Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. Leonard, F., Sciupac, E.,

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Putting Patients First Blog

JULY 2, 2024

As CMS works to achieve this balance, the NHC would like to emphasize several limitations associated clinical guidelines : Off-Label Usage: Clinical guidelines typically do not cover off-label uses of medications, which can be significant for many patient populations, especially those with rare or complex conditions. doi: 10.1002/acr.23871

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Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. 19 National Health Council, National Health Council 2024 Public Policy Issue Areas Survey (internal survey, Policy & Government Affairs, 2023).

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