Health Resources and Services Administration Pharmaceutical Pricing Agreement Addendum
November 1, 2016
The Health Resources and Services Administration's (HRSA), Office of Pharmacy Affairs (OPA) is requiring manufacturers participating in the 340B Drug Pricing Program to submit a Pharmaceutical Pricing Agreement (PPA) Addendum. This is to help to ensure that manufacturers provide HRSA with their calculated 340B ceiling prices and offer covered entities' drugs for purchase at or below the applicable ceiling price if such drugs are made available to any other purchaser at any price.
What is the purpose of the PPA Addendum?
Section 340B(a)(1) of the Public Health Service Act (PHS Act) provides that the Secretary of Health and Human Services (the Secretary) will enter into a pharmaceutical pricing agreement (the Agreement) with each Manufacturer of covered outpatient drugs in which the Manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the average Manufacturer price decreased by a rebate percentage. Section 7102(b) of the Affordable Care Act amended section 340B(a)(1) of the PHS Act to add two new requirements for inclusion in the Agreement with the Manufacturer:
The Agreement “shall require that the Manufacturer furnish the Secretary with reports, on a quarterly basis, of the price for each covered outpatient drug subject to the agreement that, according to the Manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug”; and
The Agreement “shall require that the Manufacturer offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.”
The purpose of the PPA Addendum is to include these new requirements as part of the originally signed Pharmaceutical Pricing Agreement (the “Agreement”) between the Secretary and the Manufacturer.
Manufacturers will need to submit a PPA Addendum for each PPA they have previously submitted to HRSA OPA. HRSA OPA is requesting receipt of the required PPA Addenda by December 31, 2016.
For more information manufacturers should read the following detailed description provided by HRSA.
As part of its oversight of the 340B Drug Pricing Program (340B Program), the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA), is requiring each participating manufacturer to sign and submit a Pharmaceutical Pricing Agreement (PPA) Addendum. The PPA Addendum will help to ensure that the requirements of the statute are met, including, but not limited to: that manufacturers provide HRSA with their calculated 340B ceiling prices, and that manufacturers offer covered entities drugs for purchase at or below the applicable ceiling price if such drugs are made available to any other purchaser at any price.
Manufacturers will submit a PPA Addendum for each PPA it has previously submitted to HRSA OPA. HRSA OPA understands that since the original PPA was signed, labeler codes may have been transferred, acquired or purchased by other manufacturers. The method for assessing the number of PPA Addenda a manufacturer is required to sign is outlined below:
Refer to the 340B database at https://opanet.hrsa.gov/OPA/Manufacturers.aspx.
By searching the manufacturer’s Name field, a Manufacturer can see, based upon their name, how many labeler codes are listed for that specific manufacturer.
For each labeler code there is a “Signed Date” field.
The number of “Signed Date” fields will determine the number of PPA Addenda required. Example: XYZ manufacturer performs a search by their name XYZ. Ten labeler codes appear under the name XYZ. Under the “Signed Date” field there are three separate dates representing the ten labeler codes 1/05/1993, 1/6/2005, and 12/15/2012. This denotes the number of original PPAs HRSA OPA has received from this manufacturer. HRSA OPA will then require receipt of three separate PPA Addendums to coincide with the original three PPAs.
Once a manufacturer determines the number of PPA Addenda to be signed, please refer to the attached instructions and PPA Addendum for further information. The PPA Addendum may be filled out, signed, scanned, and submitted to firstname.lastname@example.org. If a manufacturer would like to receive an original signed copy, the manufacturer should send two signed PPA Addendums to the address listed below, and OPA will return a signed copy:
Health Resources and Services Administration
Office of Pharmacy Affairs
5600 Fishers Lane, 8W03A
Rockville, MD 20857
HRSA OPA requests receipt of the required PPA Addenda by December 31, 2016. Please send any questions to the 340B Prime Vendor Program at 1-888-340-2787, or by sending an e-mail to ApexusAnswers@340bpvp.com. If a manufacturer needs to update its information on the 340B database, a manufacturer change request form can be found at Manufacturer Change Request Form. HRSA OPA appreciates the time and resources that manufacturers have devoted to compliance with the 340B Program requirements.