Kentucky 2024 Regular Session Status: Enacted Bipartisan · 3 R · 1 D cosponsors

HB 220 — AN ACT relating to step therapy protocols.

Last action — signed by Governor (Acts Ch. 4)

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. ✓
    Passed House
  4. ✓
    Passed Senate
  5. ✓
    To Executive
  6. 6
    Enacted

This bill has been enacted into law. Introduced January 10, 2024. Enacted.

Signed by Governor Andy Beshear (Democratic) on March 14, 2024.

Prognosis

Likely to advance 96% · high confidence

Where this bill stands today.

Odds of enactment

High

How often bills like it became law.

  • Enacted

    Current position in the legislative process.

  • 5 sponsors

    5 primary, 0 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (3 R · 1 D) — cross-party backing.

  • Cleared a recorded vote

    Passed 2 recorded votes so far.

Prognosis reads this bill's own signals — stage, sponsorship breadth, committee status, recorded votes and cross-state momentum. Odds come from a model trained on which bills have become law.

In plain language

The bill allows insurers to require patients to try cheaper biosimilars before branded drugs.

This legislation permits insurers to mandate that patients use biosimilar drugs prior to receiving coverage for equivalent brand-name medications, under certain conditions. It aims to standardize protocols and enhance transparency in the drug approval process.

What this means for you
  • Patients: Patients may have to try biosimilar drugs before getting coverage for branded medications.

Summary

Amend KRS 304.17A-163 to permit insurers to require insureds to try biosimilar biological products prior to providing coverage for the equivalent branded prescription drug under certain circumstances; make findings and establish intent of Act.

Bill Text

What changed in the latest version

156 added · 201 removed

156 line(s) added, 201 removed.

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Previous
Latest
UNOFFICIAL COPY 24 RS HB 220/GA AN ACT relating to step therapy protocols.
CHAPTER 4 1 CHAPTER 4 ( HB 220 ) AN ACT relating to step therapy protocols.
and (g) "Step therapy protocol" means a protocol, policy, or program that establishes the specific sequence in which prescription drugs that are for a specified medical condition and medically appropriate for a particular insured are Page 1 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA covered by an insurer or health plan.
and (g) "Step therapy protocol" means a protocol, policy, or program that establishes the specific sequence in which prescription drugs that are for a specified medical condition and medically appropriate for a particular insured are covered by an insurer or health plan.
b.
Legislative Research Commission PDF Version ACTS OF THE GENERAL ASSEMBLY b.
and Page 2 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA 5.
and 5.
(b) In the absence of clinical practice guidelines that meet the requirements of paragraph (a) of this subsection, an insurer, health plan, pharmacy benefit manager, or private review agent may use peer-reviewed publications to establish step therapy protocols.
(b) In the absence of clinical practice guidelines that meet the requirements of paragraph (a) of this subsection, an insurer, health plan, pharmacy benefit manager, or private review agent may use peer- reviewed publications to establish step therapy protocols.
(3) (a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, private review agent, or a pharmacy benefit manager by a step therapy protocol, the insured and prescribing provider shall have access to a clear, readily accessible, and Page 3 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA convenient process to request a step therapy exception.
(3) (a) When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, private review agent, or a pharmacy benefit manager by a step therapy protocol, the insured and prescribing provider shall have access to a clear, readily accessible, and convenient process to request a step therapy exception.
(4) (a) A step therapy exception request, or an internal appeal under KRS 304.17A- 617 of a step therapy exception request denial, shall be granted by the insurer, health plan, private review agent, or the pharmacy benefit manager within forty-eight (48) hours if:
(4) (a) A step therapy exception request, or an internal appeal under KRS 304.17A-617 of a step therapy exception request denial, shall be granted by the insurer, health plan, private review agent, or the pharmacy benefit manager within forty-eight (48) hours if:
Page 4 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA i.
i.
Cause a significant barrier to the insured's adherence to or compliance with the insured's plan of care;
Cause a significant barrier to the insured's adherence to or compliance with the CHAPTER 4 3 insured's plan of care;
(5) If a step therapy exception request determination, notification under subsection (4)(b) of this section, or internal appeal determination under KRS 304.17A-617 of a step therapy exception request denial by an insurer, health plan, pharmacy benefit manager, or private review agent is not received by the prescribing provider within the time period specified in subsection (4) of this section, the step therapy exception Page 5 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA request or internal appeal shall be deemed granted.
(5) If a step therapy exception request determination, notification under subsection (4)(b) of this section, or internal appeal determination under KRS 304.17A-617 of a step therapy exception request denial by an insurer, health plan, pharmacy benefit manager, or private review agent is not received by the prescribing provider within the time period specified in subsection (4) of this section, the step therapy exception request or internal appeal shall be deemed granted.
Page 6 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA UNOFFICIAL COPY 24 RS HB 220/GA 262(i)(3), prior to providing coverage for the reference product;
262(i)(3), prior to providing coverage for the reference product;
262(i)(2), prior to providing coverage for the reference product;[equivalent branded prescription drug, ] unless the requirement meets any of the criteria set forth in subsection (4)(a)2.
262(i)(2), prior to providing coverage for the reference product;[equivalent branded prescription drug, ] Legislative Research Commission PDF Version ACTS OF THE GENERAL ASSEMBLY unless the requirement meets any of the criteria set forth in subsection (4)(a)2.
of this section pursuant to a step therapy exception request submitted under subsection (4) of this section;[ or] (b)[2.] An insurer, health plan, pharmacy benefit manager, or private review agent from requiring a pharmacist to effect substitutions of prescription drugs consistent with KRS 217.814 to 217.896 and 304.17A-535;
of this section pursuant to a step therapy exception request submitted under subsection (4) of this section;[ or] (b)[2.]An insurer, health plan, pharmacy benefit manager, or private review agent from requiring a pharmacist to effect substitutions of prescription drugs consistent with KRS 217.814 to 217.896 and 304.17A-535;
Page 7 of 7 HB022010.100 - 980 - XXXX 2/2/2024 9:23 AM GA
Signed by Governor March 14, 2024.
View plain text versions (3)

How this bill changes current law

6 changes Share ↗

AI-generated reading aid from the bill's amendatory text — verify against the official bill.

The bill amends existing law to enhance regulations around step therapy protocols, ensuring clearer guidelines for establishing protocols and improving the process for requesting exceptions.

  • KRS 304.17A-163

    requiring[:

    This modification removes unnecessary language, streamlining the requirements placed on insurers regarding step therapy protocols.

  • KRS 304.17A-163

    equivalent branded prescription drug, ]

    This change eliminates redundancy in the description of medications involved in step therapy, clarifying requirements.

  • KRS 304.17A-163

    An insurer, health plan, pharmacy benefit manager, or private review agent may use its existing medical exceptions process to satisfy the requirements of paragraph (a) of this subsection; → An insurer, health plan, pharmacy benefit manager, or private review agent shall, upon written request, provide all specific written clinical review criteria relating to a particular condition or disease, including clinical review criteria relating to a step therapy exception determination.

    This amendment requires insurers to provide specific clinical review criteria upon request, improving transparency.

  • KRS 304.17A-163

    an AB-rated generic equivalent prior to providing coverage for the reference listed drug;[ or] → a biosimilar biological product, as defined in 42 U.S.C. sec. 262(i)(2), prior to providing coverage for the reference product;

    This change clarifies that a biosimilar must also be tried before coverage for a reference product is granted.

  • KRS 304.17A-163

    an interchangeable biological product, as defined in 42 U.S.C. sec. 262(i)(3), prior to providing coverage for the reference product; or

    This revision eliminates unnecessary repetition of requirements related to interchangeable biological products for clarity.

  • KRS 304.17A-163

    the duration of any step therapy protocol shall not be longer than a period of thirty (30) days if the treatment is deemed and documented as clinically ineffective by the prescribing provider. → the duration of any step therapy protocol shall not be longer than a period of thirty (30) days if the treatment is deemed and documented as clinically ineffective by the prescribing provider, unless the prescribing provider can demonstrate, through sound clinical evidence, that the originally prescribed medication is likely to require more than thirty (30) days to provide any relief or amelioration to the insured.

    This adjustment clarifies the grounds on which the duration of step therapy protocols may be extended.

Action History

  1. signed by Governor (Acts Ch. 4)

  2. delivered to Governor

  3. enrolled, signed by President of the Senate

  4. enrolled, signed by Speaker of the House

  5. received in House

  6. 3rd reading, passed 37-0

  7. posted for passage in the Regular Orders of the Day for Thursday, March 07, 2024

  8. 2nd reading, to Rules

  9. reported favorably, 1st reading, to Calendar

  10. to Banking & Insurance (S)

  11. to Committee on Committees (S)

  12. received in Senate

  13. 3rd reading, passed 91-0 with Committee Substitute (1) and Committee Amendment (1-title)

  14. posted for passage in the Regular Orders of the Day for Friday, February 02, 2024

  15. 2nd reading, to Rules

  16. reported favorably, 1st reading, to Calendar with Committee Substitute (1) and Committee Amendment (1-title)

  17. reassigned to Banking & Insurance (H)

  18. to Health Services (H)

  19. to Committee on Committees (H)

  20. introduced in House

Sponsors

Sponsorship breakdown

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5 sponsors · 0 co-sponsors · 133 not signed on

Sponsors (5)

Co-sponsors (0)

None.

Not signed on (133)

133 members have not signed on to this bill.

Show all 133 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Votes

PASS HB 220

Passed 37 Yea · 0 Nay · 1 Other
Party YeaNayPresentNot Voting
Republican 28000
Unaffiliated 7000
Democrat 2001
Total 37001
% of votes cast 97%0%0%3%
How each member voted (38)
Member Party Vote
Turner — Yea
Schickel — Yea
Southworth — Yea
Westerfield — Yea
Thayer — Yea
Yates — Yea
Harper Angel — Yea
Cassie Chambers Armstrong Democrat Yea
Gerald A. Neal Democrat Yea
Karen Berg Democrat Not Voting
Amanda Mays Bledsoe Republican Yea
Brandon J. Storm Republican Yea
Christian McDaniel Republican Yea
Danny Carroll Republican Yea
David P. Givens Republican Yea
Donald Douglas Republican Yea
Gary Boswell Republican Yea
Greg Elkins Republican Yea
Jared Carpenter Republican Yea
Jason Howell Republican Yea
Jason Nemes Republican Yea
Jimmy Higdon Republican Yea
Julie Raque Adams Republican Yea
Lindsey Tichenor Republican Yea
Matthew Deneen Republican Yea
Max Wise Republican Yea
Michael Meredith Republican Yea
Nick Wilson Republican Yea
Phillip Wheeler Republican Yea
Rick Girdler Republican Yea
Robby Mills Republican Yea
Robert Stivers Republican Yea
Robin L. Webb Republican Yea
Shelley Funke Frommeyer Republican Yea
Stephen West Republican Yea
Tom Smith Republican Yea
Wade Williams Republican Yea
Walker Thomas Republican Yea

Official roll call →

Pass

Passed 91 Yea · 0 Nay · 7 Other
Party YeaNayPresentNot Voting
Democrat 13002
Republican 68004
Unaffiliated 10001
Total 91007
% of votes cast 93%0%0%7%
How each member voted (98)
Member Party Vote
Heath — Yea
Dixon — Yea
Bentley — Yea
Palumbo — Yea
Timoney — Yea
Pratt — Yea
Raymond — Yea
Graham — Yea
Justice — Not Voting
Bratcher K. — Yea
Stevenson C — Yea
Adrielle Camuel Democrat Yea
Al Gentry Democrat Not Voting
Ashley Tackett Laferty Democrat Yea
Beverly Chester-Burton Democrat Yea
Chad Aull Democrat Yea
Daniel Grossberg Democrat Yea
George Brown Jr. Democrat Yea
Keturah J. Herron Democrat Yea
Lindsey Burke Democrat Yea
Lisa Willner Democrat Yea
Nima Kulkarni Democrat Yea
Pamela Stevenson Democrat Not Voting
Rachel Roarx Democrat Yea
Sarah Stalker Democrat Yea
Tina Bojanowski Democrat Yea
Adam Bowling Republican Yea
Amy Neighbors Republican Yea
Bill Wesley Republican Yea
Bobby McCool Republican Not Voting
Candy Massaroni Republican Yea
Chris Freeland Republican Yea
Chris Fugate Republican Yea
DJ Johnson Republican Yea
Daniel Elliott Republican Yea
Daniel Fister Republican Yea
David Hale Republican Yea
David Meade Republican Yea
David W. Osborne Republican Yea
Deanna Gordon Republican Yea
Derek Lewis Republican Yea
Emily Callaway Republican Yea
Felicia Rabourn Republican Yea
James Tipton Republican Yea
Jared Bauman Republican Yea
Jason Nemes Republican Yea
Jason Petrie Republican Yea
Jennifer Decker Republican Yea
Jim Gooch Jr. Republican Yea
John Blanton Republican Yea
John Hodgson Republican Yea
Josh Branscum Republican Yea
Josh Bray Republican Yea
Josh Calloway Republican Yea
Ken Fleming Republican Yea
Ken Upchurch Republican Yea
Kevin Jackson Republican Yea
Kim Banta Republican Yea
Kim King Republican Yea
Kimberly Poore Moser Republican Not Voting
Marianne Proctor Republican Yea
Mark Hart Republican Yea
Mary Beth Imes Republican Yea
Matt Lockett Republican Yea
Matthew Koch Republican Yea
Michael Meredith Republican Yea
Michael Sarge Pollock Republican Yea
Mike Clines Republican Yea
Myron Dossett Republican Yea
Nancy Tate Republican Yea
Nick Wilson Republican Yea
Patrick Flannery Republican Yea
Randy Bridges Republican Yea
Rebecca Raymer Republican Yea
Richard White Republican Yea
Robert Duvall Republican Yea
Ryan Dotson Republican Yea
Samara Heavrin Republican Yea
Savannah Maddox Republican Yea
Scott Lewis Republican Yea
Scott Sharp Republican Yea
Shane Baker Republican Yea
Shawn McPherson Republican Yea
Stephanie Dietz Republican Yea
Steve Bratcher Republican Yea
Steve Rawlings Republican Yea
Steve Riley Republican Yea
Steven Doan Republican Yea
Steven Rudy Republican Yea
Susan Witten Republican Yea
Suzanne Miles Republican Yea
T.J. Roberts Republican Yea
Thomas Huff Republican Yea
Timmy Truett Republican Not Voting
Tom Smith Republican Yea
Wade Williams Republican Yea
Walker Thomas Republican Yea
William Lawrence Republican Not Voting

Official roll call →

Subjects

Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does HB 220 do?
Amend KRS 304.17A-163 to permit insurers to require insureds to try biosimilar biological products prior to providing coverage for the equivalent branded prescription drug under certain circumstances; make findings and establish intent of Act.
Who sponsors HB 220?
HB 220 is sponsored by Amy Neighbors (Republican), D. Bentley, Beverly Chester-Burton (Democrat), Derek Lewis (Republican), and Michael Sarge Pollock (Republican).
What is the current status of HB 220?
This bill has been enacted into law. Introduced January 10, 2024. Enacted.
Where can I track HB 220?
Track HB 220 free on One Click Politics — get push/email alerts when it moves.

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