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Commerce and Insurance, Dept. of - As enacted, revises law relative to the treatment and coverage of treatment for stage 4 advanced metastatic cancer, blood cancer, metastatic blood cancer, and associated conditions; mak, the official text

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                         ~tate of \lCennessee

                           PUBLIC CHAPTER NO. 505

                                                    HOUSE BILL NO. 858

     By Representatives Alexander, Renea Jones, Terry, Helton-Haynes, Hardaway, Lynn,
                                                              Littleton

                                         Substituted for: Senate Bill No. 1382

       By Senators Watson, Reeves, Bailey, Hensley, Massey, Pody, Southerland, Walley

           AN ACT to amend Tennessee Code Annotated, Title 8; Title 56; Title 63; Title 68 and
 Title 71, relative to step therapy.

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

            SECTION 1. Tennessee Code Annotated, Section 56-7-3501, is amended by adding the
  following as new subdivisions:

                      ( ) "Associated conditions" means the symptoms or side effects associated with
            stage 4 advanced metastatic cancer, metastatic blood cancer, or treatment of such
            cancers and which, in the judgment of the healthcare provider, further jeopardizes the
            health of a patient if left untreated;

                      ( ) "Stage 4 advanced metastatic cancer" means cancer that has spread from the
            primary or original site of the cancer to nearby tissues, lymph nodes, or other areas or
            parts of the body;

            SECTION 2. Tennessee Code Annotated, Section 56-7-3502, is amended by adding the
  following as a new subsection:

                       (h)

                                (1) Notwithstanding this section, and except as provided in subdivision
                      (h)(3), a health benefit plan that provides coverage for stage 4 advanced
                      metastatic cancer, metastatic blood cancer, and associated conditions shall not
                      require use of a step therapy protocol before the health benefit plan provides
                      coverage of an approved prescription drug to an enrollee who has received a
                      diagnosis of stage 4 advanced metastatic cancer or metastatic blood cancer.

                                (2) For an approved prescription drug prescribed for an associated
                      condition in this section, the treating healthcare provider shall inform the health
                      benefit plan that the condition is an associated condition of stage 4 advanced
                      metastatic cancer or metastatic blood cancer when requesting authorization.

                                 (3) This subsection (h) does not apply to the group insurance plans
                      offered under title 8, chapter 27.

                                 (4) This subsection (h) does not prevent a health carrier, health benefit
                       plan, or utilization review organization from requiring a patient to try an AB-rated
                       generic equivalent product, interchangeable biological product, or biosimilar
                       product prior to providing coverage for the equivalent branded prescription drug.

                                 (5) Each treating healthcare provider who prescribes an approved
                       prescription drug to a patient pursuant to this section shall submit an annual
                       report to the department of health by such date and in such manner as the
                       commissioner of health may prescribe by rule, that includes the number of stage
                       4 advanced metastatic cancer and metastatic blood cancer cases treated, the
                       approved prescription drug involved in treatment, and the overall six-month
                       survival rate for the cases treated.
HB858
                              (6) As used in this subsection (h), "approved prescription drug" means a

                    prescription drug that is:
                                        (A) Approved by the United States food and drug administration;
                                        (8) Consistent with best practices for the treatment of stage 4

                              advanced metastatic cancer or metastatic blood cancer;
                                        (C) Supported by peer-reviewed, evidence-based literature

                              consistent with the National Comprehensive Cancer Network Drugs and
                              Biologics Compendium for the treatment of stage 4 advanced metastatic
                              cancer or metastatic blood cancer; and

                                        (D) On the health benefit plan's prescription drug formulary.
          SECTION 3. Tennessee Code Annotated, Section 56-7-3504(a), is amended by deleting
"and includes a state or local insurance program, under title 8, chapter 27" and substituting
"and, except as provided in § 56-7-3502(h)(3), includes a state or local insurance program,
under title 8, chapter 27".
          SECTION 4. The commissioner of commerce and insurance and the commissioner of
health may promulgate rules to effectuate this act. The rules must be promulgated in
accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
          SECTION 5. This act takes effect January 1, 2026, the public welfare requiring it, and
applies to policies or agreements entered into, renewed, or amended on or after that date.

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                      HOUSE BILL NO. 858

PASSED:  April 21, 2025

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                            CAMERON SEXTON, SPEAKER
                            HOUSE OF REPRESENTATIVES

                         ~  ~,.._ ')\,'=~c-_\\4\4

                                              \  RANDY MCNAL\Y

                                              SPEAKER OF THE SENATE

.:2. I APPROVED this  a◄ ~-1- day of (\I\ ,.     2025
                            I

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BILL LEE, GOVERNOR
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