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The applicant also asserted that CMS's literal application of its example that a pacemaker is integral to the procedure of implantation of a pacemaker is overly simplistic and suggests that any feature beyond the basic function of a device could be considered non-integral. In addition, the applicant asserted that CMS has previously deviated from this approach when determining transitional pass-through payment status

Performance benchmarks should include clinical studies demonstrating hair density improvement (minimum 15% in 90 days)

Standard RDA: 2.4 mcg for adults Senior-Specific Needs: Often higher than 2.4 mcg due to absorption issues Recommended Intake for Seniors: At least 2.4 mcg, potentially much higher with supplementation Why the Standard 2.4 mcg May Not Be Sufficient The standard 2.4 mcg dosage might not be enough for seniors for a few reasons: Decreased Stomach Acid: Needed for B12 release from food Atrophic Gastritis: A common condition in older adults that makes it hard to absorb B12 Medication Interference: Some medicines can also block B12 absorption For those over 50, its best to get most of their vitamin B12 from supplements and fortified foods

A Little Experiment Can Go a Long Way The lesson in all this is being willing to experiment