CMS Announces New Testing, Reporting Requirements and Enforcement Actions The Centers for Medicare & Medicaid Services (CMS) announced regulatory changes Tuesday evening for nursing facilities related to the COVID-19 pandemic. CMS will require all nursing facilities nationwide to test staff as well as offer testing to residents when new cases are identified. In addition, nursing facilities using point-of-care testing must report diagnostic test results, CMS shared. Surveyors may cite facilities for non-compliance with the new regulations. Providers would also be required to implement a plan of correction. The enforcement of sanctions will be based on the severity of noncompliance. Fines for non-compliance will start at $400 per day and can range to $8,000, with termination from Medicare and Medicaid as well as a potential for continued non-compliance. Denial of payment for new admissions (DPNA) may also be utilized as enforcement. The Interim Final Rule includes a 60-day comment period, is effective immediately, and is not expected to extend beyond the conclusion of the COVID pandemic. AHCA/NCAL has provided a high level summary of the testing requirements. AHCA/NCAL and HCAM/MCAL continue to advocate that CMS guidance on the implementation of routine testing requirements for nursing homes acknowledges ongoing challenges with access to testing supplies and timely testing results. This includes flexibility to implement evolving knowledge about optimal uses of and approaches to testing, and does not penalize providers for factors beyond their control.
CMS Releases Another Infection Control Training; Link with Stimulus Funds Still Not Clear An infection control training program aimed at stopping the spread of COVID-19 in nursing facilities is now available for frontline facility workers and managers, the Centers for Medicare & Medicaid Services announced Tuesday morning. The program was originally announced in late July as part of an additional $5 billion in coronavirus relief funding for nursing homes. The Trump administration at the time noted that providers may become eligible for the enhanced funding by participating in the online infection control training program. The link between this training and funding is still under clarification. The "CMS Targeted COVID-19 Training for Frontline Nursing Home Staff & Management" is available now, with five specific modules designed for frontline clinical staff and 10 designed for nursing home management. The training will be available on the CMS Quality, Safety & Education Portal. Each of these modules are virtual trainings that can be accessed and viewed at your convenience. OF NOTE: Members should be aware the University of New Mexico's ECHO program has also been linked to federal stimulus funds. It has been confirmed by AHCA that facilities participating in the 16-week ECHO program will receive funds to support participation from the $5B CARES Act. The ECHO Program kicks off with three webinars beginning this week. Each webinar is being recorded and will be available to access for participation at a later date. To register for the remaining live webinars, or to access the recorded webinars go HERE. Until further clarification is available regarding applicability of federal funds, HCAM recommends that members review both programs and determine capacity for participation in one or the other or both programs. We will share additional information as it becomes available.
AHCA/NCAL Media Campaign Update The AHCA/NCAL national media campaign is fully underway, with cable ads, digital ads and a website at www.ourseniorcare.org. Listed below is information regarding the planned advertising schedule. It includes several programs and times for Thursday, 8/27 to Tuesday, 9/1. The times are estimates and could potentially change but should be pretty close. Included is a mix of prime, daytime, and weekends to provide a variety of options. Sara: https://youtu.be/S3-AJtlte8w Donna: https://youtu.be/QuVHvmm3EyY
HGTV
FOOD
Discovery ID
TLC
Hallmark (Log times currently only available through 8/30)
FDA Issues POC Antigen Testing FAQs: On Monday the US Food and Drug Administration (FDA) updated FAQs to include a Q&A related to the use of antigen testing machines for screening tests.
Q: Does the FDA have recommendations for health care providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19?
A: An asymptomatic individual may be suspected of COVID-19 by their health care provider for various reasons, such as known exposure or working in a high-risk environment. Such use is within the authorized indications for use of tests intended for individuals suspected of COVID-19 by their health care provider. For health care providers who are ordering an authorized SARS-CoV-2 diagnostic test to be used off-label (outside the authorization) to screen asymptomatic individuals not suspected of having COVID-19, we recommend they consider the information below.
Although the current available literature suggests that symptomatic individuals with COVID-19 and asymptomatic individuals without known exposure may have similar levels of viral genetic material, there is limited data on the distribution of viral loads in individuals with and without symptoms across demographics, different settings, and specimen types. Therefore, when screening asymptomatic individuals, health care providers should consider using a highly sensitive test, especially if rapid turnaround times are available. If highly sensitive tests are not feasible, or if turnaround times are prolonged, health care providers may consider use of less sensitive point-of-care tests, even if they are not specifically authorized for this indication (commonly referred to as "off-label"). For congregate care settings, like nursing homes or similar settings, repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times.
If less sensitive tests, such as some rapid point-of-care tests, are used, health care providers should be aware of the performance of the tests and may want to consider different testing approaches, such as serial testing. "Negative" results should be considered as "presumptive negative," and health care providers should consider them in the context of clinical observations, patient history, and epidemiological information. Thus, if there is a significant new outbreak in a congregate care facility or high clinical suspicion of an infection in an individual resident, a negative point-of-care test should be confirmed with a highly sensitive molecular test (refer to CDC guidelines). It is not necessary to perform confirmatory high-sensitivity molecular tests on individuals with negative antigen test or other point-of-care test results if they are obtained during routine screening or surveillance.
For questions or concerns please contact Cathy Sunlin at CathySunlin@HCAM.org.
Aug. 26, 2020 |