(1) "Coveredclinical trials" means phase II, phase III, and phase IV patient researchstudies designed to evaluate new treatments, including prescription drugs, andthat: (i) involve the treatment of life‑threatening medical conditions,(ii) are medically indicated and preferable for that patient compared toavailable noninvestigational treatment alternatives, and (iii) have clinicaland preclinical data that shows the trial will likely be more effective forthat patient than available noninvestigational alternatives. Covered clinicaltrials must also meet the following requirements:
a. Must involvedeterminations by treating physicians, relevant scientific data, and opinionsof experts in relevant medical specialties.
b. Must be trialsapproved by centers or cooperative groups that are funded by the NationalInstitutes of Health, the Food and Drug Administration, the Centers for DiseaseControl, the Agency for Health Care Research and Quality, the Department ofDefense, or the Department of Veterans Affairs. The health benefit plan mayalso cover clinical trials sponsored by other entities.
c. Must be conducted ina setting and by personnel that maintain a high level of expertise because oftheir training, experience, and volume of patients.
(2) "Health benefitplan" is defined by G.S. 58‑3‑167.
(3) "Insurer"is defined by G.S. 58‑3‑167.
(b) Each health benefitplan shall provide coverage for participation in phase II, phase III, and phaseIV covered clinical trials by its insureds or enrollees who meet protocolrequirements of the trials and provide informed consent.
(c) Only medicallynecessary costs of health care services, as defined in G.S. 58‑50‑61,associated with participation in a covered clinical trial, including thoserelated to health care services typically provided absent a clinical trial, thediagnosis and treatment of complications, and medically necessary monitoring,are required to be covered by the health benefit plan and only to the extentthat such costs have not been or are not funded by national agencies,commercial manufacturers, distributors, or other research sponsors ofparticipants in clinical trials. Nothing in this section shall be construed torequire a health benefit plan to pay or reimburse for non‑FDA approveddrugs provided or made available to a patient who received the drug during acovered clinical trial after the clinical trial has been discontinued.
(d) Clinical trialcosts not required to be covered by a health benefit plan include the costs ofservices that are not health care services, those provided solely to satisfydata collection and analysis needs, those related to investigational drugs anddevices, and those that are not provided for the direct clinical management ofthe patient. In the event a claim contains charges related to services forwhich coverage is required under this section, and those charges have not beenor cannot be separated from costs related to services for which coverage is notrequired under this section, the health benefit plan may deny the claim. (2001‑446, s. 3.1.)
(1) "Coveredclinical trials" means phase II, phase III, and phase IV patient researchstudies designed to evaluate new treatments, including prescription drugs, andthat: (i) involve the treatment of life‑threatening medical conditions,(ii) are medically indicated and preferable for that patient compared toavailable noninvestigational treatment alternatives, and (iii) have clinicaland preclinical data that shows the trial will likely be more effective forthat patient than available noninvestigational alternatives. Covered clinicaltrials must also meet the following requirements:
a. Must involvedeterminations by treating physicians, relevant scientific data, and opinionsof experts in relevant medical specialties.
b. Must be trialsapproved by centers or cooperative groups that are funded by the NationalInstitutes of Health, the Food and Drug Administration, the Centers for DiseaseControl, the Agency for Health Care Research and Quality, the Department ofDefense, or the Department of Veterans Affairs. The health benefit plan mayalso cover clinical trials sponsored by other entities.
c. Must be conducted ina setting and by personnel that maintain a high level of expertise because oftheir training, experience, and volume of patients.
(2) "Health benefitplan" is defined by G.S. 58‑3‑167.
(3) "Insurer"is defined by G.S. 58‑3‑167.
(b) Each health benefitplan shall provide coverage for participation in phase II, phase III, and phaseIV covered clinical trials by its insureds or enrollees who meet protocolrequirements of the trials and provide informed consent.
(c) Only medicallynecessary costs of health care services, as defined in G.S. 58‑50‑61,associated with participation in a covered clinical trial, including thoserelated to health care services typically provided absent a clinical trial, thediagnosis and treatment of complications, and medically necessary monitoring,are required to be covered by the health benefit plan and only to the extentthat such costs have not been or are not funded by national agencies,commercial manufacturers, distributors, or other research sponsors ofparticipants in clinical trials. Nothing in this section shall be construed torequire a health benefit plan to pay or reimburse for non‑FDA approveddrugs provided or made available to a patient who received the drug during acovered clinical trial after the clinical trial has been discontinued.
(d) Clinical trialcosts not required to be covered by a health benefit plan include the costs ofservices that are not health care services, those provided solely to satisfydata collection and analysis needs, those related to investigational drugs anddevices, and those that are not provided for the direct clinical management ofthe patient. In the event a claim contains charges related to services forwhich coverage is required under this section, and those charges have not beenor cannot be separated from costs related to services for which coverage is notrequired under this section, the health benefit plan may deny the claim. (2001‑446, s. 3.1.)
(1) "Coveredclinical trials" means phase II, phase III, and phase IV patient researchstudies designed to evaluate new treatments, including prescription drugs, andthat: (i) involve the treatment of life‑threatening medical conditions,(ii) are medically indicated and preferable for that patient compared toavailable noninvestigational treatment alternatives, and (iii) have clinicaland preclinical data that shows the trial will likely be more effective forthat patient than available noninvestigational alternatives. Covered clinicaltrials must also meet the following requirements:
a. Must involvedeterminations by treating physicians, relevant scientific data, and opinionsof experts in relevant medical specialties.
b. Must be trialsapproved by centers or cooperative groups that are funded by the NationalInstitutes of Health, the Food and Drug Administration, the Centers for DiseaseControl, the Agency for Health Care Research and Quality, the Department ofDefense, or the Department of Veterans Affairs. The health benefit plan mayalso cover clinical trials sponsored by other entities.
c. Must be conducted ina setting and by personnel that maintain a high level of expertise because oftheir training, experience, and volume of patients.
(2) "Health benefitplan" is defined by G.S. 58‑3‑167.
(3) "Insurer"is defined by G.S. 58‑3‑167.
(b) Each health benefitplan shall provide coverage for participation in phase II, phase III, and phaseIV covered clinical trials by its insureds or enrollees who meet protocolrequirements of the trials and provide informed consent.
(c) Only medicallynecessary costs of health care services, as defined in G.S. 58‑50‑61,associated with participation in a covered clinical trial, including thoserelated to health care services typically provided absent a clinical trial, thediagnosis and treatment of complications, and medically necessary monitoring,are required to be covered by the health benefit plan and only to the extentthat such costs have not been or are not funded by national agencies,commercial manufacturers, distributors, or other research sponsors ofparticipants in clinical trials. Nothing in this section shall be construed torequire a health benefit plan to pay or reimburse for non‑FDA approveddrugs provided or made available to a patient who received the drug during acovered clinical trial after the clinical trial has been discontinued.
(d) Clinical trialcosts not required to be covered by a health benefit plan include the costs ofservices that are not health care services, those provided solely to satisfydata collection and analysis needs, those related to investigational drugs anddevices, and those that are not provided for the direct clinical management ofthe patient. In the event a claim contains charges related to services forwhich coverage is required under this section, and those charges have not beenor cannot be separated from costs related to services for which coverage is notrequired under this section, the health benefit plan may deny the claim. (2001‑446, s. 3.1.)
