The Massachusetts State Senate on Monday enacted legislation to limit the use of step therapy, or ‘fail first’ protocols that too often direct patients to cheaper medications rather than those more suitable to treat their condition. The bill, An Act relative to step therapy and patient safety, gives health care providers more leverage in determining the most effective treatment options for patients, saving patients expensive and painful regimens on medications they know to be ineffective or harmful. This bill builds on similar legislation passed by the Senate in 2020.

Step therapy serves as a cost-saving mechanism that can limit a patient’s ability to access the medication that is most suitable for treating their condition. Insurers that utilize step therapy protocols require medical providers to prescribe lower-cost medications to patients first, and only grant approval for alternative medications when the cheaper options have failed to improve a patient's condition. In practice, this results in insurers effectively choosing medications for the patient, even in cases where their providers have recommended an alternative. When patients change insurers, they are often forced to start at the beginning of the step therapy protocol again, which results in wasteful health care expenditures, lost time for patients, and potentially devastating health care impacts on the patient.

Step therapy is not limited to specific diseases. It affects patients across the healthcare spectrum, with particularly dramatic impacts on the allergy and asthma, antipsychotic, arthritis, cancer, coronary artery, depression, diabetes, HIV/AIDS, multiple sclerosis, and Parkinson’s patient communities.

To address this, the bill establishes guardrails to protect patients in circumstances in which following step therapy protocols are counterproductive or harmful. The bill prohibits insurance providers from establishing a step therapy protocol that requires an insured individual to utilize a medication that is not likely to be clinically effective for the prescribed purpose. When establishing clinical criteria for step therapy protocols, the bill would ensure that insurance providers determine effectiveness through clinical review and take into account the needs of typical patient populations with similar diagnoses.

The bill provides patients who are subjected to step therapy sequences with an accessible exemption request process whenever coverage is restricted. The legislation enumerates specific timelines for insurers to review requests and grant exceptions, and in cases where interruptions in the patient's medication schedule puts them at considerable risk, the turnaround time is faster. Under the bill, providers would accept or deny a request within 3 business days or within 24 hours if additional delay would significantly risk the insured individual’s health or well-being. If an exception to step therapy is denied, the bill includes a process for the decision to be appealed.  Upon granting exemptions, MassHealth and private insurers would be required to provide coverage for the drug recommended by the patient's provider.  

To assist in future reforms, the bill would create a commission on step therapy protocols within MassHealth to study and assess the implementation of this bill and any future step therapy reforms.

If passed, Massachusetts would join 28 other states in curbing unfair step therapy practices. The bill, An Act relative to step therapy and patient safety, is now before the Governor for his consideration.