Situation

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An emerging manufacturer with a lean organization and limited experience with transparency reporting requirements sought to improve their processes and ability to keep abreast of the consistently evolving statutory and regulatory environment. They recognized the need for:

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• Standard Operating Procedures for State Transparency Reporting

• A model for identifying state transparency reporting requirements based on product pricing (since inception)

• Assistance with state reporting websites

• Connections to key state contacts for reporting inquiries and website accounts

• Assistance with data elements required during a variety of reporting scenarios

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​Our Approach

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The Pharosity team undertook an effort to establish a baseline formal policy for State Transparency laws falling into multiple categories:

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• State List

• Report to State

• Advance Notice

• Price Justification 

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With the policy in place, we established an SOP that address operating provisions related to:

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• Reporting periods and due dates

• Advance notice requirements and actions

• Price increase thresholds and reporting actions

• Price justification requirements and supporting materials

• Confidentiality requirements

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Finally, our team deployed a tailored version of our State Transparency Impact model providing these features:

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• Repository of all transparency legislation enacted within last twenty years by bill name, type of law, description of legislation, manufacturer actions required, triggers, timing and confidentiality of reported information

• Identification of reporting requirements by state and by month/quarter/year based on product information (price history, therapeutic class, introductory price/new drug status, type [brand, generic, biosimilar])

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This enabled the manufacturer to quickly address reporting requirements that had been missed earlier in the year, prepare a reporting plan for active reporting requirements and data submissions to states, and plan for future reporting requirements later in the year based on established current year price increases.

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Pharosity Consulting State Transparency Service Offerings

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As more and more state transparency reporting laws are enacted, companies must track all existing and new reporting requirements and prepare timely responses to avoid financial penalties.  Pharosity Consulting has developed a tiered service plan to help alleviate some of that pressure when it comes to identifying state reporting responsibilities tied to price increases, periodic WAC/AMP reporting requirements, and state lists.