CHAPTER 7. REQUIREMENTS FOR GROUP CONTRACTS, INDIVIDUAL CONTRACTS, AND EVIDENCE OF COVERAGE
IC 27-13-7
Chapter 7. Requirements for Group Contracts, Individual
Contracts, and Evidence of Coverage
IC 27-13-7-1
Persons entitled to copies of contracts
Sec. 1. Any holder of a group or an individual contract with a
health maintenance organization is entitled to a copy of the group or
individual contract.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-2
Deceptive contract provisions prohibited
Sec. 2. A contract or an evidence of coverage referred to in
section 1 or section 5 of this chapter may not contain provisions or
statements that are unjust, unfair, inequitable, misleading, or
deceptive or that encourage misrepresentation prohibited by
IC 27-1-15.6-12 or IC 27-4-1-4.
As added by P.L.26-1994, SEC.25. Amended by P.L.132-2001,
SEC.16.
IC 27-13-7-3
Contract provisions
Sec. 3. (a) A contract referred to in section 1 of this chapter must
clearly state the following:
(1) The name and address of the health maintenance
organization.
(2) Eligibility requirements.
(3) Benefits and services within the service area.
(4) Emergency care benefits and services.
(5) Any out-of-area benefits and services.
(6) Copayments, deductibles, and other out-of-pocket costs.
(7) Limitations and exclusions.
(8) Enrollee termination provisions.
(9) Any enrollee reinstatement provisions.
(10) Claims procedures.
(11) Enrollee grievance procedures.
(12) Continuation of coverage provisions.
(13) Conversion provisions.
(14) Extension of benefit provisions.
(15) Coordination of benefit provisions.
(16) Any subrogation provisions.
(17) A description of the service area.
(18) The entire contract provisions.
(19) The term of the coverage provided by the contract.
(20) Any right of cancellation of the group or individual
contract holder.
(21) Right of renewal provisions.
(22) Provisions regarding reinstatement of a group or an
individual contract holder.
(23) Grace period provisions.
(24) A provision on conformity with state law.
(25) A provision or provisions that comply with the:
(A) guaranteed renewability; and
(B) group portability;
requirements of the federal Health Insurance Portability and
Accountability Act of 1996 (26 U.S.C. 9801(c)(1)).
(26) That the contract provides, upon request of the subscriber,
coverage for a child of the subscriber until the date the child
becomes twenty-four (24) years of age.
(b) For purposes of subsection (a), an evidence of coverage which
is filed with a contract may be considered part of the contract.
As added by P.L.26-1994, SEC.25. Amended by P.L.91-1998,
SEC.22; P.L.218-2007, SEC.50.
IC 27-13-7-4
Compliance with requirements; ten day grace period
Sec. 4. (a) An individual contract must comply with all provisions
of section 3(a) of this chapter and provide for a period of ten (10)
days during which the individual entering into the contract with the
health maintenance organization may:
(1) examine the contract; and
(2) if the individual decides, return the contract to the health
maintenance organization and obtain a refund of the premium
paid.
(b) If:
(1) services were received during the ten (10) day period
referred to in subsection (a); and
(2) the individual returns the contract to receive a refund of the
premium paid;
the individual must pay for the services received during the ten (10)
day period.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-5
Evidence of coverage
Sec. 5. (a) A subscriber under a group contract must receive an
evidence of coverage from:
(1) the group contract holder; or
(2) the health maintenance organization.
(b) A group contract holder or health maintenance organization
may provide the evidence of coverage required under subsection (a)
in electronic or paper form. The group contract holder or health
maintenance organization shall provide the evidence of coverage in
paper form upon the request of the subscriber.
(c) A health maintenance organization shall include in the health
maintenance organization's enrollment materials information
concerning the manner in which a subscriber may:
(1) obtain an evidence of coverage; and
(2) request the evidence of coverage in paper form.
As added by P.L.26-1994, SEC.25. Amended by P.L.125-2005,
SEC.6.
IC 27-13-7-6
Evidence of coverage; prohibited provisions
Sec. 6. The evidence of coverage required by section 5 of this
chapter may not contain provisions or statements:
(1) that are unfair, unjust, inequitable, misleading, or deceptive;
or
(2) that encourage misrepresentation prohibited by
IC 27-1-15.6-12 or IC 27-4-1-4.
As added by P.L.26-1994, SEC.25. Amended by P.L.132-2001,
SEC.17.
IC 27-13-7-7
Evidence of coverage; required statement
Sec. 7. The evidence of coverage required by section 5 of this
chapter must contain a clear statement of the matters set forth in
section 3(a) of this chapter.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-8
Readability standards
Sec. 8. The commissioner may adopt rules under IC 4-22-2
establishing readability standards for individual contracts and
evidence of coverage forms.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-9
Approval of forms by commissioner
Sec. 9. Subject to sections 10 and 11 of this chapter:
(1) a group or an individual contract;
(2) an evidence of coverage; or
(3) an amendment to:
(A) a group or an individual contract; or
(B) an evidence of coverage;
may not be delivered or issued for delivery in Indiana unless the form
has been filed with and approved by the commissioner.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-10
Coverage outside Indiana; commissioner's approval not required
Sec. 10. If:
(1) an evidence of coverage that is issued under and
incorporated into a contract issued in Indiana is intended for
delivery in another state;
(2) the evidence of coverage has been approved for use in the
state in which it is to be delivered; and
(3) the evidence of coverage is not delivered in Indiana;
the evidence of coverage need not be submitted to the commissioner
in Indiana for approval.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-11
Filing of form with commissioner; review period; approval;
withdrawal of approval; hearing
Sec. 11. (a) A form required by this chapter must be filed with the
commissioner at least thirty (30) days before the form is:
(1) delivered; or
(2) issued for delivery;
in Indiana.
(b) At any time during the thirty (30) day period referred to in
subsection (a), the commissioner may extend the period for review
for an additional thirty (30) days.
(c) The commissioner must give notice in writing of an extension
of a review period under subsection (b).
(d) If the commissioner does not take action on a form submitted
to the commissioner within the thirty (30) day period and any period
of extension, the form is considered approved.
(e) At any time after notice and for cause shown, the
commissioner may withdraw approval of any form, effective thirty
(30) days after notice of the withdrawal of the approval is issued.
(f) When the commissioner:
(1) disapproves a filing; or
(2) withdraws approval of a form;
under this section, the commissioner shall give the health
maintenance organization written notice of the reasons for the
disapproval or withdrawal of approval. The notice must inform the
health maintenance organization that it may, not more than thirty
(30) days after it receives the notice, request a hearing concerning the
disapproval or withdrawal of approval. If the health maintenance
organization requests a hearing not more than thirty (30) days after
it receives the notice, the commissioner shall hold a hearing upon not
less than ten (10) days notice to the health maintenance organization.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-12
Additional information required by commissioner
Sec. 12. The commissioner may require the submission of any
information the commissioner considers necessary to determine
whether to approve or disapprove a filing under this chapter.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-13
Continuation of coverage statement
Sec. 13. (a) A health maintenance organization must include in
each contract a written statement that if the contract is terminated by
the health maintenance organization, an enrollee who is hospitalized
for a medical or surgical condition on the date of termination will
have continuation of coverage for inpatient covered services.
(b) The continuation of coverage referred to in subsection (a) is
not required after one (1) of the following occurs:
(1) The discharge of the enrollee from the hospital.
(2) Sixty (60) days pass after the contract is terminated by the
health maintenance organization.
(3) The hospitalized enrollee obtains from another carrier
coverage that includes the coverage provided by the terminating
health maintenance organization.
(4) A contract holder terminates the contract with the health
maintenance organization, as determined by:
(A) the effective date specified in written communication
sent by the contract holder to the health maintenance
organization, which effective date shall be at least fifteen
(15) days after the date the written communication is placed
in the United States mail or sent by facsimile transmission;
or
(B) the failure to pay a premium within the grace period
permitted under the contract.
(5) Termination of an enrollee by a health maintenance
organization due to:
(A) the enrollee knowingly providing false information to
the health maintenance organization;
(B) the enrollee's failure to comply with the rules of the
health maintenance organization stated in the contract; or
(C) the enrollee's failure to pay a premium within the grace
period permitted under contract.
(c) In order to satisfy the requirements of subsection (a), a health
maintenance organization may provide benefits that exceed the
continuation of coverage required by this section, either in the types
or time period of health care services covered, or both.
(d) If an enrollee terminates the enrollee's coverage, the health
maintenance organization is not required to provide continuation of
coverage to that enrollee under this section after the termination.
(e) This section does not apply to a termination of coverage as the
result of the receivership of a health maintenance organization.
As added by P.L.26-1994, SEC.25.
IC 27-13-7-14
Post-mastectomy coverage
Sec. 14. (a) As used in this section, "mastectomy" means the
removal of all or part of the breast for reasons that are determined by
a licensed physician to be medically necessary.
(b) A contract with a health maintenance organization that
provides coverage for a mastectomy must provide coverage as
required under 29 U.S.C. 1185b, including coverage for:
(1) prosthetic devices; and
(2) reconstructive surgery incident to a mastectomy including:
(A) all stages of reconstruction of the breast on which the
mastectomy has been performed; and
(B) surgery and reconstruction of the other breast to produce
symmetry;
in the manner determined by the attending physician and the
patient to be appropriate.
(c) Coverage required under this section is subject to:
(1) the deductible and coinsurance provisions applicable to a
mastectomy; and
(2) all other terms and conditions applicable to other services
under the contract.
(d) A health maintenance organization shall provide to an
enrollee, at the time that an individual contract or a group contract is
entered into and annually thereafter, written notice of the coverage
required under this section. Notice that is sent by the health
maintenance organization that meets the requirements set forth in 29
U.S.C. 1185b constitutes compliance with this subsection.
(e) The coverage required under this section applies to a contract
with a health maintenance organization that provides coverage for a
mastectomy, regardless of whether an individual who:
(1) underwent a mastectomy; and
(2) is covered under the contract;
was covered under the contract at the time of the mastectomy.
(f) This section does not require a health maintenance
organization to provide coverage related to post mastectomy care that
exceeds the coverage required for post mastectomy care under
federal law.
As added by P.L.150-1997, SEC.5. Amended by P.L.2-1998, SEC.71;
P.L.96-2002, SEC.3; P.L.204-2003, SEC.2.
IC 27-13-7-14.5
Coverage for nonexperimental, surgical treatment of morbid
obesity
Sec. 14.5. (a) As used in this section, "health care provider"
means a:
(1) physician licensed under IC 25-22.5; or
(2) hospital licensed under IC 16-21;
that provides health care services for surgical treatment of morbid
obesity.
(b) As used in this section, "morbid obesity" means:
(1) a body mass index of at least thirty-five (35) kilograms per
meter squared with comorbidity or coexisting medical
conditions such as hypertension, cardiopulmonary conditions,
sleep apnea, or diabetes; or
(2) a body mass index of at least forty (40) kilograms per meter
squared without comorbidity.
For purposes of this subsection, body mass index equals weight in
kilograms divided by height in meters squared.
(c) Except as provided in subsection (d), a health maintenance
organization that provides coverage for basic health care services
under a group contract shall offer coverage for nonexperimental,
surgical treatment by a health care provider of morbid obesity:
(1) that has persisted for at least five (5) years; and
(2) for which nonsurgical treatment that is supervised by a
physician has been unsuccessful for at least six (6) consecutive
months.
(d) A health maintenance organization that provides coverage for
basic health care services may not provide coverage for surgical
treatment of morbid obesity for an enrollee who is less than
twenty-one (21) years of age unless two (2) physicians licensed
under IC 25-22.5 determine that the surgery is necessary to:
(1) save the life of the enrollee; or
(2) restore the enrollee's ability to maintain a major life activity
(as defined in IC 4-23-29-6);
and each physician documents in the enrollee's medical record the
reason for the physician's determination.
As added by P.L.78-2000, SEC.3. Amended by P.L.196-2005, SEC.6;
P.L.102-2006, SEC.5.
IC 27-13-7-14.7
Coverage for pervasive developmental disorders
Sec. 14.7. (a) As used in this section, "pervasive developmental
disorder" means a neurological condition, including Asperger's
syndrome and autism, as defined in the most recent edition of the
Diagnostic and Statistical Manual of Mental Disorders of the
American Psychiatric Association.
(b) A group contract with a health maintenance organization that
provides basic health care services must provide services for the
treatment of a pervasive developmental disorder of an enrollee.
Services provided to an enrollee under this subsection are limited to
services that are prescribed by the enrollee's treating physician in
accordance with a treatment plan. A health maintenance organization
may not deny or refuse to provide services to, or refuse to renew,
refuse to reissue, or otherwise terminate or restrict coverage under a
group contract to services to an individual solely because the
individual is diagnosed with a pervasive developmental disorder.
(c) The services required under subsection (b) may not be subject
to dollar limits, deductibles, copayments, or coinsurance provisions
that are less favorable to an enrollee than the dollar limits,
deductibles, copayments, or coinsurance provisions that apply to
physical illness generally under the contract with the health
maintenance organization.
(d) A health maintenance organization that enters into an
individual contract that provides basic health care services must offer
to provide services for the treatment of a pervasive developmental
disorder of an enrollee. Services provided to an enrollee under this
subsection are limited to services that are prescribed by the enrollee's
treating physician in accordance with a treatment plan. A health
maintenance organization may not deny or refuse to provide services
to, or refuse to renew, refuse to reissue, or otherwise terminate or
restrict coverage under an individual contract to services to an
individual solely because the individual is diagnosed with a
pervasive developmental disorder.
(e) The services that must be offered under subsection (d) may not
be subject to dollar limits, deductibles, copayments, or coinsurance
provisions that are less favorable to an enrollee than the dollar limits,
deductibles, copayments, or coinsurance provisions that apply to
physical illness generally under the contract with the health
maintenance organization.
As added by P.L.148-2001, SEC.3.
IC 27-13-7-14.8
Treatment limitations or financial requirements on coverage of
services for mental illness
Sec. 14.8. (a) As used in this section, "coverage of services for a
mental illness" includes the services defined under the contract with
the health maintenance organization. However, the term does not
include services for the treatment of substance abuse or chemical
dependency.
(b) This section applies to a group or individual contract with a
health maintenance organization that:
(1) is issued, entered into, or renewed after December 31, 1999;
and
(2) is issued to an employer that employs more than fifty (50)
full-time employees.
(c) This section does not apply to a legal business entity that has
obtained an exemption under IC 27-8-5-15.7.
(d) A group or individual contract with a health maintenance
organization may not permit treatment limitations or financial
requirements on the coverage of services for a mental illness if
similar limitations or requirements are not imposed on the coverage
of services for other medical or surgical conditions.
(e) A health maintenance organization that enters into an
individual contract or a group contract that provides coverage of
services for the treatment of substance abuse and chemical
dependency when the services are required in the treatment of a
mental illness shall offer to provide the coverage without treatment
limitations or financial requirements if similar limitations or
requirements are not imposed on the coverage of services for other
medical or surgical conditions.
(f) This section does not require a group or individual contract
with a health maintenance organization to offer mental health
benefits.
As added by P.L.42-1997, SEC.3. Amended by P.L.81-1999, SEC.5;
P.L.226-2003, SEC.2.
IC 27-13-7-15
Dental care provisions required
Sec. 15. (a) As used in this section, "child" means an individual
who is less than nineteen (19) years of age.
(b) As used in this section, "enrollee" means an enrollee who is a
child or an individual:
(1) with a physical or mental impairment that substantially
limits one (1) or more of the major life activities of the
individual; and
(2) who:
(A) has a record of; or
(B) is regarded as;
having an impairment described in subdivision (1).
(c) A health maintenance organization that provides basic health
care services shall include coverage under the terms and conditions
of the benefits contract for anesthesia and hospital charges for an
enrollee for dental care if the mental or physical condition of the
enrollee requires dental treatment to be rendered in a hospital or an
ambulatory outpatient surgical center. The Indications for General
Anesthesia, as published in the reference manual of the American
Academy of Pediatric Dentistry, are the utilization standards for
determining whether performing dental procedures necessary to treat
the enrollee's condition under general anesthesia constitutes
appropriate treatment.
(d) A health maintenance organization may:
(1) require prior authorization for hospitalization or treatment
in an ambulatory outpatient surgical center for dental care
procedures in the same manner that prior authorization is
required for hospitalization or treatment of other covered
medical conditions; and
(2) restrict coverage to include only procedures performed by
a licensed dentist who has privileges at the hospital or
ambulatory outpatient surgical center.
(e) This section does not apply to treatment rendered for temporal
mandibular joint disorders (TMJ).
As added by P.L.189-1999, SEC.3.
IC 27-13-7-15.3
Breast cancer screening mammography
Sec. 15.3. (a) As used in this section, "breast cancer screening
mammography" has the meaning set forth in IC 27-8-14-2.
(b) As used in this section, "woman at risk" has the meaning set
forth in IC 27-8-14-5.
(c) Except as provided in subsection (g), a health maintenance
organization issued a certificate of authority in Indiana shall provide
breast cancer screening mammography as a covered service under
every group contract that provides coverage for basic health care
services.
(d) Except as provided in subsection (g), the coverage that a
health maintenance organization must provide under this section
must include the following:
(1) If the enrollee is at least thirty-five (35) years of age but less
than forty (40) years of age and a female, coverage for at least
one (1) baseline breast cancer screening mammography
performed upon the enrollee before the enrollee becomes forty
(40) years of age.
(2) If the enrollee is less than forty (40) years of age and a
woman at risk, one (1) breast cancer screening mammography
performed upon the enrollee every year.
(3) If the enrollee is at least forty (40) years of age and a
female, one (1) breast cancer screening mammography
performed upon the enrollee every year.
(4) Any additional mammography views that are required for
proper evaluation.
(5) Ultrasound services, if determined medically necessary by
the physician treating the enrollee.
(e) Except as provided in subsection (g), the coverage that a
health maintenance organization must provide under this section may
not be subject to a contract provision that is less favorable to an
enrollee or a subscriber than contract provisions applying to physical
illness generally under the health maintenance organization contract.
(f) Except as provided in subsection (g), the coverage that a health
maintenance organization must provide under this section is in
addition to services specifically provided for x-rays, laboratory
testing, or wellness examinations.
(g) In the case of coverage that is not employer based, the health
maintenance organization must offer to provide the coverage
described in subsections (c) through (f).
As added by P.L.170-1999, SEC.5.
IC 27-13-7-16
Prostate specific antigen test
Sec. 16. (a) As used in this section, "prostate specific antigen test"
means a standard blood test performed to determine the level of
prostate specific antigen in the blood.
(b) Except as provided in subsection (f), a health maintenance
organization issued a certificate of authority in Indiana shall provide
prostate specific antigen testing as a covered service under every
group contract that provides coverage for basic health care services.
(c) Except as provided in subsection (f), the coverage required
under subsection (b) must include the following:
(1) At least one (1) prostate specific antigen test annually for a
male enrollee who is at least fifty (50) years of age.
(2) At least one (1) prostate specific antigen test annually for a
male enrollee who is less than fifty (50) years of age and who
is at high risk for prostate cancer according to the most recent
published guidelines of the American Cancer Society.
(d) Except as provided in subsection (f), the coverage that a health
maintenance organization must provide under this section may not be
subject to a contract provision that is less favorable to an enrollee
than a contract provision applying to physical illness generally under
the health maintenance organization contract.
(e) Except as provided in subsection (f), the coverage that a health
maintenance organization must provide under this section is in
addition to services specifically provided for x-rays, laboratory
testing, or wellness examinations.
(f) In the case of coverage that is not employer based, the health
maintenance organization must offer to provide the coverage
described in subsections (b) through (e).
As added by P.L.170-1999, SEC.6.
IC 27-13-7-17
Colorectal cancer testing coverage
Sec. 17. (a) As used in this section, "colorectal cancer testing"
means examinations and laboratory tests for cancer for any
nonsymptomatic enrollee, in accordance with the current American
Cancer Society guidelines.
(b) Except as provided in subsection (e), a health maintenance
organization issued a certificate of authority in Indiana shall provide
colorectal cancer testing as a covered service under every group
contract that provides coverage for basic health care services.
(c) For an enrollee who is:
(1) at least fifty (50) years of age; or
(2) less than fifty (50) years of age and at high risk for
colorectal cancer according to the most recent published
guidelines of the American Cancer Society;
the colorectal cancer testing required under this section must meet
the requirements set forth in subsection (d).
(d) An enrollee may not be required to pay a copayment for the
colorectal cancer examination and laboratory testing benefit that is
greater than a copayment established for similar benefits under a
group contract. If the group contract does not cover a similar covered
service, the copayment may not be set at a level that materially
diminishes the value of the colorectal cancer examination and
laboratory testing benefit required under this section.
(e) In the case of coverage that is not employer based, the health
maintenance organization is required only to offer to provide the
colorectal cancer testing described in subsections (b) through (d) as
a covered service under a proposed group contract providing
coverage for basic health care services.
As added by P.L.54-2000, SEC.3. Amended by P.L.1-2001, SEC.34.
IC 27-13-7-18
Inherited metabolic disease coverage
Sec. 18. (a) As used in this section, "inherited metabolic disease"
means a disease:
(1) caused by inborn errors of amino acid, organic acid, or urea
cycle metabolism; and
(2) treatable by the dietary restriction of one (1) or more amino
acids.
(b) As used in this section, "medical food" means a formula that
is:
(1) intended for the dietary treatment of a disease or condition
for which nutritional requirements are established by medical
evaluation; and
(2) formulated to be consumed or administered enterally under
the direction of a physician.
(c) A group health maintenance organization contract that
provides coverage for basic health care services must provide
coverage for medical food that is:
(1) medically necessary; and
(2) prescribed for an enrollee by the enrollee's treating
physician for treatment of the enrollee's inherited metabolic
disease.
(d) The coverage that must be provided under this section shall
not be subject to dollar limits, copayments, or deductibles that are
less favorable to an enrollee than the dollar limits, copayments, or
deductibles that apply to coverage for:
(1) prescription drugs generally under the group contract, if
prescription drugs are covered under the group contract; or
(2) physical illness generally under the group contract, if
prescription drugs are not covered under the group contract.
As added by P.L.166-2003, SEC.3.
IC 27-13-7-19
Coverage for prosthetic devices
Sec. 19. (a) As used in this section, "orthotic device" means a
medically necessary custom fabricated brace or support that is
designed as a component of a prosthetic device.
(b) As used in this section, "prosthetic device" means an artificial
leg or arm.
(c) An individual contract or a group contract that provides
coverage for basic health care services must provide coverage for
orthotic devices and prosthetic devices, including repairs or
replacements, that:
(1) are provided or performed by a person that is:
(A) accredited as required under 42 U.S.C. 1395m(a)(20); or
(B) a qualified practitioner (as defined in 42 U.S.C.
1395m(h)(1)(F)(iii));
(2) are determined by the enrollee's physician to be medically
necessary to restore or maintain the enrollee's ability to perform
activities of daily living or essential job related activities; and
(3) are not solely for comfort or convenience.
(d) The:
(1) coverage required under subsection (c) must be equal to the
coverage that is provided for the same device, repair, or
replacement under the federal Medicare program (42 U.S.C.
1395 et seq.); and
(2) reimbursement under the coverage required under
subsection (c) must be equal to the reimbursement that is
provided for the same device, repair, or replacement under the
federal Medicare reimbursement schedule, unless a different
reimbursement rate is negotiated.
This subsection does not require a deductible under an individual
contract or a group contract to be equal to a deductible under the
federal Medicare program.
(e) Except as provided in subsections (f) and (g), the coverage
required under subsection (c):
(1) may be subject to; and
(2) may not be more restrictive than;
the provisions that apply to other benefits under the individual
contract or group contract.
(f) The coverage required under subsection (c) may be subject to
utilization review, including periodic review, of the continued
medical necessity of the benefit.
(g) Any lifetime maximum coverage limitation that applies to
prosthetic devices and orthotic devices:
(1) must not be included in; and
(2) must be equal to;
the lifetime maximum coverage limitation that applies to all other
items and services generally under the individual contract or group
contract.
(h) For purposes of this subsection, "items and services" does not
include preventive services for which coverage is provided under a
high deductible health plan (as defined in 26 U.S.C. 220(c)(2) or 26
U.S.C. 223(c)(2)). The coverage required under subsection (c) may
not be subject to a deductible, copayment, or coinsurance provision
that is less favorable to an enrollee than the deductible, copayment,
or coinsurance provisions that apply to other items and services
generally under the individual contract or group contract.
As added by P.L.109-2008, SEC.3.
IC 27-13-7-20
Prohibition on chemotherapy coverage limitations
Sec. 20. (a) This section applies to an individual contract or a
group contract that provides coverage for both of the following:
(1) Orally administered cancer chemotherapy.
(2) Cancer chemotherapy that is administered intravenously or
by injection.
(b) As used in this section, "cancer chemotherapy" means
medication that is prescribed by a physician to kill or slow the
growth of cancer cells.
(c) Coverage for orally administered cancer chemotherapy under
an individual contract or a group contract must not be subject to
dollar limits, copayments, deductibles, or coinsurance provisions that
are less favorable to an enrollee than the dollar limits, copayments,
deductibles, or coinsurance provisions that apply to coverage for
cancer chemotherapy that is administered intravenously or by
injection under the individual contract or group contract.
As added by P.L.46-2009, SEC.2.
IC 27-13-7-20.2
Coverage for care related to cancer clinical trials
Sec. 20.2. (a) As used in this section, "care method" means the use
of a particular drug or device in a particular manner.
(b) As used in this section, "clinical trial" means a Phase I, II, III,
or IV research study:
(1) that is conducted:
(A) using a particular care method to prevent, diagnose, or
treat a cancer for which:
(i) there is no clearly superior, noninvestigational
alternative care method; and
(ii) available clinical or preclinical data provides a
reasonable basis from which to believe that the care
method used in the research study is at least as effective as
any noninvestigational alternative care method;
(B) in a facility where personnel providing the care method
to be followed in the research study have:
(i) received training in providing the care method;
(ii) expertise in providing the type of care required for the
research study; and
(iii) experience providing the type of care required for the
research study to a sufficient volume of patients to
maintain expertise; and
(C) to scientifically determine the best care method to
prevent, diagnose, or treat the cancer; and
(2) that is approved or funded by one (1) of the following:
(A) A National Institutes of Health institute.
(B) A cooperative group of research facilities that has an
established peer review program that is approved by a
National Institutes of Health institute or center.
(C) The federal Food and Drug Administration.
(D) The United States Department of Veterans Affairs.
(E) The United States Department of Defense.
(F) The institutional review board of an institution located
in Indiana that has a multiple project assurance contract
approved by the National Institutes of Health Office for
Protection from Research Risks as provided in 45 CFR
46.103.
(G) A research entity that meets eligibility criteria for a
support grant from a National Institutes of Health center.
(c) As used in this section, "nonparticipating provider" means a
health care provider that has not entered into an agreement described
in IC 27-13-1-24.
(d) As used in this section, "routine care cost" means the cost of
medically necessary services related to the care method that is under
evaluation in a clinical trial. The term does not include the following:
(1) The health care service, item, or investigational drug that is
the subject of the clinical trial.
(2) Any treatment modality that is not part of the usual and
customary standard of care required to administer or support the
health care service, item, or investigational drug that is the
subject of the clinical trial.
(3) Any health care service, item, or drug provided solely to
satisfy data collection and analysis needs that are not used in
the direct clinical management of the patient.
(4) An investigational drug or device that has not been approved
for market by the federal Food and Drug Administration.
(5) Transportation, lodging, food, or other expenses for the
patient or a family member or companion of the patient that are
associated with travel to or from a facility where a clinical trial
is conducted.
(6) A service, item, or drug that is provided by a clinical trial
sponsor free of charge for any new patient.
(7) A service, item, or drug that is eligible for reimbursement
from a source other than an enrollee's individual contract or
group contract, including the sponsor of the clinical trial.
(e) An individual contract or a group contract must provide
coverage for routine care costs that are incurred in the course of a
clinical trial if the individual contract or group contract would
provide coverage for the same routine care costs not incurred in a
clinical trial.
(f) The coverage that must be provided under this section is
subject to the terms, conditions, restrictions, exclusions, and
limitations that apply generally under the individual contract or
group contract, including terms, conditions, restrictions, exclusions,
or limitations that apply to health care services rendered by
participating providers and nonparticipating providers.
(g) This section does not do any of the following:
(1) Require a health maintenance organization to provide
coverage for clinical trial services rendered by a participating
provider.
(2) Prohibit a health maintenance organization from providing
coverage for clinical trial services rendered by a participating
provider.
(3) Require reimbursement under an individual contract or a
group contract for services that are rendered in a clinical trial by
a nonparticipating provider at the same rate of reimbursement
that would apply to the same services rendered by a
participating provider.
(h) This section does not create a cause of action against a person
for any harm to an enrollee resulting from a clinical trial.
As added by P.L.109-2009, SEC.4.