| |
Change
in CMS (HCFA) policy restricting contact of
Medicare beneficiaries for participation in research studies
As
of July 2002, CMS is no longer releasing the Medicare Name & Address
File directly to researchers. CMS is convening a committee
to look at options on how to meet researcher needs for
the Name & Address File while protecting beneficiary privacy.
One option currently under discussion is that researchers
would not contact beneficiaries prior to the beneficiary
giving consent to participate; a CMS hired contractor would
mail out descriptive information about the study. If the
beneficiary wished to participate, they would contact the
researcher via a 1-800 number and give their consent. The
researcher would not be able to contact those beneficiaries
that do not respond to the mailing.
In
addition, once a new system for obtaining the Medicare
Name & Address File has been determined, researchers will
be required to show that the Medicare Name & Address File
is absolutely necessary to conduct their study. Researchers
must provide a rigorous and detailed explanation of how
alternative sources of information cannot be used to obtain
survey participants. Alternative sources for obtaining
survey participants include, but may not be limited to,
the Department of Motor Vehicles driver's license lists,
State voter registrations lists, and Random Digit Dialing.
The relative resource intensity (e.g., money, staff time)
of obtaining survey participants from other sources versus
CMS is not considered a sufficient justification for use.
In addition, due to concerns regarding privacy of beneficiary
clinical information, requests for Name & Address for a
clinically defined cohort (e.g., beneficiaries with Diabetes,
Congestive Heart Failure, Stroke, etc.) will most likely
not be approved.
CMS
has offered to hear opinions about this change in policy,
thus the College's Policy Committee is currently evaluating
whether a formal response should be prepared.
If
you have used or are currently using CMS (HCFA) Medicare
Name & Address information for population-based control
selection, or are planning to use it in the near future,
would you please send an email just indicating YES or
NO as to whether Name & Address File access as before
should be maintained, to:
Harvey.Risch@Yale.edu
You
can include any experiences in obtaining or using HCFA
information for control selection in the email message
text if you like.
Harvey
Risch, MD, PhD, Professor of Epidemiology, Yale University
School of Medicine
|
|
