A final rule titled "340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation" was published in the Federal Register (PDF - 290 KB) on Thursday, January 5, 2017.
The provisions of the final rule include:
The final rule will be effective March 6, 2017. However, HRSA recognizes that the effective date falls in the middle of a quarter. As such, HRSA plans to begin enforcing the requirements of this final rule at the start of the next quarter, which begins April 1, 2017. Please refer to the Federal Register (PDF - 290 KB) publication for more information.
The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.
Manufacturers participating in Medicaid, agree to provide outpatient drugs to covered entities at significantly reduced prices.
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.
OPA Monthly Update - January 2017 (PDF - 55 KB)
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.
Notice Regarding 340B Pricing for Millennium Pharmaceuticals VELCADE (PDF - 40 KB) (2016)
Notice Reagarding 340B Pricing for BiCNU (PDF - 76 KB) (December 2016)
HRSA OPA Manufacturer Update 12/15/2016