A. Each (i) 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, (ii) corporation providing individual or group accident and sickness subscription contracts, and (iii) health maintenance organization providing a health care plan for health care services, whose policy, contract or plan, including any certificate or evidence of coverage issued in connection with such policy, contract or plan, includes coverage for prescription drugs, whether on an inpatient basis, outpatient basis, or both, shall provide in each such policy, contract, plan, certificate, and evidence of coverage that such benefits will not be denied for any drug approved by the United States Food and Drug Administration for use in the treatment of cancer on the basis that the drug has not been approved by the United States Food and Drug Administration for the treatment of the specific type of cancer for which the drug has been prescribed, provided the drug has been recognized as safe and effective for treatment of that specific type of cancer in any of the standard reference compendia.
B. Each (i) 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, (ii) corporation providing individual or group accident and sickness subscription contracts, and (iii) health maintenance organization providing a health care plan for health care services, whose policy, contract or plan, including any certificate or evidence of coverage issued in connection with such policy, contract or plan, includes coverage for prescription drugs, whether on an inpatient basis, outpatient basis, or both, shall provide in each such policy, contract, plan, certificate, and evidence of coverage that such benefits will not be denied for any drug prescribed to treat a covered indication so long as the drug has been approved by the United States Food and Drug Administration for at least one indication and the drug is recognized for treatment of the covered indication in one of the standard reference compendia or in substantially accepted peer-reviewed medical literature.
C. For the purposes of subsections A and B:
"Peer-reviewed medical literature" means a scientific study published only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts in a journal that has been determined by the International Committee of Medical Journal Editors to have met the Uniform Requirements for Manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier.
"Standard reference compendia" means:
1. American Hospital Formulary Service Drug Information;
2. National Comprehensive Cancer Network's Drugs & Biologics Compendium; or
3. Elsevier Gold Standard's Clinical Pharmacology.
D. Coverage, as described in subsections A and B, includes medically necessary services associated with the administration of the drug.
E. Subsections A and B shall not be construed to do any of the following:
1. Require coverage for any drug if the United States Food and Drug Administration has determined its use to be contraindicated for the treatment of the specific type of cancer or indication for which the drug has been prescribed;
2. Require coverage for experimental drugs not otherwise approved for any indication by the United States Food and Drug Administration;
3. Alter any law with regard to provisions limiting the coverage of drugs that have not been approved by the United States Food and Drug Administration;
4. Create, impair, alter, limit, modify, enlarge, abrogate, or prohibit reimbursement for drugs used in the treatment of any other disease or condition; or
5. Require coverage for prescription drugs in any contract, policy or plan that does not otherwise provide such coverage.
F. The provisions of this section shall not apply to short-term travel, or accident-only policies, or to short-term nonrenewable policies of not more than six months' duration.
G. The provisions of subsection A are applicable to contracts, policies or plans delivered, issued for delivery or renewed in this Commonwealth on and after July 1, 1994, and the provisions of subsection B are applicable to contracts, policies or plans delivered, issued for delivery or renewed in this Commonwealth on and after July 1, 1997.
1994, c. 374; 1997, c. 656; 2010, c. 443.
Structure Code of Virginia
Chapter 34 - Provisions Relating to Accident and Sickness Insurance
§ 38.2-3400. Application of chapter
§ 38.2-3401. Forms of insurance authorized
§ 38.2-3402. Certification to accompany application
§ 38.2-3403. Fraudulent procurement of policy
§ 38.2-3405.1. Commonwealth's right to certain accident and sickness benefits
§ 38.2-3406. Accident and sickness benefits not subject to legal process
§ 38.2-3406.2. Capped benefits under insurance policies and contracts
§ 38.2-3407. Health benefit programs
§ 38.2-3407.1. Interest on accident and sickness claim proceeds
§ 38.2-3407.2. Coverage for medical child support
§ 38.2-3407.3. Calculation of cost-sharing provisions
§ 38.2-3407.3:1. Premium payment arrearages; order of crediting payments
§ 38.2-3407.4. Explanation of benefits
§ 38.2-3407.4:2. Requirements for prescription benefit cards
§ 38.2-3407.5. Denial of benefits for certain prescription drugs prohibited
§ 38.2-3407.5:1. Coverage for prescription contraceptives
§ 38.2-3407.5:2. Reimbursements for dispensing hormonal contraceptives
§ 38.2-3407.6. Exclusion of podiatrist not permitted under certain circumstances
§ 38.2-3407.6:1. Denial of benefits for certain prescription drugs prohibited
§ 38.2-3407.7. Pharmacies; freedom of choice
§ 38.2-3407.9. Reimbursement for emergency medical services vehicle transportation services
§ 38.2-3407.9:01. Prescription drug formularies
§ 38.2-3407.9:02. Requirement for prescription drug coverage
§ 38.2-3407.9:03. Payment of clean claims to administrators of pharmacy benefits
§ 38.2-3407.9:04. Medication synchronization
§ 38.2-3407.9:05. Step therapy protocols
§ 38.2-3407.10. Health care provider panels
§ 38.2-3407.10:2. Credentialing of private mental health agencies
§ 38.2-3407.11. Access to obstetrician-gynecologists
§ 38.2-3407.11:1. Access to specialists; standing referrals
§ 38.2-3407.11:2. Standing referral for cancer patients
§ 38.2-3407.11:3. Breast cancer underwriting and preexisting condition restrictions
§ 38.2-3407.11:4. Disability arising out of childbirth; minimum benefit
§ 38.2-3407.11:5. Interhospital transfer for newborn or mother; prior authorization prohibited
§ 38.2-3407.12. Patient optional point-of-service benefit
§ 38.2-3407.13. Refusal to accept assignments prohibited; dentists and oral surgeons
§ 38.2-3407.13:1. Coordination of benefits; notice of priority of coverage
§ 38.2-3407.13:2. Claims paid to insureds for services from nonparticipating physicians
§ 38.2-3407.14. Notice of premium or deductible increases
§ 38.2-3407.15. Ethics and fairness in carrier business practices
§ 38.2-3407.15:2. Carrier contracts; required provisions regarding prior authorization
§ 38.2-3407.15:4. Limit on copayment for prescription drugs; permitted disclosures
§ 38.2-3407.15:5. Limit on cost-sharing payments for prescription insulin drugs
§ 38.2-3407.15:6. Prescription drug price transparency
§ 38.2-3407.16. Requirements for obstetrical care
§ 38.2-3407.17. Payment for services by dentists and oral surgeons
§ 38.2-3407.17:1. Payment and reimbursement practices for dental services; network access
§ 38.2-3407.18. Requirements for orally administered cancer chemotherapy drugs
§ 38.2-3407.19. Payment for services by optometrists and ophthalmologists
§ 38.2-3407.21. Short-term limited-duration medical plans
§ 38.2-3407.22. Option for rebates to enrollees; protected information
§ 38.2-3409. Coverage of dependent children
§ 38.2-3410. Construction of policy generally; words "physician" and "doctor" to include dentist
§ 38.2-3411. Coverage of newborn children required
§ 38.2-3411.1. Coverage for child health supervision services
§ 38.2-3411.2. Coverage of adopted children required
§ 38.2-3411.3. Coverage for childhood immunizations
§ 38.2-3411.4. Coverage for infant hearing screening and related diagnostics
§ 38.2-3412.1. Coverage for mental health and substance use disorders
§ 38.2-3414. Optional coverage for obstetrical services
§ 38.2-3414.1. Obstetrical benefits; coverage for postpartum services
§ 38.2-3415. Exclusion or reduction of benefits for certain causes prohibited
§ 38.2-3417. Deductibles and coinsurance options required
§ 38.2-3418. Coverage for victims of rape or incest
§ 38.2-3418.1. Coverage for mammograms
§ 38.2-3418.1:2. Coverage for pap smears
§ 38.2-3418.2. Coverage of procedures involving bones and joints
§ 38.2-3418.3. Coverage for hemophilia and congenital bleeding disorders
§ 38.2-3418.4. Coverage for reconstructive breast surgery; notice; eligibility
§ 38.2-3418.5. Coverage for early intervention services
§ 38.2-3418.6. Minimum hospital stay for mastectomy and certain lymph node dissection patients
§ 38.2-3418.7. Coverage for PSA testing
§ 38.2-3418.7:1. Coverage for colorectal cancer screening
§ 38.2-3418.8. Coverage for clinical trials for treatment studies on cancer
§ 38.2-3418.9. Minimum hospital stay for hysterectomy
§ 38.2-3418.10. Coverage for diabetes
§ 38.2-3418.11. Coverage for hospice care
§ 38.2-3418.12. Coverage for hospitalization and anesthesia for dental procedures
§ 38.2-3418.13. Coverage for the treatment of morbid obesity
§ 38.2-3418.14. Coverage for lymphedema
§ 38.2-3418.15. Coverage for prosthetic devices and components
§ 38.2-3418.15:1. Coverage for prosthetic devices and components
§ 38.2-3418.16. Coverage for telemedicine services
§ 38.2-3418.17. Coverage for autism spectrum disorder
§ 38.2-3418.18. Coverage for formula and enteral nutrition products as medicine
§ 38.2-3418.19. Coverage for organ, eye or tissue transplant
§ 38.2-3418.20. Coverage for hearing aids and related services
§ 38.2-3419. Additional mandated coverage made optional to group policy or contract holder
§ 38.2-3419.1. Report of costs and utilization of mandated benefits
§ 38.2-3420. Authority and jurisdiction of Commission; exception
§ 38.2-3421. How to show jurisdiction of other state agency or federal government
§ 38.2-3423. When subject to this title
§ 38.2-3424. Disclosure of extent and elements of coverage
§ 38.2-3430.1. Application of article
§ 38.2-3430.1:1. Health insurance coverage not required
§ 38.2-3430.4. Special rules for network plans
§ 38.2-3430.5. Application of financial capacity limits
§ 38.2-3430.6. Market requirements
§ 38.2-3430.7. Renewability of individual health insurance coverage
§ 38.2-3430.8. Certification of coverage
§ 38.2-3430.9. Regulations establishing standards
§ 38.2-3430.10. Effective date
§ 38.2-3431. Application of article; definitions
§ 38.2-3432.3. Limitation on preexisting condition exclusion period
§ 38.2-3434. Disclosure of information
§ 38.2-3436. Eligibility to enroll
§ 38.2-3437. Rules used to determine group size
§ 38.2-3439. Dependent coverage for individuals to age 26
§ 38.2-3440. Lifetime and annual limits
§ 38.2-3442. Preventive services
§ 38.2-3443. Choice of a health care professional
§ 38.2-3444. Preexisting condition exclusions
§ 38.2-3445. Patient access to emergency services
§ 38.2-3445.01. Balance billing for certain services; prohibited
§ 38.2-3445.03. Data sets for determining commercially reasonable payments
§ 38.2-3445.06. Applicability of certain sections
§ 38.2-3445.07. Rules and regulations
§ 38.2-3445.2. Out-of-network claims; reporting requirements
§ 38.2-3446. Applicability of federal law
§ 38.2-3447. Restrictions relating to premium rates
§ 38.2-3448. Guaranteed availability
§ 38.2-3449. Prohibiting discrimination based on health status
§ 38.2-3450. Genetic information and testing
§ 38.2-3451. Essential health benefits
§ 38.2-3454. Wellness programs
§ 38.2-3454.1. Renewal of health benefit plans; special exception
§ 38.2-3456. Prohibited activities
§ 38.2-3457. Application for registration
§ 38.2-3458. Power of Commission to investigate navigators
§ 38.2-3462. Comparable Health Care Service Incentive Program
§ 38.2-3463. Health care price transparency tools
§ 38.2-3464. Rules and regulations; orders
§ 38.2-3467. Prohibited conduct by carriers and pharmacy benefits managers
§ 38.2-3468. Examination of books and records; reports; access to records
§ 38.2-3469. (Effective October 1, 2020) Enforcement; regulations