HDMA, VA

HDMA supports CMS’ efforts to withdraw provisions, which, as defined by the agency in the DRA final rule, are inconsistent with amendments to the Medicaid Drug Rebate Statute (Social Security Act section 1927) under healthcare reform and not reflective of Congressional intent to ensure that reimbursement to retail pharmacies is fair and accurate for generic medicines dispensed to Medicaid patients. In promulgating new regulations implementing section 2503 of PPACA and to avoid future complications, HDMA urges CMS to seek stakeholder input to ensure those regulations are consistent, complete and provide necessary guidance for industry to comply with new requirements established in law. In our view, CMS should provide additional clarity on the treatment of bona fide services for purposes of AMP reporting. In particular, we urge CMS to confirm that the list of bona fide services codified in PPACA is not exclusive and that payments for additional services such as marketing and sales services, financial management services and information and data services, provided by wholesalers on behalf of manufacturers must be excluded from the calculation of AMP, even if the payment amount is set as a percentage of goods purchased, whenever the payment is properly structured as a bona fide service fee. Finally, in light of the significant impact AMP will have on the entire supply chain, and in light of previous litigation and new requirements established by PPACA, HDMA strongly urges CMS to delay publishing AMPs and implementing any FULs for purposes of Medicaid reimbursement of multiple source drugs until such time as the agency has promulgated and completed full rulemaking in accordance with the Administrative Procedures Act.