May 13, 2015—State Medicaid directors presented a wide-ranging set of 340B-related policy recommendations today to the federal agencies that oversee the 340B and Medicaid programs and the staffs of key congressional committees.[ms-protect-content id=”2799″]
Federal Medicaid and 340B policies “have not kept pace with the dramatic growth and evolution of the programs,” the National Association of State Medicaid Directors wrote in a letter accompanying its recommendations to the heads of the Health Resources and Services Administration and the Centers for Medicare & Medicaid Services. “We appreciate that HRSA has begun to devote some attention to challenges posed by the overlap and shared goals of these two programs. Still, more can be done to resolve the underlying policy and operational disconnects. These require a full understanding of states’ concerns. It also requires ongoing, meaningful communication between HRSA, CMS and the states as well as dedicated resources to address some of the technical challenges that are essential for proper administration and program integrity functions.”
NAMD said it believes its suggestions “will contribute to the important work your agencies are undertaking to improve the efficient and effective administration of the Medicaid and 340B programs.”
“We also intend for it to help guide Congress should your agencies lack the authority to advance administrative solutions,” it added.
The Medicaid directors made the following recommendations:
Effectuate technical enhancements to the Medicaid Exclusion File
- Develop a solution for providers serving patients in multiple states
- Implement HRSA-level editing against the National Provider Identifier (NPI) number
- Publish a quarterly change file that reflects HRSA-validated changes in covered entity status
- Clarify the effective date of a provider’s status on the 340B exclusion list, including “carve-in” and “carve-out” dates
- Update the Pharmaceutical Pricing Agreement to require drug manufacturers to identify “duplicate discount” issues within one year, but no more than 3 years
- Limit retroactive changes to the exclusion file in order to reduce complications to the Medicaid drug rebate process
- Provide guidance to states that addresses situations where covered entities retroactively change their status
- Require drug manufacturers to work with covered entities to prevent the “duplicate discount”
- Establish mechanisms to improve communication between covered entities and Medicaid agencies
Facilitate Claims-Level Identification of 340B-Procured Prescriptions
- Promote effective practices for coding issues, with a specific focus on systematic solutions rather than manual processes
- Ensure there is a mechanism to facilitate identification of specific covered claims within contract pharmacy arrangements
- Require Medicaid managed care entities and their pharmacy benefit managers to use unique identifiers to distinguish their 340B Medicaid claims from their 340B commercial or Medicare Part D business
Issue Clear Guidance and Strengthen Enforcement Practices
- Clarify treatment of Medicaid fee-for-service and managed care-based claims within the Medicaid Exclusion File so that states can identify covered entities which differ their 340B “carve-in” status based on the delivery system model
- Conduct timely audits of covered entities and enforce requirements that covered entities work with state Medicaid agencies and HRSA to properly identify and exclude claims from contract pharmacies
Improve Transparency Related to Reimbursement and Clearly Articulate Expectations
- Explore the development of a 340B benchmark, such as “average 340B acquisition price,” that could be shared with the states
- Collaborate with states to develop guidance related to “shared savings” arrangements with 340B entities[/ms-protect-content]