Below is a breakdown of recent and upcoming initiatives related to the 340B program, according to The National Law Review.
1. OIG report suggests reducing Medicare funding: HHS’ Office of Inspector General issued a detailed report in November to analyze the potential impact of reducing Medicare Part B payments for drugs purchased through the 340B program. The report finds shared saving arrangements between the Medicare program and 340B covered entities would result in substantial savings for Medicare while maintaining purchasing incentives for covered entities. The report offers three alternative payment methods for the 340B program.
2. OIG to tackle duplicate discount problems: The OIG’s Work Plan for fiscal year 2016 ranks duplicate discount prevention a high-priority issue. In its work plan, the OIG points out existing tools and processes to prevent duplicate discounts in fee-for-service Medicaid may not be sufficient to prevent duplicate discounts for drugs. The OIG plans to publish the risk assessment in 2016.
3. HRSA to issue overcharge penalty rule: In May 2016, the Health Resources and Services Administration plans to issue a final rule on civil monetary penalties for drug manufacturers that overcharge 340B program covered entities.
4. HRSA to define dispute resolution process: Next May HRSA also plans to propose an administrative dispute resolution process available to covered entities and drug manufacturers.
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