Knowledge Base Article

COVID-19 Updates

December 16, 2021: MLN Connects Reminder: Changes for MA Plan Claims Starting January 1, 2022

CMS reminded providers in the December 16 edition of MLN Connects (link) that “if you vaccinate or administer monoclonal antibody treatment to patients enrolled in Medicare Advantage (MA) plans on or after January 1, 2022, submit claims to the MA Plan. Original Medicare won’t pay these claims.”

December 22nd & 23rd, 2021: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 by Pfizer

• December 22nd: The FDA announced (link) the issuance of an Emergency Use Authorization (EUA) for Pfizer’s Paxlovid for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients twelve years and older weighing at least 40 kilograms.
• December 23rd: The FDA announced (link) the issuance of an EUA for Merck’s molnupiravir to treat mild-to-moderate COVID-19 in adults with a positive test for the disease and “who are at high risk for progression to severe COVID-19, including hospitalization or death.”

December 24, 2021: CDC Health Advisory – Rapid Increase of Omicron Variant Infections in the United States

The CDC released an official CDC Health Advisory (link) containing updated recommendations “to enhance protection for healthcare personnel, patients, and visitors, and ensure adequate staffing in healthcare facilities” in response to the increased transmissibility of the Omicron variant.

December 31, 2021: CDC Health Advisory – Using Therapeutics to Prevent and Treat COVID-19

In this Health Advisory (link), the CDC acknowledges that the SARS-CoV-2 Omicron variant has become the dominant variant of concern in the United States and that there are therapeutics available for preventing and treating COVID-19 in specific at risk populations. The CDC notes that this advisory “serves to familiarize healthcare providers with available therapeutics, understand how and when to prescribe and prioritize them, and recognize contraindications.

January 3, 2022: FDA Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

The FDA announced (link) amendments to the EUA for the Pfizer-BioNTech COVID-19 vaccine to:

• “Expand the use of a single booster dose to include use in individuals 12 through 15 years of age,
• Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months, and
• Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.”

Other Updates

Revised MLN Fact Sheet: Intravenous Immune Globulin (IVIG) Demonstration

CMS noted in the December 23rd Edition of MLN Connects that the IVIG Demonstration Fact Sheet (link) has been revised to add the 2022 payment rate for Q2052 and added Asceniv (J1554) to the list of drugs covered in this demonstration.

December 16, 2021: Medicare Clinical Laboratory Fee Schedule Private Payor Data Reports – Delayed until 2023

CMS included the following information in the December 16th Edition of MLN Connects (link):

“On December 10, the Protecting Medicare and American Farmers from Sequester Cuts Act delayed the Clinical Laboratory Fee Schedule private payor reporting requirement:

• Next data reporting period is January 1 – March 31, 2023
• Reporting is based on the original data collection period, January 1 – June 30, 2019

The Act also extended the statutory phase-in of payment reductions resulting from private payor rate implementation:

• No payment reductions for Calendar Years (CYs) 2021 and 2022
• Payment won’t be reduced by more than 15% for CYs 2023 through 2025

Visit the PAMA Regulations webpage for more information on what data you need to collect and how to report it.”

December 21, 2021: Medicare Overpayment for Chronic Care Services

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M published a notice (link) regarding overpayments for Chronic Care Management (CCM) Services noting that the MACs have been directed by CMS to recoup CCM Services claims identified as overpayments by the OIG.

December 27, 2021: CMS Posts FAQ Document regarding Good Faith Estimates (GFEs) for uninsured (and self-pay) Individuals

The CMS has posted an FAQ document (link) regarding implementation of Section 112 of Title I (the No Surprises Act (NSA)). The very first FAQ is a reminder that “providers and facilities are required to provide GFEs to uninsured (or self-pay) individuals in connection with items or services scheduled, or upon the request of the uninsured (self-pay) individual, on or after January 1, 2022.”

December 28, 2021: CMS Removed CPT Code from Prior Authorization and Pre-Claim Review Initiatives

CMS posted the following update (link) to their Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webpage:

“Beginning for dates of service on or after January 7, 2022, CMS is removing CPT 67911 (correction of lid retraction) from the list of codes that require prior authorization as a condition of payment. This service is not likely to be cosmetic in nature and commonly occurs secondary to another condition. The full list of HCPCS codes has been updated to reflect this change.”