Real-world Application of Racial and Ethnic Imputation and Cohort Balancing Techniques to Deliver Equitable Clinical Trial Recruitment.

Enhancing diversity and inclusion in clinical trial recruitment, especially for historically marginalized populations including Black, Indigenous, and People of Color individuals, is essential. This practice ensures that generalizable trial results are achieved to deliver safe, effective, and equitable health and healthcare. However, recruitment is limited by two inextricably linked barriers - the inability to recruit and retain enough trial participants, and the lack of diversity amongst trial populations whereby racial and ethnic groups are underrepresented when compared to national composition. To overcome these barriers, this study describes and evaluates a framework that combines 1) probabilistic and machine learning models to accurately impute missing race and ethnicity fields in real-world data including medical and pharmacy claims for the identification of eligible trial participants, 2) randomized controlled trial experimentation to deliver an optimal patient outreach strategy, and 3) stratified sampling techniques to effectively balance cohorts to continuously improve engagement and recruitment metrics.

Coverage Denials: Government And Private Insurer Policies For Medical Necessity In Medicare.

Little is publicly known about coverage denials for medical services that do not meet medical necessity criteria. We characterized the extent of these denials and their key features, using Medicare Advantage claims for a large insurer from the period 2014-19. In this setting, claims could be denied because of traditional Medicare's coverage rules or additional Medicare Advantage private insurer rules. We observed $416 million in denied spending, with 0.81 denials and $60 of denied spending per beneficiary annually. We found that 1.40 percent of services were denied and 0.68 percent of total spending was denied, with rates rising over time. Traditional Medicare's coverage rules accounted for 85 percent of denied services and 64 percent of denied spending; the remaining denials were due to additional Medicare Advantage insurer rules. Denial rates varied greatly across service type and provider type, with the most denials being for laboratory services and hospital outpatient providers. Traditional Medicare and Medicare Advantage insurer coverage policies each addressed different sources of medical spending; together they contributed to the denial of a modest but nontrivial portion of payments.

Measuring the Scope of Prior Authorization Policies: Applying Private Insurer Rules to Medicare Part B.

Importance: Health insurers use prior authorization to evaluate the medical necessity of planned medical services. Data challenges have precluded measuring the frequency with which medical services can require prior authorization, the spending on these services, the types of services and clinician specialties affected, and differences in the scope of prior authorization policies between government-administered and privately administered insurance. Objectives: To measure the extent of prior authorization requirements for medical services and to describe the services and clinician specialties affected by them using novel data on private insurer coverage policies. Design Setting and Participants: Fee-for-service Medicare claims from 2017 were analyzed for beneficiaries in Medicare Part B, which lacks prior authorization. We measured the use of services that would have been subject to prior authorization according to the coverage rules of a large Medicare Advantage insurer and calculated the associated spending. We report the rates of these services for 14 clinical categories and 27 clinician specialties. Main Outcomes and Measures: Annual count per beneficiary and associated spending for 1151 services requiring prior authorization by the Medicare Advantage insurer; likelihood of providing 1 or more such service per year, by clinician specialty. Results: Of 6 497 534 beneficiaries (mean [SD] age, 72.1 [12.1] years), 41% received at least 1 service per year that would have been subject to prior authorization under Medicare Advantage prior authorization requirements. The mean (SD) number of services per beneficiary per year was 2.2 (8.9) (95% CI, 2.17-2.18), corresponding to a mean (SD) of $1661 ($8900) in spending per beneficiary per year (95% CI, $1654-$1668), or 25% of total annual Part B spending. Part B drugs constituted 58% of the associated spending, mostly accounted for by hematology or oncology drugs. Radiology was the largest source of nondrug spending (16%), followed by musculoskeletal services (9%). Physician specialties varied widely in rates of services that required prior authorization, with highest rates among radiation oncologists (97%), cardiologists (93%), and radiologists (91%) and lowest rates among pathologists (2%) and psychiatrists (4%). Conclusions and Relevance: In this cross-sectional study, a large portion of fee-for-service Medicare Part B spending would have been subject to prior authorization under private insurance coverage policies. Prior authorization requirements for Part B drugs have been an important source of difference in coverage policy between government-administered and privately administered Medicare.