Vermont law aims to improve CAD treatment access for patients

H.766 requires insurers to grant timely exceptions to step therapy policies

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

Share this article:

Share article via email
A bill is shown on a scroll of parchment.

Vermont Governor Phil Scott has signed into law a bill that improves access to the right medication at the right time by requiring both private and public health insurers to make timely exceptions to their step therapy policies.

Misuse of step therapy protocols, which require patients to “fail first” on one or more alternative medicines before they can access the one they were first prescribed, is particularly worrying for those with rare diseases such as cold agglutinin disease (CAD).

“Individuals living with rare [diseases] already spend so much time on their diagnostic odyssey — often going years without answers as to what is causing their symptoms — and then struggle to find the right treatment,” Carolyn Sheridan, state policy manager at the National Organization for Rare Disorders (NORD), said in an organization press release that touts the new law. “Thanks to this new law, fewer rare disease patients and their caregivers in Vermont will have to ‘step’ through unnecessary, burdensome and potentially harmful hoops to get the medicine their provider initially ordered.”

Throughout the lawmaking process, NORD sent letters to legislators pushing for ending step therapy policies or for implementing amendments that would let rare disease patients access the medications they need. Members of the Rare Action Network joined NORD in the effort.

“NORD is thrilled that Vermont’s state officials responded to our advocacy and lawmakers worked together to help the one in 10 Vermonters living with rare diseases,” Sheridan said.

Recommended Reading
Rare Disease Day 2022 | Custom illustration of Rare Disease Day 2022

More Studies Confirm Hefty Economic Burden of Rare Diseases

Step therapy drawbacks

Step therapy is intended to keep healthcare costs under control, but it’s accused of paying little heed to a patient’s medical history or needs, leading to unnecessary and sometimes harmful treatment, and delays in getting the right one.

Under H.766, health insurers must grant patients timely exceptions to their step-therapy policies when the medicine covered under their protocol is likely to have side effects, not work as intended, or not be in the patients’ best interests. Such exceptions should also be applied to those who are already stable on a different medication for the same condition.

The law also limits the time within which insurers must respond to prior authorization requests and makes responses to requests for exceptions follow the same deadlines. With the new legislation, Vermont joins the more than half of U.S. states that mandate a clear exception process to protect patients from harmful policies by insurers.

“I have really enjoyed my engagement on the advocacy front with step therapy reform,” said Mary Nadon Scott, a patient advocate. “Having the opportunity to speak as a patient advocate for the Senate Hearing Committee was an incredible way to share my story and rare disease patient perspective.”

Step therapy is one of nine policy issues evaluated in NORD’s State Report Card, which evaluates how well U.S. states are serving people with rare diseases. Other issues include insurance coverage and protection, newborn screening, telehealth, and advisory bodies.

“Step therapy reform is just one of NORD’s policy priorities intended to improve access to care for the 30 million people living with rare disease,” Sheridan said. “We will continue to work with lawmakers in Montpelier to see other critical pieces of legislation like a bill to create a Rare Disease Advisory Council signed into law.”