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Chapter 33     Entire Code


ARTICLE 1. DEFINITIONS.

ARTICLE 2. INSURANCE COMMISSIONER.

ARTICLE 3. LICENSING, FEES AND TAXATION OF INSURERS.

ARTICLE 3A. STATE OF ENTRY FOR FOREIGN INSURERS.

ARTICLE 4. GENERAL PROVISIONS.

ARTICLE 4A. ALL-PAYER CLAIMS DATABASE.

ARTICLE 5. ORGANIZATION AND PROCEDURES OF DOMESTIC STOCK AND MUTUAL INSURERS.

ARTICLE 6. THE INSURANCE POLICY.

ARTICLE 6A. CANCELLATION OR NONRENEWAL OF AUTOMOBILE LIABILITY POLICIES.

ARTICLE 6B. DECLINATION OF AUTOMOBILE LIABILITY INSURANCE.

ARTICLE 6C. GUARANTEED LOSS RATIOS AS APPLIED TO INDIVIDUAL SICKNESS AND ACCIDENT INSURANCE POLICIES.

ARTICLE 6D. MOTOR VEHICLE REPAIR AND REPLACEMENT REFERRALS.

ARTICLE 6F. DISCLOSURE OF NONPUBLIC PERSONAL INFORMATION.

ARTICLE 7. ASSETS AND LIABILITIES.

ARTICLE 8. INVESTMENTS.

ARTICLE 8A. USE OF CLEARING CORPORATIONS AND FEDERAL RESERVE BOOK-ENTRY SYSTEM.

ARTICLE 9. ADMINISTRATION OF DEPOSITS.

ARTICLE 10. REHABILITATION AND LIQUIDATION.

ARTICLE 11. UNFAIR TRADE PRACTICES.

ARTICLE 11A. INSURANCE SALES CONSUMER PROTECTION ACT.

ARTICLE 12. INSURANCE PRODUCERS AND SOLICITORS.

ARTICLE 12A. CONTRACTUAL RELATIONSHIPS BETWEEN INSURANCE COMPANIES AND AGENTS.

ARTICLE 12B. ADJUSTERS.

ARTICLE 12C. SURPLUS LINE.

ARTICLE 13. LIFE INSURANCE.

ARTICLE 13A. VARIABLE CONTRACTS.

ARTICLE 13B. CHARITABLE GIFT ANNUITIES.

ARTICLE 13C. VIATICAL SETTLEMENTS ACT.

ARTICLE 13D. UNCLAIMED LIFE INSURANCE BENEFITS ACT.

ARTICLE 14. GROUP LIFE INSURANCE.

ARTICLE 15. ACCIDENT AND SICKNESS INSURANCE.

ARTICLE 15A. WEST VIRGINIA LONG-TERM CARE INSURANCE ACT.

ARTICLE 15B. UNIFORM HEALTH CARE ADMINISTRATION ACT.

ARTICLE 15C. DIABETES INSURANCE.

ARTICLE 15D. INDIVIDUAL LIMITED HEALTH BENEFITS PLANS.

ARTICLE 15E. DISCOUNT MEDICAL PLAN ORGANIZATIONS AND DISCOUNT PRESCRIPTION DRUG PLAN ORGANIZATIONS ACT.

ARTICLE 16. GROUP ACCIDENT AND SICKNESS INSURANCE.

ARTICLE 16A. GROUP HEALTH INSURANCE CONVERSION.

ARTICLE 16B. ACCIDENT AND SICKNESS RATES.

ARTICLE 16C. EMPLOYER GROUP ACCIDENT AND SICKNESS INSURANCE POLICIES.

ARTICLE 16D. MARKETING AND RATE PRACTICES FOR SMALL EMPLOYER ACCIDENT AND SICKNESS INSURANCE POLICIES.

ARTICLE 16E. CONTRACEPTIVE COVERAGE.

ARTICLE 16F. GROUP LIMITED HEALTH BENEFITS PLANS.

ARTICLE 16G. WEST VIRGINIA HEALTH BENEFIT EXCHANGE ACT.

ARTICLE 16H. REVIEW OF ADVERSE DETERMINATIONS.

ARTICLE 17. FIRE AND MARINE INSURANCE.

ARTICLE 17A. PROPERTY INSURANCE DECLINATION, TERMINATION AND DISCLOSURE.

ARTICLE 18. CASUALTY INSURANCE.

ARTICLE 19. SURETY INSURANCE.

ARTICLE 20. RATES AND RATING ORGANIZATIONS.

ARTICLE 20A. WEST VIRGINIA ESSENTIAL INSURANCE COVERAGE ACT.

ARTICLE 20B. RATES AND MALPRACTICE INSURANCE POLICIES.

ARTICLE 20C. CANCELLATION OR NONRENEWAL OF MALPRACTICE INSURANCE POLICIES.

ARTICLE 20D. TAIL INSURANCE.

ARTICLE 20E. WEST VIRGINIA MEDICAL PROFESSIONAL LIABILITY INSURANCE JOINT UNDERWRITING ASSOCIATION ACT.

ARTICLE 20F. PHYSICIANS\' MUTUAL INSURANCE COMPANY.

ARTICLE 21. RECIPROCAL INSURERS.

ARTICLE 22. FARMERS\' MUTUAL FIRE INSURANCE COMPANIES.

ARTICLE 23. FRATERNAL BENEFIT SOCIETIES.

ARTICLE 24. HOSPITAL SERVICE CORPORATIONS, MEDICAL SERVICE CORPORATIONS, DENTAL SERVICE CORPORATIONS AND HEALTH SERVICE CORPORATIONS.

ARTICLE 25. HEALTH CARE CORPORATIONS.

ARTICLE 25A. HEALTH MAINTENANCE ORGANIZATION ACT.

ARTICLE 25B. FEDERAL INSURANCE SUBSIDY FOR CHILDREN\'S HEALTH.

ARTICLE 25C. HEALTH MAINTENANCE ORGANIZATION PATIENT BILL OF RIGHTS.

ARTICLE 25D. PREPAID LIMITED HEALTH SERVICE ORGANIZATION ACT.

ARTICLE 25E. PATIENTS\' EYE CARE ACT.

ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.
§33-25F-1. Definitions.
§33-25F-2. Coverage applicable under this article.

ARTICLE 25G. PROVIDER SPONSORED NETWORKS.

ARTICLE 26. WEST VIRGINIA GUARANTY ASSOCIATION ACT.

ARTICLE 26A. WEST VIRGINIA LIFE AND HEALTH INSURANCE GUARANTY ASSOCIATION ACT.

ARTICLE 26B. WEST VIRGINIA HEALTH MAINTENANCE ORGANIZATION GUARANTY ASSOCIATION.

ARTICLE 27. INSURANCE HOLDING COMPANY SYSTEMS.

ARTICLE 28. INDIVIDUAL ACCIDENT AND SICKNESS INSURANCE MINIMUM STANDARDS.

ARTICLE 29. LIFE AND ACCIDENT AND SICKNESS INSURANCE POLICY LANGUAGE SIMPLIFICATION ACT.

ARTICLE 30. MINE SUBSIDENCE INSURANCE.

ARTICLE 31. CAPTIVE INSURANCE.

ARTICLE 31A. SPONSORED CAPTIVE INSURANCE COMPANY FORMATION.

ARTICLE 32. RISK RETENTION ACT.

ARTICLE 33. ANNUAL AUDITED FINANCIAL REPORT.

ARTICLE 34. ADMINISTRATIVE SUPERVISION.

ARTICLE 34A. STANDARDS AND COMMISSIONER\'S AUTHORITY FOR COMPANIES DEEMED TO BE IN HAZARDOUS FINANCIAL CONDITION.

ARTICLE 35. CRIMINAL SANCTIONS FOR FAILURE TO REPORT IMPAIRMENT.

ARTICLE 36. BUSINESS TRANSACTED WITH PRODUCER-CONTROLLED PROPERTY/CASUALTY INSURER ACT.

ARTICLE 37. MANAGING GENERAL AGENTS.

ARTICLE 38. REINSURANCE INTERMEDIARY ACT.

ARTICLE 39. DISCLOSURE OF MATERIAL TRANSACTIONS.

ARTICLE 40. RISK-BASED CAPITAL (RBC) FOR INSURERS.

ARTICLE 40A. RISKED-BASED CAPITAL FOR HEALTH ORGANIZATIONS.

ARTICLE 40B. RISK MANAGEMENT AND OWN RISK AND SOLVENCY ASSESSMENT ACT.

ARTICLE 41. PRIVILEGES AND IMMUNITY.

ARTICLE 42. WOMEN\'S ACCESS TO HEALTH CARE ACT.

ARTICLE 43. INSURANCE TAX PROCEDURES ACT.

ARTICLE 44. UNAUTHORIZED INSURERS ACT.

ARTICLE 45. ETHICS AND FAIRNESS IN INSURER BUSINESS PRACTICES.

ARTICLE 46. THIRD-PARTY ADMINISTRATOR ACT.

ARTICLE 46A. PROFESSIONAL EMPLOYER ORGANIZATIONS.

ARTICLE 47. INTERSTATE INSURANCE PRODUCT REGULATION COMPACT.

ARTICLE 48. MODEL HEALTH PLAN FOR UNINSURABLE INDIVIDUALS ACT.

ARTICLE 49. FLOOD INSURANCE.

ARTICLE 50. PATIENT PROTECTION AND TRANSPARENCY ACT.

ARTICLE 51. PHARMACY AUDIT INTEGRITY ACT.

ARTICLE 52. CORPORATE GOVERNANCE ANNUAL DISCLOSURE ACT.

ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.

§33-25F-1. Definitions.

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.

§33-25F-2. Coverage applicable under this article.

(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.

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