Regulations in detail

If a managed care plan, insurer, or health maintenance organization restricts the use of prescribed drugs through a fail-first protocol, it must establish a clear and convenient process that a prescribing physician may use to request an override of the restriction from the managed care plan. The managed care plan shall grant an override of the protocol within 24 hours if:
Based on sound clinical evidence, the prescribing provider concludes that the preferred treatment required under the fail-first protocol has been ineffective in the treatment of the enrollee’s disease or medical condition; or

Based on sound clinical evidence or medical and scientific evidence, the prescribing provider believes that the preferred treatment required under the fail-first protocol:
Is likely to be ineffective given the known relevant physical or mental characteristics and medical history of the enrollee and the known characteristics of the drug regimen; or

Will cause or is likely to cause an adverse reaction or other physical harm to the enrollee.

If the prescribing provider follows the fail-first protocol recommended by the managed care plan for an enrollee, the duration of treatment under the fail-first protocol may not exceed a period deemed appropriate by the prescribing provider.  Following such period, if the prescribing provider deems the treatment provided under the protocol clinically ineffective, the enrollee is entitled to receive the course of therapy that the prescribing provider recommends, and the provider is not required to seek approval of an override of the fail-first protocol. As used in this subparagraph, the term “fail-first protocol” means a prescription practice that begins medication for a medical condition with the most cost-effective drug therapy and progresses to other more costly or risky therapies only if necessary.

Amends the Managed Care Reform and Patient Rights Act. Applies the medical exemptions process to all entities licensed in the State to sell a policy of group or individual accident and health insurance or health benefits plan. Provides certain exceptions upon which a step therapy override will always be provided. Sets clinical review criteria that must be used to establish step therapy protocols.

Requires every insurer to establish and maintain a medical exceptions process that allows covered persons or their authorized representatives to request any clinically appropriate prescription drug under certain circumstances.

A step therapy override determination request 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 relevant physical or mental 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 appropriateness; or

(5) the patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration.

Requires every insurer to base their clinical review criteria for step therapy protocols on clinical practice guidelines that are based on high quality studies, research, and medical practice; are developed by an independent, multidisciplinary panel of experts not affiliated with an insurer; and more.

Requires every insurer to ensure that where step therapy protocols are used to impose clinical prerequisites for coverage of prescription drugs, such drugs shall be available to the consumer at the preferred cost-sharing level for the item once the clinical prerequisites have been satisfied.

Applies the medical exemptions process to all entities licensed in the State to sell a policy of group or individual accident and health insurance or health benefits plan. Provides certain exceptions upon which a step therapy override will always be provided. Sets clinical review criteria that must be used to establish step therapy protocols.

Specifies requirements for the establishment and use of a prescription drug step therapy protocol by a state employee health plan, an accident and sickness insurer, or a health maintenance organization.

A health insurer shall provide to prescribing healthcare providers access to a clear, convenient and readily accessible method to request override of a step therapy protocol. Such method shall be disclosed to patients and prescribing healthcare providers covered by health benefit plans provided by the health insurer. A health insurer shall expeditiously grant a prescribing healthcare provider’s request to override a step therapy protocol if:

1. The prescription drug required by the health insurer is contraindicated for the patient or will likely cause an adverse reaction or physical or mental harm to the patient;
2. The prescription drug required by the health insurer is expected to be ineffective, based on the known clinical characteristics of the patient and the known characteristics of the required prescription drug regimen;
3. The patient has previously tried the prescription drug required by the health insurer while under such patient’s current or previous 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, diminished effect or adverse physical or mental health effects;
4. The patient is stable on a different prescription drug selected by such patient’s prescribing healthcare provider for treatment of the medical condition under consideration; or
5. The prescription drug required by the health insurer is not in the best interests of the patient based on the patient’s prescribing healthcare provider’s determination of medical necessity.

A health insurer shall respond to and render a decision on a prescribing healthcare provider’s request to override a step therapy protocol, or an appeal related to such request, within 72 hours of receiving such request. If the prescribing healthcare provider indicates in the request or appeal that exigent circumstances exist, the health insurer shall respond to such request or appeal within 24 hours of receiving such request. If a health insurer does not respond to a request or appeal within the time limits established in this subsection, the request or appeal shall be deemed granted.

This bill would remove existing protections against the use of step therapy.

Mandates that any policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the commonwealth that provides coverage for prescription drugs and uses step-therapy protocols shall have the following requirements and restrictions: clinical review criteria used to establish step therapy protocols shall be based on clinical practice guidelines; exceptions; an exceptions process; and step therapy limitations.

This bill establishes certain standards for prescription drug step therapy policies under the health plan improvement law.  The clinical review criteria used by a carrier in approving prescription drugs:

• Must adhere to federal Food and Drug Administration prescription drug labeling; and,
• May not require failure on the same medication on more than one occasion for patients continuously enrolled in a health plan offered by the carrier.

This is a bill to reform step therapy.

It would 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(s) under consideration.

Patients must be exempt from step therapy protocols if they are inappropriate or otherwise not in the best interest of the patient.

Patients must have access to a fair, transparent, and independent process for requesting an exception to a step therapy protocol if the patient’s health care provider deems such exception appropriate.

A step therapy override exception request shall be expeditiously granted according to the provisions of the bill.  The insurer, health plan, or utilization review organization shall respond to a step therapy override exception request or an appeal related to such a request within 72 hours of receipt, or within 24 hours if exigent circumstances exist.  Failure to respond in the allotted time frames will result of the override request being granted.

An act to ensure the proper administration of step therapy protocols for prescription drugs.  Clinical review criteria used to establish a step therapy protocol shall be based on clinical practice guidelines that meet all the following requirements:

1. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol.
2. Are developed and endorsed by an independent, multidisciplinary panel of experts not affiliated with a health benefit plan or utilization review organization.
3. Are based on high quality studies, research, and medical practice.
4. Are created by an explicit and transparent process that: minimizes biases and conflicts of interest; explains the relationship between treatment options and outcomes; rates the quality of the evidence supporting recommendations; and, considers patient subgroups and preferences.
5. Are continually updated through a review of new evidence and research.

Further, the bill sets out transparency requirements for an exceptions process and mandates when exceptions shall be expeditiously granted.

This bill requires certain health insurers, under every policy or contract that provides coverage for outpatient prescription drugs, to provide coverage for prescription drugs used to treat pain in accordance with its provisions. The bill’s provisions apply to the following insurers and programs that provide coverage for outpatient prescription drugs under a policy or contract: health, hospital and medical service corporations; commercial individual and group health insurers; health maintenance organizations; health benefits plans issued pursuant to the New Jersey Individual Health Coverage and Small Employer Health Benefits Programs; the State Health Benefits Program (SHBP) and the School Employees’ Health Benefits Program (SEHBP).

The bill provides that if the insurer or program, in its policy or contract, restricts coverage for medications for the treatment of pain pursuant to a step therapy or fail-first protocol, the duration of the step therapy or fail-first protocol is to be determined by the prescriber. The insurer or program may not require a covered person to try and fail on more than one pain medication before providing coverage for the medication that has been prescribed. Once a covered person has tried and failed on one pain medication, the insurer or program will no longer require prior authorization for coverage of pain medication for the person, and the prescriber may write a prescription for the appropriate pain medication. The prescriber is to note in the covered person’s medical record that the person tried and failed on the step therapy or fail-first protocol, and this is to suffice as prior authorization from the insurer or program. If a prescriber notes on the prescription that the step therapy or fail-first protocols have been met, a pharmacist may process the prescription without additional communication with the insurer or program.

The bill provides that nothing in its provisions is to be construed to prohibit an insurer or program from charging a covered person a copayment or deductible for prescription drug benefits or from setting forth, in the policy or contract, limitations on maximum coverage of prescription drug benefits as permitted under law or regulation, and further provides that nothing in the bill is to be construed to require coverage of prescription drugs that are not in the drug formulary of the insurer or program or to prohibit generic drug substitutions pursuant to law.

This bill requires certain health insurers, under every policy or contract that provides coverage for outpatient prescription drugs, to provide coverage for prescription drugs used to treat pain in accordance with its provisions. The bill’s provisions apply to the following insurers and programs that provide coverage for outpatient prescription drugs under a policy or contract: health, hospital and medical service corporations; commercial individual and group health insurers; health maintenance organizations; health benefits plans issued pursuant to the New Jersey Individual Health Coverage and Small Employer Health Benefits Programs; the State Health Benefits Program (SHBP) and the School Employees’ Health Benefits Program (SEHBP).

The bill provides that if the insurer or program, in its policy or contract, restricts coverage for medications for the treatment of pain pursuant to a step therapy or fail-first protocol, the duration of the step therapy or fail-first protocol is to be determined by the prescriber. The insurer or program may not require a covered person to try and fail on more than one pain medication before providing coverage for the medication that has been prescribed. Once a covered person has tried and failed on one pain medication, the insurer or program may no longer require prior authorization for coverage of pain medication for the person, and the prescriber may write a prescription for the appropriate pain medication. The prescriber is to note in the covered person’s medical record that the person tried and failed on the step therapy or fail-first protocol, and this will suffice as prior authorization from the insurer or program. If a prescriber notes on the prescription that the step therapy or fail-first protocols have been met, a pharmacist may process the prescription without additional communication with the insurer or program.

The bill provides that nothing in its provisions is to be construed to prohibit an insurer or program from charging a covered person a copayment or deductible for prescription drug benefits or from setting forth, in the policy or contract, limitations on maximum coverage of prescription drug benefits as permitted under law or regulation, and further provides that nothing in the bill is to be construed to require coverage of prescription drugs that are not in the drug formulary of the insurer or program or to prohibit generic drug substitutions pursuant to law.

Regulates step therapy and first fail health insurance policies and contracts.

Regulates step therapy and first fail health insurance policies and contracts.  When medications for the treatment of any medical condition are restricted for use by an insurer or pharmacy benefit manager by a step therapy or fail first protocol, a prescriber shall have access to a clear and convenient process at no charge to such prescriber and/or patient to override such restrictions from the insurer and may expeditiously override such restrictions under certain circumstances outlined by statute.

To adopt requirements related to step therapy protocols implemented by health plan issuers and the Department of Medicaid.

An Act related to step therapy protocols implemented by health plan issuers and the Department of Medicaid.

This Act would require a health plan issuer or a utilization review organization that implements a step therapy protocol to implement clinical review criteria in relation to that step therapy protocol that do all of the following:

1. Recommend that the prescription drugs be taken in the specific sequence required by the step therapy protocol;
2. Are developed and endorsed by an independent, multidisciplinary panel of experts not affiliated with a health plan issuer or utilization review organization;
3. Are based on high quality studies, research, and medical practice;
4. Are created by an explicit and transparent process, as defined within the statute; and,
5. Are continually updated through a review of new evidence and research.

A health plan issuer or utilization review organization shall submit proposed clinical review criteria in relation to each step therapy protocol they wish to implement to the superintendent of insurance for review and shall not implement those criteria prior to receiving approval or accreditation from the superintendent.

When coverage of a prescription drug is restricted through the use of a step therapy protocol, the patient and prescribing practitioner shall be proveded access to a clear and convenient process to request a step therapy exemption determination.  That process shall be easily accessible on the health plan issuer or utilization review organization’s website.  The exemption shall be expeditiously granted if the step therapy protocol is not in the best interest of the patient, as defined by statute.

The Act establishes similar, though not exact, requirement for the Department of Medicaid.

This act would require that a step therapy protocol be included in all health care insurance policies and health insurance plans. This act would take effect upon passage and would apply to health insurance policies and health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2016.

This act would prevent health insurance policies, plans or contracts that provide coverage for prescription drugs, from requiring a beneficiary to use an opioid drug not indicated by the FDA for the condition being treated prior to the use of a non-opioid drug that is approved by the FDA for the condition being treated, or to use a non-abuse-deterrent formulation prior to using an abuse-deterrent formulation.

This act would require that a step therapy protocol be included in all health care insurance policies and health insurance plans. This act would take effect upon passage and would apply to health insurance policies and health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2016.

Requires health insurers that limit coverage for prescription drugs through the use of a step therapy protocol to have in place a process for a prescribing provider to request an override of the protocol for a patient. A step therapy protocol is a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition are medically appropriate for a particular patient and are covered by a health benefit plan or that conditions coverage of a prescription medication on a patient first trying an alternative medication without success. The measure requires the granting of a step therapy protocol override in certain circumstances. Finally, the measure requires an insurer that offers a health benefit plan that uses a step therapy protocol to provide (i) written notice of a determination that the protocol requires denial of coverage of a provider’s selected prescription drug, (ii) an explanation of the basis for such determination, and (iii) notice of the procedures for submitting a request for an override of the restrictions of the step therapy protocol.

Requires health benefit plans that restrict the use of any prescription drug through the use of a step therapy protocol to have in place a clear, convenient, and expeditious process for a prescribing medical provider to request an override of such restrictions for a patient. A step therapy protocol is a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition are medically appropriate for a particular covered person and are covered by a health benefit plan or that conditions coverage of a prescription medication on a patient first trying an alternative medication without success. The measure requires the granting of a step therapy protocol override if (i) the required prescription drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the patient; (ii) the required prescription drug is expected to be ineffective on the basis of the known relevant physical or mental characteristics of the covered person and the known characteristics of the prescription drug regimen; (iii) the covered person has tried the required prescription drug while under his current or a previous 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; or (iv) the required prescription drug is not in the best interest of the covered person, based on medical appropriateness.

When coverage of a prescription drug for the treatment of any medical condition is restricted for use by health plan issuer or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a step therapy exception determination.  The process shall be made easily accessible on the health plan issuer’s or utilization review organization’s website.  The health plan issuer or utilization review organization must provide a prescription drug for treatment of the medical condition at least until the step therapy exception determination is made.

A step therapy override determination request 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 relevant physical or mental 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 a 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 upon medical appropriateness.
5. The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration.

Upon the granting of a step therapy override determination, the health plan issuer or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient’s treating healthcare provider, provided such prescription drug is a covered prescription drug under such policy or contract.