Knowledge Base Article

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 3rd through November 9th.

Resource Spotlight: Telehealth Information for Providers and Patients

Telehealth.HHS.GOV offers resources for Providers and Patients.

Telehealth Resources for Providers: Content available on the Telehealth for Providers webpage includes:

• Getting Started,
• Planning your telehealth workflow,
• Preparing patients for telehealth,
• Policy changes during the COVID-19 Public Health Emergency,
• Billing and Reimbursement during the COVID-19 Public Health Emergency, and
• Legal Considerations

Telehealth Resources for Patients: Content available on the Telehealth for Patients webpage includes:

• Understanding telehealth,
• Telehealth during the COVID-19 emergency,
• Finding telehealth options, and
• Preparing for a video visit.

November 4, 2020: Provider-Specific Fact Sheets on New Waivers and Flexibilities Updated

CMS updated almost all of the Provider-Specific Fact Sheets on News Waivers and Flexibilities to include information from the October 28, 2020 Interim Final Rule (IFC) to ensure all Americans have access to a COVID-19 vaccine when one becomes available. Of note, “for calendar years 2020 and 2021, Medicare will pay directly for the COVID-19 vaccine and its administration for beneficiaries enrolled in Medicare Advantage (MA) plans. Providers should submit COVID-19 claims to Original Medicare for all patients enrolled in MA in 2020 and 2021. MA plans will not be responsible for reimbursing providers to administer the vaccine during this time. MA beneficiaries also pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.” All of the Face Sheets can be accessed on the CMS Coronavirus waivers and flexibilities webpage. Note, the Toolkit for States to Mitigate COVID-19 in Nursing Homes found on the COVID-19 Current Emergencies webpage was also updated on November 4th to include the vaccine information.

November 5, 2020: Governor Ivey Extends Safer at Home order until December for the State of Alabama

The Safer at Home order has been extended until December 11, 2020 and include the mask ordinance requiring masks be worn in schools and in public when interacting within 6 feet of someone from another household. Following are two new amendments to the order:

• Occupancy Rates: Emergency occupancy rates will be removed from retailers, gyms and fitness centers, and entertainment venues.
• Use of Partitions: An exception to social-distancing rules will be allowed for many businesses – including barber shops, hair salons, gyms, and restaurants – if people are wearing masks and separated by an “impermeable” barrier.

You can read the Press Release and access Safer at Home Information Sheets on the Alabama Governor’s Newsroom webpage.

November 5, 2020: Preparing to Administer COVID-19 Vaccine when it’s Available

CMS included the following information in their Thursday November 5th edition of MLNConnects:

“Get ready to administer the COVID-19 vaccine when it’s available. Read the enrollment section of our COVID-19 provider toolkit to see if you need to take action now:

• Many Medicare-enrolled providers don’t have to take any action until a vaccine is available – make sure your provider-type enrollment is all set
• Some Medicare-enrolled providers must also separately enroll as a mass immunizer to administer and bill for COVID-19 vaccines when they’re available – find out if you must also enroll as a mass immunizer
• If you’re not a Medicare-enrolled provider, you must enroll as a mass immunizer or other Medicare provider type that can bill for administering vaccines

Enrolling over the phone a mass immunizer is easy and quick — call your MAC-specific enrollment hotline (PDF) and give your valid legal business name, national provider identifier, tax identification number, practice location, and state license, if applicable.”

November 6, 2020: CDC Report: Telework before Illness Onset of COVID-19

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for November 6th focused on employees working in the office versus telework and positive COVID-19 test. Following are answers to questions in the summary section of this report.

“What is added by this report? Adults who received positive test results for SARS-CoV-2 infection were more likely to report exclusively going to an office or school setting in the 2 weeks before illness onset, compared with those who tested negative, even among those working in a profession outside of the critical infrastructure.

What are the implications for public health practice? Businesses and employers should promote alternative work site options, such as teleworking, where possible, to reduce exposures to SARS-CoV-2. Where telework options are not feasible, worker safety measures should continue to be scaled up to reduce possible worksite exposures.”

November 6, 2020: OIG Audit – Office of Refugee Resettlement (ORR) Preparedness to Respond to COVID-19 Pandemic

The OIG released their report where they conducted a communicable disease preparedness audit of 11 selected facilities from March through June 2020 during the COVID-19 pandemic in the United States. They found that the facilities selected for review followed preparation requirements and were prepared to respond to the pandemic. The OIG report contains no recommendations.

“ORR officials stated that, since 2006, ORR has had a policy in place that required its facilities to prepare for and respond to a communicable disease outbreak; therefore, the facilities were generally able to quickly pivot to respond to the COVID-19 pandemic.”

November 6, 2020: FDA Authorizes First Test to Detect Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Previously issued Emergency Authorization Use (EUAs) for antibody (serology) tests only detect the presence of binding antibodies. The EUA issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit is “the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.”

In the FDA’s press announcement they caution “against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.”

November 9, 2020: FDA Authorizes Monoclonal Antibody Treatment

The FDA announced the issuance of an emergency use authorization (EUA) for Bamlanivimab which is an investigational monoclonal antibody therapy. This drug is not authorized for patients already hospitalized due to COVID-19. Instead, it is to be given in an outpatient setting and  “is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

According to the Scope of Authorization in the emergency use authorization (EUA):

• Distribution of the authorized drug will be controlled by the U.S. Government,
• Again, it is authorized for use only by healthcare providers in an outpatient setting,
• The drug may only be administered in a setting where health care providers have immediate access to medications to treat a severe infusion reaction, and
• Use of the drug covered by the authorization must be in accordance with the dosing regiments in the authorized Fact Sheets.

You can also read more about the EUA in a related Lilly Investors announcement.

November 9, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Matters Article Revised

MLN Matters Article SE20011  was originally released March 16, 2020. The most recent iteration of this article includes revisions to clarify the billing instructions in the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider Information section.

November 9, 2020: Pfizer Announces Vaccine Against COVID-19

In an early Monday morning Press Release, Pfizer announced the success of a joint effort with BioNTech in the development of a vaccine. Specifically, Pfizer indicated that the “vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.” Once the required safety milestone has been achieved Pfizer is planning to submit for Emergency Use Authorization (EUA) to the FDA. At the time of the Press Release the expectation for reaching that milestone was this week.

CDC COVID Data Tracker – United States COVID-19 Cases