340B Drug Pricing Program
iPad-Compatible Course in a Convenient, Flexible Electronic Magazine Format

The 340B Drug Pricing Program is expected to generate $2 billion in savings each year to eligible healthcare providers for brand-name drugs alone.

View 340B Drug Pricing Program e-Zine Excerpt

The program, which requires drug manufacturers to provide discounts to healthcare facilities serving a large volume of low-income and uninsured patients, is meant to help eligible providers expand services to more eligible patients.

Not surprisingly, these discounts to providers are associated with decreased revenues for pharma manufacturers, and with the Patient Protection and Affordable Care Act, this impact is likely to increase.

This course is designed to strengthen commercial teams' understanding of the current healthcare environment, and provides comprehensive coverage of the 340B Drug Pricing Program and its growing impact on hospitals and pharmaceutical companies.

After completing this course, participants will understand:

  • What entities, drugs, and patients are eligible for the 340B program
  • Why the program was initiated and how the ACA has changed it
  • The impacts on the healthcare and pharmaceutical industries
  • How the program is implemented
  • Requirements for participating entities and manufacturers

Course Outline

I. Introduction to 340B
Overview and definition

II. Eligibility

  • Entities
         - Eligible Federal grantees
         - Eligible non-grantees
         - Eligibility requirements
         - Overview of Disproportionate Share Hospital Program
         - Yearly recertification
  • Drugs
         - Eligible products (i.e., outpatient products only)
         - Products covered by 340B program
  • Patients
         - Definition of “patient”
         - Controversy around definition

III. Origin and Expansion

  • History
         - Established under the Veterans Health Care Act
         - Offset consequences of Medicaid Drug Rebate program
  • Changes under the Patient Protection and Affordable Care Act of 2010
         - Increased number of eligible entities
         - Excluded orphan drugs from eligibility at these newly covered entities
         - Increased 340B discounts
         - Expanded integrity and enforcement provisions
  • 340B Today and in The Future
         - Current statistics on number of covered entities
         - Medicaid expansion and effects on 340B program
         - Hospital advocacy groups’ fight to include inpatient drugs
         - Concerns with current program (i.e., poorly implemented integrity initiatives)

IV. Program Impact

  • On Healthcare Providers
         - Significant savings (and profit) for eligible entities
         - Benefits of the program for eligible entities
         - Contribution to changing healthcare delivery models
  • On the Pharmaceutical Industry
         - Effects on drug profitability
         - Expected growth of manufacturer losses
  • Controversy
         - Industry coalition report
         - Response to report by Safety Net Hospitals for Pharmaceutical Access

V. Program Structure

  • Overview of Stakeholders
  • Program Management
         - HRSA Office of Pharmacy Affairs (OPA)
         - Prime Vendor Program (PVP)
         - Pharmacy Services Support Center (PSSC)
  • Drug Delivery Options
         - In-house pharmacy
         - Contracted pharmacy
  • Manufacturer Price Adjustment
         - Calculation of prices
         - Penny pricing
         - Quarterly adjustment
         - Overcharge and undercharge events
  • Eligible Entity Requirements
         - Updating database information
         - Maintaining appropriate and auditable records
         - Adhering to the GPO prohibition
         - Preventing diversion of 340B discounted drugs
         - Preventing duplication of discounts
         - Appropriately handling orphan drugs
         - Permitting audits by HRSA or manufacturers
         - Penalties for violations
  • Manufacturer Requirements
         - Pharmaceutical Pricing Agreement (PPA)
         - Refunds in event of overcharge
         - Penalties for violations
  • Dispute Resolution
         - Example disputes
         - Resolution process

VI. Conclusion


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