Are you ready for 2021 Public Law?

October 20, 2020 | Life sciences

On October 1, 2020, The Department of Veterans Affairs (VA) Office of the Inspector General (OIG) released a draft version of the 2021 PBM Annual Guidance Dear Manufacturer Letter (PBM DML) detailing this year’s public law timeline.

Here are some tips to help you prepare for the upcoming Public Law:

1. Read the PBM DML and visit the VA’s Office of Procurement and Logistics (OPAL) website to familiarize yourself with the timeline and requirements.
2. Review your company and product information on the VA’s National Acquisition Center (NAC) website. Here you can find the products listed on the Federal Supply Schedule (FSS) and their prices (including the Industrial Funding Fee). Below are some general items you should look out for: 
   1. Is the information correct as of September 30, 2020?
   2. Are there any products that are off the market that need to be removed?
   3. Are there any missing products that should be added on to the FSS?
   4. Is the individual who is listed as the “Contact for Contract Administration” still appropriate as this is the person who will receive the Public Law documents via email?
      1. Quick tip: Click on any of the NDC numbers on that front page to view additional company information. 
   5. If any of the information on the NAC is incorrect, submit the appropriate Request for Contract Modification.
3. Confirm the Tracking Customer, Tracking Customer Price, and Ratio for each product on the Federal Supply Schedule.
4. Review the company’s SAM.gov entity registration and make appropriate updates.   
   1. SAM.gov is the US Government’s System for Award Management. Any company wishing to do business with the government must maintain an active account that is updated annually. Like the NAC, it is important that manufacturers keep the information on this site current to prevent any Public Law hurdles.
   2. If the Entity Administrator has left the company, you will need work with the Federal Services Helpdesk (Please note: Due to COVID-19 they are temporarily not fully staffed to field phone calls) to update the administrator. This involves scanning a notarized letter from a company officer to the helpdesk (COVID-19 has not changed that requirement).
5. Calculate your Non-FAMP/FCP as early as possible
   1. Calculating early can provide more time for additional Public Law activities such as restatements. 
   2. Once you have calculated the 3rd Quarter 2020 Non-FAMP and the 2020 Annual Non-FAMP, it is time to compare the 3rd Quarter 2020 Non-FAMP to the 3rd Quarter 2019 Non-FAMP. This is done to check if the Non-FAMP increased above the rate of inflation leading to an additional penalty on 2021 FCP.
      1. There are two situations in which a recalculation of 3rd Quarter 2019 Non-FAMP would be required, if necessary:
         1. If the prices were calculated under different methodologies (direct method vs. wholesaler method), the 3rd quarter 2019 Non-FAMP must be re-calculated using the methodology used to determine the 3rd quarter 2020 Non-FAMP. 
         2. If you have changed your step by step Non-FAMP calculation methodology this year and it has been approved by the VAOIG, 3rd quarter 2019 Non-FAMP should be re-calculated to match the methodology used for the 3rd quarter 2020 Non-FAMP calculation.

Public Law reporting is a requirement for companies to be compliant with the VA. Deloitte’s team of professionals is available to assist life sciences companies through the Public Law process.

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