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Learn About Clinical Trials

  • Posted: 01/05/2010

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Insurance Coverage: Texas

Map of Texas

For more information about insurance coverage of clinical trial costs, see this feature's main page: States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.

Legislation: Senate Bill 39 (Chapter 719)

Effective: September 1, 2009

What clinical trials are covered?

Phase I, II, III, and IV clinical trials are covered provided that they are

  • Conducted to prevent, detect, or treat a life-threatening disease or condition, and
  • Approved by one of the following:
  • Centers for Disease Control and Prevention
  • National Institutes of Health
  • U.S. Food and Drug Administration
  • U.S. Department of Defense
  • U.S. Department of Veteran Affairs
  • Institutional review board of an institution in the state of Texas that has an agreement with the Office for Human Research Protections of the U.S. Department of Health and Human Services.

Who is required to pay?

All individual and group health benefit plans, including health maintenance organizations, state Medicaid and Medicaid managed care organizations (to the extent allowed by federal law), and state employee health benefit plans.

Other key provisions

  • Coverage applies to health benefit plans that are issued or renewed on or after January 1, 2010.
  • "Routine patient care costs" means the costs of medically necessary health care services that would be covered by the health benefit plan outside of a clinical trial, except for the costs of:
  • investigational new drugs or devices not approved for any indication by the U.S. Food and Drug Administration, including a drug or device that is the subject of the clinical trial
  • non­-health care services, regardless of whether these services are required for participation in the clinical trial
  • services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis
  • managing a clinical trial
  • health care services that are specifically excluded from coverage under a health benefit plan.
  • Research institutions and health care professionals must agree to accept reimbursement at insurers' established rates as payment in full for routine patient care provided in a clinical trial.
  • Insurers are not required to pay for services that are part of the subject matter of the clinical trial and are customarily paid for by the research institution conducting the trial.
  • Insurers are not required to provide benefits for:
  • routine patient care services provided outside of the plan's provider network, unless the plan normally covers out-of-network benefits
  • health care services provided outside the state of Texas, unless the plan normally provides benefits for out-of-state health care services.
  • Patients taking part in covered clinical trials pay the same deductibles, copayments, coinsurance, and other fees associated with their care that they would pay if they were not taking part in a clinical trial.

  • Insurers are prohibited from canceling or refusing to renew coverage under a plan solely because an enrollee in the plan participates in a clinical trial.

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