In 2018, meaningful conversations around 340B have included transparency. Many covered entities, large and small, have embraced the notion of transparency in their 340B program. In order to protect the 340B program, CEs have put pen to paper and began telling their stores of how 340B savings are being utilized. I think we can agree, we have all been waiting for manufacturer to follow suit. The 340B community has received long awaited news that CMS will begin to require drug manufacturers to partake of pricing transparency.
In June 2015, HHS published a notice of proposed rulemaking to implement civil monetary penalties for manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered out patient drug. To ensure this occurs, manufacturers have been asked to calculate the 340B ceiling price on a quarterly basis and to explain how the ceiling price is to be calculated. Additionally, this rule would work to establish the requirement that a manufacturer charge a $.01 for drugs when the ceiling price calculation equals zero. Then the delays began! Fast forward three years later and we finally get to stand up and clap for Secretary Azar and the HRSA Administrator Sigounas for agreeing that further delay is not necessary for the 340B ceiling price and manufacturer civil monetary penalties regulation. It appeared that we would have to wait for another hot summer at the coalition to hear if there would be yet more delays. Alas, we rejoice that we are going to start the new year on the right foot with a new effective date of January 1, 2019.
Many organizations that represent 340B hospitals are considering this a big win in an otherwise downtrodden 2018. It is time to stand up and clap for 340B Health, the American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals and many more that continued to challenge the delay of the necessary regulations. The support and advocacy from these organizations along with the many CEs that help represent the approximate 160 public comments sent to HRSA, is a testament to the necessity of using your voice to protect our 340B program.
So what comes next regarding transparency for the pharmaceutical companies? HRSA is planning to activate the new secure website to allow 340B providers to check the ceiling price on April 1, 2019. This website will force the manufacturers hand toward transparencyand accountability. Finally, hospitals and other covered entitieswill have the ability to ensure they are not being overcharged. HRSA has stated that the secure pricing component of the 340B OPAIS will be open for manufacturer submission of pricing data during the first quarter of 2019. Lastly, HRSA has encouraged all stakeholders to continue to check the OPAIS website for ongoing announcements and additional information. I think we all are looking forward to 2019, when we move closer to a time that transparency is expected by the manufacturer and not just the covered entities.