CHAPTER 315

FORMERLY

SENATE BILL NO. 341

AS AMENDED BY SENATE AMENDMENT NO. 2

AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE AND CHAPTER 96, VOLUME 73, LAWS OF DELAWARE RELATING TO HEALTH INSURANCE.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE :

Section 1. Amend Title 18, Section 3348(a) by adding a sentence at the end of that section to read as follows:

"In such circumstances, the non-network provider may not balance bill the insured."

Section 2. Amend Title 18, Section 3349 of the Delaware Code by adding a new subsection (e) to read as follows:

"(e) The provisions of this Section shall not apply to services provided by a volunteer fire department recognized as such by the State Fire Prevention Commission."

Section 3. Amend Title 18, Section 3565 of the Delaware Code by adding a new subsection (e) to read as follows:

"(e) The provisions of this Section shall not apply to services provided by a volunteer fire department recognized as such by the State Fire Prevention Commission."

Section 4. Amend Title 18, Section 3350 of the Delaware Code by striking subsection (d) in its entirety and by replacing it with the following:

"(d) This section does not require coverage for:

(1) Medication that may be obtained without a physician's prescription;

(2) Experimental drugs not otherwise approved for the proposed use or indication by the Food and Drug Administration; or

(3) Any disease, condition, service or treatment that is excluded from coverage under the policy."

Section 5. Amend Title 18, Section 3566 of the Delaware Code by striking subsection (d) in its entirety and by replacing it with the following:

"(d) This section does not require coverage for:

(1) Medication that may be obtained without a physician's prescription;

(2) Experimental drugs not otherwise approved for the proposed use or indication by the Food and Drug Administration; or

(3) Any disease, condition, service or treatment that is excluded from coverage under the policy."

Section 6. Amend Title 18, Section 332(c)(5) of the Delaware Code by striking the phrase "48 hours" contained therein and by replacing it with the term "72 hours".

Section 7. Amend Title 18, Section 3348 of the Delaware Code by striking the period, ".", at the end of the sentence reading: "Within the treatment period referred to in subparagraph (2) of this subsection, the specialist shall be permitted to treat the insured without a further referral from the insured's network provider and may authorize such further referrals, procedures, tests and other medical services as the individual's network provider would otherwise be permitted to provide or authorize", and by adding the following language:

", provided that such further referrals, procedures, tests and other medical services are part of treating the patient for the condition for which the patient was referred to the specialist."

Section 8. Amend Title 18, Section 3564 of the Delaware Code by striking the period, ".", at the end of the sentence reading: "Within the treatment period referred to in subparagraph (2) of this subsection, the specialist shall be permitted to treat the insured without a further referral from the insured's network provider and may authorize such further referrals, procedures, tests and other medical services as the individual's network provider would otherwise be permitted to provide or authorize", and by adding the following language:

", provided that such further referrals, procedures, tests and other medical services are part of treating the patient for the condition for which the patient was referred to the specialist."

Section 9. Amend Title 18 of the Delaware Code by adding a new Section 3351 to read as follows:

"§3351. Clinical Trials.

(a) This section applies to every policy or contract of health insurance, including each policy or contract issued by a health service corporation, which is delivered or issued for delivery in this State.

(b) Definitions.

(1) 'Routine patient care costs' as used in this section, include all items and services that are otherwise generally available to a qualified individual that are provided in the clinical trial except:

a. The investigational items or service itself;

b. Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patients; and

c. Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial.

(2) 'Clinical trials' for purposes of this section include clinical trials that are approved or funded by use of the following entities:

a. One of the National Institutes of Health (NIH);

b. An NIH Cooperative Group or center which is a formal network of facilities that collaborate on research projects and have an established NIH-approval peer review program operating within the group. This includes, but is not limited to, the NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program;

c. The federal Departments of Veterans' Affairs or Defense;

d. An institutional review board of an institution in this State that has a multiple project assurance contract approval by the Office of Protection for the Research Risks of the NIH; and

e. A qualified research entity that meets the criteria for NIH Center Support grant eligibility.

(3) Any clinical trial receiving coverage for routine costs under the provisions of this Act must meet the following requirements:

a. The subject or purpose of the trial must be the evaluation of an item or service that falls within the covered benefits of the policy and is not specifically excluded from coverage.

b. The trial must not be designed exclusively to test toxicity or disease pathophysiology.

c. The trial must have therapeutic intent.

d. Trials of therapeutic interventions must enroll patients with diagnosed disease.

e. The principal purpose of the trial is to test whether the intervention potentially improves the participant's health outcomes.

f. The trial is well supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

g. The trial does not unjustifiably duplicate existing studies.

h. The trial is in compliance with federal regulations relating to the protection of human subjects.

(c) Every policy described in subsection (a), including each policy or contract issued by a health service corporation, shall provide coverage for routine patient care costs as defined in subdivision (b)(1) of this section for covered persons engaging in clinical trials for treatment of life threatening diseases. Nothing in this section, however, independently requires coverage for expense of such clinical trials which are otherwise not covered under the policy or contract."

Section 10. Amend Section 13, Chapter 96, Volume 73, Laws of Delaware, by deleting the phrase "January 1, 2002", as found twice therein, and substituting in lieu thereof the phrase "July 1, 2002" at each location.

Section 11. Amend §3349, Title 18, of the Delaware Code, by adding a new subsection (e) thereto as follows:

"(e) The Insurance Commissioner shall establish a schedule of fees for arbitration. The non-prevailing party at arbitration shall reimburse the Commissioner for the expenses related to the arbitration process. Funds paid to the Insurance Commissioner under this subsection shall be placed in the arbitration fund and shall be used exclusively for the payment of appointed arbitrators. The Insurance Commissioner may, in his or her discretion, impose a schedule of maximum fees that can be charged by an arbitrator for a given type of arbitration."

Section 12. Amend §3565, Title 18, of the Delaware Code, by adding a new subsection (e) thereto as follows:

"(e) The Insurance Commissioner shall establish a schedule of fees for arbitration. The non-prevailing party at arbitration shall reimburse the Commissioner for the expenses related to the arbitration process. Funds paid to the Insurance Commissioner under this subsection shall be placed in the arbitration fund and shall be used exclusively for the payment of appointed arbitrators. The Insurance Commissioner may, in his or her discretion, impose a schedule of maximum fees that can be charged by an arbitrator for a given type of arbitration."

Section 13. Sections 1 through 9 and sections 11 and 12 shall take effect July 1, 2002.

Approved June 25, 2002