Knowledge Base Article

In this New Year, I hope all of our readers found some joy during the holiday season while socially distancing, wearing your masks and washing your hands. Having taken a couple of weeks off from our full newsletter, we are getting back to business. MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from December 15th, 2020 through January 4, 2021.

Resource Spotlight: Avoid COVID-19 Vaccine Scams

With the roll-out of COVID-19 vaccines, reminders abound to protect yourself against vaccine scams. Do you know the signs of potential scams? On December 21, 2020, Federal Agencies warned of emerging fraud schemes related to COVID-19 vaccines. This two page document includes:

• Potential indicators of fraudulent activity,
• Tips to avoid COVID-19 vaccine-related fraud, and
• General online/cyber fraud prevention techniques.

They Federal Agencies have also released a pdf document titled Protect Yourself Avoid COVID-19 Vaccine Scams.

December 13, 2020: 8 Things to Know about the U.S. COVID-19 Vaccination Program

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html?ACSTrackingID=USCDC_2067-DM44618&ACSTrackingLabel=Vaccines%20%7C%20COVID-19&deliveryName=USCDC_2067-DM44618

December 15, 2020: FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

The FDA announced a EUA for the Ellume COVID-19 Home Test. This is the first over-the-counter (OTC) fully at home diagnostic test granted EUA. FDA Commissioner Stephen M. Hahn, M.D. noted in this announcement that “today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can but it, swab their nose, run the test and find out their results in as little as 20 minutes.”

December 14 & December 18 2020: Special Edition MLNConnects - COVID-19 Vaccine Codes for Pfizer-BioNTech and Moderna

Late in the afternoon, CMS issued the following information regarding the Pfizer-BioNTech Vaccine:

“On December 11, 2020, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Review Pfizer’s Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) regarding the limitations of authorized use.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for the administration of the vaccine (when furnished consistent with the EUA). Review our updated payment and HCPCS Level I CPT code structure for specific COVID-19 vaccine information. Only bill for the vaccine administration codes when you submit claims to Medicare; don’t include the vaccine product codes when vaccines are free.

Related links:

• CMS COVID-19 Provider Toolkit
• CMS COVID-19 FAQs
• CDC COVID-19 Vaccination Communication Toolkit for medical centers, clinics, and clinicians
• FDA COVID-19 Vaccines webpage”

On December 22, 2020, CMS issued another Special Edition MLNconnects announcing that the FDA had issued a EUA for Moderna’s COVID-19 vaccine on December 18, 2020. Similar to the Pfizer-BioNTech announcement, this announcement includes links to the EUA and a Fact Sheet for Healthcare Providers Administering the Vaccine regarding the limitations of authorized use.  

December 16, 2020: FDA Issues EUA for BinaxNOW COVID-19 Ag Card Home Test

The FDA issued a new EUA for this at home test authorized for use by patients at home with a prescription. This test is authorized for individuals 15 years or older “who are suspected of COVID-19 by their healthcare provider within the first seven days of symptoms onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

December 17, 2020: CMS Memo – COVID-19 Infection Control for Psychiatric and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)

In this Memorandum (Ref: QSO-21-07-Psych Hospital, PRTF & ICF/IID) to State Survey Agency Directors, CMS indicated the following in the Memorandum Summary:

• CMS is committed to taking critical steps to protect all Americans including those with intellectual and developmental disabilities to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).
• CMS is providing guidance to psychiatric hospitals, Psychiatric Residential Treatment Facilities (PRTFs) and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to improve their infection control and prevention practices, in part, to prevent or lessen the need for use of seclusion and restraint as an infection control intervention.
• All Psychiatric hospitals, PRTFs and ICF/IIDs should monitor the CDC website for information and resources, and contact the local health department, when necessary.

December 17, 2020: AMA Announces Additional CPT codes for COVID-19 Vaccines

The AMA announced new CPT codes for the AstraZeneca vaccine noting that the codes will be effective for use “on the condition that the AstraZeneca vaccine receives approval or emergency use authorization from the Food and Drug Administration (FDA).”

December 17, 2020: New FDA webpage: Pfizer-BioNTech COVID-19 Vaccine FAQs

The FDA announced they have posted a new FAQs webpage covering specifics related to the Pfizer-BioNTech COVID-19 Vaccine. Questions range from very specific to this vaccine to more general questions, “such as how does a vaccine go from emergency use authorization to licensure.”

December 18, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines

The CDC hosted this call on December 18, 2020. In an overview statement, this call provided clinicians with an overview of the Pfizer-BioNTech and Moderna COVID-19 vaccines. Specific information included vaccine characteristics and administration, vaccinating special populations, and contraindications. In case you missed this COCA webinar hosted by the CDC on December 18th, you can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

December 18, 2020: Special Edition 2 MLNConnects: COVID-19 Add-On Payments for New Treatments

On December 18, 2020, in a second Special Edition MLNConnects, CMS provided the following information:

“CMS issued an Interim Final Rule with Comment Period, which established the New COVID-19 Treatments Add-on Payment (NCTAP) under the Medicare Inpatient Prospective Payment System (IPPS), effective from November 2, 2020, until the end of the Public Health Emergency (PHE) for COVID-19. To mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments during the COVID-19 PHE, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products with current Food and Drug Administration approval or emergency use authorization to treat COVID-19. Visit the NCTAP webpage for more information.”

December 18, 2020: Calendar Year (CY) 2021 Annual Update for Clinical Laboratory Fee Schedule (CLFS) and Laboratory Services Subject to Reasonable Payment Charge

MLN Article MM12080 provides instructions for clinical diagnostic laboratories for the CY 2021 CLFS, mapping new codes for clinical laboratory tests (including several new codes related to COVID-19 testing), and updates laboratory costs subject to the reasonable charge payment.

December 18, 2020: OCR Issues Guidance on HIPAA, Health Information Exchanges (HIE), and Disclosures of Protected Health Information (PHI) for Public Health Purposes

The OCR issued guidance providing “examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associated to disclose PHI to an HIE for reporting to a Public Health Authority (PHA) that is engaged in public health activities.”

December 21, 2020: U.S. Surgeon General Calls for COVID-19 Survivors to Donate Plasma

Surgeon General VADM Jerome Adams urges individuals who have recovered from COVID-19 to consider donating COVID-19 Convalescent Plasma (CCP). He notes that “just like wearing a mask, donating CCP is a way for individuals to help in our nation’s fight against COVID-19.  Donating CCP is safe, and may spare others from lengthy hospitalizations, and from suffering the most severe effects of COVID-19.” This HHS announcement includes a link to a YouTube recorded by the Surgeon General.

December 23, 2020: MLN Article – Instructions to Medicare Administrative Contractors (MACs) on COVID-19 Emergency Declaration Blanket Waivers for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals

MLN Article MM12070 is for Medicare-Dependent, Small Rural Hospitals and Sole Community Hospitals (SCHs). The article provides information about the actions CMS is taking to help health care providers contain the spread of COVID-19 with the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers and includes a link to all of the current blanket waivers.

December 23, 2020: MLN Article – Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Codes 87811 and 87428

MLN Matters article MM12093 informs providers of the addition of the QW modifier to the following CMS HCPCS Codes:

• 87811 [Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])] and code
• 87428 [Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B].

December 23, 2020: HHS Announcement – HHS & the Department of Defense (DOD) Purchases 100 Million Additional Doses of COVID-19 Vaccine from Pfizer

HHS indicated in this announcement that Pfizer will deliver at least 70 million doses by June 30, 2021, with the remaining 30 million to be delivered no later than July 31, 2021. Per HHS Secretary Alex Azar,

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio…This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”

December 28, 2020: New CDC webpage – New Variant of Virus that Causes COVID-19 Detected

The CDC indicated that the United Kingdom (UK) has seen a rapid increase in COVID-19 cases in London and southeast England since November 2020. A new variant of the virus causing COVID-19 has been linked to the rapid increase in cases. This CDC web page provides current information on:

• What we know,
• What we do not know.
• What it means, and
• What the CDC is doing.

December 28, 2020: Special Edition MLN Connects – 2% Sequestration Suspended Through March

CMS released the following information in a Special MLN Connects edition:

“The Coronavirus Aid, Relief, and Economic Security (CARES) Act suspended the payment adjustment percentage of 2% applied to all Medicare Fee-For-Service (FFS) claims from May 1 through December 31.  The Consolidated Appropriations Act, 2021, signed into law on December 27, extends the suspension period to March 31, 2021.”

December 30, 2020: CDC Clinical Outreach and Communication Activity (COCA) Call: COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions

This call provided clinicians an overview of recommendations for use of COVID-19 vaccines in certain populations. Information provided included recent reports of anaphylaxis following vaccination, and CDC’s update clinical considerations around contraindications and precautions to vaccination. You can access a recording of the presentation, a copy of the slides and a copy of the transcript on the CDC website.

December 30, 2020: FDA Hand Sanitizer Safety and Use Communication Toolkit

The FDA released this new toolkit for consumers, patients, and health care professionals to help increase hand sanitizer safety. Information available in the toolkit includes:

• Infographic,
• Social media images and messages,
• Drop-in newsletter article for clinicians,
• Responses for health care professionals to commonly asked questions,
• Fact Sheet,
• Online quiz,
• Consumer articles (in 6 languages), and
• A hand sanitizer safety video.

December 30, 2020: Flexibility for Exceeding the 24-hour Time Frame for Patients in ASC Setting During COVID-19 PHE

CMS has released a December 30, 2020 memorandum indicating that “as COVID-19 cases continue to surge, CMS will temporarily exercise survey enforcement discretion regarding the 24-hour time frame to allow patients to remain in the ASC longer, if needed, during the COVID-19 PHE. This applies to ASCs that have not converted to a hospital during the PHE.”

December 30, 2020: Revised COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care

CMS notes in this memorandum that they are “making revisions to the non-long term care (NLTC) focused infection control survey tool for acute and continuing care providers to reflect COVID-19 guidance updates, provide clarifications to existing information, and update the appropriate CMS regulatory tag considerations if a citation is warranted.”

December 31, 2020: List of Approved Hospitals for Acute Hospital Care at Home Program

CMS posted an updated pdf document listing the 24 systems and 51 hospitals that are currently included in this program. As a reminder, “the Acute Hospital Care at Home program is an expansion of the CMS Hospital Without Walls initiative launched in March 2020 as a part of a comprehensive effort to increase hospital capacity, maximize resources, and combat COVID-19 to keep Americans safe. This program creates additional flexibility that allows for certain health care services to be provided outside of a traditional hospital setting and within a patient’s home.” You can find a link to this document on the CMS Coronavirus Disease 2019 Current emergencies web page.

January 1, 2021: Mandatory Deadline for Renewed Advanced Beneficiary Notice (ABN) Form

Reminder, the ABN form was renewed by the Office of Management and Budget (OMG) in 2020. Due to COVID-19 concerns, CMS expanded the deadline for using the renewed from CMS-R_131 (exp. 6/30/2023). The renewed ABN was mandatory for use on 1/1/2021.

CDC COVID Data Tracker – United States COVID-19 Cases