Tennessee Code Title 47. Commercial Instruments and Transactions § 47-18-136

(1) Impose additional requirements or limitations on a 340B entity, including requiring the submission of any health information, claims or utilization data, purchasing data, payment data, or other data as a condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B entity unless such data submission is explicitly required by the United States department of health and human services or applicable state law;

(2) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial adjudication unless these actions are in the normal course of business and not related to the 340B program;

(3) Impose any requirements relating to inventory management systems of 340B drugs, unless such requirement is required by the United States department of health and human services or applicable state law;

(4) Impose any requirement relating to the frequency, duration, or scope of audits that are not imposed on pharmacies or providers that are not 340B entities;

(5) Impose requirements relating to accreditation, recertification, credentialing, or recredentialing that are not imposed on pharmacies or providers that are not 340B entities;  or

(6) Impose any requirement determined by the attorney general and reporter to interfere with the ability of a 340B entity to access discounts provided under the 340B program.

(1) Not interfere with, prohibit, restrict, or limit a 340B entity's contracts or prospective business relationships with another person or entity;

(2) Not deny, restrict, prohibit, or otherwise interfere with a 340B entity's choice of 340B drugs acquired, delivered, or otherwise distributed;  or

(3) Exclude claims from 340B entities which would result in a net loss to the covered entity.

(d)(1) A violation of subsection (a) or (c) constitutes an unfair or deceptive act or practice affecting trade or commerce and is a violation of this part;  provided, that a civil penalty may be assessed in the amount of fifty thousand dollars ($50,000) per violation.

(2) Each package of 340B drugs applicable to a violation of subsection (a) or (c) constitutes a separate violation.

(1) Applicable federal law and regulations, including limited distribution of a drug required under 21 U.S.C. § 355-1;  or

(2) Another law of this state if the law is compatible with applicable federal law, including, but not limited to, title 39, chapter 15, part 2;  title 68, chapter 1, part 1;  title 68, chapter 33;  and any other law related to a patient's citizenship status.

(1) The TennCare program administered under the Medical Assistance Act of 1968, compiled in title 71, chapter 5, part 1, or a successor medicaid program;

(2) The CoverKids Act of 2006, compiled in title 71, chapter 3, part 11, or a successor program;  or

(3) The prescription drug discount plan described in title 56, chapter 57, or a successor program.

(1) “340B drug” means a drug that is a covered outpatient drug within the meaning of 42 U.S.C. § 256b;  is eligible for any offer for reduced prices by a manufacturer under 42 U.S.C. § 256b(a)(1);  and is purchased by a 340B entity or would have been purchased by a 340B entity but for a restriction or limitation described in § 56-7-3119(b);

(2) “340B entity” means a covered entity participating in the federal 340B drug discount program, as defined in section 340B of the Public Health Service Act, 42 U.S.C. § 256b, including the entity's pharmacy or pharmacies;

(3) “Claim” means a request from a 340B entity to be reimbursed for the cost of filling, refilling, or administering a prescription drug or for providing a medical supply or device;

(4) “Health information” means any information, including demographic information collected from an individual or a group of individuals, that:

(5) “Package” has the same meaning as defined in 21 U.S.C. § 360eee(11)(A).