{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/38.2-3453.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/38.2-3453.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/38.2-3453.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/38.2-3453.html"}],"law_id":86395,"edition_id":1,"section_id":86395,"structure_id":13819,"section_number":"38.2-3453","catch_line":"Clinical trials","history":"2013, c. 751.","full_text":"A\n\nNotwithstanding any provision of § 38.2-3418.8 or any other section of this title to the contrary, if a health carrier offering a health benefit plan providing individual or group health insurance coverage provides coverage to a qualified individual, then such plan shall provide for participation in an approved clinical trial and cover routine patient costs for items and services furnished in connection with participation in such clinical trial. The health carrier shall not discriminate against the qualified individual on the basis of his participation in such clinical trial.B\n\nFor purposes of this section:1\n\n“Approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and the study or investigation is (i) a federally funded or approved trial, (ii) conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration, or (iii) a drug trial that is exempt from having an investigational new drug application.2\n\n“Life threatening condition” means any disease or condition from which the likelihood of death is probable unless the course of disease or condition is interrupted.3\n\n“Qualified individual” means a covered person who is eligible to participate in an approved clinical trial according to the trial protocol, with respect to treatment of cancer or other life-threatening disease or condition, and the referring health care professional has concluded that the individual’s participation in such trial is appropriate to treat the disease or condition, or the individual’s participation is based on medical and scientific information.4\n\n“Routine patient costs” means all items and services consistent with the coverage provided under the health benefit plan that is typically covered for a qualified individual who is not enrolled in a clinical trial. Routine patient costs do not include the investigational item, device, or service itself; items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.C\n\nNothing in this section shall preclude a health benefit plan from requiring that a qualified individual participate in an approved clinical trial through a participating provider if such provider will accept the individual as a participant in the trial. However, a health benefit plan may not preclude a qualified individual from participating in an approved clinical trial conducted outside the state in which the individual resides.\n\t\t\tThis section shall not be construed to require that a health benefit plan provide benefits outside of the plan’s health care provider network unless out-of-network benefits are otherwise provided under the plan.D\n\nThis section shall not apply to any grandfathered plan providing individual or group health insurance coverage.","order_by":null,"text":{"0":{"id":309415,"text":"Notwithstanding any provision of § 38.2-3418.8 or any other section of this title to the contrary, if a health carrier offering a health benefit plan providing individual or group health insurance coverage provides coverage to a qualified individual, then such plan shall provide for participation in an approved clinical trial and cover routine patient costs for items and services furnished in connection with participation in such clinical trial. The health carrier shall not discriminate against the qualified individual on the basis of his participation in such clinical trial.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":309416,"text":"For purposes of this section:","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"B1"},"2":{"id":309417,"text":"“Approved clinical trial” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and the study or investigation is (i) a federally funded or approved trial, (ii) conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration, or (iii) a drug trial that is exempt from having an investigational new drug application.","type":"section","prefixes":["B","1"],"prefix":"1","entire_prefix":"B1","prefix_anchor":"B1","level":2,"prior_prefix":"B","next_prefix":"B2"},"3":{"id":309418,"text":"“Life threatening condition” means any disease or condition from which the likelihood of death is probable unless the course of disease or condition is interrupted.","type":"section","prefixes":["B","2"],"prefix":"2","entire_prefix":"B2","prefix_anchor":"B2","level":2,"prior_prefix":"B1","next_prefix":"B3"},"4":{"id":309419,"text":"“Qualified individual” means a covered person who is eligible to participate in an approved clinical trial according to the trial protocol, with respect to treatment of cancer or other life-threatening disease or condition, and the referring health care professional has concluded that the individual’s participation in such trial is appropriate to treat the disease or condition, or the individual’s participation is based on medical and scientific information.","type":"section","prefixes":["B","3"],"prefix":"3","entire_prefix":"B3","prefix_anchor":"B3","level":2,"prior_prefix":"B2","next_prefix":"B4"},"5":{"id":309420,"text":"“Routine patient costs” means all items and services consistent with the coverage provided under the health benefit plan that is typically covered for a qualified individual who is not enrolled in a clinical trial. Routine patient costs do not include the investigational item, device, or service itself; items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.","type":"section","prefixes":["B","4"],"prefix":"4","entire_prefix":"B4","prefix_anchor":"B4","level":2,"prior_prefix":"B3","next_prefix":"C"},"6":{"id":309421,"text":"Nothing in this section shall preclude a health benefit plan from requiring that a qualified individual participate in an approved clinical trial through a participating provider if such provider will accept the individual as a participant in the trial. However, a health benefit plan may not preclude a qualified individual from participating in an approved clinical trial conducted outside the state in which the individual resides.\n\t\t\tThis section shall not be construed to require that a health benefit plan provide benefits outside of the plan’s health care provider network unless out-of-network benefits are otherwise provided under the plan.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B4","next_prefix":"D"},"7":{"id":309422,"text":"This section shall not apply to any grandfathered plan providing individual or group health insurance coverage.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C"}},"ancestry":[{"id":13819,"edition_id":1,"name":"Federal Market Reforms","identifier":"6","label":"article","depth":3,"order_by":1,"parent_id":12993,"metadata":{},"date_created":"2026-06-26 03:45:59","date_modified":"2026-06-26 03:45:59","permalink":{"id":215457,"object_type":"structure","relational_id":13819,"identifier":"6","token":"38.2\/34\/6","url":"\/38.2\/34\/6\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12993,"edition_id":1,"name":"Provisions Relating to Accident and Sickness Insurance","identifier":"34","label":"chapter","depth":2,"order_by":1,"parent_id":12698,"metadata":{},"date_created":"2026-06-26 03:44:07","date_modified":"2026-06-26 03:44:07","permalink":{"id":214887,"object_type":"structure","relational_id":12993,"identifier":"34","token":"38.2\/34","url":"\/38.2\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12698,"edition_id":1,"name":"Insurance","identifier":"38.2","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:49","date_modified":"2026-06-26 03:43:49","permalink":{"id":210661,"object_type":"structure","relational_id":12698,"identifier":"38.2","token":"38.2","url":"\/38.2\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":57210,"structure_id":13819,"section_number":"38.2-3438","catch_line":"Definitions","url":"\/38.2-3438\/","token":"38.2\/34\/6\/38.2-3438","metadata":false},{"id":55902,"structure_id":13819,"section_number":"38.2-3439","catch_line":"Dependent coverage for individuals to age 26","url":"\/38.2-3439\/","token":"38.2\/34\/6\/38.2-3439","metadata":false},{"id":59514,"structure_id":13819,"section_number":"38.2-3440","catch_line":"Lifetime and annual limits","url":"\/38.2-3440\/","token":"38.2\/34\/6\/38.2-3440","metadata":false},{"id":74720,"structure_id":13819,"section_number":"38.2-3441","catch_line":"Rescissions","url":"\/38.2-3441\/","token":"38.2\/34\/6\/38.2-3441","metadata":false},{"id":81548,"structure_id":13819,"section_number":"38.2-3442","catch_line":"Preventive services","url":"\/38.2-3442\/","token":"38.2\/34\/6\/38.2-3442","metadata":false},{"id":54833,"structure_id":13819,"section_number":"38.2-3443","catch_line":"Choice of a health care professional","url":"\/38.2-3443\/","token":"38.2\/34\/6\/38.2-3443","metadata":false},{"id":68187,"structure_id":13819,"section_number":"38.2-3444","catch_line":"Preexisting condition exclusions","url":"\/38.2-3444\/","token":"38.2\/34\/6\/38.2-3444","metadata":false},{"id":60836,"structure_id":13819,"section_number":"38.2-3445","catch_line":"Patient access to emergency services","url":"\/38.2-3445\/","token":"38.2\/34\/6\/38.2-3445","metadata":false},{"id":57195,"structure_id":13819,"section_number":"38.2-3445.01","catch_line":"Balance billing for certain services; 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reporting requirements","url":"\/38.2-3445.2\/","token":"38.2\/34\/6\/38.2-3445.2","metadata":false},{"id":86937,"structure_id":13819,"section_number":"38.2-3446","catch_line":"Applicability of federal law","url":"\/38.2-3446\/","token":"38.2\/34\/6\/38.2-3446","metadata":false},{"id":66501,"structure_id":13819,"section_number":"38.2-3447","catch_line":"(Effective January 1, 2026) Restrictions relating to premium rates","url":"\/38.2-3447\/","token":"38.2\/34\/6\/38.2-3447","metadata":false},{"id":79799,"structure_id":13819,"section_number":"38.2-3448","catch_line":"Guaranteed availability","url":"\/38.2-3448\/","token":"38.2\/34\/6\/38.2-3448","metadata":false},{"id":78815,"structure_id":13819,"section_number":"38.2-3449","catch_line":"Prohibiting discrimination based on health status","url":"\/38.2-3449\/","token":"38.2\/34\/6\/38.2-3449","metadata":false},{"id":67706,"structure_id":13819,"section_number":"38.2-3449.1","catch_line":"Prohibited discrimination based on gender identity or status as a transgender individual","url":"\/38.2-3449.1\/","token":"38.2\/34\/6\/38.2-3449.1","metadata":false},{"id":64622,"structure_id":13819,"section_number":"38.2-3450","catch_line":"Genetic information and testing","url":"\/38.2-3450\/","token":"38.2\/34\/6\/38.2-3450","metadata":false},{"id":83154,"structure_id":13819,"section_number":"38.2-3451","catch_line":"Essential health benefits","url":"\/38.2-3451\/","token":"38.2\/34\/6\/38.2-3451","metadata":false},{"id":76537,"structure_id":13819,"section_number":"38.2-3452","catch_line":"Waiting periods","url":"\/38.2-3452\/","token":"38.2\/34\/6\/38.2-3452","metadata":false},{"id":86395,"structure_id":13819,"section_number":"38.2-3453","catch_line":"Clinical trials","url":"\/38.2-3453\/","token":"38.2\/34\/6\/38.2-3453","metadata":false},{"id":81951,"structure_id":13819,"section_number":"38.2-3454","catch_line":"Wellness programs","url":"\/38.2-3454\/","token":"38.2\/34\/6\/38.2-3454","metadata":false},{"id":84250,"structure_id":13819,"section_number":"38.2-3454.1","catch_line":"Renewal of health benefit plans; special exception","url":"\/38.2-3454.1\/","token":"38.2\/34\/6\/38.2-3454.1","metadata":false}],"previous_section":{"id":76537,"structure_id":13819,"section_number":"38.2-3452","catch_line":"Waiting periods","url":"\/38.2-3452\/","token":"38.2\/34\/6\/38.2-3452","metadata":false},"next_section":{"id":81951,"structure_id":13819,"section_number":"38.2-3454","catch_line":"Wellness programs","url":"\/38.2-3454\/","token":"38.2\/34\/6\/38.2-3454","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/38.2-3453\/","history_text":"

This law was first created in 2013. The record of its establishment is cataloged in chapter 751<\/a> of that year\u2019s edition of \u201cActs of Assembly,\u201d the annual state publication listing all changes made to the Code of Virginia in that year.<\/p>","references":false,"refers_to":[{"id":63576,"section_number":"38.2-3418.8","catch_line":"Coverage for clinical trials for treatment studies on cancer","order_by":null,"url":"\/38.2-3418.8\/"}],"permalink":{"id":215559,"object_type":"law","relational_id":86395,"identifier":"38.2-3453","token":"38.2\/34\/6\/38.2-3453","url":"\/38.2-3453\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/38.2-3453\/","token":"38.2\/34\/6\/38.2-3453","dublin_core":{"Title":"Clinical trials","Type":"Text","Format":"text\/html","Identifier":"\u00a7 38.2-3453","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Notwithstanding any provision of § 38.2-3418.8<\/a> or any other section of this title to the contrary, if a health carrier offering a health benefit plan providing individual or group health insurance<\/span> coverage provides coverage to a qualified individual<\/span>, then such plan shall provide for participation in an approved clinical trial<\/span> and cover routine patient costs<\/span> for items and services furnished in connection with participation in such clinical trial. The health carrier shall not discriminate against the qualified individual<\/span> on the basis of his participation in such clinical trial. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> For purposes of this section: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> “Approved clinical trial<\/span>” means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, and the study or investigation is (i) a federally funded or approved trial, (ii) conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration, or (iii) a drug trial that is exempt from having an investigational new drug application. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> “Life threatening condition<\/span>” means any disease or condition from which the likelihood of death is probable unless the course of disease or condition is interrupted. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> “Qualified individual<\/span>” means a covered person<\/span> who is eligible to participate in an approved clinical trial<\/span> according to the trial protocol, with respect to treatment of cancer or other life-threatening disease or condition, and the referring health care professional has concluded that the individual’s participation in such trial is appropriate to treat the disease or condition, or the individual’s participation is based on medical and scientific information. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> “Routine patient costs<\/span>” means all items and services consistent with the coverage provided under the health benefit plan that is typically covered for a qualified individual<\/span> who is not enrolled in a clinical trial. Routine patient costs<\/span> do not include the investigational item, device, or service itself; items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> Nothing in this section shall preclude a health benefit plan from requiring that a qualified individual<\/span> participate in an approved clinical trial<\/span> through a participating provider if such provider will accept the individual as a participant in the trial. However, a health benefit plan may not preclude a qualified individual<\/span> from participating in an approved clinical trial<\/span> conducted outside the state<\/span> in which the individual resides.\n\t\t\tThis section shall not be construed to require that a health benefit plan provide benefits outside of the plan’s health care provider network unless out-of-network benefits are otherwise provided under the plan. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> This section shall not apply to any grandfathered plan providing individual or group health insurance<\/span> coverage. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nCLINICAL TRIALS (\u00a7 38.2-3453)\n\nA. Notwithstanding any provision of § 38.2-3418.8 or any other section of\nthis title to the contrary, if a health carrier offering a health benefit plan\nproviding individual or group health insurance coverage provides coverage to a\nqualified individual, then such plan shall provide for participation in an\napproved clinical trial and cover routine patient costs for items and services\nfurnished in connection with participation in such clinical trial. The health\ncarrier shall not discriminate against the qualified individual on the basis of\nhis participation in such clinical trial.\n\nB. For purposes of this section:\n\n 1. “Approved clinical trial” means a phase I, phase II, phase III,\n or phase IV clinical trial that is conducted in relation to the prevention,\n detection, or treatment of cancer or other life-threatening disease or\n condition, and the study or investigation is (i) a federally funded or\n approved trial, (ii) conducted under an investigational new drug application\n reviewed by the U.S. Food and Drug Administration, or (iii) a drug trial that\n is exempt from having an investigational new drug application.\n\n 2. “Life threatening condition” means any disease or condition\n from which the likelihood of death is probable unless the course of disease or\n condition is interrupted.\n\n 3. “Qualified individual” means a covered person who is eligible\n to participate in an approved clinical trial according to the trial protocol,\n with respect to treatment of cancer or other life-threatening disease or\n condition, and the referring health care professional has concluded that the\n individual’s participation in such trial is appropriate to treat the\n disease or condition, or the individual’s participation is based on\n medical and scientific information.\n\n 4. “Routine patient costs” means all items and services consistent\n with the coverage provided under the health benefit plan that is typically\n covered for a qualified individual who is not enrolled in a clinical trial.\n Routine patient costs do not include the investigational item, device, or\n service itself; items or services that are provided solely to satisfy data\n collection and analysis needs and that are not used in the direct clinical\n management of the patient; or a service that is clearly inconsistent with\n widely accepted and established standards of care for a particular diagnosis.\n\nC. Nothing in this section shall preclude a health benefit plan from requiring\nthat a qualified individual participate in an approved clinical trial through a\nparticipating provider if such provider will accept the individual as a\nparticipant in the trial. However, a health benefit plan may not preclude a\nqualified individual from participating in an approved clinical trial conducted\noutside the state in which the individual resides.\n\t\t\tThis section shall not be construed to require that a health benefit plan\nprovide benefits outside of the plan’s health care provider network unless\nout-of-network benefits are otherwise provided under the plan.\n\nD. This section shall not apply to any grandfathered plan providing individual\nor group health insurance coverage.\n\nHISTORY: 2013, c. 751.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}