2006 proposed fee schedule - American Society of Clinical Oncology
2006 proposed fee schedule - American Society of Clinical Oncology 2006 proposed fee schedule - American Society of Clinical Oncology
234 allowable for dispensing inhalation drugs, furnishing blood clotting factor, and supplying certain other Part B drugs. This section of the preamble also discusses proposed changes in how manufacturers calculate and report ASP data to us. 1. ASP Issues [If you choose to comment on issues in this section, please include the caption “ASP Issues” at the beginning of your comments.] Section 303(c) of the MMA amended Title XVIII of the Act by adding new section 1847A. This new section establishes the use of the ASP methodology for payment for most drugs and biologicals not paid on a cost or prospective payment basis furnished on or after January 1, 2005. The ASP reporting requirements are set forth in section 1927(b) of the Act. Manufacturers must submit ASP data to us quarterly. The manufacturers’ submissions are due to us not later than 30 days after the last day of each calendar quarter. The methodology for developing Medicare drug payment allowances based on the manufacturers’ submitted ASP data is specified in the regulations in part 414, subpart K. Based on the data we receive, we update the Part B drug payment amounts quarterly. In this section of the preamble, we discuss issues and propose changes related to the methodology manufacturers use to apply the estimate of lagged price concessions in the ASP
calculation. We also discuss the submission of ASP data, including WAC, and our intent to propose, in a separate notice, the collection of additional information from 235 manufacturers, using a revised reporting format, to ensure more accurate calculation of the Medicare payment amounts. Also, included in this section is a discussion of the weighting methodology we follow to establish the Medicare payment amounts using the ASP data. a. Estimation Methodology for Lagged Price Concessions Section 1847A(c)(5)(A) of the Act states that the ASP is to be calculated by the manufacturer on a quarterly basis. As a part of that calculation, manufacturers are to take into account price concessions such as-- ● Volume discounts. ● Prompt pay discounts. ● Cash discounts. ● Free goods that are contingent on any purchase requirement. ● Chargebacks. ● Rebates (other than rebates under the Medicaid drug rebate programs). If the data on these price concessions are lagged, then the manufacturer is required to estimate costs attributable to these price concessions. Specifically, the manufacturer sums the price concessions for the most recent 12-month
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234<br />
allowable for dispensing inhalation drugs, furnishing blood<br />
clotting factor, and supplying certain other Part B drugs.<br />
This section <strong>of</strong> the preamble also discusses <strong>proposed</strong> changes<br />
in how manufacturers calculate and report ASP data to us.<br />
1. ASP Issues<br />
[If you choose to comment on issues in this section, please<br />
include the caption “ASP Issues” at the beginning <strong>of</strong> your<br />
comments.]<br />
Section 303(c) <strong>of</strong> the MMA amended Title XVIII <strong>of</strong> the<br />
Act by adding new section 1847A. This new section<br />
establishes the use <strong>of</strong> the ASP methodology for payment for<br />
most drugs and biologicals not paid on a cost or prospective<br />
payment basis furnished on or after January 1, 2005. The<br />
ASP reporting requirements are set forth in section 1927(b)<br />
<strong>of</strong> the Act. Manufacturers must submit ASP data to us<br />
quarterly. The manufacturers’ submissions are due to us not<br />
later than 30 days after the last day <strong>of</strong> each calendar<br />
quarter. The methodology for developing Medicare drug<br />
payment allowances based on the manufacturers’ submitted ASP<br />
data is specified in the regulations in part 414, subpart K.<br />
Based on the data we receive, we update the Part B drug<br />
payment amounts quarterly.<br />
In this section <strong>of</strong> the preamble, we discuss issues and<br />
propose changes related to the methodology manufacturers use<br />
to apply the estimate <strong>of</strong> lagged price concessions in the ASP