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November 12, 2020

HHS Issues Regulations and Guidance on COVID-19 Therapeutics and Vaccines

Although COVID-19 cases, hospitalizations, and deaths are climbing at an alarming rate, we did receive some positive news this week that will help us in our ongoing effort to combat the virus. As I’m sure you saw, on Monday, November 9, Pfizer announced that its vaccine has proven to be more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection (I should note that these are initial results and that more data, especially on the safety of the vaccine, are forthcoming and still need to be analyzed). Further, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab, for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

While these announcements are a great first step, the road ahead to ensuring the safe and effective distribution and administration of COVID-19 vaccines and therapeutics is long. It will be essential going forward that you as emergency physicians understand not only the clinical effectiveness and appropriate use of these vaccines and therapeutics, but also the rules and payment mechanisms associated with them.

In other words, we must have solid regulations in place that will mitigate confusion and ensure smooth distribution and administration processes. The Department of Health and Human Services (HHS) has already issued some useful regulations and guidance around vaccines and therapeutics. With respect to vaccines, the Centers for Medicare & Medicaid Services (CMS) within HHS announced a series of actions at the end of October to ensure that many Americans have access to the COVID-19 vaccine at no cost when it becomes available. CMS released a regulation that allows for Medicare coverage of any vaccine that the FDA authorizes without beneficiary cost sharing. The reg also implements CARES Act requirements providing private health plan coverage of a COVID-19 vaccine without cost sharing from in- and out-of-network providers during the public health emergency.

CMS has also issued toolkits for state Medicaid agencies, health care practitioners, and health insurance plans that provide important information on the vaccine related to coverage and reimbursement. The agency also released new Medicare provider payment rates for COVID-19 vaccine administration, including setting the rate at $28.39 for administration of single-dose vaccines.

Moving on to therapeutics, after the FDA issued the new emergency use authorization for bamlanivimab earlier this week, HHS announced plans to distribute an initial 300,000 doses of the therapy to states and territorial health departments. HHS states that it has the ability to purchase up to another 650,000 doses by the middle of next year. CMS, in turn, announced that Medicare will cover the therapy at no cost to beneficiaries. The agency also released some initial billing and coding instructions for health care providers. The Medicare payment rate for the administration of bamlanivimab will be $309.60.

I understand that regulations are only one piece of the puzzle to ensuring that you have the information and resources you need to protect yourself and properly treat your patients. There are significant operational, supply chain, and storage and handling issues that go way beyond regs. These challenges are being addressed in part by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Biomedical Advanced Research and Development Authority, the Department of Defense, and other federal agencies through Operation Warp Speed.

However, I am sure that when vaccines are approved and additional therapeutics become available, you will have numerous questions that existing regulations and Operation Warp Speed have not yet addressed. As these issues come up, please send them to me. ACEP has biweekly discussions with the CDC and is in constant communication with the FDA and other HHS officials. We are committed to ensuring that your questions and concerns are addressed in a timely manner.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs!

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