Definitions

(a) Definition of patient Section 340B(b) of the Public Health Service Act (42 U.S.C. 256b(b)) is amended by adding at the end the following: (3) Patient (A) In general In this section, the term patient means, with respect to a covered entity described in subsection (a)(4), an individual who, on a prescription-by-prescription or order-by-order basis— (i) is dispensed or administered a covered outpatient drug that is— (I) directly related to the service described in clause (iii); (II) ordered or prescribed by a covered entity provider described in clause (ii) as a result of the service described in clause (iii); and (III) dispensed or administered on site at a covered entity location, a child site (as defined in subsection (a)(5)(E)), or an entity pharmacy (as defined in subsection (a)(5)(F)) listed in the identification system described in subsection (d)(2)(B)(iv), or on site at a contract pharmacy in accordance with subsection (a)(5)(F) or dispensed through a mail order pharmacy in accordance with subsection (a)(5)(F); (ii) receives the health care service described in clause (iii) from a covered entity provider, meaning a health care professional who either— (I) is an employee or independent contractor of the covered entity, such that the covered entity bills for services furnished by the health care professional and is responsible for the care furnished by such professional; or (II) furnishes health care services under an ongoing contractual obligation to the covered entity such that responsibility for the care provided remains with the covered entity and meets the other requirements in this paragraph, in the event State law prohibits or otherwise substantially limits the ability of the covered entity to bill for services of the health care professional; (iii) receives a covered outpatient drug in connection with a health care service furnished at the covered entity (including a child site) and such drug and service are paid by the insurer or third-party payor as outpatient items and services (or where third-party reimbursement is not made, such items and services are deemed outpatient if less than 24 hours have elapsed between such individual’s hospital registration and discharge); (iv) is described in a category of individuals within the scope of, and receives a health care service at the covered entity (including a child site) that is within the scope of— (I) the Federal grant, project, or Federal grant-authorizing statute, as applicable, that qualifies such entity for participation in the program under this section, if the covered entity is described in one of subparagraphs (A) through (K) of subsection (a)(4); or (II) the contract as required in paragraphs (4)(L)(i) and (11) of subsection (a), if the covered entity is a private nonprofit hospital which has, as the basis for participating in the program under this section, a contract with a State or local government to provide health care services to specified individuals, provided that clause (iv) shall not apply with respect to a covered entity described in subsection (a)(4)(N) or a sole community hospital described in subsection (a)(4)(O); and (v) has an ongoing relationship with the covered entity such that the covered entity creates and maintains auditable health care records which demonstrate compliance with this paragraph and that the covered entity— (I) has a provider-to-patient relationship with the individual; (II) is responsible for the individual’s health care service that resulted in the prescription or order for the drug; and (III) (aa) has provided a health care service to the individual through an in-person visit within the past 12 months, if the covered entity is a hospital described in subparagraph (L) or subparagraph (M) of subsection (a)(4) or is a rural referral center described in subparagraph (O) of such subsection; or (bb) has provided a health care service to the individual through an in-person visit within the past 24 months, if the covered entity is described in one of subparagraphs (A) through (K) of subsection (a)(4), subparagraph (N) of such subsection, or is a sole community hospital described in subparagraph (O) of such subsection. (B) Telehealth and telemedicine (i) In general A prescription for a covered outpatient drug resulting from a health care service furnished to an individual through telehealth, telemedicine, or other remote health care service arrangements shall not qualify for pricing described in subsection (a)(1) unless— (I) the covered entity (including child site, as applicable) at which such service is furnished is a covered entity (or a child site of a covered entity, as applicable) described in one of subparagraphs (A) through (K) of subsection (a)(4), subparagraph (N) of such subsection, or is a sole community hospital described in subparagraph (O) of such subsection; and (II) subject to the exception in clause (ii), a covered entity provider has conducted an in-person examination of the individual within the 6-month time period immediately preceding the health care service resulting in the prescription or order for the drug. (ii) Exception The requirement in clause (i)(II) shall not apply with respect to an individual for whom the covered entity maintains auditable records sufficient to demonstrate that such entity verified such individual is determined eligible for benefits under either title II of the Social Security Act or title XVI of such Act in accordance with the provisions of such applicable title. (C) Prescriptions from non-covered entity providers ineligible (i) In general Subject to the exception for care coordination described in clause (ii), a covered outpatient drug prescribed or ordered for an individual by a health care professional who is not a covered entity provider shall not qualify for pricing described in subsection (a)(1). (ii) Exception for care coordination In the case of a covered outpatient drug prescribed or ordered for an individual resulting from care coordination provided by the covered entity, all requirements in subparagraph (A) shall apply, except for clauses (i)(I), (i)(II), (ii), (iii), and (v)(II) of such subparagraph. For purposes of this paragraph, care coordination shall refer to the sequence of occurrences described in this clause for which a covered entity maintains documentation sufficient to demonstrate that— (I) a covered entity provider evaluates and recommends to the individual, during an encounter at the covered entity (including child site, as applicable), that such individual receive a specified type of specialty health care not available at the covered entity and such recommendation is contemporaneously documented, at the time of such encounter, in the medical record the covered entity creates and maintains for such individual; (II) within one year of the date of the encounter and recommendation described in subclause (I), the individual receives a health care service from a medical specialist of the type described in such recommendation; (III) within the time period specified in subclause (II), the covered entity provider making the recommendation receives, directly from the medical specialist that furnishes the health care service described in subclause (II), written documentation specifying the service or services furnished to such individual and the diagnoses made in connection with such service or services; and (IV) the covered entity retains overall responsibility for the care of the individual. (iii) Covered entity eligibility for care coordination Notwithstanding any other provision in this section, a covered entity shall not qualify for pricing described in subsection (a)(1) with respect to a prescription or order for a covered outpatient drug resulting from care coordination provided by the covered entity unless such covered entity— (I) is described in subparagraph (N) of subsection (a)(4); (II) is a sole community hospital described in subparagraph (O) of such subsection; or (III) is described in one of subparagraphs (A) through (K) of such subsection, is not a specified nonhospital covered entity (as defined in subsection (b)(4)), and has a Federal grant that requires such entity to contract or refer for the health care service or services furnished to the individual by the medical specialist described in clause (ii). (D) Health care service required For purposes of this section, an individual shall not be considered a patient of the covered entity described in subsection (a)(4) if the individual receives from the covered entity only the administration or infusion of a drug or drugs, or the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting, without a covered entity provider-to-patient encounter involving the provision of a health care service.. (b) Definition of specified nonhospital covered entity Section 340B(b) of the Public Health Service Act (42 U.S.C. 256b(b)) is further amended by adding at the end the following: (4) Specified nonhospital covered entity In this section, the term specified nonhospital covered entity means a covered entity that— (A) is described in one of subparagraphs (B) through (K) of subsection (a)(4), other than a covered entity described in subparagraph (G) of such subsection, and— (i) has average annual operating revenues exceeding $1,000,000,000 calculated over the most recent three-year period for which data are available, which revenue threshold shall be adjusted for inflation annually to reflect rate of change in the Consumer Price Index for All Urban Consumers published by the Bureau of Labor Statistics; or (ii) is an affiliate of a hospital; or (B) is described in subsection (a)(4)(A) and becomes affiliated with a hospital on or after December 1, 2024. For purposes of this definition, the term affiliate shall mean an entity that, directly or indirectly, controls, is controlled by, or is under common control with the referenced entity, including the referenced entity’s parent, and the term control shall mean the power to direct the management and policies of an entity, directly or indirectly, whether through the ownership of voting securities, by contract, or otherwise..