Outlier Average Manufacturer Prices in the Federal Upper Limit Program.
(10/04/2013)
To determine whether any Federal upper limit (FUL) drugs met the outlier criteria because of inconsistencies in how unit types were reported. To determine whether the outlier average manufacturer prices (AMP) for FUL drugs are accurate. To determine whether drugs with outlier AMPs are commonly available in the marketplace. The Deficit Reduction Act of 2005 (DRA) made significant changes to Medicaids FUL program, which is designed to ensure that the Federal Government acts as a prudent buyer by taking advantage of current market prices for multiple-source drugs. Under new DRA requirements, FUL amounts for most multiple-source drugs are to be...
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Số trang: 29 |
Lĩnh vực: Y học lâm sàng |
Năm XB: 2009 |
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Outlier Average Manufacturer Prices in the Federal Upper Limit Program. | Số trang: 29
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To determine whether any Federal upper limit (FUL) drugs met the outlier criteria because of inconsistencies in how unit types were reported. To determine whether the outlier average manufacturer prices (AMP) for FUL drugs are accurate. To determine whether drugs with outlier AMPs are commonly available in the marketplace. The Deficit Reduction Act of 2005 (DRA) made significant changes to Medicaids FUL program, which is designed to ensure that the Federal Government acts as a prudent buyer by taking advantage of current market prices for multiple-source drugs. Under new DRA requirements, FUL amounts for most multiple-source drugs are to be based on 250 percent of the lowest reported AMP for each drug rather than 150 percent of the lowest price published in the national compendia of drug cost information. The DRA provisions additionally require AMP data to be made available to both States and the public. As generally defined in statute, the AMP is the average price paid to the manufacturer for the drug in the United States by wholesalers for drugs distributed to the retail pharmacy class of trade. Manufacturers must provide the Centers for Medicare & Medicaid Services (CMS) with the AMP for each of their drug products on both a monthly and quarterly basis. If a product has been discontinued, the manufacturer must provide CMS with the termination date. As reports by the Office of Inspector General (OIG) and the Government Accountability Office have previously shown, the lowest AMP for many FUL drugs falls below pharmacy acquisition costs even when multiplied by 250 percent. To address this issue, CMS announced plans to remove outlier AMPs from the FUL calculation. Pursuant to this outlier policy, CMS will exclude (with certain exceptions) the lowest AMP from the FUL calculation if it is more than 60 percent below the second-lowest AMP. According to CMS, the outlier policy is designed to ensure that two or more drug products can be purchased at or below the FUL amount.
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