National Government Services (NGS) is the CMS Medicare contractor for several states
(including NY, NJ, CT, and CA) and has determined that requests for approval
of the same protocol is coming to them from many investigative sites. This has resulted
in their centralization of the review process.
Medicare Centralization of IDE requests
for Investigational Device Trials
As you can see in the NGS (formerly Empire Medicare) webpage, they have consolidated
the processing of Investigational Device Exemption (IDE) requests in an effort to
reduce the duplication and speed response to investigators. This does not mean that
they have changed their requirements. Approval for coverage/reimbursement is
required prior to enrollment of Medicare patients in investigational device trials. The
electronic submission of all documentation, by e-mail or fax, is preferred and should shorten
the time required to review the information supplied. You can view the email and/or fax
or regular mail addresses to which submissions should be made
The process for submitting a coverage request to Medicare that has been implemented at
CUMC/NYP will continue to remain in effect. All requests for coverage should continue to
include a coverletter (see attached template) The coverletter will continue to require a
signature from NYP representative (Eileen Cottrell). Obtaining this signature will continue
to be faciliated throught the CTO. The CTO will scan the signed letter and provide you with
a pdf copy that can be included with your request, should you decide to use the email option.
NGS has provided a worksheet on the IDE webpage that you can use to assure that all required
supporting documentation has been included with the request letter.