State of Illinois
92nd General Assembly

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HB0050 Engrossed                               LRB9200810DJgc

 1        AN ACT concerning tobacco settlement proceeds.

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

 4        Section  1.  Short  title.  This  Act may be cited as the
 5    Tobacco  Settlement  Proceeds  for  Investigational  Clinical
 6    Cancer Trials Act.

 7        Section 5. Use of tobacco settlement proceeds. Because  a
 8    cure  for  cancer  has  not been discovered, up to 10% of the
 9    amounts  received  by  the  State  pursuant  to   a   tobacco
10    settlement  agreement  shall  be  dedicated  to assist in the
11    payment   for   services   provided   under    a    qualified
12    investigational clinical cancer trial program in Illinois.

13        Section 10. Definitions. In this Act:
14        "External  independent  review process" means the appeals
15    and  external  independent  review  process  as  provided  in
16    Section 45 of the Managed Care Reform and Patient Rights Act.
17        "Physician" means a board certified oncologist.
18        "Program" means the  qualified  investigational  clinical
19    cancer trial program established under Section 15.
20        "Qualified investigational clinical cancer trial" means a
21    treatment  (i)  the  effectiveness  of  which  has  not  been
22    determined  and  (ii) that is under clinical investigation as
23    part of an approved National Institutes of Health or National
24    Cancer Institute sponsored Phase III  or  Phase  IV  research
25    trial.
26        "Research costs" means costs that are (i) associated with
27    conducting  the  qualified  investigational  clinical  cancer
28    trial,  including  but  not  limited  to  data collection and
29    management, physician and nurse research  time,  analysis  of
30    results, and tests performed purely for research purposes and
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 1    (ii) usually covered by the sponsoring organization.
 2        "Routine  patient  care  costs"  means  costs  for  those
 3    medical  services and supplies rendered pursuant to physician
 4    orders  which  are  necessary  to   conduct   the   qualified
 5    investigational  clinical trial. "Routine patient care costs"
 6    do not include the following:
 7             (1)  The costs of items or  services  normally  paid
 8        for by other funding sources, such as the investigational
 9        drugs,   pharmaceuticals,   or  devices  themselves,  any
10        nonhealth services that might be required for  a  patient
11        to  receive the cancer treatment, and the managing of the
12        research trial.
13             (2)  Costs associated  with  the  provision  of  any
14        goods, services, or benefits that generally are furnished
15        without charge in connection with such an investigational
16        clinical  cancer  trial  program  for treatment of cancer
17        costs.
18             (3)  Costs related to any service, supply, or device
19        that has been ordered solely for the convenience  of  the
20        patient.
21        "Standard  of  care" means that level of care a physician
22    would provide under like or similar circumstances.
23        "Tobacco   settlement   agreement"   means   the   Master
24    Settlement Agreement in the case of People of  the  State  of
25    Illinois  v.  Philip  Morris  et  al.  (Circuit Court of Cook
26    County,  No.  96-L13146).   The  term   also   includes   any
27    settlement   with  or  judgment  against  a  tobacco  product
28    manufacturer not  participating  in  that  Master  Settlement
29    Agreement,  if  the settlement or judgment is in satisfaction
30    of a released claim as that term is  defined  in  the  Master
31    Settlement Agreement.

32        Section   15.   Investigational   clinical  cancer  trial
33    program. The Department of Public Health shall establish  and
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 1    administer a program to pay for patient care costs associated
 2    with  participation  in  a  qualified  investigational cancer
 3    trial when those costs  are  not  otherwise  reimbursed.  The
 4    Department  of  Public  Health  shall  establish  eligibility
 5    standards and an application process by rule.

 6        Section  20.  Participation  in program. Participation in
 7    the  program  shall  be  limited  to  persons  who  meet  the
 8    following criteria:
 9             (1)  The person is a cancer patient  who,  according
10        to  the current diagnosis of the patient's physician, has
11        a high probability of death within 2 years.
12             (2)  The  patient's  physician  certifies  that  the
13        patient has the condition described in paragraph (1)  and
14        all of the following situations are applicable:
15                  (A)  Standard therapies have not been effective
16             in improving the patient's condition.
17                  (B)  Standard   therapies   are  not  medically
18             appropriate for the patient.
19                  (C)  In the case of an insured  patient,  there
20             is no standard therapy covered by the health insurer
21             that is more beneficial than the therapy.
22             (3)  The patient's physician has recommended a drug,
23        device,   procedure,   or   other  therapy  that  in  the
24        physician's opinion  would  be  more  beneficial  to  the
25        patient.  These  recommendations  must  be  based  on the
26        physician's written certification based on the  generally
27        accepted standard of care.
28             (4)  The  patient has been denied coverage by his or
29        her health insurance plan for a drug, device,  procedure,
30        or  other  therapy  recommended  or requested pursuant to
31        paragraph (3) based on a finding by the health  insurance
32        plan    that    the   treatment   was   experimental   or
33        investigational.
HB0050 Engrossed            -4-                LRB9200810DJgc
 1             (5)  The patient has  participated  in  an  external
 2        independent review process that has resulted in a finding
 3        in  favor  of  recommending  the patient into a qualified
 4        clinical trial.
 5             (6)  The patient is an  Illinois  resident  who  has
 6        resided in Illinois for at least 12 months.

 7        Section 17. Payments under the program.
 8        (a)  Payment  shall  be  made  under the program to or on
 9    behalf of a program  eligible  patient  only  for  costs  not
10    reimbursed  or  eligible for reimbursement by any other third
11    party or governmental entity (including, without  limitation,
12    private  or  group  insurance,  Medicaid,  Medicare,  and the
13    Veterans Administration). The Director of Public Health  may,
14    however,  waive  this  requirement in individually considered
15    cases if the Director determines that  its  enforcement  will
16    deny  services  to  a  class  of  cancer  patients because of
17    conflicting State or federal laws or regulations.
18        (b)  The  Director  of  Public  Health  may  restrict  or
19    categorize reimbursements to meet budgetary limitations.

20        Section 25. List of trials. The Director of Public Health
21    shall maintain a list  of  qualified  investigational  cancer
22    trials.  The  Director  of  Public  Health shall establish an
23    internal  review  procedure  for  updating  the  list.    The
24    procedure  shall allow the addition and deletion of qualified
25    investigational clinical  cancer  trials  to  the  list.  The
26    internal  review  procedure  shall  take  place at least once
27    during each fiscal year.

28        Section 30. Effect of Act.
29        (a)  Nothing in this Act shall be construed  to  prohibit
30    any   health   insurance  plan  from  applying  cost  sharing
31    arrangements, limitations, or exclusions.
HB0050 Engrossed            -5-                LRB9200810DJgc
 1        (b)  This Act does not relieve the sponsor of a qualified
 2    investigational clinical cancer trial  program  of  financial
 3    responsibility for the accepted costs of the program, such as
 4    research costs.
 5        (c)  This Act does not relieve a health insurance plan of
 6    financial  responsibility  for routine patient care costs for
 7    the treatment of cancer if the health insurance plan provides
 8    coverage for cancer.

 9        Section 99. Effective date. This Act  takes  effect  upon
10    becoming a law.

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