In order to provide you with critical information about the COVID-19 pandemic and how it affects your organization, we will regularly update this page with critical information and links to industry, state and federal resources.

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HRSA has published a HRSA COVID resource page regarding COVID-19 and 340B Compliance. Most topics of interest are addressed under the FAQ section of the page. Please continue to refer to this page for ongoing developments.

In addition, the National Association of Community Health Centers (NACHC) resource page also contains up-to-date information concerning your operations during the COVID-19 Pandemic.

Breaking News & Highlights:

CMS NEWS ALERT: April 6, 2020 (COVID-19)

https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/2851cca

NIDA Director outlines potential risks to people who smoke and use drugs during COVID-19 pandemic

https://www.nih.gov/news-events/news-releases/nida-director-outlines-potential-risks-people-who-smoke-use-drugs-during-covid-19-pandemic

Recordings for CMS National Stakeholder Calls on COVID-19 https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/28470b9

AMA quick guide to telemedicine in practice

https://www.ama-assn.org/practice-management/digital/ama-quick-guide-telemedicine-practice

The Affordable Care Act Federal Upper Limits Have Been Updated https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/28457f1

HRSA Webinar, Audit Trends: Findings and Focus Points. Thursday, April 2nd. 

https://secure.340bhealth.org/Shared_Content/Events/Event-Display-RT.aspx?EventKey=WEBAUD120

Trump Administration Makes Sweeping Regulatory Changes to Help U.S. Healthcare System Address COVID-19 Patient Surge

https://www.cms.gov/newsroom/press-releases/trump-administration-makes-sweeping-regulatory-changes-help-us-healthcare-system-address-covid-19 

CMS Approves 38th Section 1135 Waiver 

https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/28400a6

HRSA – Manufacturer Notices to Covered Entities

https://www.hrsa.gov/opa/manufacturer-notices/index.html

UPDATED: HRSA Registration Period

The upcoming registration period will remain the same for now per HRSA OPA. However, HRSA is aware that COVID-19 issues may affect some hospitals ability to complete registration promptly. HRSA will evaluate requests to register outside of the quarterly dates on a case-by-case basis. All requests should be sent to 340B Prime Vendor at apexusanswers@340Bpup.com. For more information on registration guidelines visit https://www.hrsa.gov/opa/eligibility-and-registration/index.html.

UPDATED: Patient Definitions for COVID-19 Related Treatment

Based on recent enforcement through 340B audits, HRSA appears to be less focused on the location of the care and more focused on the relationship the hospital has with the patient. An abbreviated health record such as a single form or note page “may be adequate” during the COVID-19 public health emergency. Such records should still “identify the patient, record the medical evaluation and the treatment provided or prescribed.” HRSA also states that “emergency documentation should be generated” to make clear the relationship between volunteer health professionals and the CE.

UPDATE: HRSA Audit Updates

We understand that all HRSA audits scheduled over the next couple of months will be conducted virtually. Many audits have been postponed either to prepare for remote auditing or at the request of the covered entity. HRSA is moving towards conducting 340B Program audits remotely for the next several months. You may request a postponement or ask to keep your existing audit date. You do not need to provide a lengthy description of the issues your organization is facing that prompt the request for postponement. If you are currently involved in an audit, contact the Bizzell Group on the specifics of your request 340baudit@thebizzellgroup.com.

Health Insurance Providers Respond to Coronavirus (COVID-19) – AHIP

https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/

COVID-19 Search Intensity Monitoring

https://covid19map.uptodate.com/

HITAC to Seek Input on COVID-19 Task Force Priorities

https://www.modernhealthcare.com/information-technology/onc-advisory-group-add-covid-19-task-force

Trump Signs $2T Stimulus Package, Clearing $100B for Struggling Hospitals

https://www.healthcaredive.com/news/trump-signs-2t-stimulus-package-clearing-100b-for-struggling-hospitals/574943/

CMS Approves 34th State Request for Medicaid Emergency Waivers

https://www.cms.gov/newsroom/press-releases/trump-administration-approves-34th-state-request-medicaid-emergency-waivers

CHCs Receive $100M for COVID-19 Response

https://www.healthcaredive.com/news/community-health-centers-coronavirus-funding/574811/

GPO prohibition for 340B hospitals

Hospitals are still subject to GPO prohibition; however, an entity may attempt to purchase drug at WAC and if unable, the hospital may use a GPO if in public health emergency only, and only if, it notifies OPA. Contact 340Bpricing@hrsa.gov immediately in this situation.

Regarding Telehealth and COVID-19

HRSA recommends CEs outline the use of these modalities in their P&Ps and ensure auditable records are maintained for each eligible patient dispensed a 340B drug.

NACHC COVID-19 Webinar Series

National Association of Community Health Centers (NACHC) is hosting a webinar series on COVID-19. Find upcoming webinars and links to join or listen to recordings at http://www.nachc.org/coronavirus/.

Additional Industry, Federal and State COVID-19 Resources:

Novel Coronavirus (COVID-19) Frequently Asked Questions

Informational site for health centers by the Bureau of Primary Care, HRSA

https://bphc.hrsa.gov/emergency-response/coronavirus-frequently-asked-questions.html

340B Health has a COVID-19 Resource Center for Members

http://www/340bhealth.org

https://www.340bhealth.org/members/government-resources/covid-19-resources/

CDC Coronavirus Disease 2019

https://www.cdc.gov/coronavirus/2019-ncov/index.html

Whitehouse Coronavirus Guidelines for America

https://www.whitehouse.gov/briefings-statements/coronavirus-guidelines-america/

Guidance to 340B providers participating in relief efforts during the Public Health Emergency Declaration by the Secretary

https://www.hrsa.gov/opa/eligibility-and-registration/index.html

NCTRC Webinar – Telehealth and COVID 19 – YouTube, March 19, 2020

https://www.youtube.com/watch?v=HtMYM9zdqM0

White House Task Force. To keep up with the work the White Task Force is doing in response to COVID-19 go to Coronavirus.gov.

CMS has launched a dedicated, Medicaid.gov, COVID-19 resource page which is continually updated with relevant information.

The complete COVID-19 FAQs for State Medicaid and CHIP agencies, including those previously issued and those, just released, can be found here:  https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/covid19/index.html

A news alert with further information can be found here: https://www.cms.gov/newsroom/press-releases/covid-19-response-news-alert-cms-frequently-asked-questions-faqs-state-medicaid-and-childrens-health

Direct Relief- https://www.directrelief.org/

See what Direct Relief is doing in the US and across the globe https://www.directrelief.org/emergency/coronavirus-outbreak/

New York: https://nyshealthfoundation.org/resource/covid-19-resources-for-grantees/

Maine: https://content.govdelivery.com/accounts/MEHHS/bulletins/2839dcb

Increased FMAP – Families First Coronavirus Response Act (Public Law 116-127)

https://www.medicaid.gov/state-resource-center/downloads/covid-19-section-6008-faqs.pdf