HPoP Attestation Language
As an organization participating in the HHS Test to Treat focused effort to distribute USG-procured therapeutics, I have read, understand, and hereby attest that all relevant officers, directors, employees, and agents of my organization understand and will comply with the following terms of agreement as conditions precedent to receiving and distributing USG-procured therapeutics. [Organization acknowledges enrollment in the ‘Test to Treat’ program. Partner attests that programs enrolled in Test to treat program are able to provide/offer comprehensive end-to-end testing (including evaluation of at-home testing), assessment, prescription, and dispensing of COVID therapeutics to support a seamless patient experience.]
- Dispense or administer COVID-19 therapeutics consistent with FDA authorization AND in accordance with guidance from HHS, and all applicable federal, state, local, and territorial dispensing laws.
- Adhere to all required dispensing requirements and other requirements of the program in accordance with the FDA, applicable regulations, and other posted guidance/requirements. Agreement expressly incorporates all recommendations, requirements, and other guidance provided by HHS officials. Organization must monitor and comply with updates posted at https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html
- Preserve the therapeutics recipient’s record following dispensing in accordance with federal law and regulations.
- Not sell or seek reimbursement for publicly funded COVID-19 therapeutics that the federal government provides at no cost to Organization.
- Dispense COVID-19 therapeutics regardless of the therapeutic recipient’s coverage status or ability to pay for COVID-19 therapeutics dispensing fees. Organization may seek appropriate reimbursement from a program or plan that covers COVID-19 therapeutics dispensing fees for the therapeutics recipient. Organization may not seek any reimbursement, including through balance billing, from the therapeutic recipient. Organization may not charge an office visit or other fee if dispensing of the COVID-19 therapeutic is the sole medical service provided. Organization may not require additional unrelated medical or other services or purchases as a condition precedent to receive the COVID-19 therapeutic.
- Report data on number of courses of COVID-19 therapeutics dispensed or administered, and on-hand. All required data will be reported through HPoP in defined reporting cadence (daily, weekly etc.) directed by HHS officials.
- Before dispensing COVID-19 therapeutics, provide an approved EUA fact sheet, as applicable, to each therapeutic recipient, the adult caregiver accompanying the recipient (if applicable), or other legal representative (if applicable). If the EUA factsheet is available electronically, Organization may provide it electronically if each recipient, the adult caregiver accompanying the recipient (if applicable), or other legal representative (if applicable) agrees to accept it electronically in the file format offered by the Organization
- Comply with HHS requirements for pharmaceutical management, to include the following:
- store and handle COVID-19 therapeutics under proper storage, security, inventory management and handling conditions;
- monitor and comply with therapeutics expiration dates; and
- preserve all records related to COVID-19 therapeutics management as required by federal, state, local, or territorial law.
- Periodically report the number of doses of COVID-19 therapeutics that were unused, spoiled, expired, or wasted as required by the relevant HHS will provide further instruction on how and when to report, however, Organization must report any COVID-19 therapeutics that are lost or damaged upon expected delivery pursuant to the process provided by the delivery service and to HHS within 24 hours.
- Comply with all federal instructions and timelines for disposing COVID-19 therapeutics including unused doses as applicable.
- Report relevant adverse events (AEs) after therapeutic dispensing to MedWatch or in accordance with EUA conditions of This reporting requirement applies to AEs that Organization knew or should have known had occurred. Organization must also comply with any other applicable dispensing or safety reporting requirements under federal, state, local, and territorial law.
- Organization may use contractors to perform some or all of Organization’s duties under Agreement. However, Organization must ensure that any contractor performs its duties in full compliance with Agreement and Organization is responsible under Agreement for any non- compliance with Agreement by any of its Furthermore, any knowledge concerning or resulting from performance of Agreement by any of Organization’s contractors is imputed to Organization.
Conditions listed above are material conditions of payment for publicly funded COVID-19 therapeutic dispensing claims submitted by Organization to any federal healthcare program, including but not limited to Medicare and Medicaid, or any HHS-sponsored COVID-19 relief program, including the Health Resources & Services Administration COVID-19 Uninsured Program. The conditions listed above, however, do not list all material conditions of payment for these programs. Organization must review the applicable statutes and regulations governing each federal healthcare program and any HHS-sponsored COVID-19 relief program for program-specific conditions. Reimbursement for dispensing COVID-19 therapeutics is not available under any federal healthcare program or any HHS- sponsored COVID-19 relief program if Organization fails to comply with any of the above-listed conditions or any other material condition of payment with respect to the dispensed COVID-19 therapeutics. Each time Organization submits a reimbursement claim for COVID-19 therapeutics dispensing to any federal healthcare program or any HHS-sponsored COVID-19 relief program, Organization expressly certifies that it has complied with all conditions of payment, including but not limited to conditions listed above.
Non-compliance with the terms of Agreement may result in suspension or termination from the HHS COVID-19 therapeutic dispensing Program and criminal and civil penalties under federal law, including but not limited to the False Claims Act, 31 U.S.C. § 3729 et seq., and other related federal laws, including but not limited to 18 U.S.C. §§ 1001, 1035, 1347, 1349.
HHS may terminate this Agreement with two weeks written notice.
Organization may cease its participation in the HHS COVID-19 Therapeutic Dispensing Program. To do so, Organization must provide written notice to HHS no later than two weeks before Organization wishes to end its participation. During that period, Organization must comply with Agreement and Organization will not receive any further deliveries of COVID-19 therapeutics.
By entering Agreement, Organization does not become a government contractor under the Federal Acquisition Regulation. In addition, this document is not intended to, and does not create a contractual relationship that would result in the signing entity be considered or treated as a contractor of the federal government for purposes of the September 9, 2021, Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.”
Coverage under the Public Readiness and Emergency Preparedness (PREP) Act extends to Organization if it complies with the PREP Act and the PREP Act Declaration of the Secretary of Health and Human Services and any amendments to that declaration.