House approves bill to reform step therapy protocols

The Mass. House of Representatives has approved bipartisan legislation limiting the use of step therapy protocols, in which insurance companies refuse to pay for the prescription drugs prescribed by a patient’s health care provider until the patient first tries cheaper, and often ineffective, alternatives. The legislation establishes exceptions a patient can use to avoid their insurer’s step therapy protocol and requires both MassHealth and commercial insurers to provide a clear and transparent process for patients and their care team to request an exception.


“A top priority of the House is to ensure that every resident of the Commonwealth has access to quality, affordable health care, but controlling costs should never come at the expense of positive patient outcomes,” said House Speaker Ronald J. Mariano (D-Quincy). “This legislation helps to achieve that goal by ensuring that patients in Massachusetts can circumvent step therapy protocols in instances where the process will result in delayed access to the only adequate medication. I want to thank Chairman John Lawn, as well as all my colleagues in the House, for their commitment to improving our health care system, and for the hard work required to get this done.”


The legislation outlines four different circumstances that trigger the patient exception process, including:

  1. The required treatment will harm the patient,

  2. The required treatment is expected to be ineffective,

  3. The patient previously tried the required treatment, or similar treatment, and it was ineffective or harmed the patient,

  4. The patient is stable on a current treatment, and switching treatments will harm the patient.

Additional highlights of the legislation include:


● A requirement that MassHealth and commercial insurers adopt a “continuity of coverage” policy to ensure patients do not experience any delay in accessing a treatment when requesting a step therapy exemption.

● A requirement that MassHealth and commercial insurers approve or deny a step therapy exemption request within three business days, or within one business day if a delay would cause harm to the patient.

● A requirement that commercial carriers annually report data related to step therapy exemption requests and related coverage determinations to the Division of Insurance.

● The creation of a commission on step therapy protocols tasked with studying, assessing, and bi-annually reporting on the implementation of step therapy process reforms made in this legislation.


“An Act Relative to Step Therapy and Patient Safety” (H.4929)passed the House of Representatives 153-0. The legislation now heads to the Senate for their consideration.

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