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.
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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
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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
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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;
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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
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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,
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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.