Dyslipidemia is a major modifiable risk factor for cardiovascular disease and its prevalence is rising in Japan alongside population aging. In June 2024 Japan replaced a long-standing disease-specific management fee for chronic conditions with a new lifestyle disease management fee, intended to promote structured, holistic care that integrates lifestyle counseling with biomedical targets. The authors used a large hospital claims and laboratory database to produce an early, descriptive assessment of real-world lipid control and cardiovascular outcomes before and after this reimbursement change. The study aims were to: (1) describe LDL-C goal attainment and major adverse cardiovascular events among patients with dyslipidemia, (2) compare lipid control and outcomes during the previous fee (M1) versus the new fee (M2), and (3) identify patient groups that might benefit from additional lifestyle-based interventions.
The analysis used the Medical Data Vision (MDV) Diagnosis Procedure Combination administrative claims and laboratory database, which covers approximately 30 million patients from more than 450 acute care hospitals in Japan. The MDV dataset contains demographics, ICD-10 diagnoses, procedures, prescriptions, hospitalizations, and laboratory results. Data access for this research was on 15 October 2025. The study was a retrospective observational cohort covering 1 January 2021 through 31 December 2024.
Adults aged 18 years or older with at least one ICD-10 code for dyslipidemia (E78.x) and at least one recorded lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) during the study period were eligible. The index date was the earliest date with both a dyslipidemia diagnosis and a lipid measurement. Inclusion required continuous observation for at least 6 months after the index date and available baseline lipid data. Patients with missing age, sex, or incomplete baseline lipid data, and those with follow-up under 6 months were excluded.
To reflect the 2024 reimbursement reform, the observation period was divided into two fee categories: (1) the specific disease management fee period (M1), from 1 January 2021 to 31 May 2024, and (2) the lifestyle disease management fee period (M2), from 1 June 2024 to 31 December 2024. The new M2 fee requires physicians to collaborate with patients to create and periodically review a structured Treatment Plan Sheet that covers biomedical targets (including LDL-C) and broader lifestyle and social determinants. The fee is billed per outpatient visit and is intended to incentivize a more comprehensive, lifestyle-focused approach while pharmacotherapy remains guideline-based.
Prespecified subgroup strata included age categories (<65, 65–74, ≥75 years), cardiovascular risk (primary prevention versus secondary prevention after established atherosclerotic cardiovascular disease), presence of diabetes or chronic kidney disease, and baseline lipid levels. The primary exposure of interest was the prevailing disease management fee category (M1 vs. M2). Pharmacologic treatment patterns were also characterized, including use of statins, ezetimibe, fibrates, PCSK9 inhibitors, and other lipid-lowering agents, alone or in combination.
The primary outcome was attainment of guideline-recommended LDL-C goals at outpatient visits. Secondary outcomes included changes in lipid parameters, major adverse cardiovascular events (MACE), and all-cause mortality. Outpatient visits were the unit of observation for visit-level lipid and fee-category analyses; cardiovascular events and patient-years were analyzed at the patient level. Individual patients could contribute multiple visits and may have contributed visits in both M1 and M2 depending on timing.
The cohort comprised approximately 590,000 patients who together contributed 23,600,010 outpatient visits. LDL-C goal attainment was reported at 58.3% of visits under the M1 period and 58.5% under M2. Overall lipid levels were broadly similar across the fee periods. Use of statins was high and combination therapy with ezetimibe or fibrates was frequent, yet LDL-C goal attainment remained lower in secondary prevention than in primary prevention.
Cardiovascular event rates were reported as similar across the fee periods; however, post-revision follow-up was limited. The authors report that post-revision patient-years were much smaller (approximately 58,500 patient-years post-revision versus 1,542,800 patient-years pre-revision), reflecting the short M2 observation window of roughly six months. Because of this imbalance and the observational design, comparisons of event rates between periods are exploratory and cannot establish causality.
Key limitations include the short post-revision observation window and the observational nature of the study, which preclude causal inference about the effect of the fee change on outcomes. The MDV database is hospital-based and excludes most small clinics and non-DPC facilities, which may limit generalizability to all outpatient settings in Japan. Detailed statistical methods and some analytic specifics beyond the descriptive results in the abstract were not fully reported in the provided source excerpt. Strengths include very large sample size, linkage of laboratory data to claims, and prespecified subgroup analyses aligned with Japanese Atherosclerosis Society guidance.
In this early, descriptive nationwide analysis, LDL-C goal attainment and overall lipid levels were similar before and shortly after implementation of Japan’s 2024 lifestyle disease management fee, with goal attainment at approximately 58% of outpatient visits. High use of statins and combination therapies did not eliminate residual gaps in achieving targets, particularly in secondary prevention. The very limited post-revision follow-up constrains interpretation of whether the policy change affects cardiovascular outcomes. The authors recommend longer follow-up and complementary study designs to evaluate the causal impact of the fee revision and to identify patient groups who may benefit from enhanced lifestyle-based interventions.
Note: The source material provided is the basis for all statements above. Some methodological and statistical details beyond the published abstract and selected sections were not available in the supplied excerpt and therefore are not reported here.