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Coverage Issues Manual
Clinical Trials
Table of Contents
- 30 CLINICAL TRIALS
- 30-1 ROUTINE COSTS IN CLINICAL TRIALS
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09-00 |
CLINICAL TRIALS |
30-1 |
30-1 ROUTINE COSTS IN CLINICAL
TRIALS
Effective for items and services furnished on or after
September 19, 2000, Medicare covers the routine costs of qualifying clinical trials,
as such costs are defined below, as well as reasonable and necessary items and
services used to diagnose and treat complications arising from participation in all
clinical trials. All other Medicare rules apply.
Routine costs of a clinical trial include all items and
services that are otherwise generally available to Medicare beneficiaries (i.e.,
there exists a benefit category, it is not statutorily excluded, and there is not a
national noncoverage decision) that are provided in either the experimental or the
control arms of a clinical trial except:
- The investigational item or service, itself;
- Items and services provided solely to satisfy data
collection and analysis needs and that are not used in the direct clinical
management of the patient (e.g., monthly CT scans for a condition usually requiring
only a single scan); and
- Items and services customarily provided by the research
sponsors free of charge for any enrollee in the trial.
Routine costs in clinical trials include:
- Items or services that are typically provided absent a
clinical trial (e.g., conventional care);
- Items or services required solely for the provision of
the investigational item or service (e.g., administration of a noncovered
chemotherapeutic agent), the clinically appropriate monitoring of the effects of
the item or service, or the prevention of complications; and
- Items or services needed for reasonable and necessary
care arising from the provision of an investigational item or service--in
particular, for the diagnosis or treatment of complications.
This policy does not withdraw Medicare coverage for items
and services that may be covered according to local medical review policies or the
regulations on category B investigational device exemptions (IDE) found in 42
CFR 405.201-405.215, 411.15, and 411.406. For information about LMRPs, refer to
www.lmrp.net, a searchable database of Medicare contractors' local
policies.
Rev. 126
30-1 (Cont.) |
CLINICAL TRIALS |
09-00 |
For noncovered items and services, including items and
services for which Medicare payment is statutorily prohibited, Medicare only covers
the treatment of complications arising from the delivery of the noncovered item or
service and unrelated reasonable and necessary care. (Refer to MCM §§2300.1
and MIM 3101.) However, if the item or service is not covered by virtue of a national
noncoverage policy in the Coverage Issues Manual and is the focus of a qualifying
clinical trial, the routine costs of the clinical trial (as defined above) will be
covered by Medicare but the noncovered item or service, itself, will not.
- Requirements for Medicare Coverage of Routine
Costs.--Any clinical trial receiving Medicare coverage of routine costs must
meet the following three requirements:
- The subject or purpose of the trial must be the
evaluation of an item or service that falls within a Medicare benefit category
(e.g., physicians' service, durable medical equipment, diagnostic test) and
is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing
aids).
- The trial must not be designed exclusively to test
toxicity or disease pathophysiology. It must have therapeutic
intent.
- Trials of therapeutic interventions must enroll
patients with diagnosed disease rather than healthy volunteers. Trials of
diagnostic interventions may enroll healthy patients in order to have a proper
control group.
The three requirements above are insufficient by themselves
to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials
also should have the following desirable characteristics; however, some trials, as
described below, are presumed to meet these characteristics and are automatically
qualified to receive Medicare coverage:
- The principal purpose of the trial is to test whether the
intervention potentially improves the participants' health
outcomes;
- The trial is well-supported by available scientific and
medical information or it is intended to clarify or establish the health outcomes
of interventions already in common clinical use;
- The trial does not unjustifiably duplicate existing
studies;
- The trial design is appropriate to answer the research
question being asked in the trial;
- The trial is sponsored by a credible organization or
individual capable of executing the proposed trial successfully;
- The trial is in compliance with Federal regulations
relating to the protection of human subjects; and
- All aspects of the trial are conducted according to the
appropriate standards of scientific integrity.
Rev. 126
09-00 |
CLINICAL TRIALS |
30-1 (Cont.) |
- Qualification Process for Clinical Trials.--Using
the authority found in §1142 of the Act (cross-referenced in
§1862(a)(1)(E) of the Act), the Agency for Healthcare Research and Quality
(AHRQ) will convene a multi-agency Federal panel (the "panel") composed
of representatives of the Department of Health and Human Services research agencies
(National Institutes of Health (NIH), Centers for Disease Control and Prevention
(CDC), the Food and Drug Administration (FDA), AHRQ, and the Office of Human
Research Protection), and the research arms of the Department of Defense (DOD) and
the Department of Veterans Affairs (VA) to develop qualifying criteria that will
indicate a strong probability that a trial exhibits the desirable characteristics
listed above. These criteria will be easily verifiable, and where possible,
dichotomous. Trials that meet these qualifying criteria will receive Medicare
coverage of their associated routine costs. This panel is not reviewing or
approving individual trials. The multi-agency panel will meet periodically to
review and evaluate the program and recommend any necessary refinements to
HCFA.
Clinical trials that meet the qualifying criteria will
receive Medicare coverage of routine costs after the trial's lead principal
investigator certifies that the trial meets the criteria. This process will require
the principal investigator to enroll the trial in a Medicare clinical trials
registry, currently under development.
Some clinical trials are automatically qualified to receive
Medicare coverage of their routine costs because they have been deemed by AHRQ, in
consultation with the other agencies represented on the multi-agency panel to be
highly likely to have the above-listed seven desirable characteristics of clinical
trials. The principal investigators of these automatically qualified trials do not
need to certify that the trials meet the qualifying criteria, but must enroll the
trials in the Medicare clinical trials registry for administrative purposes, once the
registry is established.
Effective September 19, 2000, clinical trials that are
deemed to be automatically qualified are:
- Trials funded by NIH, CDC, AHRQ, HCFA, DOD, and
VA;
- Trials supported by centers or cooperative groups that
are funded by the NIH, CDC, AHRQ, HCFA, DOD and VA;
- Trials conducted under an investigational new drug
application (IND) reviewed by the FDA; and
- Drug trials that are exempt from having an IND under 21
CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying
criteria are developed and the certification process is in place. At that time the
principal investigators of these trials must certify that the trials meet the
qualifying criteria in order to maintain Medicare coverage of routine costs. This
certification process will only affect the future status of the trial and will not
be used to retroactively change the earlier deemed status.
Medicare will cover the routine costs of qualifying trials
that either have been deemed to be automatically qualified or have certified that
they meet the qualifying criteria unless HCFA's Chief Clinical Officer
subsequently finds that a clinical trial does not meet the qualifying criteria or
jeopardizes the safety or welfare of Medicare beneficiaries.
Rev. 126
30-1 (Cont.) |
CLINICAL TRIALS |
09-00 |
Should HCFA find that a trial's principal investigator
misrepresented that the trial met the necessary qualifying criteria in order to gain
Medicare coverage of routine costs, Medicare coverage of the routine costs would be
denied under §1862(a)(1)(E) of the Act. In the case of such a denial, the
Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be
held harmless from collection) for the costs consistent with the provisions of
§§1879, 1842(l), or 1834(j)(4) of the Act, as applicable.Where appropriate,
the billing providers would be held liable for the costs and fraud investigations of
the billing providers and the trial's principal investigator may be
pursued.
Medicare regulations require Medicare+Choice (M+C)
organizations to follow HCFA's national coverage decisions. This NCD raises
special issues that require some modification of most M+C organizations' rules
governing provision of items and services in and out of network. The items and
services covered under this NCD are inextricably linked to the clinical trials with
which they are associated and cannot be covered outside of the context of those
clinical trials. M+C organizations therefore must cover these services regardless of
whether they are available through in-network providers. M+C organizations may have
reporting requirements when enrollees participate in clinical trials, in order to
track and coordinate their members' care, but cannot require prior authorization
or approval.
Rev. 126
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Last Modified on Thursday, September 16, 2004
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