Commerce and Insurance, Dept. of

Plain English Breakdown

The official source material does not provide specific details on how doctors must report information about patients' treatments.

Step Therapy Changes for Cancer Patients

This act changes Tennessee laws to prevent health plans from requiring patients with stage 4 advanced metastatic cancer or blood cancer to try less expensive drugs before getting their prescribed medicines.

What This Bill Does

• It stops health benefit plans that cover stage 4 advanced metastatic cancer, blood cancer, and associated conditions from requiring step therapy protocols before providing coverage for an approved prescription drug.
• Doctors must inform insurance companies when they prescribe a drug for these cancers or related conditions.
• Each doctor who prescribes such drugs must submit an annual report to the department of health with details about patients' treatments.
• The rules apply to policies entered into, renewed, or amended on or after January 1, 2026.
• Group insurance plans offered by the state and local governments are exempt from these provisions.

Who It Names or Affects

• People with stage 4 advanced metastatic cancer or blood cancer who have health insurance in Tennessee.
• Doctors treating people with these cancers.
• Health insurance companies and plans that cover cancer treatments.

Terms To Know

Step Therapy

A process where patients must try less expensive drugs before getting the medicine their doctor prescribed.

Prescription Drug Formulary

A list of medicines that a health plan covers and pays for.

Limits and Unknowns

• The rules don't apply to group insurance plans offered by the state or local governments.
• Doctors must report information about patients' treatments, but how they do this is not detailed in the bill.

Official Summary Text

ON MARCH 31, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PAS
SED HOUSE BILL 858, AS AMENDED.

AMENDMENT #1 rewrites the bill to, instead, make the following revisions to present law:



Generally prohibits a health benefit plan that provides coverage for stage 4 advanced metastatic cancer, blood cancer, and associated conditions from requiring 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 blood cancer.



Requires, for an approved prescription drug prescribed for an associated condition, the treating healthcare provider to inform the health benefit plan that the condition is an associated condition of stage 4 advanced metastatic cancer or blood cancer when requesting authorization.



Requires each treating healthcare provider who prescribes an approved prescription drug to a patient pursuant to such process to 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 blood cancer cases treated, the approved prescription drug involved in treatment, and the overall six-month survival rate for the cases treated.



Applies the provisions described above to policies or agreements entered into, renewed, or amended on or after January 1, 2026.



Exempts group insurance plans offered to employees of this state and political subdivisions of this state from complying with the provisions described above.



Clarifies that the provisions described above do 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.



Defines, for purposes of the provisions described above, an "approved prescription drug" as a prescription drug that is (i) approved by the United States food and drug administration; (ii) consistent with best practices for the treatment of stage 4 advanced metastatic cancer or blood cancer; (iii) 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 blood cancer; and (iv) on the health benefit plan's prescription drug formulary.



Requires the commissioner of commerce and insurance and the commissioner of health to promulgate rules to effectuate this amendment.

ON APRIL 16, 2025, THE SENATE SUBSTITUTED HOUSE BILL 858 FOR SENATE BILL 1382, ADOPTED AMENDMENT #1, AND PASSED HOUSE BILL 858, AS AMENDED.

AMENDMENT #1 includes metastatic blood cancer as another cancer covered by the bill.

Current Bill Text

HOUSE BILL 858
By Alexander

SENATE BILL 1382
By Watson

SB1382
002897
- 1 -

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. The commissioner of commerce and insurance shall use existing
departmental resources to conduct a study on the ease of access for patients and prescribing
practitioners to insurers' online processes to request step therapy exceptions pursuant to § 56-
7-3502(a). The purpose of the study is to determine whether insurers in this state are
complying with the requirement of § 56-7-3502(a) in a manner that is easily accessible by the
average patient or prescribing practitioner and does not impose any unnecessary barriers to
making an exception request. The commissioner shall deliver the commissioner's findings from
the study and any legislative recommendations to the chief clerk of the senate, the chief clerk of
the house of representatives, and the legislative librarian no later than December 15, 2025. The
commissioner may deliver such findings and recommendations by electronic means.
SECTION 2. This act takes effect upon becoming a law, the public welfare requiring it.