PRICING AND COMPLIANCE SOLUTION FOR A RADIOPHARMACEUTICAL MANUFACTURER
A manufacturer of radiopharmaceuticals and diagnostics with orphan indications is preparing to enter the United States market. A significant portion of its patient population will be covered by Medicaid, and many of the facilities administering therapy will be Covered Entities under the 340B program. As a new player in the US, the organization required a deep understanding of the Government Pricing environment, the governing statutory and regulatory regime, and the understanding and capability to deploy a pricing and Medicaid claims processing solution.
Pharosity Consulting was engaged to help establish the necessary policies and processes to comply with Government Pricing programs, and the operational capability to perform all of the necessary calculations and reporting submissions.
Pharosity Consulting assessed the needs of the organization through our 4 Pillars™ lens of Policy, Process, Organization and Automation to arrive at a pragmatic and sustainable result. To achieve this result, we considered:
The unique characteristics of the patients, radiopharmaceutical and diagnostic products, market and customers
The manufacturer’s market access strategy to assess the impact of stakeholders as the product moves from manufacture to administration
The unique considerations for radiopharmaceuticals and diagnostics within the Government programs
The likely near and long term customer types, agreement types and data volumes informing the necessary size and scale of the final solution
The results of the analysis led Pharosity Consulting to develop tailored policy documentation accounting for the nuances of radiopharmaceuticals and diagnostics. During the policy development process, we advised our client partner on a lean and effective structure for their organization, avoiding acquiring excess, unneeded resource capacity. Similarly, the analysis of the planned customer base, agreement types and anticipated transactional volumes led to well-designed calculation and process models built with desktop tools, reducing the cost and overhead associated with large, monolithic implementations while achieving the desired level of automation. These models were wrapped with tightly constructed process definitions governing the ongoing activities.
Our client partner achieved the goal of establishing a compliant, efficient Government Pricing and Medicaid claims processing operation with appropriate investments in automation appropriate to the situation defined by the patients, products and market access strategy.