Step Therapy Reform
Thank you for taking the time to learn about step therapy reform. Reasonable patient protections help ensure people with arthritis can access the treatments their healthcare providers determine are medically appropriate without unnecessary delays that can lead to worsening health outcomes. We encourage you to review the model legislation below to learn how your state can improve access to quality, affordable care for people with arthritis.
What it is
Step therapy is an insurance protocol that requires patients to try and “fail” one or more insurer-preferred medications before they may receive coverage for the medication that their physician originally recommends. This practice is also known as "fail first" and can take weeks or months. Once a patient finds a medication that does work for them, they may have to repeat the step therapy process if they switch insurance plans. When implemented inappropriately, step therapy can result in patients not being able to access the treatments they need in a timely manner. This can lead to worsened symptoms and presents a particular challenge for patients suffering from chronic diseases. Physicians can request exceptions to step therapy requirements, but insurers may not respond promptly to such requests, resulting in a further delay of treatment.Why It Matters
For the 60 million adults and children in the U.S. living with arthritis, timely access to the right medication can mean the difference between maintaining mobility and experiencing irreversible joint damage. Step therapy protocols that force patients to "fail first" on inappropriate medications waste critical treatment windows and can lead to disease progression, increased pain, and diminished quality of life. Reform ensures patients and their doctors, not insurance companies, make the best treatment decisions.Step Therapy
Model Legislation
Model Legislation:
Step Therapy Model Language
Section 1.
Legislative Findings
The legislature finds that health insurance plans are increasingly making use of step therapy protocols under which patients are required to try one or more prescription drugs before coverage is provided for a drug selected by the patient's health care provider. The legislature further finds that such step therapy protocols, where they are based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients, can play an important role in controlling health care costs. The legislature further finds that, in some cases, requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who may either not realize a benefit from taking a prescription drug or may suffer harm from taking an inappropriate drug. The legislature further finds that, without uniform policies in the state for step therapy protocols, all patients may not receive the equivalent or most appropriate treatment. The legislature further finds that it is imperative that step therapy protocols in the state preserve the health care provider's right to make treatment decisions in the best interest of the patient. Therefore, the legislature declares it a matter of public interest that it require health insurers to base step therapy protocols on appropriate clinical practice guidelines or published peer reviewed data developed by independent experts with knowledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when those protocols are inappropriate or otherwise not in the best interest of the patients; and that patients have access to a fair, transparent and independent process for requesting an exception to a step therapy protocol when the patient's physician deems appropriate.
Section 2.
Definitions
"Clinical practice guidelines" means a systematically developed statement to assist decision making by health care providers and patient decisions about appropriate healthcare for specific clinical circumstances and conditions. "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of healthcare services. "Medically necessary" means health services and supplies that under the applicable standard of care are appropriate: - to improve or preserve health, life, or function; - to slow the deterioration of health, life, or function; or - for the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury. "Step therapy protocol" means a protocol, policy, or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan. "Step therapy exception" means that a step therapy protocol should be overridden in favor of immediate coverage of the health care provider's selected prescription drug. "Utilization review organization" means an entity that conducts utilization review, other than an insurer or health plan performing utilization review for its own health benefit plans.
Section 3.
Clinical Review Criteria Requirements and Restrictions.
Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:
A. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.
B. Are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by: 1. Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves from voting if they have a conflict of interest. 2. Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus. 3. Offering opportunities for public review and comments.
C. Are based on high quality studies, research, and medical practice.
D. Are created by an explicit and transparent process that: 1. Minimizes biases and conflicts of interest; 2. Explains the relationship between treatment options and outcomes; 3. Rates the quality of the evidence supporting recommendations; and 4. Considers relevant patient subgroups and preferences.
E. Are continually updated through a review of new evidence, research and newly developed treatments. In the absence of clinical guidelines that meet the requirements in section 3(A)(2), peer reviewed publications may be substituted. When establishing a step therapy protocol, a utilization review agent shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria. An insurer, pharmacy benefit manager, or utilization review organization shall: A. Upon written request, provide all specific written clinical review criteria relating to the particular condition or disease including clinical review criteria relating to a step therapy protocol override determination; and B. Make available such clinical review criteria and other clinical information on its internet site and to a health care professional on behalf of an insured upon written request. This section shall not be construed to require insurers, health plans or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.
Section 4.
Exceptions Process Transparency
A. Exceptions Process. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear, readily accessible and convenient process to request a step therapy exception. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible on the insurer's, health plan's, or utilization review organization's website. An insurer, health plan, or utilization review organization must disclose all rules and criteria related to the step therapy protocol upon request to all prescribing practitioners, including the specific information and documentation that must be submitted by a prescribing practitioner or patient to be considered a complete exception request.
B. Exceptions. A step therapy exception shall be expeditiously granted if: 1. The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient; 2. 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; 3. 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 lack of efficacy or effectiveness, diminished effect, or an adverse event; 4. The required prescription drug is not in the best interest of the patient, based on medical necessity. 5. The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan.
C. Effect of Exception. Upon the granting of a step therapy exception, the insurer, health plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.
D. Response to Step Therapy Exception Requests and Appeal. The insurer, health plan, or utilization review organization shall grant or deny a step therapy exception request or an appeal within seventy-two hours of receipt. In cases where exigent circumstances exist an insurer, health plan, or utilization review organization shall respond within twenty-four hours of receipt. If a request for a step therapy override exception is incomplete or additional clinically relevant information is required, the insurer, health plan, or utilization review organization shall notify the prescribing practitioner within seventy-two hours of submission, or twenty-four hours in exigent circumstances, what additional or clinically relevant information is required in order to approve or deny the step therapy exception request or appeal pursuant to the criteria disclosed in section (A). Once the requested information is submitted, the applicable time period to grant or deny a step therapy exception request or appeal shall apply. Should a determination or request for incomplete or clinically relevant information by an insurer, health plan, or utilization review organization not be received by the prescribing practitioner within the time allotted, the exception or appeal shall be deemed granted. In the event of a denial, the insurer, health plan, or utilization review organization must inform the patient of a potential appeal process. Any step therapy exception as defined by this subsection shall be eligible for appeal by an insured.
E. Limitations. This section shall not be construed to prevent: 1. An insurer, health plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent or interchangeable biological product (as defined by 42 U.S.C. § 262(i)(3)), unless such a requirement meets any of the criteria of Section 4(B) pursuant to a step therapy exception request submitted under Section 4(A), prior to providing coverage for the equivalent branded prescription drug; 2. An insurer, health plan, or utilization review organization from requiring a pharmacist to effect substitutions of prescription drugs consistent with state substitution law; 3. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
Section 5.
Regulations
Notwithstanding any law to the contrary, the Division of Insurance shall promulgate any regulations necessary to enforce this Act. Annually, an insurer, health plan, or a utilization review organization shall report to the Division of Insurance, in a format prescribed by the Division: A. The number of step therapy exception requests received by exception as detailed under Section 4(B); B. The type of health care providers or the medical specialties of the health care providers submitting step therapy exception requests; C. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were denied and the reasons for the denials; D. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were approved; E. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were initially denied and then appealed; F. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were initially denied and then subsequently reversed by internal appeals or external reviews; and G. The medical conditions for which patients are granted exceptions due to the likelihood that switching from the prescription drug will likely cause an adverse reaction by or physical or mental harm to the insured.
Section 6.
Applicability
This act shall apply in the case of any state regulated plans (or health insurance coverage offered in connection with such a plan) that provides coverage of a prescription drug pursuant to a policy that meets the definition of a medication step therapy protocol as defined in Section 2(C), regardless of whether the policy is described as a step therapy protocol.
Step Therapy Model Language
Section 1.
Legislative Findings
The legislature finds that health insurance plans are increasingly making use of step therapy protocols under which patients are required to try one or more prescription drugs before coverage is provided for a drug selected by the patient's health care provider. The legislature further finds that such step therapy protocols, where they are based on well-developed scientific standards and administered in a flexible manner that takes into account the individual needs of patients, can play an important role in controlling health care costs. The legislature further finds that, in some cases, requiring a patient to follow a step therapy protocol may have adverse and even dangerous consequences for the patient who may either not realize a benefit from taking a prescription drug or may suffer harm from taking an inappropriate drug. The legislature further finds that, without uniform policies in the state for step therapy protocols, all patients may not receive the equivalent or most appropriate treatment. The legislature further finds that it is imperative that step therapy protocols in the state preserve the health care provider's right to make treatment decisions in the best interest of the patient. Therefore, the legislature declares it a matter of public interest that it require health insurers to base step therapy protocols on appropriate clinical practice guidelines or published peer reviewed data developed by independent experts with knowledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when those protocols are inappropriate or otherwise not in the best interest of the patients; and that patients have access to a fair, transparent and independent process for requesting an exception to a step therapy protocol when the patient's physician deems appropriate.
Section 2.
Definitions
"Clinical practice guidelines" means a systematically developed statement to assist decision making by health care providers and patient decisions about appropriate healthcare for specific clinical circumstances and conditions. "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of healthcare services. "Medically necessary" means health services and supplies that under the applicable standard of care are appropriate: - to improve or preserve health, life, or function; - to slow the deterioration of health, life, or function; or - for the early screening, prevention, evaluation, diagnosis or treatment of a disease, condition, illness or injury. "Step therapy protocol" means a protocol, policy, or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan. "Step therapy exception" means that a step therapy protocol should be overridden in favor of immediate coverage of the health care provider's selected prescription drug. "Utilization review organization" means an entity that conducts utilization review, other than an insurer or health plan performing utilization review for its own health benefit plans.
Section 3.
Clinical Review Criteria Requirements and Restrictions.
Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that:
A. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.
B. Are developed and endorsed by a multidisciplinary panel of experts that manages conflicts of interest among the members of the writing and review groups by: 1. Requiring members to disclose any potential conflict of interests with entities, including insurers, health plans, and pharmaceutical manufacturers and recuse themselves from voting if they have a conflict of interest. 2. Using a methodologist to work with writing groups to provide objectivity in data analysis and ranking of evidence through the preparation of evidence tables and facilitating consensus. 3. Offering opportunities for public review and comments.
C. Are based on high quality studies, research, and medical practice.
D. Are created by an explicit and transparent process that: 1. Minimizes biases and conflicts of interest; 2. Explains the relationship between treatment options and outcomes; 3. Rates the quality of the evidence supporting recommendations; and 4. Considers relevant patient subgroups and preferences.
E. Are continually updated through a review of new evidence, research and newly developed treatments. In the absence of clinical guidelines that meet the requirements in section 3(A)(2), peer reviewed publications may be substituted. When establishing a step therapy protocol, a utilization review agent shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria. An insurer, pharmacy benefit manager, or utilization review organization shall: A. Upon written request, provide all specific written clinical review criteria relating to the particular condition or disease including clinical review criteria relating to a step therapy protocol override determination; and B. Make available such clinical review criteria and other clinical information on its internet site and to a health care professional on behalf of an insured upon written request. This section shall not be construed to require insurers, health plans or the state to set up a new entity to develop clinical review criteria used for step therapy protocols.
Section 4.
Exceptions Process Transparency
A. Exceptions Process. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear, readily accessible and convenient process to request a step therapy exception. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible on the insurer's, health plan's, or utilization review organization's website. An insurer, health plan, or utilization review organization must disclose all rules and criteria related to the step therapy protocol upon request to all prescribing practitioners, including the specific information and documentation that must be submitted by a prescribing practitioner or patient to be considered a complete exception request.
B. Exceptions. A step therapy exception shall be expeditiously granted if: 1. The required prescription drug is contraindicated or will likely cause an adverse reaction by or physical or mental harm to the patient; 2. 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; 3. 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 lack of efficacy or effectiveness, diminished effect, or an adverse event; 4. The required prescription drug is not in the best interest of the patient, based on medical necessity. 5. The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan.
C. Effect of Exception. Upon the granting of a step therapy exception, the insurer, health plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.
D. Response to Step Therapy Exception Requests and Appeal. The insurer, health plan, or utilization review organization shall grant or deny a step therapy exception request or an appeal within seventy-two hours of receipt. In cases where exigent circumstances exist an insurer, health plan, or utilization review organization shall respond within twenty-four hours of receipt. If a request for a step therapy override exception is incomplete or additional clinically relevant information is required, the insurer, health plan, or utilization review organization shall notify the prescribing practitioner within seventy-two hours of submission, or twenty-four hours in exigent circumstances, what additional or clinically relevant information is required in order to approve or deny the step therapy exception request or appeal pursuant to the criteria disclosed in section (A). Once the requested information is submitted, the applicable time period to grant or deny a step therapy exception request or appeal shall apply. Should a determination or request for incomplete or clinically relevant information by an insurer, health plan, or utilization review organization not be received by the prescribing practitioner within the time allotted, the exception or appeal shall be deemed granted. In the event of a denial, the insurer, health plan, or utilization review organization must inform the patient of a potential appeal process. Any step therapy exception as defined by this subsection shall be eligible for appeal by an insured.
E. Limitations. This section shall not be construed to prevent: 1. An insurer, health plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent or interchangeable biological product (as defined by 42 U.S.C. § 262(i)(3)), unless such a requirement meets any of the criteria of Section 4(B) pursuant to a step therapy exception request submitted under Section 4(A), prior to providing coverage for the equivalent branded prescription drug; 2. An insurer, health plan, or utilization review organization from requiring a pharmacist to effect substitutions of prescription drugs consistent with state substitution law; 3. A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
Section 5.
Regulations
Notwithstanding any law to the contrary, the Division of Insurance shall promulgate any regulations necessary to enforce this Act. Annually, an insurer, health plan, or a utilization review organization shall report to the Division of Insurance, in a format prescribed by the Division: A. The number of step therapy exception requests received by exception as detailed under Section 4(B); B. The type of health care providers or the medical specialties of the health care providers submitting step therapy exception requests; C. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were denied and the reasons for the denials; D. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were approved; E. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were initially denied and then appealed; F. The number of step therapy exception requests by exception, as detailed under Section 4(B), that were initially denied and then subsequently reversed by internal appeals or external reviews; and G. The medical conditions for which patients are granted exceptions due to the likelihood that switching from the prescription drug will likely cause an adverse reaction by or physical or mental harm to the insured.
Section 6.
Applicability
This act shall apply in the case of any state regulated plans (or health insurance coverage offered in connection with such a plan) that provides coverage of a prescription drug pursuant to a policy that meets the definition of a medication step therapy protocol as defined in Section 2(C), regardless of whether the policy is described as a step therapy protocol.