Senate Passes Bill to Limit the Use of Step Therapy

On Thursday, July 30, 2020, the Massachusetts State Senate passed 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 the Senate’s ongoing commitment to creating a more affordable, accessible, and patient-centered health care system for all. The Senate has already passed legislation this session to address rising prescription drug prices, increase access to mental health services, protect patients and enhance quality care. The step therapy legislation expands on this progress.

“From the outset of the session, the Senate has prioritized life-saving patient reforms that will improve treatment outcomes for all residents,” stated Senate President Karen E. Spilka (D-Ashland). “I am proud to add limiting the use of step therapy to our long list of health care accomplishments as it will help shift the balance of care back in the direction of the patient. I want to thank Senators Cyr and Friedman for elevating this important issue.” 

“Providing the right treatment and therapies at the right time to people with cancer and debilitating diseases is all too important and critical during this extremely challenging time as is ensuring the wellbeing of patients in need,” said Senator Michael J. Rodrigues (D-Westport), Chair of the Senate Committee on Ways and Means. “With the passage of this bill today, the Senate is taking a vital step forward to providing guardrails around the use of step therapy and ensuring patient safety. I applaud Senate President Spilka for her continued leadership, Senator Cyr, Senator Friedman and others for their hard work and advocacy to move this critical legislation forward that puts patients first.”

"Patients with complicated illnesses should be receiving the medications that their doctors know they need—not repeatedly taking medications that they know to be ineffective just to help insurers save on costs," said State Senator Julian Cyr (D-Truro), Chair of the Joint Committee on Mental Health, Substance Abuse, and Recovery, who sponsored the legislation. "Step therapy is a shortsighted practice that puts patients at unnecessary risk; it takes lower costs today in exchange for more harm, more hospitalizations, and more spending in the very near future. I’m proud that the Senate took action to arrest this practice in Massachusetts." 

“This bill takes an important step toward placing treatment decisions back in the hands of the health care provider and patient by limiting opportunities for insurance companies to force a patient to fail on certain medications before they can access the one most suitable for their needs,” said Senator Cindy F. Friedman (D-Arlington), co-chair of the Joint Committee on Health Care Financing. “While we must continue to address the high cost of drugs, we cannot do it at the expense of patients, and cost can never be the primary determinant of whether a patient has to suffer needlessly before they can access the medication that is most effective for treating their condition.”

"Too often, patients whose symptoms leave them weak and fatigued find that the regimen of medicine that they need is withheld and they instead are put on a path of pharmaceuticals which are at best less expensive but at worst ineffective in overcoming their illness. This so-called fail-first then try again approach leaves people and their families feeling desperate and uncared for," said Senate Minority Leader Bruce Tarr (R - Gloucester).

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 disease states. 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. 

As such, the bill would establish guardrails to protect patients in circumstances in which following step therapy protocols are counterproductive or harmful. It would require MassHealth and private insurers to grant exemptions to step therapy protocols in cases where the protocol-required cost-effective drug is likely to cause harm, is expected to be ineffective, has been tried by the patient previously, is not in the best interest of the patient, or adopting it in concert with the patient's existing medications would cause harm. Upon granting exemptions, MassHealth and private insurers would be required to provide coverage for the drug recommended by the patient's provider.  

The bill would provide patients subject to step therapy sequences with an accessible exception request process whenever coverage is restricted. The legislation establishes 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. If an exception to step therapy is denied, the decision can be appealed. 

In addition, the bill takes several steps to enhance transparency. Under the bill, insurers would be required to file annual reports to the Division of Insurance (DOI) detailing the number of step therapy exception requests received, the number of requests denied, and the reasons for denial. This additional data is expected to keep insurers from chronically denying exception requests or making deceptive cases for keeping patients adhered to step protocols when they have requested otherwise.

The bill would also commit DOI resources to overseeing the implementation of step therapy reforms, with particular attention to cost-effectiveness and continuum of care for patients requesting exceptions. The DOI would be required to deliver biannual reports to the Massachusetts Secretary of Health and Human Services and the Joint Committee on Health Care Financing. 

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, now moves to the House of Representatives for consideration.