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2017 TN H 2220
Author: Sexton
Version: Enacted - Final
Version Date: 05/03/2018

State of Tennessee

PUBLIC CHAPTER NO. 893

HOUSE BILL NO. 2220

By Representatives Cameron Sexton, Terry, Daniel, Hardaway

Substituted for: Senate Bill No. 2361

By Senator Hensley

AN ACT to amend Tennessee Code Annotated, Title 4; Title 7; Title 33; Title 53; Title 63; Title 68 and Title 71, relative to health care.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:

SECTION 1. Tennessee Code Annotated, Title 53, Chapter 10, Part 1, is amended by adding the following as a new section:

(a) As used in this section, and unless the context otherwise requires:

(1) "Misbranding" means either the federal definition under 21 U.S.C. § 352 or drugs or devices that are misbranded under § 53-10-106; and

(2) "Off-label" means the use of an United States Food and Drug Administration ("FDA")-approved drug, biological product, or device other than the use or uses approved by the FDA.

(b)

(1) A pharmaceutical manufacturer or its representatives may engage in truthful promotion of off-label uses.

(2) This section does not require a health insurance entity, as defined in § 56-7-109, other third-party payer, or other health plan sponsor to provide coverage for the cost of any off-label treatment. A health insurance entity, other third-party payer, or other health plan sponsor may provide coverage for an off-label treatment.

(c)

(1) Notwithstanding any other law, no official, employee, or agent of this state shall enforce or apply § 53-10-106(a)(2) against or otherwise prosecute a pharmaceutical manufacturer or its representatives for engaging in truthful promotion of off-label uses.

(2) Notwithstanding any other law, no state regulatory board may revoke, fail, or renew or take any other action against a pharmaceutical manufacturer's or representative's, healthcare institution's, or physician's license solely for engaging in truthful promotion of off-label uses.

SECTION 2. This act shall take effect July 1, 2018, the public welfare requiring it.

PASSED: April 19, 2018

APPROVED this 3rd day of May 2018


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