Background:

Step therapy is a form of prior authorization whereby health carriers approve a prescription drug or class of drugs for a medical condition based on cost effectiveness and treatment best practices. Step therapy requires the patient to begin treatment with the approved drug. If the patient fails to respond to the drug or experiences an adverse effect, then coverage is allowed for another drug prescribed by the patient's health care provider.

In Washington, health carriers may design their prescription drug benefit plans to include cost control measures, including requiring preferred drug substitution in a given therapeutic class if the restriction is for a less expensive, equally therapeutic alternative product available to treat the condition. Carriers must also establish a process that a provider and an enrollee may use to request substitution for a prescribed therapy, drug, or medication that is not on the formulary.

This process may not unreasonably restrict an enrollee's access to non-formulary or alternative medicines for conditions that are not responsive to treatment. Carriers must also have a process for an enrollee to request an expedited review based on exigent circumstances such as experiencing a health condition that may jeopardize the enrollee's life or when an enrollee is undergoing a current course of treatment using a non-formulary drug.

–––––––––––––––––––––––––––––––––

Summary of Substitute Bill:

For health plans issued or renewed on or after January 1, 2021, clinical review criteria used to establish a prescription drug utilization management protocol must be evidence-based. A health carrier (carrier) may include a prior authorization requirement for its prescription drug benefit and its exception process that is based on: accepted peer reviewed clinical studies; federal food and drug administration black box warnings; whether the drug is available over the counter; objective and relevant clinical information about the enrollee's conditions; specific medical necessity criteria; patient safety; or other criteria that meet an accepted, medically applicable standard of care.

Carriers and review organizations that utilize prescription drug utilization management protocols must:

post online and provide upon request the carrier's prior authorization standards, criteria, and other information about medical necessity decisions;
allow only health care providers that hold a license, certificate, or registration, in good standing and in the same or related field as the health care provider being reviewed to consult and make decisions to deny, limit, or terminate a person's coverage; and
maintain a documented utilization review program description and written utilization review criteria based on reasonable and medical evidence.

If a carrier or review organization restricts coverage of a prescription drug through a prescription drug utilization management protocol, the patient and the prescribing practitioner must have access to a clear, readily accessible, and convenient process to request an exception. A carrier or review organization may use its existing medical exceptions process to satisfy this requirement. The process and approval criteria must be easily accessible on the entity's website, in plain language, and understandable to providers and patients.

Carriers must disclose all rules related to the prescription drug utilization management process to all participating providers, including the information and documentation that must be completed in order for a request to be complete.

A step therapy exception must be granted if sufficient evidence is submitted by the provider and patient to establish that:

the required prescription drug is:
- contraindicated or will likely cause an adverse reaction or physical or mental harm to the patient;
- expected to be ineffective based on known clinical characteristics of the patient and prescription drug regimen; and
- not in the best interest of the patient based on medical necessity;
the patient has tried the required prescription drug while under the current or a previous health insurance, 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
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.

Upon granting an exception, the carrier or review organization must authorize coverage for the prescription drug prescribed by the patient's treating health care provider. Exception requests and appeals must be approved or denied within 72 hours of receipt of all required documentation, except where exigent circumstances exist, in which case requests must be granted or denied within 24 hours of receipt of all required documentation. Exigent circumstances is defined as when an enrollee is experiencing a health condition that may seriously jeopardize the enrollee's life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug.

Carriers must cover an emergency supply fill if a health care provider determines an emergency fill is necessary to keep the patient stable while the exception is being processed. Emergency fill means a limited dispensed amount of medication that allows time for the processing of a step-therapy or prior authorization request.

When responding to a prescription drug utilization management request, a carrier or review organization must clearly state in the response if the service was approved or denied. The carrier must provide a specific reason for the denial and use evidence-based peer review literature as the basis. If the denial is based on specific payer policy, clinical criteria, or peer reviewed literature, the denial must include the specific language relied upon and information about an external appeals process.

If it is denied for administrative reasons, or for not including all of the necessary information, the carrier or review organization must inform the provider or facility what additional information is needed and the deadline for its submission.

The carrier or review organization must allow a stabilized patient to remain on a drug while the prescription drug utilization management is addressed, including the appeals process. Carriers must provide 90 days notice for any new rules that apply to prescription drug utilization management protocols. New rules or policies may not be applied retroactively.

A carrier or review organization may require a patient to try an AB-rated generic equivalent or a biological product that is an interchangeable biological product prior to providing coverage for the equivalent branded drug.

The insurance commissioner may adopt rules necessary to implement this act.

Substitute Bill Compared to Original Bill:

The substitute bill:

replaces the clinical review criteria for a prescription drug utilization management protocol and requires that the criteria be based on accepted peer reviewed clinical studies, federal food and drug administration black box warnings, whether the drug is available over-the-counter, the enrollee's condition, medical necessity criteria, and patient safety, removing requirements that the criteria be developed by a multidisciplinary panel, be based on high quality studies, minimize bias, and require disclosure of conflicts of interest;
requires carriers and review organizations that utilize prescription drug utilization management protocols to:
- post online and provide upon request the carrier's prior authorization standards, criteria, and other information about medical necessity decisions;
- allow only health care providers that hold a license, certificate, or registration, in good standing and in the same or related field as the health care provider being reviewed to consult and make decisions to deny, limit, or terminate a person's coverage; and
- maintain a documented utilization review program description and written utilization review criteria based on reasonable and medical evidence;
clarifies that a step therapy exception request must be granted if sufficient evidence is submitted by the provider and patient to establish certain criteria;
clarifies that a health carrier must approve or deny a step therapy exception request within 72 hours of receiving all required documentation, unless there are exigent circumstances, in which case an exception must be approved or denied within 24 hours of receiving all required documentation. Defines exigent circumstances as existing when an enrollee is experiencing a health condition that may seriously jeopardize the enrollee's life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug;
expands a carrier's ability to require a patient to try an AB-rated generic equivalent to include a biological product that is an interchangeable biological product; and
modifies definitions and terms used.

Staff Summary of Public Testimony:

(In support) This bill is supported by 23 patient groups. Patients deserve an understanding about how the step therapy protocol process works, and there needs to be a process for people who have unique conditions and need access to the appropriate drug. When treatment is delayed it can further an individual's disease state or have adverse effects.

Many individuals have co-existing conditions, where certain drugs could be contraindicated for people with different conditions. Typically a patient is put on the right drug for them in the end, but it is often a long and difficult process.

These groups are not asking for the removal of processes that limit access to certain prescriptions; these are tools that are used to control health care costs. However, there are scenarios where the drug being prescribed is the one that needs to be used. Accordingly, there must be a transparent exception process, which includes coverage for emergency fills and are based on good scientific studies.

(Opposed) None.

(Other) This bill started from a better place than similar bills in previous years. However, there are concerns about section 2 regarding the therapeutics committees, which are the committees that choose the formularies. Section 2 has a number of requirements related to conflicts of interest, which are not needed and unnecessary.

There is confusion about why an exception request must be responded to within 72 hours if the patient is allowed to be on the drug already. Additionally the public employees and school employee plans should be included.

There is support for a different approach that was based on an amendment from last year. That approach would require a health carrier to notify enrollees of the exception process and requires coverage of the drug during the process. It also requires notification if a drug is removed from the formulary among other things.