Establishing an exception to the physician self-referral prohibition for certain outpatient prescription drugs furnished by a physician practice under the Medicare program

(a)

In general

Section 1877(b) of the Social Security Act (42 U.S.C. 1395nn(b)) is amended by adding at the end the following new paragraph:

(6)

Certain outpatient prescription drugs

(A)

In general

In the case of designated health services described in subsection (h)(6)(J) that are covered part D drugs (as defined in section 1860D–2(e)) and furnished to an individual during the period beginning on January 1, 2026, and ending on December 31, 2030, if— (i)such drugs are prescribed by the referring physician (or by another physician or practitioner (as described in section 1842(b)(18)(C)) within the same group practice as such physician); (ii)such individual has an ongoing relationship (as defined by the Secretary) with such physician or practitioner who prescribed such drugs (or with another physician or practitioner within the same group practice as such physician or practitioner); (iii)within the 1-year period prior to the dispensing of such drugs, such individual had at least 1 face-to-face, in-person encounter with such referring physician (or with another physician or practitioner within the same group practice as such physician, as determined by tax identification number) during which items or services that are not designated health services and for which payment was made under this title were furnished to such individual; (iv)such drugs are dispensed by the referring physician, a physician who is a member of the same group practice as the referring physician, or an individual who is directly supervised by such a physician, from a building described in paragraph (2)(A)(ii), including through— (I)in-person pickup by the individual or a caregiver or family member of such individual; or (II)a mail, delivery, or courier service; and (v)such drugs are billed for by the physician dispensing or supervising the dispensing of such drugs, by a group practice of which such physician is a member under a billing number assigned to such group practice, or by an entity that is wholly owned by such physician or such group practice. (B)

Rule of Construction

Nothing in subparagraph (A) shall be construed as modifying any program requirements under part D.

(b)

GAO study and report

(1)

Study

The Comptroller General of the United States (in this section referred to as the Comptroller General) shall conduct a study examining— (A)pharmacies or pharmacy networks participating under part D of title XVIII of the Social Security Act (42 U.S.C. 1395w–101 et seq.) that, after the date of the enactment of this section, dispense significantly more (as determined by the Comptroller General) covered part D drugs (as defined in section 1860D–2 of such Act (42 U.S.C. 1395e–102)) compared to the amount of such drugs dispensed prior to such date; (B)common characteristics of the pharmacies and pharmacy networks identified under subparagraph (A), including, to the extent identifiable, the extent to which such pharmacies and pharmacy networks are owned by a physician or group practice (as defined in section 1877(h) of the Social Security Act (42 U.S.C. 1395nn(h)) or otherwise integrated into a physician’s practice or group practice; and (C)common characteristics of arrangements entered into by physicians or group practices for purposes of dispensing drugs within physicians’ offices or otherwise integrating pharmacies or the dispensing of drugs into a physician’s practice or group practice, including, to the extent feasible and identifiable, an analysis of— (i)specific physician specialties or subspecialties for which such arrangements are especially common or have shown substantial growth; (ii)the extent to which physicians and group practices participating in such arrangements have such arrangements or integration with other physicians or group practices or other drug supply chain participants (including pharmacy benefit managers, insurers, wholesalers, distributors, or management services organizations); (iii)common contracting features of such arrangements relating to the utilization of covered part D drugs or services provided in connection with such drugs, including contract terms related to administrative or dispensing fees for such drugs and the types of payments provided in connection with such services; (iv)common measures, including notices or disclosures, taken by physicians and group practices participating in such arrangements in order to mitigate or otherwise address potential conflicts of interest posed by such arrangements; and (v)any components or features of such arrangements that may influence prescribing decisions or patterns among physicians and group practices participating in such arrangements. (2)

Report

Not later than 3 years after the date of the enactment of this section, the Comptroller General shall submit to Congress a report on the findings of the study required under paragraph (1), which shall not include identifying or proprietary information with respect to the pharmacies or pharmacy networks examined.