Health and Medical News and Resources

General interest items edited by Janice Flahiff

US Government Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices

New to me!

From the US Health Resources and Services Program Web page –  340B Drug Pricing Program & Pharmacy Affairs

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.

Update here, which includes..

HRSA is currently working to formalize existing program guidance through regulation, designed to cover a number of aspects of the 340B Program. The regulation currently under development will address the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility criteria, and eligibility of off-site facilities. We expect to publish this proposed regulation, which will be open for public comment, by June 2014. In order to ensure that covered entities retain flexibility based on their size, structure, and patient population, HRSA will continue to hold covered entities accountable for implementing those requirements as appropriate for their specific circumstances.

…..

Implemenation page includes

Once a covered equity is enrolled in the 340B Program and included in the covered entities database, it is the covered entity’s responsibility to inform wholesalers and manufacturers of enrollment in order to purchase drugs at the 340B discounted price.

Covered entities may continue to work directly with individual wholesalers and manufacturers and may participate in the 340B Prime Vendor Program (PVP). As the government’s awarded 340B Prime Vendor, Apexus is responsible for securing sub-ceiling discounts on outpatient drug purchases and discounts on other pharmacy related products and services for covered entities electing to join the PVP. For complete information, see the Prime Vendor Program .

Implementation Options

HRSA does not specify how participants should implement the 340B Program. As long as participants comply with all 340B Program requirements, they have flexibility in implementing the 340B Program.

Most covered entities choose one or more of the following options:

  • In-House Pharmacy, in which the covered entity owns drugs, pharmacy and license; purchases drugs; is fiscally responsible for the pharmacy; and pays pharmacy staff.
  • Contract Pharmacy Services, in which the covered entity owns drugs; purchases drugs; pays (or arranges for patients to pay) dispensing fees to one or more contract pharmacies; and contracts with pharmacy to provide pharmacy services.
  • Provider/In-House Dispensing, in which the covered entity owns drugs; employs providers licensed in the state to dispense; holds a license for dispensing for the participating providers; and is fiscally responsible for operating and dispensing costs.
  • Alternative Methods Demonstration Project, in which HRSA Office of Pharmacy Affairs approves a model proposed by the covered entity, such as a network of 340B covered entities.

The 340B Database includes links to

 

 

 

 

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February 2, 2014 - Posted by | health care | , , , , , ,

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