February 20, 2007
Centers for Medicare and Medicaid Services Room 445-G Hubert Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201
Re: CMS-2238-P
NCSL was pleased with the Deficit Reduction Act provision that calls for monthly reporting to states and for making the prices available to the public. NCSL has called for transparency regarding the prices of prescription drugs in the Medicaid program for a number of years and looks forward to working with you on implementing that provision. On behalf of the National Conference of State Legislatures (NCSL) I submit the following additional comments on the NPRM, implementing provisions of the Deficit Reduction Act of 2005 (DRA) regarding the Medicaid prescription drug program, for your consideration.
Determination of Average Manufacturer Price – Section 447.504
NCSL supports excluding the prices of sales to long term care pharmacies from the calculation of AMP. While the proposed rule makes a strong case for the inclusion of prices of sales to mail order pharmacies and Pharmacy Benefit Managers (PBMs), the rule remains extremely vague on operational issues. Because the inclusion of these prices will have a significant impact on the AMP, the operational details are extremely important. We urge great care and consideration. With regard to “future clarifications of AMP,” the proposed rule notes that CMS plans to address future clarifications through the issuance of program releases and by posting clarifications on the CMS Web site. We urge you to reconsider this strategy and to publish a NPRM for public comment.
Determination of Best Price – Section 447.505
Over the years the statutory exceptions to the Medicaid “Best Price” calculation have grown. It is essential that “Best Price” be calculated to include all sales, discounts, or other price concessions provided by the manufacturer for covered outpatient drugs unless the entity is specifically excluded from the best price calculation by statute. NCSL supports the exclusion of Medicaid rebates and supplemental rebates to states from the best price calculation. If significant changes are under consideration for the calculation of best price, we urge you to publish a NPRM for public comment instead of the issuance of program releases and the posting of clarifications on the CMS Web site as proposed in this rule.
Regulatory Impact Analysis – Effects on Retail Pharmacies
NCSL recognizes the reform of the Medicaid prescription drug program is needed. We remain concerned about access issues for Medicaid beneficiaries in rural, inner-city and other underserved areas with large numbers of Medicaid beneficiaries due to the disproportionate impact the lower Federal Upper Limits (FULs) will have on some small retail pharmacies. Because all the details of the program have not been determined, it is difficult to know which pharmacies will have the most trouble and we appreciate your efforts to get feedback. NCSL supports efforts to encourage states to review the adequacy of their dispensing fees, but we do not believe that increasing state dispensing fees will address the problems facing these small retail pharmacies.
I thank you for your consideration and urge you to call me or Joy Johnson Wilson our Health Policy Director at 202-624-5400, if you have any questions or if we can be of additional assistance to you.
Sincerely,
Carl Tubbesing Deputy Executive Director National Conference of State Legislatures
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