The Health Resources and Services Administration (HRSA) issued its proposed omnibus guidance on the 340B Drug Pricing Program in the Aug. 28 Federal Register in the form of a notice with a 60-day comment period.
The proposed guidance seeks “to provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen the [Department of Health and Human Services’] ability to administer the 340B Program effectively” by clarifying, reiterating, and/or modifying existing guidance, memoranda, and practices.
The guidance proposes a new definition for eligible patients, requiring that the individual meet all the following criteria for the covered entity to access the discounted drug pricing:
- The individual receives a health care service at a covered entity site which is registered and listed on the public 340B database;
- The individual receives a health care service from a provider who is employed by or who is an independent contractor of the covered entity such that the covered entity may bill for services on behalf of the provider;
- The individual receives a drug that is ordered or prescribed by the covered entity provider as a result of the service described in (2). An individual will not be considered a patient if the only care received from the covered entity is the infusion or the dispensing of a drug;
- The individual receives a health care service that is consistent with the covered entity’s scope of grant, project, or contract;
- The individual is classified as an outpatient when the drug is ordered or prescribed, determined by how the services for the patient are billed to the insurer; and
- The covered entity maintains access to auditable health care records demonstrating a provider-to-patient relationship, that the responsibility for care is with the covered entity, and that each element of the patient definition is met for each 340B drug.
The proposed guidance also states that employees of the covered entity would not be considered eligible patients unless they meet the conditions of the new patient definition.
Among other issues, the proposed guidance addresses contract pharmacy arrangements; eligibility and registration of hospitals and outpatient facilities; drugs eligible for purchase under the program; duplicate discounts; notice and hearing processes for noncompliance; and manufacturer compliance.
HRSA will accept public comment on the proposed guidance through Oct. 27.