ACCC Comments on Proposed 340B Guidance

By Maureen Leddy, JD, Manager, Policy and Strategic Alliances, ACCC

On October 27, 2015, the Association of Community Cancer Centers (ACCC) submitted comments on the Health Resources and Services Administration (HRSA) “mega-guidance” on the 340B Drug Pricing Program. ACCC supports HRSA’s effort to provide more clarity in the program and we commend HRSA for taking this important step amid legal challenges and Congressional pressure. But just how far the guidance will go remains unclear. While HRSA’s guidance does not have the strength of a rulemaking, it does inform 340B participants how the agency believes the program should operate, and we can expect it will be used as a basis for future audits. It remains to be seen whether Congress will codify the guidance or move any other legislation related to 340B.

HRSA’s guidance largely focuses on laying out a narrower definition of a patient under the program. Essentially the guidance proposes to significantly strengthen the relationship between the 340B covered entity (CE) and patient in order for that patient to qualify for 340B discounted drugs. The CE would now need to provide much more comprehensive service to a patient in order to receive a 340B drug discount.

Specifically HRSA proposes a six-prong test to determine patient eligibility:

1. The patient must have received a healthcare service from a registered CE.
2. The healthcare service is provided by a CE-associated provider (employed by or an independent contractor of that CE).
3. The drug prescription is a result of the service provided by the CE and, importantly, the service is not limited to the dispensing or infusion of a drug.
4. The service is consistent with the CE’s grant or contract (typically for grantees only).
5. The prescription is the result of an outpatient service, determined by how the CE bills the payer.
6. The CE maintains access to auditable health records, demonstrating a provider-to-patient relationship and that the CE is responsible for that patient’s care.

So what does this mean for cancer care? This guidance will likely have significant implications for referrals and follow-up care, limiting the ability of cancer patients to move between sites of care. For example, under the guidance, when a patient sees a physician at a non-340B site as a referral or follow up to care, even though the patient’s care originated at a CE, that patient would no longer be eligible to receive a 340B discount. Further, under the guidance, if a community practice physician (i.e., a non-CE-physician)—potentially without the infrastructure or resources to provide certain oncology services—sends patients to a CE for an infusion, that patient would not be eligible for 340B drug pricing. This is because the guidance stipulates that the service the CE provides cannot be limited to the infusion or dispensing of a drug.

In our comments to HRSA, ACCC weighed in on the potential unintended consequences and administrative burden this revised patient definition may present for CEs. We urge the agency to consider the complexity of today’s multi-site cancer care infrastructure and to ensure that cancer patients retain access to appropriate, quality cancer care. Further, in order to qualify for 340B drug pricing, a CE must provide associated healthcare services to a referred patient beyond just dispensing or the infusion of a drug. ACCC urges HRSA to coordinate with the Centers for Medicare & Medicaid Services (CMS) to ensure CEs understand what constitutes a healthcare service for purposes of 340B drug pricing. ACCC also urges HRSA to clarify any specific requirements regarding the content of a CE’s patient records in order to demonstrate a provider-to-patient relationship for purposes of the 340B program. Finally, ACCC notes the multitude of new administrative and accountability requirements for CEs, and encourages HRSA to work with stakeholders to collect data on the financial and operational impact of these new requirements.

The agency may issue final guidance sometime in the following months. ACCC will be monitoring closely. Stayed tuned.