State of Illinois
91st General Assembly
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Public Act 91-0406

HB1622 Enrolled                                LRB9104751JSpc

    AN ACT concerning benefits for certain health treatments.

    WHEREAS, It is the intent  of  the  General  Assembly  to
recognize that cancer clinical trials are designed to compare
the  effectiveness  of  the standard medical treatment with a
new  therapy  that  researchers  believe  will   prove   more
effective,   based  on  scientific  evidence  and  that  such
research provides the foundation for  improved  patient  care
and decreased health care costs; and

    WHEREAS,  It  is  the  intent  of the General Assembly to
recognize that cancer clinical trials  involve  a  rigorously
developed  clinical  protocol  that includes goals, rationale
and background,  criteria  for  patient  selection,  specific
directions for administering therapy and monitoring patients,
definition of quantitative measures for determining treatment
response,  reporting  of results, and methods for documenting
and treating adverse reactions; and

    WHEREAS, It is the intent  of  the  General  Assembly  to
recognize that virtually every major breakthrough for current
cancer  treatment  has  been  developed  through the clinical
trial system; and

    WHEREAS, It is the intent  of  the  General  Assembly  to
acknowledge  that  cancer clinical trials can be cost neutral
in comparison to the standard therapy; therefore

    Be it enacted by the People of  the  State  of  Illinois,
represented in the General Assembly:

    Section  5.  The Civil Administrative Code of Illinois is
amended by adding Section 56.3 as follows:

    (20 ILCS 1405/56.3 new)
    Sec. 56.3.  Investigational cancer treatments; study.
    (a)  The  Department  of  Insurance  shall   conduct   an
analysis  and  study  of  costs and benefits derived from the
implementation   of    the    coverage    requirements    for
investigational  cancer  treatments established under Section
356y of the Illinois Insurance Code. The  study  shall  cover
the  years  2000, 2001, and 2002.  The study shall include an
analysis of the effect of the coverage  requirements  on  the
cost  of  insurance  and  health  care,  the  results  of the
treatments to  patients,  the  mortality  rate  among  cancer
patients,  any  improvements  in  care  of  patients, and any
improvements in the quality of life of patients.
    (b)  The Department shall report the results of its study
to the General Assembly and the Governor on or  before  March
1, 2003.

    Section  10.  The  Illinois  Insurance Code is amended by
adding Section 356y as follows:

    (215 ILCS 5/356y new)
    Sec.   356y.  Coverage   for    investigational    cancer
treatments.
    (a)  An  insurer that issues, delivers, amends, or renews
an  individual  or  group  policy  of  accident  and   health
insurance  in  this  State  more  than  120  days  after  the
effective  date  of  this  amendatory Act of the 91st General
Assembly must offer to the applicant or policyholder coverage
for  routine  patient  care  of  insureds,   when   medically
appropriate  and the insured has a terminal condition related
to cancer that according to the  diagnosis  of  the  treating
physician, licensed to practice medicine in all its branches,
is considered life threatening, to participate in an approved
cancer  research  trial  and  shall  provide coverage for the
patient care  provided  pursuant  to  investigational  cancer
treatments  as  provided  in  subsection (b).  Coverage under
this Section may have an annual benefit limit of $10,000.
    (b)  Coverage shall include routine  patient  care  costs
such  as  blood tests, x-rays, bone scans, magnetic resonance
images, patient visits,  hospital  stays,  or  other  similar
costs  generally  incurred  by  the insured party in standard
cancer treatment. Routine  patient  care  costs  specifically
shall  not  include the cost of any clinical trial therapies,
regimens,   or   combinations   thereof,   any    drugs    or
pharmaceuticals  in  connection  with  an  approved  clinical
trial,  any costs associated with the provision of any goods,
services, or benefits that are  generally  furnished  without
charge  in connection with an approved clinical trial program
for treatment of cancer, any additional costs associated with
the provision  of  any  goods,  services,  or  benefits  that
previously have been provided to, paid for, or reimbursed, or
any  other  similar  costs.  Routine patient care costs shall
specifically not include costs  for  treatments  or  services
prescribed  for  the convenience of the insured, enrollee, or
physician.  It is specifically the intent of this Section not
to relieve  the  sponsor  or  a  clinical  trial  program  of
financial responsibility for accepted costs of the program.
    (c)  For  purposes  of this Section, coverage is provided
only for cancer  trials  that  meet  each  of  the  following
criteria:
         (1)  the effectiveness of the treatment has not been
    determined relative to established therapies;
         (2)  the  trial  is  under clinical investigation as
    part of an approved cancer research trial  in  Phase  II,
    Phase III, or Phase IV of investigation;
         (3)  the  trial is approved by the U.S. Secretary of
    Health and Human Services, the Director of  the  National
    Institutes  of  Health,  the Commissioner of the Food and
    Drug Administration (through an investigational new  drug
    exemption under Section 505(l) of the federal Food, Drug,
    and  Cosmetic  Act or an investigational device exemption
    under  Section  520(g)  of  that  Act),  or  a  qualified
    nongovernmental cancer  research  entity  as  defined  in
    guidelines of the National Institutes of Health or a peer
    reviewed and approved cancer research program, as defined
    by  the  U.S.  Secretary  of  Health  and Human Services,
    conducted for the primary purpose of determining  whether
    or  not  a cancer treatment is safe or efficacious or has
    any other characteristic of a cancer treatment that  must
    be  demonstrated  in order for the cancer treatment to be
    medically necessary or appropriate;
         (4)  the trial is being conducted at multiple  sites
    throughout the State;
         (5)  the  patient's  primary care physician, if any,
    is involved in the coordination of care; and
         (6)  the results of the investigational  trial  will
    be  submitted for publication in peer-reviewed scientific
    studies, research, or literature published in or accepted
    for publication by medical journals that meet  nationally
    recognized  requirements  for  scientific manuscripts and
    that submit most of their published articles  for  review
    by  experts  who  are  not  part  of the editorial staff.
    These studies may include those conducted by or under the
    auspices of the federal government's  Agency  for  Health
    Care  Policy and Research, National Institutes of Health,
    National Cancer Institute, National Academy of  Sciences,
    Health  Care  Financing  Administration, and any national
    board recognized by the National Institutes of Health for
    the purpose of evaluating the  medical  value  of  health
    services.
    (d)  This Section is repealed on January 1, 2003.

    Section  15.  The  Health Maintenance Organization Act is
amended by changing Section 5-3 as follows:
    (215 ILCS 125/5-3) (from Ch. 111 1/2, par. 1411.2)
    Sec. 5-3.  Insurance Code provisions.
    (a)  Health Maintenance Organizations shall be subject to
the provisions of Sections 133, 134, 137, 140, 141.1,  141.2,
141.3,  143,  143c, 147, 148, 149, 151, 152, 153, 154, 154.5,
154.6, 154.7, 154.8, 155.04, 355.2, 356m, 356v,  356w,  356x,
356y, 367i, 401, 401.1, 402, 403, 403A, 408, 408.2, 409, 412,
444,  and  444.1,  paragraph (c) of subsection (2) of Section
367, and Articles VIII 1/2, XII, XII  1/2,  XIII,  XIII  1/2,
XXV, and XXVI of the Illinois Insurance Code.
    (b)  For  purposes of the Illinois Insurance Code, except
for Sections 444 and 444.1 and Articles XIII  and  XIII  1/2,
Health  Maintenance Organizations in the following categories
are deemed to be "domestic companies":
         (1)  a  corporation  authorized  under  the   Dental
    Service  Plan  Act or the Voluntary Health Services Plans
    Act;
         (2)  a corporation organized under the laws of  this
    State; or
         (3)  a  corporation  organized  under  the  laws  of
    another  state, 30% or more of the enrollees of which are
    residents of this State, except a corporation subject  to
    substantially  the  same  requirements  in  its  state of
    organization as is a  "domestic  company"  under  Article
    VIII 1/2 of the Illinois Insurance Code.
    (c)  In  considering  the merger, consolidation, or other
acquisition of control of a Health  Maintenance  Organization
pursuant to Article VIII 1/2 of the Illinois Insurance Code,
         (1)  the  Director  shall give primary consideration
    to the continuation of  benefits  to  enrollees  and  the
    financial  conditions  of the acquired Health Maintenance
    Organization after the merger,  consolidation,  or  other
    acquisition of control takes effect;
         (2)(i)  the  criteria specified in subsection (1)(b)
    of Section 131.8 of the Illinois Insurance Code shall not
    apply and (ii) the Director, in making his  determination
    with  respect  to  the  merger,  consolidation,  or other
    acquisition of control, need not take  into  account  the
    effect  on  competition  of the merger, consolidation, or
    other acquisition of control;
         (3)  the Director shall have the  power  to  require
    the following information:
              (A)  certification by an independent actuary of
         the   adequacy   of   the  reserves  of  the  Health
         Maintenance Organization sought to be acquired;
              (B)  pro forma financial statements  reflecting
         the combined balance sheets of the acquiring company
         and the Health Maintenance Organization sought to be
         acquired  as of the end of the preceding year and as
         of a date 90 days prior to the acquisition, as  well
         as   pro   forma   financial  statements  reflecting
         projected combined  operation  for  a  period  of  2
         years;
              (C)  a  pro  forma  business  plan detailing an
         acquiring  party's  plans  with   respect   to   the
         operation  of  the  Health  Maintenance Organization
         sought to be acquired for a period of not less  than
         3 years; and
              (D)  such  other  information  as  the Director
         shall require.
    (d)  The provisions of Article VIII 1/2 of  the  Illinois
Insurance  Code  and this Section 5-3 shall apply to the sale
by any health maintenance organization of greater than 10% of
its enrollee population  (including  without  limitation  the
health  maintenance organization's right, title, and interest
in and to its health care certificates).
    (e)  In considering any management  contract  or  service
agreement  subject to Section 141.1 of the Illinois Insurance
Code, the Director (i) shall, in  addition  to  the  criteria
specified  in  Section  141.2 of the Illinois Insurance Code,
take into account the effect of the  management  contract  or
service   agreement   on  the  continuation  of  benefits  to
enrollees  and  the  financial  condition   of   the   health
maintenance  organization to be managed or serviced, and (ii)
need not take into  account  the  effect  of  the  management
contract or service agreement on competition.
    (f)  Except  for  small employer groups as defined in the
Small Employer Rating, Renewability  and  Portability  Health
Insurance  Act and except for medicare supplement policies as
defined in Section 363 of  the  Illinois  Insurance  Code,  a
Health  Maintenance Organization may by contract agree with a
group or other enrollment unit to effect  refunds  or  charge
additional premiums under the following terms and conditions:
         (i)  the  amount  of, and other terms and conditions
    with respect to, the refund or additional premium are set
    forth in the group or enrollment unit contract agreed  in
    advance of the period for which a refund is to be paid or
    additional  premium  is to be charged (which period shall
    not be less than one year); and
         (ii)  the amount of the refund or additional premium
    shall  not  exceed  20%   of   the   Health   Maintenance
    Organization's profitable or unprofitable experience with
    respect  to  the  group  or other enrollment unit for the
    period (and, for  purposes  of  a  refund  or  additional
    premium,  the profitable or unprofitable experience shall
    be calculated taking into account a pro rata share of the
    Health  Maintenance  Organization's  administrative   and
    marketing  expenses,  but shall not include any refund to
    be made or additional premium to be paid pursuant to this
    subsection (f)).  The Health Maintenance Organization and
    the  group  or  enrollment  unit  may  agree   that   the
    profitable  or  unprofitable experience may be calculated
    taking into account the refund period and the immediately
    preceding 2 plan years.
    The  Health  Maintenance  Organization  shall  include  a
statement in the evidence of coverage issued to each enrollee
describing the possibility of a refund or additional premium,
and upon request of any group or enrollment unit, provide  to
the group or enrollment unit a description of the method used
to   calculate  (1)  the  Health  Maintenance  Organization's
profitable experience with respect to the group or enrollment
unit and the resulting refund to the group or enrollment unit
or (2) the  Health  Maintenance  Organization's  unprofitable
experience  with  respect to the group or enrollment unit and
the resulting additional premium to be paid by the  group  or
enrollment unit.
    In   no  event  shall  the  Illinois  Health  Maintenance
Organization  Guaranty  Association  be  liable  to  pay  any
contractual obligation of an insolvent  organization  to  pay
any refund authorized under this Section.
(Source: P.A.   89-90,  eff.  6-30-95;  90-25,  eff.  1-1-98;
90-177, eff.  7-23-97;  90-372,  eff.  7-1-98;  90-583,  eff.
5-29-98;  90-655,  eff. 7-30-98; 90-741, eff. 1-1-99; revised
9-8-98.)

    Section 20.  The Voluntary Health Services Plans  Act  is
amended by changing Section 10 as follows:

    (215 ILCS 165/10) (from Ch. 32, par. 604)
    Sec.   10.  Application  of  Insurance  Code  provisions.
Health services plan corporations and all persons  interested
therein   or  dealing  therewith  shall  be  subject  to  the
provisions of Article XII 1/2 and  Sections  3.1,  133,  140,
143,  143c,  149,  354,  355.2, 356r, 356t, 356u, 356v, 356w,
356x, 356y, 367.2, 401, 401.1, 402, 403,  403A,  408,  408.2,
and  412,  and  paragraphs (7) and (15) of Section 367 of the
Illinois Insurance Code.
(Source: P.A.  89-514,  eff.  7-17-96;  90-7,  eff.  6-10-97;
90-25,  eff.  1-1-98;  90-655,  eff.  7-30-98;  90-741,  eff.
1-1-99.)

    Section 99.  Effective date.  This Act  takes  effect  on
January 1, 2000.

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