Publications

BACKGROUND: Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction remains underused. The role of direct-to-physician marketing in accelerating uptake of GDMT is unknown.

OBJECTIVES: The authors investigated the association between industry marketing meals and GDMT prescribing rates under Medicare Part D.

METHODS: The authors linked Medicare data sets to identify general and advanced heart failure (AHF) cardiologists' prescriptions for angiotensin receptor-neprilysin inhibitors (ARNIs), sodium-glucose cotransporter 2 inhibitors (SGLT2is), angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, mineralocorticoid receptor antagonists (MRAs), and beta-blockers from 2019 to 2021. Using negative binomial regression analyses, they examined the association between marketing meals and prescribing rates of marketed and un-marketed classes of GDMT.

RESULTS: Of 11,277 general and 329 AHF cardiologists, 60% received marketing payments for ARNI and 50% for SGLT2i from 2019 to 2021. Among general cardiologists, but not AHF cardiologists, exposure to ARNI marketing meals in 2020 was associated with a greater prescribing volume of ARNI in 2021 (1-4 ARNI meals; relative ratio: 1.43 [95% CI: 1.34-1.53]; 5-9 ARNI meals; relative ratio: 1.69 [95% CI: 1.48-1.93]; ≥10 ARNI meals; relative ratio: 2.09 [95% CI: 1.80-2.43]). Findings were similar for SGLT2i. The association between marketing and prescribing of other pillars of GDMT was inconsistent across drug classes. Neither ARNI nor SGLT2i marketing was consistently associated with increased prescribing of MRAs.

CONCLUSIONS: Industry marketing to general cardiologists is associated with increased uptake of ARNIs and SGLT2is, but not with increased uptake of all pillars of GDMT. Improvements in comprehensive therapy for heart failure will require other mechanisms to accelerate uptake of MRAs and beta-blockers, as well as ARNIs and SGLT2is once multiple generic formulations become available in the United States.

INTRODUCTION: A four-drug regimen of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is underused, in part due to prescriber inertia and low patient adherence. Although fixed-dose combination pills ('polypills') have improved adherence and clinical outcomes for other conditions, there are no polypills available that combine multiple classes of GDMT for HFrEF. Pharmacy-level over-encapsulation, in which several tablets are combined into one capsule, offers an opportunity to create customised HFrEF polypills with the goal of improving delivery of HFrEF therapies.

METHODS AND ANALYSIS: In the COMBO-HF-X pilot crossover randomised clinical trial, we will enrol 30-40 patients with HFrEF in a safety-net public healthcare system in San Francisco, California. Participants will be randomised 1:1 to receive GDMT as individual tablets or as a customised, over-encapsulated HFrEF polypill. After 1 month, participants will cross over to the other formulation (individual tablets or a HFrEF polypill). Participants will attend in-person visits at 0, 4 and 8 weeks. GDMT will be initiated and titrated by study physicians as clinically indicated in accordance with HFrEF treatment guidelines. The primary outcome will be adherence to GDMT by pill count. Key feasibility outcomes will include the successful recruitment of 30-40 participants and completion of study procedures for at least 20 participants. Implementation outcomes will include the cost and time required for HFrEF polypill preparation, which will be performed by a community pharmacy partner. Exploratory clinical outcomes will include change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and Kansas City Cardiomyopathy Questionnaire. Acceptability will be assessed through a patient exit survey and semistructured exit interviews with patients, their primary care and cardiology providers, and pharmacy staff.

ETHICS AND DISSEMINATION: Study findings will be published in peer-reviewed journals. The protocol of this study was approved by the Institutional Review Board of the University of California, San Francisco. Written informed consent for COMBO-HF-X was obtained from all participants.

TRIAL REGISTRATION NUMBER: NCT06029712.

BACKGROUND: Use of pulmonary vein isolation (PVI) to treat atrial fibrillation continues to increase. Despite great interest in leveraging administrative data for real-world analyses, contemporary procedural codes for identifying PVI have not been evaluated.

METHODS AND RESULTS: In this observational retrospective cohort study, inpatient PVIs were identified among US Medicare fee-for-service beneficiaries using Current Procedural Terminology (CPT) code 93656 in Carrier Line Files. Each patient was matched with their claims from Medicare Provider Analysis and Review to compare CPT with International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) claims submitted by health care facilities to bill for PVIs. We performed the reverse for commonly matched ICD-10-PCS codes, to identify corresponding CPT-billed procedures. Finally, we reviewed institutional cases for additional comparison of CPT and ICD-10-PCS assignation for PVI. We identified 25 617 inpatient PVIs from January 2017 to December 2021, of which 18 165 (71%) were linked to Medicare Provider Analysis and Review. Of these, 16 672 (92%) were billed as ICD-10-PCS 02583ZZ: "Destruction of Conduction Mechanism, Percutaneous Approach." The reverse process yielded heterogeneous results: among 75 003 procedures billed as ICD-10-PCS 02583ZZ, only 15 691 (21%) matched with CPT 93656 (PVI), as several other unrelated procedures were billed under this ICD-10-PCS code. Institutional case review confirmed the greater specificity of CPT codes.

CONCLUSIONS: The ICD-10-PCS code associated with CPT-billed PVI procedures actually referred to ablation of the atrioventricular junction. Yet this ICD-10-PCS code also matched with a wide range of other procedures distinct from PVI. We conclude that ICD-10-PCS codes alone are not sensitive nor specific for identifying PVI in claims and cannot be reliably used in isolation for health services research on this important procedure.

IMPORTANCE: Private equity acquisitions of health care facilities have rapidly increased over the past decade. However, little is known about the effects of private equity acquisitions of US hospitals on patient care experience.

OBJECTIVE: To evaluate whether the acquisition of hospitals by private equity firms was associated with changes in measures of patient-reported experience compared with matched control hospitals from 2008 through 2019.

DESIGN, SETTINGS, AND PARTICIPANTS: This cohort study identified 73 US hospitals newly acquired by private equity firms and 293 matched control (nonacquired) US hospitals from 2008 through 2019. An event study, difference-in-differences design was used to evaluate changes in patient experiences measures from 3 years before to 3 years after private equity acquisition.

MAIN OUTCOMES AND MEASURES: The primary outcomes were 2 global measures of patient-reported care experience from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, which included patients' overall hospital rating and willingness to recommend the hospital. Secondary outcomes included the 7 other HCAHPS measures encompassing clinical process, communication, and environmental measures.

RESULTS: There were 73 private equity-acquired hospitals and 293 matched control hospitals. The percentage of patients rating hospitals as a 9 or 10, on a scale of 0 to 10, decreased at private equity-acquired hospitals (65.0% before acquisition and 65.2% after acquisition) when compared with control hospitals (66.2% to 69.2%) during the postacquisition period relative to the preacquisition period with a difference-in-differences estimate of -2.4 percentage points (95% CI, -3.9 to -0.9). In addition, the percentage of patients who would definitely recommend the hospital also decreased at private equity-acquired hospitals (66.9% before acquisition and 65.5% after acquisition) compared with control hospitals (68.2% to 69.3%) with a difference-in-difference estimate of -2.1 percentage points (95% CI, -3.6 to -0.7). For both of these global measures of patient experience, the difference between private equity-acquired and control hospitals increased over time and was largest in year 3 after acquisition (-5.2 percentage points [95% CI, -8.8 to -1.5] and -4.4 percentage points [95% CI, -8.0 to -0.70] for each measure, respectively). For secondary measures of patient care experience, there was a decrease in patient-reported responsiveness of hospital staff at private equity-acquired hospitals compared with control hospitals (-1.3 percentage points [95% CI, -2.4 to -0.2]), but no differential change across other measures of clinical process, communication, and environment.

CONCLUSIONS AND RELEVANCE: Patient care experience worsened after private equity acquisition of hospitals. These findings raise concern about the implications of private equity acquisitions on patient care experience at US hospitals.