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  • Washington Highlights

    AAMC Comments on HRSA 340B Proposed Rule


    Mary Mullaney, Director, Hospital Payment Policies

    The AAMC submitted comments on Oct. 27 on the Health Resources and Services Administration’s (HRSA’s) proposed rule that would require federally qualified health centers (FQHCs) to provide their patients access to insulin and injectable epinephrine at no more than the 340B-acquired price.

    The proposed rule is in response to Executive Order 13937 issued on July 29 that directs FQHCs to improve patients’ access to these prescription drugs. If finalized, new FQHC grant awardees would be required to establish written practices to make insulin and injectable epinephrine available at or below the 340B price to individuals with low incomes who (a) have a high cost-sharing requirement for either insulin or injectable epinephrine, (b) have a higher unmet deductible, or (c) have no health insurance.

    The AAMC’s comments note that this proposal is unnecessary. The law states that health centers must ensure that no patient is denied services due to an inability to pay. FQHCs are required to have policies in place to ensure affordable access to health care services. In Section 330 of the Public Health Service Act, requirements around the Sliding Fee Discount Schedule (SFDS) state that no patient should be denied services due to the inability to pay and underinsured and uninsured patients with incomes below 200% of the federal poverty level may be charged nominal fees for services based on the SFDS.

    While these requirements do not explicitly apply to drugs, discounts on drugs are frequently included as they are often viewed as part of the services furnished. If a health center elects to provide its patients access to supplies or equipment — including prescription drugs — that are related to, but not included in, the service itself as part of prevailing standards of care, the health center determines how to charge its patients for those supplies or equipment, such as using the SFDS to ensure affordability.