Missouri Revised Statutes
Chapter 191 - Health and Welfare
Section 191.480 - Manufacturers may make investigational drugs and devices available to eligible patients, when — definitions — requirements.

Effective - 28 Aug 2014
191.480. Manufacturers may make investigational drugs and devices available to eligible patients, when — definitions — requirements. — 1. For purposes of this section, the following terms shall mean:
(1) "Eligible patient", a person who meets all of the following:
(a) Has a terminal illness;
(b) Has considered all other treatment options currently approved by the United States Food and Drug Administration and all relevant clinical trials conducted in this state;
(c) Has received a prescription or recommendation from the person's physician for an investigational drug, biological product, or device;
(d) Has given written informed consent which shall be at least as comprehensive as the consent used in clinical trials for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf; and
(e) Has documentation from the person's physician that the person has met the requirements of this subdivision;
(2) "Investigational drug, biological product, or device", a drug, biological product, or device, any of which are used to treat the patient's terminal illness, that has successfully completed phase one of a clinical trial but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial. The term shall not include Schedule I controlled substances;
(3) "Terminal illness", a disease that without life-sustaining procedures will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.
2. A manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to eligible patients under this section. This section does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient. A manufacturer may:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or
(2) Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device.
3. This section does not require a health care insurer to provide coverage for the cost of any investigational drug, biological product, or device. A health care insurer may provide coverage for an investigational drug, biological product, or device.
4. This section does not require the department of corrections to provide coverage for the cost of any investigational drug, biological product, or device.
5. Notwithstanding any other provision of law to the contrary, no state agency or regulatory board shall revoke, fail to renew, or take any other action against a physician's license issued under chapter 334 based solely on the physician's recommendation to an eligible patient regarding prescription for or treatment with an investigational drug, biological product, or device. Action against a health care provider's Medicare certification based solely on the health care provider's recommendation that a patient have access to an investigational drug, biological product, or device is prohibited.
6. If a provision of this section or its application to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of this section that can be given effect without the invalid provision or application, and to this end the provisions of this section are severable.
7. If the clinical trial is closed due to lack of efficacy or toxicity, the drug shall not be offered. If notice is given on a drug, product, or device taken by a patient outside of a clinical trial, the pharmaceutical company or patient's physician shall notify the patient of the information from the safety committee of the clinical trial.
8. Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device to an eligible patient with a terminal illness in accordance with this section shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:
(1) The design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or
(2) The safety or effectiveness of the drug or device.
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(L. 2014 H.B. 1685)

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Structure Missouri Revised Statutes

Missouri Revised Statutes

Title XII - Public Health and Welfare

Chapter 191 - Health and Welfare

Section 191.005 - Information exchange between departments, rulemaking authority.

Section 191.025 - Health care compact.

Section 191.116 - Alzheimer's state plan task force established — members, appointment, duties — report — expiration date.

Section 191.127 - Land may be leased for farming or grazing — procedure.

Section 191.150 - Purchase of food limited to use of institution inmates.

Section 191.160 - Board and living quarters for employees of institutions.

Section 191.170 - Mistreatment of inmates — penalty.

Section 191.180 - Furnishing unfit food to institution — penalty.

Section 191.190 - Accessory to mistreatment of inmates or furnishing of unwholesome food — penalty.

Section 191.210 - Attendance of patient by private physician.

Section 191.211 - Funding of certain programs.

Section 191.213 - Additional funding sources for certain programs.

Section 191.226 - Costs of HIV testing for certain crime victims payable by department of health and senior services, when, conditions.

Section 191.227 - Medical records to be released to patient, when, exception — fee permitted, amount — liability of provider limited — annual handling fee adjustment — disclosure of deceased patient records, when.

Section 191.228 - Physician and pharmacist not subject to discipline for cooperation.

Section 191.229 - Accreditation of not-for-profit human services organizations deemed equivalent to licensure.

Section 191.231 - Community-based integrated delivery system, qualification, powers — organization, board of directors, powers — plans.

Section 191.235 - Mercury contained in immunizations, not to be administered to certain persons — insurance reimbursement for nonmercury immunizations — exemptions, when.

Section 191.237 - Failure to participate in health information organization, no fine or penalty may be imposed — no exchange of data, when — definitions.

Section 191.250 - Citation of law — definitions — DNR orders, requirements — revocation of consent — appointment of guardian, when — continuation of treatment not required, when.

Section 191.300 - Definitions.

Section 191.305 - Missouri genetic advisory committee created — purpose — appointment, terms — qualifications — expenses.

Section 191.310 - Duties of committee — liaison officers with mental health and education, appointment.

Section 191.315 - Genetics program to be established by department — rules authorized — procedure.

Section 191.317 - Confidentiality of all tests and personal information — exceptions — retention of specimens, procedure.

Section 191.320 - Genetic diagnostic and counseling services to be established — outreach centers, duties — referral for abortion, procedure, requirements.

Section 191.323 - Powers and duties of department of health and senior services in prevention and treatment of genetic diseases and birth defects.

Section 191.325 - Cost of services, how paid — free to persons financially unable to pay — residency requirement.

Section 191.331 - Infants to be tested for metabolic and genetic diseases — reports — exceptions — refusal to test — fee for screening test, department may impose by rule, use of fees — formula provided by department, when — assistance available, whe...

Section 191.332 - Supplemental newborn screening requirements — additional screenings — rulemaking authority.

Section 191.333 - Citation of law — screening for lysosomal storage diseases — rulemaking authority — fee increase authorized.

Section 191.334 - Chloe's Law — critical congenital heart disease screening, requirements — rulemaking authority.

Section 191.335 - Hemophilia program established — state assistance, when.

Section 191.340 - Hemophilia program — care and treatment — financial assistance — education — duties of department.

Section 191.360 - Trained employee of end-stage renal disease facility may initiate dialysis — not unlawful practice of medicine.

Section 191.362 - Appropriately trained employees to have completed course in dialysis techniques.

Section 191.365 - Sickle cell anemia — purposes of program — financial assistance, when.

Section 191.370 - Sickle cell anemia, development of program for care and treatment — duties of department.

Section 191.375 - Cystic fibrosis, program for care and treatment — financial assistance, when.

Section 191.380 - Cystic fibrosis, duties of department.

Section 191.400 - State board of health and senior services — appointment — terms — qualifications — limitation on other employment, exception — vacancies — compensation — meetings.

Section 191.411 - System of coordinated health care services — health access incentive fund created, purpose — enhanced Medicaid payments — rules — annual report.

Section 191.425 - Program established, eligibility — contracting authority — conditional on receipt of federal funding — sunset provision.

Section 191.480 - Manufacturers may make investigational drugs and devices available to eligible patients, when — definitions — requirements.

Section 191.500 - Definitions.

Section 191.505 - Department of health and senior services to administer — may make rules and regulations.

Section 191.510 - Contracts for loans to include terms.

Section 191.515 - Requirements for application.

Section 191.520 - Maximum amount of loans — source of funds.

Section 191.525 - Number of loans available — to whom — length of loans.

Section 191.530 - Interest on loans — repayment terms — temporary deferral.

Section 191.535 - Termination of course of study, effect.

Section 191.540 - Repayment schedules — breach of contract.

Section 191.545 - Recovery — actions for.

Section 191.550 - Approval of contracts.

Section 191.594 - Citation of law — prevalence of depression and suicide study — prohibited acts — definitions.

Section 191.596 - Research project authorized — committee established, members, duties — center study, contents — annual report.

Section 191.600 - Loan repayment program established — health professional student loan repayment program fund established — use.

Section 191.603 - Definitions.

Section 191.605 - Department to designate as areas of need — factors to be considered.

Section 191.607 - Qualifications for eligibility established by department.

Section 191.609 - Contract for repayment of loans, contents.

Section 191.611 - Loan repayment program to cover certain loans — amount paid per year of obligated service — schedule of payments — communities sharing costs to be given first consideration.

Section 191.614 - Termination of medical studies or failure to become licensed doctor, liability — breach of contract for service obligation, penalties — recovery of amount paid by contributing community.

Section 191.615 - Application for federal funds — insufficient funds, effect.

Section 191.630 - Definitions.

Section 191.631 - Testing for disease, consent deemed given, when — hospital to conduct testing, written policies and procedures required — notification for confirmed exposure, by whom — limitations on testing and duties of hospitals, coroners, and m...

Section 191.640 - Blood-borne pathogen standard required for occupational exposure of public employees to blood and other infectious materials — definitions — requirements of needleless system and sharps — violations, penalty.

Section 191.645 - Risk of exposure to Hepatitis C, information to be made available — website to be maintained, content.

Section 191.648 - Expedited partner therapy permitted, requirements for physicians utilizing — rulemaking authority.

Section 191.650 - Definitions.

Section 191.653 - HIV testing performed by whom, how — consultation with subject required, when.

Section 191.656 - Confidentiality of reports and records, exceptions — violation, civil action for injunction, damages, costs and attorney fees — health care provider participating in judicial proceeding, immune from civil liability.

Section 191.657 - Disclosure of confidential HIV information, by court order, only to certain persons, procedure, when.

Section 191.658 - HIV infection status disclosure by department of health and senior services to exposed health workers or law enforcement officers, when, violation, penalty.

Section 191.659 - Department of corrections, HIV and infectious diseases testing without right of refusal — exception — minors victim of sexual assault, testing, notice to parents or custodians required.

Section 191.662 - Department of mental health, permissive HIV testing without right of refusal, when — results of testing not to be reported to department of health and senior services, when.

Section 191.663 - HIV testing, defined — court order to test certain sexual offenders — costs — bond — disclosure of results of test — parents of unemancipated minor informed, when.

Section 191.665 - Discrimination prohibited, exceptions.

Section 191.668 - Department of health and senior services and department of elementary and secondary education to prepare education programs, contents.

Section 191.671 - Insurance companies, HMOs or health service corporations, HIV testing by, regulation by department — disclosure of test results, confidentiality.

Section 191.674 - Court-ordered HIV testing without right of refusal, department of health and senior services may seek, when — court record closed, proceeding to be in camera, when.

Section 191.677 - Serious infectious or communicable diseases, prohibited acts, criminal penalties — affirmative defense — use of pseudonym, when.

Section 191.680 - Maintaining a nuisance, abatement to be ordered, when.

Section 191.683 - Reports to general assembly by department of health and senior services.

Section 191.686 - Anonymous testing sites in central Missouri, Kansas City, Springfield and St. Louis — reports of results, use of coded system — contact notification required, when.

Section 191.689 - Schools to be given notice of identity of child with HIV infection, when, by whom — identity of infected child may be released to whom by school.

Section 191.692 - Premarital HIV testing, rulemaking authorized, when.

Section 191.694 - Infection control procedures — requirements and training for health care facilities and professionals.

Section 191.695 - Rulemaking authority, department of health and senior services — procedure.

Section 191.699 - Disciplinary action for health care professionals who discriminate or require HIV testing before treatment.

Section 191.700 - Testing of all health care professionals not justified — voluntary and confidential evaluation of infected professional, procedure — expert review panel qualifications, powers and duties, practice restrictions, when — health care fa...

Section 191.703 - Death of patient with infectious or contagious disease, notification to funeral director or coroner.

Section 191.710 - MO HealthNet program and SCHIPS to focus on premature infant health care.

Section 191.711 - Education publications to be prepared, contents — distribution.

Section 191.724 - Discrimination based on religious beliefs or moral convictions prohibited, health plan coverage of abortion — no mandatory employee coverage of certain procedures — attorney general to enforce — sterilization defined.

Section 191.725 - Physician to counsel pregnant patients on effects of cigarettes, alcohol and controlled substances — certifying form to be signed by patient on counseling — educational materials to be furnished to physicians.

Section 191.729 - School districts to be furnished information on prenatal and postnatal effects of substances, when.

Section 191.731 - Pregnant woman referred for substance abuse to have priority for treatment — confidentiality of records.

Section 191.737 - Children exposed to substance abuse, referral by physician to children's division — physician making referral immune from civil liability — confidentiality of report.

Section 191.739 - Protective and preventive services to be provided by department of social services, duties.

Section 191.748 - Shaken baby syndrome video, required viewing, when.

Section 191.755 - Department to post resources on website, content.

Section 191.756 - Grants awarded by board of health and senior services — eligibility criteria.

Section 191.758 - Information to be made available by physician to pregnant women, when.

Section 191.761 - Umbilical cord blood samples, department to provide courier service to nonprofit umbilical cord blood bank — rulemaking authority.

Section 191.765 - Definitions.

Section 191.767 - Persons not to smoke in public places or meetings, except in designated smoking areas — designation of space for smoking area, requirements.

Section 191.769 - Areas not considered public places.

Section 191.771 - Person in control of public places or public meetings, duties.

Section 191.773 - Violators, guilty of infraction.

Section 191.775 - Public schools and school buses — smoking, or tobacco or vapor product use prohibited — permissible use of tobacco, where.

Section 191.776 - Child day care facilities, smoking or tobacco use when children are present, prohibited, penalty.

Section 191.777 - More stringent ordinances or rules may be adopted by governing bodies or school boards.

Section 191.800 - Definitions.

Section 191.803 - Boards of education to establish breakfast program — rules — waiver, procedure.

Section 191.805 - Hardship grant program, distribution of, rules.

Section 191.807 - Supplemental funding, women, infants and children supplemental food program — funding of certain county health offices, use, maximum amount of grants — rules and regulations.

Section 191.810 - Department of health and senior services to establish standards for summer food service program — where established — order of priority — waiver, filing required.

Section 191.813 - Agencies to coordinate outreach programs — specific programs — public service announcements to be designed.

Section 191.815 - Administrative rules, procedure.

Section 191.828 - Evaluations, effect of initiatives.

Section 191.831 - Health initiatives fund established, use — Alt-care pilot program, components — participation may be required.

Section 191.835 - Community 2000 grants program — local commissions, members — goals, objectives — evaluations, funding.

Section 191.839 - Education programs for persons with no or inadequate health insurance.

Section 191.843 - Authorizes grants for regional research consortia in a distressed community.

Section 191.875 - Citation--definitions--estimate of cost provided, when--statement--disclosure of costs without discounts.

Section 191.900 - Definitions.

Section 191.905 - False statement to receive health care payment prohibited — kickback, bribe, purpose, prohibited, exceptions — abuse prohibited — penalty — prosecution, procedure — Medicaid fraud reimbursement fund created — restitution — civil pen...

Section 191.907 - Original source of information to receive a portion of any recovery.

Section 191.908 - Whistleblower protections — violations, penalty.

Section 191.910 - Attorney general may investigate violations, powers — service authorized — prosecuting attorney, report, prosecution — provision of records — no limitation of other actions.

Section 191.914 - False report or claim, penalty.

Section 191.915 - Breast-feeding information provided, when, by whom.

Section 191.918 - Breast-feeding in public permitted — not sexual conduct, public indecency, or obscenity — no municipal ordinances to prohibit or restrict.

Section 191.923 - Prenatally diagnosed conditions, patient to be provided information — definitions — clearinghouse of information to be established.

Section 191.925 - Screening for hearing loss, infants, when — procedures used — exemptions — information provided, by whom — no liability, when.

Section 191.928 - Surveillance and monitoring system for certain newborns — standards and follow-up procedure — confidentiality of information.

Section 191.931 - Early intervention services available — report, content.

Section 191.937 - Rulemaking authority, procedure.

Section 191.940 - Citation of law — definitions — hospitals and ambulatory surgical centers to provide information about postpartum depression.

Section 191.950 - Prostate cancer pilot programs — definitions — eligibility — services provided — grants — rulemaking authority — sunset provision.

Section 191.975 - Adoption awareness, department duties — advertising campaign authorized — rulemaking authority.

Section 191.980 - Missouri area health education centers program established — authority of director — duties.

Section 191.990 - Diabetes goals and benchmarks — report, contents.

Section 191.1050 - Definitions.

Section 191.1053 - Designation of areas — re-evaluation of designations, when — rulemaking authority.

Section 191.1056 - Fund created, use of moneys.

Section 191.1075 - Definitions.

Section 191.1080 - Council created, purpose, members, terms, duties — report — expiration date.

Section 191.1085 - Program established, purpose — website information — rulemaking authority.

Section 191.1100 - Citation of law — definitions.

Section 191.1102 - Additional licensure not required, when — inapplicability.

Section 191.1104 - Display of license or certificate, how satisfied.

Section 191.1106 - Registration with department required, fee, contents — quarterly reports — list of providers — recordkeeping requirements — rulemaking authority.

Section 191.1110 - Immunity from liability, when — no compensation to be received — certain military personnel deemed licensed.

Section 191.1112 - Volunteer crisis response teams — definitions — immunity from liability, inapplicability of.

Section 191.1140 - Treatment of chronic, common, and complex diseases, program authorized, purpose.

Section 191.1145 - Definitions — telehealth services authorized, when.

Section 191.1146 - Physician-patient relationship required, how established.

Section 191.1150 - Citation of law — definitions — designation of caregiver, when — requirements.

Section 191.1164 - Citation of law — definitions.

Section 191.1165 - Medication-assisted treatment — formulary medications and requirements — disclosure of MAT services provided — incarcerated persons and diversion program participants, assessment for substance use disorders.

Section 191.1167 - Contracts, policies, or procedures in violation of act deemed null and void.

Section 191.1168 - Severability clause.

Section 191.1400 - Citation of law — definitions — compassionate care visits to be permitted, policy — limitations — informational materials — violations may be reported — immunity from liability, when.

Section 191.1601 - Citation of law.

Section 191.1603 - Definitions.

Section 191.1604 - Long-term dignity savings account, use, requirements.

Section 191.1605 - Accounts, use of moneys — withdrawals, recapture — death of account holder, effect of.

Section 191.1606 - Reporting, forms — rulemaking authority.

Section 191.1607 - Financial institutions, requirements — no responsibility or liability, when.

Section 191.2290 - Citation of law — definitions — state of emergency, designated essential caregiver designation — requirements.