MSSNY supported the enactment of this law, which is applicable to all NY-regulated health plans as of January 1, 2018.
It requires ALL NY-regulated health insurers to grant an override of its step therapy protocol upon receipt of information from the physician “that includes supporting rationale and documentation”
that the drug(s) being required by the health insurer:
- Is contraindicated or will likely cause an adverse reaction by physical or mental harm to the patient;
- Is expected to be ineffective based on the known clinical history and conditions of the patient and his/her drug regimen;
- Has been tried by the patient or another prescription drug(s) in the same pharmacologic class or with the same mechanism for action and such drug(s) was discontinued due to a lack of efficacy or effectiveness, diminished effect or an adverse event;
- Should not be required because the patient is stable on a drug other than the drug being required by the insurer; or
- Is not in the best interest of the patient because it will likely cause a significant barrier to a patient’s adherence with his/her plan of care, will likely worsen a comorbid condition of the patient, or will likely decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities.
Health insurers must respond to a step therapy override request within 72 hours of the request. A health insurer is required to respond within 24 hours if the request is for a patient with a medical condition that places the health of the patient in serious jeopardy without the prescription drug or drugs prescribed by the patient’s physician. If the health insurer fails to act within these 72 or 24-hour time periods, the request will be granted in favor of the patient.
The new law also requires that health insurers’ step therapy protocols be based on evidence-based and peer-reviewed clinical criteria that also take into account the needs of atypical patients. These criteria must be made available to physicians upon request.