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Background: Patient-reported outcomes (PROs) may improve care for patients with heart failure. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a patient survey that captures symptom frequency, symptom burden, physical limitations, social limitations, and quality of life. Despite the utility of PROs and the KCCQ-12, the implementation and routine use of these measures can be difficult. We conducted an evaluation of clinician perceptions of the KCCQ-12 to identify barriers and facilitators to implementation into clinical practice. Methods: We conducted interviews with cardiologists from 4 institutions across the United States and Canada (n=16) and observed clinic visits at 1 institution in Northern California (n=5). Qualitative analysis was conducted in 2 rounds: (1) rapid analysis constructed around major themes related to the aims of the study and (2) content analysis with codes derived from the rapid analysis and implementation science. Results: Most heart failure physicians and advanced practice clinicians reported that the KCCQ-12 was acceptable, appropriate, and useful in clinical care. Clinician engagement efforts, trialability, and the straightforward design of the KCCQ-12 facilitated its use in clinical care. Further opportunities identified to facilitate implementation include more streamlined integration into the electronic health record and comprehensive staff education on PROs. Participants highlighted that the KCCQ-12 was useful in clinic visits to improve the consistency of patient history taking, focus patient-clinician conversations, collect a more accurate account of patient quality of life, track trends in patient well-being over time, and refine clinical decision-making. Conclusions: In this qualitative study, clinicians reported that the KCCQ-12 enhanced several aspects of heart failure patient care. Use of the KCCQ-12 was facilitated by a robust clinician engagement campaign and the design of the KCCQ-12 itself. Future implementation of PROs in heart failure clinic should focus on streamlining electronic health record integration and providing additional staff education on the value of PROs. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04164004. [ABSTRACT FROM AUTHOR]

Background: Rising drug costs have increased interest in performance-linked reimbursement (PLR) contracts that tie payment to patient outcomes. PLR is theoretically attractive to payers interested in reducing the risk of overpaying for expensive drugs, to manufacturers working to improve early drug adoption, and to patients seeking improved access. Multiple PLR contracts were developed for sacubitril-valsartan. We evaluated how the characteristics of a PLR contract influence its performance.Methods: We used a published cost-effectiveness model of sacubitril-valsartan. We evaluated hypothetical PLR contracts that adjusted drug payment based on observed therapy effectiveness. Ideally, these contracts reduce the uncertainty around the value obtained with purchasing sacubitril-valsartan. By reducing the financial risk in covering an ineffective therapy, PLR incentivizes insurers to increase patient access. We measured the uncertainty in value as the SD of the incremental net monetary benefit (INMB), an estimate of therapy value incorporating costs and clinical benefits. We evaluated the change in INMB SD under a variety of different assumptions regarding contract design, therapy effectiveness, and population characteristics.Results: Over 2 years, sacubitril-valsartan led to 0.042 additional quality-adjusted life-years at an incremental cost of $4916. Using a willingness-to-pay of $150 000 per quality-adjusted life-year, this led to a mean INMB across simulations of $1416 (SD, $1720). A PLR contract that adjusted payment based on cardiovascular mortality reduced the INMB SD moderately by 20.7% while a contract based on all-cause mortality was more effective (INMB SD reduction of 27.3%). A contract based on heart failure hospitalization reduction was ineffective. PLR effectiveness increased with greater uncertainty regarding therapy effectiveness or in sicker cohorts (eg, New York Heart Association Class III/IV heart failure). Contracts required precise estimates of treatment effect in addition to trust or verifiability between manufacturers and payers concerning patient selection.Conclusions: The development of accurate prospective estimates of treatment effectiveness using actual enrollee characteristics will be critical for successful PLR. If able to meet these requirements, PLRs could incentivize insurers to expand access to expensive treatments by reducing financial risk. [ABSTRACT FROM AUTHOR]

Background: Generic medications cost less than brand-name medications and are similarly effective, but brand-name medications are still prescribed. We evaluated patterns in generic cardiovascular medication fills and estimated the potential cost savings with increased substitution of generic for brand-name medications.Methods: This was a cross-sectional study of cardiovascular therapies using the Medicare Part D database of prescription medications in 2017. We evaluated drug fill patterns for therapies with available brand-name and generic options. We determined the generic substitution ratio and estimated the potential savings with increased generic substitution at the national, state, and clinician level. We compared states with laws related to mandatory pharmacist generic substitution and patient consent for substitution.Results: Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings.Conclusions: There are substantial potential cost savings from substituting brand-name medications with generic medications. These savings would be primarily driven by lower use of brand-name therapies by the minority of clinicians who prescribe them at increased rates. [ABSTRACT FROM AUTHOR]

Background: The Merit-Based Incentive Payment System adjusts clinician payments based on a performance score that includes cost measures. With the Centers for Medicare & Medicaid Services, we developed a novel cost measure that compared interventional cardiologists on a targeted set of costs related to elective percutaneous coronary intervention (PCI). We describe the measure and compare it to a hypothetical version including all expenditures post-PCI.Methods: Measure development was guided by 39 clinician experts. They identified services within 30 days of PCI that could be potentially affected by the interventional cardiologist. Expenditures for these PCI-related services were included as measure costs in a process termed service assignment. We used 1 year of Medicare claims to calculate clinician scores using the final measure that included only PCI-related costs (with service assignment) and a hypothetical version that included all costs post-PCI (without service assignment). We calculated reliability for both measures. This marker of precision breaks measure variance into signal (difference between clinicians) versus noise (difference between PCI episodes for a clinician). We also determined the change in clinician performance quintile between measures.Results: We identified 100 992 elective outpatient PCI episodes from May 2, 2016, to May 1, 2017. Total Medicare expenditures within 30 days of PCI averaged $13 234. After excluding costs unrelated to PCI, average cost was $10 966. For individual clinicians, mean reliability for the hypothetical measure without service assignment was 0.36. After service assignment, final measure reliability increased to 0.53. When evaluated as clinician groups, reliability increased from 0.43 to 0.73 following service assignment. Approximately 66% (2340 of 3527) of clinicians were reclassified into a different performance quintile after excluding unrelated costs.Conclusions: The elective outpatient PCI cost measure had increased precision and reclassified clinician performance relative to a hypothetical version that included total expenditures. [ABSTRACT FROM AUTHOR]