(a)(1) For purposes of cancer clinical trials, the Insurance Department, in cooperation with the Connecticut Oncology Association, the American Cancer Society, the Connecticut Association of Health Plans and Anthem Blue Cross of Connecticut, shall develop a standardized form that all providers, hospitals and institutions shall submit to the insurer or health care center when seeking to enroll an insured person in a cancer clinical trial. An insurer or health care center shall not substitute any other approval request form for the form developed by the department, except that any insurer or health care center that has entered into an agreement to provide coverage for cancer clinical trials approved pursuant to section 38a-542g may use the form or process established by such agreement.
(2) For purposes of clinical trials other than cancer clinical trials, the Insurance Department, in cooperation with at least one state nonprofit research or advocacy organization concerned with the subject of the clinical trial, at least one national nonprofit research or advocacy organization concerned with the subject of the clinical trial, the Connecticut Association of Health Plans and Anthem Blue Cross of Connecticut, shall develop a standardized form that all providers, hospitals and institutions shall submit to the insurer or health care center when seeking to enroll an insured person in a clinical trial. An insurer or health care center shall not substitute any other approval request form for the form developed by the department, except that any insurer or health care center that has entered into an agreement to provide coverage for clinical trials approved pursuant to section 38a-542g, may use the form or process established by such agreement.
(b) Any insurer or health care center that receives the department form from a provider, hospital or institution seeking coverage for the routine patient care costs of an insured person in a clinical trial shall approve or deny coverage for such services not later than five business days after receiving such request and any other reasonable supporting materials requested by the insurer or health plan pursuant to section 38a-542c, except that an insurer or health care center that utilizes independent experts to review such requests shall respond not later than ten business days after receiving such request and supporting materials.
(c) The insured, or the provider with the insured's written consent, may appeal any denial of coverage for medical necessity to an external, independent review pursuant to section 38a-591g. Such external review shall be conducted by a properly qualified review agent whom the department has determined does not have a conflict of interest regarding the clinical trial.
(d) The Insurance Commissioner shall adopt regulations, in accordance with chapter 54, to implement the provisions of this section.
(P.A. 01-171, S. 6, 25; P.A. 11-19, S. 66; 11-58, S. 84; 11-172, S. 13; P.A. 12-145, S. 21.)
History: P.A. 01-171 effective January 1, 2002; P.A. 11-19 made technical changes in Subsec. (b), effective January 1, 2012; P.A. 11-58 replaced reference to Sec. 38a-478n with “section 38a-591g” in Subsec. (c), effective July 1, 2011; P.A. 11-172 amended Subsec. (a) by designating existing provisions as Subdiv. (1) and amending same to change “may not” to “shall not” and by adding Subdiv. (2) re standardized form for clinical trials other than cancer clinical trials, amended Subsec. (b) by replacing references to cancer clinical trial with references to clinical trial, deleting provision re time period for approval or denial of coverage for phase III clinical trials for prevention of cancer and by making technical changes, and amended Subsec. (c) by replacing reference to cancer clinical trial with reference to clinical trial, effective January 1, 2012; P.A. 12-145 amended Subsec. (a)(2) to replace reference to Sec. 38a-504g with reference to Sec. 38a-542g, effective June 15, 2012.
See Sec. 38a-504f for similar provisions re individual policies.
Structure Connecticut General Statutes
Chapter 700c - Health Insurance
Section 38a-469. - Definitions.
Section 38a-472a. - Medical provider indemnification agreements prohibited.
Section 38a-472g. - Restrictions applicable to prior authorization or precertification.
Section 38a-472j. - Restrictions applicable to cost-sharing for covered benefits. Regulations.
Section 38a-472k. - Disability income policies. Discretionary clauses prohibited. Regulations.
Section 38a-476. - Preexisting condition coverage.
Section 38a-476b. - Standards re psychotropic drug availability in health plans.
Section 38a-477. - Standardized claim forms. Information necessary for filing a claim. Regulations.
Section 38a-477a. - Notification by Insurance Commissioner of required benefits and policy forms.
Section 38a-477bb. - Cost-sharing re facility fees.
Section 38a-477f. - Contract provision prohibiting certain disclosures prohibited.
Section 38a-477ff. - Third-party discounts and payments for covered benefits. Credit required.
Section 38a-477g. - Contracts between health carriers and participating providers.
Section 38a-477h. - Participating provider directories.
Section 38a-477ll. - Coverage for health enhancement programs.
Section 38a-478. - Definitions.
Section 38a-478a. - Commissioner's report to the Governor and the General Assembly.
Section 38a-478f. - Provider profile development requirements.
Section 38a-478g. - Managed care contract requirements. Plan description requirements.
Section 38a-478i. - Limitation on enrollee rights prohibited.
Section 38a-478j. - Coinsurance and deductible payments based on negotiated discounts.
Section 38a-478k. - Gag clauses prohibited.
Section 38a-478l. - Consumer report card required. Content. Data analysis by commissioner.
Section 38a-478o. - Confidentiality and antidiscrimination procedures required.
Section 38a-478p. - Expedited utilization review. Standardized process required.
Section 38a-478q. - Use of laboratories covered by plan required.
Section 38a-478t. - Commissioner of Public Health to receive data.
Section 38a-478u. - Regulations.
Section 38a-479. - Definitions. Access to fee schedules. Fee information to be confidential.
Section 38a-479gg. - Regulations.
Section 38a-479aaa. - Pharmacy benefits managers. Definitions.
Section 38a-479ddd. - Hearing on denial of certificate. Subsequent application.
Section 38a-479eee. - Claims payment to be made by electronic funds transfer upon written request.
Section 38a-479fff. - Expiration of certificates of registration. Renewal. Fees.
Section 38a-479ggg. - Regulations.
Section 38a-479hhh. - Investigations and hearings. Powers of commissioner. Appeals.
Section 38a-479iii. - Pharmacy audits.
Section 38a-479ooo. - Definitions.
Section 38a-479qqq. - Annual report by health carriers. Regulations.
Section 38a-479rrr. - Annual certification by health carriers.
Section 38a-479qq. - Medical discount plans: Definitions, prohibited sales practices, penalties.
Section 38a-482. (Formerly Sec. 38-166). - Form of policy.
Section 38a-482c. - Annual and lifetime limits.
Section 38a-483. (Formerly Sec. 38-167). - Standard provisions of individual health policy.
Section 38a-483a. - Exclusionary riders for individual health insurance policies. Regulations.
Section 38a-483b. - Time limits for coverage determinations. Notice requirements.
Section 38a-483c. - Coverage and notice re experimental treatments. Appeals.
Section 38a-486. (Formerly Sec. 38-170). - Certain acts not to operate as waiver of rights.
Section 38a-487. (Formerly Sec. 38-171). - Coverage after termination date of policy.
Section 38a-488. (Formerly Sec. 38-172). - Discrimination.
Section 38a-488b. - Coverage for autism spectrum disorder therapies.
Section 38a-488d. - Coverage for substance abuse services provided pursuant to court order.
Section 38a-488e. - Coverage for mental health wellness examinations.
Section 38a-488f. - Coverage for services provided under the Collaborative Care Model.
Section 38a-488g. - Acute inpatient psychiatric coverage. Prior authorization not required.
Section 38a-490a. - Coverage for birth-to-three program.
Section 38a-490b. - Coverage for hearing aids.
Section 38a-490c. - Coverage for craniofacial disorders.
Section 38a-490d. - Mandatory coverage for blood lead screening and risk assessment.
Section 38a-491b. - Assignment of benefits to a dentist or oral surgeon.
Section 38a-492a. - Mandatory coverage for hypodermic needles and syringes.
Section 38a-492b. - Coverage for certain off-label drug prescriptions.
Section 38a-492d. - Mandatory coverage for diabetes screening, testing and treatment.
Section 38a-492e. - Mandatory coverage for diabetes outpatient self-management training.
Section 38a-492f. - Mandatory coverage for certain prescription drugs removed from formulary.
Section 38a-492g. - Mandatory coverage for prostate cancer screening and treatment.
Section 38a-492h. - Mandatory coverage for certain Lyme disease treatments.
Section 38a-492i. - Mandatory coverage for pain management.
Section 38a-492j. - Mandatory coverage for ostomy-related supplies.
Section 38a-492k. - Mandatory coverage for colorectal cancer screening.
Section 38a-492m. - Mandatory coverage for certain renewals of prescription eye drops.
Section 38a-492n. - Mandatory coverage for certain wound-care supplies.
Section 38a-492o. - Mandatory coverage for bone marrow testing.
Section 38a-492p. - Mandatory coverage for medically monitored inpatient detoxification.
Section 38a-492q. - Mandatory coverage for essential health benefits.
Section 38a-492t. - Mandatory coverage for prosthetic devices.
Section 38a-492u. - Coverage for psychotropic drugs. Standards re availability.
Section 38a-494. (Formerly Sec. 38-174l). - Home health care by recognized nonmedical systems.
Section 38a-495b. - Medicare supplement policies and certificates. Definitions.
Section 38a-495d. - Refund of prepaid premium for Medicare supplement policies.
Section 38a-496. (Formerly Sec. 38-174q). - Coverage for occupational therapy.
Section 38a-498a. - Prior authorization prohibited for certain 9-1-1 emergency calls.
Section 38a-498b. - Mandatory coverage for mobile field hospital.
Section 38a-503a. - Mandatory coverage for breast cancer survivors.
Section 38a-503b. - Carriers to permit direct access to obstetrician-gynecologist.
Section 38a-503e. - Mandatory coverage for contraceptives and sterilization.
Section 38a-503g. - Mandatory coverage for ovarian cancer screening and monitoring.
Section 38a-504a. - Coverage for routine patient care costs associated with certain clinical trials.
Section 38a-504b. - Clinical trial criteria.
Section 38a-504d. - Clinical trials: Routine patient care costs.
Section 38a-504e. - Clinical trials: Billing. Payments.
Section 38a-504g. - Clinical trials: Submission and certification of policy forms.
Section 38a-506. (Formerly Sec. 38-173). - Penalty.
Section 38a-507. - Coverage for services performed by chiropractors.
Section 38a-508. - Coverage for adopted children.
Section 38a-509. - Mandatory coverage for infertility diagnosis and treatment. Limitations.
Section 38a-510. - Prescription drug coverage. Mail order pharmacies. Step therapy use.
Section 38a-510a. - Prescription drug coverage. Synchronized refills.
Section 38a-511. - Copayments re in-network imaging services.
Section 38a-512. - Applicability of statutes to certain major medical expense policies.
Section 38a-512a. - Continuation of coverage.
Section 38a-512c. - Annual and lifetime limits.
Section 38a-513a. - Time limits for coverage determinations. Notice requirements.
Section 38a-513b. - Coverage and notice re experimental treatments. Appeals.
Section 38a-513f. - Claims information to be provided to certain employers. Restrictions. Subpoenas.
Section 38a-513g. - Employer submission of plan cost information to Comptroller.
Section 38a-514a. - Biologically-based mental illness. Coverage required.
Section 38a-514b. - Coverage for autism spectrum disorder.
Section 38a-514d. - Coverage for substance abuse services provided pursuant to court order.
Section 38a-514e. - Coverage for mental health wellness exams.
Section 38a-514f. - Coverage for services provided under the Collaborative Care Model.
Section 38a-514g. - Acute patient psychiatric coverage. Prior authorization not required.
Section 38a-515. - Continuation of coverage of mentally or physically handicapped children.
Section 38a-516. - Coverage for newly born children. Notification to insurer.
Section 38a-516a. - Coverage for birth-to-three program.
Section 38a-516b. - Coverage for hearing aids.
Section 38a-516c. - Coverage for craniofacial disorders.
Section 38a-516d. - Coverage for neuropsychological testing for children diagnosed with cancer.
Section 38a-517. - Coverage for services performed by dentist in certain instances.
Section 38a-517b. - Assignment of benefits to a dentist or oral surgeon.
Section 38a-518a. - Mandatory coverage for hypodermic needles and syringes.
Section 38a-518b. - Coverage for certain off-label drug prescriptions.
Section 38a-518d. - Mandatory coverage for diabetes screening, testing and treatment.
Section 38a-518e. - Mandatory coverage for diabetes outpatient self-management training.
Section 38a-518f. - Mandatory coverage for certain prescription drugs removed from formulary.
Section 38a-518g. - Mandatory coverage for prostate cancer screening and treatment.
Section 38a-518h. - Mandatory coverage for certain Lyme disease treatments.
Section 38a-518i. - Mandatory coverage for pain management.
Section 38a-518j. - Mandatory coverage for ostomy-related supplies.
Section 38a-518k. - Mandatory coverage for colorectal cancer screening.
Section 38a-518l. - Mandatory coverage for certain renewals of prescription eye drops.
Section 38a-518m. - Mandatory coverage for certain wound-care supplies.
Section 38a-518o. - Mandatory coverage for bone marrow testing.
Section 38a-518p. - Mandating coverage for medically monitored inpatient detoxification.
Section 38a-518q. - Mandatory coverage for essential health benefits.
Section 38a-518t. - Mandatory coverage for prosthetic devices.
Section 38a-518u. - Coverage for psychotropic drugs. Standards re availability.
Section 38a-521. - Home health care by recognized nonmedical systems.
Section 38a-522. - Medicare supplement policies. Coverage of home health aide service.
Section 38a-524. - Coverage for occupational therapy.
Section 38a-525a. - Prior authorization prohibited for certain 9-1-1 emergency calls.
Section 38a-525b. - Mandatory coverage for mobile field hospital.
Section 38a-526. - Coverage for services of physician assistants and certain nurses.
Section 38a-530a. - Mandatory coverage for breast cancer survivors.
Section 38a-530b. - Carriers to permit direct access to obstetrician-gynecologist.
Section 38a-530e. - Mandatory coverage for contraceptives and sterilization.
Section 38a-530g. - Mandatory coverage for ovarian cancer screening and monitoring.
Section 38a-534. - Coverage for services performed by chiropractors.
Section 38a-536. - Mandatory coverage for infertility diagnosis and treatment. Limitations.
Section 38a-542a. - Coverage for routine patient care costs associated with certain clinical trials.
Section 38a-542b. - Clinical trial criteria.
Section 38a-542d. - Clinical trials: Routine patient care costs.
Section 38a-542e. - Clinical trials: Billing. Payments.
Section 38a-542g. - Clinical trials: Submission and certification of policy forms.
Section 38a-543. (Formerly Sec. 38-262j). - Reduction of payments on basis of Medicare eligibility.
Section 38a-544. - Prescription drug coverage. Mail order pharmacies. Step therapy use.
Section 38a-544a. - Prescription drug coverage. Synchronized refills.
Section 38a-549. - Coverage for adopted children.
Section 38a-550. - Copayments re in-network imaging services.
Section 38a-551. (Formerly Sec. 38-371). - Definitions.
Section 38a-552. (Formerly Sec. 38-372). - Provision of service to certain low-income individuals.
Section 38a-556a. - Connecticut Clearinghouse.
Section 38a-558. (Formerly Sec. 38-380). - Office of Health Care Access.
Section 38a-560. - Small employer grouping for health insurance coverage.
Section 38a-564. - Definitions.
Section 38a-565. - Special health care plans.
Section 38a-567. - Provisions of small employer plans and arrangements.
Section 38a-569. - Connecticut Small Employer Health Reinsurance Pool.
Section 38a-573. - Validity of separate provisions.
Section 38a-574. - Standard family health statement.
Section 38a-577. (Formerly Sec. 38-174ii). - Consumer dental health plans. Definitions.
Section 38a-578. (Formerly Sec. 38-174jj). - Certificate of authority. Application requirements.
Section 38a-580. (Formerly Sec. 38-174ll). - General surplus required.
Section 38a-584. (Formerly Sec. 38-174pp). - Complaint system.
Section 38a-588. (Formerly Sec. 38-174tt). - Penalty. Insolvency.
Section 38a-589. (Formerly Sec. 38-174uu). - Confidentiality.
Section 38a-590. (Formerly Sec. 38-174vv). - Commissioner's power to adopt regulations.
Section 38a-591. - Compliance with the Patient Protection and Affordable Care Act. Regulations.
Section 38a-591a. - Definitions.
Section 38a-591b. - Health carrier responsibilities re utilization review.
Section 38a-591c. - Utilization review criteria and procedures.
Section 38a-591g. - External reviews and expedited external reviews.
Section 38a-591h. - Record-keeping requirements. Report to commissioner upon request.
Section 38a-591i. - Regulations.
Section 38a-591k. - Violations. Notice and hearing. Penalties. Appeal.