HB1198 • 2026

Drugs, Prescription

AN ACT to amend Tennessee Code Annotated, Title 4; Title 53; Title 56; Title 68 and Title 71, relative to biosimilar medicine.

Active

The official status still shows this bill as active or still awaiting another formal step.

Sponsor: Kumar, Reeves
Last action: 2025-04-28
Official status: Effective date(s) 04/11/2025
Effective date: Not listed

Plain English Breakdown

The bill's effectiveness date is set for April 11, 2025. However, the summary does not specify if this date has been officially confirmed or delayed.

Tennessee Act on Biosimilar Medicine

This bill allows Tennessee's TennCare program to use biosimilars as cost-saving measures and requires health plans to consider them before covering branded prescription drugs.

What This Bill Does

Adds the option for TennCare to implement cost-saving measures that include biosimilars, subject to federal law and the TennCare waiver.
Requires health carriers, benefit plans, or review organizations to make patients try a biosimilar drug before providing coverage for its more expensive brand-name counterpart.
Updates guidelines for the TennCare pharmacy advisory committee to consider biosimilars when recommending drugs for inclusion in the state's preferred drug list.

Who It Names or Affects

TennCare program and beneficiaries
Health carriers, benefit plans, and review organizations
Pharmacy advisory committees

Terms To Know

biosimilar: A biological product that is similar to an already approved drug and meets the same federal standards for quality, safety, and effectiveness.

Limits and Unknowns

The bill's full impact depends on how TennCare implements these changes.
Federal law and TennCare waiver requirements may limit what Tennessee can do with biosimilars.

Amendments

These notes stay tied to the official amendment files and metadata from the legislature.

HA0140

Amendment 1-0 to HB1198

Plain English: This amendment adds definitions for 'biosimilar' in Tennessee's laws and removes requirements that patients try generic or biosimilar products before getting coverage for brand-name drugs.

Adds new definitions of 'biosimilar' to the state’s health insurance code and pharmacy law.
Removes a requirement for health carriers, plans, and organizations to make patients use generic or biosimilar products before covering branded prescription drugs.

The amendment text does not specify all details about how these changes will be implemented in practice.

SA0236

Amendment 1-0 to SB0436

Adds new definitions of 'biosimilar' to the state’s health insurance code, which refers to biological products approved by the FDA under specific federal law.
Modifies existing sections in Tennessee's laws to include references to biosimilars and removes requirements that patients try generic or biosimilar drugs before getting coverage for brand-name drugs.

The exact impact on prescription drug costs is not specified in the amendment text.

Bill History

2025-04-28 Tennessee General Assembly
Effective date(s) 04/11/2025
2025-04-28 Tennessee General Assembly
Pub. Ch. 206
2025-04-28 Tennessee General Assembly
Comp. became Pub. Ch. 206
2025-04-11 Tennessee General Assembly
Signed by Governor.
2025-04-03 Tennessee General Assembly
Transmitted to Governor for his action.
2025-04-03 Tennessee General Assembly
Signed by Senate Speaker
2025-04-02 Tennessee General Assembly
Signed by H. Speaker
2025-04-02 Tennessee General Assembly
Enrolled; ready for sig. of H. Speaker.
2025-03-31 Tennessee General Assembly
Passed Senate, Ayes 30, Nays 0
2025-03-31 Tennessee General Assembly
Amendment withdrawn. (Amendment 1 - SA0236)
2025-03-31 Tennessee General Assembly
Senate substituted House Bill for companion Senate Bill.
2025-03-31 Tennessee General Assembly
Received from House, Passed on First Consideration
2025-03-31 Tennessee General Assembly
Engrossed; ready for transmission to Sen.
2025-03-31 Tennessee General Assembly
Passed H., as am., Ayes 92, Nays 1, PNV 0
2025-03-31 Tennessee General Assembly
Sponsor(s) Added.
2025-03-31 Tennessee General Assembly
H. adopted am. (Amendment 1 - HA0140)
2025-03-31 Tennessee General Assembly
Companion House Bill substituted
2025-03-28 Tennessee General Assembly
Placed on Senate Regular Calendar for 3/31/2025
2025-03-27 Tennessee General Assembly
H. Placed on Regular Calendar for 3/31/2025
2025-03-26 Tennessee General Assembly
Placed on cal. Calendar & Rules Committee for 3/27/2025
2025-03-25 Tennessee General Assembly
Recommended for passage with amendment/s, refer to Senate Calendar Committee Ayes 9, Nays 0 PNV 0
2025-03-19 Tennessee General Assembly
Rec. for pass. if am., ref. to Calendar & Rules Committee
2025-03-19 Tennessee General Assembly
Placed on Senate Commerce and Labor Committee calendar for 3/25/2025
2025-03-18 Tennessee General Assembly
Action deferred in Senate Commerce and Labor Committee to 3/25/2025
2025-03-13 Tennessee General Assembly
Placed on Senate Commerce and Labor Committee calendar for 3/18/2025
2025-03-12 Tennessee General Assembly
Placed on cal. Insurance Committee for 3/19/2025
2025-03-12 Tennessee General Assembly
Rec for pass if am by s/c ref. to Insurance Committee
2025-03-11 Tennessee General Assembly
Placed on Senate Commerce and Labor Committee calendar for 3/18/2025
2025-03-05 Tennessee General Assembly
Placed on s/c cal Insurance Subcommittee for 3/12/2025
2025-02-12 Tennessee General Assembly
Assigned to s/c Insurance Subcommittee
2025-02-12 Tennessee General Assembly
P2C, ref. to Insurance Committee
2025-02-12 Tennessee General Assembly
Passed on Second Consideration, refer to Senate Commerce and Labor Committee
2025-02-10 Tennessee General Assembly
Intro., P1C.
2025-02-10 Tennessee General Assembly
Introduced, Passed on First Consideration
2025-02-06 Tennessee General Assembly
Filed for introduction
2025-01-28 Tennessee General Assembly
Filed for introduction

Official Summary Text

To the extent permitted by federal law and the TennCare waiver, present law authorizes the bureau of TennCare ("bureau") to implement, either independently or in co
mbination with a preferred drug list (PDL), cost-saving measures for pharmaceutical services. This bill adds that the bureau may implement cost-saving measures that include biosimilars.

STEP THERAPY PROTOCOLS

Present law provides that a "step therapy p
rotocol" is a protocol, policy, or program that establishes a specific sequence in which prescription drugs for a specified medical condition are covered by a health carrier or health benefit plan. A health carrier, health benefit plan, or utilization re
v
iew organization is authorized to require a patient to try an AB-rated generic equivalent or interchangeable biological product prior to providing coverage for the equivalent branded prescription drug. This bill adds that such organizations may require t
h
e patient to try a biosimilar product.

UNINSUREDS

Present law authorizes the TennCare prescription program to provide a prescription benefit to individuals lacking prescription drug insurance coverage who meet criteria established by the bureau and the
general assembly in its annual appropriation bill. To the extent permitted by federal law and the TennCare waiver, the bureau may implement cost-saving measures for pharmaceutical services including, for example, by mandating the use of generic drugs. T
h
is bill adds that the bureau is authorized to mandate the use of biosimilars.

TENNCARE PHARMACY ADVISORY COMMITTEE

Present law requires the TennCare pharmacy advisory committee to submit to the bureau both specific and general recommendations for drugs
to be included on any state PDL adopted by the bureau. In making its recommendations, the committee must consider factors including efficacy, the use of generic drugs and therapeutic equivalent drugs, and cost information related to each drug. This bil
l
adds that the committee must consider biosimilars in making its recommendations.

ON MARCH 31, 2025, THE HOUSE ADOPTED AMENDMENT #1 AND PASSED HOUSE BILL 1198, AS AMENDED.

AMENDMENT #1 defines, for purposes of the bill, a
"
b
iosimilar"
as
a biological
product that is licensed under
federal law that regulates biological products
and that is not listed as "discontinued" in the federal food and drug administration's database of licensed biological products, also known as the "Purple Book"
.

Current Bill Text

Read the full stored bill text

SENATE BILL 436
By Reeves

HOUSE BILL 1198
By Kumar

HB1198
001713
- 1 -

AN ACT to amend Tennessee Code Annotated, Title 4;
Title 53; Title 56; Title 68 and Title 71, relative to
biosimilar medicine.

WHEREAS, the legislature finds that increasing access to biosimilar medicines has the
potential to significantly reduce prescription drug costs; and
WHEREAS, biosimilar medicines are approved according to the same federal food and
drug administration (FDA) standards of pharmaceutical quality, safety, and efficacy as the FDA's
reference medicines; and
WHEREAS, it is the intent of the legislature to eliminate barriers impeding access to
biosimilar medicines and the savings biosimilar medicines can provide; now, therefore,
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Section 4-3-1013(e), is amended by adding
the language "or biosimilars" at the end of the subsection.
SECTION 2. Tennessee Code Annotated, Section 56-7-3502(f)(1), is amended by
deleting the subdivision and substituting:
(1) 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;
SECTION 3. Tennessee Code Annotated, Section 71-5-198(c), is amended by adding
the language "or biosimilars" at the end of the subsection.
SECTION 4. Tennessee Code Annotated, Section 71-5-2404(a), is amended by
deleting the language "including, but not limited to, efficacy, the use of generic drugs and

- 2 - 001713

therapeutic equivalent drugs, and cost information related to each drug" and substituting
"including efficacy; the use of generic drugs, biosimilars, and therapeutic equivalent drugs; and
cost information related to each drug".
SECTION 5. This act takes effect upon becoming a law, the public welfare requiring it.