CHAPTER 7. REQUIREMENTS FOR GROUP CONTRACTS, INDIVIDUAL CONTRACTS, AND EVIDENCE OF COVERAGE
IC 27-13-7
Chapter 7. Requirements for Group Contracts, IndividualContracts, 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 ahealth maintenance organization is entitled to a copy of the group orindividual 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 insection 1 or section 5 of this chapter may not contain provisions orstatements that are unjust, unfair, inequitable, misleading, ordeceptive or that encourage misrepresentation prohibited byIC 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 mustclearly state the following:
(1) The name and address of the health maintenanceorganization.
(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 individualcontract holder.
(21) Right of renewal provisions.
(22) Provisions regarding reinstatement of a group or anindividual 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 andAccountability 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 childbecomes twenty-four (24) years of age.
(b) For purposes of subsection (a), an evidence of coverage whichis 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 provisionsof section 3(a) of this chapter and provide for a period of ten (10)days during which the individual entering into the contract with thehealth maintenance organization may:
(1) examine the contract; and
(2) if the individual decides, return the contract to the healthmaintenance organization and obtain a refund of the premiumpaid.
(b) If:
(1) services were received during the ten (10) day periodreferred to in subsection (a); and
(2) the individual returns the contract to receive a refund of thepremium 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 anevidence of coverage from:
(1) the group contract holder; or
(2) the health maintenance organization.
(b) A group contract holder or health maintenance organizationmay provide the evidence of coverage required under subsection (a)in electronic or paper form. The group contract holder or healthmaintenance organization shall provide the evidence of coverage inpaper form upon the request of the subscriber.
(c) A health maintenance organization shall include in the healthmaintenance organization's enrollment materials informationconcerning 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 thischapter may not contain provisions or statements:
(1) that are unfair, unjust, inequitable, misleading, or deceptive;or
(2) that encourage misrepresentation prohibited byIC 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 thischapter must contain a clear statement of the matters set forth insection 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 4-22-2establishing readability standards for individual contracts andevidence 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 formhas 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 andincorporated into a contract issued in Indiana is intended fordelivery in another state;
(2) the evidence of coverage has been approved for use in thestate 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 thecommissioner 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 insubsection (a), the commissioner may extend the period for reviewfor an additional thirty (30) days.
(c) The commissioner must give notice in writing of an extensionof a review period under subsection (b).
(d) If the commissioner does not take action on a form submittedto the commissioner within the thirty (30) day period and any periodof extension, the form is considered approved.
(e) At any time after notice and for cause shown, thecommissioner 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 healthmaintenance organization written notice of the reasons for thedisapproval or withdrawal of approval. The notice must inform thehealth maintenance organization that it may, not more than thirty(30) days after it receives the notice, request a hearing concerning thedisapproval or withdrawal of approval. If the health maintenanceorganization requests a hearing not more than thirty (30) days afterit receives the notice, the commissioner shall hold a hearing upon notless 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 anyinformation the commissioner considers necessary to determinewhether 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 ineach contract a written statement that if the contract is terminated bythe health maintenance organization, an enrollee who is hospitalizedfor a medical or surgical condition on the date of termination willhave continuation of coverage for inpatient covered services. (b) The continuation of coverage referred to in subsection (a) isnot 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 thehealth maintenance organization.
(3) The hospitalized enrollee obtains from another carriercoverage that includes the coverage provided by the terminatinghealth maintenance organization.
(4) A contract holder terminates the contract with the healthmaintenance organization, as determined by:
(A) the effective date specified in written communicationsent by the contract holder to the health maintenanceorganization, which effective date shall be at least fifteen(15) days after the date the written communication is placedin the United States mail or sent by facsimile transmission;or
(B) the failure to pay a premium within the grace periodpermitted under the contract.
(5) Termination of an enrollee by a health maintenanceorganization due to:
(A) the enrollee knowingly providing false information tothe health maintenance organization;
(B) the enrollee's failure to comply with the rules of thehealth maintenance organization stated in the contract; or
(C) the enrollee's failure to pay a premium within the graceperiod permitted under contract.
(c) In order to satisfy the requirements of subsection (a), a healthmaintenance organization may provide benefits that exceed thecontinuation of coverage required by this section, either in the typesor time period of health care services covered, or both.
(d) If an enrollee terminates the enrollee's coverage, the healthmaintenance organization is not required to provide continuation ofcoverage to that enrollee under this section after the termination.
(e) This section does not apply to a termination of coverage as theresult 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 theremoval of all or part of the breast for reasons that are determined bya licensed physician to be medically necessary.
(b) A contract with a health maintenance organization thatprovides coverage for a mastectomy must provide coverage asrequired 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 themastectomy has been performed; and
(B) surgery and reconstruction of the other breast to produce
symmetry;
in the manner determined by the attending physician and thepatient to be appropriate.
(c) Coverage required under this section is subject to:
(1) the deductible and coinsurance provisions applicable to amastectomy; and
(2) all other terms and conditions applicable to other servicesunder the contract.
(d) A health maintenance organization shall provide to anenrollee, at the time that an individual contract or a group contract isentered into and annually thereafter, written notice of the coveragerequired under this section. Notice that is sent by the healthmaintenance organization that meets the requirements set forth in 29U.S.C. 1185b constitutes compliance with this subsection.
(e) The coverage required under this section applies to a contractwith a health maintenance organization that provides coverage for amastectomy, 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 maintenanceorganization to provide coverage related to post mastectomy care thatexceeds the coverage required for post mastectomy care underfederal 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 morbidobesity
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 morbidobesity.
(b) As used in this section, "morbid obesity" means:
(1) a body mass index of at least thirty-five (35) kilograms permeter squared with comorbidity or coexisting medicalconditions such as hypertension, cardiopulmonary conditions,sleep apnea, or diabetes; or
(2) a body mass index of at least forty (40) kilograms per metersquared without comorbidity.
For purposes of this subsection, body mass index equals weight inkilograms divided by height in meters squared.
(c) Except as provided in subsection (d), a health maintenanceorganization that provides coverage for basic health care servicesunder 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 aphysician has been unsuccessful for at least six (6) consecutivemonths.
(d) A health maintenance organization that provides coverage forbasic health care services may not provide coverage for surgicaltreatment of morbid obesity for an enrollee who is less thantwenty-one (21) years of age unless two (2) physicians licensedunder 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 thereason 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 developmentaldisorder" means a neurological condition, including Asperger'ssyndrome and autism, as defined in the most recent edition of theDiagnostic and Statistical Manual of Mental Disorders of theAmerican Psychiatric Association.
(b) A group contract with a health maintenance organization thatprovides basic health care services must provide services for thetreatment of a pervasive developmental disorder of an enrollee.Services provided to an enrollee under this subsection are limited toservices that are prescribed by the enrollee's treating physician inaccordance with a treatment plan. A health maintenance organizationmay not deny or refuse to provide services to, or refuse to renew,refuse to reissue, or otherwise terminate or restrict coverage under agroup contract to services to an individual solely because theindividual is diagnosed with a pervasive developmental disorder.
(c) The services required under subsection (b) may not be subjectto dollar limits, deductibles, copayments, or coinsurance provisionsthat are less favorable to an enrollee than the dollar limits,deductibles, copayments, or coinsurance provisions that apply tophysical illness generally under the contract with the healthmaintenance organization.
(d) A health maintenance organization that enters into anindividual contract that provides basic health care services must offerto provide services for the treatment of a pervasive developmentaldisorder of an enrollee. Services provided to an enrollee under thissubsection are limited to services that are prescribed by the enrollee'streating physician in accordance with a treatment plan. A healthmaintenance organization may not deny or refuse to provide servicesto, or refuse to renew, refuse to reissue, or otherwise terminate orrestrict coverage under an individual contract to services to anindividual solely because the individual is diagnosed with apervasive developmental disorder. (e) The services that must be offered under subsection (d) may notbe subject to dollar limits, deductibles, copayments, or coinsuranceprovisions that are less favorable to an enrollee than the dollar limits,deductibles, copayments, or coinsurance provisions that apply tophysical illness generally under the contract with the healthmaintenance organization.
As added by P.L.148-2001, SEC.3.
IC 27-13-7-14.8
Treatment limitations or financial requirements on coverage ofservices for mental illness
Sec. 14.8. (a) As used in this section, "coverage of services for amental illness" includes the services defined under the contract withthe health maintenance organization. However, the term does notinclude services for the treatment of substance abuse or chemicaldependency.
(b) This section applies to a group or individual contract with ahealth 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 hasobtained an exemption under IC 27-8-5-15.7.
(d) A group or individual contract with a health maintenanceorganization may not permit treatment limitations or financialrequirements on the coverage of services for a mental illness ifsimilar limitations or requirements are not imposed on the coverageof services for other medical or surgical conditions.
(e) A health maintenance organization that enters into anindividual contract or a group contract that provides coverage ofservices for the treatment of substance abuse and chemicaldependency when the services are required in the treatment of amental illness shall offer to provide the coverage without treatmentlimitations or financial requirements if similar limitations orrequirements are not imposed on the coverage of services for othermedical or surgical conditions.
(f) This section does not require a group or individual contractwith a health maintenance organization to offer mental healthbenefits.
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 individualwho is less than nineteen (19) years of age.
(b) As used in this section, "enrollee" means an enrollee who is achild or an individual:
(1) with a physical or mental impairment that substantially
limits one (1) or more of the major life activities of theindividual; 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 healthcare services shall include coverage under the terms and conditionsof the benefits contract for anesthesia and hospital charges for anenrollee for dental care if the mental or physical condition of theenrollee requires dental treatment to be rendered in a hospital or anambulatory outpatient surgical center. The Indications for GeneralAnesthesia, as published in the reference manual of the AmericanAcademy of Pediatric Dentistry, are the utilization standards fordetermining whether performing dental procedures necessary to treatthe enrollee's condition under general anesthesia constitutesappropriate treatment.
(d) A health maintenance organization may:
(1) require prior authorization for hospitalization or treatmentin an ambulatory outpatient surgical center for dental careprocedures in the same manner that prior authorization isrequired for hospitalization or treatment of other coveredmedical conditions; and
(2) restrict coverage to include only procedures performed bya licensed dentist who has privileges at the hospital orambulatory outpatient surgical center.
(e) This section does not apply to treatment rendered for temporalmandibular 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 screeningmammography" has the meaning set forth in IC 27-8-14-2.
(b) As used in this section, "woman at risk" has the meaning setforth in IC 27-8-14-5.
(c) Except as provided in subsection (g), a health maintenanceorganization issued a certificate of authority in Indiana shall providebreast cancer screening mammography as a covered service underevery group contract that provides coverage for basic health careservices.
(d) Except as provided in subsection (g), the coverage that ahealth maintenance organization must provide under this sectionmust include the following:
(1) If the enrollee is at least thirty-five (35) years of age but lessthan forty (40) years of age and a female, coverage for at leastone (1) baseline breast cancer screening mammographyperformed 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 mammographyperformed upon the enrollee every year.
(3) If the enrollee is at least forty (40) years of age and afemale, one (1) breast cancer screening mammographyperformed upon the enrollee every year.
(4) Any additional mammography views that are required forproper evaluation.
(5) Ultrasound services, if determined medically necessary bythe physician treating the enrollee.
(e) Except as provided in subsection (g), the coverage that ahealth maintenance organization must provide under this section maynot be subject to a contract provision that is less favorable to anenrollee or a subscriber than contract provisions applying to physicalillness generally under the health maintenance organization contract.
(f) Except as provided in subsection (g), the coverage that a healthmaintenance organization must provide under this section is inaddition to services specifically provided for x-rays, laboratorytesting, or wellness examinations.
(g) In the case of coverage that is not employer based, the healthmaintenance organization must offer to provide the coveragedescribed 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 ofprostate specific antigen in the blood.
(b) Except as provided in subsection (f), a health maintenanceorganization issued a certificate of authority in Indiana shall provideprostate specific antigen testing as a covered service under everygroup contract that provides coverage for basic health care services.
(c) Except as provided in subsection (f), the coverage requiredunder subsection (b) must include the following:
(1) At least one (1) prostate specific antigen test annually for amale enrollee who is at least fifty (50) years of age.
(2) At least one (1) prostate specific antigen test annually for amale enrollee who is less than fifty (50) years of age and whois at high risk for prostate cancer according to the most recentpublished guidelines of the American Cancer Society.
(d) Except as provided in subsection (f), the coverage that a healthmaintenance organization must provide under this section may not besubject to a contract provision that is less favorable to an enrolleethan a contract provision applying to physical illness generally underthe health maintenance organization contract.
(e) Except as provided in subsection (f), the coverage that a healthmaintenance organization must provide under this section is inaddition to services specifically provided for x-rays, laboratorytesting, or wellness examinations.
(f) In the case of coverage that is not employer based, the health
maintenance organization must offer to provide the coveragedescribed 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 anynonsymptomatic enrollee, in accordance with the current AmericanCancer Society guidelines.
(b) Except as provided in subsection (e), a health maintenanceorganization issued a certificate of authority in Indiana shall providecolorectal cancer testing as a covered service under every groupcontract 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 forcolorectal cancer according to the most recent publishedguidelines of the American Cancer Society;
the colorectal cancer testing required under this section must meetthe requirements set forth in subsection (d).
(d) An enrollee may not be required to pay a copayment for thecolorectal cancer examination and laboratory testing benefit that isgreater than a copayment established for similar benefits under agroup contract. If the group contract does not cover a similar coveredservice, the copayment may not be set at a level that materiallydiminishes the value of the colorectal cancer examination andlaboratory testing benefit required under this section.
(e) In the case of coverage that is not employer based, the healthmaintenance organization is required only to offer to provide thecolorectal cancer testing described in subsections (b) through (d) asa covered service under a proposed group contract providingcoverage 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 ureacycle metabolism; and
(2) treatable by the dietary restriction of one (1) or more aminoacids.
(b) As used in this section, "medical food" means a formula thatis:
(1) intended for the dietary treatment of a disease or conditionfor which nutritional requirements are established by medicalevaluation; and
(2) formulated to be consumed or administered enterally underthe direction of a physician. (c) A group health maintenance organization contract thatprovides coverage for basic health care services must providecoverage for medical food that is:
(1) medically necessary; and
(2) prescribed for an enrollee by the enrollee's treatingphysician for treatment of the enrollee's inherited metabolicdisease.
(d) The coverage that must be provided under this section shallnot be subject to dollar limits, copayments, or deductibles that areless favorable to an enrollee than the dollar limits, copayments, ordeductibles that apply to coverage for:
(1) prescription drugs generally under the group contract, ifprescription drugs are covered under the group contract; or
(2) physical illness generally under the group contract, ifprescription 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 amedically necessary custom fabricated brace or support that isdesigned as a component of a prosthetic device.
(b) As used in this section, "prosthetic device" means an artificialleg or arm.
(c) An individual contract or a group contract that providescoverage for basic health care services must provide coverage fororthotic devices and prosthetic devices, including repairs orreplacements, 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 medicallynecessary to restore or maintain the enrollee's ability to performactivities 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 thecoverage that is provided for the same device, repair, orreplacement under the federal Medicare program (42 U.S.C.1395 et seq.); and
(2) reimbursement under the coverage required undersubsection (c) must be equal to the reimbursement that isprovided for the same device, repair, or replacement under thefederal Medicare reimbursement schedule, unless a differentreimbursement rate is negotiated.
This subsection does not require a deductible under an individualcontract or a group contract to be equal to a deductible under thefederal 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 individualcontract or group contract.
(f) The coverage required under subsection (c) may be subject toutilization review, including periodic review, of the continuedmedical necessity of the benefit.
(g) Any lifetime maximum coverage limitation that applies toprosthetic 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 otheritems and services generally under the individual contract or groupcontract.
(h) For purposes of this subsection, "items and services" does notinclude preventive services for which coverage is provided under ahigh deductible health plan (as defined in 26 U.S.C. 220(c)(2) or 26U.S.C. 223(c)(2)). The coverage required under subsection (c) maynot be subject to a deductible, copayment, or coinsurance provisionthat is less favorable to an enrollee than the deductible, copayment,or coinsurance provisions that apply to other items and servicesgenerally 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 agroup contract that provides coverage for both of the following:
(1) Orally administered cancer chemotherapy.
(2) Cancer chemotherapy that is administered intravenously orby injection.
(b) As used in this section, "cancer chemotherapy" meansmedication that is prescribed by a physician to kill or slow thegrowth of cancer cells.
(c) Coverage for orally administered cancer chemotherapy underan individual contract or a group contract must not be subject todollar limits, copayments, deductibles, or coinsurance provisions thatare less favorable to an enrollee than the dollar limits, copayments,deductibles, or coinsurance provisions that apply to coverage forcancer chemotherapy that is administered intravenously or byinjection 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 useof 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, ortreat a cancer for which:
(i) there is no clearly superior, noninvestigationalalternative care method; and
(ii) available clinical or preclinical data provides areasonable basis from which to believe that the caremethod used in the research study is at least as effective asany noninvestigational alternative care method;
(B) in a facility where personnel providing the care methodto 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 theresearch study; and
(iii) experience providing the type of care required for theresearch study to a sufficient volume of patients tomaintain expertise; and
(C) to scientifically determine the best care method toprevent, 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 anestablished peer review program that is approved by aNational 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 locatedin Indiana that has a multiple project assurance contractapproved by the National Institutes of Health Office forProtection from Research Risks as provided in 45 CFR46.103.
(G) A research entity that meets eligibility criteria for asupport grant from a National Institutes of Health center.
(c) As used in this section, "nonparticipating provider" means ahealth care provider that has not entered into an agreement describedin IC 27-13-1-24.
(d) As used in this section, "routine care cost" means the cost ofmedically necessary services related to the care method that is underevaluation in a clinical trial. The term does not include the following:
(1) The health care service, item, or investigational drug that isthe subject of the clinical trial.
(2) Any treatment modality that is not part of the usual andcustomary standard of care required to administer or support thehealth care service, item, or investigational drug that is thesubject of the clinical trial.
(3) Any health care service, item, or drug provided solely tosatisfy data collection and analysis needs that are not used inthe 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 thepatient or a family member or companion of the patient that areassociated with travel to or from a facility where a clinical trialis conducted.
(6) A service, item, or drug that is provided by a clinical trialsponsor free of charge for any new patient.
(7) A service, item, or drug that is eligible for reimbursementfrom a source other than an enrollee's individual contract orgroup contract, including the sponsor of the clinical trial.
(e) An individual contract or a group contract must providecoverage for routine care costs that are incurred in the course of aclinical trial if the individual contract or group contract wouldprovide coverage for the same routine care costs not incurred in aclinical trial.
(f) The coverage that must be provided under this section issubject to the terms, conditions, restrictions, exclusions, andlimitations that apply generally under the individual contract orgroup contract, including terms, conditions, restrictions, exclusions,or limitations that apply to health care services rendered byparticipating providers and nonparticipating providers.
(g) This section does not do any of the following:
(1) Require a health maintenance organization to providecoverage for clinical trial services rendered by a participatingprovider.
(2) Prohibit a health maintenance organization from providingcoverage for clinical trial services rendered by a participatingprovider.
(3) Require reimbursement under an individual contract or agroup contract for services that are rendered in a clinical trial bya nonparticipating provider at the same rate of reimbursementthat would apply to the same services rendered by aparticipating provider.
(h) This section does not create a cause of action against a personfor any harm to an enrollee resulting from a clinical trial.
As added by P.L.109-2009, SEC.4.