NCHR Comments on Coverage of Colorectal Cancer Non-Invasive Biomarker Screening Tests

NCHR public comment tells CMS that the ColoSense multi-target mRNA stool-based colorectal cancer screening test needs better evidence to qualify for Medicare NCD coverage. The study sample included 3x the average number of smokers in the U.S. and since smoking increases the chances of colon cancer, that may have biased the results to make the test seem more accurate than it really is. Too many false positives or false negatives would make the test much less useful for patients.

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Breakthrough Devices

NCHR analysis of FDA breakthrough devices, their approval pathways, and the evidence available for safety and effectiveness.

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Taking Medication While Pregnant or Breastfeeding

If you are pregnant or breastfeeding and are planning to take a medication or get a vaccine, it is important to learn more about the possible risks and to discuss any potential side effects with your healthcare provider. It is also important to understand that your doctor may not know exactly what the risks are of certain prescription and over-the-counter medications. Some risks associated with medications have not been researched yet or might not be known by most doctors.

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Inside Health Policy: Prasad Leaves FDA After Sarepta Furor, Conservative Backlash

Vinay Prasad leaves his key post at the FDA after a conservative backlash from Laura Loomer and WSJ. Sarepta’s gene therapy Elevidys has killed 2 patients so Prasad’s concerns were appropriate and the opposition is not focused on the evidence. We point out that FDA must require better evidence that Elevidys is safe & effective and should limit access meanwhile in order to restore trust in the FDA and the gene therapy.

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