SOURCE: Cutting Edge Information

Cutting Edge Information

December 11, 2014 09:01 ET

Good Documentation Practices Are Key for Government Drug Reimbursement

Establishing Procedures and Recording Assumptions Help Companies Address Regulatory-Based Inquiries

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 11, 2014) - Whether seeking payer support for a single blockbuster drug or for multiple products, companies with adequate documentation about internal procedures and assumptions are better positioned to successfully navigate the government drug reimbursement process, according to pharmaceutical business intelligence provider Cutting Edge Information

The company's newest market access report -- "US Government Reimbursement: Winning Key Formulary Positions and Managing Pricing Systems" -- discusses how formal standard operating procedures (SOPs) and documentation practices provide a roadmap for navigating the drug reimbursement process. Companies without such policies risk challenges, whereas those with recorded procedures are better positioned to address issues from potential regulatory-based inquiries. 

"From establishing SOPs to recording assumptions, the documentation surrounding the government drug reimbursement process increases accountability and keeps employees on the same page," said Jacob Presson, senior research analyst at Cutting Edge Information. "This is critical for companies seeking payer support, especially when current regulations are unclear."

Under the Medicaid Rebate Program, drug manufacturers can make reasonable assumptions about calculations when sufficient guidance does not exist or when current regulations are not clear, which may occur when companies have enacted atypical pricing arrangements or are targeting a specific consumer class. However, it is critical that these companies demonstrate that their assumptions are reasonable, thereby necessitating good documentation practices. 

 "US Government Drug Reimbursement" provides a roadmap for better navigating government drug reimbursement amidst the growing influence of the Affordable Care Act. The report, which focuses exclusively on US government reimbursement strategy and trends, draws on quantitative and qualitative data from top-performing life science executives to provide actionable insights for winning and maintaining formulary position. Additional guidance outlined in the report includes:

  • Anticipating your government payer needs and developing strong market access strategies;
  • Managing payer relationships before and after product launches to maintain formulary position; and
  • Understanding compliant government reimbursement practices in the United States' new healthcare environment. 

To learn more about Cutting Edge Information and its research report offerings, please visit

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