THE SENATE	S.B. NO.	2324
THIRTIETH LEGISLATURE, 2020
STATE OF HAWAII

A BILL FOR AN ACT

relating to MEDICAid.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. Chapter 346, Hawaii Revised Statutes, is amended by adding a new section to part II to be appropriately designated and to read as follows:

"§346- Coverage for approved clinical trials. (a) Beginning on January 1, 2021, the State's medicaid managed care and fee-for-service programs shall provide coverage for the routine costs of care of an enrollee participating in an approved clinical trial.

(b) Nothing in this section shall be construed to otherwise limit or modify any existing requirements under this chapter or prevent application of any copayment or deductible provisions in a contracted health plan.

(c) A contracted health plan that provides coverage required by this section is not, based upon that coverage, liable for any adverse effects of the approved clinical trial.

(d) For purposes of this section:

"Approved clinical trial" means a trial that is:

(1) Funded by the National Institutes of Health, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, United States Department of Defense, or United States Department of Veterans Affairs;

(2) Supported by a center or cooperative group that is funded by the National Institutes of Health, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, United States Department of Defense, or United States Department of Veterans Affairs;

(3) Conducted as an investigational new drug application, an investigational device exemption, or a biologics license application subject to approval by the United States Food and Drug Administration; or

(4) Exempt by federal law from the requirement to submit an investigational new drug application to the United States Food and Drug Administration.

"Routine costs of care" means all medically necessary conventional care, items, or services consistent with the coverage provided by the contracted health plan if typically provided to an enrollee who is not participating in an approved clinical trial. "Routine costs of care" does not include:

(1) Drugs or devices that have not been approved by the federal Food and Drug Administration and that are associated with the approved clinical trial;

(2) Items or services required solely for the provision of the drug, device, or service being tested in the approved clinical trial;

(3) Items or services required solely for the clinically appropriate monitoring of the drug, device, or service being tested in the approved clinical trial;

(4) Items or services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the enrollee;

(5) Items or services customarily provided by a clinical trial sponsor free of charge to any participant in the approved clinical trial; or

(6) Items or services that are not covered by the contracted health plan if provided outside of the approved clinical trial."

SECTION 2. New statutory material is underscored.

SECTION 3. This Act shall take effect on July 1, 2020; provided that section 1 shall take effect upon approval of the Hawaii medicaid state plan by the Centers for Medicare and Medicaid Services.

INTRODUCED BY:

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Report Title:

Medicaid; Approved Clinical Trials; Routine Costs of Care

Description:

Beginning January 1, 2021, requires contracted health plans under the State's medicaid managed care and fee-for-service programs to cover routine costs of care of enrollees participating in an approved clinical trial.

The summary description of legislation appearing on this page is for informational purposes only and is not legislation or evidence of legislative intent.