The Oct. 27 deadline for submitting comments on the 340B drug pricing program's proposed federal guidance is fast approaching. Defending against potentially damaging consequences for safety net services is crucial.
In late August, the Health Resources and Services Administration, which oversees the 340B program, released proposed guidance that would be highly detrimental for patient access if enacted without change. It is critical that safety net providers familiarize themselves with the proposal, and tell HRSA about probable negative effects for underserved patients. The agency is soliciting feedback from all players in the 340B arena before finalizing the guidance. This is the one chance to seek changes in the proposed rule and providers need to take it.
The proposed guidance could significantly diminish savings and the ability to finance uncompensated care, depending on an organization's business model and how 340B savings are used to provide drugs and services to safety net patients. Policymakers promoting change need the impact modeling that only providers can furnish. Without strong numbers and patient examples, the safety net story is difficult to tell effectively.
It is a common perception that the Affordable Care Act has solved access problems for low-income populations. Coverage has been expanded, but that is not the whole picture. Unless there are hospitals, clinics and doctors to serve safety net populations, the promise of better health through coverage cannot be met. Uncompensated costs are concentrated in low-income urban and rural communities, and hospitals and doctors serving these communities continue to need resources from programs such as 340B to cover basic costs. In Detroit, where there is no public hospital, we see our uncompensated care costs at the Henry Ford Health System continuing to grow at a steady pace.
I urge 340B providers to file formal comments with HRSA illustrating how certain provisions could limit patient eligibility and end clinically proven strategies to improve quality of care and reduce costs. At Henry Ford, a proposed prohibition on 340B pricing for drugs provided at hospital discharge is particularly troubling. Many of us provide medications or prescriptions at discharge as a way to prevent readmissions and ensure compliance with doctors' orders. For the majority of our safety net patients, we already bear a cost for these medications. This cost will be much higher if we can't acquire those medications at 340B prices. That makes less money available for the many other services we provide to the needy.
Another area of concern is proposed restrictions on 340B pricing for drugs that are part of an inpatient bill (even when the service rendered is clearly provided on an outpatient basis). Equally problematic are proposed prohibitions on 340B pricing for infusion services that could hit rural hospitals particularly hard.
HRSA needs the data and examples that only safety net providers can supply. Without good numbers and instances of patient impact, national groups representing the interests of safety net patients will lack important tools to address the consequences of the proposed rule.
I urge hospital CEOs to work with their leadership teams and submit comments to HRSA before the Oct. 27 deadline. Silence now could prove disastrous.
Robert G. Riney is executive vice president and chief operating officer of Henry Ford Health System in Detroit.
