Register

Manufacturers who participate in Medicaid are required under the 340B statute to enter into an agreement with the Secretary under which the manufacturer must agree to charge a price that will not exceed the amount determined under statute (ceiling price) when selling covered outpatient drugs to 340B covered entities. This agreement, known as the Pharmaceutical Pricing Agreement (PPA This agreement is required for manufacturers who have executed a Medicaid rebate agreement with CMS. It is voluntary for those who do not have a current Medicaid rebate agreement. The PPA must be signed by a corporate officer of the company (e.g., president, chief executive officer, or general counsel). Signatures by vice presidents or directors of sales or marketing will not be accepted. A PPA remains in effect until terminated by either the manufacturer or the Secretary of HHS. It is not automatically terminated if a manufacturer terminates its Medicaid rebate agreement.), must be signed by a manufacturer as a condition for participating in Medicaid. Signing the PPA does not prohibit a manufacturer from charging a price for a covered outpatient drug that is lower than the 340B ceiling price. A manufacturer may not condition the offer of 340B discounts upon a covered entity's assurance of compliance with section 340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices. requirements.

Registration Requests