Since the 340B drug pricing program was established in 1992, participating providers have been unable to access 340B ceiling prices to verify whether they are receiving the correct price on medications purchased through the program. In 2010, the Affordable Care Act directed the US Department of Health and Human Services to develop a secure 340B ceiling price database for covered entities.

Nearly nine years later, the Health Resources and Services Administration (HRSA), which oversees the 340B program, announced that it expects to launch the database on April 1, 2019. In this article, we describe how that database will operate, based on information shared by HRSA to date, and address the implications of the database for 340B providers.

Data workflow: Submission to price publication

HRSA has developed a system and process for receiving and verifying drug pricing data from manufacturers before making 340B ceiling prices available to covered entities. The agency first will obtain data from the Centers for Medicare and Medicaid Services (CMS) for each covered outpatient drug, including average manufacturer price (AMP) and unit rebate amount (URA). HRSA also will gather from First Databank information on each drug’s package size (i.e., the quantity of units in one package sold by a manufacturer under a particular 11-digit National Drug Code [NDC]) and case package size (i.e., the number of saleable of units in a shipping container). The agency will use the pricing data and package size information to calculate a 340B ceiling price and a package-adjusted price (i.e., 340B ceiling price multiplied by package size and case package size) in the Office of Pharmacy Affairs Information System (OPAIS). 

Manufacturers’ authorizing officials (AOs) and primary contacts (PCs) will receive an email informing them that they can begin providing data using the pricing component of OPAIS, which will be available to manufacturers for approximately two weeks each quarter. The first submission period for manufacturer data will be February 15 to March 4, 2019. HRSA has asked manufacturers to take steps now to verify the accuracy and completeness of their labeler code information in OPAIS, including AO and PC contact information, and to submit any necessary change requests as soon as possible.

During the submission period, manufacturer AOs and PCs will have unlimited access to OPAIS to provide data. Manufacturers will be able to enter data manually, or upload a fixed-length .txt instrument file that includes NDC (i.e., labeler code, product code, and package size), the period covered, AMP, URA, package size, unit type, case package size, 340B ceiling price, Food and Drug Administration product name, labeler name, and wholesale acquisition cost (WAC).

If a manufacturer chooses to manually enter data, it can accept HRSA’s data or provide its own. If there is a discrepancy between the manufacturer’s data and HRSA’s corresponding data on one or more of the five pricing data points (AMP, URA, package size, case package size and 340B ceiling price), the manufacturer must provide a reason for the discrepancy. For discrepancies identified after a manufacturer uploads a fixed-length .txt instrument file, the manufacturer can (1) accept HRSA’s data; (2) not edit any of its data and provide a rationale for the discrepancies; or (3) edit its data and provide a reason for any remaining discrepancies.

After adjudicating any discrepancies, HRSA will publish the 340B ceiling price and the package-adjusted price in OPAIS. If a manufacturer does not provide or reconcile data by the end of the quarterly submission period, HRSA will publish a 340B ceiling price based solely on the data it received from CMS, noting this in OPAIS. 

HRSA shared information regarding how it will handle certain scenarios. For a new drug, HRSA will use WAC and URA data provided by the manufacturer to calculate and publish an estimated ceiling price in accordance with the agency’s 340B ceiling price and manufacturer civil monetary penalty regulation. If a drug was sold during the quarter and the manufacturer submitted data to CMS, the manufacturer is responsible for submitting data to HRSA too. If the CMS data provided to HRSA included drugs that were withdrawn from the market or have an effective termination date or expired lot date, HRSA will not publish ceiling prices for those drugs. At this time, the pricing component of OPAIS will not allow a manufacturer that voluntarily participates in 340B to submit pricing data.

HRSA anticipates that approximately 600 manufacturers will provide pricing data for around 40,000 drugs during the upcoming submission period.

Security features

Covered entities will have limited access to the database. Only covered-entity AOs and PCs will be able to view the pricing data in OPAIS. In addition, neither covered entities nor manufacturers will be permitted to export 340B ceiling prices or package-adjusted prices from OPAIS. Each time a registered user logs into OPAIS, the system will require the individual to attest to a set of rules of behavior, including adhering to a prohibition against unauthorized disclosure of data. Manufacturer AOs and PCs will not be able to view the data of labeler codes for which they are not the AO or PC.

Implications for covered entities

While the database should prove to be a valuable tool for covered entities seeking to determine if they are potentially being overcharged, providers will not be able to rely solely on the database to ensure they are receiving the correct prices on drugs. This is because the database will contain only 340B ceiling prices, not the actual prices that covered entities pay under the terms of their contracts with sellers. Factors that may cause a drug’s actual and 340B ceiling prices to differ include wholesaler cost minus/plus calculations and sub-ceiling pricing through the 340B Prime Vendor Program or a contract between a covered entity and a manufacturer.

The database also does not address certain types of scenarios relating to 340B pricing, such as:

• A dispute between a covered entity and manufacturer over whether the latter is required to offer a 340B price at all or in certain instances
• A situation where a covered entity believes a manufacturer’s limited distribution network for a drug violates HRSA’s non-discrimination policy
•  A possible misclassification of a drug by a manufacturer (e.g., classifying a product as a generic instead of a brand-name drug)

As before the existence of the database, covered entities will need to rely on a variety of information resources to ensure they are receiving the proper prices on drugs. Moreover, providers will still need to have processes in place and staff to verify pricing, investigate potential overcharge and price-availability issues, and to attempt to resolve any such issues by working in good faith with wholesalers and manufacturers before notifying HRSA.

We will monitor the database’s implementation and keep you informed of significant developments. In the meantime, please reach out to any one of us with questions.

To sign up for 340B @ Dentons, please contact Erin Whittaker at erin.whittaker@dentons.com.