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 December 1st through the 7th

Resource Spotlight: Starbucks Offering Free Coffee to Front-Line Responders

Starbucks is expressing thanks and providing a little holiday cheer to front-line responders by offering free coffee starting December 1 through December 31.

Offer Details:

• “Starting December 1 through December 31, any customer who identifies as a front-line responder to the COVID-19 outbreak will receive a tall brewed coffee (hot or iced) at no charge (see full eligibility list below).

• The offer can be redeemed at Starbucks U.S. company-operated locations and select licensed stores.”

Who is Eligible?

“Those eligible for the offer include front-line health care providers and first responders, including: doctors, nurses, public health workers, pharmacists, dispatchers, fire fighters, paramedics, EMTs, law enforcement officers, dentists and dental hygienists, mental health workers (therapist, psychologist, social worker, counselor, etc.), hospital staff such as janitor/housekeeping/security, military on active duty, contact tracers, vaccine and pharmaceutical researchers, pilots, flight attendants, TSA, and medical researchers.”

November 30, 2020: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans

This new CDC webpage notes “the possibility of one or more COVID-19 vaccines becoming available before the end of the year,” and provides 10 things healthcare professionals need to know about current plans, for example one thing is the critical role healthcare providers will play in building confidence in a COVID-19 vaccination.

December 1, 2020: Letter to the American Public on COVID-19 Vaccines

The American Hospital Association (AHA), American Medical Association (AMA), and American Nurses Association (ANA) released an open letter to the American public in support of COVID-19 Vaccines. Collectively, they remind readers that as “partners in health” they are committed to the following:

• “Following the science. We are committed to supporting the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be authorized and recommended for use in the population.

• Your health and safety. We commit to establishing safe and effective processes for administering vaccine to all who are eligible and choose to get vaccinated.
• Being transparent. We will make critical information about vaccines available as it is released, working together to share plans for vaccinating communities across this country. We will share the benefits and risks of a vaccine so that you can make an informed decision for yourself and your loved ones.”

December 1, 2020: COVID-19 FAQs on Medicare Fee-for-Service Billing Updated

CMS has updated this now 159 page document twice in the past week.

• December 1st Update:
• Section QQ. Indian Health Service (IHS) Hospitals was added at the end of the document.
• December 3rd Updates:
• Section F. Hospital Inpatient Prospective Payment Systems (IPPS) Payments two new FAQs were added answering questions about the new COVID-19 treatments add-on payment (NCTAP) under the IPPS.
• Section BB. Drugs & Vaccines under Part B 12 new FAQs were added related to monoclonal antibody treatment for COVID-19.

December 1, 2020: Alabama Public Health Announces COVID-19 Vaccination Plan

State Health Officer Dr. Scott Harris is quoted as saying that “We want to assure the public that there will be equitable distribution of vaccine to all Alabamians, especially to vulnerable populations in rural and urban areas. Many external partners will have input in vaccine allocations.” A link to the complete plan is included in this announcement.

December 1, 2020: FDA Reissues Emergency Use Authorization for use of COVID-19 Convalescent Plasma

The FDA announced in their December 1st COVID-19 bulletin that they have reissued of “the August 23, 2020 Emergency Use Authorization (EUA) for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.”

December 2, 2020: FDA Updates Fact Sheet: Combating COVID-19 with Therapeutics

This FDA Fact Sheet includes a table of the drugs and biological products to date that have been granted Emergency Use Authorization (EUA) to treat COVID-19 and serious conditions caused by COVID-19. 

December 2, 2020: CDC Updates Quarantine Guidance

The CDC has provided updated guidance related to options to reduce quarantine from 14 to 10 days. Specifically, “CDC now recommends two additional options for how long quarantine should last. Based on local availability of viral testing, for people without symptoms quarantine can end:

• On day 10 without testing

• On day 7 after receiving a negative test result

After stopping quarantine, people should

• Watch for symptoms until 14 days after exposure.

• If they have symptoms, immediately self-isolate and contact their local public health authority or healthcare provider.
• Wear a mask, stay at least 6 feet from others, wash their hands, avoid crowds, and take other steps to prevent the spread of COVID-19.

CDC continues to endorse quarantine for 14 days and recognizes that any quarantine shorter than 14 days balances reduced burden against a small possibility of spreading the virus. CDC will continue to evaluate new information and update recommendations as needed. See Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing for guidance on options to reduce quarantine.”

December 2, 2020: CY 2021 OPPS/ASC Final Rule COVID-19 Revised and New Reporting Requirements

CMS notes in the CY 2021 OPPS final rule (CMS-1736-FC) that “Infection prevention and control is a primary goal of hospitals and CAHs in their normal day-to-day operations, and these programs have been at the center of initiatives in hospitals and CAHs during the PHE for COVID-19.”

The current COVID-19 PHE hospital and Critical Access Hospital (CAH) Conditions of participation (CoP) reporting requirements, have been revised “to now require hospitals and CAH’s to report data elements that must include, but not be limited to the following: 1) the hospital’s (or the CAH’s) current inventory supplies of any COVID-19-related therapeutics that have been distributed and delivered to the hospital (or CAH) under the authority and direction of the Secretary; and (2) the hospital’s (or the CAH’s) current usage rate for any COVID-19-related therapeutics that have been distributed and delivered to the CAH under the authority and direction of the Secretary.”

In addition, CMS is also now requiring hospitals and CAHs “to report information with a frequency, and in such standardized format as specified by the Secretary during the COVID-19 PHE, on Acute Respiratory Illness (including, but not limited to, Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection).”

“The new rules make reporting a requirement of participation in the Medicare and Medicaid programs and the required reporting is needed to support broad surveillance of COVID-19 in conjunction with other acute respiratory illnesses that may further burden and strain hospital and CAH resources.”

December 3, 2020: Special Edition MLN Connects – Steps to Widen Access to COVID-19 Antibody Treatment and Vaccine & Monoclonal Antibody Infusions – Enforcement Discretion

Bamlanivimab was the first investigational monoclonal antibody therapy granted Emergency Use Authorization (EUA) by the FDA on November 9th. Similar to Bamlanvimab, the monoclonal antibody therapy of casirivimab and Imdevimab, administered together has been granted EUA “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization.

CMS’ December 3rd Special Edition MLNConnects reminds providers that this drug combination “may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary.” The following coding information is excerpted directly from the MLNConnects article:

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Regeneron’s Antibody Casirivimab and Imdevimab (REGN-COV2) (ZIP), EUA effective November 21, 2020.

Q0243:

Long descriptor: Injection, casirivimab and imdevimab, 2400 mg

Short descriptor: casirivimab and imdevimab

M0243:

Long Descriptor: intravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring

Short Descriptor: casirivi and imdevi infusion

Also included in this MLNmatters article is CMS action taken “To facilitate the efficient administration of COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising enforcement discretion with respect to statutory provisions requiring consolidated billing by SNFs as well as any associated statutory references and implementing regulations, including as interpreted in pertinent guidance.”

December 3, 2020: FDA Issues Emergency Use Authorization (EUA) for Ultraviolet Light

The FDA announced in their December 4, 2020 Daily Update an EUA for the Lumin LM3000 Bioburden Reduction UV System, “the first ultraviolet-C (UV-C) light based bioburden reduction system for emergency use in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.”

December 3, 2020: HHS Amends Public Readiness and Emergency Preparedness Act (PREP Act) to Expand Access to Countermeasures against COVID-19

HHS announced their fourth amendment to the PREP Act “to increase access to critical countermeasures against COVID-19.” One example provided in the announcement is authorizing the provision of COVID-19 covered countermeasures via telehealth across state lines noting that “many states have already authorized out-of-state healthcare personnel to deliver telehealth services to in-state patients, either generally or in the context of COVID-19; this action will ensure that COVID-19 Covered Countermeasures can be provided via telehealth across state lines.” 

December 4, 2020: FDA Approves Home Test to Detect COVID-19 and Influenza A and B (Flu)

The FDA announced they have authorized the first diagnostic test for at home collection of patient samples to detect COVID-19 and influenza A and B. The test was developed by Quest Diagnostics and is the RC COVID-19 + Flu RT-PCR test.

December 4, 2020: CDC Morbidity and Mortality Weekly Report (MMWR): Guidance to Address the High Level of COVID-19 Cases

The CDC indicates in this MMWR Report that “with colder weather, more time spent indoors, the ongoing U.S. holiday season, and silent spread of disease, with approximately 50% of transmission from asymptomatic persons (2), the United States has entered a phase of high-level transmission where a multipronged approach to implementing all evidence-based public health strategies at both the individual and community levels is essential.” Specific strategies outlined in this article includes:

• Universal face mask use,
• Maintaining physical distance from other persons and limiting in-person contacts,
• Avoiding nonessential indoor spaces and crowded outdoor spaces,
• Increasing testing to rapidly identify and isolate infected persons,
• Promptly identifying, quarantining, and testing close contacts of persons with known COVID-19,
• Safeguarding persons most at risk for severe illness or death from infection,
• Protecting essential workers with provisions of adequate personal protective equipment (PPS) and safe work practices,
• Postponing travel,
• Increasing room air ventilation and enhancing hand hygiene and environmental disinfection, and
• Achieving widespread availability and high community coverage with effective COVID-19 vaccines.

CDC COVID Data Tracker – United States COVID-19 Cases