The 340B Drug Pricing Program is essential to access care and services for people living with and vulnerable to HIV. With effective, strategic policies to ensure sustained financial support for covered entities, the 340B Program can continue to be a stable resource for the health care providers serving those most in need.
Under the 340B Program, federal law permits Ryan White clinics, community health centers, safety net hospitals, and certain other types of providers — collectively known as “covered entities” — to buy outpatient prescription drugs from drug manufacturers at a discount. In exchange for committing to serve historically marginalized and underserved patients, payors reimburse covered entities at retail rates, allowing the covered entity to realize a savings.
Covered entities reinvest that savings into their services and programs; the savings covered entities achieve through the 340B Program helps them stretch scarce federal resources. Without the 340B Program, covered entities will not be able to provide care to our nation’s most vulnerable populations, including those most impacted by the HIV epidemic in the United States.
The 340B Program is working as it was intended for safety-net providers of health care and supportive services for people living with and vulnerable to HIV.
It provides essential resources for covered entities to invest in programs and infrastructure that achieve life-saving health outcomes. What’s more, the 340B Program is just one element of a complex and tenuously designed safety-net financing system upon which patients of covered entities depend for lifesaving and life-sustaining care. The Work Group opposes any attempts to alter the scope of the 340B Program; doing so on the backs of safety-net providers will harm Americans in need of care, while resulting in increased profit for drug manufacturers. HIV treatment funded by 340B savings is saving lives.
The 340B Program should maintain the current definition of “patient” as stipulated by HRSA’s 1996 guidance. The intent of the 340B Program is to “stretch scarce Federal resources”; restricting the universe of patients who benefit from the Program has the opposite effect of that intended by Congress. For example, limiting 340B to only patients who receive in-person health care services will have negative health consequences for patients in rural and urban areas alike. Telehealth is essential to HIV prevention and care. For thousands of highly vulnerable patients on PrEP for HIV prevention, an in-person visit requirement may jeopardize their PrEP access, thus jeopardizing their health and the health of their communities. The 340B Program should not dictate how and when providers meet with patients. It is imperative that the 340B Program facilitate access to in-person and virtual health care services provided by a health care professional who is employed by, contracted with, or referred by a covered entity.
The 340B Program should continue to support the ability of covered entities to serve all patients who walk in their doors. Savings derived from 340B-priced drugs dispensed to 340B eligible patients, as defined in guidance published by HRSA in an October 24, 1996, Federal Register notice, have always been used by covered entities to provide additional needed services to all patients. Though the 340B Program does allow patients to access outpatient drugs at reduced prices — often for free — the Program was not designed solely to provide access to affordable drugs for low-income or uninsured patients. Rather, savings derived from the Program have always been used by covered entities to provide additional needed services to all patients. Restricting the program’s reach wipes out the resources covered entities use to provide comprehensive care to all patients.
Drug manufacturers should not be permitted to dictate restrictions on pharmacy locations at which the 340B Program can operate. The ability of manufacturers to restrict access to the 340B Program at contract pharmacies limits access to outpatient drugs for those in need and significantly reduces financing for HIV clinics, undermining HIV prevention efforts and risking increases in untreated HIV.
Pharmacy benefit managers and insurance companies should be prohibited from discriminating against covered entities simply by virtue of their status as participants in the 340B Program. Specifically, PBMs and insurance companies should not be allowed to force covered entities to accept lower reimbursement or pay special fees simply because they are 340B Program participants. Permitting this practice takes 340B savings away from the intended recipient — covered entities — and redirects it to PBMs and insurance companies.
Drug Companies should be prohibited from implementing punitive restrictions designed to shore up their profits at the expense of patients and communities in need. As 340B covered entities that are Federal grantees, we already comply with statutory and administrative requirements that govern their ability to participate in the 340B Program and restrict how they can use 340B savings. We respect the regulatory structure designed to ensure 340B savings support access to health care, supportive services, and needed medications for our patients. But sadly, drug manufacturers have leveled harsh, unfair, and unnecessary actions to try and limit participation in the Program to increase their profit margins at the expense of the most vulnerable populations. These punitive measures — including changing requirements for participation in patient assistance programs, eliminating sub-ceiling discounts, and restricting contract pharmacy participation — are unnecessary and duplicative of existing regulations with which safety net providers must comply. Additionally, these measures are administratively burdensome and compliance is costly, diverting resources away from patient care.
The AIDS United 340B Work Group is invested in the continued success of the 340B Drug Pricing Program. To that end, we are open to maintaining a dialogue with all stakeholder groups to protect and ensure the viability of the 340B Program. Protecting 340B means protecting the patients and communities we serve.
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