Step Therapy – Enacted Laws

• Requires health plans and pharmacy benefit managers grant a step therapy exception if the protocol will likely cause a serious adverse reaction or physical or mental harm to the patient; the prescription would be ineffective; the patient has already tried and failed on the medication in another plan; or not in the patient’s best interest due to barriers in compliance or treatment adherence, negative impact on comorbid conditions, clinically predictable negative drug interaction, or a decrease in patient’s ability to perform daily activities.
• Requires health plans and pharmacy benefit managers to act on a nonurgent prior authorization or step therapy protocol exception request within 72 hours of receiving it.

1: https://www.azleg.gov/legtext/55leg/1R/laws/0431.pdf

• Requires utilization review entities to disclose all of their step therapy requirements and restrictions in a publicly accessible manner on their website.^¹
• Requires utilization review entities to utilize a single, standardized prior authorization form.¹
  Prohibits a utilization review entity from requiring a patient to undergo step therapy multiple times for the same treatment.¹
• Requires health plans to provide access to a clear and convenient process for a provider to expeditiously request a step therapy protocol exception whenever a health care service is denied or restricted due to the protocol.¹
• If a health plan fails to provide access to a clear and convenient process for requesting a step therapy protocol exception, the health care services shall be deemed authorized or approved.¹
• Requires adverse determinations to be made only by a physician licensed to practice in Arkansas. Permits the prescribing physician to request that a physician of the same specialty review the prior authorization request.¹
• Requires health plans to act on a step therapy protocol exception request within 72 hours of receiving it.^¹
• Requires health plans to publish their formularies online, including any step therapy restrictions.²

1: http://www.arkleg.state.ar.us/assembly/2017/2017R/Bills/SB665.pdf
2: http://www.arkleg.state.ar.us/assembly/2019/2019R/Acts/Act107.pdf

• Requires health plans and pharmacy benefit managers to utilize a single, standardized form for prior authorization and step therapy protocol exception requests.^¹
• Requires health plans and pharmacy benefit managers to accept electronic prior authorization and step therapy paperwork.^¹
• Requires health plans and pharmacy benefit managers to act on a nonurgent prior authorization or step therapy protocol exception request within 72 hours of receiving it. Requires health plans and pharmacy benefit managers to act on an urgent prior authorization or step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan or pharmacy benefit manager fails to act upon a prior authorization or step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: https://govt.westlaw.com/calregs/Document/I091F75D61BBD487DA203EA0BA0AEECDC?viewType=FullText&originationContext=documenttoc&transitionType=CategoryPageItem&contextData=(sc.Default)

• Prohibits health plans from requiring a patient to undergo step therapy for a treatment that they have already tried and failed on.^¹
• ^{Requires health plans base step-therapy protocols on clinical peer reviewer criteria. 2}

1: https://law.justia.com/codes/colorado/2017/title-10/health-care-coverage/article-16/part-1/section-10-16-145/; 

2: https://leg.colorado.gov/bills/hb22-1370

• Requires health plans to establish and disclose to its health care providers the process for requesting a step therapy protocol exception.^¹
• Prohibits the use of step therapy for longer than 60 days.^¹
• If, after 60 days, the step therapy drug regimen is determined to be clinically ineffective by a patient’s prescriber, the health plan must allow the patient to access the originally prescribed treatment.^¹

1: https://www.cga.ct.gov/2014/act/pa/2014PA-00118-R00SB-00394-PA.htm

• Requires health plans and utilization review entities to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans and utilization review entities to expeditiously approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while under their current or previous health plan.^¹
• Requires health plans and utilization review entities to act on a step therapy protocol exception request within two business days of receiving it. Requires health plans and utilization review entities to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan or utilization review entity does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹
• Requires health plans and utilization review entities to utilize clinical criteria is based on peer review studies, research, and medical practice.^¹

1: https://legiscan.com/DE/text/HB105/id/1996172

• Requires health plans to approve a step therapy protocol exception request if an individual has (1) tried and failed on the required treatment while enrolled in their current or previous health plan or (2) is receiving a positive therapeutic outcome on the current prescription
• Requires health plans to act on a nonurgent step therapy protocol exception request within 48 hours of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: http://www.legis.ga.gov/Legislation/20192020/187554.pdf

• Requires health plans and utilization review organizations to consider evidence-based and peer-reviewed clinical practice guidelines when establishing a step therapy protocol.^¹
• Requires health plans to provide to a patient, upon request, any clinical review criteria applicable to a specific drug covered by the health plan or utilization review organization.^¹
• Requires health plans and utilization review organizations to provide a covered person and the prescribing health care professional access to a clear, readily accessible, and convenient process to request a step therapy protocol exception.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment is expected to cause harm to the patient.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment is expected to be ineffective.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the patient is currently stable on a treatment that was covered under their current or previous health plan.^¹
• If a request for a step therapy protocol exception is denied, the health plan or utilization review organization shall provide access to information regarding requesting external review of the denial.¹
• Requires health plans and utilization review organizations to act on a nonurgent step therapy protocol exception request within five days. Requires health plans and utilization review organizations to act on an urgent step therapy protocol exception request within 72 hours of receiving it.^¹
• If a health plan or utilization review organization fails to act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: https://www.legis.iowa.gov/docs/publications/iactc/87.1/CH0124.pdf

• Requires health plans licensed in the state to establish and maintain a process for requesting a step therapy protocol exception.^¹
• Requires step therapy protocol exception requests to be reviewed by appropriate health care professionals.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan denies a step therapy protocol exception request, the health plan must provide access to information regarding the reason for the denial and the procedure for appealing the denial.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while under their current or previous health plan.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient is stable on a treatment that was covered under their current or previous health plan.^¹
• Requires health plans to honor step therapy protocol exception approvals for 12 months following the date of the approval or until the plan is renewed.^¹

1: http://www.ilga.gov/legislation/publicacts/fulltext.asp?Name=099-0761

• Requires health plans to publish information regarding the procedure for requesting a step therapy protocol exception.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within three business days of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within one business day of receiving it.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient already tried and failed on the required treatment.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is not in the best interest of the covered individual.^¹
• If a step therapy protocol exception request is denied, health plans are required to provide access to information regarding the reason for the denial.^¹

1: http://iga.in.gov/legislative/2016/bills/senate/41#document-d46dfac7

• Only applies to Medicaid.^¹
• Prohibits the use of step therapy if a patient is stable on a treatment that was prescribed before July 1, 2016.^¹
• Prohibits the use of step therapy for longer than 30 days for multiple sclerosis treatments.^¹
• Requires the Medicaid program to provide access to a clear and convenient process for requesting a step therapy protocol exception.^¹
• Requires approval of a step therapy protocol exception request if the patient has already tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires approval of a step therapy protocol exception request if the patient is already stable on a different treatment.^¹
• Requires the Medicaid program to act upon a step therapy protocol exception request within 72 hours of receiving it.^¹
• Requires step therapy protocol exception requests to be reviewed by the Medicaid drug utilization review board.^¹

1: http://www.kslegislature.org/li_2016/b2015_16/measures/documents/sb402_enrolled.pdf

• Requires insurers and pharmacy benefit mangers to provide prescribing practitioners with access to a clear and convenient exceptions process
• Requires than an exception be granted by the insurer or pharmacy benefit manager within 48 hours if all the necessary information has been provided and the prescribing practitioner can demonstrate that the preferred treatment required under the step therapy protocol:
  • Has been ineffective to treat the enrollee’s condition;
  • It is expected or likely to be ineffective; or
  • Will or is likely to cause an adverse reaction to the enrollee.^¹
• Prohibits the duration of any step therapy protocol from lasting longer than 30 days if the treatment is ineffective.^¹
• Requires health plans to publish their written step therapy procedures.^²
• Requires utilization review to be conducted only by licensed physicians of the same specialty or subspecialty as the original prescriber.^²
• Requires health plans to maintain a toll-free telephone line for patients and providers to contact the health plan and private review agents.^²
• Requires health plans to provide written utilization review decisions to health plan patients and prescribers. This may be provided in an electronic format.^²
• If a health plan rejects a step therapy protocol exception request, the notice provided to patients and prescribers must include the reason for the denial and information for how to appeal the decision.^²
• Requires health plans to act on a nonurgent step therapy protocol exception request within 5 days of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^²
• If a health plan or utilization review organization does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^²

1: https://law.justia.com/codes/kentucky/2019/chapter-304/subtitle-304-17a/section-304-17a-163/

2: https://apps.legislature.ky.gov/recorddocuments/bill/19RS/sb54/bill.pdf

• Requires step therapy protocols to be based on clinical review criteria and clinical practice guidelines that are developed and endorsed by a multidisciplinary panel of experts.^¹
• Prohibits pharmacy benefit managers from requiring a patient to undergo step therapy if they have already tried and failed on the required treatment while enrolled in their current or previous health plan.^²
• Requires pharmacy benefit managers to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires pharmacy benefit managers to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^²
• Requires private health plans and Medicaid managed care organizations to provide access to a clear and convenient process for a requesting a step therapy protocol exception.^³,⁴
• Requires the health plan to make an explanation of the exception process easily accessible on its website.^¹
• Requires Medicaid to approve a step therapy protocol exception request if
  • The required treatment is expected to be ineffective, is contraindicated, is likely to cause an adverse event;
  • The patient is currently receiving a positive therapeutic outcome on his or her current medication that was covered by his or her current health plan or the immediately preceding health plan; or
  • The required treatment is not in the best interest of the patient based on medical necessity as evidenced by valid documentation submitted by the prescriber.^¹,³
• Denial of a step therapy exception request shall not be considered a final adverse determination and shall be eligible for appeal.^¹
• A health coverage plan shall approve or deny an exception request within 24 hours of receipt in instances where there are exigent circumstances and within 72 hours of receipt in all other instances. If the health plan fails to comply with the timeline requirements, the exception shall be considered approved.^¹

1: http://www.legis.la.gov/legis/ViewDocument.aspx?d=1181914

2: http://www.legis.la.gov/legis/ViewDocument.aspx?d=1143721

3: http://www.legis.la.gov/Legis/ViewDocument.aspx?d=857594

4: https://law.justia.com/codes/louisiana/2018/code-revisedstatutes/title-22/rs-22-1053/

• Requires utilization review organizations to utilize clinical review criteria when establishing a step therapy protocol. This clinical review criteria must be based on clinical practice guidelines and must be based on high-quality studies, research, and medical practice. The clinical review criteria must be continually updated through a review of new evidence, research, and newly developed treatments.^¹
• Requires utilization review organizations to consider the needs of atypical patient populations and diagnoses when establishing a step therapy protocol.^¹
• Requires utilization review organizations to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires utilization review organizations to approve a step therapy protocol exception if:
  • The required treatment is contraindicated, will likely cause an adverse reaction, or will likely result in physical or mental harm to the enrollee;
  • The required treatment is expected to be ineffective;^¹
  • ^{The patient has tried and failed on the required treatment while enrolled in their current or previous health plan;¹}
  • The required treatment is not in the best interest of the patient^; or^¹
  • The patient is currently stable on a different treatment that was prescribed to them while enrolled in their current or previous health plan.^¹
• Requires utilization review organizations to act on a nonurgent step therapy protocol exception request within 48 hours of receiving it. Requires utilization review organizations to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• ^{If a utilization review organization does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.¹}

1: https://www.mainelegislature.org/legis/statutes/24-A/title24-Asec4320-N.html

• • Requires an exception from step-therapy to be granted when
    • The prescription drug required under the step therapy protocol is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the enrollee;
    • The prescription drug required under the step therapy protocol is expected to be ineffective based on the known clinical characteristics of the enrollee and the known characteristics of the prescription drug regime;
    • The enrollee has tried the prescription drug required under the step therapy protocol on a MassHealth or other health plan;
    • The enrollee has tried the prescription drug required in the same pharmacologic class or with the same mechanism of actions and such prescription drug was discontinued for lack of efficacy;
    • The prescription drug required is not in the best interest of the patient; or
    • The enrollee is stable on their current prescription drug.

1: https://malegislature.gov/Bills/192/H1311

• Prohibits the use of step therapy if 1) the step therapy drug has not been approved by the FDA for the medical condition being treated; or 2) the patient’s preferred medication is covered by the health plan, the prescriber provides supporting documentation that the medication was ordered by a prescriber for the enrollee within the past 180 days; and the medication was effective at treating the patient’s medical condition.^¹
• Requires health plans to establish a process for a provider to request step therapy protocol exception.^¹,²
• Requires health plans to accept step therapy protocol exception requests electronically.^¹,²
• Requires health plans to utilize an electronic system capable of providing real-time determinations of step therapy protocol exception requests when no additional information is required to act on them.^¹,²
• Requires health plans to act on step therapy protocol exception requests for pharmaceutical services within 24 hours when they cannot be determined in real-time.^¹,²
• Prohibits health plans from requiring step therapy if a patient is currently stable on a treatment that was initiated within the past 180 days.^¹,²
• Requires pharmacy benefit managers to have a process to evaluate medical and scientific evidence concerning the safety and effectiveness of prescription drugs when recommending step therapy requirements^.³

1: https://law.justia.com/codes/maryland/2015/article-gin/title-15/subtitle-1/section-15-142/

2: https://codes.findlaw.com/md/health-general/md-code-health-gen-sect-19-108-2.html

3: https://law.justia.com/codes/maryland/2018/insurance/title-15/subtitle-16/part-iii/section-15-1617/

• Requires health plans to consider evidence-based and peer-reviewed clinical practice guidelines when establishing a step therapy protocol.^¹
• Requires health plans to provide to a patient any clinical review criteria applicable to a specific drug, upon request.^¹
• Requires health plans to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if
  • The required treatment is likely to cause harm to the patient.^¹
  • The patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
  • The patient is currently stable on a treatment prescribed while enrolled in their current or previous health plan and the required treatment is expected to be ineffective.^¹
• Requires health plans to allow patients to appeal the denial of a step therapy protocol exception request.^¹
• If a health plan denies a step therapy protocol exception request, the health plan must state why the request was denied and must provide information regarding the procedure to request external review of the denial.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within 5 days of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 72 hours of receiving it.^¹
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹
• Requires health plans to accept step therapy protocol exception requests electronically.^¹

1: https://www.revisor.mn.gov/statutes/2018/cite/62Q.184/subd/62Q.184.1#stat.62Q.184.1

• Requires health plans to provide access to a clear, convenient, and readily accessible process to request a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹

1: https://law.justia.com/codes/missouri/2019/title-xxiv/chapter-376/section-376-2034/

• Requires health plans to provide access to a clear and convenient process to request a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if the prescriber can demonstrate that the required treatment has been or will be ineffective for treating the patient’s condition.^¹
• Requires health plans to approve a step therapy protocol exception request if the prescriber can demonstrate that the required treatment is likely to cause harm to the patient.^¹
• Prohibits health plans from requiring patients to undergo step therapy for longer than 30 days.^¹

1: https://law.justia.com/codes/mississippi/2018/title-83/chapter-9/accident-and-health-insurance/section-83-9-36/

• Requires health plans to approve a step therapy protocol exception request if an individual has (1) tried and failed on the required treatment while enrolled in their current or previous health plan; or (2) is receiving a positive therapeutic outcome on the current prescription
• Requires health plans to act on a nonurgent step therapy protocol exception request within five calendar days of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 72 hours of receiving it
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved
• Requires health plans and utilization review entities to evidence-based and peer-reviewed criteria^¹

1: https://nebraskalegislature.gov/FloorDocs/107/PDF/Slip/LB337.pdf

• Requires health plans to establish clinical review criteria for their step therapy protocols. Requires the clinical review criteria to be based on high-quality studies, research, and medical practice.^¹
• Requires health plans to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is likely to cause harm to the patient.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is expected to be ineffective.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is not in the best interest of the patient.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it will be deemed approved.^¹

1: https://www.nmlegis.gov/Sessions/18%20Regular/final/SB0011.pdf

• Requires utilization review agents to utilize evidence-based and peer-reviewed clinical review criteria when establishing a step therapy protocol.^¹
• Requires utilization review agents to utilize evidence-based and peer-reviewed clinical review criteria that is appropriate for the patient’s medical condition when conducting utilization review.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours if the required treatment is likely to cause harm to the patient.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours if the required treatment is expected to be ineffective.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours if the patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours if the patient is stable on a treatment.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours if the required treatment is not in the patient’s best interest.^¹
• Requires utilization review agents to approve a step therapy protocol exception request within 24 hours if a patient has a medical condition that places their health in serious jeopardy without the treatment prescribed by the patient’s health care professional.^¹
• If a utilization review agent fails to act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: https://nyassembly.gov/leg/?default_fld=&bn=A02834&term=2015&Summary=Y&Actions=Y&Votes=Y&Memo=Y&Text=Y

• Requires utilization review agents to approve a step therapy protocol exception request within 72 hours of receiving the request.
• Requires utilization review agents to review urgent exception requests within 24 hours of receiving exception.

1: https://www.ncleg.gov/Sessions/2019/Bills/Senate/PDF/S361v7.pdf

• Requires health plans to utilize clinical review criteria when implementing a step therapy protocol. This clinical review criteria must be based on clinical practice guidelines, and medical and scientific evidence.^¹
• Requires health plans to consider atypical patient populations and diagnoses when establishing clinical review criteria.^¹
• Requires health plans to provide access to a clear, easily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans and utilization review organizations to act on a nonurgent step therapy protocol exception request within 10 days of receiving it. Requires health plans and utilization review organizations to act on an urgent step therapy protocol exception request within 72 hours of receiving it.^¹
• If a health plan or utilization review organization does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the patient is stable on a different treatment.^¹

1: https://www.legislature.ohio.gov/legislation/legislation-summary?id=GA132-SB-265

• Requires health plans and utilization review organizations to utilize recognized, peer-reviewed and evidence-based clinical practice guidelines when establishing a step therapy protocol.^¹
• Requires health plans to provide access to a clear, convenient, and readily accessible process for requesting a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is likely to cause harm to the patient.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is expected to be ineffective.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient has tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires health plans to approve a step therapy protocol exception request if the required treatment is not in the best interest of the patient.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient is currently stable on a different treatment prescribed to them while they were enrolled in their current or previous health plan.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: https://law.justia.com/codes/oklahoma/2019/title-63/section-63-7310/

• Requires health plans to make information easily accessible to providers regarding the clinical criteria for each step therapy protocol, the procedure for requesting a step therapy protocol exception, and the documentation required for a step therapy protocol exception.^¹

1: https://www.oregonlegislature.gov/bills_laws/lawsstatutes/2014R1orLaw0055ss.pdf

• Requires health plans review an urgent request within 24 hours;
• ^{Requires health plans review a step-therapy override request within 72 hours;}
• ^{Requires step-therapy override requests consider:}
  • ^{Contraindications, including adverse reactions;}
  • ^{Clinical effectiveness or ineffectiveness of each required prerequisite prescription drug or therapy;}
  • ^{Past clinical outcome of each required prerequisite prescription drug or therapy}
  • ^{The expected clinical outcomes;}
  • ^{If enrollee has previously completed the step-therapy process. ¹}

1: https://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?sYear=2021&sInd=0&body=S&type=B&bn=225

• Requires health plans to provide access to a clear and convenient process for a provider to request a step therapy protocol exception whenever a health care service is denied or restricted due to the protocol.^¹
• Requires health plans to approve a step therapy protocol exception request if the patient has (1) tried and failed on the required treatment while enrolled in their current or previous health plan or (2) if they are receiving a positive therapeutic outcome on the current prescription.^¹
• Requires health plans to act on a step therapy protocol exception request within five days of receiving it for non-urgent matters and within 72 hours for urgent matters.^¹
• If a health plan fails to respond within the required timeframes, the health care services shall be deemed granted.^¹

1: https://sdlegislature.gov/Legislative_Session/Bills/Bill.aspx?File=SB155ENR.html&Session=2020&Version=Enrolled&Bill=155

• Requires health plans to establish their step therapy protocols in accordance with clinical review criteria readily available to the health care industry. The clinical review criteria must be based on high-quality studies, research, and medical practice.^¹
• Requires health plans to update their clinical practice guidelines at appropriate intervals after a review of new evidence, research, and treatments.^¹
• Requires health plans to establish a process that is readily accessible for requesting a step therapy protocol exception.^¹
• Requires health plans to approve a step therapy protocol exception request if
  • The required treatment is likely to cause harm to the patient.^¹
  • The required treatment is expected to be ineffective.^¹
  • The patient already tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
  • The required treatment is not in the best interest of the patient.^¹
  • The patient is currently stable on a different treatment that was prescribed to them while enrolled in their current or previous health plan.^¹
• Requires health plans to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires health plans to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹
• If a health plan does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.^¹

1: https://statutes.capitol.texas.gov/Docs/IN/htm/IN.1369.htm

• Requires step-therapy protocols be based on clinical review criteria that (1) recommends prescription drugs be taken in a specific sequence; (2) are developed and endorsed by a multidisciplinary panel of experts; (3) are based on quality studies, research, and medical practice; (4) created by an explicit and transparent process; and (5) are continually updated through review of new evidence, research, and newly developed treatments.^¹
• Requires an exception to the step-therapy protocol where the prescription drug would likely cause an adverse reaction to the patient; would be ineffective based on known clinical characteristics; if the patient has already tried and failed on the prescription drug; the patient has previously failed on the prescription drug under a previous plan; or it is not in the best interest of the patient.^¹
• Requires exceptions to be grated within 72 hours or 24 for emergency exception requests..^¹

1: https://wapp.capitol.tn.gov/apps/BillInfo/Default.aspx?BillNumber=SB1310&ga=112

• Requires health plans and utilization review organizations to ensure that their step therapy protocols are based on peer-reviewed research and medical practice. Permits health plans to consider published clinical practice guidelines for relevant patient subgroups. Permits health plans and utilization review organizations to consider the needs of atypical patient populations and diagnoses when establishing clinical review criteria.^¹
• Requires health plans and utilization review organizations to continually update their step therapy protocols based on a review of new evidence, research, and newly developed treatments.^¹
• Requires health plans and utilization review organizations to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment would be ineffective.^¹
• Requires health plans to approve a step therapy protocol exception request if an individual has (1) tried and failed on the required treatment or (2) is receiving a positive therapeutic outcome on the current prescription while enrolled in his or her current or previous health plan
• Requires health plans and utilization review organizations to act on a nonurgent step therapy protocol exception request within 72 hours of receiving it. Requires health plans and utilization review organizations to act on an urgent step therapy protocol exception request within 24 hours of receiving it.^¹

1: http://lis.virginia.gov/cgi-bin/legp604.exe?191+ful+CHAP0337

• Requires health plans to develop utilization management protocols using clinical review criteria that are evidence-based and regularly updated.^¹
• Requires health plans to provide access to a clear, readily accessible, and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans to make the exceptions process easily accessible through the health carrier and utilization management entity’s website.^¹
• Requires health plans to disclose all rules and criteria related to the prescription drug utilization management process to all participating providers, including the specific information and documentation that must be submitted by a health care provider or patient to be considered a complete exception request.^¹
• Requires health plans to grant an exception to the step therapy protocol if: the required drug is contraindicated or likely to cause an adverse reaction in the patient, the required drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the drug regimen, patient has tried the required drug or another drug in the same pharmacologic class or a drug with the same mechanism of action while under his or her current or a previous health plan, and that drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event, patient is currently experiencing a positive therapeutic outcome on a drug recommended by the patient’s provider for the medical condition under consideration while on his or her current or immediately preceding health plan, and changing to the required drug may cause clinically predictable adverse reactions, or physical or mental harm to, the patient, or the required drug is not in the best interest of the patient.^¹
• Requires health plans to grant an exception to the step therapy protocol if the required drug is expected to: create a barrier to the patient’s adherence to or compliance with the patient’s plan of care, negatively impact a comorbid condition of the patient, cause a clinically predictable negative drug interaction, or decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities.^¹
• Requires health plans and drug utilization management entities to act on a nonurgent step therapy protocol exception request within three business days of receiving it. Requires health plans and drug utilization management entities to act on an urgent step therapy protocol exception request within 1 business day of receiving it.^¹
• If an insurer or drug utilization management entity does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.¹
• Requires health plans to cover an emergency supply fill if a treating health care provider determines an emergency fill is necessary to keep the patient stable while the exception request is being processed.¹
• Requires health plans to provide 60 days’ notice to providers and patients for any new policies or procedures applicable to prescription drug utilization management protocols.¹

1: http://lawfilesext.leg.wa.gov/biennium/2019-20/Pdf/Bills/Session%20Laws/House/1879-S.SL.pdf?q=20200501122656

• Requires health plans and utilization review organizations to provide access to a clear and convenient process for requesting a step therapy protocol exception.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment is likely to cause harm to the patient.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment is expected to be ineffective.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the patient has already tried and failed on the required treatment while enrolled in their current or previous health plan.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the required treatment is not in the best interest of the patient.^¹
• Requires health plans and utilization review organizations to approve a step therapy protocol exception request if the patient is stable on a different treatment.^¹

1: https://legiscan.com/WV/text/HB2300/2017

• Requires insurers, pharmacy benefit managers, and utilization review organizations to utilize recognized, peer-reviewed and evidence-based clinical practice guidelines when establishing a step therapy protocol.^¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to describe on their websites the process and criteria used for selecting and evaluating their clinical practice guidelines used to develop their step therapy protocols.^¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to grant an exception to the step therapy protocol if the required drug is likely to: cause an adverse reaction in the patient, decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities, or cause physical or psychiatric harm to the patient.^¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to grant an exception to the step therapy protocol if the required drug is likely to be ineffective based on: sound clinical evidence or medical and scientific evidence, the known clinical characteristics of the patient, or the known characteristics of the prescription drug regimen as described in peer-reviewed literature or the manufacturer’s prescribing information for the prescription drug.^¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to grant an exception to the step therapy protocol if the patient has tried the required drug under the step therapy protocol, or another prescription drug in the same pharmacologic class or with the same mechanism of action, under the policy or plan or a previous policy or plan.^¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to grant an exception to the step therapy protocol if the patient is stable on a prescription drug selected by their health care provider.¹
• Requires insurers, pharmacy benefit managers, and utilization review organizations to act on a nonurgent step therapy protocol exception request within 3 business days of receiving it. Requires health plans and utilization review organizations to act on an urgent step therapy protocol exception request by the end of the next business day after receiving it.¹
• If an insurer, pharmacy benefit manager, or utilization review organization does not act on a step therapy protocol exception request within the required timeframe, it is deemed approved.¹

1: https://docs.legis.wisconsin.gov/statutes/statutes/632/VI/866