On March 23, 2010, President Obama signed H.R. 3590, the "Patient Protection and Affordable Care Act," (PPACA) into law. This legislation, as subsequently amended by H.R. 4872, the "Health Care and Education Reconciliation Act of 2010," includes significant revisions to the Medicaid Drug Rebate Program (MDRP) and to the 340B Drug Discount Program (340B Program).

The Health Care and Life Sciences practice group will present a 90-minute webinar designed to assist pharmaceutical and biotech manufacturers in understanding the practical impact of this legislation with respect to the MDRP and the 340B Drug Discount Program. Epstein Becker Green attorneys are well-versed in government program prescription drug pricing issues and have considerable experience in counseling manufacturers regarding their compliance obligations and with defending manufacturers in government investigations.

Key themes to be addressed:  

Changes in pricing metrics under each Program

  • How is the "basic" rebate changing? 
  • How will the new AMP calculation compare to the calculation under the DRA Final Rule?  
  • How will Best Price be calculated to account for changes implemented by PPACA? 
  • Is my product a "line extension" and, if so, what does that mean to rebate liability?
  • Will my product's AMP be public? (If so, when?) 
  • What are the changes to the Federal Upper Limits?

Changes in the scope of each Program

  • How will the FUL changes affect Medicaid reimbursement? What might this mean for Medicaid utilization? 
  • How will Medicaid managed care plans utilization be included in the state invoices (and when?)
  • How might state Medicaid drug coverage expand under Health Reform? 
  • Will Medicaid utilization increase (and when is the Medicaid program expansion effective)? 
  • Who are the "new" 340B Program covered entities and how are they different from the current covered entities?  
  • Will I need to make 340B covered drugs available for inpatient purchases?

Changes in manufacturers' obligations under each Program

  • What new reporting obligations will my company have? 
  • How will the changes to the MDRP impact my company's rebate obligations? 
  • Can I recalculate my baseline AMP?
  • How will the changes to the MDRP impact my 340B financial obligations?
  • What is the so-called "must sell" provision and what does it mean to my company?
  • How will 340B "integrity" provisions impact my company?
  • When do I need to comply with the MDRP and 340B changes and what should I be doing now?

The speakers will also leave time at the end of the webinar for questions (including those last minute 1Q10 implementation questions!).

For more information, contact Kristi Swanson at (202) 861.4186 or kswanson@ebglaw.com.

Event Detail

Webinar
Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.