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  S.B. No. 39
 
 
 
 
AN ACT
  relating to health benefit plan coverage for routine patient care
  costs for enrollees participating in certain clinical trials.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subtitle E, Title 8, Insurance Code, is amended
  by adding Chapter 1379 to read as follows:
  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.
         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.
         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.
         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.
         Sec. 1379.005.  RULES. The commissioner, in accordance with
  Subchapter A, Chapter 36, may adopt rules to implement this
  chapter.
  [Sections 1379.006-1379.050 reserved for expansion]
  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.
         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.
         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.
         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.
         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.
         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.
         SECTION 2.  Section 1506.151, Insurance Code, is amended by
  adding Subsection (d) to read as follows:
         (d)  Coverage provided by the pool is subject to Chapter
  1379.
         SECTION 3.  This Act applies only to a health benefit plan
  that is delivered, issued for delivery, or renewed on or after
  January 1, 2010. A health benefit plan that is delivered, issued
  for delivery, or renewed before January 1, 2010, is governed by the
  law as it existed immediately before the effective date of this Act,
  and that law is continued in effect for that purpose.
         SECTION 4.  This Act takes effect September 1, 2009.
 
 
 
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
         I hereby certify that S.B. No. 39 passed the Senate on
  March 23, 2009, by the following vote: Yeas 31, Nays 0; and that
  the Senate concurred in House amendments on May 29, 2009, by the
  following vote: Yeas 31, Nays 0.
 
 
  ______________________________
  Secretary of the Senate    
 
         I hereby certify that S.B. No. 39 passed the House, with
  amendments, on May 19, 2009, by the following vote: Yeas 145,
  Nays 0, one present not voting.
 
 
  ______________________________
  Chief Clerk of the House   
 
 
 
  Approved:
 
  ______________________________ 
              Date
 
 
  ______________________________ 
            Governor