Step therapy legislation

 

Step therapy map 2019

SAIM logoIllustration courtesy of State Access to Innovative Medicines

 

Fast facts

  • Step therapy is a tool used by health plan to control spending on patients' medications. 
  • In 2010, nearly 60 percent of commercial insurers were using step therapy. As of 2014, 75 percent of large employers reported offering employees plans that use step therapy.
  • Step therapy has shown to have a negative impact on patients, including delayed access to the most effective treatment, disease progression, and significant burdens on health care providers and their patients, as well as increases in health care costs.

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Have you experienced step therapy and has it delayed you from accessing a necessary treatment? If so, then the AAD wants to hear from you.

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The AAD state policy team is active all year long in advocating for states to enact step therapy laws. As of 2018, the following 18 states have step therapy laws enacted: Arkansas, California, Colorado, Connecticut, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Minnesota, Missouri, Mississippi, New Mexico, New York, Texas, Washington, and West Virginia.


State legislation

California

Law: Chapter 619-2015

Summary: This law only applies to fail first exceptions and uniform prior authorization forms. It requires that a request for an exception to a health care plan’s step therapy process for prescription drugs may be submitted in the same manner as a request for prior authorization for prescription drugs and shall be treated in the same manner, and shall be responded to by the health care service plan in the same manner, as a request for prior authorization for prescription drugs. In circumstances where an insured is changing policies, the new policy shall not require the insureds to repeat step therapy when that insured is already being treated for a medical condition by a prescription drug provided that the drug is appropriately prescribed and is considered safe and effective for the insured’s condition.


Connecticut

Law: Public Act No. 14-118

Summary: Any such override process shall be convenient to use by health care providers and an override request shall be expeditiously granted when an insured's treating health care provider demonstrates that the drug regimen required under step therapy:
  • has been ineffective in the past for treatment of the insured's medical condition,
  • is expected to be ineffective based on the known relevant physical or mental characteristics of the insured and the known characteristics of the drug regimen,
  • will cause or will likely cause an adverse reaction by or physical harm to the insured, or
  • is not in the best interest of the insured, based on medical necessity.


Georgia

HB 63 (2019)
Effective January 1, 2020

A step therapy exception shall be granted by a health benefit plan if:

  • The required prescription drug is contraindicated or will cause an adverse reaction or physical or mental harm to the patient;
  • The required prescription drug is expected to be ineffective based on the known clinical condition of the patient and the known characteristics of the prescription drug regimen;
  • The patient has tried the required prescription drug or another prescription drug in the same pharmacological class or with the same mechanism of action as the required drug while on their current or immediately preceding health plan and such drug was discontinued due to lack of efficacy, diminished effect, or an adverse event; or
  • The patient is currently receiving a positive therapeutic outcome on a prescription drug for the medical condition under consideration if, while on their current or immediately preceding health plan, the patient received coverage for the prescription drug and the practitioner gives documentation in accordance with this subsection that the change in prescription drug required by the step therapy protocol is expected to be ineffective or cause harm to the patient based on the known characteristics of the patient and the known characteristics of the required prescription drug.

A health benefit plan shall grant or deny a step therapy exception or appeal of a step therapy exception within: Twenty-four hours in an urgent health care situation; and two business days from the date such request or appeal is submitted in a nonurgent health care situation.  If the health benefit plan fails to respond in accordance with the established time frame, step therapy exception or an appeal shall be deemed approved.


Illinois

Law: Public Act 099-0761

Summary: The law seeks to retain an insurance plan’s step therapy program, while providing for an exceptions process when clinically appropriate. It also applies medical exceptions procedures, approved by the General Assembly in 2014 for plans on the Exchange, to all plans sold in Illinois. The law contains the following provisions:

  • Establishes circumstances for approval of a step therapy exception request if:
    • The required drug is contraindicated.
    • The patient has tried the required prescription drug while under their current or a previous health benefit plan, and the doctor submits evidence of failure or intolerance.
    • The patient is currently stable on a prescription drug.
  • Applies a medical exceptions process that allows patients to request a prescription drug to all health plans in Illinois. Requires a carrier to approve or deny a request within 72 hours of receipt, and in expedited cases, within 24 hours. [Medicare Part D standard]. States that carriers must provide a reason for the denial, an alternative covered medication, if applicable, and information regarding how to appeal the denial.
  • Medical exceptions requests shall be granted for 12 months or until the renewal of the plan.
  • Does not apply to Medicaid.


Indiana

Law: Public Law 19-2016

Summary: The law applies to commercial and managed Medicaid plans. The new law does not apply to Medicare or Tricare patients. An exception will be granted if any of the following apply:
  • A preceding prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the insured.
  • A preceding prescription drug is expected to be ineffective, based on both of the following:
  • The insured has previously received:
  • Based on clinical appropriateness, a preceding prescription drug is not in the best interest of the insured because the insured's use of the preceding prescription drug is expected to:

Should patients or health care providers need to report any issues with health plan compliance of SEA41, DOI recommends filing a complaint with the consumer division at http://www.in.gov/idoi/2547.htm - Note: there are different forms for complaints by consumers and providers.


Kentucky

Law: KY Rev Stat § 17A.17A-163 (2013)

Summary: The prescribing practitioner can demonstrate, based on sound clinical evidence, that the preferred treatment required under step therapy or fail-first protocol has been ineffective in the treatment of the insured’s disease or medical condition; or Based on sound clinical evidence or medical and scientific evidence:
  • The prescribing practitioner can demonstrate that the preferred treatment required under the step therapy or fail-first protocol is expected or likely to be ineffective based on the known relevant physical or mental characteristics of the insured and known characteristics of the drug regimen; or
  • The prescribing practitioner can demonstrate that the preferred treatment required under the step therapy or fail-first protocol will cause or will likely cause an adverse reaction or other physical harm to the insured.

Louisiana

Law: A Rev Stat § 22:1053

Summary: The following exceptions would apply:
  • The prescribing physician can demonstrate to the health coverage plan, based on sound clinical evidence, that the preferred treatment required under step therapy or fail first protocol has been ineffective in the treatment of the insured's disease or medical condition.
  • The prescribing physician can demonstrate to the health coverage plan, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol is reasonably expected to be ineffective based on the known relevant physical or mental characteristics and medical history of the insured and known characteristics of the drug regimen.
  • The prescribing physician can demonstrate to the health coverage plan, based on sound clinical evidence, that the preferred treatment required under the step therapy or fail first protocol will cause or will likely cause an adverse reaction or other physical harm to the insured.

Maryland

Law: Maryland House Bill 1233. Chapter 317.

Summary: The law pertains to insurers, nonprofit health service plans, and health maintenance organizations in the state. Grandfathering is in place for patients already taking a prescribed drug – When a doctor provides supporting medical information that a drug was prescribed within the last 180 days for a patient and that it is effective for the patient’s medical condition, the insurer must allow the patient to continue taking the prescribed drug without having to restart the step therapy process.


Minnesota

Law: HF 3196 (2018)

Summary: When coverage of a prescription drug for the treatment of a medical condition is restricted for use by a health plan company through the use of a step therapy protocol, enrollees and prescribing health care providers shall have access to a clear, readily accessible, and convenient process to request a step therapy override, if:

  • The prescription drug required is contraindicated or will likely cause an adverse reaction by physical or mental harm to the patient.
  • The patient has tried the required prescription drug while under their current or a previous health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action, and was adherent during such trial for a period of time sufficient to allow for a positive treatment outcome, and the prescription drug was discontinued by the patients’ health care provider due to lack of effectiveness, or an adverse event.
  • The patient is currently receiving a positive therapeutic outcome on a prescription drug, while on their current health plan or the immediately preceding health plan, the patient received coverage for the prescription drug and the patient’s provider gives documentation that the change in prescription drug is expected to be ineffective or cause harm based on characteristics of the specific patient and the known characteristics of the required prescription drug.

A health plan company shall respond to a step therapy override request or an appeal within five days of receipt of a complete request. In cases of exigent circumstances, a plan shall respond within 72 hours of receipt or a complete request. If a health plan company does not send a response to the patient or provider within the time allotted, the override request or appeal is granted and binding on the health plan company. Effective January 1, 2019.


Missouri

Law: House Bill 2029 (2016)

Summary: In Missouri the following exceptions apply:
  • The required prescription drug is contraindicated or will likely cause an adverse reaction
  • The required prescription drug is expected to be ineffective
  • The patient has previously tried the required drug or a drug in the same pharmacologic class and the drug was ineffective or caused an adverse event
  • The required prescription drug is not in the best interests of the patient based on medical appropriateness
  • The patient is stable on a prescription drug for the medical condition under consideration.

Mississippi

Law: MS Code § 83-9-36 (2013)

Summary: An override of that restriction shall be expeditiously granted by the insurer under the following circumstances:
  • The prescribing practitioner can demonstrate, based on sound clinical evidence, that the preferred treatment required under step therapy or fail-first protocol has been ineffective in the treatment of the insured's disease or medical condition; or
  • Based on sound clinical evidence or medical and scientific evidence:

New Mexico

Law: SB 11 (2018)

Summary: Health plans shall expeditiously grant an exception to step therapy protocols, based on medical necessity and a clinically valid explanation from the patient's prescribing practitioner as to why a drug on the plan's formulary that is therapeutically equivalent to the prescribed drug should not be substituted for the prescribed drug if:
  • The required drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient.
  • Is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.
  • The patient has tried the prescription drug that is the subject of the exception request or another prescription drug in the same pharmacologic class or with the same mechanism of action as the prescription drug that is the subject of the exception request and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event.
  • The prescription drug is not in the best interest of the patient.

Insurers must respond to a step therapy override exception request within seventy-two hours of receipt, except in urgent situations- in which case, the insurer must respond within twenty-four hours. An insurer shall authorize continued coverage of a prescription drug that is the subject of the exception request pending the determination of the exception request.

Applies to all state regulated health plans including Medicaid. Effective January 1, 2019.


New York 

 Law: A02834D

Summary: The purpose of this bill is to regulate insurance companies, health
maintenance organizations (HMOs), and utilization review agents who
impose step therapy protocols on patients and to provide for an expe-
dited appeals process for patients and their health care professionals
to override such protocols.


Ohio

SB 265 (2019)
Effective January 1, 2020

Health care providers will have access to a convenient override procedure. An override request will be granted if the patient’s health care provider demonstrated that:

  • The required prescription drug in question is contraindicated for that specific patient, pursuant to the drug’s United States Food and Drug Administration (USFDA) prescribing information;
  • The patient has tried the required prescription drug while under their current, or a previous, health benefit plan, or another USFDA approved AB-rated prescription drug, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration, regardless of whether or not the drug was prescribed when the patient was covered under the current or a previous health benefit plan, or the patient has already gone through a step therapy protocol.

A health plan issuer must either grant or deny a step therapy exemption or appeal within ten calendar days of receiving a request, or, when related to urgent care services, within 48 hours. Any exemption request or appeal that is not replied to within this timeline is considered approved. When a health plan issuer grants a step therapy exemption, the issuer must authorize coverage for the prescription drug in question.


Texas

Law: SB 680 (2017)

Summary: A health benefit plan issuer shall establish a process in a user-friendly format that is readily accessible to a patient and prescribing provider, in the health benefit plan's formulary document and otherwise, through which an exception will be granted if:

  • The required drug is contraindicated or likely to cause harm.
  • The required drug is expected to be ineffective based on the known relevant physical or mental characteristics of the patient and the known characteristics of the drug regimen.
  • The patient has tried the required prescription drug while under their current or a previous health benefit plan, and the doctor submits evidence of failure or intolerance.
  • The treatment is not in the best interest of the patient, based on medical necessity.
  • The patient is currently stable on a prescription drug.
  • Requires notification to a plan holder at least 60 days before the modification of a step therapy restriction becomes effective.

    Insurers must respond to a step therapy override exception request or appeal within seventy-two hours of receipt, except in the case of urgent situations– in which case, the insurer must respond within twenty-four hours. If a response is not received within this period, the exception or appeal is considered granted.


    Virginia

    H 2126 (2019)
    Effective January 1, 2020

    Health care providers will have access to a convenient override procedure. An override request will be granted if the patient’s health care provider demonstrated that:

    • The required prescription drug is contraindicated.
    • The required drug would be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen.
    • The patient has tried the step therapy-required prescription drug while under their current or a previous health benefit plan, and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event.
    • The patient is currently receiving a positive therapeutic outcome on a prescription drug recommended by his provider for the medical condition under consideration while on a current or the immediately preceding health benefit plan.

    The insurer shall respond to a step therapy exception request within 72 hours of receipt, including hours on weekends, that the request is approved, denied, or requires supplementation. In cases where urgent circumstances exist, the insurer shall respond within 24 hours of receipt, including hours on weekends, that the request is approved, denied, or requires supplementation.


    Washington

    HB 1879 (2019)
    Effective January 2021

    This legislation impacts all utilization management protocols in a prescription drug benefit, including but not limited to step therapy protocol and prior authorization.

    Patients and providers will have access to a clear, readily accessible, and convenient process to request an exception through which the prescription drug utilization management can be overridden in favor of coverage of a prescription drug prescribed by a treating health care provider. Health carriers must disclose all rules and criteria related to the prescription drug utilization management process.

    An exception request must be granted if:

    • The required prescription drug is contraindicated or will likely cause a clinically predictable adverse reaction by the patient;
    • The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug regimen
    • The patient has tried the required prescription drug or another prescription 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 such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event
    • The patient is currently experiencing a positive therapeutic outcome on a prescription 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 prescription drug may cause clinically predictable adverse reactions, or physical or mental harm to, the patient
    • The required prescription drug is not in the best interest of the patient, based on documentation of medical appropriateness, because the patient’s use of the prescription drug is expected to:

    (i) Create a barrier to the patient’s adherence to or compliance with the patient’s plan of care;

    (ii) Negatively impact a comorbid condition of the patients

    (iii) Cause a clinically predictable negative drug interaction;

    (iv) Decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities.


    West Virginia

    Law: HB 4040-2016

    Summary: A step therapy override determination request shall be expeditiously granted if:
    • The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient.
    • The required prescription drug is expected to be ineffective based on the known relevant physical or mental characteristics of the patient and the known characteristics of the prescription drug regimen.
    • The patient has tried the required prescription drug while under their current or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class or with the same mechanism of action and such prescription drug was discontinued due to a lack of efficacy or effectiveness, diminished effect, or an adverse event.
    • The required prescription drug is not in the best interest of the patient, based upon medical appropriateness.
    • The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration.