REMDESIVIR DISTRIBUTION & DATA REPORTING
Urgent RDV Allocation Process Changes: In response to the updates made to the HHS RDV distribution process to hospitals, the LDH is asking hospital pharmacy directors to email email@example.com their weekly requested allocation amounts by 5:00 p.m. on Wednesdays, starting today, so that the allocation data supplied by LDH to HHS can be as accurate as possible to meet the anticipated needs of each hospital in our state and the quantity each facility intends to purchase. LDH issued a memo outlining the changes to the process and the impacts to the existing allocation methodology. If you have additional questions, contact LDH Director of Pharmacy Services Leah Michael at firstname.lastname@example.org.
July 21 Alert: ESF-8 Adds HHS-Required Data Fields to Portal; LDH to Submit Hospitals’ Data Starting July 22: Last week, the U.S. Department of Health and Human Services (HHS)
announced changes to its process for collecting mandated daily COVID-19-related data from hospitals. The request included a small subset of additional data items that was mandated to be reported beginning last Wednesday and the remaining set of additional data fields listed in the
Guidance for Hospital Reporting Document that must be reported beginning tomorrow, July 22.
The Louisiana Department of Health’s (LDH) ESF-8 Portal was able to meet last week’s data reporting requirement by adding four new fields to the COVID View in Resource Management, and
the Department will meet tomorrow's requirement with the remaining data fields being accessible in Resource Management effective at midnight tonight. HHS has given LDH permission to start collecting this data and submitting it to HHS on hospitals’ behalf beginning tomorrow.
Four new COVID Views were added to compile and organize the additional mandated fields in the ESF-8 Portal:
COVID Hospitals-1: Contains most of the original COVID fields in place since March
COVID Hospitals-2: Contains the new data elements relating to adult admits by age group for both COVID-Positive and COVID-PUI (Pending). It also includes data about ED visits.
COVID Hospitals-3: Contains most of the new data about staffing and supply shortages
COVID Hospitals-4: Contains the remainder of the supply and inventory questions
LDH is currently evaluating some language changes and a requirement to add an additional field, so hospital staff members are reminded to monitor ESF-8 Portal messages, as LDH will be sending additional materials today and tomorrow. Hospitals should contact their
Designated Regional Coordinators if they have any questions regarding data reporting.
IMPACT Weekly Article Posted July 14: Remdesivir Allocation Reporting Deadline:
HHS notes it will no longer ask for one-time requests for data to aid in the distribution of remdesivir or any other treatments or supplies. For the distribution or remdesivir, HHS will be pulling data on Wednesday of each week from the information
reported by hospitals (either through their state health department or the TeleTracking portal). As a result, HHS asks that hospitals report all of the data elements included in the recently-updated
Guidance for Hospital Reporting on a daily basis beginning no later than Wednesday, July 22. The Guidance
document provides information about what to report, where to report and when to report. For additional information, see
AHA’s special bulletin on
Remdesivir Update: On June 29, HHS announced
that it has secured 500,000 additional treatment courses of remdesivir from Gilead and its distributor, AmeriSource Bergen, that will be available to hospitals for purchase at the negotiated price of approximately $3,200 per average treatment course
and will be distributed during the months of July, August and September. Hospitals will be allowed to make purchases every two weeks for the allocated product amount determined by the federal government and their state health department. This
determination will be made using hospital-reported information on the number of currently-hospitalized COVID-19 patients and, of those hospitalized, the number requiring placement in ICUs.
Distribution Method: Unlike previous distributions, state departments will communicate to AmeriSource Bergen how the remdesivir should be allocated to their hospitals, and AmeriSource Bergen will deliver it directly to the designated facilities. To facilitate this distribution and the billing for the product received, hospitals will need to have a relationship with AmeriSource Bergen. If your hospital does not already have a relationship with
AmeriSource Bergen, you are encouraged to establish one immediately.
Louisiana Shipment of Donate Remdesivir: Hospitals can request vials as needed by contacting State Pharmacist Leah Michael at
STATE DATA REPORTING
On July 22, HHS sent a letter to LDH stating that the State of Louisiana is certified for reporting hospital capacity and utilization
data, along with in-house laboratory testing data.
- New ESF-8 Data Fields/Page: In order to meet the additional data elements currently not captured but required by HHS and FEMA, ESF-8 released modifications to the ESF-8 portal that include a dedicated page for all COVID responses and two new data fields added to this page including “Number of suspected or confirmed COVID-19 patient deaths in the facility within the past 24 hours” and “PPE Supply on-hand.”
Daily ESF-8 Reporting Clarification: For ESF-8 daily reporting, LDH recently clarified that the two data fields, “Total COVID-Positive Patients” and “Total COVID-Pending Patients” should only include inpatient cases. Please make sure your hospital is not including outpatient cases in the count for these data fields.
Two LDH Portal Updates: On April 2, LDH issued an alert requesting that hospitals update their ventilator information on the Resource Management Page in the ESF-8 Portal as they receive additional ventilators. In addition, LDH has added a data text field, “Lab(s) Used for COVID Testing,” to the Resource/All Hospitals webpage. Hospitals should add this information as soon as possible, and update it when changes occur. Some hospitals may be receiving error messages because of the lack of data in the new field. See the LDH handout
for more information.
- Additional ESF-8 Data Field Added: On March 28, LDH added a bed category to the ESF-8 Portal to capture staffed ICU surge bed capacity to facilitate the allocation of ventilators acquired by the state. LDH has provided a screenshot
that shows how to add the Surge ICU bed category through MSTAT on the Bed Mapping screen.
- Additional Daily ESF-8 Reporting for All Hospitals: On March 26, LDH requested that all Tier 1 and Tier 2 hospitals update six data points regarding COVID-19 patient treatment in the ESF-8 Portal daily by 10:00 a.m. CT until further notice.
- Mandatory Bed Poll Reporting for Tier 1 & Tier 2: On March 20, LDH mandated
daily bed poll reporting and ventilator counts for all Tier 1 and Tier 2 hospitals, effective immediately. The timeframe for reporting is between 12:00 a.m. and 10:00 a.m. every day until further notice.
FEDERAL DATA REPORTING
- Hospital Daily Data Reporting Guidance and FAQs: On July 31, HHS updated its guidance and FAQs regarding the agency’s request for daily COVID-19-related hospital data reporting. The most notable changes are detailed below, and the updated guidance is effective immediately. HHS made two significant changes to the process of reporting certain supply data:
- Hospitals may decrease the frequency of reporting supply-related data fields – i.e., items 26-32 in the guidance document’s table – from daily to three times per week. Specifically, HHS is asking hospitals to report these data on Mondays, Wednesdays and Fridays.
- For the data fields asking hospitals for the days of on-hand supply (i.e., items 27 and 28 in the guidance document’s table), hospitals now have the option of selecting a range of days, rather than calculating a specific number.
As of last week, HHS has begun to deploy “Hospital Data Liaisons.” These teams are working collaboratively with states to obtain information about barriers to reporting complete data, and over time, are expected to help states and hospitals obtain additional clarification and guidance around reporting requests. HHS has included an FAQ on hospital data liaisons, along with five other FAQs that address, among other topics, how to fix data errors; how organizations, like hospital associations, can get access to data; and what hospitals should do if they cannot report data on weekends. The LHA has a call scheduled today with HHS to obtain further guidance and will send an Alert to hospital leaders later today. See AHA’s July 13 Special Bulletin for additional details on the options hospitals can use to fulfill HHS’s reporting request.
- Daily Data Reporting Changes: HHS
announced significant changes to the federal reporting process for hospitals related to bed capacity,
utilization, personal protective equipment and in-house lab testing data. Most notably, the National Healthcare Safety Network reporting module will no longer be an option for daily data reporting beginning Wednesday, July 15. Hospitals should
report data through their state health department or the HHS TeleTracking portal. HHS sent hospital administrators a
letter outlining the change and providing the seven data elements that are due tomorrow, July 15.
Important Notice: LDH has been reporting the federal daily data reporting requirement on behalf of Louisiana hospitals for several months, but HHS has made considerable changes to the data fields that it is asking for in daily
reporting, including information on both pediatric and adult patients, staffing and remdesivir inventory. The LHA is clarifying whether, with these new data fields, LDH will be able to continue reporting daily data to HHS on behalf of Louisiana
hospitals. Until that determination is made, hospitals are encouraged to read the announcement very carefully and report the data as requested.
- Federal Data Reporting on Bed and Ventilator Capacity:
On April 18, LDH sent a letter to hospital administrators announcing that the Department
has obtained approval from the FEMA to provide requested data on behalf of Louisiana hospitals utilizing the ESF-8 Hospital Portal. Therefore, hospitals are released of the requirement to meet the reporting obligations outlined in a letter from Vice President Mike Pence on March 29, 2020 and a letter from HHS Secretary
Alex Azar on April 10, 2020.
- COVID-19 Testing Results from In-House Laboratories: Hospitals are still responsible for reporting their in-house and commercial lab testing data directly to HHS via the HHS Protect System. As hospitals acquire in-house laboratory testing capabilities for COVID-19, they should contact the FEMA/HHS COVID-19 Diagnostics Task Force at email@example.com for support and access to the HHS Protect System.
Hospitals with in-house laboratory testing are asked to email testing data using the provided standardized template
by 5:00 p.m. ET daily to firstname.lastname@example.org. Data should reflect the results through
midnight of the previous day. According to the letter, hospitals that send all their COVID-19 testing to select commercial labs do not need to submit data for this request.
ADDITIONAL DATA RESOURCES & GUIDANCE
Best Practices: HHS created a page
with resources for healthcare planning and infectious disease. In addition, FEMA shared a website
that compiles lessons learned from around the country, including for medical practitioners.
- Regional Projections from LDH: On April 16, LDH released
regional planning projections to “show that while aggressive mitigation measures appear to be effectively flattening the COVID-19 curve, Louisiana could be grappling with the virus at least until the end of the year.” (LDH
- FEMA Resource Guidance: FEMA Healthcare Resilience Task Force released a COVID-19 Hospital Resource Package that offers tools to help hospitals prepare for and respond to the pandemic.
- HIPAA and Data Sharing: HHS Office for Civil Rights issued new guidance stating
that it will not penalize healthcare providers or their business associates for violations of certain HIPAA provisions in response to COVID-19. HHS said good faith uses and disclosures of PHI to the CDC, CMS, state and local health departments,
and state emergency operations centers will help with the exchange of information to flatten the curve.