Case Study
Rule monitoring in the US pharmaceutical sector
About the Client
Government contract pricing team of a large pharmaceutical company
Business Need
- Monitor proposed rule/ final rule/ agency guidance related to specific government programmes focused on drug pricing
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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
