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| 1 | | of an approved cancer research trial in Phase II, Phase |
| 2 | | III, or Phase IV of investigation; |
| 3 | | (3) the trial is: |
| 4 | | (A) approved by the Food and Drug Administration; |
| 5 | | or |
| 6 | | (B) approved and funded by the National Institutes |
| 7 | | of Health, the Centers for Disease Control and |
| 8 | | Prevention, the Agency for Healthcare Research and |
| 9 | | Quality, the United States Department of Defense, the |
| 10 | | United States Department of Veterans Affairs, or the |
| 11 | | United States Department of Energy in the form of an |
| 12 | | investigational new drug application, or a cooperative |
| 13 | | group or center of any entity described in this |
| 14 | | subdivision (B); and
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| 15 | | (4) the patient's primary care physician, if any, is |
| 16 | | involved in the coordination of care.
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| 17 | | (c) No group policy of accident and health insurance shall |
| 18 | | exclude coverage for any routine patient care administered to |
| 19 | | an insured who is a qualified individual participating in a |
| 20 | | qualified clinical cancer trial, if the policy covers that same |
| 21 | | routine patient care of insureds not enrolled in a qualified |
| 22 | | clinical cancer trial. |
| 23 | | (d) The coverage that may not be excluded under subsection |
| 24 | | (c) of this Section is subject to all terms, conditions, |
| 25 | | restrictions, exclusions, and limitations that apply to the |
| 26 | | same routine patient care received by an insured not enrolled |
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| 1 | | in a qualified clinical cancer trial, including the application |
| 2 | | of any authorization requirement, utilization review, or |
| 3 | | medical management practices. The insured or enrollee shall |
| 4 | | incur no greater out-of-pocket liability than had the insured |
| 5 | | or enrollee not enrolled in a qualified clinical cancer trial. |
| 6 | | (e) If the group policy of accident and health insurance |
| 7 | | uses a preferred provider program and a preferred provider |
| 8 | | provides routine patient care in connection with a qualified |
| 9 | | clinical cancer trial, then the insurer may require the insured |
| 10 | | to use the preferred provider if the preferred provider agrees |
| 11 | | to provide to the insured that routine patient care. |
| 12 | | (f) A qualified clinical cancer trial may not pay or refuse |
| 13 | | to pay for routine patient care of a individual participating |
| 14 | | in the trial, based in whole or in part on the person's having |
| 15 | | or not having coverage for routine patient care under a group |
| 16 | | policy of accident and health insurance. |
| 17 | | (g) Nothing in this Section shall be construed to limit an |
| 18 | | insurer's coverage with respect to clinical trials. |
| 19 | | (h) Nothing in this Section shall require coverage for |
| 20 | | out-of-network services where the underlying health benefit |
| 21 | | plan does not provide coverage for out-of-network services. |
| 22 | | (i) As used in this Section, "routine patient care" means |
| 23 | | all health care services provided in the qualified clinical |
| 24 | | cancer trial that are otherwise generally covered under the |
| 25 | | policy if those items or services were not provided in |
| 26 | | connection with a qualified clinical cancer trial consistent |
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| 1 | | with the standard of care for the treatment of cancer, |
| 2 | | including the type and frequency of any diagnostic modality, |
| 3 | | that a provider typically provides to a cancer patient who is |
| 4 | | not enrolled in a qualified clinical cancer trial. "Routine |
| 5 | | patient care" does not include, and a group policy of accident |
| 6 | | and health insurance may exclude, coverage for: |
| 7 | | (1) a health care service, item, or drug that is the |
| 8 | | subject of the cancer clinical trial; |
| 9 | | (2) a health care service, item, or drug provided |
| 10 | | solely to satisfy data collection and analysis needs for |
| 11 | | the qualified clinical cancer trial that is not used in the |
| 12 | | direct clinical management of the patient; |
| 13 | | (3) an investigational drug or device that has not been |
| 14 | | approved for market by the United States Food and Drug |
| 15 | | Administration; |
| 16 | | (4) transportation, lodging, food, or other expenses |
| 17 | | for the patient or a family member or companion of the |
| 18 | | patient that are associated with the travel to or from a |
| 19 | | facility providing the qualified clinical cancer trial, |
| 20 | | unless the policy covers these expenses for a cancer |
| 21 | | patient who is not enrolled in a qualified clinical cancer |
| 22 | | trial; |
| 23 | | (5) a health care service, item, or drug customarily |
| 24 | | provided by the qualified clinical cancer trial sponsors |
| 25 | | free of charge for any patient; |
| 26 | | (6) a health care service or item, which except for the |
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| 1 | | fact that it is being provided in a qualified clinical |
| 2 | | cancer trial, is otherwise specifically excluded from |
| 3 | | coverage under the insured's policy, including: |
| 4 | | (A) costs of extra treatments, services, |
| 5 | | procedures, tests, or drugs that would not be performed |
| 6 | | or administered except for the fact that the insured is |
| 7 | | participating in the cancer clinical trial; and |
| 8 | | (B) costs of nonhealth care services that the |
| 9 | | patient is required to receive as a result of |
| 10 | | participation in the approved cancer clinical trial; |
| 11 | | (7) costs for services, items, or drugs that are |
| 12 | | eligible for reimbursement from a source other than a |
| 13 | | patient's contract or policy providing for third-party |
| 14 | | payment or prepayment of health or medical expenses, |
| 15 | | including the sponsor of the approved cancer clinical |
| 16 | | trial; or |
| 17 | | (8) costs associated with approved cancer clinical |
| 18 | | trials designed exclusively to test toxicity or disease |
| 19 | | pathophysiology, unless the policy covers these expenses |
| 20 | | for a cancer patient who is not enrolled in a qualified |
| 21 | | clinical cancer trial; or |
| 22 | | (9) a health care service or item that is eligible for |
| 23 | | reimbursement by a source other than the insured's policy, |
| 24 | | including the sponsor of the qualified clinical cancer |
| 25 | | trial. |
| 26 | | The definitions of the terms "health care services", |
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| 1 | | "Non-Preferred Provider", "Preferred Provider", and "Preferred |
| 2 | | Provider Program", stated in 50 IL Adm. Code Part 2051 |
| 3 | | Preferred Provider Programs apply to these terms in this |
| 4 | | Section. |
| 5 | | (j) The external review procedures established under the |
| 6 | | Health Carrier External Review Act shall apply to the |
| 7 | | provisions under this Section. |
| 8 | | (Source: P.A. 93-1000, eff. 1-1-05.)
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| 9 | | Section 99. Effective date. This Act takes effect January |
| 10 | | 1, 2012.".
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