Gain Tools to Estimate the Financial Impact of Medicaid Rebate Increase

The new law increases Medicaid Rebates in 2010 for branded drugs from 15.1 percent to 23.1 percent of AMP and for generic drugs from 11 percent to 13 percent.

• Calculate the financial impact of the increased Medicaid drug rebate percentage
• Overcome system and technical challenges of accruing for the rebate change

Prepare for Additional Discounts from the Expansion of Section 340B of the Public Health Service Act

Identify the operational, technical/systems and compliance risks for expanding covered entities receiving discounted prices pursuant to Section 340B of the Public Health Service Act by adding certain children's and other hospitals.

• Implement the new price reporting requirements in the 340B program
• Hear up to date information on how to handle the potential expansion of discounts to inpatient utilization

Strategies to Accrue for 2011 Medicare Part D Discounts for "Doughnut Hole"

Drug manufacturers must provide a 50 percent discount on branded prescription drugs to Medicare Part D participants for drugs dispensed while a beneficiary is in the doughnut hole. Estimating the amount and timing of the accrual will be challenging as companies will need data to determine when their products are being sold to someone eligible for the discount.

• Identify the administrative hurdles as the discount prices are expected to be provided to beneficiary at the point of sale of the drug
• Create a compliant rebate or chargeback process to reimburse the pharmacy for the cost at the point of sale

Compliance Tools for Financial Disclosure and Reporting Requirements

Starting in 2011 and consistent with recent OIG works plans, the compliance enforcement is increasing. These provisions will significantly impact government audit, investigation, and litigation resources and the structure for intra-agency cooperation. You must act now to prepare to be compliant with many new regulations.

• Build processes for disclosure of financial relationships between any individual provider and pharma drug and device manufacturers
• Understand how the government will implement and allocate the $250 million budget for Health Care Fraud and Abuse Control
• Clarify the new price reporting requirements for the 340B program
• Establish systems and controls to ensure compliance with new transparency provisions

Prepare Now for Annual Taxes and Fees on Pharma and Medical Device Manufacturers

Beginning in 2011, an annual fee will be imposed on pharmaceutical manufacturers and importers that sell branded prescription drugs to any specified government program. Each company's fee will be determined by the Secretary of the Treasury and due no later than September 30 of such calendar year. The fee is allocated to companies based on their prior calendar year market share for branded drug sales into various government programs (Medicare, Medicaid, VA, procured by the Department of Defense and TRICARE).

• Understand the annual fees on pharmaceutical manufacturers and excise taxes on taxable medical devices
• Quantify the impact of excluded over-the-counter drugs from being reimbursed on a tax-free basis
• Learn how the government will determine the annual fee from the programs such as Medicare, Medicaid, VA, and DOD/ TRICARE that either purchase or provide coverage for the branded drugs

Stay Compliant with Fraud and Abuse Provisions

Pharmaceutical manufacturers must prepare now for over 32 sections in the Healthcare Reform Law amendments related to fraud and abuse, including amendments to the Anti-Kickback Statute, False Claims Act, healthcare fraud criminal statute, and program integrity provisions.

• Learn tools to update your business operations, commercial transactions, and compliance policies
• Determine the impact the federal Anti-Kickback Statute amendment has on daily operations
• Identify False Claims Act Qui Tam Public Disclosures
• Understand Program Integrity Provisions to decrease your legal exposure