"Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs"
2010-10-06 2010-10-06 2010-10-06
CMS-2010-0231-0006 CMS-2010-0231-0003 CMS-2010-0231-0015
04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/CMS-2010-0231-0006 https://api.regulations.gov/v4/comments/CMS-2010-0231-0003 https://api.regulations.gov/v4/comments/CMS-2010-0231-0015
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October 4, 2010Centers for Medicare and Medicaid ServicesDepartment of Health and Human ServicesRoom 445-G Hubert H. Humphrey Building200 Independence Avenue, SWWashington, D.C. 20201Subject: Medicaid Program: Withdrawal of Determination of AMP, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (CMS 2238-P2; RIN 0938-AP67)To Whom It May Concern:The National Community Pharmacists Association (NCPA) is writing to support the proposed regulation to modify the final regulation Medicaid Program: Prescription Drugs that was published in the Federal Register on July 7, 2007. The sections that are proposed to be withdrawn are Section 447.504, Determination of AMP; Section 447.514, Upper Limits for Multiple Source Drugs; and the definition of multiple source drug in Section 447.502, as it was amended by the multiple source drug rule published on October 7, 2008.NCPA represents the owners and operators of approximately 23,000 independent community pharmacies in the United States.  We believe that it is appropriate that CMS withdraw these sections of the regulation, as Congress recently amended several sections of Section 1927 in the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148) that will require that CMS promulgate new proposed regulations regarding these particular issues. NCPA has long held that in the final 2007 regulation, CMS did not implement the provisions of the Deficit Reduction Act (DRA) of 2005 consistent with Congressional intent. Among our concerns were the inappropriate definition of AMP to include prices not paid by community retail pharmacies and the use of a definition of multiple source drug that was inconsistent with the statute.  Several independent economists certified that CMSs planned implementation of the original DRA law would have closed some 11,000 community retail pharmacies  some 20 percent of all pharmacies  and many independent pharmacies.  When issuing a new 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. In this rule, we are proposingto withdraw two provisions from theMedicaid Program; Prescription Drugsfinal rule (referred to hereafter as AMPfinal rule) published in the July 17,2007 Federal Register. The provisionswe are proposing to withdraw are asfollows: The determination of averagemanufacturer price (AMP), and theFederal upper limits (FULs) for multiplesource drugs. We are also proposing towithdraw the definition of multiplesource drug as it was revised in theMedicaid Program; Multiple SourceDrug Definition final rule published inthe October 7, 2008 Federal Register. The provisions of the AMP final ruleand the definition of multiple sourcedrug that we are proposing to withdrawwere challenged in a lawsuit that wasfiled in November 2007. The challengedregulations have been superseded insignificant part by the Patient Protectionand Affordable Care Act, as amended bythe Health Care and EducationReconciliation Act, and the FAA AirTransportation Modernization andSafety Improvement Act. This documentwould withdraw the regulatoryprovisions challenged in theaforementioned litigation.