093_SB0475sam001

 










                                     LRB093 05172 JLS 11926 a

 1                    AMENDMENT TO SENATE BILL 475

 2        AMENDMENT NO.     .  Amend Senate Bill 475 on page  3  by
 3    replacing lines 7 through 32 with the following:
 4        "Sec.  356z.4.  Clinical  trials;  routine  patient  care
 5    costs.
 6        (a)  This Section applies to:
 7             (1)  insurers  and  nonprofit  health  service plans
 8        that   provide   hospital,    medical,    surgical,    or
 9        pharmaceutical  benefits  to  individuals or groups on an
10        expense-incurred basis under a health insurance policy or
11        contract issued or delivered in this State;
12             (2)  health    maintenance    or    managed     care
13        organizations  that  provide hospital, medical, surgical,
14        or  pharmaceutical  benefits  to  individuals  or  groups
15        health insurance policy or contract issued  or  delivered
16        in this State; and
17             (3)  the  State  Medical Assistance Program, and its
18        contracted  insurers,  that  provide  hospital,  medical,
19        surgical,  or  pharmaceutical  benefits  to   individuals
20        enrolled in the Medical Assistance program.
21        (b)  This  Section  does  not apply to a policy, plan, or
22    contract paid for under Title  XVIII  or  Title  XIX  of  the
23    Social Security Act.
24        (c)  Coverage.
 
                            -2-      LRB093 05172 JLS 11926 a
 1             (1)  In  general.   If a group health plan or health
 2        insurance  issuer  that  is  providing  health  insurance
 3        coverage provides coverage to a qualified individual  (as
 4        defined in subsection (d), the plan or issuer:
 5                  (A)  may  not deny the individual participation
 6             in the clinical trial  referred  to  in  subdivision
 7             (d)(2);
 8                  (B)  subject to subsection (e) may not deny (or
 9             limit   or  impose  additional  conditions  on)  the
10             coverage of routine  patient  costs  for  items  and
11             services  furnished in connection with participation
12             in the trial; and
13                  (C)  may   not   discriminate    against    the
14             individual   on   the   basis   of   the  enrollee's
15             participation in such trial.
16             (2)  Coverage of routine patient  care  costs.   For
17        purposes  of  paragraph  (1),  subject  to paragraph (3),
18        routine patient costs  include  all  items  and  services
19        provided  in  either the experimental or the control arms
20        of a clinical trial that would be  otherwise  covered  if
21        not  provided  in the context of a clinical trial and are
22        generally available to the qualified individual.
23        Routine patient care costs include:
24                  (A)  Conventional care.  Items or services that
25             are typically provided absent a clinical trial;
26                  (B)  Administrative items.  Items  or  services
27             required   solely   for   the   provision   of   the
28             investigational   item   or  service  (such  as  the
29             administration  of  a  non-covered  chemotherapeutic
30             agent), the clinically appropriate monitoring of the
31             effects of the item or service, or the prevention of
32             complications; and
33                  (C)  Reasonable and necessary care.   Items  or
34             services  needed  for  reasonable and necessary care
 
                            -3-      LRB093 05172 JLS 11926 a
 1             arising from the  provision  of  an  investigational
 2             item   or   service,   including  the  diagnosis  or
 3             treatment of complications.
 4             (3)  Exclusion.  For the purposes of paragraph  (1),
 5        routine patient care costs do not include the cost of the
 6        tests or measurements conducted primarily for the purpose
 7        of the clinical trial involved.
 8             (4)  Use  of  in-network  providers.  If one or more
 9        participating providers is participating  in  a  clinical
10        trial,  nothing  in  paragraph  (1) shall be construed as
11        preventing a plan or issuer from  requiring  that,  if  a
12        qualified  individual  is  enrolling on the same clinical
13        trial, the qualified individual participate in the  trial
14        through  such  a  participating  provider if the provider
15        will accept the individual as a participant in that  same
16        trial.  If  the  patient  is  to enroll on a trial and no
17        acceptable in-network provider is participating or  if  a
18        participating  provider cannot accept new enrollees, then
19        the  patient  may  enroll   through   an   out-of-network
20        provider.
21        (d)  Qualified   individual  defined.   For  purposes  of
22    subsection (c), the  term  "qualified  individual"  means  an
23    individual  who  is  a  participant or beneficiary in a group
24    health plan, or who is an  enrollee  under  health  insurance
25    coverage, and who meets the following conditions:
26                  (1) (A)  the    individual   is   eligible   to
27             participate in an approved clinical  trial  protocol
28             as defined in subsection (f) of this Section;
29                  (B)  the  clinical  trial is undertaken for the
30             purposes of  the  prevention,  early  detection,  or
31             treatment  of  cancer  or  for  the  treatment  of a
32             serious or life threatening illness; and
33                  (C)  the treating facility and  personnel  have
34             the  expertise and training to provide the treatment
 
                            -4-      LRB093 05172 JLS 11926 a
 1             and  treat  a  sufficient  volume  of  patients   to
 2             maintain expertise; and
 3             (2)  either:
 4                  (A)  the referring physician is a participating
 5             health  care professional and has concluded that the
 6             individual's participation in such  trial  would  be
 7             appropriate  based  upon  the individual meeting the
 8             conditions described in paragraph (1); or
 9                  (B)  the participant, beneficiary, or  enrollee
10             provides    medical   and   scientific   information
11             establishing that the individual's participation  in
12             such  trial  would  be  appropriate  based  upon the
13             individual  meeting  the  conditions  described   in
14             paragraph (1).
15        (e)  Payment.
16             (1)  In  general.  Under this Section a group health
17        plan or health insurance issuer shall provide for payment
18        for routine patient costs described in subdivision (a)(2)
19        but is not  required  to  pay  for  costs  of  items  and
20        services that are customarily provided by the sponsors of
21        an approved clinical trial.
22             (2)  Payment rate.  In the case of covered items and
23        services provided by:
24                  (A)  a participating provider, the payment rate
25             shall be at the agreed upon rate; or
26                  (B)  a  nonparticipating  provider, the payment
27             rate shall be at the rate the  plan  would  normally
28             pay for comparable services under subparagraph (A).
29        (f)  Approved clinical trial defined.
30                  (1) (A)  In general.  In this Section, the term
31             "approved  clinical trial" means a trial approved or
32             funded (which may include  funding  through  in-kind
33             contributions) by one or more of the following:
34                       (i)  the National Institutes of Health;
 
                            -5-      LRB093 05172 JLS 11926 a
 1                       (ii)  the  Centers for Disease Control and
 2                  Prevention;
 3                       (iii)  the Agency for Health Care Research
 4                  and Quality;
 5                       (iv)  the   Centers   for   Medicare   and
 6                  Medicaid Services;
 7                       (v)  a cooperative group or center of  any
 8                  of   the  entities  described  in  clauses  (i)
 9                  through (iv)  or  the  Department  of  Defense,
10                  Veterans   Affairs,   or  Energy,  including  a
11                  qualified nongovernmental  research  entity  to
12                  which  the  National Cancer Institute (NCI) has
13                  issued a center support grant. In the  case  of
14                  the   NIH,  cooperative  groups  must  have  an
15                  established NIH-approved  Peer  Review  Program
16                  operating  within  the group. This includes the
17                  NCI Clinical Trials Cooperative  Group  Program
18                  and   the   NCI   Community  Clinical  Oncology
19                  Program; or
20                       (vi)  Any  of   the   following   if   the
21                  conditions described in paragraph (2) are met:
22                            (I)  the Department of Defense (DoD);
23                            (II)  the   Department   of  Veterans
24                       Affairs (VA);
25                            (III)  the   Department   of   Energy
26                       (DoE); or
27                  (B)  conducted by a  qualified  nongovernmental
28             research  entity where the study or investigation is
29             approved by an institutional review board (IRB) that
30             is registered with  the  Department  of  Health  and
31             Human Services and is associated with an institution
32             that  has  a  federal-wide assurance approved by the
33             Department of Health and Human  Services  specifying
34             compliance with 45 CFR 46; or
 
                            -6-      LRB093 05172 JLS 11926 a
 1                  (C)  a  study  or investigation conducted under
 2             an investigational new drug application reviewed  by
 3             the Food and Drug Administration (FDA); or
 4                  (D)  a  study  or  investigation that is exempt
 5             from  having  such  an  investigational   new   drug
 6             application.
 7             (2)  Conditions  for  departments.   The  conditions
 8        described in this paragraph, for a study or investigation
 9        conducted   by  a  Department,  are  that  the  study  or
10        investigation has been reviewed and  approved  through  a
11        system  of  peer  review  that  the appropriate Secretary
12        determines:
13                  (A)  to be comparable to  the  system  of  peer
14             review  of  studies  and  investigations used by the
15             National Institutes of Health; and
16                  (B)  assures unbiased  review  of  the  highest
17             ethical  standards  by an institutional review board
18             (IRB) or other body that meets  the  standards  laid
19             out by 45 CFR 46 or 21 CFR 50 and 21 CFR 56.
20        (g)  Coverage  for  approved  and  non-approved drugs and
21    devices.  Coverage by this Section shall include coverage for
22    patient cost incurred for drugs and devices  that  have  been
23    approved by the Food and Drug Administration (FDA) whether or
24    not  the  FDA  has  approved  the  drug  or device for use in
25    treating the patient's particular condition,  to  the  extent
26    that   the   drugs  or  devices  are  not  paid  for  by  the
27    manufacturer,  distributor,  or  provider  of  that  drug  or
28    device.  This  shall  include  coverage  for  reasonable  and
29    medically necessary services needed to administer the drug or
30    device under evaluation in the clinical trial.
31        (h)  Construction.  Nothing  in  this  Section  shall  be
32    construed to limit a plan's or issuer's coverage with respect
33    to clinical trials.
34        (i)  An    entity   seeking   coverage   for   treatment,
 
                            -7-      LRB093 05172 JLS 11926 a
 1    prevention, or early detection in a clinical  trial  approved
 2    by  an institutional review board under subdivision (f)(1)(B)
 3    of this Section shall maintain and post electronically a list
 4    of  the  clinical  trials   meeting   the   requirements   of
 5    subsections  (b)  and  (c)  of  this Section. This list shall
 6    include: the phase for which the clinical trial is  approved;
 7    the  entity approving the trial; whether the trial is for the
 8    treatment of cancer or  other  serious  or  life  threatening
 9    disease,  and  if not cancer, the particular disease; and the
10    number of  participants  in  the  trial.  If  the  electronic
11    posting  is  not practical, the entity seeking coverage shall
12    periodically provide payers and providers in the state with a
13    written list of trials providing the information required  in
14    this Section.
15        (j)  On  or  before  June  1  of each year, each insurer,
16    nonprofit health service plan, health maintenance and managed
17    care organization subject to the requirements of this Section
18    shall  submit  to  the  Director,  in  a  form  the  Director
19    requires, a report on its coverage of clinical trials  during
20    the  previous  year.  The  Director  shall  compile an annual
21    summary report based on the information provided  under  this
22    subsection and provide copies to the Speaker of the House and
23    President  of  the  Senate. The Director shall make copies of
24    the report available to members of the  general  public  upon
25    request and at a reasonable charge for copying and postage.";
26    and

27    by deleting all of page 4; and

28    on page 5 by deleting lines 1 through 27.