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

Updated 11/25/02 vs