Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women

August 23, 2022: Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.

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NCHR Letter to Senate Finance Committee on Telehealth Legislation

August 22, 2022: We urge you to act quickly to introduce and advance your telehealth legislation building on the strengths of H.R. 4040. We strongly urge that your legislation increase coverage and access to telehealth for the Medicare population, while continuing to address the underlying barriers faced by rural and underserved communities.

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NCHR Comments on Broadening Coverage for Cochlear Implants

August 4, 2022. We agree that cochlear implants have been shown to improve sentence recognition, thus helping affected adults communicate better and reducing feelings of isolation. However, there are several issues that we strongly urge CMS to consider before deciding whether to broaden the national coverage.

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NCHR Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer

The National Center for Health Research supports AHRQ's draft review finding that partial breast irradiation (PBI) is effective for select early-stage breast cancer patients, with most outcomes comparable to whole breast irradiation (WBI) at 5-10 years. NCHR emphasizes the need for additional research on different PBI types and long-term outcomes at 15-20 years, particularly across diverse patient populations.

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NCHR’s Testimony on the FDA’s Proposed Reclassification of Computer-Aided Devices which Provide Adjunctive Diagnostic Information about Lesions Suspicious for Melanoma from Class III Devices to Class II Devices

July 29, 2022. We do not support the proposed reclassification of the two skin lesion analyzers, MelaFind and Nevisense, from Class III to Class II. We have 2 major concerns: There is no guarantee that newly developed devices cleared through the 510(k) process would be as accurate as those currently on the market.  For that reason, newly developed devices should be reviewed through the PMA process and there is a clear risk of false positive and false negative results, misuse, and device failure, and the FDA has not provided adequate evidence that these risks can be adequately mitigated with the Class II special and general controls listed in the executive summary. As described, FDA cannot ensure that there will be reasonable assurance of safety or effectiveness over the lifespan of the newly submitted devices.

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