Knowledge Base Article

Resource Spotlight: COVID-19 Public Health Emergency (PHE) Extended

On January 7, 2021, Alex M. Azar II, Secretary of Health and Human Services renewed the Public Health Emergency (PHE) due to COVID-19 effective January 21, 2021. PHE declarations last for the duration of the PHE or 90 days and may then be extended.

January 4, 2021: FDA Communication - Risk of False COVID-19 Results with Curative SARS-CoV-2 Test

The FDA sent an Alert to patients and health care providers regarding the risk of false results, particularly false negative COVID-19 results with the Curative SARS-CoV-2 test. This communication goes on to provide important recommendations for health care providers, patients, and caregivers.

January 5, 2021: COVID-19 Updates in the January 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS)

MLN Matters Article MM12120 was published January 5, 2021 and provides highlights from the January 2021 updates of the Hospitals OPPS outlined in Change Request (CR) 12120. Several highlights in this article are related to COVID-19 and includes the following:

• COVID-19 Laboratory Tests and Services Coding Update,
• CPT Proprietary Laboratory Analyses (PLA) Coding Changes Effective October 6, 2020 and January 1, 2021,
• Monoclonal Antibody Therapy Product and Administration Codes for drugs granted emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 positive cases at high risk for progressing to severe COVID-19 and/or hospitalization,
• New COVID-19 CPT Vaccines and Administration Codes, and
• Comprehensive APC (C-APC) Exclusion for COVID-19 Treatments. Specifically, this article reminds providers that “in the interim final with request for comments (IFC) entitled, ‘‘Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency”, published on November 6, 2020, we stated that effective for services furnished on or after the effective date of the IFC and until the end of the PHE for COVID-19, there’s an exception to the OPPS C-APC policy to ensure separate payment for new COVID–19 treatments that meet certain criteria (85 FR 71158 through 71160). Under this exception, any new COVID-19 treatment that meets the two following criteria will, for the remainder of the PHE for COVID-19, will always be separately paid and won’t be packaged into a C-APC when it’s provided on the same claim as the primary CAPC service. MLN Matters: MM12120 Related CR 12120 Page 9 of 17

1. The treatment must be a drug or biological product (which could include a blood product) authorized to treat COVID-19, as indicated in Section I, “Criteria for Issuance of Authorization,” of the letter of authorization for the drug or biological product, or the drug or biological product must be approved by the FDA for treating COVID-19.

2. Second, the EUA for the drug or biological product (which could include a blood product) must authorize the use of the product in the outpatient setting or not limit its use to the inpatient setting, or the product must be approved by the FDA to treat COVID-19 disease and not limit its use to the inpatient setting.

For further information regarding the exception to the C-APC policy for COVID–19 treatments, please refer to the IFC (85 FR 71158 through 71160) at https://www.federalregister.gov/documents/2020/11/06/2020-24332/additional-policy-andregulatory-revisions-in-response-to-the-covid-19-public-health-emergency.”

January 7, 2021: COVID-19 Vaccine and Long-Term Care Facilities

CMS information related to the COVID-19 vaccine in their weekly MLN Connects e-newsletter. Specifically, they indicated that the CDC has recommended early vaccination for health care personnel and residents in long-term care facilities and has developed a Long-Term Care Facility toolkit to assist in preparing for and building confidence in the vaccine.

January 7, 2021: Preventing Chronic Disease (PCD) Essay: Chronic Disease and COVID-19

The CDC announced the release of a new PCD essay on COVID-19 and Chronic Disease. Specifically, senior leadership of the CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), NCCDPHP Director Karen A. Hacker, MD, MPH, and Peter A. Briss, MD, MPH, Medical Director of NCCDPHP’s Office of Medicine and Science, discuss the importance of prevention and care during the COVID-19 pandemic.

January 7, 2020: AHA, COVID-19 and Hospital Price Transparency Rule

The American Hospital Association (AHA) submitted a January 7, 2021 letter to Secretary Azar urging that CMS “exercise enforcement discretion with respect to the hospital price transparency rule.” The letter goes on to indicate that “Hospitals ability to comply with the rule at this time is particularly challenged by an increase in the volume of COVID-19 patients and the need to distribute multiple vaccines.”

January 8, 2021: FDA Alert Regarding SARS-CoV-2 Viral Mutation

The FDA notes in this Alert that they are “monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.”

January 8, 2021: FDA’s COVID-19 Update - Moderna COVID-19 Vaccine FAQs

In their January 8, 2021 COVID-19 Update, the FDA announced the post of a new webpage, Moderna COVID-19 Vaccine FAQs. Questions range from how well does the Moderna COVID-19 vaccine prevent COVID-19? To, is it possible to obtain an 11th dose from the multi-dose vial of the Moderna COVID-19 vaccine?

January 11, 2021: What to Expect After Getting a COVID-19 Vaccine

The CDC has a What to Expect after Getting a COVID-19 Vaccine webpage which includes information on the following:

• Common side effects,
• Helpful tips,
• When to call the doctor,
• Scheduling your second shot,
• About your second shot,
• Things to remember, and
• A printable handout for a vaccine recipient.

CDC COVID Data Tracker – United States COVID-19 Cases