West Virginia Code
1 - DEFINITIONS
2 - INSURANCE COMMISSIONER
3 - LICENSING, FEES AND TAXATION OF
3A - STATE OF ENTRY FOR FOREIGN INS
4 - GENERAL PROVISIONS
4A - ALL-PAYER CLAIMS DATABASE
5 - ORGANIZATION AND PROCEDURES OF
6 - THE INSURANCE POLICY
6A - CANCELLATION OR NONRENEWAL OF
6B - DECLINATION OF AUTOMOBILE LIAB
6C - GUARANTEED LOSS RATIOS AS APPL
6D - MOTOR VEHICLE REPAIR AND REPLA
6F - DISCLOSURE OF NONPUBLIC PERSON
7 - ASSETS AND LIABILITIES
8 - INVESTMENTS
8A - USE OF CLEARING CORPORATIONS A
9 - ADMINISTRATION OF DEPOSITS
10 - REHABILITATION AND LIQUIDATIO
11 - UNFAIR TRADE PRACTICES
11A - INSURANCE SALES CONSUMER PRO
12 - INSURANCE PRODUCERS AND SOLIC
12A - CONTRACTUAL RELATIONSHIPS BE
12B - ADJUSTERS
12C - SURPLUS LINE
13 - LIFE INSURANCE
13A - VARIABLE CONTRACTS
13B - CHARITABLE GIFT ANNUITIES
13C - VIATICAL SETTLEMENTS ACT
14 - GROUP LIFE INSURANCE
15 - ACCIDENT AND SICKNESS INSURAN
15A - WEST VIRGINIA LONG-TERM CARE
15B - UNIFORM HEALTH CARE ADMINIST
15C - DIABETES INSURANCE
15D - INDIVIDUAL LIMITED HEALTH BE
15E - DISCOUNT MEDICAL PLAN ORGANI
16 - GROUP ACCIDENT AND SICKNESS I
16A - GROUP HEALTH INSURANCE CONVE
16B - ACCIDENT AND SICKNESS RATES
16C - EMPLOYER GROUP ACCIDENT AND
16D - MARKETING AND RATE PRACTICES
16E - CONTRACEPTIVE COVERAGE
16F - GROUP LIMITED HEALTH BENEFIT
16G - WEST VIRGINIA HEALTH BENEFIT
16H - REVIEW OF ADVERSE DETERMINAT
17 - FIRE AND MARINE INSURANCE
17A - PROPERTY INSURANCE DECLINATI
18 - CASUALTY INSURANCE
19 - SURETY INSURANCE
20 - RATES AND RATING ORGANIZATION
20A - WEST VIRGINIA ESSENTIAL INSU
20B - RATES AND MALPRACTICE INSURA
20C - CANCELLATION OR NONRENEWAL O
20D - TAIL INSURANCE
20E - WEST VIRGINIA MEDICAL PROFES
20F - PHYSICIANS' MUTUAL INSURANCE
21 - RECIPROCAL INSURERS
22 - FARMERS' MUTUAL FIRE INSURANC
23 - FRATERNAL BENEFIT SOCIETIES
24 - HOSPITAL SERVICE CORPORATIONS
25 - HEALTH CARE CORPORATIONS
25A - HEALTH MAINTENANCE ORGANIZAT
25B - FEDERAL INSURANCE SUBSIDY FO
25C - HEALTH MAINTENANCE ORGANIZAT
25D - PREPAID LIMITED HEALTH SERVI
25E - PATIENTS' EYE CARE ACT
25G - PROVIDER SPONSORED NETWORKS
26 - WEST VIRGINIA GUARANTY ASSOCI
26A - WEST VIRGINIA LIFE AND HEALT
26B - WEST VIRGINIA HEALTH MAINTEN
27 - INSURANCE HOLDING COMPANY SYS
28 - INDIVIDUAL ACCIDENT AND SICKN
29 - LIFE AND ACCIDENT AND SICKNES
30 - MINE SUBSIDENCE INSURANCE
31 - CAPTIVE INSURANCE
31A - SPONSORED CAPTIVE INSURANCE
32 - RISK RETENTION ACT
33 - ANNUAL AUDITED FINANCIAL REPO
34 - ADMINISTRATIVE SUPERVISION
34A - STANDARDS AND COMMISSIONER'S
35 - CRIMINAL SANCTIONS FOR FAILUR
36 - BUSINESS TRANSACTED WITH PROD
37 - MANAGING GENERAL AGENTS
38 - REINSURANCE INTERMEDIARY ACT
39 - DISCLOSURE OF MATERIAL TRANSA
40 - RISK-BASED CAPITAL (RBC) FOR
40A - RISKED-BASED CAPITAL FOR HEA
40B - RISK MANAGEMENT AND OWN RISK
41 - PRIVILEGES AND IMMUNITY
42 - WOMEN'S ACCESS TO HEALTH CARE
43 - INSURANCE TAX PROCEDURES ACT
44 - UNAUTHORIZED INSURERS ACT
45 - ETHICS AND FAIRNESS IN INSURE
46 - THIRD-PARTY ADMINISTRATOR ACT
46A - PROFESSIONAL EMPLOYER ORGANI
47 - INTERSTATE INSURANCE PRODUCT
48 - MODEL HEALTH PLAN FOR UNINSUR
49 - FLOOD INSURANCE
50 - PATIENT PROTECTION AND TRANSP
51 - PHARMACY AUDIT INTEGRITY ACT
ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.
For purposes of this article:
(a) A "clinical trial" is a study that determines whether new drugs, treatments or medical procedures are safe and effective on humans. To determine the efficacy of experimental drugs, treatments or procedures, a study is conducted in four phases including the following:
Phase II: The experimental drug or treatment is given to, or a procedure is performed on, a larger group of people to further measure its effectiveness and safety.
Phase III: Further research is conducted to confirm the effectiveness of the drug, treatment or procedure, to monitor the side effects, to compare commonly used treatments and to collect information on safe use.
Phase IV: After the drug, treatment or medical procedure is marketed, investigators continue testing to determine the effects on various populations and to determine whether there are side effects associated with long-term use.
(b) "Cooperative group" means a formal network of facilities that collaborate on research projects and have an established NIH-approved peer review program operating within the group.
(c) "Cooperative group" includes:
(1) The national cancer institute clinical cooperative group;
(2) The national cancer institute community clinical oncology program;
(3) The AIDS clinical trial group; and
(4) The community programs for clinical research in AIDS.
(d) "FDA" means the federal food and drug administration.
(e) "Life-threatening condition" means that the member has a terminal condition or illness that according to current diagnosis has a high probability of death within two years, even with treatment with an existing generally accepted treatment protocol.
(f) "Member" means a policyholder, subscriber, insured, certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.
(g) "Multiple project assurance contract" means a contract between an institution and the federal department of health and human services that defines the relationship of the institution to the federal department of health and human services and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects.
(h) "NIH" means the national institutes of health.
(i) "Patient cost" means the routine costs of a medically necessary health care service that is incurred by a member as a result of the treatment being provided pursuant to the protocols of the clinical trial. Routine costs of a clinical trial include all items or services that are otherwise generally available to beneficiaries of the insurance policies. "Patient cost" does not include:
(1) The cost of the investigational drug or device;
(2) The cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided to the member for purposes of the clinical trial;
(3) Services customarily provided by the research sponsor free of charge for any participant in the trial;
(4) Costs associated with managing the research associated with the clinical trial including, but not limited to, services furnished to satisfy data collection and analysis needs that are not used in the direct clinical management of the participant; or
(5) Costs that would not be covered under the participant's policy, plan, or contract for noninvestigational treatments;
(6) Adverse events during treatment are divided into those that reflect the natural history of the disease, or its progression, and those that are unique in the experimental treatment. Costs for the former are the responsibility of the payor as provided in section two of this article, and costs for the later are the responsibility of the sponsor. The sponsor shall hold harmless any payor for any losses and injuries sustained by any member as a result of his or her participation in the clinical trial.
(a) This section applies to:
(1) Insurers and nonprofit health service plans that provide hospital, medical, surgical or pharmaceutical benefits to individuals or groups on an expense-incurred basis under a health insurance policy or contract issued or delivered in the state; and
(2) Health maintenance organizations that provide hospital, medical, surgical or pharmaceutical benefits to individuals or groups under contracts that are issued or delivered in the state.
(b) This section does not apply to a policy, plan or contract paid for under Title XVIII of the Social Security Act.
(c) A policy, plan or contract subject to this section shall provide coverage for patient cost to a member in a clinical trial, as a result of:
(1) Treatment provided for a life-threatening condition; or
(2) Prevention of, early detection of or treatment studies on cancer.
(d) The coverage under subsection (c) of this section is required if:
(1)(A) The treatment is being provided or the studies are being conducted in a Phase II, Phase III or Phase IV clinical trial for cancer and has therapeutic intent; or
(B) The treatment is being provided in a Phase II, Phase III or Phase IV clinical trial for any other life-threatening condition and has therapeutic intent;
(2) The treatment is being provided in a clinical trial approved by:
(A) One of the national institutes of health;
(B) An NIH cooperative group or an NIH center;
(C) The FDA in the form of an investigational new drug application or investigational device exemption;
(D) The federal department of Veterans Affairs; or
(E) An institutional review board of an institution in the state which has a multiple project assurance contract approved by the office of protection from research risks of the national institutes of health;
(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training and volume of patients treated to maintain expertise;
(4) There is no clearly superior, noninvestigational treatment alternative;
(5) The available clinical or preclinical data provide a reasonable expectation that the treatment will be more effective than the noninvestigational treatment alternative;
(6) The treatment is provided in this state: Provided, That, if the treatment is provided outside of this state, the treatment must be approved by the payor designated in subsection (a) of this section;
(7) Reimbursement for treatment is subject to all coinsurance, copayment and deductibles and is otherwise subject to all restrictions and obligations of the health plan; and
(8) Reimbursement for treatment by an out of network or noncontracting provider shall be reimbursed at a rate which is no greater than that provided by an in network or contracting provider. Coverage shall not be required if the out of network or noncontracting provider will not accept this level of reimbursement.
(e) Payment for patient costs for a clinical trial is not required by the provisions of this section, if:
(1) The purpose of the clinical trial is designed to extend the patent of any existing drug, to gain approval or coverage of a metabolite of an existing drug, or to gain approval or coverage relating to additional clinical indications for an existing drug; or
(2) The purpose of the clinical trial is designed to keep a generic version of a drug from becoming available on the market; or
(3) The purpose of the clinical trial is to gain approval of or coverage for a reformulated or repackaged version of an existing drug.
(f) Any provider billing a third party payor for services or products provided to a patient in a clinical trial shall provide written notice to the payor that specifically identifies the services as part of a clinical trial.
(g) Notwithstanding any provision in this section to the contrary, coverage is not required for Phase I of any clinical trial.