CHAPTER 1379. COVERAGE FOR ROUTINE PATIENT CARE COSTS FOR ENROLLEES PARTICIPATING IN CERTAIN CLINICAL TRIALS
INSURANCE CODE
TITLE 8. HEALTH INSURANCE AND OTHER HEALTH COVERAGES
SUBTITLE E. BENEFITS PAYABLE UNDER HEALTH COVERAGES
CHAPTER 1379. COVERAGE FOR ROUTINE PATIENT CARE COSTS FOR
ENROLLEES PARTICIPATING IN CERTAIN CLINICAL TRIALS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 1379.001. DEFINITIONS. In this chapter:
(1) "Enrollee" means an individual entitled to coverage under a
health benefit plan.
(2) "Life-threatening disease or condition" means a disease or
condition from which the likelihood of death is probable unless
the course of the disease or condition is interrupted.
(3) "Research institution" means the institution or other person
or entity conducting a phase I, phase II, phase III, or phase IV
clinical trial.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.002. APPLICABILITY OF CHAPTER. (a) This chapter
applies only to a health benefit plan that provides benefits for
medical or surgical expenses incurred as a result of a health
condition, accident, or sickness, including an individual, group,
blanket, or franchise insurance policy or insurance agreement, a
group hospital service contract, or an individual or group
evidence of coverage or similar coverage document that is offered
by:
(1) an insurance company;
(2) a group hospital service corporation operating under Chapter
842;
(3) a fraternal benefit society operating under Chapter 885;
(4) a stipulated premium company operating under Chapter 884;
(5) an exchange operating under Chapter 942;
(6) a health maintenance organization operating under Chapter
843;
(7) a multiple employer welfare arrangement that holds a
certificate of authority under Chapter 846; or
(8) an approved nonprofit health corporation that holds a
certificate of authority under Chapter 844.
(b) This chapter applies to group health coverage made available
by a school district in accordance with Section 22.004, Education
Code.
(c) Notwithstanding any provision in Chapter 1551, 1575, 1579,
or 1601 or any other law, this chapter applies to:
(1) a basic coverage plan under Chapter 1551;
(2) a basic plan under Chapter 1575;
(3) a primary care coverage plan under Chapter 1579; and
(4) basic coverage under Chapter 1601.
(d) Notwithstanding Section 1501.251 or any other law, this
chapter applies to coverage under a small employer health benefit
plan subject to Chapter 1501.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.003. APPLICABILITY TO CERTAIN GOVERNMENT PROGRAMS. To
the extent allowed by federal law, the state Medicaid program,
and a managed care organization that contracts with the Health
and Human Services Commission to provide health care services to
Medicaid recipients through a managed care plan, shall provide
the benefits required under this chapter to a Medicaid recipient.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.004. EXCEPTION. This chapter does not apply to:
(1) a plan that provides coverage:
(A) for wages or payments in lieu of wages for a period during
which an employee is absent from work because of sickness or
injury;
(B) as a supplement to a liability insurance policy;
(C) for credit insurance;
(D) for a specified disease or diseases;
(E) only for dental or vision care;
(F) only for hospital expenses; or
(G) only for indemnity for hospital confinement;
(2) a Medicare supplemental policy as defined by Section
1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss);
(3) a workers' compensation insurance policy;
(4) medical payment insurance coverage provided under a motor
vehicle insurance policy; or
(5) a long-term care policy, including a nursing home fixed
indemnity policy, unless the commissioner determines that the
policy provides benefit coverage so comprehensive that the policy
is a health benefit plan as described by Section 1379.002.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.005. RULES. The commissioner, in accordance with
Subchapter A, Chapter 36, may adopt rules to implement this
chapter.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
SUBCHAPTER B. COVERAGE FOR ROUTINE PATIENT CARE COSTS
Sec. 1379.051. ROUTINE PATIENT CARE COSTS. For purposes of this
chapter, routine patient care costs means the costs of any
medically necessary health care service for which benefits are
provided under a health benefit plan, without regard to whether
the enrollee is participating in a clinical trial. Routine
patient care costs do not include:
(1) the cost of an investigational new drug or device that is
not approved for any indication by the United States Food and
Drug Administration, including a drug or device that is the
subject of the clinical trial;
(2) the cost of a service that is not a health care service,
regardless of whether the service is required in connection with
participation in a clinical trial;
(3) the cost of a service that is clearly inconsistent with
widely accepted and established standards of care for a
particular diagnosis;
(4) a cost associated with managing a clinical trial; or
(5) the cost of a health care service that is specifically
excluded from coverage under a health benefit plan.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.052. COVERAGE REQUIRED. A health benefit plan issuer
shall provide benefits for routine patient care costs to an
enrollee in connection with a phase I, phase II, phase III, or
phase IV clinical trial if the clinical trial is conducted in
relation to the prevention, detection, or treatment of a
life-threatening disease or condition and is approved by:
(1) the Centers for Disease Control and Prevention of the United
States Department of Health and Human Services;
(2) the National Institutes of Health;
(3) the United States Food and Drug Administration;
(4) the United States Department of Defense;
(5) the United States Department of Veterans Affairs; or
(6) an institutional review board of an institution in this
state that has an agreement with the Office for Human Research
Protections of the United States Department of Health and Human
Services.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.053. RESEARCH INSTITUTION. (a) A health benefit plan
issuer is not required to reimburse the research institution
conducting the clinical trial for the cost of routine patient
care provided through the research institution unless the
research institution, and each health care professional providing
routine patient care through the research institution, agrees to
accept reimbursement under the health benefit plan, at the rates
that are established under the plan, as payment in full for the
routine patient care provided in connection with the clinical
trial.
(b) A health benefit plan issuer is not required to provide
benefits under this section for services that are a part of the
subject matter of the clinical trial and that are customarily
paid for by the research institution conducting the clinical
trial.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.054. LIMITATIONS ON COVERAGE. (a) Notwithstanding
Section 1379.053, this chapter does not require a health benefit
plan issuer to provide benefits for routine patient care services
provided outside of the plan's health care provider network
unless out-of-network benefits are otherwise provided under the
plan.
(b) This chapter does not require a health benefit plan issuer
to provide benefits for health care services provided outside
this state unless the health benefit plan otherwise provides
benefits for health care services provided outside this state.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.055. DEDUCTIBLE, COINSURANCE, AND COPAYMENT
REQUIREMENTS. The benefits required under this chapter may be
made subject to a deductible, coinsurance, or copayment
requirement comparable to other deductible, coinsurance, or
copayment requirements applicable under the health benefit plan.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.
Sec. 1379.056. CANCELLATION OR NONRENEWAL PROHIBITED. The
issuer of a health benefit plan may not cancel or refuse to renew
coverage under a plan solely because an enrollee in the plan
participates in a clinical trial described by Section 1379.052.
Added by Acts 2009, 81st Leg., R.S., Ch.
719, Sec. 1, eff. September 1, 2009.