The 340B program must continue to give patients the best possible access to care. The intent of the program is to bring more comprehensive care to more patients.
Any limitations on access to care that undermine a covered entity’s ability to deliver care to their communities are entirely unacceptable. Critics allege that the intent of the program should be changed, there should be fewer 340B safety net providers and less use of the program, and limitations should be made on safety net providers’ use of contract pharmacies.
Changing the intent of the program…
- Denies covered entities the ability to bring comprehensive and
accessible care to individuals who need it the most.
- Undermines safety net providers’ ability and flexibility to best serve
the individual needs of their communities.
Restricting safety net providers from participating in the program…
- Defies Congress’ deliberate determinations of which groups are
eligible for the program.
- Undermines the intended reach of the 340B program, threatening
Limiting access to drugs…
- Limits access to care.
- Limits a patient’s right to choose where they get their medicine,
forcing patients to travel farther to get their medications and/or
reducing the likelihood that patients will take their drugs, in turn,
hurting our vulnerable patient populations.
2. Beware “Transparency”
Overly burdensome new regulations and transparency requirements must not undermine the 340B program. The federal agency regulating 340B (HRSA) can improve transparency without adding unnecessary burdens or limiting the numbers of safety providers. Critics allege that the 340B program needs more federal regulation and increased reporting.
“Transparency” is often a cover for the real goal – to shrink the 340B program.
- Some drug companies want to provide fewer discounts to fewer
safety net providers, all at the expense of patients and communities.
- Some drug company actions to restrict safety net use of 340B is far
more than merely seeking more transparency.
3. Protect Federal Regulatory Authority & Preserve States Rights
340B is regulated by the federal government and by the states in the distribution of drugs within the states, all without taxpayer expense. State laws regulating discriminatory reimbursement by PBMs and state regulation of 340B drug distribution should be preserved.
Through litigation, some drug companies have stopped any regulation. Some drug companies are trying to recreate the 340B program to suit drug companies’ bottom lines.
Drug company lawsuits are paralyzing Congress and states from protecting 340B.
Some drug companies are using lawsuits to stop the federal agency
that regulates the 340B program from enforcing long-standing rules
for the 340B program. Some drug companies are using lawsuits to
paralyze Congress from regulating drug company actions in the
One of the drug companies’ tactics is to insist that 340B is only
governed by federal law, an approach that defies the rights and
importance of state legislatures and would result in federal and state
taxpayers picking up the bill for services now provided by 340B
safety net providers.
4. Protecting Program Integrity
Safety net providers know the value of the 340B program and work to ensure their compliance with the program. Some drug companies and Pharmaceutical Benefit Managers (PBMs) are seeking to upend the 340B program and accusing safety net providers of abusing the program.
Preventing non-340B stakeholders and drug companies from eroding the program’s ability to serve communities will best improve program integrity.
340B is being abused by drug companies and PBMs.
- Drug companies have unilaterally applied new rules for the 340B
- PBMs are siphoning off 340B discounts by using discriminatory
practices against safety-net providers.
- Congress and the agencies, not drug companies or courts, should
guide program integrity for the 340B program.
Community Voices for 340B (CV340B) is a grassroots organization that seeks to raise awareness of the important role that the 340B program plays in protecting and improving health care access and the quality of care for communities nationwide.
First established in 1992 through bipartisan legislation, the federal 340B drug discount program offers a lifeline to the neediest and most underserved patients in this nation.
The program operates on the simple principle of requiring pharmaceutical companies to provide drugs at a discounted price to certain types of safety net hospitals and clinics that, in turn, use their 340B savings to underwrite the cost of serving patients in their communities.