340B Ceiling Price and Civil Monetary Penalties Regulations
Effective date delayed until July 1, 2018
On September 29, 2017, Health and Human Services (HHS) published a final rule delaying the effective date of the final rule from October 1, 2017 to July 1, 2018.
December 1, 2017
A blog post by Cindy Cerneka, Practice Leader, Government Pricing, Deloitte Risk and Financial Advisory, Deloitte & Touche LLP
On September 29, 2017, the Health and Human Services (HHS) published in the Federal Register 82 FR 4511, September 29, 2017 a final rule further delaying the effective date of the final rule titled "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation" from October 1, 2017 to July 1, 2018. HHS stated that the extension would allow for more time to consider supplemental regulatory provisions and rulemaking and allow stakeholders additional time to comply with the new program requirements.
As a summary of the evolution of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, the final rule was first published on January 5, 2017 in the Federal Register 82 FR 1210, January 5, 2017. The provisions of the final rule were to be effective March 6, 2017, however HHS issued a subsequent final rule 82 FR 12508, March 6, 2017, delaying the effective date to March 21, 2017, with an anticipated enforcement date of April 1, 2017. On March 20, 2017 HHS issued another final rule delaying the effective date to May 22, 2017. At that time HHS also invited commenters to provide their views on a further delay of the effective date to October 1, 2017, 82 FR 14332, March 20, 2017. After the comment period closed HRSA reviewed the 51 comments received, and believed that delaying the effective date of the final rule to October 1, 2017 would provide regulated entities sufficient time for compliance and mitigate any concerns with implementation 82 FR 22893, May 19, 2017. On August 21, 2017, HHS published in the Federal Register a notice of proposed rulemaking soliciting comments on further delaying the effective date of the final rule from October 1, 2017 to the proposed effective date of July 1, 2018, 82 FR 39553, August 21, 2017.
340B OPAIS update
The Office of Pharmacy Affairs (OPA) posted an update on its website on August 17, 2017 providing information regarding the upcoming release of its Office of Pharmacy Affairs Information System (340B OPAIS) that impacts both manufacturers and 340B covered entities.
The important details for manufacturers to be aware of are provided below taken directly from the OPA website and may be found at https://www.hrsa.gov/opa/updates/2017/1708monthlyupdate.pdf
The 340B OPAIS will have two separate components–a new registration system and a new secure pricing system. The registration component of the new 340B OPAIS was released in mid-September 2017 and the pricing system will be released at a later date. The registration component of the new 340B OPAIS will modernize the current 340B database to enhance its functionality and security for both manufacturers and covered entities. This new system will increase the integrity and effective use of 340B stakeholder information. Some of the features of the registration component of the 340B OPAIS include:
- Enhanced security features, such as two-part authentication
- Authorizing Officials (AO) and Primary Contacts (PC) will be required to create a user-name and password
- Ability to manage your own 340B record, which will include the ability to perform registrations and change requests
- Improved efficiency and usability through a task oriented landing page
Manufacturers and covered entities are encouraged to begin to prepare for the changes to 340B OPAIS by referring to OPA’s website at https://www.hrsa.gov/opa/. Please begin to prepare for these changes and refer to our other 340B blogs for additional announcements and educational resources to assist you in becoming familiar with the registration of the new 340B OPAIS.