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Response: We point these commenters to the discussion in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82079) where we acknowledged and agreed with commenters that, although critical for determining an individual's out-of-pocket obligation, hospital standard charges do not represent either an individual's out-of-pocket obligation or a real, guaranteed price. However, as we noted in the CY 2024 OPPS/ASC final rule with comment period, individualized estimates in dollars may be obtained directly, in many circumstances, from providers and payers through other Federal price transparency efforts such as those implementing the NSA and TiC requirements

Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S

Most patients who receive their monthly supply from PlexusDx finish their medication before expiration becomes an issue, since the dosing schedule aligns with the typical stability period