Thursday, February 4, 2016

New 340B Services Caucus Focuses on Patients

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

On January 28, 2016, something peculiar happened in the debate over the future of the 340B Drug Pricing Program. The ADAP Advocacy Association launched its new 340B Service Caucus, thus giving patients living with HIV/AIDS a seat at the table.

The Health Resources and Services Administration (HRSA) summarizes the program as follows:

"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."[1]


Rx bottle with the label, "340B"
Photo by 18percentgrey on Getty Images

The 340B Drug Pricing Program has increasingly been discussed and scrutinized by lawmakers, regulators, payers, and trade associations. Throughout the debate, however, one important stakeholder group has been left out of the conversation: the patients! That is about to change.

In August 2015, HRSA issued proposed guidance on the program, and it included language important to "creating a defined link between a medically underserved, vulnerable patient and a 340B covered entity."[2] Leading up to the proposed guidance, HRSA had received feedback from many stakeholder groups.

The National Alliance of State & Territorial AIDS Directors (NASTAD) has been representing the concerns of the State AIDS Drug Assistance Programs (ADAPs); as they should be doing! The Pharmaceutical Research and Manufacturers of America (PhRMA) has been picking up the mantle of the biopharmaceutical research companies; as they should be doing! And the American Hospital Association (AHA) has been speaking up for safety-net hospitals; as they should be doing!

The ADAP Advocacy Association applauds the aforementioned advocacy efforts, but contends that the ongoing debate is further enhanced by adding yet another perspective. The caucus is designed to provide a neutral platform for stakeholders to discuss the program and related public policy initiatives, as well as the Continuum of Care for patients living with HIV/AIDS whom directly and indirectly received their care from Ryan White covered entities, ADAPs, and affiliated clinical providers.

To learn more about the 340B Drug Pricing Program, go to www.hrsa.gov/opa/.


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[1] Health Resources and Services Administration, U.S. Department of Health & Human Resources, "340B Drug Pricing Program," 2016. Last accessed online at; http://www.hrsa.gov/opa/index.html
[2] AIRx Mail, "HRSA's Long-Awaited 340B Guidance: A Good First Step, But More to Be Done," September 2015. Last accessed online at; http://archive.constantcontact.com/fs105/1118550068046/archive/1122395122062.html.

1 comment:

Robert Reynolds said...

iN jANUARY we were notified that the Part B provider, United of Florida through AARP, would pay significantly less than the wholesale cost of Drabinol. Leaving the Independent Pharmacist that supplies us all our medications, 24 prescriptions between the two of us, an $80 deficit. After researching, they were paying less than any retailer were charged. Such arbitrary decisions may be standard business practice, but not reasonable or fair to the consumer. We have a good working relationship with the pharmacist and they have accomodated our needs, but we cannot expect them to continue in the future. I recently was refused Genvoya by Welcare Part D, but was able to get approved by telephone with a supervisor within 24 hours. I have been on Atripla since 2004 ( the combination of) and recent numbers indicated it was time to consider a change in the near future. Such complications and irritants are not helpful for our overall heath outcomes. We are partners with our medical providers, and pharmacist. I feel we are adversaries with our insurance providers. Most people I know are unwilling to fight the system, obviously I refuse to be bullied.