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 that span from April 20th through April 27th.  

April 20, 2020: FDA’s Daily Roundup: Serological (Antibody) Tests Guidance

On April 20th the Food and Drug Administration (FDA) issued the following information on the use or serological (antibody) tests to help identify people potentially exposed to the SARS-CoV-2 virus or have recovered from the infection:

• Letter to Health Care Providers: Important Information on the use of serological (antibody) tests for COVID-19. This letter opens with the following important statement: “The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19.”
• FDA Fact Sheet: Serological Testing for Antibodies to SARS-CoV-2 Infection; and
• New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2 Infection.

April 20, 2020: CMS Announces Clinicians Can Earn Credit in the Merit-Incentive Payment System (MIPS) when Participating and Attesting to the New COVID-19 Clinical Trials Improvement Activity

In an April 20th Press Release, CMS announced that clinicians who participate in the CMS Quality Payment Program (QPP) may now earn credit in the MIPS for participation in a clinical trial and reporting clinical information by attesting to the new COVID-19 Clinical Trials improvement activity. CMS noted “this action will provide vital data to help drive improvement in patient care and develop innovative best practices to manage the spread of COVID-19 within communities.”

How You Will Receive Credit for Participation

“Clinicians must attest that they participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study.”

More about this Improvement Activity

• There is flexibility in the type of clinical trial, which could include the traditional double-blind placebo-controlled trial, to an adaptive or pragmatic design that flexes to workflow and clinical practice.
• Clinicians who report this activity will automatically earn half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15 percent of the MIPS final score.
• You can view a database of privately and publicly funded clinical studies currently being conducted on COVID-19 at https://clinicaltrials.gov/

April 21, 2020: COVID-19 Update: FDA Authorizes First Test for Patient At-Home Sample Collection

The U.S. FDA announced  that they had re-issued the emergency use authorization (EUA) for the LapCorp COVID-10 RT-PCR Test to permit testing of samples self-collected by patients at home using LapCorp’s Pixel by LabCorp COVID-19 Test home collection kit. FDA Commissioner Stephen M. Hahn, M.D., notes they “worked with LapCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The FDA makes it clear this authorization only applies to this LapCorp test and is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.

April 21, 2020: CMS Releases Additional Blanket Waivers for Long-Term Care Hospitals, Rural Health Clinics, Federally Qualified Health Center and Intermediate Care Facilities

Additional blanket waivers released on April 21st were related to care for patients in LTCHs, temporary expansion locations of Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs), staffing and training modifications in Intermediate Care Facilities for individuals with Intellectual disabilities, and the limit for substitute billing arrangements (locum tenens). Blanket waiver guidance can be found in the COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers document.

April 21: Memorandum to State Survey Agency Directors: Guidance for Freestanding EDs during COVID-19 Public Health Emergency

According to the Memorandum Summary, “CMS is creating additional flexibilities to allow licensed independent freestanding emergency departments (EDs) to participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide care to patients. The following ways to participate include:

• Becoming affiliated with a Medicare/Medicaid-certified hospital under the temporary expansion 1135 emergency waiver.
• Participating in Medicaid under the clinic benefit if permitted by the State, or
• Enrolling temporarily as a Medicare/Medicaid-certified hospital to provide hospital services.”

April 22, 2020: New Toolkit to Help States Navigate COVID-19 Health Workforce Challenges

An April 22nd CMS Press Release announced that the CMS and the Assistant Secretary of Preparedness and Response (ASPR) released the COVID-19 Healthcare Workforce Toolkit to help state and local healthcare decision makers maximize workforce flexibilities when confronting COVID-19 in their communities. This work was developed by the Healthcare Resilience Task Force and provides helpful information on funding flexibilities, liability protections, and workforce training. It also provides up-to-date best practices making it a go-to resource for decision makers to find out what has been implemented in the field and how it’s working.

The toolkit is housed on the ASPR Technical Resources, Assistance Center, and Information Exchange (TRACIE). This is a healthcare emergency preparedness information gateway ensuring all stakeholders have access to the information. To view the COVID-19 Healthcare Workforce Toolkit, visit: https://asprtracie.hhs.gov/Workforce-Virtual-Toolkit

April 23, 2020: COVID-19 Telehealth Toolkit to Accelerate State Use of Telehealth in Medicaid and CHIP

The Trump Administration announced in a Press Release the release of a new toolkit for states to help accelerate adoption of broader coverage policies in the Medicaid and Children’s Health Insurance Program (CHIP) during the COVID-19 pandemic. The toolkit includes the following issues for states to consider when evaluating their need to expand telehealth capabilities and coverage policies:

• Patient populations eligible for telehealth,
• Coverage and reimbursement policies,
• Providers and practitioners eligible to provide telehealth,
• Technology requirements,
• Pediatric considerations; and
• A compilation of FAQs.

April 23, 2020: Guidance for Infection Control and Prevention Concerning COVID-19 in Home Health Agencies (HHAs) and Religious Nonmedical Healthcare Institutions (RNHCIs)

This guidance was initially released on March 10, 2020 and was subsequently updated on April 23, 2020 to include RNHCI Guidance on COVID-19. The following information was added to the Memorandum Summary:

• HHA Guidance now includes additional information about CMS waivers and regulations, and CDC guidance was added for optimizing personal protective equipment and return to work criteria for healthcare personnel with confirmed or suspected COVID-19.
• Recommendations for Visitation in Residential Facilities not Certified by Medicare: CMS is providing recommendations to home health care personnel who care for patients in residential settings such as assisted and independent living facilities.
• Medicare Participating Religious Nonmedical Healthcare Institutions (RNHCIs) and Actions – CMS is providing additional guidance for RNHCIs related to addressing potential and confirmed COVID cases and mitigating transmission including screening, treatment, and transfer to higher level of care (when appropriate).

April 24, 2020: Nursing Home Five Star Quality Rating System Updates, Nursing Home Staff Counts, and Frequently Asked Questions

An April 24, 2020 Memorandum to State Survey Agency Directors indicates CMS’ commitment to ensuring nursing homes are prepared to respond to the threat of COVID-19. Specific steps outlined in the memorandum summary includes the following:

• The inspection domain of the Nursing Home Compare Five Star Quality Rating System will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair consumer information.
• CMS will post a list of the surveys conducted after the prioritization of certain surveys, and findings, through a link on the Nursing Home Compare website.
• CMS is publishing a list of the average number of nursing and total staff that work onsite in each nursing home, each day. This information can be used to help direct adequate (PPE) and testing to nursing homes.
• A list of FAQs is being released to clarify certain actions that CMS has taken related to visitation, survey, waivers, and other guidance.

April 26, 2020: CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program

On April 26, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to health care providers and suppliers through these programs and in light of the $175 billion recently appropriated for health care provider relief payments. You can read more about this in the April 26th CMS Press Release.

April 27, 2020: WPS GHA Medicare eNews: Modifier CS and COVID-19 Testing

The following reminder was included in the April 27th edition of WPS’ Medicare eNews:

“A new law waives cost-sharing under Medicare Part B for certain outpatient COVID-19 testing-related services. The CS modified signals the MACs to pay 100% for these services. This applies for claims with dates of service on or after March 18, 2020. Claims submitted without the modifier may be resubmitted.

To learn more, refer to "Families First Coronavirus Response Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services"   in the CMS MLN Connects Special Edition – Tuesday, April 7, 2020.”