Step therapy polices, also known as “fail first,” are a practice used by insurers and pharmacy benefit managers (PBMs) to require consumers to try and fail on alternative treatments, before the insurer or PBM will cover the originally prescribed treatment. As a result, treatments that may be most effective at treating a condition may be inaccessible to consumers until alternative treatments are proven ineffective. Without proper guardrails step therapy policies may also require patients to try and fail on off-label treatments; multiple different treatments; and treatments consumers have previously fail on under a different health plan. In addition, policies can also require consumers to try and fail a treatment for more than thirty-days forcing consumers to continue to experience symptoms without relief.
While health plans and PBMs allege step-therapy is used to control costs, studies report that requiring patients to “fail first” may actually increase costs because less effective medications often lead to higher health costs later.
Helpful resources for advocates, legislators, and policymakers:
Why Step Therapy is Harmful to Consumer's Health
Step therapy policies prevent timely access to necessary treatments. It prioritizes a temporary reduction in health care spending over the expertise of the health care provider treating the patient and the long-term health of the patient, ultimately undermining the patient-provider relationship and increasing long-term health care costs.
All consumers require individualized care and carefully selected treatments to manage their health and chronic conditions. Moreover, step-therapy policies can also create ethical concerns as these policies often disregard the patient’s experience with ineffective treatments; potential side effects of stopping their effective treatments; and a lack of efficacy and therapeutic equivalence within some policies. Step-therapy protocols can also consume several months of the year if patients are required to try-and-fail for more than 30 days on multiple treatments.
Many patients can't afford to waste time trying and failing on multiple ineffective treatments.
For instance, patients with progressive diseases and disorders need immediate access to their necessary treatments. If these patients do not receive a particular treatment in a timely manner, their condition could progress to an irreversible state or even death.. While a health care provider can carefully consider these factors and prescribe the most effective treatment on an individual basis, step therapy disregards these considerations, applying a standard policy to all patients.
New York Step Therapy Law – Current Status and the Need for Reform
On December 31, 2016, New York passed a step therapy law, which requires:
- Utilization review agents to use evidence-based and peer reviewed clinical review criteria when establishing a step therapy protocol;
- The clinical review criteria to be appropriate for the patient’s medical condition when conducting the utilization review; and
- Timelines for approving exception requests within 24 and 72 hours.
An exception request must be approved within 72 hours if:
- The required treatment is likely to cause harm to the patient; or
- The required treatment is expected to be ineffective; or
- The patient is stable on a treatment; or
- The required treatment is not in the patient's best interest.
An exception request must be approved within 24 hours if a patient has a medical condition that places his or her health in serious jeopardy without treatment prescribed by the patient’s health care profession The law became effective on January 1, 2017, and required all state-regulated commercial plans, exchange plans, Medicaid managed care plans, and Child Health Plus plans issued or renewed after January 1, 2017, to comply with these requirements.
Despite New York’s efforts to place guardrails and consumer protections on step-therapy policies, a 2019 survey conducted by Aimed Alliance showed that New York health care practitioners, were still finding the step therapy process burdensome and harmful for patients. In fact, only 45 percent of survey respondents felt that the New York’s step therapy law had improved patients’ abilities to access their medications.
What Type of Step Therapy Reform is Needed in 2023
Over the past several years, Aimed Alliance has worked with a group of nonprofits, patient advocacy organizations, professional associations, regulators, and legislative officials to determine how the current New York Step Therapy law could be improved to better protect patients' access to their necessary medications; and to ensure that bad actors that violate the step-therapy law are held accountable.
In 2023, Senator Breslin and Assemblyman McDonald introduced the following four bills to fix the gaps in the New York Step Therapy Law:
The current step therapy legislation developed a protocol for override determinations, however, patients with complex health conditions have historically faced challenges in obtaining coverage for medically necessary treatments and services individualized to their needs. If an override is not granted, the time a patient wastes trying and failing on less effective treatments or medications may cause irreversible harm. The policies are also particularly dangerous for individuals with progressive diseases that need timely access to their prescribed treatments to avoid disease progression.
Solution: S.2682/A.582, amends current law to ensure that step therapy does not apply to medically necessary treatments for the following therapeutic categories:
(1) Dermatology;
(2) Gastroenterology;
(3) Hematology;
(4) Neurology:
(5) Rheumatology;
(6) Oncology: and
(7) Ophthalmology.
Prohibiting the application of step-therapy policies to individuals with these types of complex health conditions prevents irreversible harm or disease progression that may result from the requirement to try and fail on ineffective medications
The current New York step therapy law requires insurers to make an override determination if certain criteria are met. Nonetheless, Aimed Alliance recently found that more than half of surveyed health care professionals do not believe that the current law made a significant difference in the frequency of step therapy exception denials. In addition, almost half of respondents reported that plans frequently required patients to try and fail on the same medication more than once, in violation of current law. Reporting requirements are essential to understanding whether insurers are complying with the law and providing patients and providers with equal access to information.
Solution: S.2800/A.1384, requires disclosure of non-confidential information regarding step therapy override requests and determinations on a website that is readily accessible to the public. Making this information available enables patients, providers and policy makers to monitor the data for potential violations of the law and opportunities for improvement.
Current law requires step therapy protocols to follow a written procedure when notifying a patient and their prescribing health care professional of an adverse determination related to a step therapy override. However, its unclear how often consumers are receiving this information; being informed of their right to appeal; and what costs are saved as a result of the step-therapy protocols.
Solution: S.2677/A.463 would require that patients are provided the reasoning for the determination, instructions for appeal, information on alternative covered medications, clinical criterial, and any other necessary information. Providing this information allows patients and health care professionals to more easily request step therapy overrides and appeals and plan for efficient treatment.
Current step therapy laws do not adequately protect patients from overly burdensome and potentially harmful protocols. Insurers may require patients to try and fail repeatedly on inappropriate medications, or impose obstacles that significantly delay access to the prescribed medication. Step therapy protocols that ignore prior failures or create delays in access to medication, can result in adverse events, including disease progression and relapse.
Solution: S.1267/A.901 would require a utilization review agent to follow certain rules when establishing a step therapy protocol. For example, it prohibits plans from requiring patient to
- Step through an off-label medication;
- Try and fail on more than one drug;
- Use the plan’s preferred drug for longer than thirty day;, and
- Impose a step therapy if the enrollee has been on the prescribed drug within the past year, among other prohibitions.
The bill would require health plans to accept an attestation from the enrollee’s prescriber that the required drug has failed as sufficient evidence of such failure.
