Okla. Admin. Code § 317:30-3-57.1 - Coverage of routine services in relation to clinical trials
(a)
Coverage. The Oklahoma Health Care Authority (OHCA) will cover
routine patient costs provided under a qualifying clinical trial to an eligible
member. The OHCA does not:
(1) Determine
eligibility for participation in any research study; or
(2) Reimburse for any costs associated in the
research study, other than for routine patient costs for clinical studies, as
defined in this Section and in the Oklahoma Medicaid State
Plan.
(b)
Qualifying clinical trials criteria.
(1) Clinical trial, as adopted from the
National Institute of Health (NIH) definition, means a research study in which
one (1) or more human subjects are prospectively assigned to one (1) or more
interventions, which may include placebo or other control, to evaluate the
effects of those interventions on health-related biomedical or behavioral
outcomes.
(2) Pursuant to Section
1905(a)(30) and 1905(gg) of the Act, as amended and added by Division CC, Title
II, Section 210 of the Consolidated Appropriations Act, 2021 (Public Law
116-260 ,
Section
210 ), qualifying clinical trial means a
clinical trial, in any clinical phase of development, that is conducted in
relation to the prevention, detection, or treatment of any serious or
life-threatening disease or condition and is described in any of the following
clauses:
(A) The clinical trial is approved,
conducted, or supported (which may include funding through in- kind
contributions) by one (1) or more of the following:
(i) The National Institutes of Health
(NIH);
(ii) The Centers for Disease
Control and Prevention (CDC);
(iii)
The Agency for Healthcare Research and Quality (AHRC);
(iv) The Centers for Medicare and Medicaid
Services (CMS);
(v) A cooperative
group or center of any of the entities described above or of the Department of
Defense or the Department of Veteran Affairs;
(vi) A qualified non-governmental research
entity identified in guidelines issued by the National Institutes of Health for
center support grants, including guidelines issued after the date of these
rules; or
(vii) Any of the
following if the clinical trial has been reviewed and approved through a system
of peer review that the Secretary determines to be comparable to the system of
peer review of studies and investigations used by the National Institutes of
Health and assures unbiased review of the highest scientific standards by
qualified individuals with no interest in the outcome of the review:
(I) The Department of Veterans
Affairs;
(II) The Department of
Defense; or
(III) The Department of
Energy.
(B) The
clinical trial is conducted pursuant to an investigational new drug exemption
under section 505(i) of the Federal Food, Drug, and Cosmetic Act or an
exemption for a biological product undergoing investigation under section
351(a)(3) of the Public Health Service Act.
(C) The clinical trial is a drug trial that
is exempt from being required to have an investigational new drug exemption or
an exemption for a biological product undergoing
investigation.
(3)
Serious disease or condition, as adopted from
21 C.F.R. §
312.300, means a disease or condition
associated with morbidity that has substantial impact on day-to-day
functioning. Short-lived and self-limiting morbidity will usually not be
sufficient, but the morbidity need not be irreversible, provided it is
persistent or recurrent. Whether a disease or condition is serious is a matter
of clinical judgment, based on its impact on such factors as survival,
day-to-day functioning, or the likelihood that the disease, if left untreated,
will progress from a less severe condition to a more serious one.
(4) Life-threatening disease or condition, as
adopted from 21 C.F.R.
§
312.300, means a stage of disease in
which there is reasonable likelihood that death will occur within a matter of
months or in which premature death is likely without early
treatment.
(c)
Clinical trials determination standards. Pursuant to Section
1905(a)(30) and 1905(gg) of the Act, as amended and added by Division CC, Title
II, Section 210 of the Consolidated Appropriations Act, 2021 (Public Law
116-260 ,
Section
210 , the OHCA will expedite and complete a
coverage determination for routine services under this Section within
seventy-two (72) hours of receiving the required attestation as described
below. The OHCA will maintain the following standards in any coverage
determination under this section:
(1)
Attestation. The health care provider and principal investigator
for the qualifying clinical trial must submit a standardized form attestation
to the OHCA regarding the appropriateness of the qualifying clinical trial for
the individual member.
(2)
Expedited determination. Upon receiving the completed required
attestation, the OHCA will expedite and complete a coverage determination under
this Section within seventy-two (72) hours. All documentation submitted to
request services must demonstrate, through adequate objective medical records,
evidence sufficient to meet at least one (1) definition in subsection
(b)(3)-(4) above for the terms "serious disease or condition" or
"life-threatening disease or condition".
(3)
Geographic and network
allowance. The OHCA will determine coverage under this Section without
limitation on the geographic location or network affiliation of the health care
provider treating the individual member or the principal investigator of the
qualifying clinical trial.
(4)
Protocols and proprietary documentation. The OHCA will determine
coverage under this Section without requiring the submission of the protocols
of the qualifying clinical trial or any other documentation that may be
proprietary or determined by the Secretary to be burden some to
provide.
(5)
Documentation of
serious or life-threatening disease or condition. In determining
coverage under this Section, the OHCA will consider existing or newly offered
documentation that the individual member has been diagnosed with or is
suffering from one (1) or more serious or life-threatening diseases or
conditions that are the subject of the qualifying clinical trial as shown in
the attestation.
(d)
Routine patient costs.
(1)
Included items and services. Routine patient costs include any
item or service provided to Medicaid-eligible members under the qualifying
clinical trial, including:
(A) Any item or
service provided to prevent, diagnose, monitor, or treat complications
resulting from participation in the qualifying clinical trial, to the extent
that the provision of such items or services to the member would otherwise be
covered outside the course of participation in the qualifying clinical trial
under the Oklahoma Medicaid State Plan or waiver, including a demonstration
project under section 1115 of the Act; and
(B) Any item or service required solely for
the provision of the investigational item or services that is the subject of
the qualifying clinical trial, including the administration of the
investigational item or service.
(2)
Excluded items and services.
The following items and services are excluded from routine patient costs in
qualifying clinical trials:
(A) Any
investigational item or service that is:
(i)
The subject of the qualifying clinical trial; and
(ii) Not otherwise covered outside of the
clinical trial under the Oklahoma Medicaid State Plan or waiver, including a
demonstration project under section 1115 of the Act; and
(B) Any item or service that is:
(i) Provided to the member solely to satisfy
data collection and analysis for the qualifying clinical trial and is not used
in the direct clinical management of the member; and
(ii) Not otherwise covered under the Oklahoma
Medicaid State Plan or waiver, including a demonstration project under section
1115 of the Act.
Notes
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