Session Laws

Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows:

SECTION 1. Chapter 175 of the General Laws is hereby amended by inserting after section 47J, inserted by section 509 of chapter 133 of the acts of 1992, the following two sections:-

Section 47K. No individual policy of accident and sickness insurance issued pursuant to section one hundred and eight which provides coverage for prescription drugs, nor any group blanket policy of accident and sickness insurance issued pursuant to section one hundred and ten which provides coverage for prescription drugs, shall exclude coverage of any such drug used for the treatment of cancer on the grounds that the off-label use of the drug has not been approved by the United States Food and Drug Administration for that indication; provided, however, that such drug is recognized for treatment of such indication in one of the standard reference compendia, or in the medical literature, or by the commissioner under the provisions of section forty-seven L.

Any coverage of a drug required by this section shall also include medically necessary services associated with the administration of the drug.

This section shall not be construed to alter existing law with regard to provisions limiting the coverage of drugs that have not been fully licensed or approved by the United States Food and Drug Administration nor shall this section create an exclusionary presumption or inference concerning other appropriate medically accepted indications.

This section shall not be construed to require coverage for any drug when the United States Food and Drug Administration has determined its use to be contraindicated for cancer.

This section shall not be construed to require coverage for experimental drugs not otherwise approved for any indication by the United States Food and Drug Administration.

For the purpose of this section, and section forty-seven L, the following words shall have the following meanings unless the context clearly requires otherwise:-

"Medical literature", published scientific studies appearing in any peer-reviewed national professional journal.

"Off-label use", a prescription drug used in the treatment of cancer which has been approved by the United States Food and Drug Administration and such drug is used for indications other than those approved by said Food and Drug Administration.

"Standard reference compendia", (a) the United States Pharmacopoeia Drug Information; (b) the American Medical Association Drug Evaluations; or (c), the American Hospital Formulary Service Drug Information.

Section 47L. The commissioner shall establish a panel of six medical experts to review off-label uses, so-called, for prescription drugs for the treatment of cancer not included in any of the standard reference compendia or in the medical literature and to advise said commissioner in such instances whether a particular off-label use is medically appropriate. The panel shall make such recommendations from time to time and whenever a particular dispute about payment for such off-label use is referred to the panel by the commissioner. The members of said panel shall include: (a) three medical oncologists selected by the state medical oncology association, (b) a physician selected by the Massachusetts medical association, (c) a physician selected by a hospital and medical service corporation and (d), a physician selected by the Massachusetts association of health maintenance organizations from a member plan.

The commissioner shall have the authority to direct any insurer to make payments, consistent with the recommendations of the panel, required by section forty-seven K, section eight N of chapter one hundred and seventy-six A, section four N of chapter one hundred and seventy-six B and section four E of chapter one hundred and seventy-six G.

SECTION 2. Chapter 176A of the General Laws is hereby amended by inserting after section 8M the following section:-

Section 8N. Any contract between a subscriber and the corporation under an individual or group hospital service plan that shall be delivered, issued or renewed in the commonwealth, which provides coverage for prescription drugs, shall provide as benefits to all individual subscribers and members and to all groups having a principal place of employment within the commonwealth, coverage for off-label uses of prescription drugs used in the treatment of cancer as defined in, and subject to the restrictions of, sections forty-seven K and forty-seven L of chapter one hundred and seventy-five.

SECTION 3. Chapter 176B of the General Laws is hereby amended by inserting after section 4M the following section:-

Section 4N. Any subscription certificate under an individual or group medical service agreement that shall be delivered, issued or renewed in the commonwealth which provides coverage for prescription drugs, shall provide as benefits to all individual subscribers and members and to all group members having a principal place of employment within the commonwealth, coverage for off-label uses of prescription drugs used in the treatment of cancer as defined in, and subject to the restrictions of, sections forty-seven K and forty-seven L of chapter one hundred and seventy-five.

SECTION 4. Chapter 176G of the General Laws is hereby amended by inserting after section 4D the following section:-

Section 4E. A group health maintenance contract shall provide coverage for off-label uses of prescription drugs used in the treatment of cancer as set forth in sections forty-seven K and forty-seven L of chapter one hundred and seventy-five; provided, however, that neither the attending physician nor the health maintenance organization shall be liable in a suit for damages as a result of the acts or omissions of the attending physician or the health maintenance organization in connection with compliance with this section.