PA 16-214—sSB 371

Insurance and Real Estate Committee

Public Health Committee

General Law Committee


SUMMARY: This act allows certain terminally ill patients, under specified conditions, to access medications and devices not approved for general use by the U. S. Food and Drug Administration (FDA). It applies to investigational drugs, biological products, or devices (hereinafter “investigational drugs”) that have completed Phase 1 of an FDA-approved clinical trial and are still part of the trial. To qualify for the program, patients must meet certain eligibility criteria and complete a detailed informed consent document.

The act allows investigational drug manufacturers to provide eligible patients with investigational drugs and charge for them. It also allows health carriers (e. g. , insurers and HMOs) to cover investigational drugs and specifies when they may deny coverage to patients being treated with them.

The act specifies that it does not create a private cause of action against (1) an investigational drug manufacturer, the treating physician, or other people or entities involved in the patient's care for any harm caused by an investigational drug or (2) a health carrier that provides or denies coverage for an insured patient being treated with an investigational drug.

The act prohibits the Department of Public Health and the Medical Examining Board from taking any disciplinary action against a physician based solely on his or her recommendation to a patient to access or use an investigational drug, as long as the recommendation is consistent with medical standards of care. It also prohibits state officials, employees, and agents from preventing or attempting to prevent an eligible patient from accessing an investigational drug.

EFFECTIVE DATE: October 1, 2016


Patient Eligibility

The act allows investigational drug manufacturers to provide terminally ill patients with investigational drugs under certain conditions. It defines a “terminal illness” as a medical condition that the treating physician anticipates, with reasonable medical judgment, will result in a patient's death or a state of unconsciousness from which recovery is unlikely within a year.

Under the act, to be eligible to receive treatment with an investigational drug, a patient must:

1. have a terminal illness verified by his or her treating physician (i. e. , a state-licensed physician with primary responsibility for the patient's medical care and treatment of the terminal illness);

2. not be a hospital inpatient;

3. have considered all other FDA-approved treatment options;

4. be unable to participate in a clinical trial within 100 miles of his or her home, or not be accepted into a clinical trial within a week after the trial application process ends;

5. receive a recommendation for the drug from his or her treating physician;

6. give written informed consent for the drug's use (see below); and

7. obtain from the treating physician written documentation that he or she meets requirements (3) through (6).

Informed Consent

Under the act, the required informed consent document must be verified by the treating physician and a witness. The patient must sign the document, unless he or she is a minor or lacks the capacity to provide informed consent, in which case his or her parent or legal guardian must consent on his or her behalf.

The document must:

1. explain the currently approved and conventionally recognized products and treatments for the terminal illness;

2. verify that the patient agrees with the treating physician in believing that all currently approved and conventionally recognized products and treatments are unlikely to prolong the patient's life;

3. clearly identify the specific proposed investigational drug with which the patient is seeking treatment;

4. describe the potentially best and worst outcomes of using the drug with a realistic description of the most likely outcome, including the possibility that new, unanticipated, or worse symptoms may result and that the treatment could hasten death, based on the physician's knowledge of the treatment and awareness of the patient's condition; and

5. state that the patient understands that he or she is liable for the costs of, or associated with, the drug and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer provides otherwise.

The document must also clearly state that:

1. the patient's health carrier, treating physician, or other providers are not obligated to pay for any care or treatment resulting from taking the investigational drug;

2. the patient's hospice care eligibility may be withdrawn if the patient begins treatment with an investigational drug, but hospice care may be reinstated if the treatment ends and the patient is hospice eligible; and

3. in-home health care may be denied if treatment begins.

Insurance Provisions

Under the act, health carriers may cover investigational drugs made available to eligible patients as set forth above but are not required to do so. While a patient is being treated with an investigational drug and for the following six months, health carriers may deny coverage to the patient, except for (1) preexisting conditions or (2) benefits that began before treatment with the drug.

The act defines a “health carrier” as an insurer, HMO, hospital or medical service corporation, fraternal benefit society, or other entity that delivers, issues, renews, amends, or continues a health insurance policy that covers (1) basic hospital expenses; (2) basic medical-surgical expenses; (3) major medical expenses; (4) hospital or medical services; or (5) ancillary services, such as dental, vision, or prescription drugs.

It specifies that (1) treatment with investigational drugs as set forth in the act is the practice of medicine and not a clinical trial for purposes of the law's requirements for insurance coverage of certain clinical trial costs and (2) it does not affect those coverage requirements.

OLR Tracking: JKL; JSB; VR; bs