Advocating for patients, Attorney General Peter F. Kilmartin has filed legislation that would expand health insurance coverage to include off-label use of prescription medications for the treatment of disabling or life-threatening chronic diseases.
The legislation (H7512/S2499) is scheduled to be heard in the House Corporations Committee on Tuesday, March 1st and the Senate Health and Human Services Committee on Wednesday, March 3rd.
Sponsored by Representative K. Joseph Shekarchi (D – District 23, Warwick) and Senator William A. Walaska (D – District 30, Warwick), the legislation states that health insurers which provide coverage of prescription drugs cannot exclude coverage of any drug used for the treatment of disabling or life-threatening chronic disease on the grounds that the drug has not been approved by the Federal Drug Administration (FDA) for that indication, provided the drug is recognized for treatment of that indication in one of the standard reference compendia, or in the medical literature. Currently, such coverage is only contemplated for the treatment of cancer.
"More than one in five prescriptions in the United States are written for off label uses, however, insurers are free to deny coverage. This is why states have laws safeguarding coverage for patients with disabling, chronic, or life-threatening conditions. This act ensures that Rhode Islanders have the appropriate insurance coverage for the treatment that their medical professionals believe is necessary to treat their condition. Rhode Islanders facing disabling or life-threatening chronic diseases should never be in a position to turn down treatment recommended by their doctor due to the fact that insurance will not cover it," said Attorney General Kilmartin.
"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. "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."
"If physicians feel that an off-label medication is the best option for their patients, then we shouldn't put those seeking health care into a position where they don't follow doctors' orders simply because they can't afford it," said Senator Walaska. "Taking away the ability of insurance companies to deny coverage for an off-label medication is a good step forward for the health of all Rhode Islanders."
The medical community has been prescribing medications for off-label purposes for many years. Currently 36 states provide for off-label prescription drug use. This practice involves prescribing currently available and marketed medications, but for an indication (i.e. a disease or a symptom) that has never received FDA approval. Hence, the specific use is "off-label" (i.e., not approved by the FDA and not listed in FDA-required drug-labeling information).
Rhode Island has required coverage of off-label prescription drug use for the treatment of cancer since 1994. Since that time medical technologies have advanced and not only has there been success in off-label prescribing in cancer treatment, there has been success in many other diseases as well. Some may ask why government approval is not obtained to convert off-label uses of drugs to on-label uses. Simply put, obtaining a new FDA approval for a medication can be costly and time-consuming. Even if eventually approved, revenues for the new use may not offset the expense and effort of obtaining approval.