2023 Tennessee Code › Title 56 - INSURANCE (§§ 56-1-101 — 56-61-125) › Chapter 7 - POLICIES AND POLICYHOLDERS 33|373 (§§ 56-7-NEW — 56-7-3722) › Part 23 - MANDATED INSURER OR PLAN COVERAGE (§§ 56-7-NEW — 56-7-2369) › Section 56-7-2365 - Health insurance coverage related to clinical trials

(a)
As used in this section, unless the context otherwise requires:
(1)
"Health benefit plan" means any hospital or medical expense policy, health, hospital or medical service corporation contract, a policy or agreement entered into by a health insurer or health maintenance organization contract offered by an employer, but does not include individually underwritten health insurance policies, or policies or certificates covering only accident, credit, dental, disability income, long-term care, hospital indemnity, medicare supplement as defined in § 1882(g)(1) of the Social Security Act (
42 U.S.C. § 1395ss(g)(1)
), specified disease, vision care, other limited benefit health insurance, coverage issued as a supplement to liability insurance, workers' compensation insurance, automobile medical payment insurance or insurance that is statutorily required to be contained in any liability insurance policy or equivalent self insurance;
(2)
"Health insurer" means any entity offering a health benefit plan; and
(3)
"Routine patient care costs" means the costs associated with the provision of health care services, including drugs, medical devices, and services that would otherwise be covered under the plan or contract, if those drugs, medical devices, and services were not provided in connection with an approved clinical trial program, including health care services that are:
(A)
Typically provided absent a clinical trial;
(B)
Required solely for the provision of the drug, medical device or service;
(C)
Required for the clinically appropriate monitoring of the drug, medical device, or service;
(D)
Provided for the prevention of complication arising from the provision of the drug, medical device, or service; and
(E)
Needed for the reasonable and necessary care arising from the provision of the drug, medical device, or service, including the diagnosis or treatment of the complications.
(b)
The subject of the trial must evaluate a drug, medical device or service that falls within a medicare benefit category and is not statutorily excluded from coverage. For purposes of this section, "routine patient care costs" does not include the costs associated with the provision of any of the following:
(1)
Drugs, medical devices, and services that have not been approved by the federal food and drug administration and that are associated with the clinical trial;
(2)
Services other than health care services, such as travel, housing, companion expenses, and other nonclinical expenses, that an enrollee may require as a result of the treatment being provided for purposes of the clinical trial;
(3)
Drugs, medical devices, and services that are provided solely to satisfy data collection and analysis needs, and that are not used in the clinical management of the patient;
(4)
Health care services that, except for the fact that they are being provided in a clinical trial, are otherwise specifically excluded from coverage under the enrollee's health plan;
(5)
Health care services customarily provided by the research sponsors free of charge for any enrollee in the trial; or
(6)
Drugs, medical devices, and services provided solely to determine trial eligibility.
(c)
For an enrollee diagnosed with cancer and accepted into a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer, every health benefit plan that is issued, amended, delivered, or renewed in this state, shall provide coverage for all routine patient care costs related to the clinical trials, if the enrollee's treating physician, who is providing covered health care services to the enrollee under the enrollee's health benefit plan contract, recommends participation in the clinical trial after determining that participation in the clinical trial has a meaningful potential benefit to the enrollee. For purposes of this section, the clinical trial's endpoints shall not be defined exclusively to test toxicity, but shall have a therapeutic intent.
(d)
The treatment shall be provided in a clinical trial that either:
(1)
Involves a drug that is exempt, under federal regulations, from new drug application; or
(2)
Is approved by one of the following:
(A)
One (1) of the national institutes of health;
(B)
The federal food and drug administration, in the form of an investigational new drug application;
(C)
The federal department of defense; or
(D)
The federal veteran's administration.
(e)
In the case of health care services provided by a participating provider, the payment rate shall be at the network negotiated rate, based on the member's plan design. In the case of a nonparticipating provider, the payment shall be at the rate that the member's plan would otherwise pay to a nonparticipating provider for the same services, less any applicable copayments and deductibles.
(f)
The provision of services, when required by this section, shall not, in itself, give rise to liability on the part of the health care service plan.
(g)
Nothing in this section shall be construed to limit, prohibit, or modify an enrollee's right to the independent review process available, or to the independent medical review system.
(h)
Nothing in this section shall be construed to otherwise limit or modify any existing requirements under this chapter, or to prevent application of copayment or deductible provisions in a plan.
(i)
Copayments and deductibles applied to services delivered in a clinical trial shall be the same as those applied to the same services, if not delivered in a clinical trial.
(j)
This section shall not apply to vision-only, dental-only, accident-only, specified disease, hospital indemnity, medicare supplement, CHAMPUS supplement, long-term care, individually underwritten policies, or disability income insurance; provided, that, for specified disease and hospital indemnity insurance, coverage for benefits under this section shall apply, but only to the extent that the benefits are covered under the general terms and conditions that apply to all other benefits under the policy. Nothing in this section shall be construed as imposing a new benefit mandate on specified disease, individually underwritten, or hospital indemnity insurance.
(k)
Nothing in this section shall be construed to require payment of costs associated with clinical trials that are not routine patient care costs, and that would not otherwise be covered by the health benefit plan, including, but not limited to, costs for services incurred that are related to or the result of the clinical trial.
(l)
This section does not require the payment of any patient care costs, routine or otherwise, that are billed by the provider to conduct the clinical trial.
(m)
Any entity seeking payment under this section must, at the time payment is sought, notify the health insurer in writing that the patient receiving the services for which payment is sought is the subject of a clinical trial. The notification shall include the patient's health insurance membership identification number. Failure to comply with this subsection (m) by the provider conducting the clinical trial shall relieve the health benefit plan and its enrollee from any obligation to reimburse the provider.
(n)
Notwithstanding any law to the contrary, any entity associated with the provision of medical services, as a part of a clinical trial pursuant to this part, shall, upon receipt of applicable payment by the health benefit plan, hold harmless, and relieve the enrollee involved, from any liability for services rendered by the provider, except for applicable copayment or coinsurance.
(o)
Nothing in this section shall be construed or interpreted as applying to the TennCare program under Title XIX of the Social Security Act (
42 U.S.C. § 1396
et seq.), or any successor to the TennCare program administered pursuant to the federal medicaid laws. Health insurance entities that contract directly with the TennCare bureau, in the provision of services for TennCare recipients, are specifically excluded from this section, only for the products and services made by the health insurance entities on behalf of the bureau of TennCare.
Acts 2005, ch. 424, § 1.