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Because
clinical research often takes place in conjunction with
routine clinical care of the patient, it is important
to ensure that billing for clinical and research procedures
is handled appropriately and in compliance with legal
requirements. A Medicare coverage analysis (MCA) is
required for all clinical trials in which any tests,
procedures and interventions performed on study subjects
are invoiced to third party payers. The MCA involves
determining the underlying eligibility of the study
for Medicare coverage and a review of the clinical events
specified in the protocol to determine which can be
reimbursed by Medicare. Medicare’s Clinical Trial Policy
only allows coverage of routine costs during a qualifying
clinical trial. Medicare will not cover routine costs
that are paid for by the sponsor, promised free in the
informed consent document, not ordinarily covered by
Medicare or solely to determine trial eligibility or
for data collection or analysis. The PHS Clinical Research
Office (PCRO) consults with investigators while preparing
Medicare coverage analyses so that PIs' expertise and
insights are reflected in the final documents.
PHRC
activation of a protocol is contingent upon PCRO's completion
of a Medicare coverage analysis or notification by PCRO
to the IRB that a Medicare coverage analysis is not
required. This policy, implemented in January 2008,
applies to all studies involving subject interaction
or intervention reviewed by the PHRC on or after January
14, 2008, including those funded by corporate, foundation,
not-for-profit and public sponsors, those funded by
departmental and sundry funds and studies with no funding.
Notify Partners Clinical Research Office as soon as
possible that a Medicare coverage analysis is required
for your study: pcro@partners.org;
http://www.partners.org/pcro/,
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