Advisory Market Update

This Advisory Market Update for June 2020 is the first of a monthly series. The goal of Market Update is to share industry insights, information, and regulations from various government program agencies that impact pharmaceutical manufacturers. If you have questions on any of the content found in this or other newsletters, reach out to your IntegriChain Advisory Lead or and they would be happy to talk you through it.

Did You Know?

If you participate in the VA Federal Supply Schedule (FSS), there’s some recent news you should know. Twice a year, the Veteran’s Affairs (VA) Office of Procurement, Acquisition and Logistics (OPAL) puts together a newsletter for manufacturers to assist in fulfilling their obligations as an FSS contractor.

In their recently published bi-annual newsletter, the VA announced their latest effort to simplify document submission and processing: broadening acceptable signature types to include digital signatures, such as Adobe Sign. Since pharmaceutical manufacturers often struggle with getting hard copy signatures in a timely manner for the VA’s contract agreements, moving to digital signatures will streamline this process and allow for more flexibility during COVID-19 and beyond.

In addition, the VA has also set the timeline for the upcoming 2021 Public Law season. They will be providing annual webinar training, repeated in two sessions, earlier in the year to better prepare for a successful season. 

If you’re not familiar with these newsletters, they discuss news and updates for FSS contractors and cover the following topics in every issue:

  • Contract Corner: Year in Review
  • FSS FAQ: Where do I submit my documents?
  • IFF/Report of Sales Reminder
  • Upcoming Training & Events
  • Useful Web Links
  • Contact Us

You can read the most recent bi-annual newsletter here and view the archives of VA newsletters here.

The Latest Updates from the Centers for Medicare & Medicaid Services

The Medicaid Drug Rebate Program (MDRP), issued CMS Manufacturer Release #112 with guidance on how to treat Authorized Generic sales transactions in Average Manufacturer Price (AMP) & Best Price (BP). 

For manufacturers who sell branded drugs as well as their own AGs, you are no longer required to blend those AMPs. This contradicts previous advice related to the October Continuing Appropriations Act 2020 and Health Extenders Act of 2019 where manufacturers were instructed to blend the AMPs for manufacturers who sell both the branded and AG drug. If you believe you have an Authorized Generic that may be impacted by this release, please contact your IntegriChain Advisory Lead to discuss any potential implications or scenario modeling you may like to have conducted. You can read the full CMS Manufacturer Release #112 here.

In CMS Manufacturer Release #113, a new enforcement authority for compliance on drug pricing and product information reported for the Medicaid Drug Rebate Program (MDRP). 

The release describes the impact of new legislation, the Medicaid Services Investment and Accountability Act of 2019, and amends sections 1903 and 1927 of the Social Security Act (the Act). The amendment grants the Secretary enforcement authority to ensure drug manufacturers report accurate drug pricing and product information. Specifically, granting expanded authority to impose civil monetary penalties for knowingly reporting misclassification of drug category, Covered Outpatient Drug (COD) status, and baseline product data. If you would like to conduct a product data review to ensure alignment and compliance specified in this release, please contact your IntegriChain Advisory Lead to discuss any potential corrections or implications. You can read the full CMS Manufacturer Release #113  here.

About the Author

Rupal Patel

Rupal Patel

Executive Director, Operational Consulting

Rupal Patel is Executive Director in IntegriChain’s Operational Consulting practice, responsible for overseeing and leading the Government Pricing Advisory team. She is a recognized trusted advisor to Life Sciences manufacturers with an extensive record of success delivering strategic solutions that improve organizational accuracy, efficiency, and compliance. Currently she oversees more than 150 small- to mid-sized manufacturers and has extensive experience in leading pre-commercial launch projects for both Government Pricing and State Price Transparency.