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  • Washington Highlights

    HHS Finalizes Jan. 1, 2019, Effective Date for 340B CMP and Ceiling Price Rule

    Ivy Baer, Senior Director and Regulatory Counsel

    The Department of Health and Human Services (HHS) Nov. 29 released a final rule that changes the effective date of the 340B Drug Pricing Program Ceiling Price and Civil Monetary Penalties (CMP) rule to Jan. 1, 2019, from July 1, 2019. The AAMC submitted comments urging the agency to finalize this change.

    The regulation was first proposed in 2015 to implement CMPs for manufacturers that knowingly and intentionally charge a covered entity more than the ceiling price for a covered drug. A final rule was published in January 2017 but has been delayed several times since then [see Washington Highlights, June 8].

    The AAMC and other associations filed a lawsuit against HHS over both the delay in the effective date of the rule and the agency’s failure to ensure that 340B drug ceiling prices are accessible to hospitals, clinics, and health centers on a secure website [see Washington Highlights, Sept. 14]. The availability of that information is the only way to ensure that these 340B hospitals are paying the correct amounts for their 340B drugs.

    The AAMC is pleased that HHS has issued this final rule regarding the effective date and looks forward to seeing the ceiling price website in the near future, as well as the education and training about the website that HHS plans to provide to all stakeholders.

    On Nov. 30, the Health Resources and Services Administration, which oversees the 340B program, announced on its website that the system for secure submission of manufacturer pricing data will be available the first quarter of 2019 and the agency “expects to publish 340B ceiling prices on April 1, 2019.”