The damage to patient access caused by proposed 340B Drug Pricing Program guidance would dwarf any clarity the guidance could add to program requirements and harm vulnerable patients, America’s Essential Hospitals said in Oct. 27 comments on the 340B Drug Pricing Program omnibus guidance.

The proposed guidance, which the Health Resources and Services Administration (HRSA) released Aug. 28, threatens access to care “by potentially restricting the definition of a patient, adding requirements for hospital outpatient facility eligibility, and narrowing the interpretation of which drugs qualify as covered outpatient drugs,” the association said.

The association also noted that the guidance runs counter to the direction in which the health care delivery system is moving: toward integrated, coordinated care. “While government initiatives in other programs encourage care coordination across different settings, many components of the guidance, such as the prohibition on the use of 340B discounts for discharge medications, push the delivery system in the opposite direction,” America’s Essential Hospitals said. “Not only does the proposed guidance threaten to limit access and quality but it will also raise overall health care costs by increasing avoidable admissions.”

The association called on HRSA to “pull back its proposal to dramatically narrow the definition of a patient to whom a covered entity may provide 340B discounted drugs” and make other changes to clarify the guidance before moving forward with a final version.