From: Robacker, Maire [Robacker.Maire@scrippshealth.org] Sent: Thursday, May 13, 2004 4:02 PM To: 'FDADocket@oc.fda.gov' Subject: comment on docket #2004N-0086 As a diabetes educator who sees patients in private clinic settings as well as community clinic settings, I am seeing the numbers of patient referrals to our practice falling sharply as the epidemic of diabetes grows. Many of the patients we do end up seeing sadly have complications. Many gaps exist in obtaining adequate education and management. Many of the insured populations in our area are denied a referral which would cover access to ADA recognized diabetes self-management education programs. Medicaid is frequently not accepted by outpatient programs because payment will not cover cost. Some insurance's will allow one or two visits which is inadequate to meet the education and behavioral/lifestyle changes needed in the self-management of diabetes. For the rising numbers who are uninsured and underinsured many clinics do not have the resources to offer diabetes education/management unless there is a source of funding. Other barriers include lack of funds to pay for co-payments for services and medications. Since the average number of medications a person with diabetes and other complications needs is approx. 20 different medications, some of which may not be covered or have high co-pays, it is not unusual to patients to have to make hard choices - food, shelter or meds. As to prevention sadly many of out patients are coming in late for care and prevention is still not a priority for insurance companies even though it is now widely reported that all will have to pay the high cost of the complications if not prevented. Thank you for your attention. Maire Robacker RN,MSN,CDE Diabetes Clinical Specialist Scripps Whittier Diabetes Program 858-626-5670 858-626-7111 Fax 619-290-6348 pager "Scripps Information Security" ------------------------------------------------------------------------------ This e-mail and any files transmitted with it may contain privileged and confidential information and are intended solely for the use of the individual or entity to which they are addressed. If you are not the intended recipient or the person responsible for delivering the e-mail to the intended recipient, you are hereby notified that any dissemination or copying of this e-mail or any of its attachment(s) is strictly prohibited. If you have received this e-mail in error, please immediately notify the sending individual or entity by e-mail and permanently delete the original e-mail and attachment(s) from your computer system. Thank you for your cooperation. ==============================================================================