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Current as of January 02, 2024 | Updated by Findlaw Staff
(a) As used in this section:
(1) “Affiliate” means a person or entity that directly or indirectly controls, is controlled by, or is under common ownership or control with another entity;
(2) “Board” means the board of pharmacy;
(3) “Control” means the power, directly or indirectly, to direct, manage, or influence the operations or policies of a pharmacy, whether through ownership, contract, shared governance, overlapping management, audit authority, exclusive provider agreement, formulary management clause, or other arrangement conferring material influence over the professional practice of pharmacy, including dispensing decisions, patient steering, clinical operations, or the independent judgment of a licensed pharmacist;
(4) “Health insurance issuer” has the same meaning as defined in § 56-7-2802;
(5) “Pharmacy” has the same meaning as defined in § 63-10-204; and
(6) “Pharmacy benefits manager” has the same meaning as defined in § 56-7-3102.
(b) On and after July 1, 2028, a person or entity shall not:
(1) Directly or indirectly own, operate, control, or direct the operation of, the whole or any part of a pharmacy; and
(2) Directly or indirectly own, operate, control, or direct the operation of, the whole or any part of:
(A) A health insurance issuer; and
(B) A pharmacy benefits manager.
(c) Subsection (b) applies when the percentage of ownership interest held by a person, entity, or affiliate is greater than five percent (5%).
(d)(1) For purposes of subsection (b), a hospital or health-system pharmacy is not a pharmacy benefits manager.
(2) This section does not limit the ability of independently owned or unaffiliated pharmacies to provide mail-order, specialty, or delivery services directly to patients of such pharmacies.
(3) This section does not apply to an FDA-designated orphan drug with limited distribution, or to a drug that is subject to an FDA-required risk evaluation and mitigation strategy (REMS) that includes limited distribution.
(e) A pharmacy that is affiliated with both a pharmacy benefits manager and a health insurance issuer in violation of subsection (b) may continue operations through December 31, 2028, if the pharmacy demonstrates to the board that it is actively pursuing a bona fide sale to an unaffiliated entity. For purposes of this subsection (e), “bona fide sale” means an arm's-length transfer evidenced by a written letter of intent or purchase agreement filed with the board. The board may grant a single extension, not to exceed six (6) months, upon proof of substantial progress toward completion of such sale.
(f)(1) The attorney general and reporter is authorized to enforce this section.
(2) The board shall refer information of potential violations of this section to the attorney general and reporter.
(3) A violation of this section is subject to a civil penalty of up to ten thousand dollars ($10,000) per violation. Each day a violation continues constitutes a separate violation.
(g) A pharmacy, health insurance issuer, or pharmacy benefits manager aggrieved by a determination under this section may request a hearing under the Uniform Administrative Procedures Act, compiled in title 4, chapter 5. Any hearing must occur within sixty (60) days of filing the request for hearing, and be concluded within thirty (30) days after the date of the hearing. A stay shall hot issue unless the appellant shows substantial likelihood of success and irreparable harm.
(h) An action to contest the enforcement or validity of this section must be filed exclusively in the chancery court for Sumner County.
(i) This section does not prohibit an employer from owning or operating a pharmacy or administering pharmacy benefits solely for its own employees, retirees, and dependents under an employee benefit plan.
(j) This section does not apply to pharmacy services provided pursuant to a contract with the United States government for the administration of a federal healthcare program by the department of defense, department of veterans affairs, Indian health service, or office of personnel management.
Cite this article: FindLaw.com - Tennessee Code Title 63. Professions of the Healing Arts § 63-10-316 - last updated January 02, 2024 | https://codes.findlaw.com/tn/title-63-professions-of-the-healing-arts/tn-code-sect-63-10-316/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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