Perspectives

340B Ceiling Price and Civil Monetary Penalties Regulations

Effective date delayed until July 1, 2019

On June 5, 2018, Health and Human Services (HHS) published a final rule delaying the effective date of the final rule from July 1, 2018 to July 1, 2019.

June 5, 2018

A blog post by Cindy Cerneka, Practice Leader, Government Pricing, Deloitte Risk and Financial Advisory, Deloitte & Touche LLP

On June 5, 2018, HHS published in the Federal Register (83 FR 25943, June 5, 2018) 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 July 1, 2018 to July 1, 2019. HHS stated that it has proposed this delay to allow for more time for alternative considerations and supplemental regulatory provisions as well as to allow stakeholders additional time to comply with the new program requirements. The final rule applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program.

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, the Health Resources and Services Administration (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), which was approved on September 29, 2017 at 82 FR 45511. More recently, on May 7, 2018, HHS published in the Federal Register a notice of proposed rulemaking soliciting comments on once again delaying the effective date of the final rule from July 1, 2018 to the proposed effective date of July 1, 2019, (83 FR 20008, May 7, 2018).

Back to top

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:

Manufacturers:

  • 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.

Back to top

Did you find this useful?