FLOOR AMENDMENTS (PUCKETT) AGREED TO BY SENATE

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, 38.2-4509 and

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and 38.2-3407.13

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§38.2-3407.13. Refusal to accept assignments prohibited.

A. No 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, no corporation providing individual or group accident and sickness subscription contracts, no health maintenance organization providing a health care plan for health care services, and no dental services plan offering or administering prepaid dental services shall refuse to accept or make reimbursement pursuant to an assignment of benefits made to a health care provider or hospital by an insured, subscriber or plan enrollee, provided that if the health care provider or hospital obtains such assignment of benefits, then the health care provider or hospital shall accept the reimbursement under such assignment as payment in full for the services covered by such assignment and shall not charge or bill the insured, subscriber or plan enrollee any further amount except for the amount of any applicable deductible, copayment or coinsurance.

B. For the purpose of this section “assignment of benefits” means the transfer of health care coverage reimbursement benefits or other rights under an insurance policy, subscription contract or health care plan by an insured, subscriber or plan enrollee to a health care provider or hospital.

C. This section shall not apply to an assignment of benefits made to a dentist or oral surgeon.

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38.2-3407.13,

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38.2-3407.13,

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§ 38.2-4509. Application of certain laws.

A. No provision of this title except this chapter and, insofar as they are not inconsistent with this chapter, §§ 38.2-200, 38.2-203, 38.2-210 through 38.2-213, 38.2-218 through 38.2-225, 38.2-229, 38.2-316, 38.2-400, 38.2-402 through 38.2-413, 38.2-500 through 38.2-515, 38.2-600 through 38.2-620, 38.2-900 through 38.2-904, 38.2-1038, 38.2-1040 through 38.2-1044, Articles 1 (§ 38.2-1300 et seq.) and 2 (§ 38.2-1306.2 et seq.) of Chapter 13, 38.2-1312, 38.2-1314, Article 4 (§ 38.2-1317 et seq.) of Chapter 13, 38.2-1400 through 38.2-1444, 38.2-1800 through 38.2-1836, 38.2-3401, 38.2-3404, 38.2-3405, 38.2-3407.10, 38.2-3407.13, 38.2-3415, 38.2-3541, 38.2-3600 through 38.2-3603, and Chapter 58 (§ 38.2-5800 et seq.) of this title shall apply to the operation of a plan.

B. The provisions of subsection A of § 38.2-322 shall apply to an optometric services plan. The provisions of subsection C of § 38.2-322 shall apply to a dental services plan.

C. The provisions of Article 1.2 (§ 32.1-137.7 et seq.) of Chapter 5 of Title 32.1 shall not apply to either an optometric or dental services plan.

FLOOR AMENDMENTS (COURIC) AGREED TO BY SENATE

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and 38.2-3418.8

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and 38.2-3418.8

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§ 38.2-3418.8. Coverage for clinical trials for life-threatening diseases.

A. 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 clinical trials for life-threatening diseases under any such policy, contract or plan delivered, issued for delivery, or renewed in this Commonwealth on and after July 1, 1999.

B. The reimbursement for the participation in clinical trials for life-threatening diseases shall be determined according to the same formula by which charges are developed for other medical and surgical procedures. Such coverage shall have durational limits, dollar limits, deductibles and coinsurance factors that are no less favorable than for physical illness generally.

C. For purposes of this section:

“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, (ii) the National Cancer Institute Community Clinical Oncology Program, (iii) the AIDS Clinical Trials Group, and (iv) the Community Programs for Clinical Research in AIDS.

“FDA” means the Federal Food and Drug Administration.

“Member” means a policyholder, subscriber, insured, or certificate holder or a covered dependent of a policyholder, subscriber, insured or certificate holder.

“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.

“NIH” means the National Institutes of Health.

“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) costs that would not be covered under the patient’s policy, plan, or contract for noninvestigational treatments.

D. Coverage for clinical trials for life-threatening diseases shall be provided for participation in a clinical trial as a result of (i) a life-threatening condition or (ii) prevention, early detection, and treatment studies on cancer. Such coverage shall be required if:

1. The treatment is being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer; or

2. The treatment is being conducted in a Phase II, Phase III, or Phase IV clinical trial for any other life-threatening condition. Such treatment may, however, be provided on a case-by-case basis if the treatment is being provided in a Phase I clinical trial for any life-threatening condition other than cancer.

E. The treatment described in subsection D shall be provided by a clinical trial approved by:

One of the National Institutes of Health;

An NIH cooperative group or an NIH center;

The FDA in the form of an investigational new drug application;

The Federal Department of Veterans Affairs; or

5. 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 NIH.

F. The facility and personnel providing the treatment shall be capable of doing so by virtue of their experience, training, and expertise.

G. Coverage under this section shall apply only if:

There is no clearly superior, noninvestigational treatment alternative; and

The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the noninvestigational alternative.

H. 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.

FLOOR AMENDMENT (BOLLING) AGREED TO BY SENATE

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4. The provisions of Section 38.2-3407.13 and Section 38.2-3418.8 shall become effective only if reenacted by the 2000 General Assembly. Prior to the 2000 General Assembly the Joint Commission on Health Care in consult with the Bureau of Insurance shall review the financial impact that the enactment of these sections would have on health care costs, health insurance premiums and the availability of health care and health insurance.