A Notice of Proposed Rulemaking (NPRM) titled "340B Drug Pricing Administrative Dispute Resolution" was published on Friday, August 12, 2016 in the Federal Register.
This NPRM establishes and implements a binding administrative dispute resolution (ADR) process for certain issues arising under the 340B Program. The purpose of the ADR is to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.
The NPRM will be open for public comment through October 11, 2016, 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.
HRSA/OPA recently conducted a 340B Recertification webinar for hospitals. Recertification will begin August 10, 2016 and end September 7th. You may access the webinar here.
HRSA/OPA recently conducted a Welcome webinar for newly enrolled 340B registrants. Topics covered in this webinar includes,
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.
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.
Contract Pharmacy: Important Tips (August 2016)
Notice to 340B Covered Entities Regarding 340B Ceiling Prices for Ascend Products (7/1/16) (PDF - 114 KB)