{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/38.2-3418.8.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/38.2-3418.8.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/38.2-3418.8.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/38.2-3418.8.html"}],"law_id":63576,"edition_id":1,"section_id":63576,"structure_id":14324,"section_number":"38.2-3418.8","catch_line":"Coverage for clinical trials for treatment studies on cancer","history":"1999, cc. 643, 649; 2013, c. 751.","full_text":"A\n\nNotwithstanding the provisions of § 38.2-3419, each insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; each corporation providing individual or group accident and sickness subscription contracts; and each health maintenance organization providing a health care plan for health care services shall provide coverage for patient costs incurred during participation in clinical trials for treatment studies on cancer, including ovarian cancer trials, under any such policy, contract or plan delivered, issued for delivery, or renewed in this Commonwealth on and after July 1, 1999.B\n\nThe reimbursement for patient costs incurred during participation in clinical trials for treatment studies on cancer shall be determined in the same manner as reimbursement is determined for other medical and surgical procedures. Such coverage shall have durational limits, dollar limits, deductibles, copayments and coinsurance factors that are no less favorable than for physical illness generally.C\n\nFor purposes of this section:\n\t\t\t“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. “Cooperative group” includes (i) the National Cancer Institute Clinical Cooperative Group and (ii) the National Cancer Institute Community Clinical Oncology Program.\n\t\t\t“FDA” means the Federal Food and Drug Administration.\n\t\t\t“Member” means a policyholder, subscriber, insured, or certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.\n\t\t\t“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.\n\t\t\t“NCI” means the National Cancer Institute.\n\t\t\t“NIH” means the National Institutes of Health.\n\t\t\t“Patient cost” means the cost of a medically necessary health care service that is incurred as a result of the treatment being provided to the member for purposes of a clinical trial. “Patient cost” does not include (i) the cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided for purposes of a clinical trial, (ii) costs associated with managing the research associated with the clinical trial, or (iii) the cost of the investigational drug or device.D\n\nCoverage for patient costs incurred during clinical trials for treatment studies on cancer shall be provided if the treatment is being conducted in a Phase II, Phase III, or Phase IV clinical trial. Such treatment may, however, be provided on a case-by-case basis if the treatment is being provided in a Phase I clinical trial.E\n\nThe treatment described in subsection D shall be provided by a clinical trial approved by:1\n\nThe National Cancer Institute;2\n\nAn NCI cooperative group or an NCI center;3\n\nThe FDA in the form of an investigational new drug application;4\n\nThe federal Department of Veterans Affairs; or5\n\nAn institutional review board of an institution in the Commonwealth that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NCI.F\n\nThe facility and personnel providing the treatment shall be capable of doing so by virtue of their experience, training, and expertise.G\n\nCoverage under this section shall apply only if:1\n\nThere is no clearly superior, noninvestigational treatment alternative;2\n\nThe available clinical or preclinical data provides a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative; and3\n\nThe member and the physician or health care provider who provides services to the member under the insurance policy, subscription contract or health care plan conclude that the member’s participation in the clinical trial would be appropriate, pursuant to procedures established by the insurer, corporation or health maintenance organization and as disclosed in the policy and evidence of coverage.H\n\nThe provisions of this section shall not apply to short-term travel, accident-only, limited or specified disease policies or contracts designed for issuance to persons eligible for coverage under Title XVIII of the Social Security Act, known as Medicare, or any other similar coverage under state or governmental plans or to short-term nonrenewable policies of not more than six months’ duration.I\n\nThe provisions of this section shall not apply in any instance in which the provisions of this section are inconsistent or in conflict with a provision of Article 6 (§ 38.2-3438 et seq.) of Chapter 34.","order_by":null,"text":{"0":{"id":231602,"text":"Notwithstanding the provisions of § 38.2-3419, each insurer proposing to issue individual or group accident and sickness insurance policies providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; each corporation providing individual or group accident and sickness subscription contracts; and each health maintenance organization providing a health care plan for health care services shall provide coverage for patient costs incurred during participation in clinical trials for treatment studies on cancer, including ovarian cancer trials, under any such policy, contract or plan delivered, issued for delivery, or renewed in this Commonwealth on and after July 1, 1999.","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"B"},"1":{"id":231603,"text":"The reimbursement for patient costs incurred during participation in clinical trials for treatment studies on cancer shall be determined in the same manner as reimbursement is determined for other medical and surgical procedures. Such coverage shall have durational limits, dollar limits, deductibles, copayments and coinsurance factors that are no less favorable than for physical illness generally.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A","next_prefix":"C"},"2":{"id":231604,"text":"For purposes of this section:\n\t\t\t“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. “Cooperative group” includes (i) the National Cancer Institute Clinical Cooperative Group and (ii) the National Cancer Institute Community Clinical Oncology Program.\n\t\t\t“FDA” means the Federal Food and Drug Administration.\n\t\t\t“Member” means a policyholder, subscriber, insured, or certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.\n\t\t\t“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.\n\t\t\t“NCI” means the National Cancer Institute.\n\t\t\t“NIH” means the National Institutes of Health.\n\t\t\t“Patient cost” means the cost of a medically necessary health care service that is incurred as a result of the treatment being provided to the member for purposes of a clinical trial. “Patient cost” does not include (i) the cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided for purposes of a clinical trial, (ii) costs associated with managing the research associated with the clinical trial, or (iii) the cost of the investigational drug or device.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"3":{"id":231605,"text":"Coverage for patient costs incurred during clinical trials for treatment studies on cancer shall be provided if the treatment is being conducted in a Phase II, Phase III, or Phase IV clinical trial. Such treatment may, however, be provided on a case-by-case basis if the treatment is being provided in a Phase I clinical trial.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C","next_prefix":"E"},"4":{"id":231606,"text":"The treatment described in subsection D shall be provided by a clinical trial approved by:","type":"section","prefixes":["E"],"prefix":"E","entire_prefix":"E","prefix_anchor":"E","level":1,"prior_prefix":"D","next_prefix":"E1"},"5":{"id":231607,"text":"The National Cancer Institute;","type":"section","prefixes":["E","1"],"prefix":"1","entire_prefix":"E1","prefix_anchor":"E1","level":2,"prior_prefix":"E","next_prefix":"E2"},"6":{"id":231608,"text":"An NCI cooperative group or an NCI center;","type":"section","prefixes":["E","2"],"prefix":"2","entire_prefix":"E2","prefix_anchor":"E2","level":2,"prior_prefix":"E1","next_prefix":"E3"},"7":{"id":231609,"text":"The FDA in the form of an investigational new drug application;","type":"section","prefixes":["E","3"],"prefix":"3","entire_prefix":"E3","prefix_anchor":"E3","level":2,"prior_prefix":"E2","next_prefix":"E4"},"8":{"id":231610,"text":"The federal Department of Veterans Affairs; or","type":"section","prefixes":["E","4"],"prefix":"4","entire_prefix":"E4","prefix_anchor":"E4","level":2,"prior_prefix":"E3","next_prefix":"E5"},"9":{"id":231611,"text":"An institutional review board of an institution in the Commonwealth that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NCI.","type":"section","prefixes":["E","5"],"prefix":"5","entire_prefix":"E5","prefix_anchor":"E5","level":2,"prior_prefix":"E4","next_prefix":"F"},"10":{"id":231612,"text":"The facility and personnel providing the treatment shall be capable of doing so by virtue of their experience, training, and expertise.","type":"section","prefixes":["F"],"prefix":"F","entire_prefix":"F","prefix_anchor":"F","level":1,"prior_prefix":"E5","next_prefix":"G"},"11":{"id":231613,"text":"Coverage under this section shall apply only if:","type":"section","prefixes":["G"],"prefix":"G","entire_prefix":"G","prefix_anchor":"G","level":1,"prior_prefix":"F","next_prefix":"G1"},"12":{"id":231614,"text":"There is no clearly superior, noninvestigational treatment alternative;","type":"section","prefixes":["G","1"],"prefix":"1","entire_prefix":"G1","prefix_anchor":"G1","level":2,"prior_prefix":"G","next_prefix":"G2"},"13":{"id":231615,"text":"The available clinical or preclinical data provides a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative; and","type":"section","prefixes":["G","2"],"prefix":"2","entire_prefix":"G2","prefix_anchor":"G2","level":2,"prior_prefix":"G1","next_prefix":"G3"},"14":{"id":231616,"text":"The member and the physician or health care provider who provides services to the member under the insurance policy, subscription contract or health care plan conclude that the member’s participation in the clinical trial would be appropriate, pursuant to procedures established by the insurer, corporation or health maintenance organization and as disclosed in the policy and evidence of coverage.","type":"section","prefixes":["G","3"],"prefix":"3","entire_prefix":"G3","prefix_anchor":"G3","level":2,"prior_prefix":"G2","next_prefix":"H"},"15":{"id":231617,"text":"The provisions of this section shall not apply to short-term travel, accident-only, limited or specified disease policies or contracts designed for issuance to persons eligible for coverage under Title XVIII of the Social Security Act, known as Medicare, or any other similar coverage under state or governmental plans or to short-term nonrenewable policies of not more than six months’ duration.","type":"section","prefixes":["H"],"prefix":"H","entire_prefix":"H","prefix_anchor":"H","level":1,"prior_prefix":"G3","next_prefix":"I"},"16":{"id":231618,"text":"The provisions of this section shall not apply in any instance in which the provisions of this section are inconsistent or in conflict with a provision of Article 6 (§ 38.2-3438 et seq.) of Chapter 34.","type":"section","prefixes":["I"],"prefix":"I","entire_prefix":"I","prefix_anchor":"I","level":1,"prior_prefix":"H"}},"ancestry":[{"id":14324,"edition_id":1,"name":"Mandated Benefits","identifier":"2","label":"article","depth":3,"order_by":1,"parent_id":12993,"metadata":{},"date_created":"2026-06-26 03:47:45","date_modified":"2026-06-26 03:47:45","permalink":{"id":215143,"object_type":"structure","relational_id":14324,"identifier":"2","token":"38.2\/34\/2","url":"\/38.2\/34\/2\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12993,"edition_id":1,"name":"Provisions Relating to Accident and Sickness 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physicians","url":"\/38.2-3408\/","token":"38.2\/34\/2\/38.2-3408","metadata":false},{"id":55621,"structure_id":14324,"section_number":"38.2-3409","catch_line":"Coverage of dependent children","url":"\/38.2-3409\/","token":"38.2\/34\/2\/38.2-3409","metadata":false},{"id":68501,"structure_id":14324,"section_number":"38.2-3410","catch_line":"Construction of policy generally; words \"physician\" and \"doctor\" to include dentist","url":"\/38.2-3410\/","token":"38.2\/34\/2\/38.2-3410","metadata":false},{"id":76551,"structure_id":14324,"section_number":"38.2-3411","catch_line":"Coverage of newborn children required","url":"\/38.2-3411\/","token":"38.2\/34\/2\/38.2-3411","metadata":false},{"id":71629,"structure_id":14324,"section_number":"38.2-3411.1","catch_line":"Coverage for child health supervision services","url":"\/38.2-3411.1\/","token":"38.2\/34\/2\/38.2-3411.1","metadata":false},{"id":70694,"structure_id":14324,"section_number":"38.2-3411.2","catch_line":"Coverage of adopted 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components","url":"\/38.2-3418.15\/","token":"38.2\/34\/2\/38.2-3418.15","metadata":false},{"id":57543,"structure_id":14324,"section_number":"38.2-3418.15:1","catch_line":"Coverage for prosthetic devices and components","url":"\/38.2-3418.15_1\/","token":"38.2\/34\/2\/38.2-3418.15_1","metadata":false},{"id":61286,"structure_id":14324,"section_number":"38.2-3418.16","catch_line":"Coverage for telemedicine services","url":"\/38.2-3418.16\/","token":"38.2\/34\/2\/38.2-3418.16","metadata":false},{"id":81144,"structure_id":14324,"section_number":"38.2-3418.17","catch_line":"Coverage for autism spectrum disorder","url":"\/38.2-3418.17\/","token":"38.2\/34\/2\/38.2-3418.17","metadata":false},{"id":60567,"structure_id":14324,"section_number":"38.2-3418.18","catch_line":"Coverage for formula and enteral nutrition products as 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holder","url":"\/38.2-3419\/","token":"38.2\/34\/2\/38.2-3419","metadata":false},{"id":57559,"structure_id":14324,"section_number":"38.2-3419.1","catch_line":"Report of costs and utilization of mandated benefits","url":"\/38.2-3419.1\/","token":"38.2\/34\/2\/38.2-3419.1","metadata":false}],"previous_section":{"id":62197,"structure_id":14324,"section_number":"38.2-3418.7:1","catch_line":"Coverage for colorectal cancer screening","url":"\/38.2-3418.7_1\/","token":"38.2\/34\/2\/38.2-3418.7_1","metadata":false},"next_section":{"id":72556,"structure_id":14324,"section_number":"38.2-3418.9","catch_line":"Minimum hospital stay for hysterectomy","url":"\/38.2-3418.9\/","token":"38.2\/34\/2\/38.2-3418.9","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/38.2-3418.8\/","history_text":"

This law was first created in 1999. The record of its establishment is cataloged in chapters 643<\/a> and 649<\/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. It has been modified 1 time. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. That modification is as follows: in 2013, chapter 751<\/a>.<\/p>","references":[{"id":86395,"section_number":"38.2-3453","catch_line":"Clinical trials","order_by":null,"url":"\/38.2-3453\/"}],"refers_to":[{"id":66144,"section_number":"38.2-3419","catch_line":"Additional mandated coverage made optional to group policy or contract holder","order_by":null,"url":"\/38.2-3419\/"},{"id":57210,"section_number":"38.2-3438","catch_line":"Definitions","order_by":null,"url":"\/38.2-3438\/"}],"permalink":{"id":215317,"object_type":"law","relational_id":63576,"identifier":"38.2-3418.8","token":"38.2\/34\/2\/38.2-3418.8","url":"\/38.2-3418.8\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/38.2-3418.8\/","token":"38.2\/34\/2\/38.2-3418.8","dublin_core":{"Title":"Coverage for clinical trials for treatment studies on cancer","Type":"Text","Format":"text\/html","Identifier":"\u00a7 38.2-3418.8","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> Notwithstanding the provisions of § 38.2-3419<\/a>, each insurer<\/span> proposing to issue<\/span> individual or group accident and sickness insurance policies<\/span> providing hospital, medical and surgical, or major medical coverage on an expense-incurred basis; each corporation providing individual or group accident and sickness subscription contracts<\/span>; and each health maintenance organization providing a health care plan for health care services shall provide coverage for patient costs<\/span> incurred during participation in clinical trials<\/span> for treatment studies on cancer, including ovarian cancer trials<\/span>, under any such policy, contract<\/span> or plan delivered, issued for delivery, or renewed in this Commonwealth on and after July 1, 1999. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> The reimbursement for patient costs<\/span> incurred during participation in clinical trials<\/span> for treatment studies on cancer shall be determined in the same manner as reimbursement is determined for other medical and surgical procedures. Such coverage shall have durational limits, dollar limits, deductibles, copayments and coinsurance factors that are no less favorable than for physical illness generally. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> For purposes of this section:\n\t\t\t“Cooperative group<\/span>” means a formal network of facilities that collaborate on research projects and have an established NIH<\/span>-approved peer review program operating within the group. “Cooperative group<\/span>” includes (i) the National Cancer Institute Clinical Cooperative Group<\/span> and (ii) the National Cancer Institute Community Clinical Oncology Program.\n\t\t\t“FDA<\/span>” means the Federal Food and Drug Administration.\n\t\t\t“Member<\/span>” means a policyholder, subscriber, insured, or certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.\n\t\t\t“Multiple project assurance contract<\/span>” 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.\n\t\t\t“NCI<\/span>” means the National Cancer Institute.\n\t\t\t“NIH<\/span>” means the National Institutes of Health.\n\t\t\t“Patient cost<\/span>” means the cost of a medically necessary health care service that is incurred as a result of the treatment being provided to the member<\/span> for purposes of a clinical trial<\/span>. “Patient cost<\/span>” does not include (i) the cost of nonhealth care services that a patient may be required to receive as a result of the treatment being provided for purposes of a clinical trial<\/span>, (ii) costs associated with managing the research associated with the clinical trial<\/span>, or (iii) the cost of the investigational drug or device. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> Coverage for patient costs<\/span> incurred during clinical trials<\/span> for treatment studies on cancer shall be provided if the treatment is being conducted in a Phase II, Phase III, or Phase IV clinical trial<\/span>. Such treatment may, however, be provided on a case-by-case basis if the treatment is being provided in a Phase I clinical trial<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

E.<\/span> The treatment described in subsection D shall be provided by a clinical trial<\/span> approved by: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> The National Cancer Institute; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> An NCI<\/span> cooperative group<\/span> or an NCI<\/span> center; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> The FDA<\/span> in the form of an investigational new drug application; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> The federal Department of Veterans Affairs; or <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> An institutional review board of an institution in the Commonwealth that has a multiple project assurance contract<\/span> approved by the Office of Protection from Research Risks of the NCI<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

F.<\/span> The facility and personnel providing the treatment shall be capable of doing so by virtue of their experience, training, and expertise. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

G.<\/span> Coverage under this section shall apply only if: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> There is no clearly superior, noninvestigational treatment alternative; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> The available clinical or preclinical data provides a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative; and <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> The member<\/span> and the physician or health care provider who provides services to the member<\/span> under the insurance policy, subscription contract or health care plan conclude that the member<\/span>’s participation in the clinical trial<\/span> would be appropriate, pursuant to procedures established by the insurer<\/span>, corporation or health maintenance organization and as disclosed in the policy and evidence<\/span> of coverage. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

H.<\/span> The provisions of this section shall not apply to short-term travel, accident-only, limited or specified disease policies or contracts<\/span> designed for issuance to persons<\/span> eligible for coverage under Title XVIII of the Social Security Act, known as Medicare<\/span>, or any other similar coverage under state<\/span> or governmental plans or to short-term nonrenewable policies of not more than six months’ duration. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

I.<\/span> The provisions of this section shall not apply in any instance in which the provisions of this section are inconsistent or in conflict with a provision of Article 6 (§ 38.2-3438<\/a> et seq.) of Chapter 34. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nCOVERAGE FOR CLINICAL TRIALS FOR TREATMENT STUDIES ON CANCER (\u00a7 38.2-3418.8)\n\nA. Notwithstanding the provisions of § 38.2-3419, each insurer proposing to\nissue individual or group accident and sickness insurance policies providing\nhospital, medical and surgical, or major medical coverage on an expense-incurred\nbasis; each corporation providing individual or group accident and sickness\nsubscription contracts; and each health maintenance organization providing a\nhealth care plan for health care services shall provide coverage for patient\ncosts incurred during participation in clinical trials for treatment studies on\ncancer, including ovarian cancer trials, under any such policy, contract or plan\ndelivered, issued for delivery, or renewed in this Commonwealth on and after\nJuly 1, 1999.\n\nB. The reimbursement for patient costs incurred during participation in clinical\ntrials for treatment studies on cancer shall be determined in the same manner as\nreimbursement is determined for other medical and surgical procedures. Such\ncoverage shall have durational limits, dollar limits, deductibles, copayments\nand coinsurance factors that are no less favorable than for physical illness\ngenerally.\n\nC. For purposes of this section:\n\t\t\t“Cooperative group” means a formal network of facilities that\ncollaborate on research projects and have an established NIH-approved peer\nreview program operating within the group. “Cooperative group”\nincludes (i) the National Cancer Institute Clinical Cooperative Group and (ii)\nthe National Cancer Institute Community Clinical Oncology Program.\n\t\t\t“FDA” means the Federal Food and Drug Administration.\n\t\t\t“Member” means a policyholder, subscriber, insured, or\ncertificate holder or a covered dependent of a policyholder, subscriber, insured\nor certificate holder.\n\t\t\t“Multiple project assurance contract” means a contract between an\ninstitution and the federal Department of Health and Human Services that defines\nthe relationship of the institution to the federal Department of Health and\nHuman Services and sets out the responsibilities of the institution and the\nprocedures that will be used by the institution to protect human subjects.\n\t\t\t“NCI” means the National Cancer Institute.\n\t\t\t“NIH” means the National Institutes of Health.\n\t\t\t“Patient cost” means the cost of a medically necessary health\ncare service that is incurred as a result of the treatment being provided to the\nmember for purposes of a clinical trial. “Patient cost” does not\ninclude (i) the cost of nonhealth care services that a patient may be required\nto receive as a result of the treatment being provided for purposes of a\nclinical trial, (ii) costs associated with managing the research associated with\nthe clinical trial, or (iii) the cost of the investigational drug or device.\n\nD. Coverage for patient costs incurred during clinical trials for treatment\nstudies on cancer shall be provided if the treatment is being conducted in a\nPhase II, Phase III, or Phase IV clinical trial. Such treatment may, however, be\nprovided on a case-by-case basis if the treatment is being provided in a Phase I\nclinical trial.\n\nE. The treatment described in subsection D shall be provided by a clinical trial\napproved by:\n\n 1. The National Cancer Institute;\n\n 2. An NCI cooperative group or an NCI center;\n\n 3. The FDA in the form of an investigational new drug application;\n\n 4. The federal Department of Veterans Affairs; or\n\n 5. An institutional review board of an institution in the Commonwealth that\n has a multiple project assurance contract approved by the Office of Protection\n from Research Risks of the NCI.\n\nF. The facility and personnel providing the treatment shall be capable of doing\nso by virtue of their experience, training, and expertise.\n\nG. Coverage under this section shall apply only if:\n\n 1. There is no clearly superior, noninvestigational treatment alternative;\n\n 2. The available clinical or preclinical data provides a reasonable\n expectation that the treatment will be at least as effective as the\n noninvestigational alternative; and\n\n 3. The member and the physician or health care provider who provides services\n to the member under the insurance policy, subscription contract or health care\n plan conclude that the member’s participation in the clinical trial\n would be appropriate, pursuant to procedures established by the insurer,\n corporation or health maintenance organization and as disclosed in the policy\n and evidence of coverage.\n\nH. The provisions of this section shall not apply to short-term travel,\naccident-only, limited or specified disease policies or contracts designed for\nissuance to persons eligible for coverage under Title XVIII of the Social\nSecurity Act, known as Medicare, or any other similar coverage under state or\ngovernmental plans or to short-term nonrenewable policies of not more than six\nmonths’ duration.\n\nI. The provisions of this section shall not apply in any instance in which the\nprovisions of this section are inconsistent or in conflict with a provision of\nArticle 6 (§ 38.2-3438 et seq.) of Chapter 34.\n\nHISTORY: 1999, cc. 643, 649; 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}}