| 
Clinical Trials Coverage –
Dashed Expectations, But Stay Tuned
By
Roger
L. Jansson and Thomas
E. Jeffry, Jr.
[July 2007]
On July 9, 2007, the Centers for Medicare & Medicaid Services
(CMS) issued a revised Clinical
Trial Policy (CTP) National Coverage Determination (NCD),
governing what types of costs Medicare pays for individuals
participating in clinical trials.
Medicare has paid for “routine costs” associated
with patients enrolled in “qualifying” clinical
trials since 2000 under the original
CTP NCD, as long as the items and services are otherwise
available to beneficiaries, are not statutorily excluded, and
are not excluded by a national non-coverage decision. The CTP
NCD contained a number of ambiguous provisions that appeared
to limit the applicability of NCD Medicare reimbursement.
Despite promises of numerous positive revisions in CMS’
Proposed Decision Memo for CTP on April 10, 2007, the Final
Memo states that comments on the Proposed Memo revealed differing
views and confusion about the existing and proposed CTP NCD.
In response, CMS reversed direction and decided to scale back
the revisions and to simply “preserve the status quo”
with the adoption of only two revisions. However, in the revised
CTP NCD, CMS also announced that it will once again reopen the
reconsideration of its CTP, posting yet another proposed Decision
Memorandum, and also promising to propose changes to the regulations
that pertain to Medicare payment of clinical trials.
The two revisions to the CTP NCD effective July 9, 2007 are:
(1) CMS modified the language in the initial CTP NCD that
could be read to restrict payment for items or services under
investigation, to the extent the item or service would be
covered outside the clinical research trial. CMS acknowledges
ambiguity on this issue, and now makes clear that items or
services during clinical trials are covered if they would
be covered outside the clinical research trial.
(2) CMS adopts the proposed Decision Memo’s addition
of Coverage with Evidence Development (CED) to the CTP NCD.
In doing so, CMS for the first time allows the NCD process
to establish additional standards for approval of research
trials through the CED process, for items and services in
clinical trials for which there is some evidence of medical
benefit but for which there is insufficient evidence to support
a “reasonable and necessary” determination.
As noted above, CMS proposed much more significant changes
in the Proposed Decision Memo on April 10, 2007.1
For now, the following changes will remain on the shelf and
will be reconsidered in the future:
- Renaming the policy from “Clinical Trials Policy”
to “Clinical Research Policy” because the conventional
definition of “clinical trial” fails to capture
the scope of opportunities available to Medicare beneficiaries
in clinical study participation;
- Adding a definition for the term “clinical research;”
- Continuing the seven highly desirable characteristics for
good clinical research and renaming them “general standards
for scientifically and technically sound clinical research
study,” and adding an eighth standard requiring that
each research study must have a written protocol;
- Revising the requirements that qualify clinical studies
for Medicare coverage, including new Medicare-specific requirements
that research studies:
- Are registered on the National Institutes of Health
(NIH) ClinicalTrials.gov website prior to enrolling
any study subjects,
- Specify and fulfill method and timing of public release
of results in the study protocol, regardless of outcome
or completion of trial,
- Explicitly discuss inclusion criteria and consider
relevant subpopulations in the study protocol,
- Discuss how the results will generalize to the Medicare
population so as to infer whether Medicare patients may
benefit from the intervention;
- Adding a definition for “administrative services”
required to carry out studies and clarifying that Medicare
will not cover administrative services;
- Adding a definition for “investigational clinical
services” and covering those services when the service
is available to Medicare beneficiaries that are not participating
in a study, or when it is required through CED;
- Clarifying those processes that ensure that both Medicare-specific
standards and the general standards for scientifically and
technically sound clinical research studies are met;
- Expanding the agencies which qualify for “deemed”
approval status to include all studies reviewed and funded
by a program with the Department of Health and Human Services,
the Veteran’s Administration, or the Department of Defense;
- Removing the following options for “deeming”
studies as approved for Medicare coverage of routine costs:
- Self-certification process;
- Investigational New Drug (IND) exempt studies.
Another unresolved issue: applicability
of Medicare Secondary Payer Rules to CTP NCD
The applicability of the Medicare Secondary Payer Rules (MSP)
to clinical trials in which sponsors or trial sites pay for
a beneficiary’s costs in the event of complications has
led to much confusion and consternation under the CTP NCD, and
sparked many comments on the proposed Clinical Research Policy
NCD. When it issued its Proposed Decision Memo on April 10,
2007, CMS stated that it would not address applicability of
the MSP rules in the revised NCD, but CMS promised future guidance
on this issue by the CMS MSP division.
CMS received many comments on the administrative barriers
posed by application of the MSP rules during the Proposed Decision
Memo comment period. As expected, rather than address public
concern, CMS once again failed to address the MSP issue in the
revised CTP NCD. It remains to be seen whether the MSP program
area will provide further guidance as promised.
Footnote
1
http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.
The CMS Tracking Sheet recounting the entire year-long reconsideration
process, starting with CMS’ July 10, 2006 announcement
of its decision to significantly reconsider the CTP NCD and
culminating in CMS’ decision to only make two relatively
minor changes, is available at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=186.
For more information, please contact:
This advisory
is a publication of the Health Law Group of Davis Wright Tremaine
LLP. Our purpose in publishing this advisory is to inform our
clients and friends of recent legal developments. It is not
intended, nor should it be used, as a substitute for specific
legal advice as legal counsel may only be given in response
to inquiries regarding particular situations.
Copyright 2007, Davis Wright Tremaine
LLP.
return to Advisory Bulletins main page
|
