COVID-19 Expanded Access Template

March 19, 2020 Alerts and Newsletters

We are aware that many companies and health care providers are working to expedite the transfer of investigational drugs that may be helpful in treating patients suffering from COVID-19. Although these expanded access arrangements are not required to be and are not always documented in written agreements, there can be benefits to both parties (company and treatment provider) to memorializing the circumstances of the provision of an investigational drug.

To that end, we have created a simple Memorandum of Understanding template that may be useful to companies and providers seeking to document these arrangements quickly and efficiently in light of the current public health emergency. The template is intentionally streamlined and balanced, to capture the common denominator of terms that are often included in these agreements in a way that is reasonable for both parties. The template is drafted to focus on the provision of investigational drugs, as we understand drugs to be the primary expanded access treatment option at this stage of the pandemic. To the extent there is a demand for the expanded access use of investigational devices, this template can be modified (or we can tailor and re-circulate a device version). The template is also focused on the requirements for expanded access under the FDA’s regulations (21 C.F.R. § 312.300 et seq.) and would require modification for the provision of investigational drugs pursuant to the federal Right to Try Act.

Please note that this template is not intended as legal advice, and our circulation of this resource does not create an attorney-client relationship. We merely want to make as many tools available to the regulated community as we can during these challenging times.

Click here to download the Memorandum of Understanding template.

Firm Highlights


HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...


The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...


Verrill Welcomes Jeffrey A. Smagula, Experienced Health Care and Life Sciences Attorney, Former Health Plan Compliance Executive

(May 12, 2021) – Verrill is pleased to welcome Jeffrey A. Smagula to the firm’s Boston office as Counsel in its nationally recognized Health Care & Life Sciences Group. Jeff Smagula brings to Verrill...


Massachusetts Health Care Bill Makes Several Significant Changes

While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...


340B Providers Get Partial Relief from New Dispute Resolution Regulation

1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...


Hospital Price Transparency Rule: Full Steam Ahead

Neither COVID-19 nor continued legal challenges appear likely to derail the Centers for Medicare & Medicaid Services ( CMS) Hospital Price Transparency Rule from going into effect on January 1, 2021. Hospitals therefore should...


65 Verrill Attorneys Recognized by Best Lawyers® 2022, Including Eight Named Lawyers of the Year

(August 31, 2021) – 65 Verrill attorneys were recognized as "Best Lawyers" by Best Lawyers® 2022 , including 8 attorneys named “Lawyer of the Year,” a distinguished recognition for only a single lawyer in...


“If I've told you once, I've told you eight times…” HHS OIG Issues Another Audit Report on Hospitals’ Failure to Report Credits for Explanted Cardiac Devices and Lays the Groundwork Collection of Overpayments


Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition.

Health care attorney Paul Shaw co-authored Fraud and Abuse Investigations Handbook for the Health Care Industry, Second Edition with Robert Griffith, published by the American Health Law Association (AHLA). Paul and Robert provide legal...

Contact Verrill at (855) 307 0700