Background
On Tuesday, May 12, 2020, House Speaker Nancy Pelosi introduced the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act to continue to address the economic impact of the COVID-19 pandemic. The previous pieces of COVID-19 relief legislation worked towards establishing and funding programs to help the economy stay solvent while states were shut down due to stay-at-home orders issued by governors around the country.
The U.S. House of Representatives is set to vote on the legislation on Friday, May 15, 2020.
Prescription Drug Refills
The bill requires private insurers to issue prescription drug refill notifications during the ongoing public health emergency. It also requires group and individual market health plans to notify consumers if their plan permits advance prescription drug refills during an emergency period.
Supply Chain Improvements
The legislation creates a Medical Supplies Response Coordinator that the President is required to appoint. The Medical Supplies Response Coordinator would serve as the point of contact for the healthcare system, supply chain officials, and states on medical supplies, including personal protective equipment (PPE), medical devices, drugs, and vaccines. The appointee for the Medical Supplies Response Coordinator position would be required to have healthcare training and a deep understanding of medical supply chain logistics.
The bill requires drug manufacturers to report on foreign drug manufacturing sites and submit quarterly reports on the volume of drugs manufactured at those sites.
The HEROES Act seeks to encourage domestic manufacturing of critical drugs by requiring the National Academies of Science, Engineering, and Medicine (NASEM) to provide recommendations to increase domestic manufacturing.
The legislation provides the U.S. Food and Drug Administration (FDA) new enforcement mechanisms related to ASHP’s drug shortage recommendations, including requiring timely notification of a permanent discontinuance or interruption in the manufacturing of certain drugs and the reasons for such discontinuance or interruption, and requiring manufacturers to develop a risk management plan, as required under current law.
The FDA will work with the National Centers of Excellence (NCEs) and the pharmaceutical industry to craft a national framework for the implementation of continuous manufacturing of drugs. The framework will include supporting additional research and development of this technology, workforce development, standardization, and collaborating with manufacturers to support adoption of continuous manufacturing of drugs.
Vaccine Manufacturing
The HEROES Act requires the Secretary of Health & Human Services (HHS) to award contracts, grants, cooperative agreements, and enter into other transactions, as appropriate, to expand and enhance manufacturing capacity of vaccines and vaccine candidates to prevent the spread of COVID¬19. It also requires a report on the vaccine supply necessary to stop the spread of COVID-19, the manufacturing capacity to produce vaccines, activities conducted to enhance such capacity, and plans for continued support of vaccine manufacturing and administration.
Essential and Frontline Worker Hazard Pay
The legislation allocates $200 billion to hazard pay for essential and frontline workers who are risking their lives during this public health crisis. The hazard pay funds come in the form of a grant, which individuals within the approved professions can apply for. Pharmacists are included within the approved professions eligible for hazard pay. Pharmacists in inpatient, outpatient and retail settings would be eligible for this hazard pay if their employer received a grant.
Practical Implications and Next Steps
The HEROES Act will most likely be passed by the House and will probably stall in the U.S. Senate, because Senate leadership is in the process of drafting their own legislation in response to the COVID-19 public health emergency. House and Senate leaders will need to come together and compromise on their versions. If you have any questions on this legislation, please contact Doug Huynh at [email protected].