Effective - 28 Aug 2006
376.429. Coverage for certain clinical trials for prevention, early detection and treatment of cancer, restrictions — definitions — exclusions. — 1. All health benefit plans, as defined in section 376.1350, that are delivered, issued for delivery, continued or renewed on or after August 28, 2006, and providing coverage to any resident of this state shall provide coverage for routine patient care costs as defined in subsection 7 of this section incurred as the result of phase II, III, or IV of a clinical trial that is approved by an entity listed in subsection 4 of this section and is undertaken for the purposes of the prevention, early detection, or treatment of cancer. Health benefit plans may limit coverage for the routine patient care costs of patients in phase II of a clinical trial to those treating facilities within the health benefit plans' provider network; except that, this provision shall not be construed as relieving a health benefit plan of the sufficiency of network requirements under state statute.
2. In the case of treatment under a clinical trial, the treating facility and personnel must have the expertise and training to provide the treatment and treat a sufficient volume of patients. There must be equal to or superior, noninvestigational treatment alternatives and the available clinical or preclinical data must provide a reasonable expectation that the treatment will be superior to the noninvestigational alternatives.
3. Coverage required by this section shall include coverage for routine patient care costs incurred for drugs and devices that have been approved for sale by the Food and Drug Administration (FDA), regardless of whether approved by the FDA for use in treating the patient's particular condition, including coverage for reasonable and medically necessary services needed to administer the drug or use the device under evaluation in the clinical trial.
4. Subsections 1 and 2 of this section requiring coverage for routine patient care costs shall apply to phase III or IV of clinical trials that are approved or funded by one of the following entities:
(1) One of the National Institutes of Health (NIH);
(2) An NIH cooperative group or center as defined in subsection 7 of this section;
(3) The FDA in the form of an investigational new drug application;
(4) The federal Departments of Veterans' Affairs or Defense;
(5) An institutional review board in this state that has an appropriate assurance approved by the Department of Health and Human Services assuring compliance with and implementation of regulations for the protection of human subjects (45 CFR 46); or
(6) A qualified research entity that meets the criteria for NIH Center support grant eligibility.
5. Subsections 1 and 2 of this section requiring coverage for routine patient care costs shall apply to phase II of clinical trials if:
(1) Phase II of a clinical trial is sanctioned by the National Institutes of Health (NIH) or National Cancer Institute (NCI) and conducted at academic or National Cancer Institute Center; and
(2) The person covered under this section is enrolled in the clinical trial. This section shall not apply to persons who are only following the protocol of phase II of a clinical trial, but not actually enrolled.
6. An entity seeking coverage for treatment, prevention, or early detection in a clinical trial approved by an institutional review board under subdivision (5) of subsection 4 of this section shall maintain and post electronically a list of the clinical trials meeting the requirements of subsections 2 and 3 of this section. This list shall include: the phase for which the clinical trial is approved; the entity approving the trial; the particular disease; and the number of participants in the trial. If the electronic posting is not practical, the entity seeking coverage shall periodically provide payers and providers in the state with a written list of trials providing the information required in this section.
7. As used in this section, the following terms shall mean:
(1) "Cooperative group", a formal network of facilities that collaborate on research projects and have an established NIH-approved Peer Review Program operating within the group, including the NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program;
(2) "Multiple project assurance contract", a contract between an institution and the federal Department of Health and Human Services (DHHS) that defines the relationship of the institution to the DHHS and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects;
(3) "Routine patient care costs" shall include coverage for reasonable and medically necessary services needed to administer the drug or device under evaluation in the clinical trial. Routine patient care costs include all items and services that are otherwise generally available to a qualified individual that are provided in the clinical trial except:
(a) The investigational item or service itself;
(b) Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; and
(c) Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.
8. For the purpose of this section, providers participating in clinical trials shall obtain a patient's informed consent for participation on the clinical trial in a manner that is consistent with current legal and ethical standards. Such documents shall be made available to the health insurer upon request.
9. The provisions of this section shall not apply to a policy, plan or contract paid under Title XVIII or Title XIX of the Social Security Act.
10. Nothing in this section shall apply to any accident-only policy, specified disease policy, hospital indemnity policy, Medicare supplement policy, long-term care policy, short-term major medical policy of six months or less duration, or other limited benefit health insurance policies.
11. The provisions of this section regarding phase II of a clinical trial shall not apply automatically to an individually underwritten health benefit plan, but shall be an option to any such plan.
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(L. 2002 S.B. 1026, A.L. 2003 S.B. 407, A.L. 2006 S.B. 567 & 792)
Structure Missouri Revised Statutes
Title XXIV - Business and Financial Institutions
Chapter 376 - Life, Health and Accident Insurance
Section 376.005 - Definitions.
Section 376.010 - Who may form company — purposes.
Section 376.020 - Various companies defined.
Section 376.050 - Declaration of corporators.
Section 376.060 - Stock companies — content of charter.
Section 376.070 - To be submitted to attorney general.
Section 376.080 - Director to examine, when.
Section 376.090 - To furnish certificate of deposit, when.
Section 376.100 - Mutual companies — contents of charter.
Section 376.110 - To be submitted to attorney general.
Section 376.120 - Director to examine and certify, when.
Section 376.130 - To furnish certificate of deposit, when.
Section 376.145 - Officers of stock company to continue as officers of mutual.
Section 376.147 - Meetings of board of mutual, notice — executive committee of board, powers.
Section 376.150 - Stock and mutual companies — content of charter.
Section 376.160 - Formation of stock and mutual companies.
Section 376.170 - Special deposits for registered policies and annuity bonds.
Section 376.190 - Additional deposits required.
Section 376.200 - Definition of net value.
Section 376.210 - Excess deposits.
Section 376.220 - May use realty to secure notes and bonds.
Section 376.230 - Changing of securities on deposit.
Section 376.240 - Deposits to be held in trust by director.
Section 376.250 - Deposits to be kept separate.
Section 376.260 - Fees collected by director of revenue.
Section 376.270 - Director may proceed against depositary companies.
Section 376.280 - Capital necessary to do business — how invested.
Section 376.290 - Deposit and transfer of securities.
Section 376.291 - Applicability and inapplicability.
Section 376.292 - Definitions.
Section 376.293 - Permissible investments — written plan for investments required.
Section 376.294 - Prohibited acts.
Section 376.295 - Additional prohibited acts — authorized actions.
Section 376.296 - Value of investments, how calculated.
Section 376.297 - Investment subsidiaries not permitted, when.
Section 376.298 - Acquisition of rate credit instruments, when.
Section 376.300 - Equity interests permitted, when.
Section 376.301 - Tangible personal property interests permitted, when.
Section 376.302 - Mortgage interests, may be acquired, when — other real estate interests.
Section 376.303 - Lending and repurchase, permitted when.
Section 376.304 - Acquisition of foreign investments, when.
Section 376.305 - Rulemaking authority.
Section 376.306 - Cash surrender value, life insurer may lend to policyholder, when.
Section 376.307 - Limits on acquisition of certain investments.
Section 376.308 - Secondary mortgage market act, not to preempt health insurer, when.
Section 376.310 - Investment of surplus and reserve funds by foreign companies.
Section 376.325 - Any willing provider provision — definitions.
Section 376.330 - Securities may be changed.
Section 376.350 - Reports to director.
Section 376.360 - Distribution of surplus funds to participating policyholders — method.
Section 376.365 - Standard valuation law — definitions.
Section 376.370 - Director to value reserves, methods.
Section 376.379 - Medication synchronization services, offer of coverage required.
Section 376.381 - Health insurance products, department duties.
Section 376.386 - Prescription drugs, one co-payment for dosage prescribed.
Section 376.387 - Pharmacy benefits manager, limitations and restrictions — enforcement.
Section 376.390 - Reserve liability for group insurance — how computed.
Section 376.391 - Co-payments for chiropractic services, cap.
Section 376.392 - Prescription drug formularies, enrollees to be notified of changes to, when.
Section 376.393 - Pharmacy benefits manager, license required — definitions — complaints, procedure.
Section 376.395 - Definitions for group health conversion policy requirements.
Section 376.398 - Application to all group policies — effective, when.
Section 376.401 - Conversion rights — retirees — dependents of insured.
Section 376.404 - Specific requirement requests of policyholder may be met by alteration.
Section 376.407 - Advance practice nurse, claims for service to be reimbursed, when.
Section 376.410 - Insurance companies to maintain reserves — exemptions.
Section 376.421 - Group health insurance, authorized categories.
Section 376.425 - Student accident policies, may not limit surgical benefits, when.
Section 376.426 - Group health policies, required provisions.
Section 376.428 - Federal COBRA provisions to apply to group health insurance policies.
Section 376.432 - Group-type basis, defined.
Section 376.434 - Carrier liable for claims incurred during grace period, when — exceptions.
Section 376.435 - Claim information to be reported, when — covered lives defined.
Section 376.442 - Rules and regulations, procedure.
Section 376.450 - Citation of law — definitions (Missouri HIPAA).
Section 376.451 - Standards prohibiting discrimination.
Section 376.453 - Premium — only cafeteria plans required, when.
Section 376.480 - Domestic companies may assume risks of foreign companies — duties of director.
Section 376.500 - Discriminations, rebates and favors prohibited — contracts to conform to policy.
Section 376.510 - Penalty for violation of section 376.500.
Section 376.540 - Policy, to whom payable.
Section 376.570 - Foreign executor or administrator.
Section 376.580 - Misrepresentation.
Section 376.600 - Penalty for violating section 376.590.
Section 376.610 - Defense in case of suits.
Section 376.620 - Suicide, effect on liability — refund of premiums, when.
Section 376.630 - Life insurance policies not to be forfeited or become invalid, when.
Section 376.640 - Paid-up policy may be demanded, when.
Section 376.650 - Rules of payment on commuted policy.
Section 376.660 - Foregoing provisions inapplicable, when.
Section 376.670 - Provisions which shall be contained in life insurance policies, exceptions.
Section 376.671 - Provisions which shall be contained in annuity contracts — inapplicability date.
Section 376.673 - Life insurance policies, regulations relative to.
Section 376.674 - Life insurance policies, no cash surrender value, regulations relative to.
Section 376.679 - Life insurance company may reinsure for risks involving aircraft, limitation.
Section 376.680 - Assignment of incidents of ownership, group life policy, effect of.
Section 376.691 - Group life policies, eligible groups authorized for issue — premiums, how paid.
Section 376.693 - Special group life policies, requirements — director's approval.
Section 376.697 - Required provisions for group life policies.
Section 376.700 - Purpose — use of additional material.
Section 376.702 - Application of law — exceptions.
Section 376.704 - Definitions.
Section 376.706 - Delivery of guide and summary required, when.
Section 376.708 - Required presentations and statements — company to maintain file.
Section 376.710 - Effect of omission.
Section 376.712 - Effective date.
Section 376.714 - Contents and form of buyer's guide.
Section 376.715 - Citation of law, purpose.
Section 376.718 - Definitions.
Section 376.720 - Association, created — accounts — director to supervise.
Section 376.722 - Board of directors, established, members, how selected — expense reimbursement.
Section 376.726 - Nonpayment of premiums, effect of.
Section 376.728 - Law not applicable, when.
Section 376.730 - Liens, association may impose, when.
Section 376.734 - Additional powers of association.
Section 376.735 - Assessments against members, when due, classes — amounts, how determined.
Section 376.738 - Certificate of contribution, when issued.
Section 376.740 - Plan of operation, required, approval of director — provisions of plan.
Section 376.742 - Director, powers and duties.
Section 376.743 - Board of directors, powers.
Section 376.745 - Assessments, offset against tax liability, when, how.
Section 376.747 - Distribution of member insurer assets upon liquidation, priority of association.
Section 376.748 - Liquidation, recovery of distributions, when, exceptions, limitations.
Section 376.752 - Member insurer's deposit with director, exemption from, amount.
Section 376.754 - Stay of proceedings, insolvent insurer, when.
Section 376.755 - Advertising, use of guaranty association prohibited.
Section 376.758 - Law inapplicable to insolvent insurers on effective date of law.
Section 376.770 - Title of law.
Section 376.773 - Definitions.
Section 376.775 - Matters required in policies.
Section 376.780 - Limits on provisions, effect of conflict of policy with law.
Section 376.783 - Insured bound only if copy of application attached to policy.
Section 376.785 - What does not constitute waiver of defenses.
Section 376.787 - Effect of age limit provision.
Section 376.789 - Definition of actual charge and actual fee.
Section 376.790 - Limits on applicability of law.
Section 376.791 - Portion of section 376.777 not applicable to individual health insurance coverage.
Section 376.810 - Definitions for policy requirements for chemical dependency.
Section 376.818 - Eligibility for Medicaid may not be considered by insurers.
Section 376.819 - MO HealthNet division to have right to payment for health care services provided.
Section 376.823 - Prohibition on kickbacks not applicable for rebates for certain chronic illnesses.
Section 376.850 - Law, how cited.
Section 376.854 - Definitions.
Section 376.859 - Medicare supplement law applicable to what policies — policies not included.
Section 376.869 - Standards for policies, minimum, director to adopt.
Section 376.874 - Requirements of policy, return to policyholders.
Section 376.882 - Cancellation of policy, refund required — notification.
Section 376.884 - Advertisement to be reviewed by director.
Section 376.886 - Regulations, requirements — rules, procedure.
Section 376.889 - Violations, penalty.
Section 376.890 - Invalidity of any section regulating Medicare supplement not to affect others.
Section 376.891 - Definitions.
Section 376.900 - Definitions.
Section 376.905 - Administration by department, powers, duties — fees.
Section 376.910 - Certificate of authority required.
Section 376.920 - Annual statement, form, contents.
Section 376.925 - Seven-day rescission period, all money or property to be refunded.
Section 376.930 - Insured to be furnished application for certificate and annual statement, when.
Section 376.940 - Escrow account for entrance fees required, released when.
Section 376.945 - Escrow account, amount required — principal, how released, investment.
Section 376.950 - Board of directors, one member to be resident of facility.
Section 376.960 - Definitions.
Section 376.965 - Board members not civilly liable for performance of duties, exception.
Section 376.982 - Rulemaking procedure.
Section 376.989 - No liability, criminal or civil, for participation in pool by members.
Section 376.1000 - Multiple employer self-insured health plan, defined.
Section 376.1007 - Plan to file copy of bylaws, coverage and agreements with director.
Section 376.1010 - Excess stop-loss coverage maintained by plan.
Section 376.1015 - Department not to grant approval, when.
Section 376.1017 - Plan to establish loss reserves — plan to establish surplus account, amount.
Section 376.1020 - Plan to maintain principal place of business in Missouri, exception.
Section 376.1025 - Director may adopt rules.
Section 376.1027 - Plan in unsound condition, powers of director.
Section 376.1032 - Plan considered insurer, when.
Section 376.1035 - Chapter 376 applicable to plan.
Section 376.1037 - Plan subject to premium taxes.
Section 376.1042 - Marketing by agent, agency or broker violation of law.
Section 376.1045 - Injunctive relief, director may seek, when — procedures.
Section 376.1065 - Official notification communications, contracting entity requirements.
Section 376.1075 - Definitions.
Section 376.1077 - Administrator to have agreement with insurer, form, contents — termination, how.
Section 376.1080 - Payments of premiums and claims deemed paid, when.
Section 376.1083 - Advertising restrictions for administrator.
Section 376.1090 - Materials delivered to administrator for insured to be promptly delivered.
Section 376.1093 - Annual report filed with director, when — contents — filing fee, amount.
Section 376.1094 - Certificate of authority, suspension or revocation, grounds — civil action, when.
Section 376.1095 - Rules and regulations, promulgation.
Section 376.1100 - Law, how cited — definitions.
Section 376.1115 - Coverage outline to be delivered to applicants, when, content.
Section 376.1121 - Denial of claim, long-term care insurance, duties of issuer.
Section 376.1130 - Rulemaking authority.
Section 376.1190 - Health care mandates — review by oversight division — actuarial analysis.
Section 376.1215 - Immunizations, mandated coverage, exceptions, rulemaking.
Section 376.1220 - Insurance coverage for newborn hearing screenings mandated.
Section 376.1226 - Fee schedule for services not covered under health benefit plans — definitions.
Section 376.1230 - Chiropractic care coverage, rates, terms, conditions, limits, and exclusions.
Section 376.1232 - Insurers to offer coverage for prosthetics.
Section 376.1237 - Refills for prescription eye drops, required, when — definitions.
Section 376.1250 - Cancer screening, health insurance coverage required, when, types.
Section 376.1290 - Coverage for lead testing.
Section 376.1300 - Reorganization of a domestic mutual life insurance company, authority.
Section 376.1305 - Formation of holding company, application — shareholder approval.
Section 376.1307 - Issuance of shares.
Section 376.1312 - Nonapplicability of certain provisions of insurance holding companies law.
Section 376.1315 - Incorporation of mutual holding company, authority, approval.
Section 376.1350 - Definitions.
Section 376.1353 - Utilization review activities monitored.
Section 376.1356 - Utilization review entity monitored, when.
Section 376.1359 - Written utilization program implemented, filed with the director.
Section 376.1363 - Utilization review decisions, procedures.
Section 376.1365 - Reconsideration of an adverse determination, when.
Section 376.1367 - Emergency services benefit determination, coverage required, when.
Section 376.1369 - Certification of compliance, when.
Section 376.1375 - Registry of grievances maintained, procedures — definitions.
Section 376.1378 - Grievances and certificate of compliance filed with the director, when.
Section 376.1385 - Second-level review procedures.
Section 376.1387 - Appeals of grievances determined by the director.
Section 376.1389 - Expedited grievance review procedure.
Section 376.1399 - Rules, effective, when — rules invalid and void, when.
Section 376.1400 - Explanation of benefits, standardized information used, contents, when.
Section 376.1403 - Referrals, standardized information used, content, when.
Section 376.1500 - Definitions.
Section 376.1502 - Requirements for transaction of business.
Section 376.1504 - Registration requirements — term of registration — renewal.
Section 376.1506 - Violations, penalty.
Section 376.1508 - Processing fee — cancellation of membership, effect of.
Section 376.1510 - Prohibited acts.
Section 376.1512 - Required disclosures.
Section 376.1514 - Written agreement required, contents.
Section 376.1518 - Net worth to be maintained, amount.
Section 376.1520 - Notice of changes.
Section 376.1522 - List of providers to be maintained on website.
Section 376.1524 - Advertising and marketing materials, approval in writing required.
Section 376.1528 - Rulemaking authority.
Section 376.1530 - Denial and refusal to issue registrations, when.
Section 376.1532 - Violations, penalties.
Section 376.1550 - Mental health coverage, requirements — definitions — exclusions.
Section 376.1575 - Definitions.
Section 376.1590 - Status as living organ donor not sole factor for insurance coverage.
Section 376.1900 - Definitions — reimbursement for telehealth services, when.
Section 376.2000 - Citation of law — definitions.
Section 376.2002 - Navigators, license required — permitted acts — prohibited acts — exemptions.
Section 376.2004 - Application procedure.
Section 376.2006 - Term of licensure — renewal — continuing education.
Section 376.2008 - Consultation with licensed insurance producer, navigator to advise, when.
Section 376.2011 - Violations, administrative orders, civil actions — penalty.
Section 376.2012 - Navigators duty to report, when.
Section 376.2014 - Applicability — severability — rulemaking authority.
Section 376.2020 - Contracts prohibiting disclosure of certain payments and costs are unenforceable.
Section 376.2030 - Definitions.
Section 376.2036 - Enforcement — applicability to health insurance plans, when.
Section 376.2050 - Citation of act.
Section 376.2051 - Definitions.
Section 376.2053 - Exemption from requirements, when.
Section 376.2080 - Funding agreement defined — authority to issue — rulemaking authority.