At this time, prior to the MegaGuidance being finalized, a 340B eligible
patient is currently defined by statute as simply “a patient of the entity.”100
In 1996, HRSA issued a definition of a 340B patient.101 In 2007, HRSA
published a notice in the Federal Register in an effort to revise the 340B
definition of patient.102 However, this proposal was met with such resistance
that HRSA subsequently rescinded its 2007 guidance.103 Accordingly, for
nearly two decades stakeholders looked to the broad 1996 HRSA definition
as the current program guidance on how to protect against diversion.104
HRSA’s 1996 definition of a patient is broad. Under current program
guidance, a person is a “patient” of the covered entity for 340B eligibility
purposes if: ( i) the covered entity has established a relationship with the
person such that the covered entity maintains records of the person’s
healthcare; ( ii) the person received health care services from a provider
employed by, or under a contractual or other arrangement with, the covered
entity such that responsibility for the care provided remains with the covered
entity; and (iii) the person receives a service or range of services consistent
with the service or range of services for which grant funding or FQHC Look-Alike status has been provided to the entity, as applicable.105 Naturally, this
definition has been subject to various interpretations.
For community health centers, defining a 340B eligible patient is easier
than for hospital covered entities, as community health centers provide only
outpatient services thereby eliminating confusion over whether the
prescription arose from an inpatient service. Still, there have been gray areas
with the 1996 patient definition with which community health centers have
had to contend. For example, the 1996 definition mentions maintenance of
records, without specifying “medical records.”106 This ambiguity has led to
some organizations that play a solely administrative role with patients to
claim the individuals as 340B patients when, in fact, the organization
delivered no direct health services to the individual. This practice is
relatively straight-forward as an abuse of the 340B Program, as the Program
100. § 256b(a)( 5)( B).
101. Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and
Entity Eligibility, 61 Fed. Reg. 55156, 55156-58 (Oct. 24, 1996) [hereinafter 61 Fed. Reg.
55156] (defining “patient” for purposes of the 340B Program).
102. Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Definition
of “Patient,” 72 Fed. Reg. 1543 (Jan. 12, 2007) [hereinafter 72 Fed. Reg.1543].
103. Werling Article, supra note 37, at 64 (noting that covered entities voiced “deep
concern that HRSA’s proposal is way too complicated for safety net pharmacists to implement
and that large segments of the patient populations served by safety net providers will lose
access to discounted drugs.”) (citing Ctrs. for Medicare & Medicaid Servs., Industry Fears
HRSA Proposal Will Reduce Access to 340B Rx Discounts, INSIDE CMS (Jan. 25, 2007)).
104. 61 Fed. Reg. 55156, supra note 101, at 55157.
105. Id. at 55157–58.