Advocacy

In conclusion, PPTA reiterates its recommendation that CMS exempt PDTs from the GUARD Model. This policy is also consistent with the CMMI statute, which requires that Models to be tested “preserv[e] or enhance[e] the quality of care furnished to individuals [with Medicare].”18 Excluding PDTs from the GUARD Model is fully consistent with this statutory requirement.

PPTA urges CMS to exempt PDTs from the GLOBE Model. This policy is also consistent with the CMMI statute, which requires that Models to be tested “preserv[e] or enhance[e] the quality of care furnished to individuals [with Medicare].”18 Excluding PDTs from the GLOBE Model is fully consistent with this statutory requirement.

The Plasma Protein Therapeutics Association (PPTA) is writing to request that you please consider expeditiously granting a reasonable and necessary regulatory reform for the SourcePlasma sector pertaining to two of New York’s clinical laboratory regulations.

Strengthening the EU Blood Directive: To meet the needs of patients using plasma-derived medicinal products and plasma donors