AHA: Major Flaws Negate Findings from Recent Study on 340B Program

The AHA today said that a recent study published in the New England Journal of Medicine “fails to draw meaningful, valid conclusions” about the 340B Drug Pricing Program “due to constraints and flaws” in the methodology. “Of particular concern are broad statements that apply the inaccurate findings of the study to all of those in the program – even though the study excluded a majority of 340B hospitals,” writes AHA Executive Vice President Tom Nickels in an AHA Stat blog post. The study alleges that the 340B program does not expand access to care to low-income populations or improve their mortality rates, while driving hospital/physician consolidation. Among other flaws, Nickels says the study uses a methodological approach called “regression-discontinuity” that does not support making broad claims about the 340B program; relies on fee-for-service Medicare data only to make claims about the impact of the 340B program on low-income individuals, ignoring that the vast majority of low-income people are not enrolled in Medicare; applies the authors’ own limited interpretation of the intent of the program when selecting measures to evaluate 340B hospitals; and fails to account for changes in coding of physician practices during the study period.