[Ip-health] Sec. 300gg-8 - Coverage for individuals participating in approved clinical trials
james.love at keionline.org
Sat May 25 01:40:10 PDT 2019
One of the lesser known subsidies for clinical trials are the requirements,
that vary by country, for insurance to cover certain costs of clinical
trials. In the USA, the law is Sec. 42 U.S.C. §300gg–8. Coverage for
individuals participating in approved clinical trials.
The FDA says that the "safety and effectiveness of Zolgensma is based on an
ongoing clinical trial and a completed clinical trial involving a total of
36 pediatric patients with infantile-onset SMA between the ages of
approximately 2 weeks and 8 months at study entry. The primary evidence of
effectiveness is based on results from the 21 patients treated with
Zolgensma in the ongoing clinical trial."
I don't think we know how much the 36 patient trial costs (of which only 21
were given the gene therapy) or how much of subsidy came from the Orphan
Drug Tax Credit, or the ACA requirement for insurance to cover some costs.
United States Code, 2010 Edition
Title 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A - PUBLIC HEALTH SERVICE
SUBCHAPTER XXV - REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
Part A - Individual and Group Market Reforms
subpart 1 - general reform
Sec. 300gg-8 - Coverage for individuals participating in approved clinical
§300gg–8. Coverage for individuals participating in approved clinical trials
(1) In general
If a group health plan or a health insurance issuer offering group or
individual health insurance coverage provides coverage to a qualified
individual, then such plan or issuer—
(A) may not deny the individual participation in the clinical trial
referred to in subsection (b)(2);
(B) subject to subsection (c), may not deny (or limit or impose additional
conditions on) the coverage of routine patient costs for items and services
furnished in connection with participation in the trial; and
(C) may not discriminate against the individual on the basis of the
individual's participation in such trial.
(2) Routine patient costs
For purposes of paragraph (1)(B), subject to subparagraph (B), routine
patient costs include all items and services consistent with the coverage
provided in the plan (or coverage) that is typically covered for a
qualified individual who is not enrolled in a clinical trial.
For purposes of paragraph (1)(B), routine patient costs does not include—
(i) the investigational item, device, or service, itself;
(ii) items and services that are provided solely to satisfy data collection
and analysis needs and that are not used in the direct clinical management
of the patient; or
(iii) a service that is clearly inconsistent with widely accepted and
established standards of care for a particular diagnosis.
(3) Use of in-network providers
If one or more participating providers is participating in a clinical
trial, nothing in paragraph (1) shall be construed as preventing a plan or
issuer from requiring that a qualified individual participate in the trial
through such a participating provider if the provider will accept the
individual as a participant in the trial.
(4) Use of out-of-network
Notwithstanding paragraph (3), paragraph (1) shall apply to a qualified
individual participating in an approved clinical trial that is conducted
outside the State in which the qualified individual resides.
(b) Qualified individual defined
For purposes of subsection (a), the term “qualified individual” means an
individual who is a participant or beneficiary in a health plan or with
coverage described in subsection (a)(1) and who meets the following
(1) The individual is eligible to participate in an approved clinical trial
according to the trial protocol with respect to treatment of cancer or
other life-threatening disease or condition.
(A) the referring health care professional is a participating health care
provider and has concluded that the individual's participation in such
trial would be appropriate based upon the individual meeting the conditions
described in paragraph (1); or
(B) the participant or beneficiary provides medical and scientific
information establishing that the individual's participation in such trial
would be appropriate based upon the individual meeting the conditions
described in paragraph (1).
(c) Limitations on coverage
This section shall not be construed to require a group health plan, or a
health insurance issuer offering group or individual health insurance
coverage, to provide benefits for routine patient care services provided
outside of the plan's (or coverage's) health care provider network unless
out-of-network benefits are otherwise provided under the plan (or coverage).
(d) Approved clinical trial defined
(1) In general
In this section, the term “approved clinical trial” means a phase I, phase
II, phase III, or phase IV clinical trial that is conducted in relation to
the prevention, detection, or treatment of cancer or other life-threatening
disease or condition and is described in any of the following subparagraphs:
(A) Federally funded trials.—The study or investigation is approved or
funded (which may include funding through in-kind contributions) by one or
more of the following:
(i) The National Institutes of Health.
(ii) The Centers for Disease Control and Prevention.
(iii) The Agency for Health Care Research and Quality.
(iv) The Centers for Medicare & Medicaid Services.
(v) cooperative 1 group or center of any of the entities described in
clauses (i) through (iv) or the Department of Defense or the Department of
(vi) A qualified non-governmental research entity identified in the
guidelines issued by the National Institutes of Health for center support
(vii) Any of the following if the conditions described in paragraph (2) are
(I) The Department of Veterans Affairs.
(II) The Department of Defense.
(III) The Department of Energy.
(B) The study or investigation is conducted under an investigational new
drug application reviewed by the Food and Drug Administration.
(C) The study or investigation is a drug trial that is exempt from having
such an investigational new drug application.
(2) Conditions for departments
The conditions described in this paragraph, for a study or investigation
conducted by a Department, are that the study or investigation has been
reviewed and approved through a system of peer review that the Secretary
(A) to be comparable to the system of peer review of studies and
investigations used by the National Institutes of Health, and
(B) assures unbiased review of the highest scientific standards by
qualified individuals who have no interest in the outcome of the review.
(e) Life-threatening condition defined
In this section, the term “life-threatening condition” means any disease or
condition from which the likelihood of death is probable unless the course
of the disease or condition is interrupted.
Nothing in this section shall be construed to limit a plan's or issuer's
coverage with respect to clinical trials.
(g) Application to FEHBP
Notwithstanding any provision of chapter 89 of title 5, this section shall
apply to health plans offered under the program under such chapter.
Notwithstanding any other provision of this chapter, nothing in this
section shall preempt State laws that require a clinical trials policy for
State regulated health insurance plans that is in addition to the policy
required under this section.
(July 1, 1944, ch. 373, title XXVII, §2709, as added Pub. L. 111–148, title
X, §10103(c), Mar. 23, 2010, 124 Stat. 892.)
Another section 2709 of act July 1, 1944, is classified to section 300gg–9
of this title.
A prior section 2709 of act July 1, 1944, was successively renumbered by
subsequent acts and transferred, see section 238h of this title.
1 So in original. Probably should be preceded by “A”.
James Love. Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
More information about the Ip-health