Physician_Fee_Schedule_Rules / pfs1

Why This Topic Matters

It helps providers, manufacturers, and billing staff identify which Medicare payment and reporting policies changed for 2006 and which operational areas were affected, especially for Part B drugs, dialysis facilities, and inhalation drug suppliers.

Article Sections

1. Pediatric ESRD Facility Exceptions

   Discussion of ESRD facility exception policy changes for pediatric facilities and CMS responses to public comments. Includes regulatory references and related procedural updates.

2. H. Payment for Covered Outpatient Drugs and Biologicals

   Overview of Part B drug payment policy for 2006, including ASP-based payment administration, reporting requirements, and related CMS responses to comments.

3. ASP Issues

   Background on the ASP methodology, manufacturer reporting, and proposed refinements to calculation and reporting processes.

4. a. Estimation Methodology for Lagged Price Concessions

   Discussion of how lagged price concession estimates are handled within the ASP framework and CMS’s treatment of related public comments.

5. b. Price Concessions: Wholesaler Chargebacks

   Consideration of wholesaler chargebacks within ASP calculations and CMS’s proposed and final treatment of sales-channel methodology.

6. c. Determining the Payment Amount Based on ASP Data

   Explanation of how CMS derives payment amounts from manufacturer ASP submissions and how billing-code level payment calculations are structured.

7. d. Reporting WAC

   Clarification of when manufacturers must report wholesale acquisition cost information and how the reporting requirement applies in different circumstances.

8. e. Revised Format for Submitting ASP Data

   Description of proposed changes to the ASP reporting template and associated data elements for manufacturer submissions.

9. f. Limitations on ASP

   CMS discussion of statutory limitations affecting ASP-based payment and the threshold used for comparison with other pricing measures.

10. 2. Payment for Drugs Furnished During CY 2006 in Connection With the Furnishing of Renal Dialysis Services if Separately Billed by Renal Dialysis Facilities

    Policy on payment methodology for separately billed ESRD drugs and related CMS reasoning, comments, and final decisions.

11. 3. Clotting Factor Furnishing Fee

    Annual update to the clotting factor furnishing fee and the basis for the 2006 amount.

12. 4. Payment for Inhalation Drugs and Dispensing Fee

    Extensive discussion of inhalation drug payment policy, including the dispensing fee, stakeholder comments, access concerns, and CMS’s final 2006 policy.