Today, the Rhode Island House of Representatives voted to approve a bill (H7512B), filed at the request of Attorney General Peter. F Kilmartin and sponsored by Representative K. Joseph Shekarchi (D- District 23, Warwick), which expands health insurance coverage to include off-label use of prescription medications for the treatment of disabling or life-threatening chronic diseases.
This legislation bans health insurers from refusing to cover non-Federal Drug Administration (FDA) approved drugs used for the treatment of disabling, chronic, or life-threatening disease on the grounds the drug was not approved for the prescribed use by the FDA. The drug does, however, have to be recognized for treatment of a disabling, chronic, or life-threatening disease in one of the standard reference compendia or other medical literature. This bill expands the kind of comprehensive coverage previously available to only cancer treatment to medication used to treat any disabling, chronic, or life-threatening disease.
"With one in five prescriptions involving off-label drug use for those suffering debilitating or life-threatening diseases, this measure in Rhode Island was long overdue," said Attorney General Kilmartin. "Patients should not have to worry that insurance companies will refuse to cover the medications they need, and their doctors prescribed, to live comfortably and pain-free. Now they won't have to."
"This legislation is vital to Rhode Islanders who are seeking nothing more than an effective treatment for their health. It is wrong to deny someone medicine that works if the medicine was not initially developed to treat certain diseases and conditions," said Representative Shekarchi (D-Dist. 23, Warwick). "Breakthroughs and new discoveries happen constantly within the prescription drug field and it is important we do not let sick people suffer by denying them effective medication because the labeling and directed uses of a certain drug are not up to date with the current medical data."
Prescribing off-label medications is an incredibly common practice within the medical community. When a doctor prescribes a medication "off label," it means said previously available medication is being used to treat a symptom or disease which has not received FDA approval, not that the medication itself has not been reviewed by the FDA.
In Rhode Island, the use of off-label medication to treat cancer has been required of insurance companies since 1994. The passing of H7512 not only highlights the dramatic medical advances made since 1994, but makes them financially accessible for all Rhode Islanders. Obtaining FDA approval for medication is a lengthy and expensive process, and Rhode Islanders with chronic, disabling, or life-threatening illnesses should not have to refuse treatment because medical data is not updated.
A companion bill in the Senate, S2499, sponsored by Senator William A. Walaska (D- District 30, Warwick), was passed on May 12, 2016.