August Updates - FFR Changes, 340B Alert, Stimulus Pending, & More
FEDERAL FINANCIAL REPORTS SUBMITTED IN PMS, NO LONGER EHB
If you received the LAL-ECT grant, you will be required to submit Federal Financial Reports (FFR). Starting September 25, HRSA will stop accepting FFR submissions through the EHBs. The FFR will be available for recipients to prepare, certify, and submit in the Payment Management System (PMS) starting October 1, 2020. Recipients will receive a notification when the FFR becomes available and is ready for submission in PMS.
Note, you’ll still receive e-mail notifications to submit FFRs from EHB, but it will not pop up as a task in your Tasks feed. The EHB will also catalog past FFRs submitted, in a read-only format. If you’re submitting a Prior Approval to carry over funds, this will be accomplished through the EHB, not PMS.
You won’t be able to request FFR extensions through the EHB after October 1. If you need an extension, you’ll have to contact your Grants Management Specialist (GMS). This individual is listed at the end of your LAL-ECT Notice of Award (NoA).
For more information, search your inbox for an email from oitgems@hrsa.gov, sent to you Thursday August 13th titled “FFR Training: Consolidation of Financial Reporting.”
MERCK & SANOFI’S REQUEST FOR 340B DATA
August 12th, NACHC sent out an e-mail penned by Feldesman Tucker Liefer Fidell LLP (FTLF) to FQHCs warning them of Merck and Sanofi’s threatening letters. Merck and Sanofi have been asking health centers send them extensive data on all of their 340B-priced drugs dispensed via contract pharmacies, using a platform called 340B ESP.
NACHC asked for 340B ESP’s Terms of Use and found several concerning items. The terms give Second Sight, a “royalty-free, perpetual, irrevocable license” to disclose and sub-license all the data the health center submits. In addition, the terms require health centers: 1) waive the option for a class action lawsuit; 2) submit an invoice number with every claim; 3) submit data on all drugs sold by the manufacturer, not just those related to Medicaid; 4) submit and correct data in the time frames selected by 340B ESP. Second Sight is seeking to monetize data owned by health centers for the manufacturer’s benefit. The manufacturers have no right to the data they are requesting and the majority of it has no connection to any compliance obligations for covered entities.
For the outlined reasons, health centers considering registered on 340B ESP are strongly advised to review the Terms of Use and consult legal counsel before agreeing to them.
NACHC is sending a letter to Second Sight, Merck, and Sanofi, outlining these issues and will share with us soon. If you have any additional questions, you can contact Colleen Meiman at cmeiman@nachc.org.
KEEP UP THE PRESSURE
Congress and the Senate went to recess without coming to a compromise on the latest coronavirus stimulus package. NACHC has published a wonderful template e-mail tool that will take you all of five minutes to fill out. Share this with your staff, your community partners, and make time to put in a phone call to your representatives!
Here is what the letter, penned by NACHC’s Health Center Advocacy Center, is requesting:
The inclusion of health center look-alikes in those able to access the $7.6 billion of emergency COVID-19 relief funds;
An extension of the PPP that would allow health centers with over 500 employees to be eligible for the program; and,
Equal reimbursement for health centers' for Medicare telehealth visits.
NEW INSTRUCTIONS FOR LOOK-ALIKE INITIAL DESIGNATION
August 13th, HRSA published a new instruction manual for Look-Alike initial designations. Yes, most of you won’t be filing this because you’re already a designated Look-Alike. However, for those of you who applied recently, were denied, and are looking to apply again: do NOT copy/paste your old application. Be mindful of the changes. Page 3 of 53 gives a summary of changes, click HERE to read.
LOOK-ALIKE RENEWAL OF DESIGNATION APPLICATIONS DUE OCTOBER 2, 2020
If you were held to a one-year project period that expires this year, you’ll be filing the Renewal of Designation (LAL-RD) application. If you have a three-year project period expiring this year, HRSA has granted a one-year extension, asking you complete the Annual Certification (LAL-AC) application (i.e. the abbreviated report you file in years 2 and 3). The extension was granted due to COVID.
GRANTS MANAGEMENT POLICIES AND PROCEDURES
We have received several emails from Look-Alikes asking for template policies and procedures to meet requirements set forth for FQHC grantees. Now that you received the LAL-ECT grant, you’re expected to demonstrate compliance with all those requirements you were exempt from in the past, dealing with federal grants management. If you have developed policies you feel meet compliance with HRSA’s requirements and you’re willing to share these with your fellow Look-Alikes, please contact us.
