House File 2075      

                            AN ACT
REQUIRING HEALTH BENEFIT COVERAGE FOR CERTAIN CANCER TREATMENT
   DELIVERED PURSUANT TO APPROVED CANCER CLINICAL TRIALS AND
   PROVIDING AN APPLICABILITY DATE.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
   Section 1.  NEW SECTION.  514C.26  Approved cancer clinical
trials coverage.
   1.  Definitions.  For purposes of this section, unless the
context otherwise requires:
   a.  "Approved cancer clinical trial" means a scientific
study of a new therapy for the treatment of cancer in human
beings that meets the requirements set forth in subsection 3
and consists of a scientific plan of treatment that includes
specified goals, a rationale and background for the plan,
criteria for patient selection, specific directions for
administering therapy and monitoring patients, a definition of
quantitative measures for determining treatment response, and
methods for documenting and treating adverse reactions.
   b.  "Institutional review board" means a board, committee, or
other group formally designated by an institution and  approved
 by the national institutes of health, office for protection
from research risks, to review, approve the initiation of,
and conduct periodic review of biomedical research involving
human subjects.  "Institutional review board" means the same
as "institutional review committee" as used in section 520(g)
of the federal Food, Drug, and Cosmetic Act, as codified in 21
U.S.C. { 301 et seq.
   c.  (1)  "Routine patient care costs" means medically
necessary services or treatments that are a benefit under
a contract or policy providing for third=party payment or
prepayment of health or medical expenses that would be covered
if the patient were receiving standard cancer treatment.
   (2)  "Routine patient care costs" does not include any of the
following:
   (a)  Costs of any treatments, procedures, drugs, devices,
services, or items that are the subject of the approved cancer
clinical trial or any other investigational treatments,
procedures, drugs, devices, services, or items.
   (b)  Costs of nonhealth care services that the patient is
required to receive as a result of participation in the approved
cancer clinical trial.
   (c)  Costs associated with managing the research that is
associated with the approved cancer clinical trial.
   (d)  Costs that would not be covered by the third=party
payment provider if noninvestigational treatments were
provided.
   (e)  Costs of any services, procedures, or tests provided
solely to satisfy data collection and analysis needs that are
not used in the direct clinical management of the patient
participating in an approved cancer clinical trial.
   (f)  Costs paid for, or not charged for, by the approved
cancer clinical trial providers.
   (g)  Costs for transportation, lodging, food, or other
expenses for the patient, a family member, or a companion of the
patient that are associated with travel to or from a facility
where an approved cancer clinical trial is conducted.
   (h)  Costs for services, items, or drugs that are eligible
for reimbursement from a source other than a patient's contract
or policy providing for third=party payment or prepayment
of health or medical expenses, including the sponsor of the
approved cancer clinical trial.
   (i)  Costs associated with approved cancer clinical
trials designed exclusively to test toxicity or disease
pathophysiology.
   (j)  Costs of extra treatments, services, procedures, tests,
or drugs that would not be performed or administered except for
participation in the cancer clinical trial. Nothing in this
subparagraph subdivision shall limit payment for treatments,
services, procedures, tests, or drugs that are otherwise a
covered benefit under subparagraph (1).
   d.  "Therapeutic intent" means that a treatment is aimed
at  improving a patient's health outcome relative to either
survival or quality of life.
   2.  Coverage required.  Notwithstanding the uniformity of
treatment requirements of section 514C.6, a policy or contract
providing for third=party payment or prepayment of health or
medical expenses shall provide coverage benefits for routine
patient care costs incurred for cancer treatment in an approved
cancer clinical trial to the same extent that such policy or
contract provides coverage for treating any other  sickness,
injury, disease, or condition covered under the policy or
contract, if the insured has been referred for such cancer
treatment by two physicians who specialize in oncology and
the cancer treatment is given pursuant to an approved cancer
clinical trial that meets the criteria set forth in subsection
3.  Services that are furnished without charge to a  participant
in the approved cancer clinical trial are not required to be
covered as routine patient care costs pursuant to this section.
   3.  Criteria.  Routine patient care costs for cancer
treatment given pursuant to an approved cancer clinical
trial shall be covered pursuant to this section if all of the
following requirements are met:
   a.  The treatment is provided with therapeutic intent and is
provided pursuant to an approved cancer clinical trial that has
been authorized or approved by one of the following:
   (1)  The national institutes of health.
   (2)  The United States food and drug administration.
   (3)  The United States department of defense.
   (4)  The United States department of veterans affairs.
   b.  The proposed treatment has been reviewed and approved by
the applicable qualified institutional review board.
   c.  The available clinical or preclinical data indicate
that the treatment that will be provided pursuant to the
approved cancer clinical trial will be at least as effective
as the standard therapy and is anticipated to constitute an
improvement in therapeutic effectiveness for the treatment of
the disease in question.
   4.  Notice.  As soon as practical after the insured provides
written consent to participate in an approved cancer clinical
trial, the physician shall provide notice to the third=party
payment provider of the insured's intent to participate in an
approved cancer clinical trial.  Failure to provide such notice
to the third=party payment provider shall not be the basis for
denying the coverage required under subsection 2.
   5.  Applicability.
   a.  This section applies to the following classes of
third=party payment provider contracts or policies delivered,
issued for delivery, continued, or renewed in this state on or
after July 1, 2010:
   (1)  Individual or group accident and sickness insurance
providing coverage on an expense=incurred basis.
   (2)  An individual or group hospital or medical service
contract issued pursuant to chapter 509, 514, or 514A.
   (3)  An individual or group health maintenance organization
contract regulated under chapter 514B.
   (4)  Any other entity engaged in the business of insurance,
risk transfer, or risk retention, which is subject to the
jurisdiction of the commissioner.
   (5)  A plan established pursuant to chapter 509A for public
employees.
   (6)  An organized delivery system licensed by the director
of public health.
   b.  This section shall not apply to accident=only,
specified disease, short=term hospital or medical, hospital
confinement indemnity, credit, dental, vision, Medicare
supplement, long=term care, basic hospital and  medical=surgical
expense coverage as defined by the commissioner, disability
income insurance coverage, coverage issued as a supplement
to liability insurance, workers' compensation or similar
insurance, or automobile medical payment insurance.


                                                            
                              PATRICK J. MURPHY
                              Speaker of the House


                                                            
                              JOHN P. KIBBIE
                              President of the Senate
   I hereby certify that this bill originated in the House and
is known as House File 2075, Eighty=third General Assembly.


                                                            
                              MARK BRANDSGARD
                              Chief Clerk of the House
Approved                , 2010


                                                            
                              CHESTER J. CULVER
                              Governor

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