Vermont Statutes
Chapter 107 - Health Insurance
§ 4100e. Required coverage for off-label use

§ 4100e. Required coverage for off-label use
(a) A health insurance plan that provides coverage for prescription drugs shall provide coverage for off-label use in cancer treatment in accordance with the following:
(1) A health insurance plan contract may not exclude coverage for any drug used for the treatment of cancer on grounds that the drug has not been approved by the federal Food and Drug Administration, provided the use of the drug is a medically accepted indication for the treatment of cancer.
(2) Coverage of a drug required by this section also includes medically necessary services associated with the administration of the drug.
(3) This section shall not be construed to require coverage for a drug when the federal Food and Drug Administration has determined its use to be contraindicated for treatment of the current indication.
(4) A drug use that is covered under subdivision (1) of this subsection may not be denied coverage based on a “medical necessity” requirement except for a reason unrelated to the legal status of the drug use.
(5) A health insurance plan contract that provides coverage of a drug as required by this section may contain provisions for maximum benefits and coinsurance and reasonable limitations, deductibles, and exclusions to the same extent these provisions are applicable to coverage of all prescription drugs and are not inconsistent with the requirements of this section.
(b) As used in this section, the following terms have the following meanings:
(1) “Health insurance plan” means a health benefit plan offered, administered, or issued by a health insurer doing business in Vermont.
(2) “Health insurer” is defined by 18 V.S.A. § 9402. As used in this subchapter, the term includes the State of Vermont and any agent or instrumentality of the State that offers, administers, or provides financial support to State government, including Medicaid or any other public health care assistance program.
(3) “Medically accepted indication” includes any use of a drug that has been approved by the federal Food and Drug Administration and includes another use of the drug if that use is prescribed by the insured’s treating oncologist and supported by medical or scientific evidence. As used in this subchapter, “medical or scientific evidence” means one or more of the following sources:
(A) peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;
(B) peer-reviewed literature, biomedical compendia, and other medical literature that meet the criteria of the National Institutes of Health’s National Library of Medicine for indexing in Index Medicus, Excerpta Medicus (EMBASE), Medline, and MEDLARS database Health Services Technology Assessment Research (HSTAR);
(C) medical journals recognized by the federal Secretary of Health and Human Services, under Section 1861(t)(2) of the federal Social Security Act;
(D) the following standard reference compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluation, and the United States Pharmacopoeia-Drug Information;
(E) findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, including the Agency for Health Care Policy and Research, National Institutes of Health, National Cancer Institute, National Academy of Sciences, Centers for Medicare and Medicaid Services, and any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health services;
(F) peer-reviewed abstracts accepted for presentation at major medical association meetings.
(4) “Off-label use” means the prescription and use of drugs for medically accepted indications other than those stated in the labeling approved by the federal Food and Drug Administration.
(c) A determination by a health insurer that an off-label use of a prescription drug under this section is not a medically accepted indication supported by medical or scientific evidence is eligible for review under section 4089f of this title. (Added 2005, No. 139 (Adj. Sess.), § 1; amended 2013, No. 79, § 13, eff. Jan. 1, 2014.)

Structure Vermont Statutes

Vermont Statutes

Title 8 - Banking and Insurance

Chapter 107 - Health Insurance

§ 4061. Definition

§ 4062. Filing and approval of policy forms and premiums

§ 4062a. Filing fees

§ 4062b. Medicare supplemental health insurance

§ 4062c. Compliance with federal law

§ 4062e. Compliance with Medicaid recovery provisions

§ 4062f. Discretionary clauses prohibited

§ 4063. Form and contents of policy

§ 4063a. Coverage for civil unions

§ 4063b. Coverage for employees of an employer domiciled outside Vermont

§ 4064. Provisions applying to policies delivered in another state

§ 4065. Required standard policy provisions

§ 4066. Optional standard policy provisions

§ 4067. Omission of inapplicable or inconsistent standard provisions

§ 4068. Order of standard policy provisions

§ 4069. Third party ownership

§ 4070. Requirements of other jurisdictions

§ 4071. Regulations on filing policies

§ 4072. Nonconforming policies

§ 4073. Applications for insurance

§ 4074. Notice as waiver

§ 4075. Age limits

§ 4076. Policies not affected

§ 4077. Termination; comprehensive major medical policies; grace period

§ 4079. Group insurance policies; definitions

§ 4079a. Association health plans

§ 4080. Required policy provisions

§ 4080d. Coordination of insurance coverage with Medicaid

§ 4080e. Medicare supplemental health insurance policies; community rating; disability

§ 4080g. Grandfathered plans

§ 4081. Blanket health insurance

§ 4082. Blanket insurance; policy contents

§ 4083. Discrimination prohibited

§ 4084. Advertising practices

§ 4084a. Short-term, limited-duration health insurance

§ 4085. Rebates and commissions prohibited for nongroup and small group policies and plans offered through the Vermont Health Benefit Exchange

§ 4085a. Rebates prohibited for group insurance policies

§ 4086. Exemption from attachment and trustee process

§ 4087. Penalties for violations

§ 4088. Appeal

§ 4088a. Chiropractic services

§ 4088b. Clinical trials for cancer patients

§ 4088c. Chemotherapy treatment

§ 4088d. Coverage for covered services provided by naturopathic physicians

§ 4088e. Notice of preferred drug list changes

§ 4088f. Prosthetic parity

§ 4088g. Coverage for covered services provided by athletic trainers

§ 4088h. Health insurance and the Blueprint for Health

§ 4088i. Coverage for diagnosis and treatment of early childhood developmental disorders

§ 4088j. Choice of providers for vision care and medical eye care services

§ 4088k. Physical therapy co-payments for certain plans

§ 4088l. Coverage for hearing aids [Effective January 1, 2024]

§ 4089. Services for victims of sexual assault

§ 4089a. Mental health care services review

§ 4089b. Health insurance coverage, mental health, and substance use disorder

§ 4089c. Diabetes treatment

§ 4089d. Coverage; dependent children

§ 4089e. Treatment of inherited metabolic diseases

§ 4089f. Independent external review of health care service decisions

§ 4089g. Craniofacial disorders

§ 4089h. Cancellation or nonrenewal of health insurance coverage

§ 4089i. Prescription drug coverage

§ 4089j. Retail pharmacies; filling of prescriptions

§ 4090a. Continuation of group

§ 4090b. Continuation; notice; terms

§ 4090c. Termination of coverage

§ 4090d. Right of conversion

§ 4090e. Conversion; notice; terms

§ 4090f. Exemptions; termination

§ 4090g. Options required

§ 4091a. Definitions

§ 4091b. Policies and contracts covered

§ 4091c. Termination for nonpayment of premium or subscription charges

§ 4091d. Notice of termination

§ 4091e. Extension of benefits

§ 4091f. Replacement coverage

§ 4092. Newborn infants; coverage

§ 4095. Definitions

§ 4096. Home health care; insurance

§ 4099c. Reproductive health equity in health insurance coverage

§ 4099d. Midwifery coverage; home births

§ 4100a. Mammograms; coverage required

§ 4100b. Coverage of children

§ 4100c. Adopted child coverage

§ 4100d. Child vaccine benefits

§ 4100e. Required coverage for off-label use

§ 4100f. Prostate screenings; coverage required

§ 4100g. Colorectal cancer screening, coverage required

§ 4100h. Orally administered anticancer medication; coverage required

§ 4100i. Anesthesia coverage for certain dental procedures

§ 4100j. Coverage for tobacco cessation programs

§ 4100k. Coverage of health care services delivered through telemedicine and by store-and-forward means

§ 4100l. Coverage of health care services delivered by audio-only telephone