Medicare Part B Drug Pricing

April 29, 2014 2:45pm

Judith A. Waltz
Partner
Foley & Lardner LLP

• Understanding Part B pricing methodologies, coverage and coding
– Average Sales Price (ASP)
– Recognizing the differences in coverage, pricing and coding among various outpatient settings
• Calculation of ASP
– Inclusions and exclusions
– Exempt and non-exempt sales
– Smoothing
– The three quarter lag
– Bona fide service fees
– Free goods
– Patient assistance
– Coupons
• Submission of ASP data: timing
– OIG and state AG efforts to obtain data
– How will late filed ASPs be dealt with when calculations are done?
 How will the data gaps be filled?
• CMS’s proposed treatment of “intentional overfill”
– How will ASP be calculated for “overfi lled” products?
• Bundling
• Special issues for radio-pharmaceuticals
• Reimbursement of biosimilars under Part B
– Managing new coding protocols and a hybrid payment model
• Preparing for the trend toward ACOs and new payment models that may be evolving.
– Policy issues
– Medicare proposed models that emphasize cost saving, e.g., accountable care
– Outcomes – passed rebates
• WAMP, AMP, LCA, and other possible risks in light of the deficit reduction efforts