COVID-19 & Other Medicare Updates - August 2021
Published on
Wednesday, August 25, 2021
COVID-19 Updates
August 12, 2021: FDA Authorized Additional Vaccine Dose for Certain Immunocompromised Individuals
The FDA has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID- 19 Vaccine and the Moderna COVID-19 Vaccine to allow for additional doses “in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” (link). CMS updated their COVID-19 webpage on August 13, 2021 (link), to reflect that they will pay the same amount to administer this additional dose as they did for the other doses (approximately $40 each). .
August 16, 2021: Actemra® (Tocilizumab) Supply Shortage
Genentech released a statement (link) indicating that due to “the unprecedented surge in worldwide demand and supply constraints driven by Delta variant spikes in much of the rest of the world that preceded the current situation in the U.S., has led to a global shortage of Actemra® (tocilizumab) supply for at least the next several weeks…This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV-- well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase.”
August 18, 2021: COVID-19 Booster Shots
The U.S. Department of Health and Human Services (HHS) published a Press Release (link) regarding the need for COVID-19 booster shots. Specifically, data has shown that protection from vaccination begins to decrease over time and they have a plan to begin offering booster shots “subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices.”
Other Updates
July 19, 2021: CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1753-P) – Hospital Price Transparency
The September 17, 2021 deadline to comment on the CY 2022 OPPS and ASC Payment System Proposed Rule is fast approaching. In a related CMS Fact Sheet (link), CMS noted several proposed “modifications designed to increase compliance and reduce hospital burden beginning January 1, 2022.” One key proposal for hospitals to be aware of is the proposed increase in Civil Monetary Penalties (CMP) for non-compliance with the Hospital Price Transparency rule. Specifically, CMS has proposed the following:
- Set a minimum CMP of $300/day that would apply to smaller hospitals with a bed count ≤30, and
- Apply a penalty of $10/bed/day for hospitals with a bed count >30, not to exceed a maximum daily dollar amount of $5,500.
Under the proposed increases, the new penalty for a full year of noncompliance would be a minimum of $109,500 per hospital and a maximum total penalty of $2,007,500 per hospital.
August 11, 2021: Hospital Price Transparency Stakeholder Webinar
This CMS webinar focused on how to meet the requirements of the Hospital Price Transparency Final Rule (link) for posting standard charge information in a comprehensible machine-readable file (link). CMS experts reviewed 8 steps to a Machine-Readable File of All & Services and provided hospital compliance examples. For those that missed this event, a pdf copy of this presentation is available on the Hospital Price Transparency Resources web page (link).
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