribute to the broader healthcare team.

Background: Chronic care management (CCM) can significantly impact the management of chronic diseases in rural patient populations. To date, few practice models have addressed its impact on clinical outcomes and access to care in rural practice settings. Objective: Implement a sustainable pharmacist-led CCM practice model while tracking clinical outcomes and healthcare access at a rural, medically underserved family medicine clinic. Methods: This study retrospectively examined data from the clinic’s CCM program from October 2020 through May 2021 and included total clinical encounters at three- and 6-months intervals, as well as changes in clinical outcomes like A1c and systolic blood pressure (SBP) at three- and 6-months intervals. Results: Over an 8-month period, 46 patients were enrolled in pharmacist-led CCM services. Those with a CCM encounter or office visit within 3 months of enrollment showed a mean A1c reduction of 1.07% after 3 months (95% CI −1.70 to −.44, P = .0016), while those with an encounter or office visit within 6 months of enrollment displayed a mean A1c reduction of 1.64% after 6 months (95% CI −2.35 to −.92, P < .001). There was a 73.8% increase in total clinical encounters in the 6 months after CCM enrollment compared to the 6 months preceding it, signifying increased access to care. Conclusion: Patients with CCM encounters or office visits within the first 3-6 months experienced statistically significant reductions in A1c. Moreover, total clinical encounters markedly increased in the 6 months after enrollment, allowing for more frequent engagement between ambulatory pharmacists and traditionally challenging rural patients.

Introduction Collaborative team-based care models have been shown to improve the quality of care provided to patients and may increase productivity along with patient access to care. Productivity is often tracked via work relative value units (wRVU). The primary objective of this project was to evaluate how a collaborative practice model affects tracked productivity. Methods Data regarding wRVU were retrospectively extracted from the electronic medical record from a single center. De-identified data points included total number of patients seen and level of service billed for the visit. Visits were grouped as collaborative (physician-pharmacist) or independent (physician alone). Relative value unit totals were calculated separately for individual physicians and pharmacy visits and also combined for collaborative team wRVU totals. Wilcoxon and descriptive statistics were used for analysis. All statistical analyses were performed using SAS v 9.4 (Cary, NC). Results A total of 624 patient visits were reviewed. Total number of patients seen by physicians working in collaboration was on average 19.25 per day versus 12.9 per day for those working independently. When evaluating only the average per encounter wRVU for each provider removing collaborative patients, the three providers who worked in the collaborative model averaged 1.45, 1.48, and 1.55 wRVU per patient respectively, compared to those who worked singularly (1.37 and 1.30). This was found to be statistically significant in the unadjusted mixed model (P = 0.0476), but not maintained once adjusted. Conclusion Physicians working in collaboration with a pharmacist were able to bill at a higher level on average suggesting more productivity.

Intense lobbying by the American Medical Association (AMA) and related professional organizations led to significant changes to requirements for documentation of outpatient clinical services. As of 2021, providers are now free to choose between either time or medical decision-making (MDM) when "leveling" such services. Despite this change, many providers and clinical pharmacists may not yet realize its full billing implications. This article discusses why these billing changes occurred, what those changes actually mean in clinical practice, and how the three factors used to determine MDM can be utilized by clinical pharmacists in daily practice. Finally, a brief introduction to other potential billing codes open to pharmacists and discussion of MDM documentation requirements is included.

Direct oral anticoagulants (DOAC) are increasingly utilized for the prevention of thrombotic events. Unlike warfarin they do not require drug‐level monitoring making dedicated DOAC monitoring uncommon. The purpose of this study is to describe the interventions made by a DOAC monitoring service over 3 years.

Background The optimal dose of apixaban therapy to prevent asecondary venous thromboembolism (VTE) event remains unconfirmed. To investigate the effects of extended phase use of apixaban (2.5 vs. 5 mg twice daily) beyond 6 months of initial treatment on the risk of recurrent VTE and major bleeding events among patients with a history of VTE. Methods A retrospective cohort analysis of two large national insurance claims databases was conducted for patients diagnosed with VTE. Cox proportional hazard models after propensity score matching were used to compare the risk of recurrent VTE and major bleeding. Results There were no detected differences in recurrent VTE or major bleeding events between patients prescribed low versus full dose apixaban. Conclusion This study provides evidence that apixaban 2.5 mg twice daily is an alternative option for extended phase therapy for risk reduction of VTE recurrence compared to apixaban 5 mg twice daily.

BACKGROUND:Direct oral anticoagulants (DOACs) are replacing warfarin for stroke prevention in patients with atrial fibrillation (AF).OBJECTIVE:To assess the effectiveness and safety of concomitant treatment with antiplatelet-DOAC compared to antiplatelet-warfarin in patients with acute coronary syndrome (ACS) and AF.DESIGN:Retrospective propensity score-matched cohort study using United States-based commercial healthcare database from January 2016 to June 2019.PARTICIPANTS:New-users of antiplatelet-DOAC and antiplatelet-warfarin who initiated the combined therapy within 30 days following incident ACS diagnosis.MEASUREMENTS:Primary study outcomes were recurrent cardiovascular diseases (CVD) (ie, a composite of stroke and myocardial infarction) and major bleeding events identified via discharge diagnoses. We controlled for potential confounders via propensity score matching (PSM). We generated marginal hazard ratios (HRs) via Cox proportional hazards regression using a robust variance estimator while adjusting for calendar time.RESULTS:After PSM, a total of 2,472 persons were included (1,236 users of antiplatelet-DOAC and 1,236 users of antiplatelet-warfarin). The use of antiplatelet-DOAC (vs. antiplatelet-warfarin) was associated with a reduced rate of recurrent CVD (adjusted HR 0.72, 95% confidence interval [CI], 0.56-0.92) and major bleeding events (adjusted HR, 0.49, 95% CI 0.33-0.72).LIMITATIONS:Residual confounding.CONCLUSIONS:In real-world data of AF patients with concurrent ACS, the use of antiplatelet-DOAC following ACS diagnosis was associated with a lower rate of recurrent CVD and major bleeding events compared with antiplatelet-warfarin. These findings highlight a potential promising role for DOACs in patients with ACS and AF requiring combined antiplatelet therapy.