A Notice of Proposed Rulemaking (NPRM) titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation” was published on Wednesday, June 17, 2015 in the Federal Register.
This NPRM implements manufacturer civil monetary penalties for manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug and provides increased clarity on the requirements of manufacturers to calculate the 340B ceiling prices on a quarterly basis. The NPRM will be open for public comment through August 17, 2015, and HRSA encourages all interested parties and stakeholders to submit comments. Please refer to the Federal Register publication for instructions about how to submit comments.
The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices.
The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.
Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers. See the full list of eligible organizations/covered entities.
To participate in the 340B Program, eligible organizations/covered entities must register and be enrolled with the 340B program and comply with all 340B Program requirements. Once enrolled, covered entities are assigned a 340B identification number that vendors verify before allowing an organization to purchase 340B discounted drugs.
New registrations are accepted October 1-15, January 1-15, April 1-15 and July 1-15.
Office of Pharmacy Affairs Director Presents to 340B Coalition video
Manufacturers are asked to review their 340B Database records and submit a Manufacturer Change Request Form (PDF - 28 KB) to 340Bpricing@hrsa.gov if any updates are necessary. Ensuring the accuracy of information on file with HRSA will facilitate the rollout of the enhanced 340B pricing system later this year.
Program Update: Contract Pharmacies (06/17/2015)
340B Glossary of Terms (PDF - 299 KB)