Business need

Government contract pricing team of a large pharmaceutical company

Business Objectives / Goals

  • Monitor proposed rule/ final rule/ agency guidance related to specific government programmes focused on drug pricing
  • The regulations covered include:
    Medicare Part D, Medicaid, PHS/340B, DoD/TRICARE, VA, Health Exchanges, Medicare Part B

Approach and Methodology

  • Conducted preliminary research during the first week after each quarter to identify amendments made to the select regulations
  • After the final check (to identify additional amendments), a summary level slide showing the spread of amendments across different stages of the process flow was prepared
  • Captured the following information for each amendment:
    • Summary of the changes (programme changes, price reporting/ calculation changes, average manufacturer price (AMP) changes, call letters, etc.)
    • Impact areas (changes to Safe Harbour Requirements, affect on usage of coupons/ vouchers, enrolment changes, etc.)
    • Important dates (due date for comments, date for implementation)

Business outcomes

  • The contract pricing team was able to stay abreast of all the regulatory changes and requirements, and was able to respond accordingly and in a timely manner

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